Levoketoconazole

Total revenue increased 48% YoY to over $60 million Recorlev® revenue grew 141% on YoY basis Tightens full-year total revenue 2025 guidance to $260 million to $275 million Announces upcoming Investor and Analyst Day on June 3 rd in New York City Hosts conference call and webcast today at 8:30 a.m. ET CHICAGO --(BUSINESS WIRE)--May 8, 2025-- Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the first quarter ended March 31, 2025 , and updated its fiscal 2025 total revenue guidance. “We’re very pleased with our strong start to the year, delivering another quarter of outstanding revenue growth,” said John Shannon , Xeris’ Chief Executive Officer. “Our performance reflects sustained momentum across the portfolio, led by strong demand for Recorlev and is a testament to the disciplined execution of our growth strategy.” Mr. Shannon continued, “Given our exceptional first quarter performance, as well as strong continued momentum and confidence in the business, we have tightened full-year 2025 total revenue guidance to $260 million to $275 million . This revision from our previous range of $255 million to $275 million underscores the success of our strategic initiatives and our commitment to driving sustainable growth while delivering value to our patients and shareholders.” First Quarter 2025 Highlights Three months ended March 31 , Change 2025 2024 $ % Product revenue (in thousands): Recorlev $ 25,530 $ 10,599 $ 14,931 140.9 Gvoke 20,845 16,579 4,266 25.7 Keveyis 11,427 13,085 (1,658 ) (12.7 ) Product revenue, net 57,802 40,263 17,539 43.6 Royalty, contract and other revenue 2,317 375 1,942 517.9 Total revenue $ 60,119 $ 40,638 $ 19,481 47.9 Recorlev®: First quarter net revenue was $25.5 million – an increase of approximately 141% compared to the first quarter of 2024. This growth was primarily driven by the average number of patients on Recorlev increasing 124% from the same period in 2024. Gvoke®: First quarter net revenue was $20.8 million – an increase of approximately 26% compared to the first quarter of 2024. Gvoke prescriptions grew 8% compared to the same period in 2024. Keveyis®: First quarter net revenue was $11.4 million – a decrease of approximately 13% compared to the first quarter of 2024. This decrease was primarily driven by a reduction in product shipments in the period. On a sequential basis, net revenue and total patients on Keveyis were both slightly up. Royalty, contract and other revenue: In the first quarter, Xeris obtained FDA approval for Gvoke VialDxTM and received an approval-based milestone from its partner, American Regent , which made up a majority of Other Revenue. Cost of goods sold (COGS) increased $2.8 million or 46% in the first quarter of 2025 compared to the same period in 2024. This increase was primarily due to an increase in product revenue. Research and development (R&D) expenses were relatively flat in the first quarter of 2025 compared to the same period last year. Expenses in the quarter supported the Company's pipeline, notably XP-8121, and included personnel related expenses and continued investment in the Company's technology platforms and partnerships. Selling, general and administrative (SG&A) expenses increased $5.6 million or 15% in the first quarter of 2025 compared to the same period last year. This increase was primarily due to incremental investment in the Recorlev commercial organization starting in the third quarter of 2024 as well as other personnel related expenses. Net Loss for the first quarter was $9.2 million or ( $0.06 ) per share. Adjusted EBITDA1 for the first quarter was positive $4.4 million , an improvement of $8.4 million compared to the first quarter of 2024. Total Shares Outstanding were 160,155,000 at April 30, 2025 . Upcoming Events Craig-Hallum Institutional Investor Conference : Senior management will participate in 1x1 meetings on May 28, 2025 , in Minneapolis, MN. Please contact the sponsor to arrange meetings with management. Analyst & Investor Day: Xeris will host an in-person and virtual Analyst and Investor Day on June 3, 2025 , at 10:00 a.m. Eastern Time in New York City . The event will feature key opinion leaders (KOLs) who will join Company management to discuss the opportunity for the Company's key near- and long-term growth drivers, specifically, Recorlev, and XP-8121. To register for the event, please use this link: https://edge.media-server.com/mmc/p/e4niwx3r/ Jefferies Global Healthcare Conference : Senior management will participate in a fireside chat and 1x1 meetings on June 4, 2025 in New York City . Please contact the sponsor to arrange meetings with management. Conference Call and Webcast Details Xeris will host a conference call and webcast at 8:30 a.m. Eastern Time today to discuss the Company's financial and operational results. To pre-register for the conference call, please use the following link: https://www.netroadshow.com/events/login?show=7ba30d1f&confId=80481 After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Thursday, May 22, 2025 at US:1 929 458 6194, US Toll Free: 1 866 813 9403, UK : 0204 525 0658, Canada : 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code: 570802. To join the webcast, please visit “Events” on investor relations page of the Company’s website at www.xerispharma.com or use this link: https://events.q4inc.com/attendee/798286025 Note Regarding Use of Non-GAAP Financial Measures This press release includes financial results prepared in accordance with generally accepted accounting principles in the United States (GAAP) and also certain historical and forward-looking non-GAAP financial measures, namely Adjusted EBITDA. This non-GAAP financial measure is not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP, and was not prepared under any comprehensive set of accounting rules or principles. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP, and the calculation of the non-GAAP financial measure included herein may differ from similarly titled measures used by other companies. The Company believes that the presentation of Adjusted EBITDA, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of the Company's ongoing and projected operating performance, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The Company believes this non-GAAP financial measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding expected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and evaluate its performance. In addition, management believes that Adjusted EBITDA is important in evaluating the administrative costs of operating the Company’s business. Adjusted EBITDA is GAAP net income (loss) before income tax (benefit) expense, plus interest and other income, less depreciation and amortization, interest expenses, share based compensation and debt refinancing fees. About Xeris Xeris (Nasdaq: XERS) is a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products: Recorlev®, for the treatment of endogenous Cushing’s syndrome; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; and Keveyis®, a proven therapy for primary periodic paralysis. Xeris also has a pipeline of development programs led by XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism, as well as multiple early-stage programs leveraging Xeris’ technology platforms, XeriSol® and XeriJect®, for its partners. Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on X, LinkedIn, or Instagram. Forward-Looking Statements Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc. including statements regarding full year total revenue guidance for 2025, including the potential for revenue growth and Adjusted EBITDA, the potential for 2025 to be financially transformative, advancing its strategic initiatives, the ability to continue to demonstrate sustained momentum across the portfolio and maintain disciplined execution of the Company's growth strategy, its ability to drive more value for patients and shareholders, the market and therapeutic potential of its products and product candidates, the potential utility of its formulation platforms, the advancement of its pipeline (including XP-8121), and other statements containing the words "achieve," "continue," “will,” “would,” “continue,” “expect,” “should,” “anticipate” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, its and collaborators’ ability to protect its intellectual property and proprietary technology, and general macroeconomic and geopolitical conditions, including the possibility of an economic downturn, changes in governmental priorities and resources, announced or implemented tariffs and market volatility. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings, including its most recently filed Annual Report on Form 10-K and subsequent filings with the U.S. Securities and Exchange Commission , the contents of which are not incorporated by reference into, nor do they form part of, this communication. Forward-looking statements in this communication are based on information available to management, as of the date of this communication and, while the Company believes its assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, the Company does not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations. 1 Adjusted EBITDA is a non-GAAP financial measure. See "Note Regarding Use of Non-GAAP Financial Measures" and the corresponding financial tables at the end of this press release for definitions and reconciliations of non-GAAP measures. XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) Three Months Ended March 31 , 2025 2024 (unaudited) (unaudited) Product revenue, net $ 57,802 $ 40,263 Royalty, contract and other revenue 2,317 375 Total revenue 60,119 40,638 Costs and expenses: Cost of goods sold 8,728 5,971 Research and development 7,753 7,821 Selling, general and administrative 44,018 38,380 Amortization of intangible assets 2,710 2,711 Total costs and expenses 63,209 54,883 Loss from operations (3,090 ) (14,245 ) Other expenses (6,130 ) (4,428 ) Net loss before benefit from income taxes (9,220 ) (18,673 ) Benefit from income taxes — (307 ) Net loss $ (9,220 ) $ (18,980 ) Net loss per common share - basic and diluted $ (0.06 ) $ (0.14 ) Weighted average common shares outstanding - basic and diluted 152,445,935 140,513,907 XERIS BIOPHARMA HOLDINGS, INC. Non-GAAP Financial Measures - EBITDA and Adjusted EBITDA (in thousands, unaudited) Three Months Ended March 31 , 2025 2024 GAAP Net Loss $ (9,220 ) $ (18,980 ) Adjustments Interest and other income (1,175 ) (1,923 ) Interest expense 7,305 7,032 Income tax (benefit) expense — 307 Depreciation and amortization 3,025 3,037 EBITDA (65 ) (10,527 ) Adjustments Share-based compensation (a) 4,443 3,767 Debt refinancing fees (b) — 2,690 Adjusted EBITDA 4,378 (4,070 ) (a) Includes non-cash, stock-based compensation, net of forfeitures. (b) Represents non-recurring fees related to financing activities. Including debt refinancing fees which related to advisory and legal fees to refinance the term loan in 2024. XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) March 31, 2025 December 31, 2024 (unaudited) Assets Current assets: Cash and cash equivalents $ 58,440 $ 71,621 Trade accounts receivable, net 46,330 40,415 Inventory 52,690 48,175 Prepaid expenses and other current assets 6,034 7,451 Total current assets 163,494 167,662 Property and equipment, net 5,260 5,562 Intangible assets, net 96,211 98,921 Goodwill 22,859 22,859 Operating lease right-of-use assets 22,531 22,649 Other assets 5,098 5,407 Total assets $ 315,453 $ 323,060 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 6,352 $ 2,290 Current portion of long-term debt 11,959 15,102 Current operating lease liabilities 6,117 6,080 Other accrued liabilities 20,050 27,716 Accrued trade discounts and rebates 30,734 29,084 Accrued returns reserve 19,704 19,082 Other current liabilities 156 1,089 Total current liabilities 95,072 100,443 Long-term debt, net of unamortized debt issuance costs 217,805 217,006 Non-current operating lease liabilities 32,870 33,259 Other liabilities 4,834 1,967 Total liabilities 350,581 352,675 Total stockholders’ equity (deficit) (35,128) (29,615) Total liabilities and stockholders’ equity (deficit) $ 315,453 $ 323,060 View source version on businesswire.com: https://www.businesswire.com/news/home/20250508156644/en/ Investor Contact Allison Wey Senior Vice President, Investor Relations and Corporate Communications awey@xerispharma.com Source: Xeris Biopharma Holdings, Inc.

CHICAGO--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced changes to its board of directors. Ricki Fairley has resigned from the board in light of other commitments, effective immediately. The Board of Directors has appointed James Brady as a new director of Xeris’ board to fill the vacancy. In addition, John Schmid has decided not to stand for re-election at the Company’s 2025 Annual Stockholders Meeting, at which time the size of the Board will be reduced to eight members. “I am honored to welcome Jim to our Board of Directors at this pivotal time in Xeris’ growth journey. Jim is a seasoned and savvy business professional deeply steeped in the biopharmaceutical industry with broad-ranging public company financial expertise. He will add to the depth and breadth of our board and will be invaluable as we continue to drive innovation and expand our market presence,” said Marla Persky, Chairperson of the Board of Directors. “On behalf of the entire Board, I’d like to thank John Schmid for his years of dedication to Xeris and excellent contributions to the Board. We also thank Ricki Fairley for her marketing and patient community insights.” Mr. Brady is an experienced international business executive who served in multiple leadership roles of increasing responsibility for AstraZeneca prior to his retirement. His more than thirty years of progressive experience at AstraZeneca included successful national, regional, and global finance roles in corporate operations, manufacturing, commercial, marketing, market access, audit, international business, and biologics discovery and development. Mr. Brady most recently served as Chief Financial Officer of MedImmune, the biologics discovery and development division of AstraZeneca. He currently serves on the Board of Directors and as a Member of the Audit Committee of Verona Pharma plc (Nasdaq: VRNA). Mr. Brady received his BS in Accounting from Saint Joseph University and his MBA from Drexel University. He is a Certified Public Accountant. About Xeris Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products: Recorlev®, for the treatment of endogenous Cushing’s syndrome; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; and Keveyis®, a proven therapy for primary periodic paralysis. Xeris also has a pipeline of development programs led by XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism, as well as multiple early-stage programs leveraging Xeris’ technology platforms, XeriSol® and XeriJect®, for its partners. Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on X, LinkedIn, or Instagram. Forward-Looking Statements Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc., and other statements containing the words “will,” “would,” “continue,” “expect,” “should,” “anticipate,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, and its and collaborators’ ability to protect its intellectual property and proprietary technology. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings, including its most recently filed Annual Report on Form 10-K filed with the Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. Forward-looking statements in this communication are based on information available to us, as of the date of this communication and, while we believe our assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, we do not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations.