8-K: Xeris Biopharma Achieves Record Revenue in Q3 2024, Raises Full-Year Guidance

Xeris Biopharma reported record total revenue of $54.3 million in the third quarter of 2024, driven by strong product sales, and raised its full-year revenue guidance.

Summary

• Xeris Biopharma announced its financial results for the third quarter and nine months ended September 30, 2024.
• The company achieved record total revenue of $54.3 million in Q3, including record product revenue of $52.9 million.
• Product revenue increased by 27% compared to the same quarter last year and 14% compared to the previous quarter.
• Gvoke revenue increased by 29% year-over-year to $22.9 million, with prescriptions topping 70,000 for the first time.
• Recorlev revenue saw a significant increase of 119% year-over-year to $17.7 million, driven by a 125% increase in the average number of patients on therapy.
• Keveyis revenue decreased by 23% year-over-year to $12.2 million due to a reduction in patients on therapy.
• For the first nine months of 2024, total revenue reached $143 million, a 19.6% increase compared to the same period in 2023.
• The company has raised its full-year total net revenue guidance to $198-$202 million and tightened its year-end cash guidance to $68-$72 million.
• The net loss for the quarter was $15.7 million, or ($0.11) per share, and $49.7 million, or ($0.34) per share, for the nine months ended September 30, 2024.
• Excluding the impact of CEO succession plan and related restructuring costs of $6.1 million, earnings per share was ($0.06) for the quarter or ($0.30) for the year-to-date.
• Cash, cash equivalents, and short-term investments totaled $69.4 million as of September 30, 2024.

Sentiment

Score: 8

Explanation: The document conveys a positive sentiment due to record revenue, raised guidance, and strong growth in key products. However, the net loss and some revenue declines temper the overall optimism.

Positives

• The company achieved record total and product revenue in the third quarter of 2024.
• Gvoke prescriptions topped 70,000 for the first time, showing strong market demand.
• Recorlev experienced substantial growth in revenue and patient numbers.
• Xeris has raised its full-year revenue guidance, indicating confidence in future performance.
• The company's cash position remains strong at $69.4 million.
• The company has maintained a strong margin profile and is managing expenses diligently.
• The company believes it does not require any dilutive financing to fund its growth.

Negatives

• Keveyis revenue decreased by 23% year-over-year due to a reduction in patients on therapy.
• Royalty, contract and other revenue decreased significantly by 78.8% in Q3 and 61.5% year-to-date.
• The company reported a net loss of $15.7 million for the quarter and $49.7 million for the nine months ended September 30, 2024.
• Cost of goods sold increased due to a $3.6 million write-off of Gvoke components.
• Selling, general and administrative expenses increased due to CEO succession plan and related restructuring costs.

Risks

• The company's reliance on third-party suppliers, including single-source suppliers, poses a risk to its supply chain.
• The company's ability to compete successfully with existing and new drugs is a risk.
• The company's ability to protect its intellectual property and proprietary technology is a risk.
• The company's financial position and need for financing, including to fund its product development programs or commercialization efforts, is a risk.
• The company's products may not achieve and maintain market acceptance in a competitive business environment.

Future Outlook

The company expects to continue driving greater than 20% product revenue growth and advancing its pipeline, notably its Phase 3 ready, XP-8121. They have raised full year revenue guidance to $198-$202 million and tightened year-end cash guidance to $68-$72 million.

Management Comments

• We are proud to report our record-breaking quarter with total revenue of our $54 million led by strong demand of Recorlev and Gvoke.
• Our product revenue growth of 27% marks the 12th consecutive quarter of over 20% growth.
• We have made investments in areas that drive growth, notably Recorlev, and we are seeing the benefits of those investments.
• Given our exceptional year-to-date performance, we are raising our revenue guidance to $198-$202 million from the previous $190-$200 million.
• While delivering exceptional revenue growth, we held our total operating expenses relatively flat to last quarter when you exclude non-routine charges.
• We will continue to drive robust revenue growth, maintain our strong margin profile, and diligently manage expenses, which gives us confidence that the business is financially sound and does not require any dilutive financing to fund our growth.

Industry Context

The biopharmaceutical industry is highly competitive, and Xeris's performance is being driven by the demand for its key products, Gvoke and Recorlev. The company's focus on innovative therapies and its proprietary formulation technology platforms positions it for continued growth in the market.

Comparison to Industry Standards

• Xeris's 27% year-over-year product revenue growth in Q3 2024 is strong compared to many established pharmaceutical companies, which often see single-digit growth.
• Companies like Novo Nordisk and Eli Lilly, which also have glucagon products, are key competitors in the diabetes market, and Xeris's Gvoke is gaining market share.
• The 119% year-over-year growth in Recorlev revenue is exceptional, indicating strong market adoption for this treatment of endogenous Cushing's syndrome.
• The decrease in Keveyis revenue highlights the challenges of maintaining patient numbers in niche markets, which is a common issue for companies with specialized therapies.
• Xeris's focus on proprietary formulation technology platforms like XeriSol and XeriJect is similar to other innovative biopharma companies that are looking to differentiate their products and improve patient outcomes.

Management Changes

Stakeholder Impact

• Shareholders will likely react positively to the record revenue and raised guidance.
• Employees may be impacted by the CEO succession plan and related restructuring.
• Customers will benefit from the continued availability of Xeris's products.
• Suppliers may see increased demand for their products and services.
• Creditors will be reassured by the company's strong financial performance.

Next Steps

• The company will host a conference call and webcast to discuss the financial and operational results.
• The company will continue to focus on driving greater than 20% product revenue growth.
• The company will continue to advance its robust pipeline, notably its Phase 3 ready, XP-8121.

Key Dates

Keywords

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