Xeris Biopharma Sues Torrent Pharmaceuticals for Patent Infringement
Xeris Biopharma's subsidiaries Xeris Pharmaceuticals and Strongbridge Dublin have filed a patent infringement lawsuit under the Hatch-Waxman Act related to Recorlev in the U.S. District Court for the District of New Jersey against Torrent Pharmaceuticals and Somerset Therapeutics, each of which filed an Abbreviated New Drug Application, or ANDA, with the FDA seeking approval to manufacture, use or sell a generic version of Recorlev. Xeris's complaint seeks an injunction to prevent the manufacture, use, and sale of a generic version of Recorlev by each ANDA Filer until the expiration of Xeris's patents in March 2040. Each ANDA Filer alleged that the four patents covering Recorlev that are listed in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations", scheduled to expire in March 2040, are invalid, unenforceable, or will not be infringed by the respective ANDA Filer's commercial manufacture, use, or sale of the generic levoketoconazole product described in its ANDA submission. Xeris intends to enforce and defend its intellectual property rights relating to Recorlev.
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- Significant Revenue Growth: Xeris Biopharma reported a 43% year-over-year increase in net product revenue for Q1, exceeding $82 million, primarily driven by Recorlev's nearly doubled revenue of $49.8 million, indicating strong market performance and growth potential.
- Guidance Revision Upwards: Management raised the 2026 revenue guidance to a range of $380 million to $390 million due to robust demand for Recorlev, reflecting confidence in future performance and positioning the company favorably in a competitive market.
- Increased R&D and SG&A Spending: CFO highlighted expected increases in R&D expenses by approximately $25 million year-over-year and SG&A expenses by about $45 million, indicating the company's commitment to investing in product development and market expansion to support future growth.
- Gvoke Performance Weakness: Despite overall strong results, Gvoke's revenue fell slightly below expectations due to Medicare policy changes, with management anticipating a recovery in the coming months, demonstrating the company's sensitivity to market dynamics and its ability to adapt.
- Profitability Improvement: Xeris Pharmaceuticals reported a Q1 GAAP EPS of $0.01, beating expectations by $0.02, indicating a significant enhancement in profitability and reflecting the effectiveness of its business model.
- Significant Revenue Growth: The company achieved revenues of $82 million in Q1, a 36.4% year-over-year increase, surpassing expectations by $2.01 million, demonstrating strengthened market competitiveness, particularly in the successful expansion of Recorlev.
- Expense Increase: Selling, general, and administrative expenses rose by $9.1 million or 21% year-over-year, primarily due to higher personnel-related costs to support commercial operations, which may impact margins in the short term but lays the groundwork for long-term growth.
- Net Income Turnaround: The net income for Q1 was $2.2 million, compared to a net loss of $9.2 million in the same period last year, showcasing a significant improvement in the company's financial health and boosting investor confidence in future growth.
- Earnings Announcement: Xeris Pharmaceuticals is set to release its Q1 2023 earnings on May 7 before market open, with consensus EPS estimated at -$0.00 and revenue projected at $79.99 million, reflecting a 33.1% year-over-year growth potential.
- Earnings Estimate Changes: Over the last three months, Xeris has seen no upward revisions and one downward revision in EPS estimates, while revenue estimates have experienced one upward and two downward revisions, indicating mixed market sentiment regarding the company's future performance.
- Growth Projections: Xeris targets over 30% revenue growth in 2026, suggesting that its strategic investments in Recorlev and advancements in XP-8121 could yield significant financial returns, enhancing its market position.
- Industry Conference Participation: Xeris Biopharma presented at the Barclays 28th Annual Global Healthcare Conference, increasing market interest in its drug portfolio potential and demonstrating the company's active engagement and influence within the industry.
- Optimistic Revenue Guidance: Xeris Biopharma projects 2026 revenue between $375 million and $390 million, exceeding the market consensus of $368 million, reflecting the company's confidence in future growth.
- Improved Profitability: The company reported a non-GAAP EPS of $0.06 for Q4, compared to a loss of $0.03 in the same period last year, indicating a significant enhancement in profitability that boosts investor confidence.
- Strong Recorlev Sales: Sales of Recorlev (levoketoconazole) surged 100% year-over-year to approximately $45.3 million, becoming the company's best-selling therapy and driving overall revenue growth of 43% year-over-year.
- Healthy Cash Position: As of the end of 2025, the company had approximately $111 million in cash and cash equivalents, a significant increase from $71.6 million on December 31, 2026, providing ample funding for future investments.
- Financial Self-Sustainability: Xeris Biopharma achieved total revenue of $85.8 million in Q4 2025, reflecting a 43% year-over-year growth, with full-year revenue reaching $291.8 million, marking a 44% increase and indicating the company's ability to self-fund its strategy and future growth.
- Recorlev Growth Engine: Revenue from Recorlev hit $45.3 million in Q4, with over 100% growth for the year and a doubling of the patient base to approximately 700, as the commercial team was nearly doubled in January to accelerate adoption, showcasing strong market demand and expansion potential.
- Positive Future Outlook: Management projects total revenue for 2026 to be between $375 million and $390 million, representing over 30% growth at the midpoint compared to 2025, while planning to increase R&D spending by $25 million and SG&A by $45 million to support the clinical advancement of XP-8121.
- Patent Protection Measures: The company has filed a patent infringement lawsuit to protect Recorlev, holding four Orange Book-listed patents valid until 2040, demonstrating a commitment to safeguarding its intellectual property and reducing potential competitive risks.
- Earnings Beat: Xeris Pharmaceuticals reported a Q4 GAAP EPS of $0.06, exceeding expectations by $0.03, indicating ongoing improvements in profitability that bolster investor confidence.
- Significant Revenue Growth: The company achieved Q4 revenue of $85.81 million, a 42.8% year-over-year increase, although it fell short of the $85.99 million consensus, reflecting strong demand for its products and increasing market recognition.
- 2026 Revenue Guidance: Xeris provided a revenue guidance range of $375 million to $390 million for 2026, which is below the $368 million consensus, yet demonstrates the company's confidence in future growth, potentially attracting long-term investor interest.
- Optimistic Market Outlook: Despite facing a rating downgrade, Xeris Pharmaceuticals shows a positive market outlook with strong momentum for its Recorlev product and pipeline opportunities, which may support future performance growth.






