Xeris Biopharma Holdings Inc (NASDAQ:XERS) posted record revenue growth for the fourth quarter and full-year 2022 and has issued bullish 2023 financial guidance.
In the results statement, Paul R. Edick, chairman and CEO of Xeris Biopharma said: “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.”
He added: "We enter 2023 well positioned to capitalize on that momentum with the continued growth of our commercial products, additional revenue from existing and potentially new partnerships and collaborations, advancement of our levothyroxine clinical program, and the continuing disciplined management of our cash.
“These key factors give us confidence that we are on track to achieve cash flow breakeven by year-end and position us to deliver continued growth and become a self-sustaining enterprise that does not require us to raise new capital to fund operations.”
READ: Xeris Biopharma sees FDA grant Orphan-drug exclusivity to Recorlev for treatment of Cushing's syndrome
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.
Looking at the performances of Xeris' commercial products, Gvoke posted fourth-quarter 2022 net revenue of $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, the company noted.
For full-year 2022, Gvoke net revenue was $52.5 million, a 35% increase when compared to full-year 2021. Total Gvoke prescriptions grew to over 145,000, or 54%, in 2022 compared to 2021, with the growth in product demand partially offset by a decrease in net pricing.
Keveyis saw fourth-quarter net revenue of $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. Keveyis net revenue was $49.3 million for full-year 2022, an increase of 23% from the same period ended December 31, 2021, on a pro forma basis, driven by an increase in patient demand and 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. Recorlev has posted net revenue of $7.4 million since its commercial launch in Q1 2022.
Xeris recently announced that the US Food and Drug Administration (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.
Overall, Xeris reported a net loss for the three months ended December 31, 2022, of $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.
The company had cash, cash equivalents, and short-term investments as at December 31, 2022, of $122.0 million compared to $102.4 million as at December 31, 2021.
2023 Financial Guidance
For full-year 2023, Xeris' financial guidance consists of:
- Combined total revenue for Gvoke, Keveyis, Recorlev, and other 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
Xeris said it will host a conference call and webcast today, Wednesday, March 8, 2023 at 8.30am Eastern Time. To pre-register for the call, interested parties can use the following link: https://www.netroadshow.com/events/login?show=f5b64cf1&confId=46221
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; all other locations: +44 204 525 0658; Access Code: 047278.
To join the webcast, interested parties can visit ‘Events’ on investor relations page of the company’s website at www.xerispharma.com or use this link: https://events.q4inc.com/attendee/393793349
Xeris, headquartered in Chicago, Illinois, is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing differentiated and innovative products across a range of therapies.
The company also 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.
Contact the author at jon.hopkins@proactiveinvestors.com