8-K: Xeris Biopharma Reports Strong Q2 2024 Results, Tightens Full-Year Guidance

Xeris Biopharma announced a strong second quarter with record product revenue, leading to tightened full-year revenue and cash guidance.

Summary

• Xeris Biopharma reported total revenue of $48.1 million for the second quarter of 2024, which includes a record $46.5 million in product revenue.
• Total revenue increased by 18% compared to the previous quarter and 26% compared to the same period last year.
• The company's product revenue growth has been over 20% for the eleventh consecutive quarter.
• Gvoke net revenue was $20.0 million, a 28% increase year-over-year, with prescriptions topping 65,000 for the first time.
• Keveyis net revenue was $13.1 million, a 7% decrease year-over-year due to generic competition, but unchanged from the first quarter of 2024.
• Recorlev net revenue was $13.3 million, an 86% increase compared to the second quarter of 2023, with a 124% increase in the average number of patients on the therapy.
• For the first six months of 2024, total revenue was $88.7 million, a 24.6% increase year-over-year.
• The company has tightened its full-year 2024 revenue guidance to $190-$200 million and year-end cash balance guidance to $60-$75 million.
• The net loss for the second quarter was $15.0 million, or $0.10 per share, and $34.0 million, or $0.24 per share, for the first six months of 2024.
• Cash, cash equivalents, and short-term investments totaled $77.6 million at the end of June 2024.

Sentiment

Score: 8

Explanation: The document conveys a positive sentiment due to strong revenue growth, record product sales, and tightened guidance. The appointment of a new CEO and promotion of a President and COO also contribute to a positive outlook. However, the net loss and impact of generic competition on Keveyis temper the overall sentiment.

Positives

• The company achieved record product revenue in the second quarter of 2024.
• Total revenue showed strong growth both year-over-year and compared to the previous quarter.
• Gvoke prescriptions and market share continue to increase significantly.
• Recorlev demonstrated substantial revenue growth and increased patient adoption.
• The company has tightened its full-year revenue and cash guidance, indicating confidence in future performance.
• The appointment of a new CEO and promotion of a President and COO suggests a stable leadership transition.
• The collaboration with Beta Bionics expands the potential applications of Xeris' glucagon product.

Negatives

• Keveyis revenue decreased by 7% year-over-year due to generic competition.
• The company reported a net loss of $15.0 million for the second quarter and $34.0 million for the first six months of 2024.
• Selling, general and administrative expenses increased by $2.4 million and $7.1 million for the three and six months ended 2024, respectively, compared to the same periods ended June 30, 2023, due to higher personnel costs.

Risks

• The company faces generic competition for Keveyis, which is impacting revenue.
• The company is still operating at a loss, which may require additional financing in the future.
• The company's future performance is subject to various risks, including market acceptance of its products, reliance on third-party suppliers, and the ability to protect its intellectual property.
• The company's financial position and need for financing could impact its product development programs or commercialization efforts.

Future Outlook

The company has tightened its full-year 2024 revenue guidance to $190-$200 million and year-end cash balance guidance to $60-$75 million, indicating a positive outlook for the remainder of the year.

Management Comments

• I am very pleased to report that we posted an outstanding quarter of $48 million in total revenue, which included record product revenue of over $46 million driven by strong demand for all three of our products, said John Shannon, CEO of Xeris Biopharma.
• Our strong performance leads us to now envision full year results at the high end of our original range, and were tightening our guidance to $190-$200 million from the previous $175-$200 million.
• We also believe that this performance will enable us to perform at the higher end of our year-end cash range, so were tightening that guidance to $60-$75 million.
• This is an exciting time for Xeris, and Im thrilled to be leading as CEO for the next phase of our journey building upon the strong foundation weve created to drive our revenues and pipeline to new heights.

Industry Context

The results indicate strong performance in the biopharmaceutical sector, particularly in the areas of rare diseases and metabolic disorders. The growth of Gvoke in the glucagon market and Recorlev in the Cushings syndrome market highlights the company's ability to capture market share and address unmet medical needs. The generic competition impacting Keveyis is a common challenge in the pharmaceutical industry.

Comparison to Industry Standards

• Xeris' 26% year-over-year revenue growth is strong compared to many established pharmaceutical companies, which often see single-digit growth.
• The 86% growth in Recorlev revenue is particularly impressive, indicating strong market adoption and potential for continued growth.
• The 28% growth in Gvoke revenue and 27% growth in prescriptions demonstrates a strong market position in the glucagon space, competing with other glucagon products such as Eli Lilly's Baqsimi.
• The impact of generic competition on Keveyis is a common challenge faced by pharmaceutical companies after patent expiration, similar to what companies like Teva and Mylan have experienced with their generic products.
• The company's cash position of $77.6 million is relatively modest compared to larger biopharma companies, but the tightened guidance suggests confidence in managing cash flow.

Management Changes

Stakeholder Impact

• Shareholders will likely react positively to the strong revenue growth and tightened guidance.
• Employees may be encouraged by the company's positive performance and leadership changes.
• Customers will benefit from the continued availability of Xeris' products.
• Suppliers may see increased demand for their products and services.
• Creditors may view the company's improved financial outlook favorably.

Next Steps

• The company will host a conference call and webcast to discuss the financial and operational results.
• Members of the senior management team will be participating in several investor conferences in September.
• The company anticipates an end-of-Phase 2 meeting with the FDA before year-end for XeriSol levothyroxine (XP-8121).

Key Dates

Keywords

Xeris Biopharma, Gvoke, Recorlev, Keveyis, biopharmaceutical, revenue, financial results, glucagon, hypoglycemia, Cushings syndrome, periodic paralysis