Antares Pharma Reports Fourth Quarter and Full-Year 2021 Financial and Operating Results
Antares Pharma reported a 23% year-over-year revenue increase, reaching $184.0 million for 2021, with a net income of $46.3 million ($0.26 per diluted share). Q4 2021 revenue was $48.7 million, driven by a 34% increase in prescriptions for XYOSTED. The company anticipates 2022 revenues between $200 million and $220 million, excluding unapproved products. Key developments include positive Phase 1 results for ATRS-1902 and a PDUFA action date for TLANDO set for March 28, 2022. The company plans to invest in R&D while navigating ongoing challenges from the pandemic.
- Full-Year 2021 revenue of $184.0 million, up 23% year-over-year.
- Net income for 2021 was $46.3 million, or $0.26 per diluted share.
- Q4 2021 revenue reached $48.7 million, a 10% increase from Q4 2020.
- XYOSTED prescriptions increased 34% year-over-year.
- 2022 revenue guidance of $200 to $220 million implies 18% to 30% growth.
- Net income decreased from $56.2 million in 2020 to $46.3 million in 2021.
- Research and development expenses rose significantly, totaling $14.5 million in 2021.
- Selling, general and administrative expenses increased to $73.9 million, impacting profitability.
Full-Year 2021 Revenue Increased
Full-Year 2021 Net Income of
Full-Year 2021 Adjusted EBITDA of
2022 Revenue Guidance Range of
EWING, N.J., March 03, 2022 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the “Company”), a specialty pharmaceutical company, today reported financial and operating results for the fourth quarter ended December 31, 2021 with record revenue of
Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, “The many accomplishments we achieved throughout the year contributed to our strong annual revenue growth of
“As we look ahead, we are excited to be able to provide a complementary offering to XYOSTED with TLANDO’s oral formulation for testosterone deficiency, pending final FDA approval, that we believe will contribute to our future growth trajectory. While TLANDO leverages our commercial organization, we expect to continue to invest in research and development of our internal pipeline. The recent advancements for ATRS-1902 for adrenal crisis rescue, including positive Phase 1 results and the FDA’s Fast Track designation, highlight another opportunity to support our potential future growth. We also anticipate the advancement of our portfolio of partner products in development while we continue to execute on potential corporate development opportunities to further enhance our growth. Our full year 2022 revenue guidance of
Fourth Quarter 2021 and Recent Highlights
- XYOSTED® total prescriptions in the fourth quarter 2021 increased ~
34% year-over-year, and increased ~45% year-over-year for the full-year 2021, according to IQVIA - Teva’s generic EpiPen prescriptions in the fourth quarter 2021 increased
35% year-over-year, contributing to a77% year-over-year increase in EpiPen royalty revenue - Entered into an exclusive U.S. license agreement for TLANDO® (testosterone undecanoate), a twice daily oral formulation of testosterone
- FDA accepted NDA resubmission for TLANDO® and set a PDUFA target action date of March 28, 2022
- Divested OTREXUP® product line assets to a subsidiary of Assertio Holdings, Inc. for a total cash consideration of
$44.0 million - Reported positive Phase I results and received FDA fast track designation for ATRS-1902 for adrenal crisis rescue
Financial Table
| Three Months Ended December 31, | Years Ended December 31, | |||||||||||||||
| (in thousands, except per share data - unaudited) | 2021 | 2020 | 2021 | 2020 | ||||||||||||
| Product revenue, net | $ | 36,560 | $ | 33,125 | $ | 126,667 | $ | 113,834 | ||||||||
| Licensing and development revenue | 3,790 | 5,703 | 19,623 | 14,466 | ||||||||||||
| Royalties | 8,380 | 5,305 | 37,692 | 21,299 | ||||||||||||
| Revenue, net | 48,730 | 44,133 | 183,982 | 149,599 | ||||||||||||
| Research and development expense | 3,892 | 2,318 | 14,502 | 10,121 | ||||||||||||
| Selling, general and administrative expense | 18,672 | 16,658 | 73,857 | 62,759 | ||||||||||||
| Net income | 32,683 | 51,386 | 46,289 | 56,201 | ||||||||||||
| Adjusted net income¹ | 4,111 | 2,098 | 17,717 | 6,913 | ||||||||||||
| Basic earnings per common share | 0.19 | 0.31 | 0.27 | 0.34 | ||||||||||||
| Diluted earnings per common share | 0.19 | 0.30 | 0.26 | 0.33 | ||||||||||||
| Adjusted diluted earnings per common share¹ | 0.02 | 0.01 | 0.10 | 0.04 | ||||||||||||
| Adjusted EBITDA¹ | 10,584 | 9,159 | 39,207 | 24,283 | ||||||||||||
| Cash and cash equivalents, end of period | 65,913 | 53,137 | ||||||||||||||
| Operating cash flows | $ | 9,492 | $ | 7,103 | $ | 36,619 | $ | 21,320 | ||||||||
¹ Denotes non-GAAP financial measure.
Fourth Quarter and Full-Year 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 December 31, 2021, cash and cash equivalents were
Full-Year 2022 Financial Guidance
The Company today provided its full-year 2022 revenue guidance range of
Webcast and Conference Call Information
The Antares management team will provide a Company update and review the fourth quarter and full-year 2021 financial results via conference call and webcast today, March 3, 2022, 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 (888) 254-3590 for domestic callers and (323) 794-2551 for international callers. Callers should reference the Antares Pharma conference call or conference ID number 9589807.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address patient needs in targeted therapeutic areas. The Company develops, manufactures and commercializes, for itself or with partners, novel therapeutic products using its advanced drug delivery systems that are designed to provide commercial or functional advantages such as improved safety and efficacy, convenience, improved tolerability, and enhanced patient comfort and adherence. The Company has a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. The Company has formed partnership arrangements with several different industry leading pharmaceutical companies.
NON-GAAP FINANCIAL MEASURES
We believe that disclosing adjusted diluted earnings per common share, which is diluted earnings per share excluding the impact from the gain on sale of assets and deferred tax benefit net valuation allowance release is useful to investors as a measure of operating performance. We use this as one measure to monitor and evaluate operating performance. Adjusted diluted earnings per common share is a financial measure that does not reflect United States Generally Accepted Accounting Principles (GAAP). We calculate this measure by adding back the after-tax effect of the gain on sale of assets and the deferred tax benefit net valuation allowance release and dividing the result by the diluted weighted average common shares outstanding.
We believe that disclosing earnings before interest, taxes, depreciation and amortization (EBITDA) and EBITDA excluding the impact from stock-based compensation and gain on sale of assets (Adjusted EBITDA) are useful to investors as a measure of leverage and operating performance. We use these measures to monitor and evaluate leverage and operating performance. EBITDA and Adjusted EBITDA are financial measures that do not reflect GAAP. We calculate EBITDA by adding back interest, taxes, depreciation and amortization expense to net income. Adjusted EBITDA is calculated by adding back stock-based compensation and gain on sale of assets to EBITDA.
Investors should consider these non-GAAP financial measures in addition to, not as a substitute for or better than, financial measures prepared in accordance with GAAP. Reconciliations of the components of these measures to the most directly comparable GAAP financial measures are included in Tables 4 and 5 of this earnings release.
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 2022 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; timing and final approval of the NDA for TLANDO®, future commercial launch, market acceptance, prescriptions and revenue for TLANDO®; the timing and results of the Company’s or its partners’ research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Company’s products or product candidates of its partners; commercial success of the Company’s products or partner products and continued growth in product, development, licensing and royalty revenue; 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 December 31, | Increase / | Years Ended December 31, | Increase / | |||||||||||||||||
| 2021 | 2020 | (Decrease) | 2021 | 2020 | (Decrease) | |||||||||||||||
| Revenue | ||||||||||||||||||||
| Product sales, net | $ | 36,560 | $ | 33,125 | $ | 126,667 | $ | 113,834 | ||||||||||||
| Licensing and development revenue | 3,790 | 5,703 | (34)% | 19,623 | 14,466 | |||||||||||||||
| Royalties | 8,380 | 5,305 | 37,692 | 21,299 | ||||||||||||||||
| Total revenue, net | 48,730 | 44,133 | 183,982 | 149,599 | ||||||||||||||||
| Operating expenses | ||||||||||||||||||||
| Cost of product sales | 16,251 | 15,404 | 54,418 | 53,960 | ||||||||||||||||
| Cost of development revenue | 2,716 | 3,655 | (26)% | 13,863 | 9,140 | |||||||||||||||
| Research and development | 3,892 | 2,318 | 14,502 | 10,121 | ||||||||||||||||
| Selling, general and administrative | 18,672 | 16,658 | 73,857 | 62,759 | ||||||||||||||||
| Total operating expenses | 41,531 | 38,035 | 156,640 | 135,980 | ||||||||||||||||
| Gain on sale of assets | 38,591 | — | 38,591 | — | ||||||||||||||||
| Operating income | 45,790 | 6,098 | 65,933 | 13,619 | ||||||||||||||||
| Other expense, net | (686 | ) | (992 | ) | (31)% | (3,662 | ) | (3,698 | ) | (1)% | ||||||||||
| Income before income taxes | 45,104 | 5,106 | 62,271 | 9,921 | ||||||||||||||||
| Income tax provision (benefit) | 12,421 | (46,280 | ) | 15,982 | (46,280 | ) | ||||||||||||||
| Net income | $ | 32,683 | $ | 51,386 | (36)% | $ | 46,289 | $ | 56,201 | (18)% | ||||||||||
| Earnings per common share | ||||||||||||||||||||
| Basic | $ | 0.19 | $ | 0.31 | $ | 0.27 | $ | 0.34 | ||||||||||||
| Diluted | $ | 0.19 | $ | 0.30 | $ | 0.26 | $ | 0.33 | ||||||||||||
| Weighted average common shares outstanding | ||||||||||||||||||||
| Basic | 170,054 | 166,744 | 169,226 | 166,066 | ||||||||||||||||
| Diluted | 174,109 | 171,412 | 174,733 | 170,155 | ||||||||||||||||
| ANTARES PHARMA, INC. Table 2 – CONSOLIDATED REVENUE DETAILS (in thousands) (unaudited) | ||||||||||||||||||||
| Three Months Ended December 31, | Increase / | Years Ended December 31, | Increase / | |||||||||||||||||
| 2021 | 2020 | (Decrease) | 2021 | 2020 | (Decrease) | |||||||||||||||
| Proprietary product sales | ||||||||||||||||||||
| XYOSTED® | $ | 17,158 | $ | 14,399 | $ | 62,234 | $ | 46,549 | ||||||||||||
| OTREXUP® | 3,241 | 4,442 | (27)% | 14,344 | 15,468 | (7)% | ||||||||||||||
| NOCDURNA® | 1,105 | 861 | 3,438 | 861 | ||||||||||||||||
| Total proprietary product sales, net | 21,504 | 19,702 | 80,016 | 62,878 | ||||||||||||||||
| Partnered product sales | 15,056 | 13,423 | 46,651 | 50,956 | (8)% | |||||||||||||||
| Total product revenue, net | 36,560 | 33,125 | 126,667 | 113,834 | ||||||||||||||||
| Licensing and development revenue | 3,790 | 5,703 | (34)% | 19,623 | 14,466 | |||||||||||||||
| Royalties | 8,380 | 5,305 | 37,692 | 21,299 | ||||||||||||||||
| Total revenue, net | $ | 48,730 | $ | 44,133 | $ | 183,982 | $ | 149,599 | ||||||||||||
| ANTARES PHARMA, INC. Table 3 – CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) | ||||||||
| December 31, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 65,913 | $ | 53,137 | ||||
| Short-term investments | 1,245 | — | ||||||
| Accounts receivable, net | 56,697 | 42,221 | ||||||
| Other receivables | 26,311 | — | ||||||
| Inventories, net | 11,544 | 18,216 | ||||||
| Contract assets | 8,030 | 8,140 | ||||||
| Prepaid expenses and other current assets | 4,532 | 4,877 | ||||||
| Deferred tax assets, net | 33,043 | 46,982 | ||||||
| Property and equipment, net | 26,015 | 24,020 | ||||||
| Goodwill and intangibles, net | 18,974 | 8,788 | ||||||
| Other long-term assets | 5,201 | 6,150 | ||||||
| Total Assets | $ | 257,505 | $ | 212,531 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Accounts payable and accrued expenses | $ | 52,099 | $ | 41,829 | ||||
| Long-term debt | 19,741 | 40,899 | ||||||
| Other liabilities | 9,907 | 10,688 | ||||||
| Stockholders’ equity | 175,758 | 119,115 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 257,505 | $ | 212,531 | ||||
| ANTARES PHARMA, INC. Table 4 - RECONCILIATION OF EBITDA AND ADJUSTED EBITDA TO NET INCOME (in thousands, except per share amounts) (unaudited) | ||||||||||||||||||||
| Three Months Ended December 31, | Increase / | Years Ended December 31, | Increase / | |||||||||||||||||
| 2021 | 2020 | (Decrease) | 2021 | 2020 | (Decrease) | |||||||||||||||
| Net income | $ | 32,683 | $ | 51,386 | (36)% | $ | 46,289 | $ | 56,201 | (18)% | ||||||||||
| Income tax provision (benefit) | 12,421 | (46,280 | ) | 15,982 | (46,280 | ) | ||||||||||||||
| Interest expense, net | 764 | 977 | (22)% | 3,611 | 3,787 | (5)% | ||||||||||||||
| Depreciation and amortization | 1,140 | 897 | 3,901 | 2,627 | ||||||||||||||||
| EBITDA¹ | 47,008 | 6,980 | 69,783 | 16,335 | ||||||||||||||||
| Stock-based compensation | 2,167 | 2,179 | (1)% | 8,015 | 7,948 | |||||||||||||||
| Gain on sale of assets | (38,591 | ) | — | (100)% | (38,591 | ) | — | (100)% | ||||||||||||
| Adjusted EBITDA¹ | $ | 10,584 | $ | 9,159 | $ | 39,207 | $ | 24,283 | ||||||||||||
¹ Denotes non-GAAP financial measure.
| ANTARES PHARMA, INC. Table 5 - RECONCILIATION OF ADJUSTED DILUTED EARNINGS PER COMMON SHARE (in thousands, except per share amounts) (unaudited) | ||||||||||||||||||||||||
| Three Months Ended | ||||||||||||||||||||||||
| December 31, 2021 | December 31, 2020 | |||||||||||||||||||||||
| Pre-tax | Tax | Net | Pre-tax | Tax | Net | |||||||||||||||||||
| Net income | $ | 45,104 | $ | 12,421 | $ | 32,683 | $ | 5,106 | $ | (46,280 | ) | $ | 51,386 | |||||||||||
| Gain on sale of assets¹ | 38,591 | 10,019 | 28,572 | — | — | — | ||||||||||||||||||
| Deferred tax benefit net valuation allowance release | — | — | — | — | (49,288 | ) | 49,288 | |||||||||||||||||
| Adjusted net income² | $ | 6,513 | $ | 2,402 | $ | 4,111 | $ | 5,106 | $ | 3,008 | $ | 2,098 | ||||||||||||
| Weighted average diluted common shares outstanding | 174,109 | 171,412 | ||||||||||||||||||||||
| Diluted earnings per common share | $ | 0.26 | $ | 0.07 | $ | 0.19 | $ | 0.03 | $ | (0.27 | ) | $ | 0.30 | |||||||||||
| Impact of gain on sale of assets | 0.22 | 0.05 | 0.17 | — | — | — | ||||||||||||||||||
| Impact of deferred tax benefit net valuation allowance release | — | — | — | — | (0.29 | ) | 0.29 | |||||||||||||||||
| Adjusted diluted earnings per common share² | $ | 0.04 | $ | 0.02 | $ | 0.02 | $ | 0.03 | $ | 0.02 | $ | 0.01 | ||||||||||||
¹ In determining the tax impact of the gain on sale of assets, we applied blended U.S. statutory tax rates, including the impact of permanent differences.
² Denotes non-GAAP financial measure.
| Years Ended | ||||||||||||||||||||||||
| December 31, 2021 | December 31, 2020 | |||||||||||||||||||||||
| Pre-tax | Tax | Net | Pre-tax | Tax | Net | |||||||||||||||||||
| Net income | $ | 62,271 | $ | 15,982 | $ | 46,289 | $ | 9,921 | $ | (46,280 | ) | $ | 56,201 | |||||||||||
| Gain on sale of assets¹ | 38,591 | 10,019 | 28,572 | — | — | — | ||||||||||||||||||
| Deferred tax benefit net valuation allowance release | — | — | — | — | (49,288 | ) | 49,288 | |||||||||||||||||
| Adjusted net income² | $ | 23,680 | $ | 5,963 | $ | 17,717 | $ | 9,921 | $ | 3,008 | $ | 6,913 | ||||||||||||
| Weighted average diluted common shares outstanding | 174,733 | 170,155 | ||||||||||||||||||||||
| Diluted earnings per common share | $ | 0.36 | $ | 0.10 | $ | 0.26 | $ | 0.06 | $ | (0.27 | ) | $ | 0.33 | |||||||||||
| Impact of gain on sale of assets | 0.22 | 0.06 | 0.16 | — | — | — | ||||||||||||||||||
| Impact of deferred tax benefit net valuation allowance release | — | — | — | — | (0.29 | ) | 0.29 | |||||||||||||||||
| Adjusted diluted earnings per common share² | $ | 0.14 | $ | 0.04 | $ | 0.10 | $ | 0.06 | $ | 0.02 | $ | 0.04 | ||||||||||||
¹ In determining the tax impact of the gain on sale of assets, we applied blended U.S. statutory tax rates, including the impact of permanent differences.
² Denotes non-GAAP financial measure.
FAQ
What were Antares Pharma's total revenues for 2021?
What is the revenue guidance for Antares Pharma in 2022?
How did Antares Pharma perform in Q4 2021?
What was the net income for Antares Pharma in 2021?
When is the PDUFA target action date for TLANDO?
