Collagenase Clostridium histolyticum(Biospecifics Technologies Corp)

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

Endo是一家大量销售阿片药物，因阿片药物诉讼和医疗器械不良反应诉讼而破产的公司，2024年完成了破产重组，重组后的Endo希望重点发展专科药，所以制定了如下战略。该战略可以为广大仿制药企业的转型提供参考。商业战略我们的战略源于成为一家充满活力、持续增长且多样化的制药企业的愿景，致力于提供创新、改善生命质量的产品。我们通过多样化且稳健的业务组合推动长期为利益相关方创造价值，具体包括：推进产品研发、追求卓越制造与商业化能力，以及培育注重质量与合规的协作型增长文化。多样化且稳健的业务组合我们通过战略性投资强化业务组合以实现可持续发展：1）品牌药业务：聚焦投资推动XIAFLEX®的长期增长，利用其"一药多适应症"平台开发非手术治疗肌肉骨骼疾病的新方案，并依托现有商业化能力拓展泌尿、骨科及相邻领域的外部机会；2）无菌注射剂业务：通过引入差异化、长效产品扩充管线，并成功推出满足客户需求的新产品；3）仿制药与国际业务：通过选择性投资获取可持续现金流，以支持核心增长领域。卓越制造与商业化近年来，我们升级了无菌注射剂产能、优化仿制药生产网络并革新管理职能。未来将持续投资关键能力建设，特别是支持复杂差异化无菌注射剂研发生产的核心技术，同时推进数字化转型以提升效率。基于前期产能投入，近期暂无重大扩产资本支出计划。高绩效文化我们致力于打造包容、高效且高度参与的文化环境，践行协作增长理念与质量合规承诺，并通过供应链体系推动全球资源的负责任使用。资本配置原则我们将分三步实现战略目标：1）投资现有非阿片类产品的市场推广、研发管线推进及生产网络升级；2）在核心增长领域开展选择性并购或业务拓展；3）利用富余资金降低负债。战略实施关键要素包括：有效执行XIAFLEX®市场增长策略、取得新适应症临床试验积极结果、按时推进无菌注射剂管线产品上市、提升关键能力、确保第三方合作伙伴稳定表现，以及保持全球团队的高效协作。ENDO的破产重组过程Endo是靠阿片药物起家、做大的公司，不仅有文章证明Endo的拳头产品Opana ER比Oxycotin更容易被滥用，而且Rajiv Silva担任CEO时期促销Opana ER的营销方案被曝光，自然而然地成为了风口浪尖——牵涉3000多件来自联邦政府、各州县、以及各种组织机构的阿片药物诉讼，虽然Endo对这些案件提供了超过3亿美元的和解费，但这只是冰山一角，因为Teva为解决3500起阿片诉讼，和解费高达40多亿美元。除了阿片药物诉讼，Endo还有大量未解决的医疗器械伤害索赔。由于曾经Astora经营治疗盆腔器官脱垂（POP）和压力性尿失禁（SUI）的器械，这些器械导致了慢性疼痛、尿失禁、肠道功能紊乱、永久性畸形等不良反应，虽Astora已关停，但遗留了大量官司，截至2022年一季度，Endo解决了7.1万件索赔，已累计赔偿了36亿美元，但有一部分还没有完全解决。面对巨大的债务和大规模的索赔，Endo再无翻身的机会，于2022年8月申请了破产保护。随着阿片官司的逐步解决，截至2023年末，仅阿片药物相关的总债务就达21.78亿美元，随着债务的快速增加，净资产减少至-65.98亿美元。2024年3月，Endo的破产重组计划和阿片药物和解方案获得了法院批准—— Endo需在未来10年内向美国联邦政府支付最高4.649亿美元的阿片药物和解费。随后，Endo及某些债务人与买方达成了资产购销协议经过四个月的破产重组，CEO Blaise Coleman离职，公司名由“Endo International plc”改为“Endo, Inc”，并在美国特拉华州注册，总部设在宾夕法尼亚州的Malvern市，由Scott Hirsch担任CEO。3月13日，Mallinckrodt与Endo共同宣布了一项重大合并计划，旨在通过整合双方的优势资源与能力，打造一个全球领先的规模化、多样化制药企业。这一战略合并不仅将增强两家公司在全球制药市场的竞争力，还将为患者带来更多创新药物和治疗方案。Mallinckrodt与Endo都曾是大量销售阿片药物的公司，因美国的阿片药物诉讼危机而面临巨额债务，最终不得不申请破产重组。Endo于2024年完成重组，重组后逐渐放弃国际制药业务和仿制药业务，与Mallinckrodt合并，共同打造一家专科药公司。合并完成后，Endo股东将获得8000万美元现金，并持有新公司49.9%的股份；Mallinckrodt股东将持有剩余的50.1%股份，Mallinckrodt将成为新公司的母公司。Mallinckrodt现任CEO Siggi Olafsson（原HIKMA CEO）将担任合并后公司的CEO。因此，上述战略并没有有效实施，因为Endo刚刚破产重组完不足一年，就对外宣称将与马琳科罗特合并（并入马琳科罗特，Mallinckrodt）。而合并之后，公司将实施新的战略。案例之二：拜耳的战略（2024年）案例之一：罗氏的战略（2024年）药事纵横投稿须知：稿费已上调，欢迎投稿