Post by icemandios on May 11, 2022 12:48:56 GMT
Xeris Biopharma Reports First Quarter Financial Results and Upcoming Events
Launched Recorlev® and Gvoke® Kit
Achieved Q1 net product revenue of $21.9M – a 33% increase from same period prior year on a pro forma basis
Ended Q1 with $132.1M in cash, cash equivalents and short-term investments
Affirming 2022 guidance for combined net product revenues of $105M - $120M, $50M in synergies, 2022 year-end cash balance of $90M-$110M, and cash flow breakeven by year-end 2023
Hosting 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 today announced financial results for the first quarter and recent highlights.
“We had another very good quarter in 1Q 2022 with continued increases in patients on Gvoke and Keveyis. In addition to this growth, we launched Recorlev and Gvoke Kit, and we added considerable cash to our balance sheet during the first three months of the year,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “Our first quarter performance gives us confidence that we can achieve our 2022 revenue and year-end cash guidance and achieve cash flow breakeven by year-end 2023. We look forward to continuing our steady and strong execution across our commercial products and advancement of our development pipeline.”
First Quarter Highlights and Upcoming Events
Gvoke®: First quarter 2022 prescriptions topped 30,000 for the first time, growing more than 88% compared to the same period in 2021. Gvoke’s market share of the retail TRx glucagon market grew to approximately 22% at the end of April. In March, Xeris launched Gvoke® Kit, the first ready-to-use liquid glucagon in a single dose vial and syringe kit for rescue.
Keveyis®: The number of patients on Keveyis increased 12% from the same period in 2021.
Recorlev®: In February 2022, Xeris launched Recorlev and is 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.
In January, 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.
In March, Xeris entered into a senior secured term loan agreement with Hayfin Capital Management LLP to provide the Company with $150.0 million. At closing, 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 for the Company to draw until March 2023.
Xeris will participate at the H. C. Wainwright Global Investment Conference, May 23-26, in Miami
Xeris will present data at the AACE Annual Meeting, May 12-14, in San Diego and at ISPOR 2022, May 15-18, in Washington DC
First Quarter 2022 Financial Results
Net product revenue increased by $13.9 million or 172% for the three months ended March 31, 2022 compared to March 31, 2021. The increase was the result of higher sales of Gvoke and sales attributable to the products, Keveyis and Recorlev, that we acquired in Q4, 2021. On a pro forma basis, net product revenue increased 33% or $5.5 million for the three months ended March 31, 2022 compared to March 31, 2021. This increase was driven by higher sales of Gvoke, Keveyis and the launch of Recorlev.
Cost of goods sold increased by $4.4 million or 244% for the three months ended March 31, 2022 compared to March 31, 2021. An increase in sales and product mix comprised $3.1 million and $0.8 million of the change.
Research and development expenses increased by $2.2 million or 55% for the three months ended March 31, 2022 compared to March 31, 2021. Higher pharmaceutical process development and clinical service costs accounted for $2.0 million of the increase for the three months ending March 31, 2022.
Selling, general and administrative expenses increased by $16.8 million or 88% for the three months ending March 31, 2022 compared to March 31, 2021. We incurred $11.5 million of increased commercial-related costs, including an increase to our sales force and increased commercial support for Gvoke, Keveyis and the launch of Recorlev. In addition, $2.3 million of the increase related to the acquisition of Strongbridge, primarily restructuring and related employee costs. The remaining change was due to an increase in general expenses given the growth of the Company.
Net Loss for the first quarter ended March 31, 2022, was $33.7 million, or $0.25 per share, compared to a net loss of $18.4 million, or $0.30 per share, for the same period in 2021.
Cash, cash equivalents, and short-term investments at March 31, 2022 was $132.1 million compared to $102.4 million at December 31, 2021. Total shares outstanding at April 30, 2022 was 135,530,756.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Wednesday, May 11, 2022, at 8:30 a.m. Eastern Time. To pre-register for the conference call please use this link: www.incommglobalevents.com/registration/q4inc/10525/xeris-biopharma-first-quarter-2022-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 Wednesday, May 25, 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: 723527. 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.
Launched Recorlev® and Gvoke® Kit
Achieved Q1 net product revenue of $21.9M – a 33% increase from same period prior year on a pro forma basis
Ended Q1 with $132.1M in cash, cash equivalents and short-term investments
Affirming 2022 guidance for combined net product revenues of $105M - $120M, $50M in synergies, 2022 year-end cash balance of $90M-$110M, and cash flow breakeven by year-end 2023
Hosting 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 today announced financial results for the first quarter and recent highlights.
“We had another very good quarter in 1Q 2022 with continued increases in patients on Gvoke and Keveyis. In addition to this growth, we launched Recorlev and Gvoke Kit, and we added considerable cash to our balance sheet during the first three months of the year,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “Our first quarter performance gives us confidence that we can achieve our 2022 revenue and year-end cash guidance and achieve cash flow breakeven by year-end 2023. We look forward to continuing our steady and strong execution across our commercial products and advancement of our development pipeline.”
First Quarter Highlights and Upcoming Events
Gvoke®: First quarter 2022 prescriptions topped 30,000 for the first time, growing more than 88% compared to the same period in 2021. Gvoke’s market share of the retail TRx glucagon market grew to approximately 22% at the end of April. In March, Xeris launched Gvoke® Kit, the first ready-to-use liquid glucagon in a single dose vial and syringe kit for rescue.
Keveyis®: The number of patients on Keveyis increased 12% from the same period in 2021.
Recorlev®: In February 2022, Xeris launched Recorlev and is 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.
In January, 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.
In March, Xeris entered into a senior secured term loan agreement with Hayfin Capital Management LLP to provide the Company with $150.0 million. At closing, 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 for the Company to draw until March 2023.
Xeris will participate at the H. C. Wainwright Global Investment Conference, May 23-26, in Miami
Xeris will present data at the AACE Annual Meeting, May 12-14, in San Diego and at ISPOR 2022, May 15-18, in Washington DC
First Quarter 2022 Financial Results
Net product revenue increased by $13.9 million or 172% for the three months ended March 31, 2022 compared to March 31, 2021. The increase was the result of higher sales of Gvoke and sales attributable to the products, Keveyis and Recorlev, that we acquired in Q4, 2021. On a pro forma basis, net product revenue increased 33% or $5.5 million for the three months ended March 31, 2022 compared to March 31, 2021. This increase was driven by higher sales of Gvoke, Keveyis and the launch of Recorlev.
Cost of goods sold increased by $4.4 million or 244% for the three months ended March 31, 2022 compared to March 31, 2021. An increase in sales and product mix comprised $3.1 million and $0.8 million of the change.
Research and development expenses increased by $2.2 million or 55% for the three months ended March 31, 2022 compared to March 31, 2021. Higher pharmaceutical process development and clinical service costs accounted for $2.0 million of the increase for the three months ending March 31, 2022.
Selling, general and administrative expenses increased by $16.8 million or 88% for the three months ending March 31, 2022 compared to March 31, 2021. We incurred $11.5 million of increased commercial-related costs, including an increase to our sales force and increased commercial support for Gvoke, Keveyis and the launch of Recorlev. In addition, $2.3 million of the increase related to the acquisition of Strongbridge, primarily restructuring and related employee costs. The remaining change was due to an increase in general expenses given the growth of the Company.
Net Loss for the first quarter ended March 31, 2022, was $33.7 million, or $0.25 per share, compared to a net loss of $18.4 million, or $0.30 per share, for the same period in 2021.
Cash, cash equivalents, and short-term investments at March 31, 2022 was $132.1 million compared to $102.4 million at December 31, 2021. Total shares outstanding at April 30, 2022 was 135,530,756.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Wednesday, May 11, 2022, at 8:30 a.m. Eastern Time. To pre-register for the conference call please use this link: www.incommglobalevents.com/registration/q4inc/10525/xeris-biopharma-first-quarter-2022-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 Wednesday, May 25, 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: 723527. 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.