Post by icemandios on Mar 2, 2021 13:41:17 GMT
Antares Pharma Reports Fourth Quarter and Full-Year 2020 Financial and Operating Results
Full-Year 2020 Revenue Increases 21% Year-Over-Year to $149.6 Million
Full-Year 2020 Net Income Before Income Taxes of $9.9 Million, or $0.06 per Share
Full-Year 2020 Net Income of $56.2 Million, including a Net Tax Benefit of $46.3 million
EWING, N.J., March 02, 2021 (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, 2020 with record revenue of $44.1 million and net income of $51.4 million, or basic and diluted earnings per share of $0.31 and $0.30, respectively, which included a net tax benefit of $46.3 million. The Company also reported record full-year 2020 revenue of $149.6 million and net income of $56.2 million, or basic and diluted earnings per share of $0.34 and $0.33, respectively. The full year net income included the above referenced net tax benefit of $46.3 million or $0.28 and $0.27 per basic and diluted share, respectively, resulting from a deferred tax asset valuation allowance reversal. ( See Table 3 for details of the components of net income and computation of per share amounts. )
Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, “We are very proud of our accomplishments this past year that contributed to record annual revenue of $150 million. Despite ongoing challenges due to the global COVID-19 pandemic, the diversification of our business with our proprietary and partner revenue continues to bolster our overall growth, profitability, and cash flow. Driven by strong demand for XYOSTED, our proprietary revenue grew to $63 million in 2020. The reach of our commercial sales organization to urologists and endocrinologists has continued to drive the success of XYOSTED as well as support the expansion of our proprietary portfolio with NOCDURNA. We look forward to further expanding our internal pipeline as we advance our endocrinology and urology assets from successful Pre-IND meetings with the FDA last year to IND submissions this year. Our partner business also had another strong year with total revenue of $87 million driven in large part to the significant increases in market share of Teva’s generic EpiPen.”
“As we look ahead, our full-year 2021 revenue guidance of $175-200 million, which represents 17% to 34% year-over-year growth, anticipates continued growth in XYOSTED as well as our partner products. We also remain excited about the potential FDA approval of Teva’s generic Forteo, ongoing progress for Pfizer’s undisclosed asset, and the initiation of Idorsia’s Phase III trial for their selatogrel rescue pen program that has received fast-track designation by the FDA. Overall, the diversification of our business has proven to be a strong foundation from which we will continue to expand.”
Fourth Quarter 2020 and Recent Highlights
XYOSTED ® total prescriptions in the fourth quarter 2020 increased 13% sequentially and 76% year-over-year, according to IQVIA.
Entered an exclusive license agreement with Ferring Pharmaceuticals for NOCDURNA ® in the U.S. that expands our proprietary portfolio and leverages our commercial organization.
Recorded an income tax benefit of $46.3 million for the fourth quarter and full-year 2020 resulting primarily from the net valuation allowance release of $53.4 million on deferred tax assets.
Announced full-year 2021 revenue guidance of $175-200 million, which represents a 17% to 34% year-over-year growth rate and assumes a range of revenue scenarios for the potential approval and launch of generic Forteo ® by our partner Teva in the U.S.
Fourth Quarter and Full-Year 2020 Financial Results
Total revenue generated from product sales, license and development activities and royalties was $44.1 million for the three months ended December 31, 2020, a 17% increase compared to $37.8 million in the same period in 2019. For the full year ended December 31, 2020, total revenue was $149.6 million, a 21% increase from $123.9 million for the comparable period in 2019.
Product sales were $33.1 million for the three months ended December 31, 2020, a 16% increase compared to $28.5 million for the same period in 2019. For the twelve-month period ended December 31, 2020, product sales were $113.8 million, a 24% increase from $92.1 million in the comparable period in 2019.
Sales of our proprietary products XYOSTED ® , OTREXUP ® and NOCDURNA ® generated revenue of $19.7 million and $62.9 million for the three months and full-year ended December 31, 2020, respectively, as compared to $14.0 million and $39.2 million for the three months and full-year ended December 31, 2019, respectively. The 41% and 60% increase in proprietary product sales for the three-month and full-year ended December 31, 2020 respectively, compared to the three months and full-year ended December 31, 2019 were principally attributable to continued growth in prescriptions and sales of XYOSTED ® .
Partnered product sales were $13.4 million and $14.5 million for the three months ended December 31, 2020 and 2019, respectively, and $51.0 million and $52.9 million for the full year ended December 31, 2020 and 2019, respectively. The net decrease in sales of partnered products for the fourth quarter and full-year ended December 31, 2020 as compared to the same periods in 2019 is attributable to decreased sales of needle-free devices to Ferring, a decrease in sales of Makena ® auto injectors to AMAG and a reduction in pre-launch quantities of generic teriparatide devices sold to Teva in previous periods. These decreases were offset by an increase in sales to Teva of their generic EpiPen auto-injectors.
Licensing and development revenue was $5.7 million and $14.5 million for the three and twelve-month periods ended December 31, 2020, respectively, as compared to $3.2 million and $7.5 million for the comparable periods in 2019, respectively. The increase in licensing and development revenue for the fourth quarter and full year ended December 31, 2020 was primarily from the Pfizer rescue pen and the Idorsia selatogrel pen development programs.
Royalty revenue was $5.3 million for the three months ended December 31, 2020 compared to $6.2 million for the same period in 2019. For the twelve-month period ended December 31, 2020, royalty revenue was $21.3 million, as compared to $24.2 million for the same period in 2019. The net decrease in royalty revenue was primarily attributable to a decline in royalties recognized from AMAG on their net sales of the Makena ® subcutaneous auto injectors offset by an increase in royalties from Teva on their net sales of generic EpiPen.
Research and development expenses were $2.3 million and $10.1 million for the three and twelve-month periods ended December 31, 2020, respectively, as compared to $2.9 million and $10.6 million for the comparable periods in 2019, respectively. The decrease in research and development costs incurred in 2020 as compared to 2019 was due to the timing of clinical studies for our internal pipeline products.
Selling, general and administrative expenses were $16.7 million and $62.8 million for the three and twelve-month periods ended December 31, 2020, respectively, as compared to $15.4 million and $61.8 million for the comparable periods in 2019, respectively. The net increase in selling, general and administrative expenses for the three and twelve-month period ended December 31, 2020 was primarily due to increases in payroll and equity-based compensation costs and additional overhead costs of our new facility, offset by reductions in sales and marketing costs incurred as a result of the various stay at home orders and travel restrictions related to the COVID-19 pandemic.
Antares recorded an income tax benefit of $46.3 million for the fourth quarter and full-year 2020 resulting primarily from the net valuation allowance release of $53.4 million on our deferred tax assets. As of December 31, 2020, management concluded that as a result of generating pre-tax earnings, utilization of net operating loss carryovers and future projected pre-tax earnings, it is more likely than not that nearly all of our deferred taxes are realizable and may be utilized to offset future tax liabilities.
Including the tax benefit, net income was $51.4 million, or $0.31 and $0.30 per basic and diluted share, respectively, for the fourth quarter of 2020, compared to $4.7 million, or $0.03 per basic and diluted share in the same period in 2019. Net income was $56.2 million, or $0.34 and $0.33 per basic and diluted share, respectively, for the full year ended December 31, 2020 compared to a net loss of $2.0 million, or $0.01 loss per basic and diluted share in the comparable period of 2019.
As of December 31, 2020, cash and cash equivalents were $53.1 million compared to $45.7 million as of December 31, 2019. Cash generated from operations was $21.3 million for the full-year ended December 31, 2020, compared to cash used in operations of $10.6 million for the full-year ended December 31, 2019.
Full-Year 2021 Financial Guidance
The Company today reaffirmed full-year 2021 revenue guidance in the range of $175-200 million, which represents a 17% to 34% year-over-year growth rate and assumes no significant disruptions to supply or operations due to the ongoing COVID-19 pandemic and a range of revenue scenarios for the potential approval and launch of generic Forteo ® by our partner Teva in the U.S.
Webcast and Conference Call Information
The Antares management team will provide a Company update and review the fourth quarter and full-year 2020 financial results via conference call and webcast today, March 2, 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 (888) 254-3590 for domestic callers and (323) 994-2093 for international callers. Callers should reference the Antares Pharma conference call or conference ID number 1389407.
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., which was licensed from Ferring Pharmaceuticals.
Full-Year 2020 Revenue Increases 21% Year-Over-Year to $149.6 Million
Full-Year 2020 Net Income Before Income Taxes of $9.9 Million, or $0.06 per Share
Full-Year 2020 Net Income of $56.2 Million, including a Net Tax Benefit of $46.3 million
EWING, N.J., March 02, 2021 (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, 2020 with record revenue of $44.1 million and net income of $51.4 million, or basic and diluted earnings per share of $0.31 and $0.30, respectively, which included a net tax benefit of $46.3 million. The Company also reported record full-year 2020 revenue of $149.6 million and net income of $56.2 million, or basic and diluted earnings per share of $0.34 and $0.33, respectively. The full year net income included the above referenced net tax benefit of $46.3 million or $0.28 and $0.27 per basic and diluted share, respectively, resulting from a deferred tax asset valuation allowance reversal. ( See Table 3 for details of the components of net income and computation of per share amounts. )
Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, “We are very proud of our accomplishments this past year that contributed to record annual revenue of $150 million. Despite ongoing challenges due to the global COVID-19 pandemic, the diversification of our business with our proprietary and partner revenue continues to bolster our overall growth, profitability, and cash flow. Driven by strong demand for XYOSTED, our proprietary revenue grew to $63 million in 2020. The reach of our commercial sales organization to urologists and endocrinologists has continued to drive the success of XYOSTED as well as support the expansion of our proprietary portfolio with NOCDURNA. We look forward to further expanding our internal pipeline as we advance our endocrinology and urology assets from successful Pre-IND meetings with the FDA last year to IND submissions this year. Our partner business also had another strong year with total revenue of $87 million driven in large part to the significant increases in market share of Teva’s generic EpiPen.”
“As we look ahead, our full-year 2021 revenue guidance of $175-200 million, which represents 17% to 34% year-over-year growth, anticipates continued growth in XYOSTED as well as our partner products. We also remain excited about the potential FDA approval of Teva’s generic Forteo, ongoing progress for Pfizer’s undisclosed asset, and the initiation of Idorsia’s Phase III trial for their selatogrel rescue pen program that has received fast-track designation by the FDA. Overall, the diversification of our business has proven to be a strong foundation from which we will continue to expand.”
Fourth Quarter 2020 and Recent Highlights
XYOSTED ® total prescriptions in the fourth quarter 2020 increased 13% sequentially and 76% year-over-year, according to IQVIA.
Entered an exclusive license agreement with Ferring Pharmaceuticals for NOCDURNA ® in the U.S. that expands our proprietary portfolio and leverages our commercial organization.
Recorded an income tax benefit of $46.3 million for the fourth quarter and full-year 2020 resulting primarily from the net valuation allowance release of $53.4 million on deferred tax assets.
Announced full-year 2021 revenue guidance of $175-200 million, which represents a 17% to 34% year-over-year growth rate and assumes a range of revenue scenarios for the potential approval and launch of generic Forteo ® by our partner Teva in the U.S.
Fourth Quarter and Full-Year 2020 Financial Results
Total revenue generated from product sales, license and development activities and royalties was $44.1 million for the three months ended December 31, 2020, a 17% increase compared to $37.8 million in the same period in 2019. For the full year ended December 31, 2020, total revenue was $149.6 million, a 21% increase from $123.9 million for the comparable period in 2019.
Product sales were $33.1 million for the three months ended December 31, 2020, a 16% increase compared to $28.5 million for the same period in 2019. For the twelve-month period ended December 31, 2020, product sales were $113.8 million, a 24% increase from $92.1 million in the comparable period in 2019.
Sales of our proprietary products XYOSTED ® , OTREXUP ® and NOCDURNA ® generated revenue of $19.7 million and $62.9 million for the three months and full-year ended December 31, 2020, respectively, as compared to $14.0 million and $39.2 million for the three months and full-year ended December 31, 2019, respectively. The 41% and 60% increase in proprietary product sales for the three-month and full-year ended December 31, 2020 respectively, compared to the three months and full-year ended December 31, 2019 were principally attributable to continued growth in prescriptions and sales of XYOSTED ® .
Partnered product sales were $13.4 million and $14.5 million for the three months ended December 31, 2020 and 2019, respectively, and $51.0 million and $52.9 million for the full year ended December 31, 2020 and 2019, respectively. The net decrease in sales of partnered products for the fourth quarter and full-year ended December 31, 2020 as compared to the same periods in 2019 is attributable to decreased sales of needle-free devices to Ferring, a decrease in sales of Makena ® auto injectors to AMAG and a reduction in pre-launch quantities of generic teriparatide devices sold to Teva in previous periods. These decreases were offset by an increase in sales to Teva of their generic EpiPen auto-injectors.
Licensing and development revenue was $5.7 million and $14.5 million for the three and twelve-month periods ended December 31, 2020, respectively, as compared to $3.2 million and $7.5 million for the comparable periods in 2019, respectively. The increase in licensing and development revenue for the fourth quarter and full year ended December 31, 2020 was primarily from the Pfizer rescue pen and the Idorsia selatogrel pen development programs.
Royalty revenue was $5.3 million for the three months ended December 31, 2020 compared to $6.2 million for the same period in 2019. For the twelve-month period ended December 31, 2020, royalty revenue was $21.3 million, as compared to $24.2 million for the same period in 2019. The net decrease in royalty revenue was primarily attributable to a decline in royalties recognized from AMAG on their net sales of the Makena ® subcutaneous auto injectors offset by an increase in royalties from Teva on their net sales of generic EpiPen.
Research and development expenses were $2.3 million and $10.1 million for the three and twelve-month periods ended December 31, 2020, respectively, as compared to $2.9 million and $10.6 million for the comparable periods in 2019, respectively. The decrease in research and development costs incurred in 2020 as compared to 2019 was due to the timing of clinical studies for our internal pipeline products.
Selling, general and administrative expenses were $16.7 million and $62.8 million for the three and twelve-month periods ended December 31, 2020, respectively, as compared to $15.4 million and $61.8 million for the comparable periods in 2019, respectively. The net increase in selling, general and administrative expenses for the three and twelve-month period ended December 31, 2020 was primarily due to increases in payroll and equity-based compensation costs and additional overhead costs of our new facility, offset by reductions in sales and marketing costs incurred as a result of the various stay at home orders and travel restrictions related to the COVID-19 pandemic.
Antares recorded an income tax benefit of $46.3 million for the fourth quarter and full-year 2020 resulting primarily from the net valuation allowance release of $53.4 million on our deferred tax assets. As of December 31, 2020, management concluded that as a result of generating pre-tax earnings, utilization of net operating loss carryovers and future projected pre-tax earnings, it is more likely than not that nearly all of our deferred taxes are realizable and may be utilized to offset future tax liabilities.
Including the tax benefit, net income was $51.4 million, or $0.31 and $0.30 per basic and diluted share, respectively, for the fourth quarter of 2020, compared to $4.7 million, or $0.03 per basic and diluted share in the same period in 2019. Net income was $56.2 million, or $0.34 and $0.33 per basic and diluted share, respectively, for the full year ended December 31, 2020 compared to a net loss of $2.0 million, or $0.01 loss per basic and diluted share in the comparable period of 2019.
As of December 31, 2020, cash and cash equivalents were $53.1 million compared to $45.7 million as of December 31, 2019. Cash generated from operations was $21.3 million for the full-year ended December 31, 2020, compared to cash used in operations of $10.6 million for the full-year ended December 31, 2019.
Full-Year 2021 Financial Guidance
The Company today reaffirmed full-year 2021 revenue guidance in the range of $175-200 million, which represents a 17% to 34% year-over-year growth rate and assumes no significant disruptions to supply or operations due to the ongoing COVID-19 pandemic and a range of revenue scenarios for the potential approval and launch of generic Forteo ® by our partner Teva in the U.S.
Webcast and Conference Call Information
The Antares management team will provide a Company update and review the fourth quarter and full-year 2020 financial results via conference call and webcast today, March 2, 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 (888) 254-3590 for domestic callers and (323) 994-2093 for international callers. Callers should reference the Antares Pharma conference call or conference ID number 1389407.
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., which was licensed from Ferring Pharmaceuticals.