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What changed in Xeris Biopharma Holdings, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Xeris Biopharma Holdings, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+417 added−351 removedSource: 10-K (2026-03-02) vs 10-K (2025-03-06)

Top changes in Xeris Biopharma Holdings, Inc.'s 2025 10-K

417 paragraphs added · 351 removed · 288 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

85 edited+24 added−14 removed277 unchanged
Biggest changeThe auto-injector used to deliver drug product in Gvoke HypoPen is a proprietary multi-product device platform developed by SHL Medical AG and SHL Pharma, LLC (collectively "SHL"). SHL produces device sub-assemblies at its facility in Taiwan and performs final drug product/device assembly operations at its facility in Florida. We have entered into a supply agreement with SHL.
Biggest change("Pyramid") has been actively involved in the development and manufacturing of Gvoke. Its facility in California is our primary source for drug product. We have entered into a non-exclusive supply agreement with Pyramid. The auto-injector used to deliver drug product in Gvoke HypoPen is a proprietary multi-product device platform developed by SHL Medical AG and SHL Pharma, LLC (collectively "SHL").
In addition, our efforts include the support of a single, highly experienced specialty pharmacy that provides logistical assistance in the securing of coverage from third-party payors and then subsequent distribution of Recorlev to the patients. Gvoke Gvoke is our ready-to-use, room-temperature stable, liquid glucagon product.
In addition, our efforts include the support of a single, highly experienced specialty pharmacy that provides logistical assistance in the securing of coverage from third-party payors and then subsequent distribution of Recorlev to patients. Gvoke Gvoke is our ready-to-use, room-temperature stable, liquid glucagon product.
Our most widely prescribed presentation, HypoPen, is designed to be administered subcutaneously in a simple two-step process requiring no dose calibration. Gvoke has patent protection through 2036.
Our most widely prescribed presentation, Gvoke HypoPen, is designed to be administered subcutaneously in a simple two-step process requiring no dose calibration. Gvoke has patent protection through 2036.
When an entity is determined to have violated the FCA, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs; the anti-inducement law prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of items or services reimbursable by a federal or state governmental program; 20 Table of Contents the federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 ("HITECH") and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates, independent contractors or agents of covered entities, that perform services for them that involve the creation, maintenance, receipt, use, or disclosure of, individually identifiable health information relating to the privacy, security and transmission of individually identifiable health information.
When an entity is determined to have violated the FCA, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs; the anti-inducement law prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of items or services reimbursable by a federal or state governmental program; 21 Table of Contents the federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 ("HITECH") and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates, independent contractors or agents of covered entities, that perform services for them that involve the creation, maintenance, receipt, use, or disclosure of, individually identifiable health information relating to the privacy, security and transmission of individually identifiable health information.
Among the provisions of the ACA of greatest importance to the pharmaceutical industry are that the ACA: 22 Table of Contents made several changes to the Medicaid Drug Rebate Program, including increasing pharmaceutical manufacturers’ rebate liability by raising the minimum basic Medicaid rebate on most branded prescription drugs; imposed a requirement on manufacturers of branded drugs to provide a 70% point-of-sale discount off the negotiated price of branded drugs dispensed to Medicare Part D beneficiaries in the coverage gap (i.e., "donut hole") as a condition for a manufacturer’s outpatient drugs being covered under Medicare Part D; extended a manufacturer’s Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations, expanded the entities eligible for discounts under the 340B Drug Discount Program, imposed an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs, apportioned among these entities according to their market share in certain government healthcare programs, and established a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
Among the provisions of the ACA of greatest importance to the pharmaceutical industry are that the ACA: 23 Table of Contents made several changes to the Medicaid Drug Rebate Program, including increasing pharmaceutical manufacturers’ rebate liability by raising the minimum basic Medicaid rebate on most branded prescription drugs; imposed a requirement on manufacturers of branded drugs to provide a 70% point-of-sale discount off the negotiated price of branded drugs dispensed to Medicare Part D beneficiaries in the coverage gap (i.e., "donut hole") as a condition for a manufacturer’s outpatient drugs being covered under Medicare Part D; extended a manufacturer’s Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; expanded the entities eligible for discounts under the 340B Drug Discount Program; imposed an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs, apportioned among these entities according to their market share in certain government healthcare programs; and established a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
Current prescription volumes suggest that approximately 1 million people with diabetes are adequately protected today, leaving a significant number of people without protection as recommended by the latest guidelines. If all at risk persons were adequately protected, the market potential is estimated to be nearly $5.0 billion annually.
Current prescription volumes suggest that approximately 1 million people with diabetes are adequately protected today, leaving a significant number of people without protection as recommended by the latest guidelines. If all at risk persons were adequately protected, the market potential is estimated to be nearly $5 billion annually.
Date of first licensure does not include the date of licensure of (and a new period of exclusivity is not available for) a biological product if the licensure is for a supplement for the biological product or for a subsequent application by the same sponsor or manufacturer of the biological product (or licensor, predecessor in interest, or other related entity) for a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or for a modification to the structure of the biological product that does not result in a change in safety, purity, or potency. 15 Table of Contents Hatch-Waxman Patent Certification and the 30-Month Stay Upon approval of an NDA, including a 505(b)(2) NDA, or a supplement thereto, NDA sponsors are required to list with the FDA each patent with claims that cover the applicant’s product or an approved method of using the product.
Date of first licensure does not include the date of licensure of (and a new period of exclusivity is not available for) a biological product if the licensure is for a supplement for the biological product or for a subsequent application by the same sponsor or manufacturer of the biological product (or licensor, predecessor in interest, or other related entity) for a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or for a modification to the structure of the biological product that does not result in a change in safety, purity, or potency. 16 Table of Contents Hatch-Waxman Patent Certification and the 30-Month Stay Upon approval of an NDA, including a 505(b)(2) NDA, or a supplement thereto, NDA sponsors are required to list with the FDA each patent with claims that cover the applicant’s product or an approved method of using the product.
Our Products Recorlev Recorlev is our new therapy approved in 2022 for the treatment of Cushing’s syndrome, a rare condition which is the result of sustained, elevated levels of cortisol in the body (hypercortisolism). Cushing’s syndrome affects approximately 25,000 people in the United States of which approximately two-thirds are cured by surgery.
Our Products Recorlev Recorlev, approved in 2022, is our therapy for the treatment of Cushing’s syndrome, a rare condition which is the result of sustained, elevated levels of cortisol in the body (hypercortisolism). Cushing’s syndrome affects approximately 25,000 people in the United States of which approximately two-thirds are cured by surgery.
Xeris is uniquely positioned to execute on this strategy through the continued growth of our three commercial products, which enables us to invest in and develop therapies for unmet medical needs. We believe this will generate a value to all of our stakeholders.
Xeris is uniquely positioned to execute on this strategy through the continued growth of our three commercial products, which enables us to invest in and develop therapies for unmet medical needs. We believe this will generate value for all of our stakeholders.
In addition, other legislative and regulatory changes have been proposed and adopted in the United States since the ACA was enacted, including: the Budget Control Act of 2011, which, among other things, included aggregate reductions of Medicare payments to providers of 2% per fiscal year through 2031; on January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years; on April 13, 2017, CMS published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces; on May 23, 2019, CMS published a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020; due to the Statutory Pay-As-You-Go Act of 2010, estimated budget deficit increases resulting from the American Rescue Plan Act of 2021, and subsequent legislation, Medicare payments to providers will be further reduced starting in 2025 absent further legislation; and in August 2022, the Inflation Reduction Act of 2022, or IRA was signed into law.
In addition, other legislative and regulatory changes have been proposed and adopted in the United States since the ACA was enacted, including: the Budget Control Act of 2011, which, among other things, included aggregate reductions of Medicare payments to providers of 2% per fiscal year through 2031; on January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years; on April 13, 2017, CMS published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces; on May 23, 2019, CMS published a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020; due to the Statutory Pay-As-You-Go Act of 2010, estimated budget deficit increases resulting from the American Rescue Plan Act of 2021, and subsequent legislation, Medicare payments to providers were further reduced starting in 2025; and in August 2022, the Inflation Reduction Act of 2022, or IRA was signed into law.
The FDA may then approve the new drug candidate for all or some of the labeled indications for which the referenced product has been approved, as well as for any new indication sought by the Section 505(b)(2) applicant. 14 Table of Contents Abbreviated New Drug Applications for Generic Drugs In 1984, with passage of the Hatch-Waxman Amendments to the FDCA, Congress established an abbreviated regulatory scheme authorizing the FDA to approve generic drugs that are shown to contain the same active ingredients as, and to be bioequivalent to, drugs previously approved by the FDA pursuant to NDAs.
The FDA may then approve the new drug candidate for all or some of the labeled indications for which the referenced product has been approved, as well as for any new indication sought by the Section 505(b)(2) applicant. 15 Table of Contents Abbreviated New Drug Applications for Generic Drugs In 1984, with passage of the Hatch-Waxman Amendments to the FDCA, Congress established an abbreviated regulatory scheme authorizing the FDA to approve generic drugs that are shown to contain the same active ingredients as, and to be bioequivalent to, drugs previously approved by the FDA pursuant to NDAs.
Several other types of drugs have been reported to have benefits for chronic or acute use in one or more than one PPP variant, including potassium-sparing diuretics, beta receptor agonists, mexelitine and other sodium channel blockers, and others. 10 Table of Contents Intellectual Property Proprietary Protection Our commercial success depends in part on our ability to obtain and maintain proprietary protection for our products and product candidates, manufacturing and process discoveries and other know-how, to operate without infringing the proprietary rights of others, and to prevent others from infringing our proprietary rights.
Several other types of drugs have been reported to have benefits for chronic or acute use in one or more than one PPP variant, including potassium-sparing diuretics, beta receptor agonists, mexelitine and other sodium channel blockers, and others. 11 Table of Contents Intellectual Property Proprietary Protection Our commercial success depends in part on our ability to obtain and maintain proprietary protection for our products and product candidates, manufacturing and process discoveries and other know-how, to operate without infringing the proprietary rights of others, and to prevent others from infringing our proprietary rights.
Many states have adopted laws similar to the AKS, some of which apply to the referral of patients for healthcare services reimbursed by any source, not just governmental payors, including private insurers.
For example, many states have adopted laws similar to the AKS, some of which apply to the referral of patients for healthcare services reimbursed by any source, not just governmental payors, including private insurers.
In February 2023, HHS also issued a proposal in response to an October 2022 executive order from President Biden that includes a proposed prescription drug pricing model that will test whether targeted Medicare payment adjustments will sufficiently incentivize manufacturers to complete confirmatory trials for drugs approved through the FDA’s accelerated approval pathway.
In February 2023, HHS also issued a proposal in response to an October 2022 executive order from President Biden that included a proposed prescription drug pricing model that will test whether targeted Medicare payment adjustments will sufficiently incentivize manufacturers to complete confirmatory trials for drugs approved through the FDA’s accelerated approval pathway.
Under the goals and policies agreed to by the FDA under the Prescription Drug User Fee Act ("PDUFA"), the FDA’s goal to complete its substantive review and respond to the applicant is ten months from the 13 Table of Contents receipt of a standard NDA or ten months from the filing date of an NDA for a new molecular entity or original BLA.
Under the goals and policies agreed to by the FDA under the Prescription Drug User Fee Act ("PDUFA"), the FDA’s goal to complete its substantive review and respond to the applicant is ten months from the 14 Table of Contents receipt of a standard NDA or ten months from the filing date of an NDA for a new molecular entity or original BLA.
Orphan drug exclusivity will not bar approval of another product with the same drug for the same condition under certain circumstances, including if a subsequent product with the same drug for the same condition is shown to be clinically superior to the approved product on the basis of greater efficacy or safety, or providing a major contribution to patient care, or if the company with orphan drug exclusivity cannot assure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated. 18 Table of Contents Pediatric Studies and Exclusivity Under the Pediatric Research Equity Act of 2003, as amended, an NDA or supplement thereto must contain data to assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
Orphan drug exclusivity will not bar approval of another product with the same drug for the same approved use or indication under certain circumstances, including if a subsequent product with the same drug for the same approved use or indication is shown to be clinically superior to the approved product on the basis of greater efficacy or safety, or providing a major contribution to patient care, or if the company with orphan drug exclusivity cannot assure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated. 19 Table of Contents Pediatric Studies and Exclusivity Under the Pediatric Research Equity Act of 2003, as amended, an NDA or supplement thereto must contain data to assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
Our proprietary non-aqueous XeriSol and XeriJect technologies offer the opportunity to eliminate the need for reconstitution and refrigeration, enable long-term room-temperature stability, significantly reduce injection volume, and allow for a more convenient SC or IM administration as opposed to IV infusion and other routes of administration.
Our proprietary non-aqueous XeriSol and XeriJect technologies offer the opportunity to eliminate the need for reconstitution and refrigeration, enable long-term stability, significantly reduce injection volume, and allow for a more convenient SC or IM administration as opposed to IV infusion and other routes of administration.
The IRB also approves the information regarding the clinical trial and the consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. 12 Table of Contents Each new clinical protocol and any amendments to the protocol must be submitted for FDA review and to the IRBs for approval.
The IRB also approves the information regarding the clinical trial and the consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. 13 Table of Contents Each new clinical protocol and any amendments to the protocol must be submitted for FDA review and to the IRBs for approval.
Any agency or judicial enforcement action could have a material adverse effect on us. 11 Table of Contents Certain of our products and product candidates are subject to regulation as combination products, which means that they are composed of both a drug product and device product.
Any agency or judicial enforcement action could have a material adverse effect on us. 12 Table of Contents Certain of our products and product candidates are subject to regulation as combination products, which means that they are composed of both a drug product and device product.
Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain CGMP compliance. These regulations also impose certain organizational, procedural and 17 Table of Contents documentation requirements with respect to manufacturing and quality assurance activities.
Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain CGMP compliance. These regulations also impose certain organizational, procedural and 18 Table of Contents documentation requirements with respect to manufacturing and quality assurance activities.
If a product is designated as Breakthrough Therapy, the FDA will work to expedite the development and review of such product. 19 Table of Contents Fast Track designation, Breakthrough Therapy designation and priority review do not change the standards for approval but may expedite the development or approval process.
If a product is designated as Breakthrough Therapy, the FDA will work to expedite the development and review of such product. 20 Table of Contents Fast Track designation, Breakthrough Therapy designation and priority review do not change the standards for approval but may expedite the development or approval process.
Injectable pharmaceuticals have conventionally been developed using aqueous formulations. To optimize their stability and enable longer-term storage, many of these products are freeze dried into a powder and, when needed, must be 8 Table of Contents reconstituted with an aqueous diluent. This is typically associated with a challenging multi-step procedure with significant potential for error.
Injectable pharmaceuticals have conventionally been developed using aqueous formulations. To optimize their stability and enable longer-term storage, many of these products are freeze dried into a powder and, when needed, must be reconstituted with an aqueous diluent. This is typically associated with a challenging multi-step procedure with significant potential for error.
Any negotiated prices for any of our products covered by a Part D prescription drug plan will likely be lower than the prices we might otherwise obtain. Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment 24 Table of Contents limitations in setting their own payment rates.
Any negotiated prices for any of our products covered by a Part D prescription drug plan will likely be lower than the prices we might otherwise obtain. Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own payment rates.
We believe that our novel approach to treatment has the potential to establish a new standard of care for hypothyroidism. Our Proprietary Technology In the presence of water, many drugs have poor solubility and stability. Our proprietary non-aqueous technology is designed to address the challenges associated with formulating certain drugs and overcome the inherent limitations of conventional aqueous-based formulation approaches.
We believe that our novel approach to treatment has the potential to establish a new standard of care for hypothyroidism. Our Proprietary Technology In the presence of water, many drugs have poor solubility and stability. Our proprietary non-aqueous technologies are designed to address the challenges associated with formulating certain drugs and overcome the inherent limitations of conventional aqueous-based formulation approaches.
Many of our potential competitors have substantially greater financial, technical and human resources than we do, as well as more experience in the development of product candidates, obtaining FDA and other regulatory approvals of products, and the commercialization of those products. Recorlev : A number of therapies are currently approved or in various stages of development for endogenous Cushing’s syndrome.
Many of our potential competitors have substantially greater financial, technical and human resources than we do, as well as more experience in the development of product candidates, obtaining FDA and other regulatory approvals of products, and the commercialization of those products. 10 Table of Contents Recorlev : A number of therapies are currently approved or in various stages of development for endogenous Cushing’s syndrome.
It is also responsible for developing guidance and regulations to clarify the regulation of combination products and for 16 Table of Contents assignment of the FDA center that has primary jurisdiction for review of combination products where the jurisdiction is unclear or in dispute.
It is also responsible for developing guidance and regulations to clarify the regulation of combination products and for 17 Table of Contents assignment of the FDA center that has primary jurisdiction for review of combination products where the jurisdiction is unclear or in dispute.
The suspensions use FDA-approved excipients and leverage known manufacturing processes. XeriJect formulation science is well suited for drugs and biologics including large molecules such as proteins, monoclonal antibodies, and vaccines. The technology associated with both the XeriSol and XeriJect is protected by an extensive patent estate, trade secrets and know-how, and it is available for licensing.
The suspensions use FDA-approved excipients and leverage known manufacturing processes. XeriJect formulation science is well suited for drugs and biologics including large molecules such as proteins, monoclonal antibodies, and vaccines. The technology associated with both the XeriSol and XeriJect are protected by an extensive patent estate, trade secrets and know-how, and they are available for licensing.
Our common stock is listed on The Nasdaq Global Select Market under the symbol "XERS." Our website and the information contained on, or that can be accessed through, the website will not be deemed to be incorporated by reference in, and are not considered part of, this Annual Report. Available Information Our website address is www.xerispharma.com.
Our common stock is listed on The Nasdaq Global Select Market under the symbol "XERS." Our website and the information contained on, or that can be accessed through, the website will not be deemed to be incorporated by reference in, and are not considered part of, this Annual Report. 27 Table of Contents Available Information Our website address is www.xerispharma.com.
Overview We are a commercial-stage biopharmaceutical company focused on developing and commercializing therapies for people with chronic endocrine and neurological diseases in the United States. We offer Recorlev for the treatment of Cushing’s syndrome, Gvoke for the treatment of severe hypoglycemia, and Keveyis for the treatment of Primary Periodic Paralysis ("PPP").
Overview We are a commercial-stage biopharmaceutical company focused on developing and commercializing therapies for people with chronic endocrine and neurological diseases in the United States. We offer Recorlev for the treatment of endogenous hypercortisolemia in patients with Cushing’s syndrome, Gvoke for the treatment of severe hypoglycemia, and Keveyis for the treatment of Primary Periodic Paralysis ("PPP").
Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including penalties, fines, disgorgement, imprisonment and/or exclusion or suspension from federal and state healthcare programs such as Medicare and Medicaid and 21 Table of Contents debarment from contracting with the United States government.
Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including penalties, fines, disgorgement, imprisonment and/or exclusion or suspension from federal and state healthcare programs such as Medicare and Medicaid and debarment from contracting with the United States government.
The estimated total addressable market for this therapy is 3-5 million patients or more in the United States which we estimate is a $1.0 billion or greater market opportunity. • Partnerships: We are pursuing formulation and development partnerships to apply our XeriSol and XeriJect formulation technologies to enhance the drug delivery and clinical profile of other companies’ proprietary drugs and biologics.
The estimated total addressable market for this therapy is 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. • Partnerships: We are pursuing formulation and development partnerships to apply our XeriSol and XeriJect formulation technologies to enhance the drug delivery and clinical profile of other companies’ proprietary drugs and biologics.
To support employee development, as well as plan for short- and long-term business success, we review and update a company succession plan regularly and we offer a number of development opportunities for our employees through various methods. Our succession plan is reviewed with our board of directors annually.
In addition and to support employee development, as well as plan for short- and long-term business success, we offer a number of other development opportunities for employees through various methods and we review and update a company succession plan regularly. Our succession plan is reviewed with our board of directors annually.
Patent Rights We currently own 163 patents issued globally, including composition of matter patents covering our ready-to-use glucagon formulation that expire in 2036.
Patent Rights We currently own 175 patents issued globally, including composition of matter patents covering our ready-to-use glucagon formulation that expire in 2036.
We have completed a Phase 1 study of XP-8121 to evaluate the 7 Table of Contents pharmacokinetics, safety and tolerability, and potential for weekly dosing in the treatment of hypothyroidism and a Phase 2 study of XP-8121 to evaluate the dose conversion of oral levothyroxine to XP-8121.
We have completed a Phase 1 study of XP-8121 to evaluate the pharmacokinetics, safety and tolerability, and potential for weekly dosing in the treatment of hypothyroidism and a Phase 2 study of XP-8121 to evaluate the dose conversion of oral levothyroxine to XP-8121.
The FDA agreed with our proposal to conduct a single non-inferiority efficacy trial comparing once-daily oral levothyroxine to once-weekly XP-8121 in adults with primary hypothyroidism. Efficacy will be determined by the percentage of participants achieving euthyroidism (normal TSH) at 30 weeks. Market Opportunity Hypothyroidism affects approximately 15 to 25 million people in the United States.
The FDA agreed with our proposal to conduct a single non-inferiority efficacy trial comparing once-daily oral levothyroxine to once-weekly XP-8121 in adults with primary hypothyroidism. Efficacy will be determined by the percentage of participants achieving euthyroidism (normal TSH) at 30 weeks. Market Opportunity Hypothyroidism affects over 20 million people in the United States.
In late 2024, the FDA announced it is allowing a further exemption period for eligible trading partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data. The exemption period for eligible manufacturers and repackagers now extends until May 27, 2025.
In late 2024, the FDA announced it is allowing a further exemption period for eligible trading partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data. The exemption period for eligible manufacturers and repackagers extended through May 27, 2025.
We believe XP-8121 to be well-suited to address these challenges. XP-8121 is designed to be a once-weekly, small-volume, subcutaneous injection which, given its route of administration, bypasses the gastrointestinal tract and could avoid many of the therapeutic complications associated with the use of oral forms of levothyroxine.
We believe XP-8121 to be well-suited to address these challenges. XP-8121 is designed to be a once-weekly, small-volume, subcutaneous injection that, given its route of administration, bypasses the gastrointestinal tract and could avoid many of the therapeutic 8 Table of Contents complications associated with the use of oral forms of levothyroxine.
We estimate that nearly 15 million people in the United States are at heightened risk of severe hypoglycemia and, per guidelines issued by the American Diabetes Association and others, should have a ready-to-use glucagon product like the Gvoke HypoPen with them at all times.
We estimate that more than 14 million people in the United States are at heightened risk of severe hypoglycemia and, per guidelines issued by the American Diabetes Association and others, should have a ready-to-use glucagon product like the Gvoke HypoPen with them at all times.
Included in the total patents, we have 64 granted patents globally related to our platform technologies, and 8 patents granted in the United States and listed in the United States Food and Drug Administration ("FDA") Orange Book covering proprietary formulations of levoketoconazole (the active pharmaceutical ingredient in Recorlev) and the uses of such formulations in treating certain endocrine-related diseases and syndromes.
Included in the total patents, we have 69 granted patents globally related to our platform technologies, and 5 patents granted and in force in the United States and listed in the United States Food and Drug Administration ("FDA") Orange Book covering proprietary formulations of levoketoconazole (the active pharmaceutical ingredient in Recorlev) and the uses of such formulations in treating certain endocrine-related diseases and syndromes.
Accordingly, we encourage investors to review the information we make available through these channels. 26 Table of Contents
Accordingly, we encourage investors to review the information we make available through these channels. 28 Table of Contents
One third-party payor’s decision to cover a particular pharmaceutical drug product or service does not ensure that other payors will also provide coverage for the pharmaceutical drug product or service or will provide coverage at an adequate reimbursement rate.
One third-party payor’s decision to cover a particular pharmaceutical drug product or service does not ensure that other payors will also provide coverage for the 25 Table of Contents pharmaceutical drug product or service or will provide coverage at an adequate reimbursement rate.
To work to ensure our compensation and benefits programs are competitive, we engage nationally recognized outside compensation and benefits consulting firms to 25 Table of Contents independently evaluate the effectiveness of our programs and to provide benchmarking against our peers within the industry.
To ensure our compensation and benefits programs are competitive, we engage nationally recognized outside compensation and benefits consulting firms to independently evaluate the effectiveness of our programs and to provide benchmarking against our peers within the industry.
Isturisa (osilodrostat), a cortisol synthesis inhibitor indicated for adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative, is also marketed by Recordati. A number of products, including ketoconazole, metyrapone, cabergoline, mitotane and etomidate are used off-label for the treatment of Cushing’s syndrome in the United States.
Isturisa (osilodrostat), a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative, is also marketed by Recordati. A number of products, including ketoconazole, metyrapone, cabergoline, mitotane and etomidate are used off-label for the treatment of Cushing’s syndrome in the United States.
Efforts to ensure that our current and future business arrangements with third parties, and our business generally, will comply with applicable healthcare laws and regulations will involve substantial costs.
Efforts to ensure that our current and future business arrangements with third parties, and our business 22 Table of Contents generally, will comply with applicable healthcare laws and regulations will involve substantial costs.
Pharmacologic products like Recorlev are used for the balance 6 Table of Contents of patients for whom surgery was not curative or was not indicated. Recorlev has received orphan drug exclusivity status in the United States through December 30, 2028 and patent protection through 2040.
Pharmacologic products like Recorlev are used for the balance of patients for whom surgery was not curative or was not an option. Recorlev has received orphan drug exclusivity status in the United States through December 30, 2028 and patent protection through 2040.
Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more of our products or product candidates for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
Even if favorable coverage and reimbursement status is attained for one or more of our products or product candidates for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
Both XeriSol and XeriJect offer the opportunity to create ready-to-use, room-temperature stable, highly concentrated, injectable formulations of both small and large molecules. • XP-8121: We are in the process of developing the first and only, once-weekly, subcutaneous injection of levothyroxine for the treatment of hypothyroidism.
XeriSol and XeriJect offer the opportunity to create ready-to-use, room-temperature stable, highly concentrated, injectable formulations of both small and large molecules. • XP-8121: We are in the process of developing the first and only, once-weekly, subcutaneous injection of levothyroxine for the treatment of hypothyroidism. We plan to initiate a Phase 3 clinical trial of XP-8121 in 2026.
Orphan exclusivity does not block the approval of a different drug for the same rare disease or condition, nor does it block the approval of the same drug for different conditions.
Orphan exclusivity does not block the approval of a different drug for the same rare disease or condition, nor does it block the approval of the same drug for different approved use or indication.
The latter includes United States Patent Nos. 11,020,393, 11,278,547, 11,478,471, and 11,903,940, which were granted on June 1, 2021, March 22, 2022, October 25, 2022, and February 20, 2024, respectively, and which provide patent protection through 2040 for the use of Recorlev in the treatment of certain patients with persistent or recurrent Cushing's syndrome.
The latter includes United States Patent Nos. 11,020,393, 11,278,547, 11,903,940, and 12,377,096, which were granted on June 1, 2021, March 22, 2022, February 20, 2024, and August 5, 2025, respectively, and which provide patent protection through 2040 for the use of Recorlev in the treatment of certain patients with persistent or recurrent Cushing's syndrome.
Orphan drug exclusivity means that the FDA may not approve another sponsor’s marketing application for the same drug for the same condition for seven years, except in certain limited circumstances.
Orphan drug exclusivity means that the FDA may not approve another sponsor’s marketing application for the same drug for the same approved use or indication for seven years, except in certain limited circumstances.
We also continue to seek patents to restore our exclusive rights. We currently have two United States patent applications pending with claims protecting therapeutic uses of Keveyis. Both of these patent applications are on appeal at the United States Court of Appeals for the Federal Circuit. In late 2022, the FDA approved a generic version of our Keveyis product.
We also continue to seek patents to restore our exclusive rights. We currently have two United States patent applications pending with claims protecting therapeutic uses of Keveyis. Both of these patent applications are on appeal at the United States Court of Appeals for the Federal Circuit.
We are also facing potential competition from a number of pipeline products in development, such as Relacorilant (CORT125134), a selective glucocorticoid receptor antagonist being developed by Corcept Therapeutics Incorporated, Clofutriben (SPI-62), a HSD-1 inhibitor being developed by Sparrow Pharmaceuticals, Atumelnant (CRN04894), an ACTH Antagonist being developed by Crinetics Pharmaceuticals, and AG13909, an anti-ACTH monoclonal antibody being developed by Lundbeck.
There are also a number of pipeline products in development, such as Relacorilant (CORT125134), a selective glucocorticoid receptor antagonist being developed by Corcept Therapeutics Incorporated, Clofutriben (SPI-62), a HSD-1 inhibitor being developed by Sparrow Pharmaceuticals, Atumelnant (CRN04894), an ACTH Antagonist being developed by Crinetics Pharmaceuticals, Fluasterone (ST-002), a glucocorticoid inhibitor being developed by Stero Therapeutics, and Lu AG13909, an anti-ACTH monoclonal antibody being developed by Lundbeck.
The goal being to ultimately enter into commercial licensing agreements with our partners upon successful completion of formulation development. Manufacturing and Supply We currently contract with third parties for the manufacture, assembly, testing, packaging, storage and distribution of our products.
The ultimate goal of these partnerships is to enter into commercial licensing agreements with our partners upon successful completion of formulation development. 9 Table of Contents Manufacturing and Supply We currently contract with third parties for the manufacture, assembly, testing, packaging, storage and distribution of our products.
PPP is an inherited group of neuromuscular conditions that are characterized by interference with the electrical-chemical communications between nerve cells and skeletal muscles that can cause paralytic attacks. PPP is estimated to affect approximately 4,000 to 5,000 people in the United States.
Keveyis Keveyis (dichlorphenamide) is the first FDA-approved therapy for the treatment of the ultra-rare condition of PPP. PPP is an inherited group of neuromuscular conditions that are characterized by interference with the electrical-chemical communications between nerve cells and skeletal muscles that can cause paralytic attacks. PPP is estimated to affect approximately 4,000 to 5,000 people in the United States.
As a long-term incentive, to encourage our employees to think like owners and share in the Company’s long-term success, employees are granted equity in the form of stock options or restricted stock units and can elect to participate in our employee stock purchase plan.
Annual salary increases and incentive bonuses are based on both individual and corporate performance factors. As a long-term incentive, to encourage our employees to think like owners and share in the Company’s long-term success, employees are granted equity in the form of stock options or restricted stock units and can elect to participate in our employee stock purchase plan.
Our pay for performance philosophy seeks to motivate and reward employees while accomplishing the Company’s short and long-term strategic goals. As part of a robust performance management process, employees are evaluated both on what they accomplished and how they demonstrated our values. Annual salary increases and incentive bonuses are based on both individual and corporate performance factors.
From a compensation perspective, our pay for performance philosophy seeks to motivate and reward employees while accomplishing the Company’s short and long-term strategic goals. As part of a robust performance management process, employees are evaluated both on what they accomplished and how they demonstrated our values.
We have a supply agreement with Taro Pharmaceuticals North America, Inc. ("Taro") to produce Keveyis including all packaging. If the supply agreement is terminated by Taro at the conclusion of the renewal term, we have the right to manufacture the product on our own or have the product manufactured by a third party on our behalf.
If the supply agreement is terminated by Taro at the conclusion of the renewal term, we have the right to manufacture the product on our own or have the product manufactured by a third party on our behalf.
Human Capital Resources As of December 31, 2024, we had 394 full-time employees in the United States, 229 of whom were primarily engaged in sales and marketing, 108 of whom were primarily engaged in general administration, and 57 of whom were primarily engaged in product development and research.
Human Capital Resources As of December 31, 2025, we had 435 full-time employees in the United States, 216 of whom were primarily engaged in sales and marketing, 169 of whom were primarily engaged in general administration, and 50 of whom were primarily engaged in product development and research.
Many people failing to reach target TSH levels are managed by increasing their levothyroxine daily dose. However, levothyroxine is a drug with a narrow therapeutic index, meaning that relatively small deviations from the proper dose can cause a clinically meaningful shift in pharmacological effects when administered; thus, the titration of levothyroxine oral drug may be a tailored and incremental process.
However, levothyroxine is a drug with a narrow therapeutic index, meaning that relatively small deviations from the proper dose can cause a clinically meaningful shift in pharmacological effects when administered; thus, the titration of levothyroxine oral drug may be a tailored and incremental process.
Keveyis : In late 2022, the FDA approved a generic version of our Keveyis product, which is marketed by Torrent Pharmaceuticals Ltd. ("Torrent"). In May 2024, Torrent partnered with Cycle Pharmaceuticals Ltd ("Cycle Pharmaceuticals") to launch Ormalvi, a branded generic version of our Keveyis product.
Keveyis : In late 2022, the FDA approved a generic version of Keveyis, which is marketed by Torrent Pharmaceuticals Ltd. (“Torrent”). In May 2024, Torrent partnered with Cycle Pharmaceuticals Ltd ("Cycle Pharmaceuticals") to launch Ormalvi, a branded generic version of Keveyis. In November 2025, Rising Pharmaceuticals received FDA approval for a generic version of dichlorphenamide.
For nearly 100 years, the only available option to treat people with hypothyroidism has been with oral levothyroxine. Levothyroxine in its various branded and generic forms is one of the five most prescribed drugs in the United States with more than one hundred million prescriptions written annually.
For nearly 100 years, the only available options to treat people with hypothyroidism have been with oral levothyroxine and oral desiccated thyroid extract (which contains levothyroxine). Levothyroxine in its various branded and generic forms is one of the most prescribed drugs in the United States with approximately one hundred million prescriptions written annually.
Our experienced commercial organization focuses on educating prescribing clinicians and patients to raise awareness of the benefits of normalizing cortisol with Recorlev. Our Xeris’ CareConnection program provides direct, dedicated support to treating clinicians and patients throughout their Recorlev journey.
Because of the complex nature of Cushing’s syndrome, many patients are inadequately treated with currently available medicines. Our experienced commercial organization focuses on educating prescribing clinicians and patients to raise awareness of the benefits of normalizing cortisol with Recorlev. Our Xeris’ CareConnection program provides direct, dedicated support to treating clinicians and patients throughout their Recorlev journey.
Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one orphan designation and for which the only approved indication is for that disease or condition. If a product receives multiple orphan designations or has multiple approved indications, it will not qualify for the orphan drug exemption.
Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one orphan designation and for which the only approved indication is for that disease or condition.
("Regis") has been actively involved in the development and manufacturing of levoketoconazole and its facility in Illinois is our sole source for API. We have entered into a supply agreement with Regis. We believe that Regis has sufficient capacity to satisfy our long-term API requirements for Recorlev. Manufacturing Recorlev drug product requires a conventional solid oral dosage form manufacturing facility.
Levoketoconazole is the active pharmaceutical ingredient ("API") used in Recorlev. Regis Technologies, Inc. ("Regis") has been actively involved in the development and manufacturing of levoketoconazole and its facility in Illinois is our sole source for API. We have entered into a supply agreement with Regis. Manufacturing Recorlev drug product requires a conventional solid oral dosage form manufacturing facility.
Lonza Tampa, LLC (f/k/a Xcelience, LLC, "Lonza") has been actively involved in the development and manufacturing of Recorlev and its facility in Florida is our sole source for drug product. We have entered into a supply agreement with Lonza. We believe that Lonza has sufficient capacity to satisfy our long-term development and manufacturing requirements for Recorlev.
Lonza Tampa, LLC (f/k/a Xcelience, LLC, "Lonza") has been actively involved in the development and manufacturing of Recorlev and its facility in Florida is our sole source for drug product. We have entered into a supply agreement with Lonza. Glucagon is the API used in Gvoke. Bachem Americas, Inc., ("Bachem") is our primary commercial source for glucagon API.
These laws and future state and federal healthcare reform measures may be adopted in the future, any of which may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our products or product candidates for which we may obtain regulatory approval or the frequency with which any such product is prescribed or used.
These laws and future state and federal healthcare reform measures may be adopted in the future, any of which may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our products or product candidates for which we may obtain regulatory approval or the frequency with which any such product is prescribed or used. 26 Table of Contents As noted above, the marketability of any products for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement.
Currently, there are no therapies broadly marketed for the treatment of endogenous Cushing’s syndrome patients in the United States. Korlym (mifepristone), marketed by Corcept Therapeutics, is indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.
Korlym (mifepristone), marketed by Corcept Therapeutics, is indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. In addition, Teva Pharmaceutical Industries Limited initiated the launch of a generic version of mifepristone in early 2024.
In addition, Teva Pharmaceutical Industries Limited initiated the launch of a generic version of mifepristone in early 2024. Signifor (pasireotide) and Signifor LAR are marketed by Recordati in the United States and are indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.
Signifor (pasireotide) and Signifor LAR are marketed by Recordati Rare Diseases Inc. (“Recordati”) in the United States and are indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.
Although proposals to lower prescription drug costs may require authorization through additional legislation to become effective, Congress have indicated that they will continue to seek new legislative measures to control drug costs. 23 Table of Contents At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
Health and Safety We are committed to the safety of our employees and the communities we serve. We provide regular health and safety training programs for employees, which includes, upon on-boarding, an overview during new hire orientation, as well as ongoing training throughout the year.
We provide regular health and safety training programs for employees, which includes, upon on-boarding, an overview during new hire orientation, as well as ongoing training throughout the year. Employees are trained on workplace safety, including security and inspection, work related injuries and emergency protocols as applicable for their role and work location.
Training and Talent Development We believe that our employees are the key to our success, and we believe their development is what drives our growth and prosperity as a company.
The executive management team regularly updates our board of directors and its committees on the operation and status of our human capital trends and activities. Training and Talent Development We believe that our employees are the key to our success, and we believe their development is what drives our growth and prosperity as a company.
We estimate that at least half of the approximately 30 million people with diabetes in the United States fall into this at-risk category and should be prescribed and have handy, a ready-to-use rescue glucagon, like the Gvoke HypoPen for use during a potential severe hypoglycemic episode.
There are more than 14 million people with diabetes taking insulin or insulin secretagogues in the United States, and as such, are at-risk and should be prescribed and have handy, a ready-to-use rescue glucagon, like the Gvoke HypoPen for use during a potential severe hypoglycemic episode.
Glucagon is the API used in Gvoke and our ready-to-use glucagon product candidates. Bachem Americas, Inc., ("Bachem") is our primary commercial source for glucagon API. Bachem holds a United States drug master file for glucagon produced at its facility in Switzerland, and its manufacturing process is fully validated. We have entered into a non-exclusive supply agreement with Bachem.
Bachem holds a United States drug master file for glucagon produced at its facility in Switzerland, and its manufacturing process is fully validated. We have entered into a non-exclusive supply agreement with Bachem. Manufacturing drug product for Gvoke requires an aseptic fill/finish facility capable of handling solvents and a cyclic olefinic polymer syringe. Pyramid Laboratories, Inc.
We believe our success will depend on, among other things, our ability to continue to hire and retain the necessary qualified personnel across all departments in our organization, as we expand the commercialization of our products. Our Senior Vice President, Human Resources is responsible for developing and executing our human capital strategy.
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.
In addition to Gvoke, two ready-to-use glucagon products are currently available to treat severe hypoglycemia. The first is Amphastar's intranasal glucagon dry powder, Baqsimi, and the second is Zealand Pharma’s dasiglucagon auto-injector, Zegalogue, which is currently commercialized by Novo Nordisk.
Gvoke : In addition to Gvoke, two ready-to-use glucagon products are currently available to treat severe hypoglycemia: Baqsimi, Amphastar's intranasal glucagon dry powder, and Zegalogue, Zealand Pharma’s dasiglucagon auto-injector. Traditional emergency glucagon kits are also available to treat severe hypoglycemia, including a Glucagon Emergency Kit marketed by Fresenius Kabi and generic glucagon kits marketed by a number of pharmaceutical manufacturers.
Our Product Candidates Once Weekly Subcutaneous Injection of Levothyroxine (XP-8121) XP-8121 is a novel hypothyroidism product candidate, a once weekly subcutaneous levothyroxine formulated with XeriJect.
In 2022 and 2025, the FDA approved generic versions of our Keveyis product. 7 Table of Contents Our Product Candidates Once Weekly Subcutaneous Injection of Levothyroxine (XP-8121) XP-8121 is a novel hypothyroidism product candidate, a once weekly subcutaneous levothyroxine formulated with XeriSol.
As noted above, the marketability of any products for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement. We expect that an increasing emphasis on cost containment measures in the United States will continue to increase the pressure on pharmaceutical pricing.
We expect that an increasing emphasis on cost containment measures in the United States will continue to increase the pressure on pharmaceutical pricing. Coverage policies and third-party reimbursement rates may change at any time.
Our Pipeline Our company name, Xeris, is derived from the ancient Greek word xērós meaning 'dry' or 'without water/non-aqueous'. Our proprietary, non-aqueous formulation capabilities are designed to enable the convenient injection of medicines previously uninjectable or poorly injectable when utilizing aqueous approaches.
Our proprietary, non-aqueous formulations are designed to enable the convenient injection of medicines previously uninjectable or poorly injectable when utilizing aqueous approaches.
Information on our website is not part of this Annual Report or any of our other securities filings unless specifically incorporated herein by reference. In addition, our filings with the SEC may be accessed through the SEC’s Interactive Data Electronic Applications system at www.sec.gov .
Information that is contained in or can be accessed through our website is not part of this Annual Report or any of our other securities filings unless specifically incorporated herein by reference. Our website address is included in this Annual Report as an inactive technical reference only.
The estimated total addressable market for this therapy is approximately $3.0 billion in the United States. • Gvoke is a ready-to-use, liquid-stable glucagon for the treatment of severe hypoglycemia. The product is indicated for use in pediatric and adult patients with diabetes age two years and above and can be administered in two simple steps.
The product is indicated for use in pediatric and adult patients with diabetes age two years and above and can be administered in two simple steps.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeOur bylaws designate certain courts as the sole and exclusive forums for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders ’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees and may discourage such lawsuits with respect to such claims. 58 Table of Contents Our amended and restated bylaws provide that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for any state law claim for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of, or a claim based on, a breach of or based on a fiduciary duty owed by any of our current or former directors, officers and employees to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law, our certificate of incorporation or our bylaws, or (iv) any action asserting a claim that is governed by the internal affairs doctrine, in each case subject to the Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein (the "Delaware Forum Provision").
Biggest changeOur amended and restated bylaws provide that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for any state law claim for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of, or a claim based on, a breach of or based on a fiduciary duty owed by any of our current or former directors, officers and employees to us or our stockholders, (iii) any action asserting a claim arising pursuant to any 63 Table of Contents provision of the Delaware General Corporation Law, our certificate of incorporation or our bylaws, or (iv) any action asserting a claim that is governed by the internal affairs doctrine, in each case subject to the Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein (the "Delaware Forum Provision").
On September 29, 2023, we completed the exchange of $32.0 million in aggregate principal amount of the 2025 Convertible Notes for $33.6 million in aggregate principal amount of new 8.00% Convertible Senior Notes due 2028 (the "2028 Convertible Notes" and together with the 2025 Convertible Notes, the "Convertible Notes").
On September 29, 2023, we completed the exchange of $32.0 million in aggregate principal amount of the Convertible Notes due 2025 (the "2025 Convertible Notes") for $33.6 million in aggregate principal amount of new 8.00% Convertible Senior Notes due 2028 (the "2028 Convertible Notes" and together with the 2025 Convertible Notes, the "Convertible Notes").
Our estimates of the potential market opportunity for Gvoke, Recorlev, Keveyis, and our product candidates include several key assumptions of the market size and pricing for commercially available products as of the date of the estimate and are based on industry and market data obtained from industry publications, studies conducted by us, our industry knowledge, third-party research reports and other surveys.
Our estimates of the potential market opportunity for Recorlev, Gvoke, and Keveyis, and our product candidates include several key assumptions of the market size and pricing for commercially available products as of the date of the estimate and are based on industry and market data obtained from industry publications, studies conducted by us, our industry knowledge, third-party research reports and other surveys.
We cannot be sure that we know of each and every patent and pending application in the United States and abroad that is relevant or necessary to the commercialization of Gvoke, Recorlev, Keveyis, or our product candidates. Generally, we do not conduct independent reviews of patents issued to third parties.
We cannot be sure that we know of each and every patent and pending application in the United States and abroad that is relevant or necessary to the commercialization of Recorlev, Gvoke, Keveyis, or our product candidates. Generally, we do not conduct independent reviews of patents issued to third parties.
The trading price of our common stock historically has been highly volatile and could continue to be subject to large fluctuations in response to the risk factors discussed in this section, and others beyond our control, including: our ability to successfully commercialize Recorlev, Gvoke, and Keveyis; regulatory actions with respect to our products and product candidates; regulatory actions with respect to our competitors’ products and product candidates; the success of existing or new competitive products or technologies; results of clinical trials of product candidates of our competitors; announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; the timing and results of clinical trials of our pipeline product candidates; commencement or termination of collaborations for our development programs; the results of our efforts to develop additional product candidates or products; the level of expenses related to any of our product candidates or clinical development programs; failure or discontinuation of any of our development programs; the pricing and reimbursement of Recorlev, Gvoke, Keveyis or any of our product candidates that may be approved; regulatory or legal developments in the United States and other countries; developments, disputes or any litigation concerning, among other topics, patent applications, issued patents or other proprietary rights or our license and collaboration agreements or our third-party suppliers; the recruitment or departure of key personnel; actual or anticipated changes in estimates as to financial results or development timelines; announcement or expectation of additional financing efforts; dilution, or expected or potential dilution, relating to the issuance of additional shares of our common stock to satisfy conversion or make-whole payment obligations under, or interest on, our Convertible Notes; sales of our common stock by our insiders or other stockholders; variations in our financial results or those of companies that are perceived to be similar to us; changes in estimates or recommendations by securities analysts, if any, that cover our stock; changes in the structure of healthcare payment systems; market conditions in the pharmaceutical and biotechnology sectors; general economic, industry and market conditions, including impacts from inflation, interest rate fluctuations, major bank failure or sustained financial market illiquidity; and events that affect or have the potential to affect, general economic conditions, including but not limited to political unrest, trade disputes and tariffs, natural disasters, acts of war or terrorism, or any public health crisis.
The trading price of our common stock historically has been highly volatile and could continue to be subject to large fluctuations in response to the risk factors discussed in this section, and others beyond our control, including: our ability to successfully commercialize Recorlev, Gvoke, and Keveyis; regulatory actions with respect to our products and product candidates; regulatory actions with respect to our competitors’ products and product candidates; the success of existing or new competitive products or technologies; results of clinical trials of product candidates of our competitors; announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; the timing and results of clinical trials of our pipeline product candidates; commencement or termination of collaborations for our development programs; the results of our efforts to develop additional product candidates or products; the level of expenses related to any of our product candidates or clinical development programs; failure or discontinuation of any of our development programs; the pricing and reimbursement of Recorlev, Gvoke, Keveyis or any of our product candidates that may be approved; regulatory or legal developments in the United States and other countries; developments, disputes or any litigation concerning, among other topics, patent applications, issued patents or other proprietary rights or our license and collaboration agreements or our third-party suppliers; the recruitment or departure of key personnel; actual or anticipated changes in estimates as to financial results or development timelines; announcement or expectation of additional financing efforts; dilution, or expected or potential dilution, relating to the issuance of additional shares of our common stock to satisfy conversion or make-whole payment obligations under, or interest on, our 2028 Convertible Notes; sales of our common stock by our insiders or other stockholders; variations in our financial results or those of companies that are perceived to be similar to us; changes in estimates or recommendations by securities analysts, if any, that cover our stock; changes in the structure of healthcare payment systems; market conditions in the pharmaceutical and biotechnology sectors; general economic, industry and market conditions, including impacts from inflation, interest rate fluctuations, major bank failure or sustained financial market illiquidity; and events that affect or have the potential to affect, general economic conditions, including but not limited to political unrest, trade disputes and tariffs, natural disasters, acts of war or terrorism, or any public health crisis.
We are exposed to the risk that our employees, independent contractors, consultants, collaborators and CROs may engage in fraud or other misconduct, including intentional failures to comply with FDA regulations or similar regulations of comparable non-United States regulatory authorities, to provide accurate information to the FDA or comparable non-United States regulatory authorities, to comply with manufacturing standards we have established, to comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established and enforced by comparable non-United States regulatory authorities, to report financial information or data accurately or to disclose unauthorized activities to us.
We are exposed to the risk that our employees, independent contractors, consultants, collaborators, CMOs, and CROs may engage in fraud or other misconduct, including intentional failures to comply with FDA regulations or similar regulations of comparable non-United States regulatory authorities, to provide accurate information to the FDA or comparable non-United States regulatory authorities, to comply with manufacturing standards we have established, to comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established and enforced by comparable non-United States regulatory authorities, to report financial information or data accurately or to disclose unauthorized activities to us.
For example, the FDA: could determine that we cannot rely on the Section 505(b)(2) regulatory pathway or other pathways we have selected, as applicable, for our product candidates; could determine that the information provided by us was inadequate, contained clinical deficiencies or otherwise failed to demonstrate the safety and effectiveness of our product candidates for any indication; may not find the data from bioequivalence studies and/or clinical trials sufficient to support the submission of an NDA or to obtain marketing approval, including any findings that the clinical and other benefits of our product candidates do not outweigh their safety risks; may disagree with our trial design or our interpretation of data from preclinical studies, bioequivalence studies and/or clinical trials, or may change the requirements for approval even after it has reviewed and commented on the design for our trials; may determine that we have identified the wrong listed drug or drugs or that approval of our Section 505(b)(2) application for any of our product candidates is blocked by patent or non-patent exclusivity of the listed drug or drugs or of other previously approved drugs with the same conditions of approval as any of our product candidates (as applicable); may identify deficiencies in the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for the manufacturing of our product candidates; may audit some or all of our clinical research and human factors study sites to determine the integrity of our data and may reject any or all of such data; may approve our product candidates for fewer or more limited indications than we request, or may grant approval contingent on the performance of costly post-approval clinical trials or implementation of a REMS; may change its criteria for approval, policies or adopt new regulations; or may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our product candidates.
For example, the FDA: could determine that we cannot rely on the Section 505(b)(2) regulatory pathway or other pathways we have selected, as applicable, for our product candidates; could determine that the information provided by us was inadequate, contained clinical deficiencies or otherwise failed to demonstrate the safety and effectiveness of our product candidates for any indication; may not find the data from bioequivalence studies and/or clinical trials sufficient to support the submission of an NDA or to obtain marketing approval, including any findings that the clinical and other benefits of our product candidates do not outweigh their safety risks; 40 Table of Contents may disagree with our trial design or our interpretation of data from preclinical studies, bioequivalence studies and/or clinical trials, or may change the requirements for approval even after it has reviewed and commented on the design for our trials; may determine that we have identified the wrong listed drug or drugs or that approval of our Section 505(b)(2) application for any of our product candidates is blocked by patent or non-patent exclusivity of the listed drug or drugs or of other previously approved drugs with the same conditions of approval as any of our product candidates (as applicable); may identify deficiencies in the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for the manufacturing of our product candidates; may audit some or all of our clinical research and human factors study sites to determine the integrity of our data and may reject any or all of such data; may approve our product candidates for fewer or more limited indications than we request, or may grant approval contingent on the performance of costly post-approval clinical trials or implementation of a REMS; may change its criteria for approval, policies or adopt new regulations; or may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our product candidates.
Our ability to generate revenue from Recorlev, Gvoke and Keveyis, and our product candidates, if successfully developed and approved, depends on a number of factors, including, but not limited to, our ability to: obtain commercial quantities of our products at acceptable cost levels; successfully manage inventory; sell and distribute our products on terms acceptable to us; achieve an adequate level of market acceptance of our products in the medical community and with third-party payors, including placement in accepted clinical guidelines for the conditions for which our product candidates are intended to target; obtain and maintain third-party coverage and adequate reimbursement for our products; compete effectively against our competitors; and launch and commercialize our products utilizing our own sales force or by entering into partnership or co-promotion arrangements with third parties. 27 Table of Contents We have incurred and expect to continue to incur significant sales and marketing costs as we commercialize Recorlev, Gvoke and Keveyis.
Our ability to generate revenue from Recorlev, Gvoke, and Keveyis, and our product candidates, if successfully developed and approved, depends on a number of factors, including, but not limited to, our ability to: obtain commercial quantities of our products at acceptable cost levels; successfully manage inventory; sell and distribute our products on terms acceptable to us; achieve an adequate level of market acceptance of our products in the medical community and with third-party payors, including placement in accepted clinical guidelines for the conditions for which our product candidates are intended to target; obtain and maintain third-party coverage and adequate reimbursement for our products; compete effectively against our competitors; and launch and commercialize our products utilizing our own sales force or by entering into partnership or co-promotion arrangements with third parties. 29 Table of Contents We have incurred and expect to continue to incur significant sales and marketing costs as we commercialize Recorlev, Gvoke, and Keveyis.
It is possible that governmental authorities will conclude that our business practices or those of our partners, including our arrangements with physicians and other healthcare providers, some of whom may receive stock options as compensation for services provided, may not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.
It is possible that governmental authorities will conclude that our business practices or those of our partners, including our arrangements or interactions with physicians and other healthcare providers, some of whom may receive stock options as compensation for services provided, may not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.
A fundamental change includes certain acquisition transactions and the failure of our common stock to be listed on the Nasdaq Global Select Market or certain similar national securities exchanges. We may not have enough available cash or be able to obtain financing at the time we are required to repurchase the Convertible Notes.
A fundamental change includes certain acquisition transactions and the failure of our common stock to be listed on the Nasdaq Global Select Market or certain similar national securities exchanges. We may not have enough available cash or be able to obtain financing at the time we are required to repurchase the 2028 Convertible Notes.
Any failure or perceived failure by us or any third-party collaborators, service providers, contractors or consultants to comply with our cybersecurity obligations to third parties, or any cybersecurity incidents or data breaches that result in the unauthorized access, release or transfer of sensitive information, including personally identifiable information, may result in: governmental investigations, litigation, regulatory enforcement actions, fines, sanctions or other penalties, injunctive relief requiring costly compliance measures, required notification and credit monitoring, public statements against us, third parties to lose trust in us, or claims by third parties 59 Table of Contents asserting that we have breached our privacy, confidentiality, data security or similar obligations, any of which could have a material adverse effect on our reputation, business, financial condition or results of operations.
Any failure or perceived failure by us or any third-party collaborators, service providers, contractors or consultants to comply with our cybersecurity obligations to third parties, or any cybersecurity incidents or data breaches that result in the unauthorized access, release or transfer of sensitive information, including personally identifiable information, may result in: governmental investigations, litigation, regulatory enforcement actions, fines, sanctions or other penalties, injunctive relief requiring costly compliance measures, required notification and credit monitoring, public statements against us, third parties to lose trust in us, or claims by third parties asserting that we have breached our privacy, confidentiality, data security or similar obligations, any of which could have a material 64 Table of Contents adverse effect on our reputation, business, financial condition or results of operations.
For example, Gvoke has numerous competitors in the severe hypoglycemia market, which currently include Amphastar’s Baqsimi, an intranasal glucagon dry powder, Zealand Pharma’s Zegalogue, a dasiglucagon outlicensed to Novo Nordisk, Novo Nordisk’s GlucaGen HypoKit, Fresenius Kabi's glucagon emergency kit for low blood sugar, and Amphastar’s generic Glucagon for Injection Emergency Kit.
Gvoke has numerous competitors in the severe hypoglycemia market, which currently include Amphastar’s Baqsimi, an intranasal glucagon dry powder, Zealand Pharma’s Zegalogue, a dasiglucagon outlicensed to Novo Nordisk, Novo Nordisk’s GlucaGen HypoKit, Fresenius Kabi's glucagon emergency kit for low blood sugar, and Amphastar’s generic Glucagon for Injection Emergency Kit.
At any time before the close of business on the second scheduled trading day immediately before the maturity date, holders of Convertible Notes may convert their Convertible Notes at their option into shares of our common stock, together, if applicable, with cash in lieu of any fractional share, at the then-applicable conversion rate.
At any time before the close of business on the second scheduled trading day immediately before the maturity date, holders of the 2028 Convertible Notes may convert their 2028 Convertible Notes at their option into shares of our common stock, together, if applicable, with cash in lieu of any fractional share, at the then-applicable conversion rate.
If any more or all of the Convertible Notes are converted into shares of common stock, our existing stockholders will experience immediate dilution of voting rights and the price of shares of our common stock may decline. Furthermore, the perception that such dilution could occur may cause the market price of our common stock to decline.
If any more or all of the 2028 Convertible Notes are converted into shares of common stock, our existing stockholders will experience immediate dilution of voting rights and the price of shares of our common stock may decline. Furthermore, the perception that such dilution could occur may cause the market price of our common stock to decline.
As a result of the conversion rates of the Convertible Notes adjusting upward upon the occurrence of certain events, our existing stockholders may experience more dilution if any or all of the Convertible Notes are converted into shares of common stock after the adjusted conversion rate became effective.
As a result of the conversion rates of the 2028 Convertible Notes adjusting upward upon the occurrence of certain events, our existing stockholders may experience more dilution if any or all of the 2028 Convertible Notes are converted into shares of common stock after the adjusted conversion rate became effective.
Any of these events could also prevent us from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues from the sale of our products. 40 Table of Contents We have received orphan drug designation for Recorlev, Keveyis, and certain of our product candidates with respect to certain indications and may pursue such designation for others, but we may be unable to obtain such designation or to maintain the benefits associated with orphan drug status, including market exclusivity, even if that designation is granted.
Any of these events could also prevent us from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues from the sale of our products. 43 Table of Contents We have received orphan drug designation for Recorlev, Keveyis, and certain of our product candidates with respect to certain indications and may pursue such designation for others, but we may be unable to obtain such designation or to maintain the benefits associated with orphan drug status, including market exclusivity, even if that designation is granted.
We have a global supply chain and manufacture some components of our products outside the United States, including without limitation, in Taiwan and Israel. The current war between Israel and Hamas has in the past and could in the future directly and indirectly affect our operations.
We have a global supply chain and manufacture some components of our products outside the United States, including without limitation, in Taiwan and Israel. The war between Israel and Hamas has in the past and could in the future directly and indirectly affect our operations.
The conversion rate for the Convertible Notes is 326.7974 shares of our common stock per $1,000 principal amount of Convertible Notes, which represents an initial conversion price of approximately $3.06 per share of common stock, and is subject to adjustment under the terms of the Convertible Notes.
The conversion rate for the 2028 Convertible Notes is 326.7974 shares of our common stock per $1,000 principal amount of 2028 Convertible Notes, which represents an initial conversion price of approximately $3.06 per share of common stock, and is subject to adjustment under the terms of the 2028 Convertible Notes.
The term loans and the Convertible Notes may create additional financial risk for us, particularly if our business or prevailing financial market conditions are not conducive to paying off or refinancing our outstanding debt obligations at maturity.
The term loans and the 2028 Convertible Notes may create additional financial risk for us, particularly if our business or prevailing financial market conditions are not conducive to paying off or refinancing our outstanding debt obligations at maturity.
Our approved products and product candidates, if approved, will also be subject to ongoing regulatory requirements for manufacturing, distribution, sale, labeling, packaging, storage, advertising, promotion, record-keeping and submission of safety and other post-market information.
Our approved products and product candidates, if approved, will also be subject to ongoing regulatory requirements for manufacturing, distribution, sale, labeling, sampling, packaging, storage, advertising, promotion, record-keeping and submission of safety and other post-market information.
Our employees, independent contractors, consultants, collaborators and CROs may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm to our reputation.
Our employees, independent contractors, consultants, collaborators, CMOs, and CROs may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm to our reputation.
Noteholders may require us to repurchase their Convertible Notes following a fundamental change at a cash repurchase price generally equal to the principal amount of the Convertible Notes to be repurchased, plus accrued and unpaid interest, if any.
Noteholders may require us to repurchase their 2028 Convertible Notes following a fundamental change at a cash repurchase price generally equal to the principal amount of the 2028 Convertible Notes to be repurchased, plus accrued and unpaid interest, if any.
Risks Related to Employee Matters, Managing Growth and Ongoing Operations Risks Related to Potentially Under-Resourced Regulatory Authorities Disruptions at the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Risks Related to Employee Matters, Managing Growth and Ongoing Operations Risks Related to Potentially Under-Resourced Regulatory Authorities Disruptions at the FDA, the SEC and other U.S. government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Additionally, we expect to see increasing government and supranational regulation related to artificial intelligence use and ethics, which may also significantly increase the burden and cost of research, development and compliance in this area.
We expect to see increasing government and supranational regulation related to artificial intelligence use and ethics, which may also significantly increase the burden and cost of research, development and compliance in this area.
Orphan drug exclusivity means that the FDA may not approve any other applications, including an NDA, to market the same drug for the same indication for seven years, except in limited circumstances such as if the FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated.
Orphan drug exclusivity means that the FDA may not approve any other applications, including an NDA, to market the same drug for the same approved use or indication for seven years, except in limited circumstances such as if the FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated.
Under the FDA’s interpretation, the approval of one or more of our product candidates may be blocked by exclusivity awarded to a previously-approved drug product that shares certain innovative features with our product candidates, even if our 505(b)(2) application does not identify the previously-approved drug product as a 39 Table of Contents listed drug or rely upon any of its safety or efficacy data.
Under the FDA’s interpretation, the approval of one or more of our product candidates may be blocked by exclusivity awarded to a previously-approved drug product that shares certain innovative features with our product candidates, even if our 505(b)(2) application does not identify the previously-approved drug product as a 42 Table of Contents listed drug or rely upon any of its safety or efficacy data.
Even if our product candidates receive marketing approval, if we or others later identify undesirable or unacceptable side effects caused by one of our products: regulatory authorities may require the addition of labeling statements, including "black box" warnings, contraindications or dissemination of field alerts to physicians and pharmacies; we may be required to change instructions regarding the way the product is administered, conduct additional clinical trials or change the labeling of the product; we may be subject to limitations on how we may promote the product; sales of the product may decrease significantly; regulatory authorities may require us to take our approved product off the market; we may be subject to litigation or products liability claims; and our reputation may suffer.
Even if our product candidates receive marketing approval, if we or others later identify undesirable or unacceptable side effects caused by one of our products: regulatory authorities may require the addition or modification of labeling statements, including "black box" warnings, contraindications or dissemination of field alerts to physicians and pharmacies; we may be required to change instructions regarding the way the product is administered, conduct post-marketing surveillance, conduct additional clinical trials or change the labeling of the product; we may be subject to limitations on how we may promote the product; sales of the product may decrease significantly; regulatory authorities may require us to take our approved product off the market; we may be subject to litigation or products liability claims; and our reputation may suffer.
For example, at the request of the FDA we are conducting an enhanced pharmacovigilance program for all cases of hepatotoxicity reported with patients taking Recorlev tablets, for a period of 5 years from the date of approval. Global health authorities may impose regulatory requirements to monitor safety that may burden our ability to commercialize our drug products.
For example, at the request of the FDA we are conducting an enhanced pharmacovigilance program for all cases of hepatotoxicity reported with patients taking Recorlev tablets, for a period of five years from the date of approval. Global health authorities may impose regulatory requirements to monitor safety that may burden our ability to commercialize our drug products.
Healthcare providers, physicians and third-party payors play a primary role in the recommendation and prescription use of any products for which we obtain marketing approval. Our arrangements with investigators, healthcare practitioners, consultants, third-party payors and customers, if any, will subject us to broadly applicable fraud and abuse and other healthcare laws and regulations.
Healthcare providers, physicians and third-party payors play a primary role in the recommendation and prescription use of any products for which we obtain marketing approval. Our arrangements or interactions with investigators, healthcare practitioners, consultants, third-party payors and customers, if any, will subject us to broadly applicable fraud and abuse and other healthcare laws and regulations.
If we are unable to continue to attract and retain highly qualified personnel, our ability to commercialize our products and to develop and commercialize our product candidates will be limited. 55 Table of Contents Risks Related to Our Common Stock Risks Related to Investment in Securities Our stock price has been and will likely continue to be volatile, and you may lose part or all of your investment.
If we are unable to continue to attract and retain highly qualified personnel, our ability to commercialize our products and to develop and commercialize our product candidates will be limited. 60 Table of Contents Risks Related to Our Common Stock Risks Related to Investment in Securities Our stock price has been and will likely continue to be volatile, and you may lose part or all of your investment.
These laws impose a broad range of strict requirements on companies subject to the GDPR, such as including requirements relating to having legal bases for processing personal data relating to identifiable individuals and transferring such information outside the EEA or the UK, providing details to those individuals regarding the processing of their personal data, implementing safeguards to keep personal data secure, having data processing agreements with third parties who process personal data, providing information to individuals regarding data processing activities, responding to individuals’ requests to exercise their rights in respect of their personal data, obtaining consent of the individuals to whom the personal data relates, reporting security and privacy breaches involving personal data to the competent national data protection authority and affected individuals, appointing data protection officers, conducting data protection impact assessments, and record-keeping.
These laws impose a broad range of strict requirements on companies subject to the GDPR, such as including requirements relating to having legal bases (or conditions for sensitive data) for processing personal data relating to identifiable individuals and transferring such information outside the EEA or the UK, providing details to those individuals regarding the processing of their personal data, implementing safeguards to keep personal data secure, having data processing agreements with third parties who process personal data, providing information to individuals regarding data processing activities, responding to individuals’ requests to exercise their rights in respect of their personal data, where required, obtaining consent of the individuals to whom the personal data relates, reporting security and privacy breaches involving personal data to the competent national data protection authority and affected individuals, appointing data protection officers, conducting data protection impact assessments, and record-keeping.
The United States government has established guidelines that suggest that it is lawful for pharmaceutical manufacturers to make donations to charitable organizations who provide copay assistance to Medicare patients, provided that such organizations, among other things, are bona fide charities, are entirely independent of and not controlled by the manufacturer, provide aid to applicants on a first-come basis according to consistent financial criteria and do not link aid to use of a donor's product.
The United States government has established guidelines that suggest that it is lawful for pharmaceutical manufacturers to make donations to charitable organizations who provide copay assistance to Medicare patients, provided that such organizations, among other things, are bona fide charities, are entirely independent of and not 47 Table of Contents controlled by the manufacturer, provide aid to applicants on a first-come basis according to consistent financial criteria and do not link aid to use of a donor's product.
International jurisdictions require separate regulatory approvals and compliance 41 Table of Contents with numerous and varying regulatory requirements. The approval procedures vary among countries and may involve requirements for additional testing, and the time required to obtain approval may differ from country to country and from that required to obtain clearance or approval in the United States.
International jurisdictions require separate regulatory approvals and compliance 44 Table of Contents with numerous and varying regulatory requirements. The approval procedures vary among countries and may involve requirements for additional testing, and the time required to obtain approval may differ from country to country and from that required to obtain clearance or approval in the United States.
In addition, the current military conflicts between Russia and Ukraine and Israel and Hamas could disrupt or otherwise adversely impact our operations.
In addition, the military conflicts between Russia and Ukraine and Israel and Hamas could disrupt or otherwise adversely impact our operations.
Legislative proposals are pending that, if enacted, could negatively impact U.S. funding for certain biotechnology providers, including some of our vendors, that have relationships with certain foreign governments 33 Table of Contents or which pose a threat to national security.
Legislative proposals are pending that, if enacted, could negatively impact U.S. funding for certain biotechnology providers, including some of our vendors, that have relationships with certain foreign governments 35 Table of Contents or which pose a threat to national security.
As further discussed in "Note 2 - Basis of presentation and summary of significant accounting policies and estimates" to our consolidated financial statements, for the years ended December 31, 2024, 2023 and 2022, four customers accounted for over 90% of the Company’s gross product revenue.
As further discussed in "Note 2 - Basis of presentation and summary of significant accounting policies and estimates" to our consolidated financial statements, for the years ended December 31, 2025, 2024 and 2023, four customers accounted for over 90% of the Company’s gross product revenue.
Risk Related to Employment Matters Our business could suffer if we lose the services of key members of our senior management or if we are not able to attract and retain other key employees and consultants. We are dependent upon the continued services of key members of our executive management and a limited number of key advisors and personnel.
Risks Related to Employment Matters Our business could suffer if we lose the services of key members of our senior management or if we are not able to attract and retain other key employees and consultants. We are dependent upon the continued services of key members of our executive management and a limited number of key advisors and personnel.
Even with the FDA approval of Recorlev, Gvoke and Keveyis in the United States, and the EMA and MHRA approval of Ogluo in the European Union ("EU") and the United Kingdom ("UK"), we may not be able to obtain or maintain foreign regulatory approvals to market our products in other countries.
Even with the FDA approval of Recorlev, Gvoke and Keveyis in the United States, and the EMA and MHRA approval of Ogluo in the EU and the United Kingdom ("UK"), we may not be able to obtain or maintain foreign regulatory approvals to market our products in other countries.
For example, under Section 174 of the Code, in taxable years beginning after December 31, 2021, expenses that are incurred for research and development in the United States are capitalized and amortized, which may have an adverse effect on our cash flow.
For example, under Section 174 of the Code, in taxable years beginning after December 31, 2024, expenses that are incurred for research and development in the United States are capitalized and amortized, which may have an adverse effect on our cash flow.
Further, exclusivity may not effectively protect the product from competition because different drugs with different active moieties can be approved for the same condition, the same drugs can be approved for different indications and might then be used off-label in our approved indication, and different drugs for the same condition may already be approved and commercially available.
Further, exclusivity may not effectively protect the product from competition because different drugs with different active moieties can be approved for the same approved use or indication, the same drugs can be approved for different indications and might then be used off-label in our approved indication, and different drugs for the same condition may already be approved and commercially available.
In addition, any testing by us conducted in connection with Section 404 of the Sarbanes-Oxley Act, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement.
In addition, any testing by us conducted in connection with Section 404 of the Sarbanes-Oxley Act of 2002, as amended (the "Sarbanes-Oxley Act"), or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement.
As a result, we may not obtain sufficient quantities of products, product candidates, components or other 32 Table of Contents key materials in the future, which could have a material adverse effect on our business as a whole.
As a result, we may not obtain sufficient quantities of products, product candidates, components or other 34 Table of Contents key materials in the future, which could have a material adverse effect on our business as a whole.
If a patent infringement lawsuit is filed within 45 days of the patent owner’s or NDA holder’s receipt of notice (whichever is later), a one-time, automatic stay of the FDA’s ability to approve the 505(b)(2) NDA is triggered, which typically extends for 30 months unless patent litigation is resolved in favor of the Paragraph IV filer or the patent expires before that time.
If a patent infringement lawsuit is filed within 45 days of the patent owner’s or NDA holder’s receipt of notice (whichever is later), a one-time, automatic stay of the FDA’s ability to approve the 57 Table of Contents 505(b)(2) NDA is triggered, which typically extends for 30 months unless patent litigation is resolved in favor of the Paragraph IV filer or the patent expires before that time.
For example, the conflicts could result in sanctions, export controls or other actions that may be initiated by nations including the United States, the EU, Russia or countries or actors in the Middle East 63 Table of Contents (e.g., potential cyberattacks, disruption of energy flows, etc.) that could adversely affect our business and/or our supply chain or those of our third-party service providers.
For example, the conflicts could result in sanctions, export controls or other actions that may be initiated by nations including the United States, the EU, Russia or countries or actors in the Middle East (e.g., potential cyberattacks, disruption of energy flows, etc.) that could adversely affect our business and/or our supply chain or those of our third-party service providers.
If our ESG practices fail to meet investor, customer, consumer, employee or other stakeholders’ evolving expectations and standards in areas such as environmental 64 Table of Contents stewardship, board of directors and employee diversity, human capital management, corporate governance and transparency, our reputation could be negatively impacted, which could have a material adverse effect on our business or financial condition.
If our ESG practices fail to meet investor, customer, consumer, employee or other stakeholders’ evolving expectations and standards in areas such as environmental stewardship, board of directors and employee diversity, human capital management, corporate governance and transparency, our reputation could be negatively impacted, which could have a material adverse effect on our business or financial condition.
At December 31, 2024 and 2023, the same four customers accounted for over 90% of the trade accounts receivable, net. We expect to continue to depend upon a relatively small number of customers for a high percentage of our revenue.
At December 31, 2025 and 2024, the same four customers accounted for over 90% of the trade accounts receivable, net. We expect to continue to depend upon a relatively small number of customers for a high percentage of our revenue.
The Convertible Notes are convertible into shares of our common stock at any time at the option of the holder subject to certain conditions. We have reserved a sufficient number of shares of common stock for issuance upon conversion of the Convertible Notes, CVRs and warrants.
The 2028 Convertible Notes are convertible into shares of our common stock at any time at the option of the holder subject to certain conditions. We have reserved a sufficient number of shares of common stock for issuance upon conversion of the 2028 Convertible Notes and warrants.
In addition, we will continue to incur costs associated with our public company reporting requirements, and we expect those costs may 60 Table of Contents increase in the future, particularly since we ceased to qualify as an "emerging growth company," as defined in the Jumpstart Our Business Startups Act enacted in April 2012, as of December 31, 2023 and as a "smaller reporting company" as of June 30, 2023.
In addition, we will continue to incur costs associated with our public company reporting requirements, and we expect those costs may increase in the future, particularly since we ceased to qualify as an "emerging growth company," as defined in the Jumpstart Our Business Startups Act enacted in April 2012, as of December 31, 2023 and as a "smaller reporting company" as of June 30, 2023.
In addition, patent holding companies that focus solely on extracting royalties and settlements by enforcing patent rights may target us. As the biotechnology and pharmaceutical industries 51 Table of Contents expand and more patents are issued, the risk increases that our products and product candidates may be subject to claims of infringement of the intellectual property rights of third parties.
In addition, patent holding companies that focus solely on extracting royalties and settlements by enforcing patent rights may target us. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our products and product candidates may be subject to claims of infringement of the intellectual property rights of third parties.
Such fraud or abuse or other issues, if they occur and are not successfully remediated, could have a material adverse effect on our research, development, and commercialization activities and results. 37 Table of Contents Risks Related to the Product Development and Regulatory Approval of Our Product Candidates Risks Related to Regulatory Approval We cannot be certain that our product candidates will receive marketing approval.
Such fraud or abuse or other issues, if they occur and are not successfully remediated, could have a material adverse effect on our research, development, and commercialization activities and results. Risks Related to the Product Development and Regulatory Approval of Our Product Candidates Risks Related to Regulatory Approval We cannot be certain that our product candidates will receive marketing approval.
A default under the Indentures or the fundamental change itself could also lead to a default under agreements governing our other existing or future indebtedness, which may result in that other indebtedness becoming immediately payable in full. For instance, a fundamental change without lender consent would constitute an event of default under our Amended and Restated Credit Agreement.
A default under the 2028 Indenture or the fundamental change itself could also lead to a default under agreements governing our other existing or future indebtedness, which may result in that other indebtedness becoming immediately payable in full. For instance, a fundamental change without lender consent would constitute an event of default under our Amended and Restated Credit Agreement.
The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly 45 Table of Contents reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.
The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.
Also, regulatory approval for any of our product candidates may be withdrawn. 38 Table of Contents Clinical failure may occur at any stage of clinical development, and the results of our clinical trials may not support our proposed indications for our product candidates.
Also, regulatory approval for any of our product candidates may be withdrawn. 41 Table of Contents Clinical failure may occur at any stage of clinical development, and the results of our clinical trials may not support our proposed indications for our product candidates.
Securities litigation brought against us in connection with volatility in our stock price, regardless of the merit or ultimate results of such litigation, could result in substantial costs, which would hurt our financial condition and operating results and divert management’s attention and resources from our business. 56 Table of Contents The conversion of any of the Convertible Notes or other convertible securities into shares of common stock could have a material dilutive effect that could cause our share price to decline.
Securities litigation brought against us in connection with volatility in our stock price, regardless of the merit or ultimate results of such litigation, could result in substantial costs, which would hurt our financial condition and operating results and divert management’s attention and resources from our business. 61 Table of Contents The conversion of the 2028 Convertible Notes or other convertible securities into shares of common stock could have a material dilutive effect that could cause our share price to decline.
Federal net operating losses generated in taxable years beginning after December 31, 2017 can be carried forward indefinitely; however, such net operating losses may only offset up to 80% of taxable income in taxable years beginning after December 31, 2024.
Federal net operating losses generated in taxable years beginning after December 31, 2017 can be carried forward indefinitely; however, such net operating losses may only offset up to 80% of taxable income in taxable years beginning after December 31, 2025.
If we experience significant shortages in the supply of our marketed products, our results could be materially impacted. 34 Table of Contents We are party to a number of material agreements which contain complex commercial terms that could result in litigation or liability that could adversely affect our business, results of operations and financial condition.
If we experience significant shortages in the supply of our marketed products, our results could be materially impacted. We are party to a number of material agreements which contain complex commercial terms that could result in litigation or liability that could adversely affect our business, results of operations and financial condition.
The patent positions of pharmaceutical, biotechnology and other life sciences companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. Changes in either the patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property.
The patent positions of pharmaceutical, biotechnology and other life sciences companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. Changes in either the patent laws or in 53 Table of Contents interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property.
In addition, increased scrutiny by the United States Congress of the FDA’s approval process may significantly delay or prevent 42 Table of Contents marketing approval of those product candidates for which we seek marketing approval, as well as subject us to more stringent labeling and post-marketing testing and other requirements.
In addition, increased scrutiny by the United States Congress of the FDA’s approval process may significantly delay or prevent marketing approval of those product candidates for which we seek marketing approval, as well as subject us to more stringent labeling and post-marketing testing and other requirements.
If any of these actions are successful, in addition to any potential liability for damages, we could be required to obtain a license to continue to manufacture or market the affected product, in which case we may be required to pay substantial royalties or grant cross-licenses to our patents.
If any of these actions are successful, in addition to any potential liability for damages, we could be required to obtain a license to continue to manufacture or market the affected product, in which case we may be required to pay substantial royalties or grant cross- 56 Table of Contents licenses to our patents.
Risk Related to Intellectual Property Laws Changes to the patent law in the United States and other jurisdictions could diminish the value of our patents in general, thereby impairing our ability to protect our products. As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.
Risk Related to Intellectual Property Laws Changes to the patent law in the United States and other jurisdictions could diminish the value of our patents in general, thereby impairing our ability to protect our products. 58 Table of Contents As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.
In a reporting period, we have in the past and may in the future constrain revenue for product returns based on information from various sources, including channel inventory levels, inventory dating, prescription data, the expiration dates of product, price changes of 29 Table of Contents competitive products and introductions of generic products.
In a reporting period, we have in the past and may in the future constrain revenue for product returns based on information from various sources, including channel inventory levels, inventory dating, prescription data, the expiration dates of product, price changes of competitive products and introductions of generic products.
We are dependent and may in the future be dependent upon other pharmaceutical companies, academic scientists and other researchers to sell or license product candidates, approved products or the underlying technology to us. The process of proposing, negotiating and implementing a license or acquisition of a product candidate or approved product is lengthy and complex.
We are dependent and may in the future be dependent upon other pharmaceutical companies, academic scientists and other researchers to sell or license product candidates, approved products or the underlying technology to us. The process of proposing, negotiating and 50 Table of Contents implementing a license or acquisition of a product candidate or approved product is lengthy and complex.
Our existing net operating losses or credits may be subject to limitations arising from previous ownership changes, and if we undergo future ownership changes, many of which may be outside of 57 Table of Contents our control, our ability to utilize our net operating losses or credits could be further limited by Sections 382 and 383 of the Code.
Our existing net operating losses or credits may be subject to limitations arising from previous ownership changes, and if we undergo future ownership changes, many of which may be outside of our control, our ability to utilize our net operating losses or credits could be further limited by Sections 382 and 383 of the Code.
There is no assurance 48 Table of Contents that all of the potentially relevant prior art relating to our patents and patent applications has been found. If such prior art exists, it may be used to invalidate a patent or may prevent a patent from issuing from a pending patent application.
There is no assurance that all of the potentially relevant prior art relating to our patents and patent applications has been found. If such prior art exists, it may be used to invalidate a patent or may prevent a patent from issuing from a pending patent application.
These provisions may also prevent changes in our management or limit the price that investors are willing to pay for our stock. In addition, certain provisions in the Indentures governing our Convertible Notes could make a third-party attempt to acquire us more difficult or expensive.
These provisions may also prevent changes in our management or limit the price that investors are willing to pay for our stock. In addition, certain provisions in the Indenture governing our 2028 Convertible Notes could make a third-party attempt to acquire us more difficult or expensive.
Even with respect to the indications for which we have received orphan designation, we may not be the first to obtain marketing approval for any particular orphan indication due to the uncertainties associated with developing pharmaceutical products, and thus approval of our product candidates could be blocked for seven years if another company previously obtained approval and orphan drug exclusivity for the same drug and same condition.
Even with respect to the indications for which we have received orphan designation, we may not be the first to obtain marketing approval for any particular orphan indication due to the uncertainties associated with developing pharmaceutical products, and thus approval of our product candidates could be blocked for seven years if another company previously obtained approval and orphan drug exclusivity for the same drug and same approved use or indication.
We may not have sufficient funds to satisfy all amounts due under the other indebtedness and the Convertible Notes. In addition, we have $200.0 million of term loans outstanding under our Amended and Restated Credit Agreement as of December 31, 2024.
We may not have sufficient funds to satisfy all amounts due under the other indebtedness and the 2028 Convertible Notes. In addition, we have $200.0 million of term loans outstanding under our Amended and Restated Credit Agreement as of December 31, 2025.
Inaccurate data could cause us to estimate our return reserves incorrectly and could have an adverse impact on our results of operations and financial condition. Risks Related to the Commercialization and Marketing of our Products and Product Candidates Risks Related to Commercialization and Marketing Our business depends entirely on the commercial success of our products and product candidates.
Inaccurate data could cause us to estimate our return reserves incorrectly and could have an adverse impact on our results of operations and financial condition. 31 Table of Contents Risks Related to the Commercialization and Marketing of our Products and Product Candidates Risks Related to Commercialization and Marketing Our business depends entirely on the commercial success of our products and product candidates.
Risks Related to our Indentures for our Convertible Notes, Charter and Bylaws Provisions in the Indentures for our Convertible Notes and corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management or hinder efforts to acquire a controlling interest in us.
Risks Related to our Indenture for our 2028 Convertible Notes, Charter and Bylaws Provisions in the Indenture for our 2028 Convertible Notes and corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management or hinder efforts to acquire a controlling interest in us.
In some cases, even this limited 46 Table of Contents bioequivalence testing can be waived by the FDA. Laws have also been enacted to facilitate the development of generic drugs and biologics based off recently approved NDAs and BLAs.
In some cases, even this limited bioequivalence testing can be waived by the FDA. Laws have also been enacted to facilitate the development of generic drugs and biologics based off recently approved NDAs and BLAs.
These risks and uncertainties include the following: the United States Patent and Trademark Office ("USPTO") and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process.
These risks and uncertainties include the following: 52 Table of Contents the United States Patent and Trademark Office ("USPTO") and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process.
In addition, our accumulated deficit as of December 31, 2024 was $671.9 million. We expect to continue to incur significant operating expenses as we continue the commercialization of Recorlev, Gvoke and Keveyis, develop, enhance and commercialize new products, and incur additional operational and reporting costs associated with being a public company.
In addition, our accumulated deficit as of December 31, 2025 was $671.3 million. We expect to continue to incur significant operating expenses as we continue the commercialization of Recorlev, Gvoke, and Keveyis, develop, enhance and commercialize new products, and incur additional operational and reporting costs associated with being a public company.
Efforts to ensure that our business arrangements with third parties, and our business generally, comply with applicable healthcare laws and regulations involve substantial costs.
Efforts to ensure that our business arrangements or interactions with third parties, and our business generally, comply with applicable healthcare laws and regulations involve substantial costs.
Even if they are unchallenged, our patents and pending patent applications, if issued, may not provide us with any meaningful protection or prevent competitors from designing around our patent claims to circumvent our patents by developing similar or alternative technologies or therapeutics in a non-infringing manner.
Even if they are unchallenged, our patents and pending patent applications, if issued, may not provide us with any meaningful protection or prevent competitors from designing around our patent claims to circumvent our patents by developing similar or 51 Table of Contents alternative technologies or therapeutics in a non-infringing manner.
In these adversarial actions, the USPTO reviews patent claims without the presumption of validity afforded to the United States patents 54 Table of Contents in lawsuits in the United States federal courts and uses a lower burden of proof than used in litigation in the United States federal courts.
In these adversarial actions, the USPTO reviews patent claims without the presumption of validity afforded to the United States patents in lawsuits in the United States federal courts and uses a lower burden of proof than used in litigation in the United States federal courts.
Any inability to transfer personal data from the EEA and UK to the United States in compliance with data protection laws may impede our ability to conduct trials and may adversely affect our business and financial position. 61 Table of Contents The EU commission has adopted its adequacy decision for the EU-U.S.
Any inability to transfer personal data from the EEA and UK to the United States in compliance with data protection laws may impede our ability to conduct trials and may adversely affect our business and financial position. The EU commission has adopted its adequacy decision for the EU-U.S.
To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost effectiveness of our product candidates to other available therapies.
To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost 45 Table of Contents effectiveness of our product candidates to other available therapies.
If such banking institution or any future banking institutions where we maintain our cash were to fail, we could lose all or a portion of those amounts held in excess of such insurance limits.
If such banking institution or any future banking 70 Table of Contents institutions where we maintain our cash were to fail, we could lose all or a portion of those amounts held in excess of such insurance limits.
If our products do not achieve and maintain market acceptance, we will not be able to generate sufficient revenue from product sales to attain profitability. We operate in a competitive business environment, which may have an adverse impact on our revenue .
If our products do not achieve and maintain market acceptance, we will not be able to generate sufficient revenue from product sales to attain profitability. 32 Table of Contents We operate in a competitive business environment, which may have an adverse impact on our revenue .
To counter infringement or unauthorized use, we may be required to file infringement lawsuits, which can be expensive and time consuming and divert the time and attention of our management and scientific personnel.
To counter 55 Table of Contents infringement or unauthorized use, we may be required to file infringement lawsuits, which can be expensive and time consuming and divert the time and attention of our management and scientific personnel.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe have established a cybersecurity incident response plan and provide cybersecurity training to our employees and monitor their activity for adherence to our security protocols. As of the date of this report, we have not experienced a cybersecurity incident that resulted in a material effect on our business strategy, results of operations, or financial condition.
Biggest changeWe have established a cybersecurity incident response plan and provide cybersecurity training to our employees and monitor their activity for adherence to our security protocols. 71 Table of Contents As of the date of this report, we have not experienced a cybersecurity incident that resulted in a material effect on our business strategy, results of operations, or financial condition.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Removed
ITEM 3. LEGAL PROCEEDINGS We are not currently subject to any material legal proceedings. From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities.
Added
ITEM 3. LEGAL PROCEEDINGS We received Paragraph IV certification notice letters (each, a “Notice Letter”) from three pharmaceutical companies (each, an “ANDA Filer”), providing notification to us that each ANDA Filer had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of RECORLEV®.
Removed
Although the results of litigation and claims cannot be predicted with certainty, as of the date of this report, we do not believe we are party to any claim or litigation the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably expected to have a material adverse effect on our business.
Added
The ANDAs each contained Paragraph IV certifications alleging that four of our Orange Book listed patents covering RECORLEV® that are scheduled to expire in March 2040 (U.S. Patent Numbers 11,020,393, 11,278,547, 11,903,940, and 12,377,096) are invalid, unenforceable and/or will not be infringed by each ANDA Filer’s manufacture, use or sale of the generic product described in its respective ANDA submission.
Removed
Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Added
On February 26, 2026, our wholly-owned subsidiaries, Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited, filed a patent infringement lawsuit under the Hatch-Waxman Act in the United States District Court for the District of New Jersey against Torrent Pharmaceuticals Limited (along with its affiliate, "Torrent") and Somerset Therapeutics, LLC (along with its affiliates, "Somerset").
Added
Our complaint alleges that, by filing the ANDAs, each of Torrent and Somerset has infringed RECORLEV®’s Orange Book patents included in its respective Paragraph IV certification, and seek an injunction preventing the FDA from granting final approval of the ANDA before the expiration of the asserted patents, and a permanent injunction to prevent Torrent and Somerset from commercializing a generic version of RECORLEV®, until the expiration of the asserted patents, including any applicable extensions and additional periods of exclusivity.
Added
No trial date has been set. The filing of the lawsuit within 45 days of receipt of each of the respective Notice Letters triggered an automatic stay of the FDA’s approval of each of the respective ANDAs for up to 30 months in accordance with the Hatch-Waxman Act. ANDA litigation is common in the U.S. pharmaceutical industry.
Added
We may receive additional Notice Letters in the future from ANDA filers seeking approval of a generic version of RECORLEV® and may file additional ANDA lawsuits in the future. We intend to enforce and defend our intellectual property rights related to RECORLEV®. We are also involved in various other legal proceedings arising in the normal course of business.
Added
Although the outcomes of these other legal proceedings are inherently difficult to predict, we do not expect the resolution of these other legal proceedings to have a material adverse effect on our financial position, results of operations, or cash flows.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe stockholder returns shown on the graph below are based on historical results and are not necessarily indicative of future performance, and we do not make or endorse any predictions as to future stockholder returns.
Biggest changeThe stockholder returns shown on the graph below are based on historical results and are not necessarily indicative of future performance, and we do not make or endorse any predictions as to future stockholder returns. $100 investment in stock or index Ticker 2021 2022 2023 2024 2025 Xeris XERS $ 100.00 $ 45.39 $ 80.20 $ 115.70 $ 267.92 Nasdaq Composite Total Return XCMP $ 100.00 $ 67.46 $ 97.58 $ 126.44 $ 153.17 Nasdaq Biotechnology (Total Return) Index XNBI $ 100.00 $ 89.88 $ 94.01 $ 93.47 $ 124.72 73 Table of Contents
An investment of $100 is assumed to have been made in our common stock (including our predecessor entity) and each index on December 31, 2019 and its relative performance is tracked through December 31, 2024.
An investment of $100 is assumed to have been made in our common stock (including our predecessor entity) and each index on December 31, 2021 and its relative performance is tracked through December 31, 2025.
Holders of Record On March 4, 2025, there were approximately 196 stockholders of record of our common stock, one of which is Cede & Co., a nominee for Depository Trust Company ("DTC").
Holders of Record On February 27, 2026, there were approximately 114 stockholders of record of our common stock, one of which is Cede & Co., a nominee for Depository Trust Company ("DTC").
Removed
December 31, $100 investment in stock or index Ticker 2019 2020 2021 2022 2023 2024 Xeris XERS $ 100.00 $ 69.79 $ 41.56 $ 18.87 $ 33.33 $ 48.09 Nasdaq Composite Total Return XCMP $ 100.00 $ 144.92 $ 177.06 $ 119.45 $ 172.77 $ 223.87 Nasdaq Biotechnology (Total Return) Index XNBI $ 100.00 $ 126.42 $ 126.45 $ 113.65 $ 118.87 $ 118.20 66 Table of Contents

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeResults of Operations The following table summarizes our results of operations for the year ended December 31, 2024 and 2023 (in thousands): 69 Table of Contents Years Ended December 31, Change 2024 2023 $ % Product revenue, net: Gvoke $ 82,829 $ 67,045 $ 15,784 23.5 Recorlev 64,277 29,547 34,730 117.5 Keveyis 49,530 56,772 (7,242) (12.8) Product revenue, net 196,636 153,364 43,272 28.2 Royalty, contract and other revenue 6,434 10,550 (4,116) (39.0) Total revenue 203,070 163,914 39,156 23.9 Cost and expenses: Cost of goods sold, excluding amortization of intangible assets 36,832 28,645 8,187 28.6 Research and development 25,560 22,341 3,219 14.4 Selling, general and administrative 163,481 146,095 17,386 11.9 Amortization of intangible assets 10,843 10,843 — — Total cost and expenses 236,716 207,924 28,792 13.8 Loss from operations (33,646) (44,010) 10,364 (23.5) Other income (expense): Interest and other income 5,321 4,751 570 12.0 Loss on debt extinguishment — (2,837) 2,837 (100.0) Debt refinancing costs (2,690) — (2,690) 100.0 Interest expense (30,485) (26,609) (3,876) 14.6 Change in fair value of warrants 8 1 7 700.0 Change in fair value of contingent value rights 4,388 5,200 (812) (15.6) Total other expense (23,458) (19,494) (3,964) 20.3 Net loss before benefit from income taxes (57,104) (63,504) 6,400 (10.1) Income tax benefit 2,268 1,249 1,019 81.6 Net loss $ (54,836) $ (62,255) $ 7,419 (11.9) Product revenue, net Gvoke Net revenue increased by $15.8 million or 23.5% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
Biggest changeResults of Operations The following table summarizes our results of operations for the years ended December 31, 2025 and 2024 (in thousands): 76 Table of Contents Years Ended December 31, Change 2025 2024 $ % Product revenue, net: Recorlev $ 139,283 $ 64,277 $ 75,006 116.7 Gvoke 94,108 82,829 11,279 13.6 Keveyis 47,649 49,530 (1,881) (3.8) Other product revenue 1,963 — 1,963 — Product revenue, net 283,003 196,636 86,367 43.9 Royalty, contract and other revenue 8,842 6,434 2,408 37.4 Total revenue 291,845 203,070 88,775 43.7 Cost and expenses: Cost of goods sold, excluding amortization of intangible assets 42,569 36,832 5,737 15.6 Research and development 31,165 25,560 5,605 21.9 Selling, general and administrative 182,372 163,481 18,891 11.6 Amortization of intangible assets 10,843 10,843 — — Total cost and expenses 266,949 236,716 30,233 12.8 Income (loss) from operations 24,896 (33,646) 58,542 174.0 Other income (expense): Interest and other income 4,742 5,321 (579) (10.9) Debt refinancing costs — (2,690) 2,690 100.0 Interest expense (29,084) (30,485) 1,401 (4.6) Change in fair value of warrants — 8 (8) (100.0) Change in fair value of contingent value rights — 4,388 (4,388) (100.0) Total other expense (24,342) (23,458) (884) 3.8 Net income (loss) before income taxes 554 (57,104) 57,658 101.0 Income tax benefit — 2,268 (2,268) 100.0 Net income (loss) $ 554 $ (54,836) $ 55,390 101.0 Product revenue, net Recorlev Net revenue increased by $75.0 million or 116.7% for the year ended December 31, 2025 compared to the year ended December 31, 2024.
Other income (expense) Other income (expense) consists primarily of interest expense related to our convertible debt and loan, interest income earned on deposits and investments, debt refinancing costs and gains and losses on the change in fair value of the Contingent Value Rights ("CVRs").
Other income (expense) Other income (expense) consists primarily of interest expense related to our loan and convertible debt, interest income earned on deposits and investments, debt refinancing costs and gains and losses on the change in fair value of the Contingent Value Rights ("CVRs").
Revenue is recognized when our customer (e.g., a wholesaler or specialty pharmacy) obtains control of promised goods or services, which is when our obligations under the terms of the contract with the customer are satisfied, based on the consideration we expect to receive in exchange for those goods or services.
Revenue is recognized when our customer (e.g., a wholesaler or specialty pharmacy) obtains control of promised goods, which is when our obligations under the terms of the contract with the customer are satisfied, based on the consideration we expect to receive in exchange for those goods.
Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those set forth in Part I, Item 1A. Risk Factors, of this Annual Report. This discussion and analysis compares 2024 results to 2023.
Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those set forth in Part I, Item 1A. Risk Factors, of this Annual Report. This discussion and analysis compares 2025 results to 2024.
In the near term, we expect to continue to incur net losses as we: continue our marketing and selling efforts related to commercialization of Recorlev, Gvoke and Keveyis; continue our research and development efforts; continue to operate as a public company; and continue to fund our operations with an increased cost of borrowing due to a higher interest rate environment and tighter lending requirements.
In the near term, we may incur net losses as we: continue our marketing and selling efforts related to commercialization of Recorlev, Gvoke and Keveyis; continue our research and development efforts; continue to operate as a public company; and continue to fund our operations with an increased cost of borrowing due to a higher interest rate environment and tighter lending requirements.
In addition, we may not be profitable even if we commercialize any of our product candidates. Components of our Results of Operations The following discussion sets forth certain components of the statement of operations of Xeris for the year ended December 31, 2024 and 2023 as well as factors that impact those items.
In addition, we may not be profitable even if we commercialize any of our product candidates. Components of our Results of Operations The following discussion sets forth certain components of the statement of operations of Xeris for the year ended December 31, 2025 and 2024 as well as factors that impact those items.
Cost of goods sold also includes losses from excess, slow-moving or obsolete inventory and inventory purchase commitments, if any. Research and development expenses 68 Table of Contents Research and development expenses consist of expenses incurred in connection with the discovery and development of our products and product candidates. We recognize research and development expenses as incurred.
Cost of goods sold also includes losses from excess, slow-moving or obsolete inventory and inventory purchase commitments, if any. 75 Table of Contents Research and development expenses Research and development expenses consist of expenses incurred in connection with the discovery and development of our products and product candidates. We recognize research and development expenses as incurred.
For discussion and analysis that compares 2023 results to 2022, see Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in Part II, Item 7. of this Annual Report for the year ended December 31, 2023.
For discussion and analysis that compares 2024 results to 2023, see Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in Part II, Item 7. of this Annual Report for the year ended December 31, 2024.
We are a commercial-stage biopharmaceutical company focused on developing and commercializing therapies for people with chronic endocrine and neurological diseases in the United States. We offer Recorlev for the treatment of Cushing’s syndrome, Gvoke for the treatment of severe hypoglycemia, and Keveyis for the treatment of Primary Periodic Paralysis ("PPP").
We are a commercial-stage biopharmaceutical company focused on developing and commercializing therapies for people with chronic endocrine and neurological diseases in the United States. We offer Recorlev for the treatment of endogenous hypercortisolemia in patients with Cushing’s syndrome, Gvoke for the treatment of severe hypoglycemia, and Keveyis for the treatment of Primary Periodic Paralysis ("PPP").
We accrue estimated rebates and discounts based on actual average rebate amounts and estimated percent of product that will be prescribed to qualified patients and record the 73 Table of Contents rebates as a reduction of product revenue. Accrued government rebates are included in accrued trade discounts and rebates on the consolidated balance sheets.
We accrue estimated rebates and discounts based on actual average rebate amounts and estimated percent of product that will be prescribed to qualified patients and record the rebates as a reduction of product revenue. Accrued government rebates are included in accrued trade discounts and rebates on the consolidated balance sheets.
In May 2022, we entered into an Open Market Sale Agreement with Jefferies LLC, as agent, dated May 11, 2022 ("Sales Agreement") for the offering, issuance and sale of up to a maximum aggregate offering price of $75.0 million of common stock.
Financing Transactions In May 2022, we entered into an Open Market Sale Agreement with Jefferies LLC, as agent, dated May 11, 2022 ("Sales Agreement") for the offering, issuance and sale of up to a maximum aggregate offering price of $75.0 million of our common stock.
As detailed in "Note 1 – Liquidity and Capital Resources" above, there can be no assurance that such funding may be available to us on acceptable terms, or at all, or that we will be able to successfully market and sell Recorlev, Gvoke and Keveyis.
As detailed in "Note 2 – Liquidity and Capital Resources", there can be no assurance that such funding may be available to us on acceptable terms, or at all, or that we will be able to successfully market and sell Recorlev, Gvoke and Keveyis.
The Sales Agreement will terminate upon the earlier of (i) the sale of all shares of common stock subject to the Sales Agreement and (ii) the 71 Table of Contents termination of the Sales Agreement as permitted therein. Either party may each terminate the Sales Agreement at any time upon ten days’ prior notice.
The Sales Agreement will terminate upon the earlier of (i) the sale of all shares of common stock subject to the Sales Agreement and (ii) the termination of the Sales Agreement as permitted therein. Either party may each terminate the Sales Agreement at any time upon ten days’ prior notice.
We expect to incur substantial additional expenditures in the near term to support the marketing and selling of Recorlev, Gvoke and Keveyis as well as our ongoing research and development activities. We expect to continue to incur net losses for at least the next twelve months.
We may incur substantial additional expenditures in the near term to support the marketing and selling of Recorlev, Gvoke and Keveyis as well as our ongoing research and development activities. We may incur net losses for at least the next twelve months.
The cash provided by financing activities in 2024 was primarily due to the net proceeds of $38.2 million from the term loan made to the Company on the closing date of the Amended and Restated Credit Agreement.
The net cash provided by financing activities in the year ended December 31, 2024 was primarily due to the net proceeds of $38.2 million from the term loan made to the Company on the closing date of the Amended and Restated Credit Agreement.
The Credit Agreement provides for the New Lenders to extend $200.0 million in term loans to the Company on the closing date and up to an additional $15.2 million in additional term loans, which additional term loans are available only to redeem the Company's 2025 Convertible Notes.
The Amended and Restated Credit Agreement provides for the Lenders to extend $200.0 million in term loans to the Company on the closing date and up to an additional $15.2 million in additional term loans, which additional term loans are available only to redeem the Company's then outstanding 2025 Convertible Notes.
The increase was due to higher volume ($30.8 million or 104.4%) and favorable net pricing ($3.9 million or 13.1%). Keveyis Net revenue decreased by $7.2 million or 12.8% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
The increase was due to favorable net pricing ($8.6 million or 10.4%) and higher volume ($2.7 million or 3.2%). Keveyis Net revenue decreased by $1.9 million or 3.8% for the year ended December 31, 2025 compared to the year ended December 31, 2024.
The decrease in net cash used in operating activities was primarily driven by reduced working capital usage. For a discussion regarding product revenue, net and increases in spending, refer to "Results of Operations" included in this "Item 7 - Management's Discussion and Analysis of Financial Condition and Results of Operations" of Part I of this Annual Report.
The increase in net cash provided by operating activities was primarily driven by higher product sales. For a discussion regarding product revenue, net and increases in spending, refer to "Results of Operations" included in this "Item 7 - Management's Discussion and Analysis of Financial Condition and Results of Operations" of Part I of this Annual Report.
Based on our current operating plans and existing working capital at December 31, 2024, we believe that our cash resources are sufficient to sustain operations and capital expenditure requirements for at least the next twelve months.
Capital Resources and Funding Requirements We have an accumulated deficit of $671.3 million at December 31, 2025. Based on our current operating plans and existing working capital at December 31, 2025, we believe that our cash resources are sufficient to sustain operations and capital expenditure requirements for at least the next twelve months.
Cash Flows Years Ended December 31, ( in thousands ) 2024 2023 Net cash used in operating activities $ (36,981) $ (47,023) Net cash used in investing activities $ 4,883 $ (6,004) Net cash provided by/(used in) financing activities $ 36,168 $ (1,613) Operating Activities Net cash used in operating activities was $37.0 million for the year ended December 31, 2024, compared to $47.0 million used for the year ended December 31, 2023.
Cash Flows Years Ended December 31, ( in thousands ) 2025 2024 Net cash provided by (used in) operating activities $ 28,626 $ (36,981) Net cash provided by (used in) investing activities $ (696) $ 4,883 Net cash provided by financing activities $ 11,389 $ 36,168 Operating Activities Net cash provided by operating activities was $28.6 million for the year ended December 31, 2025, compared to $37.0 million used in operating activities for the year ended December 31, 2024.
Amortization of intangible assets For the years ended December 31, 2024 and December 31, 2023, amortization of intangible assets were both $10.8 million. Other income (expense) For the year ended December 31, 2024, interest expense increased $3.9 million or 14.6% compared to the year ended December 31, 2023.
Amortization of intangible assets For the years ended December 31, 2025 and December 31, 2024, amortization of intangible assets were both $10.8 million, respectively. Other income (expense) For the year ended December 31, 2025, interest expense decreased $1.4 million or 4.6% compared to the year ended December 31, 2024.
For the years ended December 31, 2024 and 2023, we reported net losses of $54.8 million and $62.3 million, respectively. We have not been profitable since inception, and, as of December 31, 2024, our accumulated deficit was $671.9 million .
For the year ended December 31, 2024 we reported a net loss of $54.8 million. The year ended December 31, 2025 is the first year we have been profitable since inception, and, as of December 31, 2025, our accumulated deficit was $671.3 million .
In March 2024, we entered into an Amended and Restated Credit Agreement and Guaranty (the "Amended and Restated Credit Agreement") with the lenders from time to time parties thereto (the "New Lenders") and Hayfin Services LLP, as administrative agent for the New Lenders, pursuant to which we and our subsidiaries granted a first priority security interest on substantially all of our assets, including intellectual property, subject to certain exceptions.
In September 2023, we completed the exchange of $32.0 million in aggregate principal amount of our 5.00% Convertible Senior Note due 2025 ("2025 Convertible Notes") for $33.6 million in aggregate principal amount of our 8.00% Convertible Senior Note due 2028 ("2028 Convertible Notes"). 78 Table of Contents In March 2024, we entered into an Amended and Restated Credit Agreement and Guaranty (the "Amended and Restated Credit Agreement") with the lenders from time to time parties thereto (the "Lenders") and Hayfin Services LLP, as administrative agent for the New Lenders, pursuant to which we and our subsidiaries granted a first priority security interest on substantially all of our assets, including intellectual property, subject to certain exceptions.
Investing Activities 72 Table of Contents Net cash provided by investing activities was $4.9 million for the year ended December 31, 2024, compared to $6.0 million used for the year ended December 31, 2023. The c ash provided by investing activities in 2024 was primarily due to fewer purchases of short-term investments.
The decrease in c ash provided by investing activities for the year ended December 31, 2025 was due to was due to fewer purchases of short-term investments. Financing Activities Net cash provided by financing activities was $11.4 million for the year ended December 31, 2025, compared to $36.2 million provided by financing activities for the year ended December 31, 2024.
The following table summarizes our research and development expenses by type for the year ended December 31, 2024 and 2023: Years Ended December 31, Change 2024 2023 $ % Project specific expenses: Pipeline $ 6,945 $ 5,941 $ 1,004 16.9 Technology development (1) 1,160 1,720 (560) -32.6 Personnel related expenses 14,296 12,069 2,227 18.5 Lab supplies and equipment depreciation 1,655 1,409 246 17.5 Other 1,504 1,202 302 25.1 Total $ 25,560 $ 22,341 $ 3,219 14.4 (1) Technology development represents any investment in our proprietary technology platforms, XeriSol and XeriJect.
The following table summarizes our research and development expenses by type for the year ended December 31, 2025 and 2024: Years Ended December 31, Change 2025 2024 $ % Project specific expenses: Pipeline $ 9,681 $ 6,945 $ 2,736 39.4 Technology development (1) 1,005 1,160 (155) (13.4) Personnel related expenses 17,818 14,296 3,522 24.6 Lab supplies and equipment depreciation 1,422 1,655 (233) (14.1) Other 1,239 1,504 (265) (17.6) Total $ 31,165 $ 25,560 $ 5,605 21.9 (1) Technology development represents any investment in our proprietary technology platforms, XeriSol and XeriJect.
Accrued copay fees are recorded as a reduction of product revenue and included in accrued trade discounts and rebates on the consolidated balance sheets. Commercial Rebates We contract with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, to provide rebates with respect to utilization of the products and contracted formulary status.
Commercial Rebates We contract with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, to provide rebates with respect to utilization of the products and contracted formulary status.
NEW ACCOUNTING STANDARDS Refer to "Note 2 - Basis of presentation and summary of significant accounting policies and estimates," for a description of recent accounting pronouncements applicable to our financial statements.
We record estimated product returns in accrued returns reserve on the consolidated balance sheets and as a reduction of product revenue. NEW ACCOUNTING STANDARDS Refer to "Note 2 - Basis of presentation and summary of significant accounting policies and estimates," for a description of recent accounting pronouncements applicable to our financial statements. 80 Table of Contents
Financing Activities Net cash provided by financing activities was $36.2 million for the year ended December 31, 2024, compared to $1.6 million used for the year ended December 31, 2023.
Investing Activities Net cash used in investing activities was $696.0 thousand for the year ended December 31, 2025, compared to $4.9 million in net cash provided by investing activities for the year ended December 31, 2024.
Government Rebates We participate in certain federal and state government rebate programs such as the Medicaid Drug Rebate Program, TRICARE Retail Refunds Program, and Medicare Part D Program.
If actual results differ from its estimates, adjustments are made to these allowances in the period in which the actual results or updates to estimates become known. Government Rebates We participate in certain federal and state government rebate programs such as the Medicaid Drug Rebate Program, TRICARE Retail Refunds Program, and Medicare Part D Program.
The increase was due to higher volume ($12.0 million or 17.9%), primarily driven by prescription growth, and favorable net pricing ($3.8 million or 5.6%). Recorlev Net revenue increased by $34.7 million or 117.5% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
The increase was due to higher volume ($79.6 million or 123.9%), primarily driven by increased patient demand, offset by unfavorable net pricing ($4.6 million or 7.2%). Gvoke Net revenue increased by $11.3 million or 13.6% for the year ended December 31, 2025 compared to the year ended December 31, 2024.
Selling, general and administrative expenses Selling, general and administrative expenses increased by $17.4 million or 11.9% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
Research and development expenses Research and development expenses increased by $5.6 million or 21.9% for the year ended December 31, 2025 compared to the same period ended December 31, 2024.
As of December 31, 2024, the outstanding balance of the 2025 Convertible Notes was $15.2 million and the outstanding balance of the 2028 Convertible Notes was $33.6 million.
In March and April of 2025, holders of the 2025 Convertible Senior Notes converted the outstanding $15.2 million in aggregate principal amount of the notes into 4,978,152 shares of the Company's common stock. As of December 31, 2025, the outstanding balance of the 2028 Convertible Notes was $33.6 million.
The decrease was due to lower volume ($8.3 million or 14.6%) partially offset by favorable net pricing ($1.1 million or 1.9%). Cost of goods sold Cost of goods sold increased by $8.2 million or 28.6% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
The decrease was due to unfavorable net pricing ($5.0 million or 10.1%), offset by higher volume ($3.1 million or 6.3%). Other product revenue Net revenue increased by $2.0 million for the year ended December 31, 2025. This includes sales of our products to commercialization partners.
Cost of goods sold as a percent of total product revenue was 18.7% for the years ended December 31, 2024 and December 31, 2023. Additional inventory reserves from process changes required for Gvoke capacity expansion ($4.5 million or 2.3%) were offset by higher sales of products with a lower cost of goods sold (2.3%).
Cost of goods sold as a percent of total revenue improved by 3.7%, to 15.0% for the year ended December 31, 2025 compared to 18.7% for the same period ended December 31, 2024, primarily due to higher sales of products with a lower cost of goods sold ($8.9 million or 4.5%), offset by a one-time credit for Keveyis purchased in 2024 ($1.6 million or 0.8%).
We leverage our proprietary formulation technologies (XeriSol and XeriJect) in the creation of new products such as our own XP-8121 (once-weekly subcutaneous (SC) levothyroxine) as well as through the formation of development partnerships with other biopharmaceutical companies. Financing We have funded our operations to date primarily with proceeds from the sale of our common stock and debt financing.
We are advancing our Phase 3-ready pipeline product, XP-8121, once-weekly subcutaneous ("SC") levothyroxine, which leverages our proprietary technology XeriSol. Financing We have funded our operations to date primarily with proceeds from the sale of our common stock and debt financing. For the year ended December 31, 2025 we reported a net income of $0.6 million.
The increase is primarily due to a higher principal amount and increased interest rates. For the year ended December 31, 2024, change in fair value of CVRs was a gain of $4.4 million, compared to $5.2 million for the year ended December 31, 2023.
The decrease is primarily due to a lower principal amount of debt outstanding during the period. For the year ended December 31, 2025, interest and other income decreased $0.6 million or 10.9% compared to the year ended December 31, 2024.
For the year ended December 31, 2024, debt refinancing costs were $2.7 million related to the third party debt arrangements for advisory and legal fees.
Royalty, contract and other revenue Royalty, contract and other revenue increased $2.4 million for the year ended December 31, 2025 compared to the year ended December 31, 2024.
Removed
Income tax We have incurred operating losses since inception and therefore do not have any taxable income.
Added
The increase primarily reflects the recognition of milestones from partnership agreements. 77 Table of Contents Cost of goods sold Cost of goods sold increased by $5.7 million or 15.6% for the year ended December 31, 2025 compared to the same period ended December 31, 2024.
Removed
As of December 31, 2024, we had federal net operating loss carryforwards of $480.1 million and various state net operating loss carryforwards of $375.1 million, $6.1 million in federal income tax credits will begin to expire in 2038, and the $5.5 million of state economic development and research and development credits began to expire in 2024.
Added
Selling, general and administrative expenses Selling, general and administrative expenses increased $18.9 million or 11.6% for the year ended December 31, 2025 compared to the same period ended December 31, 2024. This increase was primarily due to higher personnel related expense ($13.5 million), largely due to personnel-related expenses to support the commercial enterprise, including the Recorlev expansion.
Removed
Research and development expenses 70 Table of Contents Research and development expenses increased by $3.2 million or 14.4% for the year ended December 31, 2024 compared to the year ended December 31, 2023, primarily driven by higher personnel related expense ($2.2 million), and increased spending for our pipeline ($1.0 million).
Added
The decrease is driven by the decline in interest rates which began in the later half of 2024, resulting in lower overall interest income.
Removed
This increase was due to higher personnel related expense ($13.5 million), primarily due to investments made in the Recorlev commercial organization in the fourth quarter 2023 and the third quarter 2024, and the CEO succession plan and related restructuring the third quarter 2024 ($6.1 million), partially offset by lower external spend.
Added
To date, we have not sold any shares pursuant to the Sales Agreement.
Removed
The gains were primarily due to the remeasurement of the CVR liability as a result of changes in our stock price prior to issuance of the common stock issued in settlement of a CVR in the first quarter of 2024 and the release of the CVR liability related to the Recorlev 2024 sales milestone.
Added
The net cash provided by financing activities for the year ended December 31, 2025 was driven by proceeds from the exercise of stock awards and issuance of common shares in settlement of 79 Table of Contents warrants of $20.7 million offset by repurchase of common stock withheld for taxes of $10.9 million.
Removed
Financing Transactions In March 2022, we entered into a Credit Agreement and Guaranty, as amended (the "Credit Agreement") with the lenders from time to time parties thereto (the "Lenders") and Hayfin Services LLP, as administrative agent for the Lenders, pursuant to which we and our subsidiaries granted a first priority security interest on substantially all of our assets, including intellectual property, subject to certain exceptions.
Removed
The Credit Agreement provided for the Lenders to extend $100.0 million in term loans to us on the closing date and up to an additional $50.0 million in delayed draw term loan(s) during the one year period immediately following the closing date (collectively, the "Loans").
Removed
In December 2022, we borrowed the full amount of such $50.0 million delayed draw term loan under the Credit Agreement.
Removed
In conjunction with the execution of the Credit Agreement, we repaid in full the outstanding balance under our Amended and Restated Loan agreement dated September 10, 2019, as amended ("Oxford Loan Agreement") with Oxford Finance LLC ("Oxford") of $43.5 million and fees of $2.1 million in connection with the loan repayment.
Removed
In addition to utilizing the proceeds to repay the obligations under the Oxford Loan Agreement in full, the proceeds were otherwise used for general corporate purposes.
Removed
To date, we have not sold any shares pursuant to the Sales Agreement and we are unable to make sales under the Sales Agreement until a new Shelf Registration Statement is declared effective, a prospectus relating to the sales pursuant to the Sales Agreement is filed and we take certain steps in accordance with the terms of the Sales Agreement.
Removed
In September 2023, we completed the exchange of $32.0 million in aggregate principal amount of our 5.00% Convertible Senior Note due 2025 ("2025 Convertible Notes") for $33.6 million in aggregate principal amount of our 8.00% Convertible Senior Note due 2028 ("2028 Convertible Notes").
Removed
The Amended and Restated Credit Agreement amended and restated the Credit Agreement in its entirety.
Removed
Capital Resources and Funding Requirements We have incurred operating losses since inception, and we have an accumulated deficit of $671.9 million at December 31, 2024.
Removed
If actual results differ from its estimates, adjustments are made to these allowances in the period in which the actual results or updates to estimates become known. Patient Copay Assistance Program We offer savings programs to commercially insured patients under which the cost of a prescription to a patient is discounted.
Removed
We reimburse pharmacies for this discount through a third-party vendor. We record an accrual to reduce gross sales for the estimated copay on units sold to wholesalers and other customers.
Removed
The estimate is based on estimated percentages of products that will be prescribed to qualified patients, expected patient utilization of the discount program, average assistance paid based on reporting from the third-party vendor as well as industry data and estimated levels of inventory in the distribution channel.
Removed
Chargebacks We arrange with certain commercial and government entities allowing them to buy products directly from wholesalers at specific prices. These entities purchase products through wholesalers at the discounted price and the wholesalers charge the difference between their list price and the discounted price back to us.
Removed
We accrue estimated chargebacks based on estimated percentages of products sold to these entities, contract prices, and estimated levels of inventory in the distribution channel and record the chargebacks as a reduction of product revenue. Accrued chargebacks are recorded as an allowance against trade receivables on the consolidated balance sheets.
Removed
While we believe that our returns reserve is sufficient to avoid a significant reversal of revenue in future periods, if it were to increase or decrease the rate by 1%, it would have a $ 1.8 million impact on revenue in the year ended December 31, 2024.
Removed
We record estimated product returns in accrued returns reserve on the consolidated balance sheets and as a reduction of product revenue. Contingent considerations The fair value of the CVRs was calculated by using a discounted cash flow method for the Keveyis patent milestone and an option pricing method for the Recorlev and Keveyis sales milestones.
Removed
In the case of Keveyis milestones, we applied a scenario-based method and weighted them based on the possible achievement of the milestone. This fair value measurement is based on significant inputs not observable in the market and thus represents a Level 3 measurement as defined in ASC Topic 820, Fair Value Measurement .
Removed
The key assumptions used include the discount rate and sales growth. The estimated value of the CVR consideration is based upon available information and certain assumptions which our management believes are reasonable under the circumstances. The ultimate payout under the CVRs may differ materially from the assumptions used in determining the fair value of the CVR consideration.
Removed
This value is then remeasured for future expected payout as well as the increase in fair value due to the time value of money. These gains or losses, if any, are recognized in the consolidated statements of operations and comprehensive loss.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

4 edited+0 added−0 removed3 unchanged
Biggest changeThe remaining balance of unamortized debt issuance costs have been reflected as a direct reduction to the loan balance. Interest on the 2025 Convertible Notes is assessed at a fixed rate of 5.0% annually and interest on the 2028 Convertible Notes is assessed at a fixed rate of 8.0% annually and therefore do not subject us to interest rate risk.
Biggest changeThe remaining balance of unamortized debt issuance costs have been reflected as a direct reduction to the loan balance. Interest on the 2028 Convertible Notes is assessed at a fixed rate of 8.0% annually and therefore does not subject us to interest rate risk. Foreign Currency Exchange Risk We contract with organizations outside the United States at times.
A hypothetical one-percentage point increase or decrease in interest rates applicable to our cash, cash equivalents, restricted cash and investments outstanding at December 31, 2024 would increase or decrease interest income by approximately $0.8 million on an annual basis. Long-term Debt —Our interest rate risk relates primarily to the United States dollar SOFR-indexed borrowings.
A hypothetical one-percentage point increase or decrease in interest rates applicable to our cash, cash equivalents, restricted cash and investments outstanding at December 31, 2025 would increase or decrease interest income by approximately $1.0 million on an annual basis. Long-term Debt —Our interest rate risk relates primarily to the United States dollar SOFR-indexed borrowings.
Net foreign currency gains and losses did not have a material effect on our results of operations for the year ended December 31, 2024. 74 Table of Contents
Net foreign currency gains and losses did not have a material effect on our results of operations for the year ended December 31, 2025. 81 Table of Contents
Foreign Currency Exchange Risk We contract with research organizations outside the United States at times. We may be subject to fluctuations in foreign currency exchange rates in connection with certain of these agreements. Transactions denominated in currencies other than the functional currency are recorded based on exchange rates at the time such transactions arise.
We may be subject to fluctuations in foreign currency exchange rates in connection with certain of these agreements. Transactions denominated in currencies other than the functional currency are recorded based on exchange rates at the time such transactions arise.

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