Post by icemandios on Mar 10, 2022 13:47:59 GMT
Xeris Biopharma Reports Fourth Quarter and Full-year 2021 Financial Results and Recent Events
Acquisition and integration of Strongbridge Biopharma completed; $50M in synergies to be realized by year-end 2022
Recorlev® approved by FDA
FY ‘21 pro forma net product revenues of $79M – a 56% increase from prior year
Well-capitalized with cash, cash equivalents, and short-term investments of $102.4M at YE 2021
Double-digit net product revenues growth expected in 2022 to be $105M - $120M
Cash position further strengthened with a recent PIPE and the restructuring of debt with Hayfin Capital; 2022 year-end cash, cash equivalents, and short-term investments of $90M-$110M expected
Cash flow breakeven expected by year-end 2023
Conference call and webcast today at 8:30 a.m. ET
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, and Xeris Pharmaceuticals, Inc., today announced financial results for the fourth quarter and full-year 2021 and recent highlights.
“During 2021, we made significant progress toward achieving critical mass and becoming a fully integrated pharmaceutical company with the acquisition of Strongbridge, the continued growth of Gvoke and Keveyis, and the recent approval and launch of our third commercial product, Recorlev,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “2022 is all about execution and building long-term shareholder value. With three commercial products in large addressable markets and a strong cash position, we believe we can achieve 2022 net product revenues in the range of $105 million to $120 million and drive to cash flow breakeven by year-end 2023.”
Fourth Quarter and Full-year 2021 Highlights and Recent Events
Marketed Products
Gvoke®: Fourth quarter 2021 prescriptions topped 29,000 for the first time, growing more than 85% compared to the same period in 2020. Gvoke’s market share of the retail TRx glucagon market grew to approximately 17% at year-end. In June, the FDA approved the extension of room temperature shelf-life of the Gvoke 1mg HypoPen and PFS from 24 months to 30 months. In August, the FDA approved the sNDA for the Gvoke Kit®, which will be available in March 2022.
Keveyis®: Full-year pro forma 2021 net revenues for Keveyis were at the high end of the previously announced guidance of $38-40 million.
Ogluo®: In December, Xeris’ commercialization partner, Tetris Pharma launched Ogluo® in the UK. Tetris plans to launch Ogluo in several European countries in 2022.
Recorlev®: On December 30, 2021, The U.S. Food and Drug Administration (FDA) approved Recorlev for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. In February 2022, Xeris launched Recorlev and is now exclusively available through a specialty pharmacy. The Company has established Xeris CareConnection™, a comprehensive support program, which includes $0 co-pay for commercially insured patients, one-on-one support and education for patients, and reimbursement and access support.
Pipeline Programs
Levothyroxine: Xeris anticipates having data from its Phase 1 single ascending dose study in the third quarter 2022.
Exercise-induced Hypoglycemia (EIH): Xeris submitted an IND in February 2022 and recently received FDA clearance. The Company is actively planning a new phase 2 clinical program by the end of 2022 to further address the management of EIH in people with diabetes who use insulin.
XeriJect™ Technology Platform Collaborations: Xeris has four ongoing evaluation projects with large pharmaceutical companies, which includes Merck, for the purpose of engineering ultra-high concentration, ready-to-use formulations.
Corporate Highlights
On October 5, 2021, Xeris completed its acquisition of Strongbridge Biopharma plc.
On January 2, 2022, Xeris entered into a Securities Purchase Agreement with Armistice Capital Master Fund Ltd. for $30.0 million and the issuance of 10,238,908 shares of common stock and warrants to purchase 5,119,454 shares of common stock at an exercise price of $3.223 per share.
On March 8, 2022, Xeris entered into a senior secured term loan agreement with Hayfin Capital Management LLP to provide the Company with $150.0 million. On the closing date, Xeris drew down $100.0 million to repay its existing debt facility of $43.5 million with Oxford Finance LLC and Silicon Valley Bank and provide additional working capital to fund the Company’s business plan. An additional $50.0 million will be available during the 12-month period following the closing date.
Fourth Quarter and Full-year 2021 Financial Results
Net product revenues increased by $14.3 million or 201% and $29.1 million or 145% for the three and twelve months ended December 31, 2021, respectively, compared to December 31, 2020. The increases were due to an increased demand and the acquisition of a new product, Keveyis.
Cost of goods sold increased by $1.5 million or 43% and $4.0 million or 43% for the three and twelve months ended December 31, 2021, respectively, compared to December 31, 2020. The increases were due to increased sales, primarily offset by lower excess and obsolete.
Research and development expenses increased by $5.0 million or 97% and $4.2 million or 20% for the three- and twelve-months ended December 31, 2021, respectively, compared to December 31, 2020. Higher pharmaceutical process development and clinical service costs accounted for $3.7 million and $4.3 million of the increase for the three- and twelve-months ending December 31, 2021.
Selling, general and administrative expenses increased by $36.2 million or 201% and $52.0 million or 71% for the three- and twelve-months ending December 31, 2021, respectively, compared to December 31, 2020. The increases are primarily driven by costs associated with the Strongbridge acquisition of approximately $18.3 million and $24.4 million for the three-and twelve-months ending, respectively. Additionally, increases in sales force and commercial related expenses accounted for approximately $15.7 million and $16.8 million for the three- and twelve-months ending, respectively.
Net Loss for the fourth quarter ended December 31, 2021, was $50.8 million, or $0. 42 per share, compared to a net loss of $21.9 million, or $0.41 per share, for the same period in 2020. For the full year ended December 31, 2021, the Company reported a net loss of $122.7 million, or $1.55 per share, compared to a net loss of $91.1 million, or $2.14 per share, for the same period in 2020.
Cash, cash equivalents, and short-term investments at December 31, 2021, was $102.4 million compared to $133.8 million at December 31, 2020. Total shares outstanding at February 28, 2022, was 135,523,511.
Financial Outlook
The Company is providing the following financial guidance:
Net product revenue of $105 million to $120 million for full-year 2022
Year-end 2022 cash, cash equivalents, and short-term investments in the range of $90 million to $110 million
Cash flow breakeven by year-end 2023, which assumes performance is consistent with annual net product revenues guidance
Expectations for growth assume full access to health care provider facilities, as a continuation or escalation of access restrictions or lockdown orders resulting from the ongoing COVID-19 pandemic would adversely affect financial results.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Thursday, March 10, 2022, at 8:30 a.m. Eastern Time. To pre-register for the conference call please use this link: www.incommglobalevents.com/registration/q4inc/9809/xeris-biopharma-fourth-quarter-2021-financial-results-conference-call-and-webcast/ . After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Thursday, March 24, 2022, at US:1 929 458 6194, US Toll Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code: 872042. To join the webcast, please visit “Events” on investor relations page of the Company’s website at www.xerispharma.com .
About Xeris
Xeris (Nasdaq: XERS) is a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.
Acquisition and integration of Strongbridge Biopharma completed; $50M in synergies to be realized by year-end 2022
Recorlev® approved by FDA
FY ‘21 pro forma net product revenues of $79M – a 56% increase from prior year
Well-capitalized with cash, cash equivalents, and short-term investments of $102.4M at YE 2021
Double-digit net product revenues growth expected in 2022 to be $105M - $120M
Cash position further strengthened with a recent PIPE and the restructuring of debt with Hayfin Capital; 2022 year-end cash, cash equivalents, and short-term investments of $90M-$110M expected
Cash flow breakeven expected by year-end 2023
Conference call and webcast today at 8:30 a.m. ET
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, and Xeris Pharmaceuticals, Inc., today announced financial results for the fourth quarter and full-year 2021 and recent highlights.
“During 2021, we made significant progress toward achieving critical mass and becoming a fully integrated pharmaceutical company with the acquisition of Strongbridge, the continued growth of Gvoke and Keveyis, and the recent approval and launch of our third commercial product, Recorlev,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “2022 is all about execution and building long-term shareholder value. With three commercial products in large addressable markets and a strong cash position, we believe we can achieve 2022 net product revenues in the range of $105 million to $120 million and drive to cash flow breakeven by year-end 2023.”
Fourth Quarter and Full-year 2021 Highlights and Recent Events
Marketed Products
Gvoke®: Fourth quarter 2021 prescriptions topped 29,000 for the first time, growing more than 85% compared to the same period in 2020. Gvoke’s market share of the retail TRx glucagon market grew to approximately 17% at year-end. In June, the FDA approved the extension of room temperature shelf-life of the Gvoke 1mg HypoPen and PFS from 24 months to 30 months. In August, the FDA approved the sNDA for the Gvoke Kit®, which will be available in March 2022.
Keveyis®: Full-year pro forma 2021 net revenues for Keveyis were at the high end of the previously announced guidance of $38-40 million.
Ogluo®: In December, Xeris’ commercialization partner, Tetris Pharma launched Ogluo® in the UK. Tetris plans to launch Ogluo in several European countries in 2022.
Recorlev®: On December 30, 2021, The U.S. Food and Drug Administration (FDA) approved Recorlev for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. In February 2022, Xeris launched Recorlev and is now exclusively available through a specialty pharmacy. The Company has established Xeris CareConnection™, a comprehensive support program, which includes $0 co-pay for commercially insured patients, one-on-one support and education for patients, and reimbursement and access support.
Pipeline Programs
Levothyroxine: Xeris anticipates having data from its Phase 1 single ascending dose study in the third quarter 2022.
Exercise-induced Hypoglycemia (EIH): Xeris submitted an IND in February 2022 and recently received FDA clearance. The Company is actively planning a new phase 2 clinical program by the end of 2022 to further address the management of EIH in people with diabetes who use insulin.
XeriJect™ Technology Platform Collaborations: Xeris has four ongoing evaluation projects with large pharmaceutical companies, which includes Merck, for the purpose of engineering ultra-high concentration, ready-to-use formulations.
Corporate Highlights
On October 5, 2021, Xeris completed its acquisition of Strongbridge Biopharma plc.
On January 2, 2022, Xeris entered into a Securities Purchase Agreement with Armistice Capital Master Fund Ltd. for $30.0 million and the issuance of 10,238,908 shares of common stock and warrants to purchase 5,119,454 shares of common stock at an exercise price of $3.223 per share.
On March 8, 2022, Xeris entered into a senior secured term loan agreement with Hayfin Capital Management LLP to provide the Company with $150.0 million. On the closing date, Xeris drew down $100.0 million to repay its existing debt facility of $43.5 million with Oxford Finance LLC and Silicon Valley Bank and provide additional working capital to fund the Company’s business plan. An additional $50.0 million will be available during the 12-month period following the closing date.
Fourth Quarter and Full-year 2021 Financial Results
Net product revenues increased by $14.3 million or 201% and $29.1 million or 145% for the three and twelve months ended December 31, 2021, respectively, compared to December 31, 2020. The increases were due to an increased demand and the acquisition of a new product, Keveyis.
Cost of goods sold increased by $1.5 million or 43% and $4.0 million or 43% for the three and twelve months ended December 31, 2021, respectively, compared to December 31, 2020. The increases were due to increased sales, primarily offset by lower excess and obsolete.
Research and development expenses increased by $5.0 million or 97% and $4.2 million or 20% for the three- and twelve-months ended December 31, 2021, respectively, compared to December 31, 2020. Higher pharmaceutical process development and clinical service costs accounted for $3.7 million and $4.3 million of the increase for the three- and twelve-months ending December 31, 2021.
Selling, general and administrative expenses increased by $36.2 million or 201% and $52.0 million or 71% for the three- and twelve-months ending December 31, 2021, respectively, compared to December 31, 2020. The increases are primarily driven by costs associated with the Strongbridge acquisition of approximately $18.3 million and $24.4 million for the three-and twelve-months ending, respectively. Additionally, increases in sales force and commercial related expenses accounted for approximately $15.7 million and $16.8 million for the three- and twelve-months ending, respectively.
Net Loss for the fourth quarter ended December 31, 2021, was $50.8 million, or $0. 42 per share, compared to a net loss of $21.9 million, or $0.41 per share, for the same period in 2020. For the full year ended December 31, 2021, the Company reported a net loss of $122.7 million, or $1.55 per share, compared to a net loss of $91.1 million, or $2.14 per share, for the same period in 2020.
Cash, cash equivalents, and short-term investments at December 31, 2021, was $102.4 million compared to $133.8 million at December 31, 2020. Total shares outstanding at February 28, 2022, was 135,523,511.
Financial Outlook
The Company is providing the following financial guidance:
Net product revenue of $105 million to $120 million for full-year 2022
Year-end 2022 cash, cash equivalents, and short-term investments in the range of $90 million to $110 million
Cash flow breakeven by year-end 2023, which assumes performance is consistent with annual net product revenues guidance
Expectations for growth assume full access to health care provider facilities, as a continuation or escalation of access restrictions or lockdown orders resulting from the ongoing COVID-19 pandemic would adversely affect financial results.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Thursday, March 10, 2022, at 8:30 a.m. Eastern Time. To pre-register for the conference call please use this link: www.incommglobalevents.com/registration/q4inc/9809/xeris-biopharma-fourth-quarter-2021-financial-results-conference-call-and-webcast/ . After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Thursday, March 24, 2022, at US:1 929 458 6194, US Toll Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code: 872042. To join the webcast, please visit “Events” on investor relations page of the Company’s website at www.xerispharma.com .
About Xeris
Xeris (Nasdaq: XERS) is a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.