Antares Pharma Reports Third Quarter 2021 Financial and Operating Results
Increased Revenue
Net Income of
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
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 Teva’s generic EpiPen remain the chief drivers of the
“With these accomplishments, we have updated our full year 2021 revenue guidance range to
Third Quarter 2021 and Recent Highlights
- XYOSTED® total prescriptions in the third quarter 2021 increased
40% year-over-year, according to IQVIA. - Teva’s generic EpiPen prescriptions in the third quarter 2021 increased
91% year-over-year, contributing to a97% 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 September 30, | Nine Months Ended September 30, | ||||||||||||||
| (in thousands, except per share data - unaudited) | 2021 | 2020 | 2021 | 2020 | |||||||||||
| 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 | |||||||||||
| Revenue, net | 48,191 | 40,003 | 135,252 | 105,466 | |||||||||||
| Research and development expense | 3,923 | 2,405 | 10,610 | 7,803 | |||||||||||
| Selling, general and administrative expense | 19,874 | 15,231 | 55,185 | 46,101 | |||||||||||
| Net income | 5,393 | 4,996 | 13,606 | 4,815 | |||||||||||
| Basic earnings per share | 0.03 | 0.03 | 0.08 | 0.03 | |||||||||||
| Diluted earnings per share | 0.03 | 0.03 | 0.08 | 0.03 | |||||||||||
| Cash and cash equivalents, end of period | 57,365 | 50,172 | |||||||||||||
| Operating 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
Product sales were
Sales of our proprietary products XYOSTED®, OTREXUP® and NOCDURNA® generated revenue of
Partnered product sales were
Licensing and development revenue was
Royalty revenue was
Research and development expenses were
Selling, general and administrative expenses were
Net income was
As of September 30, 2021, cash and cash equivalents were
Full-Year 2021 Financial Guidance
The Company today updated its full-year 2021 revenue guidance range from
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 Company’s 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 Pharma’s 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 Company’s 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 XYOSTED® and future revenue from the same; market acceptance of Teva’s 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 Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva’s ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; Teva’s 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 Teva’s ANDAs for both generic Forteo® and Byetta® and future revenue from the same; the timing and results of the Company’s or its partners’ research projects or clinical trials of product candidates in development including the Company’s urology assets in development as well as Pfizer’s undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company’s products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company’s ability to repay the debt obligation to Wells Fargo; the Company’s 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 Bui
Vice President, Corporate Communications and Investor Relations
609-359-3016
tbui@antarespharma.com
TABLES FOLLOW
ANTARES PHARMA, INC.
Table 1 - CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
| Three Months Ended September 30, | Increase/ (Decrease) | Nine Months Ended September 30, | Increase/ (Decrease) | ||||||||||||||||
| 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)% | 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 | (1)% | ||||||||||||||
| Cost of development revenue | 2,390 | 2,902 | (18)% | 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 expense, net | (744 | ) | (854 | ) | (13)% | (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 | |||||||||||||||
ANTARES PHARMA, INC.
Table 2 – CONSOLIDATED REVENUE DETAILS
(in thousands)
(unaudited)
| Three Months Ended September 30, | Increase / (Decrease) | Nine Months Ended September 30, | Increase / (Decrease) | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||
| Proprietary product sales | |||||||||||||||||
| XYOSTED® | $ | 15,948 | $ | 12,245 | $ | 45,076 | $ | 32,150 | |||||||||
| OTREXUP® | 4,109 | 3,520 | 11,103 | 11,027 | |||||||||||||
| NOCDURNA® | 770 | — | 2,333 | — | |||||||||||||
| Total proprietary product sales, net | 20,827 | 15,765 | 58,512 | 43,177 | |||||||||||||
| Partnered product sales | 12,241 | 13,182 | (7)% | 31,595 | 37,532 | (16)% | |||||||||||
| Total product revenue, net | 33,068 | 28,947 | 90,107 | 80,709 | |||||||||||||
| Licensing and development revenue | 3,682 | 4,321 | (15)% | 15,833 | 8,763 | ||||||||||||
| Royalties | 11,441 | 6,735 | 29,312 | 15,994 | |||||||||||||
| Total revenue, net | $ | 48,191 | $ | 40,003 | $ | 135,252 | $ | 105,466 | |||||||||
ANTARES PHARMA, INC.
Table 3 – CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
| September 30, 2021 | December 31, 2020 | ||||
| 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 | |||
| Deferred tax assets, net | 43,987 | 46,982 | |||
| Property and equipment, net | 25,832 | 24,020 | |||
| Other long-term assets | 13,487 | 14,938 | |||
| Total Assets | $ | 216,739 | $ | 212,531 | |
| Liabilities and Stockholders’ Equity | |||||
| Accounts payable and accrued expenses | $ | 44,895 | $ | 43,032 | |
| Long-term debt | 21,319 | 40,899 | |||
| Other liabilities | 9,697 | 9,485 | |||
| Stockholders’ equity | 140,828 | 119,115 | |||
| Total Liabilities and Stockholders’ Equity | $ | 216,739 | $ | 212,531 | |
