ANTARES PHARMA, INC. (Form: 10-Q, Received: 11/06/2018 17:05:37)

Large accelerated filer

Accelerated filer

Non–accelerated filer

Smaller reporting company

Emerging growth company

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, 2018

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 every Interactive Data File required to be submitted 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 such files). Yes ☒ No ☐

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

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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 1, 2018 was 157,541,269 .

ANTARES PHARMA, INC.

INDEX

			PAGE

PART I.		FINANCIAL INFORMATION	3

	Item 1.	Financial Statements	3

		Consolidated Balance Sheets, as of September 30, 2018 (Unaudited) and December 31, 2017	3

		Consolidated Statements of Operations (Unaudited) for the three and nine months ended September 30, 2018 and 2017	4

		Consolidated Statements of Comprehensive Loss (Unaudited) for the three and nine months ended September 30, 2018 and 2017	5

		Consolidated Statements of Cash Flows (Unaudited) for the nine months ended September 30, 2018 and 2017	6

		Notes to Consolidated Financial Statements (Unaudited)	7

	Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	15

	Item 3.	Quantitative and Qualitative Disclosures About Market Risk	24

	Item 4.	Controls and Procedures	24

PART II.		OTHER INFORMATION	25

	Item 1.	Legal Proceedings	25

	Item 1A.	Risk Factors	25

	Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	29

	Item 3.	Default Upon Senior Securities	29

	Item 4.	Mine Safety Disclosures	30

	Item 5.	Other Information	30

	Item 6.	Exhibits	30

		SIGNATURES	31

PART I – F INANCIAL INFORMATION

Item 1.

FINANCIAL STATEMENTS

ANTARES PHARMA, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands, except per share amounts)

	September 30,			December 31,
	2018			2017
	(Unaudited)
Assets
Current Assets:
Cash and cash equivalents	$	28,160		$	26,562
Short-term investments		—			4,993
Accounts receivable		15,483			11,878
Inventories		11,275			9,275
Deferred costs		275			505
Prepaid expenses and other current assets		1,806			2,323
Total current assets		56,999			55,536
Equipment, molds, furniture and fixtures, net		15,325			16,158
Patent rights, net		998			1,401
Goodwill		1,095			1,095
Other assets		148			148
Total Assets	$	74,565		$	74,338
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable	$	7,497		$	5,957
Accrued expenses and other liabilities		9,124			6,982
Deferred gain		7,500			—
Deferred revenue		811			2,794
Total current liabilities		24,932			15,733
Long-term debt		25,059			24,858
Deferred revenue – long term		200			200
Total liabilities		50,191			40,791
Stockholders’ Equity:
Preferred Stock: $0.01 par, authorized 3,000 shares, none outstanding		—			—
Common Stock: $0.01 par; 300,000 shares authorized; 157,521 and 156,675 issued and outstanding at September 30, 2018 and December 31, 2017, respectively		1,575			1,567
Additional paid-in capital		306,435			302,965
Accumulated deficit		(282,934	)		(270,285	)
Accumulated other comprehensive loss		(702	)		(700	)
		24,374			33,547
Total Liabilities and Stockholders’ Equity	$	74,565		$	74,338

See accompanying notes to consolidated financial statements.

ANTARES PHARMA, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(UNAUDITED)

	For the Three Months Ended						For the Nine Months Ended
	September 30,						September 30,
	2018			2017			2018			2017
Revenue:
Product sales	$	11,597		$	13,328		$	33,641		$	30,709
Licensing and development revenue		2,554			1,504			5,624			8,952
Royalties		3,717			220			5,468			815
Total revenue		17,868			15,052			44,733			40,476
Cost of revenue:
Cost of product sales		6,982			7,600			20,195			16,682
Cost of development revenue		307			923			1,240			3,677
Total cost of revenue		7,289			8,523			21,435			20,359
Gross profit		10,579			6,529			23,298			20,117
Operating expenses:
Research and development		3,611			3,289			10,581			9,535
Selling, general and administrative		8,327			8,186			23,606			23,013
Total operating expenses		11,938			11,475			34,187			32,548
Operating loss		(1,359	)		(4,946	)		(10,889	)		(12,431	)
Interest expense		(674	)		(626	)		(1,959	)		(794	)
Other income		97			119			199			197
Net loss	$	(1,936	)	$	(5,453	)	$	(12,649	)	$	(13,028	)
Basic and diluted net loss per common share	$	(0.01	)	$	(0.03	)	$	(0.08	)	$	(0.08	)
Basic and diluted weighted average common shares outstanding		157,471			156,401			157,076			155,852

See accompanying notes to consolidated financial statements.

ANTARES PHARMA, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(in thousands)

(UNAUDITED)

	For the Three Months Ended						For the Nine Months Ended
	September 30,						September 30,
	2018			2017			2018			2017
Net loss	$	(1,936	)	$	(5,453	)	$	(12,649	)	$	(13,028	)
Foreign currency translation adjustment		(2	)		(4	)		(2	)		13
Comprehensive loss	$	(1,938	)	$	(5,457	)	$	(12,651	)	$	(13,015	)

See accompanying notes to consolidated financial statements.

ANTARES PHARMA, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(UNAUDITED)

	Nine Months Ended
	September 30,
	2018			2017
Cash flows from operating activities:
Net loss	$	(12,649	)	$	(13,028	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		3,655			2,371
Depreciation and amortization		1,808			1,520
Accretion of interest expense		157			66
Amortization of debt issuance costs		43			18
Other		(7	)		52
Changes in operating assets and liabilities:
Accounts receivable		(3,606	)		(1,069	)
Inventories		(2,000	)		(2,615	)
Prepaid expenses and other assets		517			(300	)
Deferred costs		230			560
Accounts payable		1,518			702
Accrued expenses and other current liabilities		2,157			550
Deferred revenue		(1,983	)		(4,309	)
Net cash used in operating activities		(10,160	)		(15,482	)
Cash flows from investing activities:
Proceeds from sale of assets		7,500			—
Proceeds from maturities of investment securities		5,000			—
Purchases of investment securities		—			(9,964	)
Purchases of equipment, molds, furniture and fixtures		(526	)		(879	)
Additions to patent rights		(40	)		(83	)
Net cash provided by (used in) investing activities		11,934			(10,926	)
Cash flows from financing activities:
Proceeds from issuance of long-term debt		—			25,000
Payment of debt issuance costs		—			(293	)
Proceeds from exercise of stock options		366			1,670
Taxes paid related to net share settlement of equity awards		(543	)		(249	)
Net cash (used in) provided by financing activities		(177	)		26,128
Effect of exchange rate changes on cash		1			(1	)
Net increase (decrease) in cash and cash equivalents		1,598			(281	)
Cash and cash equivalents:
Beginning of period		26,562			27,715
End of period	$	28,160		$	27,434
Supplemental disclosure of non-cash investing activities:
Purchases of equipment, molds, furniture and fixtures recorded in accounts payable and accrued expenses	$	56		$	93
Additions to patent rights recorded in accounts payable and accrued expenses	$	—		$	6

See accompanying notes to consolidated financial statements.

ANTARES PHARMA, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except per share amounts)

(UNAUDITED)

1.	Description of Business

Antares Pharma, Inc. (“Antares” or the “Company”) is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered parenteral pharmaceutical products and technologies. The Company develops and commercializes, for itself or with partners, novel therapeutic products using its advanced drug delivery technology to enhance existing drug compounds and delivery methods. The Company’s intramuscular and subcutaneous injection technology platforms include the VIBEX ^® and VIBEX ^® QuickShot ^® pressure-assisted auto injector systems suitable for branded and generic injectable drugs in unit dose containers and disposable multi-dose pen injectors. The Company has a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. The Company has formed significant strategic alliances with Teva Pharmaceutical Industries, Ltd. (“Teva”), AMAG Pharmaceuticals, Inc. (“AMAG”) and Pfizer Inc. (“Pfizer”.)

The Company developed XYOSTED ^TM (testosterone enanthate) injection, which is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, and was approved by the U.S. Food and Drug Administration (“FDA”) on September 28, 2018. XYOSTED ^TM is the only FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration. The Company is preparing for the commercial launch of XYOSTED ^TM by the end of 2018. The Company also markets and sells its proprietary product OTREXUP ^® (methotrexate) injection in the U.S., which is indicated for adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis, and was launched for commercial sale in February 2014. Through its commercialization partner Teva, the Company sells Sumatriptan Injection USP, indicated in the U.S. for the acute treatment of migraine and cluster headache in adults. Sumatriptan Injection USP was launched for commercial sale in June 2016.

In collaboration with AMAG, the Company developed a subcutaneous auto injector for use with AMAG’s progestin hormone drug Makena ^® (hydroxyprogesterone caproate injection) under an exclusive license and development agreement. In February 2018, the FDA approved AMAG’s supplemental New Drug Application (“sNDA”) for the Makena ^® subcutaneous auto injector drug-device combination product, which is a ready-to-administer treatment indicated to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past. The Company is the exclusive supplier of the devices and final assembled and packaged commercial product. AMAG launched the product for commercial sale in the first quarter of 2018.

Through a license, development and supply agreement with Teva, Antares developed and is the exclusive supplier of the device for an epinephrine auto injector product to be sold in the U.S. Teva’s epinephrine auto injector drug-device combination product, indicated for emergency treatment of severe allergic reactions in adults and certain pediatric patients, was approved by the FDA in August 2018.

The Company is also developing two multi-dose pen injector products in collaboration with Teva, a combination drug device rescue pen in collaboration with Pfizer, and has other ongoing internal research and development programs.

2.	Basis of Presentation and Significant Accounting Policies

The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles (“GAAP”) 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, 2017. Operating results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018.

Accounting Pronouncements Recently Adopted

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606), supplemented with a number of subsequent amendments issued by the FASB and collectively referred to herein as “Topic 606”. This guidance supersedes the revenue recognition requirements in Topic 605 Revenue Recognition (“Topic 605”) and requires entities to recognize revenues when control of promised goods or services is transferred to customers at an amount that reflects the consideration to which the entity expects to be entitled to in

ANTARES PHARMA, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except per share amounts)

(UNAUDITED)

exchange for those goods or services. The Company adopted Topic 606 as of January 1, 2018 using the modified retrospective transition method. Results for reporting periods beginning on or after January 1, 2018 are presented under Topic 60 6, while prior period amounts, as reported, were not adjusted. The cumulative effects of the adoption of the new standard were not material to the Company or its consolidated financial statements. In addition, the difference between the amount of revenue r ecognized for the three and nine months ended September 30, 2018 under Topic 606 as compared to the amount of revenue that would have been recognized under Topic 605 is not material. See Revenue Recognition below for additional information about the Compan y’s revenue recognition policy in accordance with Topic 606.

In May 2017, the FASB issued ASU No. 2017-05, Other Income – Gains and Losses from the Derecognition of Nonfinancial Assets (Subtopic 610-20): Clarifying the Scope of Asset Derecognition Guidance and Accounting for Partial Sales of Nonfinancial Assets (“ASU 2017-05”). The amendments clarify that an entity should identify each distinct nonfinancial asset or in-substance nonfinancial asset promised to a counterparty and derecognize each asset when a counterparty obtains control of it. The Company adopted ASU 2017-05 effective January 1, 2018, which did not have any impact on the consolidated financial statements or result in any adjustment to opening retained earnings. See additional information about the impact of this standard in connection the accounting for the sale of assets discussed in Note 3.

In May 2017, the FASB issued ASU No. 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting (“ASU 2017-09”), which provides guidance on determining which changes to terms and conditions of share-based awards require an entity to apply modification accounting under Topic 718. This new standard is effective for annual reporting periods beginning after December 15, 2017. The adoption of ASU 2017-09 did not have a significant impact on the Company’s consolidated financial statements.

Recent Accounting Pronouncements Not Yet Adopted

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). This new standard requires entities to recognize on its balance sheet assets and liabilities associated with the rights and obligations created by leases with terms greater than twelve months. This new standard is effective for annual reporting periods beginning after December 15, 2018, and interim periods within those annual periods. The Company is currently evaluating the impact of ASU 2016-02 on its consolidated financial statements and currently expects that its operating lease commitments will be subject to the new standard and recognized as operating lease liabilities and right-of-use assets in the statement of financial position upon adoption of ASU 2016-02 effective January 1, 2019.

Investments

From time to time, the Company has invested in U.S. Treasury bills and government agency notes that are classified as held-to-maturity because of the Company’s intent and ability to hold the securities to maturity. Investments with maturities of one year or less are classified as short-term. These securities are carried at their amortized cost and fair value is determined by quoted market prices. At September 30, 2018, the Company had no short-term investments, and at December 31, 2017, the Company’s investments had a carrying value of $4,993, which approximated fair value.

Inventories

Inventories are stated at the lower of cost or net realizable value. 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 $352 and $510 at September 30, 2018 and December 31, 2017, respectively. Inventories consist of the following:

	September 30,		December 31,
	2018		2017
Inventories:
Raw material	$	117	$	118
Work in process		8,140		6,223
Finished goods		3,018		2,934
	$	11,275	$	9,275

ANTARES PHARMA, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except per share amounts)

(UNAUDITED)

Equipment, Molds, Furniture, and Fixtures

Equipment, molds, furniture, and fixtures are stated at cost, net of accumulated depreciation, and are depreciated using the straight-line method over their estimated useful lives ranging from three to ten years. As of September 30, 2018 and December 31, 2017, the Company’s equipment, molds, furniture and fixtures totaled $15,325 and $16,158, respectively, which is presented net of accumulated depreciation of $6,820 and $5,445 as of September 30, 2018 and December 31, 2017, respectively. Depreciation expense was $1,376 and $1,068 for the nine months ended September 30, 2018 and 2017, respectively.

Long-term debt

The carrying value of the Company’s term loan was $25,059 and $24,858 as of September 30, 2018 and December 31, 2017, respectively, which is presented net of unamortized debt issuance costs. As of September 30, 2018, the prime-based variable interest rate was 9.50%. The Company believes that the carrying value of the term loan approximates its fair value based on the borrowing rates currently available for loans with similar terms.

Revenue Recognition

The Company generates revenue from product sales, license and development activities and royalty arrangements. Revenue is recognized when or as the Company transfers control of the promised goods or services to its customers at the transaction price, which is the amount that reflects the consideration to which it expects to be entitled to in exchange for those goods or services.

The Company sells its proprietary product OTREXUP ^® to wholesale pharmaceutical distributors. Product revenue from sales of OTREXUP ^® is recognized upon delivery of the product to distributors and is presented net of estimated returns and product sales allowances for wholesaler discounts, prompt pay discounts, chargebacks, rebates and other patient discount programs. The Company estimates returns and product sales allowances based on historical trends, inventory levels remaining in the distribution channel, the terms of contracts in place and other known factors or market expectations.

The Company sells Sumatriptan Injection USP to Teva under a license, supply and distribution agreement. The Company is initially compensated at cost for shipments of product to Teva and is entitled to receive 50 percent of the net profits from commercial sales made by Teva. The Company recognizes revenue, including the estimated variable consideration it expects to receive for contract margin on future commercial sales, upon shipment of the goods to Teva. The estimated variable consideration is recognized at an amount the Company believes is not subject to significant reversal based on historical experience and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed.

The Company is the exclusive supplier of the Makena ^® subcutaneous auto injector product to AMAG under a manufacturing agreement. Because the product that the Company produces for AMAG is custom product with no alternative use and the Company has a right to payment for performance completed to date, control is continuously transferred to the customer with respect to the product supply and therefore revenue is recognized at the transaction price as product is manufactured pursuant to firm purchase orders. The amount of revenue recognized in excess of the amount billed to the customer, if any, is recorded in accounts receivable due to the short-term nature in which the amount is ultimately expected to be billed and collected from the customer.

The Company generally contracts with its partners/customers for license, development and supply arrangements involving highly-customized customer-specific deliverables and development activities that often span multiple phases of a product lifecycle and include multiple performance obligations. For such arrangements, the Company allocates consideration to each performance obligation at inception of the arrangement based on relative standalone selling price, which is generally determined based on the expected cost plus margin. License fees received in exchange for the grant of a license to the Company’s functional intellectual property (“IP”) such as patented technology and know-how in connection with a partnered development arrangement are generally recognized at inception of the arrangement or over the development period depending on the facts and circumstances, as the license is not generally distinct from the non-licensed goods or services to be provided under the contract. Sales or usage based royalties for which the license is the predominant item to which the royalties relate are recognized at the later of when sales or usage occurs. Other forms of variable consideration, such as milestone payments that are contingent upon the occurrence of future events, are evaluated and recorded at the most likely amount, and to the extent that it is probable that a significant reversal will not occur when the associated uncertainty is resolved.

ANTARES PHARMA, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except per share amounts)

(UNAUDITED)

The Company’s typical payment terms for development contracts may include an upfront payment equal to a percentage of the to tal contract value with the remaining portion to be billed upon completion and transfer of the individual deliverables or satisfaction of the individual performance obligations. The Company records a liability for the cash received in advance of performanc e, which is presented within deferred revenue on the balance sheet and recognized as revenue when the associated performance obligations have been satisfied. The advance payment typically is not considered a significant financing component because it is us ed to meet working capital demands that can be higher in the early stages of a contract.

Revenues from development contracts and partnered product supply arrangements, other than the product supplied under the AMAG manufacturing agreement described above, are recognized at the point in time in which the performance obligation is satisfied and control of the good or service is transferred to the customer. Factors that may indicate that the transfer of control has occurred include the transfer of legal title, transfer of physical possession, the customer has obtained the significant risks and rewards of ownership of the assets and the Company has a present right to payment.

Most often, amendments or modifications to existing development contracts are for goods or services that are distinct from the initial contract and are accounted for as a separate contract.

The Company has elected to recognize the cost for freight and shipping activities as fulfilment cost. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of underlying products is transferred to the customer. The related shipping and freight charges incurred by the Company are included in cost of revenue.

Remaining Performance Obligations

Remaining performance obligations represents the transaction price of firm orders and development contract deliverables for which work has not been completed or orders fulfilled, and excludes potential purchase orders under ordering-type supply contracts with indefinite delivery or quantity. As of September 30, 2018, the aggregate value of remaining performance obligations, excluding contracts with an original expected length of one year or less, was $5.6 million. The Company expects to recognize revenue on the remaining performance obligations over the next twelve months.

3.	Sale of Assets

In October 2017, the Company entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Ferring International Center S.A (together with Ferring Pharmaceuticals Inc. and Ferring B.V. individually and collectively referred to as “Ferring”) to sell the worldwide rights, including certain assets, related to the needle-free auto injector device product line for a total purchase price of $14.5 million.

The purchase price was agreed to be paid in four installments consisting of the following: a $2.0 million non-refundable upfront payment, which was received upon entry into the Asset Purchase Agreement and the transfer of certain assets; a second installment of $2.75 million received in February 2018 upon delivery of certain documentation and satisfaction of certain conditions primarily related to product manufacturing; a third installment of $4.75 million received in May 2018 upon satisfaction of certain conditions including further document transfer, Ferring’s successful completion of a regulatory audit by a notified body, and a pilot manufacturing run under Ferring’s supervision; and a final installment of $5.0 million to be paid upon Ferring’s receipt of the CE Mark needed to continue to commercialize the product in certain territories and the final transfer of certain product-related inventory, equipment and agreements to Ferring, which the Company anticipates may occur by the end of 2018.

In the fourth quarter of 2017, the Company recognized a gain on sale of assets upon receipt of the $2.0 million non-refundable upfront payment and transfer of certain manufacturing equipment and patents to Ferring. The second and third installments are refundable to Ferring under certain circumstances if completion of the transaction does not occur within a specified timeframe. Given the uncertainty about the payment and refundability of each subsequent milestone, under ASU 2017-05, the gain on the remaining milestone payments will be recognized when it becomes probable that a significant reversal of the gain will not occur, to be reviewed and updated at each reporting period. During the nine months ended September 30, 2018, the Company satisfied certain conditions and received the second and third installments of $2.75 million and $4.75 million, respectively. These cash proceeds received in excess of recognized gain have been recorded as deferred gain in the accompanying consolidated balance sheet.

ANTARES PHARMA, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except per share amounts)

(UNAUDITED)

4 .	Share-Based Compensation

The Company’s 2008 Equity Compensation Plan (the “Plan”) allows for grants in the form of incentive stock options, nonqualified stock options, stock units, stock awards, stock appreciation rights, and other stock-based awards. All of the Company’s officers, directors, employees, consultants and advisors are eligible to receive grants under the Plan. The maximum number of shares authorized for issuance under the amended and restated Plan is 32,200 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 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, 2018, the Plan had approximately 2,800 shares available for grant. Stock option exercises are satisfied through the issuance of new shares.

Stock Options

The following is a summary of stock option activity under the Plan as of and for the nine months ended September 30, 2018:

						Weighted
				Weighted		Average
				Average		Remaining		Aggregate
	Number of			Exercise		Contractual		Intrinsic
	Shares			Price		Term (Years)		Value
Outstanding at December 31, 2017		12,149		$	2.04
Granted		2,633			2.72
Exercised		(415	)		1.05
Cancelled/Forfeited		(143	)		2.21
Outstanding at September 30, 2018		14,224			2.19		7.1	$	16,971
Exercisable at September 30, 2018		9,932		$	2.06		6.2	$	13,240

The per share weighted average fair value of all options granted during the nine months ended September 30, 2018 and 2017 was $1.44 and $1.37, respectively, estimated 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.

	For the Nine Months Ended September 30,
	2018		2017
Risk-free interest rate	2.8%		1.8%
Annualized volatility	53.7%		53.3%
Weighted average expected life, in years		6.0		6.0
Expected dividend yield	0.0%		0.0%

During the nine months ended September 30, 2018, stock option exercises resulted in cash proceeds to the Company of $366 and the issuance of 385 shares of common stock. A portion of the stock options were net exercised, whereby the Company withheld 30 shares, the fair value of which was equivalent to the aggregate exercise price and tax withholding on the date of exercise. For the nine months ended September 30, 2017, stock option exercises resulted in proceeds of $1,670 and the issuance of 1,063 shares of common stock.

The Company recognized $2,158 and $1,680 of compensation expense related to stock options for the nine months ended September 30, 2018 and 2017, respectively, and $811 and $693 for the three months ended September 30, 2018 and 2017, respectively. As of September 30, 2018, there was $5,331 of total unrecognized compensation cost related to non-vested outstanding stock options that is expected to be recognized over a weighted average period of approximately 2.0 years.

Long Term Incentive Program

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

ANTARES PHARMA, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except per share amounts)

(UNAUDITED)

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 years.

The PSU awards and RSU awards granted under the long-term incentive program are summarized 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, 2017		1,456		$	2.20		1,157		$	2.12
Granted		611			2.89		611			2.70
Vested/settled		(173	)		2.18		(500	)		1.99
Forfeited/expired		—			—		—			—
Outstanding at September 30, 2018		1,894		$	2.48		1,268		$	2.46

The LTIP awards granted in 2018 include PSUs that may be earned based on the Company’s achievement of certain corporate development goals, 2020 net revenue and total shareholder return (“TSR”) relative to the Nasdaq Biotechnology Index at the end of the performance period. The performance period is January 1, 2018 to December 31, 2020, and depending on the outcome of the individual performance goals, a recipient may ultimately earn a number of shares greater or less than their target number of shares granted, ranging from 0% to 150% of the PSUs granted. The fair value of the TSR PSUs is expensed over the performance period and was determined using a Monte Carlo simulation utilizing the following inputs and assumptions:

	2018 Award
Closing stock price on grant date	$	2.70
Performance period starting price	$	1.92
Term of award (in years)		2.57
Volatility		64.9	%
Risk-free interest rate		2.6	%
Expected dividend yield		0.0	%
Fair value per TSR PSU	$	3.27

In connection with PSU awards, the Company recognized compensation expense of $456 and $152 for the three months ended September 30, 2018 and 2017, respectively and $636 and $240 for the nine months ended September 30, 2018 and 2017, respectively. Compensation expense recognized in connection with RSU awards was $338 and $243 for the three months ended September 30, 2018 and 2017, respectively, and $861 and $451 for the nine months ended September 30, 2018 and 2017, respectively.

The LTIP awards that vested during the nine months ended September 30, 2018 and 2017 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 211 and 98 in the nine months ended September 30, 2018 and 2017, respectively, based on the fair value of the shares on the respective vesting date as determined by the Company’s closing stock price on such date. Total withholding for employees’ tax obligations to be paid to the taxing authorities were $543 and $249 for the nine months ended September 30, 2018 and 2017, respectively, which is reflected as a financing activity within the consolidated statements of cash flows. Net-share settlements have the effect of share repurchases by the Company as they reduce the number of shares that would have otherwise been issued as a result of the vesting and do not represent an expense to the Company.

ANTARES PHARMA, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except per share amounts)

(UNAUDITED)

5 .	Revenues, Significant Customers and Concentrations of Risk

The following table presents the Company’s revenue on a disaggregated basis by types of products and services and major product lines:

	Three months ended September 30,				Nine months ended September 30,
	2018		2017		2018		2017
OTREXUP ^®	$	4,094	$	4,624	$	11,820	$	13,111
Sumatriptan Injection USP		3,983		6,375		9,438		12,264
Auto injector and pen injector devices		1,829		1,571		7,925		2,225
Needle-free injector devices and components		1,691		758		4,458		3,109
Total product sales		11,597		13,328		33,641		30,709
Licensing and development revenue		2,554		1,504		5,624		8,952
Royalties		3,717		220		5,468		815
Total revenue	$	17,868	$	15,052	$	44,733	$	40,476

Revenues disaggregated by customer location are as follows:

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2018		2017		2018		2017
United States of America	$	16,027	$	14,174	$	39,448	$	37,009
Europe		1,830		750		5,044		3,018
Other		11		128		241		449
	$	17,868	$	15,052	$	44,733	$	40,476

Significant customers from which the Company derived 10% or more of its total revenue in any of the periods presented are as follows:

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2018		2017		2018		2017
Teva	$	6,099	$	7,664	$	14,582	$	17,044
AMAG		5,321		1,768		12,046		6,338
McKesson		1,481		2,339		5,051		6,333
AmerisourceBergen		1,887		1,470		4,703		4,323
Ferring		2,202		724		5,662		3,018

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 and other share-based awards excluded from dilutive loss per share because their effect was anti-dilutive totaled 17,386 and 15,085 at September 30, 2018 and 2017, respectively.

7.	Commitments and Contingencies

Pending Litigation

ANTARES PHARMA, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except per share amounts)

(UNAUDITED)

contends that defe ndants made false and/or misleading statements and/or failed to disclose that: (i) Antares had provided insufficient data to the FDA in connection with the NDA for XYOSTED ^TM ; and (ii) accordingly, Antares had overstated the approval prospects for XYOSTED ^TM . On July 27, 2018, the court entered an order appointing Serghei Lungu as lead plaintiff, Pomerantz LLP as lead counsel, and Lite DePalma Greenberg, LLC as liaison counsel for plaintiff. On August 3, 2018, the parties submitted a stipulation and propose d order, setting forth an agreed-upon schedule for responding to the complaint, which the court granted. Pursuant to that order, plaintiff filed a Consolidated Amended Class Action Complaint on October 9, 2018 and defendants intend to file a motion to dism iss on or before November 26, 2018. The Company believes that the claims in the Smith action lack merit and intends to defend them vigorously.

On January 12, 2018, a stockholder of the Company filed a derivative civil action, captioned Chiru Mackert, derivatively on behalf of Antares Pharma, Inc., v. Robert F. Apple, et al. (“ Mackert ”), in the Superior Court of New Jersey Chancery Division, Mercer County (Case No. C-000011-18). On January 17, 2018, another stockholder filed a derivative action in the same court, captioned Vikram Rao, Derivatively on Behalf of Antares Pharma, Inc. v. Robert F. Apple, et al. (“ Rao ”) (Case No. C-000004-18). Both complaints name Robert F. Apple, Fred M. Powell, Thomas J. Garrity, Jacques Gonella, Anton Gueth, Leonard S. Jacob, Marvin Samson and Robert P. Roche, Jr. as defendants, and the Company as nominal defendant, and they assert claims for breach of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement, and waste of corporate assets arising from the same facts underlying the Smith securities class action. The plaintiffs seek damages, corporate governance and internal procedure reforms and improvements, restitution, reasonable attorneys’ fees, experts’ fees, costs, and expenses. The parties have filed a stipulation consolidating the two actions and staying the proceedings pending the court’s decision on defendants’ anticipated motion to dismiss the Smith action.

On January 17, 2018, a stockholder of the Company filed a derivative civil action, captioned Robert Clark, Derivatively on Behalf of Antares Pharma, Inc. v. Robert F. Apple, et al. (“ Clark ”) (Case No. 3:18-cv-00703-MAS-DEA), against Robert F. Apple, Thomas J. Garrity, Jacques Gonella, Leonard S. Jacob, Marvin Samson, Anton G. Gueth and Robert P. Roche, Jr. as defendants, and Company as a nominal defendant. The action was filed in the U.S. District Court for the District of New Jersey and asserts claims for breach of fiduciary duties, unjust enrichment, abuse of control, waste of corporate assets, and a violation of Section 14(a) of the Securities Exchange Act of 1934. This complaint relates to the same facts underlying the Smith securities class action and the other derivative actions. The plaintiff in Clark seeks damages, corporate governance and internal procedure reforms and improvements, reasonable attorneys’ fees, accountants’ and experts’ fees, costs, and expenses. The parties have filed a stipulation staying the action pending the court’s decision on defendants’ anticipated motion to dismiss the Smith action.

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” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties. Forward-looking statements can be identified by the words “expect,” “estimate,” “plan”, “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 sales of OTREXUP ^® (methotrexate) injection;

•

our expectations regarding sales of Sumatriptan Injection USP to our partner, Teva Pharmaceutical Industries, Ltd. (“Teva”), and Teva’s ability to successfully distribute and sell Sumatriptan Injection USP;

•

our expectations regarding commercialization of XYOSTED ^TM (testosterone enanthate) injection for testosterone replacement therapy, and future revenue related thereto;

•

our plans and ongoing process of hiring and onboarding approximately 60 additional sales representatives;

•

our expectations of pricing, reimbursement, marketing and distribution strategies related to XYOSTED ^TM ;

•

our plans to make XYOSTED ^TM available to patients before the end of 2018;

•

our expectations regarding the ability of our partner, AMAG Pharmaceuticals, Inc. (“AMAG”), to continue to successfully commercialize the Makena ^® auto injector product, and any future revenue related thereto;

•

our expectations regarding the ability of our partner, Teva, to successfully commercialize the VIBEX ^® Epinephrine Pen (“epinephrine auto injector”), and any future revenue related thereto;

•

our expectations regarding continued product development with Teva of the teriparatide multi-dose disposable pen injector and exenatide multi-dose disposable pen injector, and Teva’s ability to obtain FDA approval and AB-rating for each of those products;

•

our plans to develop a rescue pen for an undisclosed drug and our intention to enter into a separate supply agreement with Pfizer, Inc. (“Pfizer”) for the same;

•

our expectations about the timing and successful completion of the sale of our worldwide rights, including certain assets, for the needle-free auto injector device product line to Ferring International Center S.A. (together with Ferring Pharmaceuticals Inc. and Ferring B.V. individually and collectively referred to as “Ferring”);

•

our expectations about the timing and outcome of pending or potential claims and litigation, including without limitation, the pending securities class action and derivative actions;

•

our expectations regarding trends in pharmaceutical drug delivery and drug pricing;

•

our anticipated continued reliance on contract manufacturers to manufacture our and our partners’ 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;

•

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

•

timing and results of our research and development projects, including clinical trials, and our anticipated continued reliance on third parties in conducting studies, trials and other research and development activities;

•

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

•

our estimates and expectations regarding the sufficiency of our cash resources, anticipated capital requirements and our need for and ability to obtain additional financing ;

•

our expectations and estimates with regard to current accounting practices and the potential impact of new accountin g pronouncements and tax legislation;

•

our expectations regarding our financial and operating results for the year ending December 31, 2018; and

•

other statements regarding matters that are not historical facts or statements of current condition.

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 or unsuccessful marketing and commercialization efforts by us or our partners;

•

interruptions in supply or an inability to adequately manage third party contract manufacturers to meet customer supply requirements;

•

our inability to obtain or maintain adequate third-party payer coverage of marketed products;

•

the timing and results of our or our partners’ research projects or clinical trials of product candidates in development including projects with Teva and Pfizer;

•

actions by the FDA or other regulatory agencies with respect to our products or product candidates of our partners;

•

our inability to generate continued growth in product, product development, licensing and royalties;

•

the lack of market acceptance of our and our partners’ products and future revenues from these products;

•

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 or our marketing capabilities;

•

our inability to establish and maintain sales and marketing capability, effectively market our products and services or obtain and maintain arrangements with our customers, partners and manufacturers;

•

changes or delays in the regulatory review and approval process;

•

our inability to effectively protect our intellectual property;

•

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

•

our inability to attract and retain key personnel;

•

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

•

adverse economic and political conditions.

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, 2017 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 Overview and Recent Developments

Antares Pharma, Inc. (“Antares,” “we,” “our,” “us” or the “Company”) is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered parenteral pharmaceutical products and technologies. Our strategy is to identify new or existing approved drug formulations and apply our drug delivery technology to enhance the drug compounds and delivery methods. We develop, manufacture and commercialize, for ourselves or with partners, novel therapeutic products using our advanced drug delivery systems that are designed to improve safety and efficacy, reduce side effects, and enhance patient comfort and adherence. Our intramuscular and subcutaneous injection technology platforms include the VIBEX ^® and VIBEX ^® QuickShot ^® pressure-assisted auto injector systems suitable for branded and generic injectable drugs in unit dose containers as well as disposable multi-dose pen injectors. We have a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. We have formed significant strategic alliances and partnership arrangements with industry leading pharmaceutical companies including Teva, AMAG and Pfizer.

We developed XYOSTED™ (testosterone enanthate) injection, which is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone and was approved by the U.S. Food and Drug Administration (“FDA”) on September 28, 2018. XYOSTED™ is the only FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration and is approved in three dosage strengths, 50 mg, 75 mg and 100 mg. We are currently in the process of onboarding approximately 60 sales representatives and are working on our pricing, reimbursement, marketing and distribution strategies. We expect to make XYOSTED™ available to patients before the end of 2018.

We market and sell our proprietary product OTREXUP ^® (methotrexate) injection, a subcutaneous methotrexate for once weekly self-administration with an easy-to-use, single dose, disposable auto injector, 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 dosage strengths of 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg and 25 mg of OTREXUP ^® .

Through our commercialization partner Teva, we sell Sumatriptan Injection USP indicated in the U.S. for the acute treatment of migraine and cluster headache in adults. We received FDA approval of our Abbreviated New Drug Application (“ANDA”) for 4 mg/0.5 mL and 6 mg/0.5 mL single-dose prefilled syringe auto-injectors, a generic equivalent to Imitrex ^® STATdose Pen ^® . Sumatriptan Injection USP is the Company’s first ANDA approval of a complex generic and second product approved using the VIBEX ^® auto injector platform.

We developed and supply a variation of our VIBEX ^® QuickShot ^® subcutaneous auto injector for use with AMAG’s progestin hormone drug Makena ^® (hydroxyprogesterone caproate injection) under an exclusive license and development agreement. The Makena ^® subcutaneous auto injector drug-device combination product is a ready-to-administer treatment indicated to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past, which was approved by the FDA in February 2018. We are the exclusive supplier of the devices and the final assembled and packaged commercial product, which was launched in the U.S. for commercial sale by AMAG in March 2018, and we receive royalties on net sales of the product.

In collaboration with Teva, we developed and supply the device for an epinephrine auto injector product pursuant to an exclusive license, development and supply agreement. Teva’s epinephrine auto injector drug-device combination product, indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients, was approved by the FDA in August 2018 as a generic drug product with an AB rating, meaning that it is therapeutically equivalent to Mylan, Inc.’s branded products EpiPen ^® and EpiPen Jr ^® and therefore, subject to state law, substitutable at the pharmacy. Under the license development and supply agreement, Antares is responsible for supply of the device, which is sold to Teva, and Teva is responsible for commercialization and distribution of the final product for which we receive royalties on net sales. Teva has indicated it is preparing to launch the generic epinephrine auto injector product in the fourth quarter of 2018.

In August 2018, we entered into a collaboration agreement with Pfizer to develop a combination drug device rescue pen. This rescue pen will utilize the Antares QuickShot ^® auto injector and an undisclosed Pfizer drug. We will develop the product and Pfizer will be responsible for obtaining FDA approval of the combination product. We intend to enter into a separate supply agreement with Pfizer pursuant to which we will provide fully packaged commercial ready finished product to Pfizer and Pfizer will then be responsible for commercializing the product in the United States, pending FDA approval, for which the Company will receive royalties on net sales.

We are collaborati ng with Teva on a multi-dose pen for a generic form of BYETTA ^® (exenatide injection) for the treatment of diabetes, and another multi-dose pen for a generic form of Forteo ^® (teriparatide [rDNA origin] injection) for the treatment of osteoporosis. Teva cont inues to work through the regulatory process with the FDA for exenatide and teriparatide using the ANDA pathway. Teva and Eli Lilly and Company (“Lilly”) settled their Paragraph IV patent litigation related to Teva’s ANDA for teriparatide, the terms of wh ich have not been disclosed. Teva also successfully completed a decentralized procedure registration process in 17 countries in Europe for teriparatide, and is awaiting patent clearance in the EU prior to launch.

We also make reusable, needle-free injection devices that administer injectable drugs, which are currently marketed primarily through Ferring and JCR Pharmaceuticals Co., Ltd., for use with human growth hormone. In October 2017, we entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Ferring (the “Ferring Transaction”) to sell the worldwide rights, including certain assets, related to the needle-free auto injector device product line for a total purchase price of $14.5 million.

The purchase price is to be paid in four installments consisting of the following: a $2.0 million non-refundable upfront payment received upon entry into the Asset Purchase Agreement and the transfer of certain assets; a second installment of $2.75 million received in February 2018 upon delivery of certain documentation and satisfaction of certain conditions primarily related to the needle-free product manufacturing; a third installment of $4.75 million received in May 2018 upon satisfaction of certain conditions, including further document transfer, Ferring’s successful completion of a regulatory audit by a notified body, and a pilot manufacturing run under Ferring’s supervision; and a final installment of $5.0 million upon Ferring’s receipt of the CE Mark needed to continue to commercialize the needle-free product in certain territories and the final transfer of certain product-related inventory, equipment and agreements to Ferring (the “Completion Date”), which we anticipate may occur by the end of 2018. The completion of the transaction is subject to significant conditions and uncertainties, and the second and third installments are refundable to Ferring under certain circumstances if completion of the transaction does not occur within a specified timeframe. There can be no assurances that the Completion Date will occur within this estimated timeframe or at all.

We will continue to manufacture and supply needle-free devices until the Completion Date and will receive payment for devices and a royalty on net product sales in accordance with the existing license and supply agreements.

Critical Accounting Policies

Our management’s discussion and analysis of our results of operations and financial condition is based upon our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of our financial statements in accordance with GAAP requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, revenues and expenses. We have identified certain of our significant accounting policies that we believe to be the most critical to understanding our results of operations and financial condition because they require the most subjective and complex judgments. The following supplements our critical accounting policies, which are 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, 2017.

Revenue Recognition

Effective January 1, 2018, we adopted Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (Topic 606), as amended (“Topic 606”) using the modified retrospective transition method. This new standard supersedes the former revenue recognition requirements in Topic 605 Revenue Recognition (“Topic 605”). Our results of operations for reporting periods beginning on or after January 1, 2018 are presented under Topic 606, while prior period amounts, as reported, are not adjusted. The effects of the adoption of the new standard were not material to our consolidated financial statements, and the difference between the amount of revenue recognized for the three months ended September 30, 2018 under Topic 606 as compared to the amount of revenue that would have been recognized under Topic 605 was not material. The following is a summary, and the critical aspects, of our revenue recognition policy under Topic 606.

We generate revenue from proprietary and partnered product sales, license and development activities and royalty arrangements. Revenue is recognized when or as we transfer control of the promised goods or services to our customers in an amount that reflects the consideration to which we expect to be entitled to in exchange for those goods or services.

We enter into contracts with customers and partners that often contain multiple elements such as licensing, development, manufacturing and commercialization components. These arrangements are often complex and we may receive various types of consideration over the life of the arrangement, including: up-front fees, reimbursements for research and development services, milestone payments, payments on product shipments, margin sharing arrangements, license fees and royalties.

In assessing our revenue arrangements, we must identify the contract and consider whether one or more contracts or elements should be combined to form a contract, determine the transaction price including an estimation of any variable consideration we expect to receive under the contract, identify each of our performance obligations or promises of goods or services to the customer, allocate the tran saction price to each of the performance obligations, and recognize revenue when or as the performance obligations are satisfied. Each of these steps in the revenue recognition process requires management to make judgements and/or estimates. The most sign ificant judgements and estimates include: the estimation of product returns and sales allowances and other variable consideration such as expected contract margin and royalties. We base these estimates on historical experience and a review of the facts and circumstances that exist as of each reporting date.

Results of Operations

We reported a net loss of $1.9 million and $5.5 million for the three months ended September 30, 2018 and 2017, respectively, and $12.6 million and $13.0 million for the nine months ended September 30, 2018 and 2017, respectively. Net loss per share was $0.01 for the three months ended September 30, 2018 as compared to $0.03 for the three months ended September 30, 2017, and was $0.08 for both the nine months ended September 30, 2018 and 2017. Operating results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018. The following is an analysis and discussion of our operations for the three and nine months ended September 30, 2018 as compared to the same periods in 2017.

Revenues

Total revenue for the three months ended September 30, 2018 and 2017 was $17.9 million and $15.1 million, respectively, and was $44.7 million and $40.5 million for the nine months ended September 30, 2018 and 2017, respectively, representing period over period growth in total revenue of 19% and 11% for the three and nine months ended September 30, 2018, respectively. The increases in total revenue for the three and nine months ended September 30, 2018 as compared to 2017 were primarily attributable to product revenue and royalties related to sales of the Makena® auto injector product to AMAG and a $2.0 million milestone payment received from Teva in connection with the FDA approval of Teva’s epinephrine auto injector. The table below and following discussion provides additional details about the components of and changes in our revenue mix (in thousands):

	Three months ended September 30,				Nine months ended September 30,
	2018		2017		2018		2017
OTREXUP ^®	$	4,094	$	4,624	$	11,820	$	13,111
Sumatriptan Injection USP		3,983		6,375		9,438		12,264
Auto injector and pen injector devices		1,829		1,571		7,925		2,225
Needle-free injector devices and components		1,691		758		4,458		3,109
Total product sales		11,597		13,328		33,641		30,709
Licensing and development revenue		2,554		1,504		5,624		8,952
Royalties		3,717		220		5,468		815
Total revenue	$	17,868	$	15,052	$	44,733	$	40,476

OTREXUP ^®

For the three months ended September 30, 2018 and 2017, we recognized revenue of $4.1 million and $4.6 million, respectively, from sales of OTREXUP ^® , which is presented net of estimated product returns and sales allowances. The net decrease in OTREXUP ^® sales revenue for the three months ended September 30, 2018 as compared to the three months ended September 30, 2017 was primarily a result of an increase in plan rebates and other sales allowances.

For the nine months ended September 30, 2018, we recognized $11.8 million in OTREXUP ^® sales as compared to $13.1 million for the nine months ended September 30, 2017. Revenue recognized for OTREXUP ^® sales in the nine months ended September 30, 2018 was driven by an increase in unit sales in comparison to prior year; however, the overall decrease in OTREXUP ^® revenue in comparison to the nine months ended September 30, 2017 was attributable to an increase in plan rebates and other sales allowances in 2018, and the recognition of an additional $1.3 million of revenue in the first quarter of 2017 as a result of a change in estimation and recognition method for revenues that were previously deferred. Prior to the first quarter of 2017, due to lack of sufficient sales and returns history, revenue was initially deferred upon shipment to distributors and recognized based on estimated prescriptions dispensed or expiration of customer right of return. We began recognizing revenue upon delivery to distributors, net of estimated returns, in the first quarter of 2017.

Sumatriptan Injection USP

We sell, through our commercialization partner Teva, Sumatriptan Injection USP indicated in the U.S. for the acute treatment of migraine and cluster headache in adults. We recognized $4.0 million and $6.4 million for the three months ended September 30, 2018 and 2017, respectively and $9.4 million and $12.3 million for the nine months ended September 30, 2018 and 2017, respectively. The decrease in revenue for the three and nine months ended September 30, 2018 compared to 2017, respectively, is attributable to fluctuations in quantities and timing of product shipments to Teva, lower unit sales and lower contract margin recognized and received thereon.

Auto injector and pen injector devices

Product sales of auto injector devices were $1.8 million and $1.6 million for the three months ended September 30, 2018 and 2017, respectively, and $7.9 million and $2.2 million for the nine months ended September 30, 2018 and 2017, respectively. We manufacture and sell devices and device components to Teva, and fully assembled and packaged Makena ^® product to AMAG. The increase in sales of auto injector devices for the three and nine months ended September 30, 2018 as compared to the same periods in 2017 was primarily attributable to sales of Makena ^® auto injectors to AMAG, which was approved by the FDA and launched in the U.S. for commercial sale by AMAG in the first quarter of 2018, and sales of pre-commercial devices and components to Teva related to the pen injector programs. Teva’s generic epinephrine auto injector product was approved by the FDA in August 2018 and Teva has indicated it is preparing to launch the generic epinephrine auto injector product in the fourth quarter of 2018.

Needle-free injector devices and components

Revenue from reusable needle-free injector devices and disposable components was $1.7 million and $0.8 million for the three months ended September 30, 2018 and 2017, respectively, and $4.5 million and $3.1 million for the nine months ended September 30, 2018 and 2017, respectively. These revenues were generated primarily from sales to Ferring, which sells our needle-free injector for use with its hGH products in Europe, Asia and the U.S. In October 2017, we announced the sale of the worldwide rights related to the needle-free auto injector product to Ferring and anticipate that the transaction may be completed by the end of 2018. During the transfer and completion period, we will continue to manufacture and supply devices until the completion date and will receive payment for devices and a royalty on net product sales in accordance with the existing license and supply agreements. Revenue from sales of needle free injector devices and components increased for the three and nine months ended September 30, 2018 as compared to 2017 due to additional sales made to Ferring as we work toward the transfer and completion of the transaction.

Licensing and development revenue

Licensing and development revenue includes license fees received from partners for the right to use our intellectual property and amounts earned in joint development arrangements with partners under which we perform development activities or develop new products on their behalf. Licensing and development revenue was $2.6 million and $1.5 million for the three months ended September 30, 2018 and 2017, respectively, and $5.6 million and $9.0 million for the nine months ended September 30, 2018 and 2017, respectively. The increase in licensing and development revenue for the three-month period ended September 30, 2018 as compared to the same period in 2017 was principally a result of the $2.0 million milestone received from Teva in connection with the FDA approval of Teva’s epinephrine auto injector product in August 2018. The decrease in licensing and development revenue for the nine-month period ended September 30, 2018 as compared to 2017 was principally a result of a reduction in development activities with AMAG for the Makena ^® auto injector product, which was approved by the FDA in February 2018 and is now in the commercialization stage.

Royalties

Royalty revenue was $3.7 million and $0.2 million for the three months ended September 30, 2018 and 2017, respectively, and $5.5 million and $0.8 million for the nine months ended September 30, 2018 and 2017, respectively. The increase in royalty revenue was principally attributable to the launch of the Makena ^® auto injector product by AMAG in the first quarter of 2018, upon which we earn royalties based on a percentage of AMAG’s net sales of the product. We also receive royalties on sales of gel-based products commercialized through partners, and from Ferring related to needle-free injector device sales and on its sales of ZOMACTON ^TM . However, as discussed above, in October 2017 we announced the sale of the worldwide rights related to the needle-free device product line to Ferring and anticipate that the transaction may be completed by the end of 2018. During the transfer and completion period, we will continue to manufacture and supply needle-free devices until the Completion Date and will receive payment for devices and a royalty on net product sales in accordance with the existing license and supply agreements.

Cost of Re venue and Gross Profit

The following table summarizes our total revenue, cost of revenue and gross profit (in thousands):

	Three months ended September 30,						Nine months ended September 30,
	2018			2017			2018			2017
Total revenue	$	17,868		$	15,052		$	44,733		$	40,476
Total cost of revenue		7,289			8,523			21,435			20,359
Gross profit	$	10,579		$	6,529		$	23,298		$	20,117
Gross profit percentage		59	%		43	%		52	%		50	%

Our gross profit was $10.6 million and $6.5 million for the three months ended September 30, 2018 and 2017, respectively, and $23.3 million and $20.1 million for the nine months ended September 30, 2018 and 2017, respectively. The increase in our gross profit was primarily attributable to an increase in royalties received from sales of Makena ^® auto injectors and a $2.0 million license and development milestone received from Teva in connection with the FDA approval of the epinephrine auto injector product, both of which have no associated costs, offset by a decrease in our product gross profit. Product revenue, cost of sales and gross profit are summarized in the following table (in thousands):

	Three months ended September 30,						Nine months ended September 30,
	2018			2017			2018			2017
Product sales	$	11,597		$	13,328		$	33,641		$	30,709
Cost of product sales		6,982			7,600			20,195			16,682
Product gross profit	$	4,615		$	5,728		$	13,446		$	14,027
Product gross margin percentage		40	%		43	%		40	%		46	%

Product gross profit decreased for the three and nine months ended September 30, 2018 as compared to the same periods in 2017, primarily due to lower net revenue from OTREXUP ^® sales, lower contract margin received from Teva on sales of Sumatriptan Injection USP, and an increase in sales of Makena ^® auto injectors to AMAG, which have a lower product sales margin than our proprietary products and provide for back-end royalties on net sales made by AMAG. The cost of product sales includes product acquisition costs from third-party manufacturers and internal manufacturing and overhead expenses.

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. 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 and development activities for the Makena ^® auto injector with AMAG.

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 our research and development activities. Research and development expenses were $3.6 million and $3.3 million for the three months ended September 30, 2018 and 2017, respectively, and $10.6 million and $9.5 million for the nine months ended September 30, 2018 and 2017, respectively. The increase in research and development costs on a comparative basis is primarily due to additional spending associated with undisclosed potential new products and post-CRL activities for XYOSTED ^TM , which was approved by the FDA on September 28, 2018.

Selling, General and Administrative

Selling, general and administrative expenses were $8.3 million and $8.2 million for three months ended September 30, 2018 and 2017, respectively, and $23.6 million and $23.0 million for the nine months ended September 30, 2018 and 2017, respectively. The increase in selling, general and administrative expenses was attributable to an increase in compensation and benefits expense, primarily related to annual salary increases and non-cash stock-based compensation, including performance-based awards for executives.

Liquidity and Capital Resources

At September 30, 2018, we had cash and cash equivalents of $28.2 million. Our principal liquidity needs are to fund the commercial launch of XYOSTED ^TM and our ongoing research and development activities, and for the payment of other operating expenses. We have not historically generated, and do not currently expect to generate, enough revenue or operating cash flow to sustain or grow our operations and we expect to continue to support our operations by raising capital. Our primary sources of liquidity are cash receipts from sales, proceeds from equity offerings and debt issuance. We believe that the combination of our current cash and cash equivalents, projected product sales, development revenue milestones and royalties will provide us with sufficient funds to meet our obligations and support operations through at least the next twelve months from the date of this report.

Long-Term Debt Financing

In June 2017, we entered into a loan and security agreement for a term loan of up to $35.0 million (the “Term Loan”), the proceeds of which are to be used for working capital and general corporate purposes. The first advance of $25.0 million was funded upon execution of the Loan Agreement in June 2017. Payments under the Loan Agreement are interest only until the first principal payment is due on August 1, 2019, provided that the interest only period may be extended to February 1, 2020 if the certain corporate milestones are achieved. The Loan Agreement also requires us to pay a fee equal to 4.25% of the total original principal amount of all term loan advances, which is due upon repayment of the Term Loan at either maturity or earlier repayment.

At the Market Common Stock Offering Program

In August 2017, we entered into a sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”) under which we may offer and sell, from time to time at our sole discretion, shares of common stock having an aggregate offering price of up to $30.0 million through Cowen as our sales agent and/or principal . Cowen may sell the common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 of the Securities Act of 1933, as amended. We will pay Cowen a commission of 3.0% of the gross sales proceeds of any common stock sold through Cowen under the Sales Agreement. We are not obligated to make any sales of our common stock under the Sales Agreement and as of the date of this report we have not sold any common stock pursuant to the Sales Agreement.

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 expenses, research and development projects, 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 $10.2 million for the nine months ended September 30, 2018 and $15.5 million for the nine months ended September 30, 2017. The net cash used in operating activities was primarily driven by our net loss, inventory build, changes in accounts receivable and deferred revenue, and other changes in operating assets and liabilities due to timing of cash receipts and cash payments.

Net Cash Flows from Investing Activities

Net cash provided by investing activities was $11.9 million for the nine months ended September 30, 2018 as compared to net cash used in investing activities of $10.9 million for the nine months ended September 30, 2017. The net cash inflow for the nine months ended September 30, 2018 was attributable to the receipt of $7.5 million in connection with the Ferring Transaction and proceeds from maturities of investments of $5.0 million offset by payments for capital expenditures and patent acquisition costs. The cash outflow for the nine months ended September 30, 2017 was attributable to purchases of investment securities of $10.0 million and payments for capital expenditures and patent acquisition costs.

Net Cash Flows from Financing Activities

The net cash flows used in financing activities was $0.2 million for the nine months ended September 30, 2018, and consisted of cash proceeds received from the exercise of stock options offset by amounts remitted to taxing authorities in connection with net-share settled awards for which we withheld shares equivalent to the value of the employees’ minimum statutory obligation for the applicable income and other employment taxes. Cash provided by financing activities for the nine months ended September 30, 2017 was $26.1 million, which included $25.0 million in proceeds from the issuance of long-term debt and $1.6 million received in connection with the exercise of stock options, net of payments for debt issuance costs of $0.3 million and $0.2 million remitted to taxing authorities in connection with net-share settled equity awards.

Contractual Obligations

There have been no changes or material modifications to our contractual obligations as presented in our Annual Report on Form 10-K as of and for the year ended December 31, 2017.

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.

Research and Development Programs

Our research and development programs consist primarily of clinical, regulatory, formulation development, engineering, device development and commercial development activities for our current products , next generation versions of current products, and new proprietary and partnered products and technologies in development . Our internal research and development team works with external consultants, industry experts, physicians and other medical personnel in an effort to drive a robust product development pipeline. We also have a business development team that actively seeks and evaluates product opportunities and business alliances. In addition, our clinical, quality and regulatory teams are committed to verifying and maintaining the safety and efficacy of our products according to regulatory standards enforced by the FDA and other international regulatory bodies . The following is a discussion of our significant research and development programs.

XYOSTED™ (testosterone) injection . We developed XYOSTED™ (testosterone enanthate) injection for self-administered weekly injections of testosterone enanthate in a preservative-free formulation indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. XYOSTED™ was approved by the FDA on September 28, 2018 and is the only FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration. XYOSTED™ is approved in three dosage strengths, 50 mg, 75 mg and 100 mg.

As a post-marketing requirement, the FDA has asked us to conduct a label comprehension study that assesses patients’ understanding of key risk messages in the Medication Guide for XYOSTED™ and a study of testosterone replacement therapy in pediatric males ages 14 years and older for conditions associated with a deficiency or absence of endogenous testosterone. The label comprehension study must be completed by 2020 and the pediatric study must be completed by the end of 2026. The conduct of these studies will require a dedication of funds and resources.

Partnered Development Projects . We have entered into license and development agreements and collaboration arrangements with our pharmaceutical partners Teva and Pfizer to conduct research and development activities related to our VIBEX ^® disposable pressure assisted auto injectors and our disposable pen injectors to be used in drug/device combination products. The development programs consist of various activities including 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 stages for each of the partnered products in development.

VIBEX ^® auto injector with epinephrine

We, in collaboration with Teva, developed a VIBEX ^® auto injector device for a product containing epinephrine. Teva was responsible for development work on the drug epinephrine, and we were responsible for development of the device. Teva filed an ANDA for the VIBEX ^® epinephrine pen as a generic substitute of Mylan’s branded product, EpiPen ^® , which was as approved by the FDA in August 2018 as a generic drug product with an AB rating, meaning that it is therapeutically equivalent to Mylan, Inc.’s branded products EpiPen ^® and EpiPen Jr ^® and therefore, subject to state law, substitutable at the pharmacy. Teva has indicated it is preparing to launch the generic epinephrine auto injector product in the fourth quarter of 2018.

Exenatide multi-dose disposable pen injector

We designed and produced, under a license, development and supply agreement with Teva, a multi-dose disposable pen injector for use with a generic form of BYETTA ^® (exenatide injection) for the treatment of diabetes. Teva is working through the U.S. regulatory approval process for its exenatide pen using the ANDA pathway.

Teriparatide multi-dose disposable pen injector

We also designed and produced for Teva another multi-dose disposable pen for a generic form of Forteo ^® (teriparatide [rDNA origin] injection) for the treatment of osteoporosis. Teva is working through the U.S. regulatory approval process for a generic version of Forteo ^® (teriparatide [rDNA origin] injection) using the ANDA pathway. Teva and Lilly settled their Paragraph IV patent litigation, the terms of which have not been disclosed. Teva also successfully completed a decentralized procedure registration process in 17 countries in Europe for teriparatide, and is awaiting patent clearance in the EU prior to launch .

Rescue pen (undisclosed drug)

Other Research and Development Costs. In addition to our development of XYOSTED ^TM and our device development projects with Teva and Pfizer, we incur direct costs associated with other internal research and development projects and indirect costs that include personnel costs, administrative and other operating costs related to managing our research and development activities.

Recently Issued Accounting Pronouncements Not Yet Adopted

In February 2016, the Financial Accounting Standards Board issued Accounting Standard Update (“ASU”) No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). This new standard requires entities to recognize on its balance sheet assets and liabilities associated with the rights and obligations created by leases with terms greater than twelve months. This new standard is effective for annual reporting periods beginning after December 15, 2018, and interim periods within those annual periods and early adoption is permitted. We are in the process of evaluating the impact that the adoption of ASU 2016-02 will have on our consolidated financial statements and currently expect that most of our operating lease commitments will be subject to the new standard and recognized as operating lease liabilities and right-of-use assets upon our adoption of ASU 2016-02 effective January 1, 2019.

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. 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 period ended September 30, 2018 was not material.

We may be exposed to interest rate risk and interest rate fluctuations as a result of our long-term debt financing we obtained in June 2017. Our Term Loan, with a current outstanding principal of $25.0 million accrues interest at a calculated prime-based variable rate with a maximum interest rate of 9.50%, which was the rate in effect as of September 30, 2018.

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 Financ ial 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.

PART II - OTHER INFORMATION

Item 1.

LEGAL PROCEEDINGS

On October 23, 2017, Randy Smith filed a complaint in the District of New Jersey , captioned Randy Smith, Individually and on Behalf of All Others Similarly Situated v. Antares Pharma, Inc., Robert F. Apple and Fred M. Powell (“Smith”) , Case No. 3:17-cv-08945-MAS-DEA, on behalf of a putative class of persons who purchased or otherwise acquired Antares securities between December 21, 2016 and October 12, 2017, inclusive, asserting claims for purported violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 against Antares, Robert F. Apple and Fred M. Powell. The Smith complaint contends that defendants made false and/or misleading statements and/or failed to disclose that: (i) Antares had provided insufficient data to the FDA in connection with the NDA for XYOSTED ^TM ; and (ii) accordingly, Antares had overstated the approval prospects for XYOSTED ^TM . On July 27, 2018, the court entered an order appointing Serghei Lungu as lead plaintiff, Pomerantz LLP as lead counsel, and Lite DePalma Greenberg, LLC as liaison counsel for plaintiff. On August 3, 2018, the parties submitted a stipulation and proposed order, setting forth an agreed-upon schedule for responding to the complaint, which the court granted. Pursuant to that order, plaintiff filed a Consolidated Amended Class Action Complaint on October 9, 2018 and defendants intend to file a motion to dismiss on or before November 26, 2018. The Company believes that the claims in the Smith action lack merit and intends to defend them vigorously.

On January 12, 2018, a stockholder of our Company filed a derivative civil action, captioned Chiru Mackert, derivatively on behalf of Antares Pharma, Inc., v. Robert F. Apple, et al. (“ Mackert ”), in the Superior Court of New Jersey Chancery Division, Mercer County (Case No. C-000011-18). On January 17, 2018, another stockholder filed a derivative action in the same court, captioned Vikram Rao, Derivatively on Behalf of Antares Pharma, Inc. v. Robert F. Apple, et al. (“ Rao ”) (Case No. C-000004-18). Both complaints name Robert F. Apple, Fred M. Powell, Thomas J. Garrity, Jacques Gonella, Anton Gueth, Leonard S. Jacob, Marvin Samson and Robert P. Roche, Jr. as defendants, and the Company as nominal defendant, and they assert claims for breach of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement, and waste of corporate assets arising from the same facts underlying the Smith securities class action. The plaintiffs seek damages, corporate governance and internal procedure reforms and improvements, restitution, reasonable attorneys’ fees, experts’ fees, costs, and expenses. The parties have filed a stipulation consolidating the two actions and staying the proceedings pending the court’s decision on defendants’ anticipated motion to dismiss the Smith action.

On January 17, 2018, a stockholder of our Company filed a derivative civil action, captioned Robert Clark, Derivatively on Behalf of Antares Pharma, Inc. v. Robert F. Apple, et al. (“ Clark ”) (Case No. 3:18-cv-00703-MAS-DEA), against Robert F. Apple, Thomas J. Garrity, Jacques Gonella, Leonard S. Jacob, Marvin Samson, Anton G. Gueth and Robert P. Roche, Jr. as defendants, and Company as a nominal defendant. The action was filed in the U.S. District Court for the District of New Jersey and asserts claims for breach of fiduciary duties, unjust enrichment, abuse of control, waste of corporate assets, and a violation of Section 14(a) of the Securities Exchange Act of 1934. This complaint relates to the same facts underlying the Smith securities class action and the other derivative actions. The plaintiff in Clark seeks damages, corporate governance and internal procedure reforms and improvements, reasonable attorneys’ fees, accountants’ and experts’ fees, costs, and expenses. The parties have filed a stipulation staying the action pending the court’s decision on defendants’ anticipated motion to dismiss the Smith action.

Item 1A.

RISK FACTORS

In addition to the 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, 2017, 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 discussed below are not the only risks we face. 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.

Risks Related to Our Operations

We have limited sales and marketing experience and limited experience working with payers on coverage issues, and we can provide no assurance on the successful launch and commercialization of our products.

We have limited sales and marketing experience, and limited experience working with payers on coverage issues. The launch and successful commercialization of a new product requires substantial dedication of financial and other resources and include steps related to manufacturing, logistics, sales and marketing, and establishing insurance coverage and reimbursement. We launched OTREXUP ^® in February 2014, and are in the process of launching XYOSTED™. Although we have hired and expect to continue to hire highly qualified personnel with specialized expertise, as a company, we have limited experience commercializing pharmaceutical products on our own. In order to commercialize our products, we have built and expect to continue to build our sales, marketing, distribution, managerial and other non-technical capabilities and have made and expect to continue to make arrangements with third parties to perform these services when needed. In January 2015, we hired sales representatives and district managers to fill our sales territories for OTREXUP ^® . In connection with the launch of XYOSTED™, we will begin the process of onboarding approximately 60 sales representatives and are working on our pricing, reimbursement, marketing and distribution strategies.

If we are unable to successfully implement our sales and marketing plans and drive adoption by patients and physicians of our products through our sales, marketing and commercialization efforts, then we may not be able to generate sustainable revenues growth from product sales which will have a material adverse effect on our business and future product opportunities.

Similarly, we may not be successful in maintaining the necessary commercial infrastructure, including sales representatives, managed care, medical affairs and pharmacovigilance teams. The development of commercialization capabilities to market of our products has been and will continue to be expensive and time-consuming. As we continue to develop, maintain and grow these capabilities, we will have to compete with other pharmaceutical companies to recruit, hire, train and retain sales and marketing personnel. If we have underestimated the necessary sales and marketing capabilities or have not established the necessary infrastructure to support successful commercialization, or if our efforts to do so take more time and expense than anticipated, our ability to market and sell any drug products may be adversely affected.

There is no guarantee that patients and healthcare providers will adopt our or our partners’ products, and that we and our partners will be able to receive adequate payer coverage and reimbursement. New information concerning our or our partners’ products learned through required post-approval studies and product use may also result in changes to our or our partners’ products. Should any of these events occur, they could have a material and adverse effect on our operations and business.

There is no guarantee that patients and healthcare providers will adopt any newly approved products, or that insurers will provide adequate coverage and reimbursement. Any labeled limitations on the use of a product or warnings could discourage adoption of the product by patients, healthcare providers, and insurers. By example, the XYOSTED™ label includes a boxed warning concerning blood pressure increases that can increase the risk for major adverse cardiovascular events. Teva’s epinephrine auto injector drug-device combination product is also subject to certain labeled warnings. These could ultimately discourage patients from using and healthcare providers from prescribing our and our partners’ products.

Moreover, we and our partners may experience a delay in receiving coverage and reimbursement for any new products or may not receive adequate levels of coverage or reimbursement at all. Product labeling restrictions and warnings may also discourage payers from providing adequate levels of coverage and reimbursement. We and our partners, accordingly, may need to take steps to assist patients to afford our products, such as offering bridge programs, free-trial, discounts, rebates and co-pay coupon programs. These programs, however, may not ultimately be successful.

If patients and healthcare providers do not adopt any new product, or if insurers restrict patient access or disadvantage our or our partners’ products in their formularies or otherwise do not provide adequate coverage and reimbursement, we and our partners may not be able to generate sustainable revenues growth from product sales and royalties which will have a material adverse effect on our business and future product opportunities.

Any post-approval requirements, including phase IV studies and Risk Evaluation and Mitigation Strategies, or REMS, may also require the dedication of substantial time and resources. By example, as a post-marketing requirement for XYOSTED™, the FDA has asked us to conduct a label comprehension study that assesses patients’ understanding of key risk messages in the Medication Guide for XYOSTED™ and a study of testosterone replacement therapy in pediatric males ages 14 years and older for conditions associated with a deficiency or absence of endogenous testosterone. The label comprehension study findings may result in revisions to the Medication Guide to optimize patients’ understanding of important risks of XYOSTED™ and potentially other label restrictions. Additionally, the outcome of any post-approval studies, including the pediatric study, is uncertain and may not result in

an expanded label indication or could result in additional labeling requirements or other post-approval restrictions or regulatory act ions. The label comprehension study must be completed by 2020 and the pediatric study by the end of 2026. The conduct of these studies will require dedication of funds and resources.

Additionally, use of our or our partners’ products by patients and in phase IV and post-marketing studies may result in the discovery of new information concerning the products. By example, the products may be found to be less effective than initially demonstrated, or new, more severe, or more frequent adverse events or side effects may be reported. This may result in regulatory or other actions, including, product liability actions, enforcement actions, distribution and manufacturing restrictions, changes to product labeling and promotional materials, the imposition of post-market requirements, such as REMS or additional phase IV studies, withdrawal of marketing application approvals, withdrawal of the product from the market, refusal to approve new marketing applications or supplements, product recalls, clinical holds and suspension of clinical studies, safety alerts, dear healthcare provider letters, adverse publicity, and reimbursement and insurance coverage consequences, among others. Should any of these events occur, they could have a material and adverse effect on our operations and business.

If we or our partners are unable to achieve and maintain adequate levels of coverage and reimbursement for our or our partners’ products or any of our or our partners’ future products for which we or our partners receive regulatory approval, their commercial success may be severely hindered.

Successful sales of our products depend on the availability of adequate coverage and reimbursement from third-party payers. Patients who are prescribed medicine for the treatment of their conditions generally rely on third-party payers to reimburse all or part of the costs associated with their prescription drugs. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payers is critical to new product acceptance. Coverage decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become available. Assuming coverage is approved, the resulting reimbursement payment rates might not be adequate or may require co-payments that patients find unacceptably high. Patients are unlikely to use our products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products.

In addition, the market for our products will depend significantly on access to third-party payers' drug formularies, or lists of medications for which third-party payers provide coverage and reimbursement. Health plans often used tiered formularies that prefer one branded product in a therapeutic class over another through different patient co-payment amounts, and disadvantaging some products through techniques such as step therapy and prior authorization. Many states use formularies and preferred drug lists to obtain supplemental Medicaid rebates in excess of those required for Medicaid coverage. The industry competition to be included in such formularies and not disadvantaged often leads to downward pricing pressures on pharmaceutical companies. Also, third-party payers may refuse to include a particular branded drug in their formularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent or other alternative is available. Additionally, certain third-party payers restrict or block access to patients for new products until a clinical review has occurred or clinical evidence is provided to support the benefits for covered patients. These restrictions may be imposed for months or longer and some third-party payers may refuse to add new products to their formularies or otherwise restrict patient access. To ensure sales, manufacturers often must provide multiple discounts on the same drug in the chain of distribution to the health care provider and the payer. Further, manufacturers are required to assume responsibility for Medicare Part D prescription costs for innovator drugs and biologics and authorized generics while the beneficiary is in the coverage gap. Increasingly, payers are looking for metrics and performance-based pricing to justify increased cost of therapeutic advancements. Even if coverage is obtained, the net realization from price concessions may negatively impact our profitability. Government health programs also impose inflation penalties which may have adverse consequences if we increase prices in the future.

Our partnered products encounter similar issues in obtaining reimbursement from third-party payers. While we are unable to control the reimbursement rate or discounts contracted with third-party payers by our partners, these rates ultimately affect our profit sharing on Sumatriptan Injection USP and royalties on products such as the Makena ^® Subcutaneous Auto-Injector, the Teva epinephrine auto injector drug-device combination product, Elestrin ^® and Gelnique ^® .

Third-party payers, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In addition, in the U.S., no uniform policy of coverage and reimbursement for drug products exists among third-party payers. Therefore, coverage and reimbursement for drug products can differ significantly from payer to payer.

Further, we believe that future coverage and reimbursement will likely be subject to increased restrictions both in the U.S. and in international markets. Third-party coverage and reimbursement for OTREXUP ^® , XYOSTED™ or any of our other products and product candidates for which we may receive regulatory approval may not be available or adequate in either the U.S. or international markets, which could have a material adverse effect on our business, results of operations, financial condition and prospects.

We depend on Teva to manufacture the drug and finished packaged product and to distribute and commercialize the epinephrine auto-injector in the U.S .

We have entered into a license, development and supply agreement with Teva, pursuant to which Antares developed and is the exclusive supplier of the device for an epinephrine auto injector product to be marketed by Teva in the U.S. Teva’s ANDA for a generic epinephrine auto injector drug-device combination product was approved by the FDA in August 2018 and Teva is preparing for a launch of the product.

There is no guarantee that our partnership with Teva will be successful. Teva controls the manufacture and supply of the drug, epinephrine, and the final assembly of the devices and packaging of the finished product, and has complete control over the launch and continuous commercialization and sale of the epinephrine auto injector product. If, at any time, Teva ceases to manufacture and supply the epinephrine drug or fails to produce sufficient supplies of the drug, Teva will be unable to produce a finished product and we may be unable to sell our auto injectors for this product to Teva resulting in less revenue for us.

In addition, if Teva is unable to complete the final assembly and packaging of the finished epinephrine auto injector product, we may receive less revenue than desired or expected. If Teva is unable to produce sufficient supplies of the drug or finished epinephrine auto injector product in accordance with cGMPs, Teva may be subject to regulatory enforcement action. We will also rely on Teva to commercialize and distribute the product, including determining the price and payer coverage. If Teva is unsuccessful in commercializing the product, the resulting revenue may be lower than expected. Additionally, Teva controls the business strategy, manufacturing and distribution decisions concerning the epinephrine auto injector product. Such decisions by Teva may be beyond our control and may impact the success of the epinephrine auto injector product. As a result, we may receive less revenue than desired or expected.

Further, Teva is subject to potential competition regarding another generic version of the epinephrine auto injector product, such additional competition could result in receiving less revenue than expected.

We rely on third parties to manufacture our and our partners’ products. If we do not develop and maintain relationships with manufacturers and/or assemblers of our and our partners’ drug/device products or product candidates, or if such third parties are unable to manufacture or supply product, or assemble and package the final products, we may be unable to successfully manufacture, assembly, package and sell our and our partners’ products, which could have a material adverse effect on our business.

We do not possess the facilities to manufacture commercial quantities of our or our partners’ drug/device combination products or components, including OTREXUP ^® , XYOSTED ^TM , VIBEX ^® Sumatriptan Injection USP, epinephrine auto-injector devices, Makena ^® auto injectors or any other of our or our partners’ products or product candidates. We also do not possess the facilities to manufacture clinical supplies of any product candidates or components. We must contract with third parties to produce products, components, and product candidates and to assemble and package products and components according to specifications and government regulations. The future development and delivery of our and our partners’ products and product candidates depends on the capability, timely, profitable and competitive performance of these third parties. There is also no assurance that such third parties will be willing to manufacture, assemble or sell the drug/device products or components. A limited number of manufacturers exist that are capable of manufacturing our and our partners’ products, components, and product candidates. We and our partners may fail to contract with the necessary third parties or we and our partners may contract with third parties on terms that may not be favorable to us.

Our and our partners’ contract manufacturers must comply with all applicable manufacturing requirements, including cGMPs for drug products and QSRs for medical devices. Before approving any marketing application, FDA will inspect the product manufacturing facilities. We and/or our partners must obtain FDA approval for a product’s or product candidate’s manufacturing process and facilities to receive product marketing approval, which we and/or our partners may never obtain or may not be able to maintain. Moreover, following product approval, FDA regularly also inspects drug and device manufacturers to ensure continued compliance with FDA’s requirements. If we or our partners are not able to obtain or maintain this approval and regulatory compliance, we and/or they would not be able to receive product approval, and commercialize and/or sell the applicable products. Moreover, should any manufacturer fail to comply with the applicable regulatory requirements, we, our partners, and/or the manufacturer may face regulatory consequences, including enforcement actions and/or product recalls. Additionally, use of contract manufacturers exposes us to risks in the manufacturer's business such as their potential inability to perform from a technical, operational or financial standpoint. Failure by a contract manufacturer to supply product, could have a material adverse effect on our ability to generate revenue and profit.

In addition, contract manufacturers may utilize their own technology, technology developed by us, technology developed by our partners, or technology acquired or licensed from third parties. When contract manufacturers develop proprietary process technology, our reliance on such contract manufacturers is increased. Technology transfer from the original contract manufacturer may be required. Any such technology transfer may also require transfer of requisite data for regulatory purposes, including information contained in a proprietary drug or device master file held by a contract manufacturer. We and/or our partners would be dependent on

the contract manufacturer for the maintenance and right of reference to the drug or device master file. If the contract manufacturer fails to maintain a drug or device master file or withdraws our or our partners’ right of reference, we and/or our partners may no longer be able to manufacture, develop, market, and sell our or our partners’ products or product candidates. F DA approval of the new manufacturer and manufacturing site, as well as certain changes to the manufacturing process, would also be required.

We rely on multiple commercial supply arrangements with third-party manufacturers for, including, without limitation:

•

the production and supply of the methotrexate, sumatriptan and testosterone drug substance in pre-filled syringes;

•

the manufacture of prefillable syringes;

•

the manufacture of device components;

•

the manufacture and partial assembly of VIBEX ^® and Quickshot auto injectors; and

•

the final assembly and packaging of our products and product candidates and our certain of partners’ products and product candidates.

Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured products ourselves, including:

•

reliance on the third party for regulatory compliance, quality assurance and adequate training in management of manufacturing staff;

•

the possible breach of the manufacturing agreement or purchase orders by the third party because of factors beyond our control;

•

failure to supply adequate quantities of product or product candidates or failure to supply product or product candidates meeting the required product specification or other manufacturing requirements; and

•

the possibility of termination or non-renewal of the agreement or purchase orders by the third party, based on its own business priorities, at a time that is costly or inconvenient for us.

We and our partners depend on these third-party manufacturers to comply with cGMPs/QSRs enforced by the FDA and other regulatory requirements and to deliver materials on a timely basis. To the extent that a contract manufacturer cannot deliver adequate quantities of clinical supplies, our or our partners’ product development efforts may be delayed. To the extent that a contract manufacturer cannot deliver adequate quantities of commercial products, our commercialization efforts would be inhibited and as a result our revenue and profit may be adversely impacted. In addition, because regulatory approval to manufacture a drug is site-specific, the FDA and other regulatory authorities will repeatedly inspect our and our partners’ current and future third-party manufacturers’ facilities for compliance with cGMPs/QSRs. If we, our partners, or third-party manufacturers fail to comply with applicable regulatory requirements, a regulatory agency may issue warning letters or suspend or withdraw our regulatory approval for approved or in-market products, refuse to approve any marketing applications, or refuse to allow future or current development of product candidates, among other things. Our third-party manufacturers may also fail to pass the audits by our or our partners’ internal quality and regulatory group. Any of these actions could delay or prevent our development of products, delay or prevent the submission of these products for regulatory approval, delay or prevent marketing approval, or result in insufficient product or product candidate quantity to support commercial demand or development. We may also be required to replace manufacturers, which would be time consuming and expensive, and we may not be able to reach favorable agreements with or FDA approval for alternative manufacturers. As a result, our business, financial condition and results of operations could be seriously harmed. See additional risk factors associated with manufacturing in the section “Risks Related to Regulatory Matters.”

In addition, we may consider entering into additional manufacturing arrangements with third party manufacturers. In each case, we will incur significant costs in obtaining the regulatory approvals and taking the other steps necessary to begin commercial production by these manufacturers.

Item 2. UNREGISTERED SALES OF EQUI TY SECURITIES AND USE OF PROCEEDS

None.

Item 3.

DEFAULT UPON SENIOR SECURITIES

None.

Item 4.

MINE SAF ETY DISCLOSURES

Not applicable.

Item 5.

OTHER INFORMATION

None.

Item 6.

EXHIBITS

(a)	Exhibit Index

Exhibit No.		Description

10.1#		Employment Agreement dates as of August 6, 2018 between Antares Pharma, Inc. and James P. Tursi, M.D.

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, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

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, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

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, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

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, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

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.

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 6, 2018		/s/ Robert F. Apple
		Robert F. Apple
		President and Chief Executive Officer
		(Principal Executive Officer)

November 6, 2018		/s/ Fred M. Powell
		Fred M. Powell
		Executive Vice President and Chief Financial Officer
		(Principal Financial and Accounting Officer)

Exhibit 10.1

ANTARES PHARMA, INC.

EMPLOYMENT AGREEMENT

THIS EMPLOYMENT AGREEMENT (this “ Agreement ”) is made and entered into on this 25th day of July, 2018, effective as of the 6th day of August 2018 (the “ Effective Date ”) by and between Antares Pharma, Inc., a Delaware corporation (the “ Company ”), and James P. Tursi, M.D. (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 Executive Vice President, Head of Research and Development, Chief Medical 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 interfe re with or conflict with his obligations to the Company hereunder, including, without limitation, obligations pursuant to Section 6 below. Effective as of the Effective Date, Executive currently participates in the outside activities specified on Schedule 1 and agrees that his participation in such activities do not and will not violate the terms of this Agreement, including, without limitation, the terms set forth in this Section 1(c) and Section 6 below.

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

2. Compensation .

(a) Base Salary . During the Term, the Company shall pay the Executive a base salary (“ Base Salary ”) at the annual rate of $425,000, 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. Notwithstanding the foregoing, any increase in the Executive’s Base Salary for calendar year 2019 will be multiplied by a fraction, the numerator of which is the number of whole months during which the Executive was employed by the Company during calendar year 2018 and the denominator of which is twelve (12).

(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 forty-five percent (45%) 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. Notwithstanding the foregoing, any Annual Bonus for calendar year 2018 will be multiplied by a fraction, the numerator of which is the number of days during which the Executive was employed by the Company during calendar year 2018 and the denominator of which is three hundred sixty-five (365).

(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 thirty-three and one-third percent (33-1/3%) vests annually until the option is fully vested.

(ii) In addition, during the Term and commencing with calendar year 2019, 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 Equity 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 five (5) 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-five percent (45%) 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 Executive Vice President, Head of Research and Development, Chief Medical 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 (for the avoidance of doubt, a change in Executive’s title that removes either Head of Research and Development or Chief Medical Officer responsibilities shall not give rise to the right to resign for Good Reason hereunder); (iv) a material change in the geographic location at which Executive must perform services that results in the relocation of Executive’s principal business location to a location that is sixty (60) miles or more from 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 e vent 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 Agreeme nt.

(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).

(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, 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 emp loyment 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 reimbursement for medical and dental coverage under this subsection 3(c)(iii)). 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 executes 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 requi rements 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 o f 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 acc rued 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 perform ing 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, independen t 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 280G . In the event that it shall be determined that any payment or distribution in the nature of compensation (within the meaning of section 280G(b)(2) of the Internal Revenue Code of 1986, as amended (the “ Code ”)) to or for the ben efit 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 provid e 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 t his 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 a n 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 t en (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 of the Code, 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. 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 of nonqualified deferred compensation subject to section 409A of the Code, and if a payment of nonqualified deferred compensation subject to section 409A of the Code 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. All reimbursements and in-kind benefits provided un der 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 shor ter 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 Section 6(g) 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 Section 6(g) 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, wi thout 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 one percent (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 Section 6(g) 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 Section 6(g) 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 Section 6(g) 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, p roviding 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, i ncluding 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 “ Re gulators ”), or from making other disclosures that are protected under the whistleblower provisions of state or federal law or regulation. This Agreement does not limit the Executive’s right to receive an award from any Regulator that provides awards for p roviding 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 uniq ue 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 re lief, 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 lega l 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 ack nowledges 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, effective August 6, 2018, 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 elec ts 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.

16. 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.

17. 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.

18. Counterpart s. This Agreement may be executed in 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.

19. 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.

20. 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/ James P. Tursi
James P. Tursi, M.D.

Exhibit 10.1

Schedule 1

Outside Activities

Agile Therapeutics – Executive is member of the Board of Directors

CV Consulting – Executive owns 33% of the company, but does not provide any services to the company

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 James P. Tursi, M.D. (the “ Executive ”).

RECITALS

WHEREAS , pursuant to the terms of an Employment Agreement, effective as of August 6, 2018, entered into by and between the Company and Executive (the “ Employment Agreement ”), Executive has been employed as the Company’s Executive Vice President, Head of Research and Development, Chief Medical 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 effective August 6, 2018 (defined in Section 6(a) of the Employment Agreement) and the restrictive covenants

and representat ions 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, 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 reimbursement 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 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 Termin ation 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 and the Release, (ii) revokes the release of claims in accordance with the Release, or (iii) violates any of the terms and conditions set forth in this A greement.

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 effective August 6, 2018) 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 withho ld 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.

10. 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 o r 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.

11. 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 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.

(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.

12. 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.

13. 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.

14. 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.

15. 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:


JAMES P. TURSI, M.D.

Exhibit A

GENERAL RELEASE OF CLAIMS

In consideration of the severance benefits payable to James P. Tursi, M.D. (“ 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 s hall 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.

(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, Executive 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:


James P. Tursi, M.D.	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 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, respondi ng 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 gov ernment 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 Gen eral (collectively, the “Regulators”), or from making other disclosures that are protected under the whistleblower provisions of state or federal law or regulation. This Agreement does not limit my right to receive an award from any Regulator that provide s 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 I do not need to notify the Company that I have engaged in such conduct.

(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, s upplies, 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.



Effective Date:		August 6, 2018


Employee Signature:

Employee Name:
			Printed or typed


ACCEPTED AND AGREED TO:
ANTARES PHARMA, INC.

By:
	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, 2018 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;

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:

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;

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;

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

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):

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

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 6, 2018

/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, 2018 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;

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):

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 6, 2018

/s/ Fred M. Powell

Fred M. Powell

Executive 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, 2018 (the “Report”).

The undersigned hereby certifies that:

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

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 6th day of November, 2018.

/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, 2018 (the “Report”).

The undersigned hereby certifies that:

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

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 6th day of November, 2018.

/s/ Fred M. Powell

Fred M. Powell

Executive Vice President and Chief Financial Officer