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

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

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

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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~~Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the ~~registrant’s Common Stock, $.01~~Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☐ No ☐

As of August 1, 2021, the registrant had 169,967,638, shares of common stock, $0.01 par value ~~as of November 1, 2017 was~~ ~~156,674,504~~.

	September 30,			December 31,
	2017			2016			June 30,			December 31,
	(Unaudited)						2021			2020
Assets
Current Assets:
Cash and cash equivalents	$	27,433,489		$	27,714,588		$	45,126		$	53,137
Short-term investments		9,976,984			—
Accounts receivable		10,146,966			9,073,173			54,224			42,221
Inventories		7,942,376			5,326,962			18,644			18,216
Deferred costs		1,213,507			1,773,446
Contract assets								5,725			8,140
Prepaid expenses and other current assets		1,680,208			1,376,299			4,244			4,877
Total current assets		58,393,530			45,264,468			127,963			126,591
Equipment, molds, furniture and fixtures, net		17,296,719			17,867,412
Patent rights, net		1,630,785			2,044,608
Goodwill		1,095,355			1,095,355
Deferred tax assets, net								45,249			46,982
Property and equipment, net								25,590			24,020
Operating lease right-of-use assets								4,014			4,621
Intangibles, net								7,280			7,693
Other assets		53,778			53,607			2,523			2,624
Total Assets	$	78,470,167		$	66,325,450		$	212,619		$	212,531
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable	$	8,245,154		$	7,884,983		$	15,797		$	16,194
Accrued expenses and other liabilities		6,394,379			5,872,846			29,655			25,635
Long-term debt, current portion								22,813			16,230
Operating lease liabilities, current portion								1,035			1,203
Deferred revenue		2,842,801			6,149,087			2,675			3,943
Total current liabilities		17,482,334			19,906,916			71,975			63,205
Long-term debt		24,791,214			—			3,338			24,669
Deferred revenue – long term		200,000			1,200,000
Operating lease liabilities, long-term								4,552			4,816
Other long-term liabilities								726			726
Total liabilities		42,473,548			21,106,916			80,591			93,416
Stockholders’ Equity:
Preferred Stock: $0.01 par, authorized 3,000,000 shares, none outstanding		—			—
Common Stock: $0.01 par; 300,000,000 shares authorized; 156,425,904 and 155,167,677 issued and outstanding at September 30, 2017 and December 31, 2016, respectively		1,564,259			1,551,677
Preferred Stock: $0.01 par; 3,000 shares authorized, NaN outstanding								—			—
Common Stock: $0.01 par; 300,000 shares authorized; 169,584 and 166,836 issued and outstanding at June 30, 2021 and December 31, 2020, respectively								1,696			1,668
Additional paid-in capital		301,703,929			297,826,433			345,431			340,756
Accumulated deficit		(266,570,874	)		(253,445,306	)		(214,413	)		(222,626	)
Accumulated other comprehensive loss		(700,695	)		(714,270	)		(686	)		(683	)
		35,996,619			45,218,534			132,028			119,115
Total Liabilities and Stockholders’ Equity	$	78,470,167		$	66,325,450		$	212,619		$	212,531

	For the Three Months Ended						For the Nine Months Ended						For the Three Months Ended						For the Six Months Ended
	September 30,						September 30,						June 30,						June 30,
	2017			2016			2017			2016			2021			2020			2021			2020
Revenue:
Product sales	$	13,327,525		$	11,049,840		$	30,708,750		$	30,580,889		$	27,904		$	24,665		$	57,039		$	51,762
Development revenue		1,485,091			2,101,203			7,894,640			6,466,974
Licensing revenue		19,486			38,618			1,057,204			128,040
Licensing and development revenue														7,167			2,687			12,151			4,442
Royalties		220,295			289,102			815,421			850,022			9,907			5,032			17,871			9,259
Total revenue		15,052,397			13,478,763			40,476,015			38,025,925			44,978			32,384			87,061			65,463
Cost of revenue:
Operating expenses:
Cost of product sales		7,600,180			7,206,280			16,681,689			18,670,363			11,630			10,927			24,128			24,941
Cost of development revenue		922,717			827,441			3,677,363			3,457,197			4,810			1,550			8,757			2,583
Total cost of revenue		8,522,897			8,033,721			20,359,052			22,127,560
Gross profit		6,529,500			5,445,042			20,116,963			15,898,365
Operating expenses:
Research and development		3,289,445			5,958,550			9,535,089			15,554,599			4,047			2,417			6,687			5,398
Selling, general and administrative		8,185,865			5,622,937			23,013,130			20,240,635			17,704			14,448			35,311			30,870
Total operating expenses		11,475,310			11,581,487			32,548,219			35,795,234			38,191			29,342			74,883			63,792
Operating loss		(4,945,810	)		(6,136,445	)		(12,431,256	)		(19,896,869	)
Operating income														6,787			3,042			12,178			1,671
Other income (expense):
Interest expense		(625,938	)		—			(794,129	)		—			(1,135	)		(967	)		(2,097	)		(2,028	)
Other income		119,227			15,462			197,003			58,313
Net loss	$	(5,452,521	)	$	(6,120,983	)	$	(13,028,382	)	$	(19,838,556	)
Basic and diluted net loss per common share	$	(0.03	)	$	(0.04	)	$	(0.08	)	$	(0.13	)
Basic and diluted weighted average common shares outstanding		156,400,702			155,060,811			155,851,639			154,952,060
Other, net														(89	)		100			(135	)		176
Total other expense, net														(1,224	)		(867	)		(2,232	)		(1,852	)
Net income (loss) before income taxes														5,563			2,175			9,946			(181	)
Income tax expense														(1,143	)		—			(1,733	)		—
Net income (loss)													$	4,420		$	2,175		$	8,213		$	(181	)
Net income (loss) per common share, basic													$	0.03		$	0.01		$	0.05		$	(0.00	)
Net income (loss) per common share, diluted													$	0.03		$	0.01		$	0.05		$	(0.00	)
Weighted average common shares outstanding:
Basic														169,043			165,703			168,436			165,566
Diluted														174,813			169,228			174,851			165,566

CONDENSED CONSOLIDATED STATEMENTS OF ~~COMPREHENSIVE LOSS~~CHANGES IN STOCKHOLDERS’ EQUITY

For the Three Months Ended

For the Nine Months Ended

September 30,

September 30,

2017

2016

2017

2016

Net loss

$
(5,452,521
)

$
(6,120,983
)

$
(13,028,382
)

$
(19,838,556
)
Foreign currency translation adjustment

(3,621
)

2,632

13,575

(7,820
)
Comprehensive loss

$
(5,456,142
)

$
(6,118,351
)

$
(13,014,807
)

$
(19,846,376
)

	Common Stock										Accumulated
	Shares		Amount		Additional Paid-In Capital			Accumulated Deficit			Other Comprehensive Loss			Total Stockholders’ Equity
March 31, 2021		168,798	$	1,688	$	344,063		$	(218,833	)	$	(693	)	$	126,225
Common stock issued under equity compensation plan, net of shares withheld for taxes		525		5		(1,228	)								(1,223	)
Exercise of options		261		3		535			—			—			538
Share-based compensation		—		—		2,061			—			—			2,061
Net income		—		—		—			4,420			—			4,420
Other comprehensive income		—		—		—			—			7			7
June 30, 2021		169,584	$	1,696	$	345,431		$	(214,413	)	$	(686	)	$	132,028


	Common Stock										Accumulated
	Shares		Amount		Additional Paid-In Capital			Accumulated Deficit			Other Comprehensive Loss			Total Stockholders’ Equity
December 31, 2020		166,836	$	1,668	$	340,756		$	(222,626	)	$	(683	)	$	119,115
Common stock issued under equity compensation plan, net of shares withheld for taxes		942		10		(2,851	)		—			—			(2,841	)
Exercise of options		1,806		18		3,860			—			—			3,878
Share-based compensation		—		—		3,666			—			—			3,666
Net income		—		—		—			8,213			—			8,213
Other comprehensive loss		—		—		—			—			(3	)		(3	)
June 30, 2021		169,584	$	1,696	$	345,431		$	(214,413	)	$	(686	)	$	132,028

CONDENSED CONSOLIDATED STATEMENTS OF ~~CASH FLOWS~~CHANGES IN STOCKHOLDERS’ EQUITY

Nine Months Ended

September 30,

2017

2016

Cash flows from operating activities:

Net loss

$
(13,028,382
)

$
(19,838,556
)
Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation expense

2,371,453

1,886,823

Depreciation and amortization

1,520,197

1,371,538

Loss on disposal of equipment

22,600

17,785

Write-off of capitalized patent costs

45,600

—

Accretion of interest expense

66,406

—

Amortization of debt issuance costs

18,347

—

Amortization of premiums and discounts on investment securities

(16,638
)

10,913

Changes in operating assets and liabilities:

Accounts receivable

(1,069,614
)

(624,232
)
Inventories

(2,615,414
)

(999,158
)
Prepaid expenses and other assets

(299,825
)

2,922,527

Deferred costs

559,939

(762,413
)
Accounts payable

701,704

3,308,607

Accrued expenses and other current liabilities

549,929

(146,376
)
Deferred revenue

(4,308,571
)

1,156,309

Net cash used in operating activities

(15,482,269
)

(11,696,233
)
Cash flows from investing activities:

Purchase of investment securities

(9,963,978
)

—

Purchases of equipment, molds, furniture and fixtures

(878,855
)

(4,278,643
)
Additions to patent rights

(83,592
)

(103,788
)
Proceeds from maturities of investment securities

—

12,000,000

Net cash (used in) provided by investing activities

(10,926,425
)

7,617,569

Cash flows from financing activities:

Proceeds from issuance of long-term debt

25,000,000

—

Payment of debt issuance costs

(293,538
)

—

Proceeds from exercise of stock options

1,670,149

24,071

Taxes paid related to net share settlement of equity awards

(248,709
)

(64,096
)
Net cash provided by (used in) financing activities

26,127,902

(40,025
)
Effect of exchange rate changes on cash

(307
)

1,440

Net decrease in cash and cash equivalents

(281,099
)

(4,117,249
)
Cash and cash equivalents:

Beginning of period

27,714,588

32,898,676

End of period

$
27,433,489

$
28,781,427

Supplemental disclosure of non-cash investing activities:

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

$
92,674

$
552,556

Additions to patent rights recorded in accounts payable and accrued expenses

$
6,160

$
23,369

	Common Stock										Accumulated
	Shares		Amount		Additional Paid-In Capital			Accumulated Deficit			Other Comprehensive Loss			Total Stockholders’ Equity
March 31, 2020		165,560	$	1,656	$	334,025		$	(281,183	)	$	(700	)	$	53,798
Common stock issued under equity compensation plan, net of shares withheld for taxes		451		4		(757	)		—			—			(753	)
Exercise of options		74		1		117			—			—			118
Share-based compensation		—		—		1,987			—			—			1,987
Net income		—		—		—			2,175			—			2,175
Other comprehensive loss		—		—		—			—			4			4
June 30, 2020		166,085	$	1,661	$	335,372		$	(279,008	)	$	(696	)	$	57,329


	Common Stock										Accumulated
	Shares		Amount		Additional Paid-In Capital			Accumulated Deficit			Other Comprehensive Loss			Total Stockholders’ Equity
December 31, 2019		165,221	$	1,652	$	332,377		$	(278,827	)	$	(702	)		54,500
Common stock issued under equity compensation plan, net of shares withheld for taxes		669		7		(1,357	)		—			—			(1,350	)
Exercise of options		195		2		387			—			—			389
Share-based compensation		—		—		3,965			—			—			3,965
Net loss		—		—		—			(181	)		—			(181	)
Other comprehensive income		—		—		—			—			6			6
June 30, 2020		166,085	$	1,661	$	335,372		$	(279,008	)	$	(696	)	$	57,329

	Six Months Ended
	June 30,
	2021			2020
Cash flows from operating activities:
Net income (loss)	$	8,213			(181	)
Adjustments to reconcile net income (loss) to cash provided by operating activities:
Stock-based compensation expense		3,666			3,965
Depreciation and amortization		1,815			1,132
Other		353			519
Changes in operating assets and liabilities:
Accounts receivable		(12,007	)		785
Inventories		(427	)		(3,605	)
Contract assets		2,415			1,222
Prepaid expenses and other assets		633			(106	)
Deferred taxes		1,733			—
Accounts payable		(960	)		3,680
Accrued expenses and other liabilities		4,242			1,247
Deferred revenue		(1,265	)		603
Net cash provided by operating activities		8,411			9,261
Cash flows from investing activities:
Purchases of property and equipment		(2,457	)		(2,444	)
Proceeds from maturities of investment securities		—			14,500
Net cash provided by (used in) investing activities		(2,457	)		12,056
Cash flows from financing activities:
Principal payments on long-term debt		(15,000	)		—
Proceeds from exercise of stock options		3,878			389
Taxes paid related to net share settlement of equity awards		(2,841	)		(1,350	)
Net cash used in financing activities		(13,963	)		(961	)
Effect of exchange rate changes on cash		(2	)		1
Net increase (decrease) in cash and cash equivalents		(8,011	)		20,357
Cash and cash equivalents:
Beginning of period		53,137			23,201
End of period	$	45,126		$	43,558
Supplemental disclosure of cash flow information:
Cash paid for interest	$	1,719		$	1,810
Supplemental disclosure of non-cash investing activities:
Purchases of property and equipment recorded in accounts payable and accrued expenses	$	2,534		$	3,334

Antares Pharma, Inc. (“~~Antares”~~Antares,” “we,” “our,” “us” or the “Company”) is ~~an emerging,~~a specialty pharmaceutical company focused primarily on the development and commercialization of ~~self-administered parenteral~~ pharmaceutical products and ~~technologies. The Company develops~~technologies in targeted therapeutic areas. We develop, manufacture and ~~manufactures,~~commercialize, for ~~itself~~ourselves or with partners, novel therapeutic products using ~~its~~our advanced drug delivery ~~technology~~systems that are designed to ~~enhance the existing drug compounds~~provide commercial or functional advantages, such as improved safety and ~~delivery methods. The subcutaneous injection technology platforms include the VIBEX~~^® ~~pressure-assisted auto injector system suitable for branded~~efficacy, convenience, improved tolerability, and ~~generic injectable drugs in unit dose containers, reusable needle-free spring-action injector devices,~~enhanced patient comfort and ~~disposable multi-dose pen injectors for use with standard cartridges. The Company has~~adherence. We also seek product opportunities that complement and leverage our commercial platform. We have a portfolio of proprietary and partnered ~~products, including approved~~ commercial products and ~~several partnered~~ongoing product ~~candidates~~development programs in ~~advanced~~various stages of ~~development and under active review by the U.S. Food and Drug Administration (“FDA”). The Company has~~development. We have formed significant strategic alliances and partnership arrangements with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (“Teva”), AMAG Pharmaceuticals, Inc. (“AMAG”), ~~Ferring~~Pfizer Inc. (“Pfizer”) and Idorsia Pharmaceuticals ~~Inc. and Ferring B.V. (together “Ferring”~~Ltd (“Idorsia”)~~, and has multiple ongoing internal~~.

The Company is also party to various partnered product development ~~programs.~~

~~The Company markets~~ and ~~sells its proprietary product OTREXUP~~^® ~~(methotrexate) injection in the U.S., which was launched in February 2014. OTREXUP~~^®~~is the first subcutaneous methotrexate for once weekly self-administration with an easy-to-use, single dose, disposable auto injector approved by the FDA. OTREXUP~~^® ~~is indicated for adults with severe active rheumatoid arthritis (“RA”), children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis.~~ supply arrangements:

The Company is also developing ~~XYOSTED~~^TM ~~(testosterone enanthate) injection for testosterone replacement therapy,~~two multi-dose pen injector products in collaboration with Teva, a combination drug device rescue pen in collaboration with Pfizer, a combination drug device product with Idorsia, and ~~submitted a 505 (b) (2) New Drug Application (“NDA”) to the FDA in December 2016. On October 20, 2017, the Company received a Complete Response Letter (the “CRL”) from the FDA for XYOSTED~~^TM~~, which identified two deficiencies~~advancing other internal research and ~~indicated that the NDA cannot be approved in its present form. The Company is assessing the content of the CRL, including the information that may be needed to address the deficiencies.~~development programs.

The accompanying unaudited condensed 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 condensed 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, ~~2016.~~2020. Operating results

for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2021 are not necessarily indicative of the results that may be expected for the year ending December 31, ~~2017.~~2021.

Certain reclassifications have been made to prior year amounts to conform with the current year presentation. Beginning as of and for the year ended December 31, 2020, the cost of product sales and the cost of development revenue are being classified under the heading Operating expenses in the accompanying consolidated statement of operations, and the corresponding prior period amounts have been reclassified to conform to this presentation. The ~~primary objectives of~~reclassifications have no impact on the Company’s ~~investment policy are to protect principal, maintain adequate liquidity~~operating income (loss) or net income (loss) as previously reported.

Cash and cash equivalents consist of ~~U.S. Treasury bills~~demand deposits at commercial banks and ~~government agency notes that~~highly liquid investments with an original maturity of three months or less. Cash equivalents, consisting of investments in money market funds, are ~~classified as held-to-maturity because the Company has the intent~~remeasured and ~~ability to hold the securities to maturity. Investments with maturities of one year or less are classified as short-term. The securities are carried~~reported at ~~their amortized cost and the~~ fair value ~~is determined by~~each reporting period, in accordance with ASC Topic 820, Fair Value Measurements (“ASC 820”) based on quoted market ~~prices. At September 30, 2017,~~prices, which is a Level 1 input within the ~~Company’s investments had a carrying~~three-level valuation hierarchy for disclosure of fair value ~~of $9,976,984, which approximated fair value. The Company held no investments~~measurements, and totaled $36,140 and $36,133 as of June 30, 2021 and December 31, ~~2016.~~ 2020, respectively.

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.

Property and equipment are stated at cost and depreciated using the straight-line method over their estimated useful lives as follows:

Expenditures, including interest costs, for assets under construction that are not yet ready for their intended use are capitalized and will be depreciated based on the above guidelines when placed in service.

The Company generates revenue from proprietary and partnered 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.

At inception of each contract, the Company identifies the goods and services that have been promised to the customer and each of those that represent a distinct performance obligation, determines the transaction price including any variable consideration, allocates the transaction price to the distinct performance obligations and determines whether control transfers to the customer at a point in time or over time. Variable consideration is included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company reassesses its reserves for variable consideration at each reporting date and makes adjustments if necessary, which may affect revenue and earnings in periods in which any such changes become known.

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 goods are transferred to the customer. The related shipping and freight charges incurred by the Company are included in cost of product sales.

The Company sells its proprietary commercial products primarily to wholesale and specialty distributors. Revenue is recognized when control has transferred to the customer, which is typically upon delivery, at the net selling price, which reflects the variable consideration for which reserves and sales allowances are established for estimated returns, wholesale distribution fees, prompt payment discounts, government rebates and chargebacks, plan rebate arrangements and patient discount and support programs.

The determination of certain of these reserves and sales allowances require management to make a number of judgements and estimates to reflect the Company’s best estimate of the transaction price and the amount of consideration to which it believes it is ultimately entitled to receive. The expected value is determined based on unit sales data, contractual terms with customers and third-party payers, historical and expected utilization rates, any new or anticipated changes in programs or regulations that would impact the amount of the actual rebates, customer purchasing patterns, product expiration dates and levels of inventory in the distribution channel. Reserves for prompt payment discounts are recorded as a reduction in accounts receivable. Reserves for returns, rebates and chargebacks, distributor fees and customer co-pay support programs are included within current liabilities in the consolidated balance sheets.

The Company is party to several license, development, supply and distribution arrangements with pharmaceutical partners, under which the Company produces and is the exclusive supplier of certain products, devices and/or components. Revenue is recognized when or as control of the goods transfers to the customer as follows:

The Company is the exclusive supplier of the Makena^® subcutaneous auto injector product to AMAG. Because the product is custom manufactured for AMAG with no alternative use and the Company has a contractual right to payment for performance completed to date, control is continuously transferred to the customer as product is produced pursuant to firm purchase orders. Revenue is recognized over time using the output method based on the contractual selling price and number of units produced. The amount of revenue recognized in excess of the amount shipped/billed to the customer, if any, is recorded as contract assets due to the short-term nature in which the amount is ultimately expected to be billed and collected from the customer.

All other partnered product sales are recognized at the point in time in which control is transferred to the customer, which is typically upon shipment. Sales terms and pricing are governed by the respective supply and distribution agreements, and there is generally no right of return. Revenue is recognized at the transaction price, which includes the contractual per unit selling price and estimated variable consideration, such as volume-based pricing arrangements or profit sharing arrangements, if any. 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 the Company’s partner. 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 has entered into several license, development and supply arrangements with pharmaceutical partners under which the Company grants a license to its device technology and know-how and provides research and development services that often involve multiple performance obligations and highly customized deliverables. For such arrangements, the Company identifies each of the promised goods and services within the contract and the distinct performance obligations at inception, and allocates consideration to each performance obligation based on relative standalone selling price, which is generally determined based on the expected cost plus margin.

If the contract includes an enforceable right to payment for performance completed to date and performance obligations are satisfied over time, the Company recognizes revenue over the development period using either the input or output method depending on which is most appropriate given the nature of the distinct deliverable. For other contracts that do not contain an enforceable right to payment for performance completed to date, revenue is recognized when control 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.

The Company’s typical payment terms for development contracts may include an upfront payment equal to a percentage of the total 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 contract liability for cash received in advance of performance, which is presented within deferred revenue on the consolidated balance sheet and recognized as revenue when the associated performance obligations have been satisfied. The Company recognized $2,776 in licensing and development revenue in connection with contract liabilities that were outstanding as of December 31, 2020 and satisfied during the six months ended June 30, 2021.

License fees and milestones received in exchange for the grant of a license to the Company’s functional intellectual property 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. 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.

The Company earns royalties in connection with licenses granted under license and development arrangements with partners. Royalties are based upon a percentage of commercial sales of partnered products with rates ranging from mid-single digit to low double digit and are tiered based on levels of net sales. These sales-based royalties, for which the license was deemed the predominant element to which the royalties relate, are estimated and recognized in the period in which the partners’ commercial sales occur. The royalties are generally reported and payable to the Company within 45 to 60 days of the end of the period in which the commercial sales are made. The Company bases its estimates of royalties earned on actual sales information from its partners when available or estimated prescription sales from external sources and estimated net selling price. If actual royalties received are different than amounts estimated, the Company would adjust the royalty revenue in the period in which the adjustment becomes known.

Remaining performance obligations represents the allocation of 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 June 30, 2021, the aggregate value of remaining performance obligations, excluding contracts with an original expected length of one year or less, was $14,409. The Company expects to recognize revenue on the remaining performance obligations over the next three years.

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 ~~$1,000,000~~$777 and ~~$900,000~~$619 at ~~September~~June 30, ~~2017~~2021 and December 31, ~~2016,~~2020, respectively. ~~Inventories consist of the following:~~

~~Revenue Recognition — OTREXUP~~^®NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

~~The Company began detailing OTREXUP~~^® ~~to health care professionals~~ (in ~~February 2014. OTREXUP~~^® is sold in packages of four pre-filled, single-dose disposable auto injectors to wholesale pharmaceutical distributors, its customers, subject to rights of return within a period beginning six months prior to, and ending 12 months following, product expiration.

~~Prior to the first quarter of 2017, the Company could not reliably estimate expected returns of OTREXUP~~^® at the time of shipment given its limited sales history of the product. Accordingly, the recognition of revenue was deferred on product shipments until the rights of return no longer existed, which occurred at the earlier of the time OTREXUP^® ~~units were dispensed through patient prescriptions or expiration of the right of return of the product. Patient prescriptions dispensed were estimated using third-party market prescription data.~~

~~In the first quarter of 2017, the Company determined it had developed sufficient historical information to reasonably estimate future returns of OTREXUP~~^®and began recognizing revenue, net of estimated returns, upon delivery to the distributors. As a result, the Company recognized an additional $1,297,054 for product shipped to distributors in previous periods that was not previously recognized as revenue at the time of shipment, net of the returns allowance established in the first quarter of 2017. The Company also recognized $254,425 of related product costs that had been previously deferred. The net impact of these changes resulted in a decrease in net loss of $1,042,629, less than $0.01thousands, except per share ~~for the nine months ended September 30, 2017.~~amounts)

~~Product sales revenue for OTREXUP~~^®is presented net of estimated returns and product sales allowances for wholesaler discounts, prompt pay discounts, chargebacks, rebates and patient discount programs. The estimated product returns reserve was $650,000 as of September 30, 2017 and zero at December 31, 2016. Product sales allowances were $1,986,553 as of September 30, 2017 and $1,540,488 as of December 31, 2016.

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

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

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

~~Chargebacks~~. The Company provides discounts to authorized users of the Federal Supply Schedule (“FSS”) of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs and various organizations under Medicaid contracts and regulations. These entities purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to the Company the difference between the current wholesale

acquisition cost and the price the entity paid for the product. The Company estimates and accrues chargebacks based on estimated wholesaler inventory levels, current contract prices and historical chargeback activity. Chargebacks are recognized as a reduction of revenue in the same period the related revenue is recognized.

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

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

Under a license, supply and distribution agreement with Teva for an auto-injector product containing sumatriptan, the Company produces devices and assembles product for shipment to Teva, and Teva is responsible for commercial distribution and sale of the product. The Company is compensated, and recognizes revenue, at cost for shipments of product delivered to Teva. The Company is also entitled to receive 50 percent of the net profits from commercial sales made by Teva, payable to the Company within 45 days after the quarter in which the commercial sales are made by Teva.

Sumatriptan Injection USP was launched for commercial sale in June 2016. Initially, given the limited access to sales data and the 45-day lag in reporting of the profit split from Teva, management was not able to estimate the profit margin the Company expected to receive from commercial sales made by Teva at the time of sale. Accordingly, prior to the third quarter of 2017, revenue from the profit sharing arrangement was recognized in the period following the commercial sales by Teva when amounts were reported and paid to the Company. Beginning in the third quarter of 2017, management determined it had developed sufficient history and is now able to obtain additional sales information in order to reasonably estimate and recognize revenue from the profit sharing arrangement when product is sold by Teva.

OnIn June 6, 2017, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Capital, Inc. (the “Lender”), for a term loan of up to ~~$35,000,000~~$35.0 million (the “Term Loan”), ~~the proceeds of~~under which are to be used for working capital and general corporate purposes. The first advance of $25,000,000 was funded upon execution of the Loan Agreement on June 6, 2017. Under the terms of the Loan Agreement, the Company may, but is not obligated to, request one or more additional advances of at least $5,000,000 not to exceed $10,000,000 in the aggregate, subject to the Company achieving certain corporate milestones and satisfying customary conditions.initially borrowed $25.0 million (“Tranche I”.) The ~~Company must exercise its option to request additional advances prior to September 30, 2018.~~

~~The~~amortizing Term Loan is secured by substantially all of the Company’s assets, excluding intellectual property, ~~and will mature on July 1, 2022. The Term Loan~~ accrues interest at a ~~calculated~~ prime-based variable rate with a maximum ~~interest rate~~ of ~~9.50%. As~~9.5%, and initially provided for payments of ~~September 30, 2017,~~interest-only until August 1, 2019 with a maturity date of July 1, 2022.

In June 2019, the ~~interest rate was 8.75%. Payments under~~Company entered into a First Amendment (the “Amendment”) to the Loan Agreement, ~~are interest only until~~which increased the ~~first~~aggregate principal amount available under the Term Loan from $35.0 million to $50.0 million and extended the interest-only payment ~~is due on~~period of the Term Loan to August 1, ~~2019, provided that~~2021. Under the Amendment, the interest only period ~~may~~could be further extended to August 1, 2022 if the Company achieved a certain loan extension milestone, requested such extension by July 31, 2021, and paid an extension fee equal to one half of one percent of the principal amount outstanding. Upon signing of the Amendment, an additional $15.0 million (“Tranche II”) was funded to the Company. The Term Loan maturity date remained July 1, 2022, which could be extended to ~~February~~July 1, ~~2020 if the~~2024.

The Company ~~achieves certain corporate milestones. The Loan Agreement also requires the Company~~is required to pay aan end of term fee (“End of Term Charge”) equal to 4.25% of Tranche I and 3.95% of the ~~total original principal amount~~borrowings under Tranche II, payable upon the earlier of ~~all term loan advances (“End of Term Charge”), which is due upon~~July 1, 2022 or full repayment of the ~~Term~~loan. The Loan ~~at either maturity or earlier repayment, and~~Agreement also imposes a prepayment fee of 1.0% to 3.0% if any or all of the balance is prepaid prior to the maturity date.

AsOn June 30, 2021, the Company made a $15.0 million prepayment of ~~September 30, 2017, the~~principal and paid a 1.0% prepayment fee. The carrying value of the Term Loan was ~~$24,791,214,~~$26,151 and $40,899 as of June 30, 2021 and December 31, 2020, respectively, which consisted of the ~~$25,000,000~~ principal ~~balance~~amounts outstanding and the End of Term Charge accrual, ~~of $66,406,~~ less unamortized debt issuance costs ~~of $275,192. The Company incurred debt issuance costs~~ that ~~along with the End of Term Charge,~~ are being amortized/accrued to interest expense over the term of the Term Loan using the effective interest method.

~~Future~~ As of June 30 2021, the future principal payments under the ~~term loan, including~~Term Loan consisted of $10,144 due in 2021 and $14,856 due in 2022, excluding the contractual End of Term ~~Charge, are as follows:~~Charges.

~~The~~In July 2021, having previously met the loan extension milestone, the Company ~~believes~~requested that the ~~carrying value~~interest-only period be extended to August 1, 2022 and the maturity date be extended to July 1, 2024 in accordance with the terms of the ~~Term Loan approximates its fair value based on~~Amendment. The Lender granted the ~~borrowing rates currently available for loans with similar terms.~~extension of the interest-only period and maturity date and waived the extension fee.

~~On August 11, 2017, the Company entered into a sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”) under which the Company may offer and sell,~~ ~~from time to time and at its sole discretion, shares of its common stock having an aggregate offering price of up to $30,000,000 through Cowen as the Company’s sales agent and/or as 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. The Company will pay Cowen a commission of 3.0% of the gross sales proceeds of any common stock sold through Cowen under the Sales Agreement. The Company is not obligated to make any sales of common stock under the Sales Agreement and no sales of common stock were made pursuant to the Sales Agreement in the period ended September 30, 2017.

The ~~Company’s 2008~~Company has an Equity Compensation Plan (the “Plan”), which 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 Plan was amended and restated in June 2021 to increase the ~~Company’s officers, directors, employees, consultants and advisors are eligible to receive grants under the Plan. The maximum~~total number of shares ~~authorized~~available for ~~issuance~~grant under the ~~amended~~Plan by 10 million shares. The Company also has a long-term incentive program (“LTIP”), pursuant to which the Company’s senior executives have been awarded stock options, restricted stock units (“RSUs”) and ~~restated Plan is 32,200,000 and the maximum number of shares of~~performance stock that may be granted to any one employee for qualified performance-based compensation during a calendar year is 4,000,000 shares. Options to purchase shares of common stock are granted at exercise prices not less than 100% of fair market value on the dates of grant. The term of each option is ten years and the options typically vest in quarterly installments over a three-year period with a minimum vesting period of one year. As of September 30, 2017, the Plan had approximately 6,400,000 shares available for grant. Stock option exercises are satisfied through the issuance of new shares.

The following is a summary of stock option activity under the Plan as of and for the ~~nine~~six months ended ~~September~~June 30, ~~2017:~~2021:

The per share weighted average fair values of all options granted during the nine months ended September 30, 2017 and 2016 were estimated as $1.62 and $0.54, respectively, on the date of grant using the Black-Scholes option pricing model based on the assumptions noted in the table below. Expected volatilities are based on the historical volatility of the Company’s stock price. The weighted average expected life is based on both historical and anticipated employee behavior.

During the nine months ended September 30, 2017, stock option exercises resulted in cash proceeds to the Company of $1,670,149 and the issuance of 1,062,693 shares of common stock. Stock option exercises resulted in proceeds of $24,071 and the issuance of 21,492 shares of common stock in the nine months ended September 30, 2016.

The Company recognized $1,680,437 and $1,572,710 of compensation expense related to stock options for the nine months ended September 30, 2017 and 2016, respectively, and $692,834 and $505,663 for the three months ended September 30, 2017 and 2016, respectively. As of September 30, 2017, there was approximately $4,500,000 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 2.1 years.

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

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

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

In 2017, 2016 and 2015, the LTIP awards include PSUs that may be earned based on the Company’s total shareholder return (“TSR”) relative to the Nasdaq Biotechnology Index (“NBI”) at the end of the performance period. The performance period is January 1, 2015 to December 31, 2017 for the 2015 award, January 1, 2016 to December 31, 2018 for the 2016 award and January 1, 2017 to December 31, 2019 for the 2017 award. Depending on the outcome of the performance goal, a recipient may ultimately earn a number of shares greater or less than their target number of shares granted, ranging from 0% to 150% of the PSUs granted. The fair values of the TSR PSUs granted was determined using a Monte Carlo simulation and utilized the following inputs and assumptions:

2017 Award

2016 Award

2015 Award

Closing stock price on grant date

$
2.66

$
1.12

$
2.18

Performance period starting price

$
2.17

$
1.29

$
2.52

Term of award (in years)

2.57

2.58

2.59

Volatility

54.6
%

70.1
%

60.5
%
Risk-free interest rate

1.39
%

0.97
%

0.83
%
Expected dividend yield

0.00
%

0.00
%

0.00
%
Fair value per TSR PSU

$
3.10

$
1.25

$
1.71

						Weighted
				Weighted		Average
				Average		Remaining		Aggregate
	Number of			Exercise		Contractual		Intrinsic
	Shares			Price		Term (Years)		Value
Outstanding at December 31, 2020		15,521		$	2.49
Granted		2,572			4.40
Exercised		(1,806	)		2.15
Cancelled/Forfeited		(195	)		2.75
Outstanding at June 30, 2021		16,092			2.83		6.95	$	24,824
Exercisable at June 30, 2021		11,094		$	2.46		5.88	$	21,060

The ~~performance period starting price~~following is ~~measured as the average closing price over the last 20 trading days prior to the performance period start. The Monte Carlo simulation model also assumed correlations~~a summary of ~~returns of the prices of the Company’s common stock~~PSU and ~~the common stocks of the NBI companies and stock price volatilities of the NBI companies. The fair value of the target number of shares that can be earned~~RSU award activity under the ~~TSR PSUs is being recognized~~Plan as ~~compensation expense over~~of and for the ~~performance period.~~six months ended June 30, 2021:

In connection with PSU awards, the Company recognized compensation expense of $239,995 and $11,331 for the nine months ended September 30, 2017 and 2016, respectively. Compensation expense recognized in connection with RSU awards was $451,021 and $302,782 for the nine months ended September 30, 2017 and 2016, respectively.

~~Shares issued in connection with~~The LTIP awards that vested induring the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2021 and ~~2016~~2020 were net-share settled such that the Company withheld shares with a value equivalent to the employees’ ~~minimum statutory obligation~~tax obligations for ~~the~~ applicable income and other employment taxes, and remitted ~~the~~ cash to the appropriate taxing authorities. The ~~total~~Company withheld 626 and 419 shares ~~withheld~~during the six months ended June 30, 2021 and 2020, respectively, to satisfy tax obligations, ~~were 97,586 and 65,575 in the nine months ended September 30, 2017 and 2016, respectively, and were~~which was determined based on the fair value of the shares on their vesting date ~~as determined by~~equal to the Company’s closing stock ~~price. Total payments~~price on such date. The Company paid $2,841 and $1,350 during the six months ended June 30, 2021 and 2020, respectively, to taxing authorities for the employees’ tax obligations, ~~to the taxing authorities were $248,709 and $64,096 in the nine months ended September 30, 2017 and 2016, respectively, and are~~which is reflected as a cash outflow from financing ~~activity~~activities within the consolidated statements of cash flows. ~~These net-share~~Net-share settlements ~~had~~have the effect of share repurchases by the Company as they ~~reduced~~reduce the number of shares that would have otherwise been issued as a result of the ~~vesting~~vesting.

Members of the Company’s Board of Directors also receive grants of restricted stock units that vest in full one year from the date of grant. Directors may elect to defer receipt of vested shares until retirement or separation from the Board; 30 shares were vested and ~~did not represent an~~deferred during the six months ended June 30, 2021.

In connection with Plan awards, the Company recognized share-based compensation expense tofor the ~~Company.~~three and six months ended June 30, 2021 and 2020 as follows:

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

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

Three Months Ended

Nine Months Ended

September 30,

September 30,

2017

2016

2017

2016

Teva

$
7,663,701

$
5,522,996

$
17,043,954

$
18,513,972

AMAG

1,767,702

2,369,950

6,338,275

3,275,832

McKesson

2,339,238

1,946,261

6,333,080

5,501,810

AmerisourceBergen

1,470,268

1,156,566

4,323,013

3,658,453

Ferring

723,502

1,246,300

3,018,098

3,960,689

	Three Months Ended		Six Months Ended
	June 30,		June 30,
	2021	2020	2021	2020
Teva	44%	40%	43%	41%
McKesson Corporation	12%	11%	12%	11%
AmerisourceBergen Corporation	11%	13%	12%	13%
Cardinal Health	11%	13%	11%	11%
AMAG	<10%	<10%	<10%	12%

The Company’s gross unrecognized tax benefits as of June 30, 2021 was $2,127 and there were no material changes during the quarter and six months then ended. There are 0 interest or penalties accrued in relation to unrecognized tax benefits. The Company will classify any future interest and penalties as a component of income tax expense. The Company is subject to federal and state examinations for the years 2017 and thereafter.

Basic earnings or loss per common share is computed by dividing the net income or loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted ~~loss~~earnings per common share ~~reflects~~is computed in a similar manner, except that the weighted average number of shares outstanding is increased to reflect 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~~Diluted earnings per share ~~because their effect was anti-dilutive totaled 15,084,877~~contemplate a complete conversion to common shares of all convertible instruments only if such instruments are dilutive in nature with respect to earnings per share. The following table sets forth the computation for basic and ~~14,100,835 at September~~diluted net earnings (loss) per share for the three and six months ended June 30, ~~2017~~2021 and ~~2016, respectively.~~2020:

	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2021		2020		2021		2020
Numerator
Numerator for basic and diluted earnings (loss) per share	$	4,420	$	2,175	$	8,213	$	(181	)
Denominator
Basic weighted average common shares outstanding		169,043		165,703		168,436		165,566
Dilutive effects of stock options and share-based awards issuable under equity compensation plans		5,770		3,525		6,415		—
Diluted weighted average common shares outstanding		174,813		169,228		174,851		165,566
Computation of:
Basic net earnings (loss) per share	$	0.03	$	0.01	$	0.05	$	(0.00	)
Diluted net earnings (loss) per share	$	0.03	$	0.01	$	0.05	$	(0.00	)

Anti-dilutive common stock equivalents ⁽¹⁾		849		6,361		530		5,145

~~In July 2015,~~From time to time, the ~~Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2015-11,~~ ~~Simplifying~~Company may be involved in various legal matters generally incidental to its business. Although the ~~Measurement of Inventory~~. The new standard changed the measurement principle for inventory from the lower of cost or market to lower of cost and net realizable value. The Company adopted this standard during the first quarter of 2017, and the adoption did not have an impact on the consolidated results of ~~operations, cash flows or financial position~~litigation and claims cannot be predicted with certainty, after discussion with legal counsel, management is not aware of any matters for which the ~~Company.~~

~~In March 2016, the FASB issued ASU No. 2016-09,~~ ~~Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting~~ (“~~ASU 2016-09”). The new standard involves several aspects~~likelihood of ~~the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities~~a loss is probable and ~~classification on the statement of cash flows. The Company adopted ASU 2016-09 effective January 1, 2017,~~reasonably estimable and ~~the adoption did not~~which could have a ~~significant~~material impact on the Company’s consolidated financial statements. As required under previous GAAP, the Company had estimated forfeitures in determining its periodic compensation costs related to share-based awards. Upon adoption of the new standard, the Company has elected to recognize forfeitures as they occur, and recorded a cumulative effect adjustment to accumulated deficit and additional paid-in capital of $97,000, the net of which had no impact on the Company’s consolidated results of operations, cash flows or financial position.

~~In January 2017, the FASB issued ASU 2017-04,~~ ~~Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment~~ (“ASU 2017-04”). This new standard eliminates Step 2 from the goodwill impairment test. ASU 2017-04 requires an entity to perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value. ASU 2017-04 still allows the option to perform a qualitative assessment for a reporting unit to determine if the quantitative impairment test is necessary. The Company early adopted this standard effective January 1, 2017 and will apply the standard prospectively for its annual goodwill impairment tests. The adoption of the standard did not have an impact on the Company’s consolidated financial statements.

~~In May 2014, the FASB issued 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 “ASU 2014-09”. This guidance requires an entity to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The standard creates a five-step model that requires a company to identify customer contracts, identify the separate performance obligations, determine the transaction price, allocate the transaction price to the separate performance obligations and recognize revenue when each performance obligation is satisfied. This guidance also requires an entity to disclose sufficient information to enable users of financial statements to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. Qualitative and quantitative information is required about contract balances and remaining performance obligations, significant judgments made in determining the timing of satisfaction of performance obligations (over time or at a point in time), and estimates made in determining the transaction price and amounts allocated to performance obligations.

~~The Company continues to monitor and evaluate the impact the adoption of this standard will have~~ on its consolidated financial ~~statements and has performed an initial review~~condition, liquidity, or results of its major contracts with customers. Based on the initial reviews, the Company believes the adoption of the new standard may accelerate the timing of revenue recognition for certain product sales and development revenue under certain license, development and supply agreements, and will require management to estimate and potentially recognize certain variable revenue streams such as royalties and profit sharing arrangements earlier at an amount it believes will not be subject to significant reversal.

The Company anticipates adopting the new revenue recognition standard on the effective date of January 1, 2018 utilizing the modified retrospective method of adoption, under which the cumulative effect of the change is recognized as an adjustment to the opening balance of the accumulated deficit within the consolidated balance sheet, and prior reporting periods are not retrospectively adjusted. The Company anticipates recognizing a transition adjustment upon adoption, however the amount

cannot currently be quantified, as the calculation of such will depend upon the open contracts and performance obligations as of the transition date. No significant changes to business processes or systems are currently expected to be necessary, as the processes and controls used in recording revenue transactions are largely manual.

~~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 and early adoption is permitted. The Company is currently evaluating the impact of ASU 2016-02 on its consolidated financial statements and currently expects that most of 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.

~~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, including interim periods within those annual periods, and early adoption is permitted. The adoption of ASU 2017-09 is not expected to have a significant impact on the Company’s consolidated financial statements.

~~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. ASU 2017-05 is effective for annual reporting periods beginning after December 15, 2017, including interim periods within those annual periods. The Company is currently evaluating the potential impact, if any, on its consolidated financial statements upon the adoption of ASU 2017-05 and expects to adopt the standard effective January 1, 2018.

On October 10, 2017, the Company entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Ferring to sell the worldwide rights, including certain assets, related to the ZOMAJET™ needle-free auto injector device (the “Product”) 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 upfront payment received upon entry into the Asset Purchase Agreement and the transfer of certain assets; a second installment of $2.75 million payable upon delivery of certain documentation and satisfaction of certain conditions primarily related to Product manufacturing; a third installment of $4.75 million payable upon satisfaction of certain conditions, including further document transfer, the 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 Product in certain territories and the final transfer of certain Product-related inventory, equipment and agreements to Ferring (the “Completion Date”), which is expected to occur by the end of 2018.

The Company will continue to manufacture and supply ZOMAJET™ devices until the Completion Date and will receive payment for devices manufactured and supplied to its partners, and a royalty on net product sales, in accordance with the existing license and supply agreements.

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, as amended, 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®. ~~Motions~~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 ~~appointment~~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. On November 26, 2018, defendants filed a motion to dismiss. Plaintiff filed an opposition to the motion on January 10, 2019 and defendants filed a reply in support of ~~Lead Plaintiff are~~their motion on February 25, 2019. On July 2, 2019, the court dismissed the complaint in its entirety without prejudice. On July 29, 2019, plaintiff filed a Consolidated Second Amended Class Action Complaint against the same parties alleging substantially similar claims. On September 12, 2019, defendants filed a motion to dismiss the Consolidated Second Amended Class Action Complaint. Plaintiffs’ opposition was filed on October 28, 2019 and defendants’ reply in support of their motion was filed on November 27, 2019. On April 28, 2020, the court dismissed the Consolidated

Second Amended Class Action Complaint in its entirety. The court further ordered that plaintiff may file an amended complaint by May 29, 2020 and provide the court with a form of the amended complaint that indicates in what respect(s) it differs from the complaint which it proposes to amend. On May 29, 2020, plaintiff filed a Consolidated Third Amended Class Action Complaint and defendants filed a motion to dismiss on July 10, 2020. Briefing on defendants’ motion was complete on August 25, 2020. On February 26, 2021, the court granted defendants’ motion to dismiss with prejudice, and on March 29, 2021 the plaintiff filed a notice of appeal. On June 21, 2021, plaintiff-appellant filed his opening brief. Defendants-appellees’ response brief is due ~~December 22, 2017.~~on August 4, 2021 and plaintiff-appellant’s reply is due on August 25, 2021. The Company believes that the claims in the Smith action lack merit and intends to continue 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., 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. (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 and order consolidating the two actions and staying the proceedings pending the court’s decision on defendants’ motion to dismiss the Smith action; the motion to dismiss in Smith was granted on February 26, 2021 and a notice of appeal was filed on March 29, 2021.

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 and order staying the action pending the court’s decision on defendants’ motion to dismiss the Smith action; the motion to dismiss in Smith was granted on February 26, 2021 and a notice of appeal was filed on March 29, 2021. After the expiration of all appeals related to the Smith dismissal, the parties shall submit a proposed order regarding the derivative action.

Certain statements in this report, including statements in the management’s discussion and analysis section set forth below, may be considered “forward-looking statements” ~~as that term is defined in~~within the ~~U.S. Private~~meaning of Section 27A of the Securities ~~Litigation Reform~~ Act of ~~1995.~~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:

~~Forward-looking~~These 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:

In addition, you should refer to the “Risk Factors” ~~sections of this report~~section in our other filings with the Securities and ~~of our Annual Report on Form 10-K for the year ended December 31, 2016~~Exchange Commission 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.

Antares Pharma, Inc. (“Antares,” “we,” “our,” “us” or the “Company”) is ~~an emerging,~~a specialty pharmaceutical company ~~that focuses~~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.~~technologies that address unmet needs in targeted therapeutic areas. We develop, manufacture and commercialize, for ourselves or with partners, novel therapeutic products using our advanced drug delivery systems that are designed to ~~help improve~~provide commercial or functional advantages, such as improved safety and efficacy, ~~reduce side effects,~~convenience, improved tolerability, and ~~enhance~~enhanced patient comfort and adherence. ~~Our subcutaneous injection technology platforms include the VIBEX~~^® ~~pressure-assisted auto injector system suitable for branded~~We also seek product opportunities that complement and ~~generic injectable drugs in unit dose containers, reusable needle-free spring-action injector devices, and disposable multi-dose pen injectors for use with standard cartridges.~~leverage our commercial platform. We have a portfolio of proprietary and partnered ~~products, including approved~~ commercial products and ~~several~~ongoing product ~~candidates~~development programs in ~~advanced~~various stages of ~~development and under active FDA review.~~development. We have formed significant strategic alliances and partnership arrangements with industry leading pharmaceutical companies including Pfizer, Idorsia, Teva ~~AMAG~~ and ~~Ferring.~~AMAG.

We market and sell in the U.S., our proprietary product XYOSTED^® (testosterone enanthate) injection, indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. XYOSTED^® is the only FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration. XYOSTED^®was approved by the FDA and launched for commercial sale in late 2018. In August 2020, we entered into an exclusive distribution agreement with Lunatus to distribute and promote the sale of XYOSTED^® in Saudi Arabia and the United Arab Emirates. Lunatus is responsible for obtaining regulatory approval and, assuming approval, for the promotion and commercialization of the product in the territories.

We also market and sell our proprietary product OTREXUP^® (methotrexate) injection, which ~~was launched in the U.S. in February 2014. OTREXUP~~^®is ~~the first FDA-approved~~a subcutaneous methotrexate injection 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,~~

In October 2020, we ~~have received~~entered into an exclusive license agreement (the “License Agreement”) with Ferring for the marketed product NOCDURNA^® (desmopressin acetate) in the United States, which is indicated for the treatment of nocturia due to nocturnal polyuria (NP) in adults who awaken at least two times per night to urinate. Under the terms of the License Agreement, the Company paid Ferring an upfront payment of $5.0 million upon execution and will pay an additional $2.5 million at one year from execution. Ferring is eligible for tiered royalties and additional commercial milestone payments potentially totaling up to $17.5 million based on the Company’s net sales of NOCDURNA^® in the United States. We began detailing NOCDURNA^®with a soft launch in the fourth quarter of 2020 and are currently executing a reintroduction of the product through a comprehensive re-launch strategy to increase awareness and demand.

In collaboration with Teva, we developed a version of our VIBEX^® auto injector for use in a generic epinephrine auto injector product that was approved by the FDA ~~approval~~in August 2018 and launched in late fourth quarter of 2018. Teva’s Epinephrine Injection USP is indicated for ~~dosage strengths~~emergency treatment of ~~7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg~~severe allergic reactions including those that are life threatening (anaphylaxis) in adults and ~~25 mg~~certain pediatric patients and was approved as a generic drug product with an AB rating, meaning that it is therapeutically equivalent to the branded products EpiPen^® and EpiPen Jr^® and therefore, subject to state law, substitutable at the pharmacy. We are the exclusive supplier of ~~OTREXUP~~^®.the device and Teva is responsible for commercialization and distribution of the finished product, for which we also receive royalties on Teva’s net sales.

~~With~~Through our commercialization partner Teva, we ~~launched~~sell Sumatriptan Injection USP indicated in the U.S. for the acute treatment of migraine and cluster headache in ~~adults, in June 2016. We received FDA approval~~adults.

Under an exclusive license and development agreement with AMAG, we developed, manufacture and supply a variation 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~~^®~~, in December 2015. Sumatriptan Injection USP represents the Company’s first ANDA approval of a complex generic and second product approved using the~~ VIBEX^® QuickShot^® subcutaneous auto injector ~~platform and is commercialized and distributed by Teva under the terms of a license, supply and distribution arrangement.~~

We also have two gel-based products that are commercialized through our partners pursuant to licensing arrangements and make reusable, needle-free injection devices that administer injectable drugs, which are currently marketed primarily through our partner Ferring, for use with ~~human growth hormone.~~

~~On October 10, 2017, we entered into an asset purchase agreement (the “Asset Purchase Agreement”)~~AMAG’s progestin hormone drug Makena^® (hydroxyprogesterone caproate injection), indicated to help reduce the risk of preterm birth in women pregnant with ~~Ferring to sell~~one baby and who spontaneously delivered one preterm baby in the ~~worldwide rights, including certain assets, related to the ZOMAJET™ needle-free~~past. The Makena^® (hydroxyprogesterone caproate injection) subcutaneous auto injector ~~device (the “Product”) for a total purchase price of $14.5 million.~~

We will continue to manufacture and supply ZOMAJET™ 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.

~~We are developing XYOSTED~~^TM ~~(testosterone enanthate) injection for testosterone replacement therapy, and submitted a 505 (b)(2) New Drug Application (“NDA”) to the FDA in December 2016. The NDA submission~~ was ~~accepted for standard review~~approved by the FDA and ~~assigned~~commercialized in February 2018. We are the exclusive supplier of the devices and the final assembled and packaged commercial product and receive royalties on AMAG’s net sales of the product. In October 2019, AMAG announced that

the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee met to better understand and interpret the PROLONG (Progestin’s Role in Optimizing Neonatal Gestation) confirmatory clinical trial for Makena^® (hydroxyprogesterone caproate) injection. Nine advisory committee members voted to recommend that the FDA pursue withdrawal of approval for Makena^® and seven committee members voted to leave the product on the market under accelerated approval and require a ~~Prescription Drug User Fee Act (“PDUFA”) target date for completion~~new confirmatory trial. In October 2020, AMAG received notice that the FDA is proposing to withdraw approval of ~~its review by October 20, 2017.~~

~~On September 22, 2017, we received FDA labeling comments with regard~~Makena^® (hydroxyprogesterone caproate injection). AMAG has formally requested a public hearing in response to the ~~NDA~~FDA’s proposal to withdraw its approval and ~~responded~~has stated that it remains committed to ~~the comments on September 29, 2017.~~ ~~On October 11, 2017, we received a letter from the FDA stating that,~~ ~~as part of its ongoing review of the NDA, the FDA has identified deficiencies that preclude the continuation of the discussion of labeling and postmarketing requirements/commitments. On October 20, 2017, we received a Complete Response Letter (“CRL”) from the FDA regarding our NDA for XYOSTED~~^TM, which identified two deficiencies and indicated that the NDA cannot be approved in its current form. We are assessing the content of the CRL, including the information that may be needed to resolve the deficiencies, and intend to work closelyworking with the FDA to ~~determine the appropriate responses~~maintain patient access to ~~the deficiencies noted in the CRL.~~

~~The clinical basis of our NDA submission for XYOSTED~~^TM ~~included a multi-center, phase 3 clinical study (“QST-13-003”) evaluating the efficacy and safety of testosterone enanthate administered once-weekly by subcutaneous injection using the QuickShot~~Makena^® auto injector in adult males diagnosed with testosterone deficiency, in which positive top-line pharmacokinetic results that showed that the primary endpoint for this study was achieved. Based upon a written response we received from the FDA related to our clinical development program for XYOSTED^TM~~, we conducted an additional supplemental safety study QST-15-005. The study included a screening phase,~~ as a treatment titration phase and a treatment phase for evaluation of safety and tolerability assessments, including laboratory assessments, adverse events and injection site assessments. In September 2016, we announced the successful completion of the QST-15-005 study. The results of these two studies formed the clinical basis of our NDA submission for XYOSTED^TM ~~and are further discussed in the “Research and Development Programs” section below.~~

~~The CRL for XYOSTED~~^TM ~~identified two deficiencies related~~option to ~~the clinical data. Based on findings in studies QST-13-003 and QST-15-005, the FDA is concerned that XYOSTED~~^T^M could cause a clinically meaningful increase in blood pressure. In addition, the CRL also raised a concern regarding the occurrence of depression and suicidality. The Company anticipates that the next step will be

~~to request a meeting with the FDA to further evaluate the deficiencies raised and to agree upon a path forward for a potential approval of XYOSTED~~^TM.reduce pre-term birth.

We are also collaborating with Teva on a ~~VIBEX~~^® ~~auto injector pen containing epinephrine used for the treatment of severe allergic reactions (anaphylaxis). Teva submitted an amendment to the VIBEX~~^® epinephrine pen ANDA in December 2014 and received a Complete Response Letter from the FDA in February 2016 in which, according to Teva, the FDA identified certain major deficiencies. Teva has disclosed that they submitted a response to this Complete Response Letter. We continue to work with Teva toward a potential approval of the epinephrine auto injector pen ANDA, which remains under active review at the FDA.

~~Our other combination product development projects in collaboration with Teva include 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 filed an ANDA~~osteoporosis, and another multi-dose pen for ~~exenatide, which was accepted by the FDA in October 2014 and is currently under FDA review. In 2016, we announced that Teva had settled the patent litigation with~~ ~~AstraZeneca Pharmaceuticals, LP, AstraZeneca AB, and Amylin Pharmaceuticals, LLC (collectively “AstraZeneca”)~~ ~~relating to certain AstraZeneca U.S. patents and their drug, BYETTA~~^® ~~(exenatide). AstraZeneca and Teva entered into~~ a ~~settlement and license agreement pursuant to which AstraZeneca granted Teva a license to manufacture and commercialize the~~ generic ~~version~~form of BYETTA^® described in Teva’s ANDA. The settlement allows Teva to commercialize their exenatide product in the U.S. beginning October 15, 2017 or earlier under certain circumstances. Teva also filed an ANDA for a generic version of Forteo^® (teriparatide [rDNA origin] injection), which was accepted by the FDA in February 2016 and is currently under review. In response to Teva’s paragraph IV certification contained in Teva’s ANDA for teriparatide, Eli Lilly & Co (“Lilly”) filed a lawsuit against Teva alleging infringement of six U.S. patents related to Forteo^® (teriparatide [rDNA origin] injection) resulting in a 30-month stay in FDA approval of the ANDA. The stay will expire in August 2018 unless the litigation is resolved sooner. Teva also successfully concluded a decentralized procedure registration process in Europe. According to Teva, the Public Assessment Report for the decentralized procedure has been published and the product was filed in 17 countries, which addresses the majority of the market value in Europe.

~~In partnership with AMAG, we are currently developing a variation of our VIBEX~~^® ~~QuickShot~~^® ~~subcutaneous auto injector for use with AMAG’s Makena~~^® ~~(hydroxyprogesterone caproate~~(exenatide injection) for the treatment of ~~pre-term birth. Under a license, development~~type 2 diabetes. Teva continues to work through the U.S. regulatory process with the FDA for exenatide and ~~supply agreement, AMAG~~teriparatide using the ANDA pathway. Teva recently launched Teriparatide Injection (“teriparatide”), the generic version of Eli Lilly’s branded product Forsteo^® featuring the Antares multi-dose pen platform in several countries outside the United States.Antares is responsible for the clinical development and preparation, submission and maintenance of all regulatory applications, the manufacture and supply of the drug, and the marketing, sale and distribution of the product. We are responsible for the design and development of the auto-injection device, the manufacturing and supply of the multi-dose pen utilized in Teva’s generic teriparatide product under an exclusive development, license and supply agreement with Teva, the scope of which is worldwide.

In August 2018, we entered into a development agreement with Pfizer to develop a combination drug device rescue pen. This rescue pen will utilize the Antares QuickShot^® auto injector and ~~assembly~~an undisclosed Pfizer drug. We are developing the product and ~~packaging~~Pfizer will be responsible for obtaining FDA approval of the ~~final~~combination product. ~~AMAG initiated~~We entered into a ~~pharmacokinetic (“PK”) study~~separate commercial 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 ~~October 2016~~ the U.S., pending FDA approval, for which the Company will receive royalties on net sales.

In November 2019, we entered into a global agreement with Idorsia to develop a novel, drug-device product containing selatogrel. Thenewchemicalentity selatogrelisbeingdevelopedforthetreatmentofasuspectedacutemyocardialinfarction(AMI)inadultpatientswithahistoryofAMI.Idorsiawillpayforthedevelopmentofthecombinationproductand ~~disclosed positive top line results~~willberesponsibleforapplyingforandobtainingglobalregulatoryapprovalsfortheproduct.ThepartiesintendtoenterintoaseparatecommerciallicenseandsupplyagreementpursuanttowhichAntareswillprovidefullyassembledandlabelledproducttoIdorsiaatcostplusmargin.Idorsiawillthenberesponsibleforglobalcommercializationoftheproduct,pendingFDAorforeignapproval.Antareswillbeentitledtoreceiveroyalties on net sales of the commercial product.

In June 2021, Idorsia announced it is initiating its Phase 3 registration study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia’s P2Y₁₂ receptor antagonist, in ~~February 2017. According to AMAG, the study successfully demonstrated comparable bioavailability between subcutaneous injection of Makena~~suspected AMI utilizing Antares’ Quickshot^® ~~compared~~auto-injector. The study is an international, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to ~~intra muscular injection. AMAG submitted its sNDA~~assess the clinical efficacy and safety of 16 mg selatogrel when self-administered (on top of standard-of-care) upon occurrence of symptoms suggestive of an acute myocardial infarction. The primary efficacy endpoint is the occurrence of death from any cause, or non-fatal AMI after any study treatment self-administration. The study will enroll approximately 14,000 patients who are at high risk of recurrent AMI, at approximately 250 sites in approximately 30 countries. A Special Protocol Assessment has been agreed with the FDA for Idorsia’s selatogrel, which indicates the FDA is in agreement with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints and planned analyses) for a study intended to support a future marketing application. In December 2020, the FDA designated Idorsia’s investigation of selatogrel for the ~~Makena~~^®~~subcutaneous auto injector~~treatment of a suspected AMI in ~~April 2017, which was accepted by~~adult patients with a history of AMI as a “fast-track” development program. This designation is intended to promote communication and collaboration between the FDA and ~~given~~pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need.

We are also committed to advancing our internal research and development programs and continue to invest in the development of our proprietary product pipeline. Our research and development efforts are focused primarily on leveraging our existing product and technology platforms by broadening their applications for use in other drug device combination products, as well as exploring new pharmaceutical products, technologies and drug delivery methods.

In 2019, we initiated development of a ~~PDUFA target action~~proprietary drug device combination product for the urology oncology market, identified as ATRS-1901. We have conducted formulation development work and non-clinical studies to help advance this program. In 2020, we received a response from the FDA regarding our pre-IND (Investigational New Drug) submission and believe we have determined our clinical and regulatory pathway forward. We expect to file an IND for this program with the FDA in the second half of 2021.

In 2019, we identified a program to develop a proprietary drug device combination product for the endocrinology market, identified as ATRS-1902. We conducted initial formulation work and developed a working prototype of a new device to support this

program. We received a response from the FDA regarding our pre-IND submission and believe we have determined the regulatory and clinical path forward.

In June 2021, we submitted an IND application with the FDA for the initiation of a Phase 1 clinical study of ATRS-1902 for adrenal crisis rescue. The IND application for ATRS-1902, and its corresponding development program, supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone. The IND application includes the protocol for an initial clinical study to compare the pharmacokinetic profile of our novel formulation of hydrocortisone versus Solu-Cortef^®, which is an anti-inflammatory glucocorticoid and is the current standard of care for the management of acute adrenal crises.

In July 20201, the FDA accepted our IND for ATRS-1902 enabling us to initiate our Phase 1 clinical study. After this study is completed, we expect a second study will then be conducted utilizing our proprietary auto-injector technology which has been developed for high reliability and ease-of-use in emergency situations by the patient or caregiver. We believe these two studies will be the basis of our anticipated 505(b)(2) NDA filing with the FDA towards the end of 2022.

In December 2019, a novel strain of coronavirus (COVID-19) emerged in China, and has since spread worldwide, including every state in the United States. On March 11, 2020, the World Health Organization declared the outbreak a Pandemic and on March 13, 2020, the United States declared a national emergency with respect to the outbreak. The Pandemic has impacted global economic activity and lead to disruptions in supply chain, labor shortages, business closures, travel restrictions and other health, safety and social distancing requirements.

We have taken several measures to help minimize the impact of the Pandemic on our business and have implemented safety measures and protocols to protect the health and safety of our employees and comply with governmental and public health regulations while working to ensure the sustainability of our business operations and continuity of product supply. We continue to monitor the situation and potential effects on our business, suppliers, partners and workforce.

Most of our employees, including our corporate and administrative functions, have returned to work onsite at our facilities. Our sales force has resumed in-person office visits in most areas and continue to reach healthcare providers virtually in other territories based on the varying restrictions, protocols and phased re-openings. The restrictions and closures during the Pandemic have, to some extent, limited or reduced patient access to physicians for non-essential services. These limitations have had, and may continue to have, an impact on the rate of new prescriptions for our proprietary products. Our partners may also experience a decrease or fluctuation in demand for our partnered products due to the Pandemic or the related restrictions. Although we have not experienced any significant delays or disruption in our development programs due to the Pandemic, a worsening or sustained outbreak could also impact our or our partners’ clinical trials or lead to delays or disruptions in activities with the FDA.

While we have taken measures to help minimize the potential impact of the Pandemic and various government orders, and believe any potential or significant disruption, when and if experienced, could be temporary, there is continued uncertainty around the timing and duration of the potential disruption, and the magnitude of any potential impact. As a result, we are unable to estimate the potential impact on our operations or cash flows as of the date of ~~February 14, 2018.~~

~~Our management’s discussion~~this filing. For more information on these risks, see “Part II — Item 1A. Risk Factors — We face uncertainty and ~~analysis~~risks related to the outbreak of the novel coronavirus disease, COVID-19, which could significantly disrupt our ~~results of~~ operations and ~~financial condition is based upon~~may materially and adversely impact 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 the understanding our results of operationsbusiness 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”conditions” in our ~~Annual Report~~most recent annual report on Form 10-K ~~for~~as filed with the ~~year ended December 31, 2016.~~

~~We sell OTREXUP~~^® in packages of four pre-filled, single-dose disposable auto injectors to wholesale pharmaceutical distributors, our customers, subject to rights of return within a period beginning six months prior to,Securities and ~~ending 12 months following, product expiration. We began detailing OTREXUP~~^® ~~to health care professionals in February 2014.~~

~~Prior to the first quarter of 2017, we could not reliably estimate expected returns of OTREXUP~~^® at the time of shipment given our limited sales history of the product. Accordingly, the recognition of revenue was deferred on product shipments until the rights of return no longer existed, which occurred at the earlier of the time that OTREXUP^® ~~units were dispensed through patient prescriptions or expiration of the right of return of the product. Patient prescriptions dispensed were estimated using third-party market prescription data.~~

~~In the first quarter of 2017, we determined we had developed sufficient historical information to reasonably estimate future returns of OTREXUP~~^®and began recognizing revenue upon delivery to the distributors, net of estimated returns. Accordingly, we recognized $1,297,054 in revenue for product shipped to distributors in previous periods but not previously recognized as revenue at the time of shipment, net of the returns allowance established during the first quarter of 2017. We also recognized $254,425 of related product costs in the first quarter of 2017. The net impact of these changes resulted in a decrease to net loss of $1,042,629, or less than $0.01 per share, for the nine months ended September 30, 2017.Exchange Commission.

We reported net ~~losses~~income of ~~$5,452,521~~$4.4 million and ~~$6,120,983~~$8.2 million for the three and six months ended ~~September~~June 30, ~~2017~~2021 as compared to net income of $2.2 million and ~~2016, respectively, and $13,028,382 and $19,838,556 for the nine months ended September 30, 2017 and 2016, respectively. Net~~a net loss ~~per share was $0.03~~of $0.2 million for the three and six months ended ~~September~~June 30, ~~2017~~2020, respectively. Our earnings per share were $0.03 and $0.05 for the three and six months ended June 30, 2021 as compared to ~~$0.04~~$0.01 and $0.0 per share for the three and six months ended ~~September~~June 30, ~~2016, and $0.08 and $0.13 for the nine months ended September 30, 2017 and 2016,~~2020, respectively. Operating results for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2021 are not necessarily indicative of the results that may be expected for the full year ending December 31, ~~2017.~~2021. The following is an analysis and discussion of our operations for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2021 as compared to the same periods in ~~2016.~~2020.

We generate revenue from proprietary and partnered product sales, license and development activities and royalty arrangements. Total revenue for the three months ended ~~September~~June 30, ~~2017~~2021 and ~~2016~~2020 was ~~$15,052,397~~$45.0 million and ~~$13,478,763,~~$32.4 million, respectively, representing an increase in total revenue of ~~12%~~39% on a comparative basis. ~~Revenue~~Total revenue for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2021 and 2020 was ~~$40,476,015 as compared to $38,025,925 for the nine months ended September 30, 2016,~~$87.1 and $65.5 million, respectively, representing an increase of 6%33%. The following ~~is a detailed discussion of~~table provides details about the components and drivers of our overall revenue growth (in thousands):

~~For~~$24.7 million for the three months ended ~~September~~June 30, ~~2017~~2021 and ~~2016, we recognized revenue~~2020, respectively, an increase of ~~$4,623,326 and $3,904,329, respectively, from~~13% on a period over period basis. The increase was driven primarily by increased sales of our proprietary product XYOSTED^®offset by a decrease in shipments of epinephrine auto injectors to Teva and sales of other partnered products, as discussed below. For the six months ended June 30, 2021 and 2020, revenue from product sales was $57.0 million and $51.8 million, respectively, an increase of 10% on a period over period basis. The increase for the comparative six-month period was primarily attributable to an increase in XYOSTED^®sales and sales of epinephrine auto injectors to Teva, offset by a reduction in sales of Makena^® subcutaneous auto-injectors to AMAG.

Sales of our proprietary products XYOSTED^®, OTREXUP^® and NOCDURNA^®, which isare presented net of estimated product returns and sales ~~allowances. The increase in~~allowances, generated revenue of $19.0 million and $14.8 million for the three months ended ~~September~~June 30, ~~2017~~2021 and 2020, respectively, representing a 28% increase on a comparative basis. For the six months ended June 30, 2021 and 2020, proprietary product sales were $37.7 million and $27.4 million, respectively, representing a 37% increase. The increases in proprietary product sales for the three and six months ended June 30, 2021 as compared to the three and six months ended ~~September~~June 30, ~~2016~~2020 was ~~driven by an increase in shipments~~principally attributable to ~~distributors and an underlying~~continued growth in prescriptions ~~dispensed. However, as discussed in our “Critical Accounting Policies” above,~~and sales of XYOSTED^®, and to new sales of NOCDURNA^®, which we in-licensed and began ~~recognizing revenue upon delivery to distributors, net of estimated returns,~~detailing in the ~~first~~fourth quarter of 2017. 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. This change in estimation and recognition method may affect the comparability of revenues on a period over period basis.2020.

We ~~recognized revenue of $13,110,489~~also manufacture and ~~$11,024,394 from OTREXUP~~^®sell devices, components and fully assembled and packaged product to our partners. Partnered product sales ~~for the nine months ended September 30, 2017~~were $9.0 million and ~~2016, respectively. The increase in OTREXUP~~^® revenue for the nine months ended September 30, 2017 as compared with the same period in 2016 included the recognition of $1,297,054 in previously deferred revenue. If we underestimate or overestimate product returns for a given period, adjustments to revenue may be necessary in future periods.

~~Product sales of auto injector devices were $7,946,313 and $5,943,786~~$9.8 million for the three months ended ~~September~~June 30, ~~2017~~2021 and ~~2016,~~2020, respectively, ~~and $14,489,839 and $15,836,179 for~~representing a decrease of 9% on a comparative basis. For the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2021 and ~~2016,~~2020, partnered product revenue was $19.4 million and $24.4 million, respectively. ~~We manufacture devices and sell fully assembled and packaged Sumatriptan Injection USP~~The net decreases in partnered product ~~to Teva. We also sell pre-launch~~

~~quantities of injector devices for use with Teva’s generic epinephrine pen, and auto injector devices for use with AMAG’s Makena~~^® ~~in anticipation of potential approvals and launch of these products.~~

~~The increase in auto injector product revenue~~sales for the three and six months ended ~~September~~June 30, ~~2017~~2021 as compared to the same ~~period~~periods in ~~2016 was principally~~2020 is primarily attributable to ~~an increase~~a decrease in ~~shipments of Sumatriptan Injection USP and the related profit earned under the margin sharing arrangement with Teva. Revenue from auto injector~~ sales ~~for the three months ended September 30, 2017 was principally attributable to~~ sumatriptan ~~product sold~~ to Teva ~~totaling $6,400,000 including the profit sharing recognized during the quarter,~~ and ~~approximately $1,000,000~~a decrease in production and ~~$500,000~~sales of ~~pre-launch quantities of devices for use with Makena~~^®and epinephrine, respectively. Revenue for the three months ended September 30, 2016 included approximately $3,400,000 in shipments of sumatriptan product at cost, $1,400,000 in auto-injector devices for use with Makena^® product for AMAG.

Licensing and ~~$1,100,000 of pre-launch quantities of auto injector devices sold to Teva for use with their generic epinephrine product.~~

The decrease in product revenue from sales of auto injectors for the nine months ended September 30, 2017 as compared to the nine months ended September 30, 2016 was a result of a significant reduction in sales of pre-launch quantities of auto-injectors for use with Teva’s generic epinephrine product. As previously discussed, Teva’s ANDA for the epinephrine auto injector is under review by the FDA and Teva is targeting a launch in early 2018. The decrease in revenue from pre-launch shipments of epinephrine auto injectors was partially offset by a significant increase in sales of Sumatriptan Injection USP, which was launched in June 2016.

Our revenue from reusable needle-free injector devices and disposable components was $757,886 and $1,201,725 for the three months ended September 30, 2017 and 2016, respectively, and $3,108,422 and $3,720,316 for the nine months ended September 30, 2017 and 2016 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. We do not control our partners’ sales volume or inventory levels of our injectors and components, which can cause fluctuations in our product sales in comparative periods.

On October 10, 2017, we announced the sale of the worldwide rights related to the ZOMAJET™ needle-free auto injector device and expect the transaction to be completed by the end of 2018. During the transfer and completion period, we will continue to manufacture and supply ZOMAJET™ 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.

~~Development revenue typically represents amounts earned under arrangements with partners for which we develop new products on their behalf. Frequently, we receive up-front~~Licensing and ~~milestone payments from our partners that are initially deferred and recognized as revenue over a~~ development period or upon completion of defined deliverables. Development revenue was $1,485,091 and $2,101,203 for the three months ended September 30, 2017 and 2016, respectively, and was $7,894,640 and $6,466,974 for the nine months ended September 30, 2017 and 2016, respectively. The increase in development revenue recognized for the nine months ended September 30, 2017 as compared to 2016 was primarily a result of increases in development activities with AMAG for the Makena^® auto injector product offset by reductions in revenue for development activities with Teva in connection with the epinephrine auto injector and pen injector programs. The decrease in development revenue for the three months ended September 30, 2017 as compared to the same period in 2016 was primarily a result of lower development revenue related to the Makena^® ~~auto injector development program with AMAG and the exenatide pen injector program with Teva.~~

~~Licensing revenue represents amounts~~revenues include license fees received from partners for the right to use ~~certain~~our intellectual ~~property. Generally, the up-front~~property and amounts earned in joint development arrangements with partners under which we perform joint development activities or ~~milestone payments received were initially deferred~~develop new products on their behalf. Licensing and ~~recognized in~~development revenue ~~over the license period. We recognized $19,486~~was $7.2 million and ~~$38,618~~$2.7 million for the three months ended ~~September~~June 30, ~~2017~~2021 and ~~2016,~~2020, respectively, and ~~$1,057,204~~$12.2 million and ~~$128,040~~$4.4 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2021 and ~~2016,~~2020, respectively. The ~~significant~~ increase in licensing and development revenue recognized infor the ~~nine~~three and six months ended ~~September~~June 30, ~~2017 is due~~2021 as compared to the ~~recognition~~same periods in 2020 was primarily a result of ~~$1,000,000 in licensing fees previously received~~incremental development and ~~initially deferred due to potential contractual refund rights of the customer under certain circumstances. During the second quarter of 2017, the License, Supply and Distribution Agreement~~maintenance activities with Teva for Sumatriptan Injection USP was amended such that the refund provisions relating to the licensing fee was removed. Accordingly, we recognized the deferred revenue in income, as the license had been delivered and there were no remaining obligations related to the ~~license granted.~~epinephrine auto injector production line and continuing development activities under the other ongoing partnered development projects.

Royalty revenue was ~~$220,295~~$9.9 million and ~~$289,102~~$5.0 million for the three months ended ~~September~~June 30, ~~2017~~2021 and ~~2016,~~2020, respectively and ~~$815,421~~$17.9 million and ~~$850,022~~$9.3 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2021 and ~~2016,~~2020, respectively. ~~We receive~~The net increase in royalty revenue was principally a result of an increase in royalties from ~~Ferring related to needle-free injector device sales and~~Teva on its net sales of ~~ZOMACTON~~generic EpiPens^TM® ~~in the U.S., and on sales of gel-based products commercialized through partners.~~.

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

~~Our gross profit was $6,529,500~~The increase and ~~$20,116,963~~decrease in our cost of product sales for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017, respectively,~~2021 as compared to ~~$5,445,042~~2020, respectively, is a function of the product revenue mix in the respective periods. Proprietary products generally have a lower cost of sales as a percentage of revenue than partnered product sales.

The increase in our cost of development revenue is attributable to, and ~~$15,898,365~~consistent with, the significant growth in development revenue from partnered development activities for the three and ~~nine~~six months ended ~~September~~June 30, 2016, respectively. The increase in our gross profit for the nine months ended September 30, 2017 was primarily attributable to the recognition of $1,000,000 in licensing revenue previously deferred, for which there was no associated costs, the recognition of previously deferred revenue related to OTREXUP^® ~~sales, and other changes in our product revenue and cost of sales, which is summarized in the following table and discussed below.~~

~~Product gross profit increased in the three months ended September 30, 2017~~2021 as compared to the three and six months ended ~~September~~June 30, ~~2016, primarily due to sales of OTREXUP~~^®~~and to sales of Sumatriptan Injection USP, which is initially sold at cost to Teva, and profit recognized from~~2020, as shown in the margin sharing arrangement in trailing periods. The increase in product gross profit for the nine months ended September 30, 2017 compared to the nine months ended September 30, 2016 included the $1,042,629 net impact of recognizing previously deferred revenue ~~and related product costs for OTREXUP~~^® as described in “Critical Accounting Policies” above, and sales of Sumatriptan Injection USP, which was launched in June 2016. These increases were offset by the reduction in epinephrine auto injector device sales and the associated cost of sales. The cost of product sales includes product acquisition costs from third-party manufacturers and internal manufacturing 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 of the Makena^® ~~auto injector with AMAG.~~ table above.

Research and development expenses consist of external costs for clinical studies and analysis activities, design work and prototype development, FDA application fees, personnel costs and other general operating expenses associated with our research and development activities. Research and development expenses were ~~$3,289,445~~$4.0 million and ~~$5,958,550~~$2.4 million for the three months ended ~~September~~June 30, ~~2017~~2021 and ~~2016,~~2020, respectively, and ~~$9,535,089~~$6.7 million and ~~$15,554,599~~$5.4 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2021 and ~~2016,~~2020, respectively. ~~The decrease in research~~Research and development costs were attributable to our ongoing internal development programs including, but not limited to, ATRS-1901 and ATRS-1902, and fluctuate based on ~~a comparative basis is primarily due to a decrease in~~the respective phases of development and timing of clinical studies and external ~~clinical and~~ development costs ~~related to XYOSTED~~^TM ~~for testosterone replacement therapy. We completed clinical trials and~~incurred. As discussed above, we submitted ~~our NDA for XYOSTED~~^TM toan IND application with the FDA in June 2021 for the ~~fourth quarter~~initiation of ~~2016.~~ O~~n October 20, 2017, we received~~ a ~~CRL from the FDA regarding our NDA~~

Phase 1 clinical study of ATRS-1902 for ~~XYOSTED~~^TM~~. See further discussion of our research and development activities related to XYOSTED~~^TM ~~in the “Research and Development Programs” section below.~~adrenal crisis rescue.

Selling, general and administrative expenses were ~~$8,185,865~~$17.7 million and ~~$5,622,937~~$14.4 million for the three months ended ~~September~~June 30, ~~2017~~2021 and ~~2016,~~2020, respectively, and ~~$23,013,130~~totaled $35.3 million and ~~$20,240,635~~$30.9 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2021 and ~~2016,~~2020, respectively. The ~~overall increase~~increases in selling, general and administrative expenses for the three and six months ended June 30, 2021 compared to 2020 was primarily ~~attributable~~due to an increase in sales and marketing costs, which were down in 2020 due to the Pandemic as the various restrictions and limitations imposed during the Pandemic lead to decreased spending that has now returned to pre-Pandemic levels. The increase is also attributable to sales and marketing costs associated with our new proprietary product NOCDURNA^®, which we in-licensed and began detailing in the ~~preparation~~fourth quarter of 2020. We also experienced an increase in general and administrative expenses, primarily employee compensation, professional services and facility costs, to support the continued growth of the business.

We recorded income tax expense of $1.1 million and $1.7 million for the three and six months ended June 30, 2021, respectively, or 20.8% and 17.4% of earnings before income taxes. Income tax expense was $0 in 2020, or 0% of our net income (loss) before taxes, as a ~~potential launch~~result of ~~XYOSTED~~^TM.our full valuation allowance on our deferred taxes that was released in the fourth quarter of 2020. The effective income tax rate for the three and six months ended June 30, 2021 reflected a net discrete income tax benefit related to share-based compensation expense in connection with stock option exercises and vesting of performance and restricted stock units, which favorably impacted the effective tax rate by 5.3% for the quarter and 8.6% year to date.

At ~~September~~June 30, ~~2017,~~2021, we had cash and cash equivalents of ~~$27,433,489 and short-term investments of $9,976,984.~~$45.1 million. Our principal liquidity needs are to fund our product manufacturing costs, research and development activities, sales and ~~for the payment of~~marketing and other general operating expenses. We have not historically generated, and do not currently expect to generate, enough revenue or operating cash flow to support or grow our operations and we continue to operate primarily by raising capital. Our primary sources of liquidity are proceeds from equity offeringsexpenses, as well as capital expenditures and debt ~~issuance.~~service. We believe that the combination of our current cash and cash equivalents, ~~short-term investments,~~ 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.

~~On June 6, 2017, we entered into~~The Company is party to a loan and security agreement, ~~for a term loan of up to $35,000,000~~as amended, with Hercules Capital, Inc. (the “Term Loan”). The amortizing Term Loan is secured by substantially all of the Company’s assets, excluding intellectual property and accrues interest at a prime-based variable rate with a maximum of 9.5%, which was 8.5% at June 30, 2021. On June 30, 2021, we made a $15.0 million prepayment of principal due under the ~~proceeds~~Term Loan along with a 1.0% prepayment fee. The outstanding principal balance under the Term Loan was $25.0 million and $40.0 million as of June 30, 2021 and December 31, 2020, respectively.

The Term Loan, as amended, provided for payments of interest-only until August 1, 2021 with a maturity date of July 1, 2022, both of which ~~are to~~could be ~~used for working capital~~extended contingent upon satisfaction of a certain loan extension milestones and ~~general corporate purposes. The first advance~~upon formal request of ~~$25,000,000 was funded upon execution~~such extension. In July 2021, we requested, and the lender granted, the extension of the ~~Loan Agreement on June 6, 2017. Under the terms of the Loan Agreement, we may, but are not obligated~~interest-only period to request one or more additional advances of at least $5,000,000 not to exceed $10,000,000 in the aggregate, subject to the company achieving certain corporate milestones and satisfying customary conditions. The option to request additional advances must be exercised prior to September 30, 2018. Payments under the Loan Agreement are interest only until the first principal payment is due on August 1, ~~2019, provided that~~2022 and maturity date to July 1, 2024 in accordance with the ~~interest only period may be extended to February 1, 2020 if certain corporate milestones are achieved.~~ loan and security agreement, as amended.

The ~~Loan Agreement also requires us~~Company is required to pay aan end of term fee equal to 4.25% of the ~~total original principal amount~~first $25.0 million and 3.95% of all ~~term~~other borrowings under the loan, ~~advances (“End~~payable upon the earlier of ~~Term Charge”), which is due upon~~July 1, 2022 or full repayment of the ~~Term Loan at either maturity or earlier repayment.~~

~~On August 11, 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 $30,000,000 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.loan.

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,~~activities, and sales and marketing ~~activities.~~costs. Fluctuations in cash ~~used in~~from operating activities are primarily a result of the timing of cash receipts and disbursements. Net cash ~~used in~~provided by operating activities was ~~$15,482,269~~$8.4 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017 and $11,696,233~~2021 as compared $9.3 million for the ~~nine~~six months ended ~~September~~June 30, ~~2016. For~~2020. The change in the ~~nine months ended September 30, 2017, the increase in~~ net cash ~~used in~~from operating activities was primarily ~~driven by~~a result of our ~~inventory build, changes in accounts receivable~~net income(loss) for the period and ~~deferred revenue, and other~~the changes in operating assets and liabilities due to timing of cash receipts and cash ~~payments.~~disbursements, principally driven by our growth in sales and accounts receivable in 2021.

Net cash used in investing activities was $2.5 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2021 and was ~~$10,926,425 as compared to net~~primarily for capital expenditures for our manufacturing facility. Net cash provided by investing activities ~~of $7,617,569~~ for the ~~nine~~six months ended ~~September~~June 30, ~~2016. The net~~2020 was $12.1 million and was comprised of $14.5 million in cash ~~outflow for the nine months ended September 30, 2017, was attributable to purchases~~receipts from maturities of ~~investment securities totaling $9,963,978 and payments for~~short-term investments offset by capital expenditures ~~and patent acquisition costs, while the net cash inflow for the nine months ended September 30, 2016 was attributable to~~

~~maturities~~ of ~~investment securities of $12,000,000, offset by payments for capital expenditures and patent acquisition costs totaling $4,278,643.~~ $2.4 million.

~~Cash~~The net cash flow ~~provided by~~used in financing activities was ~~$26,127,902~~$14.0 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017,~~2021, and ~~was primarily attributable to the receipt~~consisted of ~~$25,000,000 proceeds from debt issuance and $1,670,149 cash~~$3.9 million in proceeds received from ~~the exercise~~exercises of stock options offset by ~~payments~~a $15.0 million prepayment of ~~debt issuance costs~~principal on our Term Loan and tax withholding payments in connection with settlement of share-based awards. The net cash used in financing activities was $40,025 for the nine months ended September 30, 2016, included the receipt of $24,000 in proceeds from the exercise of stock options and $64,000 remitted$2.8 million paid to taxing authorities in connection with net-share settled stock-based awards for which we withheld shares equivalent to the value of the employees’ ~~minimum statutory~~tax obligation for the applicable income and other employment taxes. Net cash used in financing activities for the six months ended June 30, 2020 was $1.0 million, which included $0.4 million in proceeds from the exercise of stock options offset by $1.4 million paid to taxing authorities in connection with net-share settled stock-based awards.

The ~~following table presents~~preceding discussion and analysis of our ~~contractual obligations~~results of operations and financial condition is based upon our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, revenues and expenses. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results could differ from our estimates, and significant variances could materially impact our financial condition and results of operations.

The accounting policies we believe to be most critical to understanding our results of operations and financial condition related ~~payments, including interest, due by period as~~to revenue recognition and valuation of ~~September 30, 2017:~~

deferred tax assets, which are fully described in our Annual Report on Form 10-K for the year ended December 31, 2020.

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

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

~~XYOSTED~~^TM ~~(testosterone enanthate) Injection~~ ~~(Formerly referred to as VIBEX~~^® ~~QuickShot~~^® ~~Testosterone or “QST”)~~.

~~We are developing XYOSTED~~^TM ~~for self-administered weekly injections of testosterone enanthate for clinically diagnosed testosterone deficient men requiring testosterone replacement therapy.~~

~~On December 5, 2012, we conducted a pre-IND (Investigational New Drug application) meeting with the FDA as part of preparing to initiate clinical development of XYOSTED~~^TM, establishing an agreed upon clinical path forward. In September 2013, we announced that the first patients were dosed in a clinical study evaluating the PK profile of testosterone enanthate administered weekly by subcutaneous injection at doses of 50 mg and 100 mg via the XYOSTED^TM auto injector device in testosterone deficient adult males. The study enrolled 39 patients at nine investigative sites in the U.S. On February 20, 2014, we announced positive top line results of this study that showed that the primary endpoint was achieved in that XYOSTED^TM ~~treatment resulted in most patients achieving average levels of testosterone within the normal range from the first dose onward.~~

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

On February 25, 2015, we announced positive top-line pharmacokinetic results that showed that the primary endpoint was achieved in QST-13-003. The protocol for the study required that at the week 12 endpoint: (i) at least 75% of all patients’ C_avg ~~are within the normal range of 300 to 1100 ng/dL, with a lower limit of a 95% 2-sided confidence interval of greater than or equal to 65%, (ii) at least 85% of patients’ C~~_max ~~are less than1500 ng/dL and (iii) no more than 5% of patients had a C~~_max ~~greater than 1800 ng/dL. The primary endpoint of the population that received one or more doses of XYOSTED~~^TM was met by 139 out of 150 patients, equating to 92.7% with a 95% confidence interval of 87.3% to 96.3%. Among the 137 patients that completed all 12 weeks of dosing and PK sampling, 98.5% were within the pre-defined range. The top-line results of the PK study are summarized in the table below.

~~Overall, the regimen demonstrated a mean (± standard deviation) steady state concentration of testosterone of 553.3 ± 127.3 ng/dL at 12 weeks. Participants in the study remained on XYOSTED~~^TM ~~and were followed for an additional 40 weeks for the collection of safety data.~~

After we initiated study QST-13-003, but before we announced positive top-line pharmacokinetic results in February 2015, we received written recommendations from the FDA related to our clinical development program for XYOSTED^TM. The recommendations received were in response to various clinical, chemistry, manufacturing and controls and user study submissions that we made through November 2014. We believe that we had already factored many of the recommendations cited in the advice letter into the protocol of the ongoing QST-13-003 study and into the protocols for planned human use studies as a result of guidance provided by the FDA at the May 2014 Type C meeting. Based on a single reported occurrence of hives in our phase 2 study, the FDA recommended that we create a larger safety database, including approximately 350 subjects exposed to XYOSTED^TM with approximately 200 subjects exposed for six months and approximately 100 subjects exposed for a year. We assessed the FDA’s comments in the advice letter and their impact on the timing of the filing of a NDA for XYOSTED^TM ~~with the FDA. Based on the number of subjects in previous studies and in the current QST-13-003 study, we concluded that we would need additional subjects exposed to XYOSTED~~^TM for six months. The timing and design of the study to obtain the additional subjects and data required was determined based on further discussion with the FDA. We submitted our response to the FDA’s written recommendations in early March 2015.

In October 2015, we announced that the last patient in study QST-13-003 received their week 52 treatment, which marked the end of the treatment phase of this study. In March 2016, we announced that the pharmacokinetic results of QST-13-003 were final and reported the results from the 52-week safety study. The safety population, defined as patients who received at least one dose of study drug, was comprised of 150 patients. The most common adverse reactions (incidence ≥5%) in this phase 3 study were increased hematocrit, hypertension, increased prostate-specific antigen, upper respiratory tract infection, sinusitis, injection site bruising and headache. Serious adverse events (SAE’s) reported included one case each of worsening depression, vertigo and suicide. None of the SAE’s were considered to be related to the study drug by the investigators, however the Company determined that the case of suicide could not be ruled out as potentially being related to study drug. There have been no reported adverse events consistent with urticaria (hives), pulmonary oil micro embolism (“POME”), anaphylaxis or major adverse cardiovascular events in this study.

~~In May 2015, we received an additional written update from the FDA related to our clinical development program for XYOSTED~~^TM~~. Based on that update received from the FDA, we concluded there was an agreed upon path forward for the completion of an additional study to support the filing of a NDA for XYOSTED~~^TM. In June 2015, we finalized and submitted the protocol for the study, and in August 2015, we enrolled the first patients in the study, which is known as QST-15-005. The study was a dose-blind, multiple-dose, concentration controlled 26-week supplemental safety and pharmacokinetic study of XYOSTED^TM, which included a screening phase, a treatment titration phase, and a treatment phase for evaluation of safety and tolerability assessments including laboratory assessments, adverse events and injection site assessment. Patients meeting all eligibility criteria were assigned to receive 75 mg of XYOSTED^TM ~~once weekly for six weeks. According to the protocol, adjustments to dose could be made at week seven based upon the week six C~~_trough ~~value. XYOSTED~~^TM ~~was provided to clinical sites at dosage strengths of 100 mg, 75 mg and 50 mg to be utilized in dose titration.~~

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

~~Based upon the completion of our clinical and development work and the results of the studies detailed above, we submitted a 505 (b) (2) New Drug Application for XYOSTED~~^TM ~~to the FDA in December 2016. The NDA submission was accepted for standard review by the FDA and assigned a PDUFA target date for completion of its review by October 20, 2017.~~

~~On September 22, 2017, we received FDA labeling comments with regard to the NDA and responded to the comments on September 29, 2017.~~ ~~On October 11, 2017, we received a letter from the FDA stating that,~~ ~~as part of its ongoing review of the NDA, the FDA has identified deficiencies that preclude the continuation of the discussion of labeling and postmarketing requirements/commitments.~~ ~~On October 20, 2017, we received the CRL from the FDA regarding our NDA for XYOSTED~~^TM, which identified two deficiencies and indicated that the NDA cannot be approved in its current form. We are assessing the content of the CRL, including the information that may be needed to resolve the deficiencies, and intend to work closely with the FDA to determine the appropriate responses to the deficiencies noted in the CRL.

~~The CRL for XYOSTED~~^TM ~~identified two deficiencies related to the clinical data. Based on findings in studies QST-13-003 and QST-15-005, the FDA is concerned that XYOSTED~~^TM could cause a clinically meaningful increase in blood pressure. In addition, the CRL also raised a concern regarding the occurrence of depression and suicidality. The Company anticipates that the next step will be to request a meeting with the FDA to further evaluate the deficiencies raised and to agree upon a path forward for a potential approval of XYOSTED^TM.

~~Device Development Projects. We, along with our pharmaceutical partners, are engaged in research and development activities related to our VIBEX~~^® ~~disposable pressure assisted auto injectors and our disposable pen injectors. We have signed license agreements with Teva for our VIBEX~~^® ~~system for a product containing epinephrine and for our pen injector devices for use with generic versions of BYETTA~~^® ~~(exenatide) and Forteo~~^® ~~(teriparatide). We also have a license, development and supply agreement with AMAG for our auto injector device for use with its drug Makena~~^®. The development programs consist of determination of the device design, development of prototype tooling, production of prototype devices for testing and clinical studies, and development of commercial tooling and assembly. We expect development related to these products to continue, however, the development timelines are generally controlled by our partners and the extent of near-term and future development will be dependent on decisions made by our partners. The following is a summary of the development stages for each of the products in development with Teva and AMAG.

~~VIBEX~~^® ~~auto injector with Makena~~^®~~(hydroxyprogesterone caproate injection)~~

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

~~AMAG initiated a PK study for the Makena~~^®auto injector in October 2016 and announced positive top-line results of the study in February 2017. According to AMAG, the study successfully demonstrated comparable bioavailability between subcutaneous injection of Makena^® ~~compared to intra muscular injection. AMAG submitted its sNDA for the Makena~~^®~~subcutaneous auto injector in April 2017, which was accepted by the FDA and given a PDUFA target action date of February 14, 2018.~~

~~We, in collaboration with Teva, have developed a VIBEX~~^® auto injector device for a product containing epinephrine. Teva is responsible for development work on the drug epinephrine, and we are 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 accepted by the FDA, and amended in December 2014. We have scaled up the commercial tooling and molds for this product and delivered pre-~~

~~launch quantities of the product in anticipation of a potential approval and launch. However, Teva received a Complete Response Letter to its ANDA for the VIBEX~~^® epinephrine pen from the FDA in February 2016 in which, according to Teva, the FDA identified certain major deficiencies. Teva has disclosed that they submitted a response to the FDA’s Complete Response Letter. We continue to work with Teva toward a potential approval of the epinephrine auto injector pen ANDA, which remains under active review at the FDA.

~~We have designed and produced a pen injector product for use with exenatide for Teva. Teva filed an ANDA for a generic version of BYETTA~~^®~~, which was accepted by the FDA in October 2014 and is currently under review. Teva settled patent litigation with AstraZeneca relating to certain AstraZeneca U.S. patents and their drug, BYETTA~~^® ~~(exenatide). AstraZeneca and Teva entered into a settlement and license agreement pursuant to which AstraZeneca granted Teva a license to manufacture and commercialize the generic version of BYETTA~~^® described in Teva’s ANDA. The settlement allows Teva to commercialize their exenatide product in the U.S., assuming FDA approval, beginning October 15, 2017 or earlier under certain circumstances.

We have designed and produced a multi-dose disposable pen injector for use with teriparatide for Teva and have delivered devices for a drug stability program to support a regulatory filing. Teva is developing this product for use in both Europe and the U.S. with the European clinical/regulatory team leading the development.

~~Teva filed an ANDA for a generic version of Forteo~~^® (teriparatide [rDNA origin] injection), which was accepted by the FDA and is currently under review. In response to Teva’s paragraph IV certification contained in Teva’s ANDA for teriparatide, Lilly filed a lawsuit against Teva alleging infringement of six U.S. patents related to Forteo^® (teriparatide [rDNA origin] injection) resulting in a 30-month stay in FDA approval of the ANDA. The stay will expire in August 2018 unless the litigation is resolved sooner. Teva also successfully concluded a decentralized procedure registration process in Europe. According to Teva, the Public Assessment Report for the decentralized procedure has been published and the product was filed in 17 countries, which addresses the majority of the market value in Europe.

~~Other Research and Development Costs.~~ ~~In addition to our development of XYOSTED~~^TM and our device development projects with Teva and AMAG, 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.

We are exposed to foreign exchange rate fluctuations of the Swiss Franc to the U.S. dollar as the financial position and operating results of our subsidiaries in Switzerland are translated into U.S. dollars for consolidation. ~~Our exposure to foreign exchange rate fluctuations also arises from transferring funds to our Swiss subsidiaries in Swiss Francs.~~ In addition, we have exposure to exchange rate fluctuations between the Euro and the U.S. dollar ~~in connection with a licensing agreement with Ferring, under which certain products sold to Ferring and royalties are denominated in Euros. Most~~for some of our product sales, including a portion of our product sales to Ferring, and our development and licensing fees and royalties are denominated in U.S. dollars, thereby significantly mitigating the risk of exchange rate fluctuations on trade receivables. transactions. We do not currently use derivative financial instruments to hedge against exchange rate risk. The effect of foreign exchange rate fluctuations on our financial results for the ~~periods~~period ended ~~September~~June 30, ~~2017~~2021 was not material.

We may also be exposed to interest rate risk and interest rate fluctuations as a result of our long-term debt ~~financing we obtained on June 6, 2017.~~financing. Our ~~Term Loan,~~loan, with a current outstanding principal balance of ~~$25,000,000,~~$25.0 million accrues interest at a calculated prime-based variable rate, which was 8.5% as of June 30, 2021, with a maximum interest rate of 9.50%. ~~The calculated prime-based variable rate was 8.75% at September 30, 2017. An~~A hypothetical increase toor decrease in the ~~maximum~~ interest rate of ~~9.50%~~1.0% would result in additional ~~incremental~~or lower annual interest expense of ~~$187,500.~~$250,000.

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.

There have not been any material 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.

~~On October 23, 2017, Randy Smith filed a complaint in the District of New Jersey~~, ~~captioned~~ ~~Randy Smith, Individually~~The information set forth under “Note 10—Commitments 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 dataContingencies—Pending Litigation” to the ~~FDA~~consolidated financial statements included in ~~connection with the NDA for XYOSTED~~^TM~~; and (ii) accordingly, Antares had overstated the approval prospects for XYOSTED~~^TM~~. Motions~~Part I, Item 1 in this Quarterly Report on Form 10-Q for the ~~appointment of Lead Plaintiff are due December 22, 2017. The company believes that the claims in the Smith action lack merit~~quarter ended June 30, 2021 and ~~intends to defend them vigorously.~~is incorporated herein by reference.

In addition to the ~~risk factors and other~~ information contained in this report, you should carefully consider the risk factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, ~~2016,~~2020, which could materially affect our business, financial condition or future results. The risks described ~~in this report and~~ in our Annual Report on Form 10-K 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.

~~Timing and results of clinical trials to demonstrate the safety and efficacy of products as well as the FDA’s approval of products are uncertain.~~

Drug development is an inherently risky and uncertain process. Before obtaining regulatory approvals for the sale of any new product candidates, we and our partners must demonstrate through preclinical studies and clinical trials that the product is safe and effective for each intended use. Preclinical and clinical studies may fail to demonstrate the safety and effectiveness of a product. Likewise, we and our partners may not be able to demonstrate through clinical trials that a product candidate’s therapeutic benefits outweigh its risks. Even promising results from preclinical and early clinical studies do not always accurately predict results in later, large scale trials. A failure to demonstrate safety and efficacy could or would result in the failure to obtain regulatory approvals.

The rate of patient enrollment sometimes delays completion of clinical studies. There is substantial competition to enroll patients in clinical trials and such competition has delayed clinical development of our products in the past. For example, patients may not enroll in clinical trials at the rate expected or patients may drop out after enrolling in the trials or during the trials. Delays in planned patient enrollment can result in increased development costs and delays in regulatory approval. In addition, we rely on

collaboration partners that may control or make changes in trial protocol and design enhancements, or encounter clinical trial compliance-related issues, which may also delay clinical trials. Product supplies may be delayed or be insufficient to treat the patients participating in the clinical trials, or manufacturers or suppliers may not meet the requirements of the FDA or foreign regulatory authorities, such as those relating to cGMP. We and our partners may also experience delays in obtaining, or we and our partners may not obtain, required initial and continuing approval of our clinical trials from institutional review boards, FDA, or other applicable regulatory authorities. We cannot assure you that we or our partners will not experience delays or undesired results in these or any other clinical trials. Clinical trials may also be suspended, placed on hold, or terminated by us, institutional review boards, FDA, or other applicable regulatory authorities for a number of reasons, including failure to comply with the applicable regulatory requirements, including GCPs, and issues involving subject safety.

We cannot assure you that the FDA or foreign regulatory agencies will approve, clear for marketing or certify any products developed by us or our partners, on a timely basis, if at all, or, if granted, that such approval will not subject the marketing of our products to certain limits or other costly and burdensome requirements. Such limits and requirements may include warnings, including black box warnings, limitations on the indicated use, including the applicable population, contraindications, Risk Evaluation and Mitigation Strategies, and post-approval studies and/or monitoring. The FDA or foreign regulatory authorities may not agree with the assessment by us or our clinical partners of the clinical data or they may interpret it differently. Such regulatory authorities may require additional or expanded clinical trials. On October 20, 2017, we received from the FDA the CRL for XYOSTED^TM ~~which identified two deficiencies and indicated that the XYOSTED~~^TM NDA cannot be approved in its current form. We are assessing the content of the CRL, including the information that may be needed to resolve the deficiencies, which may include additional clinical trials. We intend to work closely with the FDA to determine the appropriate responses to the deficiencies noted in the CRL.

Any limitation on use imposed by the FDA or delay in or failure to obtain FDA approvals or clearances of products developed by us and our partners would adversely affect the marketing of these products and our ability to generate product revenue, which would adversely affect our financial condition and results of operations.

Before obtaining regulatory approvals for certain generic products, we and our partners must conduct limited clinical or other trials to show comparability to the branded products. A failure to obtain satisfactory results in these trials would prevent us from obtaining required regulatory approvals.

~~The CRL for XYOSTED~~^TM ~~identified two deficiencies and indicated that the XYOSTED~~^TM NDA cannot be approved in its current form. To the extent that we are unable to resolve these deficiencies in a timely manner or at all, or if we fail to obtain, or have delays in obtaining, regulatory approvals for any of our other products and product candidates, our business, financial condition and results of operations may be materially adversely affected.

~~XYOSTED~~^TM and our other products and product candidates are subject to extensive and rigorous government regulation by the FDA and other foreign regulatory agencies. The FDA regulates the research, development, pre-clinical and clinical testing, manufacture, safety, effectiveness, record keeping, reporting, labeling, storage, approval, advertising, promotion, sale, distribution, import and export of pharmaceutical and medical device products. Failure to comply with FDA and other applicable regulatory requirements may, either before or after product approval, subject us to administrative or judicially imposed sanctions.

~~In the United States, the FDA regulates drug and device products under the Federal Food, Drug, and Cosmetic Act (FFDCA), and its implementing regulations. XYOSTED~~^TM, as well as other of our products and product candidates are subject to regulation by the FDA as combination products, which means they are composed of both a drug product and device product. If marketed individually, each component would therefore be subject to different regulatory pathways and reviewed by different centers within the FDA. A combination product, however, is assigned to a center that will have primary jurisdiction over its pre-market review and regulation based on a determination of the product’s primary mode of action, which is the single mode of action that provides the most important therapeutic action. In the case of XYOSTED^TM and our other products and product candidates, the primary mode of action is attributable to the drug component of the product, which means that the Center of Drug Evaluation and Research (CDER) has primary jurisdiction over its pre-market development and review. Following product approval, however, our products may be subject to regulation under FDA’s drug and device requirements.

~~We are not permitted to market our product candidates, including XYOSTED~~^TM, in the United States unless and until we obtain regulatory approval from the FDA. To market the product in the United States, we must submit to the FDA and obtain FDA approval of a marketing application. We have historically used FDA’s 505(b)(2) NDA and ANDA pathways. A 505(b)(2) NDA must be supported by extensive clinical and preclinical data, as well as extensive information regarding chemistry, manufacturing and controls, or CMC, to demonstrate the safety and effectiveness of the applicable product candidate. An ANDA must be supported by studies demonstrating that the product candidate is bioequivalent to the reference listed drug, as well as extensive information

regarding CMC. The number and types of preclinical studies and clinical trials that will be required varies depending on the product candidate, the approval pathway, the disease or condition that the product candidate is designed to target and the regulations applicable to any particular product candidate.

Despite the time and expense associated with preclinical and clinical studies, failure can occur at any stage, and we could encounter problems that cause us to repeat or perform additional preclinical studies, CMC studies or clinical trials. We may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including, failure to receive FDA or IRB authorization to begin a trial, negative or inconclusive results, slow or insufficient subject enrollment, failure to obtain adequate clinical supply of product candidates, and failure by us, our partners, Contract Research Organizations, and clinical trial sites to follow the applicable regulatory requirements, including GCPs. The FDA and similar foreign authorities could also delay, limit or deny approval of a product candidate for many reasons, including because they:

~~Significant delays also~~ ~~could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow competitors, to bring products to market before we do.~~

~~Additionally, based on the written recommendations from the FDA related to our clinical development program for XYOSTED~~^TM~~, we launched a supplemental safety study QST-15-005 with additional participants, which we completed in 2016 in support of our NDA submission for XYOSTED~~^TM. However, the FDA may have additional recommendations or require further trials and the timing, cost and design of any such study could negatively affect our business if we incur significant costs or delays. Products of this nature may carry with them the need to monitor safety in an on-going manner, called a Risk Evaluation Mitigation Strategy, or REMS. The REMS for testosterone products is well-defined, and a class-labeling letter has been issued to all approved testosterone replacement products that will likely include being part of a clinical outcomes trial intended to explore cardiovascular risks.

Undesirable side effects caused by any product candidate that we develop, a lack of bioequivalence for ANDA product candidates, and/or an inability to demonstrate product candidate efficacy could result in the denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications or cause us to evaluate the future of our development programs.

~~Undesirable side effects could also interrupt, delay, or halt clinical trials. The regulatory review and approval process is lengthy, expensive and inherently uncertain.~~

~~In December 2016, we submitted the XYOSTED~~^TM ~~NDA which was accepted for filing by FDA in February 2017. On October 20, 2017, we received from the FDA the CRL for XYOSTED~~^TM ~~which identified two deficiencies and indicated that the XYOSTED~~^TM NDA cannot be approved in its current form. We are assessing the content of the CRL, including the information that may be needed to resolve the deficiencies, which may include additional clinical trials. We intend to work closely with the FDA to determine the appropriate responses to the deficiencies noted in the CRL. However, there can be no assurance that we will be able to resolve these deficiencies, and, even if we resolve these deficiencies, the FDA may find that overall, the benefits of XYOSTED^TM ~~do not outweigh the risks identified in the FDA’s CRL.~~

We may never receive approval for certain of our product candidates, and even if our product candidates are approved, the approval may be subject to limitations on the indicated uses for which the products may be marketed, distribution restrictions, or to other conditions of approval; may contain significant safety warnings, including boxed warnings, contraindications, and precautions; may not be approved with label statements necessary or desirable for successful commercialization; or may contain requirements for costly post‑market testing and surveillance or other requirements, including REMS, to monitor the safety or efficacy of the products. Moreover, any future actions or inquiries by the FDA with respect to the reference listed drug may require that we make changes to our labeling or, possibly, withdraw the product from the market. Any of the foregoing may impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.

~~The market price of our common stock has been, and may continue to be volatile and fluctuate significantly, which could result in substantial losses for investors.~~

The trading price for our common stock has been, and we expect it to continue to be, volatile. The price at which our common stock trades depends upon a number of factors, including our historical and anticipated operating results, our financial situation, clinical trial results, announcements of technological innovations or new products by us, our partners or our competitors, our ability or inability to raise the additional capital we may need and the terms on which we raise it, and general market and economic conditions. Some of these factors are beyond our control. Broad market fluctuations may lower the market price of our common stock and affect the volume of trading in our stock, regardless of our financial condition, results of operations, business or prospect. Among the factors that may cause the market price of our common stock to fluctuate are the risks described in this “Risk Factors” section and other factors, including:

In addition, the stock markets, in general, the NASDAQ Capital Market and the market for specialty pharmaceutical companies in particular, may experience a loss of investor confidence. Such loss of investor confidence may result in extreme price and volume fluctuations in our common stock that are unrelated or disproportionate to the operating performance of our business, financial condition or results of operations. These broad market and industry factors may materially harm the market price of our common stock and expose us to securities class action litigation. For example, on October 23, 2017, Randy Smith filed a complaint in the District of New Jersey on behalf of a putative class of persons who purchased or otherwise acquired Antares securities against Antares, Robert F. Apple and Fred M. Powell. Litigation, even if unsuccessful, could be costly to defend and divert management’s attention and resources, which could further materially harm our financial condition and results of operations.

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.

100 Princeton South, Suite 300,Ewing,NJ		08628
(Address of PrincipalExecutiveOffices)		(ZipCode)

Large accelerated filer	☐	Accelerated filer	☒

Non–accelerated filer	☐ ~~(do not check if a smaller reporting company)~~	Smaller reporting company	☐

Emerging growth company	☐		~~Emerging growth company~~	☐

			PAGE

PART I.		FINANCIAL INFORMATION	3

	Item 1.	Financial Statements	3

		Condensed Consolidated Balance Sheets as of ~~September~~June 30, ~~2017 (Unaudited)~~2021 and December 31, ~~2016~~2020 (Unaudited)	3

		Condensed Consolidated Statements of Operations ~~(Unaudited)~~ for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2021 and ~~2016~~2020 (Unaudited)	4

		Condensed Consolidated Statements of Comprehensive ~~Loss (Unaudited)~~Income (Loss) for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2021 and ~~2016~~2020 (Unaudited)	5

		Condensed Consolidated Statements of ~~Cash Flows (Unaudited)~~Changes in Stockholders’ Equity for the ~~nine~~three and six months ended ~~September~~June 30, ~~2017~~2021 and ~~2016~~2020 (Unaudited)	6

		~~Notes to~~Condensed Consolidated ~~Financial~~ Statements of Cash Flows for the six months ended June 30, 2021 and 2020 (Unaudited)	78

		Notes to Condensed Consolidated Financial Statements (Unaudited)	9

	Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	1518

	Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26

	Item 4.	Controls and Procedures	26

PART II.		OTHER INFORMATION	27

	Item 1.	Legal Proceedings	27

	Item 1A.	Risk Factors	27

	Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	3127

	Item 3.	Default Upon Senior Securities	3127

	Item 4.	Mine Safety Disclosures	3127

	Item 5.	Other Information	3127

	Item 6.	Exhibits	3128

		SIGNATURES	3229

		Useful Life
Computer equipment and software		3-5 Years
Furniture, fixtures and office equipment		5-7 years
Production molds, tooling and equipment		3-10 years
Leasehold improvements		Lesser of useful life or lease term

	September 30,		December 31,
	2017		2016
Inventories:
Raw material	$	126,070	$	142,491
Work in process		4,357,554		2,429,075
Finished goods		3,458,752		2,755,396
	$	7,942,376	$	5,326,962

	Nine Months Ended
	September 30,
	2017			2016
Cash flows from operating activities:
Net loss	$	(13,028,382	)	$	(19,838,556	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		2,371,453			1,886,823
Depreciation and amortization		1,520,197			1,371,538
Loss on disposal of equipment		22,600			17,785
Write-off of capitalized patent costs		45,600			—
Accretion of interest expense		66,406			—
Amortization of debt issuance costs		18,347			—
Amortization of premiums and discounts on investment securities		(16,638	)		10,913
Changes in operating assets and liabilities:
Accounts receivable		(1,069,614	)		(624,232	)
Inventories		(2,615,414	)		(999,158	)
Prepaid expenses and other assets		(299,825	)		2,922,527
Deferred costs		559,939			(762,413	)
Accounts payable		701,704			3,308,607
Accrued expenses and other current liabilities		549,929			(146,376	)
Deferred revenue		(4,308,571	)		1,156,309
Net cash used in operating activities		(15,482,269	)		(11,696,233	)
Cash flows from investing activities:
Purchase of investment securities		(9,963,978	)		—
Purchases of equipment, molds, furniture and fixtures		(878,855	)		(4,278,643	)
Additions to patent rights		(83,592	)		(103,788	)
Proceeds from maturities of investment securities		—			12,000,000
Net cash (used in) provided by investing activities		(10,926,425	)		7,617,569
Cash flows from financing activities:
Proceeds from issuance of long-term debt		25,000,000			—
Payment of debt issuance costs		(293,538	)		—
Proceeds from exercise of stock options		1,670,149			24,071
Taxes paid related to net share settlement of equity awards		(248,709	)		(64,096	)
Net cash provided by (used in) financing activities		26,127,902			(40,025	)
Effect of exchange rate changes on cash		(307	)		1,440
Net decrease in cash and cash equivalents		(281,099	)		(4,117,249	)
Cash and cash equivalents:
Beginning of period		27,714,588			32,898,676
End of period	$	27,433,489		$	28,781,427
Supplemental disclosure of non-cash investing activities:
Purchases of equipment, molds, furniture and fixtures recorded in accounts payable and accrued expenses	$	92,674		$	552,556
Additions to patent rights recorded in accounts payable and accrued expenses	$	6,160		$	23,369

	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, 2016		1,347,289		$	1.50		822,658		$	1.39
Granted		689,180			3.12		689,180			2.69
Vested/settled		—					(287,508	)		1.49
Forfeited/expired		(502,308	)		2.16		(67,464	)		1.70
Outstanding at September 30, 2017		1,534,161		$	2.20		1,156,866		$	2.12

	2017 Award			2016 Award			2015 Award
Closing stock price on grant date	$	2.66		$	1.12		$	2.18
Performance period starting price	$	2.17		$	1.29		$	2.52
Term of award (in years)		2.57			2.58			2.59
Volatility		54.6	%		70.1	%		60.5	%
Risk-free interest rate		1.39	%		0.97	%		0.83	%
Expected dividend yield		0.00	%		0.00	%		0.00	%
Fair value per TSR PSU	$	3.10		$	1.25		$	1.71

	Three months ended September 30,				Nine months ended September 30,
	2017		2016		2017		2016
OTREXUP^®	$	4,623,326	$	3,904,329	$	13,110,489	$	11,024,394
Auto injector and pen injector devices		7,946,313		5,943,786		14,489,839		15,836,179
Needle-free injector devices and components		757,886		1,201,725		3,108,422		3,720,316
Total product sales		13,327,525		11,049,840		30,708,750		30,580,889
Development revenue		1,485,091		2,101,203		7,894,640		6,466,974
Licensing revenue		19,486		38,618		1,057,204		128,040
Royalties		220,295		289,102		815,421		850,022
Total revenue	$	15,052,397	$	13,478,763	$	40,476,015	$	38,025,925

	Three Months Ended June 30,				Six months ended June 30,
	2021		2020		2021		2020
Cost of product sales	$	11,630	$	10,927	$	24,128	$	24,941
Cost of development revenue		4,810		1,550		8,757		2,583
Total cost of revenue	$	16,440	$	12,477	$	32,885	$	27,524

	Payments Due by Period
			Less than		1 - 3		3 - 5		More than
	Total		1 year		years		years		5 years
Long-Term Debt Obligations	$	33,706,453	$	2,217,882	$	12,930,373	$	18,558,198	$	—
Operating Lease Obligations		1,882,226		629,600		896,282		356,344		—
Total	$	35,588,679	$	2,847,482	$	13,826,655	$	18,914,542	$	—

Population/Analysis	C_avgLower limit of the 95% 2-sided C. I.			C_avg% in range 300 – 1100 ng/dL n (%)		C_max <1500 ng/dL n (%)		C_max >1800 ng/dL n (%)
Primary analysis* N=150		87.3	%	139 (92.7	%)	137 (91.3	%)**		0	%
Completers N=137		94.8	%	135 (98.5	%)	137 (100	%)		0	%
Protocol-Required Outcomes		≥65	%	75	%	≥85	%		≤5	%

Exhibit No.		Description
10.1		Antares Pharma, Inc. Equity Compensation Plan, as amended and restated, and approved by stockholders (Filed as Exhibit 4.1 to the Company’s Form S-8 filed June 24, 2021 and incorporated herein by reference.)

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 (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.)

101.SCH#		Inline XBRL Taxonomy Extension Schema Document

101.CAL#		Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.LAB#		Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE#		Inline XBRL Taxonomy Extension Presentation Linkbase Document

101.DEF#		Inline XBRL Taxonomy Extension Definition Document

104#		Cover Page Interactive Data File (the cover page interactive data does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)

		ANTARES PHARMA, INC.

~~November 7, 2017~~August 5, 2021		/s/ Robert F. Apple
		Robert F. Apple
		President and Chief Executive Officer
		(Principal Executive Officer)

~~November 7, 2017~~August 5, 2021		/s/ Fred M. Powell
		Fred M. Powell
		~~Senior~~Executive Vice President and Chief Financial Officer
		(Principal Financial and Accounting Officer)