Xeris Biopharma Holdings Inc.

03/02/2026 | Press release | Distributed by Public on 03/02/2026 15:26

Annual Report for Fiscal Year Ending December 31, 2025 (Form 10-K)

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes appearing elsewhere in this Annual Report on Form 10-K ("Annual Report"). This discussion contains forward-looking statements that involve significant risks and uncertainties. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those set forth in Part I, Item 1A. Risk Factors, of this Annual Report. This discussion and analysis compares 2025 results to 2024. For discussion and analysis that compares 2024 results to 2023, see Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in Part II, Item 7. of this Annual Report for the year ended December 31, 2024.
Overview
Xeris Biopharma Holdings, Inc. along with its subsidiaries, is referenced herein as the "Company", "Xeris", "Xeris Biopharma", "we" or "our". Throughout this document, unless otherwise noted, references to Gvoke include Gvoke PFS, Gvoke HypoPen, and Gvoke Kit.
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 are advancing our Phase 3-ready pipeline product, XP-8121, once-weekly subcutaneous ("SC") levothyroxine, which leverages our proprietary technology XeriSol.
Financing
We have funded our operations to date primarily with proceeds from the sale of our common stock and debt financing.
For the year ended December 31, 2025 we reported a net income of $0.6 million. For the year ended December 31, 2024 we reported a net loss of $54.8 million. The year ended December 31, 2025 is the first year we have been profitable since inception, and, as of December 31, 2025, our accumulated deficit was $671.3 million. In the near term, we may incur net losses as we:
<</span> continue our marketing and selling efforts related to commercialization of Recorlev, Gvoke and Keveyis;
<</span> continue our research and development efforts;
<</span> continue to operate as a public company; and
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continue to fund our operations with an increased cost of borrowing due to a higher interest rate environment and tighter lending requirements.
We may continue to seek public equity and debt financing to meet our capital requirements. 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 commercialize our product candidates, if approved. In addition, we may not be profitable even if we commercialize any of our product candidates.
Components of our Results of Operations
The following discussion sets forth certain components of the statement of operations of Xeris for the year ended December 31, 2025 and 2024 as well as factors that impact those items.
Product revenue, net
Product revenue, net, represents gross product sales less estimated allowances for patient copay assistance programs, prompt payment discounts, payor rebates, chargebacks, service fees, and product returns, all of which are recorded at the time of sale to the pharmaceutical wholesaler or other customer. We apply significant judgment and estimates in determining some of these allowances. If actual results differ from our estimates, we make adjustments to these allowances in the period in which the actual results or updates to estimates become known.
Royalty, contract and other revenue
Royalty and contract revenue is recognized as earned in accordance with contract terms when it can be reasonably estimated and collectability is reasonably assured. Revenue generated from various collaboration and technology partnerships are included in this line item.
Cost of goods sold
Cost of goods sold primarily includes product costs, which include all costs directly related to the purchase of raw materials, charges from our contract manufacturing organizations, and manufacturing overhead costs, as well as shipping and distribution charges. Cost of goods sold also includes losses from excess, slow-moving or obsolete inventory and inventory purchase commitments, if any.
Research and development expenses
Research and development expenses consist of expenses incurred in connection with the discovery and development of our products and product candidates. We recognize research and development expenses as incurred. Expenses that are paid in advance of performance are capitalized until services are provided or goods are delivered. We track external research and development costs by project, however, personnel related expenses related to research and development are not allocated by project. Research and development expenses primarily include:
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the cost of acquiring and manufacturing preclinical study and clinical trial materials and manufacturing costs related to commercial production and scale-up until a product is approved and initially available for commercial sale;
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expenses incurred under agreements with contract research organizations ("CROs") as well as investigative sites and consultants that conduct our preclinical studies and clinical trials;
<</span> personnel-related expenses, which include salaries, benefits and stock-based compensation;
<</span> laboratory materials and supplies used to support our research activities;
<</span> outsourced product development services;
<</span> expenses relating to regulatory activities, including filing fees paid to regulatory agencies; and
<</span> allocated expenses for facility-related costs.
Research and development activities are central to our business model. We expect to continue to incur significant research and development expenses as we advance our pipeline candidates and in particular plan and conduct clinical trials, prepare regulatory filings for our product candidates, and utilize internal resources to support these efforts.
Our research and development expenses may vary significantly over time due to uncertainties relating to the timing and results of our clinical trials, feedback received from interactions with the FDA and the timing of regulatory approvals.
Selling, general and administrative expenses
Selling, general and administrative expenses consist primarily of compensation and related personnel costs, marketing and selling expenses, professional fees and facility costs not otherwise included in research and development expenses.
Amortization of intangible assets
Amortization of intangible assets relates to the amortization of our products: Recorlev and Keveyis. These two intangible assets are being amortized over a five-year and fourteen-year period, respectively, using the straight-line method.
Other income (expense)
Other income (expense) consists primarily of interest expense related to our loan and convertible debt, interest income earned on deposits and investments, debt refinancing costs and gains and losses on the change in fair value of the Contingent Value Rights ("CVRs").
Results of Operations
The following table summarizes our results of operations for the years ended December 31, 2025 and 2024 (in thousands):
Years Ended December 31, Change
2025 2024 $ %
Product revenue, net:
Recorlev $ 139,283 $ 64,277 $ 75,006 116.7
Gvoke
94,108 82,829 11,279 13.6
Keveyis
47,649 49,530 (1,881) (3.8)
Other product revenue
1,963 - 1,963 -
Product revenue, net 283,003 196,636 86,367 43.9
Royalty, contract and other revenue 8,842 6,434 2,408 37.4
Total revenue 291,845 203,070 88,775 43.7
Cost and expenses:
Cost of goods sold, excluding amortization of intangible assets 42,569 36,832 5,737 15.6
Research and development 31,165 25,560 5,605 21.9
Selling, general and administrative 182,372 163,481 18,891 11.6
Amortization of intangible assets 10,843 10,843 - -
Total cost and expenses 266,949 236,716 30,233 12.8
Income (loss) from operations 24,896 (33,646) 58,542 174.0
Other income (expense):
Interest and other income 4,742 5,321 (579) (10.9)
Debt refinancing costs - (2,690) 2,690 100.0
Interest expense (29,084) (30,485) 1,401 (4.6)
Change in fair value of warrants - 8 (8) (100.0)
Change in fair value of contingent value rights - 4,388 (4,388) (100.0)
Total other expense (24,342) (23,458) (884) 3.8
Net income (loss) before income taxes 554 (57,104) 57,658 101.0
Income tax benefit - 2,268 (2,268) 100.0
Net income (loss) $ 554 $ (54,836) $ 55,390 101.0
Product revenue, net
Recorlev
Net revenue increased by $75.0 million or 116.7% for the year ended December 31, 2025 compared to the year ended December 31, 2024. The increase was due to higher volume ($79.6 million or 123.9%), primarily driven by increased patient demand, offset by unfavorable net pricing ($4.6 million or 7.2%).
Gvoke
Net revenue increased by $11.3 million or 13.6% for the year ended December 31, 2025 compared to the year ended December 31, 2024. The increase was due to favorable net pricing ($8.6 million or 10.4%) and higher volume ($2.7 million or 3.2%).
Keveyis
Net revenue decreased by $1.9 million or 3.8% for the year ended December 31, 2025 compared to the year ended December 31, 2024. The decrease was due to unfavorable net pricing ($5.0 million or 10.1%), offset by higher volume ($3.1 million or 6.3%).
Other product revenue
Net revenue increased by $2.0 million for the year ended December 31, 2025. This includes sales of our products to commercialization partners.
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
Cost of goods sold increased by $5.7 million or 15.6% for the year ended December 31, 2025 compared to the same period ended December 31, 2024.
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%).
Research and development expenses
Research and development expenses increased by $5.6 million or 21.9% for the year ended December 31, 2025 compared to the same period ended December 31, 2024.
The following table summarizes our research and development expenses by type for the year ended December 31, 2025 and 2024:
Years Ended December 31, Change
2025 2024 $ %
Project specific expenses:
Pipeline $ 9,681 $ 6,945 $ 2,736 39.4
Technology development (1)
1,005 1,160 (155) (13.4)
Personnel related expenses 17,818 14,296 3,522 24.6
Lab supplies and equipment depreciation 1,422 1,655 (233) (14.1)
Other 1,239 1,504 (265) (17.6)
Total $ 31,165 $ 25,560 $ 5,605 21.9
(1) Technology development represents any investment in our proprietary technology platforms, XeriSol and XeriJect.
Selling, general and administrative expenses
Selling, general and administrative expenses increased $18.9 million or 11.6% for the year ended December 31, 2025 compared to the same period ended December 31, 2024. This increase was primarily due to higher personnel related expense ($13.5 million), largely due to personnel-related expenses to support the commercial enterprise, including the Recorlev expansion.
Amortization of intangible assets
For the years ended December 31, 2025 and December 31, 2024, amortization of intangible assets were both $10.8 million, respectively.
Other income (expense)
For the year ended December 31, 2025, interest expense decreased $1.4 million or 4.6% compared to the year ended December 31, 2024. The decrease is primarily due to a lower principal amount of debt outstanding during the period.
For the year ended December 31, 2025, interest and other income decreased $0.6 million or 10.9% compared to the year ended December 31, 2024. The decrease is driven by the decline in interest rates which began in the later half of 2024, resulting in lower overall interest income.
Liquidity and Capital Resources
Our primary uses of cash are to fund costs related to the manufacturing, marketing and selling of products, the research and development of our product candidates, general and administrative expenses and working capital requirements. Historically, we have funded our operations primarily through private placements of convertible preferred stock, public equity offerings of common stock, and the issuance of debt.
Financing Transactions
In May 2022, we entered into an Open Market Sale Agreement with Jefferies LLC, as agent, dated May 11, 2022 ("Sales Agreement") for the offering, issuance and sale of up to a maximum aggregate offering price of $75.0 million of our common stock. 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.
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").
In March 2024, we entered into an Amended and Restated Credit Agreement and Guaranty (the "Amended and Restated Credit Agreement") with the lenders from time to time parties thereto (the "Lenders") and Hayfin Services LLP, as administrative agent for the New Lenders, pursuant to which we and our subsidiaries granted a first priority security interest on substantially all of our assets, including intellectual property, subject to certain exceptions. The Amended and Restated Credit Agreement provides for the Lenders to extend $200.0 million in term loans to the Company on the closing date and up to an additional $15.2 million in additional term loans, which additional term loans are available only to redeem the Company's then outstanding 2025 Convertible Notes.
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.
Capital Resources and Funding Requirements
We have an accumulated deficit of $671.3 million at December 31, 2025. Based on our current operating plans and existing working capital at December 31, 2025, we believe that our cash resources are sufficient to sustain operations and capital expenditure requirements for at least the next twelve months. We may incur substantial additional expenditures in the near term to support the marketing and selling of Recorlev, Gvoke and Keveyis as well as our ongoing research and development activities. We may incur net losses for at least the next twelve months. 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:
<</span> our degree of success in commercializing Recorlev, Gvoke and Keveyis;
<</span> the costs of commercialization activities, including product marketing, sales and distribution;
<</span> the costs, timing and outcomes of clinical trials and regulatory reviews associated with our product candidates;
<</span> the effect on our product development activities of actions taken by the FDA or other regulatory authorities;
<</span> the number and types of future products we develop and commercialize;
<</span> the emergence of competing technologies and products and other adverse market developments; and
<</span>
the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims.
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 2 - Liquidity and Capital Resources", there can be no assurance that such funding may be available to us on acceptable terms, or at all, or that we will be able to successfully market and sell Recorlev, Gvoke and Keveyis.
Cash Flows
Years Ended December 31,
(in thousands)
2025 2024
Net cash provided by (used in) operating activities $ 28,626 $ (36,981)
Net cash provided by (used in) investing activities $ (696) $ 4,883
Net cash provided by financing activities $ 11,389 $ 36,168
Operating Activities
Net cash provided by operating activities was $28.6 millionfor the year ended December 31, 2025, compared to $37.0 million used in operating activities for the year ended December 31, 2024. The increase in net cash provided by operating activities was primarily driven by higher product sales. For a discussion regarding product revenue, net and increases in spending, refer to "Results of Operations" included in this "Item 7 - Management's Discussion and Analysis of Financial Condition and Results of Operations" of Part I of this Annual Report.
Investing Activities
Net cash used in investing activities was $696.0 thousandfor the year ended December 31, 2025, compared to $4.9 million in net cash provided by investing activities for the year ended December 31, 2024. The decrease in cash provided by investing activities for the year ended December 31, 2025was due towas due to fewer purchases of short-term investments.
Financing Activities
Net cash provided by financing activities was $11.4 millionfor the year ended December 31, 2025, compared to $36.2 million provided by financing activities for the year ended December 31, 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.
CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES AND ASSUMPTIONS
Our management's discussion and analysis of our financial condition and results of operations on our financial statements have been prepared in accordance with generally accepted accounting principles ("GAAP") in the United States. The preparation of these financial statements requires us to make estimates that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments, including, among others, those related to revenue recognition and contingent considerations. We base our estimates on historical experience and on various other factors we believe to be appropriate under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.
We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management's judgments and estimates. Our significant accounting policies are more fully described in "Note 2 - Summary of Significant Accounting Policies" of Item 8 in this Annual Report.
Revenue recognition
We apply the guidance in Accounting Standards Codification ("ASC") Topic 606,Revenue from Contracts with Customers, to all contracts with customers within the scope of the standard.
We sell product primarily to wholesalers or a specialty pharmacy that subsequently resell to retail pharmacies or patients. We enter into arrangements with payors, group purchasing organizations, and healthcare providers that provide for government-mandated or privately-negotiated rebates, chargebacks and discounts related to our products. We currently sell Recorlev, Gvoke and Keveyis in the United States.
Revenue is recognized when our customer (e.g., a wholesaler or specialty pharmacy) obtains control of promised goods, which is when our obligations under the terms of the contract with the customer are satisfied, based on the consideration we expect to receive in exchange for those goods.
Revenues are recorded at the net product sales price, which includes estimated allowances for patient copay assistance programs, prompt payment discounts, payor rebates, chargebacks, service fees, and product returns, all of which are recorded at the time of sale to the pharmaceutical wholesaler or other customer. The Company applies significant judgments and estimates in determining some of these allowances. If actual results differ from its estimates, adjustments are made to these allowances in the period in which the actual results or updates to estimates become known.
Government Rebates
We participate in certain federal and state government rebate programs such as the Medicaid Drug Rebate Program, TRICARE Retail Refunds Program, and Medicare Part D Program. We accrue estimated rebates and discounts based on actual average rebate amounts and estimated percent of product that will be prescribed to qualified patients and record the rebates as a reduction of product revenue. Accrued government rebates are included in accrued trade discounts and rebates on the consolidated balance sheets.
Commercial Rebates
We contract with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, to provide rebates with respect to utilization of the products and contracted formulary status. We accrue estimated rebates based on actual average rebate amounts and estimated percent of product that will be prescribed to qualified patients and record the rebate as a reduction of product revenue. Accrued commercial rebates are included in accrued trade discounts and rebates on the consolidated balance sheets.
Product Returns
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. We record estimated product returns in accrued returns reserve on the consolidated balance sheets and as a reduction of product revenue.
NEW ACCOUNTING STANDARDS
Refer to "Note 2 - Basis of presentation and summary of significant accounting policies and estimates," for a description of recent accounting pronouncements applicable to our financial statements.
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