Post by icemandios on Nov 9, 2023 13:53:45 GMT
Xeris Biopharma Reports Third Quarter 2023 Financial Results
Achieved record revenue of $48.3M – a 27% increase from prior quarter, and a 63% increase from same period prior year
Tightens full-year 2023 revenue guidance from $155M-$165M to $160M-$165M
Ended Q3 with $66.0M in cash, cash equivalents and short-term investments and remains on track to achieve cash flow breakeven in the fourth quarter
Extended maturity of approximately two-thirds of 2025 Convertible Senior Notes to 2028
Successfully formulated the prespecified target product profile of the XeriJect™ formulation of TEPEZZA®
Hosting conference call and webcast today at 8:30 a.m. ET
November 09, 2023 07:00 AM Eastern Standard Time
CHICAGO--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the third quarter and nine months ended September 30, 2023 and corporate highlights.
“We continue to demonstrate record revenue growth as we execute on our strategy. Because of this strong performance, we are further tightening our full year 2023 revenue guidance from $155 million - $165 million to $160 million - $165 million, which is at the high end of our original range,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “Due to continued disciplined expense management coupled with our strong revenue growth we are confident we will achieve cash flow breakeven in the fourth quarter.”
Third Quarter 2023 Highlights (product revenue)
Commercial Products
Gvoke®: Third quarter 2023 net revenue was $17.7 million as compared to $13.7 million in the third quarter of 2022 – an increase of approximately 30%. Gvoke prescriptions topped 58,000 for the first time, growing 52% compared to the same period in 2022. Gvoke’s market share of the retail TRx glucagon market grew to over 31% through late October.
Keveyis®: Third quarter net revenue was $15.9 million – an increase of approximately 19% compared to the same period in 2022. The average number of patients on Keveyis increased approximately 5% from the same period in 2022.
Recorlev®: Third quarter net revenue was $8.1 million – an increase of $5.6 million compared to the same period of 2022. The average number of patients on Recorlev increased over 203% from the same period in 2022.
Pipeline Program
XeriSol® levothyroxine (XP-8121): The Phase 2 clinical study is over 85% enrolled, and the study should be completed in the first half of 2024 based on the current enrollment rate.
Technology Partnerships
Horizon/Amgen: Xeris successfully formulated the prespecified target product profile of the XeriJect™ formulation of TEPEZZA® which triggered revenue of $6.0 million in the third quarter from a milestone payment under the research collaboration and option agreement with Horizon (subsequently acquired by Amgen) that was signed in November 2022. The payment was subsequently received in the fourth quarter. Amgen has the option to license the XeriJect technology to further the development of an ultra-concentrated, ready-to-use, subcutaneous injection of TEPEZZA®.
Gvoke®: Net revenue was $48.4 million for the nine months ended September 30, 2023, a 29% increase compared to prior year. Gvoke prescriptions for the first three quarters of 2023 were over 156,000 TRx’s, growing 51% compared to the same period in 2022. The growth in product demand was partially offset by a decrease in net pricing.
Keveyis®: Net revenue was $42.7 million for the nine months ended September 30, 2023, a 20% increase from last year. This increase was driven by higher patient demand and an increase in net pricing.
Recorlev®: Net revenue was $19.7 million for the nine months ended September 30,2023, a $16.1 million increase from last year, driven primarily by increases in the number of patients on therapy.
Cost of goods sold increased by $2.9 million for the three months ended September 30, 2023 compared to the same period ended September 30, 2022. The increase was mainly attributable to higher product sales. Cost of goods sold increased by $4.7 million for the nine months ended September 30, 2023 compared to the same period ended September 30, 2022. The increase was mainly attributable to higher product sales partially offset by the product mix and a one-time contract credit in the first quarter of 2023.
Research and development expenses decreased by $1.0 million for the three months ended September 30, 2023 compared to the same period ended September 30, 2022 driven by lower product development costs. Research and development expenses were flat in the nine months ended September 30, 2023 compared to the same period ended September 30, 2022.
Selling, general and administrative expenses increased by $2.8 million and $5.1 million for the three and nine months ended 2023, respectively, compared to the same periods ended September 30, 2022, due to higher personnel costs and rent expenses related to the new lease commenced in April 2023.
Net Loss was $12.2 million, or $0.09 per share, for the three months ended September 30, 2023 and a net loss of $48.9 million, or $0.36 per share, for the nine months ended September 30, 2023.
Cash, cash equivalents, and short-term investments at September 30, 2023 was $66.0 million compared to $122.0 million at December 31, 2022.
Shares outstanding at October 31, 2023 was 138,124,595.
Upcoming Events
Xeris will participate in the following investor conferences:
Jefferies London Healthcare Conference, November 14-16, 2023
14th Annual Craig-Hallum Alpha Select Conference, November 16, 2023 (1x1s only)
35th Annual Piper Sandler Healthcare Conference, November 28-30, 2023
Details of each event will be available on Xeris’ website. Contact the respective sponsor to request a 1x1 meeting.
Third Quarter Conference Call and Webcast Details
Xeris will host a conference call and webcast on Thursday, November 9, 2023 at 8:30 a.m. Eastern Time. To pre-register for the conference call, please use the following link: www.netroadshow.com/events/login?show=59946218&confId=55658. 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, November 23, 2023 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: 328140.
In addition, a live audio of the conference call will be available as a webcast. To join the webcast, please visit “Events” on the investor relations page of the Company’s website at www.xerispharma.com or use the following link: events.q4inc.com/attendee/482975153.
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. 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.
Achieved record revenue of $48.3M – a 27% increase from prior quarter, and a 63% increase from same period prior year
Tightens full-year 2023 revenue guidance from $155M-$165M to $160M-$165M
Ended Q3 with $66.0M in cash, cash equivalents and short-term investments and remains on track to achieve cash flow breakeven in the fourth quarter
Extended maturity of approximately two-thirds of 2025 Convertible Senior Notes to 2028
Successfully formulated the prespecified target product profile of the XeriJect™ formulation of TEPEZZA®
Hosting conference call and webcast today at 8:30 a.m. ET
November 09, 2023 07:00 AM Eastern Standard Time
CHICAGO--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the third quarter and nine months ended September 30, 2023 and corporate highlights.
“We continue to demonstrate record revenue growth as we execute on our strategy. Because of this strong performance, we are further tightening our full year 2023 revenue guidance from $155 million - $165 million to $160 million - $165 million, which is at the high end of our original range,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “Due to continued disciplined expense management coupled with our strong revenue growth we are confident we will achieve cash flow breakeven in the fourth quarter.”
Third Quarter 2023 Highlights (product revenue)
Commercial Products
Gvoke®: Third quarter 2023 net revenue was $17.7 million as compared to $13.7 million in the third quarter of 2022 – an increase of approximately 30%. Gvoke prescriptions topped 58,000 for the first time, growing 52% compared to the same period in 2022. Gvoke’s market share of the retail TRx glucagon market grew to over 31% through late October.
Keveyis®: Third quarter net revenue was $15.9 million – an increase of approximately 19% compared to the same period in 2022. The average number of patients on Keveyis increased approximately 5% from the same period in 2022.
Recorlev®: Third quarter net revenue was $8.1 million – an increase of $5.6 million compared to the same period of 2022. The average number of patients on Recorlev increased over 203% from the same period in 2022.
Pipeline Program
XeriSol® levothyroxine (XP-8121): The Phase 2 clinical study is over 85% enrolled, and the study should be completed in the first half of 2024 based on the current enrollment rate.
Technology Partnerships
Horizon/Amgen: Xeris successfully formulated the prespecified target product profile of the XeriJect™ formulation of TEPEZZA® which triggered revenue of $6.0 million in the third quarter from a milestone payment under the research collaboration and option agreement with Horizon (subsequently acquired by Amgen) that was signed in November 2022. The payment was subsequently received in the fourth quarter. Amgen has the option to license the XeriJect technology to further the development of an ultra-concentrated, ready-to-use, subcutaneous injection of TEPEZZA®.
Gvoke®: Net revenue was $48.4 million for the nine months ended September 30, 2023, a 29% increase compared to prior year. Gvoke prescriptions for the first three quarters of 2023 were over 156,000 TRx’s, growing 51% compared to the same period in 2022. The growth in product demand was partially offset by a decrease in net pricing.
Keveyis®: Net revenue was $42.7 million for the nine months ended September 30, 2023, a 20% increase from last year. This increase was driven by higher patient demand and an increase in net pricing.
Recorlev®: Net revenue was $19.7 million for the nine months ended September 30,2023, a $16.1 million increase from last year, driven primarily by increases in the number of patients on therapy.
Cost of goods sold increased by $2.9 million for the three months ended September 30, 2023 compared to the same period ended September 30, 2022. The increase was mainly attributable to higher product sales. Cost of goods sold increased by $4.7 million for the nine months ended September 30, 2023 compared to the same period ended September 30, 2022. The increase was mainly attributable to higher product sales partially offset by the product mix and a one-time contract credit in the first quarter of 2023.
Research and development expenses decreased by $1.0 million for the three months ended September 30, 2023 compared to the same period ended September 30, 2022 driven by lower product development costs. Research and development expenses were flat in the nine months ended September 30, 2023 compared to the same period ended September 30, 2022.
Selling, general and administrative expenses increased by $2.8 million and $5.1 million for the three and nine months ended 2023, respectively, compared to the same periods ended September 30, 2022, due to higher personnel costs and rent expenses related to the new lease commenced in April 2023.
Net Loss was $12.2 million, or $0.09 per share, for the three months ended September 30, 2023 and a net loss of $48.9 million, or $0.36 per share, for the nine months ended September 30, 2023.
Cash, cash equivalents, and short-term investments at September 30, 2023 was $66.0 million compared to $122.0 million at December 31, 2022.
Shares outstanding at October 31, 2023 was 138,124,595.
Upcoming Events
Xeris will participate in the following investor conferences:
Jefferies London Healthcare Conference, November 14-16, 2023
14th Annual Craig-Hallum Alpha Select Conference, November 16, 2023 (1x1s only)
35th Annual Piper Sandler Healthcare Conference, November 28-30, 2023
Details of each event will be available on Xeris’ website. Contact the respective sponsor to request a 1x1 meeting.
Third Quarter Conference Call and Webcast Details
Xeris will host a conference call and webcast on Thursday, November 9, 2023 at 8:30 a.m. Eastern Time. To pre-register for the conference call, please use the following link: www.netroadshow.com/events/login?show=59946218&confId=55658. 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, November 23, 2023 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: 328140.
In addition, a live audio of the conference call will be available as a webcast. To join the webcast, please visit “Events” on the investor relations page of the Company’s website at www.xerispharma.com or use the following link: events.q4inc.com/attendee/482975153.
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. 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.