10-K: Xeris Biopharma Achieves First Profit, Boosted by Recorlev

Xeris Biopharma Holdings, Inc. reported its first net income since inception in 2025, driven by strong growth in Recorlev sales and overall revenue increase.

Summary

• Xeris Biopharma Holdings, Inc. is a commercial-stage biopharmaceutical company focused on chronic endocrine and neurological diseases in the United States.
• The company achieved a net income of $0.6 million for the fiscal year ended December 31, 2025, marking its first profitable year since inception, compared to net losses of $54.8 million in 2024 and $62.3 million in 2023.
• Total revenue increased by 43.7% to $291.8 million in 2025 from $203.1 million in 2024.
• Recorlev net revenue surged by 116.7% to $139.3 million in 2025, primarily due to increased patient demand.
• Gvoke net revenue increased by 13.6% to $94.1 million in 2025, driven by favorable net pricing and higher volume.
• Keveyis net revenue decreased by 3.8% to $47.6 million in 2025, mainly due to unfavorable net pricing, partially offset by higher volume.
• Research and development expenses increased by 21.9% to $31.2 million in 2025, with pipeline-specific expenses rising by 39.4%.
• Selling, general and administrative expenses increased by 11.6% to $182.4 million in 2025, primarily due to personnel costs supporting commercial expansion.
• The company's lead pipeline product, XP-8121 (once-weekly subcutaneous levothyroxine), is Phase 3-ready, with a Phase 3 clinical trial planned for 2026, targeting a $1.0 to $3.0 billion peak net sales opportunity.
• As of December 31, 2025, the accumulated deficit was $671.3 million, a reduction from $671.9 million in 2024.
• The company has $200.0 million in term loans outstanding under its Amended and Restated Credit Agreement as of December 31, 2025, maturing on March 5, 2029, or potentially January 15, 2028, if certain conditions regarding 2028 Convertible Notes are not met.
• A patent infringement lawsuit was filed on February 26, 2026, against Torrent Pharmaceuticals Limited and Somerset Therapeutics, LLC, regarding generic versions of Recorlev, triggering a 30-month stay on FDA approval for the generic ANDAs.

Sentiment

Score: 7

Explanation: StockSavvy.ai views this as a positive development, with the company achieving its first net income and strong revenue growth, particularly from Recorlev. However, ongoing generic competition for Keveyis and the need for future capital to fund pipeline development and commercialization temper the overall sentiment.

Positives

• Achieved first net income of $0.6 million in 2025 since inception, indicating a significant turnaround in financial performance.
• Total revenue increased substantially by 43.7% year-over-year to $291.8 million in 2025.
• Recorlev net revenue grew by an impressive 116.7% to $139.3 million, driven by increased patient demand.
• Gvoke net revenue increased by 13.6% to $94.1 million, benefiting from favorable net pricing and higher volume.
• XP-8121, a once-weekly subcutaneous levothyroxine, is Phase 3-ready with a planned trial in 2026, targeting a significant market opportunity of $1.0 to $3.0 billion in peak net sales.
• Positive topline Phase 1 data for XP-8121 showed slower absorption, lower peak plasma, and higher extended exposure compared to oral levothyroxine, with weekly SC doses suggesting a 4x dose conversion factor.
• Phase 2 study for XP-8121 confirmed the 4x dose conversion factor and showed higher treatment satisfaction and strong patient preference (72%) for subcutaneous administration.
• FDA agreed with the proposal to conduct a single non-inferiority efficacy trial for XP-8121, streamlining the path to potential approval.
• Successfully reduced the accumulated deficit from $671.9 million in 2024 to $671.3 million in 2025.
• Net cash provided by operating activities was $28.6 million in 2025, a significant improvement from $37.0 million used in 2024.
• Maintained effective internal control over financial reporting as of December 31, 2025, as attested by independent auditors.

Negatives

• Keveyis net revenue decreased by 3.8% to $47.6 million in 2025, primarily due to unfavorable net pricing and competition from generic versions.
• Orphan drug exclusivity for Keveyis expired in August 2022, leading to the approval of generic versions by Torrent Pharmaceuticals Ltd. in 2022 and Rising Pharmaceuticals in 2025, which will likely continue to erode sales.
• The company has a history of operating losses and an accumulated deficit of $671.3 million as of December 31, 2025, despite achieving net income in 2025.
• Reliance on a relatively small number of major customers (four customers accounted for over 90% of gross product revenue and trade accounts receivable in 2025) poses a concentration risk.
• The 2029 Loans will mature on January 15, 2028, if the 2028 Convertible Notes are outstanding and certain conditions regarding extension or sufficient cash for redemption are not met, creating a potential accelerated maturity risk.
• Interest and other income decreased by 10.9% in 2025 due to a decline in interest rates.
• The company may incur net losses in the near term as it continues marketing, R&D, and public company operations, with increased cost of borrowing due to higher interest rates.

Risks

• Limited operating history and experience commercializing pharmaceutical products, with significant losses since inception.
• Inability to achieve or sustain profitability in the future and potential need for additional funding, which may cause dilution to stockholders or not be available on favorable terms.
• Business depends entirely on the commercial success of products and product candidates, which may not be accepted in the marketplace.
• Operating in a competitive business environment with larger, more resourced competitors, which may adversely impact revenue and commercialization efforts.
• Inability to establish or maintain sufficient marketing, sales, and distribution capabilities or acceptable third-party agreements.
• Reliance on third-party suppliers, including single-source suppliers, for manufacturing and key materials, leading to potential supply disruptions, delays, or increased costs.
• Reimbursement decisions by third-party payors and consolidation within the healthcare industry may adversely affect pricing and market acceptance.
• Clinical failure may occur at any stage of clinical development, potentially delaying or preventing marketing approval and incurring additional costs.
• Products and product candidates may have undesirable side effects, leading to delayed approval, safety warnings, market withdrawal, or limited sales.
• Failure to successfully identify, develop, and market additional product candidates, or acquire/collaborate on new candidates, could impair growth.
• Inability to protect intellectual property and proprietary formulation science, or the ability of collaborators to do so.
• Stock price volatility, leading to potential loss of investment.
• Data collection and processing activities are governed by restrictive regulations, including cross-border transfer of personal information, posing compliance challenges.
• Potential for greater than expected product returns exceeding reserves, impacting revenue and operating results.
• Complex commercial terms in material agreements could result in litigation or liability.
• Disruptions at regulatory authorities (FDA, SEC) could hinder timely review and approval of products.
• Loss of key senior management or inability to attract and retain other key employees and consultants.
• Dilutive effect from conversion of 2028 Convertible Notes or other convertible securities.
• No anticipated cash dividends in the foreseeable future, relying on stock price appreciation for investor returns.
• Inability to utilize a significant portion of net operating loss carryforwards and research and development tax credit carryforwards due to ownership changes or limitations.
• Changes in tax law, such as the OBBBA Act, may adversely affect the company or investors.
• Provisions in indenture for 2028 Convertible Notes and corporate charter documents may prevent or frustrate attempts by stockholders to change management or acquire a controlling interest.
• Bylaws designate specific courts as sole and exclusive forums for certain actions, potentially limiting stockholders' ability to obtain favorable judicial forums.
• Significant disruptions in information technology systems, including cybersecurity incidents, could adversely affect business.
• Products liability lawsuits could harm business and require payment of damages exceeding insurance coverage.
• Failure to maintain an effective system of internal control over financial reporting could lead to inaccurate financial reporting or fraud.
• Increased costs associated with corporate governance requirements as a public company, especially after ceasing to qualify as an 'emerging growth company' and 'smaller reporting company'.
• Inaccurate or unfavorable research reports by securities analysts, or lack of coverage, could cause stock price decline.
• Artificial intelligence presents risks and challenges, including security risks, data privacy, and intellectual property concerns.
• Employees, independent contractors, consultants, collaborators, CMOs, and CROs may engage in misconduct or improper activities, leading to liability and reputational harm.
• Global economic uncertainty and weakening product demand caused by political instability, changes in trade agreements, and conflicts (e.g., Israel and Hamas) could adversely affect business and financial performance.
• Operations are subject to effects of fluctuating inflation and interest rates.
• Cash held at financial institutions may exceed federally-insured limits, posing risk in case of bank failure.

Future Outlook

The company expects to continue incurring significant operating expenses for commercialization of its approved products and research and development of pipeline candidates, potentially leading to net losses in the near term. Future capital requirements will depend on commercial success, clinical trial outcomes, regulatory actions, and competitive landscape. The company plans to initiate a Phase 3 clinical trial for XP-8121 in 2026 and continues to pursue formulation and development partnerships to broaden revenue streams. The implementation of the Inflation Reduction Act and other legislative proposals, including potential MFN pricing models, could impact future revenues and profitability. The company believes its cash resources are sufficient for at least the next twelve months based on current operating plans.

Management Comments

• Our top priority is maximizing the potential of our three commercial products: Recorlev, Gvoke, and Keveyis.
• We believe Recorlev represents a significant commercial opportunity in the United States, with the potential to generate approximately $1 billion in annual net revenue at peak penetration.
• We estimate that more than 14 million people in the United States are at heightened risk of severe hypoglycemia and should have a ready-to-use glucagon product like the Gvoke HypoPen with them at all times, with an estimated total addressable market of approximately $5.0 billion.
• The estimated total addressable market for Keveyis is greater than $0.5 billion in the United States.
• We plan to initiate a Phase 3 clinical trial of XP-8121 in 2026, with an estimated total addressable market for this therapy of 3-5 million patients or more in the United States, which we estimate is a $1.0 to $3.0 billion peak net sales opportunity.
• We believe that our novel approach to treatment (XP-8121) has the potential to establish a new standard of care for hypothyroidism.
• We believe our long-term success depends on, among other things, our ability to continue to hire and retain highly qualified talent across all departments in our organization, as we expand the commercialization of our products.
• Management believes that our internal control over financial reporting is effective as of December 31, 2025.

Industry Context

StockSavvy.ai notes that Xeris Biopharma's focus on rare endocrine and neurological diseases aligns with a broader industry trend towards specialized therapies, which often command premium pricing and benefit from orphan drug designations. The company's proprietary XeriSol and XeriJect formulation technologies represent a strategic advantage in improving drug delivery, a key differentiator in a competitive biopharmaceutical landscape. The increasing competition from generic versions of products like Keveyis highlights the ongoing challenge for specialty pharma companies to maintain market exclusivity and pricing power post-patent expiration. The industry is also grappling with evolving regulatory scrutiny on drug pricing and the potential impact of new legislation like the Inflation Reduction Act and proposed MFN pricing models, which could significantly alter revenue streams for U.S.-centric companies.

Comparison to Industry Standards

• Recorlev competes with Korlym (mifepristone) by Corcept Therapeutics, Signifor (pasireotide) and Isturisa (osilodrostat) by Recordati Rare Diseases Inc., and off-label ketoconazole, metyrapone, and mitotane. Corcept is also developing relacorilant (Phase 3).
• Gvoke competes with other ready-to-use glucagon products such as Baqsimi (Amphastar's intranasal glucagon dry powder) and Zegalogue (Zealand Pharma's dasiglucagon auto-injector), as well as traditional emergency glucagon kits from Fresenius Kabi and generic manufacturers.
• Keveyis faces direct competition from generic dichlorphenamide, with Torrent Pharmaceuticals Ltd. launching a generic in 2022 and partnering with Cycle Pharmaceuticals Ltd. to launch Ormalvi in May 2024. Rising Pharmaceuticals also received FDA approval for a generic in November 2025. Acetazolamide and potassium supplements are also used off-label for PPP.
• The company's R&D spending of $31.2 million in 2025, while increased, is relatively modest compared to large pharmaceutical companies, reflecting its focus on leveraging existing commercial capabilities and proprietary formulation technologies for pipeline development rather than broad-spectrum discovery.

Management Changes

Corporate Governance

Legal Proceedings

• Received Paragraph IV certification notice letters from three pharmaceutical companies seeking FDA approval to manufacture, use, or sell generic versions of Recorlev.
• Filed a patent infringement lawsuit on February 26, 2026, against Torrent Pharmaceuticals Limited and Somerset Therapeutics, LLC, alleging infringement of Recorlev's Orange Book patents (expiring March 2040).
• The lawsuit triggered an automatic 30-month stay of FDA approval for the generic ANDAs.
• The company intends to vigorously enforce and defend its intellectual property rights related to Recorlev.
• Involved in various other legal proceedings arising in the normal course of business, not expected to have a material adverse effect on financial position, results of operations, or cash flows as of December 31, 2025.

Stakeholder Impact

• **Shareholders:** Positive impact from the company achieving its first net income and strong revenue growth, potentially leading to increased stock value. However, dilution risk from future capital raises and convertible note conversions remains. Patent litigation outcomes for Recorlev will significantly influence future revenue and profitability.
• **Employees:** Continued investment in talent development, competitive compensation, and benefits aims to attract and retain key personnel, fostering a positive work environment. Stock-based compensation aligns employee interests with company success.
• **Customers (Wholesalers/Specialty Pharmacies):** Continued reliance on a small number of major customers for a high percentage of revenue creates dependency. Supply chain risks from third-party manufacturers could impact product availability.
• **Patients:** Development of XP-8121 aims to provide a new, more convenient treatment option for hypothyroidism. Commercialization of Recorlev, Gvoke, and Keveyis continues to address chronic endocrine and neurological diseases. Potential side effects and reimbursement challenges could impact patient access and experience.
• **Suppliers:** Reliance on single-source suppliers for key product components (e.g., Regis for Recorlev API, Pyramid for Gvoke drug product, SHL for Gvoke auto-injector) creates dependency and supply chain risk. The Israel-Hamas war could impact suppliers in the region.
• **Creditors:** The company's ability to meet debt obligations depends on continued profitability and access to capital. The potential for accelerated maturity of 2029 Loans if conditions for 2028 Convertible Notes are not met poses a risk.

Next Steps

• Initiate a Phase 3 clinical trial of XP-8121 in 2026.
• Continue pursuing formulation and development partnerships to apply XeriSol and XeriJect technologies.
• Vigorously enforce and defend intellectual property rights related to Recorlev against generic challenges.
• Monitor and adapt to evolving healthcare laws and regulations, including those related to drug pricing and AI use.
• Continue efforts to hire and retain highly qualified talent across all departments.

Key Dates

Recommendation

Xeris Biopharma's achievement of its first net income and robust revenue growth, particularly from Recorlev, is a significant positive indicator. The advancement of XP-8121 into Phase 3 with FDA alignment presents a substantial future growth opportunity. However, the company faces ongoing challenges including declining Keveyis revenue due to generic competition, the inherent risks and capital intensity of biopharmaceutical R&D, and the uncertainty of patent litigation outcomes for Recorlev. While the financial turnaround is encouraging, these headwinds and the need for future financing suggest a 'hold' recommendation, as the stock's future performance will heavily depend on successful execution of its pipeline, effective defense of its intellectual property, and navigating a complex regulatory and competitive landscape.

Keywords

Biopharma, Endocrine diseases, Neurological diseases, Recorlev, Cushing's syndrome, Gvoke, Severe hypoglycemia, Keveyis, Primary Periodic Paralysis, XP-8121, Levothyroxine, Hypothyroidism, XeriSol, XeriJect, Drug delivery, Orphan drug, SEC filing, 10-K, Financial results, Patent litigation, Generic competition, Biotechnology, Pharmaceuticals, Clinical trials, Regulatory approval, Commercialization, Capital resources, Debt financing, Stock options, Restricted stock units, Corporate governance, Cybersecurity, Healthcare reform