XERS 10-K & 10-Q changes, risk factors and insider trading
Xeris Biopharma Holdings, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1867096 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models could impact our product revenues and materially harm our business.”
New heading “The increasing use of social media platforms presents risks and challenges.”
Removed heading “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.”
Largest changes
“Economic uncertainty in various global markets caused by political instability, conflict and economic challenges has in the past resulted, and may continue to result, in weakened demand for our products. Geopolitical developments impacting government spending and international trade, including, changes in or disruptions of U.S. governmental agencies, whether due to potential government shutdowns or reduced resources, new laws and regulations, or amendments to existing laws and regulations in the U.S. …”see in full comparison
“Further, bad actors around the world use increasingly sophisticated methods, including the use of artificial intelligence, to engage in illegal activities involving the theft and misuse of personal information, confidential information, and intellectual property. In addition, the use of generative AI models in our internal or third-party systems may create new attack surfaces or methods for adversaries, which could impact us and our vendors. …”see in full comparison
“Regulation related to AI is evolving as new laws are implemented globally which could increase the burden and operational cost of compliance, including through requirements related to transparency, accountability, risk management, human oversight, and data governance. 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. …”see in full comparison
“For example, 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 has submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of Recorlev. The FDA’s Orange Book currently lists nine issued U.S. patents as covering Recorlev: four that expire in January 2026, one that expires in May 2028, and four that expire in March 2040. …”see in full comparison
“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.”see in full comparison
“Additionally, severe or prolonged economic downturn or additional global financial crises could result in a variety of risks to our business, including weakened demand for any product candidates we develop or our ability to raise additional capital when needed on acceptable terms, if at all. For example, on October 1, 2025, the U.S. federal government shutdown through November 12, 2025, suspending services deemed non-essential as a result of the failure by Congress to enact regular appropriations for the 2026 fiscal year. …”see in full comparison
Full comparison: every changed paragraph (88)
Historically, we have funded our operations primarily through private placements of convertible preferred stock, public offerings of common stock and convertible notes, and debt issuances. We have five pharmaceutical products that werehave been commercially launched inover the past sixseveral years, i.e., Keveyis (2017), Gvoke PFS (2019), Gvoke HypoPen (2020), Recorlev (2022), and Gvoke Kit (2022). We are in the early stages of commercializing our biopharmaceutical products and have a limited operating history.
WeFor have incurred significant losses in every fiscalthe year sinceended inception.December 31, 2025, we reported net income of $0.6 million. For the years ended December 31, 2024, 20232024 and 2022,2023, we reported a net losslosses of $54.8 million, $62.3 million and $94.7$62.3 million, respectively. In addition, our accumulated deficit as of December 31, 20242025 was $671.9$671.3 million.
We expect to continue to incur significant operating expenses as we continue the commercialization of Recorlev, GvokeGvoke, and Keveyis, develop, enhance and commercialize new products, and incur additional operational and reporting costs associated with being a public company. In particular, we anticipate that we will continue to incur significant expenses as we:
We have a history of operating losses and may never be profitable ornot be able to sustainachieve revenues or, if achieved,or sustain profitability in the futurefuture, and we may not be able to continue operations without additional fundings.
Our ability to generate revenue from Recorlev, GvokeGvoke, 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:
We have incurred and expect to continue to incur significant sales and marketing costs as we commercialize Recorlev, GvokeGvoke, and Keveyis. Regardless of these expenditures, our products and our product candidates, if developed and approved, may not be commercially successful. Although we generate revenue from Recorlev, GvokeGvoke, and Keveyis, if we are unable to generate sufficient product revenue, we will not become profitable. In addition, although we are pursuing formulation and development partnerships related to our XeriSol and XeriJect formulation technologies, we may not enter into any additional partnerships or, even if we enter into future partnerships, we may not generate significant revenue in connection with those agreements. Our failure to become and remain profitable would depress the market price of our common stock and could impair our ability to raise capital, expand our business, diversify our product offerings or continue our operations. If we continue to suffer losses as we have in the past, investors may not receive any return on their investment and may lose their entire investment.
Biopharmaceutical development is a time consuming, expensive and uncertain process that takes years to complete. We are incurring significant commercialization expenses related to product sales, marketing, manufacturing, packaging and distribution of Recorlev, GvokeGvoke, and Keveyis and expect to continue to incur such expenses for our products, as well as for any of our product candidates, if approved. We expect to require additional capital to complete the clinical trials associated with our product candidates and begin commercialization efforts, if approved. Accordingly, we may need additional funding in connection with our continuing operations. In the future, if we are unable to raise capital when needed or on attractive terms, we may be forced to delay, reduce or eliminate our research and development programs and/or sales and marketing activities. Market volatility, including due to geopolitical instability, fluctuating interest rates and inflation rates, the tightening of lending standards, any further deterioration in the macroeconomic economy or financial services industry resulting from actual or potential bank failures, or other factors could also materially and adversely impact our ability to access capital as and when needed and increase our cost of capital even if available.
On June 30, 2020, we completed a public offering of $86.3 million aggregate principal amount of our 5.00% Convertible Senior Notes due 2025 (the "2025 Convertible Notes"), including $11.3 million pursuant to the underwriters' option to purchase additional notes which was exercised in July 2020. A total principal amount of $39.1 million of the 2025 Convertible Notes converted into equity in the second half of 2020. 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"). In March and April of 2025, holders of all outstanding 2025 Convertible Notes, totaling $15.2 million in aggregate principal amount, were converted by the noteholders into 4,978,151 shares of our common stock. As of December 31, 2024, the outstanding balance of the 2025 Convertible Notes was $15.2 million and2025, the outstanding balance of the 2028 Convertible Notes was $33.6 million. Under the Amended and Restated Credit Agreement, $15.2 million of the debt facility iswas available to redeem, if needed, Xeris’the then outstanding 2025 Convertible Notes. The 2025 Convertible Notes are governed by the terms of a base indenture for senior debt securities dated June 30, 2020 (the "2025 Base Indenture"), as supplemented by the first supplemental indenture thereto dated June 30, 2020 and the second supplemental indenture thereto dated October 5, 2021 (collectively, the "2025 Supplemental Indentures" and together with the 2025 Base Indenture, the "2025 Indenture"), each between us and U.S. Bank Trust Company, National Association (f/k/a U.S. Bank National Association) ("U.S. Bank"), as trustee. The 2028 Convertible Notes are governed by the terms of an indenture for senior debt securities dated September 29, 2023 (the "2028 Indenture" and together with the 2025 Indenture, the "Indentures") between us and U.S. Bank,Bank Trust Company, National Association (f/k/a U.S. Bank National Association) ("U.S. Bank"), as trustee. Failure to satisfy our current and future debt obligations under the Indentures2028 Indenture could result in an event of default and, as a result, all of the amounts outstanding could immediately become due and payable. In the event of an acceleration of amounts due under the Indentures as a result of an event of default, we may not have sufficient funds or may be unable to arrange for additional financing to repay our indebtedness.
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. 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. In addition, applicable law, regulatory authorities and the agreements governing our existing and future indebtedness may restrict our ability to repurchase the 2028 Convertible Notes. Our failure to repurchase the 2028 Convertible Notes when required will constitute a default under the Indentures2028 Indenture that governgoverns the 2028 Convertible Notes. A default under the Indentures2028 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. 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, 2024.2025. All obligations under our Amended and Restated Credit Agreement are secured by substantially all of our property and assets, including our intellectual property assets, subject to certain limited exceptions. 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. Failure to satisfy our current and future debt obligations under our Amended and Restated Credit Agreement could result in an event of default thereunder and, as a result, our lenders could accelerate all amounts due. Events of default also include our failure to comply with customary affirmative and negative covenants as well as a default under any indenture or other agreement governing convertible indebtedness permitted by the Amended and Restated Credit Agreement, including the Indentures. The Amended and Restated Credit Agreement contains customary representations and warranties, events of default and affirmative and negative covenants, including, among others, covenants that limit or restrict our ability to incur additional indebtedness, grant liens, merge or consolidate, make acquisitions, pay dividends or other distributions or repurchase equity, make investments, dispose of assets and enter into certain transactions with affiliates, in each case subject to certain exceptions. In the event of an acceleration of amounts due under our Amended and Restated Credit Agreement as a result of an event of default, we may not have sufficient funds or may be unable to arrange for additional financing to repay our indebtedness. In addition, our lenders could seek to enforce their security interests in any collateral securing such indebtedness.
To date, we have expended significant time, resources, and effort on the development of our product candidates, and a substantial portion of our resources recently has been and will continue to be focused on marketing and commercializing our approved products, Recorlev, GvokeGvoke, and Keveyis, in the United States. Our business and future success are substantially dependent on our ability to generate and increase product revenue in the near term. Our estimates of the potential market opportunity for Recorlev, Gvoke, Recorlev,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. While we believe that our internal assumptions are reasonable, if any of these assumptions proves to be inaccurate, the actual market for our product and product candidates could be smaller than our estimates of our potential market opportunity. Our product candidates are in various stages of development and subject to the risks of failure inherent in developing drug products. Any delay or setback in the regulatory approval, product launch, commercialization or distribution of any of our product candidates will adversely affect our business. The infrastructure, systems, processes, policies, relationships and materials we have built for the commercialization of Recorlev, Gvoke and Keveyis may not be sufficient for us to achieve success at the levels we expect. Further, our products may contain undetected manufacturing defects, including mislabeling, which might require product replacement, re-labeling or product recalls, which could further harm our business. For more information, see the section entitled, "Business — Coverage and Reimbursement".
For example, we are aware of various companies that are marketing existing drugs that may compete with Recorlev, such as Corcept Therapeutics and Recordati. To our knowledge, the products used for the treatment of endogenous Cushing's syndrome patients who fail or are ineligible for surgery in the United States and Europe are: Korlym (mifepristone) marketed by Corcept Therapeutics in the United States; Signifor LAR (pasireotide) and Isturisa (osilodrostat), both marketed by Recordati in the United States and European Union ("EU"); and ketoconazole, metyrapone and mitotane marketed by HRA in the EU. Corcept is developing relacorilant, a second-generation glucocorticoid receptor modulator; currently in Phase 3. Ketoconazole is used off-label for treatment of Cushing's syndrome in the United States. Regulatory approval of ketoconazole for the treatment of endogenous Cushing's syndrome in the United States, which is not currently being sought by any sponsor to our knowledge, could significantly increase competition for Recorlev due to the similar mechanisms of action between the drug products.
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. At any time, these or other industry participants may develop alternative treatments, products, or procedures for the treatment of severe hypoglycemia that compete directly or indirectly with Gvoke.
We are also currently aware of various companies that are marketing existing drugs that may compete with Recorlev, such as Corcept Therapeutics and Recordati. To our knowledge, the products used for the treatment of endogenous Cushing's syndrome patients who fail or are ineligible for surgery in the United States and Europe are: Korlym (mifepristone) marketed by Corcept Therapeutics in the United States; Signifor LAR (pasireotide) and Isturisa (osilodrostat), both marketed by Recordati in the United States and European Union ("EU"); and ketoconazole, metyrapone and mitotane marketed by HRA in the EU. Corcept is developing relacorilant, a second-generation glucocorticoid receptor modulator; currently in Phase 3. Ketoconazole is used off-label for treatment of Cushing's syndrome in the United States. Regulatory approval of ketoconazole for the treatment of endogenous Cushing's syndrome in the United States, which is not currently being sought by any sponsor to our knowledge, could significantly increase competition for Recorlev due to the similar mechanisms of action between the drug products.
Any disruption to the facilities or operations of our third-party suppliers resulting from weather-related events, epidemics, global health concerns, fire, acts of terrorism, political instability, war, labor or geopolitical issues, or any other cause could materially impair our ability to manufacture our products and to distribute our products to customers. 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. For example, the Israel-Hamas war could result in damage, destruction or disruptions to the facilities or operations of our third-party suppliers, including, but not limited to, our supplier of Keveyis, longer lead times for our products or product candidates, export delays or restrictions or other adverse events which adverse events we cannot predict with any certainty. Any interruption or other delay in the production or delivery of our supplies could reduce sales of our products and increase our costs and any negative impact of such matters on our third-party suppliers and manufacturers may also have an adverse impact on our results of operations or financial condition. In addition, further attacks by Hamas, Hezbollah or other groups on Israel could further impact our third-party supplier's operations in Israel. Furthermore, a widening of the conflict in the Middle East or further escalation could lead to broader geopolitical destabilization and macro-economic impacts.
Further, as part of their manufacture of our products, product candidates, components and other key materials, our third-party suppliers are expected to comply with and respect the rights of others. From time to time, our third-party suppliers have in the past and may in the future not properly maintain or defend intellectual property rights that they license to us or act in such a way as to invite complaints and litigation that could jeopardize or invalidate our intellectual property or other rights or expose us to potential litigation. If a third-party supplier has failed or fails to maintain or acquire the proper licenses, otherwise infringes the proprietary rights of others or otherwise breaches an agreement with any of their partners in the course of providing services to us, we may have to find alternative third-party suppliers or defend against litigation claims, either of which would significantly impact our ability to develop, obtain or maintain regulatory approval for or commercialize our products and our product candidates, if approved. There are a limited number of third-party suppliers that are compliant with CGMP and/or the QSR, as required by the FDA, the EU, and other regulatory authorities, and that also have the necessary expertise and capacity to manufacture our materials and products. As a result, it may be difficult for us to locate third-party suppliers for our anticipated future needs, and our anticipated growth could strain the ability of our current third-party suppliers to deliver products, raw materials, and components to us. In addition, there is typically a transition period when a new third-party supplier commences work. 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 or which pose a threat to national security. For example, on December 18, 2025, the National Defense Authorization Act for Fiscal Year 2026 ("NDAA") was enacted, which includes Section 851, commonly referred to as the "BIOSECURE Act." The BIOSECURE Act restricts U.S. government agencies from procuring certain biotechnology equipment or services from, or entering into contracts with, entities that use biotechnology equipment or services from designated "biotechnology companies of concern," and from expending certain federal loan or grant funds for such equipment or services. While the BIOSECURE Act is primarily directed at U.S. government procurement and funding and has not yet been fully implemented through final regulations, there remains a continued policy interest in limiting U.S. companies' relationships with biotechnology providers with relationships with foreign adversaries. Its implementation has the potential to impact supply of our products and services, and if we are required to change manufacturers or service providers for any reason, we will be required to verify that the new manufacturer or provider maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines. The potential downstream adverse impacts on entities having only commercial relationships with any impacted biotechnology providers is unknown but may include supply chain disruptions or delays. If we are unable to arrange for third-party suppliers for our materials and products, or to do so on commercially reasonable terms, we may not be able to complete development of or market our products.
Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models could impact our product revenues and materially harm our business.
On May 12, 2025, President Trump issued an executive order calling on pharmaceutical manufacturers to voluntarily reduce the prices of medicines in the U.S. and directing the Secretary of Health and Human Services (HHS) to communicate MFN price targets to pharmaceutical manufacturers to align prices with those in comparably developed nations and, in the event significant progress towards MFN pricing is not delivered, to propose rulemaking to impose MFN pricing.
Since the May 12, 2025 order, the Trump administration has continued to exert pressure on drug manufacturers to implement MFN pricing, including by suggesting that the administration may impose significant tariffs on pharmaceuticals if such manufacturers do not reach agreements to implement MFN pricing. Further, in November 2025, CMS introduced the GENEROUS Model, a voluntary Medicaid payment initiative under which participating drug manufacturers may voluntarily offer supplemental rebates to participating state Medicaid programs that are intended to provide such Medicaid programs with an MFN price for the manufacturers’ products. Additionally, in December 2025, CMS announced proposals for new mandatory demonstration payment models through two proposed rules under its Center for Medicare and Medicaid Innovation (“CMMI”) authority, the Global Benchmark for Efficient Drug Pricing (GLOBE) for Medicare Part B and Guarding U.S. Medicare Against Rising Drug Costs (GUARD) for Medicare Part D. If finalized, these models would impose additional mandatory rebates on manufacturers of certain Medicare Part B and Medicare Part D drugs, for select Medicare populations intended to represent 25% of Medicare patients, if the Medicare prices for such products exceed those paid in economically comparable countries. Both the GLOBE and GUARD models have proposed seven-year testing periods, with the GLOBE model proposed to begin on October 1, 2026 and the GUARD model proposed to begin on January 1, 2027.
If the GLOBE and GUARD models are finalized as proposed under CMMI authority, we could be required to pay additional rebates on products reimbursed by Medicare for the covered populations during the applicable model periods. In addition, if MFN pricing or similar reference pricing policies are enacted or implemented in the U.S. outside of the CMMI framework and applied more broadly, we could be required to pay rebates on products on utilization by a broader portion of U.S. patients to align with prices in certain reference countries. We currently derive the substantial portion of our revenue from U.S. sales, and any requirement to pay additional rebates in the U.S. to match international reference prices would impact our overall net revenue.
MFN pricing models in the U.S. could also affect our international pricing strategy and future decisions on reimbursement and commercialization in certain jurisdictions. If our U.S. pricing becomes tied to international reference prices, we may face decisions regarding pricing in foreign markets that could result in reduced patient access internationally, affect our relationships with foreign regulatory authorities and payers, or impact our ability to obtain or maintain reimbursement approvals in ex-U.S. markets.
These reforms remain subject to change, potential legal challenges, or expansion through additional rulemaking or sub regulatory guidance, creating uncertainty for our overall pricing strategy. It remains to be seen whether and how these drug pricing initiatives will apply to our products, how they will affect the broader pharmaceutical industry, and whether similar reform measures may be adopted in the future.
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.
We are currently party to various material agreements, including (i) collaboration and license agreements for the use of certain of our intellectual property by third parties, (ii) supply agreements for the supply of materials and components used in our products and product candidates, (iii) distribution agreements for the commercialization of our existing or future products by third parties, and (iv) transaction agreements. These agreements contain complex commercial terms, including:
From time to time, we have had and may in the future have informal dispute resolution discussions with third parties regarding the appropriate interpretation of the complex commercial terms contained in our agreements. One or more of these informal dispute resolution discussions may ultimately result in costly litigation, require us to make payments or incur liabilities, result in the unfavorable interpretation of contract terms and/or result in the inability for us to commercialize one or more of our products or manufacture one or more of our product candidates, which would have a material adverse impact on our business, results of operations or financial condition. In addition, many of the rights we have received related to our products or product candidates were received from parties who in turn received those rights from other parties to which we are not in privity of contract. Our counterparties have in the past and may in the future be subject to disputes that they have breached the terms of the agreements from which our rights are derived but to which we are not a party or act in such a way as to invite complaints and litigation that could jeopardize or invalidate our intellectual property or other rights or expose us to potential litigation. If one of our partners breached an agreement with any of their partners in the course of providing services or rights to us, we may have to defend against litigation claims, which would significantly impact our ability to develop, obtain or maintain regulatory approval for or commercialize our products and our product candidates, if approved.
For our product candidates in development, undesirable side effects that may be caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials, and result in delay of, or failure to obtain, marketing approval from the FDA and other regulatory authorities, or result in marketing approval from the FDA and other regulatory authorities with restrictive label warnings, and for our approved products, the emergence of new or more serious side effects may cause regulatory authorities to impose additional requirements on our marketing and monitoring of these products. The range and potential severity of possible side effects from systemic therapies are significant. Recent developments in the pharmaceutical industry have prompted heightened government focus on safety reporting during both pre- and post-approval time periods and pharmacovigilance. 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 5five 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. In addition, drug-related side effects of our product candidates could affect patient recruitment or the ability of enrolled patients to complete the trial or could also adversely affect physician or patient acceptance thereof. Any of these occurrences may harm our business, financial condition and prospects.
If a product that has orphan drug designation subsequently receives the first FDA approval for a particular active ingredient for the disease for which it has such designation, the product is entitled to orphan drug exclusivity. 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. Similarly, the FDA can subsequently approve a drug with the same active moiety for the same conditionapproved use or indication during the exclusivity period if the FDA concludes that the later drug is clinically superior, meaning the later drug is safer, more effective or makes a major contribution to patient care. In assessing whether a drug provides a "major contribution to patient care" over and above the currently approved drugs, which is evaluated by the FDA on a case-by-case basis, there is no one objective standard and the FDA may, in appropriate circumstances, consider such factors as convenience of treatment location, duration of treatment, patient comfort, reduced treatment burden, advances in ease and comfort of drug administration, longer periods between doses, and potential for self-administration. However, such a demonstration to overcome the seven-year market exclusivity may be difficult to establish with limited precedents and there can be no assurance that we will be successful in these efforts if and where we pursue them. 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.approved use or indication. If we do obtain exclusive marketing rights in the United States, they may be limited if we seek approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective or if we are unable to assure sufficient quantities of the product to meet the needs of the relevant patients. Further, exclusivity may not effectively protect the product from competition because different drugs with different active moieties can be approved for the same condition,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.
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.
In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay regulatory approval of our product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any products or product candidates for which we obtain marketing approval. For example, in December 2020, CMS issued a final rule implementing significant manufacturer price reporting changes under the Medicaid Drug Rebate Program, including an alternative rebate calculation for a line extension that is tied to the price increases of the original drug, and Best Price reporting related to certain value-based purchasing arrangements. Under the American Rescue Plan Act of 2021, effective January 1, 2024, the statutory cap on Medicaid Drug Rebate Program rebates that manufacturers pay to state Medicaid programs is eliminated. Elimination of this cap may, in some cases, require pharmaceutical manufacturers to pay more in rebates than they receive on the sale of products. It is unclear to what extent these regulations or any future legislation or regulations will affect our business, including our ability to generate revenue and achieve profitability. For more information, see the section entitled, "Business — Healthcare Reform".
The cost of prescription pharmaceuticals in the United States has also been the subject of considerable debate, and members of Congress have indicated that they will address such costs through new legislative measures. To date, there have been several recent United States congressional inquiries and proposed state and federal legislation designed to, among other things, improve transparency in drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the costs of drugs under Medicare, and reform government program reimbursement methodologies for drug products. There has recently been intense publicity regarding the pricing of pharmaceutical products generally, including publicity and pressure resulting from the prices charged for new products as well as price increases for older products that the government and public deem excessive. WeRecent mayCMS experienceproposals, downwardincluding the GLOBE, GUARD, and GENEROUS which seek to incorporate MFN pricing pressureprincipals oninto thefederal pricereimbursement offor prescription drugs, could materially impact our products due to social or political pressure to lower the cost of drugs, which could reduce our revenue and future profitability. Many companies in our industry have received governmental requests for documents and information relating to drug pricing and patient support programs. We could incur significant expense and experience reputational harm as a result of these or other similar future inquiries, as well as reduced market acceptance and demand for our products, which could harm our ability to market our products in the future. These factors could also result in changes in our product pricing and distribution strategies, reduced demand for our products and/or reduced reimbursement of products, including by federal health care programs such as Medicare and Medicaid and state health care programs.revenue.
We may experience downward pricing pressure on the price of our products due to social or political pressure to lower the cost of drugs, which could reduce our revenue and future profitability. Many companies in our industry have received governmental requests for documents and information relating to drug pricing and patient support programs. We could incur significant expense and experience reputational harm as a result of these or other similar future inquiries, as well as reduced market acceptance and demand for our products, which could harm our ability to market our products in the future. These factors could also result in changes in our product pricing and distribution strategies, reduced demand for our products and/or reduced reimbursement of products, including by federal health care programs such as Medicare and Medicaid and state health care programs.
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. Approved products, third-party suppliers and their facilities are required to comply with extensive FDA requirements and requirements of other regulatory authorities even after approval, including ensuring that quality control and manufacturing procedures conform to CGMPs and applicable QSRs and applicable product tracking and tracing requirements. As such, we and our third-party suppliers are subject to continual review and periodic inspections, both announced and unannounced, to assess compliance with CGMPs and the QSR. Accordingly, we and our third-party suppliers must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control. We will also be required to report certain adverse events and production problems, if any, to the FDA and other regulatory authorities and to comply with certain requirements concerning advertising and promotion of our products. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label. Accordingly, we may not promote our approved products for indications or uses for which they are not approved.
Regulatory agencies may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of a product. Additionally, under FDORA,the Food and Drug Omnibus Reform Act ("FDORA"), sponsors of approved drugs and biologics must provide 6six months’ notice to the FDA of any changes in marketing status, suchor asfor discontinuing or interrupting supply of certain drugs, including the withdrawal of a drug, and failure to do so could result in the FDA placing the product on a listletter citing such failure to comply and public posting of discontinuedsuch products,letter and redacted company response which wouldcould revokedamage theour product’s ability to be marketed.reputation. The FDA, the FTC and other agencies and government entities, including the DOJ and the Office of Inspector General of HHS, closely regulate and monitor the post-approval marketing and promotion of products to ensure that they are manufactured, marketed and distributed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers’ communications regarding off-label use, and if we, or any future collaborators, do not market any of our products for which we, or they, receive marketing approval for only their approved indications, we, or they, may be subject to warning or enforcement action for off-label marketing, government investigations, or litigation. Violation of the FDCA and other statutes, including the FCA, relating to the promotion and advertising of prescription drugs may lead to investigations or allegations of violations of federal and state healthcare fraud and abuse laws and state consumer protection laws. On June 7, 2023, we received an untitled letter from FDA’s Office of Prescription Drug Promotion ("OPDP") regarding specific sections of the Recorlev consumer website. The letter raised concerns that the webpages made false or misleading claims about the safety and efficacy of Recorlev that misbrand Recorlev within the meaning of the FDCA. We submitted a response to the FDA regarding our plan to revise those sections of the webpages at issue. The FDA completed evaluation of our response and issued a close-out letter in August 2023 stating that it appears that we have addressed all the concerns contained in the untitled letter. In the current administration, the FDA has increased its enforcement scrutiny over prescription drug advertising, particularly direct-to-consumer product promotion and advertising. If the FDA finds any of our promotional communications or advertising to be violative, we may receive an untitled or warning letter, requests for corrective advertising, or fines, amongst other enforcement tools available to the FDA.
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. These laws and regulations may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute any products for which we obtain marketing approval. For more information, see the section entitled, "Business — Other Healthcare Laws and Compliance Requirements".
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. 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. If our operations or those of our partners are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of products from government funded healthcare programs, such as Medicare and Medicaid, disgorgement, contractual damages, diminished profits and future earnings, reputational harm and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement, deferred prosecution agreement or other agreement to resolve allegations of non-compliance with these laws, any of which could adversely affect our ability to operate our business and our financial results. Defending against any such actions can be costly and time consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.
Third party patient assistance programs that receive financial support from companies have become the subject of enhanced government and regulatory scrutiny. Government enforcement agencies have shown increased interest in pharmaceutical companies' product and patient assistance programs, including reimbursement support services, and a number of investigations into these programs have resulted in significant civil and criminal settlements. 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. However, donations to patient assistance programsorganizations have received some negative publicity and have been the subject of multiple government enforcement actions, related to allegations regarding their use to promote branded pharmaceutical products over other less costly alternatives. Specifically, in recent years, there have been multiple settlements resulting out of government claims challenging the legality of patient assistance programs under a variety of federal and state laws. It is possible that we may make grants to independent charitable foundations that help financially needy patients with their premium, copay, and co-insurance obligations. If we choose to do so, and if we or our vendors or donation recipients are deemed to fail to comply with relevant laws, regulations or evolving government guidance in the operation of these programs, we could be subject to damages, fines, penalties, or other criminal, civil, or administrative sanctions or enforcement actions. We cannot ensure that our compliance controls, policies, and procedures will be sufficient to protect against acts of our employees, business partners, or vendors that may violate the laws or regulations of the jurisdictions in which we operate. Regardless of whether we or our vendors have complied with the law, a government investigation could impact our business practices, harm our reputation, divert the attention of management, increase our expenses, and reduce the availability of foundation support for our patients who need assistance. Further, it is possible that changes in insurer policies regarding copay coupons and/or the introduction and enactment of new legislation or regulatory action could restrict or otherwise negatively affect these patient support programs, which could result in fewer patients using affected products, and therefore could have a material adverse effect on our sales, business, and financial condition.
Our failure to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program and other governmental programs could negatively impact our financial results. CMS issued a final rule that modified prior Medicaid Drug Rebate Program regulations to permit reporting multiple best price figures with regard to value‑based purchasing arrangements; and to provide definitions for “line extension,” “new formulation,” and related terms, with the practical effect of expanding the scope of drugs considered to be line extensions that are subject to an alternative rebate formula.
We currently have operations in the United States and in Ireland, and we maintain relationships with CMOs in certain parts of Europe, AsiaAsia, and the United States for the manufacture of our products and product candidates. The FCPA prohibits any United States individual or business from paying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. 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. The anti-bribery provisions of the FCPA are enforced primarily by the DOJ. The Securities and Exchange Commission ("SEC") is involved with enforcement of the books and records provisions of the FCPA and may suspend or bar issuers from having its securities traded on United States exchanges for violations of the FCPA’s accounting provisions.
Accordingly, our failure to comply with the FCPA or other export control, anti-corruption, anti-money laundering and anti-terrorism laws or regulations and other similar laws governing international business practices may result in substantial penalties, including suspension or debarment from government contracting. The termination of a government contract or relationship as a result of our failure to satisfy any of our obligations under such laws would have a negative impact on our operations and harm our reputation and ability to procure government contracts. We cannot assure you that our compliance policiespolicies, procedures, and procedurestrainings are or will be sufficient or that our directors, officers, employees, representatives, consultants and agents have not engaged and will not engage in conduct for which we may be held responsible, nor can we assure you that our business partners have not engaged and will not engage in conduct that could materially affect their ability to perform their contractual obligations to us or even result in our being held liable for such conduct.
Pending and future patent applications may not result in patents being issued which protect our business, in whole or in part, or which effectively prevent others from commercializing competitive products. For example, 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. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. In addition, the laws of foreign countries may not protect our rights to the same extent or in the same manner as the laws of the United States. For example, patent laws in various jurisdictions, including significant commercial markets such as Europe, restrict the patentability of methods of treatment of the human body more than United States law does.
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, Recorlev, Keveyis, or our product candidates. Generally, we do not conduct independent reviews of patents issued to third parties. The large number of patents, the rapid rate of new patent issuances, the complexities of the technology involved, and uncertainty of litigation increase the risk of business assets and management’s attention being diverted to patent litigation. Because patent applications can take up to 18 months after filing to become public, and many years to issue, there may be currently pending patent applications that may later result in issued patents upon which our products or product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of any of our products or product candidates, any compositions formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize such product or product candidate unless we obtained a license under the applicable patents, or until such patents expire or are finally determined to be invalid or unenforceable. Similarly, if any third-party patents were held by a court of competent jurisdiction to cover aspects of our compositions, formulations, or methods of treatment, prevention or use, the holders of any such patents may be able to block our ability to develop and commercialize the applicable product or product candidate unless we obtained a license or until such patent expires or is finally determined to be invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms, or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us.
Even where laws provide protection or we are able to obtain patents, costly and time-consuming litigation may be necessary to enforce and determine the scope of our proprietary rights, and the outcome of such litigation would be uncertain. To counter infringement or unauthorized use of any patents we may obtain, we may be required to file infringement claims, which can be expensive and time-consuming to litigate. In addition, if we or one of our future collaborators were to initiate legal proceedings against a third party to enforce a patent covering one of our products, current product candidates, or one of our future products, the defendant could counterclaim that the patent is invalid or unenforceable. In patent litigation in the U.S., defendant counterclaims alleging invalidity or unenforceability are commonplace and challenges to validity of patents in certain foreign jurisdictions are common as well. We may assert the patents in Hatch-Waxman litigation against the party filing the ANDA to keep the competing product off of the market until the patents expire but there is a risk that we will not succeed. The party filing the ANDA may also counterclaim in the litigation that our patents are not valid or unenforceable, and the court may find one or more claims of our patents invalid or unenforceable. If this occurs, a competing generic product could be marketed prior to expiration of our patents listed in the Orange Book, which would harm our business.
For example, 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 has submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of Recorlev. The FDA’s Orange Book currently lists nine issued U.S. patents as covering Recorlev: four that expire in January 2026, one that expires in May 2028, and four that expire in March 2040. In its Notice Letter, each ANDA Filer alleges that the four Orange Book listed patents 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 or will not be infringed by each ANDA Filer’s manufacture, use or sale of the generic product described in its ANDA submission. 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"). 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. 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. While we intend to enforce and defend our intellectual property rights related to Recorlev, the success of such litigation will depend on the strength of the patents covering Recorlev and our ability to prove infringement. The outcome of such litigation will be inherently uncertain and may result in potential loss of market exclusivity for Recorlev. Competition that Recorlev could face from an approved generic and other versions of Recorlev could materially and adversely affect our future revenue, profitability, and cash flows and substantially limit our ability to obtain a return on the investments we have made in developing Recorlev.
We intend to vigorously enforce and defend our intellectual property rights related to Recorlev.
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.
The ability of the FDA or other similar regulatory agencies to review and approve new products can be affected by a variety of factors, including government budget and funding levels, global health concerns, the retirement of personnel, the FDA's or other comparable regulatory authorities' ability to hire and retain key personnel and accept the payment of user fees, the availability of personnel and other resources, statutory, regulatory, executive orders and policy changes.changes, and other events that may otherwise affect the FDA's or other comparable regulatory authorities' ability to perform routine functions. Average review times at the FDA and other comparable regulatory authorities have fluctuated in recent years as a result. In addition, government funding of the SEC and other U.S. government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, including executive and congressional priorities, which is inherently fluid and unpredictable and there have been efforts to reduce the costs of government agencies. Currently, most federal agencies in the U.S. are operating under a continuing resolution that funds the federal government through January 30, 2026. The FDA is currently funded through September 30, 2026.
Disruptions and personnel turnover, as a result of leadership changes, staff reductions or otherwise, at the FDA and other agencies may also slow the time necessary for product applications to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. Changes and cuts in FDA staffing have been reported by some in the pharmaceutical industry as creating instances of delays in the FDA’s responsiveness or in its ability to review investigational new drug submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all. For example, over the last several years the United States government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. Specifically, in October 2025, the U.S. federal government entered a shutdown suspending services deemed non-essential as a result of the failure by Congress to enact regular appropriations for the 2026 fiscal year. In addition, the U.S. government has issued certain policies and executive orders directed towards reducing the employee headcount and costs associated with U.S. administrative agencies, including the FDA, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA's ability to conduct routine activities. If a prolonged government shutdown occurs, such as the one that occurred in October 2025, or if global health concerns, funding shortages or staffing limitations hinder or prevent the FDA, the SEC, or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, including formal and informal interactions with product developers, it could significantly impact the ability of the FDA or other such regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, in our operations as a public company, future government shutdowns or other substantial disruptions at other government agencies, such as the SEC, may also impact our business by delaying review of our public filings, which in turn could delay or frustrate our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations. Similar developments at regulators in other countries (including the EMA) could have similar impacts on our applications for marketing approval and on our business. In addition, changes in the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our products, including applicable pricing and reimbursement frameworks under federal healthcare programs, could affect the commercial viability of our products, create revenue uncertainty, and impact our ability to achieve profitability. Regulatory challenges may introduce new challenges in obtaining FDA approval or navigating commercialization, and any delay in securing applicable regulatory approvals would adversely affect our business and prospects.
For example, over the last several years the United States government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
RiskRisks Related to Employment Matters
We are dependent upon the continued services of key members of our executive management and a limited number of key advisors and personnel. In particular, we are highly dependent on the skills and leadership of our executive management team, including John Shannon, our Chief Executive Officer, Steven Pieper, our Chief Financial Officer, Kevin McCulloch, our President and Chief Operating Officer, KenAnh Johnson,Nguyen, our Senior Vice President, Global Development andChief Medical Affairs,Officer, and Beth Hecht, our Chief Legal Officer and Corporate Secretary. The loss of any one of these individuals could disrupt our operations or our strategic plans. In addition, we could also incur significant expenses related to the loss of any of these individuals. For example, in 2024, we incurred expenses related to the CEO succession plan. Our industry has experienced a high rate of turnover of management personnel in recent years. Any of our personnel may terminate their employment at will. If we lose one or more of our executive officers or other key employees, our ability to implement our business strategy successfully could be seriously harmed. Furthermore, replacing executive officers or other key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to develop, gain marketing approval of and commercialize products successfully.
Additionally, our future success will depend on, among other things, our ability to continue to hire and retain the necessary qualified scientific, technical, and managerial personnel, for whom we compete with numerous other companies, academic institutions, and organizations. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these additional key employees on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions.
The conversion of anythe of the2028 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.
We have a number of convertible securities outstanding, including Contingentthe Value Rights ("CVRs"),2028 Convertible Notes and warrants, and the conversion of such securities into shares of our common stock could have a material dilutive effect that could cause our share price to decline.
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, CVRsNotes and warrants. During the secondfirst half of 2020,2025, $39.1$15.2 million in principal amount of the then outstanding 2025 Convertible Notes were converted into 13,171,7914,978,151 shares of our common stock. As of December 31, 2024,2025, the outstanding balance of the 2028 Convertible Notes was $48.8$33.6 million. 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. 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. 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. In the event of certain circumstances, we will increase the conversion rate, provided that the conversion rate will not exceed 367.6470 shares of our common stock per $1,000 principal amount of Convertible Notes in the case of the 2025 Convertible Notes and 549.4505 shares of our common stock per $1,000 principal amount of Convertible Notes in the case of the 2028 Convertible Notes. 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.
Each CVR is worth up to $1.00, payable to CVR holders if future performance milestones are achieved, and settleable in cash, common stock, or a combination of cash and common stock, at our sole election. As of December 31, 2024, a performance milestone was achieved and settled in 7,525,048 shares of common stock worth $15.8 million and no other CVR obligation is outstanding.
The rules dealing with the United States federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service ("IRS") and the United States Treasury Department. For example, the One Big Beautiful Bill Act ("OBBBA Act") was signed into law on July 4, 2025 and made significant changes to U.S. federal tax law.
The rules dealing with the United States federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service ("IRS") and the United States Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect us or holders of our common stock. For example, under Section 174 of the Code, in taxable years beginning after December 31, 2021,2024, 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. Additionally, under the OBBBA Act, modifications were made to the capitalization of research and development expenses, limitations on the deductibility of interest expense and accelerated fixed asset depreciation, among other changes. In recent years, many suchchanges changesto tax laws have been made, and changes are likely to continue to occur in the future. It cannot be predicted whether, when, in what form or with what effective dates tax laws, regulations and rulings may be enacted, promulgated or issued, which could result in an increase in our or our shareholders’ tax liability or require changes in the manner in which we operate in order to minimize or mitigate any adverse effects of changes in tax law.
Risks Related to our IndenturesIndenture for our 2028 Convertible Notes, Charter and Bylaws
Provisions in the IndenturesIndenture 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 addition, certain provisions in the IndenturesIndenture governing our 2028 Convertible Notes could make a third-party attempt to acquire us more difficult or expensive. For example, if a takeover constitutes a fundamental change, then noteholders will have the right to require us to repurchase their notes for cash. In addition, if a takeover constitutes a make-whole fundamental change, then we may be required to temporarily increase the conversion rate. In either case, and in other cases, our obligations under the notes and the indentures could increase the cost of acquiring us or otherwise discourage a third party from acquiring us or removing incumbent management, including in a transaction that noteholders or holders of our common stock may view as favorable.
Management's Discussion & Analysis (MD&A)
New heading “Royalty, contract and other revenue”
Removed heading “Patient Copay Assistance Program”
Removed heading “Contingent considerations”
Largest changes
“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. 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. The key assumptions used include the discount rate and sales growth. …”see in full comparison
Selling, general and administrative expenses increasedsee in full comparisonby $17.4$18.9 million or11.9%11.6% for the year ended December 31,20242025 compared to theyearsame period ended December 31,2023.2024. This increase was primarily due to higher personnel related expense ($13.5 million),primarilylargely due toinvestmentspersonnel-relatedmadeexpensesinto support the commercial enterprise, including the Recorlevcommercial 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.expansion.
“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. The decrease is driven by the decline in interest rates which began in the later half of 2024, resulting in lower overall interest income.”see in full comparison
Full comparison: every changed paragraph (43)
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 leverageare advancing our Phase 3-ready pipeline product, XP-8121, once-weekly subcutaneous ("SC") levothyroxine, which leverages our proprietary formulationtechnology 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.XeriSol.
For the yearsyear ended December 31, 2025 we reported a net income of $0.6 million. For the year ended December 31, 2024 and 2023, we reported a net lossesloss of $54.8 millionmillion. andThe $62.3year million,ended respectively.December We31, 2025 is the first year we have not been profitable since inception, and, as of December 31, 2024,2025, our accumulated deficit was $671.9$671.3 million. In the near term, we expect to continue tomay incur net losses as we:
Other income (expense) consists primarily of interest expense related to our convertible debtloan and loan,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").
Income tax
We have incurred operating losses since inception and therefore do not have any taxable income. 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.
The following table summarizes our results of operations for the yearyears ended December 31, 20242025 and 20232024 (in thousands):
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. 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%).
Net revenue increased by $34.7$75.0 million or 117.5%116.7% for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. The increase was due to higher volume ($30.8$79.6 million or 104.4%123.9%), andprimarily favorabledriven by increased patient demand, offset by unfavorable net pricing ($3.9$4.6 million or 13.1%7.2%).
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. The increase was due to favorable net pricing ($8.6 million or 10.4%) and higher volume ($2.7 million or 3.2%).
Net revenue decreased by $7.2$1.9 million or 12.8%3.8% for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. The decrease was due to lower volume ($8.3 million or 14.6%) partially offset by favorableunfavorable net pricing ($1.1$5.0 million or 1.9%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.
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. The increase primarily reflects the recognition of milestones from partnership agreements.
Cost of goods sold increased by $8.2$5.7 million or 28.6%15.6% for the year ended December 31, 20242025 compared to the yearsame period ended December 31, 2023.2024.
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%).
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%).
Research and development expenses increased by $3.2$5.6 million or 14.4%21.9% for the year ended December 31, 20242025 compared to the yearsame period ended December 31, 2023, primarily driven by higher personnel related expense ($2.2 million), and increased spending for our pipeline ($1.0 million).2024.
Selling, general and administrative expenses increased by $17.4$18.9 million or 11.9%11.6% for the year ended December 31, 20242025 compared to the yearsame period ended December 31, 2023.2024. This increase was primarily due to higher personnel related expense ($13.5 million), primarilylargely due to investmentspersonnel-related madeexpenses into support the commercial enterprise, including 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.expansion.
For the years ended December 31, 20242025 and December 31, 2023,2024, amortization of intangible assets were both $10.8 million.million, respectively.
For the year ended December 31, 2024,2025, interest expense increaseddecreased $3.9$1.4 million or 14.6%4.6% compared to the year ended December 31, 2023.2024. The increasedecrease is primarily due to a higherlower principal amount andof increaseddebt interestoutstanding rates.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. The decrease is driven by the decline in interest rates which began in the later half of 2024, resulting in lower overall interest income.
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 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.
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.
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. 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"). In December 2022, we borrowed the full amount of such $50.0 million delayed draw term loan under the Credit Agreement. 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. 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.
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. 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. 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.
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"). 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 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. The Amended and Restated Credit Agreement amended and restated the Credit Agreement in its entirety. 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 then outstanding 2025 Convertible Notes.
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.
We have incurred operating losses since inception, and we have an accumulated deficit of $671.9$671.3 million at December 31, 2024.2025. Based on our current operating plans and existing working capital at December 31, 2024,2025, we believe that our cash resources are sufficient to sustain operations and capital expenditure requirements for at least the next twelve months. We expect tomay 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 tomay incur net losses for at least the next twelve months. Our ability to fund the marketing and selling of Recorlev, Gvoke and Keveyis, as well as our product development and clinical operations, including completion of future clinical trials, will depend on the amount and timing of cash received from product revenue and potential future financings. Our future capital requirements will depend on many factors, including, but not limited to:
As we continue the marketing and selling of Recorlev, Gvoke and Keveyis, we may not generate a sufficient amount of product revenue to fund our cash requirements. Accordingly, we may need to obtain additional financing in the future which may include public or private debt and/or equity financings. As detailed in "Note 12 – 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.
Cash Flows
Net cash usedprovided inby operating activities was $37.0$28.6 million for the year ended December 31, 2024,2025, compared to $47.0$37.0 million used in operating activities for the year ended December 31, 2023.2024. The decreaseincrease in net cash usedprovided inby operating activities was primarily driven by reducedhigher workingproduct capital usage.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.
Net cash providedused byin investing activities was $4.9$696.0 millionthousand for the year ended December 31, 2024,2025, compared to $6.0$4.9 million usedin net cash provided by investing activities for the year ended December 31, 2023.2024. The decrease in cash provided by investing activities infor 2024the year ended December 31, 2025 was primarilydue to was due to fewer purchases of short-term investments.
Net cash provided by financing activities was $36.2$11.4 million for the year ended December 31, 2024,2025, compared to $1.6$36.2 million usedprovided by financing activities for the year ended December 31, 2023.2024. 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 warrants of $20.7 million offset by repurchase of common stock withheld for taxes of $10.9 million. 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.
Revenue is recognized when our customer (e.g., a wholesaler or specialty pharmacy) obtains control of promised goods or services,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 or services.goods.
Patient Copay Assistance Program
We offer savings programs to commercially insured patients under which the cost of a prescription to a patient is discounted. 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. 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. Accrued copay fees are recorded as a reduction of product revenue and included in accrued trade discounts and rebates on the consolidated balance sheets.
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. 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.
For some products, our customers generally have the right to return product during the period beginning six months prior to the product expiration date and up to one year after the product expiration date. We use actual return data to estimate the provision for returns. In a reporting period, we may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels, inventory dating, prescription data, the expiration dates of product currently being shipped, price changes of competitive products and introductions of generic products. 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. 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. 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. 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. 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.
What changed in the latest 10-Q
Risk Factors
In addition to the information set forth in this report, you should carefully consider the risks discussed under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent filings with the SEC, which could have a material adverse effect on our business or consolidated financial statements, results of operations, and cash flows. Additional risks not currently known, or risks that are currently believed to be not material, may also impair business operations. There have been no material changes to our risk factors since the filing of our Annual Report on Form 10-K for the year ended December 31, 2025.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
Largest changes
“Cost of goods sold as a percent of total product revenue improved by 3.1%, to 13.3% for the six months ended June 30, 2026 compared to 16.4% for the same period ended June 30, 2025, primarily due to favorable product mix dynamics ($7.3 million or 5.8%), partially offset by higher write-downs of expired and excess inventory ($3.4 million or 2.7%).”see in full comparison
“For the six months ended June 30, 2026, interest expense decreased $0.8 million or 5.7% compared to the same period ended June 30, 2025. This decrease was primarily due to a reduction in the interest rate.”see in full comparison
“In July 2026, we completed the privately negotiated exchange transactions with certain holders of our 2028 Convertible Notes ("collectively, the "Exchanging Noteholders"), pursuant to which the Exchanging Noteholders exchanged approximately $23.0 million in aggregate principal amount of their 2028 Convertible Notes for an aggregate of approximately 5.0 million shares of our common stock and approximately $23.0 million in cash and, separately, a holder of approximately $10.5 million in principal amount of the 2028 Convertible Notes elected to convert its 2028 Convertible Notes into …”see in full comparison
“In June 2026, we executed an exchange agreement with certain holders of the 2028 Convertible Notes to enable settlement of the outstanding principal amount in cash. Execution of this exchange agreement resulted in recognition of an extinguishment loss of $30.8 million, which represents the difference between the amortized cost of the 2028 Convertible Notes immediately prior to the exchange and their fair value of $53.7 million, which has been presented on the Condensed Consolidated Balance Sheet as a component of the current portion of long-term debt. …”see in full comparison
Net cash used in financing activities wassee in full comparison$8.8$6.9 million for thethreesix months endedMarchJune31,30, 2026, compared to$3.1$2.2 million used in financing activities for thethreesix months endedMarchJune31,30, 2025. The net cash used in financing activities for thethreesix months endedMarchJune31,30, 2026 was primarily driven by repurchases of common stock withheld for taxes of$17.0$17.2 million, offset by proceeds from the exercise of stockawardsawards,andproceeds from issuance ofcommonshares under the employee stock purchase plan and proceeds from the issuance of sharesinof common stock upon settlement of warrants of$8.2$10.3 million. The net cash used in financing activities for thethreesix months endedMarchJune31,30, 2025 was driven by repurchases of common stock withheld for taxes of$8.0$8.9 million, offset by proceeds from the exercise of stock awards and proceeds from the issuance of$4.9shares of common stock under the employee stock purchase plan of $6.7 million.
“Selling, general and administrative expenses increased $25.8 million or 29.1% for the six months ended June 30, 2026 compared to the same period ended June 30, 2025. This increase was primarily due to higher personnel related expense ($22.7 million) to support the commercial enterprise, including the Recorlev expansion.”see in full comparison
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The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and notes to those financial statements appearing elsewhere in this Quarterly Report on Form 10-Q and with the audited financial statements and the notes to those financial statements included in the Annual Report on Form 10-K filed on March 2, 2026 with the U.S. Securities and Exchange Commission ("SEC"). In addition to financial information, the following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. All statements in this document other than statements of historical fact are, or could be, "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "will," "would," "may," "should," "expects," "focus," "goal," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue," and terms of similar meaning are also generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including without limitation, the regulatory approval of our product candidates, including potential impacts of changes in or disruptions of U.S. governmental agencies, whether from a future U.S. federal government shutdown, reduced resources or shifting policiespolicy priorities and the resulting impact on regulatory feedback and timing thereof, new laws and regulations or amendment to existing laws and regulations in the U.S and foreign counties,countries, changes in the macroeconomic conditions, such as possibility of an economic downturn, concerns regarding a potential global recession or general economic uncertainty, inflationary pressures and capital market disruptions, interest rate fluctuations, our ability to market and sell our products and product candidates if approved, increasing geopolitical tensions and military conflicts, such as the ongoing conflicts between Russia and Ukraine, the U.S. and Iran, and in the Middle East, and market volatility, including announced or implemented tariffs, and factors discussed in Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2025 and in our other subsequent filings with the SEC, including elsewhere in this Quarterly Report on Form 10-Q. Any forward-looking statements contained herein speak only as of the date hereof, and Xeris expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
As of AprilJuly 30,31, 2026, we owned 181191 patents issued globally, including composition of matter patents covering our ready-to-use glucagon formulation that expire in 2036. Included in the total patents, we have 70 granted patents globally related to our platform technologies and nine patents granted in the United States and listed in the 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. 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.
For the threesix months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025, we reported net incomelosses of $2.2$28.9 million and a net loss of $9.2$11.1 million, respectively. Our accumulated deficit was $669.1$700.2 million. In the near term, we may incur net losses as we, among other things:
The following discussion sets forth certain components of the statement of operations of Xeris for the three and six months ended MarchJune 31,30, 2026 and 2025 as well as factors that impact those items.
The following table summarizes our results of operations for the three and six months ended MarchJune 31,30, 2026 and 2025 (in thousands):
Net revenue increased by $24.2$25.3 million or 94.9%80.6% for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The increase was due to higher volume ($20.6$21.9 million or 80.8%69.6%), primarily driven by increased patient demand, and favorable net pricing ($3.6$3.4 million or 14.1%11.0%).
Net revenue increased by $49.6 million or 87.0% for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was due to higher volume ($42.6 million or 74.7%), primarily driven by increased patient demand, and favorable net pricing ($7.0 million or 12.3%).
Net revenue wasdecreased $20.8by $0.9 million or 3.9% for the three months ended MarchJune 31,30, 2026 andcompared Marchto 31,the three months ended June 30, 2025. LowerThe decrease was due to lower volume ($0.4$1.5 million or 1.9%6.5%), waspartially offset by favorable net pricing ($0.4$0.6 million or 1.7%2.6%).
Net revenue decreased by $1.0 million or 2.2% for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The decrease was due to lower volume ($1.9 million or 4.3%), partially offset by favorable net pricing ($0.9 million or 2.1%).
Net revenue increased by $0.5$0.2 million or 4.0%1.7% for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The increase was due to favorable net pricing ($0.6$0.7 million or 5.6%5.8%), partially offset by lower volume ($0.1$0.5 million or 1.6%4.1%).
Net revenue increased by $0.6 million or 2.8% for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was due to favorable net pricing ($1.3 million or 5.7%), partially offset by lower volume ($0.7 million or 2.9%).
Royalty, contract and other revenue decreased $1.6$2.7 million or 71.4% for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The decrease primarily reflects the recognition of a milestone from a partnership agreement in 2025.
Royalty, contract and other revenue decreased $4.4 million or 71.2% for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The decrease primarily reflects the recognition of a milestone from a partnership agreement in 2025.
Cost of goods sold increased by $1.8$0.6 million or 21.2%5.2% for the three months ended MarchJune 31,30, 2026 compared to the same period ended MarchJune 31,30, 2025. Cost of goods sold increased by $2.5 million or 11.9% for the six months ended June 30, 2026 compared to the same period ended June 30, 2025.
Cost of goods sold as a percent of total product revenue improved by 2.3%,3.9%, to 12.8%13.7% for the three months ended MarchJune 31,30, 2026 compared to 15.1%17.6% for the same period ended MarchJune 31,30, 2025, primarily due to favorable product mix dynamics ($2.1$4.5 million or 3.7%6.8%), partially offset by higher write-downs of expired and excess inventory ($1.4$1.9 million or 1.4%2.9%).
Cost of goods sold as a percent of total product revenue improved by 3.1%, to 13.3% for the six months ended June 30, 2026 compared to 16.4% for the same period ended June 30, 2025, primarily due to favorable product mix dynamics ($7.3 million or 5.8%), partially offset by higher write-downs of expired and excess inventory ($3.4 million or 2.7%).
Research and development expenses increased by $1.0$2.6 million or 13.3%32.5% for the three months ended MarchJune 31,30, 2026 compared to the same period ended MarchJune 31,30, 2025.
The following table summarizes our researchResearch and development expenses increased by type$3.6 million or 23.1% for the threesix months ended MarchJune 31,30, 2026 andcompared 2025:to the same period ended June 30, 2025.
The following table summarizes our research and development expenses by type for the six months ended June 30, 2026 and 2025:
Selling, general and administrative expenses increased $9.1$16.6 million or 20.7%37.5% for the three months ended MarchJune 31,30, 2026 compared to the same period ended MarchJune 31,30, 2025. This increase was primarily due to higher personnel related expense ($7.9$14.7 million) to support the commercial enterprise, including the Recorlev expansion.
Selling, general and administrative expenses increased $25.8 million or 29.1% for the six months ended June 30, 2026 compared to the same period ended June 30, 2025. This increase was primarily due to higher personnel related expense ($22.7 million) to support the commercial enterprise, including the Recorlev expansion.
For the three and six months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025, amortization of intangible assets were both $2.7 million and $5.4 million, respectively.
For the three months ended MarchJune 31,30, 2026, interest expense decreased $0.4 million or 5.8%5.6% compared to the same period ended MarchJune 31,30, 2025. This decrease was primarily due to a reduction in the interest rate.
For the six months ended June 30, 2026, interest expense decreased $0.8 million or 5.7% compared to the same period ended June 30, 2025. This decrease was primarily due to a reduction in the interest rate.
During the three months ended June 30, 2026, the Company executed an exchange agreement with certain holders of the 2028 Convertible Notes to enable settlement of the outstanding principle amount in cash. Execution of this exchange agreement resulted in recognition of an extinguishment loss of $30.8 million.
For the three months ended March 31, 2026 and March 31, 2025, interest and other income was $1.2 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 MarchJune 31,30, 2026, the outstanding balance of the 2028 Convertible Notes was $33.6 million.
In June 2026, we executed an exchange agreement with certain holders of the 2028 Convertible Notes to enable settlement of the outstanding principal amount in cash. Execution of this exchange agreement resulted in recognition of an extinguishment loss of $30.8 million, which represents the difference between the amortized cost of the 2028 Convertible Notes immediately prior to the exchange and their fair value of $53.7 million, which has been presented on the Condensed Consolidated Balance Sheet as a component of the current portion of long-term debt. This exchange resulted in a loss on extinguishment of debt of $30.8 million, recognized in other income (expense) on the condensed consolidated statements of operations and comprehensive loss.
As of June 30, 2026, the outstanding aggregate principal amount of the 2028 Convertible Notes was $33.6 million. The remaining balance of unamortized debt issuance costs have been reflected as a direct reduction to the loan balance.
In July 2026, we completed the privately negotiated exchange transactions with certain holders of our 2028 Convertible Notes ("collectively, the "Exchanging Noteholders"), pursuant to which the Exchanging Noteholders exchanged approximately $23.0 million in aggregate principal amount of their 2028 Convertible Notes for an aggregate of approximately 5.0 million shares of our common stock and approximately $23.0 million in cash and, separately, a holder of approximately $10.5 million in principal amount of the 2028 Convertible Notes elected to convert its 2028 Convertible Notes into approximately 3.6 million shares of our common stock. Following the completion of the exchange transactions and the conversion, no 2028 Convertible Notes remain outstanding.
We have an accumulated deficit of $669.1$700.2 million at MarchJune 31,30, 2026. Based on our current operating plans and existing working capital at MarchJune 31,30, 2026, we believe that our cash resources are sufficient to sustain operations and capital expenditure requirements 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 KeveyisKeveyis, as well as our ongoing research and development activities. We may incur net losses for at least the next twelve months. Our ability to fund the marketing and selling of Recorlev, Gvoke and Keveyis, as well as our product development and clinical operations, including completion of future clinical trials, will depend on the amount and timing of cash received from product revenue and potential future financings. Our future capital requirements will depend on many factors, including, but not limited to:
Net cash provided by operating activities was $9.9$18.1 million for the threesix months ended MarchJune 31,30, 2026, compared to $10.0$9.8 million used in operating activities for the threesix months ended MarchJune 31,30, 2025. 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 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations" of Part I of this Quarterly Report on Form 10-Q.
Net cash used in investing activities was $325$534 thousand for the threesix months ended MarchJune 31,30, 2026, compared to $13$292 thousand used in investing activities for the threesix months ended MarchJune 31,30, 2025. The increase in cash used by investing activities for the threesix months ended MarchJune 31,30, 2026 was due to was due to higher capital expenditures.
Net cash used in financing activities was $8.8$6.9 million for the threesix months ended MarchJune 31,30, 2026, compared to $3.1$2.2 million used in financing activities for the threesix months ended MarchJune 31,30, 2025. The net cash used in financing activities for the threesix months ended MarchJune 31,30, 2026 was primarily driven by repurchases of common stock withheld for taxes of $17.0$17.2 million, offset by proceeds from the exercise of stock awardsawards, andproceeds from issuance of commonshares under the employee stock purchase plan and proceeds from the issuance of shares inof common stock upon settlement of warrants of $8.2$10.3 million. The net cash used in financing activities for the threesix months ended MarchJune 31,30, 2025 was driven by repurchases of common stock withheld for taxes of $8.0$8.9 million, offset by proceeds from the exercise of stock awards and proceeds from the issuance of $4.9shares of common stock under the employee stock purchase plan of $6.7 million.
XERS insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 19 filings (7 insiders, 12 trade dates, 386,498 shares, about $3.0M; 19 of these filings say the sales were made under a Rule 10b5-1 trading plan). Net open-market shares: -386,498 (purchases minus sales); net value about -$3.0M.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-10-01 | Pieper Steven |
Open-market sale |
5,000 | $9.41 | $47.0K |
| 2026-10-01 | Mcculloch Kevin |
Open-market sale |
15,000 | $9.41 | $141.1K |
| 2026-10-01 | Hecht Beth |
Open-market sale |
16,666 | $9.41 | $156.8K |
| 2026-09-28 | Mcculloch Kevin |
Open-market sale |
25,000 | $10.00 | $250.0K |
| 2026-09-01 | Mcculloch Kevin |
Open-market sale |
15,000 | $8.49 | $127.3K |
| 2026-09-01 | Hecht Beth |
Open-market sale |
16,666 | $8.49 | $141.5K |
| 2026-09-01 | Pieper Steven |
Open-market sale |
5,000 | $8.50 | $42.5K |
| 2026-08-12 | Pieper Steven |
Open-market sale |
5,000 | $8.50 | $42.5K |
| 2026-08-03 | Mcculloch Kevin |
Open-market sale |
15,000 | $8.02 | $120.3K |
| 2026-08-03 | Hecht Beth |
Open-market sale |
16,666 | $8.01 | $133.5K |
| 2026-08-01 | Shannon John Patrick Jr |
Shares withheld for tax | 36,645 | $8.08 | $296.1K |
| 2026-08-01 | Mcculloch Kevin |
Shares withheld for tax | 21,918 | $8.08 | $177.1K |
| 2026-07-07 | Pieper Steven |
Open-market sale |
27,600 | $8.52 | $235.2K |
| 2026-07-06 | Pieper Steven |
Open-market sale |
17,400 | $8.50 | $147.9K |
| 2026-07-01 | Kreher Nerissa |
Grant/award | 33,582 | — | — |
| 2026-07-01 | Mcculloch Kevin |
Open-market sale |
90,000 | $8.03 | $722.7K |
| 2026-07-01 | Hecht Beth |
Open-market sale |
16,666 | $8.03 | $133.8K |
| 2026-06-04 | Kong Garheng |
Grant/award | 24,193 | — | — |
| 2026-06-04 | Persky Marla |
Grant/award |
24,193 | — | — |
| 2026-06-04 | Halkuff Dawn |
Open-market sale |
20,000 | $6.09 | $121.8K |
| 2026-06-04 | Halkuff Dawn |
Grant/award |
24,193 | — | — |
| 2026-06-04 | Bormann-Kennedy Barbara-Jean Anne |
Open-market sale |
16,000 | $6.09 | $97.4K |
| 2026-06-04 | Bormann-Kennedy Barbara-Jean Anne |
Grant/award |
24,193 | — | — |
| 2026-06-04 | Johnson John |
Grant/award |
24,193 | — | — |
| 2026-06-04 | Johnson John |
Open-market sale |
15,000 | $6.09 | $91.3K |
| 2026-06-04 | Brady James Aloysius |
Grant/award | 24,193 | — | — |
| 2026-06-03 | Persky Marla |
Open-market sale |
15,500 | $5.90 | $91.5K |
| 2026-06-01 | Hecht Beth |
Open-market sale |
16,667 | $6.06 | $101.0K |
| 2026-05-01 | Hecht Beth |
Open-market sale |
16,667 | $6.23 | $103.8K |
Well-known investors holding XERS (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| D. E. Shaw & Co. | 2026-06-30 | 7,804,758 | $61.8M | 0.04% | No change |
| Two Sigma Investments | 2026-06-30 | 1,885,503 | $14.9M | 0.01% | Reduced 2% |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 1,540,985 | $12.2M | 0.0% | Added 11% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 664,564 | $5.3M | 0.0% | Reduced 3% |
| Millennium Management (Israel Englander) | 2026-06-30 | 131,664 | $1.0M | 0.0% | Reduced 94% |
| Gotham Asset Management (Joel Greenblatt) | 2026-06-30 | 123,914 | $981.4K | 0.0% | Added 186% |
| Renaissance Technologies | 2026-06-30 | 67,337 | $533.3K | 0.0% | Reduced 85% |