Latest news with #XIAFLEX®
Malaysian Reserve
4 days ago
- Health
- Malaysian Reserve
"Prime Time," a Branded Peyronie's Disease Commercial for XIAFLEX® (collagenase clostridium histolyticum)
The 90-second commercial builds on the 'Bent Carrot' campaign, launched in 2021, with creative that highlights a couple's journey from diagnosis to treatment. It spotlights the copay program designed to increase patient access and support a potential $0 out-of-pocket pathway for commercially insured patients. XIAFLEX is the only FDA-approved treatment for Peyronie's disease. DUBLIN, Aug. 12, 2025 /PRNewswire/ — Endo, a wholly-owned subsidiary of Mallinckrodt plc, announced today the launch of its XIAFLEX® (collagenase clostridium histolyticum or CCH) television commercial, Prime Time. The spot encourages men who may be experiencing Peyronie's disease (PD) symptoms to seek diagnosis and ask a urology specialist about XIAFLEX, the first and only FDA-approved nonsurgical treatment for PD. The campaign also spotlights the copay program designed to increase patient access, as ~94% of eligible commercially insured patients should pay $0 out of pocket for XIAFLEX.* The copay program is not available for government-insured patients. PD is a condition in which a buildup of fibrous scar tissue causes a curvature deformity of the penis. This curvature can be bothersome during arousal and intimacy.1 It is estimated that PD can affect as many as 1 in 10 men in the U.S.,2 but diagnosis rates remain low because men may be too uncomfortable to speak up and get help.3 'We're proud to continue our strong commitment to men's health and speak directly to men who may be worried about their Peyronie's disease symptoms,' said Justin Mattice, Senior Vice President & General Manager, Branded Specialty at Endo. 'With this campaign, we're urging men to speak with a urology specialist and explore whether XIAFLEX is right for them, while sharing information about common hesitations or misconceptions that might be holding them back.' Endo believes men should not suffer alone and aims to continue to help drive diagnosis improvement—both in the time it takes to seek a diagnosis and the number of people who are diagnosed. 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. Patient-Centric Campaign CreativePrime Time builds on Bent Carrot, the original branded commercial for XIAFLEX that debuted in 2021. This new campaign features creative and messages that highlight a couple's experience navigating the PD journey from symptom onset to treatment—including fears and hesitations they experienced along the way, as well as gratitude for the treatment outcome. The commercial opens with the couple watching television as the original Bent Carrot spot plays. The man reflects on his experience with PD and admits that embarrassment delayed his decision to seek help. Beside him, his partner offers encouragement and commends his decision to speak with a urology specialist. The couple also reflects on two hesitations that can deter PD patients: cost misinformation and fear of treatment. The commercial reinforces the copay program for XIAFLEX when the couple states that they ultimately paid nothing out of pocket, and they underscore the role of a trusted urology specialist who can explain the treatment side effects, process, and other information to help men and their partners make the decisions that are right for them. The commercial also includes the now familiar PD metaphor. During the spot, a bent carrot gradually straightens from 45 degrees to 26 degrees, symbolizing progress. The vegetable has been prominently featured in PD ads since the Bent Carrot launch four years ago. The campaign retains its call to action, Watch the commercial. Media BuyThe 90-second spot will air on streaming platforms and online video services like Prime Video, CBS, HBO Max, Hulu, and Peacock starting August 11. The commercial is also part of a larger surround-sound campaign that includes social media and digital ads on platforms where patients are active. About Peyronie's DiseasePeyronie's disease (PD) is a condition in which a buildup of fibrous scar tissue causes a curvature deformity of the penis. This curvature can be bothersome during arousal and intimacy.1 It is estimated that PD can affect as many as 1 in 10 men in the U.S.,2 but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help.3 IMPORTANT SAFETY INFORMATIONDo not receive XIAFLEX if: the Peyronie's plaque to be treated involves the 'tube' that your urine passes through (urethra). you are allergic 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: 1. Penile fracture (corporal rupture) or other serious injury to the penis. Receiving an injection of XIAFLEX may cause damage to the tubes in your penis called the corpora. After treatment with XIAFLEX, one of these tubes may break during an erection. This is called a corporal rupture or penile fracture. This could require surgery to fix the damaged area. Damage to your penis might not get better after a corporal rupture. After treatment with XIAFLEX, blood vessels in your penis may also break, causing blood to collect under the skin (hematoma). This could require a procedure to drain the blood from under the skin. If a hematoma appears, skin and soft tissue necrosis (death of skin cells) may develop in that area, which could require surgery. After treatment with XIAFLEX, blood vessels in your penis may also break, causing blood to collect under the skin (hematoma). This could require a procedure to drain the blood from under the skin. If a hematoma appears, skin and soft tissue necrosis (death of skin cells) may develop in that area, which could require surgery. Symptoms of corporal rupture or other serious injury to your penis may include: a popping sound or sensation in an erect penis sudden loss of the ability to maintain an erection pain in your penis purple bruising and swelling of your penis difficulty urinating or blood in the urine a popping sound or sensation in an erect penis sudden loss of the ability to maintain an erection pain in your penis purple bruising and swelling of your penis difficulty urinating or blood in the urine Call your healthcare provider right away if you have any of the symptoms of corporal rupture or serious injury to the penis listed above. Do not have sex or any other sexual activity between the first and second injections of a treatment cycle. Do not have sex or have any other sexual activity for at least 4 weeks after the second injection of a treatment cycle with XIAFLEX and after any pain and swelling has gone away. XIAFLEX for the treatment of Peyronie's disease is only available through a restricted program called the XIAFLEX Risk Evaluation and Mitigation Strategy (REMS) Program. 2. 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 3. Back pain reactions. After receiving an injection of XIAFLEX for Peyronie's disease, you may suddenly feel back pain, including severe lower back pain moving to your legs, feet, chest and arms. The back pain may also include spasms and make it hard to walk. These symptoms usually go away in 15 minutes or less, but may last longer. Tell your healthcare provider right away if you have sudden back pain, chest pain, or hard time walking after an injection. 4. Fainting. Fainting (passing out) or near fainting can happen in men who receive XIAFLEX, especially if they have severe penile pain. If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away. Before receiving XIAFLEX, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX injection, have a bleeding problem, received XIAFLEX for another condition, or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter 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 not sure. What should I avoid while receiving XIAFLEX? Avoid situations that may cause you to strain your stomach (abdominal) muscles, such as straining during bowel movements. Do not use a vacuum erection device during your treatment with XIAFLEX. XIAFLEX can cause serious side effects, including 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. The most common side effects with XIAFLEX for the treatment of Peyronie's disease include: a small collection of blood under the skin at the injection site (hematoma) swelling at the injection site or along your penis pain or tenderness at the injection site, along your penis and above your penis penis bruising itching of your penis or scrotum (genitals) painful erection erection problems (erectile dysfunction) changes in the color of the skin of your penis blisters at the injection site pain with sex a lump at the injection site (nodule) 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. You may report side effects to FDA at 1-800-FDA-1088. WHAT IS XIAFLEX? XIAFLEX is a prescription medicine used to treat adult men with Peyronie's disease who have a 'plaque' that can be felt and a curve in their penis greater than 30 degrees when treatment is started. It is not known if XIAFLEX is safe and effective in children under the age of 18. Rx Only Click for full Prescribing Information, including BOXED WARNING and Medication Guide. About EndoEndo, a wholly owned subsidiary of Mallinckrodt plc, is a diversified therapeutics manufacturer 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 Statements Related To Forward-Looking StatementsThis release contains forward-looking statements, including with regard to XIAFLEX the potential of this product to improve health and treatment outcomes, and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of each of Endo's and Mallinckrodt's recent emergences from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with XIAFLEX; and other risks identified and described in more detail in the 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' sections of Mallinckrodt's and Endo's most recent Annual Reports on Form 10-K, Mallinckrodt's Registration Statement on Form S-4, as amended, and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and we do not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. * Most eligible patients with commercial insurance plans should pay a $0 copay for XIAFLEX. Predictions based on historical analysis of claims filed September 2022 through August 2023. References Hellstrom WJ. Int J Impot Res. 2003;15:S91-S92. Stuntz M, Perlaky A, des Vignes F, et al. PLoS One. 2016;11(2):e0150157. DiBenedetti DB, Nguyen D, Zografoset L, et al. Adv Urol. 2011:282503. ### Logo – View original content:
Cision Canada
07-05-2025
- Business
- Cision Canada
Endo Reports First-Quarter 2025 Financial Results and Reaffirms 2025 Financial Guidance
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 /CNW/ --- 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) Successor (a) Predecessor (a) Three Months Ended March 31, 2025 Three Months Ended March 31, 2024 % Change 2025 vs. 2024 Branded Pharmaceuticals $ 209,491 $ 200,796 4 % Sterile Injectables $ 71,271 $ 98,234 (27) % Generic Pharmaceuticals $ 99,084 $ 103,317 (4) % International Pharmaceuticals $ 12,987 $ 17,160 (24) % Total Revenues, Net $ 392,833 $ 419,507 (6) % Net Loss $ (128,630) $ (154,230) (17) % Adjusted Net Income (b) $ 23,780 $ 131,415 (82) % Adjusted EBITDA (b) $ 99,049 $ 146,302 (32) % __________ (a) Endo acquired substantially all of the assets of Endo International plc ("EIP") on April 23, 2024, as contemplated by EIP's plan of reorganization. (b) The information presented in the table above includes non-GAAP financial measures such as Adjusted Net Income and Adjusted EBITDA. Please refer to the "Supplemental Financial Information" section below for reconciliations of certain non-GAAP financial measures to the most directly comparable GAAP financial measures. 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. 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 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): __________ (1) Products included within Other Specialty include, but are not limited to, AVEED ®. (2) Products included within Other Established include, but are not limited to, EDEX ®. (3) Individual products presented above represent the top two performing products for the periods presented and/or any product having revenues in excess of $25 million during the quarter. (4) Products included within Other Sterile Injectables include, but are not limited to, APLISOL ®. No individual product within Other Sterile Injectables has exceeded 5% of consolidated total revenues for the periods presented. (5) The Generic Pharmaceuticals segment is comprised of a portfolio of products that are generic versions of branded products, are distributed primarily through the same wholesalers, generally have limited or no intellectual property protection and are sold within the U.S. During the Successor three months ended March 31, 2025 and the Predecessor three months ended March 31, 2024, Lidocaine patch 5% made up 9% and 7%, respectively, of consolidated revenues. Dexlansoprazole delayed release capsules, which launched in November 2022, made up 5% for the Predecessor three months ended March 31, 2024 of consolidated total revenues. No other individual product within the segment has exceeded 5% of consolidated total revenues for the periods presented. (6) No individual product within the International Pharmaceuticals segment accounted for more than 5% of consolidated total revenues for any of the periods presented. 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): __________ (a) Beginning during the third-quarter of 2022, Endo International plc (EIP) became obligated to make certain adequate protection payments as a result of its previously disclosed Chapter 11 proceedings. 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. The following table provides a reconciliation of Net Loss (GAAP) to Adjusted EBITDA (non-GAAP) (in thousands): __________ (a) Certain prior period non-GAAP adjustments have been reclassified to conform to the current period presentation. Unless otherwise noted in the footnotes below, there have been no changes to the adjustment amounts. The following table provides a reconciliation of Endo's Net Loss (GAAP) to Adjusted Net Income (non-GAAP) (in thousands): __________ (a) Certain prior period non-GAAP adjustments have been reclassified to conform to the current period presentation. Unless otherwise noted in the footnotes below, there have been no changes to the adjustment amounts. The following tables provide detailed reconciliations of select other income statement data for Endo, Inc. between the GAAP and non-GAAP measure (in thousands): __________ (a) Gross profit is calculated as total revenues less cost of revenues. Gross margin is calculated as gross profit divided by total revenues. Adjusted gross profit is calculated as total revenues less adjusted cost of sales. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues. (b) Total operating expenses is calculated as the total of: (i) Selling, general and administrative; (ii) Research and development; (iii) Acquired in-process research and development; (iv) Litigation-related and other contingencies, net; (v) Asset impairment charges; and (vi) Acquisition related and integration items, net. (c) Certain prior period non-GAAP adjustments have been reclassified to conform to the current period presentation. Unless otherwise noted in the footnotes below, there have been no changes to the adjustment amounts. 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: (1) Depreciation and amortization and Share-based compensation per the Adjusted EBITDA reconciliations do not include amounts reflected in other lines of the reconciliations, including amounts related to restructuring or other transactions. (2) To exclude property, plant and equipment impairment charges for the Predecessor three months ended March 31, 2024. (3) Adjustments for acquisitions and divestitures included the following (in thousands): __________ (a) For the purposes of calculating Adjusted EBITDA (non-GAAP), amortization of intangible assets is excluded from the adjustments for acquisitions and divestitures as it is included as an adjustment to arrive at EBITDA (non-GAAP). Amortization of intangible assets is an adjustment included in the acquisitions and divestitures line item for the purposes calculating Adjusted Net Income (non-GAAP). (b) The Company has incurred certain transaction costs during the Successor three months ended March 31, 2025 in connection with the execution of the combination of Mallinckrodt and Endo. (4) Adjustments for Restructuring or similar transactions included the following (in thousands): (5) Amounts relate to the net expense or income recognized during Endo International plc's bankruptcy proceedings required to be presented as Reorganization items, net under Accounting Standards Codification Topic 852, Reorganizations. (6) The "Other" row included in the above reconciliation of Net (Loss) Income (GAAP) to Adjusted Net Income (non-GAAP) includes the following adjustments: (7) Adjusted income taxes are calculated by tax effecting adjusted pre-tax income and permanent book-tax differences at the applicable effective tax rate that will be determined by reference to statutory tax rates in the relevant jurisdictions in which Endo, Inc. operates or EIP operated. Adjusted income taxes include current and deferred income tax expense commensurate with the non-GAAP measure of profitability. (8) To exclude from the results of the Predecessor reported as discontinued operations. No portion of Endo, Inc.'s business is currently reported as a discontinued operation. 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.
Cision Canada
24-04-2025
- Health
- Cision Canada
Endo's New Spatial Computing Injection Simulator for Peyronie's Disease Creates Immersive Learning Environment for Urology Specialists
Endo Will Launch the Simulator at the American Urological Association (AUA) Annual Meeting MALVERN, Pa., April 24, 2025 /CNW/ -- Endo, Inc. (OTCQX: NDOI) announced today the launch of a Spatial Computing Injection Simulator for Peyronie's disease. The simulator allows urology specialists to interact simultaneously with both physical and digital objects—blending a physical penile model and digital content via an Apple Vision Pro app—to help refine their injection technique. Endo will launch the experience at the American Urological Association (AUA) Annual Meeting, the largest gathering of urologists in the world, which takes place April 26-29, 2025. "We know that healthcare providers value hands-on approaches to learning, and technology like the Spatial Computing Injection Simulator can make a huge difference for the surgeons and advanced practice providers who treat Peyronie's disease," said Justin Mattice, Senior Vice President & General Manager, Branded Specialty at Endo. "With a mix of tactical practice, videos of real procedures, and the inclusion of practical information, the simulator is an example of innovation that can enhance patient care." The Spatial Computing Injection Simulator was designed to help urology specialists refine their injection technique in the penis for the administration of XIAFLEX ® (collagenase clostridium histolyticum), the only FDA-approved nonsurgical treatment for Peyronie's disease. 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. During the immersive, 20-minute Spatial Computing Injection Simulator experience, urology specialists receive hands-on practice on product reconstitution and injection angles, watch procedures in action, practice their injection technique on the penile model, and acquire information on the post-injection process. This can help them refine their technique for the treatment of real patients with XIAFLEX, which represents an important treatment option to help appropriate patients. 1 This is the second time Endo has used the power of spatial computing (also called "mixed reality") to create an immersive learning environment for healthcare providers. The first was developed for hand specialists who treat patients with Dupuytren's contracture. Endo worked with technology agency Lucid Dream to create the Apple Vision Pro app and spatial computing experience. About Peyronie's Disease Peyronie's disease (PD) is a condition in which a buildup of fibrous scar tissue causes a curvature deformity of the penis. This curvature can be bothersome during arousal and intimacy. 2 It is estimated that PD can affect as many as 1 in 10 men in the U.S., 3 but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help. 4 IMPORTANT SAFETY INFORMATION Do not receive XIAFLEX if: the Peyronie's plaque to be treated involves the "tube" that your urine passes through (urethra). you are allergic 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: 1. Penile fracture (corporal rupture) or other serious injury to the penis. Receiving an injection of XIAFLEX may cause damage to the tubes in your penis called the corpora. After treatment with XIAFLEX, one of these tubes may break during an erection. This is called a corporal rupture or penile fracture. This could require surgery to fix the damaged area. Damage to your penis might not get better after a corporal rupture. After treatment with XIAFLEX, blood vessels in your penis may also break, causing blood to collect under the skin (hematoma). This could require a procedure to drain the blood from under the skin. If a hematoma appears, skin and soft tissue necrosis (death of skin cells) may develop in that area, which could require surgery. Symptoms of corporal rupture or other serious injury to your penis may include: a popping sound or sensation in an erect penis sudden loss of the ability to maintain an erection pain in your penis purple bruising and swelling of your penis difficulty urinating or blood in the urine Call your healthcare provider right away if you have any of the symptoms of corporal rupture or serious injury to the penis listed above. Do not have sex or any other sexual activity between the first and second injections of a treatment cycle. Do not have sex or have any other sexual activity for at least 4 weeks after the second injection of a treatment cycle with XIAFLEX and after any pain and swelling has gone away. XIAFLEX for the treatment of Peyronie's disease is only available through a restricted program called the XIAFLEX Risk Evaluation and Mitigation Strategy (REMS) Program. 2. 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: 3. Back pain reactions. After receiving an injection of XIAFLEX for Peyronie's disease, you may suddenly feel back pain, including severe lower back pain moving to your legs, feet, chest and arms. The back pain may also include spasms and make it hard to walk. These symptoms usually go away in 15 minutes or less, but may last longer. Tell your healthcare provider right away if you have sudden back pain, chest pain, or hard time walking after an injection. 4. Fainting. Fainting (passing out) or near fainting can happen in men who receive XIAFLEX, especially if they have severe penile pain. If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away. Before receiving XIAFLEX, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX injection, have a bleeding problem, received XIAFLEX for another condition, or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter 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 not sure. What should I avoid while receiving XIAFLEX? Avoid situations that may cause you to strain your stomach (abdominal) muscles, such as straining during bowel movements. Do not use a vacuum erection device during your treatment with XIAFLEX. XIAFLEX can cause serious side effects, including 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. The most common side effects with XIAFLEX for the treatment of Peyronie's disease include: a small collection of blood under the skin at the injection site (hematoma) swelling at the injection site or along your penis pain or tenderness at the injection site, along your penis and above your penis penis bruising itching of your penis or scrotum (genitals) painful erection erection problems (erectile dysfunction) changes in the color of the skin of your penis blisters at the injection site pain with sex a lump at the injection site (nodule) 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. You may report side effects to FDA at 1-800-FDA-1088. WHAT IS XIAFLEX? XIAFLEX is a prescription medicine used to treat adult men with Peyronie's disease who have a "plaque" that can be felt and a curve in their penis greater than 30 degrees when treatment is started. It is not known if XIAFLEX is safe and effective in children under the age of 18. Rx Only Click for full Prescribing Information, including BOXED WARNING and Medication Guide. About Endo Endo is a diversified specialty 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. Mattice and any statements relating to the injection simulator, 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; 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. XIAFLEX ® [Prescribing Information]. Rochester, MI: Endo USA, Inc. Hellstrom WJ. Int J Impot Res. 2003;15:S91-S92. Stuntz M, Perlaky A, des Vignes F, et al. PLoS One. 2016;11(2):e0150157. DiBenedetti DB, Nguyen D, Zografoset L, et al. Adv Urol. 2011:282503.
Associated Press
17-02-2025
- Health
- Associated Press
Endo Launches 'Steve's Journey,' the First Branded Dupuytren's Contracture Commercial for XIAFLEX® (collagenase clostridium histolyticum)
Campaign builds on the momentum of Endo's disease awareness efforts. Commercial features a real patient—who was an untreated patient in a prior Endo video series—and his wife, sharing their personal experience with the condition and the patient's treatment with XIAFLEX®. Dupuytren's contracture is a progressive hand condition affecting an estimated 17 million Americans, making it likely that most people know someone who has been impacted. MALVERN, Pa., Feb. 17, 2025 /CNW/ -- Endo, Inc. (OTCQX: NDOI) announced today the launch of its new branded television commercial, Steve's Journey. The campaign, featuring a real Dupuytren's contracture patient, encourages patients to consult a hand specialist and ask about XIAFLEX® (collagenase clostridium histolyticum), the only FDA-approved nonsurgical treatment for Dupuytren's contracture. Dupuytren's 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* 'Those with the best understanding of Dupuytren's contracture are patients who have faced similar challenges and uncertainties,' said Justin Mattice, Vice President & General Manager, Branded Specialty at Endo. 'By spotlighting authentic experiences like Steve's, we are emboldening patients to connect with a hand specialist and ask for nonsurgical XIAFLEX®, positioning them as knowledgeable decision makers.' 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. Please note that, receiving an injection of XIAFLEX® may cause damage to a tendon or ligament in your hand and cause it to break or weaken. Steve's Sequel This isn't Steve's first time in the spotlight. Endo's Coffee & Cords video series featured five patients at different points in their treatment journeys, and Steve lent his perspective as an untreated Dupuytren's contracture sufferer. After Coffee & Cords wrapped, Steve chose to get treated with XIAFLEX®. Steve's Journey revisits Steve's experience with the condition, and it highlights his treatment and recovery. The campaign also incorporates the partner perspective by including Steve's wife, Gisele. 'Endo is passionate about using firsthand experiences to amplify the voices of real-life patients,' noted Dayna Sracic, Executive Director, Consumer Marketing at Endo. 'By sharing these powerful, personal stories, we believe we can inspire and educate others regarding Dupuytren's contracture and nonsurgical treatment with XIAFLEX®.' Insights-Driven Campaign Endo's own research and consumer insights show many Dupuytren's contracture patients delay treatment due to concerns about surgery, often adapting to the condition instead.5† The branded approach puts patients in the driver's seat, giving them the knowledge and product name for a nonsurgical option. Endo's research indicates that Dupuytren's contracture patients that ask for XIAFLEX® by name receive the medication more than half of the time. Patient-Centric Campaign Creative The commercial opens with a close-up of Steve's hand, as he and Gisele describe how Dupuytren's contracture made everyday tasks difficult. The scene transitions to them holding hands, with Steve—now treated with XIAFLEX®—expressing how much he missed this simple intimacy with his wife. Additional shots show Steve's hands-on approach to life: working on a laptop, placing his hand flat on a table, flexing it while driving, and enjoying outdoor activities with Gisele. These moments demonstrate how XIAFLEX® has helped Steve regain the freedom to live life on his own terms. Through Steve's Journey, Endo aims to help more Americans living with Dupuytren's contracture by showcasing the outcomes of patients who have completed their nonsurgical treatment journey with XIAFLEX®. Underscoring the desire of many patients to lead a hands-on life, the campaign drives to Watch the commercial. Media Buy The 60-second spot will air during a variety of programming, including news, sports (e.g., NASCAR and NCAA basketball), and popular TV series across networks (e.g., Survivor and Matlock), as well as on cable channels (e.g., History and Discovery), on streaming services like Hulu and Amazon, and online. About Dupuytren's Contracture Dupuytren's 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's 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 specialty 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. Mattice and Ms. Sracic 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; 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-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. *Dupuytren's contracture prevalence estimation calculation: average Dupuytren's contracture prevalence in the US (5%) multiplied by US population (332 million per 2021 US Census data) = ~17 million. †Data sourced from 2024 consumer market research based on a web-based survey of 200 adults who were either diagnosed with Dupuytren's contracture or believe they have Dupuytren's contracture based on a detailed description of symptoms. 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. 'Dupuytren's contracture consumer awareness trial usage online survey report.' Endo USA, Inc. 2024.
