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

or

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

Delaware						41-1350192
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)

100 Princeton South, Suite 300, Ewing, NJ						08628
(Address of principal executive offices)						(Zip Code)

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.01 per share

ATRS

NASDAQ

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

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

Large accelerated filer

☐

Accelerated filer

☒

Emerging growth company

☐

Non–accelerated filer

☐

Smaller reporting company

☐

Emerging growth company

☐

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 ☒

PART I – FINANCIAL INFORMATION
			Item 1.			Financial Statements			2
						Condensed Consolidated Balance Sheets as of September 30, 2021 and December 31, 2020 (unaudited)			2
						Consolidated Statements of Operations for the three and nine months ended September 30, 2021 and 2020 (unaudited)			3
						Consolidated Statements of Comprehensive Income for the three and nine months ended September 30, 2021 and 2020 (unaudited)			4
						Consolidated Statements of Changes in Stockholders’ Equity for the three and nine months ended September 30, 2021 and 2020 (unaudited)			5
						Consolidated Statements of Cash Flows for the nine months ended September 30, 2021 and 2020 (unaudited)			7
						Notes to Condensed Consolidated Financial Statements (unaudited)			8
			Item 2.			Management’s Discussion and Analysis of Financial Condition and Results of Operations			18
			Item 3.			Quantitative and Qualitative Disclosures About Market Risk			28
			Item 4.			Controls and Procedures			29
PART II – OTHER INFORMATION
			Item 1.			Legal Proceedings			30
			Item 1A.			Risk Factors			30
			Item 6.			Exhibits			31
SIGNATURES									32

Item 1.     FINANCIAL STATEMENTS

			September 30, 2021						December 31, 2020
Assets
Current assets
Cash and cash equivalents			$	57,365					$	53,137
Accounts receivable, net			54,471						42,221
Inventories, net			16,493						18,216
Contract assets			2,942						8,140
Prepaid expenses and other current assets			2,162						4,877
Total current assets			133,433						126,591
Deferred tax assets, net			43,987						46,982
Property and equipment, net			25,832						24,020
Operating lease right-of-use assets			3,892						4,621
Intangibles, net			7,072						7,693
Other long-term assets			2,523						2,624
Total Assets			$	216,739					$	212,531
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable			$	12,885					$	16,194
Accrued expenses and other liabilities			32,010						25,635
Current maturities of long-term debt, net			2,918						16,230
Operating lease liabilities, current			917						1,203
Deferred revenue			3,804						3,943
Total current liabilities			52,534						63,205
Long-term debt, less current maturities			18,401						24,669
Operating lease liabilities, long-term			4,613						4,816
Other long-term liabilities			363						726
Total liabilities			75,911						93,416
Stockholders’ Equity
Preferred Stock: $0.01 par; 3,000 shares authorized, none outstanding			—						—
Common Stock: $0.01 par; 300,000 shares authorized; 170,042 and 166,836 issued and outstanding at September 30, 2021 and December 31, 2020, respectively			1,700						1,668
Additional paid-in capital			348,834						340,756
Accumulated deficit			(209,020)						(222,626)
Accumulated other comprehensive loss			(686)						(683)
Total stockholders' equity			140,828						119,115
Total liabilities and stockholders’ equity			$	216,739					$	212,531
The accompanying Notes to Condensed Consolidated Financial Statements (Unaudited) are an integral part of these condensed consolidated financial statements.

			Three Months Ended September 30,												Nine Months Ended September 30,
			2021						2020						2021						2020
Revenue
Product sales, net			$	33,068					$	28,947					$	90,107					$	80,709
Licensing and development revenue			3,682						4,321						15,833						8,763
Royalties			11,441						6,735						29,312						15,994
Total revenue, net			48,191						40,003						135,252						105,466
Operating expenses
Cost of product sales			14,039						13,615						38,167						38,556
Cost of development revenue			2,390						2,902						11,147						5,485
Research and development			3,923						2,405						10,610						7,803
Selling, general and administrative			19,874						15,231						55,185						46,101
Total operating expenses			40,226						34,153						115,109						97,945
Operating income			7,965						5,850						20,143						7,521
Other income (expense)
Interest expense			(750)						(782)						(2,847)						(2,810)
Other income (expense), net			6						(72)						(129)						104
Total other expense, net			(744)						(854)						(2,976)						(2,706)
Income before income taxes			7,221						4,996						17,167						4,815
Income tax expense			(1,828)						—						(3,561)						—
Net income			$	5,393					$	4,996					$	13,606					$	4,815
Earnings per common share
Basic			$	0.03					$	0.03					$	0.08					$	0.03
Diluted			$	0.03					$	0.03					$	0.08					$	0.03
Weighted average common shares outstanding
Basic			169,953						166,375						168,947						165,838
Diluted			175,128						169,655						174,937						169,759

			Three Months Ended September 30,												Nine Months Ended September 30,
			2021						2020						2021						2020
Net income			$	5,393					$	4,996					$	13,606					$	4,815
Foreign currency translation adjustment			—						5						(3)						11
Comprehensive income			$	5,393					$	5,001					$	13,603					$	4,826

			Common Stock												Additional Paid-In Capital						Accumulated Deficit						Accumulated Other Comprehensive Loss						Total Stockholders’ Equity
			Shares						Amount
Balance, June 30, 2021			169,584						$	1,696					345,431						$	(214,413)					$	(686)					$	132,028
Exercise of options			458						4						1,221						—						—						1,225
Stock-based compensation			—						—						2,182						—						—						2,182
Net income			—						—						—						5,393						—						5,393
Other comprehensive income			—						—						—						—						—						—
Balance, September 30, 2021			170,042						$	1,700					$	348,834					$	(209,020)					$	(686)					$	140,828
			Common Stock												Additional Paid-In Capital						Accumulated Deficit						Accumulated Other Comprehensive Loss						Total Stockholders’ Equity
			Shares						Amount
Balance, 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			2,264						22						5,081						—						—						5,103
Stock-based compensation			—						—						5,848						—						—						5,848
Net income			—						—						—						13,606						—						13,606
Other comprehensive income (loss)			—						—						—						—						(3)						(3)
Balance, September 30, 2021			170,042						$	1,700					$	348,834					$	(209,020)					$	(686)					$	140,828

			Common Stock												Additional Paid-In Capital						Accumulated Deficit						Accumulated Other Comprehensive Loss						Total Stockholders’ Equity
			Shares						Amount
Balance, June 30, 2020			166,085						$	1,661					$	335,372					$	(279,008)					$	(696)					$	57,329
Common stock issued under equity compensation plan, net of shares withheld for taxes			7						—						(16)						—						—						(16)
Exercise of options			580						6						1,117						—						—						1,123
Stock-based compensation			—						—						1,804						—						—						1,804
Net income			—						—						—						4,996						—						4,996
Other comprehensive loss			—						—						—						—						5						5
Balance, September 30, 2020			166,672						$	1,667					$	338,277					$	(274,012)					$	(691)					$	65,241
			Common Stock												Additional Paid-In Capital						Accumulated Deficit						Accumulated Other Comprehensive Loss						Total Stockholders’ Equity
			Shares						Amount
Balance, 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			676						7						(1,373)						—						—						(1,366)
Exercise of options			775						8						1,504						—						—						1,512
Stock-based compensation			—						—						5,769						—						—						5,769
Net income			—						—						—						4,815						—						4,815
Other comprehensive income			—						—						—						—						11						11
Balance, September 30, 2020			166,672						$	1,667					$	338,277					$	(274,012)					$	(691)					$	65,241

			Nine Months Ended September 30,
			2021						2020
Cash Flows from Operating Activities
Net income			$	13,606					$	4,815
Adjustments to reconcile net income to net cash provided by operating activities:
Stock-based compensation			5,848						5,769
Depreciation and amortization			2,761						1,730
Other			719						662
Changes in operating assets and liabilities:
Accounts receivable			(12,250)						(7,422)
Inventories, net			1,723						(3,809)
Contract assets			5,198						(549)
Prepaid expenses and other assets			2,715						1,345
Deferred taxes			2,995						—
Accounts payable			(2,251)						5,171
Accrued expenses and other liabilities			6,202						4,967
Deferred revenue			(139)						1,538
Net cash provided by operating activities			27,127						14,217
Cash Flows from Investing Activities
Purchases of property and equipment			(4,960)						(7,893)
Proceeds from maturities of investment securities			—						20,500
Net cash provided by (used in) investing activities			(4,960)						12,607
Cash Flows from Financing Activities
Principal payments on long-term debt			(20,000)						—
Prepayment fees on long-term debt			(200)						—
Proceeds from exercise of stock options			5,103						1,512
Taxes paid related to net share settlement of equity awards			(2,841)						(1,366)
Net cash provided by (used in) financing activities			(17,938)						146
Effect of exchange rate changes on cash and cash equivalents			(1)						1
Increase in cash and cash equivalents			4,228						26,971
Cash and cash equivalents
Beginning of period			53,137						23,201
End of period			$	57,365					$	50,172
Supplemental disclosure of cash flow information
Cash paid for interest			$	2,365					$	2,679
Cash paid for income taxes			$	1,224					$	—
Supplemental disclosure of non-cash investing activities
Purchases of property and equipment recorded in accounts payable and accrued expenses			$	1,009					$	1,577

•XYOSTED® (testosterone enanthate) injection, indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, and is the first and only subcutaneous testosterone enanthate product for once-weekly, at-home self-administration to be approved by the U.S. Food and Drug Administration (“FDA”);

•OTREXUP® (methotrexate) injection, indicated for adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis; and

•NOCDURNA® (desmopressin acetate), marketed in the U.S. for the treatment of nocturia due to nocturnal polyuria (“NP”) in adults who awaken at least two times per night to urinate.

•We developed and are the exclusive supplier of devices for Teva’s Epinephrine Injection USP products, the generic equivalent of EpiPen® and EpiPen® Jr., indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients;

•Through our commercialization partner Teva, we sell Sumatriptan Injection USP, a generic equivalent to the Imitrex® STATdose Pen®, in the U.S. indicated for the acute treatment of migraine headaches and cluster headache in adults;

•In collaboration with AMAG, we developed a subcutaneous auto injector and are the exclusive supplier of devices and the final assembled and packaged commercial product of AMAG’s Makena® (hydroxyprogesterone caproate injection) subcutaneous auto injector, which is a ready-to-administer treatment indicated to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered at least one preterm baby in the past; and

•We developed and are the exclusive supplier of devices for Teva’s generic equivalent of Forsteo® (Teriparatide Injection) which is approved and currently sold by Teva in various countries outside the United States.

Cash and cash equivalents consist of demand deposits at commercial banks and highly liquid investments with an original maturity of three months or less. Cash equivalents, consisting of investments in money market funds, are remeasured and reported at fair value each reporting period, in accordance with ASC Topic 820, Fair Value Measurements based on quoted market prices, which is a Level 1 input within the three-level valuation hierarchy for disclosure of fair value measurements, and totaled $36,141 and $36,133 as of September 30, 2021 and December 31, 2020, respectively.

			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

We are 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 we have 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 in the Condensed Consolidated Balance Sheets due to the short-term nature in which the amount is ultimately expected to be billed and collected from the customer.

			September 30, 2021						December 31, 2020
Raw material			$	422					$	325
Work in process			8,186						7,120
Finished goods			7,885						10,771
Total inventories, net			$	16,493					$	18,216

			September 30, 2021						December 31, 2020
Production molds, tooling and equipment			$	21,069					$	20,260
Leasehold improvements			7,457						6,298
Furniture, fixtures and office equipment			907						865
Computer equipment and software			1,348						756
Construction and tooling in process			7,506						6,214
Total property and equipment			38,287						34,393
Less: Accumulated depreciation			(12,455)						(10,373)
Total property and equipment, net			$	25,832					$	24,020

			Number of Shares						Weighted Average Exercise Price						Weighted Average Remaining Contractual Term (Years)						Aggregate Intrinsic Value
Outstanding at December 31, 2020			15,521						$	2.49
Granted			2,591						4.39
Exercised			(2,278)						2.26
Cancelled / Forfeited			(229)						2.85
Outstanding at September 30, 2021			15,605						2.83						6.79						$	14,768
Exercisable at September 30, 2021			10,633						$	2.45					5.71						$	12,773

			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, 2020			1,641						$	2.61					1,567						$	2.77
Granted			243						5.55						769						4.42
Incremental shares earned			209						3.18						—						—
Vested / Settled			(766)						2.86						(832)						2.76
Outstanding at September 30, 2021			1,327						$	3.04					1,504						$	3.62

Members of our Board of Directors also receive grants of RSUs 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. During the nine months ended September 30, 2021, 30 shares were vested and deferred under this election.

			Three Months Ended September 30,												Nine Months Ended September 30,
			2021						2020						2021						2020
Stock options			$	1,170					$	1,045					$	2,947					$	2,801
Restricted stock units			724						579						1,896						1,661
Performance stock units			288						180						1,005						1,307
Total share-based compensation expense			$	2,182					$	1,804					$	5,848					$	5,769

			Three Months Ended September 30,												Nine Months Ended September 30,
			2021						2020						2021						2020
Types of goods and services
Proprietary product sales, net			$	20,827					$	15,765					$	58,512					$	43,177
Partnered product sales			12,241						13,182						31,595						37,532
Total product revenue, net			33,068						28,947						90,107						80,709
Licensing and development revenue			3,682						4,321						15,833						8,763
Royalties			11,441						6,735						29,312						15,994
Total revenue, net			$	48,191					$	40,003					$	135,252					$	105,466
Customer location
United States of America			$	47,881					$	39,370					$	132,520					$	103,638
Europe			310						633						2,732						1,828
Total revenue, net			$	48,191					$	40,003					$	135,252					$	105,466

			Three Months Ended September 30,												Nine Months Ended September 30,
			2021						2020						2021						2020
Teva			47%						45%						45%						42%
McKesson Corporation			13%						12%						13%						12%
AmerisourceBergen Corporation			11%						11%						12%						12%
Cardinal Health			10%						11%						11%						11%
AMAG			<10%						<10%						<10%						10%

Our gross unrecognized tax benefits as of September 30, 2021 was $2,127 with no material changes during the three and nine months then ended. There are no interest or penalties accrued in relation to unrecognized tax benefits. We will classify any future interest and penalties as a component of income tax expense. We are subject to federal and state examinations for the years 2017 and thereafter.

			Three Months Ended September 30,												Nine Months Ended September 30,
			2021						2020						2021						2020
Net income			$	5,393					$	4,996					$	13,606					$	4,815
Weighted average common shares outstanding			169,953						166,375						168,947						165,838
Dilutive effects of stock options and share-based awards issuable under equity compensation plans			5,175						3,280						5,990						3,921
Weighted average dilutive common shares outstanding			175,128						169,655						174,937						169,759
Earnings per common share
Basic			$	0.03					$	0.03					$	0.08					$	0.03
Diluted			$	0.03					$	0.03					$	0.08					$	0.03
Anti-dilutive common stock equivalents (1)			3,696						8,596						1,639						6,719

(1) These common stock equivalents were outstanding for the period but were not included in the computation of diluted earnings per share for those periods as their inclusion would have had an anti-dilutive effect.

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®; and (ii) accordingly, Antares had overstated the approval prospects for XYOSTED®. On July 27, 2018, the court entered an order appointing Serghei Lungu as lead plaintiff, Pomerantz LLP as lead counsel, and Lite DePalma Greenberg, LLC as liaison counsel for plaintiff. On August 3, 2018, the parties submitted a stipulation and proposed order, setting forth an agreed-upon schedule for responding to the complaint, which the court granted. Pursuant to that order, plaintiff filed a Consolidated Amended Class Action Complaint on October 9, 2018. 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 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 was filed on August 4, 2021 and plaintiff-appellant’s reply was filed on September 8, 2021. We believe 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. Plaintiff’s-appellant’s appeal in Smith is still pending.

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 the 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. Plaintiff’s-appellant’s appeal in Smith is still pending.

TLANDO® Exclusive License Agreement

In October 2021, we entered into an exclusive license agreement (the “Agreement”) with Lipocine Inc. (“Lipocine”) for the product TLANDO® (testosterone undecanoate) in the U.S., a twice-daily oral formulation of testosterone for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. TLANDO® was granted tentative approval from the FDA based upon an FDA conclusion at the time that TLANDO® met all required efficacy, quality and safety standards. TLANDO® may be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. for JATENZO® on March 27, 2022; however, there is no assurance FDA approval will be received. Under the terms of the Agreement, we paid Lipocine an upfront payment of $11,000. Lipocine is eligible for additional milestone payments up to $10,000 and tiered royalty and commercial milestones based on net sales of TLANDO® in the U.S. We will be responsible for the manufacturing and commercialization of TLANDO®.

•Forward-Looking Statements

•our expectations about the ongoing COVID-19 pandemic (the “Pandemic”) and any potential disruption or impact to our operations, financial position or cash flows;

•our expectations regarding the continued successful commercialization of XYOSTED® (testosterone enanthate) injection and the continued growth in prescriptions and revenues related thereto;

•our expectations regarding continued sales of OTREXUP® (methotrexate) injection;

•our expectations regarding the commercialization of NOCDURNA® (desmopressin acetate) in the U.S. under a licensing agreement with Ferring International Center S.A. and its affiliates, (“Ferring”) and future sales and revenue from the same;

•our expectations regarding future FDA approval of TLANDO® in the U.S. under a licensing agreement with Lipocine Inc. (“Lipocine”), the manufacturing and commercialization of TLANDO® and future sales and revenue from the same;

•our expectations regarding whether we will exercise the option for TLANDO XR and if exercised, the future timing and success of the clinical development program for TLANDO XR and future FDA approval, market acceptance and revenue from the same;

•our expectations regarding the ability of our partner, Teva Pharmaceutical Industries, Ltd. (“Teva”), to continue to successfully commercialize Epinephrine Injection USP, the generic equivalent version of EpiPen® (“generic epinephrine injection”), and any future revenue related thereto;

•our expectations regarding the ability of AMAG Pharmaceuticals, Inc. (“AMAG”) to continue to commercialize Makena® (hydroxyprogesterone caproate injection), and our continued future sales to AMAG and royalty revenue from the same, in light of the FDA proposal to withdraw approval of Makena® (hydroxyprogesterone caproate injection), AMAG’s request for a hearing to maintain its approval of Makena® (hydroxyprogesterone caproate injection), and the timing and outcome of any hearings and future regulatory actions by the FDA;

•our expectations regarding continued sales of Sumatriptan Injection USP to our partner, Teva, and Teva’s ability to successfully distribute and sell Sumatriptan Injection USP;

•our expectations regarding continued product development with Teva of the teriparatide and exenatide disposable pen injectors, Teva’s ability to obtain FDA approval and AB-rating for each of those products, and if approved, Teva’s ability to successfully commercialize the teriparatide disposable pen injector product outside the U.S.;

•our expectations about the development of a rescue pen for an undisclosed drug with our partner Pfizer Inc. (“Pfizer”) and potential future regulatory approval and future revenue from the same;

•our expectations about our development activities with Idorsia Pharmaceuticals Ltd (“Idorsia”) and the timing and results of the Phase 3 clinical trial of the drug device combination product for selatogrel, a new chemical entity being developed for the treatment of a suspected acute myocardial infarction (“AMI”) in adult patients with a history of AMI, and the potential future FDA and global regulatory approval of the same;

•our expectations about the development of ATRS-1902 for adrenal crisis rescue, including the timing and results of clinical trials and our anticipated 505(b)(2) NDA filing with the FDA;

•our expectations about our other internal and external research and development projects, including but not limited to ATRS-1901, the timing and results of clinical trials, and our anticipated continued reliance on third parties in conducting studies, trials and other research and development activities;

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

•our anticipated continued reliance on contract manufacturers to manufacture, assemble and package our products;

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

•our sales and marketing plans;

•our expectations about our future revenues, including the 2021 revenue guidance, our cash flows and our ability to support our operations and maintain profitability;

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

•our expectations and estimates made in connection with current accounting practices, including but not limited to, the carrying value of our deferred tax assets and our ability to utilize net operating loss and other credit carryforwards to offset future U.S. federal taxable income;

•the potential impact of new accounting pronouncements and tax legislation; and

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

•potential business interruptions and/or any financial or operational impact as a result of the Pandemic;

•delays in product introduction or unsuccessful marketing and commercialization efforts by us or our partners;

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

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

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

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

•our inability to generate or sustain continued growth in product sales and royalties;

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

•a decrease in business from our major customers and partners;

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

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

•changes or delays in the regulatory review and approval process;

•our inability to effectively protect our intellectual property;

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

•our inability to attract and retain key personnel; and

•adverse economic and political conditions.

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 in the U.S., our proprietary product OTREXUP® (methotrexate) injection, which is 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.

In October 2020, we 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, we paid Ferring an upfront payment of $5.0 million upon execution and paid an additional $2.5 million on October 1, 2021. Ferring is eligible for tiered royalties and additional commercial milestone payments potentially totaling up to $17.5 million based on our 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 October 2021, we entered into an exclusive license agreement (the “Agreement”) with Lipocine for the product TLANDO® (testosterone undecanoate) in the U.S., a twice-daily oral formulation of testosterone for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. TLANDO® was granted tentative approval from the FDA based upon an FDA conclusion at the time that TLANDO® met all required efficacy, quality and safety standards. TLANDO® may be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. for JATENZO® on March 27, 2022; however, there is no assurance FDA approval will be received. Under the terms of the Agreement, we paid Lipocine an upfront payment of $11.0 million. Lipocine is eligible for additional milestone payments up to $10.0 million and tiered royalty and commercial milestones based on net sales of TLANDO® in the U.S. We will be responsible for the manufacturing and commercialization of TLANDO®.

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 in August 2018 and launched in late fourth quarter of 2018. Teva’s Epinephrine Injection USP is indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and 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 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.

Under an exclusive license and development agreement with AMAG, we developed, manufacture and supply a variation of our VIBEX® QuickShot® subcutaneous auto injector for use with AMAG’s progestin hormone drug Makena® (hydroxyprogesterone caproate injection), indicated to help reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past. The Makena® (hydroxyprogesterone caproate injection) subcutaneous auto injector was approved by the FDA and 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 new confirmatory trial. In October 2020, AMAG received notice that the FDA is proposing to withdraw approval of Makena® (hydroxyprogesterone caproate injection). AMAG has formally requested a public hearing in response to the FDA’s proposal to withdraw its approval and has stated that it remains committed to working with the FDA to maintain patient access to Makena® as a treatment option to reduce pre-term birth.

We are also collaborating with Teva on a multi-dose pen for a generic form of Forteo® (teriparatide rDNA origin injection) for the treatment of osteoporosis, and another multi-dose pen for a generic form of BYETTA® (exenatide injection) for the treatment of type 2 diabetes. Teva continues to work through the U.S. regulatory process with the FDA for exenatide and 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 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 an undisclosed Pfizer drug. We are developing the product and Pfizer will be responsible for obtaining FDA approval of the combination product. We entered into a 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 the U.S., pending FDA approval, for which we will receive royalties on net sales.

In June 2021, Idorsia announced it was initiating its Phase 3 registration study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia’s P2Y12 receptor antagonist, in suspected AMI utilizing Antares’ QuickShot® auto-injector. The study is an international, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to 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 treatment of a suspected AMI in 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 pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need.

In July 2021, the FDA accepted our IND for ATRS-1902 enabling us to initiate our Phase 1 clinical study. The Phase 1 clinical study designed to evaluate the safety, tolerability and pharmacokinetics (“PK”) of a liquid stable formulation of hydrocortisone was initiated in September 2021. The study is a cross-over design to establish the PK profile of ATRS-1902 (100 mg) compared to Solu-Cortef® (100 mg), the reference-listed drug, in 32 healthy adults. After this study is completed, we expect to conduct a bioequivalence study and second human factor study 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 studies will be the basis of our anticipated 505(b)(2) NDA filing with the FDA towards the end of 2022.

			Three Months Ended September 30,												Increased / (Decreased)												Nine Months Ended September 30,												Increased / (Decreased)
			2021						2020						$						%						2021						2020						$						%
Proprietary product sales, net			$	20,827					$	15,765					$	5,062					32.1		%				$	58,512					$	43,177					$	15,335					35.5		%
Partnered product sales			12,241						13,182						(941)						(7.1)		%				31,595						37,532						(5,937)						(15.8)		%
Total product revenue, net			33,068						28,947						4,121						14.2		%				90,107						80,709						9,398						11.6		%
Licensing and development revenue			3,682						4,321						(639)						(14.8)		%				15,833						8,763						7,070						80.7		%
Royalties			11,441						6,735						4,706						69.9		%				29,312						15,994						13,318						83.3		%
Total revenue, net			$	48,191					$	40,003					$	8,188					20.5		%				$	135,252					$	105,466					$	29,786					28.2		%

Net revenue from product sales for the three months ended September 30, 2021 increased 14.2% primarily due to increased sales of our proprietary product XYOSTED®. For the nine months ended September 30, 2021, net revenue from product sales increased 11.6% primarily driven by increased sales of our proprietary products, XYOSTED® and NOCDURNA®, partially offset by a reduction in sumatriptan sales to Teva and sales of Makena® subcutaneous auto-injectors to AMAG.

Sales of our proprietary products XYOSTED®, OTREXUP® and NOCDURNA® are presented net of estimated product returns and sales allowances. The increases in proprietary product sales of 32.1% and 35.5% for the three and nine months ended September 30, 2021, respectively, were primarily attributable to continued growth in prescriptions and sales of XYOSTED® and new sales of NOCDURNA®, which we in-licensed and began detailing in the fourth quarter of 2020.

We also manufacture and sell devices, components and fully assembled and packaged product to our partners. Partnered product sales decreased 7.1% for the three months ended September 30, 2021 due to a decrease in epinephrine auto injector shipments and sumatriptan sales to Teva and lower production and sales volumes of Makena® for AMAG, partially offset by higher sales volumes of teriparatide to Teva. For the nine months ended September 30, 2021, partnered product sales decreased 15.8% due to a decrease in sumatriptan sales to Teva, lower production and sales volumes of Makena® for AMAG and a decrease in shipments of epinephrine auto injectors to Teva, partially offset by higher teriparatide sales to Teva.

			Three Months Ended September 30,												Increased / (Decreased)												Nine Months Ended September 30,												Increased / (Decreased)
			2021						2020						$						%						2021						2020						$						%
Cost of product sales			$	14,039					$	13,615					$	424					3.1		%				$	38,167					$	38,556					$	(389)					(1.0)		%
Cost of development revenue			2,390						2,902						(512)						(17.6)		%				11,147						5,485						5,662						103.2		%
Total cost of revenue			$	16,429					$	16,517					$	(88)					(0.5)		%				$	49,314					$	44,041					$	5,273					12.0		%

			Three Months Ended September 30,												Increased / (Decreased)												Nine Months Ended September 30,												Increased / (Decreased)
			2021						2020						$						%						2021						2020						$						%
Research and development			$	3,923					$	2,405					$	1,518					63.1		%				$	10,610					$	7,803					$	2,807					36.0		%

			Three Months Ended September 30,												Increased / (Decreased)												Nine Months Ended September 30,												Increased / (Decreased)
			2021						2020						$						%						2021						2020						$						%
Selling, general and administrative			$	19,874					$	15,231					$	4,643					30.5		%				$	55,185					$	46,101					$	9,084					19.7		%

Selling, general and administrative expenses increased 30.5% and 19.7% for the three and nine months ended September 30, 2021, respectively, primarily due to an increase in XYOSTED® sales and marketing costs, which were down in 2020 due to the Pandemic as the various restrictions and limitations imposed during the Pandemic led 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 fourth quarter of 2020, along with higher employee compensation. General and administrative expenses also increased primarily driven by higher professional service fees, compensation costs, facility costs and insurance expense to support the continued growth of the business.

			Three Months Ended September 30,												Increased / (Decreased)												Nine Months Ended September 30,												Increased / (Decreased)
			2021						2020						$						%						2021						2020						$						%
Income tax expense			$	1,828					$	—					$	1,828					100.0		%				$	3,561					$	—					$	3,561					100.0		%
Effective tax rate			25.3		%				—		%																20.7		%				—		%

			Three Months Ended September 30,												Increased / (Decreased)												Nine Months Ended September 30,												Increased / (Decreased)
			2021						2020						$						%						2021						2020						$						%
Net income			$	5,393					$	4,996					$	397					7.9		%				$	13,606					$	4,815					$	8,791					182.6		%
Earnings per common share
Basic			$	0.03					$	0.03					$	—					—		%				$	0.08					$	0.03					$	0.05					166.7		%
Dilutive			$	0.03					$	0.03					$	—					—		%				$	0.08					$	0.03					$	0.05					166.7		%

			Nine Months Ended September 30,
			2021						2020
Total cash provided by (used in):
Operating activities			$	27,127					$	14,217
Investing activities			(4,960)						12,607
Financing activities			(17,938)						146
Effect of exchange rate changes on cash			(1)						1
Increase (decrease) in cash and cash equivalents			4,228						26,971
Cash and cash equivalents, beginning of period			53,137						23,201
Cash and cash equivalents, end of period			$	57,365					$	50,172

Item 3.    QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Item 4.    CONTROLS AND PROCEDURES

Item 1.    LEGAL PROCEEDINGS

Item 1A.    RISK FACTORS

In addition to the information contained in this report, you should carefully consider the risk factors discussed in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2020, which could materially affect our business, financial condition or future results. The information below includes an additional risk relating to our exclusive license agreement of TLANDO®. The risks described below 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 may also materially adversely affect our business, financial condition and/or operating results in future periods.

We recently entered into an exclusive license agreement with Lipocine for TLANDO® in the U.S. TLANDO® may not receive final FDA approval or be successfully commercialized.

TLANDO® received tentative FDA approval on December 8, 2020, for testosterone replacement therapy in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). In granting tentative approval, the FDA concluded that, at that time, TLANDO® met all required quality, safety and efficacy standards necessary for approval. TLANDO® has not received final approval and is not yet eligible for final approval and marketing in the U.S. At the earliest, TLANDO® will be eligible for final approval and marketing upon expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. for JATENZO®, the TLANDO® reference listed drug, on March 27, 2022. We will not be able to market TLANDO® in the U.S. until we receive final approval.

Item 6.    EXHIBITS

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).
10.2						Credit Agreement, dated November 1, 2021, by and among Antares Pharma, Inc., Wells Fargo Bank, National Association, and the lenders from time to time party thereto (filed as Exhibit 10.1 to the Company's Form 8-K filed November 2, 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 (filed herewith).
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 (filed herewith).
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 (furnished herewith).
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 (furnished herewith).
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) (filed herewith).
101.SCH						Inline XBRL Taxonomy Extension Schema Document (filed herewith).
101.CAL						Inline XBRL Taxonomy Extension Calculation Linkbase Document (filed herewith).
101.DEF						Inline XBRL Taxonomy Extension Definition Document (filed herewith).
101.LAB						Inline XBRL Taxonomy Extension Label Linkbase Document (filed herewith).
101.PRE						Inline XBRL Taxonomy Extension Presentation Linkbase Document (filed herewith).
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) (filed herewith).

									ANTARES PHARMA, INC.
									(Registrant)
Date:			November 4, 2021						/s/ Robert F. Apple
									Robert F. Apple
									President and Chief Executive Officer
									(Principal Executive Officer)
Date:			November 4, 2021						/s/ Fred M. Powell
									Fred M. Powell
									Executive Vice President and Chief Financial Officer
									(Principal Financial and Accounting Officer)