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 September 30, 2016

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       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       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

 

 

 

 

 

 

 

 

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  

The number of shares outstanding of the registrant’s Common Stock, $.01 par value, as of November 5, 2016 was 155,086,727 .

 

 

 

 


 

ANTARES PHARMA, INC.

INDEX

 

 

 

 

 

 

 

PAGE

 

 

 

 

 

 

 

PART I.

 

 

 

FINANCIAL INFORMATION

 

3

 

 

 

 

 

 

 

 

 

Item 1.

 

Financial Statements

 

3

 

 

 

 

 

 

 

 

 

 

 

Consolidated Balance Sheets, as of September 30, 2016 (Unaudited) and December 31, 2015

 

3

 

 

 

 

 

 

 

 

 

 

 

Consolidated Statements of Operations (Unaudited) for the three and nine months ended September 30, 2016 and 2015

 

4

 

 

 

 

 

 

 

 

 

 

 

Consolidated Statements of Comprehensive Loss (Unaudited) for the three and nine months ended September 30, 2016 and 2015

 

5

 

 

 

 

 

 

 

 

 

 

 

Consolidated Statements of Cash Flows (Unaudited) for the nine months ended September 30, 2016 and 2015

 

6

 

 

 

 

 

 

 

 

 

 

 

Notes to Consolidated Financial Statements (Unaudited)

 

7

 

 

 

 

 

 

 

 

 

Item 2.

 

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

 

13

 

 

 

 

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

23

 

 

 

 

 

 

 

 

 

Item 4.

 

Controls and Procedures

 

23

 

 

 

 

 

 

 

PART II.

 

 

 

OTHER INFORMATION

 

24

 

 

 

 

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

24

 

 

 

 

 

 

 

 

 

Item 1A.

 

Risk Factors

 

24

 

 

 

 

 

 

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

24

 

 

 

 

 

 

 

 

 

Item 3.

 

Default Upon Senior Securities

 

24

 

 

 

 

 

 

 

 

 

Item 4.

 

Mine Safety Disclosures

 

24

 

 

 

 

 

 

 

 

 

Item 6.

 

Exhibits

 

24

 

 

 

 

 

 

 

 

 

 

 

SIGNATURES

 

25

 

 

 

2


 

PART I – F INANCIAL INFORMATION

Item 1.

FINANCIAL STATEMENTS

ANTARES PHARMA, INC.

CONSOLIDATED BALANCE SHEETS

 

 

 

September 30,

 

 

December 31,

 

 

 

2016

 

 

2015

 

 

 

(Unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

 

 

Cash

 

$

28,781,427

 

 

$

32,898,676

 

Short-term investments

 

 

3,001,312

 

 

 

15,012,225

 

Accounts receivable

 

 

8,561,738

 

 

 

7,952,478

 

Inventories

 

 

6,723,555

 

 

 

5,724,397

 

Deferred costs

 

 

1,961,630

 

 

 

1,199,217

 

Prepaid expenses and other current assets

 

 

376,212

 

 

 

3,274,254

 

Total current assets

 

 

49,405,874

 

 

 

66,061,247

 

Equipment, molds, furniture and fixtures, net

 

 

17,993,431

 

 

 

14,793,084

 

Patent rights, net

 

 

2,149,225

 

 

 

2,434,542

 

Goodwill

 

 

1,095,355

 

 

 

1,095,355

 

Other assets

 

 

153,800

 

 

 

177,943

 

Total Assets

 

$

70,797,685

 

 

$

84,562,171

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

8,096,400

 

 

$

5,187,703

 

Accrued expenses and other liabilities

 

 

6,656,351

 

 

 

6,488,032

 

Deferred revenue

 

 

5,801,902

 

 

 

5,143,825

 

Total current liabilities

 

 

20,554,653

 

 

 

16,819,560

 

Deferred revenue – long term

 

 

1,200,000

 

 

 

700,000

 

Total liabilities

 

 

21,754,653

 

 

 

17,519,560

 

Stockholders’ Equity:

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

Common Stock: $0.01 par; 300,000,000 shares authorized; 155,086,393 and

   154,848,512 issued and outstanding at September 30, 2016 and

   December 31, 2015, respectively

 

 

1,550,864

 

 

 

1,548,485

 

Additional paid-in capital

 

 

297,136,832

 

 

 

295,292,414

 

Accumulated deficit

 

 

(248,945,058

)

 

 

(229,106,502

)

Accumulated other comprehensive loss

 

 

(699,606

)

 

 

(691,786

)

 

 

 

49,043,032

 

 

 

67,042,611

 

Total Liabilities and Stockholders’ Equity

 

$

70,797,685

 

 

$

84,562,171

 

 

See accompanying notes to consolidated financial statements.

 

 

3


 

ANTARES PHARMA, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

 

 

 

For the Three Months Ended

 

 

For the Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

$

11,049,840

 

 

$

8,027,029

 

 

$

30,580,889

 

 

$

18,490,193

 

Development revenue

 

 

2,101,203

 

 

 

2,608,336

 

 

 

6,466,974

 

 

 

8,024,184

 

Licensing revenue

 

 

38,618

 

 

 

42,960

 

 

 

128,040

 

 

 

6,112,341

 

Royalties

 

 

289,102

 

 

 

407,427

 

 

 

850,022

 

 

 

1,227,462

 

Total revenue

 

 

13,478,763

 

 

 

11,085,752

 

 

 

38,025,925

 

 

 

33,854,180

 

Cost of revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

 

7,206,280

 

 

 

3,265,983

 

 

 

18,670,363

 

 

 

7,763,734

 

Cost of development revenue

 

 

827,441

 

 

 

1,833,780

 

 

 

3,457,197

 

 

 

5,718,852

 

Total cost of revenue

 

 

8,033,721

 

 

 

5,099,763

 

 

 

22,127,560

 

 

 

13,482,586

 

Gross profit

 

 

5,445,042

 

 

 

5,985,989

 

 

 

15,898,365

 

 

 

20,371,594

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

5,958,550

 

 

 

5,142,387

 

 

 

15,554,599

 

 

 

14,089,100

 

Selling, general and administrative

 

 

5,622,937

 

 

 

6,611,169

 

 

 

20,240,635

 

 

 

20,253,489

 

Total operating expenses

 

 

11,581,487

 

 

 

11,753,556

 

 

 

35,795,234

 

 

 

34,342,589

 

Operating loss

 

 

(6,136,445

)

 

 

(5,767,567

)

 

 

(19,896,869

)

 

 

(13,970,995

)

Other income (expense)

 

 

15,462

 

 

 

29,526

 

 

 

58,313

 

 

 

(61,366

)

Net loss

 

$

(6,120,983

)

 

$

(5,738,041

)

 

$

(19,838,556

)

 

$

(14,032,361

)

Basic and diluted net loss per common share

 

$

(0.04

)

 

$

(0.04

)

 

$

(0.13

)

 

$

(0.10

)

Basic and diluted weighted average common shares outstanding

 

 

155,060,811

 

 

 

154,808,641

 

 

 

154,952,060

 

 

 

143,819,033

 

 

See accompanying notes to consolidated financial statements.

 

 

4


 

ANTARES PHARMA, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)

 

 

 

For the Three Months Ended

 

 

For the Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

Net loss

 

$

(6,120,983

)

 

$

(5,738,041

)

 

$

(19,838,556

)

 

$

(14,032,361

)

Foreign currency translation adjustment

 

 

2,632

 

 

 

(22,044

)

 

 

(7,820

)

 

 

6,165

 

Comprehensive loss

 

$

(6,118,351

)

 

$

(5,760,085

)

 

$

(19,846,376

)

 

$

(14,026,196

)

 

See accompanying notes to consolidated financial statements.

 

 

5


 

ANTARES PHARMA, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2016

 

 

2015

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(19,838,556

)

 

$

(14,032,361

)

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

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

1,886,823

 

 

 

2,649,062

 

Depreciation and amortization

 

 

1,371,538

 

 

 

1,169,745

 

Loss on disposal of equipment

 

 

17,785

 

 

 

167,097

 

Amortization of premiums and discounts

 

 

10,913

 

 

 

7,070

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(624,232

)

 

 

(3,045,011

)

Inventories

 

 

(999,158

)

 

 

202,588

 

Prepaid expenses and other assets

 

 

2,922,527

 

 

 

316,315

 

Deferred costs

 

 

(762,413

)

 

 

1,394,545

 

Accounts payable

 

 

3,308,607

 

 

 

(5,742,113

)

Accrued expenses and other current liabilities

 

 

(146,376

)

 

 

236,434

 

Deferred revenue

 

 

1,156,309

 

 

 

(9,173,966

)

Net cash used in operating activities

 

 

(11,696,233

)

 

 

(25,850,595

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of equipment, molds, furniture and fixtures

 

 

(4,278,643

)

 

 

(5,013,012

)

Additions to patent rights

 

 

(103,788

)

 

 

(1,008,363

)

Proceeds from maturities of investment securities

 

 

12,000,000

 

 

 

6,000,000

 

Purchases of investment securities

 

 

 

 

 

(15,037,675

)

Net cash provided by (used in) investing activities

 

 

7,617,569

 

 

 

(15,059,050

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock, net

 

 

 

 

 

42,850,677

 

Proceeds from exercise of stock options and warrants

 

 

24,071

 

 

 

 

Taxes paid related to net share settlement of equity awards

 

 

(64,096

)

 

 

(87,770

)

Net cash provided by (used in) financing activities

 

 

(40,025

)

 

 

42,762,907

 

Effect of exchange rate changes on cash

 

 

1,440

 

 

 

(1,193

)

Net increase (decrease) in cash

 

 

(4,117,249

)

 

 

1,852,069

 

Cash:

 

 

 

 

 

 

 

 

Beginning of period

 

 

32,898,676

 

 

 

34,028,889

 

End of period

 

$

28,781,427

 

 

$

35,880,958

 

Supplemental disclosure of non-cash investing activities:

 

 

 

 

 

 

 

 

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

   and accrued expenses

 

$

552,556

 

 

$

42,758

 

Additions to patent rights recorded in accounts payable and accrued expenses

 

$

23,369

 

 

$

 

 

See accompanying notes to consolidated financial statements.

 

 

 

6


 

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 multiple internal product development programs as well as numerous partnership arrangements with several industry leading pharmaceutical companies. The Company has formed strategic alliances with Teva Pharmaceutical Industries, Ltd. (“Teva”), Ferring Pharmaceuticals Inc. and Ferring B.V. (together “Ferring”), JCR Pharmaceuticals Co., Ltd. (“JCR”) and AMAG Pharmaceuticals, Inc. (“AMAG”).  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.

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 two gel-based products which are commercialized through partners.

In February 2014, the Company launched its proprietary 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, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis.  

In December 2015, the Company received FDA approval for an Abbreviated New Drug Application (“ANDA”) for 4 mg/0.5 mL and 6 mg/0.5 mL Sumatriptan Injection USP in adults for the acute treatment of migraine and cluster headache. Sumatriptan Injection USP is the Company’s first ANDA approval of a complex generic and second product approved using the VIBEX ® auto injector platform. The Company previously entered into a license, supply and development agreement with Teva pursuant to which Teva is responsible for the commercialization of the sumatriptan product, and in June 2016, the Company and Teva announced the launch of the generic equivalent to Imitrex ® (sumatriptan succinate) injection, 4 mg and 6 mg single-dose prefilled syringe auto-injectors in the U.S.

Antares also has a pipeline of proprietary and partnered products at various stages of development.  The Company completed  clinical studies of VIBEX ® QuickShot ® Testosterone for testosterone replacement therapy in the third quarter of 2016 and is working toward the submission of the New Drug Application (NDA) with the FDA by December 31, 2016.   In addition, the Company is working with Teva on the development and approval of an auto-injector containing epinephrine and two pen injector products, which are all currently under FDA review.  

 

 

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, 2015.  Operating results for the three and nine months ended September 30, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016.

Investments

All 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 September 30, 2016 and December 31, 2015, the Company had investments with a carrying value of $3,001,312 and $15,012,225, respectively.  The fair value of the Company’s investments approximated their carrying value as of September 30, 2016 and December 31, 2015.

7


 

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 a reserve for potentially excess, dated or obsolete inventories based on an analysis of inventory on hand compared to forecasts of future sales, which was $900,000 and $800,000 at September 30, 2016 and December 31, 2015, respectively.  Inventories consist of the following:

 

 

 

September 30,

 

 

December 31,

 

 

 

2016

 

 

2015

 

Inventories:

 

 

 

 

 

 

 

 

Raw material

 

$

178,345

 

 

$

305,149

 

Work in process

 

 

3,155,238

 

 

 

1,539,319

 

Finished goods

 

 

3,389,972

 

 

 

3,879,929

 

 

 

$

6,723,555

 

 

$

5,724,397

 

 

OTREXUP TM Revenue Recognition

In February 2014, the Company began detailing OTREXUP™ to health care professionals. OTREXUP™ is sold in a package of four pre-filled, single-dose disposable auto injectors to wholesale pharmaceutical distributors, its customers, 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. The Company uses this third party prescription data, among other information, as a basis for revenue recognition in each reporting period.  If patient prescriptions dispensed for a given period are underestimated or overestimated, adjustments to revenue may be necessary in future periods.

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 may 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.

The Company recognized $3,904,329 and $11,024,394 in OTREXUP™ product sales revenue for the three and nine months ended September 30, 2016, respectively, as compared to $3,592,779 and $9,943,182 for the three and nine months ended September 30, 2015, respectively, which is presented net of product sales allowances for estimated wholesaler discounts, prompt pay discounts, chargebacks, rebates and patient discount programs. The Company had deferred revenue balances of $1,154,112 and $1,064,874 at September 30, 2016 and December 31, 2015, respectively, for OTREXUP™ product shipments, which is net of product sales allowances, discussed below.

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.

8


 

Prompt Pay Discounts . The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for p rompt 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 . The Company provides discounts 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 estimates and accrues 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.

Revenue Recognition – Sumatriptan

Under a license, supply and distribution agreement with Teva for an auto-injector product containing sumatriptan, the Company produces devices and assembles final product for shipment to Teva, and Teva is responsible for commercial distribution of the product.  The Company is compensated, and recognizes revenue, at cost for shipments of product delivered to Teva.  The Company is also entitled to receive 50 percent of the future net profits from commercial sales made by Teva.  Revenues from the profit sharing arrangement will be recognized in future periods when amounts are fixed and determinable and are payable to the Company within 45 days after the end of each fiscal quarter in which commercial sales are made.

 

 

3 .

Stockholders’ Equity

The Company’s Board of Directors unanimously approved, and recommended to the stockholders to approve and adopt, an amendment to the Company’s Certificate of Incorporation to increase the number of authorized shares of capital stock of the Company from 203,000,000 to 303,000,000 in order to increase the number of authorized shares of common stock, par value $0.01 per share, of the Company from 200,000,000 shares to 300,000,000 shares.  The amendment was approved and adopted by a vote of the stockholders at the Company’s Annual Meeting of Stockholders held on June 2, 2016.

 

 

4 .

Share-Based Compensation

The Company’s 2008 Equity Compensation Plan (the “Plan”) was amended and restated pursuant to stockholder approval on June 2, 2016 in order to increase the number of shares available for issuance under the Plan, extend the term of the Plan, impose a one-year minimum vesting requirement and provide for double trigger vesting for certain awards in the event of a change in control.  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 amended and restated Plan is 32,200,000 and the maximum number of shares of stock that may be granted to any one employee for qualified performance-based compensation during a calendar year is 4,000,000 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 with a minimum vesting period of one year.  As of September 30, 2016 the Plan had approximately 8,900,000 shares available for grant.

9


 

Stock Options

The following is a summary of stock option activity under the Plan as of and for the nine months ended September 30, 2016:   

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

Average

 

 

 

 

 

 

 

 

 

 

 

Average

 

 

Remaining

 

 

Aggregate

 

 

 

Number of

 

 

Exercise

 

 

Contractual

 

 

Intrinsic

 

 

 

Shares

 

 

Price ($)

 

 

Term (Years)

 

 

Value ($)

 

Outstanding at December 31, 2015

 

 

9,480,497

 

 

$

2.19

 

 

 

 

 

 

 

 

 

Granted

 

 

3,784,500

 

 

 

1.10

 

 

 

 

 

 

 

 

 

Exercised

 

 

(21,492

)

 

 

1.12

 

 

 

 

 

 

 

 

 

Cancelled/Forfeited

 

 

(1,433,293

)

 

 

1.90

 

 

 

 

 

 

 

 

 

Outstanding at September 30, 2016

 

 

11,810,212

 

 

 

1.88

 

 

 

7.2

 

 

$

3,429,807

 

Exercisable at September 30, 2016

 

 

7,824,499

 

 

$

2.13

 

 

 

6.1

 

 

$

1,666,229

 

 

The per share weighted average fair values of all options granted during the nine months ended September 30, 2016 and 2015 were estimated as $0.54 and $1.13, 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.

 

 

 

September 30,

 

 

 

2016

 

 

2015

 

Risk-free interest rate

 

 

1.3

%

 

 

1.3

%

Annualized volatility

 

 

51.6

%

 

 

53.5

%

Weighted average expected life, in years

 

 

6.00

 

 

 

6.00

 

Expected dividend yield

 

 

0.0

%

 

 

0.0

%

 

During the nine months ended September 30, 2016, stock option exercises resulted in proceeds of $24,071 and the issuance of 21,492 shares of common stock. No stock options were exercised during the nine months ended September 30, 2015.

The Company recognized $1,572,710 and $2,177,067 in compensation expense related to stock options for the nine months ended September 30, 2016 and 2015, respectively, and stock compensation expense of $505,663 and $766,062 for the three months ended September 30, 2016 and 2015, respectively.  As of September 30, 2016, there was approximately $2,300,000 of total unrecognized compensation cost related to nonvested outstanding stock options that is expected to be recognized over a weighted average period of approximately 2.0 years.

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 to similarly situated senior executives in 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 as established by the Company’s Board of Directors over a performance period, which is typically three to five years.

10


 

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

 

 

 

Performance Stock Units

 

 

Restricted Stock Units

 

 

 

Number of

Shares

 

 

Weighted

Average   Grant

Date Fair

Value ($)

 

 

Number of

Shares

 

 

Weighted

Average Grant

Date Fair

Value ($)

 

Outstanding at December 31, 2015

 

 

956,178

 

 

$

2.40

 

 

 

714,828

 

 

$

2.32

 

Granted

 

 

750,500

 

 

 

1.12

 

 

 

750,500

 

 

 

1.12

 

Vested/settled

 

 

(11,223

)

 

 

3.96

 

 

 

(264,002

)

 

 

2.41

 

Forfeited/expired

 

 

(227,490

)

 

 

1.70

 

 

 

(378,668

)

 

 

1.55

 

Outstanding at September 30, 2016

 

 

1,467,965

 

 

$

1.85

 

 

 

822,658

 

 

$

1.53

 

 

In 2016 and 2015, the LTIP awards include PSUs that may be earned based on the Company’s total shareholder return (“TSR”) relative to the Nasdaq Biotechnology Index (“NBI”) at the end of the performance period, which performance period is January 1, 2015 to December 31, 2017 for the 2015 award and January 1, 2016 to December 31, 2018 for the 2016 award.  Depending on the outcome of the performance goal, a recipient may ultimately earn a number of shares greater or less than the target number of shares granted, ranging from 0% to 150% of the PSUs granted. The fair values of the TSR PSUs granted in June 2016 and May 2015 was determined using a Monte Carlo simulation and utilized the following inputs and assumptions: 

 

 

 

2016 Award

 

 

2015 Award

 

Closing stock price on grant date

 

$

1.12

 

 

$

2.18

 

Performance period starting price

 

$

1.29

 

 

$

2.52

 

Term of award (in years)

 

 

2.58

 

 

 

2.59

 

Volatility

 

 

70.1

%

 

 

60.5

%

Risk-free interest rate

 

 

0.97

%

 

 

0.83

%

Expected dividend yield

 

 

0.00

%

 

 

0.00

%

Fair value per TSR PSU

 

$

1.25

 

 

$

1.71

 

 

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.

Total compensation expense recognized in connection with PSU awards was $11,331 and $89,911 for the nine months ended September 30, 2016 and 2015, respectively.  Compensation expense recognized in connection with RSU awards was $302,782 and $382,084 for the nine months ended September 30, 2016 and 2015, respectively.

Some of the shares issued in connection with RSU awards that vested in the nine months ended September 30, 2016 and 2015 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 65,575 and 39,665 in the nine months ended September 30, 2016 and 2015, 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 $64,096 and $87,770 in the nine months ended September 30, 2016 and 2015, 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.

 

 

11


 

5 .

Significant Customers and Concentrations of Risk

Revenues by customer location are summarized as follows:

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

United States of America

 

$

12,036,590

 

 

$

9,740,486

 

 

$

33,631,332

 

 

$

30,055,925

 

Europe

 

 

1,215,218

 

 

 

1,309,731

 

 

 

3,829,809

 

 

 

3,609,798

 

Other

 

 

226,955

 

 

 

35,535

 

 

 

564,784

 

 

 

188,457

 

 

 

$

13,478,763

 

 

$

11,085,752

 

 

$

38,025,925

 

 

$

33,854,180

 

 

Significant customers from which the Company derived 10% or more of total revenue are as follows:

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

Teva

 

$

5,522,996

 

 

$

5,097,912

 

 

$

18,513,972

 

 

$

12,227,129

 

AMAG

 

 

2,369,950

 

 

 

362,775

 

 

 

3,275,832

 

 

 

362,775

 

McKesson (1)

 

 

1,946,261

 

 

 

2,105,422

 

 

 

5,501,810

 

 

 

5,440,323

 

Ferring

 

 

1,246,300

 

 

 

1,309,731

 

 

 

3,960,689

 

 

 

3,609,798

 

LEO Pharma (2)

 

 

 

 

 

 

 

 

 

 

 

6,000,000

 

 

 

(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.

 

(2)

The licensing agreement with LEO Pharma A/S was terminated effective June 23, 2015 and accordingly no revenue was recognized or received from this customer for the three and nine months ended September 30, 2016.

 

 

6 .

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 excluded from dilutive loss per share because their effect was anti-dilutive totaled 11,810,212 and 9,571,079 at September 30, 2016 and 2015, respectively.

 

 

7 .

Recent Accounting Pronouncements

In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases”, which is intended to increase transparency and comparability among organizations by recognizing all lease transactions (with terms in excess of 12 months) on the balance sheet as a lease liability and a right-of-use asset (as defined). ASU No. 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, with earlier application permitted.  Upon adoption, the lessee will apply the new standard retrospectively to all periods presented or retrospectively using a cumulative effect adjustment in the year of adoption. The Company is currently assessing the effect that ASU No. 2016-02 will have on its results of operations, cash flows and financial position.

In March 2016, FASB issued ASU No. 2016-09, “Improvements to Employee Share-Based Payment Accounting”, as part of its simplification initiative. The areas of simplification involve several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows.  ASU No. 2016-09 is effective for annual and interim periods beginning after December 15, 2016. The Company is currently assessing the impact that the standard will have on its results of operations, cash flows and financial position.

In March 2016, FASB issued ASU No. 2016-08 “Principal Agent Considerations (Reporting Revenue Gross versus Net)” and in April 2016, FASB issued ASU No. 2016-10 “Identifying Performance Obligations and Licensing.” These updates amend, clarify and provide implementation guidance on the new revenue recognition standard ASU No. 2014-09, “Revenue from Contract with Customers”, which is effective for annual and interim periods beginning after December 15, 2017. The Company is currently evaluating the impact the adoption of these standards will have on its results of operations, cash flows and financial position.  

 

12


 

Item 2.

M ANAGEMENT’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 and sales of OTREXUP™ (methotrexate) injection for subcutaneous use;

 

our expectations regarding product development and potential approval by the United States Food and Drug Administration (“FDA”) of VIBEX ® QuickShot ® for Testosterone injection (“QST”);

 

our expectations regarding continued product development with Teva Pharmaceutical Industries, Ltd.’s (“Teva”), and potential FDA approval, of the VIBEX ® Epinephrine Pen (“epinephrine auto injector”), teriparatide disposable pen injector and exenatide disposable pen injector, and Teva’s ability to successfully commercialize each of those products;

 

our expectations regarding our and our partner Teva’s ability to successfully commercialize VIBEX ® Sumatriptan (sumatriptan injection);

 

our expectations regarding continued product development with our partners, including Teva and AMAG Pharmaceuticals, Inc. (“AMAG”), and the pursuit of FDA approval of products developed with such partners;

 

our expectations regarding trends in pharmaceutical drug delivery characteristics;

 

our anticipated continued reliance on third-party contract manufacturers to manufacture our products;

 

our anticipated continued reliance on third parties to provide certain services for our products including logistics, warehousing, distribution, invoicing, contract administration and chargeback processing;

 

our sales and marketing plans;

 

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

 

timing and results of our clinical trials;

 

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, including estimates of OTREXUP™ prescription data provided by third-party sources, which are used in our revenue recognition methods; and

 

our expectations regarding financial and operating results for the year ending December 31, 2016.

Forward-looking statements are based on assumptions that we have made in light of our industry experience as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. As you read and consider this report, you should understand that these statements are not guarantees of performance results. Forward-looking statements involve known and unknown risks, uncertainties and assumptions, 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;

13


 

 

our in ability 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;

 

changes or delays in the regulatory process;

 

adverse economic and political conditions; and

 

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

In addition, you should refer to the “Risk Factors” sections of this report and of our Annual Report on Form 10-K for the year ended December 31, 2015 and our Quarterly Report on Form 10-Q for the quarters ended March 31, 2016 and June 30, 2016 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 thereto and other information contained in this report.

Overview

Company and Product 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 multiple internal product development programs as well as numerous partnership arrangements with several industry leading pharmaceutical companies. We have formed strategic alliances with Teva, Ferring Pharmaceuticals Inc. and Ferring B.V. (together “Ferring”), JCR Pharmaceuticals Co., Ltd. (“JCR”) and AMAG.  We develop and apply our drug delivery systems in collaborations with these pharmaceutical partners to enhance our partners' drug compounds and delivery methods.

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 that 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 two gel-based products that are commercialized through partners.

We launched our product OTREXUP™, which is the first FDA approved subcutaneous methotrexate for once weekly self-administration with an easy-to-use, single dose, disposable auto injector, in February 2014.  OTREXUP™ is indicated for adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis.   To date, we have received FDA approval for eight dosage strengths of OTREXUP™ (7.5 mg,10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg and 25 mg).  

In December 2015, the FDA approved our Abbreviated New Drug Application (ANDA) for 4 mg/0.5 mL and 6 mg/0.5 mL Sumatriptan Injection USP, indicated for adults for the acute treatment of migraine and cluster headache.  Sumatriptan Injection USP represents the Company’s first ANDA approval of a complex generic and second product approved using the VIBEX ® auto injector platform.  Under the terms of a license, supply and distribution arrangement, the VIBEX ® Sumatriptan product will be distributed by Teva.  We and our partner Teva announced the launch of the generic equivalent to Imitrex® (sumatriptan succinate) injection, 4 mg and 6 mg single-dose prefilled syringe auto-injectors in the U.S. in June 2016.

14


 

Overview of Clinical, Regulatory and Product Development Activities

We are developing QuickShot ® Testosterone for testosterone replacement therapy.  We previously announced positive top-line pharmacokinetic results that showed that the primary endpoint was achieved in our 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.  In October 2015, we announced that the last patient in study QST-13-003 received their week 52 treatment, which marked the end of the treatment and follow up phase of this study, and in March 2016, we announced the results of the 52 week safety follow-up for the QST-13-003 trial. Based upon a written response we received from the FDA related to our clinical development program for QST, we conducted an additional study, QST-15-005, to support the filing of our expected 505 (b) (2) New Drug Application (“NDA”) for QST.  The study included a screening phase, a treatment titration phase and a treatment phase for evaluation of safety and tolerability assessments, including laboratory assessments, adverse events and injection site assessments.  We completed enrollment in study QST-15-005 in October 2015 and announced on June 1, 2016 that the last patient had completed their treatment under the 26-week safety and pharmacokinetic phase 3 study. In September 2016, we announced the completion and results of the supplement study QST-15-005, signifying the conclusion of our clinical work necessary to begin the NDA submission process with the FDA. We expect to file the NDA for QST by December 31, 2016.

We are collaborating with Teva on a combination product development project for a VIBEX ® auto injector pen containing epinephrine, used for the treatment of severe allergic reactions (anaphylaxis).  Teva submitted an amendment to the VIBEX ® epinephrine pen ANDA in December 2014 and received a Complete Response Letter (“CRL”) from the FDA on February 23, 2016 in which, according to Teva, the FDA identified certain major deficiencies.  Teva is evaluating the CRL and intends to submit a response. However, due to the major deficiencies identified in the CRL, Teva expects that its epinephrine product will be substantially delayed from their previously anticipated launch date in the second half of 2016 and that any launch will not take place before 2017.

Our other combination product development projects in collaboration with Teva include an exenatide multi-dose pen for the treatment of type 2 diabetes, and another multi-dose pen for a generic form of Forteo ® (teriparatide [rDNA origin] injection) for the treatment of osteoporosis. Teva filed an ANDA for exenatide, which was accepted by the FDA in October 2014 and is currently under FDA review.  We recently announced that Teva had settled the patent litigation with AstraZeneca Pharmaceuticals, LP, AstraZeneca AB, and Amylin Pharmaceuticals, LLC (collectively “AstraZeneca”), relating to certain AstraZeneca U.S. patents and their drug, BYETTA ® (exenatide).  AstraZeneca and Teva entered into a settlement and license agreement pursuant to which AstraZeneca granted Teva a license to manufacture and commercialize the generic version of BYETTA ® described in Teva’s ANDA.  The settlement allows Teva to commercialize their exenatide product in the U.S. beginning October 15, 2017 or earlier under certain circumstances. Teva also filed an ANDA for a generic version of Forteo ® (teriparatide [rDNA origin] injection), which was accepted by the FDA and is currently under review.  In response to Teva’s paragraph IV certification contained in Teva’s ANDA for teriparatide, Eli Lilly and Company (“Lilly”) filed a lawsuit against Teva alleging infringement of six U.S. patents related to Forteo ® (teriparatide [rDNA origin] injection) resulting in a 30-month stay in FDA approval of the ANDA.  The stay will expire in August 2018 unless the litigation is resolved sooner.

In partnership with AMAG, we are currently developing a variation of our VIBEX ® QuickShot ® auto injector for use with AMAG’s progestin hormone drug Makena ® (hydroxy-progesterone caproate injection) for the prevention of pre-term labor in pregnant women.  Under a license, development and supply agreement, AMAG is responsible for the clinical development and preparation, submission and maintenance of all regulatory applications, manufacturing and supplying the drug, and marketing, selling and distributing the final product.  We are responsible for the design and development of the auto-injection device, manufacturing and supplying the device, and assembly and packaging of the final product.  

Results of Operations

We reported net losses of $6,120,983 and $19,838,556 for the three and nine months ended September 30, 2016, respectively as compared to net losses of $5,738,041 and $14,032,361 for the three and nine months ended September 30, 2015, respectively.  Operating results for the three and nine months ended September 30, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016.  The following is an analysis and discussion of our operations for the three and nine months ended September 30, 2016 as compared to 2015.

15


 

Revenues

 

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

OTREXUP™

 

$

3,904,329

 

 

$

3,592,779

 

 

$

11,024,394

 

 

$

9,943,182

 

Auto injector and pen injector devices

 

 

5,943,786

 

 

 

3,240,437

 

 

 

15,836,179

 

 

 

5,207,463

 

Needle-free injector devices and components

 

 

1,201,725

 

 

 

1,193,813

 

 

 

3,720,316

 

 

 

3,339,548

 

Total product sales

 

 

11,049,840

 

 

 

8,027,029

 

 

 

30,580,889

 

 

 

18,490,193

 

Development revenue

 

 

2,101,203

 

 

 

2,608,336

 

 

 

6,466,974

 

 

 

8,024,184

 

Licensing revenue

 

 

38,618

 

 

 

42,960

 

 

 

128,040

 

 

 

6,112,341

 

Royalties

 

 

289,102

 

 

 

407,427

 

 

 

850,022

 

 

 

1,227,462

 

Total revenue

 

$

13,478,763

 

 

$

11,085,752

 

 

$

38,025,925

 

 

$

33,854,180

 

 

Total revenue for the three months ended September 30, 2016 and 2015 was $13,478,763 and $11,085,752, respectively.  Total revenue for the nine months ended September 30, 2016 was $38,025,925 as compared to $33,854,180 for the nine months ended September 30, 2015.  The following is a detailed discussion of the components of and changes in revenue.

OTREXUP™

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. 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.  We use this third party prescription data, among other information, as a basis for revenue recognition in each reporting period.

For the three months ended September 30, 2016 and 2015, we recognized revenue of $3,904,329 and $3,592,779, respectively, from OTREXUP™ sales, which is presented net of product sales allowances for estimated wholesaler discounts, prompt pay discounts, chargebacks, rebates and patient discount programs.  For the nine months ended September 30, 2016 and 2015, we recognized revenue from OTREXUP™ sales of $11,024,394 and $9,943,182, respectively. Sales of OTREXUP™ increased by $311,550, or 9%, and $1,081,212 or 11% for the three and nine months ended September 30, 2016, respectively, as compared with sales in the same periods in 2015.  We believe the growth in sales and revenue recognized in each of the periods presented is a result of an increase in, and broadening of, our marketing efforts.

We had deferred revenue of $1,154,112 and $1,064,874 at September 30, 2016 and December 31, 2015, 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 may record a one-time increase in net revenue related to the recognition of revenue previously deferred.

Auto injector and pen injector devices

We recognize revenue from shipments of auto injector and pen injector devices to our partner/customers Teva and AMAG.  Product sales of auto injector and pen injector devices were $5,943,786 and $3,240,437 for the three months ended September 30, 2016 and 2015, respectively, representing an overall increase of 83% on a year over year basis.  This increase is primarily due to the sale of approximately $3.4 million in sumatriptan injection drug/device combination product to Teva and $1.4 million in device sales to AMAG, offset by a decrease in pre-launch epinephrine device sales during the third quarter of 2016 versus 2015. In June 2016, we announced the launch of the generic equivalent of Imitrex ® (sumatriptan succinate) injection in the U.S. with Teva.  Under a license, supply and distribution agreement, we produce the devices and assemble the final combination product, and Teva is responsible for distribution of the product.  We are compensated at cost for shipments of product to Teva and are entitled to receive 50 percent of the future net profits from commercial sales made by Teva.  There were no profit sharing revenues recognized on shipments of sumatriptan product during the three months ended September 30, 2016.  Revenues from the profit sharing arrangement, if any, will be recognized in future periods, likely beginning in the fourth quarter of 2016, when amounts are fixed and determinable and will be payable to us within 45 days after the end of each fiscal quarter in which commercial sales are made.  

Sales from auto injector and pen injector devices were $15,836,179 and $5,207,463 for the nine months ended September 30, 2016 and 2015, respectively. The significant increase in auto injector sales for the nine months ended September 30, 2016 as

16


 

compared to nine months ended September 30, 2015 is attributable to approximately $6.4 million in year to date shipments of sumatriptan product to Teva, $1.4 million in device sales to AMAG, and a $3.0 million increase in sales of pre-launch quantities of auto injector devices sold to Teva for use with their generic epinephrine product, which is currently under FDA review, in anticipation of a pot ential launch.  However, as discussed above, Teva received a CRL from the FDA citing certain major deficiencies related to its ANDA for its epinephrine product.  As a result, Teva expects that its epinephrine product will be substantially delayed from thei r previously anticipated launch date in the second half of 2016 and that any launch will not take place before 2017 .  Accordingly, this delay may impact our future sales of epinephrine devices to Teva.  The trend in increased revenue from auto injector dev ices may not be sustained, and may not be indicative of revenues in future quarters or for the year ending December 31, 2016.

Needle-free injector devices and components

Our revenue from reusable needle-free injector devices and disposable components was $1,201,725 and $1,193,813 for the three months ended September 30, 2016 and 2015, respectively, and $3,720,316 and $3,339,548 for the nine months ended September 30, 2016 and 2015, respectively.  These revenues are generated primarily from sales to Ferring, which sells our needle-free injector with 4 mg and 10 mg hGH formulations in Europe and Asia.  We do not control our partners’ sales volume or inventory levels of our injectors and components, which can cause fluctuations in our product sales in comparative periods.

Development revenue

Development revenue typically represents amounts earned under arrangements with partners for which we develop new products on their behalf.  Frequently, we receive up-front and milestone payments from our partners that are initially deferred and recognized as revenue over a development period or upon completion of defined deliverables.  Development revenue was $2,101,203 and $2,608,336 for the three months ended September 30, 2016 and 2015, respectively, and $6,466,974 and $8,024,184 for the nine months ended September 30, 2016 and 2015, respectively.  The decrease in development revenue recognized for the comparative three and nine month periods was primarily a result of a reduction in development activities with Teva in connection with the epinephrine auto injector, which is currently under FDA review, offset by increases in development activities with Teva for the exenatide and teriparatide pen injector products and with AMAG for the Makena ® auto injector.

Licensing Revenue

Licensing revenue represents amounts received from partners for the right to use certain intellectual property.  Generally, the up-front or milestone payments received are initially deferred and recognized in revenue over the license period. We recognized $38,618 and $42,960 for the three months ended September 30, 2016 and 2015, respectively and $128,040 and $6,112,341 for the nine months ended September 30, 2016 and 2015, respectively.  The licensing revenue recognized for the nine months ended September 30, 2015 was principally attributable to our license and promotion agreement with LEO Pharma A/S (“LEO”), which was terminated effective June 23, 2015.  The upfront and milestone payments received from LEO totaling $10.0 million were being recognized into revenue over a 35-month period.  As a result of the termination of the agreement, we recognized the remaining unamortized balance of the deferred revenue in the second quarter of 2015.  No additional revenue related to this arrangement has been or is expected to be recognized in subsequent or future periods, which resulted in the decrease in licensing revenue for the nine months ended September 30, 2016 as compared to the same period in 2015.

Royalties

Royalty revenue was $289,102 and $407,427 for the three months ended September 30, 2016 and 2015, respectively, and $850,022 and $1,227,462 for the nine months ended September 30, 2016 and 2015, 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 ® .  

Cost of Revenue and Gross Profit

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

 

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

Total revenue

 

$

13,478,763

 

 

$

11,085,752

 

 

$

38,025,925

 

 

$

33,854,180

 

Total cost of revenue

 

 

8,033,721

 

 

 

5,099,763

 

 

 

22,127,560

 

 

 

13,482,586

 

Gross profit

 

$

5,445,042

 

 

$

5,985,989

 

 

$

15,898,365

 

 

$

20,371,594

 

Gross profit percentage

 

 

40

%

 

 

54

%

 

 

42

%

 

 

60

%

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Our gross profit was $5,445,042 and $15,898,365 for the three and nine months ended September 30, 2016, respectively as compared to $5,985,989 and $20,371,594 for the three and nine months ended September 30, 2015, respectively.  The decrease in our gross profit for the nine-month comparative period ended September 30, 2016 is principally attributable to the termination of the LEO agreement in the second quarter of 2015, during which we recognized the remaining balance of the deferred revenue received under the agreement of approximately $5.1 million, which had no associated cost.  In addition, product sales recognized in the three and nine months ended September 30, 2016 include approximately $3.4 million and $6.4 million, respectively, in generic sumatriptan injection product sold to Teva at cost, for which profit sharing will be recognized in future periods following commercial sale by Teva.  The sumatriptan sales in 2016, for which no margin has yet been recognized, was the primary cause of the lower gross profit percentage for the three-month comparative period ended September 30, 2016.  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 September 30,

 

 

Nine months ended September 30,

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

Product sales

 

$

11,049,840

 

 

$

8,027,029

 

 

$

30,580,889

 

 

$

18,490,193

 

Cost of product sales

 

 

7,206,280

 

 

 

3,265,983

 

 

 

18,670,363

 

 

 

7,763,734

 

Product gross profit

 

$

3,843,560

 

 

$

4,761,046

 

 

$

11,910,526

 

 

$

10,726,459

 

Product gross margin percentage

 

 

35

%

 

 

59

%

 

 

39

%

 

 

58

%

 

The cost of product sales includes product acquisition costs from third-party manufacturers and internal manufacturing overhead expenses. The product gross profit decreased for the three months ended September 30, 2016 compared to 2015 primarily as a result of the $3.4 million sales of sumatriptan product to Teva during the quarter, for which no margin has yet been recognized. The increase in product gross profit for the nine months ended September 30, 2016 compared to 2015 was principally a result of the overall increase in product sales for the comparative nine month periods, as discussed above. The reduction in our product gross margin percentage was caused primarily by the sale of approximately $3.4 million and $6.4 million, respectively, of generic sumatriptan product at cost with no corresponding gross margin to be recognized until commercial sales are made by Teva and our portion of profit margin is calculated and paid to us in future periods.  Our profit sharing arrangement with Teva for generic sumatriptan injection may create fluctuation in revenues and cost of sales recognized in a given period depending upon the timing of product shipments to Teva and the subsequent commercial sales by Teva into the distribution channel.

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 clinical 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 $5,958,550 and $5,142,387 for the three months ended September 30, 2016 and 2015, respectively, and were $15,554,599 and $14,089,100 for the nine months ended September 30, 2016 and 2015, respectively.  The costs primarily relate to external expenses.  The increase in research and development costs on a quarter and year to date comparative basis was mainly attributable to an overall increase in personnel costs and FDA fees.  In addition, the increase for the quarterly period was attributable to additional external costs incurred in connection with the development of QST for testosterone replacement therapy.

Selling, General and Administrative

Selling, general and administrative expenses were $5,622,937 and $6,611,169 for three months ended September 30, 2016 and 2015, respectively, and $20,240,635 and $20,253,489 for the nine months ended September 30, 2016 and 2015, respectively.  The net decrease was attributable to a reduction in litigation fees, which were incurred in the prior year in connection with litigation settled in early 2015, and a reduction in personnel costs and share-based compensation in connection with the departures of our former CEO and CFO in 2016, offset by an increase in personnel costs associated with the growth in our sales force.

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Liquidity and Capital Resources

At September 30, 2016, our cash and investments totaled $31,782,739, which consisted of $28,781,427 in cash and $3,001,312 in short-term investments.  All investments are U.S. Treasury bills or U.S. Treasury notes which we intend to hold to maturity.

We believe that the combination of our current cash and investments balances and projected product sales, product development 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 Flows From 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, personnel 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 disbursements. Net cash used in operating activities was $11,696,233 for the nine months ended September 30, 2016 as compared to $25,850,595 for the nine months ended September 30, 2015.  The decrease in cash used in operating activities in the first nine months of 2016 as compared to 2015 was primarily the result of a growth in accounts payable as of September 30, 2016, which conserved cash, as compared to greater cash used to pay down accounts payable and accrued expenses during the first nine months of 2015.  For the nine months ended September 30, 2016, the net cash used in operating activities was primarily driven by our net loss, adjusted for non-cash operating costs plus increases in accounts receivable, inventories and deferred costs, offset by the growth in our accounts payable and deferred revenue.

Net Cash Flows from Investing Activities

Net cash provided by investing activities for the nine months ended September 30, 2016 was $7,617,569 as compared to net cash used in investing activities $15,059,050 for the nine months ended September 30, 2015.  The net cash inflow for the nine months ended September 30, 2016, was attributable to maturities of investment securities of $12,000,000, offset by payments for capital expenditures and patent acquisition costs.   The net cash outflow for the nine months ended September 30, 2015 included the purchase of $15,037,675 in investments with proceeds from our common stock offering in May 2015, capital expenditures and payment of patent legal defense costs related to litigation settled in 2015, offset by maturities of investment securities of $6,000,000.

Net Cash Flows from Financing Activities

Net cash used in financing activities was $40,025 for the nine months ended September 30, 2016 and was related to proceeds from the exercise of stock options, less amounts withheld and remitted to the appropriate taxing authorities for an employee’s minimum statutory obligation for the applicable income and employment taxes in connection with the net settlement of restricted stock awards that vested. Net cash provided by financing activities was $42,762,907 for the nine months ended September 30, 2015 and was principally attributable to the receipt of net cash proceeds of $42,850,677 from the offering and sale of our common stock in May 2015.

Research and Development Programs

We conduct clinical, regulatory, formulation development, parenteral device development and commercial development activities for internal and partnered products.  The following is a discussion of our significant research and development programs.

VIBEX ® QuickShot ® Testosterone (“QST”).    We are developing QST for self-administered weekly injections of testosterone enanthate in a preservative free formulation for men requiring testosterone replacement.  

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 QST, 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 QST 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 QST treatment resulted in most patients achieving average levels of testosterone within the normal range from the first dose onward.  QST was also safe and well-tolerated by all dosed patients.

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On November 3, 2014, we announced that the last patient has been enrolled in a double-blind, multiple-dose, phase 3 study (QST-13-003) to evaluate the efficacy and safety of QST administered subcutaneously once each week to testosterone-de ficient 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 included a screening phase, a treatment titration and efficacy pha se and an extended treatment phase.  One hundred fifty patients were enrolled in this study.  Patients meeting all eligibility criteria were assigned to receive a starting dose of QST once weekly for six weeks.  Adjustments to dose could be made at week se ven based upon the week six pre-dose blood level.  The efficacy of QST 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 than1500 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 QST 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 pharmacokinetic 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

 

 

≥65

%

 

75

%

 

≥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 remained on QST and were followed for an additional 40 weeks for the collection of safety data.  On March 16, 2016, we announced that the pharmacokinetic results were final and reported the results from the 52-week safety study.  The safety population, defined as patients who received at least one dose of study drug, was comprised of 150 patients.  The most common adverse reactions (incidence ≥5%) in this phase 3 study were increased hematocrit, hypertension, increased prostate-specific antigen, upper respiratory tract infection, sinusitis, injection site bruising and headache. Serious adverse events (SAE’s) reported included one case each of worsening depression, vertigo and suicide.  None of the SAE’s were considered to be related to the study drug by the investigators, however the Company determined that the case of suicide could not be ruled out as potentially being related to study drug.  There have been no reported adverse events consistent with urticaria (hives), pulmonary oil micro embolism (“POME”), anaphylaxis or major adverse cardiovascular events in this study.

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 QST.  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 2 study, the FDA recommended that we create a larger safety database, including approximately 350 subjects exposed to QST with approximately 200 subjects exposed for six months and approximately 100 subjects exposed for a year.  We assessed the FDA’s comments in the advice letter and their impact on the timing of the filing of a NDA for QST with the FDA.  Based on the number of subjects in previous studies and in the current QST-13-003 study, we concluded that we would need additional subjects exposed to QST for six months.  The timing and design of the study to obtain the additional 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 QST. 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 NDA for QST.  In June 2015, we finalized and submitted the protocol for the study, and in August 2015, we enrolled the first patients in the study, which is known as QST-15-005. The study included a screening phase, a treatment titration phase and a

20


 

treatment phase for evaluation of sa fety and tolerability assessments, including laboratory assessments, adverse events and injection site assessments.  The study was a dose-blind, multiple-dose, concentration controlled 26-week supplemental safety and pharmacokinetic study of QST.  Patients meeting all eligibility criteria were assigned to receive 75 mg of QST once weekly for six weeks.  According to the protocol, adjustments to dose may be made at week seven based upon the week six C trough value.  QST was provided to clinical sites at dosag e strengths of 100 mg, 75 mg and 50 mg to be utilized in dose titration.

In early November 2015, the Company announced that enrollment was complete in study QST-15-005. The safety population, defined as patients who received at least one dose of the study drug, consisted of 133 patients dosed with QST.  On June 1, 2016 we announced that the last patient had completed treatment under the 26-week safety and pharmacokinetic phase 3 study QST-15-005, and in September, 2016 we announced the results of the study. The most common adverse reactions (incidence ≥5%) in the QST-15-005 study were increased hematocrit, upper respiratory tract infection and injection site ecchymosis.  There were four patients with treatment emergent SAE’s, which included one patient with transient visual impairment determined not to be drug related, one patient with appendicitis that was not drug related and one patient with deep vein thrombosis (DVT).  The investigator attributed DVT as possibly drug related, which is consistent with known testosterone class SAE’s.  The fourth patient had multiple hospitalizations related to septic arthritis and coronary artery disease, with a complicated clinical course post-angioplasty. These multiple reported events from the fourth patient were deemed not to be drug related.  There have been no reported adverse events consistent with urticaria, POME or anaphylaxis.  The safety data collected also included an assessment of pain.  Of the 965 injections assessed, pain was reported one time.  In that instance, the pain reported was classified as mild.

The Company believes that with the successful completion of this supplemental safety study we should be able to satisfy the FDA’s recommendation for the larger safety database, as discussed above, and begin the NDA submission process.  We are presently preparing our NDA for QST for submission to the FDA and expect to file in by December 31, 2016.

In addition to the clinical trial program, we completed a Human Factors program to demonstrate safe and reliable at-home usability of QST.  Study populations included trained and untrained subjects, including patients, non-patient caregivers and health care providers.  The goals of the program were to optimize and document reliable and proper administration in study subjects in the setting of at-home use in order to support the approvability of the product.

Device Development Projects .  We, along with our pharmaceutical partners, are engaged in research and development activities related to our VIBEX ® disposable pressure assisted auto injectors, our QuickShot ® (“QS”) auto injectors, and our disposable pen injectors.  We have signed license agreements with Teva for our VIBEX ® system for a product containing epinephrine and for our pen injector devices for a product containing exenatide and a product containing teriparatide. We also have a license, development and supply agreement with AMAG for our QS device containing Makena ® indicated for reduced risk of pre-term labor. Our pressure assisted auto injectors are designed to deliver drugs by injection from single dose prefilled syringes.  The disposable pen injector device is designed to deliver drugs by injection through needles from multi-dose cartridges.  The development programs consist of determination of the device design, development of prototype tooling, production of prototype devices for testing and clinical studies, and development of commercial tooling and assembly equipment.  The following is a summary of the development stage for the three products in development with Teva and the development stage of our product with AMAG.

VIBEX ® with Epinephrine

We have designed the VIBEX ® device for a product containing epinephrine and have scaled up the commercial tooling and molds for this product.  From a regulatory standpoint Teva filed this product as an ANDA, and the FDA accepted the filing as such.  Currently, Teva is conducting its own development work on the drug product (epinephrine).  Teva filed an amendment to the ANDA with the FDA in December 2014.  Teva received a complete response letter on February 23, 2016 relating to its epinephrine ANDA in which, according to Teva, the FDA identified certain major deficiencies. Teva is evaluating the CRL and intends to submit a response. Due to the major deficiencies identified in the CRL, Teva expects that its epinephrine product will be substantially delayed from the previously anticipated launch date in the second half of 2016 and that any launch will not take place before 2017.

Teriparatide disposable pen injector

We have developed, produced and provided clinical supplies for a previously undisclosed pen injector product, which was referred to as “Pen 1”.  In April 2016, we disclosed that the “Pen 1” project with Teva relates to a generic form of Forteo ® (teriparatide [rDNA origin] injection) (“Teriparatide”), marketed by Eli Lilly and Company (“Lilly”).  Forteo ® is an injectable treatment for osteoporosis in postmenopausal women and men at high risk for fracture and for glucocorticoid induced osteoporosis in men and postmenopausal women.  Teva previously filed an ANDA for Teriparatide, which was accepted by the FDA and is currently under review.  On March 16, 2016, Lilly filed a lawsuit against Teva alleging patent infringement in response to Teva’s Paragraph IV notice and filing contained in its ANDA for Teriparatide, resulting in a thirty-month stay on FDA’s approval of the ANDA.  The stay will expire in August 2018 unless the litigation is resolved prior to that time.  Based on available information, we believe that Teva may be

21


 

the "first applicant" to file an ANDA for a generic equivalent of Forteo ® and, should Teva’s ANDA be approved, may be entitled to 180 days of generic market exclusivity. The ANDA for Teriparatide represents the fourth ANDA for which the Company is the de vice developer and the third drug device combination product with first-to-file status using one of our devices.

Exenatide disposable pen injector

We have designed and produced pen injectors for the exenatide pen injector product (“Exenatide”).  Teva initiated drug stability and completed the device development program and filed an ANDA with the FDA in the second half of 2013.  The ANDA was accepted by the FDA in October 2014 and is currently under FDA review.  In December 2014, AstraZeneca Pharmaceuticals, LP, AstraZeneca AB, and Amylin Pharmaceuticals, LLC (collectively “AstraZeneca”) filed a lawsuit alleging patent infringement against Teva with respect to certain patents related to their generic version of BYETTA ® (exenatide).  Teva settled the patent litigation with AstraZeneca and entered into a settlement and license agreement pursuant to which AstraZeneca granted Teva a license to manufacture and commercialize Teva’s generic version of BYETTA ® in the U.S. beginning October 15, 2017 or earlier under certain circumstances. Based on available information, we believe that Teva may be the "first applicant" to file an ANDA for Exenatide as a generic equivalent of BYETTA ® and, should Teva’s ANDA be approved, may be entitled to 180 days of generic market exclusivity.

VIBEX ® QS with Makena ® (hydroxyprogesterone caproate injection)

We are in the process of developing a variation of our VIBEX ® QuickShot ® auto injector for use with the progestin hormone drug Makena ® under a license, development and supply agreement with AMAG.  Under this arrangement, AMAG is responsible for the clinical development and preparation, and submission and maintenance of all regulatory applications.  We are responsible for the design and development of the auto-injection device.  

Other Research and Development Costs.   In addition to our QST project and our device development projects with Teva and AMAG, 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, inventory valuation, valuation of long-lived and intangible assets, and share-based compensation and are 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, 2015.

Recently Issued Accounting Pronouncements

In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases”, which is intended to increase transparency and comparability among organizations by recognizing all lease transactions (with terms in excess of 12 months) on the balance sheet as a lease liability and a right-of-use asset (as defined). ASU No. 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, with earlier application permitted.  Upon adoption, the lessee will apply the new standard retrospectively to all periods presented or retrospectively using a cumulative effect adjustment in the year of adoption. We are currently assessing the effect that ASU No. 2016-02 will have on our results of operations, cash flows and financial position.

In March 2016, FASB issued ASU No. 2016-09, “Improvements to Employee Share-Based Payment Accounting”, as part of its simplification initiative. The areas of simplification involve several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows.  ASU No. 2016-09 is effective for annual and interim periods beginning after December 15, 2016. We are currently assessing the impact that the standard will have on our results of operations, cash flows and financial position.

In March 2016, FASB issued ASU No. 2016-08 “Principal Agent Considerations (Reporting Revenue Gross versus Net)” and in April 2016, FASB issued ASU No. 2016-10 “Identifying Performance Obligations and Licensing.” These updates amend, clarify and

22


 

provide implementation guidance on the new revenue recognition standard ASU No. 2014-09, Revenue from Contract with Customers, which is effective for annual and interim periods beginning after Decembe r 15, 2017. We are currently evaluating the impact the adoption of these standards will have on our results of operations, cash flows and financial position.

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 September 30, 2016 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, under the supervision and 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.

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.

 

23


 

PART II - O THER INFORMATION

Item 1.

LEGAL PROCEEDINGS

None.

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, 2015 and in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016 and June 30, 2016, which could materially affect our business, financial condition or future results.  There have been no material changes to these risk factors other than the supplemental information and risk factors discussed below.  The risks described in our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016 and June 30, 2016 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 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

Item 3.

DEFAULT UPON SENIOR SECURITIES

None.

Item 4.

MINE SAFETY DISCLOSURES

Not applicable.

Item 6.

EXHIBITS

(a) Exhibit Index

 

Exhibit No.

 

Description

 

 

 

10.1#+  

 

Employment Agreement dated as of October 31, 2016 between Antares Pharma, Inc. and Fred M. Powell.

 

 

 

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.

 

 

 

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.

+

Indicates management contract or compensatory plan or arrangement.

 

24


 

S IGNATURES

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.

 

 

 

November 9, 2016

 

/s/ Robert F. Apple

 

 

Robert F. Apple

 

 

President and Chief Executive Officer

 

 

(Principal Executive Officer)

 

 

 

November 9, 2016

 

/s/ Fred M. Powell

 

 

Fred M. Powell

 

 

Senior Vice President and Chief Financial Officer

 

 

(Principal Financial and Accounting Officer)

 

 

25

Exhibit 10.1

ANTARES PHARMA, INC.

EMPLOYMENT AGREEMENT

THIS EMPLOYMENT AGREEMENT (this “ Agreement ”) is made and entered into on this 11 th day of October, 2016, effective as of the 31st day of October 2016 (the “ Effective Date ”) by and between Antares Pharma, Inc., a Delaware corporation (the “ Company ”), and Fred Powell (the “ Executive ”).

WITNESSETH:

WHEREAS, 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, Chief Financial Officer 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 prior 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.

2. Compensation .

(a) Base Salary . During the Term, the Company shall pay the Executive a base salary (“ Base Salary ”) at the annual rate of $345,000, which shall be paid in accordance with the Company’s normal payroll practices. The Executive’s Base Salary shall be subject to review, and at the approval of the Compensation Committee of the Board (the “ Compensation Committee ”), subject to increase (but not decrease) during the Term, based upon the performance of the Executive and the Company, as determined by the Compensation Committee with input from the CEO, in accordance with the Company’s normal compensation and performance review policies for senior 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 ”) in accordance with the terms of the Company’s Annual Incentive Plan, as amended from time to time (or successor plan). 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 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. Executive will not be eligible to receive an Annual Bonus for 2016.

(c) Equity Compensation .

(i) On the Effective Date, pursuant to the Antares Pharma, Inc. 2008 Equity Compensation 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 fifty thousand (150,000) 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 in quarterly increments over the three year period commencing on the date of grant, such that 33-1/3% vests annually until the option is fully vested.

(ii) In addition, during the Term, the Executive shall be eligible to participate in any long-term equity incentive programs established by the Company for its senior level

 

 


 

executives generally, including the 2008 Plan (or successor 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 senior executives of the Company, in accordance with the Company’s vacation, holiday and other pay-for-time-not worked policies; provided, however, that the Executive shall be entitled to not less than four (4) weeks of paid vacation each calendar year, prorated from any period of employment of less than twelve (12) months in a calendar year. 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 business 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 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 or (B) the Company’s reduction in the target annual bonus opportunity below forty (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, Chief Financial Officer 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; (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 Ewing, New Jersey; 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. The Company may, in its sole and absolute discretion, pay the Executive his Base Salary in lieu of any unexpired period of notice and terminate his employment immediately. 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 substantially the form attached hereto as Exhibit A , 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 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 subsections 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 as follows: the rate of the Executive’s Base Salary as in effect at the time of termination will be added together with the dollar value of the Executive’s target Annual Bonus for the year in which termination occurs and the sum of the foregoing amounts will be divided by twelve (12) (the “ Monthly Severance Amount ”). The Monthly Severance Amount will be paid each month over the twelve (12) month period following the Termination Date, less applicable tax withholding, paid in approximately equal 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) The Company will pay to the Executive a pro rata Annual Bonus for the year in which the termination of employment occurs, which shall be determined based on Executive’s actual Annual Bonus earned for the year in which termination of employment occurs (if any), based on actual performance, 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 three hundred sixty-five (365). The pro rata Annual Bonus described in this subsection 3(c)(ii) will be paid at the same time and under the same terms and conditions as bonuses are paid to other executives of the Company, on or after January 1 but not later than March 15 of the calendar year following the calendar year in which the Executive’s employment terminates, subject to Section 5(b) below.

(iii) For the twelve (12) 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 the such twelve (12) month period (the COBRA continuation coverage period shall run concurrently with the twelve (12) month period that the Executive is provided with medical and dental coverage under subsection 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 subsection 3(c)(iii) shall cease immediately upon the earlier of: (A) the end of the twelve (12) 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 determined by the Company in its sole and absolute discretion.

(iv) 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 twelve (12) month period following the Executive’s termination date had the Executive remained employed during such twelve (12) 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.

(v) 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 without Good Reason.

 

 


 

4. Change of Control .

(a) Termination without Cause or Resignation for Good Reason Within Sixty Days  Before or Eighteen 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 without Cause or by the Executive for Good Reason within sixty (60) days before or within eighteen (18) months following such Change of Control (a “ CIC Termination ”), the Executive shall be entitled to (i) the payments set forth under subsection 3(c)(i), except that the Monthly Severance Amount will be multiplied by eighteen (18) months, (ii) the payment described in subsection 3(c)(ii) on the same terms and conditions described in subsection 3(c)(ii), (iii) the payments set forth under subsection 3(c)(iii), except that twelve (12) months shall be replaced with eighteen (18) months, and (iv) in lieu of the benefit described in subsection 3(c)(iv), 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 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. 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.

(b) Application of Section 2800 . 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

 

 


 

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 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 . Contemporaneously with this Agreement, the Executive executed the Company’ s standard Proprietary Information and Invention Assignment Agreement, attached hereto as Exhibit B (the “ Proprietary Information and Invention Assignment Agreement ”), all of the terms 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 or in accordance with Sections 6(g) and (h) below. 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 or in accordance with Sections 6(g) and (h) below, 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 twelve (12) months after the Executive’s date of termination of employment for any reason except a CIC Termination, or eighteen (18) months after a CIC Termination (such twelve (12) month period or eighteen (18) 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 (the “ Business ”). It will not be considered a violation of this Section 6(b) for the Executive to be a passive owner of not more than 1% of the outstanding stock of any class of a corporation which is publicly traded, so long as the Executive has no active participation in the business of such corporation. In addition, the restrictions contained in this section 6(b) shall not prevent the

 

 


 

Executive from accepting employment following termination of employment with the Company with a large diversified organization with separate and distinct divisions that do not compete, directly or indirectly, with the Business, as long as prior to accepting such employment, the Company receives separate written assurances from the prospective employer and from the Executive, satisfactory to the Company, to the effect that Executive will not render any services, directly or indirectly, to any division or business unit that competes, directly or indirectly, with the Business. During the restrictive period set forth in the section, Executive will inform any new employer, prior to accepting employment, of the existence of this Agreement and provide such employer with a copy of this Agreement.

(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 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 Restriction 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, except as otherwise permitted in accordance with Sections 6(g) and (h) below. 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, except as otherwise permitted in accordance with Sections 6(g) and (h) below.

(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, except as otherwise permitted in accordance with Sections 6(g) and (h) below. 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.

(g) Reports to Government Entities . Nothing in this Agreement or the Proprietary Information and Invention Assignment Agreement, restricts or prohibits the Executive from initiating communications directly with, responding to any inquiries from, providing testimony before, providing Confidential Information to, reporting possible violations of law or regulation to, or from filing a claim or assisting with an investigation directly with a self-regulatory authority or a government agency or entity, including the U.S. Equal Employment Opportunity Commission, the Department of Labor, the National Labor Relations Board, the Department of Justice, the Securities and Exchange Commission, the Congress, and any agency Inspector General (collectively, the “ Regulators ”), or from making other disclosures that are protected under the whistleblower provisions of state or federal law or regulation. However, to the maximum extent permitted by law, the Executive is waiving his right to receive any individual monetary relief from the Company or any others covered by the Release of Claims resulting from such claims or conduct, regardless of whether the Executive or another party has filed them, and in the event the Executive obtains such monetary relief the Company will be entitled to an offset for the payments made pursuant to this Agreement. This Agreement does not limit the Executive’s right to receive an award from any Regulator that provides awards for providing information relating to a potential violation of law. The Executive does not need the prior authorization of the Company to engage in conduct protected by this paragraph, and the Executive does not need to notify the Company that the Executive has engaged in such conduct.

Please take notice that federal law provides criminal and civil immunity to federal and state claims for trade secret misappropriation to individuals who disclose a trade secret to their attorney, a court, or a government official in certain, confidential circumstances that are set forth at 18 U.S.C. §§ 1833(b)(1) and 1833(b)(2), related to the reporting or investigation of a suspected violation of the law, or in connection with a lawsuit for retaliation for reporting a suspected violation of the law.

(h) 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 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 fifteen (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 and that certain Indemnification Agreement by and between the Executive and the Company dated November 17, 2014, 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 the Prior Agreement (such that the Prior Agreement shall be void and of no further force and effect) and any 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 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. Indemnification . The Company agrees to indemnify and hold the Executive harmless to the fullest extent permitted by the laws of the State of Delaware and under the bylaws of the Company, both as in effect at the time of the subject act or omission. In connection therewith, the Executive shall be entitled to the protection of any insurance policies which the Company elects to maintain generally for the benefit of the Company’s directors and officers, against all costs, charges and expenses whatsoever incurred or sustained by the Executive in connection with any action, suit or proceeding to which the Executive may be made a party by reason of his being or having been a director, officer or employee of the Company. This provision shall survive any termination of the Executive’s employment hereunder.

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 Crossroads Corporate Center

 

 


 

100 Princeton South, Suite 300

Ewing, New Jersey 08628

Attn: Chief Executive Officer

(609) 359-3015 (facsimile)

 

With a copy to:

 

Morgan, Lewis and Bockius LLP

1701 Market Street

Philadelphia, PA 19103

Attn: Joanne R. Soslow, Esq.

(215) 963-5001 (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 16.

1. 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.

2. Counterpart s. 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.

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

4. 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]

 

 

 

 

 


 

 


 

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

ANTARES PHARMA, INC.

 

 

By:

/s/ Robert F. Apple

Name:

Robert F. Apple

Its

President & CEO

 

 

EXECUTIVE:

 

/s/ Fred M. Powell

Fred Powell

 

 

 

 


 

Exhibit A

SEPARATION AGREEMENT AND RELEASE

This SEPARATION AGREEMENT AND RELEASE (this “ Agreement ”) is entered into as of ____________, 20__ to be effective on the Effective Date (as defined in Section 1 below), by and between Antares Pharma, Inc. (the “ Company ”) and Fred Powell (the “ Executive ”).

RECITALS

WHEREAS , pursuant to the terms of an Employment Agreement, effective as of October 31, 2016, entered into by and between the Company and Executive (the “Employment Agreement”), Executive has been employed as the Company’s Senior Vice President, Chief Financial Officer;

WHEREAS , the Company and Executive have come to a mutual agreement with respect to Executive’s termination from employment with the Company to be effective (the “Termination Date”);

WHEREAS , in connection with Executive’s termination from employment with the Company, at the request of the Board of Directors of the Company, Executive resigned as an officer of the Company effective as of the Termination Date; and

WHEREAS , as consideration for Executive’s execution and non-revocation of a release of all claims against the Company and its affiliates upon the Termination Date, the Company desires to provide Executive with the severance payments and benefits set forth in Section 1(a) below following the Termination Date.

NOW, THEREFORE , in consideration of the mutual promises hereinafter set forth and intending to be legally bound hereby, the parties hereby agree as follows:

1. Termination from Employment .  Executive resigns as an officer of the Company as of the Termination Date. Executive’s termination from employment with the Company shall be effective on the Termination Date. Consistent with Section 3(c) of the Employment Agreement and provided that the terms and conditions set forth herein are satisfied, Executive shall be entitled to the following:

(a) Severance Payments and Benefits .   [Based on Non-CIC Related Severance. To be modified if termination is following a CIC.] In consideration of the payments in this Section 1(a), Executive hereby agrees to execute and not revoke the General Release of Claims attached hereto as Exhibit A (the “ Release ”). Provided that the Release becomes effective in accordance with the terms set forth therein (such date the Release becomes effective, the “ Effective Date ”), and so long as Executive continues to comply with the provisions of the Proprietary Information and Invention Assignment Agreement dated June 30, 2016 (defined in Section 6(a) of the Employment Agreement) and the restrictive covenants and representations in Section 6 of the Employment Agreement, Executive will receive the following severance payments:

 

 


 

(i) Continued Base Salary Plus Target Annual Bonus .  The Company will pay Executive severance as follows: the rate of the Executive’s Base Salary as in effect at the time of termination will be added together with the dollar value of the Executive’s target Annual Bonus for the year in which termination occurs and the sum of the foregoing amounts will be divided by twelve (12) (the “ Monthly Severance Amount ”). The Monthly Severance Amount will be paid each month over the twelve (12) month period following the Termination Date, less applicable tax withholding, paid in approximately equal 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) Health Benefits .  For the twelve (12) month period following the Termination Date, provided that Executive is eligible for, and timely elects COBRA continuation coverage, the Company will pay on Executive’s behalf, the monthly cost of COBRA continuation coverage under the Company’s group health plan for Executive and, where applicable, his spouse and dependents, at the level in effect as of the Termination Date, less the employee portion of the applicable premiums that Executive would have paid had he remained employed during the such twelve (12) month period (the COBRA continuation coverage period shall run concurrently with the twelve (12) month period that COBRA premium payments are made on Executive’s behalf under this subsection 1(a)(ii)). These payments on Executive’s behalf will commence within the sixty (60)-day period following the Termination Date and will be paid on the first payroll date of each month through the twelfth (12th) month following the Termination Date. Notwithstanding the foregoing, the Company’s payment of the monthly COBRA premiums in accordance with this subsection 1(a)(ii) shall cease immediately upon the earlier of: (A) the end of twelve (12) month period following the Termination Date, or (B) the date that Executive is eligible for comparable coverage with a subsequent employer. Executive agrees to notify the Company in writing immediately if subsequent employment is accepted prior to the end of the twelve (12) month period following the Termination Date and Executive agrees to repay to the Company any COBRA premium amount paid on Executive’s behalf during such period for any period of employment during which group health coverage is available through a subsequent employer. Notwithstanding the foregoing, the Company reserves the right to restructure the foregoing COBRA premium payment arrangement in any manner necessary or appropriate to avoid fines, penalties or negative tax consequences to the Company or 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 determined by the Company in its sole and absolute discretion.

(iii) Time-Based Equity Award Acceleration .  All outstanding equity awards held by Executive immediately prior to the Termination Date granted under the Antares Pharma, Inc. 2008 Equity Incentive Plan, as amended from time to time (the “ 2008 Plan ”) or a successor plan, which vest based on Executive’s continued services over time that would have become vested during the twelve (12) month period following the Termination Date had Executive remained employed during such twelve (12) month period following Executive’s Termination Date, shall accelerate, become fully vested and exercisable as of the Termination Date. All equity awards that have not vested as of the Termination Date will automatically

 

 


 

terminate and be canceled on the Termination Date, and Executive hereby fully and forever waives and releases any and all right to such terminated and canceled equity awards.

(iv) 20   Annual Bonus .  The Company will pay Executive the amount of Executive’s bonus earned for any fiscal year ended prior to Executive’s Termination Date but for which any bonus earned for such fiscal year has not yet been paid, if any, less applicable taxes, which will be determined in accordance with Section 2(b) of the Employment Agreement and will be paid to Executive at the same time and under the same terms and conditions as such bonus is paid to other executives of the Company who participate in the Company’s Annual Incentive Plan.

(v) 20   Annual Bonus .  The Company will pay to Executive a pro rata annual bonus for fiscal year 20___ the fiscal year in which the Termination Date occurs), which shall be determined based on Executive’s actual annual bonus earned for fiscal year 20___, if any, based on actual performance, multiplied by a fraction, the numerator of which is (representing the number of days in which Executive was employed by Company during fiscal year 20___), and the denominator of which is three hundred sixty-five (365). The pro rata annual bonus for fiscal year 20___ will be paid at the same time and under the same terms and conditions as bonuses are paid to other executives of the Company who participate in the Company’s Annual Incentive Plan, on or after January 1, 20___ but not later than March 15, 20___.

(b) Payment in lieu of Notice .  Without regard to whether Executive executes or revokes the Release, the Company will pay Executive an amount equal to $ which equals thirty (30) days of base salary, in lieu of the Company’s obligation to provide notice of termination pursuant to Section 3(c) of the Employment Agreement, less applicable tax withholding and normal deductions. Such amount will be paid to Executive on the Company’s next regular payroll date after the Termination Date.

(c) Accrued Wages and Benefits .  Without regard to whether Executive executes or revokes the Release, the Company will pay or provide Executive with any amounts earned, accrued and owing but not yet paid under Section 2 of the Employment Agreement including but not limited to base salary for services rendered through the Termination Date and any benefits accrued and due under any applicable benefit plans and programs of the Company. The Company will pay Executive the amount of $_____ based on ____ hours of accrued but unused vacation. Upon the Executive’s receipt of his final paycheck, which includes payment for services through the Termination Date and the amount set forth in the preceding sentence for accrued but unused vacation, Executive will have received all wages and benefits owed to him by virtue of his employment with the Company or termination thereof

(d) Executive is not eligible for any other payments or benefits by virtue of his employment with the Company or termination thereof except for those expressly described in this Agreement. Employee will receive the payments described in Sections 1(b) and 1(c) whether or not he signs this Agreement. Employee will not receive the separation pay or benefits described in Section 1(a) of this Agreement if he (i) does not sign this Agreement, (ii) revokes the release of claims in accordance with the Release, or (iii) violates any of the terms and conditions set forth in this Agreement.

 

 


 

2. Restrictive Covenants .  Executive and the Company agree that Section 6 of the Employment Agreement continues to remain in full force and effect in accordance with the terms therein and are hereby incorporated by reference.

3. Non-Admission .  It is expressly understood that this Agreement does not constitute, nor will it be construed as an admission by the Company of any liability or unlawful conduct whatsoever. The Company specifically denies any liability or unlawful conduct.

4. Section 409A .  This Agreement is intended to comply with section 409A of the Internal Revenue Code of 1986, as amended (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 of the Code, to the 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 Executive, directly or indirectly, designate the calendar year of payment of any severance benefits. 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.

5. Entire Agreement, Amendment and Assignment .  Except as otherwise provided in a separate writing between the Company and Executive, this Agreement, including the attachments hereto, is the sole agreement between the Company and Executive with respect to the subject matter hereof and it supersedes all prior agreements and understandings with respect thereto, and all prior agreements and understandings with respect to his employment with the Company prior to the Termination Date, whether oral or written, including, but not limited to, the Employment Agreement (except for Section 6 (including the Proprietary Information and Invention Assignment Agreement dated June 30, 2016) and 15 therein). No modification to any provision of this Agreement shall be binding unless in writing and signed by the Company and Executive. 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 permitted assigns of the parties hereto, except that the duties and responsibilities of Executive hereunder are of a personal nature and shall not be assignable or delegable in whole or in part by Executive.

6. Waiver .  No waiver of any rights under this Agreement shall be effective unless in writing signed by the party to be charged. A waiver by any of the parties hereto of a breach of any provision of this Agreement by another party shall not operate or be construed as a waiver of any subsequent breach.

7. Taxes .  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. 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.

 

 


 

8. Governing Law; Venue .  This Agreement shall be governed in accordance with the laws of the State of New Jersey, without regard to the conflicts of law or choice of law principles thereof. If any dispute between the parties leads to litigation, the parties agree that the courts of the State of New Jersey or the federal courts in New Jersey shall have the exclusive jurisdiction and venue over such litigation. All parties consent to personal jurisdiction in the State of New Jersey, and agree to accept service of process outside of the State of New Jersey as if service had been made in that state.

9. Notices .  All notices, demands or other communications to be given or delivered under or by reason of the provisions of this Agreement shall be in writing and shall be deemed to have been given when delivered personally to the recipient, two business days after the date when sent to the recipient by reputable express courier service (charges prepaid) or four (4) business days after the date when mailed to the recipient by certified or registered mail, return receipt requested and postage prepaid. Such notices, demands and other communications shall be sent to Executive and to the Company at the addresses set forth below,

 

If to Executive:

The most recent address in the Company’s files.

 

 

If to the Company:

Antares Pharma, Inc.

 

100 Princeton South

 

Suite 300

 

Ewing, NJ 08628

 

Attn: Peter J. Graham, Senior Vice President, General

 

Counsel, Chief Compliance Officer, Human Resources and

 

Secretary

 

 

 

With a copy to:

 

Morgan, Lewis and Bockius LLP

 

1701 Market Street

 

Philadelphia, PA 19103

 

Attn: Joanne R. Soslow, Esq.

 

(215) 963-5001 (facsimile)

 

 

 

or to such other address or to the attention of such other person as the recipient party has specified by prior written notice to the sending party.

1. Confidentiality of this Agreement .  Executive agrees not disclose to others the fact or terms of this Agreement, except Executive may disclose such information to his spouse or domestic/civil union partner and to his attorney or accountant (in order for such individuals to render professional services to Executive), so long as such individuals agree to keep such information confidential. Nothing in this Section 10, or elsewhere in this Agreement, is intended to prevent or prohibit Executive from (a) providing information regarding Executive’s former employment relationship with the Company, as may be required by law or legal process, or (b) cooperating, participating or assisting in any government entity investigation or proceeding.

 

 


 

2. Reports to Government Entities .

(a) Nothing in this Agreement, including the restrictive covenants incorporated herein or the “ Confidentiality of this Agreement ” clause, restricts or prohibits Executive from initiating communications directly with, responding to any inquiries from, providing testimony before, providing confidential information to, reporting possible violations of law or regulation to, or from filing a claim or assisting with an investigation directly with a self-regulatory authority or a government agency or entity, including but not limited to the U.S. Equal Employment Opportunity Commission, the Department of Labor, the National Labor Relations Board, the Department of Justice, the Securities and Exchange Commission, the Congress, and any agency Inspector General (collectively, the “ Regulators ”), or from making other disclosures that are protected under the whistleblower provisions of state or federal law or regulation. However, to the maximum extent permitted by law, the Executive is waiving his right to receive any individual monetary relief from the Company or any others covered by the Release of Claims resulting from such claims or conduct, regardless of whether the Executive or another party has filed them, and in the event the Executive obtains such monetary relief the Company will be entitled to an offset for the payments made pursuant to this Agreement. This Agreement does not limit the Executive’s right to receive an award from any Regulator that provides awards for providing information relating to a potential violation of law. The Executive does not need the prior authorization of the Company to engage in conduct protected by this paragraph, and the Executive does not need to notify the Company that the Executive has engaged in such conduct.

Please take notice that federal law provides criminal and civil immunity to federal and state claims for trade secret misappropriation to individuals who disclose a trade secret to their attorney, a court, or a government official in certain, confidential circumstances that are set forth at 18 U.S.C. §§ 1833(b)(1) and 1833(b)(2), related to the reporting or investigation of a suspected violation of the law, or in connection with a lawsuit for retaliation for reporting a suspected violation of the law.

(b) Executive recognizes and agrees that, in connection with any such activity outlined above, Executive must inform the Regulators, Executive’s attorney, a court or a government official that the information Executive is providing is confidential. Despite the foregoing, Executive is not permitted to reveal to any third-party, including any governmental, law enforcement, or regulatory authority, information Executive came to learn during the course of Executive’s employment with the Company that is protected from disclosure by any applicable privilege, including but not limited to the attorney-client privilege and/or attorney work product doctrine. The Company does not waive any applicable privileges or the right to continue to protect its privileged attorney-client information, attorney work product, and other privileged information.

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

4. Counterparts and Electronic Signatures .  This Agreement shall become binding when any one or more counterparts hereof, individually or taken together, shall bear the

 

 


 

signatures of Executive and the Company. This Agreement may be executed in two or more counterparts (including facsimile counterparts or as a “pdf’ or similar attachment to an email), each of which shall be deemed to be an original as against any party whose signature appears thereon, but all of which together shall constitute but one and the same instrument.

5. 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.

6. Headings .  The headings of sections and subsections appearing in this Agreement are inserted for convenience only and shall not control the meaning or interpretation of any provisions of this Agreement.

[Signature Page Follows]

 


 

 


 

IN WITNESS WHEREOF, the undersigned, intending to be legally bound, have duly executed this Agreement as of the date first above written.

ANTARES PHARMA, INC.

 

By:

 

Name:

 

Title:

 

 

 

FRED POWELL

 

 

 

 


 

Exhibit A

GENERAL RELEASE OF CLAIMS

In consideration of the severance benefits payable to Fred Powell (“ Executive ”) under Section 1(a) of the attached Separation Agreement dated as of _______, 20, by and between Antares Pharma, Inc. (the “ Company ”) and Executive (the “ Agreement ”), the terms of which are incorporated by reference to this General Release of Claims (this “ Release ”)), Executive hereby executes this Release on his own behalf and also on behalf of any heirs, agents, representatives, successors and assigns that he has now or may have in the future.

1. General Waiver & Release . Executive hereby waives and releases any and all claims, subject to and without waiving any rights identified in Section 1(c), whether or not now known to Executive, whether legal, equitable or otherwise, against the Company, its parent, subsidiary and affiliated companies, and all of their past and present officers, directors, employees, agents and assigns (collectively, “ Releasees ”), arising from or relating to any and all acts, events and omissions occurring prior to the date Executive signs this Release.

(a) Included Claims . The claims being waived and released include, without limitation:

(i) any and all claims arising from or relating to Executive’s recruitment, hire, employment and termination of employment with the Company;

(ii) any and all claims of wrongful discharge, emotional distress, defamation, misrepresentation, fraud, detrimental reliance, breach of contractual obligations, promissory estoppel, negligence, assault and battery, violation of public policy;

(iii) any and all claims for monetary damages arising under the Age Discrimination in Employment Act of 1967 (“ ADEA ”) as amended, the Older Workers Benefit Protection Act of 1990 (“ OWBPA ”), Title VII of the Civil Rights Act of 1964 as amended, and the Americans with Disabilities Act of 1990 as amended;

(iv) any and all claims, outside of those identified in Section (1)(a)(iii), of unlawful discrimination, harassment and retaliation under applicable federal, state and local laws and regulations;

(v) any and all claims, outside of those identified in Section (1)(a)(iii), of violation of any federal, state and local law relating to recruitment, hiring, terms and conditions of employment, and termination of employment; and

(vi) any and all claims for monetary damages and any other form of personal relief.

(b) Unknown Claims . In waiving and releasing any and all claims, subject to and without waiving any rights identified in Section 1(c), against the Releasees, whether or not now known to Executive, Executive understands that this means that, if Executive later discovers facts different from or in addition to those facts currently known by Executive, or believed by

 

 


 

Executive to be true, the waivers and releases of this Release shall remain effective in all respects -- despite such different or additional facts and Executive’s later discovery of such facts, even if Executive would not have agreed to this Release if Executive had prior knowledge of such facts.

(c) Exceptions . Executive may still bring claims:

(i) for unemployment, state disability and/or paid family leave insurance benefits pursuant to the terms of applicable state law;

(ii) for continuation of existing participation in Company-sponsored group health benefit plans, at Executive’s full expense, under the federal law known as “COBRA” and/or under an applicable state counterpart law;

(iii) for any benefit entitlements that are vested as of the Termination Date pursuant to the terms of a Company-sponsored benefit plan governed by the federal law known as “ ERISA ;”

(iv) for any vested stock and/or vested option shares pursuant to the written terms and conditions of Executive’s existing stock and stock option grants and agreements, existing as of the Termination Date and for all such rights that are granted in and survive the Agreement, including accelerated vesting rights;

(v) for violation of any federal, state or local statutory and/or public policy right or entitlement that, by applicable law, is not waivable;

(vi) for any wrongful act or omission occurring after the date Executive signs this Release;

(vii) for any continuing rights to indemnification and defense under Section 13 of the Employment Agreement and under the Company’s governing documents, by-laws, policies and insurance policies; and

(viii) in his capacity as a stockholder of the Company.

2. Entire Agreement . This Release and the Agreement contain the entire agreement of Executive and the Company with respect to the subject matter hereof and supersede and render null and void any and all prior or contemporaneous oral or written understandings, statements, representations or promises pertaining to the matters set forth herein and in the Agreement.

3. Governing Law; Venue . This Release shall be governed in accordance with the laws of the State of New Jersey, without regard to the conflicts of law or choice of law principles thereof. If any dispute between the parties leads to litigation, the parties agree that the courts of the State of New Jersey or the federal courts in New Jersey shall have the exclusive jurisdiction and venue over such litigation. All parties consent to personal jurisdiction in the State of New Jersey, and agree to accept service of process outside of the State of New Jersey as if service had been made in that state.

 

 


 

4. Further Acknowledgements . Executive acknowledges that:

(i) Executive has been offered a period of at least twenty-one (21) 1 calendar days from the date he received this Release within which to review and consider its terms before signing it;

(ii) The Company hereby advises the Executive to consult with an attorney prior to executing this Release, and he fully understands this right;

(iii) Executive has carefully read and understands all of the provisions of this Release and that he is entering into this Release freely, knowingly, and voluntarily;

(iv) Executive is not waiving any rights or claims that may arise after this Release is executed or any other claims that cannot be waived as a matter of law;

(v) The consideration provided to Executive in consideration for his execution of this Release is greater than any benefits to which Executive would have been entitled had he not executed this Release;

(vi) Any changes made to this Release before Executive signs it will not entitle him to an additional twenty-one (21) calendar days to review the new version of this Release;

(vii) Executive is not entitled to the severance benefits set forth in Section 1(a) of the Agreement, unless he signs and does not revoke this Release;

(viii) Executive may revoke this Release within seven (7) calendar days following its execution (the “ Revocation Period ”) by notifying the Company in writing, by certified letter delivered to the attention of Peter J. Graham, Senior Vice President, General Counsel, Chief Compliance Officer, Human Resources, and Secretary, Antares Pharma, Inc., 100 Princeton South, Suite 300, Ewing, NJ 08628, and the terms of this Release shall not become effective or enforceable until the day after the expiration of the Revocation Period; and

(ix) Executive is not relying upon any promises, inducements, representations, or statements that are not expressly set forth in this Release or the Agreement.

 

1  

If the Executive’s employment is terminated as part of a group termination, then the Executive must be provided with 45 calendar days to consider the Release, and provided with additional information about the employees considered and selected for the group termination.

 

 


 

IN WITNESS WHEREOF, Executive, acknowledging that he is acting of his own free will after receiving a reasonable period of time to consider the terms of this Release, has caused the execution of this Release as of this day and year written below.

 

Agreed and Accepted:

 

 

 

 

 

Fred Powell

Date

 

 

 

 


 

Exhibit B

ANTARES PHARMA, INC.

PROPRIETARY INFORMATION
AND
INVENTION ASSIGNMENT AGREEMENT

As an employee of Antares Pharma, Inc. (the “Company”), I acknowledge that the Company operates in a competitive environment and that it enhances its opportunities to succeed by establishing policies designed to identify and secure the Company’s Intellectual Property and Proprietary Information. This Agreement is designed to make clear that:

 

i)

I will maintain the confidentiality of the Company’s Proprietary Information and use such Proprietary Information for the exclusive benefit of the Company;

 

ii)

Inventions that I create will be owned by the Company; and

 

iii)

My activities separate from the Company will not conflict with the Company’s development of its proprietary rights.

In consideration of my employment and/or the continuation of my employment by the Company, I hereby agree as follows:

1.

Provisions Related to Trade Secrets

 

(a)

I acknowledge that the Company possesses and will continue to develop and acquire valuable Proprietary Information (as defined below), including information that I may develop or discover as a result of my employment with the Company.

 

(b)

As used in this Agreement, “Proprietary Information” means any information (including any compilation, device, method, technique or process) that derives independent economic value, actual or potential, from not being generally known to the public or other persons who can obtain economic value from its disclosure or use, and includes information of the Company, its customers, suppliers, joint ventures, licensors, licensees, distributors and other persons and entities with whom the Company does business.

 

(c)

I will not disclose or use at any time, either during or after my employment with the Company, any Proprietary Information except for the exclusive benefit of the Company as required by my duties for the Company, as the Company expressly may consent to in writing or in accordance with Sections 1(d) and (e) below. Except as specifically authorized under Sections 1(d) and (e) below, I will cooperate with the Company to implement reasonable measures to maintain the secrecy of, and will use my best efforts to prevent the unauthorized disclosure, use or reproduction of, all Proprietary Information.

 

 


 

 

(d)

I understand that nothing in this Agreement restricts or prohibits me from initiating communications directly with, responding to any inquiries from, providing testimony before, providing confidential information to, reporting possible violations of law or regulation to, or from filing a claim or assisting with an investigation directly with a self-regulatory authority or a government agency or entity, including the U.S. Equal Employment Opportunity Commission, the Department of Labor, the National Labor Relations Board, the Department of Justice, the Securities and Exchange Commission, the Congress, and any agency Inspector General (collectively, the “Regulators”), or from making other disclosures that are protected under the whistleblower provisions of state or federal law or regulation. However, to the maximum extent permitted by law, I am waiving my right to receive any individual monetary relief from the Company or any others covered by the Release of Claims resulting from such claims or conduct, regardless of whether I or another party has filed them, and in the event I obtain such monetary relief the Company will be entitled to an offset for the payments made pursuant to this Agreement. This Agreement does not limit my right to receive an award from any Regulator that provides awards for providing information relating to a potential violation of law. I do not need the prior authorization of the Company to engage in conduct protected by this paragraph, and the Executive does not need to notify the Company that I have engaged in such conduct.

Please take notice that federal law provides criminal and civil immunity to federal and state claims for trade secret misappropriation to individuals who disclose a trade secret to their attorney, a court, or a government official in certain, confidential circumstances that are set forth at 18 U.S.C. §§ 1833(b)(1) and 1833(b)(2), related to the reporting or investigation of a suspected violation of the law, or in connection with a lawsuit for retaliation for reporting a suspected violation of the law.

 

(e)

Upon leaving employment with the Company for any reason, I immediately will deliver to the Company any property, records, documents and other tangible materials (including all copies) in my possession or under my control, including data incorporated in word processing, computer and other data storage media, containing or disclosing Proprietary Information, except as otherwise permitted in accordance with Sections 1(d) and (e) above.

 

 


 

2.

Ownership of Inventions

 

(a)

I agree to communicate to the Company as promptly and fully as practicable all Inventions (as defined below) conceived or reduced to practice by me (alone or jointly by others) at any time during my employment with the Company. I hereby assign to the Company and/or its nominees all my right, title and interest in such Inventions, and all my right, title and interest in any patents, copyrights, patent applications or copyright applications based thereon. I will give the Company and/or its nominees (at no expense to me) any assistance it reasonably requires to perfect, protect and use its rights to all such Inventions anywhere in the world.

 

(b)

As used in this Agreement, the term “Inventions” includes, but is not limited to, all discoveries, improvements, processes, developments, designs, know-how, data, computer programs and formulae, whether patentable or unpatentable or protectable by copyright or other intellectual property law.

 

(c)

Any provision in this Agreement requiring me to assign my rights in any Invention does not apply to an Invention for which no equipment, supplies, facility or trade secret information of the Company was used, and which was developed entirely on my own time, and which:

 

(i)

does not relate directly to the Company’s business or to the Company’s anticipated research or development, or

 

(ii)

does not result from any work performed by me for the Company.

 

(d)

I hereby designate and appoint the Company and each of its duly authorized officers as my agent and attorney-in-fact to act for and in my behalf to execute and file any document, and to do all other lawfully permitted acts to further the prosecution, issuance and enforcement of patents, copyrights and other proprietary rights with the same force and effect as if executed and delivered by me.

3.

Conflicts With Other Activities

I understand that my employment with the Company and my compliance with this Agreement do not and will not breach any agreement to keep in confidence any information acquired by me prior to or outside of my employment with the Company. I have not brought and will not bring with me to the Company for use in the performance of my duties at the Company any materials, documents or information of a former employer or any third party that are not generally available to the public unless I have obtained express written authorization from the owner for their possession and use by or for the Company. I have not entered into and will not enter into any agreement, either oral or written, in conflict with this Agreement.

4.

Miscellaneous

 

(a)

My obligations under this Agreement may not be modified or terminated, in whole or in any part, except in a writing signed by the Company. Any waiver by

 

 


 

 

the Company of a breach of any provision of this Agreement will not operate or be construed as a waiver of any subsequent breach.

 

(b)

Each provision of this Agreement will be treated as a separate and independent clause, and the unenforceability of any one provision will in no way impair the enforceability of any other provision. If any provision is held to be unenforceable, such provision will be construed by the appropriate judicial body by limiting or reducing it to the minimum extent necessary to make it legally enforceable.

 

(c)

My obligations under this Agreement will survive the termination of my employment, regardless of the manner of such termination. This Agreement will inure to the benefit of and will be binding upon the successors and assigns of the Company.

 

(d)

I understand that the provisions of this Agreement are a material condition to my employment and/or continued employment with the Company. I also understand that this Agreement is not an employment contract, and nothing in this Agreement creates any right to my continuous employment by the Company, or to my employment for any particular term.

 

(e)

Any breach of this Agreement likely will cause irreparable harm to the Company for which money damages could not reasonably or adequately compensate the Company. Accordingly, I agree that the Company will be entitled to injunctive relief to enforce this Agreement, in addition to damages and other available remedies.

SIGNING THIS AGREEMENT CREATES IMPORTANT OBLIGATIONS OF TRUST AND AFFECTS THE EMPLOYEE’S RIGHTS TO INVENTIONS THE EMPLOYEE MAY MAKE DURING HIS/HER EMPLOYMENT.

 

Dated:

October 11, 2016

 

Employee Signature:

/s/ Fred M. Powell

 

Employee Name:

Fred M. Powell

 

Printed or typed

 

 

ACCEPTED AND AGREED TO:

ANTARES PHARMA, INC.

 

By:

/s/ Robert F. Apple

 

Authorized Signer

 

 

 

 

Exhibit 31.1

CERTIFICATIONS

I, Robert F. Apple, certify that:

1.

I have reviewed this report on Form 10-Q for the fiscal quarter ended September 30, 2016 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: November 9, 2016

 

/s/ Robert F. Apple

Robert F. Apple

President and Chief Executive Officer

 

 

Exhibit 31.2

CERTIFICATIONS

I, Fred M. Powell, certify that:

1.

I have reviewed this report on Form 10-Q for the fiscal quarter ended September 30, 2016 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: November 9, 2016

 

/s/ Fred M. Powell

Fred M. Powell

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, Robert F. Apple, 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 September 30, 2016 (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 9th day of November, 2016.

 

/s/ Robert F. Apple

Robert F. Apple

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, Fred M. Powell, 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 September 30, 2016 (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 9th day of November, 2016.

 

/s/ Fred M. Powell

Fred M. Powell

Senior Vice President and Chief Financial Officer