Post by icemandios on Mar 3, 2022 14:03:32 GMT
Antares Pharma Reports Fourth Quarter and Full-Year 2021 Financial and Operating Results
Full-Year 2021 Revenue Increased 23% Year-Over-Year to $184.0 Million
Full-Year 2021 Net Income of $46.3 Million, or $0.26 Per Diluted Earnings Per Share
Full-Year 2021 Adjusted EBITDA of $39.2 Million
2022 Revenue Guidance Range of $200 to $220 Million
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 $48.7 million, net income of $32.7 million, or $0.19 per diluted earnings per share, and adjusted net income of $4.1 million, or $0.02 per adjusted diluted earnings per share, which excludes the gain on the sale of OTREXUP ® . The Company also reported record full-year 2021 revenue of $184.0 million, net income of $46.3 million, or $0.26 per diluted earnings per share, and adjusted net income of $17.7 million, or $0.10 per adjusted diluted earnings per share, which excludes the gain on the sale of OTREXUP ® .
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 23% to $184 million and increased adjusted EBITDA to almost $40 million for the full year. In 2021, our commercial team continued to build and maintain strong physician relationships that helped drive the 34% annual revenue increase in our flagship proprietary asset XYOSTED. We also worked relentlessly supplying devices for the strong demand of Teva’s generic EpiPen, which contributed approximately $70 million in annual revenue. Despite consistent challenges due to the pandemic, we successfully executed on our strategic initiatives and believe we have positioned the Company for continued growth.”
“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 $200 to $220 million does not include any products with the potential for approval this year. We appreciate the continued hard work and dedication of our employees and partners as we embark on another expected record year,” concluded Mr. Apple.
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 a 77% 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
Fourth Quarter and Full-Year 2021 Financial Results
Total net revenue generated from product sales, license and development activities and royalties was $48.7 million for the three months ended December 31, 2021, a 10% increase compared to $44.1 million in the same period in 2020. For the twelve months ended December 31, 2021, total revenue was $184.0 million, a 23% increase from $149.6 million for the comparable period in 2020.
Product sales were $36.6 million for the three months ended December 31, 2021, a 10% increase compared to $33.1 million for the same period in 2020. For the twelve months ended December 31, 2021, product sales were $126.7 million, an 11% increase from $113.8 million in the comparable period in 2020.
Sales of our proprietary products XYOSTED ® , OTREXUP ® and NOCDURNA ® generated revenue of $21.5 million and $80.0 million for the three and twelve months ended December 31, 2021, respectively, as compared to $19.7 million and $62.9 million for the three and twelve months ended December 31, 2020, respectively. The 9% and 27% increase in proprietary product sales for the three and twelve months ended December 31, 2021, respectively, compared to the same periods in 2020 were principally attributable to continued growth in prescriptions and sales of XYOSTED ® partially offset by the divestiture of OTREXUP ® that was completed in December 2021.
Partnered product sales were $15.1 million and $46.7 million for the three and twelve months ended December 31, 2021, respectively, as compared to $13.4 million and $51.0 million for the three and twelve months ended December 31, 2020, respectively.
Licensing and development revenue was $3.8 million and $19.6 million for the three and twelve months ended December 31, 2021, respectively, as compared to $5.7 million and $14.5 million for the comparable periods in 2020, respectively. The decrease in licensing and development revenue for the fourth 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 twelve months ended December 31, 2021 was primarily a result of incremental development and maintenance activities with Teva and timing of other ongoing partnered development projects.
Royalty revenue was $8.4 million for the three months ended December 31, 2021 compared to $5.3 million for the same period in 2020. For the twelve months ended December 31, 2021, royalty revenue was $37.7 million, as compared to $21.3 million for the same period in 2020. The net increase in royalty revenue in the three and twelve months ended December 31, 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 $14.5 million for the three and twelve months ended December 31, 2021, respectively, as compared to $2.3 million and $10.1 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 $18.7 million and $73.9 million for the three and twelve months ended December 31, 2021, respectively, as compared to $16.7 million and $62.8 million for the comparable periods in 2020, respectively. The net increase in selling, general and administrative expenses for the three and twelve months ended December 31, 2021 was primarily due to expenses associated with the relaunch of NOCDURNA ® and an increase in sales and marketing expenses that had declined during the COVID-19 pandemic.
Net income was $32.7 million, or $0.19 per basic and diluted earnings per share and $46.3 million, or $0.27 and $0.26 per basic and diluted earnings per share, respectively, for the fourth quarter and full year ended December 31, 2021, respectively, inclusive of a gain on the sale of OTREXUP ® of $38.6 million. Net income for the comparable periods in 2020 was $51.4 million for the quarter, or $0.31 and $0.30 per basic and diluted earnings per share, respectively, and $56.2 million for the year, or $0.34 and $0.33 per basic and diluted earnings per share, respectively, included a tax benefit of $46.3 million resulting primarily from the net valuation allowance release of $53.4 million on our deferred tax assets.
As of December 31, 2021, cash and cash equivalents were $65.9 million compared to $53.1 million as of December 31, 2020. The Company generated cash from operations of $36.6 million for the twelve months ended December 31, 2021. In 2021, the Company paid down $20.0 million of long-term debt.
Full-Year 2022 Financial Guidance
The Company today provided its full-year 2022 revenue guidance range of $200 to $220 million, which does not include any unapproved products and assumes no significant disruptions to supply or operations due to the ongoing COVID-19 pandemic. Excluding 2021 OTREXUP ® proprietary revenue, the guidance range represents a 18% to 30% year-over-year growth rate.
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.
Full-Year 2021 Revenue Increased 23% Year-Over-Year to $184.0 Million
Full-Year 2021 Net Income of $46.3 Million, or $0.26 Per Diluted Earnings Per Share
Full-Year 2021 Adjusted EBITDA of $39.2 Million
2022 Revenue Guidance Range of $200 to $220 Million
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 $48.7 million, net income of $32.7 million, or $0.19 per diluted earnings per share, and adjusted net income of $4.1 million, or $0.02 per adjusted diluted earnings per share, which excludes the gain on the sale of OTREXUP ® . The Company also reported record full-year 2021 revenue of $184.0 million, net income of $46.3 million, or $0.26 per diluted earnings per share, and adjusted net income of $17.7 million, or $0.10 per adjusted diluted earnings per share, which excludes the gain on the sale of OTREXUP ® .
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 23% to $184 million and increased adjusted EBITDA to almost $40 million for the full year. In 2021, our commercial team continued to build and maintain strong physician relationships that helped drive the 34% annual revenue increase in our flagship proprietary asset XYOSTED. We also worked relentlessly supplying devices for the strong demand of Teva’s generic EpiPen, which contributed approximately $70 million in annual revenue. Despite consistent challenges due to the pandemic, we successfully executed on our strategic initiatives and believe we have positioned the Company for continued growth.”
“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 $200 to $220 million does not include any products with the potential for approval this year. We appreciate the continued hard work and dedication of our employees and partners as we embark on another expected record year,” concluded Mr. Apple.
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 a 77% 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
Fourth Quarter and Full-Year 2021 Financial Results
Total net revenue generated from product sales, license and development activities and royalties was $48.7 million for the three months ended December 31, 2021, a 10% increase compared to $44.1 million in the same period in 2020. For the twelve months ended December 31, 2021, total revenue was $184.0 million, a 23% increase from $149.6 million for the comparable period in 2020.
Product sales were $36.6 million for the three months ended December 31, 2021, a 10% increase compared to $33.1 million for the same period in 2020. For the twelve months ended December 31, 2021, product sales were $126.7 million, an 11% increase from $113.8 million in the comparable period in 2020.
Sales of our proprietary products XYOSTED ® , OTREXUP ® and NOCDURNA ® generated revenue of $21.5 million and $80.0 million for the three and twelve months ended December 31, 2021, respectively, as compared to $19.7 million and $62.9 million for the three and twelve months ended December 31, 2020, respectively. The 9% and 27% increase in proprietary product sales for the three and twelve months ended December 31, 2021, respectively, compared to the same periods in 2020 were principally attributable to continued growth in prescriptions and sales of XYOSTED ® partially offset by the divestiture of OTREXUP ® that was completed in December 2021.
Partnered product sales were $15.1 million and $46.7 million for the three and twelve months ended December 31, 2021, respectively, as compared to $13.4 million and $51.0 million for the three and twelve months ended December 31, 2020, respectively.
Licensing and development revenue was $3.8 million and $19.6 million for the three and twelve months ended December 31, 2021, respectively, as compared to $5.7 million and $14.5 million for the comparable periods in 2020, respectively. The decrease in licensing and development revenue for the fourth 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 twelve months ended December 31, 2021 was primarily a result of incremental development and maintenance activities with Teva and timing of other ongoing partnered development projects.
Royalty revenue was $8.4 million for the three months ended December 31, 2021 compared to $5.3 million for the same period in 2020. For the twelve months ended December 31, 2021, royalty revenue was $37.7 million, as compared to $21.3 million for the same period in 2020. The net increase in royalty revenue in the three and twelve months ended December 31, 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 $14.5 million for the three and twelve months ended December 31, 2021, respectively, as compared to $2.3 million and $10.1 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 $18.7 million and $73.9 million for the three and twelve months ended December 31, 2021, respectively, as compared to $16.7 million and $62.8 million for the comparable periods in 2020, respectively. The net increase in selling, general and administrative expenses for the three and twelve months ended December 31, 2021 was primarily due to expenses associated with the relaunch of NOCDURNA ® and an increase in sales and marketing expenses that had declined during the COVID-19 pandemic.
Net income was $32.7 million, or $0.19 per basic and diluted earnings per share and $46.3 million, or $0.27 and $0.26 per basic and diluted earnings per share, respectively, for the fourth quarter and full year ended December 31, 2021, respectively, inclusive of a gain on the sale of OTREXUP ® of $38.6 million. Net income for the comparable periods in 2020 was $51.4 million for the quarter, or $0.31 and $0.30 per basic and diluted earnings per share, respectively, and $56.2 million for the year, or $0.34 and $0.33 per basic and diluted earnings per share, respectively, included a tax benefit of $46.3 million resulting primarily from the net valuation allowance release of $53.4 million on our deferred tax assets.
As of December 31, 2021, cash and cash equivalents were $65.9 million compared to $53.1 million as of December 31, 2020. The Company generated cash from operations of $36.6 million for the twelve months ended December 31, 2021. In 2021, the Company paid down $20.0 million of long-term debt.
Full-Year 2022 Financial Guidance
The Company today provided its full-year 2022 revenue guidance range of $200 to $220 million, which does not include any unapproved products and assumes no significant disruptions to supply or operations due to the ongoing COVID-19 pandemic. Excluding 2021 OTREXUP ® proprietary revenue, the guidance range represents a 18% to 30% year-over-year growth rate.
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.