Collagenase Clostridium histolyticum(Biospecifics Technologies Corp)

MALVERN, Pa., March 24, 2025 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today that data related to the use of XIAFLEX® (collagenase clostridium histolyticum, or CCH) for the treatment of recurrence of Dupuytren contracture following surgical correction will be presented during the Triennial Congress of the International Federation of Societies for Surgery of the Hand (IFSSH) and International Federation of Societies for Hand Therapy (IFSHT), taking place March 24-28, 2025. Dupuytren contracture is a progressive hand condition in which a collagen rope-like cord forms beneath the skin of the palm, pulling fingers inward toward the palm.1,2 It affects an estimated 17 million Americans.3,4* "These findings may help healthcare providers manage Dupuytren contracture in patients experiencing a recurrent deformity following initially successful surgery," said Dr. Clayton A. Peimer, Adjunct Clinical Professor of Orthopedics at the Warren Alpert Medical School of Brown University, and lead author of the study. "The use of collagenase in these cases provides an alternative to repeat surgery. I look forward to sharing this information with the medical community so that we can further enhance our understanding of treatment options for recurrent Dupuytren contracture and, ultimately, improve patient outcomes." The presentation covers data from the Phase 4 retrospective study of treatment with XIAFLEX in Dupuytren contracture patients with disease recurrence after surgical correction. The Endo-sponsored presentation is below: Treatment of Dupuytren Contracture Recurrence After Surgery with Collagenase Clostridium Histolyticum: A Retrospective Multicenter Series Authors: Clayton A. Peimer, MD; Marie A. Badalamente, PhD; Philip Blazar, MD; Keith A. Denkler, MD; William Dzwierzynski, MD; Mark Elzik, MD; F. Thomas D. Kaplan, MD; Jason A. Nydick, DO; Gary M. Pess, MD; James Verheyden, MD; Mark A. Vitale, MD; Jeffrey Andrews, MS; Qinfang Xiang, PhD; David Hurley, MD; Lawrence C. Hurst, MD About the Study This Phase 4, multicenter, noninterventional, retrospective study analyzed medical records collected from 10 clinical centers in the United States (U.S.). Patients were included who experienced recurrence of Dupuytren contracture ≥ 6 months after a previously successful surgical correction and were then treated with collagenase clostridium histolyticum (CCH) between January 1, 2010 and August 15, 2020. Primary endpoints were the measured joint contracture change from baseline, at first and last clinical evaluation within 12 months of CCH treatment of metacarpophalangeal and proximal interphalangeal joint contractures. Secondary endpoints were clinical success (percentage of joints with reduction in contracture to 0–5°) and adverse events. Results from this Phase 4 retrospective study demonstrated that CCH was effective and well tolerated for the treatment of Dupuytren contracture recurrence in patients after surgery. Most adverse events were rated as mild in severity and there were no reported treatment-related serious adverse events. About Dupuytren Contracture Dupuytren contracture is a lifelong condition that may get worse over time. It's caused by a buildup of collagen in the hand, which forms a rope-like cord that pulls fingers toward the palm so they can't be straightened. As Dupuytren contracture progresses, it may become difficult for individuals to use their hand(s) for daily tasks and activities.1,2 WHAT IS XIAFLEX®? XIAFLEX is a prescription medicine used to treat adults with Dupuytren's contracture when a "cord" can be felt. It is not known if XIAFLEX is safe and effective in children under the age of 18. IMPORTANT SAFETY INFORMATION FOR XIAFLEX Do not receive XIAFLEX if you have had an allergic reaction to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX. XIAFLEX can cause serious side effects, including: Tendon rupture or ligament damage. Receiving an injection of XIAFLEX may cause damage to a tendon or ligament in your hand and cause it to break or weaken. This could require surgery to fix the damaged tendon or ligament. Call your healthcare provider right away if you have trouble bending your injected finger (towards the wrist) after the swelling goes down or you have problems using your treated hand after your follow-up visit Nerve injury or other serious injury of the hand. After finger procedures, some people developed tears in the skin (lacerations), and local skin and soft-tissue necrosis (death of skin cells). Some lacerations and necrosis required skin grafting, or other surgery including amputation. Call your healthcare provider right away if you get numbness, tingling, increased pain, or tears in the skin (laceration) in your treated finger or hand after your injection or after your follow-up visit Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive XIAFLEX because it contains foreign proteins. Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX: hives swollen face breathing trouble chest pain low blood pressure dizziness or fainting Fainting. Fainting (passing out) or near fainting can happen in people who receive XIAFLEX, especially following finger procedures If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away. Increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive XIAFLEX. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX may not be right for you. Before receiving XIAFLEX, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX injection, or have a bleeding problem or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using XIAFLEX with certain other medicines can cause serious side effects. Especially tell your healthcare provider if you take medicines to thin your blood (anticoagulants). If you are told to stop taking a blood thinner before your XIAFLEX injection, your healthcare provider should tell you when to restart the blood thinner. Ask your healthcare provider or pharmacist for a list of these medicines if you are unsure. The most common side effects with XIAFLEX for the treatment of Dupuytren's contracture include: swelling of the injection site or the hand bruising or bleeding at the injection site pain or tenderness of the injection site or the hand swelling of the lymph nodes (glands) in the elbow or armpit itching breaks in the skin redness or warmth of the skin pain in the armpit Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with XIAFLEX. For more information, ask your healthcare provider or pharmacist. Rx Only Click for full Prescribing Information , including Medication Guide . 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. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Dr. Peimer and any statements relating to product efficacy, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated 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 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: changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition; the timing and uncertainty of the results of the research and development and the regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; litigation and other disputes; 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; the ability to develop and expand our product pipeline, to launch new products and to continue to develop the market for our products; the proposed business combination transaction between Endo and Mallinckrodt; and the effectiveness of advertising and other promotional campaigns. 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 and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. *Dupuytren contracture prevalence estimation calculation: average Dupuytren contracture prevalence in the U.S. (5%) multiplied by U.S. population (332 million per 2021 U.S. Census data) = ~17 million. References: Hurst, LC, Badalamente, MA, et al. New England Journal of Medicine.2009;361(10),968-979. Bayat, A, McGrouther, DA. Annals of the Royal College of Surgeons of England. 2006;88(1),3-8. "How common is Dupuytren disease?" Dupuytren Research Group. April 1, 2017. Accessed January 13, 2025. "U.S. and world population clock." U.S. Census Bureau. Updated April 13, 2023. Accessed January 13, 2025. 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 achieved 2024 revenues and adjusted EBITDA expectations, while progressing the Company's strategic priorities XIAFLEX® hit record revenues of $516 million in 2024, up 9% versus 2023 The Company provides 2025 revenue guidance of $1,775 to $1,860 million and adjusted EBITDA guidance of $620 to $650 million MALVERN, Pa., March 13, 2025 /PRNewswire/ -- Endo, Inc. ("Endo" or the "Company") (OTCQX: NDOI) today reported financial results for the fourth quarter and full-year ended December 31, 2024. "We ended the year strong, with XIAFLEX® annual revenues exceeding $500 million for the first time and the successful launch of ADRENALIN® ready-to-use premixed bags," said Scott Hirsch, Interim Chief Executive Officer. "These milestones, along with the strategic realignment of our sterile product pipeline and the two recently announced transformative transactions, underscore our commitment to deliver growth and shareholder value." Separately, the Company announced that it has entered into a definitive agreement to combine with Mallinckrodt plc in a cash and stock transaction. ENDO FOURTH-QUARTER FINANCIAL PERFORMANCE (in thousands) CONSOLIDATED RESULTS Total revenues in fourth-quarter 2024 were $467 million, a decrease of 6% compared to $498 million in fourth-quarter 2023. This decrease was primarily attributable to competitive pressure across the Generic Pharmaceuticals and Sterile Injectables segments. Net Loss in fourth-quarter 2024 was $349 million, compared to a net loss of $2,441 million in fourth-quarter 2023. This change was driven by fourth-quarter 2023 adjustments to estimated allowed claims, including with respect to certain litigation matters and debt obligations that were reduced to actual payments upon emergence from the Chapter 11 process in second-quarter 2024. This was partially offset by fourth-quarter 2024 asset impairment charges and the application of fresh start accounting. Adjusted Net Income in fourth-quarter 2024 was $70 million, compared to $151 million in fourth-quarter 2023. This change was primarily due to increased interest and income tax expenses in fourth-quarter 2024. Adjusted EBITDA in fourth-quarter 2024 was $164 million, compared to $166 million in fourth-quarter 2023. This change was primarily driven by decreased revenues, partially offset by higher adjusted gross margin due to changes in segment and product mix. SEGMENT RESULTS Branded Pharmaceuticals segment revenues in fourth-quarter 2024 were $247 million, compared to $246 million in fourth-quarter 2023. XIAFLEX® revenues were $148 million in both fourth-quarter 2024 and fourth-quarter 2023. Fourth-quarter 2023 results included the benefit of a one-time reserve reversal of approximately $14 million following application of the final Inflation Reduction Act vial-wastage rebate determination to XIAFLEX®. Fourth-quarter 2024 XIAFLEX® revenues were primarily driven by an 8% increase in volume due to strong underlying demand. Sterile Injectables segment revenues in fourth-quarter 2024 were $92 million, compared to $96 million in fourth-quarter 2023. This change was primarily driven by competitive pressure on VASOSTRICT®, partially offset by the resolution of previously disclosed temporary supply disruptions. During fourth-quarter 2024, the Company launched three sterile injectable products, including ADRENALIN® ready-to-use (RTU) premixed bags, the first and only FDA-approved, manufacturer-prepared epinephrine premixed IV bags. Generic Pharmaceuticals segment revenues in fourth-quarter 2024 were $111 million, compared to $139 million in fourth-quarter 2023. This change was primarily attributable to competitive pressure across a number of products, mainly dexlansoprazole delayed-release capsules, partially offset by increased revenues from lidocaine patch 5%. International Pharmaceuticals segment revenues in fourth-quarter 2024 were $17 million, compared to $17 million in fourth-quarter 2023. BALANCE SHEET AND LIQUIDITY As of December 31, 2024, Endo had $387 million in unrestricted cash and cash equivalents. Net cash provided by operating activities in fourth-quarter 2024 was $30 million, compared to $115 million in fourth-quarter 2023. This change was primarily driven by increased interest and tax payments in fourth-quarter 2024 compared to fourth-quarter 2023. FINANCIAL GUIDANCE Endo is providing the following financial guidance for the full year ending December 31, 2025 based on Endo's current views, beliefs, estimates and assumptions. Guidance for the full year 2025 includes the International Pharmaceuticals business and will be updated following completion of the divestiture. 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 and Mallinckrodt will host a joint conference call to discuss the proposed transaction and their respective fourth quarter and full year 2024 results today, March 13, 2025, at 8:00 a.m. ET. The webcast may be accessed through this webcast link or from 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 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 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. 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 combination with Mallinckrodt, 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, 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 and Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. 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. 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