Xeris Biopharma Holdings, Inc.
A Chicago-based biopharmaceutical company that turns hard-to-inject medicines into stable, ready-to-use shots. Its brands include Gvoke, a liquid glucagon that treats dangerously low blood sugar in people with diabetes, plus Keveyis and Recorlev for rare conditions. Founded in 2005, its name comes from the Greek word for "dry," reflecting its water-free (non-aqueous) formulation technology that keeps drugs stable without the fuss of mixing before use.
10-Q · Quarter ended Jun 30, 2026 · SEC filing ↗
The original filing sections are available below.
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 e…
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 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 policy 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 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. 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. 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 two years and above and can be administered in two 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") and plan to 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 21 Table of Contents currently collaborating with several major pharmaceutical companies on the development of formulations of their proprietary therapeutics. Our Strategy Our strategy is to continue 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 July 31, 2026, 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 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. 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 six months ended June 30, 2026 and June 30, 2025, we reported net losses of $28.9 million and $11.1 million, respectively. Our accumulated deficit was $700.2 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 six months ended June 30, 2026 and 2025 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. 22 Table of Contents Research and development expenses Research and development expenses consist of expenses incurred in connection with the discovery and development of our products and product candidates. We recognize research and development expenses as incurred. 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 loan and convertible debt, interest income earned on deposits and investments. 23 Table of Contents Results of Operations The following table summarizes our results of operations for the three and six months ended June 30, 2026 and 2025 (in thousands): Three Months Ended June 30, Change Six Months Ended June 30, Change 2026 2025 $ % 2026 2025 $ % Product revenue, net: Recorlev $ 56,780 $ 31,444 $ 25,336 80.6 106,548 $ 56,974 49,574 87.0 Gvoke 22,549 23,467 (918) (3.9) 43,349 44,312 (963) (2.2) Keveyis 11,675 11,485 190 1.7 23,561 22,912 649 2.8 Other product revenue — 1,312 (1,312) (100.0) — 1,312 (1,312) (100.0) Product revenue, net 91,004 67,708 23,296 34.4 173,458 125,510 47,948 38.2 Royalty, contract and other revenue 1,096 3,831 (2,735) (71.4) 1,769 6,148 (4,379) (71.2) Total revenue 92,100 71,539 20,561 28.7 175,227 131,658 43,569 33.1 Cost and expenses: Cost of goods sold, excluding amortization of intangible assets 12,512 11,898 614 5.2 23,086 20,626 2,460 11.9 Research and development 10,669 8,055 2,614 32.5 19,452 15,808 3,644 23.1 Selling, general and administrative 61,035 44,393 16,642 37.5 114,179 88,411 25,768 29.1 Amortization of intangible assets 2,711 2,711 — — 5,421 5,421 — — Total cost and expenses 86,927 67,057 19,870 29.6 162,138 130,266 31,872 24.5 Income from operations 5,173 4,482 691 15.4 13,089 1,392 11,697 840.3 Other income (expense): Interest and other income 1,455 948 507 53.5 2,657 2,123 534 25.2 Loss on debt extinguishment (30,782) — (30,782) — (30,782) — (30,782) — Interest expense (6,947) (7,358) 411 5.6 (13,831) (14,663) 832 5.7 Total other expense (36,274) (6,410) (29,864) 465.9 (41,956) (12,540) (29,416) 234.6 Net loss before income taxes (31,101) (1,928) (29,173) (1513.1) (28,867) (11,148) (17,719) (158.9) Income tax benefit — — — — — — — — Net loss $ (31,101) $ (1,928) $ (29,173) (1513.1) $ (28,867) $ (11,148) $ (17,719) (158.9) Product revenue, net Recorlev Net revenue increased by $25.3 million or 80.6% for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was due to higher volume ($21.9 million or 69.6%), primarily driven by increased patient demand, and favorable net pricing ($3.4 million or 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%). Gvoke Net revenue decreased by $0.9 million or 3.9% for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The decrease was due to lower volume ($1.5 million or 6.5%), partially offset by favorable net pricing ($0.6 million or 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%). 24 Table of Contents Keveyis Net revenue increased by $0.2 million or 1.7% for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was due favorable net pricing ($0.7 million or 5.8%), partially offset by lower volume ($0.5 million or 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 Royalty, contract and other revenue decreased $2.7 million or 71.4% for the three months ended June 30, 2026 compared to the three months ended June 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 Cost of goods sold increased by $0.6 million or 5.2% for the three months ended June 30, 2026 compared to the same period ended June 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 3.9%, to 13.7% for the three months ended June 30, 2026 compared to 17.6% for the same period ended June 30, 2025, primarily due to favorable product mix dynamics ($4.5 million or 6.8%), partially offset by higher write-downs of expired and excess inventory ($1.9 million or 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 Research and development expenses increased by $2.6 million or 32.5% for the three months ended June 30, 2026 compared to the same period ended June 30, 2025. Research and development expenses increased by $3.6 million or 23.1% for the six months ended June 30, 2026 compared 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: Three Months Ended June 30, Change Six Months Ended June 30, Change 2026 2025 $ % 2026 2025 $ % Project specific expenses: Pipeline $ 4,438 $ 2,444 $ 1,994 81.6 $ 6,420 $ 5,030 $ 1,390 27.6 Technology development (1) 2 529 (527) (99.6) 188 815 (627) (76.9) Personnel related expenses 5,403 4,325 1,078 24.9 11,196 8,552 2,644 30.9 Lab supplies and equipment depreciation 505 434 71 16.4 963 776 187 24.1 Other 321 323 (2) (0.6) 685 635 50 7.9 Total $ 10,669 $ 8,055 $ 2,614 32.5 $ 19,452 $ 15,808 $ 3,644 23.1 (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 $16.6 million or 37.5% for the three months ended June 30, 2026 compared to the same period ended June 30, 2025. This increase was primarily due to higher personnel related expense ($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. Amortization of intangible assets For the three and six months ended June 30, 2026 and June 30, 2025, amortization of intangible assets were both $2.7 million and $5.4 million, respectively. Other income (expense) 25 Table of Contents For the three months ended June 30, 2026, interest expense decreased $0.4 million or 5.6% compared to the same period ended June 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. 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 sales 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 June 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. Capital Resources and Funding Requirements We have an accumulated deficit of $700.2 million at June 30, 2026. Based on our current operating plans and existing working capital at June 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 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 26 Table of Contents 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 the section titled "Financing" included in "Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations" of Part I of this Quarterly Report, 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 Six Months Ended June 30, (in thousands) 2026 2025 Net cash provided by (used in) operating activities $ 18,133 $ (9,849) Net cash used in investing activities $ (534) $ (292) Net cash used in financing activities $ (6,894) $ (2,195) Operating Activities Net cash provided by operating activities was $18.1 million for the six months ended June 30, 2026, compared to $9.8 million used in operating activities for the six months ended June 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. Investing Activities Net cash used in investing activities was $534 thousand for the six months ended June 30, 2026, compared to $292 thousand used in investing activities for the six months ended June 30, 2025. The increase in cash used by investing activities for the six months ended June 30, 2026 was due to higher capital expenditures. Financing Activities Net cash used in financing activities was $6.9 million for the six months ended June 30, 2026, compared to $2.2 million used in financing activities for the six months ended June 30, 2025. The net cash used in financing activities for the six months ended June 30, 2026 was primarily driven by repurchases of common stock withheld for taxes of $17.2 million, offset by proceeds from the exercise of stock awards, proceeds from issuance of shares under the employee stock purchase plan and proceeds from the issuance of shares of common stock upon settlement of warrants of $10.3 million. The net cash used in financing activities for the six months ended June 30, 2025 was driven by repurchases of common stock withheld for taxes of $8.9 million, offset by proceeds from the exercise of stock awards and proceeds from the issuance of shares of common stock under the employee stock purchase plan of $6.7 million. CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES AND ASSUMPTIONS Our Annual Report on Form 10-K for the year ended December 31, 2025 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, 2025. 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. 27 Table of Contents
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 exp…
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 June 30, 2026 would increase or decrease interest income by approximately $1.3 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 six months ended June 30, 2026.
Read original filing text →On February 26, 2026, March 20, 2026, June 4, 2026, and July 13, 2026, the Company’s wholly owned subsidiaries, Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited, filed patent infringement lawsuits under the Hatch-Waxman Act in the United States District Court for the…
On February 26, 2026, March 20, 2026, June 4, 2026, and July 13, 2026, the Company’s wholly owned subsidiaries, Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited, filed patent infringement lawsuits under the Hatch-Waxman Act in the United States District Court for the District of New Jersey against defendants (i) Torrent Pharmaceuticals Limited (along with its affiliate, “Torrent”) and Somerset Therapeutics, LLC (along with its affiliates, “Somerset”), (ii) Sandoz Inc. (“Sandoz”) and Zydus Lifesciences Global FZZE (along with its affiliates, “Zydus”), and (iii) Novitium Pharma, LLC (along with its affiliate, “Novitium”) in two separate actions, respectively (each, an “ANDA Filer”). These lawsuits were filed following receipt of a Paragraph IV certification notice letter (each, a “Notice Letter”) from each of Torrent, Somerset, Sandoz, Zydus, and Novitium regarding the filing of its respective Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture, use, or sell a generic version of Recorlev®. The Notice Letters stated that each ANDA Filer’s ANDAs contained Paragraph IV certifications alleging that four of the Company’s Orange Book-listed patents covering Recorlev® (U.S. Patent Nos. 11,020,393, 11,278,547, 11,903,940 and 12,377,096) (collectively, the “Orange Book Patents), which are scheduled to expire in March 2040, are invalid, unenforceable and/or will not be infringed by each ANDA Filer’s manufacture, use, or sale of the generic product described in its respective ANDA submission. Collectively, the complaints allege that, by filing ANDAs for their respective generic products, each of Torrent, Somerset, Sandoz, Zydus, and Novitium has infringed the Orange Book Patents for Recorlev®. The complaints seek an order preventing the FDA from granting final approval of the respective ANDAs before the expiration of the Orange Book Patents and a permanent injunction to prevent each of the defendants from commercializing a generic version of Recorlev®, until the expiration of the Orange Book Patents, including any applicable extensions and additional periods of exclusivity. On June 8, 2026, the United States District Court for the District of New Jersey entered an order consolidating for all pretrial purposes the actions filed on February 26, 2026 against Somerset and Torrent and the action filed on March 20, 2026 against Sandoz and Zydus (“Consolidated Action”). On July 20, 2026, the United States District Court for the District of New Jersey entered an order consolidating for all pretrial purposes the actions against Novitium filed on June 4, 2026 and July 13, 2026 into the Consolidated Action. A bench trial has been tentatively scheduled for November 2028. The filing of each lawsuit within 45 days of receipt of each of the respective Notice Letters triggered an automatic stay of the FDA’s approval of each of the respective ANDAs in accordance with the Hatch-Waxman Act until up to June 30, 2029, in the absence of a decision from the court finding all asserted claims invalid or not infringed before that date. The Company may receive additional Notice Letters in the future from ANDA filers seeking approval of a generic version of Recorlev and may file additional ANDA lawsuits in the future. We are also involved in various other legal proceedings arising in the normal course of business. Although the outcomes of these other legal proceedings are inherently difficult to predict, we do not expect the resolution of these other legal proceedings to have a material adverse effect on our financial position, results of operations, or cash flows. 29 Table of Contents
Read original filing text →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 adv…
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.
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