GlobeNewswire Inc | Nov 4, 2021 07:00AM EDT

November 04, 2021

Increased Revenue 20% Year-Over-Year to $48.2 Million

Net Income of $5.4 Million, or $0.03 Per Basic and Diluted Earnings Per Share

EWING, N.J., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the Company), a specialty pharmaceutical company, today reported financial and operating results for the third quarter ended September 30, 2021 with record revenue of $48.2 million and net income of $5.4 million, or $0.03 per basic and diluted earnings per share.

Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, Our third quarter financial and operating results are illustrative of the strong execution that we continue to deliver across our diversified business. While XYOSTED and Tevas generic EpiPen remain the chief drivers of the 20% revenue growth this quarter, we also advanced our corporate development initiatives and internal R&D programs that we believe will be drivers of our future growth trajectory. The recent signing of the license agreement for TLANDO, a twice daily oral formulation of testosterone tentatively approved by the FDA will expand our commercial portfolio and leverage our proven commercial organization that has strong physician relationships and clinical acumen in the large and growing testosterone replacement therapy market. We anticipate launching this exciting new oral product in the second quarter of 2022. Additionally, the initiation of the Phase I study for ATRS-1902 for adrenal crisis rescue should also further highlight our commitment to the endocrinology therapeutic area and enhances our proprietary pipeline.

With these accomplishments, we have updated our full year 2021 revenue guidance range to $180-190 million, representing 20-27% year-over-year growth. As we look ahead, our balance sheet continues to strengthen with our cash generation and provides a stronger foundation for additional growth opportunities. Furthermore, we expect our partners to continue to advance their development programs that will further enhance our overall future growth, concluded Mr. Apple.

Third Quarter 2021 and Recent Highlights

-- XYOSTED total prescriptions in the third quarter 2021 increased 40% year-over-year, according to IQVIA. -- Tevas generic EpiPen prescriptions in the third quarter 2021 increased 91% year-over-year, contributing to a 97% increase in EpiPen royalty revenue -- Entered into an exclusive U.S. license agreement for TLANDO (testosterone undecanoate), a twice daily oral formulation of testosterone -- Initiated the Phase I study for ATRS-1902 for adrenal crisis rescue -- Replaced $20.0 million Hercules Capital term loan with a Wells Fargo credit facility and reduced associated interest expense by approximately $1.2 million annually -- Appointed seasoned healthcare executive Carmen Volkart to the Board of Directors

Financial Table

Three Months Ended Nine Months Ended September 30, September 30,(in thousands, exceptper share data - 2021 2020 2021 2020unaudited)Product revenue, net $ 33,068 $ 28,947 $ 90,107 $ 80,709 Licensing and 3,682 4,321 15,833 8,763 development revenueRoyalties 11,441 6,735 29,312 15,994 Revenue, net 48,191 40,003 135,252 105,466 Research and 3,923 2,405 10,610 7,803 development expenseSelling, general and 19,874 15,231 55,185 46,101 administrative expenseNet income 5,393 4,996 13,606 4,815 Basic earnings per 0.03 0.03 0.08 0.03 shareDiluted earnings per 0.03 0.03 0.08 0.03 shareCash and cashequivalents, end of 57,365 50,172 periodOperating cash flows $ 18,716 $ 4,956 $ 27,127 $ 14,217

Third Quarter 2021 Financial Results

Total net revenue generated from product sales, license and development activities and royalties was $48.2 million for the three months ended September 30, 2021, a 20% increase compared to $40.0 million in the same period in 2020. For the nine months ended September 30, 2021, total revenue was $135.3 million, a 28% increase from $105.5 million for the comparable period in 2020.

Product sales were $33.1 million for the three months ended September 30, 2021, a 14% increase compared to $28.9 million for the same period in 2020. For the nine months ended September 30, 2021, product sales were $90.1 million, a 12% increase from $80.7 million in the comparable period in 2020.

Sales of our proprietary products XYOSTED, OTREXUP and NOCDURNA generated revenue of $20.8 million and $58.5 million for the three and nine months ended September 30, 2021, respectively, as compared to $15.8 million and $43.2 million for the three and nine months ended September 30, 2020, respectively. The 32% and 36% increase in proprietary product sales for the three and nine months ended September 30, 2021, respectively, compared to the same periods in 2020 were principally attributable to continued growth in prescriptions and sales of XYOSTED.

Partnered product sales were $12.2 million and $31.6 million for the three and nine months ended September 30, 2021, respectively, as compared to $13.2 million and $37.5 million for the three and nine months ended September 30, 2020, respectively. The net decrease in sales of partnered products for the third quarter and nine months ended September 30, 2021 as compared to the same periods in 2020 is attributable to a decrease in epinephrine auto injectors and sales of sumatriptan to Teva and lower production of Makena autoinjectors for AMAG.

Licensing and development revenue was $3.7 million and $15.8 million for the three and nine months ended September 30, 2021, respectively, as compared to $4.3 million and $8.8 million for the comparable periods in 2020, respectively. The decrease in licensing and development revenue for the third quarter of 2021 compared to the comparable period in 2020 was driven by fluctuations in timing of development activities and the overall increase for the nine months ended September 30, 2021 was primarily a result of incremental development and maintenance activities with Teva and our other ongoing partnered development projects.

Royalty revenue was $11.4 million for the three months ended September 30, 2021 compared to $6.7 million for the same period in 2020. For the nine months ended September 30, 2021, royalty revenue was $29.3 million, as compared to $16.0 million for the same period in 2020. The net increase in royalty revenue in the three and nine months ended September 30, 2021 was attributable to an increase in royalties from Teva on their net sales of generic EpiPen.

Research and development expenses were $3.9 million and $10.6 million for the three and nine months ended September 30, 2021, respectively, as compared to $2.4 million and $7.8 million for the comparable periods in 2020, respectively. The increase in research and development costs incurred in 2021 as compared to 2020 was attributable to our ongoing internal development programs.

Selling, general and administrative expenses were $19.9 million and $55.2 million for the three and nine months ended September 30, 2021, respectively, as compared to $15.2 million and $46.1 million for the comparable periods in 2020, respectively. The net increase in selling, general and administrative expenses for the three and nine months ended September 30, 2021 was primarily due to an increase in sales and marketing expenses that had declined during the COVID-19 pandemic and incremental costs associated with NOCDURNA, which was in-licensed in October 2020. General and administrative expenses increased due to increases in professional services, compensation, facility costs and insurance expense to support the growth of the business.

Net income was $5.4 million, or $0.03 per basic and diluted earnings per share for the third quarter 2021, compared to $5.0 million, or $0.03 per basic and diluted earnings per share in the same period in 2020. Net income was $13.6 million, or $0.08 per basic and diluted earnings per share for the nine months ended September 30, 2021 compared to a net income of $4.8 million, or $0.03 per basic and diluted earnings per share in the comparable period of 2020.

As of September 30, 2021, cash and cash equivalents were $57.4 million compared to $53.1 million as of December 31, 2020. In November 2021, Antares replaced its $20.0 million Hercules Capital term loan with a Wells Fargo credit facility, which includes a $20.0 million term loan and $20.0 million revolving line of credit. The Company generated cash from operations of $27.1 million for the nine months ended September 30, 2021.

Full-Year 2021 Financial Guidance

The Company today updated its full-year 2021 revenue guidance range from $175-200 million to $180-190 million, which represents a 20% to 27% year-over-year growth rate and assumes no significant disruptions to supply or operations due to the ongoing COVID-19 pandemic.

Webcast and Conference Call Information

The Antares management team will provide a Company update and review the third quarter and year-to-date financial results via conference call and webcast today, November 4, 2021, at 8:30am ET (Eastern Time). The webcast of the conference call will include a slide presentation, which can be accessed in the investor relations section of the Companys website (www.antarespharma.com) under Webcasts & Presentations. Alternatively, callers may participate in the audio portion of the conference call by dialing (800) 353-6461 for domestic callers and (334) 323-0501 for international callers. Callers should reference the Antares Pharma conference call or conference ID number 2794616.

About Antares Pharma

Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharmas FDA-approved products include XYOSTED (testosterone enanthate) injection, OTREXUP (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA (desmopressin acetate) in the U.S. and expects to commercially launch TLANDO (testosterone undecanoate) in the U.S. pending final FDA approval.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Companys ability to achieve the updated 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTEDand future revenue from the same; market acceptance of Tevas generic epinephrine auto-injector product and future revenue from the same;future prescriptions and sales of OTREXUP; successful commercialization of NOCDURNA in the U.S. and market acceptance and future revenue from the same;uncertainties regarding future FDA approval of TLANDO, market acceptance and future revenue from the same, whether Antares will exercise the option for LPCN 1111 (TLANDO XR) and if exercised, future timing and success of the clinical development program for TLANDO XR and future FDA approval, market acceptance and revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals Makena subcutaneous auto injector following the FDA letter seeking withdrawal, the outcome of the FDA hearing and whether Makenawill be successful and future prescriptions, market acceptance and revenue from the same; Tevas ability to successfully commercialize VIBEX Sumatriptan Injection USP and the amount of revenue from the same; Tevas ability to successfully commercialize generic teriparatide in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 trial of the drug device combination product for selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; the timing and results of the clinical development program for ATRS-1902 adrenal crisis rescue auto-injector, future NDA submission and FDA approval of the same, and if approved, future market acceptance and revenue for the same; FDA approval of Tevas ANDAs for both generic Forteo and Byetta and future revenue from the same; the timing and results of the Companys or its partners research projects or clinical trials of product candidates in development including the Companys urology assets in development as well as Pfizers undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Companys products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Companys ability to repay the debt obligation to Wells Fargo; the Companys ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

Contact:Tram BuiVice President, Corporate Communications and Investor Relations609-359-3016tbui@antarespharma.com

TABLES FOLLOW

ANTARES PHARMA, INC.Table 1 - CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share amounts)(unaudited)

Three Months Ended Increase/ Nine Months Ended Increase/ September 30, (Decrease) September 30, (Decrease) 2021 2020 2021 2020 Revenue Product sales, $ 33,068 $ 28,947 14% $ 90,107 $ 80,709 12%netLicensing anddevelopment 3,682 4,321 (15)% 15,833 8,763 81%revenueRoyalties 11,441 6,735 70% 29,312 15,994 83%Total revenue, 48,191 40,003 20% 135,252 105,466 28%net Operating expensesCost of 14,039 13,615 3% 38,167 38,556 (1)%product salesCost ofdevelopment 2,390 2,902 (18)% 11,147 5,485 103%revenueResearch and 3,923 2,405 63% 10,610 7,803 36%developmentSelling,general and 19,874 15,231 30% 55,185 46,101 20%administrativeTotaloperating 40,226 34,153 18% 115,109 97,945 18%expenses Operating 7,965 5,850 36% 20,143 7,521 168%incomeOther expense, (744 ) (854 ) (13)% (2,976 ) (2,706 ) 10%netIncome before 7,221 4,996 45% 17,167 4,815 257%income taxesIncome tax (1,828 ) ? ** (3,561 ) ? **expenseNet income $ 5,393 $ 4,996 8% $ 13,606 $ 4,815 183% Earnings per common shareBasic $ 0.03 $ 0.03 $ 0.08 $ 0.03 Diluted $ 0.03 $ 0.03 $ 0.08 $ 0.03 Weightedaverage common sharesoutstandingBasic 169,953 166,375 168,947 165,838 Diluted 175,128 169,655 174,937 169,759

ANTARES PHARMA, INC.Table 2 CONSOLIDATED REVENUE DETAILS(in thousands)(unaudited)

Three Months Ended Increase / Nine Months Ended Increase / September 30, (Decrease) September 30, (Decrease) 2021 2020 2021 2020 Proprietaryproduct salesXYOSTED $ 15,948 $ 12,245 30% $ 45,076 $ 32,150 40%OTREXUP 4,109 3,520 17% 11,103 11,027 1%NOCDURNA 770 ? 100% 2,333 ? 100%Totalproprietary 20,827 15,765 32% 58,512 43,177 36%productsales, netPartneredproduct 12,241 13,182 (7)% 31,595 37,532 (16)%salesTotalproduct 33,068 28,947 14% 90,107 80,709 12%revenue,netLicensingand 3,682 4,321 (15)% 15,833 8,763 81%developmentrevenueRoyalties 11,441 6,735 70% 29,312 15,994 83%Totalrevenue, $ 48,191 $ 40,003 20% $ 135,252 $ 105,466 28%net

ANTARES PHARMA, INC.Table 3 CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(unaudited)

September 30, December 31, 2021 2020Assets Cash and cash equivalents $ 57,365 $ 53,137Accounts receivable, net 54,471 42,221Inventories, net 16,493 18,216Contract assets 2,942 8,140Prepaid expenses and other current assets 2,162 4,877Deferred tax assets, net 43,987 46,982Property and equipment, net 25,832 24,020Other long-term assets 13,487 14,938Total Assets $ 216,739 $ 212,531 Liabilities and Stockholders? Equity Accounts payable and accrued expenses $ 44,895 $ 43,032Long-term debt 21,319 40,899Other liabilities 9,697 9,485Stockholders? equity 140,828 119,115Total Liabilities and Stockholders? Equity $ 216,739 $ 212,531