SciClone Pharmaceuticals, Inc.
SCICLONE PHARMACEUTICALS INC (Form: 10-Q, Received: 05/12/2014 16:06:58)
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2014

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                      to                     

Commission file number: 0-19825

 

 

SCICLONE PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   94-3116852

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. employer

Identification no.)

950 Tower Lane, Suite 900, Foster City, California   94404
(Address of principal executive offices)   (Zip code)

(650) 358-3456

(Registrant’s telephone number, including area code)

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

 

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes   x     No   ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes   x     No   ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer   ¨    Accelerated filer   x
Non-accelerated filer   ¨    Smaller Reporting Company   ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes   ¨     No   x

As of May 6, 2014, 51,493,840 shares of the registrant’s Common Stock, $0.001 par value, were issued and outstanding.

 

 

 


Table of Contents

SCICLONE PHARMACEUTICALS, INC.

FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 2014

INDEX

 

     PAGE
NO.
 

PART I.

 

FINANCIAL INFORMATION

  
Item 1.  

Financial Statements (Unaudited)

  
 

Condensed Consolidated Balance Sheets as of March 31, 2014 and December 31, 2013

     3   
 

Condensed Consolidated Statements of Income for the three-month periods ended March 31, 2014 and 2013

     4   
 

Condensed Consolidated Statements of Comprehensive Income (Loss) for the three-month periods ended March 31, 2014 and 2013

     5   
 

Condensed Consolidated Statements of Cash Flows for the three-month periods ended March 31, 2014 and 2013

     6   
 

Notes to Unaudited Condensed Consolidated Financial Statements

     7   
Item 2.  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     17   
Item 3.  

Quantitative and Qualitative Disclosures About Market Risk

     27   
Item 4.  

Controls and Procedures

     27   

PART II.

 

OTHER INFORMATION

  
Item 1.   Legal Proceedings      28   
Item 1A.  

Risk Factors

     30   
Item 2.  

Unregistered Sales of Equity Securities and Use of Proceeds

     51   
Item 3.  

Defaults Upon Senior Securities

     51   
Item 4.  

Mine Safety Disclosures

     51   
Item 5.  

Other Information

     51   
Item 6.  

Exhibits

     52   

Signature

     53   

 

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PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements (Unaudited)

SCICLONE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

 

     March 31,
2014
    December 31,
2013
 
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 87,470      $ 85,803   

Accounts receivable, net of allowance of $3,592 and $3,587 as of March 31, 2014 and December 31, 2013, respectively

     32,271        40,008   

Inventories

     14,049        15,238   

Restricted cash and investments

     75        75   

Prepaid expenses and other current assets

     2,489        2,287   

Deferred tax assets

     107        —     
  

 

 

   

 

 

 

Total current assets

     136,461        143,411   

Property and equipment, net

     1,026        843   

Deferred tax assets

     —          374   

Goodwill

     34,435        35,357   

Other assets

     270        242   
  

 

 

   

 

 

 

Total assets

   $ 172,192      $ 180,227   
  

 

 

   

 

 

 
LIABILITIES AND STOCKHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable

   $ 3,276      $ 7,190   

Accrued and other current liabilities

     15,832        21,464   

Deferred revenue

     2,844        2,915   

Deferred tax liabilities

     —          368   

Short-term borrowings on credit facilities

     1,608        1,651   
  

 

 

   

 

 

 

Total current liabilities

     23,560        33,588   

Deferred tax liabilities

     101        —     

Other long-term liabilities

     76        44   

Commitments and contingencies (Note 8)

    

Stockholders’ equity:

    

Preferred stock; $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding

     —          —     

Common stock; $0.001 par value; 100,000,000 shares authorized; 51,958,666 and 52,371,664 shares issued and outstanding as of March 31, 2014 and December 31, 2013, respectively

     52        52   

Additional paid-in capital

     279,481        278,327   

Accumulated other comprehensive income

     3,317        4,176   

Accumulated deficit

     (134,395     (135,960
  

 

 

   

 

 

 

Total stockholders’ equity

     148,455        146,595   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 172,192      $ 180,227   
  

 

 

   

 

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

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SCICLONE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(In thousands, except per share amounts)

 

     Three Months Ended
March 31,
 
     2014     2013  

Revenues:

    

Product sales, net

   $ 26,064      $ 20,533   

Promotion services

     501        9,273   
  

 

 

   

 

 

 

Total net revenues

     26,565        29,806   

Operating expenses:

    

Cost of product sales

     4,561        4,618   

Sales and marketing

     9,834        11,199   

Research and development

     1,476        365   

General and administrative

     6,033        8,600   
  

 

 

   

 

 

 

Total operating expenses

     21,904        24,782   

Income from operations

     4,661        5,024   

Non-operating income (expense):

    

Interest and investment income

     19        19   

Interest and investment expense

     (29     (37

Other expense, net

     (119     (16
  

 

 

   

 

 

 

Income before provision for income tax

     4,532        4,990   

Provision for income tax

     398        787   
  

 

 

   

 

 

 

Net income

   $ 4,134      $ 4,203   
  

 

 

   

 

 

 

Basic net income per share

   $ 0.08      $ 0.08   

Diluted net income per share

   $ 0.08      $ 0.08   

See accompanying notes to unaudited condensed consolidated financial statements.

 

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SCICLONE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(In thousands)

 

     Three Months Ended
March 31,
 
     2014     2013  

Net income

   $ 4,134      $ 4,203   

Other comprehensive income (loss):

    

Net change in unrealized gain (loss) and foreign currency translation on foreign currency denominated available-for-sale securities

     —          (10

Foreign currency translation

     (859     178   
  

 

 

   

 

 

 

Total other comprehensive income (loss)

     (859     168   
  

 

 

   

 

 

 

Total comprehensive income

   $ 3,275      $ 4,371   
  

 

 

   

 

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

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SCICLONE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

 

     Three Months Ended
March 31,
 
     2014     2013  

Operating activities:

    

Net income

   $ 4,134      $ 4,203   

Adjustments to reconcile net income to net cash provided by operating activities:

    

Non-cash expense related to stock-based compensation

     882        1,019   

Depreciation and amortization

     207        202   

Loss on disposal of fixed assets

     15        —     

Other long-term liabilities

     (29     (105

Changes in operating assets and liabilities:

    

Accounts receivable, net

     7,516        10,283   

Inventories

     1,188        2,766   

Prepaid expenses and other assets

     (288     (126

Accounts payable

     (4,189     (5,503

Accrued and other current liabilities

     (5,324     (1,808

Deferred revenue

     5        —     
  

 

 

   

 

 

 

Net cash provided by operating activities

     4,117        10,931   

Investing activities:

    

Purchases of property and equipment

     (111     (41
  

 

 

   

 

 

 

Net cash used in investing activities

     (111     (41

Financing activities:

    

Repurchase of common stock

     (2,569     (2,500

Borrowing on short-term loan

     —          567   

Proceeds from issuances of common stock

     248        104   
  

 

 

   

 

 

 

Net cash used in financing activities

     (2,321     (1,829

Effect of exchange rate changes on cash and cash equivalents

     (18     16   
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

     1,667        9,077   

Cash and cash equivalents, beginning of period

     85,803        84,228   
  

 

 

   

 

 

 

Cash and cash equivalents, end of period

   $ 87,470      $ 93,305   
  

 

 

   

 

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

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SCICLONE PHARMACEUTICALS, INC.

Notes to Unaudited Condensed Consolidated Financial Statements

 

1. Basis of Presentation

The accompanying unaudited condensed consolidated financial statements of SciClone Pharmaceuticals, Inc. (“SciClone” or the “Company”) have been prepared in conformity with generally accepted accounting principles in the United States (“GAAP”) consistent with those applied in, and should be read in conjunction with, the audited consolidated financial statements and the notes thereto for the year ended December 31, 2013 included in the Company’s Form 10-K as filed with the Securities and Exchange Commission (“SEC”). The Company prepared the unaudited condensed consolidated financial statements following the requirements of the SEC for interim reporting. As permitted under those rules, certain footnotes or other information that are normally required by GAAP can be condensed or omitted.

The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated.

The interim financial information reflects all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the results for the interim periods presented and are not necessarily indicative of results for subsequent interim periods or for the full year. The unaudited condensed consolidated balance sheet data as of December 31, 2013 is derived from the audited consolidated financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make judgments, assumptions and estimates that affect the amounts reported in the unaudited condensed consolidated financial statements and accompanying notes. Actual results could differ significantly from those estimates.

Customer Concentration

In China, pharmaceutical products are imported and distributed through a tiered method of distribution. For the Company’s proprietary product ZADAXIN ® , the Company manufactures its product using its US and European contract manufacturers, and it generates its product sales revenue through sales of ZADAXIN products to Sinopharm Lingyun Biopharmaceutical (Shanghai) Co. Ltd. (“SinoPharm”). SinoPharm and its affiliates act as an importer, and also as the top “tier” of the distribution system (“Tier 1”) in China. The Company’s ZADAXIN sales occur when the importer purchases product from the Company, without any right of return except for damaged product or quality control issues and after passage of title and risk of loss are transferred to SinoPharm at the time of shipment. After the Company’s sale, SinoPharm clears products through China import customs, sells directly to large hospitals and holds additional product it has purchased in inventory for sale to the next tier in the distribution system. The second-tier distributors are responsible for the further sale and distribution of the products they purchase from the importer, either through sales of product directly to the retail level (hospitals and pharmacies), or to third-tier local or regional distributors who, in turn, sell products to hospitals and pharmacies. The Company’s other product sales revenues result from the sale of the Company’s in-licensed products to importing agents and distributors.

Promotion services revenues result from fees received for exclusively promoting products for certain pharmaceutical partners. These importing agents, distributors and partners are the Company’s customers.

 

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Customers that exceeded 10% of the Company’s total net revenue and related to the Company’s China segment were as follows:

 

     Three Months Ended
March 31,
 
     2014     2013  

Customer A

     94     66

Customer B

     —          29

As of March 31, 2014, approximately $31.2 million, or 87%, of the Company’s accounts receivable were attributable to two customers in China. The Company generally does not require collateral from its customers.

Accounts Receivable

Receivable Reserve. The Company records a receivable reserve based on a specific review of its overdue invoices. The Company’s estimate for a reserve is determined after considering its existing contractual payment terms, payment patterns of its customers and individual customer circumstances, the age of any outstanding receivables and its current customer relationships. Accounts receivable are charged off at the point when they are considered uncollectible. As of March 31, 2014, the Company had $7.6 million in accounts receivable that were past due ninety days or more. As of March 31, 2014 and December 31, 2013, the Company recorded a receivable reserve of approximately $3.5 million related to gross accounts receivable of $3.5 million from one customer that is more than one year past due. The accounts receivable reserve was established as a result of continual negotiations that indicate the accounts receivable balance may not be recoverable. The receivable reserve reflects the Company’s best estimate of the ultimate collection, though actual collections may vary and the Company continues to pursue the full amount of the accounts receivables. The Company also had an additional receivable reserve of $0.1 million as of March 31, 2014 and December 31, 2013 related to another customer due to the Company’s uncertainty of collecting a portion of the outstanding accounts receivable balance. The remaining amount past due ninety days or more related to receivables from affiliates of Sanofi Aventis S. A. (“Sanofi”) and had not been reserved for as of March 31, 2014 due to (i) the progress towards resolving the current dispute and (ii) the fact that a substantial portion of the total receivables due from Sanofi were offset by unrecognized revenue that had been deferred in the fourth quarter of 2013. Refer to further information regarding this matter under “Revenue Recognition” “ Promotion Services Revenue.

Revenue Reserve. The Company maintains a revenue reserve for product returns based on estimates of the amount of product to be returned by its customers which may result from expired or damaged product on delivery or for price reductions on the related sales and is based on historical patterns, analysis of market demand and/or a percentage of sales based on industry trends, and management’s evaluation of specific factors that may increase the risk of product returns. Importing agents or distributors do not have contractual rights of return except under limited terms regarding product quality. However, the Company is expected to replace products that have expired on delivery or are deemed to be damaged or defective when delivered. The calculation of the revenue reserve requires estimates and involves a high degree of subjectivity and judgment. As a result of the uncertainties involved in estimating the revenue reserve, there is a possibility that materially different amounts could be reported under different conditions or using different assumptions. As of March 31, 2014 and December 31, 2013, the Company’s revenue reserves were immaterial.

Revenue Recognition

The Company recognizes revenue when persuasive evidence of an arrangement exists, services have been rendered or delivery has occurred, the price to the buyer is fixed or determinable and collectability is reasonably assured.

Product Revenue . The Company recognizes product revenue from selling manufactured ZADAXIN product at the time of delivery. Sales of ZADAXIN to SinoPharm and its affiliates are recognized at time of shipment when title to the product is transferred to them. The Company also earns product revenue from purchasing medical products from pharmaceutical companies and selling them directly to importers or distributors. The Company recognizes revenue related to these products based on the “sell-in” method, when the medical products have been delivered to the importers or distributors. Payments by the importing agents and distributors are not contingent upon sale to the end user by the importing agents or distributors.

 

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Promotion Services Revenue . The Company recognizes promotion services revenue after designated medical products are delivered to the distributors as specified in the promotion services contract, which marks the period when marketing and promotion services have been rendered and the revenue recognition criteria are met. In certain arrangements, the Company is required to return or refund a portion of promotion services fees received during interim periods from pharmaceutical customers if defined annual sales targets are not achieved. Under the Company’s agreements with these customers, if the agreement is terminated, and provided such targets have been met on a “pro rata” basis at the date of contract termination, the Company is entitled to retain the amounts paid. Due to the ability to retain amounts paid upon contract termination, provided applicable targets have been met on a “pro rata” basis at any interim date, the Company elected to recognize revenue during interim periods without reduction for amounts subject to refund based on Method 2 of Accounting Standards Codification 605-20-S99-1, “Accounting for Management Fees Based on a Formula.”

The Company’s promotion agreements with Sanofi, consisting of individual promotional agreements for certain pharmaceutical products and supplementary agreements extending the terms thereof, were not renewed and expired on December 31, 2013. The Company received initial notification of non-renewal from Sanofi in early October 2013. Subsequent thereto, the Company believes that Sanofi breached its obligations under these agreements by, among other things, failing to supply product for the fourth quarter of 2013 in relation to sales the Company generated, and failing to pay promotion fees due to NovaMed Pharmaceuticals (Shanghai) Co. Ltd. (“NovaMed”) under the agreements. As of March 31, 2014 and December 31, 2013, the Company had $3.3 million and $4.3 million, respectively, of uncollected receivables due from Sanofi that related to revenue recognized during the first three quarters of 2013. The Company has demanded that Sanofi make full payment of the promotional fees due to NovaMed. If this matter is not resolved to the Company’s satisfaction, the Company intends to vigorously pursue its claims against Sanofi in arbitration. The Company is also pursuing settlement options outside of formal arbitration.

The Company’s agreements with Sanofi contain provisions (identical regardless of individual product promotion agreement) that required a refund of a portion of promotion services fees received during interim periods from them if defined annual sales targets were not achieved. Consistent with the Company’s past practice, and consistent with its achievement (or excess achievement) of annual revenue targets in each prior period based on Method 2 of Accounting Standards Codification 605-20-S99-1, “Accounting for Management Fees Based on a Formula,” the Company recognized revenue during interim periods without reduction for amounts subject to refund because it met and substantially exceeded such targets on a “pro rata” basis at interim dates. The Company’s treatment of the subject-to-refund portion is consistent with the contractual provisions, which provide that the sales targets will be measured on a pro-rated basis if an agreement were to hypothetically terminate as of any given date.

Due to Sanofi’s failure to place orders for shipment in the fourth quarter and fully meet the demand the Company generated, the Company’s actual promotional fees receivable in the fourth quarter of 2013 were negatively impacted. Due to this failure, the Company did not achieve the defined annual sales targets for fiscal 2013. Under the Company’s agreements with Sanofi, a failure to reach the annual sales target would result in approximately $6.2 million subject to refund related to the Company’s performance in the first three quarters of 2013. However, the Company’s agreements required that Sanofi continue to support the Company’s sales efforts by continuing to provide product through the end of the terms of the agreements. The Company believes it has no obligation to refund any amounts subject to this provision because its inability to achieve the defined annual sales was the result of a failure to perform by Sanofi.

As the Company is in a dispute with Sanofi concerning Sanofi’s performance, the Company therefore deferred revenue recognition of approximately $2.8 million of Sanofi promotion fees related to the fourth quarter of 2013, pending resolution of the dispute. As the Company is legally entitled to at least the $2.8 million recorded as a receivable, the non-recognition of revenue resulted in an equal and offsetting amount of deferred revenue.

 

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Inventories

Inventories consist of raw materials, work in progress and finished goods products. Inventories are valued at the lower of cost or market (net realizable value), with cost determined on a first-in, first-out basis, and include amounts related to materials, labor and overhead. The Company periodically reviews the inventory in order to identify excess and obsolete items, including pharmaceutical products approaching their expiry dates. If obsolete or excess items are observed and there are no alternate uses for the inventory, the Company will record a write-down to net realizable value in the period that the impairment is first recognized. For the three-month period ended March 31, 2014, the Company did not record any write-downs related to inventory.

Net Income Per Share

Basic net income per share has been computed by dividing net income by the weighted-average number of shares of common stock outstanding for the period. Diluted net income per share is computed by dividing net income by the weighted-average number of common equivalent shares outstanding for the period. Diluted net income per share includes any dilutive impact from outstanding stock options, restricted stock units (“RSUs”) and the employee stock purchase plan using the treasury stock method.

The following is a reconciliation of the numerator and denominators of the basic and diluted net income per share computations (in thousands, except per share amounts):

 

     Three Months Ended
March 31,
 
     2014      2013  

Numerator:

     

Net income

   $ 4,134       $ 4,203   

Denominator:

     

Weighted-average shares outstanding used to compute basic net income per share

     52,026         54,084   

Effect of dilutive securities

     1,208         1,388   
  

 

 

    

 

 

 

Weighted-average shares outstanding used to compute diluted net income per share

     53,234         55,472   
  

 

 

    

 

 

 

Basic net income per share

   $ 0.08       $ 0.08   

Diluted net income per share

   $ 0.08       $ 0.08   

For the three months ended March 31, 2014 and 2013, outstanding stock options and RSUs for 3,592,835 and 2,856,805 shares, respectively, were excluded from the calculation of diluted net income per share because the effect from the assumed exercise of these options and RSUs calculated under the treasury stock method would have been anti-dilutive. In addition, for the three months ended March 31, 2014 and 2013, shares subject to market or performance conditions of 62,500 and 12,500, respectively, were excluded from the calculation of diluted net income per share because the performance or market criteria had not been met and the inclusion would provide an anti-dilutive effect.

 

2. Fair Value Measurements

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. The three levels of input are:

Level 1 - Quoted prices in active markets for identical assets or liabilities.

Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

 

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Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The following table represents the Company’s fair value hierarchy for its financial assets (cash equivalents and restricted cash and investments) measured at fair value on a recurring basis (in thousands):

 

     Fair Value Measurements as of March 31, 2014 Using  

Description

   Quoted Prices in
Active Markets
for
Identical Assets
(Level 1)
     Significant
Other
Observable
Inputs
(Level 2)
     Significant
Unobservable
Inputs

(Level 3)
     Balance
as of
   March 31, 2014   
 

Certificate of deposit

   $ —         $ 75       $ —         $ 75   

Money market funds

     19,678         —           —           19,678   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 19,678       $ 75       $ —         $ 19,753   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

     Fair Value Measurements as of December 31, 2013 Using  

Description

   Quoted Prices in
Active Markets
for
Identical Assets
(Level 1)
     Significant
Other
Observable
Inputs
(Level 2)
     Significant
Unobservable
Inputs

(Level 3)
     Balance
as of
December 31, 2013
 

Certificate of deposit

   $ —         $ 75       $ —         $ 75   

Money market funds

     28,262         —           —           28,262   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 28,262       $ 75       $ —         $ 28,337   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

3. Inventories

Inventories consisted of the following (in thousands):

 

     March 31,
2014
     December 31,
2013
 

Raw materials

   $ 7,763       $ 7,746   

Work in progress

     363         319   

Finished goods

     5,923         7,173   
  

 

 

    

 

 

 
   $ 14,049       $ 15,238   
  

 

 

    

 

 

 

Included in the Company’s inventory as of March 31, 2014 and December 31, 2013, was $1.6 million and $2.4 million, respectively, in inventory held at distributors related to products marketed by its NovaMed Pharmaceuticals, Inc. subsidiary.

 

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4. Credit Facilities

Credit Facility

In December 2013, the Company’s subsidiary, NovaMed, entered into a 10.0 million Chinese Yuan Renminbi (“Renminbi”) revolving line of credit facility (approximately $1.6 million USD) and a maximum 15.0 million Renminbi loan facility (approximately $2.4 million USD) secured by its accounts receivable with Shanghai Pudong Development Bank Co. Ltd. (“the Credit Facility”). As of March 31, 2014, 10.0 million Renminbi (approximately $1.6 million USD) in borrowings were outstanding on the revolving line of credit facility that must be repaid by June 4, 2014 and early repayment is allowed. The Credit Facility bears interest on borrowed funds at the People’s Bank of China 6-month base rate plus 15% (6.44% as of March 31, 2014). The Credit Facility expires November 30, 2014 and any amounts borrowed must be repaid by the expiration date. For the three months ended March 31, 2014, the Company paid interest of approximately $26,000 related to the Credit Facility.

Loan Agreement

The Company’s previous loan agreement for 12.5 million Renminbi (approximately $2.0 million) with Shanghai Pudong Development Bank Co. Ltd. expired August 29, 2013. All amounts borrowed were repaid by the expiration date. The loan bore interest on borrowed funds at 7.5%. For the three months ended March 31, 2013, the Company paid interest of approximately $31,000 related to this loan agreement.

 

5. Accrued and Other Current Liabilities

Accrued and other current liabilities consisted of the following (in thousands):

 

     March 31,
2014
     December 31,
2013
 

Accrued taxes, tax reserves and interest

   $ 4,879       $ 5,029   

Accrued sales and marketing expenses

     4,210         6,419   

Accrued estimated SEC and DOJ investigation loss (Note 8)

     2,000         2,000   

Accrued compensation and benefits

     1,597         3,475   

Accrued professional fees

     1,335         1,601   

Accrued manufacturing costs

     915         1,617   

Other

     896         1,323   
  

 

 

    

 

 

 
   $ 15,832       $ 21,464   
  

 

 

    

 

 

 

 

6. Accumulated Other Comprehensive Income (Loss)

Changes in the composition of accumulated other comprehensive income (loss) for the three months ended March 31, 2014 and 2013 are as follows ( in thousands ):

 

     Foreign
Currency
Translation
    Available-for-Sale
Investments
     Total  

Balances as of January 1, 2014

   $ 4,176      $ —         $ 4,176   

Other comprehensive loss

     (859     —           (859
  

 

 

   

 

 

    

 

 

 

Balances as of March 31, 2014

   $ 3,317      $ —         $ 3,317   
  

 

 

   

 

 

    

 

 

 

 

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     Foreign
Currency
Translation
     Available-for-Sale
Investments
    Total  

Balances as of January 1, 2013

   $ 3,055       $ (67   $ 2,988   

Other comprehensive income (loss)

     178         (10     168   
  

 

 

    

 

 

   

 

 

 

Balances as of March 31, 2013

   $ 3,233       $ (77   $ 3,156   
  

 

 

    

 

 

   

 

 

 

 

7. Stockholders’ Equity

Stock-based Compensation

The following table summarizes the stock-based compensation expenses included in the unaudited condensed consolidated statements of income ( in thousands ):

 

     Three Months Ended
March 31,
 
     2014      2013  

Sales and marketing

   $ 201       $ 246   

Research and development

     47         9   

General and administrative

     634         764   
  

 

 

    

 

 

 
   $ 882       $ 1,019   
  

 

 

    

 

 

 

Stock Options

During the three months ended March 31, 2014, the Company granted options to purchase a total of 1,434,500 shares of common stock and options to purchase 80,622 shares of common stock were exercised. As of March 31, 2014, there was approximately $5.7 million of unrecognized compensation expense, net of forfeitures, related to non-vested stock options, which is expected to be recognized over a weighted average remaining period of approximately 3.11 years.

The Company has granted a total of 100,000 shares under two performance-based option awards to purchase shares of the Company’s common stock at an exercise price equal to the closing price of a share of the Company’s common stock as of the grant date. The options will fully vest upon meeting a performance goal within an established time frame. If the performance goal is met for the option within the established time frame, the option generally has a ten-year term measured from the date of grant. If the performance goal is not met within the established time frame, the option expires in its entirety. The grant date fair value per share of the performance-based awards has been calculated using the Black-Scholes option pricing model using the following assumptions: expected term of 4.95 to 5.97 years, volatility factor of 61.74% to 64.65%, and risk free interest rates of 0.95% to 1.49%. The Company recognizes expense related to a performance-based option over the period of time the Company determines that it is probable that the performance goal will be achieved. If it is subsequently determined that the performance goal is not probable of achievement, the expense related to the performance-based option is reversed. For the three-month periods ended March 31, 2014 and 2013, the Company recognized approximately $24,000 and $0, respectively, of expense related to performance-based options.

RSUs

During the three months ended March 31, 2014, 7,000 RSUs were granted and 625 RSUs vested and were released. As of March 31, 2014, there was approximately $0.6 million of unrecognized compensation cost, net of forfeitures, related to non-vested RSUs, which is expected to be recognized over a weighted average remaining period of approximately 1.17 years.

Repurchase of Common Stock

The Company’s Board of Directors has authorized a $50.5 million share repurchase program that expires December 31, 2014. The Company repurchased and retired 500,003 shares at a cost of $2.6 million during the three-month period ended March 31, 2014. As of March 31, 2014, $7.1 million of the $50.5 million share repurchase program authorized by the Board of Directors was available for future share repurchases. Repurchased shares have been retired and constitute authorized but unissued shares.

 

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8. Contingencies and Commitments

Legal Matters

The Company is a party to various legal proceedings and subject to government investigations, as noted in this section below. All legal proceedings and any government investigations are subject to inherent uncertainties, unfavorable rulings or other adverse events which could occur. Unfavorable outcomes could include substantial monetary damages or awards, injunctions or other remedies, and if any of these were to occur, the possibility exists for a material adverse impact on the Company’s business, results of operations, financial position, and overall trends. The Company might also conclude that settling one or more such matters is in the best interests of its stockholders and its business, and any such settlement could include substantial payments. On August 5, 2010, SciClone was contacted by the SEC and advised that the SEC has initiated a formal, non-public investigation of SciClone, and the SEC issued a subpoena to SciClone requesting a variety of documents and other information including, but not limited to, potential payments or transfers of anything of value to regulators and government-owned entities in China, bids or contracts with state or government-owned entities in China, any joint venture partner, intermediary or local agent of the Company in China, the Company’s ethics and anti-corruption policies, training, and audits, and certain company financial and other disclosures. On August 6, 2010, the Company received a letter from the US Department of Justice (“DOJ”) indicating that the DOJ was investigating Foreign Corrupt Practices Act (“FCPA”) issues in the pharmaceutical industry generally, and that the DOJ had information about the Company’s practices suggesting possible violations. The Company received a further subpoena from the SEC in the fourth quarter of fiscal 2012 on additional matters including, but not limited to, matters related to its acquisition of NovaMed and FCPA matters, and certain sales and marketing expenses.

In response to these matters, the Company’s Board of Directors appointed a Special Committee of independent directors (the “Special Committee”) to oversee the Company’s response to the government inquiry. The Special Committee has undertaken independent investigations as to matters reflected in and arising from the SEC and DOJ investigations in order to evaluate whether any violation of the FCPA or other laws occurred. The Company will continue to cooperate fully with the SEC and DOJ in the conduct of their investigations.

The Company cannot predict what the outcome of those investigations will be, or the timing of any resolution. However, the Company has determined that a payment of $2.0 million to the government in penalties, fines and/or other remedies is probable. Accordingly, the Company recorded $2.0 million of operating expense in its fourth quarter 2013 results of operations to reflect the Company’s estimate of a probable loss incurred related to potential penalties, fines and/or other remedies in the ongoing investigations with the SEC and DOJ. Any actual fines or penalties that may be imposed, or other losses that may be realized related to the investigations, could materially differ and could be higher from the amount of the Company’s estimated loss and could materially impact the Company’s financial statements. The Company has re-assessed the potential liability in this matter with no significant developments noted in the current quarter, and will continue to reassess the potential liability related to the investigations and adjust its estimates accordingly in future periods.

NovaMed was a party to a Distribution and Supply Agreement with MEDA Pharma GmbH & Co. KG (“MEDA”). Following the Company’s acquisition of NovaMed, MEDA claimed it had a right to terminate the agreement under a change of control provision. NovaMed does not believe that MEDA had a right of termination under the agreement. As provided in the agreement, disputes, including disputes regarding termination, must be resolved in binding arbitration. NovaMed filed an application for binding arbitration with the China International Economic and Trade Arbitration Commission (“CIETAC”) on July 26, 2012. On April 3, 2014, CIETAC issued the final Award of the Arbitral Tribunal. The Arbitral Tribunal found that MEDA did have a right to terminate the agreement upon a change of control, but that MEDA must make reasonable reimbursement to NovaMed before any products rights are returned to MEDA. The amount that must be paid includes $333,333 as “unjust enrichment” plus an amount for reasonable compensation for such services provided by NovaMed to MEDA. The amount of such payment for services was not determined by the Arbitral Tribunal, but was left to be determined by NovaMed. While NovaMed has the right to make a

 

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determination of the reasonable amount of its compensation for services, MEDA may elect to initiate another arbitration if it determines to dispute the reasonableness of NovaMed’s determination. However, NovaMed is not required to return the product rights to MEDA until MEDA either makes payment to NovaMed, or (i) pays $333,333 to NovaMed, (ii) initiates a second CIETAC arbitration and (iii) posts a security bond of $2,666,666. On April 30, 2014, NovaMed informed MEDA that its determination of reasonable compensation for its services was $3,314,629, including the $333,333 for unjust enrichment. As MEDA has not agreed to such amount and could pursue further arbitration, the amount of any final payment to NovaMed remains uncertain, and as such the Company has not recognized it as a gain contingency.

On March 11, 2013, Adam Crum filed a derivative lawsuit, purportedly in the name of SciClone, against Friedhelm Blobel, Gary Titus, Jon Saxe, Peter Barrett, Richard Hawkins, Gregg Lapointe and Ira Lawrence in California Superior Court, San Mateo County, captioned Crum v. Blobel, et al., Case No. CIV520331. The lawsuit alleges, based on the restatement of the Company’s consolidated financial statements for the year ended December 31, 2011 and certain quarters of 2011 and 2012, that the Board of Directors and management breached their fiduciary duties to the Company by not exercising oversight in such a way that they allowed the Company to file consolidated financial statements that were materially inaccurate. Plaintiff asserts claims for breach of fiduciary duty, abuse of control and mismanagement. Plaintiff seeks, among other things, injunctive relief, disgorgement, undisclosed damages and attorneys’ fees and costs. The Company and other defendants filed motions to dismiss the complaint. The court granted the motions to dismiss but allowed plaintiff to amend the complaint. An amended complaint has not yet been filed. Given the procedural process and the nature of this case, including that a motion to dismiss has been filed, the Company is unable to make a reasonable estimate of the potential loss or range of losses, if any, that might arise from this matter.

On or about November 20, 2013, counsel for the Company sent a letter on behalf of the Company’s subsidiary, NovaMed, to Sanofi (Hangzhou) Pharmaceuticals Co. Ltd. and Sanofi (Beijing) Pharmaceuticals Co., Ltd. (collectively, “Sanofi”) (i) asserting that Sanofi had breached its obligations under various agreements (the “Promotion Agreements”) between the parties for the promotion of Depakine®, Stilnox®, Tritace® and Xatral® (collectively the “Products”) by, among other things, failing to supply Products for the fourth quarter of 2013 in relation to sales the Company generated, and failing to pay promotion fees due to NovaMed under the Promotion Agreements, and (ii) demanding that Sanofi make full payment of the promotional fees due to NovaMed, and that Sanofi cause orders to be placed for the Products for November and December of 2013 in specified quantities. NovaMed and Sanofi have discussed potential settlement of the dispute. However, the dispute has not been resolved by the parties. NovaMed has communicated to Sanofi that if the dispute is not resolved to its satisfaction, it intends to exercise all of its legal rights and remedies under the Promotion Agreements, including pursuing arbitration of the dispute through CIETAC pursuant to the terms of the Promotion Agreements. No formal legal proceedings were initiated by or filed against the Company in connection with this matter.

Purchase Obligations

Under agreements with certain of the Company’s pharmaceutical partners, the Company is committed to certain annual minimum product purchases where the contract is subject to termination if the annual minimum order is not met. As of March 31, 2014, the Company did not have any material unmet purchase obligations.

 

9. Segment Information and Geographic Data

The Company reports segment information based on the internal reporting used by management for evaluating segment performance based on management’s estimates of the appropriate allocation of resources to segments.

The Company operates and manages its business primarily on a geographic basis. Accordingly, the Company determined its operating and reporting segments, which are generally based on the nature and location of its customers, to be 1) China and 2) Rest of the World, including the US and Hong Kong.

The Company evaluates the performance of its operating segments based on revenues and operating income (loss). Revenues for geographic segments are generally based on the location of customers. Operating income (loss) for each segment includes revenues, related cost of sales and operating expenses directly attributable to the segment. Operating income (loss) for each segment excludes non-operating income and expense.

 

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Summary information by operating segment for the three-month periods ended March 31, 2014 and 2013 is as follows ( in thousands ):

 

     Three Months Ended
March 31,
 
     2014     2013  

Revenue:

    

China

   $ 25,679      $ 28,810   

Rest of the World (including the US and Hong Kong)

     886        996   
  

 

 

   

 

 

 

Total net revenues

   $ 26,565      $ 29,806   

Income (loss) from operations:

    

China

   $ 7,572      $ 10,951   

Rest of the World (including the US and Hong Kong)

     (2,911     (5,927
  

 

 

   

 

 

 

Total income from operations

   $ 4,661      $ 5,024   

Non-operating income (expense), net:

    

China

   $ (125   $ (26

Rest of the World (including the US and Hong Kong)

     (4     (8
  

 

 

   

 

 

 

Total non-operating expense, net

   $ (129   $ (34

Income (loss) before provision for income tax:

    

China

   $ 7,447      $ 10,925   

Rest of the World (including the US and Hong Kong)

     (2,915     (5,935
  

 

 

   

 

 

 

Total income before provision for income tax

   $ 4,532      $ 4,990   

Long-lived assets as of March 31, 2014 by operating segment are as follows ( in thousands ):

 

China

   $ 35,397   

Rest of the World (including the US and Hong Kong)

     334   
  

 

 

 
   $ 35,731   
  

 

 

 

 

10. Subsequent Event

Stock Repurchases : The Company repurchased and retired 464,826 shares at a cost of $2.2 million from April 1, 2014 through May 6, 2014 under its share repurchase program. As of May 6, 2014, $4.9 million of the total $50.5 million was available for future share repurchase.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Special Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based on our current expectations, estimates and projections about our business, industry, management’s beliefs and certain assumptions made by us. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe” or similar expressions are intended to identify forward-looking statements including those statements we make regarding our future financial results; anticipated product sales of current or anticipated products; the sufficiency of our resources to complete clinical trials and other new product development initiatives; government regulatory actions that may affect product reimbursement, product pricing or otherwise affect the scope of our sales and marketing; the timing and outcome of clinical trials; prospects for ZADAXIN ® and our plans for its enhancement and commercialization as well as our expectations regarding other products; future size of the hepatitis B virus (“HBV”) and hepatitis C virus (“HCV”) and other markets, particularly in China; research and development and other expense levels; the ability of our suppliers to continue financially viable production of our products; cash and other asset levels; the allocation of financial resources to certain trials and programs, and the outcome and expenses related to litigation and regulatory investigations. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors including, but not limited to, those described under the caption “Risk Factors” in this Quarterly Report on Form 10-Q. We undertake no obligation to revise or update publicly any forward-looking statements for any reason.

Overview

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) is a United States (“US”)-headquartered, China-focused, specialty pharmaceutical company with a substantial commercial business and a product portfolio of therapies for oncology, infectious diseases and cardiovascular. We are focused on continuing to grow our revenue and profitability in the future. Our business and corporate strategy is focused primarily on the People’s Republic of China (“China”) where we have built a solid reputation and established a strong brand through many years of experience marketing our lead product, ZADAXIN (thymalfasin). In addition, we have an established product promotion business model with large pharmaceutical partners and we are focused on establishing profitability in all of these collaborations. We believe our sales and marketing strengths position us to benefit from the long-term expansion of the pharmaceutical market in China. This pharmaceutical market currently ranks third among the global pharmaceutical markets, and we believe China will rank second among global pharmaceutical markets by 2020. We seek to expand our presence in China and increase revenues by growing sales and profits of our current product portfolio, launching new products from our development pipeline, adding new, profitable product services agreements and leveraging our strong cash position to in-license additional products.

We operate in two segments which are generally based on the nature and location of our customers: 1) China and 2) the rest of the world, which includes our US and Hong Kong operations.

We have two categories of revenues: “product sales revenues” and “promotion services revenues.” Our product sales revenues result from our proprietary and in-licensed products, including our lead product, ZADAXIN, and products from Pfizer International Trading (Shanghai) Ltd. (“Pfizer”) and Cardiome Pharma Corp. (formerly Correvio, LLC). ZADAXIN has the highest margins in our portfolio as it is a premium product sold exclusively by SciClone. Aggrastat ® , an intervention cardiology product launched in China in 2009, is an in-licensed product with higher margins than the products we promote under services agreements and we anticipate revenues from this product will grow as it further penetrates the China market. In addition, we anticipate that new marketed products, when and if introduced, can increase the future revenues and profitability of our pharmaceutical business in China over the coming years. Our “promotion services revenues” result from fees we receive for exclusively promoting products under services agreements with certain pharmaceutical partners including Baxter International, Inc. (“Baxter”) in China. We refer to these agreements as promotion agreements, service agreements and distribution contract rights agreements. We recognize promotion services revenues as a percentage of our collaborators’ product sales revenue for these exclusively promoted products. Over time, as additional proprietary or in-licensed products come to the market, we aim to shift our product mix towards those products providing higher margin for us.

 

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Our promotion agreements with Sanofi Aventis S.A. (“Sanofi”), consisting of individual promotional agreements for certain pharmaceutical products and supplementary agreements extending the terms thereof, were not renewed and expired on December 31, 2013. We received initial notification of non-renewal from Sanofi in early October 2013. Subsequent thereto, we believe that Sanofi breached its obligations under these agreements by, among other things, failing to supply product for the fourth quarter of 2013 in relation to sales we generated, and failing to pay promotion fees due to NovaMed Pharmaceuticals (Shanghai) Co. Ltd. (“NovaMed”) under the agreements. As of March 31, 2014, we had $3.3 million of uncollected receivables due from Sanofi that related to revenue recognized during the first three quarters of 2013. We have demanded that Sanofi make full payment of the promotional fees due to NovaMed. If this matter is not resolved to our satisfaction, we intend to vigorously pursue our claims against Sanofi in arbitration. We are also pursuing settlement options outside of formal arbitration.

Our agreements with Sanofi contain provisions (identical regardless of individual product promotion agreement) that required a refund of a portion of promotion service fees received during interim periods from them if defined annual sales targets were not achieved. Consistent with our past practice, and consistent with our achievement (or excess achievement) of annual revenue targets in each prior period, based on Method 2 of Accounting Standards Codification 605-20-S99-1, “Accounting for Management Fees Based on a Formula,” we recognized revenue during interim periods without reduction for amounts subject to refund because we met and substantially exceeded such targets on a “pro rata” basis at interim dates. Our treatment of the subject-to-refund portion is consistent with the contractual provisions, which provide that the sales targets will be measured on a pro-rated basis if an agreement were to hypothetically terminate as of any given date.

Due to Sanofi’s failure to place orders for shipment in the fourth quarter and fully meet the demand we generated, our actual promotional fees receivable in the fourth quarter of 2013 were negatively impacted. Due to this failure, we did not achieve the defined annual sales targets for fiscal 2013. Under our agreements with Sanofi, a failure to reach the annual sales target would result in approximately $6.2 million subject to refund related to our performance in the first three quarters of 2013. However, our agreements required that Sanofi continue to support our sales efforts by continuing to provide product through the end of the terms of the agreements. We believe we have no obligation to refund any amounts subject to this provision because our inability to achieve the defined annual sales was the result of a failure to perform by Sanofi.

As we are in a dispute with Sanofi concerning their performance, we therefore deferred revenue recognition of approximately $2.8 million of Sanofi promotion fees for the fourth quarter of 2013, pending resolution of the dispute. As we are legally entitled to at least the $2.8 million recorded as a receivable, the non-recognition of revenue resulted in an equal and offsetting amount of deferred revenue. Our revenues for 2013, 2012 and 2011 with Sanofi were approximately $25.0 million, $30.8 million, and $19.7 million, respectively.

In June 2013, we renewed our promotion agreement with Baxter for a 5-year term, through December 2017. Our other significant agreement is with Pfizer, and has been renewed, and is expected to be renewed month-to-month until our negotiation for an extended or renegotiated agreement is concluded. Revenues for 2013, 2012 and 2011 related to our agreement with Pfizer were approximately $3.1 million, $8.8 million, and $5.5 million, respectively. We are actively negotiating renewal or extension of this agreement.

We are pursuing additional promotion service agreements to generate additional revenue. At the same time, we continue to assess the financial performance of the products we promote under our agreements and their overall value within our entire portfolio of products. As part of this process, we have recently discontinued promotion of certain products including certain oncology products for Pfizer. Revenues related to these discontinued products were approximately $0.7 million, $1.5 million, and $2.7 million in 2013, 2012, and 2011, respectively. Over time, we anticipate the product mix that we promote will change, which may affect our revenues and profitability in the future. If any of these agreements are determined to no longer be beneficial to us and are allowed to expire, or if third parties will not renegotiate, renew or extend the agreements on terms acceptable to us, our revenues would be adversely affected and our profitability may be adversely or beneficially affected. If on the other hand our efforts to renegotiate result in better terms, there may be a positive impact on our revenues and profitability.

ZADAXIN is approved in over 30 countries and may be used for the treatment of HBV, HCV, and certain cancers, and as a vaccine adjuvant according to the local regulatory approvals we have in these countries. In China, thymalfasin is included in the treatment guidelines issued by the Ministry of Health (“MOH”) for liver cancer, as well as guidelines for treatment of chronic HBV (issued by both the Chinese Medical Association and the Asian-Pacific Association for the Study of the Liver) and invasive fungal infections of critically ill patients (issued by the Chinese Medical Association). Our sales force is focused on increasing sales to the country’s largest hospitals (class 3

 

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with over 500 beds) as well as mid-size hospitals (class 2). These hospitals serve Tier 1 and Tier 2 cities located mostly in the eastern part of China, which are the largest and generally have the most affluent populations. We are widening our market strategies by targeting numerous smaller hospitals as well as hospitals in more rural areas. We are also seeking to expand the indications for which ZADAXIN could be used, including sepsis.

We are also pursuing the registration of several other therapeutic products in China. These include: DC Bead ® , an embolic-acting bead with drug-loading capabilities that can be used for targeted delivery of cancer chemotherapy drugs directly to the tumor; Loramyc ® , a mucoadhesive tablet formulation of miconazole lauriad to treat oropharyngeal candidiasis; Rapinyl ® , a sublingual tablet formulation of fentanyl to treat breakthrough cancer pain; and RapidFilm ® , an oral film formulation of ondansetron to treat nausea induced by chemotherapy.

We continue to seek in-licensing arrangements for approved or late-stage, branded, well-differentiated products that if not yet approved, have a clear regulatory approval pathway in China based on existing regulatory approval outside of China. Our objective is to in-license products that provide us with higher margins, augmenting our product sales revenue and profitability, and we continue to explore opportunities to optimize our promotion services revenues. In May 2013, we entered into a framework agreement with Zensun (Shanghai) Science & Technology Co., Ltd. (“Zensun”) for the exclusive promotion, marketing, distribution and sale of Neucardin TM in China, Hong Kong and Macau. Neucardin is a novel, first-in-class therapeutic for the treatment of patients with intermediate to advanced heart failure, for which a New Drug Application (“NDA”) was submitted to and accepted for review by the China Food and Drug Administration (“CFDA”) in 2012. The CFDA has recently informed Zensun that its Phase 2 data is insufficient, and has asked Zensun to submit a new NDA once the ongoing Phase 3 study has reached its endpoints.

In June 2013, we entered into a license agreement with Taiwan Liposome Company (“TLC”) which granted us a license and the exclusive rights in China, Hong Kong and Macau to promote, market, distribute and sell ProFlow ® for the treatment of peripheral arterial disease (“PAD”) and other indications. PAD is a serious cardiovascular condition in which blood flow to the limbs (usually the legs) is restricted due to arterial plaque build-up. Under the terms of the agreement, TLC will be responsible for the continued development including potential clinical trials and regulatory activities, as well as the manufacture and supply of ProFlow, and we will be responsible for all aspects of commercialization including pre-and post-launch activities. ProFlow has been submitted to CFDA for clinical trial approval, and it is expected that some additional clinical testing may be required prior to approval. The agreement provides for the principal terms of the arrangement between SciClone and TLC, and in March 2014, the companies entered into a supplemental collaboration and license agreement.

We believe that these licensing agreements for Neucardin and ProFlow provide us the opportunity to use our considerable sales and marketing expertise to expand our product portfolio with differentiated, high-quality products that have significant therapeutic advantages and near-term commercial potential, and that can contribute to our long-term growth.

We believe our cash and investments as of March 31, 2014 and ongoing revenue generating business operations will be sufficient to support our current operating plan for at least the next 12 months. Our results may fluctuate from quarter to quarter and we may report losses in the future.

Results of Operations

Revenues:

The following table summarizes the period over period changes in our product sales and promotion services (in thousands):

 

     Three Months Ended
March 31,
        
     2014      2013      Change  

Product Sales, net

   $ 26,064       $ 20,533         27

Promotion Services

     501         9,273         -95
  

 

 

    

 

 

    

Total Net Revenues

   $ 26,565       $ 29,806         -11
  

 

 

    

 

 

    

Product sales were $26.1 million for the three-month period ended March 31, 2014, compared to $20.5 million for the corresponding period in 2013, an increase of $5.5 million, or 27%. ZADAXIN sales were $24.7 million for

 

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the three-month period ended March 31, 2014, compared to $19.0 million for the corresponding period of 2013, an increase of $5.7 million that mainly related to an increase in volume sold, and to a lesser extent related to an increase in selling price. We believe our ZADAXIN product revenues in the first half of fiscal 2013 were adversely affected by the increase in channel inventory we experienced in the third quarter of 2012. We believe channel inventory for ZADAXIN has returned to normalized levels, and we anticipate that ZADAXIN revenues in 2014 will be higher than 2013.

In China, pharmaceutical products are imported and distributed through a tiered method of distribution. For our proprietary product ZADAXIN, we manufacture our product using our US and European contract manufacturers, and we generate our product sales revenue through sales of ZADAXIN product to SinoPharm Lingyun Biopharmaceutical (Shanghai) Co. Ltd. (“SinoPharm”). SinoPharm and its affiliates act as an importer, and also as the top “tier” of the distribution system (“Tier 1”) in China. Our ZADAXIN sales occur when SinoPharm purchases product from us without any right of return except for damaged product or quality control issues. Passage of title and risk of loss are transferred to SinoPharm at the time of shipment. After the sale, SinoPharm clears products through China import customs, sells directly to large hospitals and holds additional product it has purchased in inventory for sale to the next tier in the distribution system. The second-tier distributors are responsible for the further sale and distribution of the products they purchase from the importer, either through sales of product directly to the retail level (hospitals and pharmacies), or to third-tier local or regional distributors who, in turn, sell products to hospitals and pharmacies.

All of our promotion services revenue and a majority of our product revenues related to our China segment. Promotion services revenue was $0.5 million, for the three-month period ended March 31, 2014 and related to products promoted under our agreement with Baxter, compared to $9.3 million for the corresponding period in 2013 that related to the products promoted under agreements with Sanofi and Baxter.

The decrease of $8.8 million in promotion services revenue related to the expiration of our promotion agreements with Sanofi. Our promotion agreements with Sanofi, consisting of individual promotional agreements for certain pharmaceutical products and supplementary agreements extending the terms thereof, were not renewed and expired on December 31, 2013. We received initial notification of non-renewal from Sanofi in early October 2013. Subsequent thereto, we believe that Sanofi breached its obligations under these agreements by, among other things, failing to supply product for the fourth quarter of 2013 in relation to sales we generated, and failing to pay promotion fees due to NovaMed under the agreements. As of March 31, 2014, we had $3.3 million of uncollected receivables due from Sanofi that related to revenue recognized during the first three quarters of 2013. We have demanded that Sanofi make full payment of the promotional fees due to NovaMed. If this matter is not resolved to our satisfaction, we intend to vigorously pursue our claims against Sanofi in arbitration. We are also pursuing settlement options outside of formal arbitration.

Our agreements with Sanofi contain provisions (identical regardless of individual product promotion agreement) that required a refund of a portion of promotion service fees received during interim periods from them if defined annual sales targets were not achieved. Consistent with our past practice, and consistent with our achievement (or excess achievement) of annual revenue targets in each prior period, based on Method 2 of Accounting Standards Codification 605-20-S99-1, “Accounting for Management Fees Based on a Formula,” we recognized revenue during interim periods without reduction for amounts subject to refund because we met and substantially exceeded such targets on a “pro rata” basis at interim dates. Our treatment of the subject-to-refund portion is consistent with the contractual provisions, which provide that the sales targets will be measured on a pro-rated basis if an agreement were to hypothetically terminate as of any given date.

Due to Sanofi’s failure to place orders for shipment in the fourth quarter and fully meet the demand we generated, our actual promotional fees receivable in the fourth quarter of 2013 were negatively impacted. Due to this failure, we did not achieve the defined annual sales targets for fiscal 2013. Under our agreements with Sanofi, a failure to reach the annual sales target would result in approximately $6.2 million subject to refund related to our performance in the first three quarters of 2013. However, our agreements required that Sanofi continue to support our sales efforts by continuing to provide product through the end of the terms of the agreements. We believe we have no obligation to refund any amounts subject to this provision because our inability to achieve the defined annual sales was the result of a failure to perform by Sanofi.

As we are in a dispute with Sanofi concerning their performance, we therefore deferred revenue recognition of approximately $2.8 million of Sanofi promotion fees for the fourth quarter of 2013, pending resolution of the dispute. As we are legally entitled to at least the $2.8 million recorded as a receivable, the non-recognition of revenue resulted in an equal and offsetting amount of deferred revenue. Our revenues for 2013, 2012 and 2011 with Sanofi were approximately $25.0 million, $30.8 million, and $19.7 million, respectively.

 

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The termination of these agreements will negatively affect our promotion services revenues in 2014; however, due to our restructuring activities, including a significant reduction in our sales force, we believe it will have only a modest effect on our profitability in 2014.

In June 2013, we renewed our promotion agreement with Baxter for a 5-year term, through December 2017. Our other significant agreement with Pfizer is expected to be renewed month-to-month until our negotiation for an extended or renegotiated agreement is concluded. Revenues for 2013, 2012, and 2011 related to our agreement with Pfizer were approximately $3.1 million, $8.8 million, and $5.5 million, respectively. We are actively negotiating the renewal or extension of this agreement. We continue to assess the financial performance of the products we promote under our agreements and their overall value within our entire portfolio of products. As part of this process, we have recently discontinued promotion of certain oncology products for Pfizer. Revenues related to these products were approximately $0.7 million, $1.5 million, and $2.7 million, in 2013, 2012, and 2011, respectively. Over time, we anticipate the product mix that we promote will change, which may affect our revenues and profitability in the future. If any of these agreements are determined to no longer be beneficial to us and are allowed to expire, or if third parties will not renegotiate, renew or extend the agreements on terms acceptable to us, our revenues would be adversely affected and our profitability may be adversely or beneficially affected. On the other hand, if we are successful in negotiating better terms, there may be a positive impact on our revenues and profitability.

Total China revenues were $25.7 million, or 97% of total revenues for the three-month period ended March 31, 2014, compared to $28.8 million, or 97% of total revenues for the corresponding period in 2013. Rest of the World segment revenues were $0.9 million, or 3% of our revenues for the three-month period ended March 31, 2014, compared to $1.0 million, or 3%, for the three-month period ended March 31, 2013, and related to sales of ZADAXIN product.

For the three-month period ended March 31, 2014, sales to one customer in China accounted for approximately 94% of our revenues. For the three-month period ended March 31, 2013, sales to two customers in China accounted for approximately 66% and 29% of our revenues (prior to the designation of the larger of those customers as our exclusive importer and distributor for China). Our experience with our largest customer has been good and we anticipate that we will continue to sell a majority of our product to them.

Cost of Product Sales:

The following table summarizes the period over period changes in our cost of product sales (in thousands) :

 

     Three Months Ended
March 31,
        
     2014      2013      Change  

Cost of Product Sales

   $ 4,561       $ 4,618         -1

Cost of product sales was $4.6 million for both the three-month periods ended March 31, 2014 and 2013. Gross margin for ZADAXIN was 84.9% and 80.3% for the three months ended March 31, 2014 and 2013, respectively. The increase in gross margin for ZADAXIN for the three months ended March 31, 2014, compared to March 31, 2013, was due to lower overhead costs related to higher production volume and due to an increase in the average per vial sales price of ZADAXIN.

We expect our ZADAXIN cost of product sales and gross margins to fluctuate from period to period depending on the level of sales and price of our products, the absorption of product-related fixed costs, currency exchange fluctuations, any charges associated with excess or expiring finished product inventory, and the timing of other inventory period costs such as manufacturing process improvements for the goal of future cost reductions.

Overall, we expect our gross margin percentages in 2014 to remain comparable to 2013, although they may fluctuate from quarter to quarter.

 

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Sales and Marketing:

The following table summarizes the period over period changes in our sales and marketing expenses (in thousands):

 

     Three Months Ended
March 31,
        
     2014      2013      Change  

Sales and Marketing

   $ 9,834       $ 11,199         -12

Sales and marketing expenses for the three months ended March 31, 2014 decreased by $1.4 million, or 12%, compared to the same period in 2013. Sales and marketing expenses have decreased for the three months ended March 31, 2014, compared to the same quarter of the prior year, related to the expiration of the Sanofi distribution agreements and the reduction in costs associated with marketing the products under the Sanofi agreements. In addition, as result of our restructuring in the fourth quarter of 2013 related to the expiration of our Sanofi distribution agreements and other expense-saving measures, we have reduced our sales force by over 200 salespersons compared to March 31, 2013. The reductions in sales and marketing expenses for the three months ended March 31, 2014, compared to the same period of the prior year, that primarily related to the expiration of the Sanofi distribution agreements, were partially offset by increases in our sales and marketing efforts for ZADAXIN.

We anticipate total sales and marketing expenses for the year ending December 31, 2014 to be comparable to those incurred for the year ended December 31, 2013. Although we anticipate savings in 2014 from our fourth quarter 2013 restructuring, related to the expiration of the Sanofi distribution agreements, and from reductions in our sales force that occurred in 2013, we expect these reductions to be offset by growth in our sales and marketing efforts related to ZADAXIN.

Research and Development (“R&D”):

The following table summarizes the period over period changes in our R&D expenses (in thousands):

 

     Three Months Ended
March 31,
        
     2014      2013      Change  

Research and Development

   $ 1,476       $ 365         304

R&D expenses for the three months ended March 31, 2014, increased by $1.1 million, or 304%, compared to the same period in 2013, primarily related to costs incurred in preparation for potential sepsis clinical studies for ZADAXIN.

The major components of R&D expenses include salaries and other personnel-related expenses, including associated stock-based compensation, facility-related expenses, depreciation of facilities and equipment, license-related fees, services performed by clinical research organizations and research institutions and other outside service providers.

We expect our research and development expenses to increase in 2014 compared to 2013 related to our support of local trials in China for Loramyc and ZADAXIN, potentially including trials of ZADAXIN for the treatment of sepsis. We may also incur an additional milestone payment to TLC of $0.8 million upon clinical trial application approval which the Company anticipates may occur in 2014. We continue to evaluate opportunities to in-license the marketing rights to proprietary products primarily in China, which may result in increased research and development expenses due to license fee payments, local registration clinical trials, or other expenses related to in-licensing and development of new products in the future.

 

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General and Administrative:

The following table summarizes the period over period changes in our general and administrative expenses (in thousands):

 

     Three Months Ended
March 31,
        
     2014      2013      Change  

General and Administrative

   $ 6,033       $ 8,600         -30

General and administrative expenses for the three-month period ended March 31, 2014 decreased by $2.6 million, or 30%, compared to the same period in 2013. General and administrative expenses decreased for the three months ended March 31, 2014, compared to the same period of the prior year, mainly related to a decrease of approximately $1.9 million related to legal matters associated with the ongoing government investigation and the MEDA Pharma GmbH & Co. KG (“MEDA”) arbitration. In addition, general and administrative expenses decreased related to accounting matters associated with the restatement of our consolidated financial statements for the year ended December 31, 2011 and certain quarters of 2011 and 2012, that were recorded in the three month period ended March 31, 2013.

We expect our general and administrative expenses in 2014 to decrease compared to 2013 as we anticipate lower legal and accounting costs in 2014 in addition to lower bad debt expense. However, our ongoing investigations with the SEC and DOJ are unpredictable and may result in higher legal costs or fines or penalties and could affect our expenses or the timing thereof. We do not expect to incur any significant acquisition-related costs in 2014, though we continue to evaluate opportunities in China, which may result in increased general and administrative expenses in the future. See Part II, Item 1 “Legal Proceedings”.

Provision for Income Tax:

The provision for income tax was $0.4 million and $0.8 million for the three-month periods ended March 31, 2014 and 2013, respectively, and related to taxable income of our China operations. The decrease of $0.4 million in the provision for income tax for the three-month period ended March 31, 2014, compared to the same period of the prior year, was primarily the result of the expiration of the Sanofi distribution agreements resulting in a reduction in our forecasted profitability for 2014 for our NovaMed operations, compared to 2013.

Our statutory tax rate in China was 25% in 2014 and 2013. We expect the provision for income tax to decrease for the year ending December 31, 2014, compared to the year ended December 31, 2013, related to our China operations.

Liquidity and Capital Resources

We continue to closely manage our liquidity and capital resources. We rely on our operating cash flows, cash and cash equivalents, short-term investments and our short-term loan arrangement to provide for our liquidity requirements. We continue to believe that we have the ability to meet our liquidity needs for at least the next 12 months to fund our working capital requirements of our operations, including investments in our business, share repurchases, to pay down our short-term borrowing arrangements, and to fund our business development activities.

The following tables summarize our cash and investments and our cash flow activities as of the end of, and for each of, the periods presented (in thousands):

 

     As of
March 31, 2014
     As of
December 31, 2013
 

Cash, cash equivalents and investments

   $ 87,545       $ 85,878   

As of March 31, 2014, we had $87.5 million in cash, cash equivalents and investments of which $77.0 million was located in subsidiaries of the Company outside the US. Cash and cash equivalents held by subsidiaries outside the US are held primarily in US dollars. Such cash and cash equivalents are used to fund the operating activities of

 

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our foreign subsidiaries and for further investment in foreign operations, which may include in-licensing new products, particularly for China, and for potential acquisitions. As of March 31, 2014, we determined that our remaining $100.7 million of accumulated undistributed earnings of foreign subsidiaries continues to be indefinitely reinvested outside of the US. In making this determination, the following attributes were considered: (i) the expected future needs of the foreign subsidiaries, including working capital, debt service, capital expenditures, as well as additional investments to support the infrastructure in our China subsidiaries, (ii) additional investments to support our expansion in the China market as well as planned business acquisitions and/or product licensing transactions, and (iii) there is no foreseeable need to repatriate any additional undistributed earnings to fund our limited US operations. Should circumstances change and it becomes apparent that some or all of the undistributed earnings will be remitted, we will accrue for income taxes not previously recognized. Upon distribution of those earnings, we may be subject to US federal and state income taxes. Determination of such additional tax is not practicable as it is dependent on several future uncertainties, including the amount of US tax losses, available net operating losses and, potentially, foreign tax credits available at the time of the repatriation. Based on our current operating plan, we do not anticipate the need to repatriate cash and cash equivalents held by foreign subsidiaries in the foreseeable future.

 

     Three Months Ended
March 31,
 
     2014     2013  

Cash provided by (used in):

    

Operating activities

   $ 4,117      $ 10,931   

Investing activities

   $ (111   $ (41

Financing activities

   $ (2,321   $ (1,829

Net cash provided by operating activities was $4.1 million for the three-months ended March 31, 2014 and primarily reflected the net income for the period, adjusted for non-cash items such as stock-based compensation expense, depreciation and amortization expense, and changes in operating assets and liabilities. As of March 31, 2014, in addition to the outstanding balances relative to Sanofi, we have accounts receivable totaling approximately $3.5 million, which are substantially delinquent and which we are actively trying to collect, and for which we have recorded a reserve of $3.5 million. The customer has a binding obligation to pay us, but we may have to pursue legal remedies, and there can be no assurance if we are not paid and we pursue legal action what the timing or result of such action would be. Accounts receivable decreased $7.5 million related to payments received from customers during the three months ended March 31, 2014 and a decrease in sales of ZADAXIN for the first quarter of 2014 as compared to the fourth quarter of 2013. Inventory decreased $1.2 million mainly related to Methotrexate inventory sold during the first quarter of 2014, and accounts payable and accrued liabilities decreased $9.5 million mainly related to compensation and benefits, sales and marketing and manufacturing expense payments made during the first quarter of 2014.

Net cash provided by operating activities was $10.9 million for the three months ended March 31, 2013 and primarily reflected the net income for the period adjusted for non-cash items such as stock-based compensation expense, depreciation and amortization expense and changes in operating assets and liabilities.

Net cash used in investing activities was $0.1 million and $41,000 for the three months ended March 31, 2014 and 2013, respectively, and was related to the purchase of property and equipment.

Net cash used in financing activities was $2.3 million and $1.8 million for the three months ended March 31, 2014 and 2013, respectively. For the three months ended March 31, 2014 and 2013, we used $2.6 million and $2.5 million to repurchase and retire approximately 500,003 and 502,400 shares of our common stock under our stock repurchase program, respectively. For the three months ended March 31, 2014 and 2013, we also received $0.2 million and $0.1 million of proceeds, respectively, from the issuances of common stock made pursuant to options exercised, or shares otherwise issued for cash, under our stock award plans. For the three months ended March 31, 2013, our subsidiary borrowed $0.6 million under its loan agreement with Shanghai Pudong Development Bank Co. Ltd that expired August 29, 2013. All amounts borrowed were repaid by the expiration date.

 

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In December 2013, our subsidiary, NovaMed Pharmaceuticals (Shanghai) Co. Ltd., entered into a 10.0 million Renminbi revolving line of credit facility (approximately $1.6 million USD) and a maximum 15.0 million Renminbi loan facility (approximately $2.4 million USD) secured by its accounts receivable with Shanghai Pudong Development Bank Co. Ltd. (the “Credit Facility”). As of March 31, 2104, 10.0 million Renminbi (approximately $1.6 million USD) in borrowings were outstanding on the revolving line of credit facility that must be repaid by June 4, 2014 with early repayment allowed. The Credit Facility bears interest on borrowed funds at the People’s Bank of China 6-month base rate plus 15% (6.44% as of March 31, 2014). The Credit Facility expires on November 30, 2014 and any amounts borrowed must be repaid by the expiration date.

The following summarizes our future contractual obligations as of March 31, 2014 ( in thousands):

 

     Payments Due by Period  

Contractual Obligations

   Total      Less than
1 Year
     1-3 Years      3-5 Years      More Than
5 Years
 

Short-term debt obligation (1)

   $ 1,626       $ 1,626       $ —         $ —         $ —     

Operating leases (2)

     4,913         2,075         1,996         842         —     

Purchase obligations (3)

     8,110         8,110         —           —           —     

Uncertain tax positions (4)

     4,203         —           —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 18,852       $ 11,811       $ 1,996       $ 842       $ —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) Our short term debt obligations include our expected principal and interest obligations related to our Credit Facility with Shanghai Pudong Development Bank Co. Ltd. Our calculations of expected principal and interest payments incorporate only current period assumptions for interest rates and borrowings.
(2) These are future minimum rental commitments for office space and copiers leased under non-cancelable operating lease arrangements.
(3) These consist of purchase obligations with manufacturers and distributors.
(4) As we are not able to reasonably estimate the timing of the payments or the amount by which our obligations for unrecognized tax benefits will increase or decrease over time, the related balances have not been reflected in the “Payments Due by Period” section of the table.

Our promotion agreements with Sanofi, consisting of individual promotional agreements for certain pharmaceutical products and supplementary agreements extending the terms thereof, were not renewed and expired on December 31, 2013. We received initial notification of non-renewal from Sanofi in early October 2013. Subsequent thereto, we believe that Sanofi breached its obligations under these agreements by, among other things, failing to supply product for the fourth quarter of 2013 in relation to sales we generated, and failing to pay promotion fees due to NovaMed under the agreements. As of March 31, 2014, we had $3.3 million of uncollected receivables due from Sanofi that related to revenue recognized during the first three quarters of 2013. We have demanded that Sanofi make full payment of the promotional fees due to NovaMed. If this matter is not resolved to our satisfaction, we intend to vigorously pursue our claims against Sanofi in arbitration. We are also pursuing settlement options outside of formal arbitration.

Our agreements with Sanofi contain provisions (identical regardless of individual product promotion agreement) that required a refund of a portion of promotion service fees received during interim periods from them if defined annual sales targets were not achieved. Consistent with our past practice, and consistent with our achievement (or excess achievement) of annual revenue targets in each prior period, based on Method 2 of Accounting Standards Codification 605-20-S99-1, “Accounting for Management Fees Based on a Formula,” we recognized revenue during interim periods without reduction for amounts subject to refund because we met and substantially exceeded such targets on a “pro rata” basis at interim dates. Our treatment of the subject-to-refund portion is consistent with the contractual provisions, which provide that the sales targets will be measured on a pro-rated basis if an agreement were to hypothetically terminate as of any given date.

Due to Sanofi’s failure to place orders for shipment in the fourth quarter and fully meet the demand we generated, our actual promotional fees receivable in the fourth quarter of 2013 were negatively impacted. Due to this failure, we did not achieve the defined annual sales targets for fiscal 2013. Under our agreements with Sanofi, a failure to reach the annual sales target would result in approximately $6.2 million subject to refund related to our

 

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performance in the first three quarters of 2013. However, our agreements required that Sanofi continue to support our sales efforts by continuing to provide product through the end of the terms of the agreements. We believe we have no obligation to refund any amounts subject to this provision because our inability to achieve the defined annual sales was the result of a failure to perform by Sanofi. We are pending resolution of the dispute with Sanofi regarding the amount of $6.2 million subject to refund.

We have also reorganized our business as a result of the expiration of this agreement, and have incurred restructuring charges in the amount of approximately $1.2 million that were recorded in the fourth quarter of 2013, of which approximately $0.3 million remains accrued as of March 31, 2014 and is expected to be paid during the remainder of fiscal 2014.

On March 15, 2012, we filed a shelf registration with the SEC under which we may offer and sell up to $100.0 million of our securities, assuming we continue to meet the SEC’s eligibility requirements for primary offerings on Form S-3. Subsequently, affiliates of Sigma-Tau sold approximately 6.3 million shares for an aggregate price of approximately $33.1 million under this registration statement, and we have approximately $66.9 million available for future use.

Our Board of Directors has authorized a $50.5 million stock repurchase program, initiated in October 2011, which will expire December 31, 2014. Under this program, we repurchased and retired 500,003 shares at a cost of $2.6 million during the three months ended March 31, 2014 bringing the total repurchases since the program’s inception to approximately 8.4 million shares at a cost of $43.4 million through March 31, 2014. We consider several factors in determining when to make share repurchases including, among other things, our cash needs, the availability of funding and the market price of our stock. We expect that cash provided by future operating activities, as well as available cash and cash equivalents and short-term investments, will be the sources of funding for our share repurchase program.

In May 2013, as part of our framework agreement with Zensun, we agreed to enter into a $12.0 million loan facility to Zensun. We have finalized the licensing agreement with Zensun and anticipate funding approximately $2.3 million of the loan in 2014.

We believe that our existing cash, cash equivalents and investments and ongoing revenue generating business operations will be sufficient to support our current operating plan for at least the next 12 months. We have no current commitments to offer and sell any securities that may be offered or sold pursuant to our registration statement. To the extent that we raise additional capital by issuing equity securities, our stockholders may experience dilution. Debt financing, if available, may subject us to restrictive covenants and significant interest costs. To the extent that we raise additional funds through collaboration and licensing arrangements, we would be required to relinquish some rights to our technologies, product candidates or marketing territories. Additional financing or collaboration and licensing arrangements may not be available when needed either at all or, on favorable terms.

We intend to continue to explore alternatives for financing to provide additional flexibility in managing our operations, in-licensing new products, particularly for China, and potential acquisitions, as may be required. The unavailability or the inopportune timing of any financing could prevent or delay our long-term product development and commercialization programs, either of which could hurt our business. We cannot assure you that funds from financings, if any, will be sufficient to in-license additional products. The need, timing and amount of any such financing would depend upon numerous factors, including the status of the pending regulatory investigations and pending litigations, the level and price of our products, the timing and amount of manufacturing costs related to our products, the availability of complementary products, technologies and businesses, the initiation and continuation of preclinical and clinical trials and testing, the timing of regulatory approvals, developments in relationships with existing or future collaborative parties, the status of competitive products, and various alternatives for financing. We have not determined the timing or structure of any transaction.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

 

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Critical Accounting Estimates and Assumptions

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make judgments, estimates and assumptions in the preparation of our unaudited condensed consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates.

Our revenue recognition policy is as follows.

Revenue Recognition

We recognize revenue when persuasive evidence of an arrangement exists, services have been rendered or delivery has occurred, the price to the buyer is fixed or determinable and collectability is reasonably assured.

Product Revenue. We recognize product revenue from selling manufactured ZADAXIN product at the time of delivery. Sales of ZADAXIN to SinoPharm and its affiliates are recognized at time of shipment when title to the product is transferred to them. We also earn product revenue from purchasing medical products from pharmaceutical companies and selling them directly to importers or distributors. We recognize revenue related to these products based on the “sell-in” method, when the medical products have been delivered to the importers or distributors. Payments by the importing agents and distributors are not contingent upon sale to the end user by the importing agents or distributors.

Promotion Services Revenue. We recognize promotion services revenue after designated medical products are delivered to the distributors as specified in the promotion services contract, which marks the period when marketing and promotion services have been rendered, and the revenue recognition criteria are met. In certain arrangements, we are required to return or refund a portion of promotion services fees received during interim periods from pharmaceutical customers if defined annual sales targets are not achieved. Under our agreements with these customers, if the agreement is terminated, and provided such targets have been met on a “pro rata” basis at the date of contract termination, we are entitled to retain the amounts paid. Due to these contractual provisions, we recognize revenue during interim periods without reduction for amounts subject to refund based on Method 2 of Accounting Standards Codification 605-20-S99-1, “Accounting for Management Fees Based on a Formula.”

For a discussion of the Company’s other significant accounting policies, please see our Annual Report on Form 10-K for the fiscal year ended December 31, 2013. There have been no material changes in our critical accounting policies, estimates and judgments for the three months ended March 31, 2014 compared to the disclosures in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2013.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

There have been no material changes in our market risk for the three months ended March 31, 2014 compared to the disclosure in Part II, Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2013.

 

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), we evaluated the effectiveness of the design and operation of our disclosure controls and procedures, as such term is defined in Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended. Based on their evaluation at the end of the period covered by this quarterly report on Form 10-Q, our CEO and CFO have concluded that our disclosure controls and procedures were not effective at the reasonable assurance level due to the unremediated material weakness in our internal controls over financial reporting relating to the design and operating effectiveness of certain corporate monitoring controls which we have previously disclosed in Part II, Item 9A of our Annual Report on Form 10-K for the year ended December 31, 2013.

Status of Remediation of Material Weakness

As of March 31, 2014, we have implemented procedures designed to address the material weakness disclosed in our Annual Report on Form 10-K for the year ended December 31, 2013 related to the design and operating effectiveness of certain corporate monitoring controls. Management has implemented corporate monitoring controls and other controls to provide increased oversight over our China operations. As the Company continues to evaluate

 

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and work to improve its internal control over financial reporting, management may determine to take additional measures to address this material weakness or to modify the remediation steps described above. We will not be able to assess whether the steps we are taking will fully remediate the material weakness in our internal control over financial reporting until we have completed our implementation efforts and sufficient time passes in order to evaluate their effectiveness.

Changes in Internal Controls

There were no changes in our internal control over financial reporting during the quarter ended March 31, 2014 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Limitations of the Effectiveness of Internal Controls

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the internal control system are met. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. We are continuously seeking to improve the efficiency and effectiveness of our operations and of our internal controls. This results in refinements to processes throughout our organization.

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

The US Securities and Exchange Commission (“SEC”) and the US Department of Justice (“DOJ”) are each conducting formal investigations of us regarding a range of matters including the possibility of violations of the Foreign Corrupt Practices Act (“FCPA”). We will continue to cooperate fully with the SEC and DOJ in the conduct of their investigations.

In response to these matters, our Board of Directors appointed a Special Committee of independent directors (the “Special Committee”) to oversee our response to the government inquiry. Based on an initial review, the Special Committee decided to undertake an independent investigation as to matters reflected in and arising from the SEC and DOJ investigations including, but not limited to, certain sales and marketing matters in China, in order to evaluate whether any violation of the FCPA or other laws occurred.

During the investigation, the Special Committee instructed management to (i) evaluate and to expand the Company’s training of employees regarding understanding and compliance with laws including the FCPA and other anti-bribery laws and regulations, (ii) evaluate existing compliance and anti-bribery policies and guidelines and to prepare new, more detailed policies and guidelines for implementation after review by our Board of Directors and/or committees of the Board of Directors, (iii) implement a pre-approval policy for certain expenses including payments for, or reimbursement of, travel and entertainment expenses, and sponsorships of certain third-party events, (iv) establish an automated system for recording and approving travel and entertainment expenditures, and (v) hire a Vice President of Compliance and Internal Audit to monitor and enforce compliance with our policies. Also, upon the recommendation of the Special Committee, the Audit Committee of the Board has retained a forensic accountant to observe and make recommendations regarding our FCPA compliance.

The Special Committee substantially concluded its investigation of those matters and on May 4 and 5, 2011 reported its findings and recommendations to the Board of Directors. The Special Committee has also reported those findings to the SEC and DOJ, and the Special Committee and the Company have continued to cooperate with the on-going SEC and DOJ investigations.

In the Company’s Form 10-Q for the period ended September 30, 2012, filed with the SEC on November 9, 2012, the Company disclosed, among other things, a non-cash impairment loss to fully write down the value of intangible assets recorded as part of the NovaMed acquisition; a remeasurement of the valuation of the contingent consideration expense recorded as part of the NovaMed acquisition; a significant increase in ZADAXIN channel inventory levels; and internal control issues primarily within the NovaMed organization, and the corporate monitoring thereof, that was concluded to represent a material weakness in internal control over financial

 

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reporting. Following our disclosure of these items, the Company received a subpoena from the SEC requesting documents related to these and various other matters regarding the NovaMed acquisition and the Company’s operations in China. After review of the subpoena, and in order to respond to inquiries from the DOJ and SEC and to determine if any wrong-doing occurred, the Audit Committee determined to undertake an independent investigation as to additional matters, including but not limited to our acquisition of NovaMed and FCPA matters, including certain sales and marketing expenses.

We are unable to predict what consequences any investigation by any regulatory agency or by our Audit Committee may have on us. Our cooperation with these investigations has resulted in substantial legal and accounting expenses, has diverted management’s attention from other business concerns and could harm our business. The ongoing investigations and any other regulatory investigations that might be initiated in the future, will result in similar substantial expenses, management diversion and harm to our business. If we fail to comply with regulations or to carry out controls in our Chinese or other foreign operations in a manner that satisfies all applicable laws, our business would be harmed. Any civil or criminal action commenced against us by a regulatory agency could result in administrative orders against us, the imposition of significant penalties and/or fines against us, and/or the imposition of civil or criminal sanctions against certain of our officers, directors and/or employees. The investigations, results of the investigations or remedial actions we have taken or may take, if any, as a result of such investigations, may adversely affect our business in China. For the year ended December 31, 2013, we determined that a payment of $2.0 million to the government in penalties, fines and/or other remedies is probable. Accordingly, we have recorded $2.0 million of operating expense in our 2013 results of operations to reflect our estimate of a probable loss incurred related to potential penalties, fines and/or other remedies in the ongoing investigations with the SEC and DOJ. If we are subject to adverse findings resulting from the SEC and DOJ investigations, or from our own independent investigation, we could be required to pay higher or lower damages or penalties or have other remedies imposed upon us. In addition, we will incur additional expenses related to remedial measures we are undertaking, and could incur fines or other penalties. The period of time necessary to resolve the investigations by the DOJ and the SEC is uncertain, and these matters are requiring significant management, Board of Directors and financial resources which could otherwise be devoted to the operation of our business.

NovaMed is a party to a Distribution and Supply Agreement with MEDA originally entered into in early 2007. Following our acquisition of NovaMed on April 18, 2011, NovaMed continued to perform this agreement; however, MEDA claimed it had a right to terminate the agreement under a change of control provision. NovaMed does not believe that MEDA had a right of termination under the agreement. NovaMed and MEDA were in negotiations since the acquisition regarding potential amendments to the agreement that would resolve the disagreement. However, no resolution was reached. MEDA notified NovaMed that the termination was effective as of May 2011; however, as provided in the agreement, disputes, including disputes regarding termination, must be resolved in binding arbitration. We did not expect any significant revenues from the products which are the subject of this agreement until after 2014. NovaMed filed an application for binding arbitration with the China International Economic and Trade Arbitration Commission (“CIETAC”) on July 26, 2012. On April 3, 2014 CIETAC issued the final Award of the Arbitral Tribunal. The Arbitral Tribunal found that MEDA did have a right to terminate the agreement upon a change of control, but that MEDA must make reasonable reimbursement to NovaMed before any products’ rights are returned to MEDA. The amount that must be paid includes $333,333 as “unjust enrichment” plus an amount for reasonable compensation for such services provided by NovaMed to MEDA since the entry into the Distribution and Supply Agreement and up to the date of the Award. The amount of such payment for services was not determined by the Arbitral Tribunal, but was left to be determined by NovaMed. While NovaMed has the right to make a determination of the reasonable amount of its compensation for services, MEDA may elect to initiate another arbitration if it determines to dispute the reasonableness of NovaMed’s determination. However, NovaMed is not required to return to the product rights to MEDA until MEDA either makes concurrent payment to NovaMed, or (i) pays $333,333 to NovaMed, (ii) initiates a second CIETAC arbitration and (iii) posts a security bond of $2,666,666. On April 30, 2014, NovaMed informed MEDA that its determination of reasonable compensation for its services was $3,314,629, including the $333,333 for unjust enrichment. As MEDA has not yet agreed to such amount and could pursue further arbitration, the amount of any final payment to NovaMed remains uncertain.

On March 11, 2013, Adam Crum filed a derivative lawsuit, purportedly in the name of SciClone, against Friedhelm Blobel, Gary Titus, Jon Saxe, Peter Barrett, Richard Hawkins, Gregg Lapointe and Ira Lawrence in California Superior Court, San Mateo County, captioned Crum v. Blobel, et al , Case No. CIV520331. The lawsuit alleges, based on the restatement of our consolidated financial statements for the year ended December 31, 2011 and certain quarters of 2011 and 2012 resulting from the timing of revenue recognition for certain products sold by the

 

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Company’s subsidiary NovaMed, that the Board of Directors and management breached their fiduciary duties to the Company by not exercising oversight in such a way that they allowed the Company to file financial statements that were materially inaccurate. Plaintiff asserts claims for breach of fiduciary duty, abuse of control and mismanagement. Plaintiff seeks, among other things, injunctive relief, disgorgement, undisclosed damages and attorneys’ fees and costs. The Company and other defendants filed motions to dismiss the complaint. The court granted the motions to dismiss but allowed plaintiff to amend the complaint. An amended complaint has not yet been filed. Given the procedural process and the nature of this case, including that a motion to dismiss has been filed, the Company is unable to make a reasonable estimate of the potential loss or range of losses, if any, that might arise from this matter.

On or about November 20, 2013, counsel for the Company sent a letter on behalf of the Company’s subsidiary, NovaMed Pharmaceuticals (Shanghai) Co. Ltd. (“NovaMed”), to Sanofi (Hangzhou) Pharmaceuticals Co. Ltd. and Sanofi (Beijing) Pharmaceuticals Co., Ltd. (collectively, “Sanofi”) (i) asserting that Sanofi had breached its obligations under various agreements (the “Promotion Agreements”) between the parties for the promotion of Depakine®, Stilnox®, Tritace® and Xatral® (collectively the “Products”) by, among other things, failing to supply Products for the fourth quarter of 2013 in relation to sales the Company generated, and failing to pay promotion fees due to NovaMed under the Promotion Agreements, and (ii) demanding that Sanofi make full payment of the promotional fees due to NovaMed, and that Sanofi cause orders to be placed for the Products for November and December of 2013 in specified quantities. On or about December 4, 2013, counsel for Sanofi responded to such demand letter (i) denying any wrongful action or breach or failure to supply Products under the Promotion Agreements, and (ii) demanding that NovaMed provide certain in-market sales data from January to November 2013, provide a sales forecast for December 2013 and cooperate with an audit by Sanofi. On December 23, 2013, counsel for NovaMed responded to Sanofi’s request for additional data and proposed a potential settlement of the dispute. The parties have been meeting to discuss potential settlement of the dispute. However, the dispute has not been resolved by the parties. NovaMed has communicated to Sanofi that if the dispute is not resolved to its satisfaction, it intends to exercise all of its legal rights and remedies under the Promotion Agreements, including pursuing arbitration of the dispute through CIETAC pursuant to the terms of the Promotion Agreements. No formal legal proceeding has been initiated by or filed against the Company in connection with this matter.

 

Item 1A. Risk Factors

Consider these risks and uncertainties before investing in our common stock. We have marked with an asterisk (*) those risk factors below that reflect changes from the risk factors included in our Annual Report on Form 10-K filed with the SEC on March 17, 2014 .

Our stock price may be volatile, and an investment in our stock could suffer a decline in value. *

Although we reported net income of $4.1 million and $4.2 million for the quarters ended March 31, 2014 and 2013, respectively, we have experienced significant operating losses in the past, and as of March 31, 2014, we had an accumulated deficit of approximately $134 million. If our operating expenses were to increase or if we were not able to increase or sustain revenue, we may not achieve profitability over the next 12 months.

The market price of our common stock has experienced, and may continue to experience, substantial volatility due to many factors, some of which we have no control over, including:

 

    developments related to the pending SEC and DOJ investigations, our efforts to cooperate with the investigations and events related to pending litigation;

 

    government regulatory action affecting our Company or our drug products or our competitors’ drug products in China, the US and other foreign countries, including the effect of government initiatives in China, particularly actions intended to reduce pharmaceutical prices such as the reduction in the governmentally permitted maximum listed price for our products and increased oversight of the health care market and pharmaceutical industry;

 

    actual or anticipated fluctuations in our quarterly operating results, some of which may result from undertaking new clinical development projects, or from licensing or acquisition-related expenses including up-front fees, milestone payments, and other items;

 

    progress and results of clinical trials and the regulatory approval process in Europe and in China;

 

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    timing and achievement of our corporate objectives;

 

    charges related to expired inventory or bad debt;

 

    terminations of, or changes in our agreements or relationships with collaborative partners;

 

    announcements of technological innovations or new products by us or our competitors;

 

    announcement and completion of corporate acquisition, merger, licensing or marketing arrangements, or sales of assets;

 

    developments or disputes concerning patent or proprietary rights;

 

    changes in the composition of our management team or board of directors;

 

    changes in company assessments or financial estimates by securities analysts;

 

    changes in assessments of our internal control over financial reporting;

 

    general stock market conditions and fluctuations for the emerging growth and pharmaceutical market sectors;

 

    unanticipated increases in our G&A expense due to legal and accounting expenses, including expenses relating to the governmental investigations, our disputes with MEDA, and arising out of matters relating to any additional or uncorrected control deficiency or related matters;

 

    economic and political conditions in the US or abroad, particularly in China; and

 

    broad financial market fluctuations in the US, Europe or Asia.

Our acquisition of NovaMed involves a number of risks. Although we believe we have substantially completed the integration, there are some challenges that still could affect us and we have not realized all the anticipated benefits of the acquisition. We may acquire other companies or products that present similar risks.

We believe we have substantially completed the integration of our NovaMed acquisition and our operations and personnel are utilizing common business, information and communication systems, operating procedures, financial controls and human resources practices. We have experienced a number of challenges in the process of integration which have had, and could have further adverse effects on our business.

We may enter into other acquisition transactions in the future which could present similar risks and may also cause us to:

 

    issue common stock that would dilute our current shareholders’ percentage ownership;

 

    assume liabilities, some of which may be unknown at the time of such acquisitions;

 

    record goodwill and intangible assets that would be subject to impairment testing and potential periodic impairment charges;

 

    incur amortization expenses related to certain intangible assets; and

 

    incur large and immediate write-offs of in-process research and development costs; or become subject to litigation.

Our revenue will continue to be substantially dependent on our sale of ZADAXIN in China. The China government has previously imposed price restrictions on ZADAXIN, Aggrastat and several of our oncology products. If we experience difficulties in our sales efforts as a result, our operating results and financial condition will be harmed. *

Our product revenue is highly dependent on the sale of ZADAXIN in China. The percentage of our revenue that comes from ZADAXIN has declined since our acquisition of NovaMed as a result of additional product sales from NovaMed. However, we anticipate that sales of ZADAXIN will continue to be a majority of our revenue for at least the next two years. For the three months ended March 31, 2014 and 2013, approximately 96% and 95% of our ZADAXIN sales, respectively, were to customers in China. Sales of ZADAXIN in China may be limited due to the low average personal income, lack of patient cost reimbursement, poorly developed infrastructure and competition from other products, including generics. ZADAXIN sales growth in recent years has benefited from the rapidly

 

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growing Chinese economy and growing personal disposable income. Sales of ZADAXIN in China could be adversely affected by a slowing or downturn of the Chinese economy and from the recent and future decisions of the National Development Reform Commission (“NDRC”) and provincial agencies pricing reform.

In China, ZADAXIN is approved for the treatment of hepatitis B virus (“HBV”) and as a vaccine adjuvant. We face competition from pharmaceutical companies who are aggressively marketing competing products for the treatment of HBV and for other indications where we believe ZADAXIN may be used on an off-label basis. In addition, several local companies are selling lower-priced, locally manufactured generic thymalfasin, which is a competitive product and is selling in substantial and increasing quantities. While generic products outsell ZADAXIN in unit volumes, we have been able to maintain a pricing advantage through the reputation of our imported, branded product. We believe such competition will continue with added new local manufacturers of generic thymalfasin and there could be a negative impact on the price and the volume of ZADAXIN sold in China, which would harm our business. Our efforts to in-license or acquire other pharmaceutical products for marketing in China and other markets may be unsuccessful or even if successful may not have a meaningful effect on our dependence on ZADAXIN sales in those markets.

Sales of ZADAXIN may fluctuate significantly from quarter to quarter due to financing limitations on importers, changes in inventory levels at our customers, and surges in sales and inventories due to epidemics. Importers and distributors of ZADAXIN borrow funds in China from banks to purchase, hold and distribute ZADAXIN. Substantial increases in restrictions on fund availability and/or increases in borrowing costs could limit the ability of our importers and distributors to finance their import and distribution process. Further, our customers tend to purchase large orders, and inventory levels may fluctuate significantly as a result, or as a result of changes in the distribution channel, potentially affecting quarterly periodic results.

During the third quarter of 2012, we estimated that there was a substantial increase in ZADAXIN channel inventory levels and we believe that our sales to our customers exceeded the pace at which our customers were able to sell the ZADAXIN through to other parties, primarily hospital pharmacies. As a result, ZADAXIN revenues were lower in first quarter of 2013, as compared to the same period of 2014. We believe channel inventory has returned to normal levels, and we continue to believe that we will grow demand for ZADAXIN through increased penetration in the market; however, we may not be successful or we may experience future fluctuations in channel inventory either of which could adversely affect our future ZADAXIN revenue.

We could experience fluctuations in channel inventory due to actual or expected epidemics. For example, during the second quarter of 2009, we experienced a strong upsurge in ZADAXIN sales, which we believe was attributable both to the increasing penetration of ZADAXIN within the Chinese market, as well as concerns in China from the H1N1 influenza virus. If distributors and hospitals that purchase ZADAXIN stockpile more ZADAXIN than needed for current use, our subsequent sales of ZADAXIN may suffer as distributors and hospitals use ZADAXIN already in their inventory before purchasing additional product from us. This could lead to uneven future revenue results for ZADAXIN and in turn materially impact our cash flows and business condition.

The Chinese government is increasing its efforts to reduce overall health care costs, including pricing controls on pharmaceutical products. Individual provinces in China and, in some cases, individual hospitals can and have established pricing requirements for a product to be included on formulary lists. In some cases, these price limits have been significantly lower than prices at which our distributors have been selling ZADAXIN, in which case we have been removed from formulary lists, which consequently has reduced sales to certain hospitals and could adversely affect our future sales. The price for pharmaceutical products is regulated in China both at the national and at the provincial level. The process and timing for price restrictions is unpredictable. In addition, we are aware that ZADAXIN may be used on an off-label basis, and the Chinese government’s pricing, reimbursement or other actions might reduce such uses.

In November 2009, thymalfasin, the generic chemical name for our pharmaceutical product ZADAXIN, was included as a Category B product in the NRDL and pricing for ZADAXIN on the National Reimbursement Drug List (“NRDL”) was reviewed by the authorities. As a result of the China government’s review of pharmaceutical prices once a product has been included in the Reimbursement Drug List (“RDL”), the national reimbursement retail list price of ZADAXIN in China (i.e., the price at the hospital pharmacy level) was reduced by approximately 18% effective October 8, 2012. SinoPharm, our primary importer of ZADAXIN into China agreed to take a larger share of the impact of this price reduction in exchange for certain exclusive importation rights into China and as a result, the impact on our sales price per unit has been insignificant. As SinoPharm is now our exclusive importer of ZADAXIN into China, we have not made any subsequent sales of ZADAXIN to other importers. In addition, the NDRC price of Aggrastat, as well as several of our oncology products exclusively promoted in China for Pfizer and Baxter were reduced by amounts ranging from 10 to 20%.

 

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These pricing regulations, as well as regulation of the importation of pharmaceutical products have reduced and may further reduce prices for ZADAXIN or our other products to levels significantly below those that would prevail in an unregulated market, limit the volume of product which may be imported and sold or place high import duties on the product, any of which may limit the growth of our revenues or cause them to decline.

Our business strategy is dependent in part on our agreements with third parties for the rights to develop and commercialize products, or promote products, particularly in China. We have experienced challenges in maintaining some of our agreements and if we fail to enter into additional agreements, our business will suffer. *

Our sales and marketing strategy in China depends significantly on agreements with third parties, and potentially on entering into additional agreements with third parties, or renegotiating agreements with third parties. Except for ZADAXIN, our rights to develop, market and sell our products in China, including the products recently licensed from Zensun and TLC and products currently promoted or sold by our subsidiary, NovaMed, are held by us under license, promotion, distribution or marketing agreements with third parties. These agreements for products on the market including Aggrastat, and products in the regulatory review process, including DC Bead and several of NovaMed’s products in clinical trials, are held under license, distribution or marketing agreements. In addition, our success in the future may be dependent on entering into similar agreements with other parties and the renewal of any such agreements. The third parties to these agreements are generally not under an obligation to renew the agreements. If any of these agreements are terminated, or if they are not renewed, our ability to distribute, or develop, the products or product candidates could be terminated and our business could be affected. In addition, if any of such agreements acquired in our NovaMed acquisition are not renewed, we could incur a decline in sales revenues.

All of our products were originally obtained by us under licenses, promotion, distribution or similar third-party agreements. We do not conduct product discovery and our ability to bring new products to market is dependent upon our entering into additional acquisition, in-licensing, promotion or distribution agreements, particularly in China. The competition for attractive products is intense, and we cannot be certain that we will be able to negotiate in-license, promotion or distribution agreements for additional products in the future.

Our promotion agreements with Sanofi, consisting of individual promotional agreements for certain pharmaceutical products and supplementary agreements extending the terms thereof, were not renewed and expired on December 31, 2013. We received initial notification of non-renewal from Sanofi in early October 2013. Subsequent thereto, we believe that Sanofi breached its obligations under these agreements by, among other things, failing to supply product for the fourth quarter of 2013 in relation to sales we generated, and failing to pay promotion fees due to NovaMed under the agreements. As of December 31, 2013, we had $3.3 million of uncollected receivables due from Sanofi that related to revenue recognized during the first three quarters of 2013. We have demanded that Sanofi make full payment of the promotional fees due to NovaMed. If this matter is not resolved to our satisfaction, we intend to vigorously pursue our claims against Sanofi in arbitration. We are also pursuing settlement options outside of formal arbitration.

Our agreements with Sanofi contain provisions (identical regardless of individual product promotion agreement) that required a refund of a portion of promotion service fees received during interim periods from them if defined annual sales targets were not achieved. Consistent with our past practice, and consistent with our achievement (or excess achievement) of annual revenue targets in each prior period, based on Method 2 of Accounting Standards Codification 605-20-S99-1, “Accounting for Management Fees Based on a Formula,” we recognized revenue during interim periods without reduction for amounts subject to refund because we met and substantially exceeded such targets on a “pro rata” basis at interim dates. Our treatment of the subject-to-refund portion is consistent with the contractual provisions, which provide that the sales targets will be measured on a pro-rated basis if an agreement were to hypothetically terminate as of any given date.

Due to Sanofi’s failure to place orders for shipment in the fourth quarter and fully meet the demand we generated, our actual promotional fees receivable in the fourth quarter of 2013 were negatively impacted. Due to this failure, we did not achieve the defined annual sales targets for fiscal 2013. Under our agreements with Sanofi, a failure to reach the annual sales target would result in approximately $6.2 million subject to refund related to our performance in the first three quarters of 2013. However, our agreements required that Sanofi continue to support

 

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our sales efforts by continuing to provide product through the end of the terms of the agreements. We believe we have no obligation to refund any amounts subject to this provision because our inability to achieve the defined annual sales was the result of a failure to perform by Sanofi.

As we are in a dispute with Sanofi concerning their performance, we therefore deferred revenue recognition of approximately $2.8 million of Sanofi promotion fees for the fourth quarter of 2013, pending resolution of the dispute. As we are legally entitled to at least the $2.8 million recorded as a receivable, the non-recognition of revenue resulted in an equal and offsetting amount of deferred revenue. Our revenues for 2013, 2012 and 2011 with Sanofi were approximately $25.0 million, $30.8 million, and $19.7 million, respectively. The termination of these agreements will negatively affect our revenues in 2014, however we believe it will have only a modest effect upon our profitability in 2014.

In June 2013, we renewed our promotion agreement with Baxter for a 5-year term through December 2017. Our other significant agreement with Pfizer is expected to be renewed month-to-month until our negotiation for an extended or renegotiated agreement is concluded. Revenues for 2013, 2012, and 2011 related to our agreement with Pfizer were approximately $3.1 million, $8.8 million, and $5.5 million, respectively. We are actively negotiating the renewal or extension of this agreement. We continue to assess the financial performance of the products we promote under our agreements and their overall value within our entire portfolio of products. As part of this process, we have recently discontinued promotion of certain oncology products for Pfizer. Revenues related to these products were approximately $0.7 million, $1.5 million, and $2.7 million in 2013, 2012, and 2011, respectively. Over time, we anticipate the product mix that we promote will change which may affect our revenues and profitability in the future. Terminations or failures to renew these or any other agreement as to some or all of the products covered by the agreement could result in a decline in revenue and in other costs including restructuring charges if a resulting revenue decline required us to reduce costs. On the other hand, if we are successful in negotiating better terms there may be a positive impact on our revenues and profitability.

Our revenue will continue to be substantially dependent on our maintaining regulatory licenses and compliance with other regulations. *

We have received regulatory approvals to import and market ZADAXIN in China and to manufacture ZADAXIN and export the product from Italy. In order to continue our sales to China, we need to maintain these approvals. Our license to import ZADAXIN into China needs to be renewed every five years and the next renewal is required in 2017. Cardiome Pharma Corp. (formerly Correvio, LLC) has obtained a license to import Aggrastat into China that also needs to be renewed every five years with the next renewal required in July 2014. Although renewals in the past were obtained successfully, there is no assurance that SciClone or Cardiome Pharma Corp. will receive renewals in the future when applied for or that the renewals will not be conditioned or limited in ways that limit our ability to sell ZADAXIN or Aggrastat to China.

Our licenses to manufacture and export ZADAXIN from Italy are dependent upon our continuing compliance with regulations in Italy. Our business would be adversely affected if we are not able to maintain these approvals. In order to sell ZADAXIN to the licensed importers in China, our manufacturers must 1) be approved by the Italian Ministry of Health (“AIFA”) and 2) be accepted by the China Food and Drug Administration (“CFDA”). Some manufacturing changes may require: 1) approval by AIFA in Italy and/or 2) be accepted by the CFDA, the Chinese equivalent of the FDA. In addition, we must obtain an Imported Drug License (“IDL”) from the CFDA in order to sell ZADAXIN to the licensed importers in China. ZADAXIN registration in Italy has been essential to the renewal of our IDL from the CFDA permitting the importation of ZADAXIN into China. Our ability to continue to renew our IDL from the CFDA permitting the importation of ZADAXIN into China could be adversely affected, if we were to fail to maintain ZADAXIN registration in Italy. The CFDA, AIFA and other regulatory agencies may, and have, changed their internal administrative rules in ways that may delay or complicate the regulatory approval process. Those changes are not always disclosed or known to us and we may experience unexpected delays or additional costs as a result of such changes. Our product has been distributed in Italy through BioFutura Pharma Srl (“BioFutura”), a subsidiary of Sigma-Tau Finanziaria, S.p.A. (“Sigma-Tau”). In August 2012, we entered into an agreement with BioFutura to continue to distribute ZADAXIN for SciClone in Italy. However, if we are not able to continue this arrangement, we will need to establish alternative distribution operations in Italy to ensure continuing compliance with regulations in Italy and maintain our Italian licenses.

Our ZADAXIN sales and operations in other parts of China and the world are subject to a number of risks and increasing regulations, including difficulties and delays in obtaining registrations, renewals of registrations, permits, pricing approvals and reimbursement, increasing regulation of product promotion and selling practices, unexpected changes in regulatory requirements and political instability.

 

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We face risks related to the potential outcomes of the SEC and DOJ investigations regarding FCPA compliance and other matters, including potential penalties, substantial expense, the use of significant management time and attention, and changes in our marketing and sales practices that could affect our ability to generate revenue, any of which could adversely affect our business. *

In August 2010, we received notices of investigations by US government agencies that relate to our operations in China including compliance with the FCPA and we subsequently initiated an internal investigation regarding these matters. In connection with the formal, non-public SEC investigation, the SEC issued a subpoena to us requesting documents regarding a range of matters including but not limited to documents relating to potential payments or transfer of anything of value to regulators and government-owned entities in China; documents relating to bids or contracts with state or government-owned entities in China; documents relating to intermediary or local agent of the Company in China; documents regarding the Company’s ethics and anti-corruption policies, training, and audits; and documents relating to certain Company financial and other disclosures made by the Company. The DOJ is currently conducting an investigation of us in connection with compliance with the FCPA, as to which they have advised us that the DOJ has information about the Company’s practices suggesting possible violations. We have been cooperating with, and will continue to cooperate with, the investigations by and inquiries from the SEC and DOJ. In response to these matters, our Board of Directors appointed the Special Committee of independent directors to oversee our response to the government inquiry. The Special Committee conducted an independent investigation as to matters reflected in and arising from the SEC and DOJ investigations including, but not limited to, certain sales and marketing matters in China, in order to evaluate whether any violation of the FCPA or other laws occurred.

The Special Committee substantially concluded its investigation of those matters and on May 4 and 5, 2011 reported its findings and recommendations to the Board of Directors. The Special Committee reached a number of findings, including that we lacked appropriate internal controls to assure compliance with laws, including the FCPA, with respect to sales and marketing practices including payments for, or reimbursement of, third-party gifts, travel and entertainment expenses, and sponsorships of certain conferences and symposia. The Special Committee identified evidence of sales and marketing activities that might constitute potential violations of the FCPA. We are undertaking certain remedial measures recommended by the Special Committee and adopted by our Board of Directors.

In the Company’s Form 10-Q for the period ending September 30, 2012, filed with the SEC on November 9, 2012, the Company disclosed, among other things, a non-cash impairment loss to fully write down the value of intangible assets recorded as part of the NovaMed acquisition; a remeasurement of the valuation of the contingent consideration expense recorded as part of the NovaMed acquisition; a significant increase in ZADAXIN channel inventory levels; and internal control issues primarily within the NovaMed organization that were concluded to represent a material weakness in internal control over financial reporting. Following our disclosure of these items, the Company received a subpoena from the SEC requesting documents related to these and various other matters regarding the NovaMed acquisition and the Company’s operations in China. After review of the subpoena, and in order to respond to inquiries from the DOJ and SEC and to determine if any wrong-doing occurred, the Audit Committee determined to undertake an additional independent investigation as to additional matters, including, but not limited to, matters related to our acquisition of NovaMed and FCPA matters, and certain sales and marketing expenses.

We are unable to predict what consequences any investigation by any regulatory agency or by our Audit or Special Committees may have on us. Our cooperation with these investigations has resulted in substantial legal and accounting expenses, has diverted management’s attention from other business concerns and could harm our business. The ongoing investigations and any other regulatory investigations that might be initiated in the future will result in similar substantial expenses, management diversion and harm to our business. If we fail to comply with regulations or to carry out controls on our Chinese or other foreign operations in a manner that satisfies all applicable laws, our business would be harmed. Any civil or criminal action commenced against us by a regulatory agency could result in administrative orders against us, the imposition of significant penalties and/or fines against us, and/or the imposition of civil or criminal sanctions against certain of our officers, directors and/or employees. The investigations, results of the investigations, or remedial actions we have taken or may take as a result of such investigations may adversely affect our business in China. If we are subject to adverse findings resulting from the

 

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SEC and DOJ investigations, or from our own independent investigation, we could be required to pay damages or penalties or have other remedies imposed on us. As of March 31, 2014, we estimate that a payment of $2.0 million to the government in penalties, fines and/or other remedies is probable. This expense of $2.0 million was recorded to operating expense in our fourth quarter 2013 results of operations to reflect our estimate of a probable loss incurred related to potential penalties, fines and/or other remedies in the ongoing investigations with the SEC and DOJ. In addition, we will incur additional expenses related to remedial measures we are undertaking, and could incur fines that are more than the estimated or other penalties. The period of time necessary to resolve the investigations by the DOJ and the SEC is uncertain, and these matters are requiring significant management and financial resources, which could otherwise be devoted to the operation of our business.

If we fail to achieve or maintain an effective system of internal controls, we may not be able to accurately report our financial results. As a result, current and potential stockholders could lose confidence in our financial reporting, which would harm our business and the trading price of our stock. *

Effective internal controls are necessary for us to provide reliable financial reports and to protect from fraudulent, illegal or unauthorized transactions. If we cannot establish effective controls and provide reliable financial reports, our business and operating results could be harmed. Moreover, as a US-based corporation doing business in China, these controls often need to satisfy the requirements of Chinese law as well as the requirements of US law which frequently differ in certain aspects. We have in the past discovered, and may in the future discover, areas of our internal controls that need improvement. For example, during the third quarter of 2012, our management determined that we had a material weakness in internal control over financial reporting related to the design and operation of our controls primarily associated with product returns reserves and the override of certain controls in the financial statement close process related to our NovaMed subsidiary. Furthermore, during the fourth quarter of 2012, our management determined that we had an additional indicator of the same material weakness related to the timing of revenue recognition for our Pfizer products and the override of related controls at our NovaMed subsidiary, and the corporate monitoring thereof. Except for certain root causes which we have remediated, the material weakness around internal control over financial reporting, related to our China operations and corporate monitoring thereof, remained unremediated as of March 31, 2014. We continue to work on improvements to our internal controls and there can be no assurance that these or other material weaknesses will not occur in the future, or otherwise cause us to inaccurately report our financial statements. For example, the restatement of our financial statements for each of our first, second, and third quarters of 2012, and our financial statements for each of the second and third quarters of 2011 and the year ended December 31, 2011, were in part caused by the material weakness related to the design and operation of our controls disclosed as of December 31, 2012 discussed above. Any failure to implement and maintain controls over our financial reporting or difficulties encountered in the implementation of improvements in our controls, could cause us to fail to meet our reporting obligations. Any failure to improve our internal controls or to address identified weaknesses in the future, if they were to occur, could also cause investors to lose confidence in our reported financial information, which could have a negative impact on the trading price of our stock.

Compliance with changing regulations concerning corporate governance and public disclosure has resulted in and may continue to result in additional expenses. Changing laws, regulations and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002, new SEC regulations and The NASDAQ Stock Market rules, are creating uncertainty for companies such as ours and costs are increasing as a result of this uncertainty and other factors. We are committed to maintaining high standards of corporate governance and public disclosure. As a result, we intend to invest all reasonably necessary resources to comply with evolving standards, and this investment has and may continue to result in increased general and administrative expenses and a diversion of management time and attention from revenue-generating activities to compliance activities.

We may not be able to effectively manage our employees and distribution network, and our reputation, business, prospects and brand may be materially and adversely affected by actions taken by our distributors and third-party marketing firms.

Our company policies prohibit our employees from making improper payments to hospitals or otherwise engaging in improper activities to influence the procurement decisions of hospitals, and we take remedial actions, including termination, when employees do not adhere to our policies. However, we may not be able to effectively ensure that every employee complies at all times with our policies. The compensation of our sales and marketing personnel is partially linked to their sales performance. Although we have made numerous changes to ensure compliance with our policies and to attempt to avoid any violation of law, we cannot assure you that employees will not violate the anticorruption laws of China, the United States and other countries. Such violations could have a material adverse effect on our reputation, business, prospects and brand.

 

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Furthermore, our employees in China have access to our facilities and internal systems and we have identified from time to time certain minor instances of improperly submitted expense reporting by our employees. Although these instances have involved insignificant sums, our employees may seek to create additional opportunities to engage in misappropriation or other employee malfeasance. If our controls and procedures to prevent such activities fail or are circumvented, our business would be negatively affected by, among other things, the related financial losses, diminished reputation and threat of litigation and regulatory inquiry and investigation.

We do not control, and therefore have limited ability to manage, the activities of third-parties who assist us in marketing and distributing our products. Our distributors or other third parties with whom we do business could take actions which violate the anti-corruption laws of China, the United States or other countries. Failure to adequately manage our employees, and third parties and, or their non-compliance with employment, distribution or marketing agreements, could harm our corporate image among hospitals and end users of our products and disrupt our sales, resulting in a failure to meet our sales goals. Furthermore, we could be liable for actions taken by our employees, distributors or third-party marketing or third-party firms, including any violations of applicable law in connection with the marketing or sale of our products, including China’s anticorruption laws and the FCPA of the United States. In particular, if our employees, distributors or third-party marketing firms make any payments that are forbidden under the FCPA, we could be subject to civil and criminal penalties imposed by the US government.

Recently, the Chinese government has increased its anti-corruption measures. In the pharmaceutical industry, corrupt practices include, among others, acceptance of kickbacks, bribes or other illegal gains or benefits by the hospitals and medical practitioners from pharmaceutical manufacturers and distributors in connection with the prescription of certain pharmaceuticals. Our employees, affiliates, distributors or third-party marketing firms may violate these laws or otherwise engage in illegal practices with respect to their sales or marking of our products or other activities involving our products. If our employees, affiliates, distributors or third-party marketing firms violate these laws, we could be required to pay damages or fines, which could materially and adversely affect our financial condition and results of operations. In addition, Chinese laws regarding what types of payments to promote or sell our products are impermissible are not always clear, and local regulatory authorities enforcing these laws are not always consistent. As a result, we, our employees, affiliates, our distributors or third-party marketing firms could make certain payments in connection with the promotion or sale of our products or other activities involving our products which at the time are considered by us or them to be legal but are later deemed impermissible by the Chinese government, or we may be asked to make payments by local government authorities that may not be permissible under China’s anticorruption laws or the FCPA. Furthermore, our brand and reputation, our sales activities or the price of our common stock could be adversely affected if we become the target of any negative publicity as a result of actions taken by our employees, affiliates, distributors or third-party marketing firms.

The audit report as of and for the year ended December 31, 2013 included in our most recent Annual Report on Form 10-K was prepared by auditors who are not inspected by the Public Company Accounting Oversight Board (“PCAOB”), and, although they may be subject to other inspections, you do not have the benefits of PCAOB inspections. *

Although our independent auditors’ quality control practices and individual audits may be subject to review or inspection from time to time by peers or by industry bodies in China, such reviews or inspections often are substantially different from, or not comparable to, an inspection by the PCAOB in accordance with the professional standards thereof. Auditors of companies that are registered with the SEC and traded publicly in the US, including our independent registered public accounting firm, must be registered with the PCAOB, and are required by the laws of the United States to undergo regular inspections by the PCAOB to assess their compliance with the laws of the United States and professional standards. Because our auditors are located in the People’s Republic of China, a jurisdiction where the PCAOB is currently unable to conduct inspections without the approval of the Chinese authorities, our auditors are not currently inspected by the PCAOB. This lack of PCAOB inspections in China prevents the PCAOB from regularly evaluating audits and quality control procedures of any auditors operating in China, including our auditors. As a result, investors in our equity securities may be deprived of the benefits of PCAOB inspections. The inability of the PCAOB to conduct inspections of auditors in China makes it more difficult to evaluate the effectiveness of our auditors’ audit procedures or quality control procedures as compared to other public company auditors outside of China that are subject to PCAOB inspections. As a result, investors in our stock may lose confidence in our reported financial information and procedures and the quality of our financial statements.

 

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An initial decision in proceedings instituted by the SEC against five People’s Republic of China (“PRC”)-based accounting firms, including our independent registered public accounting firm, could result in our financial statements being determined to not be in compliance with the requirements of the Securities Exchange Act of 1934. *

In December 2012, the SEC instituted administrative proceedings against five PRC-based accounting firms, including our independent registered public accounting firm, alleging that these firms had violated US securities laws and the SEC’s rules and regulations thereunder by failing to provide to the SEC the firms’ work papers related to their audits of certain PRC-based companies that are publicly traded in the United States and which are the subject of certain ongoing SEC investigations. We were not and are not the subject involved in the proceedings brought by the SEC against the accounting firms. On January 22, 2014, the SEC Administrative Law Judge (the “ALJ”) presiding over the matter reached an initial decision. The ALJ concluded that each of the accounting firms, including our independent registered accounting firm, violated the SEC’s Rules of Practice by failing to produce audit workpapers directly to the SEC. It further determined that each of the firms (except for one which no longer provides audit services to China-based U.S. companies) should be censured and barred from practicing before the SEC for a period of six months. These affected firms prepared and filed appeals to the initial decision in February 2014, which will require further time to review and administer. This initial decision, however, has no binding legal effect until it is reviewed and endorsed by the full SEC Commission, although that endorsement could then be subject to appeal by the accounting firms through the courts. While we cannot predict the outcome of the SEC Commission’s review or that of any subsequent appeal process, if the appeals of the initial decision do not have an effect and the initial decision is upheld, endorsed, and not further successfully appealed at a higher level, the accounting firms, including our independent registered public accounting firm, would be temporarily denied the ability to practice before the SEC. If during this temporary period, there was a need to issue an audit report on our financial statements under the US federal securities laws, principally the Securities Exchange Act of 1934, as amended, or the Exchange Act, and we are unable to timely find another registered public accounting firm which can audit and issue a report on our financial statements, our financial statements could be determined to not be in compliance with the requirements for financial statements of public companies registered under the Securities Exchange Act of 1934, as amended, or the Exchange Act. Such a determination could ultimately lead to the delisting of our common stock from the NASDAQ Global Select Market or deregistration from the SEC, or both, which would substantially reduce or effectively terminate the trading of our common stock in the United States.

Our compliance with the Foreign Corrupt Practices Act may put us at a competitive disadvantage, while our failure to comply with the Foreign Corrupt Practices Act may result in substantial penalties.

As a US reporting company, we are required to comply with the FCPA. If our employees or other agents are found to have engaged in practices in violation of the FCPA, we could suffer severe penalties. Non-US companies, including some of our competitors, are not subject to the provisions of the FCPA. Corruption, extortion, bribery, pay-offs, theft and other fraudulent practices occur from time to time in mainland China. If our competitors engage in these practices, they may receive preferential treatment from personnel of some companies, giving our competitors an advantage in securing business or from government officials who might give them priority in their business dealings, which would put us at a disadvantage.

Retaliation from terminated employees may damage our reputation or make claims that could subject us to further regulatory action.

From time to time we have terminated the employment of certain employees for performance-related reasons, including, in particular, our policies intended to prevent corruption. Employees who are terminated may seek more favorable terms of separation by threatening to damage our reputation in the marketplace. Further, they may seek to retaliate against us by making so-called “whistleblower” claims under the provisions enacted by the Dodd-Frank Act that may entitle persons who report alleged wrong-doing to the SEC to cash rewards. We anticipate that these provisions will result in a significant increase in whistleblower claims across our industry, and dealing with such claims could generate significant expenses and take up significant management time, even for frivolous and non-meritorious claims. Any investigations of whistleblower claims may impose additional expense on us, may require the attention of senior management and members of the Board of Directors and may result in fines and/or reputational damage whether or not we are deemed to have violated any regulations. Furthermore, terminated employees may also seek to retaliate against us by making claims against us to other regulatory agencies, including local regulatory authorities. Inquiries by local regulatory agencies about such claims, even if frivolous and non-meritorious, could also generate significant expenses and take up significant management and Board of Directors’ time.

 

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We may incur unexpected charges relating to our operations.

Although we have generally experienced minimal product returns and our customers have historically paid all invoiced amounts, we could incur future charges relating to inventory that expires or as a result of customer failures to pay invoiced amounts timely or in full. For example, we recorded $2.4 million to bad debt expense for the year ended December 31, 2013 related to one customer whose accounts receivable are significantly past due and for which collectability is uncertain. In addition, we could also experience a charge for inventory obsolescence related to Aggrastat or other products if we are unable to sell units of Aggrastat or other products that are nearing their expiry dates, or for bad debt if a former distributor does not pay an outstanding receivable in full. Those or similar future events would have an adverse impact upon our operating results.

We are at risk of additional securities class action and derivative lawsuits. *

Securities class action and derivative lawsuits are often filed against public companies following a decline in the market price of their securities. After our announcement regarding SEC and DOJ investigations in 2010, we and certain of our officers and directors were named as parties in purported stockholder class actions and derivative lawsuits. Those class action lawsuits were dismissed and we have settled those derivative lawsuits. Our stock price declined following the announcement of a restatement of our financial statements for fiscal 2011 and the first three quarters of fiscal 2012, and that our predecessor independent auditing firm had elected not to stand for reappointment for the 2013 fiscal year. Soon after that announcement, we and certain of our officers and directors were named as parties in a purported derivative lawsuit relating to the restatement. We may experience stock price volatility in the future, either related to announcements regarding the SEC and DOJ investigations, our own investigations related thereto, or other matters. This risk is especially relevant for us because biotechnology companies have experienced greater than average stock price volatility in recent years. We may be named in additional litigation, which will require significant management time and attention and result in significant legal expenses and may result in an unfavorable outcome, which could have a material adverse effect on our business, financial condition, results of operations and cash flows. Such litigation could result in additional substantial costs and a diversion of management’s and the Board of Directors’ attention and resources, which could harm our business.

We may not be able to successfully develop or commercialize our products.

We have numerous products under development in China, some of which were acquired in the NovaMed acquisition and others were in-licensed by us. We have recently in-licensed two additional product candidates, Neucardin from Zensun and ProFlow from TLC, for each of which our future development expenses and milestone payments could be material.

Clinical trials are inherently risky and may reveal that our product candidates are ineffective or have unanticipated side effects and/or drug interactions that may significantly decrease the likelihood of regulatory approval. For example, in March 2012 we announced the discontinuation of our phase 2b clinical trial evaluating SCV-07 for the delayed onset of oral mucositis. This decision was based on the results of a pre-planned interim analysis that indicated that the trial would not meet the pre-specified efficacy endpoints, and we have no plans to proceed with further development of SCV-07 at this time.

The regulatory approval processes in the US, Europe and China are demanding, lengthy and expensive. We have committed significant resources, including capital and time, to develop and seek approval for products under development, and if we do not obtain approvals we are seeking, we may be unable to achieve any revenue from these products. All new drugs, including our product candidates, are subject to extensive and rigorous regulation by the FDA, CFDA and similar regulatory agencies. These regulations govern, among other things, the development, testing, manufacturing, labeling, storage, pre-market approval, importation, advertising, promotion, sale and distribution of our products. These regulations may change from time to time and new regulations may be adopted.

Satisfaction of government regulations may take several years and the time needed to satisfy them varies substantially based on the type, complexity and novelty of the pharmaceutical product. As a result, government regulation may cause us to delay the introduction of, or prevent us from marketing, our existing or potential products for a considerable period of time and impose costly procedures on our activities. We have experienced delays in the regulatory process and continue to experience delays, and there exists risk that we may not receive approval,

 

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including with the approval process for DC Bead or other in-licensed products. In addition, the Chinese government is increasing its efforts to reduce overall health care costs, including pricing controls on pharmaceutical products. We cannot determine what the potential government pricing constraints are likely to be for products in development in advance. Therefore, we may be required to abandon the development or commercialization of a product after significant effort and expense if we determine at any time that trends in government pricing constraints will make the commercialization of a product unprofitable.

To fully develop these products and other products we may acquire, substantial resources are required for extensive research, development, pre-clinical testing, clinical trials, and manufacturing scale-up and regulatory approval prior to the potential products being ready for sale. We cannot assure that our efforts will produce commercially viable products. We face significant technological risks inherent in developing these products. We may also abandon some or all of our proposed products before they become commercially viable. We are obligated to make a milestone payment upon regulatory approval of certain products under development. If any of our products, even if developed and approved, cannot be successfully commercialized in a timely manner, our business will be harmed and the price of our stock may decline.

Market acceptance of any product that is successfully developed and approved will depend on many factors, including our ability to convince prospective customers to use our products as an alternative to other treatments and therapies. In addition, doctors must opt to use treatments involving our products. If doctors elect to use a different course of treatment, demand for our drug products would be reduced. In addition, for certain products we may need to convince partners to manufacture or market our products. Failure to do any of the above will lead to an unfavorable outcome on the results of our operations.

Our success is dependent upon the success of our sales and marketing efforts in China, and we may experience difficulties in complying with regulations, slow collections or other matters that could adversely affect our revenue in China.

Following the acquisition of NovaMed, we have several products on the market in China in addition to ZADAXIN. Our future revenue growth depends to a great extent on increased sales of ZADAXIN to China and increased sales of the products promoted or marketed by NovaMed. If we fail to continue to successfully market ZADAXIN or NovaMed’s product portfolio, our revenue and operating results will be limited. If unexpected and serious adverse events are reported, or if expected efficacy results are not achieved, it would have a material adverse effect on our business.

Our sales are concentrated in China and we face risks relating to operating in China, including pricing and other regulations, slow payment cycles and exposure to fluctuations in the Chinese economy. *

The Chinese government is increasing its efforts to reduce overall health care costs, including pricing controls on pharmaceutical products. Individual provinces in China and, in some cases, individual hospitals can and have established pricing requirements for a product to be included on formulary lists. The Chinese government has imposed price restrictions on ZADAXIN, Aggrastat and various oncology products we promote. As a result of the China government’s review of pharmaceutical prices once a product has been included in the Reimbursement Drug List (“RDL”), the national reimbursement retail list price of ZADAXIN in China (i.e., the price at the hospital pharmacy level) was reduced by approximately 18% effective October 8, 2012. SinoPharm, our primary importer of ZADAXIN into China agreed to take a larger share of the impact of this price reduction in exchange for certain exclusive importation rights into China. Since the terms of our agreement with SinoPharm went into effect, the average impact on our sales price per unit has been insignificant. As SinoPharm is now our exclusive importer of ZADAXIN into China, we have not made any subsequent sales of ZADAXIN to other importers.

Over the long term, we believe that the price reductions may positively affect our sales volumes and result in broader penetration into Tier 3 and Tier 2 cities in target geographies, potentially increasing our total sales revenues from these products. However, the process and timing for any price restrictions is unpredictable and further price reduction could be imposed that could adversely affect our business. Further, the successful sales and marketing of all of our products requires continuing compliance with other regulations in China relating to the import, manufacture, approval and distribution of products and if we or our partners are not able to obtain or maintain necessary licenses or other approvals, our operations would be adversely affected.

We experience other issues with managing sales operations in China including long payment cycles, potential difficulties in timely accounts receivable collection and, especially from significant customers, fluctuations in the timing and amount of orders and the adverse effect of any of these issues on our business could be increased due to

 

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the concentration of our business with a small number of distributors. Problems with collections from, or sales to, any one of those distributors could materially adversely affect our results. Operations in foreign countries including China also expose us to risks relating to difficulties in enforcing our proprietary rights, currency fluctuations and adverse or deteriorating economic conditions. If we experience problems with these matters, or if significant political, economic or regulatory changes occur, our results could be adversely affected. As of March 31, 2014, we have accounts receivable, not related to Sanofi, totaling approximately $3.5 million that are substantially delinquent and which we are actively trying to collect, and for which we have recorded a reserve of $3.5 million as a result of continual negotiations that indicate the accounts receivable balance may not be recoverable. The customer has a binding obligation to pay us, but we may have to pursue legal remedies, and there can be no assurance if we are not paid and we pursue legal action what the timing or result of such action would be.

Our operations throughout the world including China are potentially subject to the laws and regulations of the US including the FCPA, in addition to the laws and regulations of the other countries. Regulation in China of the activities in the pharmaceutical industry has increased and may continue to undergo significant and unanticipated changes. A number of companies have faced significant expenses or fines as a result of the increasing regulation of, and enforcement activity regarding, the pharmaceutical industry. The Chinese government has recently made arrests of pharmaceutical company employees for allegedly illegal sales and marketing activities. Recent or future arrests of sales personnel, doctors or others in the pharmaceutical industry, whether or not the individuals violated laws or regulations, could impact the operations and results of pharmaceutical companies in China, including our own. The Chinese government has also been investigating the costs to manufacture approximately 40 pharmaceutical products sold in China. While SciClone was not involved in either of these actions, these actions may be an indication of heightened Chinese government oversight of the pharmaceutical industry, and of multinational pharmaceutical companies in particular. Such activities could have long-term implications for the pharmaceutical industry in China including increased pricing pressure and a heightened level of government oversight and investigations, either of which could adversely affect the industry as a whole or individual companies, including SciClone.

Currently all of our revenue is generated from customers located outside the US, and a substantial portion of our assets, including employees, are located outside the US. US income taxes and foreign withholding taxes have not been provided on undistributed earnings of non-US subsidiaries, because such earnings are intended to be indefinitely reinvested in the operations of those subsidiaries. The US government may propose initiatives that would substantially reduce our ability to defer US taxes including: repealing deferral of US taxation of foreign earnings, eliminating utilization or substantially reducing our ability to claim foreign tax credits, and eliminating various tax deductions until foreign earnings are repatriated to the US. If any of these proposals are constituted into legislation, they could increase our US income tax liability and as a result have a negative impact on our financial position and results of operations.

Chinese healthcare regulation and the Chinese market are changing rapidly and we may modify our strategy in response to those changes and we cannot assure you that we will be successful in implementing changes. *

The Chinese healthcare and regulatory environment have changed and are likely to continue to change in response to Chinese government policies and other factors. We intend to evaluate and make modifications to our strategy in response to these changes. We intend to continue our strategies of growing business in China by expanding ZADAXIN sales, entering into new promotional agreements, and seeking of products that have been approved outside China, but we may implement additional strategies, including expanding our capabilities in China to develop earlier stage products in-licensed from third parties in China or elsewhere. If we make significant additions or changes to our strategy, we may not be successful in implementing such changes, or the Chinese market may change in unexpected directions to which we are not able to respond timely.

We may lose market share or otherwise fail to compete effectively in the intensely competitive pharmaceutical industry.

Competition in the pharmaceutical industry in China is intense, and we believe that competition will increase. Our success depends on our ability to compete in this industry, but we cannot assure you that we will be able to successfully compete with our competitors. Increased competitive pressure could lead to intensified price-based competition resulting in lower prices and margins, which would hurt our operating results. We cannot assure you that we will compete successfully against our competitors or that our competitors, or potential competitors, will not develop drugs or other treatments for our targeted indications that will be superior to ours.

 

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We depend on sales to China, and global conditions could negatively affect our operating results or limit our ability to expand our operations in and outside of China. Changes in China’s political, social, regulatory and economic environment may affect our financial performance.

Our business is concentrated in China. Heightened tensions resulting from the current geopolitical conditions in the Middle East, North Korea and elsewhere could worsen, causing disruptions in foreign trade, which would harm our sales. In particular, our commercial product is manufactured in Europe and distributed by us from our operations in Hong Kong. Any disruption of our supply and distribution activities due to geopolitical conditions could decrease our sales and harm our operating results.

With respect to China, our financial performance may be affected by changes in China’s political, social, regulatory and economic environment. The role of the Chinese central and local governments in the Chinese economy is significant. Chinese policies toward economic liberalization, and laws and policies affecting foreign companies, currency exchange rates and other matters could change, resulting in greater restrictions on our ability to do business in China. Any imposition of surcharges or any increase in Chinese tax rates could hurt our operating results. The Chinese government could revoke, terminate or suspend our license for national security and similar reasons without compensation to us. If the government of China were to take any of these actions, we would be prevented from conducting all or part of our business. Any failure on our part to comply with governmental regulations could result in the loss of our ability to market our products in China.

Because of China’s tiered method of importing and distributing finished pharmaceutical products, our quarterly results may vary substantially from one period to the next; we are dependent upon SinoPharm as the exclusive importer of ZADAXIN. *

Imported products in China, including ZADAXIN and NovaMed’s imported products, are distributed through a tiered method to import and distribute finished pharmaceutical products. Promoted products are typically sold from our partner companies within China to the primary distributor with the following distribution being the same for imported as well as promoted products. At each port of entry, and prior to moving the product forward to the distributors, government-licensed importing agents must process and evaluate each imported product shipment to determine whether it satisfies China’s quality assurance requirements. In order to efficiently manage this process, the importing agents typically place large, and therefore relatively few, orders within an annual period. Therefore, sales to an importing agent can vary substantially from quarter to quarter depending on the size and timing of the orders, which has in the past and may in the future cause our quarterly results to fluctuate. We rely on SinoPharm to supply our ZADAXIN sales. Our receivables from SinoPharm are material, and if we were unable to collect receivables from SinoPharm or any other importer, our business and cash-flow would be adversely affected. In 2012, we also relied on another distributor to supply our ZADAXIN product. Receivables from this importer are $3.5 million as of March 31, 2014 that are more than one year past due and fully reserved, and if we were unable to collect these receivables, our business and cash-flow would be adversely affected.

Generally, our importers are not obligated to place purchase orders for our product, and if they determined for any reason not to place purchase orders, we would need to seek alternative licensed importers, which could cause fluctuations in our revenue. As a result of our recent agreement granting certain exclusive importation rights to SinoPharm for ZADAXIN, we are dependent upon SinoPharm’s performance of its obligations under that agreement. We have a long-standing and, we believe excellent, relationship with SinoPharm; however, if SinoPharm were unable to adequately perform its obligations under, or breached, the agreement our business would be adversely affected.

The existence of counterfeit pharmaceutical products in China’s pharmaceutical retail market may damage our brand and reputation and have a material adverse effect on our business, financial condition, results of operations and prospects. *

Certain medicine products distributed or sold in China’s pharmaceutical retail market, including those appearing to be our products, may be counterfeit. Counterfeit products are products sold under the same or very similar brand names and/or have a similar appearance to genuine products. Counterfeit products, including counterfeit pharmaceutical products, are a significant problem in China. Such products divert sales from genuine products, often are of lower cost, often are of lower quality (having different ingredients or formulations, for example), and have the potential to damage the reputation for quality and effectiveness of the genuine product. The counterfeit pharmaceutical product regulation control and enforcement system in China is not able to completely eliminate production and sale of counterfeit pharmaceutical products. To increase our ability to prevent

 

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counterfeiting, we have taken several actions, including enhancements of our product labeling to implement industry-leading labeling technology and implementation of product tracking applications. However we cannot eliminate counterfeiting and, any sale of counterfeit products resulting in adverse side effects to consumers may subject us to negative publicity and expenses. It could have a material adverse effect on our business, financial condition, results of operations and prospects.

We may be subject to currency exchange rate fluctuations, which could adversely affect our financial performance. *

A majority of our product sales are denominated in US dollars and a significant portion of our sales and expenses are denominated in Renminbi. Fluctuation in the US dollar exchange rate with local currency directly affects the customer’s cost for our product. In particular, a stronger US dollar vis-à-vis the local currency would tend to have an adverse effect on sales and potentially on collection of accounts receivable. China currently maintains the value of the Renminbi in a narrow currency trading band that may or may not fluctuate based on government policy. The Chinese government has recently announced a small widening of the trading band. Depending on market conditions and the state of the Chinese economy, China has intervened in the foreign exchange market in the past to prevent significant short-term fluctuations in the Renminbi exchange rate, and it could make future adjustments, including moving to a managed float system, with opportunistic interventions. This reserve diversification may negatively impact the US dollar and US interest rates. A trend to a stronger US dollar would erode margins earned by our Chinese importers and prompt them to ask us to lower our prices. A weaker US dollar would increase our in-country China operating expenses, and with the addition of NovaMed, our China operating expenses have increased. We are subject to currency exchange rate fluctuations as a result of expenses incurred by our foreign operations. In particular, one of our supply arrangements under which we purchase finished products is denominated in euros and costs of our operations in China are paid in local currency. Consequently, changes in exchange rates could unpredictably and adversely affect our operating results and could result in exchange losses. To date, we have not hedged against the risks associated with fluctuations in exchange rates and, therefore, exchange rate fluctuations could have a material adverse impact on our future operating results and stock price.

We cannot predict the safety profile of the use of ZADAXIN or other drugs we may develop or market particularly when used in combination with other drugs. *

While the products we market generally have excellent safety profiles, we cannot predict whether any product may have unexpected safety issues in a particular patient population or when used in new indications. In addition, we cannot predict how ZADAXIN or other drugs we may develop or market will work with other drugs, including causing possible adverse side effects not directly attributable to the other drugs that could compromise the safety profile of ZADAXIN or other drugs we may develop or market when used in certain combination therapies.

If third-party reimbursement is not available or patients cannot otherwise pay for ZADAXIN or other drugs we may develop, we may not be able to successfully market them.

Significant uncertainty exists as to the reimbursement status of therapeutic products, such as ZADAXIN or other drugs we may develop. We cannot assure you that third-party insurance coverage and reimbursement will be available for therapeutic products we might develop. Although ZADAXIN receives some limited reimbursement in certain provinces in China, we cannot assure you that we will be able to maintain existing reimbursements or increase third-party payments for ZADAXIN or obtain third-party payments for other products that we sell or develop in China. The failure to obtain or maintain third-party reimbursement for our products would harm our business. Further, we cannot assure you that additional limitations will not be imposed in the future in the US or elsewhere on drug coverage and reimbursement due to proposed health care reforms. In many emerging markets where we have marketing rights to ZADAXIN, but where government resources and per capita income may be so low that our products will be prohibitively expensive, we may not be able to market our products on economically favorable terms, if at all.

Recent efforts by governmental and third-party payers to contain or reduce health care costs and the announcement of legislative proposals and reforms to implement government controls has caused us to reduce the prices at which we market our drugs in China, and additional reforms, if they were to occur, could cause us to further reduce our prices which could reduce our gross margins and may harm our business.

We rely on third parties who are our sole source suppliers for our clinical trial and commercial products and their inability to deliver products that meet our quality-control standards could delay or harm one or more important areas of our business including our sales, clinical trials or the regulatory approval process. *

 

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We rely on third parties, who are subject to regulatory oversight, to supply our commercial products. Any deficiencies or shortages in supply of our commercial products would adversely affect our ability to realize our sales plans. For example, the manufacturing of the raw material and the processing to finished product of ZADAXIN is done in few batches in any given three-month period and any manufacturing errors have the potential to require a product recall. We currently have only one approved finished vial manufacturer and two approved active pharmaceutical ingredient (“API”) suppliers. If we experience a problem with the manufacturer or our suppliers, our sales may suffer. We and NovaMed have each experienced difficulties with obtaining product from manufacturers in the past. During 2012, we experienced limitations on supply of Depakine IV, Perenan , Methotrexate , and Rulide (each of which we no longer market) and the growth in the sales of those products was affected. During 2011, we experienced manufacturing delays related to repairs for general, non-production-related facilities equipment at one of our API suppliers. During 2010, we experienced difficulties validating upgrades to equipment with one of our API manufacturers. Although we are taking steps to ensure that such problems do not continue, there is no assurance that we will either be successful in doing so with our current supplier or be able to timely and cost-effectively qualify new suppliers for this component. Manufacturing interruptions or failure or delay of product to meet quality assurance specifications could adversely affect shipments and recognition of sales of our products in any period and impair our relationships with customers and our competitive position and may increase the cost of material produced. In addition, each of the products that are marketed through our NovaMed subsidiary is manufactured by, or obtained from, a single source.

China has mandated a unique serialization barcode for the smallest unit carton of each pharmaceutical product intended for importation and commercial sale in China. We are required to have the serialization for ZADAXIN in effect by 2015. Implementation of the new unique barcode on each unit carton involves a long lead time, including physical hardware and software changes to the only approved existing packaging line at our sole finished product packaging contract manufacturing site. There are technical and regulatory risks associated with the packaging line changes that may be beyond our control. If the packaging line changes and/or validation are delayed or if the packaging line change regulatory submission to the Italian regulatory authorities is not approved in a timely manner, the commercial supply of ZADAXIN could be limited or stopped completely until barcode serialization is successfully implemented at the contract manufacturer and subsequently approved by regulatory authorities in Italy, which could materially adversely affect our sales and operating results.

We also rely on third parties, who are subject to regulatory oversight, to supply drug product. For example, Bioalliance is the sole supplier of Loramyc. Any unanticipated deficiencies in this supplier, or the suppliers of our raw materials, and/or recall of the manufacturing lots could also impede commercialization of our products and impair our competitive position. In addition, any unanticipated deficiencies in suppliers used in our clinical trials could delay the trials or detract from the integrity of the trial data and its potential use in future regulatory filings. In addition, manufacturing interruptions or failure to comply with regulatory requirements by any of these suppliers could significantly delay clinical development of potential products and reduce third-party or clinical researcher interest and support of proposed trials.

If our thymalfasin API or ZADAXIN products are not shipped and stored at precision temperatures, the products could become damaged, which could negatively affect our sales and operating results.

Thymalfasin API and ZADAXIN are temperature sensitive products. SciClone relies on third-party organizations to provide controlled temperature shipping logistics services from the point of ownership transfer from the API contract manufacturer to the point where thymalfasin API is converted to ZADAXIN drug product, and from the ZADAXIN drug product manufacturing site to our storage locations in Hong Kong and then to China. Although some temperature excursions are allowable and thymalfasin and ZADAXIN are relatively stable when exposed to temperatures higher than recommended, if any third-party logistics or equipment provider fails to perform their required oversight duties with respect to temperature control or a shipment is delayed in transit for a prolonged period of time, the thymalfasin API or ZADAXIN drug product could become unsuitable for subsequent processing or commercial use. Although we have not experienced cold chain interruptions in the past and our distributor in China may maintain several months supply of our product, were our cold chain distribution or warehouse capability to be interrupted, our ability to timely deliver finished product to China could be adversely affected, which in turn could materially adversely affect our sales and operating results.

 

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We rely on third parties for development of our products and the inability of any of these parties to reliably, timely or cost-effectively provide us with their obligated services could materially harm the timing of bringing our products to market and accordingly adversely affect our business.

We rely on third parties, such as contract research organizations, medical institutions, clinical investigators, contract laboratories, and collaborative partners in the conduct of clinical trials for our product candidates. If these parties, whom we do not control, do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines or choose not to continue their relationship with us, if the third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical or clinical activities may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize our product candidates.

Commercialization of some of our products depends on collaborations with others. If our collaborators are not successful, or if we are unable to find future collaborators, we may not be able to properly develop and commercialize our products.

We depend in part on our distributors and business partners to develop or promote our drugs, and if they are not successful in their efforts or fail to do so, our business will suffer. For example, Biocompatibles is providing SciClone with product samples, clinical and product data, and the necessary supporting documents to obtain regulatory approval in China for DC Bead. We generally do not have control over the amount and timing of resources that our business partners devote to our collaborative efforts, and some have not always performed as or when expected. If they do not perform their obligations as we expect, particularly obligations regarding clinical trials, our development expenses would increase and the development or sale of our products could be limited or delayed, which could hurt our business and cause our stock price to decline. In addition, our relationships with these companies may not be successful. Disputes may arise with our collaborators, including disputes over ownership rights to intellectual property, know-how or technologies developed with our collaborators. We may not be able to negotiate similar additional arrangements in the future to develop and commercialize ZADAXIN or other products.

If we are unable to retain our key personnel, or are unable to attract and retain additional, highly skilled and experienced personnel, including the ability to expand our sales staff, our business will suffer. *

We are highly dependent upon our ability to attract and retain qualified personnel because of the specialized, scientific and worldwide nature of our business. We are also dependent on our ability to appropriately staff these personnel in appropriate positions as our business fluctuates. Further, our efforts to in-license or acquire, develop and commercialize product candidates for China may require the addition of clinical and regulatory personnel and the expansion of, or changes in our sales and marketing operation. In addition, we assign numerous key responsibilities to a limited number of individuals, and we would experience difficulty in finding immediate replacements for any of them were any one of them to choose to leave employment with us. There is intense competition for qualified management, scientific, clinical, regulatory, and sales and marketing personnel in the pharmaceutical industry.

Our Senior Vice President and Chief Financial Officer resigned from the Company on May 31, 2013 to pursue other opportunities. Our Vice President, Finance and Controller resigned from the Company on August 2, 2013 to pursue other opportunities. We hired a new Chief Financial Officer in July 2013 and a new Vice President, Finance and Controller in October 2013.

There is significant turnover in the industry, in China in particular, and we have also experienced turnover in our sales personnel and key employees. We may not be able to attract and retain the qualified personnel we need to grow and develop our business globally. In particular, if we are unable to retain key personnel from the acquisition of NovaMed, particularly sales and marketing personnel with expertise in the products they promote and regulatory personnel, our business may suffer and could result in our not achieving the anticipated benefits of the acquisition.

The former Chief Executive Officer and the former Chief Operating Officer of our China operations resigned in the fourth quarter of 2012 and we have also had departures in our senior sales personnel. We may experience other departures. In addition, we have terminated personnel for violations of our policies and procedures as well as for lack of performance. Our future success will depend in part on our retaining key personnel and on recruiting additional senior sales and other personnel in China. We are continuously recruiting executives and other level personnel to address departures and to expand and strengthen our China operations and hired a new Chief Executive Officer of SciClone’s China operations, who began on April 1, 2013 and we hired a new General Counsel and Vice President of Compliance, who began in China in February 9, 2014.

 

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Conversely, if we need to reduce the size of a particular aspect of our business, including if we have contracts that are not renewed or renegotiated for products we market or promote, we are also dependent on our ability to make such adjustments while retaining suitably skilled personnel. For example, we recently reduced the size of our sales force as a result of the expiration of our agreement with Sanofi. In addition, we have taken corrective measures based on the findings of our Special Committee relating to its investigation of matters relating to the FCPA and have taken, and expect to continue to take, corrective measures relating to managements’ evaluation of internal control over financial reporting which could have adverse effects on our business, including the loss of personnel, and changes in marketing, sales and educational practices or programs. If we were unable to attract and retain qualified personnel as needed or promptly replace those employees who are critical to our sales, development and other operations, and in particular senior executives, our financial results and operations would be adversely affected. At this time, we do not maintain “key person” life insurance for any of our personnel.

We may need to obtain additional funding to support our long-term product development and commercialization programs. *

We believe our existing cash and investments and ongoing revenue generating business operations will be sufficient to support our current operating plan for at least the next 12 months. Our Board of Directors has approved a share repurchase program that authorizes the Company to repurchase up to a total of $50.5 million of its outstanding common stock. As of March 31, 2014, $7.1 million of the $50.5 million remained available under the repurchase program for future share repurchases . Further, we may use cash to acquire additional product rights or for future acquisitions. Our ability to achieve and sustain operating profitability is dependent on numerous factors including our ability to achieve our goal of increasing sales of ZADAXIN, securing regulatory approval for DC Bead in China, and for our other products including those products we acquired as a result of the NovaMed acquisition, the execution and successful completion of clinical trials in China, securing partnerships for those programs that lead to regulatory approvals in major pharmaceutical markets, and successfully continuing NovaMed’s sales and integrating NovaMed into our business. We cannot assure you that such funds from operating activities will be sufficient, or that we will attain profitable operations in future periods. In addition, we intend to develop other products and we may need additional funds in the future to support such development and to support future growth and achieve profitability. If we need to raise additional funds in the future and such funds are not available on reasonable terms, if at all, our commercialization efforts may be impeded, our revenues may be limited and our operating results may suffer.

We are subject to the risk of increased income taxes which could reduce our future operating income.

We have structured our operations in a manner designed to maximize income in countries where:

 

    tax incentives have been extended to encourage foreign investment; or

 

    income tax rates are low.

Our taxes could increase if certain tax holidays or incentives are not renewed upon expiration, or if tax rates applicable to us in such jurisdictions are otherwise increased. For example, on March 16, 2007, the Chinese government passed a unified enterprise income tax law which became effective on January 1, 2008. Among other things, the law cancels many income tax incentives previously applicable to one of our subsidiaries in China. The law provides a transition rule which increased the tax rate of one of our subsidiaries in China over a 5-year period to 25% by 2012. The law also increased the standard withholding rate on earnings distributions to between 5% and 10% depending on the residence of the shareholder. The ultimate effect of these and other changes in Chinese tax laws on our overall tax rate will be affected by, among other things, our China income, the manner in which China interprets, implements and applies the new tax provisions, and by our ability to qualify for any exceptions or new incentives.

In addition, the Company and its subsidiaries are regularly subject to tax return audits and examinations by various taxing jurisdictions, particularly in the US and China, and the US Internal Revenue Service is currently examining our 2011 US federal tax return. In determining the adequacy of our provision for income taxes, we regularly assess the likelihood of adverse outcomes resulting from tax examinations. While it is often difficult to predict the final outcome or the timing of the resolution of a tax examination, we believe that our reserves for uncertain tax positions reflect the outcome of tax positions that are more likely than not to occur. However, we cannot be certain that the final determination of any tax examinations will not be materially different than that which

 

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is reflected in our income tax provisions and accruals. Should additional taxes be assessed as a result of a current or future examination, there could be a material adverse effect on our tax provision, operating results, financial position and cash flows in the period or periods for which that determination is made.

If we fail to protect our products, technologies and trade secrets, we may not be able to successfully use, manufacture, market or sell our products, or we may fail to advance or maintain our competitive position, and we have limited intellectual property protection in China.

Our success depends significantly on our ability to obtain and maintain meaningful patent protection for our products and technologies and to preserve our trade secrets. Our pending patent applications may not result in the issuance of patents in the future. Our patents or patent applications may not have priority over others’ applications. Our existing patents and additional patents that may be issued, if any, may not provide a competitive advantage to us or may be invalidated or circumvented by our competitors. Others may independently develop similar products or design around patents issued or licensed to us. Patents issued to, or patent applications filed by, other companies could harm our ability to use, manufacture, market or sell our products or maintain our competitive position with respect to our products. Although many of our patents relating to thymalfasin have expired, including composition of matter patents, we have rights to other patents and patent applications relating to thymalfasin and thymalfasin analogues, including method of use patents with respect to the use of thymalfasin for certain indications. Additionally, thymalfasin has received Orphan Drug designation in the US for the treatment of stage 2b through stage 4 melanoma, for the treatment of chronic active hepatitis B, for the treatment of DiGeorge anomaly with immune defects, and for the treatment of hepatocellular carcinoma. If other parties develop generic forms of thymalfasin for other indications, including conducting clinical trials for such indications, our patents and other rights might not be sufficient to prohibit them from marketing and selling such generic forms of thymalfasin or their brands of thymalfasin. If other parties develop analogues or derivatives of thymalfasin, our patents and other rights might not be sufficient to prohibit them from marketing these analogues or derivatives.

Pharmaceutical products are either not patentable or have only recently become patentable in some of the countries in which we market or may market thymalfasin. We do not have composition patent claims directed to the thymalfasin that is currently marketed in China, our largest market, although we do have other type of patent claims, pending or issued, directed to other aspects of thymalfasin therapy. Other companies market generic thymalfasin in China, potentially in violation of our patent, trademark or other rights which, to date, we have defended by informing physicians and hospitals of the practice. Past enforcement of intellectual property rights in many of these countries, including China in particular, has been limited or non-existent. Future enforcement of patents and proprietary rights in many other countries will likely be problematic or unpredictable. Moreover, the issuance of a patent in one country does not assure the issuance of a similar patent in another country. Claim interpretation and infringement laws vary by nation, so the extent of any patent protection is uncertain and may vary in different jurisdictions.

If we are involved in intellectual property claims and litigation, the proceedings may divert our resources and subject us to significant liability for damages, substantial litigation expense and the loss of our proprietary rights.

Our commercial success depends in part on our not infringing valid, enforceable patents or proprietary rights of third parties, and not breaching any licenses that may relate to our technologies and products. In addition, we may not be aware of all patents or patent applications that may impact our ability to make, use or sell any of our potential products. For example, US patent applications may be kept confidential for 12 or more months while pending in the Patent and Trademark Office, and patent applications filed in foreign countries are often first published nine months or more after filing. It is possible that we may unintentionally infringe these patents or other patents or proprietary rights of third parties. We may in the future receive notices claiming infringement from third parties as well as invitations to take licenses under third-party patents. Any legal action against us or our collaborative partners claiming damages and seeking to enjoin commercial activities relating to our products and processes affected by third-party rights may require us or our collaborative partners to obtain licenses in order to continue to manufacture or market the affected products and processes. Our efforts to defend against any of these claims, regardless of merit, would require us to devote resources and attention that could have been directed to our operations and growth plans. In addition, these actions may subject us to potential liability for damages. We or our collaborative partners may not prevail in a patent action and any license required under a patent may not be made available on commercially acceptable terms, or at all. Any conflicts resulting from the patent rights of others could significantly reduce the coverage of our patents and limit our ability to obtain meaningful patent protection.

 

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If other companies obtain patents with conflicting claims, we may be required to obtain licenses to those patents or develop or obtain alternate technology to manufacture or market the affected products and processes. We may not be able to obtain any such licenses on acceptable terms or at all. Any failure to obtain such licenses could delay or prevent us from pursuing the development or commercialization of our potential products. Our efforts to defend against any of these claims would require us to devote resources and attention that could have been directed to our operations and growth plans.

We may need to initiate litigation, which could be time-consuming and expensive, to enforce our proprietary rights or to determine the scope and validity of others’ rights. If litigation results, a court may find our patents or those of our licensors invalid or may find that we have infringed on a competitor’s rights. If any of our competitors have filed patent applications in the US that claim technology we also have invented, the Patent and Trademark Office may require us to participate in expensive interference proceedings to determine who has the right to a patent for the technology. These actions may subject us to potential liability for damages. We or our collaborative partners may not prevail in a patent action and any license required under a patent may not be made available on commercially acceptable terms, or at all.

Substantial sales of our stock or the exercise or conversion of options may impact the market price of our common stock. *

In March 2012, we filed a Form S-3 Shelf registration with the SEC under which we may offer and sell up to $100.0 million of our securities, assuming we continue to meet the SEC’s eligibility requirements for primary offerings on Form S-3. Subsequently, affiliates of Sigma-Tau sold approximately 6.3 million shares for an aggregate price of approximately $33.1 million under this registration statement, and we have approximately $66.9 million available for future use.

Future issuances of substantial amounts of our common stock could adversely affect the market price of our common stock. Similarly, if we raise additional funds through the issuance of common stock or securities convertible into or exercisable for common stock or sell equity in a subsidiary, the percentage ownership of our present stockholders of the respective entities will be reduced and the price of our common stock may fall.

Our cash, cash equivalents and investments are subject to certain risks which could materially adversely affect our overall financial position.

We invest our cash and cash equivalents in accordance with an established internal policy and customarily in instruments which historically have been highly liquid and carried relatively low risk. However, with turmoil in the credit markets, similar types of investments have experienced losses in value or liquidity issues which differ from their historical pattern. For example, we routinely have invested in money market funds with large financial institutions. One or more of these funds could experience losses or liquidity problems and, although to date some of the largest financial institutions who sponsor such funds have offset similar losses, there is no assurance that our financial institutions would either not incur losses or would offset any losses were they to occur.

Any adjustment to decrease the ratings of our investments by an Interest Rate Rating Agency may have a negative impact on the value of our investments.

Should any of our cash investments permanently lose value or have their liquidity impaired, it would have a material and adverse effect on our overall financial position by imperiling our ability to fund our operations and forcing us to seek additional financing sooner than we would otherwise and such financing may not be available on commercially attractive terms.

In addition, financial instruments may subject us to a concentration of credit risk. Most of our cash and cash equivalents are held by a limited number of financial institutions. To date, we have not experienced any losses on our deposits of cash and cash equivalents. However, if any of these instruments permanently lost value or have their liquidity impaired, it would also have a material and adverse effect on our overall financial position by imperiling our ability to fund our operations and forcing us to seek additional financing sooner than we would otherwise and such financing may not be available on commercially attractive terms.

We expect that we may need to transfer capital to NovaMed from time to time to fund its operations. We need to obtain regulatory approval from China’s State Administration of Foreign Exchange (“SAFE”) in order to make such transfers and there can be no assurance that we will be able to obtain such approval in a timely manner. We have been able to fund the operations of NovaMed to date through commercial credit facilities or through intercompany loans, but we could face difficulties in the future if our efforts to improve profitability and cash flow in NovaMed are not successful, or if we are unable to obtain SAFE approval or obtain further funding for NovaMed.

 

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Furthermore, a majority of our cash is held by our foreign subsidiaries. While such cash is used to fund the operating activities of our foreign subsidiaries and for further investment in foreign operations, and we do not anticipate the need to repatriate cash held by foreign subsidiaries under our current operating plan, if we were to repatriate cash to the US, these amounts may be subject to US income tax upon repatriation.

Our ability to utilize our tax attributes may be limited by an “ownership change.”

Our ability to use our tax attributes, such as our US federal income tax net operating loss carryforwards and our tax credit carryforwards, may be substantially restricted if we have had in the past, or have in the future, an “ownership change” as defined in Section 382 of the US Internal Revenue Code. An ownership change occurs if increases in the percentage of our stock held by “5-percent shareholders” (within the meaning of Section 382, which provides that certain public groups can be treated as 5-percent shareholders) collectively exceed more than fifty percent, comparing the lowest percentage of stock owned by each 5-percent shareholder at any time during the testing period (which is generally a three-year rolling period) to the percentage of stock owned by the 5-percent shareholder immediately after the close of any owner shift testing date. Our issuance of Common Stock in the acquisition of NovaMed, our repurchases of our Common Stock and trading in our stock by stockholders, may have increased the possibility that in the future we could experience an ownership change. Trading by our stockholders, our stock repurchases or other transactions could, in the future, cause an ownership change, resulting in an annual limitation on utilization of our tax attributes. If our tax attribute usage is subject to limitation and if we are profitable, our future cash flows could be adversely affected due to an increased tax liability.

Anti-takeover provisions in our charter documents and under Delaware law may make an acquisition of us, which may be beneficial to our stockholders, more difficult.

Certain anti-takeover provisions of Delaware law and our charter documents as currently in effect may make a change in control of our company more difficult, even if a change in control would be beneficial to our stockholders. Our charter documents contain certain anti-takeover provisions, including provisions in our certificate of incorporation providing that stockholders may not cumulate votes, stockholders’ meetings may be called by stockholders only if they hold 25% or more of our common stock and provisions in our bylaws providing that the stockholders may not take action by written consent. Additionally, our Board of Directors has the authority to issue 10 million shares of preferred stock and to determine the terms of those shares of stock without any further action by the stockholders. The rights of holders of our common stock are subject to the rights of the holders of any preferred stock that may be issued. The issuance of preferred stock could make it more difficult for a third-party to acquire a majority of our outstanding voting stock. Delaware law also prohibits corporations from engaging in a business combination with any holders of 15% or more of their capital stock until the holder has held the stock for three years unless, among other possibilities, the board of directors approves the transaction. Our Board of Directors may use these provisions to prevent changes in the management and control of our company. Also, on December 18, 2006, our Board of Directors declared a dividend distribution of one Preferred Stock Purchase Right (collectively, the “Rights”) for each outstanding share of our Common Stock, each Right which entitles the registered holder to purchase from the Company one one-thousandth of a share of the Company’s Series D Preferred Stock, $0.001 par value, at a price of $25.00 pursuant to a Rights Agreement dated as of December 19, 2006, between the Company and Mellon Investor Services LLC. The Rights have certain anti-takeover effects. Under certain circumstances the Rights could cause substantial dilution to a person or group who attempts to acquire the Company on terms not approved by our Board of Directors. Although the Rights should not interfere with an acquisition of the Company approved by the board, the Rights may have the effect of delaying and perhaps improving the terms of an acquisition for our stockholders, or deterring an acquisition of the Company. Also, under applicable Delaware law, our Board of Directors may adopt additional anti-takeover measures in the future.

We may be subject to product liability lawsuits, and our insurance may be inadequate to cover damages.

Clinical trials of any of our current and potential products or the actual commercial sales of our product may expose us to liability claims from the use of these products. We currently carry product liability insurance. However, we cannot be certain that we will be able to maintain insurance on acceptable terms, if at all, for clinical and commercial activities, that any insurance we have will cover any particular claim that is asserted, or that the insurance would be sufficient to cover any potential product liability claim or recall. If we fail to have sufficient coverage, our business, results of operations and cash flows could be adversely affected.

 

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If we are unable to comply with environmental and other laws and regulations, our business may be harmed.

We are subject to various federal, state and local laws, regulations and recommendations relating to the use, manufacture, storage, handling and disposal of hazardous materials and waste products (including radioactive compounds and infectious disease agents), as well as safe working conditions, laboratory and manufacturing practices and the experimental use of animals. The extent of government regulation that might result from future legislation or administrative action in these areas cannot be accurately predicted.

We do not currently maintain hazardous materials at our facilities. While we outsource our research and development programs involving the controlled use of biohazardous materials, if in the future we conduct these programs ourselves, we might be required to incur significant cost to comply with environmental laws and regulations. Further, in the event of an accident, we would be liable for any damages that result, and the liability could exceed our resources.

Our business and operations are subject to the risks of being based in particular locations known for earthquakes, other natural catastrophic disasters and service interruptions.

Our corporate headquarters are located in the Silicon Valley area of Northern California, a region known for seismic activity. Although we maintain a disaster recovery policy that includes storage of important corporate data in a different geographic region of the US, all of our significant corporate data is stored in our headquarters facility and accordingly, a significant natural disaster, such as an earthquake, could have a material adverse impact on our business, operating results, and financial condition. Most of our sales are into China for which we maintain our warehouses for finished goods in Hong Kong, which can experience severe typhoon storms, earthquakes or other natural catastrophic disasters. Although our distributors in China may maintain several months supply of our product, were our warehouse capability to be interrupted, either through a natural disaster such as flooding or through a service interruption, such as a lack of electricity to power required air conditioning, our ability to timely deliver finished product to China could be adversely affected which in turn would materially adversely affect our sales and ensuing operating results.

We may be affected by climate change and market or regulatory responses to climate change.

Climate change, including the impact of global warming, could have a material adverse effect on our results of operations, financial condition, and liquidity if it were to disrupt the demand, supply or delivery of product, management of our business, or result in cost increases as a result of government regulation.

Security breaches and other disruptions could compromise our information and expose us to liability, which would cause our business and reputation to suffer. *

In the ordinary course of our business, we store sensitive data, including intellectual property, our proprietary business information, certain information regarding our business partners, and personally identifiable information of our employees, in our computer networks. The secure maintenance and transmission of this information is critical to our operations and reputation. Despite our security measures, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions. Although we have not been adversely affected in any significant manner, we have experienced problems with information security in the past which we believe is primarily due to breaches of security by current or former employees gaining access to restricted information. Any such breach could compromise our computer networks and the information stored there could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, and regulatory penalties, and damage our reputation, any of which could adversely affect our business and competitive position.

 

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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Issuer Purchases of Equity Securities

The table below summarizes our stock repurchase activity for the three months ended March 31, 2014 ( in thousands, except per share amounts ):

 

     Total
Number
of Shares
Purchased
     Average
Price
Paid
per Share
     Total Number
of Shares
Purchased as Part
of Publicly
Announced

Plans
or Programs
     Approximate
Dollar
Value of Shares
that May Yet Be
Purchased

Under the
Plans or Programs (1)
 

January 1, 2014 through January 31, 2014

     468       $ 5.13         468       $ 7,228   

February 1, 2014 through February 28, 2014

     17       $ 4.51         17         7,150   

March 1, 2014 through March 31, 2014

     15       $ 4.58         15         7,081   
  

 

 

       

 

 

    

Total

     500       $ 5.10         500      
  

 

 

       

 

 

    

 

(1) “Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs” reflects the $50.5 million total authorized since the program’s inception in October 2011, less the $43.4 million we repurchased through March 31, 2014, including $0.3 million of commissions paid.

 

Item 3. Defaults Upon Senior Securities

Not applicable.

 

Item 4. Mine Safety Disclosures

Not applicable.

 

Item 5. Other Information

Not applicable.

 

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Item 6. Exhibits

 

Exhibit
Number

 

Description

  10.1 (1)**   Employment Agreement with Chun Cai Meng, effective February 9, 2014 by and between Chun Cai Meng and SciClone Pharmaceuticals Hong Kong Ltd.
  10.2 (1)**   Change in Control Agreement effective February 9, 2014 by and between Chun Cai Meng and SciClone Pharmaceuticals, Inc.
  10.3 (1)**   Executive Severance Agreement effective February 9, 2014 by and between Chun Cai Meng and SciClone Pharmaceuticals, Inc.
  31.1 (1)   Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
  31.2 (1)   Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
  32.1 (1)   Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
  32.2 (1)   Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101 (1)   The following materials from Registrant’s Quarterly Report on Form 10-Q for the three-months ended March 31, 2014, formatted in Extensible Business Reporting Language (XBRL) includes: (i) Unaudited Condensed Consolidated Balance Sheets as of March 31, 2014 and December 31, 2013, (ii) Unaudited Condensed Consolidated Statements of Income for the three-months ended March 31, 2014 and 2013, (iii) Unaudited Condensed Consolidated Statements of Comprehensive Income (Loss) for the three-months ended March 31, 2014 and 2013, (iv) Unaudited Condensed Consolidated Statements of Cash Flows for the Three-Months ended March 31, 2014 and 2013, and (v) Notes to Condensed Consolidated Financial Statements.

 

(1) Filed Herewith.
** Management compensatory plan or arrangement.

 

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

      SCICLONE PHARMACEUTICALS, INC.
Date:   May 12, 2014    

/s/    Wilson W. Cheung        

     

Wilson W. Cheung

Senior Vice President, Finance and Chief Financial Officer

 

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INDEX TO EXHIBITS

 

Exhibit
Number

 

Description

  10.1 (1)**   Employment Agreement with Chun Cai Meng, effective February 9, 2014 by and between Chun Cai Meng and SciClone Pharmaceuticals Hong Kong Ltd.
  10.2 (1)**   Change in Control Agreement effective February 9, 2014 by and between Chun Cai Meng and SciClone Pharmaceuticals, Inc.
  10.3 (1)**   Executive Severance Agreement effective February 9, 2014 by and between Chun Cai Meng and SciClone Pharmaceuticals, Inc.
  31.1 (1)   Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
  31.2 (1)   Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
  32.1 (1)   Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
  32.2 (1)   Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101 (1)   The following materials from Registrant’s Quarterly Report on Form 10-Q for the three-months ended March 31, 2014, formatted in Extensible Business Reporting Language (XBRL) includes: (i) Unaudited Condensed Consolidated Balance Sheets as of March 31, 2014 and December 31, 2013, (ii) Unaudited Condensed Consolidated Statements of Income for the three-months ended March 31, 2014 and 2013, (iii) Unaudited Condensed Consolidated Statements of Comprehensive Income (Loss) for the three-months ended March 31, 2014 and 2013, (iv) Unaudited Condensed Consolidated Statements of Cash Flows for the Three-Months ended March 31, 2014 and 2013, and (v) Notes to Condensed Consolidated Financial Statements.

 

(1) Filed Herewith.
** Management compensatory plan or arrangement.

 

54

EXHIBIT 10.1

 

 

EMPLOYMENT AGREEMENT

 

 


TABLE OF CONTENTS

 

1.

  

DEFINED TERMS & INTERPRETATION

     1   

2.

  

APPOINTMENT, POSITION AND TERM

     1   

3.

  

EMPLOYEE’S DUTIES

     2   

4.

  

WORKING HOURS

     3   

5.

  

REMUNERATION, BENEFITS AND REVIEW

     3   

6.

  

BONUS

     4   

8.

  

EXPENSES

     5   

9.

  

EMPLOYEE’S LEAVE AND HOLIDAYS

     5   

10.

  

SICKNESS ALLOWANCE

     6   

11.

  

CONFIDENTIAL INFORMATION

     6   

12.

  

INTELLECTUAL PROPERTY AND MORAL RIGHTS

     7   

13.

  

TERMINATION

     8   

14.

  

WHAT HAPPENS AFTER TERMINATION OF EMPLOYMENT

     9   

16.

  

COMPLIANCE

     10   

17.

  

GENERAL

     10   

SCHEDULE 1 - INTERPRETATION

     13   

SCHEDULE 2 - DUTIES

     15   

SIGNING PAGE

     17   

ANNEXURE

     18   


DETAILS

 

DATE   January 22, 2014     
PARTIES       
Name   MENG Chun Cai   (‘Employee’)   
Name   SciClone Pharmaceuticals Hong Kong Limited    (‘Employer’)

AGREED TERMS

 

1. DEFINED TERMS & INTERPRETATION

The interpretation provisions of this document are in Schedule 1.

 

2. APPOINTMENT, POSITION AND TERM

 

  2.1. Appointment and position

The Employer will employ the Employee in the position of General Counsel and Vice President Compliance reporting to the President and CEO and the Audit Committee of the Board of Directors for your role as Compliance Officer.

The Employment Agreement is contingent upon the clearance of reference and background checks satisfactory to the Company.

 

  2.2. Location

The Employee will be seconded to NovaMed Pharmaceuticals (Shanghai) Co., Ltd. and will be based in 30F Shanghai Time Square, No. 93 Huai Hai Zhong Road, Shanghai 200021 China, although the Employee may be required to travel to perform the Employee’s duties and may be required to be based at a different location.

 

  2.3. Commencement

Subject to clause 2.4 (probationary employment), the Employee’s employment in accordance with this agreement will commence on February 8, 2014 and will continue for an indefinite period unless and until terminated in accordance with clause 13 below.

 

  2.4. Probationary employment

Initially, the Employee’s employment will be for a probationary period of four (4) months unless terminated sooner:

 

  2.4.1 during the first month of employment, by the Employee or Employer without notice;

 

  2.4.2 after the first month of employment until the end of the probationary period, by the Employee or Employer giving one (1) week’s written notice or by paying an amount calculated in accordance with the Employment Ordinance (Cap. 57) in lieu of notice for that period; or

 

  2.4.3 by the Employer in accordance with clause 13.3 (termination without notice.)

 

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3. EMPLOYEE’S DUTIES

 

  3.1. Duties Employee must perform

The Employee must:

 

  3.1.1 perform to the best of the Employee’s abilities and knowledge the duties assigned to the Employee from time to time which may include duties for the benefit of any Related Company of the Employer. The duties initially assigned to the Employee include those listed in Schedule 2;

 

  3.1.2 work such hours as are reasonably necessary to perform the Employee’s duties (overtime is not payable);

 

  3.1.3 use all reasonable efforts to promote the interests of the Employer;

 

  3.1.4 disclose to the Employer any facts which might involve a conflict between the Employee’s interests and the interests of the Employer;

 

  3.1.5 comply with all policies of the Employer in place or as varied or replaced from time to time that are intended to apply to the Employee (although these do not form part of the Employee’s contract of employment); and

 

  3.1.6 comply with all laws and the rules and regulations of external agencies applying to the Employee’s position and the duties assigned to the Employee.

 

  3.2. What the Employee must not do

Without limiting the Employee’s duties, during the Employee’s employment the Employee must not:

 

  3.2.1 act in conflict with the Employer’s best interests;

 

  3.2.2 on discovery, allow a conflict between the Employee’s interests and the interests of the Employer to continue;

 

  3.2.3 prepare to be engaged or involved, or engage or be involved in any business or employment other than for the Employer except with the prior approval of the Employer or where the Employee holds or is interested in investments (quoted or unquoted) representing not more than one percent (1%) of the issued investments of any class of any such company.

 

  3.2.4 compete with the Employer;

 

  3.2.5 in performing the Employee’s duties, accept any financial or other benefit except from the Employer;

 

  3.2.6 use internet, email or voicemail at the Employer’s workplace for excessive personal use or to view or distribute offensive or illegal material; and

 

  3.2.7 unlawfully discriminate or harass another person.

 

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  3.3. Limits of Employee’s authority

The Employee must not bind the Employer in contract, unless otherwise authorized by his supervisor.

 

4. WORKING HOURS

The Employee’s normal working hours shall be 09:00 to 18:00 on Mondays to Fridays and such additional hours as are necessary for the proper performance of the Employee’s duties. The Employee acknowledges that the Employee shall not receive further remuneration in respect of such additional hours.

 

5. REMUNERATION, BENEFITS AND REVIEW

 

  5.1. Total Remuneration

During your secondment to NovaMed Pharmaceuticals (Shanghai) Co., Ltd., the Employer will pay the Employee RMB 1,200,000  per annum (China salary) . In addition, RMB 800,000 per annum will be paid through non-taxable reimbursement subject to your submission of valid invoices from China.

In respect of the Employee’s direct responsibilities with the Employer outside of the PRC, the Employer will pay the Employee RMB 400,000  per annum (HK salary) (or RMB 33,333 per month) payable monthly in arrears on or about the last working day of each calendar month and all days in the month are deemed to be fully paid. The Employee is responsible for paying salaries’ tax.

In case of any incomplete calendar month, the salary shall be pro-rated according to the number of days, which the Employee has actually worked during such calendar month.

In recognition of the benefit of the Employee’s services to the Company, the Company will provide to the Employee with a sign-on bonus in the amount of RMB 620,000 less applicable withholdings. The sign-on bonus will be advanced to you after your first month of employment. The Employee is responsible for paying sign-on bonus’ tax. However, in the event that the Employee voluntarily end his employment relationship prior to at least 18 months of service with the Company, the Employee promises and agrees to repay the Company the full amount of the sign-on bonus on his resignation date. The tax amount should be able to be deducted from the Employee’s regular taxable monthly compensation for the month he voluntarily end his employment relationship.

 

  5.2. Mandatory Provident Fund Scheme

The Employee is entitled to participate in the Company’s Mandatory Provident Fund (‘MPF’) Scheme in accordance with the provisions of the Mandatory Provident Fund Scheme Ordinance (Cap 485).

 

  5.3. Reimbursement

The non-taxable reimbursement mentioned in Section 5.1 will be paid through reimbursement subject to the Employee providing to NovaMed Pharmaceuticals (Shanghai) Co., Ltd. with valid invoices. The reimbursement non-taxable expenses are restricted to the following items:

 

  5.3.1 meal expense;

 

3


  5.3.2 laundry expense;

 

  5.3.3 housing rental expense;

 

  5.3.4 two-time home trip expense of the Employee himself;

 

  5.3.5 children’s school tuition; (children should be under 18 years old)

 

  5.3.6 language training expense of the Employee himself;

 

  5.4. Insurance Benefits

During the secondment in NovaMed Pharmaceuticals (Shanghai) Co., Ltd., The Employer will take reasonable steps to provide for the Employee and for the Employee’s spouse and children at the Employer’s cost, medical insurance capped at RMB 12,500 per month.

The Employer may review the remuneration and Employee’s performance not less than once each year.

 

6. BONUS

 

  6.1. Bonus may be payable

The Employee will be eligible to participate in the Company’s annual bonus program, under which the Employee will have an annual bonus opportunity targeted at 52.5% of the Employee then current annual base salary excluding the non-taxable reimbursement and which will be earned based on your achievement of business objectives as established by the Chief Executive Officer in accordance with the terms of the executive bonus program. For 2014 you will be paid a fixed bonus corresponding to 100% achievement equal to RMB 770,000 (prorated for 11 months). Such bonus, if earned, shall be paid not later than the date that is two and one-half months following the close of the year in which such bonus is earned. You are responsible for paying tax on bonus payments you receive. If there are withholding rules the company will withheld corresponding taxes.

 

  6.2. Employment until end of Bonus period

Despite clause 6.1 to be entitled to be paid the Bonus, the Employee must be employed by the Employer on the date that the Bonus is paid.

 

  6.3. Bonus after first year of employment

Nothing in this clause is intended to restrict the Employer’s right to determine after the end of any Bonus period whether a bonus may be payable to the Employee in a later bonus period and if so, then on what terms.

 

7. OPTIONS

 

  7.1. Provision of options

In addition to the Total Remuneration, it will be recommended at the first meeting of the Company’s Board of Directors following your employment start date that the company grant you an option to purchase 80,000 shares of the Company’s common stock at a price per share equal to the fair market value per share of the Company’s common stock on the date of the first day of employment. Subject to the Employee’s continued employment, twenty-five percent

 

4


(25%) of the option shares shall initially vest (become exercisable) on the first anniversary of your employment start date (and no shares shall vest before such date) and the remaining shares shall vest monthly over the next thirty-six (36) months in substantially equal monthly amounts. The option shares shall be subject to the terms and conditions of the Company’s stock option plan and an appropriate form of stock option agreement, which the Employee will be required to sign as a condition of receiving any option. Over time, additional stock option grants may be made available in the sole discretion of the Board of Directors.

 

  7.2. Conditions prior to granting of options

The Employee acknowledges that the Employer is not required to offer the Employee any options in accordance with clause 7.1 until the Employee has signed this agreement.

 

8. EXPENSES

The Employer will pay or reimburse the Employee for the Employee’s reasonable travel and out of pocket expenses in accordance with the Employer’s expense reimbursement policy and practices. All reimbursements must be claimed promptly, but otherwise not later than the calendar month after the expense is incurred.

 

9. EMPLOYEE’S LEAVE AND HOLIDAYS

 

  9.1. Annual leave

Annual leave will apply as follows:

 

  9.1.1 The Employer will grant the Employee annual leave of 10 Business Days in the first calendar year of employment and one additional day each year of service, with the maximum of 15 annual leave days;

 

  9.1.2 for annual leave in excess of the minimum statutory requirement, the Employer may grant annual leave on a pro rata basis during the year in which it accrues or in advance;

 

  9.1.3 any annual leave taken will first be applied against any statutory annual leave entitlement;

 

  9.1.4 when taking annual leave, Statutory Holidays, Saturdays and Sundays will not be counted as annual leave days;

 

  9.1.5 untaken annual leave in excess of the minimum statutory requirement will be forfeited, unless otherwise agreed in writing, if not taken in the year it falls due; and

 

  9.1.6 subject to applicable law, on termination of the Employee’s employment other than termination in accordance with clause 13.3 (Termination without notice), the Employer will pay the Employee accrued but untaken annual leave and pro rata annual leave calculated since the end of the last leave year at the rate the Employee would have been paid had the leave been granted.

 

  9.2. Holidays

The Employer will pay the Employee for Statutory Holidays although the Employee is not required to work on these days.

 

  9.3. Rest day

Saturday and Sunday are rest days.

 

5


10. SICKNESS ALLOWANCE

The Employee is entitled to sickness allowance in accordance with the provisions of the Employment Ordinance (Cap. 57).

Application for sickness leave for more than one day must be supported by a valid medical certificate issued by a registered medical practitioner, a Chinese medical practitioner or a registered dentist specifying the number of days for which the Employee is unfit for work and the nature of the sickness or injury on account of which the Employee is unfit for work. Any sickness leave taken without the support of a valid medical certificate will be deemed to be unpaid or annual leave as appropriate.

Any paid sickness leave taken by the Employee will be deducted from the sickness day credits accumulated by the Employee in accordance with applicable law.

 

11. CONFIDENTIAL INFORMATION

 

  11.1. Duty not to disclose

Without limiting the Employee’s duties at law, the Employee must keep Confidential Information confidential.

 

  11.2. Exceptions to duty not to disclose

Notwithstanding clause 11.1, the Employee may disclose Confidential Information:

 

  11.2.1 the Employee is required to disclose in the course of the Employee’s duties with the Employer;

 

  11.2.2 that was public knowledge when this agreement was signed or became so at a later date (other than as a result of a breach of confidentiality by the Employee); or

 

  11.2.3 that the Employee is required by a court, tribunal or law to disclose (in which event, the Employee must inform the Employer prior to disclosure).

 

  11.3. Disclosure in the course of the Employee’s duties

The Employee may only disclose Confidential Information under clause 11.2.1 if:

 

  11.3.1 the disclosure is solely for the purpose of performing the Employee’s duties with the Employer; and

 

  11.3.2 the disclosure is to persons who:

 

  11.3.2.1 are aware and agree that the Confidential Information must be kept confidential; or

 

  11.3.2.2 have signed any confidentiality obligation required by the Employer from time to time;

 

  11.3.2.3 have a need to know (and only to the extent that each has a need to know); or

 

  11.3.2.4 have been approved by the person or persons nominated by the Employer from time to time.

 

6


  11.4. Preservation of Confidential Information

The Employee must take whatever measures are reasonably necessary to preserve the Confidential Information, including:

 

  11.4.1 complying with all security measures established to safeguard Confidential Information from access or unauthorised use;

 

  11.4.2 keeping Confidential Information under the Employee’s control; and

 

  11.4.3 not removing Confidential Information from, or accessing Confidential Information from outside, the Employer’s premises without the prior approval of the Employer.

 

  11.5. Notification of breach

The Employee must immediately notify the Employer of any suspected or actual unauthorised use, copying or disclosure of Confidential Information.

 

  11.6. Indemnification

The Employee hereby undertakes to indemnify and keep indemnified the Employer against any loss or damage suffered by the Employer arising from the breach of the Employee’s obligations under this clause 11. Notwithstanding the aforesaid and without prejudice to any other rights or remedies that the Employer may have, the Employee acknowledges and agrees that damages alone would not be an adequate remedy for any breach by the Employee of this clause 11, and accordingly the Employer shall be entitled, without proof of special damages, to the remedies of injunction, specific performance or other equitable relief for any threatened or actual breach of this clause 11.

 

12. INTELLECTUAL PROPERTY AND MORAL RIGHTS

 

  12.1. Assignment by Employee

The Employee:

 

  12.1.1 presently assigns to the Employer all existing and future Intellectual Property Rights in all inventions, models, designs, drawings, plans, software, reports, proposals and other materials created or generated by the Employee (whether alone or with the Employer, its other employees, agents or contractors) for use by the Employer (or a Related Company of the Employer); and

 

  12.1.2 acknowledges that by virtue of this clause, all such existing rights are vested in the Employer and, on their creation, all such future rights will vest in the Employer.

 

  12.2. Employee’s assistance

The Employee must do all things reasonably requested by the Employer to enable the Employer to assure further the rights assigned under clause 12.1.

 

7


  12.3. Moral Rights

The Employee:

 

  12.3.1 voluntarily and unconditionally consents to all or any acts or omissions by the Employer, or persons authorised by the Employer, in relation to any and all works made or to be made by the Employee (whether before or after this consent is given) in the course of the employment (‘ Works ’) which would otherwise infringe the Employee’s Moral Rights;

 

  12.3.2 waives any and all existing and future Moral Rights in the Works; and

 

  12.3.3 acknowledges that the Employee has given this consent

 

  12.3.3.1 voluntarily; and

 

  12.3.3.2 without reliance on any statement or representation made by the Employer, a Related Company of the Employer or anyone acting on their behalf.

 

13. TERMINATION

 

  13.1. Termination with notice or payment in lieu

After the probationary period ends, either the Employer or the Employee may at any time terminate the Employee’s employment. Employee shall give to the Employer notice of 30 days in writing of the Employee’s intention to do so. Even though the Employee’s position, title or report may change during the employment, unless otherwise agreed the period of notice of termination will not change.

 

  13.2. Employment during notice period

Following the provision of notice to terminate the Employee’s employment by either party or, if the Employer is undertaking an investigation at any time during the employment, the Employer may by written notice require the Employee not to perform any services (or to perform only specified services) for the Employer or any Related Company of the Employer until the termination of the employment or a specified date.

During any period of Garden Leave, the Employer shall be under no obligation to provide any work to, or vest any powers in the Employee, who shall have no right to perform any services for the Employer or any Related Company of the Employer.

During any period of Garden Leave the Employee shall:

 

  13.2.1 continue to receive salary and all contractual benefits in the usual way and subject to the terms of any benefit arrangement;

 

  13.2.2 remain an employee of the Employer and bound by the terms of this agreement;

 

  13.2.3 not, without the prior written consent of the Employer, attend the Employee’s place of work or any other premises of the Employer;

 

  13.2.4 not, without the prior written consent of the Employer, contact or deal with (or attempt to contact or deal with) any officer, employee, consultant, client, customer, supplier, agent, distributor, shareholder, advisor or other business contact of the Employer or any Related Company of the Employer; and

 

  13.2.5 (except during any periods taken as holiday in the usual way) ensure that the Employer knows where the Employee will be and how the Employee can be contacted during each working day and shall comply with any written requests to contact a specified employee of the Employer at specified intervals.

 

8


  13.3. Termination without notice

The Employee’s employment maybe terminated by the Employer at any time without notice if the Employee:

 

  13.3.1 disobeys proper legal reason a lawful direction of the Employer;

 

  13.3.2 is guilty of serious misconduct;

 

  13.3.3 breaches clause 11 (Confidential Information);

 

  13.3.4 materially fails to perform the Employee’s duties;

 

  13.3.5 unlawfully discriminates or harasses any other person;

 

  13.3.6 breaches any material provision of this agreement;

 

  13.3.7 is found guilty by a court of a serious criminal offence;

 

  13.3.8 has accepted employment with the Employer in breach of clause 16.1 (Warranties);

 

  13.3.9 becomes a bankrupt; or

 

  13.3.10 is guilty of a serious breach of any rules issued by the Employer from time to time.

If the Employee’s employment is terminated without notice, then the Employer will pay the Employee’s Total Remuneration, Benefits and MPF up to the date of termination.

 

14. WHAT HAPPENS AFTER TERMINATION OF EMPLOYMENT

 

  14.1. Requirements following termination

If the Employee’s employment is terminated for any reason, then:

 

  14.1.1 the Employee must resign from the Employer and any Related Company of the Employer without claim for compensation for loss of office, and the Employee authorises the Company Secretary of the Employer to do all things necessary to give effect to such resignations on the Employee’s behalf;

 

  14.1.2 the Employee must return all the Employer’s property (including property leased by the Employer) to the Employer on termination including all written or machine readable material, Confidential Information, software, computers, credit cards, keys and vehicles;

 

  14.1.3 the Employee’s obligations under clause 11 (Confidential Information) continue after termination; and

 

  14.1.4 the Employee must not record any Confidential Information in any form after termination.

 

9


  14.2. Employee’s assistance with legal proceedings

After the Employee’s employment ends, the Employer may require the Employee to assist in any threatened or actual legal or other proceedings in which the Employer or a Related Company of the Employer is involved, for which the Employee will be reimbursed all reasonable costs.

 

15. COMPLIANCE

The exercise of or compliance with any discretion, right or obligation under this agreement is subject to:

 

  15.1. compliance with all applicable laws;

 

  15.2. compliance with the Memorandum and Articles of the Employer; and

 

  15.3. the approval of the shareholders of the Employer where such approval is required.

If the approval of the shareholders of the Employer is required before a payment may be made to the Employee, then the board of directors of the Employer must ensure that the approval of the members is sought.

 

16. GENERAL

 

  16.1. Warranties by Employee

The Employee warrants:

 

  16.1.1 other than what the Employee has disclosed to the Employer in writing, the Employee is not involved and has not been involved in any litigation with any previous employer;

 

  16.1.2 that the Employee has disclosed to the Employer information about any possible restrictions on the Employee from performing the Employee’s duties set out in this agreement;

 

  16.1.3 other than what the Employee has disclosed to the Employer, that the Employee is not restricted from performing the Employee’s duties for the Employer arising from a restrictive covenant or other non-competition obligation owed to anyone, or a restriction imposed on the Employee concerning the use of any information or the intellectual property rights of anyone;

 

  16.1.4 that the credentials and information provided by the Employee to the Employer (or to the Employer’s agent) touching upon the Employee’s qualifications and ability to perform the duties under this agreement are true and correct;

 

  16.1.5 other than what the Employee has disclosed to the Employer, that prior to accepting employment, the Employee has not suffered from an occupational disease in any trade, industry or process;

 

  16.1.6 that the Employee has all the necessary licences, permissions, consents, approvals, qualifications and memberships required of the Employee to perform the duties under this agreement and that the Employee has never been suspended, censured or otherwise subjected to any disciplinary action or other proceeding, litigation or investigation by any state or governmental body or agency or any regulatory authority or self-regulatory organisation;

 

10


  16.1.7 that the Employee is not a person subject to any statutory disqualification under the Companies Ordinance (Cap.32) and that the Employee has not been the cause of any other person or entity becoming subject to any statutory disqualification; and

 

  16.1.8 that the Employee shall comply with all applicable law and regulation including, without limitation, the applicable codes and guidelines issued by the Hong Kong Securities and Futures Commission from time to time.

 

  16.2. Notification of restrictions

The Employee agrees that in the event of receiving from any person, company, business entity or other organisation an offer of employment or for services (whether oral or in writing) either during the continuance of this agreement or during the continuance in force of any of the restrictions set out in clause 11, the Employee will forthwith provide to such offeror a full and accurate copy of these clauses 11 and notify the Employer of such offer. The Employee further agrees that if the Employee accepts any such offer, the Employee will forthwith (i) notify the Employer of the identity of the offeror, (ii) provide the Employer with a description of the principal duties of the position accepted; and (iii) confirm to the Employer in writing that the Employee has provided a copy of these clauses to the offeror.

 

  16.3. Right to vary

The Employer reserves the right to vary any of the terms and conditions of this agreement at any time in its reasonable discretion.

 

  16.4. Severability

Part or all of any clause of this agreement that is illegal or unenforceable will be severed from this agreement and the remaining provisions continue in force.

 

  16.5. Waiver

The failure of either party at any time to insist on performance of any provision of this agreement is not a waiver of their right at any later time to insist on performance of that or any other provision of this agreement.

 

  16.6. Governing Law

This agreement is governed by the law applicable in Hong Kong SAR and the parties irrevocably and unconditionally submit to the exclusive jurisdiction of the court of Hong Kong SAR.

 

  16.7. Agreement is confidential

This agreement including any amendments is confidential and may not be disclosed by the Employee to any other person, other than for the purpose of obtaining professional legal or accounting advice, without the prior approval of the Employer.

 

11


  16.8. Entire agreement

This agreement (including its Schedules):

 

  16.8.1 constitutes the entire agreement between the Employer and Employee as to its subject matter; and

 

  16.8.2 as to its subject matter, supersedes and cancels any contract, deed, arrangement, related condition, collateral arrangement, condition, warranty, indemnity or representation imposed, given or made by the Employer or Employee (or an agent of either of them) prior to entering into this agreement.

 

  16.9. Release from prior arrangements

The Employee releases the Employer from all claims and demands touching upon any contract, deed, arrangement, related condition, collateral arrangement, condition, warranty, indemnity or representation imposed, given or made by one of them (or an agent of one of them) prior to entering into this agreement.

 

  16.10. Data privacy

The Employee must sign the Employee Collection Statement annexed to this agreement.

 

  16.11. Deduction of sums owed

To the extent permitted by law, at any time during the Employee’s employment, or upon its termination (howsoever arising), the Employer shall be entitled to deduct from the Employee’s remuneration (or from any other payments due to the Employee in respect of the employment or its termination) any monies due from the Employee to the Employer including, without limitation, any outstanding loans, advances, overpayment of wages, the cost of repairing any damage or loss to the Employer’s property caused by him (and of recovering the same), excess annual leave pay and any other monies owed by him to the Employer.

 

  16.12. Counterparts

This agreement may be executed in counterparts.

 

  16.13. Force Majeure

This agreement shall be terminated with immediate effect and neither part y shall be liable for a breach of this agreement nor liable for any failure in performance of any obligations under this agreement (save and except the Employee’s post-termination duties set out in clause 11 (Confidentiality) and 15 (Restraint on an Employee’s conduct) which shall survive the termination of this agreement) arising from or attributable to acts, events, omissions or accidents beyond its reasonable control ( Force Majeure Event ).

A Force Majeure Event shall include, but is not limited to, any act of God, war, fire, flood, drought, tempest, epidemic or pandemic, terrorist attack and collapse of building structure.

 

12


SCHEDULE 1 - INTERPRETATION

 

1. DEFINITIONS

In this document, unless the context otherwise requires, the following words have these meanings.

Business Day means any day in Hong Kong SAR other than Saturdays, Sundays and a general holiday as defined in the General Holidays Ordinance Cap. 149.

Confidential Information means all confidential information of the Employer or a Related Company of the Employer including but not limited to the terms of this agreement (and any amendments or variations thereof), trade secrets, confidential know-how, client lists, supplier lists, price lists, information about tenders and proposals to prospective clients, prospective client lists, information about products and services in development, business plans, marketing plans and computer software owned or used by the Employer or a Related Company of the Employer of which the Employee becomes aware or generates (both before and after the day this agreement is signed) touching upon the Employee’s employment with the Employer.

Garden Leave means any period during which the Employer has exercised its rights under clause 13.2.

Intellectual Property Rights means all intellectual property rights including without limitation:

 

  (a) patents, copyrights, rights in circuit layouts, registered designs, trademarks and the right to have Confidential Information kept confidential; and

 

  (b) any application or right to apply for registration of the rights in (a).

Moral Rights means any and all rights conferred by Division IV Part II of the Copyright Ordinance Cap. 528.

MPF means a mandatory provident fund as defined in the Mandatory Provident Fund Schemes Ordinance Cap. 485.

Related Company has the meaning as that term is defined in section 49BA(9) of the Companies Ordinance Cap. 32.

Statutory Holidays mean the statutory holidays as defined in the Employment Ordinance (Cap. 57).

 

2. INTERPRETATION

In this document, unless the contrary intention appears:

 

  (a) (singular/plural) words denoting the singular include the plural and vice versa;

 

  (b) (reference to any instrument) a reference to any instrument (such as a deed, agreement or document) is to that instrument (or, if required by the context, to a part of it) as amended, novated, substituted or supplemented at any time and from time to time;

 

  (c) (headings) headings are for ease of reference only and do not affect the meaning of this document.

 

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3. SCHEDULE AND ANNEXURE

The Schedules and annexure form part of this document.

 

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SCHEDULE 2 - DUTIES (CLAUSE 3.1.1)

The duties initially assigned include:

This position will have primary responsibility for SciClone’s company-wide compliance programs, legal affairs and global legal strategies. This position plans and directs programs, policies, and practices to ensure that all business units’ activities are in compliance with regulatory requirements. This position tracks laws and regulations in China, the USA, as well as in other countries relevant for the business of the Company that might affect the organizations policies and implements necessary changes.

The General Counsel position will have responsibility for all legal matters in the USA, China as well as the Cayman companies including SciClone and all its subsidiaries. It coordinates with the Chief Financial Officer, of SciClone work regarding corporate legal matters.

The following will be the key priorities and requirements of the position:

Legal Affairs

Responsible for overseeing all legal matters pertaining to the organization, including patent, copyright, intellectual property and employment law matters and the coordination of any legal matters handled by outside counsel. Develops functional plans for managing legal matters, including activities to be performed in-house or through third-party relationships to best manage SciClone’s legal activities and minimize risk for the business. Oversee the retention and management of outside counsel.

Provide advice and counsel on a day-to-day basis with respect to all laws, rules and regulations governing the commercial sale of pharmaceuticals, in China, Hong Kong and other countries where SciClone Pharmaceuticals International Ltd is doing business.

Prepare and review commercial agreements, including clinical trial, marketing, distribution, and other commercial agreements to ensure agreements reflect SciClone’s business objectives and to ensure compliance with all applicable laws, rules and regulations. Coordinate the contract review, approval and record keeping processes with business development and U.S. and China finance.

Advise on other legal matters relevant for the business including employment, real estate or other matters in China

In addition to the above responsibilities, we would anticipate that you would over time take increasing responsibility for the following areas:

In conjunction with our outside counsel and our Finance and Accounting team, participate in the preparation of filings with the Securities and Exchange Commission.

In conjunction with outside legal counsel, advise the Board of Directors on legal matters.

Compliance

Lead the development, implementation and/or review of SciClone’s compliance policies and procedures to ensure continued compliance and identify potential areas of risk with US and China laws, unethical or improper conduct.

Respond to alleged violations of rules, regulations, policies, procedures, and the Code of Conduct by evaluating or recommending the initiation of investigative procedures.

 

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Act as an independent review and evaluation body to ensure that compliance issues and concerns with the organization are being appropriately evaluated, investigated, and resolved.

Monitor and coordinate compliance activities of other departments to remain abreast of the status of all compliance activities.

Provide reports on a regular basis and, as directed or requested, keep the Audit Committee of the Board of Directors of SciClone and President and CEO of SciClone informed of the operation and progress of compliance efforts.

 

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SIGNING PAGE

IN WITNESS whereof this agreement has been executed and delivered as a Deed on the day and year first before written.

 

Executed as a deed by or on behalf of SciClone Pharmaceuticals Hong Kong Limited acting by     
Friedhelm Blobel, Ph.D., Director     
    

/s/ Friedhelm Blobel

     Signature of Friedhelm Blobel, Ph.D.
SIGNED SEALED AND DELIVERED BY      [Name, address [and occupation] of witness]
MENG Chun Cai:     
     In the presence of:

/s/ Chun Cai Meng

    

 

Signature of Chun Cai Meng      [Signature of witness]

 

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ANNEXURE

ANNEXURE TO EMPLOYMENT

AGREEMENT EMPLOYEE COLLECTION

STATEMENT

Your privacy is important to SciClone Pharmaceuticals Hong Kong Limited (‘Company’).

Throughout the course of your employment with the Company, the Company needs to collect personal data from you and about you. The type of information that may be collected includes (but is not limited to):

 

    Recruitment, engagement or training records;

 

    Information about your medical condition;

 

    Information regarding termination of employment;

 

    Terms and conditions of employment;

 

    Personal and emergency contact details;

 

    Performance, conduct and disciplinary records;

 

    Remuneration details, bonus and share plan information;

 

    Membership of professional associations or trade unions;

 

    Leave records (including annual leave, sick leave and maternity leave);

 

    Taxation, banking and mandatory provident fund details;

 

    Health and safety information;

 

    Any other information that you provide to the Company.

The purposes for which the Company collects this data is for use concerning your employment or working relationship with the Company and for various human resources, management and reporting purposes.

The Company from time to time transfers your personal data to the following classes of persons:

 

    a Related Company (as defined in section 49BA(9) of the Companies Ordinance Cap.32);

 

    the Company’s insurers and banks;

 

    medical practitioners appointed by the Company;

 

    administrator of the Company’s mandatory provident fund scheme;

 

    outside parties involved in a merger, acquisition or due diligence exercise;

 

    companies the Company engages to perform the functions listed above on the Company’s behalf; and

 

    anyone you authorise.

If you do not provide complete and accurate personal data to the Company as and when it is required, there may be potentially serious consequences for you and, depending on the circumstances, your future employment relationship with the Company.

It is the Company’s policy to retain certain personal data of employees when they cease to be employed. This data may be required for any residual employment-related activities, including for example, provision of references, processing of applications for re-employment, matters relating to retirement benefits and allowing the Company to fulfil any of the Company’s contractual or statutory obligations.

To the extent applicable law allows, you may request access to, and correction of, your personal data in relation to your employment. For any further information, please contact Friedhelm Blobel.

 

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Please indicate your understanding and acceptance of the above by signing and returning the acknowledgement form below to Friedhelm Blobel .

 

 

Acknowledgment

I have read and fully understand the above contents and acknowledge that I accept these terms voluntarily and freely.

 

Chun Cai Meng

   

/s/ Chun Cai Meng

Name of employee     Signature of employee

 

   
Date    

 

19

EXHIBIT 10.2

SCICLONE PHARMACEUTICALS, INC.

CHANGE IN CONTROL AGREEMENT

This Change in Control Agreement (the “Agreement” ) is effective as of February 9, 2014 by and between MENG Chun Cai (the “Employee” ) and SciClone Pharmaceuticals, Inc., a Delaware corporation (the “Company” ).

RECITALS

A. The Employee presently serves as Vice President, Compliance and Legal Affairs of the Company and performs significant strategic and management responsibilities necessary to the continued conduct of the Company’s business and operations.

B. The Board of Directors of the Company (the “ Board ”) has determined that it is in the best interests of the Company and its stockholders to assure that the Company will have the continued dedication and objectivity of the Employee, notwithstanding the possibility or occurrence of a Change in Control (as defined below) of the Company.

C. The Board believes that it is imperative to provide the Employee with certain severance benefits upon the Employee’s termination of employment following a Change in Control that will provide the Employee with enhanced financial security and provide sufficient incentive and encouragement to the Employee to remain with the Company following a Change in Control.

AGREEMENT

The Employee and the Company agree as set forth below:

1. Terms of Employment . The Company and the Employee agree that the Employee’s employment is based on the original offer letter and labor contract terms and that their employment relationship may be terminated by either party at any time, with or without Cause, and, if applicable, in accordance with Section 2 below. If the Employee’s employment with the Company terminates for any reason following a Change in Control, but on or before the first anniversary of the Change in Control, the Employee shall not be entitled to any payments, benefits, damages, awards or compensation other than as provided by this Agreement. During his employment with the Company, the Employee agrees to devote his full business time, energy and skill to his duties with the Company. These duties shall include, but not be limited to, any duties consistent with the Employee’s position that may be assigned to the Employee from time to time by the Company or the Board.

 

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2. Severance Benefits Upon Termination following a Change in Control . Subject to the limitations set forth in Sections 3 and 4 below, if the Employee’s employment with the Company terminates following a Change in Control but on or before the first anniversary of such Change in Control, then the Employee shall be entitled to receive, in addition to the compensation and benefits earned by the Employee through the date of his termination, severance benefits as follows:

(a) Involuntary Termination . If the Employee’s employment with the Company is terminated as a result of Involuntary Termination, then the Employee shall be entitled to receive the following severance benefits:

(i) The Employee shall be entitled to receive severance pay in an amount equal to one hundred percent (100%) of his annual base salary and allowances as in effect at the time of such termination (at the time of entering into this agreement an amount of RMB 2,300,000). Any severance to which the Employee is entitled pursuant to this section shall be paid in a lump sum, less applicable withholding, within thirty (30) days following the Employee’s termination.

(ii) The Executive shall be entitled to receive a separation bonus equal to the gross amount of fifty percent (50%) of the average annual performance bonus paid to the Executive for the two (2) most recent fiscal years for which bonuses have been paid prior to the termination date.

(iii) With respect to any unvested options to purchase shares of the stock of the Company held by the Employee; Section 12.1 (b) of the 2005 Equity Incentive Plan, as amended (the “Plan”), notwithstanding, if a Change in Control occurs and the “Acquiror”, as defined in the Plan, does not assume the “Awards”, as defined in the Plan, held by Employee, then all such Awards held by Employee shall become fully vested and exercisable as of a date ten (10) business days prior to the occurrence of the closing of the transaction resulting in the Change in Control, with any acceleration and exercise subject to, and conditional upon, the actual closing of such transaction.”

(iv) The Employee shall be entitled to exercise all vested options to purchase shares of the stock of the Company held be the Employee (including any options to purchase shares that become vested for a period of twelve (12) months after the date of such termination (notwithstanding anything to the contrary otherwise provided under the terms and conditions of such options).

(v) The Company shall, if permitted under the Company’s existing health insurance plans, continue the Executive’s existing group health insurance coverage. If not so permitted, the Company shall reimburse the Executive for any health insurance premiums paid by the Executive for continued group health insurance coverage. Such health insurance coverage or reimbursement of premiums shall continue until the earlier of (i) twelve (12) months after the date of the Executive’s Involuntary Termination or (ii) the date on which the Executive commences New Employment.

(b) Voluntary Resignation; Termination For Cause . If the Employee’s employment terminates by reason of the Employee’s voluntary resignation (but not as a result of an Involuntary Termination) or as a result of the Employee’s termination for Cause, then the Employee shall not be entitled to receive any severance pay or benefits under this Agreement.

(c) Disability; Death . If the Company terminates the Employee’s employment as a result of the Employee’s Disability, or death, then the Employee shall not be entitled to receive any severance pay or benefits under this Agreement.

 

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3. Release of Claims; Resignation . The Employee’s entitlement to any severance pay or benefits under Section 2(a) is conditioned upon the Employee’s execution and delivery to the Company of (a) a general release of known and unknown claims in the form attached hereto as Exhibit A and (b) a resignation from all of the Employee’s positions with the Company, including from the Board of Directors and any committees thereof on which the Employee serves, in a form satisfactory to the Company.

4. Parachute Payments . In the event that any payment or benefit received or to be received by the Employee pursuant to this Agreement or otherwise (collectively, the “Payments” ) would result in a “parachute payment” as described in section 280G of the Internal Revenue Code of 1986, as amended, notwithstanding the other provisions of this Agreement, the amount of such Payments will not exceed the amount which produces the greatest after-tax benefit to the Employee. For purposes of the foregoing, the greatest after-tax benefit will be determined within thirty (30) days of the occurrence of such payment to the Employee, in the Employee’s sole and absolute discretion. If no such determination is made by the Employee within thirty (30) days of the occurrence of such payment, the Company will promptly make such determination in a fair and equitable manner.

5. Consulting Services . During the six (6) months following any Involuntary Termination for which the Employee receives the severance pay and benefits described in Section 2(a), the Employee shall be retained by the Company as an independent contractor to provide consulting services to the Company at its request for up to eight (8) hours per week. These services shall include any reasonable requests for information or assistance by the Company, including, but not limited to, the transition of the Employee’s duties. Such services shall be provided at mutually convenient times. For the actual provision of such services, the Company shall pay to the Employee a consulting fee of $1,000 per eight hour day, plus reasonable out-of-pocket expenses (for example, travel and lodging).

6. Company’s Successors . Any successor to the Company or to all or substantially all of the Company’s business and/or assets will be bound by this Agreement in the same manner and to the same extent as the Company. For all purposes under this Agreement, the term “Company” will include any successor to the Company’s business and/or assets.

7. Employee’s Successors . All rights of Employee hereunder will inure to the benefit of, and be enforceable by, Employee’s personal or legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees. The Employee will have no right to assign any of his obligations or duties under this Agreement to any other person or entity.

8. Definition of Terms . The following terms referred to in this Agreement shall have the following meanings:

(a) “ Cause ” shall mean any of the following:

(i) the Employee’s theft, dishonesty, misconduct or falsification of any records of the Company, its successor, or any subsidiary of the Company or its successor (collectively, the “ Company Group ”);

 

3


(ii) the Employee’s misappropriation or improper disclosure of confidential or proprietary information of the Company Group;

(iii) any intentional action by the Employee which has a material detrimental effect on the reputation or business of the Company Group;

(iv) the Employee’s failure or inability to perform any reasonable assigned duties after written notice from the Company Group of, and a reasonable opportunity to cure, such failure or inability;

(v) any material breach by the Employee of any employment agreement between the Employee and the Company Group, which breach is not cured pursuant to the terms of such agreement; or

(vi) the Employee’s conviction of any criminal act which impairs the Employee’s ability to perform his duties for the Company Group.

(b) “ Change in Control ” shall mean: (i) a merger or other transaction in which the Company or substantially all of its assets is sold or merged and as a result of such transaction, the holders of the Company’s common stock prior to such transaction do not own or control a majority of the outstanding shares of the successor corporation, (ii) the election of nominees constituting a majority of the Board which nominees were not approved by a majority of the Board prior to such election, or (iii) the acquisition by a third party of twenty percent (20%) or more of the Company’s outstanding shares which acquisition was without the approval of a majority of the Board in office prior to such acquisition.

(c) “ Constructive Termination ” shall mean any one or more of the following:

(i) without the Employee’s express written consent, the assignment to the Employee, following the Change in Control, of any title or duties, or any limitation of the Employee’s responsibilities, that are substantially inconsistent with the Employee’s title(s), duties, or responsibilities with the Company Group immediately prior to the date of the Change in Control;

(ii) without the Employee’s express written consent, the relocation of the principal place of the Employee’s employment, following the Change in Control, to a location that is more than fifty (50) miles from the Employee’s principal place of employment immediately prior to the date of the Change in Control, or the imposition of travel requirements substantially more demanding of the Employee than such travel requirements existing immediately prior to the date of the Change in Control;

(iii) any failure by the Company Group, following the Change in Control, to pay, or any material reduction by the Company Group of, (1) the Employee’s base salary in effect immediately prior to the date of the Change in Control, or (2) the Employee’s bonus compensation, if any, in effect immediately prior to the date of the Change in Control (subject to applicable performance requirements with respect to the actual amount of bonus compensation earned by the Employee), unless base salary and/or bonus reductions comparable in amount and duration are concurrently made for a majority of the other employees of the Company Group who have substantially similar titles and responsibilities as the Employee; and

 

4


(iv) any failure by the Company Group, following the Change in Control, to (1) continue to provide the Employee with the opportunity to participate, on terms no less favorable than those in effect for the benefit of any employee group which customarily includes a person holding the employment position or a comparable position with the Company Group then held by the Employee, in any benefit or compensation plans and programs, including, but not limited to, the Company Group’s life, disability, health, dental, medical, savings, profit sharing, stock purchase and retirement plans, if any, in which the Employee was participating immediately prior to the date of the Change in Control, or in substantially similar plans or programs, or (2) provide the Employee with all other fringe benefits (or substantially similar benefits), including, but not limited to, relocation benefits, provided to any employee group which customarily includes a person holding the employment position or a comparable position with the Company Group then held by the Employee, which the Employee was receiving immediately prior to the date of the Change in Control.

However, the foregoing conditions shall not constitute a Constructive Termination unless the Employee has given written notice of any such condition(s) to the Chairman of the Board and allowed the Company Group at least twenty (20) days thereafter to correct such condition(s). If such condition(s) are not corrected within that twenty (20) day period, the Employee may give written notice of his Constructive Termination to the Board, which shall be an Involuntary Termination.

(d) Disability means the inability of the Employee, in the opinion of a qualified physician, to perform the essential functions of the Employee’s position with the Company Group, with reasonable accommodation, because of the sickness or injury of the Employee.

(e) Involuntary Termination shall mean the occurrence of either of the following events after a Change in Control, but on or before the first anniversary of such Change in Control:

(i) termination by Company Group of the Employee’s employment without Cause; or

(ii) the Employee’s Constructive Termination.

“Involuntary Termination” shall not include any termination of the Employee’s employment that is (1) for Cause, (2) a result of the Employee’s death or Disability, or (3) a result of the Employee’s voluntary resignation.

(f) New Employment shall mean any employment obtained by the Employee after the termination of the Employee’s employment with the Company.

9. Nonsolicitation . During his employment with the Company, and for a period of one (1) year following the termination of his employment for any reason, the Employee shall not directly or indirectly recruit, solicit, or induce any person who on the date hereof is, or who subsequently becomes, an employee, sales representative or consultant of the Company, to terminate his relationship with the Company.

 

5


10. Successors .

(a) Company’s Successors . Any successor to the Company or to all or substantially all of the Company’s business and/or assets shall be bound by this Agreement in the same manner and to the same extent as the Company. For all purposes under this Agreement, the term “Company” shall include any successor to the Company’s business and/or assets.

(b) Employee’s Successors . All rights of the Employee hereunder shall inure to the benefit of, and be enforceable by, the Employee’s personal or legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees. The Employee shall have no right to assign any of his obligations or duties under this Agreement to any other person or entity.

11. Notice .

(a) General . Notices and all other communications contemplated by this Agreement shall be in writing and shall be deemed to have been duly given when personally delivered or when mailed by U.S. registered or certified mail, return receipt requested and postage prepaid. In the case of the Employee, mailed notices shall be addressed to the Employee at the home address which he most recently communicated to the Company in writing. In the case of the Company, mailed notices shall be addressed to its corporate headquarters, and all notices shall be directed to the attention of its Secretary.

(b) Notice of Termination . Any termination by the Company Group or the Employee of their employment relationship shall be communicated by a written notice of termination to the other party.

12. Miscellaneous Provisions .

(a) No Duty to Mitigate . The Employee shall not be required to mitigate the amount of any payment contemplated by this Agreement (whether by seeking New Employment or in any other manner), nor shall any such payment be reduced by any earnings that the Employee may receive from any other source.

(b) Waiver . No provision of this Agreement shall be modified, waived or discharged unless the modification, waiver or discharge is agreed to in writing and signed by the Employee and by an authorized officer of the Company (other than the Employee). No waiver by either party of any breach of, or of compliance with, any condition or provision of this Agreement by the other party shall be considered a waiver of any other condition or provision or of the same condition or provision at another time.

(c) Choice of Law . The validity, interpretation, construction and performance of this Agreement shall be governed by the laws of the State of California.

 

6


(d) Severability . The invalidity or unenforceability of any provision or provisions of this Agreement shall not affect the validity or enforceability of any other provision hereof, which shall remain in full force and effect.

(e) Arbitration . Any dispute, controversy or claim arising out of or relating to this contract, including the validity, invalidity, breach or termination thereof, shall be settled by arbitration in Hong Kong under the Hong Kong International Arbitration Centre Administered Arbitration Rules in force with the Notice of Arbitration is submitted in accordance with these rules. Judgment upon any decision or award rendered by the arbitrator may be entered in any court having jurisdiction over the matter. The Employee and the Company knowingly and willingly waive their respective rights to have any such disputes or claims tried to a judge or jury.

(f) Prior Agreements . This Agreement supersedes all prior understandings and agreements, whether written or oral, regarding the subject matter of this Agreement.

IN WITNESS WHEREOF, each of the parties has executed this Agreement, in the case of the Company by its duly authorized officer, as of the day and year first above written.

 

SCICLONE PHARMACEUTICALS, INC.
By:  

/s/ Friedhelm Blobel

 

EMPLOYEE

/s/ Chun Cai Meng

MENG Chun Cai

 

7


Exhibit A

RELEASE

In exchange for the severance pay and benefits described in the Executive Severance Agreement between SciClone Pharmaceuticals, Inc. (the “ Company ”) and me of February 9, 2014, I hereby release the Company, its parents and subsidiaries, and their officers, directors, employees, attorneys, stockholders, successors, assigns and affiliates, of and from any and all claims, liabilities, and causes of action of every kind and nature, whether known or unknown, based upon or arising out of any agreements, events, acts, omissions or conduct at any time prior to and including the execution date of this Release, including, but not limited to: all claims concerning my employment with the Company or the termination of that employment; all claims pursuant to any PRC Labor Contract Law and the regulations promulgated by the local government having jurisdiction over the employment.

I am knowingly, willingly and voluntarily releasing any claims I may have under relevant local laws. I acknowledge that the consideration given for the release in the preceding paragraph hereof is in addition to anything of value to which I was already entitled.

I hereby waive and relinquish all rights and benefits under that section and any law of any jurisdiction of similar effect with respect to my release of any unknown claims I may have, and I affirm that it is my intention to release all known and unknown claims that I have or may have against the parties released above.


This Release contains the entire agreement between the Company and me regarding the subjects above, and it cannot be modified except by a document signed by me and an authorized representative of the Company.

 

      EMPLOYEE
Date:  

 

   

 

      MENG Chun Cai
      SCICLONE PHARMACEUTICALS, INC.
Date:  

 

    By:  

 

      Its:  

 

EXHIBIT 10.3

SCICLONE PHARMACEUTICALS, INC.

EXECUTIVE SEVERANCE AGREEMENT

This Executive Severance Agreement (the Agreement ) is effective as of February 9, 2014, by and between MENG Chun Cai (the Executive ) and SciClone Pharmaceuticals, Inc., a Delaware corporation (the Company ).

RECITALS

A. The Executive presently serves as Vice President, Compliance and Legal Affairs of the Company, and performs significant strategic and management responsibilities necessary to the continued conduct of the Company’s business and operations.

B. The Board of Directors of the Company (the Board ) through its Compensation Committee has determined that it is in the best interests of the Company and its stockholders to assure that the Company will have the continued dedication and objectivity of the Executive of the Company.

C. The Board believes that it is imperative to provide the Executive with certain severance benefits upon the Executive’s termination of employment without Cause that will provide the Executive with enhanced financial security and provide sufficient incentive and encouragement to the Executive to remain with the Company.

AGREEMENT

The Executive and the Company agree as set forth below:

1. Terms of Employment . The Company and the Executive agree that the Executive’s employment is based on the original offer letter and labor contract terms and that their employment relationship may be terminated by either party at any time, with or without Cause, and, if applicable, in accordance with Section 2 below. If the Company terminates Executive’s employment without Cause, the Executive shall not be entitled to any payments, benefits, damages, awards or compensation other than as provided by this Agreement. During his employment with the Company, the Executive agrees to devote his full business time, energy and skill to his duties with the Company. These duties shall include, but not be limited to, any duties consistent with the Executive’s position that may be assigned to the Executive from time to time by the Company or the Board.

2. Severance Benefits Upon Termination without Cause . Subject to the limitations set forth in Sections 3 and 4 below, if the Executive’s employment with the Company is terminated without Cause, then the Executive shall be entitled to receive, in addition to the compensation and benefits earned by the Executive through the date of his or his termination, severance benefits as follows:

(a) The Executive shall be entitled to receive severance pay in the form of continuation of Employee’s base salary and allowances (at the time of entering into this agreement an annual amount of RMB 2,300,000) in effect on Employee’s termination date for

 

1


twelve (12) months following such termination date. These payments will be made on the Company’s ordinary payroll dates starting with the first pay date after the termination date, and will be subject to standard payroll deductions and withholdings.

(b) The Executive shall be entitled to receive a separation bonus equal to the gross amount of fifty percent (50%) of the average annual performance bonus paid to the Executive for the two (2) most recent fiscal years for which bonuses have been paid prior to the termination date.

(c) The Company shall, if permitted under the Company’s existing health insurance plans, continue the Executive’s existing group health insurance coverage. If not so permitted, the Company shall reimburse the Executive for any health insurance premiums paid by the Executive for continued group health insurance coverage. Such health insurance coverage or reimbursement of premiums shall continue until the earlier of (i) twelve (12) months after the date of the Executive’s Involuntary Termination or (ii) the date on which the Executive commences New Employment.

(d) Disability; Death . If the Company terminates the Executive’s employment as a result of the Executive’s Disability, or death, then the Executive shall not be entitled to receive any severance pay or benefits under this Agreement.

3. Release of Claims; Resignation . The Executive’s entitlement to any severance pay or benefits under Section 2 is conditioned upon the Executive’s execution and delivery to the Company of (a) a general release of known and unknown claims in the form attached hereto as Exhibit A and (b) a resignation from all of the Executive’s positions with the Company, including from the Board and any committees thereof on which the Executive serves, in a form satisfactory to the Company.

4. Consulting Services . During the six (6) months following any termination without Cause for which the Executive receives the severance pay and benefits described in Section 2, the Executive shall be retained by the Company as an independent contractor to provide consulting services to the Company at its request for up to eight (8) hours per week. These services shall include any reasonable requests for information or assistance by the Company, including, but not limited to, the transition of the Executive’s duties. Such services shall be provided at mutually convenient times. For the actual provision of such services, the Company shall pay to the Executive a consulting fee of $1,000 on a full eight hour day basis, pro-rated for the number of hours of service, plus reasonable out-of-pocket expenses (for example, travel and lodging).

5. Definition of Terms . The following terms referred to in this Agreement shall have the following meanings:

(a) “ Cause ” shall mean any of the following:

(i) the Executive’s theft, dishonesty, misconduct or falsification of any records of the Company, its successor, or any subsidiary of the Company or its successor (collectively, the Company Group );

 

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(ii) the Executive’s misappropriation or improper disclosure of confidential or proprietary information of the Company Group;

(iii) any intentional action by the Executive which has a material detrimental effect on the reputation or business of the Company Group;

(iv) the Executive’s failure or inability to perform any reasonable assigned duties after written notice from the Company Group of, and a reasonable opportunity to cure, such failure or inability;

(v) any material breach by the Executive of any employment agreement between the Executive and the Company Group, which breach is not cured pursuant to the terms of such agreement; or

(vi) the Executive’s conviction of any criminal act which impairs the Executive’s ability to perform his or hisduties for the Company Group.

(b) “ Disability ” means the inability of the Executive, in the opinion of a qualified physician, to perform the essential functions of the Executive’s position with the Company Group, with or without reasonable accommodation, because of the sickness or injury of the Executive.

(c) “ New Employment ” shall mean any employment obtained by the Executive after the termination of the Executive’s employment with the Company.

6. Nonsolicitation . During his or his employment with the Company, and for a period of one (1) year following the termination of his or his employment for any reason, the Executive shall not directly or indirectly recruit, solicit, or induce any person who on the date hereof is, or who subsequently becomes, an executive, sales representative or consultant of the Company, to terminate his or his relationship with the Company.

7. Successors .

(a) Company’s Successors . Any successor to the Company or to all or substantially all of the Company’s business and/or assets shall be bound by this Agreement in the same manner and to the same extent as the Company. For all purposes under this Agreement, the term “Company” shall include any successor to the Company’s business and/or assets.

(b) Executive’s Successors . All rights of the Executive hereunder shall inure to the benefit of, and be enforceable by, the Executive’s personal or legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees. The Executive shall have no right to assign any of his or his obligations or duties under this Agreement to any other person or entity.

 

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8. Notice .

(a) General . Notices and all other communications contemplated by this Agreement shall be in writing and shall be deemed to have been duly given when personally delivered or when mailed by U.S. registered or certified mail, return receipt requested and postage prepaid. In the case of the Executive, mailed notices shall be addressed to the Executive at the home address which he most recently communicated to the Company in writing. In the case of the Company, mailed notices shall be addressed to its corporate headquarters, and all notices shall be directed to the attention of its Secretary.

(b) Notice of Termination . Any termination by the Company Group or the Executive of their employment relationship shall be communicated by a written notice of termination to the other party.

9. Miscellaneous Provisions .

(a) No Duty to Mitigate . The Executive shall not be required to mitigate the amount of any payment contemplated by this Agreement (whether by seeking New Employment or in any other manner), nor shall any such payment be reduced by any earnings that the Executive may receive from any other source.

(b) Waiver . No provision of this Agreement shall be modified, waived or discharged unless the modification, waiver or discharge is agreed to in writing and signed by the Executive and by an authorized officer of the Company (other than the Executive). No waiver by either party of any breach of, or of compliance with, any condition or provision of this Agreement by the other party shall be considered a waiver of any other condition or provision or of the same condition or provision at another time.

(c) Choice of Law . The validity, interpretation, construction and performance of this Agreement shall be governed by the laws of the State of California.

(d) Severability . The invalidity or unenforceability of any provision or provisions of this Agreement shall not affect the validity or enforceability of any other provision hereof, which shall remain in full force and effect.

(e) Arbitration . Any dispute, controversy or claim arising out of or relating to this contract, including the validity, invalidity, breach or termination thereof, shall be settled by arbitration in Hong Kong under the Hong Kong International Arbitration Centre Administered Arbitration Rules in force with the Notice of Arbitration is submitted in accordance with these rules . Judgment upon any decision or award rendered by the arbitrator may be entered in any court having jurisdiction over the matter. The Executive and the Company knowingly and willingly waive their respective rights to have any such disputes or claims tried to a judge or jury.

(f) Prior Agreements; Controlling Agreement in the Case of a Change in Control . This Agreement supersedes all prior understandings and agreements, whether written or oral, regarding the subject matter of this Agreement, provided, however, that the Change in Control Agreement dated February 9, 2014 (the “ CIC Agreement ”) between Executive and

 

4


Company shall remain in place and is not amended or waived in any way hereby. If Executive is entitled to receive severance benefits under the CIC Agreement, then the CIC Agreement shall be controlling.

[Remainder of Page Left Intentionally Blank]

 

5


IN WITNESS WHEREOF, each of the parties has executed this Agreement, in the case of the Company by its duly authorized officer, as of the day and year first above written.

 

SCICLONE PHARMACEUTICALS, INC.
By:  

/s/ Friedhelm Blobel

  FRIEDHELM BLOBEL

 

EXECUTIVE

/s/ Chun Cai Meng

MENG Chun Cai

 

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Exhibit A

RELEASE

In exchange for the severance pay and benefits described in the Executive Severance Agreement between SciClone Pharmaceuticals, Inc. (the “ Company ”) and me of February 9, 2014, I hereby release the Company, its parents and subsidiaries, and their officers, directors, employees, attorneys, stockholders, successors, assigns and affiliates, of and from any and all claims, liabilities, and causes of action of every kind and nature, whether known or unknown, based upon or arising out of any agreements, events, acts, omissions or conduct at any time prior to and including the execution date of this Release, including, but not limited to: all claims concerning my employment with the Company or the termination of that employment; all claims pursuant to any PRC Labor Contract Law and the regulations promulgated by the local government having jurisdiction over the employment.

I am knowingly, willingly and voluntarily releasing any claims I may have under relevant local laws. I acknowledge that the consideration given for the release in the preceding paragraph hereof is in addition to anything of value to which I was already entitled.

I hereby waive and relinquish all rights and benefits under that section and any law of any jurisdiction of similar effect with respect to my release of any unknown claims I may have, and I affirm that it is my intention to release all known and unknown claims that I have or may have against the parties released above.

 

1


This Release contains the entire agreement between the Company and me regarding the subjects above, and it cannot be modified except by a document signed by me and an authorized representative of the Company.

 

      EXECUTIVE
Date:  

 

   

 

      MENG Chun Cai
      SCICLONE PHARMACEUTICALS, INC.
Date:  

 

    By:  

 

      Its:  

 

 

2

EXHIBIT 31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO SECTION 302 OF THE

SARBANES-OXLEY ACT OF 2002

I, Friedhelm Blobel, Ph.D., certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of SciClone Pharmaceuticals, Inc. (the “Registrant”);

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 12, 2014    

/s/    Friedhelm Blobel, Ph.D.        

    Friedhelm Blobel, Ph.D.
   

Chief Executive Officer and President

(Principal Executive Officer)

EXHIBIT 31.2

CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 302 OF THE SARBANES-

OXLEY ACT OF 2002

I, Wilson W. Cheung, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of SciClone Pharmaceuticals, Inc. (the “Registrant”);

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 12, 2014    

/s/    Wilson W. Cheung        

    Wilson W. Cheung
   

Senior Vice President, Finance and Chief Financial Officer

(Principal Financial Officer)

EXHIBIT 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906

OF THE SARBANES-OXLEY ACT OF 2002

I, Friedhelm Blobel, Chief Executive Officer and President, of SciClone Pharmaceuticals, Inc. (the “Registrant”), do hereby certify in accordance with 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, based on my knowledge:

 

(1) the Quarterly Report on Form 10-Q of the Registrant, to which this certification is attached as an exhibit (the “Report”), fully complies with the requirements of section 13(a) of the Securities Exchange Act of 1934 (15 U.S.C. 78m); and

 

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.

 

Date: May 12, 2014    

/s/    Friedhelm Blobel, Ph.D.        

    Friedhelm Blobel, Ph.D.
   

Chief Executive Officer and President

(Principal Executive Officer)

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to SciClone Pharmaceuticals, Inc. and will be retained by SciClone Pharmaceuticals, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

EXHIBIT 32.2

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906

OF THE SARBANES-OXLEY ACT OF 2002

I, Wilson W. Cheung, Senior Vice President, Finance and Chief Financial Officer, of SciClone Pharmaceuticals, Inc. (the “Registrant”), do hereby certify in accordance with 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, based on my knowledge:

 

(1) the Quarterly Report on Form 10-Q of the Registrant, to which this certification is attached as an exhibit (the “Report”), fully complies with the requirements of section 13(a) of the Securities Exchange Act of 1934 (15 U.S.C. 78m); and

 

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.

 

Date: May 12, 2014    

/s/    Wilson W. Cheung        

    Wilson W. Cheung
    Senior Vice President, Finance and Chief Financial Officer
    (Principal Financial Officer)

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to SciClone Pharmaceuticals, Inc. and will be retained by SciClone Pharmaceuticals, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.