Dexlansoprazole

XIAFLEX® revenues grew 7% compared to first-quarter 2024 The Company reaffirms 2025 revenue guidance of $1,775 to $1,860 million and adjusted EBITDA guidance of $620 to $650 million Combination with Mallinckrodt expected to close in second half of 2025 MALVERN, Pa., May 7, 2025 /PRNewswire/ --- Endo, Inc. ("Endo" or the "Company") (OTCQX: NDOI) today reported financial results for the first quarter ended March 31, 2025. "As we advance Endo's transformation with two major transactions announced in March, the Company remains focused on executing our growth drivers, as evidenced by strong XIAFLEX® performance in our Branded Pharmaceuticals business and the advancement of our Sterile Injectables pipeline," said Scott Hirsch, Endo's Interim CEO. "As a result of our first-quarter results, which met internal expectations across all segments, we are reaffirming our full-year 2025 earnings guidance." ENDO FIRST-QUARTER FINANCIAL PERFORMANCE (in thousands) CONSOLIDATED RESULTS Total revenues in first-quarter 2025 were $393 million, a decrease of 6% compared to $420 million in first-quarter 2024. This change was primarily attributable to competitive pressure across the Sterile Injectables and Generic Pharmaceuticals segments, partially offset by Branded Pharmaceuticals revenue growth. Net Loss in first-quarter 2025 was $129 million, compared to $154 million in first-quarter 2024. This change was primarily due to decreased expenses related to the Chapter 11 reorganization process, partially offset by increased costs of revenues driven by non-cash amortization of inventory fair value adjustments and increased interest expense. Adjusted EBITDA in first-quarter 2025 was $99 million, compared to $146 million in first-quarter 2024. This change was primarily driven by decreased revenues, lower adjusted gross margin due to changes in segment and product mix and investments in the Sterile Injectables manufacturing network, and additional investments in Sterile Injectables research and development. Adjusted Net Income in first-quarter 2025 was $24 million, compared to $131 million in first-quarter 2024. This change was primarily due to the decrease in adjusted EBITDA coupled with an increase in interest expense. SEGMENT RESULTS Branded Pharmaceuticals segment revenues in first-quarter 2025 were $209 million, compared to $201 million in first-quarter 2024. This change was primarily due to XIAFLEX® revenue growth. XIAFLEX® revenues were $121 million in first-quarter 2025, an increase of 7% compared to $113 million in first-quarter 2024, primarily driven by volume growth. Sterile Injectables segment revenues in first-quarter 2025 were $71 million, compared to $98 million in first-quarter 2024. This change was primarily driven by competitive pressure on VASOSTRICT® and ADRENALIN® vials. Additionally, during first-quarter 2025, the Company advanced its sterile injectables pipeline through increased adoption of the recently launched ADRENALIN® ready-to-use premixed bags and the completion of three FDA submissions. Generic Pharmaceuticals segment revenues in first-quarter 2025 were $99 million, compared to $103 million in first-quarter 2024. This change was primarily attributable to competitive pressure on dexlansoprazole delayed-release capsules and several other products, partially offset by a 16% increase in revenues from lidocaine patch 5%. International Pharmaceuticals segment revenues in first-quarter 2025 were $13 million, compared to $17 million in first-quarter 2024. This change was primarily attributable to the expiration of a license to distribute a product. BALANCE SHEET AND LIQUIDITY As of March 31, 2025, Endo had $370 million in unrestricted cash and cash equivalents compared to $387 million as of December 31, 2024. This change reflects the use of cash for interest expense, investment in working capital, taxes and expenses related to the previously announced corporate transactions. RECENTLY ANNOUNCED TRANSACTIONS Mallinckrodt and Endo Combination On March 13, 2025, Endo and Mallinckrodt plc entered into a definitive agreement to create a global, scaled, diversified pharmaceutical industry leader. Under the terms of the agreement, Endo shareholders will receive a total of $80 million in cash (subject to possible adjustment) and will own 49.9% of the combined company. Mallinckrodt shareholders will own 50.1% of the combined company on a pro-forma basis. The transaction is expected to close in the second half of 2025, subject to approval by shareholders of both companies, regulatory approvals and customary closing conditions. Mallinckrodt and Endo plan to combine their generic pharmaceuticals businesses and Endo's sterile injectables business after the transaction closes and to separate that business from the combined company at a later date. The planned separation would be subject to approval by the combined company's Board of Directors and other conditions. International Pharmaceuticals Business Divestiture On March 10, 2025, Endo entered into a definitive agreement to divest its International Pharmaceuticals business. The transaction is expected to close in mid-2025, pending regulatory approvals and customary closing conditions. FINANCIAL GUIDANCE Based on first-quarter 2025 results, Endo is reaffirming its previously provided financial guidance for the full year ending December 31, 2025. Guidance for the full year 2025 is based on Endo's current views, beliefs, estimates and assumptions. It includes the International Pharmaceuticals business and will be updated following completion of the divestiture. It does not include any potential impact related to future tariffs and trade policy changes, which the Company is unable to predict at this time. All financial expectations provided by Endo are forward-looking, and actual results may differ materially from such expectations, as further discussed below under the heading "Cautionary Note Regarding Forward-Looking Statements." CONFERENCE CALL INFORMATION Endo will host a conference call to discuss this press release today, May 7, 2025, at 8:30 a.m. ET. The audio webcast may be accessed through the Investor Relations section of the Company's website at investor.endo.com/events. To access the call through a conference line, participants may dial 800-836-8184 (U.S. and Canada toll-free) or 646-357-8785 (outside the U.S.). Participants are advised to join 10 minutes prior to the scheduled start time. A replay of the webcast will be available following the event. FINANCIAL SCHEDULES The following table presents unaudited Total Revenues, Net (dollars in thousands): The following table presents the unaudited Condensed Consolidated Statement of Operations (dollars in thousands): The following table presents the unaudited Condensed Consolidated Balance Sheet (dollars in thousands): The following table presents the unaudited Condensed Consolidated Statement of Cash Flow data (dollars in thousands): SUPPLEMENTAL FINANCIAL INFORMATION Non-GAAP Financial Measures To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain financial information of Endo, Inc. in this release that are not prescribed by or prepared in accordance with GAAP. The Company utilizes these non-GAAP financial measures as supplements to financial measures determined in accordance with GAAP when evaluating operating performance and the Company believes that these measures will be used by certain investors to evaluate operating results. The Company believes that presenting these non-GAAP financial measures provides useful information about performance across reporting periods on a consistent basis by excluding certain items, which may be favorable or unfavorable, as more fully described in the reconciliation tables below. Despite the importance of these measures to management in goal setting and performance measurement, the Company stresses that these are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. Because of the non-standardized definitions, non-GAAP adjusted EBITDA and non-GAAP adjusted net income (unlike GAAP net income and its components) may differ from, and may not be comparable to, the calculation of similar measures of other companies. These non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses performance. These non-GAAP financial measures should not be viewed in isolation or as substitutes for, or superior to, financial measures calculated in accordance with GAAP. Investors are encouraged to review the reconciliations of the non-GAAP financial measures used in this press release to their most directly comparable GAAP financial measures. However, the Company does not provide reconciliations of projected non-GAAP financial measures to GAAP financial measures, nor does it provide comparable projected GAAP financial measures for such projected non-GAAP financial measures. The Company is unable to provide such reconciliations without unreasonable efforts due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations, including adjustments that could be made for asset impairments, contingent consideration adjustments, legal settlements, gain / loss on extinguishment of debt, adjustments to inventory and other charges reflected in the reconciliation of historic numbers, the amounts of which could be significant. The tables below provide reconciliations of certain of the non-GAAP financial measures included in this release to their most directly comparable GAAP metrics. Refer to the "Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures" section below for additional details regarding the adjustments to the non-GAAP financial measures detailed throughout this Supplemental Financial Information section. Reconciliation of Net Loss (GAAP) to EBITDA (non-GAAP) and Adjusted EBITDA (non-GAAP) The following table provides a reconciliation of Net Loss (GAAP) to Adjusted EBITDA (non-GAAP) (in thousands): Reconciliation of Net Loss (GAAP) to Adjusted Net Income (non-GAAP) The following table provides a reconciliation of Endo's Net Loss (GAAP) to Adjusted Net Income (non-GAAP) (in thousands): Reconciliation of Select Other Adjusted Income Statement Data (non-GAAP) The following tables provide detailed reconciliations of select other income statement data for Endo, Inc. between the GAAP and non-GAAP measure (in thousands): Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures Notes to certain line items included in the reconciliations of the GAAP financial measures to the non-GAAP financial measures are as follows: About Endo Endo is a diversified pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. No Offer or Solicitation This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Additional Information about the Combination and Where to Find It In connection with the proposed transaction, on April 23, 2025, Mallinckrodt filed with the U.S. Securities and Exchange Commission ("SEC") a registration statement on Form S-4, as amended by Amendment No. 1 filed on May 6, 2025, that includes a joint proxy statement of Mallinckrodt and Endo and that also constitutes a prospectus of Mallinckrodt ordinary shares. Each of Mallinckrodt and Endo may also file other relevant documents with the SEC regarding the proposed transaction. This document is not a substitute for the joint proxy statement/prospectus or registration statement or any other document that Mallinckrodt or Endo may file with the SEC. The definitive joint proxy statement/prospectus (if and when available) will be mailed to shareholders of Mallinckrodt and Endo. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, THE JOINT PROXY STATEMENT/PROSPECTUS INCLUDED WITHIN THE REGISTRATION STATEMENT, AND ANY OTHER RELEVANT DOCUMENTS THAT ARE FILED WITH OR WILL BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE, BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders are able to obtain free copies of the registration statement and joint proxy statement/prospectus, any amendments or supplements thereto and other documents containing important information about Mallinckrodt, Endo, and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at . Copies of the documents filed with the SEC by Mallinckrodt are available free of charge on Mallinckrodt's website at . Copies of the documents filed with the SEC by Endo are available free of charge on Endo's website at . Participants in the Solicitation of Proxies Mallinckrodt, Endo, and certain of their respective directors, executive officers, and other members of management and employees may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information about the directors and executive officers of Mallinckrodt, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in (i) Mallinckrodt's proxy statement for its 2024 Annual Meeting of Shareholders, which was filed with the SEC on April 15, 2024 (and which is available at ), including under the headings "Corporate Governance", "Our Director Nominees," "Board of Directors and Board Committees," "Compensation of Non-Employee Directors," "Executive Officers" "Compensation of Executive Officers," "Pay Versus Performance," "Security Ownership and Reporting," "Equity Compensation Plan Information" and "Proposals 1(A) Through 1(E): Election of Directors", (ii) Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended December 27, 2024, which was filed with the SEC on March 13, 2025 (and which is available at ), including under the headings "Item 10. Directors, Executive Officers and Corporate Governance", "Item 11. Executive Compensation", "Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters", "Item 13. Certain Relationships and Related Transactions and Director Independence", and (iii) to the extent holdings of Mallinckrodt's securities by its directors or executive officers have changed since the amounts set forth in Mallinckrodt's proxy statement for its 2024 Annual Meeting of Shareholders, such changes have been or will be reflected on Initial Statement of Beneficial Ownership of Securities on Form 3, Statement of Changes in Beneficial Ownership on Form 4, or Annual Statement of Changes in Beneficial Ownership on Form 5 filed with the SEC, which are available at EDGAR Search Results (? action=getcompany&CIK=0001567892&type=&dateb=&owner=only&count=40&search_text=). Information about the directors and executive officers of Endo, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in (i) the registration statement on Form S-4 that includes a joint proxy statement of Mallinckrodt and Endo, which was filed with the SEC on April 23, 2025 (and which is available at ), as amended by Amendment No. 1, which was filed with the SEC on May 6, 2025 (and which is available at ), (ii) Endo's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the SEC on March 13, 2025 (and which is available at ), (iii) Endo's registration statement on Form S-1, which was filed with the SEC on July 31, 2024 (and which is available at ), including under the headings "Management," "Executive and Director Compensation of Endo International plc," "Certain Relationships and Related Party Transactions," and "Principal and Registering Stockholders" and (iv) to the extent holdings of Endo's securities by its directors or executive officers have changed since the amounts set forth in Endo's S-1 registration statement, such changes have been or will be reflected on Initial Statement of Beneficial Ownership of Securities on Form 3, Statement of Changes in Beneficial Ownership on Form 4, or Annual Statement of Changes in Beneficial Ownership on Form 5 filed with the SEC, which are available at EDGAR Search Results (? action=getcompany&CIK=0002008861&type=&dateb=&owner=only&count=40&search_text=). Other information regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the definitive joint proxy statement/prospectus and will be contained in other relevant materials to be filed with the SEC regarding the proposed transaction when such materials become available. Investors should read these materials carefully before making any voting or investment decisions. You may obtain free copies of these documents from Mallinckrodt or Endo using the sources indicated above. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to the statements by Mr. Hirsch and any statements relating to financial guidance, expectations, plans or projections, supply disruptions, pipeline development or realignment, product launches and submissions, strategic priorities, the announced combination with Mallinckrodt and the potential separation of the generics and sterile injectables businesses, improving performance, revenue growth, competition, demand and any other statements that refer to expected, estimated, predicted or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are examples of forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: with respect to the announced combination with Mallinckrodt and the potential separation of the generics and sterile injectables businesses, necessary governmental and regulatory approvals, satisfaction of closing conditions and shareholder approval; changes in competitive, market or regulatory conditions; changes in legislation or regulations; global political changes, including those related to the new U.S. presidential administration; our use of artificial intelligence and data science; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition such as those related to XIAFLEX®; the timing and uncertainty of the results of both the research and development and regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; litigation; the performance including the approval, introduction and consumer and physician acceptance of current and new products; the performance of third parties upon whom we rely for goods and services; issues associated with our supply chain; our ability to develop and expand our product pipeline and to launch new products and to continue to develop the market for XIAFLEX® and other branded, sterile injectable or generic products; the effectiveness of advertising and other promotional campaigns; and the timely and successful implementation of business development opportunities and/or any other strategic priorities. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-K. Copies of the Company's press releases and additional information about the Company are available at or you can contact the Company's Investor Relations Department at [email protected]. SOURCE Endo, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED