Xeris Biopharma Holdings, Inc.: Form 10-Q for the period ended Sep 30, 2025
Filed with the SEC on Nov 6, 2025 and accepted by EDGAR at Nov 6, 2025, 16:07 ET.
Management's discussion and analysis
As filed, 28,431 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
Cautionary statements for forward-looking information
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 6, 2025 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 regulatory agency staffing cuts and reduced resources as well as shifting policy priorities and the impact on regulatory feedback and timing thereof, changes in macroeconomic conditions such as the possibility of an economic downturn or general economic uncertainty, our ability to market and sell our products and product candidates if approved, increasing geopolitical tensions 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, 2024 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.
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 Cushing’s syndrome, Gvoke for the treatment of severe hypoglycemia, and Keveyis for the treatment of Primary Periodic Paralysis ("PPP"). We leverage our proprietary formulation technologies (XeriSol and XeriJect) in the creation of new products such as our own XP-8121 (once-weekly subcutaneous (SC) levothyroxine) as well as through the formation of development partnerships with other biopharmaceutical companies.
Commercial Products
Our top priority is maximizing the potential of our three commercial products:
- Recorlev is a cortisol synthesis inhibitor approved for the treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome for whom surgery is not an option or has not been curative. Endogenous Cushing's syndrome is a rare but serious and potentially fatal endocrine disease caused by chronic elevated cortisol exposure.
- Gvoke is a ready-to-use, liquid-stable glucagon for the treatment of severe hypoglycemia. The product is indicated for use in pediatric and adult patients with diabetes age 2 years and above and can be administered in 2 simple steps.
- Keveyis is the first therapy approved in the United States to treat hyperkalemic, hypokalemic, and related variants of PPP. PPP is a rare genetic, neuromuscular disorder that can cause extreme muscle weakness and/or paralysis; some forms are also commonly associated with myotonia or muscle stiffness.
Our Pipeline
Our company name, Xeris, is derived from the ancient Greek word xērós meaning 'dry' or 'without water/non-aqueous'. Our proprietary, non-aqueous formulation capabilities are designed to enable the convenient injection of medicines previously uninjectable or poorly injectable when utilizing aqueous approaches. Both XeriSol and XeriJect offer the opportunity to create ready-to-use, room-temperature stable, highly concentrated, injectable formulations of both small and large molecules.
- XP-8121: We are in the process of developing the first and only, once-weekly, subcutaneous injection of levothyroxine for the treatment of hypothyroidism. We are working with the United States Food and Drug Administration ("FDA") to plan and initiate a Phase 3 clinical trial of our XP-8121 product candidate.
- Partnerships: We are pursuing formulation and development partnerships to apply our XeriSol and XeriJect formulation technologies to enhance the drug delivery and clinical profile of other companies’ proprietary drugs and biologics. We are currently collaborating with several major pharmaceutical companies on the development of formulations of their proprietary therapeutics.
Our Strategy
Our strategy is to build a profitable biopharmaceutical company focused on developing and commercializing therapies for people with chronic endocrine and neurological diseases. Xeris is uniquely positioned to execute on this strategy through the continued growth of our three commercial products, which enables us to invest in and develop therapies for unmet medical needs. We believe this will generate value to all of our stakeholders.
Patent Rights
As of October 31, 2025, we owned 191 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 66 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.
Financing
We have funded our operations to date primarily with proceeds from the sale of our preferred and common stock and debt financing.
For the nine months ended September 30, 2025 and September 30, 2024, we reported net losses of $10.5 million and $49.7 million, respectively. Our accumulated deficit was $682.4 million. In the near term, we may incur net losses as we, among other things:
| < | continue our selling and marketing efforts related to our commercial products; |
| < | continue our research and development efforts; |
| < | continue to operate as a public company; and |
| < | continue to fund our operations with an increased cost of borrowing due to a high 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 three and nine months ended September 30, 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:
| < | 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; |
| < | expenses incurred under agreements with contract research organizations ("CROs") as well as investigative sites and consultants that conduct our preclinical studies and clinical trials; |
| < | personnel-related expenses, which include salaries, benefits and stock-based compensation; |
| < | laboratory materials and supplies used to support our research activities; |
| < | outsourced product development services; |
| < | expenses relating to regulatory activities, including filing fees paid to regulatory agencies; and |
| < | 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 convertible debt and loan, interest income earned on deposits and investments, debt refinancing costs and gains and losses on the change in fair value of the Contingent Value Rights ("CVRs").
Results of Operations
The following table summarizes our results of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands):
| Product revenue, net: | Three Months Ended September 30, 2025 | 2024 | Change $% | Nine Months Ended September 30, 2025 | 2024 | Change $% | ||
|---|---|---|---|---|---|---|---|---|
| Recorlev | $36,975 | $17,726 | $19,249 | 108.6 | $93,949 | $41,663 | $52,286 | 125.5 |
| Gvoke | 25,151 | 22,942 | 2,209 | 9.6 | 69,463 | 59,567 | 9,896 | 16.6 |
| Keveyis | 11,937 | 12,193 | (256) | (2.1) | 34,849 | 38,406 | (3,557) | (9.3) |
| Other product revenue | — | — | — | — | 1,312 | — | 1,312 | — |
| Product revenue, net | 74,063 | 52,861 | 21,202 | 40.1 | 199,573 | 139,636 | 59,937 | 42.9 |
| Royalty, contract and other revenue | 317 | 1,407 | (1,090) | (77.5) | 6,465 | 3,335 | 3,130 | 93.9 |
| Total revenue | 74,380 | 54,268 | 20,112 | 37.1 | 206,038 | 142,971 | 63,067 | 44.1 |
| Cost and expenses: | ||||||||
| Cost of goods sold, excluding amortization of intangible assets | 10,996 | 13,593 | (2,597) | (19.1) | 31,622 | 27,354 | 4,268 | 15.6 |
| Research and development | 7,483 | 5,888 | 1,595 | 27.1 | 23,291 | 19,468 | 3,823 | 19.6 |
| Selling, general and administrative | 46,459 | 44,969 | 1,490 | 3.3 | 134,870 | 123,342 | 11,528 | 9.3 |
| Amortization of intangible assets | 2,711 | 2,711 | — | — | 8,132 | 8,132 | — | — |
| Total cost and expenses | 67,649 | 67,161 | 488 | 0.7 | 197,915 | 178,296 | 19,619 | 11.0 |
| Income (loss) from operations | 6,731 | (12,893) | 19,624 | (152.2) | 8,123 | (35,325) | 43,448 | (123.0) |
| Other income (expense): | ||||||||
| Interest and other income | 1,158 | 1,197 | (39) | (3.3) | 3,281 | 4,411 | (1,130) | (25.6) |
| Debt refinancing costs | — | — | — | — | — | (2,690) | 2,690 | 100.0 |
| Interest expense | (7,268) | (7,786) | 518 | (6.7) | (21,931) | (22,782) | 851 | (3.7) |
| Change in fair value of warrants | — | — | — | — | — | 7 | (7) | (100.0) |
| Change in fair value of contingent value rights | — | 420 | (420) | (100.0) | — | 4,388 | (4,388) | (100.0) |
| Total other expense | (6,110) | (6,169) | 59 | (1.0) | (18,650) | (16,666) | (1,984) | 11.9 |
| Net income (loss) before income taxes | 621 | (19,062) | 19,683 | (103.3) | (10,527) | (51,991) | 41,464 | (79.8) |
| Income tax benefit | — | 3,324 | (3,324) | (100.0) | — | 2,268 | (2,268) | (100.0) |
| Net income (loss) | $621 | $(15,738) | $16,359 | (103.9) | $(10,527) | $(49,723) | $39,196 | (78.8) |
Product revenue, net
Recorlev
Net revenue increased by $19.2 million or 108.6% for the three months ended September 30, 2025 compared to the same period ended September 30, 2024. The increase was due to higher volume ($20.6 million or 115.9%), primarily driven by increased patient demand, offset by unfavorable net pricing ($1.4 million or 7.3%).
Net revenue increased by $52.3 million or 125.5% for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The increase was due to higher volume ($56.3 million or 135.1%), primarily driven by increased patient demand, offset by unfavorable net pricing ($4.0 million or 9.6%).
Gvoke
Net revenue increased by $2.2 million or 9.6% for the three months ended September 30, 2025 compared to the same period ended September 30, 2024. The increase was due to higher volume ($0.6 million or 2.7%) and favorable net pricing ($1.6 million or 6.9%).
Net revenue increased by $9.9 million or 16.6% for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The increase was due to higher volume ($3.9 million or 6.5%) and favorable net pricing ($6.0 million or 10.1%).
Keveyis
Net revenue decreased by $0.3 million or 2.1% for the three months ended September 30, 2025 compared to the same period ended September 30, 2024. The decrease was due to unfavorable net pricing ($1.1 million or 8.8%) offset by higher volume ($0.8 million or 6.7%).
Net revenue decreased by $3.6 million or 9.3% for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The decrease was due to unfavorable net pricing ($4.9 million or 12.6%), offset by higher volume ($1.3 million or 3.3%).
Other product revenue
Other product revenue increased by $1.3 million for the nine months ended September 30, 2025. This includes the sale of Gvoke VialDx units to American Regent.
Cost of goods sold
Cost of goods sold decreased by $2.6 million or 19.1% for the three months ended September 30, 2025 compared to the same period ended September 30, 2024. Cost of goods sold increased by $4.3 million or 15.6% for the nine months ended September 30, 2025 compared to the same period ended September 30, 2024.
Cost of goods sold as a percent of total product revenue improved by 10.9%, to 14.8% for the three months ended September 30, 2025 compared to 25.7% for the same period ended September 30, 2024, primarily due to higher sales of products with a lower cost of goods sold ($3.1 million or 5.8%) and a reduction of Gvoke inventory write-offs ($2.0 million or 5.1%).
Cost of goods sold as a percent of total product revenue improved by 3.8%, to 15.8% for the nine months ended September 30, 2025 compared to 19.6% for the same period ended September 30, 2024, primarily due to higher sales of products with a lower cost of goods sold ($5.2 million or 3.7%).
Research and development expenses
Research and development expenses increased by $1.6 million or 27.1% for the three months ended September 30, 2025 compared to the same period ended September 30, 2024.
Research and development expenses increased by $3.8 million or 19.6% for the nine months ended September 30, 2025 compared to the same period ended September 30, 2024.
The following table summarizes our research and development expenses by type for the three and nine months ended September 30, 2025 and 2024:
| Project specific expenses: | Three Months Ended September 30, 2025 | 2024 | Change $% | Nine Months Ended September 30, 2025 | 2024 | Change $% | ||
|---|---|---|---|---|---|---|---|---|
| Pipeline | $2,015 | $1,539 | $476 | 30.9 | $7,046 | $5,610 | $1,436 | 25.6 |
| Technology development (1) | 29 | 235 | (206) | (87.7) | 844 | 1,074 | (230) | (21.4) |
| Personnel related expenses | 4,826 | 3,280 | 1,546 | 47.1 | 13,377 | 10,288 | 3,089 | 30.0 |
| Lab supplies and equipment depreciation | 368 | 442 | (74) | (16.7) | 1,144 | 1,206 | (62) | (5.1) |
| Other | 245 | 392 | (147) | (37.5) | 880 | 1,290 | (410) | (31.8) |
| Total | $7,483 | $5,888 | $1,595 | 27.1 | $23,291 | $19,468 | $3,823 | 19.6 |
(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 $1.5 million or 3.3% for the three months ended September 30, 2025 compared to the same period ended September 30, 2024. This increase was due to incremental personnel related expenses.
Selling, general and administrative expenses increased $11.5 million or 9.3% for the nine months ended September 30, 2025 compared to the same period ended September 30, 2024. This increase was primarily due to higher personnel related expense ($7.9 million), largely due to investments made in the Recorlev commercial organization starting in the third quarter of 2024.
Amortization of intangible assets
For the three and nine months ended September 30, 2025 and September 30, 2024, amortization of intangible assets were both $2.7 million and $8.1 million, respectively.
Other income (expense)
For the three months ended September 30, 2025, interest expense decreased $0.5 million or 6.7% compared to the three months ended September 30, 2024. The decrease is primarily due to a lower principal amount of debt outstanding during the period.
For the nine months ended September 30, 2025, interest expense decreased $0.9 million or 3.7% compared to the nine months ended September 30, 2024. The decrease is primarily due to a lower principal amount of debt outstanding during the period.
For the nine months ended September 30, 2025, interest and other income decreased $1.1 million or 25.6% compared to the nine months ended September 30, 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 September 30, 2025, the outstanding balance of the 2028 Convertible Notes was $33.6 million.
Capital Resources and Funding Requirements
We have an accumulated deficit of $682.4 million at September 30, 2025. Based on our current operating plans and existing working capital at September 30, 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 to incur substantial additional expenditures in the near term to support the marketing and selling of Recorlev, Gvoke and Keveyis as well as our ongoing research and development activities. We expect to continue to incur net losses for at least the next twelve months. 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:
| < | our degree of success in commercializing Recorlev, Gvoke and Keveyis; |
| < | the costs of commercialization activities, including product marketing, sales and distribution; |
| < | the costs, timing and outcomes of clinical trials and regulatory reviews associated with our product candidates; |
| < | the effect on our product development activities of actions taken by the FDA or other regulatory authorities; |
| < | the number and types of future products we develop and commercialize; |
| < | the emergence of competing technologies and products and other adverse market developments; and |
| < | 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 1 – Liquidity and Capital Resources" above, there can be no assurance that such funding may be available to us on acceptable terms, or at all, or that we will be able to successfully market and sell Recorlev, Gvoke and Keveyis.
(in thousands)
| Cash Flows | Nine Months Ended September 30, 2025 | 2024 |
|---|---|---|
| Net cash provided by (used in) operating activities | $8,583 | $(38,956) |
| Net cash used in investing activities | $(363) | $(5,133) |
| Net cash provided by financing activities | $11,655 | $35,770 |
Operating Activities
Net cash provided by operating activities was $8.6 million for the nine months ended September 30, 2025, compared to $39.0 million used in operating activities for the nine months ended September 30, 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 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations" of Part I of this Quarterly Report on Form 10-Q.
Investing Activities
Net cash used in investing activities was $363.0 thousand for the nine months ended September 30, 2025, compared to $5.1 million used in investing activities for the nine months ended September 30, 2024. The decrease in cash used by investing activities for the nine months ended September 30, 2025 was due to fewer purchases of short-term investments.
Financing Activities
Net cash provided by financing activities was $11.7 million for the nine months ended September 30, 2025, compared to $35.8 million provided by financing activities for the nine months ended September 30, 2024. The net cash provided by financing activities for the nine months ended September 30, 2025 was driven by proceeds from the exercise of stock awards and issuance of common shares in settlement of warrants of $20.2 million offset by repurchase of common stock withheld for taxes of $9.3 million. The net cash provided by financing activities in the nine months ended September 30, 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 Annual Report on Form 10-K for the year ended December 31, 2024 describes the critical accounting policies for which management uses significant judgments and estimates in the preparation of our consolidated financial statements. There have been no significant changes to our critical accounting policies since December 31, 2024.
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.
Market risk
As filed, 1,991 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
We are subject to certain market risks arising from transactions in the normal course of business, principally risk associated with interest rate and foreign currency exchange rate fluctuations.
Interest Rate Risk
*Cash, Cash Equivalents Restricted Cash and Investments—*We are exposed to the risk of interest rate fluctuations on the interest income earned on our cash, cash equivalents, restricted cash and investments. A hypothetical one-percentage point increase or decrease in interest rates applicable to our cash, cash equivalents, restricted cash and investments outstanding at September 30, 2025 would increase or decrease interest income by approximately $1.0 million on an annual basis.
*Long-term Debt—*Our interest rate risk relates primarily to the United States dollar SOFR-indexed borrowings. Based on our outstanding borrowings pursuant to the Amended and Restated Credit Agreement, interest is incurred at a floating per annum rate in an amount equal to the sum of (i) 6.95% (or 5.95% if the replacement rate is in effect) plus (ii) the greater of (x) the forward-looking term rate based on SOFR for a three month tenor (or the replacement rate, if applicable), and (y) 2.00% per annum. The remaining balance of unamortized debt issuance costs have been reflected as a direct reduction to the loan balance. Interest on the 2028 Convertible Notes is assessed at a fixed rate of 8.0% annually and therefore does not subject us to interest rate risk.
Foreign Currency Exchange Risk
We contract with organizations outside the United States at times. We may be subject to fluctuations in foreign currency exchange rates in connection with certain of these agreements. Transactions denominated in currencies other than the functional currency are recorded based on exchange rates at the time such transactions arise. Net foreign currency gains and losses did not have a material effect on our results of operations for the three and nine months ended September 30, 2025.
Controls and procedures
As filed, 1,631 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our chief executive officer (principal executive officer) and chief financial officer (principal financial officer), evaluated the effectiveness of our disclosure controls and procedures, as such term is defined under Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended ("Exchange Act"). Based on such evaluation, our chief executive officer and chief financial officer have concluded that the disclosure controls and procedures were effective as of September 30, 2025 to ensure that information required to be disclosed by the Company in the reports it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time period specified in the U.S. Securities and Exchange Commission's ("SEC") rules and forms, and to ensure that information required to be disclosed by the Company in the reports it files or submits under the Exchange Act is accumulated and communicated to the Company's management, including its chief executive and chief financial officers, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three months ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Risk factors
As filed, 696 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
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, 2024 and subsequent filings with the U.S. Securities and Exchange Commission, 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, 2024.
Figures reported in this filing
Standardized line items from the XBRL in this filing, for the period ended 2025-09-30. Comparative periods it repeats are left out.
| Line item | Period | Value | XBRL concept |
|---|---|---|---|
| Revenue | 3 months2025-07-01 to 2025-09-30 | $74.4m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Revenue | 9 months2025-01-01 to 2025-09-30 | $206.0m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Research and development | 3 months2025-07-01 to 2025-09-30 | $7.5m | us-gaap:ResearchAndDevelopmentExpense |
| Research and development | 9 months2025-01-01 to 2025-09-30 | $23.3m | us-gaap:ResearchAndDevelopmentExpense |
| Selling, general and administrative | 3 months2025-07-01 to 2025-09-30 | $46.5m | us-gaap:SellingGeneralAndAdministrativeExpense |
| Selling, general and administrative | 9 months2025-01-01 to 2025-09-30 | $134.9m | us-gaap:SellingGeneralAndAdministrativeExpense |
| Operating income | 3 months2025-07-01 to 2025-09-30 | $6.7m | us-gaap:OperatingIncomeLoss |
| Operating income | 9 months2025-01-01 to 2025-09-30 | $8.1m | us-gaap:OperatingIncomeLoss |
| Interest expense | 3 months2025-07-01 to 2025-09-30 | $7.3m | us-gaap:InterestExpenseNonoperating |
| Interest expense | 9 months2025-01-01 to 2025-09-30 | $21.9m | us-gaap:InterestExpenseNonoperating |
| Income tax | 3 months2025-07-01 to 2025-09-30 | $0 | us-gaap:IncomeTaxExpenseBenefit |
| Income tax | 9 months2025-01-01 to 2025-09-30 | $0 | us-gaap:IncomeTaxExpenseBenefit |
| Net income | 3 months2025-07-01 to 2025-09-30 | $621.0k | us-gaap:NetIncomeLoss |
| Net income | 9 months2025-01-01 to 2025-09-30 | −$10.5m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months2025-07-01 to 2025-09-30 | $0.00 | us-gaap:EarningsPerShareDiluted |
| Diluted EPS | 9 months2025-01-01 to 2025-09-30 | −$0.07 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months2025-07-01 to 2025-09-30 | $0.00 | us-gaap:EarningsPerShareBasic |
| Basic EPS | 9 months2025-01-01 to 2025-09-30 | −$0.07 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months2025-07-01 to 2025-09-30 | 177,617,307 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Diluted shares (weighted) | 9 months2025-01-01 to 2025-09-30 | 158,559,467 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 9 months2025-01-01 to 2025-09-30 | $8.6m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Cash and equivalents | At period end2025-09-30 | $91.6m | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | At period end2025-09-30 | $224.0m | us-gaap:AssetsCurrent |
| Total assets | At period end2025-09-30 | $370.2m | us-gaap:Assets |
| Current liabilities | At period end2025-09-30 | $116.2m | us-gaap:LiabilitiesCurrent |
| Total liabilities | At period end2025-09-30 | $371.1m | us-gaap:Liabilities |
| Long-term debt | At period end2025-09-30 | $219.5m | us-gaap:LongTermDebtNoncurrent |
| Current portion of debt | At period end2025-09-30 | $0 | us-gaap:LongTermDebtCurrent |
| Shareholders' equity | At period end2025-09-30 | −$861.0k | us-gaap:StockholdersEquity |
Source: SEC EDGAR, the filing index for accession 0001867096-25-000159. Last ingested by Listed: Nov 6, 2026, 17:33 ET. Listed shows no prices and gives no investment advice.