Post by icemandios on Mar 8, 2023 14:03:37 GMT
Xeris Biopharma Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides 2023 Financial Guidance
Achieved fourth quarter net product revenue of $32.5M representing 52% growth compared to Q4 2021
Achieved full-year net product revenue of $109.3M representing 38% annual growth compared to 2021 on a pro forma basis
Ended 2022 with $122.0M in cash, cash equivalents, and short-term investments realizing $50M in synergies in 2022 from the Strongbridge acquisition
Announced research collaboration and option agreement with Horizon Therapeutics for XeriJect® formulation of TEPEZZA®
Provides 2023 guidance: total revenues of $135M-$165M; cash utilization from operating activities of $57M-$77M; year-end cash, cash equivalents, and short-term investments of $45M-$65M
Projects cash flow breakeven in the fourth quarter of 2023
Hosting conference call and webcast today at 8:30 a.m. ET
March 08, 2023 06:00 AM Eastern Standard Time
CHICAGO--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the fourth quarter and full-year 2022 and provided 2023 financial guidance.
“Xeris had another record-breaking quarter to finish 2022 achieving net product revenue growth of 52% compared to last year and delivering 38% full-year net product revenue growth compared to 2021 on a pro forma basis”
Fourth Quarter Highlights and Recent Events
Commercial Products
Gvoke®: Fourth quarter 2022 net revenue was $14.9 million as compared to $11.0 million in the fourth quarter of 2021, an increase of approximately 36%. Gvoke prescriptions topped 41,000 for the first time, growing more than 42% compared to the same period in 2021. Momentum has continued at the start of 2023 as Gvoke’s NRx market share of the retail glucagon market exceeded 28% at the end of February.
Keveyis®: Fourth quarter net revenue was $13.8 million, an increase of approximately 33% compared to the same period in 2021, driven by higher patient demand coupled with an increase in net pricing.
Recorlev®: Fourth quarter net revenue was $3.8 million driven primarily by increases in the number of patients on therapy. Xeris recently announced that the FDA granted orphan-drug exclusivity for Recorlev. As the first approval of levoketoconazole (Recorlev) for Cushing’s syndrome, Xeris is entitled to seven years of orphan-drug market exclusivity from its FDA approval date of December 30, 2021.
Pipeline and Partnership Programs
XeriSol® levothyroxine (XP-8121): In October, Xeris reported positive topline results from its Phase 1 study of XP-8121. Based on feedback from the FDA, the Company anticipates initiating a Phase 2 study in patients in mid-2023.
XeriJect® teprotumumab: In November, Xeris announced a research collaboration and option agreement with Horizon Therapeutics to develop an ultra-concentrated, ready-to-use, sub-cutaneous injection of teprotumumab, known as brand name TEPEZZA® in the U.S., using Xeris’ proprietary formulation technology platform, XeriJect™. Xeris received an upfront payment of $2.75 million in the fourth quarter and will be entitled to receive a payment of $6.0 million on successful achievement of the target formulation. If the commercial option is exercised by Horizon, Xeris would also be entitled to future development, regulatory and sales-based milestones, and royalties based on future sales.
Gvoke®: Net revenue was $52.5 million, a 35% increase, for the full year 2022 when compared to full year 2021. Total Gvoke prescriptions grew to over 145,000, or 54%, in 2022 compared to 2021. The growth in product demand was partially offset by a decrease in net pricing.
Keveyis®: Net revenue was $49.3 million for the full year 2022, an increase of 23% from the same period ended December 31, 2021 on a pro forma basis. This growth is driven by an increase in patient demand and an increase in net pricing.
Recorlev®: Net revenue was $7.4 million since its commercial launch in Q1 2022.
Fourth Quarter and Full-year 2022 Other Results
Cost of goods sold increased $1.4 million for the three months ended December 31, 2022, and $9.3 million for the full-year 2022. These increases when compared to the same periods in 2021 were attributable to sales growth.
Research and development expenses decreased $5.1 million for the three months ended December 31, 2022 and $4.2 million for the full-year 2022, respectively, when compared to the same periods in 2021. The decreases in both periods were primarily driven by lower overall product development costs.
Selling, general and administrative expenses decreased $19.8 million for the three months ended December 31, 2022 when compared to the same period in 2021. The decrease was primarily driven by the incremental transaction and restructuring costs of the Strongbridge acquisition in Q4 of last year.
Full-year 2022 expenses increased $12.0 million when compared to the same period in 2021. Personnel-related costs increased by $24.9 million primarily to support Keveyis, acquired in October 2021, Recorlev, launched in 2022, as well as an expansion of our Gvoke sales force. The increases were partially offset by lower transaction and restructuring costs in 2022 related to the Strongbridge acquisition when compared to 2021.
Net Loss for the three months ended December 31, 2022, was $12.9 million, or $0.10 per share, and a net loss of $94.7 million, or $0.70 per share, for the full year ended December 31, 2022.
Cash, cash equivalents, and short-term investments at December 31, 2022 was $122.0 million compared to $102.4 million at December 31, 2021. Total shares outstanding at February 28, 2023 was 137,288,602.
2023 Financial Guidance
Full-year 2023 financial guidance consists of the following:
Combined total revenue for Gvoke, Keveyis, Recorlev, and Other1 Revenue of $135 million to $165 million
Cash utilization from operating activities of $57 million to $77 million
Year-end cash, cash equivalents, and short-term investments of $45 million to $65 million
Cash flow breakeven in the fourth quarter
1 Revenues from current and/or new partnerships or collaborations
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Wednesday, March 8, 2023 at 8:30 a.m. Eastern Time.
To pre-register for the call, please go to the following link:
www.netroadshow.com/events/login?show=f5b64cf1&confId=46221
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, March 22, 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: 047278.
To join the webcast, please visit “Events” on investor relations page of the Company’s website at www.xerispharma.com or use this link: events.q4inc.com/attendee/393793349
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing differentiated and 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®, a proven therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris has a diverse pipeline of development and partnered programs using its formulation sciences, XeriSol™ and XeriJect™, to support long-term product development and commercial success.
Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on Twitter, LinkedIn, or Instagram.
Financial Tables
Achieved fourth quarter net product revenue of $32.5M representing 52% growth compared to Q4 2021
Achieved full-year net product revenue of $109.3M representing 38% annual growth compared to 2021 on a pro forma basis
Ended 2022 with $122.0M in cash, cash equivalents, and short-term investments realizing $50M in synergies in 2022 from the Strongbridge acquisition
Announced research collaboration and option agreement with Horizon Therapeutics for XeriJect® formulation of TEPEZZA®
Provides 2023 guidance: total revenues of $135M-$165M; cash utilization from operating activities of $57M-$77M; year-end cash, cash equivalents, and short-term investments of $45M-$65M
Projects cash flow breakeven in the fourth quarter of 2023
Hosting conference call and webcast today at 8:30 a.m. ET
March 08, 2023 06:00 AM Eastern Standard Time
CHICAGO--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the fourth quarter and full-year 2022 and provided 2023 financial guidance.
“Xeris had another record-breaking quarter to finish 2022 achieving net product revenue growth of 52% compared to last year and delivering 38% full-year net product revenue growth compared to 2021 on a pro forma basis”
Fourth Quarter Highlights and Recent Events
Commercial Products
Gvoke®: Fourth quarter 2022 net revenue was $14.9 million as compared to $11.0 million in the fourth quarter of 2021, an increase of approximately 36%. Gvoke prescriptions topped 41,000 for the first time, growing more than 42% compared to the same period in 2021. Momentum has continued at the start of 2023 as Gvoke’s NRx market share of the retail glucagon market exceeded 28% at the end of February.
Keveyis®: Fourth quarter net revenue was $13.8 million, an increase of approximately 33% compared to the same period in 2021, driven by higher patient demand coupled with an increase in net pricing.
Recorlev®: Fourth quarter net revenue was $3.8 million driven primarily by increases in the number of patients on therapy. Xeris recently announced that the FDA granted orphan-drug exclusivity for Recorlev. As the first approval of levoketoconazole (Recorlev) for Cushing’s syndrome, Xeris is entitled to seven years of orphan-drug market exclusivity from its FDA approval date of December 30, 2021.
Pipeline and Partnership Programs
XeriSol® levothyroxine (XP-8121): In October, Xeris reported positive topline results from its Phase 1 study of XP-8121. Based on feedback from the FDA, the Company anticipates initiating a Phase 2 study in patients in mid-2023.
XeriJect® teprotumumab: In November, Xeris announced a research collaboration and option agreement with Horizon Therapeutics to develop an ultra-concentrated, ready-to-use, sub-cutaneous injection of teprotumumab, known as brand name TEPEZZA® in the U.S., using Xeris’ proprietary formulation technology platform, XeriJect™. Xeris received an upfront payment of $2.75 million in the fourth quarter and will be entitled to receive a payment of $6.0 million on successful achievement of the target formulation. If the commercial option is exercised by Horizon, Xeris would also be entitled to future development, regulatory and sales-based milestones, and royalties based on future sales.
Gvoke®: Net revenue was $52.5 million, a 35% increase, for the full year 2022 when compared to full year 2021. Total Gvoke prescriptions grew to over 145,000, or 54%, in 2022 compared to 2021. The growth in product demand was partially offset by a decrease in net pricing.
Keveyis®: Net revenue was $49.3 million for the full year 2022, an increase of 23% from the same period ended December 31, 2021 on a pro forma basis. This growth is driven by an increase in patient demand and an increase in net pricing.
Recorlev®: Net revenue was $7.4 million since its commercial launch in Q1 2022.
Fourth Quarter and Full-year 2022 Other Results
Cost of goods sold increased $1.4 million for the three months ended December 31, 2022, and $9.3 million for the full-year 2022. These increases when compared to the same periods in 2021 were attributable to sales growth.
Research and development expenses decreased $5.1 million for the three months ended December 31, 2022 and $4.2 million for the full-year 2022, respectively, when compared to the same periods in 2021. The decreases in both periods were primarily driven by lower overall product development costs.
Selling, general and administrative expenses decreased $19.8 million for the three months ended December 31, 2022 when compared to the same period in 2021. The decrease was primarily driven by the incremental transaction and restructuring costs of the Strongbridge acquisition in Q4 of last year.
Full-year 2022 expenses increased $12.0 million when compared to the same period in 2021. Personnel-related costs increased by $24.9 million primarily to support Keveyis, acquired in October 2021, Recorlev, launched in 2022, as well as an expansion of our Gvoke sales force. The increases were partially offset by lower transaction and restructuring costs in 2022 related to the Strongbridge acquisition when compared to 2021.
Net Loss for the three months ended December 31, 2022, was $12.9 million, or $0.10 per share, and a net loss of $94.7 million, or $0.70 per share, for the full year ended December 31, 2022.
Cash, cash equivalents, and short-term investments at December 31, 2022 was $122.0 million compared to $102.4 million at December 31, 2021. Total shares outstanding at February 28, 2023 was 137,288,602.
2023 Financial Guidance
Full-year 2023 financial guidance consists of the following:
Combined total revenue for Gvoke, Keveyis, Recorlev, and Other1 Revenue of $135 million to $165 million
Cash utilization from operating activities of $57 million to $77 million
Year-end cash, cash equivalents, and short-term investments of $45 million to $65 million
Cash flow breakeven in the fourth quarter
1 Revenues from current and/or new partnerships or collaborations
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Wednesday, March 8, 2023 at 8:30 a.m. Eastern Time.
To pre-register for the call, please go to the following link:
www.netroadshow.com/events/login?show=f5b64cf1&confId=46221
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, March 22, 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: 047278.
To join the webcast, please visit “Events” on investor relations page of the Company’s website at www.xerispharma.com or use this link: events.q4inc.com/attendee/393793349
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing differentiated and 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®, a proven therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris has a diverse pipeline of development and partnered programs using its formulation sciences, XeriSol™ and XeriJect™, to support long-term product development and commercial success.
Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on Twitter, LinkedIn, or Instagram.
Financial Tables