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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D)

OF THE SECURITIES EXCHANGE ACT OF 1934.

For the quarterly period ended June 30, 2015

Commission File Number 1-32302

 

 

ANTARES PHARMA, INC.

 

 

 

A Delaware Corporation   IRS Employer Identification No. 41-1350192

100 Princeton South, Suite 300

Ewing, New Jersey 08628

(609) 359-3020

 

 

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 Website, 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 the definitions 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   ¨   (do not check if a smaller reporting company)    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

The number of shares outstanding of the registrant’s Common Stock, $.01 par value, as of August 5, 2015 was 154,806,749.

 

 

 


Table of Contents

ANTARES PHARMA, INC.

INDEX

 

             PAGE  

PART I.

   

FINANCIAL INFORMATION

  
  Item 1.  

Financial Statements

  
   

Consolidated Balance Sheets, as of June 30, 2015 (Unaudited) and December 31, 2014

     3   
   

Consolidated Statements of Operations (Unaudited) for the three and six months ended June 30, 2015 and 2014

     4   
   

Consolidated Statements of Comprehensive Loss (Unaudited) for the three and six months ended June 30, 2015 and 2014

     5   
   

Consolidated Statements of Cash Flows (Unaudited) for the six months ended June 30, 2015 and 2014

     6   
   

Notes to Consolidated Financial Statements (Unaudited)

     7   
  Item 2.  

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

     16   
  Item 3.  

Quantitative and Qualitative Disclosures About Market Risk

     25   
  Item 4.  

Controls and Procedures

     25   

PART II.

   

OTHER INFORMATION

  
  Item 1A.  

Risk Factors

     26   
  Item 6.  

Exhibits

     26   
   

SIGNATURES

     28   

 

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PART I – FINANCIAL INFORMATION

 

Item 1. FINANCIAL STATEMENTS

ANTARES PHARMA, INC.

CONSOLIDATED BALANCE SHEETS

 

     June 30,     December 31,  
     2015     2014  
     (Unaudited)        

Assets

    

Current Assets:

    

Cash and cash equivalents

   $ 43,124,635      $ 34,028,889   

Short-term investments

     6,001,895        6,002,438   

Accounts receivable

     6,449,885        3,510,051   

Inventories

     5,465,568        5,859,924   

Deferred costs

     943,933        1,913,921   

Prepaid expenses and other current assets

     2,849,001        2,322,464   
  

 

 

   

 

 

 

Total current assets

     64,834,917        53,637,687   

Equipment, molds, furniture and fixtures, net

     13,558,628        10,828,741   

Patent rights, net

     2,700,722        2,885,024   

Goodwill

     1,095,355        1,095,355   

Long-term investments

     9,016,818        —     

Other assets

     326,184        325,955   
  

 

 

   

 

 

 

Total Assets

   $ 91,532,624      $ 68,772,762   
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity

    

Current Liabilities:

    

Accounts payable

   $ 4,762,221      $ 10,071,504   

Accrued expenses and other liabilities

     5,657,979        5,635,559   

Deferred revenue

     3,029,854        8,520,517   
  

 

 

   

 

 

 

Total current liabilities

     13,450,054        24,227,580   

Deferred revenue – long term

     738,800        3,349,026   
  

 

 

   

 

 

 

Total liabilities

     14,188,854        27,576,606   
  

 

 

   

 

 

 

Stockholders’ Equity:

    

Preferred Stock: $0.01 par, authorized 3,000,000 shares, none outstanding

     —          —     

Common Stock: $0.01 par; authorized 200,000,000 shares; 154,806,749 and 131,743,365 issued and outstanding at June 30, 2015 and December 31, 2014, respectively

     1,548,068        1,317,433   

Additional paid-in capital

     293,215,156        249,032,066   

Accumulated deficit

     (216,741,976     (208,447,656

Accumulated other comprehensive loss

     (677,478     (705,687
  

 

 

   

 

 

 
     77,343,770        41,196,156   
  

 

 

   

 

 

 

Total Liabilities and Stockholders’ Equity

   $ 91,532,624      $ 68,772,762   
  

 

 

   

 

 

 

See accompanying notes to consolidated financial statements.

 

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ANTARES PHARMA, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

 

     For the Three Months Ended     For the Six Months Ended  
     June 30,     June 30,  
     2015     2014     2015     2014  

Revenue:

        

Product sales

   $ 5,840,034      $ 3,360,003      $ 10,463,164      $ 5,165,305   

Development revenue

     3,027,445        1,788,401        5,415,848        3,209,550   

Licensing revenue

     5,186,372        928,350        6,069,381        1,856,479   

Royalties

     366,540        250,031        820,035        1,297,646   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     14,420,391        6,326,785        22,768,428        11,528,980   

Cost of revenue:

        

Cost of product sales

     2,540,178        1,846,193        4,497,751        2,863,630   

Cost of development revenue

     2,167,916        283,887        3,885,072        443,195   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total cost of revenue

     4,708,094        2,130,080        8,382,823        3,306,825   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     9,712,297        4,196,705        14,385,605        8,222,155   

Operating expenses:

        

Research and development

     4,568,732        3,942,948        8,946,713        8,476,574   

Selling, general and administrative

     6,605,030        9,344,910        13,642,320        17,645,078   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     11,173,762        13,287,858        22,589,033        26,121,652   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (1,461,465     (9,091,153     (8,203,428     (17,899,497

Other income (expense)

     (45,181     (6,572     (90,892     7,167   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (1,506,646   $ (9,097,725   $ (8,294,320   $ (17,892,330
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted net loss per common share

   $ (0.01   $ (0.07   $ (0.06   $ (0.14
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted weighted average common shares outstanding

     144,650,269        130,051,896        138,233,155        129,855,169   
  

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes to consolidated financial statements.

 

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ANTARES PHARMA, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)

 

     For the Three Months Ended     For the Six Months Ended  
     June 30,     June 30,  
     2015     2014     2015     2014  

Net loss

   $ (1,506,646   $ (9,097,725   $ (8,294,320   $ (17,892,330

Foreign currency translation adjustment

     16,145        (2,281     28,209        (90
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $ (1,490,501   $ (9,100,006   $ (8,266,111   $ (17,892,420
  

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes to consolidated financial statements.

 

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ANTARES PHARMA, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

     For the Six Months Ended  
     June 30,  
     2015     2014  

Cash flows from operating activities:

    

Net loss

   $ (8,294,320   $ (17,892,330

Adjustments to reconcile net loss to net cash used in operating activities:

    

Depreciation and amortization

     768,931        503,786   

Disposal of equipment

     167,097        —     

Stock-based compensation expense

     1,650,918        1,203,596   

Amortization of premiums and discounts

     3,824        17,587   

Changes in operating assets and liabilities:

    

Accounts receivable

     (2,932,698     (2,030,674

Inventories

     394,356        (1,873,637

Prepaid expenses and other current assets

     (508,362     675,851   

Deferred costs

     969,988        (686,281

Accounts payable

     (4,052,526     (1,083,503

Accrued expenses and other current liabilities

     76,220        2,003,987   

Deferred revenue

     (8,106,486     6,022,693   
  

 

 

   

 

 

 

Net cash used in operating activities

  (19,863,058   (13,138,925
  

 

 

   

 

 

 

Cash flows from investing activities:

Purchases of equipment, molds, furniture and fixtures

  (4,091,319   (918,337

Additions to patent rights

  (960,260   (252,580

Proceeds from maturities of investment securities

  6,000,000      15,000,000   

Purchases of investment securities

  (15,037,675   —     
  

 

 

   

 

 

 

Net cash provided by (used in) investing activities

  (14,089,254   13,829,083   
  

 

 

   

 

 

 

Cash flows from financing activities:

Proceeds from issuance of common stock, net

  43,115,000      —     

Proceeds from exercise of stock options and warrants

  —        1,415,725   

Taxes paid related to net share settlement of equity awards

  (67,924   (154,397
  

 

 

   

 

 

 

Net cash provided by financing activities

  43,047,076      1,261,328   
  

 

 

   

 

 

 

Effect of exchange rate changes on cash and cash equivalents

  982      (747
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

  9,095,746      1,950,739   

Cash and cash equivalents:

Beginning of period

  34,028,889      39,067,236   
  

 

 

   

 

 

 

End of period

$ 43,124,635    $ 41,017,975   
  

 

 

   

 

 

 

Supplemental disclosure of non-cash investing activities:

Purchases of equipment, molds, furniture and fixtures recorded in accounts payable and accrued expenses

$ 423,360    $ 1,133,065   
  

 

 

   

 

 

 

Additions to patent rights recorded in accounts payable and accrued expenses

$ 47,287    $ 1,145,128   
  

 

 

   

 

 

 

Supplemental disclosure of non-cash financing activities:

Expenses incurred in connection with issuance of common stock recorded in accounts payable and accrued expenses

$ 323,087    $ —     
  

 

 

   

 

 

 

See accompanying notes to consolidated financial statements.

 

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ANTARES PHARMA, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

1. Description of Business

Antares Pharma, Inc. (“Antares” or the “Company”) is an emerging, specialty pharmaceutical company focusing on the development and commercialization of self-administered parenteral pharmaceutical products and technologies. The Company has numerous partnership arrangements with several industry leading pharmaceutical companies, as well as multiple internal product development programs.

The Company develops and manufactures, for itself and with its partners, novel, pressure-assisted injector devices, with and without needles, which allow patients to self-inject drugs. It makes a reusable, needle-free spring action injection device which is marketed through its partners for use with human growth hormone (hGH). The Company has also developed variations of the needle-free injector by adding a small shielded needle to a pre-filled, single-use disposable injector, called the Vibex ® pressure assisted auto injection system. This system is an alternative to the needle-free system for use with injectable drugs in unit dose containers and is suitable for branded and generic injectables. Additionally, the Company developed a disposable multi-dose pen injector for use with standard cartridges, and has a portfolio of gel-based products which are commercialized through various partners.

In February 2014, the Company launched its product OTREXUP™ (methotrexate) injection, which is the first subcutaneous methotrexate for once weekly self-administration with an easy-to-use, single dose, disposable auto injector approved by the U.S. Food and Drug Administration (“FDA”). OTREXUP™ is indicated for adults with severe active rheumatoid arthritis (“RA”), children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis (“psoriasis”). To date, Antares has received FDA approval for dosage strengths of 7.5 mg, 10 mg, 15 mg, 20 mg and 25 mg of OTREXUP™.

The Company has other products at various stages of development and approval. Antares is developing Vibex ® Sumatriptan for the acute treatment of migraines and has begun commercial scale tooling and mold fabrication in anticipation of a potential approval and launch. The Company is currently conducting clinical studies of Vibex ® QuickShot ® Testosterone (“QS T”), for testosterone replacement therapy, and has also initiated manufacturing development work for QS M, a combination product for an undisclosed central nervous system indication.

The Company has formed significant strategic alliances with several leading pharmaceutical companies, including Teva Pharmaceutical Industries, Ltd. (“Teva”), Ferring Pharmaceuticals Inc. and Ferring B.V. (together “Ferring”), and JCR Pharmaceuticals Co., Ltd. (“JCR”). Through these relationships, the company develops and applies its drug delivery systems in collaborations with the pharmaceutical partners to enhance the partners’ drug compounds and delivery methods.

 

2. Basis of Presentation and Significant Accounting Policies

The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the U.S. for interim financial information and with the instructions to Form 10-Q and Article 10 of the Securities and Exchange Commission’s Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the U.S. for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. The accompanying consolidated financial statements and notes thereto should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2014. Operating results for the three and six months ended June 30, 2015 are not necessarily indicative of the results that may be expected for the year ending December 31, 2015.

Certain prior year amounts have been reclassified in the consolidated financial statements to conform to the current year presentation. These reclassifications were made to present selling, general and administrative expenses in one line in the consolidated statements of operations. In prior years, sales and marketing expenses and general and administrative expenses were presented in separate lines. These reclassifications had no effect on previously reported net income or total operating expenses.

 

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Investments

All short-term and long-term investments are U.S. Treasury bills or U.S. Treasury notes that are classified as held-to-maturity because of the Company’s positive intent and ability to hold the securities to maturity. The securities are carried at their amortized cost and the fair value of all securities is determined by quoted market prices. At June 30, 2015 and December 31, 2014, the Company’s short-term investments had a carrying value of $6,001,895 and $6,002,438, respectively. As of June 30, 2015, the Company had long-term investments with a carrying value of $9,016,818, and held no long-term investments as of December 31, 2014. The carrying value of the Company’s short-term and long-term investments as of June 30, 2015 and December 31, 2014, approximated fair value.

Inventories

Inventories are stated at the lower of cost or market. Cost is determined on a first-in, first-out basis. Certain components of the Company’s products are provided by a limited number of vendors, and the Company’s production, assembly, warehousing and distribution operations are outsourced to third-parties where substantially all of the Company’s inventory is located. Disruption of supply from key vendors or third-party suppliers may have a material adverse impact on the Company’s operations. The Company provides reserves for potentially excess, dated or obsolete inventories based on an analysis of inventory on hand compared to forecasts of future sales. Inventories consist of the following:

 

     June 30,      December 31,  
     2015      2014  

Inventories:

     

Raw material

   $ 388,499       $ 461,396   

Work in process

     3,243,499         3,896,837   

Finished goods

     1,833,570         1,501,691   
  

 

 

    

 

 

 
   $ 5,465,568       $ 5,859,924   
  

 

 

    

 

 

 

Capitalized Patent Costs

The Company capitalizes external legal patent defense costs and costs for pursuing patent infringements when it determines that a successful outcome is probable and will lead to an increase in the value of the patent. The capitalized costs are amortized over the remaining life of the related patent. If changes in the anticipated outcome were to occur that reduce the likelihood of a successful outcome of the entire action to less than probable, the capitalized costs would be charged to expense in the period in which the change is determined. As of June 30, 2015 and December 31, 2014, approximately $1,800,000 in external legal patent defense costs were capitalized within patent rights, net.

Product Revenue

In February 2014, the Company began detailing OTREXUP™ to health care professionals in the U.S. and began shipping to wholesale pharmaceutical distributors, subject to rights of return within a period beginning six months prior to, and ending 12 months following, product expiration. Given the limited sales history of OTREXUP™, the Company currently cannot reliably estimate expected returns of the product at the time of shipment. Accordingly, recognition of revenue is deferred on product shipments of OTREXUP™ until the right of return no longer exists, which occurs at the earlier of the time OTREXUP™ units are dispensed through patient prescriptions or expiration of the right of return. Units dispensed are generally not subject to return, except in the rare cases where the product malfunctions or the product is damaged in transit. Patient prescriptions dispensed are estimated using third-party market prescription data. These third-party sources poll pharmacies, hospitals, mail order and other retail outlets for OTREXUP™ prescriptions and project this sample on a national level. If patient prescriptions dispensed for a given period are underestimated or overestimated, adjustments to revenue may be necessary in future periods.

 

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The Company recognized $3,346,094 and $6,350,403 in OTREXUP™ product revenue for the three and six months ended June 30, 2015, respectively, as compared to $1,671,470 and $1,884,315 for the three and six months ended June 30, 2014, which is presented net of product allowances for estimated wholesaler discounts, prompt pay discounts, chargebacks, rebates and patient discount programs. The Company had deferred revenue balances of $986,517 and $1,061,947 at June 30, 2015 and December 31, 2014, respectively, for OTREXUP™ product shipments, which is net of product sales allowances.

The Company will continue to recognize revenue upon the earlier to occur of prescription units dispensed or expiration of the right of return until it can reliably estimate product returns, at which time the Company will record a one-time increase in net revenue related to the recognition of revenue previously deferred. In addition, the costs of manufacturing OTREXUP™ associated with the deferred revenue are recorded as deferred costs, which are included in inventory, until such time as the related deferred revenue is recognized.

Product Sales Allowances

The Company recognizes product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. These estimates take into consideration the terms of our agreements with customers and third-party payors and the levels of inventory within the distribution channels that may result in future rebates or discounts taken. In certain cases, such as patient support programs, the Company recognizes the cost of patient discounts as a reduction of revenue based on estimated utilization. If actual future results vary, it may be necessary to adjust these estimates, which could have an effect on product revenue in the period of adjustment. Product sales allowances include:

Wholesaler Distribution Fees . Distribution fees are paid to certain wholesale distributors based on contractually determined rates. The Company accrues the fee on shipment to the respective wholesale distributors and recognizes the fee as a reduction of revenue in the same period the related revenue is recognized.

Prompt Pay Discounts . The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for prompt payment. The Company accounts for cash discounts by reducing accounts receivable by the prompt pay discount amount and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized.

Chargebacks . Through June 30, 2015, the Company has been subject to a minimal amount of chargebacks. The Company expects to provide discounts primarily to authorized users of the Federal Supply Schedule (“FSS”) of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs and various organizations under Medicaid contracts and regulations. These entities purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to the Company the difference between the current wholesale acquisition cost and the price the entity paid for the product. The Company will estimate and accrue chargebacks based on estimated wholesaler inventory levels, current contract prices and historical chargeback activity. Chargebacks are recognized as a reduction of revenue in the same period the related revenue is recognized.

Rebates . The Company participates in certain rebate programs, which provide discounted prescriptions to qualified insured patients. Under these rebate programs, the Company will pay a rebate to the third-party administrator of the program, generally two to three months after the quarter in which prescriptions subject to the rebate are filled. The Company estimates and accrues for these rebates based on current contract prices, historical and estimated percentages of product sold to qualified patients. Rebates are recognized as a reduction of revenue in the same period the related revenue is recognized.

Patient Discount Programs . The Company offers discount card programs to patients for OTREXUP™ in which patients receive discounts on their prescriptions that are reimbursed by the Company. The Company estimates the total amount that will be redeemed based on historical redemption experience and on levels of inventory in the distribution and retail channels and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized.

 

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3. Licensing Agreements and Contractual Arrangements

The Company has entered into multiple license agreements for its devices with Teva. The Company’s development projects in collaboration with Teva include VIBEX ® epinephrine, an exenatide multi-dose pen, and another undisclosed multi-dose pen. In December 2014, Teva submitted the final amendment to the VIBEX ® epinephrine ANDA, and FDA accepted Teva’s filing of an ANDA in October 2014 for exenatide, formerly referred to as Teva “Pen 2”.

Antares is also developing VIBEX ® Sumatriptan for the acute treatment of migraines which, if approved will be distributed by Teva. The Company received a complete response letter from the FDA regarding its Abbreviated New Drug Application (“ANDA”) for VIBEX ® Sumatriptan, providing revisions to labelling and citing minor deficiencies. The Company submitted its response to the FDA in March, 2015, and received a second complete response letter from the FDA primarily requesting additional labeling revisions, to which it responded in July 2015. Commercial scale tooling and mold fabrication has begun in anticipation of potential approval and launch.

The Company also makes a reusable, needle-free, spring-action injector device, which is marketed for use with human growth hormone, hGH, through licenses to its pharmaceutical partners Ferring and JCR, which generates product sales and royalties. Ferring commercializes the Company’s needle-free injection system with their 4 mg and 10 mg hGH formulations marketed as Zomajet ® 2 Vision and Zomajet ® Vision X worldwide. Ferring purchased the U.S. rights to TEV-TROPIN ® (Teva’s hGH), and Tjet ® from Teva in December 2014. In March 2015, Ferring received FDA approval of a name change enabling TEV-TROPIN ® to be marketed in the U.S. as ZOMACTON (somatropin [rDNA origin]) for injection and the Tjet ® needle-free delivery system to be marketed in the U.S. as ZOMA-Jet™. Also in March 2015, Ferring received approval from the FDA to market the 10 mg needle free injector device which, along with certain consumables, is supplied by Antares to Ferring. Distribution of growth hormone injectors occurs in the U.S., Europe, Japan and other Asian countries through pharmaceutical company relationships.

Antares has a portfolio of gel-based products which are marketed through licensing agreements. Actavis plc (“Actavis”) is currently marketing Gelnique ® (oxybutynin chloride), 3% gel, which is indicated in the U.S. for the treatment of overactive bladder. Elestrin ® (estradiol gel) is currently marketed by Meda Pharmaceuticals, Inc. (“Meda”) in the U.S. for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.

LEO Pharma Promotion and License Agreement

In November 2013, the Company entered into a promotion and license agreement with LEO Pharma (“LEO”), under which the Company granted LEO the exclusive right to promote OTREXUP TM to dermatologists for symptomatic control of psoriasis in adults in the U.S. The Company received a non-refundable upfront payment of $5,000,000 and a subsequent milestone payment of $5,000,000 pursuant to the terms of the agreement. The deliverables in the agreement were accounted for as a single unit of accounting, and the $10,000,000 in total payments received were recorded as deferred revenue and were being amortized to licensing revenue over a three-year period.

Effective June 23, 2015, the agreement with LEO was terminated and the Company regained the exclusive U.S. marketing rights to OTREXUP™. As a result, the Company recognized the remaining unamortized balance of the deferred revenues related to this arrangement in the second quarter of 2015. The Company recognized revenue of $6,000,000 and $1,714,286 for the six month periods ended June 30, 2015 and 2014, respectively, and $5,142,857 and $857,143 for the three month periods ended June 30, 2015 and 2014, respectively, related to the LEO agreement. Deferred revenue in connection with this agreement totaled $6,000,000 at December 31, 2014 and zero as of June 30, 2015.

 

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4. Stockholders’ Equity

On May 11, 2015, the Company completed an underwritten offering of 23,000,000 shares of its common stock at a price to the public of $2.00 per share. The Company received net proceeds of approximately $42.8 million after deducting underwriting discounts, commissions and offering expenses paid by the Company. The Company intends to use the net proceeds from the offering for general corporate purposes including business development, in-licensing and acquisitions.

The Company’s 2008 Equity Compensation Plan (the “Plan”) allows for grants in the form of incentive stock options, nonqualified stock options, stock units, stock awards, stock appreciation rights, and other stock-based awards. All of the Company’s officers, directors, employees, consultants and advisors are eligible to receive grants under the Plan. The maximum number of shares authorized for issuance under the Plan is 21,000,000 and the maximum number of shares of stock that may be granted to any one participant during a calendar year is 1,000,000 shares. Options to purchase shares of common stock are granted at exercise prices not less than 100% of fair market value on the dates of grant. The term of each option is ten years and the options typically vest in quarterly installments over a three-year period. As of June 30, 2015, the Plan had 365,599 shares available for grant.

Stock Options

A summary of stock option activity under the Plan as of June 30, 2015, and the changes during the six months then ended is as follows:

 

     Number of
Shares
     Weighted
Average
Exercise
Price ($)
     Weighted
Average
Remaining
Contractual
Term (Years)
     Aggregate
Intrinsic
Value ($)
 

Outstanding at December 31, 2014

     7,245,485         2.25         

Granted

     2,801,510         2.23         

Exercised

     —           —              —     

Cancelled/Forfeited

     (170,754      3.19         
  

 

 

          

Outstanding at June 30, 2015

     9,876,241         2.22         7.2         2,818,000   
  

 

 

    

 

 

    

 

 

    

 

 

 

Exercisable at June 30, 2015

     5,657,117         2.04         5.4         2,818,000   
  

 

 

    

 

 

    

 

 

    

 

 

 

The per share weighted average fair values of all options granted during the first half of 2015 and 2014 were estimated as $1.10 and $3.08, respectively, on the date of grant using the Black-Scholes option pricing model based on the assumptions noted in the table below. Expected volatilities are based on the historical volatility of the Company’s stock price. The weighted average expected life is based on both historical and anticipated employee behavior.

 

     June 30,  
     2015     2014  

Risk-free interest rate

     1.3     1.7

Annualized volatility

     53.8     62.0

Weighted average expected life, in years

     6.0        6.0   

Expected dividend yield

     0.0     0.0

There were no stock option exercises in the first six months of 2015. In the first six months of 2014, 699,678 stock options with a weighted average exercise price of $1.24 were exercised which generated proceeds of $870,726 to the Company.

Total recognized compensation expense for stock options was $1,411,005 and $807,727 for the first six months of 2015 and 2014, respectively and totaled $770,214 and $447,831 for the three month periods ended June 30, 2015 and 2014, respectively. As of June 30, 2015, there was $4,557,345 of total unrecognized compensation cost related to nonvested outstanding stock options that is expected to be recognized over a weighted average period of approximately 2.16 years.

 

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Long Term Incentive Program (LTIP)

The Company’s Board of Directors has approved a long term incentive program (“LTIP”) for the benefit of the Company’s senior executives. Pursuant to the LTIP, the Company’s senior executives have been awarded stock options, restricted stock units (“RSU”) and performance stock units (“PSU”) with targeted values based on values granted by the Company’s peer group.

The stock options have a ten-year term, have an exercise price equal to the closing price of the Company’s common stock on the date of grant, vest in quarterly installments over three years, were otherwise granted on the same standard terms and conditions as other stock options granted pursuant to the Plan and are included in the stock options table above. The RSUs vest in three equal annual installments. The PSU awards made to the senior executives vest and convert into shares of the Company’s common stock based on the Company’s attainment of certain performance goals over a performance period of three years.

The performance stock unit awards and restricted stock unit awards granted under the long term incentive program are summarized in the following table:

 

     Performance Stock Units      Restricted Stock  
     Number of
Shares
     Weighted
Average Grant
Date Fair
Value ($)
     Number of
Shares
     Weighted
Average Grant
Date Fair
Value ($)
 

Outstanding at December 31, 2014

     463,542         3.08         231,124         3.07   

Granted

     664,391         2.09         664,391         2.18   

Vested

     —              (80,781      3.11   

Forfeited/Expired

     (40,453      3.09         (13,485      3.09   
  

 

 

    

 

 

    

 

 

    

 

 

 

Outstanding at June 30, 2015

     1,087,480         2.59         801,249         2.33   
  

 

 

    

 

 

    

 

 

    

 

 

 

In 2015 and 2014, the LTIP awards include PSUs that will be earned based on the Company’s total shareholder return (“TSR”) as compared to the Nasdaq Biotechnology Index (“NBI”) at the end of the performance period, which performance period is January 1, 2014 to December 31, 2016 for the 2014 award and January 1, 2015 to December 31, 2017 for the 2015 award. Depending on the outcome of the performance goal, a recipient may ultimately earn a number of shares greater or less than their target number of shares granted, ranging from 0% to 150% of the PSUs granted. The fair values of the TSR PSUs granted in May 2015 and 2014 was determined using a Monte Carlo simulation and utilized the following inputs and assumptions:

 

     2015
Award
    2014
Award
 

Closing stock price on grant date

   $ 2.18      $ 3.09   

Performance period starting price

   $ 2.57      $ 4.08   

Term of award (in years)

     2.59        2.59   

Volatility

     60.45     50.87

Risk-free interest rate

     0.83     0.61

Expected dividend yield

     0.00     0.00

Fair value per TSR PSU

   $ 1.71      $ 2.64   

The performance period starting price is measured as the average closing price over the last 20 trading days prior to the performance period start. The Monte Carlo simulation model also assumed correlations of returns of the prices of the Company’s common stock and the common stocks of the NBI companies and stock price volatilities of the NBI companies. The fair value of the target number of shares that can be earned under the TSR PSUs is being recognized as compensation expense over the performance period.

 

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Total compensation expense recognized in connection with PSU awards totaled $62,638 in the first six months of 2015. The Company recognized a net expense reduction of $47,955 in the first six months of 2014 due to the forfeiture of PSU awards in connection with the departure of the former CEO. Compensation expense recognized in the first six months of 2015 and 2014 in connection with the RSUs was $177,275 and $100,752, respectively.

Shares issued in connection with PSU and RSU awards that vested in the first half of 2015 and 2014 were net-share settled such that the Company withheld shares with a value equivalent to the employees’ minimum statutory obligation for the applicable income and other employment taxes, and remitted the cash to the appropriate taxing authorities. The total shares withheld to satisfy tax obligations were 29,914 and 38,768 in the six months ended June 30, 2015 and 2014, respectively, and were based on the fair value of the shares on their vesting date as determined by the Company’s closing stock price. Total payments for the employees’ tax obligations to the taxing authorities were $67,924 and $154,397 in the six months ended June 30, 2015 and 2014, respectively, and are reflected as a financing activity within the consolidated statements of cash flows. These net-share settlements had the effect of share repurchases by the Company as they reduced the number of shares that would have otherwise been issued as a result of the vesting and did not represent an expense to the Company.

Warrants

In the first six months of 2014, the Company received proceeds of $545,000 from the exercise of 545,000 warrants. There were no warrants outstanding at June 30, 2015 or December 31, 2014.

Stock Awards

At times, the Company makes discretionary grants of its common stock to members of management and other employees in lieu of cash bonus awards or in recognition of special achievements. There were no discretionary grants of common stock in the first six months of 2015. In the first six months of 2014, there were 150,000 shares of common stock granted to members of executive management as bonus compensation for achievements in 2013.

In addition to the shares granted to members of management and employees, at times directors receive a portion of their annual compensation in shares of Company common stock. In 2015 and 2014, no shares were granted to the directors, as all directors’ compensation was paid in cash and stock options. Expense is recognized on a straight line basis over the one-year period in which the compensation is earned. Expense recognized in connection with shares granted to directors in 2013 was $163,456 and $343,073 for the three and six month periods ended June 30, 2014, respectively.

 

5. Net Loss Per Share

Basic loss per common share is computed by dividing net loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted loss per common share reflects the potential dilution from the exercise or conversion of securities into common stock. Potentially dilutive stock options and warrants excluded from dilutive loss per share because their effect was anti-dilutive totaled 9,876,241 and 8,853,417 at June 30, 2015 and 2014, respectively.

 

6. Industry Segment and Operations by Geographic Areas

The Company has one operating segment, drug delivery, which includes the development of injection devices and injection based pharmaceutical products as well as transdermal gel products.

 

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Revenues by customer location are summarized as follows:

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2015      2014      2015      2014  

United States of America

   $ 13,552,664       $ 4,572,808       $ 20,315,440       $ 8,487,467   

Europe

     828,651         1,744,907         2,300,067         2,830,003   

Other

     39,076         9,070         152,921         211,510   
  

 

 

    

 

 

    

 

 

    

 

 

 
   $ 14,420,391       $ 6,326,785       $ 22,768,428       $ 11,528,980   
  

 

 

    

 

 

    

 

 

    

 

 

 

Significant customers comprising 10% or more of total revenue are as follows:

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2015      2014      2015      2014  

Teva

   $ 4,796,402       $ 1,856,526       $ 7,129,217       $ 4,304,813   

LEO Pharma

     5,142,857         857,143         6,000,000         1,714,286   

McKesson (1)

     1,435,196         603,431         3,334,901         656,835   

AmerisourceBergen (1)

     1,393,527         587,520         2,268,672         659,807   

Ferring

     828,651         1,744,912         2,300,067         2,830,008   

 

(1) Represents estimated revenue based on OTREXUP™ shipments, a portion of which has not been recognized as revenue but is recorded in deferred revenue at the end of each period as discussed in Note 2 to the Consolidated Financial Statements.

 

7. Legal Proceedings

In the first quarter of 2014, medac Pharma, Inc. (“Medac Pharma”) announced that it submitted a New Drug Application (“NDA”) to the FDA for an auto-pen containing methotrexate. On February 28, 2014, Antares filed a complaint against Medac Pharma and medac GmbH, the parent company of Medac Pharma, (medac GmbH, together with Medac Pharma, “Medac”) in the U.S. District Court for the District of Delaware, alleging infringement of two of the Company’s patents for technology regarding an auto injector and an auto injector containing methotrexate. On March 14, 2014, Antares filed a motion for preliminary injunction seeking to enjoin Medac from selling its methotrexate auto-pen product if and when such product is approved for sale in the United States, pending the final resolution of the litigation. On April 18, 2014 an amended complaint was filed asserting four Antares patents, and the motion for preliminary injunction was updated. On July 10, 2014, the District Court denied Antares’ motion for preliminary injunction. Antares filed an appeal of the denial of the motion for preliminary injunction with the U.S. Court of Appeals for the Federal Circuit, and in February 2015, that motion was denied. In 2014, a total of approximately $1,800,000 in legal costs in connection with this suit was capitalized.

On March 7, 2014, Medac filed suit against Antares, LEO Pharma, Inc. and its parent company, LEO Pharma A/S (LEO Pharma, Inc. together with LEO Pharma A/S, the “LEO Entities”) in the U.S. District Court for the District of New Jersey, alleging that Antares and the LEO Entities infringe Medac Pharma’s U.S. Patent 8,664,231 (the “231 patent”) that was issued by the U.S. Patent and Trademark Office on March 4, 2014. Under the terms of the promotion and license agreement between the Company and the LEO Entities, the Company agreed to indemnify the LEO Entities from claims that OTREXUP™ infringes the intellectual property rights of any third party. On July 1, 2014, Antares filed a petition with the Patent Trial and Appeal Board (the “PTAB”) of the U.S. Patent and Trademark Office seeking an inter partes review of the 231 patent, and in January 2015, the PTAB decided to institute review of the 231 patent. Legal costs in connection with this suit and the inter partes review were expensed as incurred.

 

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In April 2015, Antares, Medac and the LEO Entites entered into a settlement agreement pursuant to which all of the proceedings related to Antares’ and Medac’s respective patents mentioned above and the proceeding pending before the Technical Board of Appeal of the European Patent Office were dismissed. The settlement agreement also provides for a royalty-free cross-license under the patents-named in-the proceedings and their families allowing the manufacture and sale of OTREXUP™ (methotrexate) injection and RASUVO™ in and for the U.S. As a result, the $1,800,000 million of capitalized legal patent defense costs will continue to be amortized over the estimated useful life of the patents.

 

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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-Looking Statements

Certain statements in this report, including statements in the management’s discussion and analysis section set forth below, may be considered “forward-looking statements” as that term is defined in the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the words “expect,” “estimate,” “project,” “anticipate,” “should,” “intend,” “may,” “will,” “believe,” “continue” or other words and terms of similar meaning in connection with any discussion of, among other things, future operating or financial performance, strategic initiatives and business strategies, regulatory or competitive environments, our intellectual property and product development. In particular, these forward-looking statements include, among others, statements about:

 

    our expectations regarding commercialization of OTREXUP™ (methotrexate) injection for subcutaneous use;

 

    our expectations regarding product development and potential approval by the United States (“U.S.”) Food and Drug Administration (“FDA”) of Vibex ® QuickShot ® (“Vibex ® QS T”) (testosterone injection);

 

    our expectations regarding continued product development with Teva Pharmaceutical Industries, Ltd. (“Teva”);

 

    our expectations regarding product development and potential FDA approval of Vibex ® Sumatriptan (sumatriptan injection);

 

    our expectations regarding product development and potential FDA approval of Vibex ® epinephrine pen (“epinephrine auto injector”) and Teva’s ability to successfully commercialize the epinephrine auto injector;

 

    our expectations regarding trends in pharmaceutical drug delivery characteristics;

 

    our anticipated continued reliance on contract manufacturers to manufacture our products;

 

    our sales and marketing plans;

 

    product development and commercialization plans regarding our other products and product candidates;

 

    our plans regarding potential manufacturing and marketing partners;

 

    our future cash flow and our ability to support our operations;

 

    the impact of new accounting pronouncements and our expectations and estimates with regard to current accounting practices; and

 

    our expectations regarding the year ending December 31, 2015.

Forward-looking statements involve known and unknown risks, uncertainties and achievements, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. While we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that these statements are based on a combination of facts and factors currently known by us and projections of the future about which we cannot be certain. Many factors may affect our ability to achieve our objectives, including:

 

    delays in product introduction and marketing or interruptions in supply;

 

    a decrease in business from our major customers and partners;

 

    our inability to compete successfully against new and existing competitors or to leverage our research and development capabilities and our marketing capabilities;

 

    our inability to effectively market our services or obtain and maintain arrangements with our customers, partners and manufacturers;

 

    our inability to effectively protect our intellectual property;

 

    costs associated with future litigation and the outcome of such litigation;

 

    our inability to attract and retain key personnel;

 

    regulatory changes or delays in the regulatory process;

 

    adverse economic and political conditions; and

 

    our inability to obtain additional financing, reduce expenses or generate funds when necessary.

 

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In addition, you should refer to the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2014 for a discussion of other factors that may cause our actual results to differ materially from those described by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements contained in this report will prove to be accurate and, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material.

We encourage readers of this report to understand forward-looking statements to be strategic objectives rather than absolute targets of future performance. Forward-looking statements speak only as of the date they are made. We do not intend to update publicly any forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements are made or to reflect the occurrence of unanticipated events except as required by law. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, if at all.

The following discussion and analysis, the purpose of which is to provide investors and others with information that we believe to be necessary for an understanding of our financial condition, changes in financial condition and results of operations, should be read in conjunction with the financial statements, notes and other information contained in this report.

Overview

Antares Pharma, Inc. (“Antares,” “we,” “our,” “us” or the “Company”) is an emerging, specialty pharmaceutical company that focuses on developing and commercializing self-administered parenteral pharmaceutical products and technologies. We have numerous partnerships with pharmaceutical companies as well as multiple internal product development programs.

We develop and manufacture for ourselves and with partners, novel, pressure-assisted injectors, with and without needles, which allow patients to self-inject drugs. We make a reusable, needle-free spring action injection device which is marketed through our partners for use with human growth hormone (hGH). We have developed variations of the needle-free injector by adding a small shielded needle to a pre-filled, single-use disposable injector, called the Vibex ® pressure assisted auto injection system. This system is an alternative to the needle-free system for use with injectable drugs in unit dose containers and is suitable for branded and generic injectables. Additionally, we have developed a disposable multi-dose pen injector for use with standard cartridges, and have a portfolio of gel-based products that are commercialized through various partners.

In February 2014, we launched our product OTREXUP™ (methotrexate) injection, which is the first FDA approved subcutaneous methotrexate for once weekly self-administration with an easy-to-use, single dose, disposable auto injector. OTREXUP™ is indicated for adults with severe active rheumatoid arthritis (“RA”), children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis (“psoriasis”). To date, we have received FDA approval for dosage strengths of 7.5 mg, 10 mg, 15 mg, 20 mg and 25 mg of OTREXUP™. We have worldwide marketing rights for OTREXUP™ and commercialize OTREXUP™ on our own in the U.S. for the treatment of RA. We previously provided LEO Pharma A/S (“LEO Pharma”) an exclusive license to commercialize OTREXUP™ in the U.S. for the treatment of psoriasis. As discussed in Note 3 to the Consolidated Financial Statements, the agreement with LEO Pharma was terminated effective June 23, 2015, at which time we regained the exclusive marketing rights in the U.S. for the treatment of psoriasis.

We have formed significant strategic alliances with several leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (“Teva”), Ferring Pharmaceuticals Inc. and Ferring B.V. (together “Ferring”), and JCR Pharmaceuticals Co., Ltd. (“JCR”). Through these relationships, we develop and apply our drug delivery systems in collaborations with the pharmaceutical partners to enhance the partners’ drug compounds and delivery methods.

We make a reusable, needle-free, spring-action injector device known as the Tjet ® and Zomajet ® , which is marketed for use with human growth hormone (“hGH”). We have achieved distribution of our devices for use with hGH through licensing arrangements with our pharmaceutical partners Ferring and JCR, resulting in product sales and royalties for the company. Ferring commercializes our needle-free injection system with their 4 mg and 10 mg hGH

 

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formulations marketed as Zomajet ® 2 Vision and Zomajet ® Vision X worldwide. Ferring purchased the U.S. rights to TEV-TROPIN ® (Teva’s hGH) and Tjet ® , in December 2014 from Teva. In March 2015, Ferring received FDA approval of a name change enabling TEV-TROPIN ® to be marketed in the U.S. as ZOMACTON (somatropin [rDNA origin]) for injection and the Tjet ® needle-free delivery system to be marketed in the U.S. as ZOMA-Jet™. Also in March 2015, Ferring received approval from the FDA to market the 10 mg needle free injector device which, along with certain consumables, is supplied by Antares to Ferring. Distribution of growth hormone injectors occurs in the U.S., Europe, Japan and other Asian countries through our pharmaceutical company relationships.

We have a pipeline of other products at various stages of development and approval. We are currently conducting clinical studies of Vibex ® QS T, for testosterone replacement therapy, and on February 25, 2015, we announced positive top-line pharmacokinetic results that showed that the primary endpoint was achieved in the Company’s ongoing, multi-center, phase 3 clinical study (QST-13-003) evaluating the efficacy and safety of testosterone enanthate administered once-weekly by subcutaneous injection using the QuickShot ® auto injector in testosterone deficient adult males. We have also initiated manufacturing development work for QS M, a combination product for an undisclosed central nervous system (“CNS”) indication.

Our development projects in collaboration with Teva include VIBEX ® epinephrine, an exenatide multi-dose pen, and another undisclosed multi-dose pen. In December 2014, Teva submitted the final amendment to the VIBEX ® epinephrine pen ANDA, and FDA accepted Teva’s filing of an ANDA in October 2014 for exenatide, formerly referred to as Teva “Pen 2”.We are also developing VIBEX ® Sumatriptan for the acute treatment of migraines, which if approved, will be sold by Teva. In January 2015, we received a complete response letter from FDA regarding our Abbreviated New Drug Application (“ANDA”) for VIBEX ® Sumatriptan, providing revisions to labelling and citing minor deficiencies, and we submitted our response to FDA in March 2015. We received a second complete response letter from the FDA, primarily requesting additional labeling revisions, and submitted our response in July 2015. We have begun commercial scale tooling and mold fabrication in anticipation of potential approval and launch.

We also have a portfolio of gel-based products which are commercialized through various partners, including an oxybutynin gel product, Gelnique ® (oxybutynin chloride), 3% gel, for the treatment of overactive bladder (“OAB”) which is currently marketed in the U.S. through a licensing agreement with Actavis plc. (“Actavis”). Elestrin ® (estradiol gel) is currently marketed by Meda Pharmaceuticals, Inc. (“Meda”) in the U.S. for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.

Results of Operations

We reported a net loss of $1,506,646 and $8,294,320 for the three and six month periods ended June 30, 2015, respectively. Operating results for the three and six months ended June 30, 2015 are not necessarily indicative of the results that may be expected for the year ending December 31, 2015. The following is an analysis and discussion of our operations for the three and six months ended June 30, 2015 as compared to the same periods in 2014.

Revenues

 

     Three Months Ended June 30,      Six Months Ended June 30,  
     2015      2014      2015      2014  

OTREXUP™

   $ 3,346,094       $ 1,671,470       $ 6,350,403       $ 1,884,315   

Needle-free injector devices and components

     724,982         1,688,533         2,145,735         2,945,004   

Auto injector and pen injector devices

     1,768,958         —           1,967,026         335,986   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total product sales

     5,840,034         3,360,003         10,463,164         5,165,305   

Development revenue

     3,027,445         1,788,401         5,415,848         3,209,550   

Licensing revenue

     5,186,372         928,350         6,069,381         1,856,479   

Royalties

     366,540         250,031         820,035         1,297,646   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total revenue

   $ 14,420,391       $ 6,326,785       $ 22,768,428       $ 11,528,980   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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Total revenues for the three and six month periods ended June 30, 2015 grew to $14,420,391 and $22,768,428, respectively, as compared to $6,326,785 and $11,528,980 for the three and six month periods ended June 30, 2014, respectively, representing an overall growth in total revenue of 128% and 97% for the three and six month periods, respectively, as compared to the same periods in the prior year. Below is a detailed discussion of the components of revenue.

OTREXUP™

In 2014, we began recognizing OTREXUP™ product revenue. We began detailing OTREXUP™ to rheumatologists in February 2014, and LEO Pharma began detailing to dermatologists in March 2014. In June 2015, our license and promotion arrangement with LEO was terminated and we regained the exclusive rights to market OTREXUP™ in the U.S. We sell OTREXUP™ in a package of four pre-filled, single-dose disposable auto injectors to wholesale pharmaceutical distributors, our customers. Sales to our customers are subject to specified rights of return. We currently defer recognition of revenue on product shipments of OTREXUP™ to our customers until the right of return no longer exists, which occurs at the earlier of the time OTREXUP™ units are dispensed through patient prescriptions or expiration of the right of return.

For the three and six month periods ended June 30, 2015, we recognized $3,346,094 and $6,350,403, respectively related to the sale of our product OTREXUP™ based on prescription data. Sales of OTREXUP™ increased $1,674,624, or 100%, and $4,466,088, or 237% for the quarter and six month periods ended June 30, 2015, respectively, as compared with sales in the same periods in 2014. The increase in sales is a result of an increase in our sales force and marketing efforts.

We had deferred revenue of $986,517 and $1,061,947 at June 30, 2015 and December 31, 2014, respectively, for OTREXUP™ product shipments to wholesalers, which is net of product sales allowances. We will continue to recognize revenue upon the earlier to occur of prescription units dispensed or expiration of the right of return until we can reliably estimate product returns, at which time we will record a one-time increase in net revenue related to the recognition of revenue previously deferred.

Needle-free injector devices and components

Our revenues from reusable needle-free injector devices and disposable components are generated primarily from sales to Ferring and decreased by $963,551 (57%) and $799,269 (27%) for the three and six month periods ended June 30, 2015, respectively as compared to the same periods in 2014. Ferring uses our needle-free injector with their 4 mg and 10 mg hGH formulations marketed as Zomajet ® 2 Vision and Zomajet ® Vision X, respectively, in Europe and Asia. In the fourth quarter of 2014, Ferring purchased the U.S. rights to Tev-Tropin ® from Teva. Teva used our Tjet ® needle-free device with their 5 mg hGH Tev-Tropin ® marketed in the U.S. In April 2014, Teva initiated a recall of the drug product, Tev-Tropin ® (not the device which we supply) and had halted sales of the drug earlier that year. The recall had a negative effect on the level of product sales to Teva. In March 2015, Ferring received FDA approval of a name change enabling its newly acquired recombinant human growth hormone to be marketed in the U.S. as ZOMACTON (somatropin [rDNA origin]) for injection, and the needle-free delivery system to be marketed in the U.S. as ZOMA-Jet™. Also in March 2015, Ferring received approval from the FDA to market the 10 mg needle free injector device. Ferring launched ZOMACTON™ in the U.S. in the second quarter of 2015 and the ZOMA-Jet™ needle-free devices are expected to be available later in 2015. However, we do not control our partners’ inventory levels of our hGH injectors or disposable components and this can cause significant fluctuations in product sales.

Auto injector and pen injector devices

Product sales from auto injector and pen injector devices totaled $1,768,958 and $1,967,026 for the quarter and six months ended June 30, 2015, and included $1,761,593 in connection with shipments of auto injectors to Teva for use with their generic epinephrine product in anticipation of a possible launch. Amounts recognized in the six month periods ended June 30, 2015 and 2014 also included sales of $187,500 and $335,987, respectively, of pre-commercial pen injector devices to Teva for use with an undisclosed product (Pen 1).

 

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Development revenue

Development revenues typically represent amounts earned under arrangements with partners in which we develop new products on their behalf. Frequently, we receive payments from our partners that are initially deferred and recognized as revenue over a development period or upon completion of defined deliverables. Development revenue totaled $5,415,848 and $3,209,550 for the six months ended June 30, 2015 and 2014, respectively and $3,027,445 and $1,788,401 for the three month periods ended June 30, 2015 and 2014, respectively. The development revenue for each period presented was primarily related to the Teva auto injector and pen injector programs.

Licensing Revenue

Licensing revenue represents amounts recognized in connection with up-front or milestone payments received from partners that are initially deferred and recognized over the estimated term of the agreement. We recognized $5,186,372 and $6,069,381 for the three and six months ended June 30, 2015, respectively as compared with $928,350 and $1,856,479 for the three and six month periods and June 30, 2014, respectively. The licensing revenue recognized in each period was primarily attributable to our license and promotion agreement with LEO Pharma, which began in November of 2013. The upfront and milestone payments received from LEO totaling $10.0 million were being recognized into revenue over a 35-month period. As discussed above, and in Note 3 to the Consolidated Financial Statements, the agreement with LEO Pharma was terminated effective June 23, 2015. As a result of the termination of the agreement, we recognized the remaining unamortized balance of the deferred revenue of $5,142,857 as licensing revenue in the second quarter of 2015. No additional revenue related to this arrangement will be recognized in future periods.

Royalties

Royalty revenue totaled $366,540 and $820,035 for the three and six month periods ended June 30, 2015 as compared to $250,031 and $1,297,646 for the three and six month periods ended June 30, respectively. We receive royalties from Ferring related to needle-free injector device sales, from Meda Pharmaceuticals, Inc. on sales of Elestrin ® and from Actavis plc on sales of Gelnique 3% ® . In 2014, we also received royalties from Teva for hGH sales. The overall decrease in royalty revenue in the three and six month periods in 2015 compared to 2014 was primarily the result of receiving no royalties from Teva after the first quarter of 2014. Our royalties from Teva were based on Teva’s sales of their hGH drug, Tev-Tropin ® . Teva initiated a recall of the drug product, Tev-Tropin ® (not the device which we supply), at the end of April 2014 and had halted sales of the drug earlier in the year. In the fourth quarter of 2014, Ferring purchased the U.S. rights to Tev-Tropin ® from Teva. In March 2015, Ferring received FDA approval of a name change enabling its newly acquired recombinant human growth hormone to be marketed in the U.S. as ZOMACTON (somatropin [rDNA origin]) for injection, and the needle-free delivery system to be marketed in the U.S. as ZOMA-Jet™. Also in March 2015, Ferring received approval from the FDA to market the 10 mg needle free injector device. Ferring launched ZOMACTON™ in the U.S. in the second quarter of 2015 and the ZOMA-Jet™ needle-free devices are expected to be available later in 2015.

Cost of Revenue and Gross Profit

The following table summarizes our total cost of revenue and gross profit:

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2015     2014     2015     2014  

Total revenue

   $ 14,420,391      $ 6,326,785      $ 22,768,428      $ 11,528,980   

Total cost of revenue

     4,708,094        2,130,080        8,382,823        3,306,825   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

   $ 9,712,297      $ 4,196,705      $ 14,385,605      $ 8,222,155   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit percentage

     67     66     63     71

 

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Our gross profit rose to $9,712,297 and $14,385,605 for the three and six month periods ended June 30, 2015, respectively, representing an increase of 131% and 75% in our gross profit as compared to the same periods in the previous year. Overall, the significant increase in our revenues and gross profit is primarily attributable to licensing revenue recognized in connection with the termination of our agreement with LEO, along with the increase in sales of our product OTREXUP™, which was launched in February 2014. Other variations in revenue, cost of revenue and gross profit are attributable to our development activities, which fluctuate depending on the mix of development projects in progress and stages of completion in each period, as discussed in more detail below.

The following table summarizes the revenue, cost of sales and gross margin associated with our product sales:

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2015     2014     2015     2014  

Product sales

   $ 5,840,034      $ 3,360,003      $ 10,463,164      $ 5,165,305   

Cost of product sales

     2,540,178        1,846,193        4,497,751        2,863,630   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross margin

   $ 3,299,856      $ 1,513,810      $ 5,965,413      $ 2,301,675   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross margin percentage

     57     45     57     45

The cost of product sales includes product acquisition costs from third-party manufacturers and internal manufacturing overhead expenses. The product gross margin increase in the three and six month periods in 2015 compared to 2014 was the result of an increase in sales of OTREXUP™, which generates a higher gross margin than our other products.

The cost of development revenue consists primarily of direct external costs, some of which may have been previously incurred and deferred. The cost of development revenue in each period was primarily related to revenue recognized under the Teva auto injector and pen injector programs. Development gross profits can vary significantly from period to period depending on the mix of development projects in progress and stages of completion in each period.

Research and Development

Research and development expenses consist of external costs for studies and analysis activities, design work and prototype development, FDA fees, personnel costs and other general operating expenses associated with research and development. Research and development expenses were relatively consistent at $4,568,732 and $8,946,713 for the three and six month periods ended June 30, 2015, respectively as compared to $3,942,948 and $8,476,574 incurred in the same periods in the prior year. Research and development expenses in each period were driven primarily by external expenses in connection with development of Vibex ® QS T for testosterone replacement therapy.

Selling, General and Administrative

Selling, general and administrative expenses were $6,605,030 and $13,642,320 for the three and six month periods ended June 30, 2015, respectively, as compared to $9,344,910 and $17,645,078 for the three and six month periods ended June 30, 2014, respectively. The decrease in 2015 was primarily due to a reduction in expenses related to OTREXUP™ market research, product branding, commercialization and pre-commercialization activities as well as a reduction in litigation fees incurred in the prior year periods in connection with litigation settled in early 2015.

Liquidity and Capital Resources

At June 30, 2015, our cash, cash equivalents and short-term investments totaled $49.1 million which consisted of cash and cash equivalents of $43.1 million and short-term investments of $6.0 million. We also held long-term investments totaling $9.0 million as of June 30, 2015. All investments are U.S. Treasury bills or U.S. Treasury notes which we intend to hold to maturity.

On May 11, 2015, we completed an underwritten offering of 23,000,000 shares of our common stock at a price to the public of $2.00 per share. We received net proceeds of approximately $42.8 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the net proceeds from the offering for general corporate purposes including business development, in-licensing and acquisitions.

 

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We believe that the combination of our current cash and investments balances and projected product sales, product development, license revenues, milestone payments and royalties will provide us with sufficient funds to support operations. We do not currently have any bank credit lines. If in the future we do not turn profitable or generate cash from operations as anticipated and additional capital is needed to support operations, we may raise additional funds through public or private equity offerings, debt financings or from other sources. We may be unable to obtain such financing, or obtain it on favorable terms, in which case we may be required to curtail development of new products, limit expansion of operations or accept financing terms that are not as attractive as we may desire.

Cash Flows

Net Cash Used in Operating Activities

Operating cash inflows are generated primarily from product sales, license and development fees and royalties. Operating cash outflows consist principally of expenditures for manufacturing costs, general and administrative costs, research and development projects including clinical studies, and sales and marketing activities. Fluctuations in cash used in operating activities are primarily a result of the timing of cash receipts and disbursement. Net cash used in operating activities was $19,863,058 for the six months ended June 30, 2015 as compared to $13,138,925 for the six months ended June 30, 2014. The increase in cash used in operating activities is primarily the result of additional cash used to pay down accounts payable in the second quarter of 2015 as compared to 2014, combined with a reduction in deferred revenue related to cash payments received from LEO and Teva in prior periods that were recognized in income in 2015.

Net Cash Provided by (Used in) Investing Activities

Net cash used in investing activities for the six months ended June 30, 2015 was $14,089,254 as compared to net cash provided by investing activities of $13,829,083 for the six months ended June 30, 2014. The change is primarily attributable to timing of purchases and maturities of investment securities. In the first six months of 2014, we received $15,000,000 in connection with the maturities of investments as compared to a cash outflow of $9,037,675 towards the net purchase of investments in the first six months of 2015. The remaining change is due to an increased use of cash for purchases of equipment, molds, furniture and fixtures, primarily related to Vibex ® QS T and Vibex ® Sumatriptan commercial molds and assembly equipment, and capitalized patent costs.

Net Cash Provided by Financing Activities

Net cash provided by financing activities in the first six months of 2015 totaled $43,047,076, and was principally attributable to proceeds received in connection with our underwritten offering of common stock which resulted in net proceeds to us of approximately $42,800,000 after underwriter discounts and expenses payable by us. The net cash provided by financing activities in the first six months of 2014 totaled $1,261,328 and was primarily due to $1,415,725 received from the exercise of 545,000 warrants and 570,178 options. There were no options or warrants exercised in the first six months of 2015.

Research and Development Programs

Our current research and development activities are primarily related to Vibex ® QS T and other device development projects.

Vibex ® QS T. We are developing Vibex ® QS T for self-administered weekly injections of testosterone enanthate in a preservative free formulation for men requiring testosterone replacement. The Vibex ® QS T injector is based on our Vibex ® QS auto injector system which offers a dose capacity of 1 mL and greater in a compact design. Vibex ® QS is designed to enhance performance on the attributes most critical to patient acceptance - speed, comfort and discretion. We believe Vibex ® QS achieves these advancements by incorporating a novel triggering mechanism and space-saving spring configuration. The design also accommodates fast injection of highly-viscous drug products, such as testosterone, that stall less-powerful conventional auto injectors.

 

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On December 5, 2012, we conducted a pre-IND (Investigational New Drug application) meeting with the FDA as part of preparing to initiate clinical development of Vibex ® QS T, establishing an agreed upon clinical path forward. In September 2013, we announced that the first patients were dosed in a clinical study evaluating the pharmacokinetics of testosterone enanthate administered weekly by subcutaneous injection at doses of 50 mg and 100 mg via the Vibex ® QS T auto injector device in adult males with testosterone deficiency. The study enrolled 39 patients at nine investigative sites in the U.S. We announced our top-line results of this study on February 20, 2014. The results are considered positive in that Vibex ® QS T treatment resulted in most patients achieving average levels of testosterone within the normal range from the first dose onward. Vibex ® QS T was also safe and well-tolerated by all dosed patients.

On November 3, 2014, we announced that the last patient has been enrolled in a double-blind, multiple-dose, phase III study (QST-13-003) to evaluate the efficacy and safety of Vibex ® QS T administered subcutaneously once each week to testosterone-deficient adult males. Patients enrolled in this study had a documented diagnosis of hypogonadism or testosterone deficiency defined as having testosterone levels below 300 ng/dL. The study includes a screening phase, a treatment titration and efficacy phase and an extended treatment phase. One hundred fifty patients are enrolled in this study. Patients meeting all eligibility criteria were assigned to receive a starting dose of Vibex ® QS T once weekly for six weeks. Adjustments to dose could be made at week seven based upon the week six pre-dose blood level. The efficacy of Vibex ® QS T and dose adjustment to regulate testosterone levels were evaluated after 12 weeks of treatment.

On February 25, 2015, we announced positive top-line pharmacokinetic results that showed that the primary endpoint was achieved in QST-13-003. The protocol for the study required that at the week 12 endpoint: (i) at least 75% of all patients’ C avg are within the normal range of 300 to 1100 ng/dL, with a lower limit of a 95% 2-sided confidence interval of greater than or equal to 65%, (ii) at least 85% of patients’ C max are less than 1500 ng/dL and (iii) no more than 5% of patients had a C max greater than 1800 ng/dL. The primary endpoint of the population that received one or more doses of QS T was met by 139 out of 150 patients, equating to 92.7% with a 95% confidence interval of 87.3% to 96.3%. Among the 137 patients that completed all 12 weeks of dosing and PK sampling, 98.5% were within the pre-defined range. The top-line results are summarized in the table below.

 

Population/Analysis

   C avg  Lower limit
of the 95% 2-
sided C. I.
    C avg  % in range
300 – 1100 ng/dL
n (%)
    C max  <1500
ng/dL

n (%)
    C max  >1800
ng/dL

n (%)
 

Primary analysis* N=150

     87.3     139 (92.7 %)      137 (91.3 %)**      0

Completers N=137

     94.8     135 (98.5 %)      137 (100 %)      0

Protocol-Required Outcomes

     ³ 65     75     ³ 85     £ 5

 

* All patients with 1 or more doses, C avg 0-168 hours post week 12 injection or last measured concentration carried forward
** Patients without a C max determination at week 12 are assigned above 1500 ng/dL

Overall, the regimen demonstrated a mean (± standard deviation) steady state concentration of testosterone of 553.3 ± 127.3 ng/dL at 12 weeks.

Participants in the study will remain on QS T and will be followed for an additional 40 weeks, and the collection of safety data is ongoing. One hundred fifty patients have received at least one dose of study drug. To date, there has been one reported death, which was caused by suicide, and one serious adverse event (“SAE”) of hospitalization for worsening depression. This patient received a single dose of QS T, and the SAE was not considered to be related to the study drug. Thus far, there have been no reported adverse events consistent with urticaria (hives).

After we initiated study QST-13-003, but before we announced positive top-line pharmacokinetic results in February 2015, we received written recommendations from the FDA related to our clinical development program for QS T. The recommendations received were in response to various clinical, Chemistry, Manufacturing and Controls and user study submissions that we made through November 2014. We believe that we had already factored many of the recommendations cited in the advice letter into the protocol of the ongoing QST-13-003 study and into the protocols for planned human use studies as a result of guidance provided by the FDA at the May 2014 Type C meeting. Based on a single reported occurrence of hives in our phase II study, which the FDA characterized as an apparent allergic reaction, as well as the known safety experience with other parenteral testosterone products, the FDA recommended that we create a larger safety database, including approximately 350 subjects exposed to QS T with approximately 200 subjects exposed for six months and approximately 100 subjects exposed for a year. Based

 

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on the number of subjects in previous studies and in the current QST-13-003 study, we anticipated that we need approximately 70 additional subjects exposed to QS T for six months. We assessed the FDA’s comments in the advice letter and their impact on the timing of the filing of a New Drug Application (“NDA”) for QS T with the FDA. The timing and design of the study to obtain the additional 70 subjects and data required was determined based on further discussion with the FDA. We submitted our response to the FDA’s written recommendations in early March 2015.

In May 2015, we received a written update from the FDA related to our clinical development program for QS T. We believe, based on the update received from the FDA, there is an agreed upon path forward for the completion of an additional study to support the filing of a New Drug Application for QS T. In June 2015, we finalized and submitted the protocol for the study, and in August 2015, we enrolled the first patients in the study. Approximately 70 patients will be needed to collect 26 weeks of safety data.

Device Development Projects . We are also engaged in research and development activities related to our Vibex ® disposable pressure-assisted auto injectors and our disposable pen injectors. We have signed license agreements with Teva for our Vibex ® system for use with epinephrine and sumatriptan and for our pen injector device for use with exenatide and one undisclosed product. Our pressure-assisted auto injectors are designed to deliver drugs by injection from single-dose prefilled syringes. The auto injectors are in the advanced commercial stage of development. The disposable pen injector device is designed to deliver drugs by injection through needles from multi-dose cartridges. The disposable pen is entering the commercial stage of development. Our development programs consist of the determination of the device design, development of prototype tooling, production of prototype devices for testing and clinical studies, performance of clinical studies, and development of commercial tooling and assembly.

The development timelines of the auto and pen injectors related to the Teva products are controlled by Teva. We expect development related to the Teva products to continue in 2015, but the timing and extent of near-term future development will be dependent on certain decisions made by Teva. Although development work payments and certain upfront and milestone payments have been received from Teva, there have been no commercial sales by Teva from the auto injector or pen injector programs, timelines have been extended and there can be no assurance that there ever will be commercial sales or future milestone payments under these agreements.

Other Research and development costs. In addition to the Vibex ® QS T project and the Teva-related device development projects, we incur direct costs in connection with other research and development projects related to our technologies and indirect costs that include personnel costs, administrative and other operating costs related to managing our research and development projects.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements, including any arrangements with any structured finance, special purpose or variable interest entities.

Critical Accounting Policies

We have identified certain of our significant accounting policies that we consider particularly important to the portrayal of our results of operations and financial position and which may require the application of a higher level of judgment by management and, as a result, are subject to an inherent level of uncertainty. These policies are characterized as “critical accounting policies” and address revenue recognition and valuation of long-lived and intangible assets and goodwill, as more fully described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2014.

Recently Issued Accounting Pronouncements

In June 2014, the Financial Accounting Standards Board (“FASB”) issued ASU 2014-12, Compensation – Stock Compensation: Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could be Achieved after the Requisite Service Period , which provides explicit guidance for the accounting treatment for these types of awards. The ASU requires that a performance target that affects vesting and that could be achieved after the requisite service period be treated as a performance condition. As such, the performance target should not be reflected in estimating the grant-date fair value of the award. This update is effective for annual

 

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periods and interim periods within those annual periods beginning after December 15, 2015. Early adoption is permitted. The Company does not expect the adoption of this ASU will have a material impact on its consolidated financial statements.

On May 28, 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers , which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The ASU will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. The new standard is effective for the Company on January 1, 2017. Early application is not permitted. The standard permits the use of either the retrospective or cumulative effect transition method. The Company is evaluating the effect that ASU 2014-09 will have on its consolidated financial statements and related disclosures. The Company has not yet selected a transition method nor has it determined the effect of the standard on its ongoing financial reporting.

 

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Our primary market risk exposure is foreign exchange rate fluctuations of the Swiss Franc to the U.S. dollar as the financial position and operating results of our subsidiaries in Switzerland are translated into U.S. dollars for consolidation. Our exposure to foreign exchange rate fluctuations also arises from transferring funds to our Swiss subsidiaries in Swiss Francs. In addition, we have exposure to exchange rate fluctuations between the Euro and the U.S. dollar in connection with a licensing agreement with Ferring, under which certain products sold to Ferring and royalties are denominated in Euros. Most of our product sales, including a portion of our product sales to Ferring, and our development and licensing fees and royalties are denominated in U.S. dollars, thereby significantly mitigating the risk of exchange rate fluctuations on trade receivables. We do not currently use derivative financial instruments to hedge against exchange rate risk. The effect of foreign exchange rate fluctuations on our financial results for the periods ended June 30, 2015 was not material.

We also have limited exposure to market risk due to interest income sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because a significant portion of our investments are in debt securities issued by the U.S. government and institutional money market funds. The primary objective of our investment activities is to preserve principal. To minimize market risk, we have in the past and, to the extent possible, will continue in the future, to hold debt securities to maturity at which time the debt security will be redeemed at its stated or face value. Due to the nature of our marketable securities, we believe that we are not exposed to any material market interest rate risk related to our investment portfolio.

 

Item 4. CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

The Company’s management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this report. The evaluation was performed to determine whether the Company’s disclosure controls and procedures have been designed and are functioning effectively to provide reasonable assurance that the information required to be disclosed by the Company in reports filed under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and is accumulated and communicated to management, including the Company’s principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Based on such evaluation, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures as of the end of the period covered by this report were effective.

Internal Control over Financial Reporting

There have not been any changes in the Company’s internal control over financial reporting during the fiscal quarter to which this report relates that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

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A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, control may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

PART II - OTHER INFORMATION

 

Item 1A. RISK FACTORS

In addition to the other information contained in this report, you should carefully consider the risk factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2014, which could materially affect our business, financial condition or future results. There have been no material changes to these risk factors. The risks described in our Annual Report on Form 10-K are not the only risks facing us. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.

 

Item 6. EXHIBITS

 

(a) Exhibit Index

 

Exhibit
No.

  

Description

  10.1#    Form of Indemnification Agreement between Antares Pharma, Inc. and each of its directors and executive officers.
  10.2#    Employment Agreement dated as of July 8, 2015 between Antares Pharma, Inc. and Peter J. Graham
  10.3#    Form of Restricted Stock Unit Grant Agreement delivered by Antares Pharma, Inc. to each of its grantees.
  10.4    Separation and Consulting Services Agreement, dated July 13, 2015, by and between Antares Pharma, Inc. and Jennifer Evans Stacey (Filed as Exhibit 99.1 to Form 8-K filed on July 16, 2015 and incorporated herein by reference).
  10.5    Special Cash Bonus Plan of Antares Pharma, Inc. for named executive officers in connection with achievement of certain milestones regarding the approval by the U.S. Food and Drug Administration of the Abbreviated New Drug Application for the VIBEX ® epinephrine pen (Incorporated herein by reference to the disclosure under Item 5.02 of the Form 8-K filed on June 3, 2015).
  31.1#    Certificate of the Chief Executive Officer of Antares Pharma, Inc. required by Rule 13a-14(a) under the Securities Exchange Act of 1934, as amended.
  31.2#    Certificate of the Chief Financial Officer of Antares Pharma, Inc. required by Rule 13a-14(a) under the Securities Exchange Act of 1934, as amended.

 

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  32.1##    Certificate of the Chief Executive Officer of Antares Pharma, Inc. required by Rule 13a-14(b) under the Securities Exchange Act of 1934, as amended.
  32.2##    Certificate of the Chief Financial Officer of Antares Pharma, Inc. required by Rule 13a-14(b) under the Securities Exchange Act of 1934, as amended.
101.INS#    XBRL Instance Document
101.SCH#    XBRL Taxonomy Extension Schema Document
101.CAL#    XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB#    XBRL Taxonomy Extension Label Linkbase Document
101.PRE#    XBRL Taxonomy Extension Presentation Linkbase Document
101.DEF#    XBRL Taxonomy Extension Definition Document

 

# Filed herewith.
## Furnished herewith.

 

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SIGNATURES

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.

 

      ANTARES PHARMA, INC.

August 10, 2015

     

/s/ Eamonn Hobbs

      Eamonn Hobbs
     

President and Chief Executive Officer

(Principal Executive Officer)

August 10, 2015

     

/s/ James E. Fickenscher

      James E. Fickenscher
     

Senior Vice President and Chief Financial Officer

(Principal Financial and Accounting Officer)

 

28

Exhibit 10.1

INDEMNIFICATION AGREEMENT

This Indemnification Agreement, dated as of                     , is made by and between Antares Pharma, Inc., a Delaware corporation (the “ Company ”), and [                    ] (the “Indemnitee”) an agent (as hereinafter defined) of the Company.

R   E   C   I   T   A   L   S

A. The Company recognizes that competent and experienced persons are sometimes reluctant to serve as directors or officers of corporations unless they are protected by comprehensive liability insurance or indemnification, or both, due to increased exposure to litigation costs and risks resulting from their service to such corporations, and due to the fact that the exposure frequently bears no reasonable relationship to the compensation of such directors and officers;

B. The statutes and judicial decisions regarding the duties of directors and officers are often difficult to apply, ambiguous, or conflicting, and therefore fail to provide such directors and officers with adequate, reliable knowledge of legal risks to which they are exposed or information regarding the proper course of action to take;

C. The Company and the Indemnitee recognize that because plaintiffs often seek damages in such large amounts and the costs of litigation may be onerous (whether or not the case is meritorious), the defense and/or settlement of such litigation is often beyond the personal resources of directors and officers;

D. The Company believes that it is unfair for its directors and officers to assume the risk of personal judgments and other expenses which may occur in cases in which the director or officer received no personal profit and in cases where the director or officer was not culpable;

E. The Company believes that the interests of the Company and its stockholders would best be served by a combination of the Company’s liability insurance and the indemnification by the Company of its directors and officers;

F. In accordance with the provisions of Delaware General Corporation Law, Section 145, the Company is permitted or required to indemnify the Indemnitee;

G. The Company’s Board of Directors has determined that contractual indemnification as set forth herein is not only reasonable and prudent but necessary to promote the best interests of the Company and its stockholders;

H. The Company desires and has requested the Indemnitee to serve or continue to serve as a director or officer of the Company free from undue concern for claims for damages arising out of or related to such services to the Company; and

I. The Indemnitee is willing to serve, or to continue to serve, the Company, only on the condition that he is furnished the indemnity provided for herein.


A   G   R   E   E   M   E   N   T

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth below, the parties hereto, intending to be legally bound, hereby agree as follows:

1. Definitions .

(a) Agent . For purposes of this Agreement, “ agent ” of the Company means any person who is or was a director, officer, manager, employee or other agent of the Company or a subsidiary of the Company; or is or was serving at the request of the Company or a subsidiary of the Company as a director, officer, manager, employee or agent of another foreign or domestic corporation, partnership, limited liability company, joint venture, trust or other enterprise; or was a director, officer, manager, employee or agent of a foreign or domestic corporation which was a predecessor corporation of the Company or a subsidiary of the Company; or was a director, officer, manager, employee or agent of another foreign or domestic corporation, partnership, limited liability company, joint venture, trust or other enterprise at the request of, for the convenience of, or to represent the interests of such predecessor corporation.

(b) Expenses . For purposes of this Agreement, “ expenses ” means any and all costs and expenses, including attorney’s fees, reasonably related to, or incurred by the director in connection with a proceeding.

(c) Liability . For the purpose of this Agreement, “ Liability ” means any obligation to pay a judgment, settlement, penalty, fine or excise tax assessed with respect to an employee benefit plan, or expenses incurred with respect to a proceeding and includes obligations and expenses that have not yet been paid, but that have been or may be incurred;

(d) Proceedings . For the purpose of this Agreement, “ proceeding ” means any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative and whether formal or informal.

(e) Subsidiary. For purposes of this Agreement, “ subsidiary ” means any foreign or domestic corporation, partnership, limited liability company, joint venture, trust or other enterprise of which more than 50% of the outstanding voting securities (or comparable interests) are owned directly or indirectly by the Company, by the Company and one or more other subsidiaries, or by one or more other subsidiaries.

(f) Other Enterprise . For purposes of this Agreement, “ other enterprise ” shall include employee benefit plans; references to “ fines ” shall include any excise tax assessed with respect to any employee benefit plans; references to “ serving at the request of the Company ” shall include any service as a director, officer, manager, employee or agent of the Company which imposes duties on, or involves services by, such director, officer, manager, employee or agent with respect to an employee benefit plan, its participants, or beneficiaries; if the Indemnitee acts in good faith and in a manner he reasonably believes to be in the best interest of the participants and beneficiaries of an employee benefit plan, he shall be deemed to have acted in a manner “ not opposed to the best interests of the Company ” as referred to in this Agreement.

 

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(g) Company . “ Company ” shall include, in addition to the resulting corporation, any constituent corporation (including any constituent of a constituent) absorbed in a consolidation or merger which, if its separate existence had continued, would have had power and authority to indemnify its directors, officers, managers, employees or agents, so that any person who is or was a director, officer, manager, employee or agent of such constituent corporation, or is or was serving at the request of such constituent corporation as a director, officer, manager, employee or agent of another corporation, partnership, limited liability company, joint venture, trust or other enterprise, shall stand in the same position under the provisions of this Agreement with respect to the resulting or surviving corporation as he would have with respect to such constituent corporation if its separate existence had continued.

2. Agreement to Serve . The Indemnitee agrees to serve and/or continue to serve as an agent of the Company, at its will (or under separate agreement, if such agreement now or hereafter exists), in the capacity Indemnitee currently serves (or in such other positions which he agrees to assume) as an agent of the Company, so long as he is duly appointed or elected and qualified in accordance with the applicable provisions of the Bylaws of the Company, any subsidiary of the Company, or any applicable other foreign or domestic corporation, partnership, limited liability company, joint venture, trust or other enterprise, or until such time as he tenders his resignation in writing; provided, however, that nothing contained in this Agreement is intended to create any right to continued employment by Indemnitee in any capacity.

3. Indemnity of Indemnitee . The Company hereby agrees to hold harmless and indemnify Indemnitee to the fullest extent permitted by law. In furtherance of the foregoing indemnification, and without limiting the generality thereof:

(a) Indemnity in Third Party Proceedings . The Company shall indemnify the Indemnitee if the Indemnitee is a party to or threatened to be made a party to or otherwise involved in any proceeding (other than a proceeding by or in the name of the Company to procure judgment in its favor) by reason of the fact that the Indemnitee is or was an agent of the Company, or by reason of any act or inaction by him in any such capacity, against any and all expenses and liabilities of any type whatsoever (including, but not limited to, settlements, judgments, fines and penalties), actually and reasonably incurred by him in connection with the investigation, defense, settlement or appeal of such proceeding, but only if the Indemnitee acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the Company, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful. The termination of any proceeding by judgment, order of court, settlement, conviction or on plea of nolo contedere, or its equivalent, shall not, of itself, create a presumption that Indemnitee did not act in good faith in a manner which he reasonably believed to be in or not opposed to the best interests of the Company, and with respect to any criminal proceedings, that such person had reasonable cause to believe that his conduct was unlawful.

(b) Indemnity in Derivative Action . The Company shall indemnify the Indemnitee if the Indemnitee is a party to or threatened to be made a party to or otherwise involved in any proceeding by or in the name of the Company to procure a judgment in its favor by reason of the fact that the Indemnitee is or was an agent of the Company, or by reason of any

 

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act or inaction by him in any such capacity, against all expenses actually and reasonably incurred by the Indemnitee in connection with the investigation, defense, settlement, or appeal of such proceeding but only if the Indemnitee acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the Company, except that no indemnification under this subsection shall be made in respect of any claim, issue or matter as to which the Indemnitee shall have been finally adjudged to be liable to the Company by a court of competent jurisdiction, unless and only to the extent that any court in which such proceeding was brought or another court of competent jurisdiction shall determine upon application that, despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses as such court shall deem proper.

(c) Indemnification of Expenses of Successful Party . Notwithstanding any other provisions of this Agreement, to the extent that the Indemnitee has been successful on the merits or otherwise in defense of any proceeding or in defense of any claim, issue or matter therein, including the dismissal of an action without prejudice, the Company shall indemnify the Indemnitee against all expenses actually and reasonably incurred in connection with the investigation, defense or appeal of such proceeding.

(d) Partial Indemnification . If the Indemnitee is entitled under any provision of this Agreement to indemnification by the Company for some or a portion of any expenses or liabilities of any type whatsoever (including, but not limited to, judgments, fines or penalties), but is not entitled, however, to indemnification for the total amount thereof, the Company shall nevertheless indemnify the Indemnitee for the portion thereof to which the Indemnitee is entitled, which shall be reasonably determined in good faith by the Company’s Board of Directors.

4. Advancement of Expenses . Subject to Sections 5 and 8 below, the Company shall advance all expenses incurred by the Indemnitee in connection with the investigation, defense, settlement or appeal of any proceeding to which the Indemnitee is a party or is threatened to be made a party by reason of the fact that the Indemnitee is or was an agent of the Company. Indemnitee hereby undertakes to repay such amounts advanced only if, and to the extent that, it shall ultimately be determined, following the final disposition of such claims, that the Indemnitee is not entitled to be indemnified by the Company as authorized by this Agreement or otherwise. The advances to be made hereunder shall be paid by the Company to or on behalf of the Indemnitee promptly and in any event within thirty (30) days following delivery of a written request therefore by the Indemnitee to the Company.

5. Notice and Other Indemnification Procedures . Promptly after receipt by the Indemnitee of notice of the commencement of or the threat of commencement of any proceeding, the Indemnitee shall, if the Indemnitee believes that indemnification with respect thereto may be sought from the Company under this Agreement, notify the Company of the commencement or threat of commencement thereof, provided that the failure to provide such notification shall not diminish Indemnitee’s indemnification hereunder, except to the extent that the Company can demonstrate that it was actually prejudiced as a result thereof. The Company shall indemnify the Indemnitee against all expenses incurred in connection with any hearing or proceeding under this Section 5 unless a court of competent jurisdiction makes a final judicial determination that each of the claims and/or defenses of the Indemnitee in any such proceeding was frivolous or in bad faith.

 

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6. Assumption of Defense . In the event the Company shall be obligated to pay the expenses of any proceeding against or involving the Indemnitee, the Company, if appropriate, shall be entitled to assume the defense of such proceeding, with counsel reasonably acceptable to the Indemnitee, upon the delivery to the Indemnitee of written notice of its election to do so. After delivery of such notice, approval of such counsel by the Indemnitee, which shall not be unreasonably withheld, and the retention of such counsel by the Company, the Company will not be liable to the Indemnitee under this Agreement for any fees of counsel subsequently incurred by the Indemnitee with respect to the same proceeding, provided that: (i) the Indemnitee shall have the right to employ his counsel in such proceeding at the Indemnitee’s expense; and (ii) if (a) the employment of counsel by the Indemnitee has been previously authorized in writing by the Company, (b) the Company shall have reasonably concluded that there may be a conflict of interest between the Company and the Indemnitee in the conduct of such defense, or (c) the Company shall not, in fact, have employed counsel to assume the defense of such proceeding, the reasonable fees and expenses of the Indemnitee’s counsel shall be at the expense of the Company.

7. Insurance . The Company may, but is not obligated to, obtain directors’ and officers’ liability insurance (“ D&O Insurance ”) as may be or become available in reasonable amounts from established and reputable insurers with respect to which the Indemnitee is named as an insured. Notwithstanding any other provision of the Agreement, the Company shall not be obligated to indemnify the Indemnitee for expenses, judgments, fines or penalties, which have been paid directly to or on behalf of the Indemnitee by D&O Insurance. If the Company has D&O Insurance in effect at the time the Company receives from the Indemnitee any notice of the commencement of a proceeding, the Company shall give notice of the commencement of such proceeding to the insurer in accordance with the procedures set forth in the policy. The Company shall thereafter take all necessary or desirable action to cause such insurers to pay, to or on behalf of the Indemnitee, all amounts payable as a result of such proceeding in accordance with the terms of such policy.

8. Exceptions . Any other provision herein to the contrary notwithstanding, the Company shall not be obligated pursuant to the terms of this Agreement:

(a) Section 16 Violations . To indemnify Indemnitee on account of any proceeding with respect to which final judgment is rendered against Indemnitee for payment or an accounting of profits arising from the purchase or sale by Indemnitee of securities in violation of Section 16(c) of the Securities Exchange Act of 1934, as amended, or any similar provisions of any federal, state or local statue.

(b) Claims Initiated by Indemnitee . To indemnify or advance expenses to Indemnitee with respect to an action, suit or proceeding (or part thereof) initiated by Indemnitee, except with respect to an action, suit or proceeding brought to establish or enforce a right to indemnification (which shall be governed by the provisions of Section 8(c) of this Agreement), unless such action, suit or proceeding (or part thereof) was authorized or consented to by the Board of Directors of Company.

 

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(c) Action for Indemnification . To indemnify Indemnitee for any expenses incurred by Indemnitee with respect to any action, suit or proceeding instituted by Indemnitee to enforce or interpret this Agreement, unless Indemnitee is successful in establishing Indemnitee’s right to indemnification in such action, suit or proceeding, in whole or in part, or unless and to the extent that the court in such action, suit or proceeding shall determine that, despite Indemnitee’s failure to establish their right to indemnification, Indemnitee is entitled to indemnity for such expenses; provided, however, that nothing in this Section 8(c) is intended to limit the Company’s obligation with respect to the advancement of expenses to Indemnitee in connection with any such action, suit or proceeding instituted by Indemnitee to enforce or interpret this Agreement, as provided in Section 4 hereof.

(d) Non-compete and Non-disclosure . To indemnify Indemnitee in connection with proceedings or claims involving the enforcement of non-compete and/or non-disclosure agreements or the non-compete and/or non-disclosure provisions or employment, consulting or similar agreements the Indemnitee may be a party to with the Company.

(e) Amounts Otherwise Covered . To indemnify the Indemnitee under this Agreement for any amounts indemnified by the Company other than pursuant to this Agreement and amounts paid to or for the benefit of Indemnitee by D&O Insurance pursuant to Section 7 hereof.

9. Nonexclusivity . The provisions for indemnification and advancement of expenses set forth in this Agreement shall not be deemed exclusive of, but shall be in addition to and shall not be deemed to diminish or otherwise restrict, any other rights which the Indemnitee may have under any provision of law, the Company’s Certificate of Incorporation or Bylaws, in any court in which a proceeding is brought, the vote of the Company’s stockholders or disinterested directors, other agreements or otherwise, both as to action in his official capacity and to action in another capacity while occupying his position as an agent of the Company. To the extent applicable law or the Company’s Certificate of Incorporation or Bylaws permit greater indemnification than as provided for in this Agreement, the parties hereto agree that Indemnitee shall enjoy by this Agreement the greater benefits so afforded by such law or provision of Certificate of Incorporation or Bylaws, and this Agreement shall be deemed amended without any further action by the Company or Indemnitee to grant such greater benefits.

10. Settlement . The Company shall not settle any proceeding in which Indemnitee has been named without the Indemnitee’s written consent, which shall not be unreasonably withheld. The Company shall have no obligation to indemnify Indemnitee under this Agreement for amounts paid in settlement of any action, suit or proceeding without the Company’s prior written consent, which shall not be unreasonably withheld.

11. Subrogation. In the event of payment under this Agreement, the Company shall be subrogated to the extent of such payment to all of the rights of recovery of the Indemnitee, who shall execute all papers required and shall do everything that may reasonably be necessary to secure such rights, including the execution of such documents necessary to enable the Company effectively to bring suit to enforce such rights. The Company shall pay or reimburse all reasonable expenses incurred by Indemnitee in connection with such subrogation.

 

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12. Interpretation of Agreement . It is understood that the parties hereto intend this Agreement to be interpreted and enforced so as to provide indemnification to the Indemnitee to the fullest extent now or hereafter permitted by law.

13. Severability . If any provision or provisions of this Agreement shall be held to be invalid, illegal or unenforceable for any reason whatsoever, (i) the validity, legality and enforceability of the remaining provisions of the Agreement (including, without limitation, all portions of any paragraphs of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that are not themselves invalid, illegal or unenforceable) shall not in any way be affected or impaired thereby, and (ii) to the fullest extent possible, the provisions of this Agreement (including, without limitation, all portions of any paragraph of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that are not themselves invalid, illegal or unenforceable) shall not in any way be affected or impaired thereby, and (iii) to the fullest extent possible, the provisions of this Agreement (including, without limitation, all portions of any paragraph of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that are not themselves invalid, illegal or unenforceable) shall be construed so as to give effect to the intent manifested by the provision held invalid, illegal or unenforceable and to give effect to Section 9 and Section 12 hereof. If this Agreement or any portion thereof shall be invalidated on any ground by any court of competent jurisdiction, then the Company shall nevertheless indemnify the Indemnitee to the full extent permitted by any applicable portion of this Agreement that shall not have been invalidated and to the full extent permitted by applicable law.

14. Modification and Waiver . No supplement, modification or amendment of this Agreement shall be binding unless executed in writing by both of the parties hereto. No waiver of any of the provisions to this Agreement shall be deemed or shall constitute a waiver of any other provision hereof (whether or not similar) nor shall such waiver constitute a continuing waiver.

15. Continuance of Rights, Successor and Assigns . The Indemnitee’s rights hereunder shall continue after the Indemnitee has ceased acting as an agent of the Company. The terms of this Agreement shall bind, and shall inure to the benefit of, the successor and assigns of the parties hereto.

16. Notice . All notices, requests, demands and other communications under this Agreement shall be in writing and shall be deemed duly given (i) if delivered by hand and receipted for by the party addressee, (ii) if mailed by certified or registered mail with postage prepaid, on the third business day after the mailing date, or (iii) if transmitted electronically by a means by which receipt thereof can be demonstrated. Addresses for notice to either party are set out on the signature page hereof and may be subsequently modified by written notice.

17. Supersedes Prior Agreement . This Agreement supersedes any prior indemnification agreement between Indemnitee and the Company or its predecessors.

18. Service of Process and Venue . For purposes of any claims or proceeding to enforce this agreement, the Company and Indemnitee consent to the jurisdiction and venue of any federal or state court of competent jurisdiction in the state of Delaware, and waive and agree not to raise any defense that any such court is an inconvenient forum or any similar claim.

 

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19. Governing Law . This Agreement shall be governed exclusively by and construed according to the laws of the State of Delaware, as applied to contracts between Delaware residents entered into and to be performed entirely within Delaware. If a court of competent jurisdiction shall make a final determination that the provisions of the law of any state other than Delaware govern indemnification by the Company of its officers and directors, then the indemnification provided under this Agreement shall in all instances be enforceable to the fullest extent permitted under such law, notwithstanding any provision of this Agreement to the contrary.

20. Change in Law . Notwithstanding any other provision of this Agreement, any modification to the Company’s Certificate of Incorporation or Bylaws from or after the date of this Agreement shall not impair, impede or limit the rights of the Indemnitee under this Agreement. In the event of any change after the date of this Agreement to any applicable law, statute or rule that expands the right of a Delaware corporation to indemnify a member of its Board of Directors, or former director, or an officer, as applicable, such changes shall be ipso facto within the purview of the Indemnitee’s rights and the Company’s obligations under this Agreement. In the event of any change in applicable law, statute or rule that narrows the right of the Delaware corporation to indemnify a member of the Board of Directors or former director, or an officer, as applicable, the rights and obligations of the parties hereunder shall be modified only to the extent that such law, statute or rule requires that any such modification be applied in a retroactive manner and only to the extent that such retroactive application is, itself, not an unlawful ex post facto modification of the Indemnitee’s rights.

21. Contribution . The parties acknowledge and agree that, in the event the Indemnitee is not entitled to indemnification from the Company pursuant to terms of this Agreement, or otherwise, the Company shall contribute to any Liability with respect to which the Indemnitee would otherwise have been entitled to indemnification of this Agreement, in such proportion as is just and equitable in the circumstances, taking into account, among other things, contributions by other directors and officers of the Company or others pursuant to indemnification agreements or otherwise.

22. Employment Rights . Nothing in this Agreement is intended to create in Indemnitee any right to employment or continued employment.

23. Counterparts . This Agreement may be executed in two or more counterparts, each of which shall be deemed to be an original and all of which together shall be deemed to be one and the same instrument, notwithstanding that both parties are not signatories to the original or same counterpart.

[Signatures follow on page 9.]

 

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The parties hereto have entered into this Indemnification Agreement effective as of the date first above written.

 

ANTARES PHARMA, INC.

By:

 

 

Name:

 

Title:

 

Address:

 

    Princeton Crossroads Corporate Center

    250 Phillips Boulevard, Suite 290

    Ewing, NJ 08618

Indemnitee:

 

By:

 

 

Name:

  [Insert name]

Address:    

   
   
   

 

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Exhibit 10.2

ANTARES PHARMA, INC.

EMPLOYMENT AGREEMENT

THIS EMPLOYMENT AGREEMENT (this “ Agreement ”) is made and entered into on this 8 th day of July, 2015 , effective as of the 14 th day of July, 2015(the “ Effective Date ”) by and between Antares Pharma, Inc., a Delaware corporation (the “ Company ”), and Peter Graham (the “ Executive ”).

WITNESSETH :

WHEREAS, the Company has successfully completed the background and reference checks and, accordingly, the Company desires to secure for itself the services of the Executive, and the Executive wishes to furnish such services to the Company, pursuant to the terms and subject to the conditions hereinafter set forth.

NOW, THEREFORE, in consideration of the premises and of the mutual promises and covenants contained herein, the Company and the Executive, intending to be legally bound, hereby agree as follows:

 

1. Employment .

(a) Term . This Agreement shall be effective as of the Effective Date and continue until the one-year anniversary thereof, unless sooner terminated by either party as hereinafter provided. In addition, this Agreement shall automatically renew for periods of one (1) year unless either party gives written notice to the other party at least ninety (90) days prior to the end of the Term (as defined below) or at least ninety (90) days prior to the end of any one (1) year renewal period that the Agreement shall not be further extended. The period commencing on the Effective Date and ending on the date on which the term of the Executive’s employment under this Agreement terminates is referred to herein as the “ Term .”

(b) Duties . During the Term, the Executive shall be employed by the Company as the Senior Vice President, General Counsel, Human Resources, and Secretary, with the duties, responsibilities and authority commensurate therewith. The Executive shall report to the Chief Executive Officer (the “ CEO ”) and shall perform all duties and accept all responsibilities incident to such position as may be reasonably assigned to him by the CEO.

(c) Best Efforts . During the Term, the Executive shall devote his best efforts and full time and attention to promote the business and affairs of the Company, and may not, without the prior written consent of the Company, operate, participate in the management, operations or control of, or act as an employee, officer, consultant, agent or representative of, any type of business or service (other than as an employee of the Company). It shall not be deemed a violation of the foregoing for the Executive to (i) act or serve as a director, trustee or committee member of any civic or charitable organization; (ii) manage his personal, financial and legal affairs; or (iii) serve as a director of an organization that is not a civic or charitable organization with the consent of the Board of Directors of the Company (the “ Board ”), which consent shall not be unreasonably withheld, in all cases so long as such activities (described in clauses (i), (ii) and (iii)) are permitted under the Company’s code of conduct and employment policies and do not materially interfere with or conflict with his obligations to the Company hereunder, including, without limitation, obligations pursuant to Section 6 below.


(d) Location . The Executive’s principal place of employment shall be the Company’s principal corporate offices located in Ewing, New Jersey. The Executive may be required to travel for business from time to time in the course of performing his duties for the Company.

 

2. Compensation .

(a) Base Salary . During the Term, the Company shall pay the Executive a base salary (“ Base Salary ”) at the annual rate of $343,000, which shall be paid in accordance with the Company’s normal payroll practices. The Executive’s Base Salary shall be subject to review, the first review being on or around January 1, 2016 and increase (but not decrease) during the Term in accordance with the Company’s normal compensation and performance review policies for executives generally.

(b) Bonus . In addition to the Executive’s Base Salary, the Executive shall be eligible to receive a bonus for each calendar year during the Term, based on attainment of certain individual and corporate performance goals and targets (the “ Annual Bonus ”). The target amount of the Executive’s Annual Bonus shall be 40% of Base Salary. The performance goals and targets shall be determined by the Compensation Committee of the Board (the “ Compensation Committee ”) in consultation with the CEO. Once determined, the applicable performance goals and targets shall be communicated to the Executive as soon as reasonably practicable following the Compensation Committee’s determination of the applicable goals and targets. The actual Annual Bonus amount paid will be based upon the Compensation Committee’s determination, in its sole discretion, whether and to what extent the applicable performance goals and targets have been achieved, and such amount may be more or less than the target amount, as determined by the Compensation Committee in its sole discretion. Any Annual Bonus earned and payable to the Executive hereunder shall be paid on or after January 1 but not later than March 15 of the calendar year following the calendar year for which the Annual Bonus is earned. Notwithstanding the foregoing, any Annual Bonus for calendar year 2015 will be multiplied by a fraction, the numerator of which is the number of days during which the Executive was employed by the Company during calendar year 2015 and the denominator of which is 365.

(c) Equity Compensation .

(i) Stock Option Grant . On the Effective Date, pursuant to the Antares Pharma, Inc. 2008 Equity Incentive Plan, as amended from time to time (the “ 2008 Equity Plan ”) (or successor plan), the Executive shall be granted a stock option to purchase one hundred twenty-five thousand (125,000) shares of common stock of the Company, $0.01 par value (the “ Stock ”) at an exercise price equal to the closing price of the Stock on the date of grant, subject in all respects to the terms and conditions of the 2008 Equity Plan (or a successor plan) and the Stock Option Agreement evidencing the terms and conditions of the grant. Provided that the Executive is employed by the Company on the applicable vesting date, the option shall vest 33-1/3% annually until the option is fully vested.

 

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(ii) Additional Grants . During the Term, the Executive shall also be eligible to participate in any long-term equity incentive programs established by the Company for its senior level executives generally, including the 2008 Equity Plan, at levels determined by the Compensation Committee in its sole discretion, commensurate with the Executive’s position.

(d) Vacation . During the Term, the Executive shall be entitled to vacation, holiday and sick leave at levels generally commensurate with those provided to other executives of the Company, in accordance with the Company’s vacation, holiday and other pay-for-time-not worked policies. Such paid time off may be carried over from year to year to the extent permitted in accordance with standard Company policy and shall be paid to the extent accrued (and to the extent not used) as of the Executive’s termination of employment.

(e) Employee Benefits . The Executive shall be entitled to participate in the Company’s health, life insurance, long and short-term disability, dental, retirement, savings, flexible spending accounts and medical programs, if any, pursuant to their respective terms and conditions. Nothing in this Agreement shall preclude the Company or any parent, subsidiary or affiliate of the Company from terminating or amending any employee benefit plan or program from time to time after the Effective Date.

(f) Expense Reimbursement . During the Term, the Company shall reimburse the Executive, in accordance with the policies and practices of the Company in effect from time to time, for all reasonable and necessary traveling expenses and other disbursements incurred by him for or on behalf of the Company in connection with the performance of his duties hereunder upon presentation by the Executive to the Company of appropriate documentation thereof.

 

3. Termination of Employment .

(a) Termination for Cause . The Company may terminate the Executive’s employment hereunder at any time for Cause (as defined below) upon written notice to the Executive (as described below), in which event all payments under this Agreement shall cease, except for any amounts earned, accrued and owing, but not yet paid under Section 2 above and any benefits accrued and due under any applicable benefit plans and programs of the Company. For purposes of this Agreement, the term “ Cause ” shall mean any of the following grounds for termination of the Executive’s employment: (i) the Executive’s knowing and material dishonesty or fraud committed in connection with the Executive’s employment; (ii) theft, misappropriation or embezzlement by the Executive of the Company’s funds; (iii) the Executive’s conviction of or a plea of guilty or nolo contendere to any felony, a crime involving fraud or misrepresentation, or any other crime (whether or not connected with his employment) the effect of which is likely to adversely affect the Company or its parents, subsidiaries or affiliates; or (iv) a material breach by the Executive of any of the provisions or covenants set forth in this Agreement.

(b) Voluntary Resignation . The Executive may voluntarily terminate his employment without Good Reason (as defined below) upon thirty (30) days advance written notice to the Company. In such event, after the effective date of such termination, no payments shall be due under this Agreement, except that the Executive shall be entitled to any amounts earned, accrued and owing, but not yet paid under Section 2 above and any benefits accrued and due under any applicable benefit plans and programs of the Company. For purposes of this Agreement, “ Good

 

3


Reason ” shall mean the occurrence of one or more of the following without the prior written consent of the Executive: (i) a material reduction in Executive’s Base Salary; (ii) the Company’s material breach of terms of this Agreement (which for purposes of this Agreement shall include (A) the failure of the Company to require any successor to the Company to assume the obligations of the Company to Executive under this Agreement and any other agreement between the Company and Executive then in effect and (B) the Company’s reduction in the target annual bonus opportunity below 40% of Base Salary for any calendar year during the Term) (for the avoidance of doubt for purposes of this clause (ii), both of the events described in subclauses (A) and (B) do not need to occur for a material breach of this Agreement to be triggered); (iii) a change in the Executive’s designation of title from Senior Vice President, General Counsel and Secretary of the Company or successor entity (unless such change is to a higher title and level of responsibility) that results in a material diminution in Executive’s authority, duties and responsibilities (for the avoidance of doubt, a change in the Executive’s title that removes Human Resources responsibilities shall not give rise to the right to resign for Good Reason hereunder); (iv) a material change in the geographic location at which Executive must perform services that results in the relocation of Executive’s principal business location to a location that is sixty (60) miles or more from Center City Philadelphia; or (v) the Company’s delivery to the Executive of a notice of its intent not to renew the Term pursuant to Section 1(a) above; provided that the Executive is willing and able to execute a new contract providing terms and conditions substantially similar to those in this Agreement and to continue providing services to the Company.

Notwithstanding any provision of this definition of Good Reason to the contrary, the Executive shall not have Good Reason for termination unless the Executive gives written notice of termination for Good Reason within thirty (30) days after the event giving rise to Good Reason occurs, the Company does not correct the action or failure to act that constitutes the grounds for Good Reason, as set forth in the Executive’s notice of termination, within thirty (30) days after the date on which the Executive gives written notice of termination, and the Executive terminates employment within sixty (60) days after the event that constitutes Good Reason. If the Executive’s resignation occurs after such time, the resignation shall be treated as a voluntary resignation other than for Good Reason and the Executive will not be entitled to severance benefits under this Agreement.

(c) Termination without Cause; Resignation for Good Reason . Except as provided in Section 4(a) below, if the Executive’s employment is terminated by the Company (or the surviving company following a Change of Control (as defined in Section 4(c) below)) without Cause or by the Executive for Good Reason, either before or after a Change of Control, the provisions of this Section 3(c) shall apply (subject to the modifications of Section 4(a) below, if applicable). The Company may terminate the Executive’s employment with the Company at any time without Cause upon not less than thirty (30) days’ prior written notice to the Executive. Except as provided in Section 4(a) below, upon termination of the Executive ’s employment by the Company under this Section 3(c) or by the Executive for Good Reason, either before or after a Change of Control, if the Executive executes and does not revoke a written release, in a form reasonably acceptable to the Company, of any and all claims against the Company and all related parties with respect to all matters arising out of the Executive’s employment by the Company, or the termination thereof (other than claims for any entitlements under the terms of this Agreement or under any plans or programs of the Company under which the Executive has accrued and is

 

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due a benefit) (the “ Release ”), and continues to comply with the provisions of the Proprietary Information and Invention Assignment Agreement (as defined in Section 6(a) below) and restrictive covenants and representations in Section 6 below, the Executive shall be entitled to receive the payments and benefits set forth in Sections 3(c)(i), (ii) and (iii), in lieu of any other payments and benefits due under any severance plan or program for employees or executives (subject to the modifications of Section 4(a) below, if applicable). Notwithstanding any provision of this Agreement to the contrary, in no event shall the timing of the Executive’s execution of the Release, directly or indirectly, result in the Executive designating the calendar year of payment, and if a payment that is subject to execution of the Release could be made in more than one taxable year, payment shall be made in the later taxable year.

(i) The Company will pay to the Executive severance equal to six (6) months of the Executive’s Base Salary at the rate in effect immediately prior to the Executive’s termination of employment, less applicable tax withholding, paid in equal monthly installments beginning within the sixty (60)-day period following the date of the Executive’s termination of employment and continuing on each payroll date thereafter until fully paid, in accordance with the Company’s regular payroll practices. The first severance payment will include any missed payments during such sixty (60)-day period.

(ii) For the six (6) month period following the Executive’s termination of employment, provided that the Executive timely elects COBRA, the Company will reimburse the Executive for the monthly COBRA cost of continued medical and dental coverage for the Executive and, where applicable , his spouse and dependents, at the level in effect as of the date of the Executive’s termination of employment, less the employee portion of the applicable premiums that the Executive would have paid had he remained employed during such six (6) month period (the COBRA continuation coverage period shall run concurrently with the six (6) month period that the Executive is provided with medical and dental coverage under Section 3(c)(i)). These reimbursements will commence within the sixty (60)-day period following the date of the Executive’s termination of employment and will be paid on the first payroll date of each month, provided that the Executive demonstrates proof of payment of the applicable premiums prior to the applicable reimbursement payment date. Notwithstanding the foregoing, the Company’s reimbursement of the monthly COBRA premiums in accordance with this Section 3(c)(ii) shall cease immediately upon the earlier of: (A) the end of the six (6) month period following the Executive’s termination of employment, or (B) the date that the Executive is eligible for comparable coverage with a subsequent employer. Notwithstanding the foregoing, the Company reserves the right to restructure the foregoing COBRA premium reimbursement arrangement in any manner necessary or appropriate to avoid fines, penalties or negative tax consequences to the Company or the Executive (including, without limitation, to avoid any penalty imposed for violation of the nondiscrimination requirements under the Patient Protection and Affordable Care Act or the guidance issued thereunder), as reasonably determined by the Company.

(iii) Notwithstanding any provision to the contrary in the 2008 Equity Plan (or a successor plan) or any applicable agreement (including this Agreement), all outstanding equity grants held by the Executive immediately prior to the Executive’s termination date which vest based upon the Executive’s continued service over time that would have become vested during the six (6) month period following the Executive’s termination date had the Executive remained

 

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employed during such six (6) month period shall accelerate, become fully vested and/or exercisable, as the case may be, as of the Executive’s termination date. All outstanding equity grants held by the Executive immediately prior to the Executive’s termination date which vest based upon attainment of performance criteria shall remain subject to the terms and conditions of the agreement evidencing such performance based award.

(iv) The Executive shall also be entitled to any amounts earned, accrued and owing but not yet paid under Section 2 above and any benefits accrued and due under any applicable benefit plans and programs of the Company without regard to whether the Executive does not execute or revokes the Release.

(d) Death or Disability . The Executive’s employment hereunder shall terminate upon the Executive’s death or involuntary termination of employment by the Company on account of his Disability (as defined below), subject to the requirements of applicable law. If the Executive’s employment terminates due to death or involuntary termination by the Company on account of the Executive’s Disability, no payments shall be due under this Agreement, except that the Executive (or in the event of the Executive’s death, the Executive’s executor, legal representative, administrator or designated beneficiary, as applicable), shall be entitled to receive any amounts earned, accrued and owing but not yet paid under Section 2 above and any benefits accrued and due under any applicable benefit plans and programs of the Company. For purposes of this Agreement, the term “ Disability ” shall mean such physical or mental illness or incapacity of the Executive as shall (i) prevent him from substantially performing his customary services and duties to the Company, and (ii) continue for periods aggregating more than sixty (60) days in any six (6)-month period. The Company shall determine whether there is a Disability after consultation with a qualified, independent physician. The Executive shall cooperate with the Company, including making himself reasonably available for examination by physicians at the Company’s request, to determine whether or not he has incurred a Disability. The Executive’s failure (other than a failure caused by the Disability) to cooperate with the Company in a determination of Disability shall be treated as the Executive’s voluntary resignation from the Company.

 

4. Change of Control .

(a) Termination without Cause or Resignation for Good Reason Within Sixty Days Before or Twelve Months Following a Change of Control . Notwithstanding anything to the contrary herein, if there is both a Change of Control and the Executive’s employment is terminated by the Company without Cause or by the Executive for Good Reason within sixty (60) days before or within twelve (12) months following such Change of Control (a “ CIC Termination ”), the Executive shall be entitled to (i) the payments set forth under Sections 3(c)(i) and (ii) above, except that in each case, six (6) months shall be replaced with twelve (12) months, (ii) in addition to the payments set forth under Sections 3(c)(i) and (ii), a pro rata Annual Bonus for the year in which the termination of employment occurs, which shall be determined as the target amount in effect for the year in which termination of employment occurs, multiplied by a fraction, the numerator of which is the number of days in which the Executive was employed by Company during the year in which the termination of employment occurs, and the denominator of which is 365, and (iii) in lieu of the benefit described in Section 3(c)(iii), notwithstanding any provision to the contrary in the 2008 Equity Plan (or a successor plan) or

 

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any applicable agreement (including this Agreement), all outstanding equity grants held by the Executive immediately prior to the CIC Termination which vest based upon the Executive’s continued service over time shall accelerate, become fully vested and/or exercisable, as the case may be, as of the date of the CIC Termination and all outstanding equity grants held by the Executive immediately prior to the CIC Termination which vest based upon attainment of performance criteria shall remain subject to the terms and conditions of the agreement evidencing such performance based award. As provided in Section 3(c)(iv), the Executive shall also be entitled to any amounts earned, accrued and owing but not yet paid under Section 2 above and any benefits accrued and due under any applicable benefit plans and programs of the Company.

The pro rata bonus described in clause 4(a)(ii) above will be paid in a lump sum within the sixty (60)-day period following the date of the Executive’s termination of employment if such termination occurs on or within twelve (12) months following a Change of Control, or within sixty (60) days following the date of the Change of Control if Executive becomes entitled to such payment as a result of the occurrence of a Change of Control within sixty (60) days following Executive’s termination without Cause or resignation for Good Reason prior to a Change of Control. Notwithstanding the foregoing in this Section 4(a), no amounts under this Section 4(a) will be paid or benefits under this Section 4(a) will be provided, in each case, upon a CIC Termination unless the Executive executes and does not revoke a Release and continues to comply with the covenants set forth in Section 6 below and the provisions of any confidentiality, non-competition, non-solicitation or invention assignment agreement with the Company to which the Executive is subject; provided that the Executive shall be entitled to the amounts earned, accrued and owing but not yet paid under Section 2 above and any benefits accrued and due under any applicable benefit plans and programs of the Company without regard to whether the Executive does not execute or revokes the Release.

(b) Application of Section 280G . In the event that it shall be determined that any payment or distribution in the nature of compensation (within the meaning of section 280G(b)(2) of the Internal Revenue Code of 1986, as amended (the “ Code ”)) to or for the benefit of the Executive, whether paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise (a “ Payment ”), would constitute an “excess parachute payment” within the meaning of section 280G of the Code, the aggregate present value of the Payments under the Agreement shall be reduced (but not below zero) to the Reduced Amount (defined below), provided that the reduction shall be made only if the Accounting Firm (described below) determines that the reduction will provide the Executive with a greater net after-tax benefit than would no reduction. The “ Reduced Amount ” shall be an amount expressed in present value which maximizes the aggregate present value of Payments under this Agreement without causing any Payment under this Agreement to be subject to the Excise Tax (defined below), determined in accordance with section 280G(d)(4) of the Code. The term “ Excise Tax ” means the excise tax imposed under section 4999 of the Code, together with any interest or penalties imposed with respect to such excise tax. Payments under this Agreement shall be reduced on a nondiscretionary basis in such a way as to minimize the reduction in the economic value deliverable to the Executive. Where more than one payment has the same value for this purpose and they are payable at different times they will be reduced on a pro rata basis. Only amounts payable under this Agreement shall be reduced pursuant to this Section 4(b). All determinations to be made under this Section 4(b) shall be made by an independent certified public accounting

 

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firm selected by the Company immediately prior to the Change of Control (the “ Accounting Firm ”), which shall provide its determinations and any supporting calculations both to the Company and the Executive within ten (10) days of the Change of Control. Any such determination by the Accounting Firm shall be binding upon the Company and the Executive. All of the fees and expenses of the Accounting Firm in performing the determinations referred to in this Section 4(b) shall be borne solely by the Company.

(c) Definition of a Change of Control . For purposes of this Agreement, the term “ Change of Control ” shall have the same meaning ascribed to such term under the 2008 Equity Plan, as in effect on the date hereof and as it may be amended from time to time, or if the 2008 Equity Plan is no longer in effect, a successor plan thereto.

 

5. Section 409A .

(a) Compliance with Section 409A . This Agreement is intended to comply with section 409A of the Code and its corresponding regulations, or an exemption, and payments may only be made under this Agreement upon an event and in a manner permitted by section 409A, to the extent applicable. Severance benefits under the Agreement are intended to be exempt from section 409A of the Code under the “short-term deferral” exception, to the maximum extent applicable, and then under the “separation pay” exception, to the maximum extent applicable. For purposes of section 409A of the Code, all payments to be made upon a termination of employment under this Agreement may only be made upon a “separation from service” within the meaning of such term under section 409A of the Code, each payment made under this Agreement shall be treated as a separate payment and the right to a series of installment payments under this Agreement is to be treated as a right to a series of separate payments. In no event shall the Executive, directly or indirectly, designate the calendar year of payment. All reimbursements and in-kind benefits provided under this Agreement shall be made or provided in accordance with the requirements of section 409A of the Code, including, where applicable, the requirement that (i) any reimbursement is for expenses incurred during the Executive’s lifetime (or during a shorter period of time specified in this Agreement), (ii) the amount of expenses eligible for reimbursement, or in-kind benefits provided, during a calendar year may not affect the expenses eligible for reimbursement, or in-kind benefits to be provided, in any other calendar year, (iii) the reimbursement of an eligible expense will be made on or before the last day of the calendar year following the year in which the expense is incurred, and (iv) the right to reimbursement or in-kind benefits is not subject to liquidation or exchange for another benefit.

(b) Payment Delay . Notwithstanding any provision in this Agreement to the contrary, if at the time of the Executive’s separation from service with the Company, the Company has securities which are publicly-traded on an established securities market and the Executive is a “specified employee” (as defined in section 409A of the Code) and it is necessary to postpone the commencement of any severance payments otherwise payable pursuant to this Agreement as a result of such separation from service to prevent any accelerated or additional tax under section 409A of the Code, then the Company will postpone the commencement of the payment of any such payments hereunder (without any reduction in such payments ultimately paid or provided to the Executive) that are not otherwise exempt from section 409A of the Code, until the first payroll date that occurs after the date that is six (6) months following the

 

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Executive’s separation from service with the Company. If any payments are postponed due to such requirements, such postponed amounts will be paid in a lump sum to the Executive on the first payroll date that occurs after the date that is six (6) months following the Executive’s separation from service with the Company. If the Executive dies during the postponement period prior to the payment of the postponed amount, the amounts withheld on account of section 409A of the Code shall be paid to the personal representative of the Executive’s estate within sixty (60) days after the date of the Executive’s death.

 

6. Restrictive Covenants and Representations .

(a) Confidential Information . As a condition to the commencement of his employment hereunder, the Executive agrees to enter into the Company’ s standard Proprietary Information and Invention Assignment Agreement, attached hereto as Exhibit A (the “ Proprietary Information and Invention Assignment Agreement ”), prior to commencing employment hereunder, all of which are hereby incorporated into this Agreement by reference. The Executive hereby agrees that, during the Term and thereafter, the Executive shall hold in strict confidence any proprietary or Confidential Information (as defined below) related to the Company and its parents, subsidiaries and affiliates, except that he may disclose such information pursuant to law, court order, regulation or similar order. For purposes of this Agreement, the term “ Confidential Information ” shall mean all information of the Company or any of its parents, subsidiaries and affiliates (in whatever form) which is not generally known to the public, including without limitation any inventions, processes, methods of distribution, customer lists or trade secrets. The Executive hereby agrees that, upon the termination of this Agreement, he shall not take, without the prior written consent of the Company, any document (in whatever form) of the Company or its parents, subsidiaries or affiliates, which is of a confidential nature relating to the Company or its parents, subsidiaries or affiliates, or, without limitation, relating to its or their methods of distribution, or any description of any formulas or secret processes and will return any such information (in whatever form) then in his possession.

(b) Non-Competition . The Executive hereby acknowledges that during his employment with the Company, the Executive will become familiar with trade secrets and other Confidential Information concerning the Company, its subsidiaries and their respective predecessors, and that the Executive’s services will be of special, unique and extraordinary value to the Company. Accordingly, the Executive hereby agrees that, subject to the requirements of applicable law, at any time during the Term, and for a period of six (6) months after the Executive’s date of termination of employment for any reason except a CIC Termination, or twelve (12) months after a CIC Termination (such six (6) month period or twelve (12) month period, as applicable, shall be referred to as the “ Restriction Period ”), the Executive will not, directly or indirectly, own, manage, control, participate in, consult with, render services for, or in any manner engage in any business involving or related to (directly or indirectly) the research, development, marketing and/or sale or other delivery of injection devices, within any geographical area in which, as of the date of the Executive’s termination of employment, the Company or its subsidiaries engage in business or demonstrably plan to engage in business.

(c) Non-Solicitation . The Executive hereby agrees that during the Term and the Restriction Period, (i) the Executive will not, directly or indirectly through another entity, induce or attempt to induce any employee of the Company or its subsidiaries to leave the employ of the

 

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Company or its subsidiaries, or in any way interfere with the relationship between the Company or its subsidiaries and any employee thereof or otherwise employ or receive the services of an individual who was an employee of the Company or its subsidiaries at any time during such Non-Solicitation Period, except any such individual whose employment has been terminated by the Company and (ii) the Executive will not induce or attempt to induce any customer, supplier, client, broker, licensee or other business relation of the Company or its subsidiaries to cease doing business with the Company or its subsidiaries.

(d) Return of Property . Upon termination of the Executive’s employment with the Company for any reason whatsoever, voluntarily or involuntarily (and in all events within five (5) days of the Executive’s date of termination), and at any earlier time the Company requests, the Executive will deliver to the person designated by the Company all originals and copies of all documents and property of the Company in the Executive’s possession, under the Executive’s control or to which the Executive may have access, including but not limited to, any office, computing or communications equipment (e.g., laptop computer, facsimile machine, printer, cellular phone, etc.) that he has had or has been using, and any business or business-related files that he has had in his possession. The Executive will not reproduce or appropriate for the Executive’s own use, or for the use of others, any property, Confidential Information or Company inventions, and shall remove from any personal computing or communications equipment all information relating to the Company.

(e) Non-Disparagement . The Executive agrees that the Executive will not disparage the Company, its subsidiaries and parents, and their respective Executives, directors, investors, employees, and agents, and its and their respective successors and assigns, heirs, executors, and administrators, or make any public statement reflecting negatively on the Company, its subsidiaries and parents, and their respective officers, directors, investors, employees, and agents, and its and their respective successors and assigns, heirs, executors, and administrators, to third parties, including, but not limited to, any matters relating to the operation or management of the Company, irrespective of the truthfulness or falsity of such statement, except as may otherwise be required by applicable law or compelled by process of law. The Company shall instruct the members of the Board and members of executive management not make any disparaging or negative remarks, either oral or in writing, regarding the Executive.

(f) Cooperation . During the Term and thereafter, the Executive shall cooperate with the Company and its parents, subsidiaries and affiliates, upon the Company’s reasonable request, with respect to any internal investigation or administrative, regulatory or judicial proceeding involving matters within the scope of the Executive’s duties and responsibilities to the Company during the Term (including, without limitation, the Executive being available to the Company upon reasonable notice for interviews and factual investigations, appearing at the Company’s reasonable request to give testimony without requiring service of a subpoena or other legal process, and turning over to the Company all relevant Company documents which are or may come into the Executive’s possession during the Term); provided , however , that any such request by the Company shall not be unduly burdensome or interfere with the Executive’s personal schedule or ability to engage in gainful employment. In the event the Company requires the Executive’s cooperation in accordance with this Section 6(f), the Company shall reimburse the Executive for reasonable out-of-pocket expenses (including travel, lodging and meals and reasonable attorneys’ fees) incurred by the Executive in connection with such cooperation, subject to reasonable documentation.

 

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(g) Executive Representations .

(i) The Executive represents and warrants to the Company that there are no restrictions, agreements or understandings whatsoever to which the Executive is a party which would prevent or make unlawful the Executive’s execution of this Agreement or the Executive’s employment hereunder, which is or would be inconsistent or in conflict with this Agreement or the Executive’s employment hereunder, or would prevent, limit or impair in any way the performance by the Executive of the obligations hereunder. In addition, the Executive has disclosed to the Company all restraints, confidentiality commitments, and other employment restrictions that he has with any other employer, person or entity. The Executive covenants that in connection with his provision of services to the Company, the Executive shall not breach any obligation (legal, statutory, contractual or otherwise) to any former employer or other person, including, but not limited to, obligations relating to confidentiality and proprietary rights.

(ii) Upon and after the Executive’s termination or cessation of employment with the Company and until such time as no obligations of the Executive to the Company hereunder exist, the Executive shall (A) provide a complete copy of this Agreement to any person, entity or association engaged in a competing business with whom or which the Executive proposes to be employed, affiliated, engaged, associated or to establish any business or remunerative relationship prior to the commencement of any such relationship and (B) shall notify the Company of the name and address of any such person, entity or association prior to the commencement of such relationship.

7. Legal and Equitable Remedies . Because the Executive’s services are personal and unique and the Executive has had and will continue to have access to and has become and will continue to become acquainted with the proprietary information of the Company , and because any breach by the Executive of any of the restrictive covenants contained in Section 6 would result in irreparable injury and damage for which money damages would not provide an adequate remedy, the Company shall have the right to enforce Section 6 and any of its provisions by injunction, specific performance or other equitable relief, without bond and without prejudice to any other rights and remedies that the Company may have for a breach, or threatened breach, of the restrictive covenants set forth in Section 6. The Executive agrees that in any action in which the Company seeks injunction, specific performance or other equitable relief, the Executive will not assert or contend that any of the provisions of Section 6 are unreasonable or otherwise unenforceable. The Executive irrevocably and unconditionally (a) agrees that any legal proceeding arising out of this paragraph may be brought in the United States District Court for the District of New Jersey, or if such court does not have jurisdiction or will not accept jurisdiction, in any court of general jurisdiction in Mercer County, New Jersey, (b) consents to the non-exclusive jurisdiction of such court in any such proceeding, and (c) waives any objection to the laying of venue of any such proceeding in any such court. The Executive also irrevocably and unconditionally consents to the service of any process, pleadings, notices or other papers.

8. Arbitration; Expenses . In the event of any dispute under the provisions of this Agreement, other than a dispute in which the primary relief sought is an equitable remedy such

 

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as an injunction, the parties shall be required to have the dispute, controversy or claim settled by arbitration in Trenton, New Jersey in accordance with the National Rules for the Resolution of Employment Disputes then in effect of the American Arbitration Association, before an arbitrator agreed to by both parties. If the parties cannot agree upon the choice of arbitrator, the Company and the Executive will each choose an arbitrator. The two arbitrators will then select a third arbitrator who will serve as the actual arbitrator for the dispute, controversy or claim. Any award entered by the arbitrators shall be final, binding and nonappealable and judgment may be entered thereon by either party in accordance with applicable law in any court of competent jurisdiction. This arbitration provision shall be specifically enforceable. The arbitrators shall have no authority to modify any provision of this Agreement or to award a remedy for a dispute involving this Agreement other than a benefit specifically provided under or by virtue of the Agreement. Each party shall be responsible for its own expenses, unless the Executive shall prevail in an arbitration proceeding as to any material issue, in which case the Company shall reimburse the Executive for all reasonable costs, expenses and fees relating to the conduct of the arbitration, and shall share the fees of the American Arbitration Association. The Company shall pay the reasonable costs, expenses and fees relating to the conduct of the arbitration to the Executive within thirty (30) days after the date on which it is finally determined that the Executive has prevailed on any material issue which is the subject of such arbitration.

9. Survivability . The respective rights and obligations of the parties under this Agreement shall survive any termination of the Executive’s employment to the extent necessary to the intended preservation of such rights and obligations.

10. Assignment . All of the terms and provisions of this Agreement shall be binding upon and inure to the benefit of and be enforceable by the respective heirs, executors, administrators, legal representatives, successors and assigns of the parties hereto, except that the duties and responsibilities of the Executive under this Agreement are of a personal nature and shall not be assignable or delegable in whole or in part by the Executive. The Company shall require any successor (whether direct or indirect, by purchase, merger, consolidation, reorganization or otherwise) to all or substantially all of the business or assets of the Company, within 15 days of such succession, expressly to assume and agree to perform this Agreement in the same manner and to the same extent as the Company would be required to perform if no such succession had taken place and the Executive acknowledges that in such event the obligations of the Executive hereunder, including but not limited to those under Section 6, will continue to apply in favor of the successor.

11. Entire Agreement; Amendment; Waiver . This Agreement, together with the Proprietary Information and Invention Assignment Agreement, sets forth the entire understanding between the parties hereto with respect to the subject matter hereof and cannot be changed, modified, extended or terminated except upon written amendment approved by the Board and executed on its behalf by a duly authorized officer (other than the Executive) and by the Executive. This Agreement supersedes the provisions of any employment or other agreement between the Executive and the Company that relate to any matter that is also the subject of this Agreement.

12. Remedies Cumulative; No Waiver . No remedy conferred upon a party by this Agreement is intended to be exclusive of any other remedy, and each and every such remedy shall be cumulative and shall be in addition to any other remedy given under this Agreement or now or

 

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hereafter existing at law or in equity. No delay or omission by a party in exercising any right, remedy or power under this Agreement or existing at law or in equity shall be construed as a waiver thereof, and any such right, remedy or power may be exercised by such party from time to time and as often as may be deemed expedient or necessary by such party in its sole discretion.

13. Beneficiaries/References . The Executive shall be entitled, to the extent permitted under any applicable law, to select and change a beneficiary or beneficiaries to receive any compensation or benefit payable under this Agreement following the Executive’s death by giving the Employer written notice thereof. In the event of the Executive’s death or a judicial determination of the Executive’s incompetence, reference in this Agreement to the Executive shall be deemed, where appropriate, to refer to the Executive’s beneficiary, estate or other legal representative.

14. Withholding . All payments under this Agreement shall be made subject to applicable tax withholding, and the Company shall withhold from any payments under this Agreement all federal, state and local taxes as the Company is required to withhold pursuant to any law or governmental rule or regulation. The Executive shall bear all expense of, and be solely responsible for, all federal, state and local taxes due with respect to any payment received under this Agreement.

15. Notices . Any notice or communication required or permitted under the terms of this Agreement shall be in writing and shall be delivered personally, or sent by registered or certified mail, return receipt requested, postage prepaid, or sent by nationally recognized overnight carrier, postage prepaid, or sent by facsimile transmission to the Company at the Company’s principal office and facsimile number or to the Executive at the address and facsimile number, if any, appearing on the books and records of the Company. Such notice or communication shall be deemed given (a) when delivered if personally delivered; (b) five (5) mailing days after having been placed in the mail, if delivered by registered or certified mail; (c) the business day after having been placed with a nationally recognized overnight carrier, if delivered by nationally recognized overnight carrier, and (d) the business day after transmittal when transmitted with electronic confirmation of receipt, if transmitted by facsimile. Any party may change the address or facsimile number to which notices or communications are to be sent to it by giving notice of such change in the manner herein provided for giving notice. Until changed by notice, the following shall be the address and facsimile number to which notices shall be sent:

If to the Company, to:

Antares Pharma, Inc.

Princeton South Corporate Center

100 Princeton South, Suite 300

Ewing, New Jersey 08628

Attn: Chief Executive Officer

(609) 359-3015 (facsimile)

 

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With a copy to:

Morgan, Lewis and Bockius LLP

1701 Market Street

Philadelphia, PA 19103

Attn: Amy Pocino Kelly, Esq.

(877) 432-9652 (facsimile)

If to the Executive, to the most recent address on file with the Company or to such other names or addresses as the Company or the Executive, as the case may be, shall designate by notice to each other person entitled to receive notices in the manner specified in this Section 15.

16. Governing Law . This Agreement will be governed by and construed in accordance with the laws of the State of New Jersey, without regard to conflict of law principles.

17. Counterparts . This Agreement may be executed in counterparts, each of which shall be deemed to be an original, but all such counterparts shall together constitute one and the same instrument.

18. Headings; Gender . The headings of sections herein are included solely for convenience of reference and shall not control the meaning or interpretation of any of the provisions of this Agreement.

19. Severability . If any provision of this Agreement or application thereof to anyone or under any circumstances is adjudicated to be invalid or unenforceable in any jurisdiction, such invalidity or unenforceability shall not affect any other provision or application of this Agreement which can be given effect without the invalid or unenforceable provision or application and shall not invalidate or render unenforceable such provision or application in any other jurisdiction. If any provision is held void, invalid or unenforceable with respect to particular circumstances, it shall nevertheless remain in full force and effect in all other circumstances.

[Signature Page Follows]

 

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IN WITNESS WHEREOF, the parties have executed this Agreement as of the day and year first above written.

 

ANTARES PHARMA, INC.

By:  

/s/ Eamonn P. Hobbs

Name: Eamonn P. Hobbs
Its President & CEO
EXECUTIVE:

/s/ Peter Graham

Peter Graham

 

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Exhibit A

Proprietary Information and Invention Assignment Agreement

 

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Exhibit 10.3

ANTARES PHARMA, INC.

2008 EQUITY COMPENSATION PLAN

RESTRICTED STOCK UNIT GRANT AGREEMENT

This RESTRICTED STOCK UNIT GRANT AGREEMENT (this “Agreement”), dated as of                     , 2015 (the “Date of Grant”) is delivered by Antares Pharma, Inc. (the “Company”), to                     (the “Grantee”).

RECITALS

WHEREAS, the Company maintains the Antares Pharma, Inc. 2008 Equity Compensation Plan, as amended and restated (the “Plan”) that provides for the grant of restricted stock units in accordance with the terms and conditions of the Plan;

WHEREAS, the Board of Directors of the Company (the “Board”) desires to grant restricted stock units to the Grantee as an inducement for the Grantee to promote the best interests of the Company and its stockholders;

WHEREAS, the Board is authorized to appoint a committee to administer the Plan and if a committee is appointed, all references in this Agreement to the “Board” shall be deemed to refer to the committee; and

WHEREAS, the terms and conditions of the restricted stock units granted to the Grantee herein are memorialized in this Agreement.

NOW, THEREFORE, the parties to this Agreement, intending to be legally bound hereby, agree as follows:

1. Restricted Stock Unit Grant . Subject to the terms and conditions set forth in this Agreement and the Plan, the Company hereby grants to the Grantee              restricted stock units (“Stock Units”). Each Restricted Stock Unit shall represent the right of the Grantee to receive a share of Company common stock (“Company Stock”) on the applicable Redemption Date (as defined below). The Grantee accepts the grant of Stock Units and agrees to be bound by the terms and conditions of this Agreement and the Plan.

2. Restricted Stock Unit Account . Stock Units represent hypothetical shares of Company Stock and not actual shares of stock. The Company shall establish and maintain a Restricted Stock Unit account, as a bookkeeping account on its records, for the Grantee and shall record in such account the number of Stock Units granted to the Grantee. No shares of Company Stock shall be issued to the Grantee at the time the grant is made, and the Grantee shall not be, nor have any of the rights or privileges of, a stockholder of the Company with respect to any Stock Units recorded in the account. The Grantee shall not have any interest in any fund or specific assets of the Company by reason of this award or the Restricted Stock Unit account established for the Grantee.

 

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3. Vesting and Nonassignability of Stock Units .

(a)         % of the Stock Units shall become vested on the first anniversary of the Date of Grant (the “First Service Date”), provided that the Grantee continues to be Employed by, or providing service to, the Employer (as defined in the Plan) from the Date of Grant through the First Service Date;

(b)         % of the Stock Units shall become vested on the second anniversary of the Date of Grant (the “Second Service Date”), provided the Grantee continues to be Employed by, or providing service to, the Employer from the Date of Grant through the Second Service Date; and

(c)         % of the Stock Units shall become vested on the third anniversary of the Date of Grant (the “Third Service Date”), provided the Grantee continues to be Employed by, or providing service to, the Employer from the Date of Grant through the Third Service Date, so that 100% of the Stock Units are vested on the third anniversary of the Date of Grant.

The vesting of Stock Units shall be cumulative, but shall not exceed 100% of the Stock Units. If the foregoing schedule would produce fractional Stock Units, the number of Stock Units that vest shall be rounded down to the nearest whole Restricted Stock Unit.

Except as otherwise provided in a written employment agreement entered into by and between the Grantee and the Employer, if any, if the Grantee ceases to be Employed by, or provide service to, the Employer for any reason before the Stock Units vest, any Stock Units that have not yet vested shall automatically terminate and be forfeited as of the date on which the Grantee ceases to be Employed by, or provide service to, the Employer.

4. Redemption .

(a) The Stock Units that become vested pursuant to Paragraph 3 above shall be redeemed by the Company on each of the First Service Date, Second Service Date, or Third Service Date, as applicable, or as soon as administratively practicable thereafter, but not later than 30 days following the First Service Date, Second Service Date, or Third Service Date, as applicable, if the Grantee continues to be Employed by, or providing service to, the Employer, from the Date of Grant to the First Service Date, Second Service Date, or Third Service Date, as applicable (each such date, the “Redemption Date”). On the respective Redemption Date, all Stock Units that have become vested pursuant to Paragraph 3 will be redeemed and converted to an equivalent number of shares of Company Stock, and the Grantee shall receive a single sum distribution of such shares of Company Stock, which shall be issued under the Plan.

(b) All obligations of the Company under this Agreement shall be subject to the rights of the Employer as set forth in the Plan to withhold amounts required to be withheld for any taxes, if applicable. The Grantee shall be required to pay to the Employer, or make other arrangements satisfactory to the Employer to provide for the payment of, any federal, state, local or other taxes that the Employer is required to withhold with respect to the Stock Units. Unless the Board determines otherwise, the Grantee shall be required to satisfy any tax withholding obligation of the Employer with respect to Stock Units by having shares withheld up to an amount that does not exceed the minimum applicable withholding tax rate for federal (including FICA), state, local and other tax liabilities.

 

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(c) The obligation of the Company to deliver Company Stock shall also be subject to the condition that if at any time the Board shall determine in its discretion that the listing, registration or qualification of the shares upon any securities exchange or under any state or federal law, or the consent or approval of any governmental regulatory body is necessary or desirable as a condition of, or in connection with, the issue of shares of Company Stock, the shares may not be issued in whole or in part unless such listing, registration, qualification, consent or approval shall have been effected or obtained free of any conditions not acceptable to the Board. The issuance of shares of Company Stock to Grantee pursuant to this Agreement is subject to any applicable taxes and other laws or regulations of the United States or of any state having jurisdiction thereof.

5. Change of Control . The provisions of the Plan applicable to a Change of Control shall apply to the Stock Units, and, in the event of a Change of Control, the Board may take such actions as it deems appropriate pursuant to the Plan.

6. Grant Subject to Plan Provisions . This Agreement is made pursuant to the Plan, the terms of which are incorporated herein by reference, and in all respects shall be interpreted in accordance with the Plan. The grant of, and issuance of shares of Company Stock with respect to, the Stock Units are subject to interpretations, regulations and determinations concerning the Plan established from time to time by the Board in accordance with the provisions of the Plan, including, but not limited to, provisions pertaining to (a) rights and obligations with respect to withholding taxes, (b) the registration, qualification or listing of the shares, (c) changes in capitalization of the Company, and (d) other requirements of applicable law. The Board shall have the authority to interpret and construe the grant of Stock Units pursuant to the terms of the Plan, and its decisions shall be conclusive as to any questions arising hereunder and the Grantee’s acceptance of this grant of Stock Units is the Grantee’s agreement to be bound by the interpretations and decisions of the Board with respect to this grant and the Plan.

7. No Employment or Other Rights . This Agreement shall not confer upon the Grantee any right to be retained by or in the employ or service of the Employer and shall not interfere in any way with the right of the Employer to terminate the Grantee’s employment or service at any time. The right of the Employer to terminate at will the Grantee’s employment or service at any time for any reason is specifically reserved.

8. No Stockholder Rights . Neither the Grantee, nor any person entitled to exercise the Grantee’s rights in the event of the Grantee’s death, shall have any of the rights and privileges of a stockholder with respect to the Stock Units, until certificates for shares have been issued upon redemption of the Stock Units.

9. Assignment and Transfers . The rights and interests of the Grantee under this Agreement may not be sold, assigned, encumbered or otherwise transferred except, in the event of the death of the Grantee, by will or by the laws of descent and distribution. In the event of any attempt by the Grantee to alienate, assign, pledge, hypothecate, or otherwise dispose of the Stock Units or any right hereunder, except as provided for in this Agreement, or in the event of the levy or any

 

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attachment, execution or similar process upon the rights or interests hereby conferred, the Company may terminate the Stock Units by notice to the Grantee, and the Stock Units and all rights hereunder shall thereupon become null and void. The rights and protections of the Company hereunder shall extend to any successors or assigns of the Company and to the Company’s parents, subsidiaries, and affiliates. This Agreement may be assigned by the Company without the Grantee’s consent.

10. Complete Agreement. This Agreement will become effective as of the Date of Grant. Each executed counterpart of this Agreement will constitute an original document and, all of them, together, will constitute the same agreement. This Agreement records the final, complete, and exclusive understanding of the parties with respect to the matters addressed herein and, except with respect to any written employment agreement by and between the Grantee and the Employer, supersedes any prior or contemporaneous agreement, representation, or understanding, whether oral or written, by either of them, relating to the matters addressed herein.

11. Applicable Law . The validity, construction, interpretation and effect of this Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to the conflicts of laws provisions thereof.

12. Section 409A of the Code . This Agreement is not intended to constitute or result in deferred compensation subject to the requirements of section 409A of the Internal Revenue Code of 1986, as amended (the “Code”). However, to the extent any amount payable under this Agreement is subsequently determined to constitute deferred compensation subject to the requirements of section 409A of the Code, this Agreement shall be administered in accordance with the requirements of section 409A of the Code. In such case, distributions made under this Agreement may only be made in a manner and upon an event permitted by section 409A of the Code, including the requirement that distributions to a “specified employee” (as such term is defined in section 409A(a)(2)(B)(i) of the Code and its corresponding regulations) as determined by the Board (or its delegate) in its discretion in accordance with the requirements of sections 409A and 416 of the Code, payable within six months following such Grantee’s “separation from service” shall be postponed for a period of six months following the Grantee’s “separation from service” with the Company. To the extent that any provision of this Agreement would cause a conflict with the requirements of section 409A of the Code, or would cause the administration of this Agreement to fail to satisfy the requirements of section 409A of the Code, such provision shall be deemed null and void to the extent permitted by applicable law. In no event shall the Grantee, directly or indirectly, designate the calendar year of redemption. This Agreement may be amended without the consent of the Grantee in any respect deemed by the Board to be necessary in order to preserve compliance with section 409A of the Code. All distributions pursuant to this Agreement shall be deemed as a separate payment.

13. Notice . Any notice to the Company provided for in this Agreement shall be addressed to the Company in care of the General Counsel at the corporate headquarters of the Company, and any notice to the Grantee shall be addressed to such Grantee at the current address shown on the payroll of the Employer, or to such other address as the Grantee may designate to the Employer in writing. Any notice shall be delivered by hand, sent by telecopy or enclosed in a properly sealed envelope addressed as stated above, registered and deposited, postage prepaid, in a post office regularly maintained by the United States Postal Service.

[Signature Page Follows]

 

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IN WITNESS WHEREOF, the Company has caused its duly authorized officers to execute and attest this Agreement, and the Grantee has placed his or her signature hereon, effective as of the Date of Grant.

 

ANTARES PHARMA, INC.

By:  

 

Name:  

 

Title:  

 

I hereby accept the grant of Stock Units described in this Agreement, and I agree to be bound by the terms of the Plan and this Agreement. I hereby further agree that all of the decisions and determinations of the Board shall be final and binding.

 

Grantee:  

 

Name:  
Date:                     , 2015

 

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Exhibit 31.1

CERTIFICATIONS

I, Eamonn P. Hobbs, certify that:

 

1. I have reviewed this report on Form 10-Q for the fiscal quarter ended June 30, 2015 of Antares Pharma, Inc.;

 

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 15(d)-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: August 10, 2015

 

/s/ Eamonn P. Hobbs

Eamonn P. Hobbs
President and Chief Executive Officer

Exhibit 31.2

CERTIFICATIONS

I, James E. Fickenscher, certify that:

 

1. I have reviewed this report on Form 10-Q for the fiscal quarter ended June 30, 2015 of Antares Pharma, Inc.;

 

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 15(d)-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: August 10, 2015

 

/s/ James E. Fickenscher

James E. Fickenscher
Senior Vice President and Chief Financial Officer

Exhibit 32.1

ANTARES PHARMA, INC.

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 (18 U.S.C. 1350)

The undersigned, Eamonn P. Hobbs, the Chief Executive Officer of Antares Pharma, Inc. (the “Company”), has executed this Certification in connection with the filing with the Securities and Exchange Commission of the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2015 (the “Report”).

The undersigned hereby certifies that:

 

  1. The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

 

  2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

IN WITNESS WHEREOF, the undersigned has executed this Certification as of the 10th day of August, 2015.

 

/s/ Eamonn P. Hobbs

Eamonn P. Hobbs
President and Chief Executive Officer

Exhibit 32.2

ANTARES PHARMA, INC.

CERTIFICATION OF CHIEF FINANCIAL OFFICER

PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 (18 U.S.C. 1350)

The undersigned, James E. Fickenscher, the Chief Financial Officer of Antares Pharma, Inc. (the “Company”), has executed this Certification in connection with the filing with the Securities and Exchange Commission of the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2015 (the “Report”).

The undersigned hereby certifies that:

 

  1. The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

 

  2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

IN WITNESS WHEREOF, the undersigned has executed this Certification as of the 10th day of August, 2015.

 

/s/ James E. Fickenscher

James E. Fickenscher
Senior Vice President and Chief Financial Officer