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Associated Press
3 days ago
- Business
- Associated Press
Xeris Unveils Strategy for Long-Term Growth and Value Creation at 2025 Analyst & Investor Day
CHICAGO--(BUSINESS WIRE)--Jun 3, 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, will host its first-ever Analyst and Investor Day today to showcase its strategy for sustainable growth and value creation. 'We have built a strong foundation through innovation and a relentless commitment to improving patient lives. We will showcase how these achievements have positioned us to take the next bold step in our journey of growth and transformation. We are excited to share our vision for the future—one that builds on our successes, leverages our capabilities, and propels us toward making an even greater impact delivering meaningful solutions for patients,' said John Shannon, Chief Executive Officer. Path to Long Term Value Creation Financial Guidance & Long-range Outlook 2025 Analyst and Investor Day Event Details The Company's first in-person and virtual analyst and investor day will be in New York City on Tuesday, June 3, 2025, at 10:00 a.m. EDT. To access the live webcast of the event, please use this link: A replay of the webcast, along with the related presentation materials, will be available on the 'Events & Presentations' section of the Company's Investor Relations website following the conclusion of the event. 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 a gastrointestinal motility inhibitor when used during radiology exams as a diagnostic aid; 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 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 financial guidance for 2025, including its expected total revenue and commitment to remaining adjusted EBITDA positive, the outlook for 2030 and outlook for 2035 and beyond, including statements regarding total revenue, product growth, annual net revenue expected for Recorlev® and XP-8121, the market and therapeutic potential of its products and product candidates, including Recorlev and XP-8121, the ability to continue to demonstrate rapid revenue growth, sustained momentum across the portfolio and maintain disciplined execution of the Company's growth strategy, the beneficial impact on the lives of patients, including XP-8121's potential to transform the treatment landscape for millions living with hypothyroidism, capital management enabling the self-funding of both near and long-term growth, and other statements containing the words 'will,' 'would,' 'continue,' 'expect,' 'should,' 'anticipate,' 'new,' 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 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 recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, as well as 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. View source version on CONTACT: Xeris Investor Contact Allison Wey Senior Vice President, Investor Relations and Corporate Communications [email protected] KEYWORD: ILLINOIS NEW YORK UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: OTHER HEALTH RESEARCH MANAGED CARE GENERAL HEALTH PHARMACEUTICAL MEDICAL DEVICES CLINICAL TRIALS SCIENCE BIOTECHNOLOGY MEDICAL SUPPLIES OTHER SCIENCE HEALTH SOURCE: Xeris Biopharma Holdings, Inc. Copyright Business Wire 2025. PUB: 06/03/2025 07:30 AM/DISC: 06/03/2025 07:31 AM
Business Wire
3 days ago
- Business
- Business Wire
Xeris Unveils Strategy for Long-Term Growth and Value Creation at 2025 Analyst & Investor Day
CHICAGO--(BUSINESS WIRE)--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, will host its first-ever Analyst and Investor Day today to showcase its strategy for sustainable growth and value creation. 'We have built a strong foundation through innovation and a relentless commitment to improving patient lives. We will showcase how these achievements have positioned us to take the next bold step in our journey of growth and transformation. We are excited to share our vision for the future—one that builds on our successes, leverages our capabilities, and propels us toward making an even greater impact delivering meaningful solutions for patients," said John Shannon, Chief Executive Officer. Path to Long Term Value Creation Proven track record of strong execution — successfully developed and launched a portfolio of products that address unmet medical needs. Recorlev® revenue acceleration has propelled Xeris to a pivotal inflection point, marking a new phase of expected growth. Financial strength enables self-funding of near- and long-term growth — driven by rapid revenue growth and disciplined capital management. XP-8121 has the potential to transform the treatment landscape for millions living with hypothyroidism, reinforcing the Company's commitment to innovation. Financial Guidance & Long-range Outlook 2025 Guidance: The Company reaffirms total revenue in the range of $260 to $275 million and its commitment to remaining adjusted EBITDA positive going forward. 2030 Outlook: The Company expects total revenue of approximately $750 million, reflecting growth across our current portfolio of products, with Recorlev® leading the way. 2035 Outlook & Beyond: The Company anticipates Recorlev® annual net revenue of approximately $1 billion in 2035. XP-8121 peak net revenue is expected to be $1 to $3 billion. 2025 Analyst and Investor Day Event Details The Company's first in-person and virtual analyst and investor day will be in New York City on Tuesday, June 3, 2025, at 10:00 a.m. EDT. To access the live webcast of the event, please use this link: A replay of the webcast, along with the related presentation materials, will be available on the "Events & Presentations" section of the Company's Investor Relations website following the conclusion of the event. 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 a gastrointestinal motility inhibitor when used during radiology exams as a diagnostic aid; 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 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 financial guidance for 2025, including its expected total revenue and commitment to remaining adjusted EBITDA positive, the outlook for 2030 and outlook for 2035 and beyond, including statements regarding total revenue, product growth, annual net revenue expected for Recorlev® and XP-8121, the market and therapeutic potential of its products and product candidates, including Recorlev and XP-8121, the ability to continue to demonstrate rapid revenue growth, sustained momentum across the portfolio and maintain disciplined execution of the Company's growth strategy, the beneficial impact on the lives of patients, including XP-8121's potential to transform the treatment landscape for millions living with hypothyroidism, capital management enabling the self-funding of both near and long-term growth, and other statements containing the words 'will,' 'would,' 'continue,' 'expect,' 'should,' 'anticipate,' 'new,' 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 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 recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, as well as 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.
Business Wire
08-05-2025
- Business
- Business Wire
Xeris Biopharma Reports Record First Quarter 2025 Financial Results
CHICAGO--(BUSINESS WIRE)--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 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 VialDx TM 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 EBITDA 1 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: 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: 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 or use this link: 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 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. 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 Expand 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. Expand XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) 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 Expand
Yahoo
17-03-2025
- Business
- Yahoo
Xeris Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke VialDx™ (glucagon) for Use as a Diagnostic Aid
First concentrated, ready-to-dilute liquid glucagon available for growing procedural gastroenterology market American Regent to commercialize GVOKE VialDx™ Availability is expected in the third quarter of 2025 CHICAGO, March 17, 2025--(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 that its supplemental new drug application (sNDA) of Gvoke VialDx™ has received U.S Food and Drug Administration (FDA) approval for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. Xeris also announced it has partnered with American Regent to commercialize Gvoke VialDx. Under the terms of the agreement, Xeris will be responsible for product supply, and American Regent will be responsible for the commercialization of Gvoke VialDx in the U.S. Financial terms were not disclosed. "We're excited about the approval of Gvoke VialDx and our partnership with American Regent. Gvoke VialDx has the potential to modernize the handling and administration of glucagon for diagnostic procedures," said Kevin McCulloch, President and COO of Xeris. "American Regent is the perfect partner for Gvoke VialDx given their long history as a leading provider of high quality, sterile injectable products to the hospital and acute care marketplace." Joann Gioia, Vice President and Chief Commercial Officer at American Regent, said, "We are eager to bring our commercial expertise in the hospital and acute care setting to our partnership with Xeris and contribute to the success of Gvoke VialDx. With an estimated 20 million gastrointestinal endoscopic procedures performed annually, the addition of Gvoke VialDx to our portfolio aligns perfectly with our mission to provide patients with the essential medicines they need." Gvoke VialDx will be available as a 1-count or 10-count package of 1 mg per 0.2 mL single-dose vials. Indications and Important Safety InformationGvoke is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged 2 years and older with diabetes. Gvoke VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. Gvoke and Gvoke VialDx are contraindicated in patients with: Pheochromocytoma because of the risk of substantial increase in blood pressure Insulinoma because of the risk of hypoglycemia Prior hypersensitivity reaction to glucagon or to any of the excipients. Serious hypersensitivity reactions have been reported with glucagon, including generalized rash, and anaphylactic shock with breathing difficulties and hypotension Gvoke VialDx is also contraindicated in patients with glucagonoma because of risk of hypoglycemia Glucagon may stimulate the release of catecholamines from the tumor. If patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate intravenously has been shown to be effective in lowering blood pressure In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, glucagon may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of Gvoke or Gvoke VialDx, give glucose orally or intravenously Patients with insufficient hepatic stores of glycogen may not respond to Gvoke for treatment of hypoglycemia. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation, or in patients with adrenal insufficiency or chronic hypoglycemia A skin rash called necrolytic migratory erythema (NME), has been reported post-marketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. Gvoke and Gvoke VialDx are not approved for continuous infusion. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks Gvoke VialDx in patients with diabetes mellitus may cause hyperglycemia. Monitor diabetic patients for changes in blood glucose levels during treatment with Gvoke VialDx and treat hyperglycemia, if indicated Gvoke VialDx may increase myocardial oxygen demand, blood pressure, and pulse rate which may be life threatening in patients with cardiac disease. Cardiac monitoring is recommended in patients with cardiac disease during use of Gvoke VialDx, and an increase in blood pressure and pulse rate may require therapy Gvoke VialDx administered to patients with glucagonoma may cause secondary hypoglycemia. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment and monitor for changes in blood glucose during treatment Most common adverse reactions reported for Gvoke in adult patients were nausea, vomiting, injection site edema raised 1 mm or greater, and headache Most common adverse reactions reported for Gvoke in pediatric patients were nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site discomfort and reaction, and urticaria. Most common adverse reactions reported for Gvoke VialDx were nausea, dysgeusia, headache, dizziness and hot flush Gvoke and Gvoke VialDx may increase the anticoagulant effect of warfarin; and in patients taking beta-blockers, may have a transient increase in pulse and blood pressure. In patients taking indomethacin Gvoke may lose its ability to raise glucose or may produce hypoglycemia. Concomitant use of anticholinergic drugs with Gvoke VialDx is not recommended. Monitor blood glucose when Gvoke VialDx is used in patients receiving insulin. For full Prescribing Information, visit About XerisXeris (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 a gastrointestinal motility inhibitor when used during radiology exams as a diagnostic aid; 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 or follow us on X, LinkedIn, or Instagram. About American RegentAmerican Regent, Inc., a Daiichi Sankyo Group company, is an industry leading US-based pharmaceutical company. For nearly 60 years, American Regent has been developing, manufacturing and supplying quality generic and branded injectables to healthcare providers. For more than 20 years, American Regent has been a leader in IV iron therapy supplying the market with the two top-selling brands in the US. We are committed to setting a higher standard for responsiveness, reliability, and quality and helping patients live better lives by providing the essential medicines they need is the constant motivation behind everything we do, everyday. Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need. For more information, visit Forward-Looking StatementsAny 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 the development and potential of a glucagon diagnostic product utilizing Xeris' XeriSol™ technology, the potential for Gvoke VialDx to modernize the handling and administration of glucagon for diagnostic procedures, the expectations regarding future commercialization of Gvoke VialDx by American Regent, the timing of availability of Gvoke VialDx, Xeris' potential entitlements to milestone and royalty payments from American Regent, the potential utility of its formulation platforms such as XeriSol™, the market and therapeutic potential of its products and product candidates, 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. View source version on Contacts Xeris Investor Contact Allison WeySenior Vice President, Investor Relations and Corporate Communicationsawey@ American Regent Contact Gennine KellySr. Director of Marketing and Portfolio Managementgkelly@
