Mallinckrodt Plc (MNK)

Keenova Champions Men's Health Month with Education and OutreachJune 1, 2026 4:15 PM
PR Newswire (US) Reddit AMA and New Sexual Health Screening Tool Headline the Awareness MonthDUBLIN, June 1, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced today its Men's Health Month initiative, reaffirming its commitment to advancing men's health by hosting a Reddit "Ask Me Anything" (AMA) focused on Peyronie's disease and launching a new provider intake tool designed to support conversations about sensitive health conditions. Why It Matters
Throughout June, Keenova is spearheading activities designed to empower men to take charge of their physical, mental, and sexual health. The effort also aims to raise awareness among healthcare providers and patients about commonly underdiagnosed and stigmatized conditions such as Peyronie's disease."Men's Health Month is a powerful reminder that meaningful progress requires both awareness and action," said Stephanie Wenstrup, Head of Marketing at Keenova. "At Keenova, we are committed to advancing men's health through innovative therapies that address unmet needs, supporting research that expands medical understanding, and empowering patients with the tools and resources to take charge of their health."Key Components and EventsReddit AMA – Dr. Denise Asafu-Andjei, a leading urologist, and Geoff Kaplan, a patient with Peyronie's disease, will answer questions about the condition, the patient journey, treatment options, and the importance of prioritizing men's health during a Reddit AMA on June 18 at 3 p.m. ET. People can submit questions in advance or join live to take part in the discussion.Intake tool for providers – Keenova's new Men's Sexual Health Screener is designed to help healthcare practitioners guide more effective sexual health conversations with patients. The tool enables clinicians to ask targeted questions that may uncover sensitive or otherwise difficult-to-discuss concerns.Advertising – Targeted digital outreach through social media and online ads will reach men and their partners with messages designed to provide educational information, inspire action, and empower men to take charge of their health.Online content – Keenova.com will feature stories for both men and healthcare providers that share insights about prioritizing and managing men's health, including a primer on the difference between Peyronie's disease, erectile dysfunction, and low testosterone; the connection between sexual health and mental health; and a checklist that providers can use with men in the exam room.Wear Blue Day – Keenova team members will show their support by participating in Wear Blue Day. Celebrated nationally each Friday in June, the initiative encourages men's health advocates to wear blue to raise awareness of men's health issues.About Men's Health Month
Men's Health Month is observed every June to raise awareness about health issues that specifically affect men. The initiative emphasizes the importance of early detection, preventive care, and effective treatment, encouraging men to take proactive steps toward managing their overall health and well-being.About Keenova  
Keenova Therapeutics is a leading U.S.-focused branded therapeutics company that strives to help patients with rare or unaddressed conditions live happier and healthier lives.Keenova's rare disease capabilities underpin our diversified brands portfolio, which is focused across a wide range of specialty therapeutic areas of significant unmet need. These include rheumatology, ophthalmology, nephrology, neurology, pulmonology, orthopedics, urology, and neonatal respiratory critical care.Headquartered in Dublin, Ireland, Keenova benefits from a strong U.S. manufacturing footprint with facilities in Louisiana, New Jersey, New York, Pennsylvania, and Wisconsin. To learn more, please visit www.keenova.com. Keenova uses its website as a channel of distribution of important company information, such as press releases, investor presentations, and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission ("SEC") disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website. Information Regarding Forward-Looking Statements
This release contains forward-looking statements, including the potential of Keenova's products to improve health and treatment outcomes. 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: 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 Keenova's products; 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 Keenova's most recent Annual Report on Form 10-K, and other filings and furnishings with the Securities and Exchange Commission (SEC), all of which are available on the SEC's website (www.SEC.gov) and Keenova's website (www.keenova.com). The forward-looking statements made herein speak only as of the date hereof and Keenova does 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.Contacts
Media: Investors: media.relations@keenova.cominvestor.relations@keenova.com   View original content to download multimedia:https://www.prnewswire.com/news-releases/keenova-champions-mens-health-month-with-education-and-outreach-302787545.htmlSOURCE Keenova Therapeutics Original: Keenova Champions Men's Health Month with Education and Outreach

Keenova Announces Newly Updated Peyronie's Disease Study Results at American Urology Association MeetingMay 15, 2026 7:36 AM
PR Newswire (US) DUBLIN, May 15, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced today that new and final updated data from its dedicated ventral curvature analysis of Peyronie's disease and XIAFLEX® (collagenase clostridium histolyticum) will be shared at the American Urological Association (AUA) annual meeting, taking place May 15–18, 2026. The data to be presented will highlight that the clinical effectiveness and safety of XIAFLEX (collagenase clostridium histolyticum) in patients with ventral curvature are consistent with outcomes observed in patients with other clinical presentations of Peyronie's disease. "These new results are consistent with earlier studies and reinforce that XIAFLEX (collagenase clostridium histolyticum) is both effective and well tolerated for men with Peyronie's disease, including those with ventral curvature," said Jesse Mills, MD, Clinical Professor and Director of the Men's Clinic at UCLA, who is presenting the findings. "Such outcomes are encouraging to clinicians and patients looking for nonsurgical treatment options, and they underscore the importance of continued research to further expand our understanding of Peyronie's disease and its treatment."Presentation DetailsTitle: Final Results of a Multicenter, Retrospective Analysis of Collagenase Clostridium Histolyticum (CCH) for Ventral Penile Curvature in Peyronie's DiseaseAuthors: Matthew J. Ziegelmann, MD; Billy H. Cordon, MD; Majdee M. Islam, MD; Alexander J. Tatem, MD; Richard C. Bennett, MD; Faysal A. Yafi, MD, FRCSC; Peter Bajic, MD; Nelson E. Bennett, Jr., MD; Helen L. Bernie, DO, MPH; Marcelo Mass-Lindenbaum, MD; Muhammed A. M. Hammad, MBBCh, MS; Kristen Gumpf, PA-C; David Hurley, MD; Jeffrey Andrews, MS; Tina Rezakhani, PharmD, MBA; Marian Ayad, PharmD, BCPS; Mohit Khera, MD, MBA, MPH; Bruce R. Kava, MD; Jesse N. Mills, MDAbout 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.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.3XIAFLEX® PD Professional Indication and Important Safety Information INDICATION
XIAFLEX® is indicated for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.IMPORTANT SAFETY INFORMATION FOR XIAFLEX WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE'S DISEASE
Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) XIAFLEX-treated patients in clinical studies. In other XIAFLEX-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or a penile "popping" sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) XIAFLEX-treated patients.
Signs or symptoms that may reflect serious penile injury should be promptly evaluated to assess for corporal rupture or severe penile hematoma which may require surgical intervention.
Because of the risks of corporal rupture or other serious penile injury, XIAFLEX is available for the treatment of Peyronie's disease only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XIAFLEX REMS Program.Contraindications: XIAFLEX is contraindicated in the treatment of Peyronie's plaques that involve the penile urethra due to potential risk to this structure and in patients with a history of hypersensitivity to XIAFLEX or to collagenase used in any other therapeutic application or application methodCorporal Rupture or Other Serious Injury to the Penis: Injection of XIAFLEX into collagen-containing structures such as the corpora cavernosa of the penis may result in damage to those structures and possible injury such as corporal rupture (penile fracture). Therefore, XIAFLEX should be injected only into the Peyronie's plaque and care should be taken to avoid injecting into the urethra, nerves, blood vessels, corpora cavernosa or other collagen-containing structures of the penis. Cases of localized skin and soft tissue necrosis occurring as sequelae of penile hematoma, some requiring surgical intervention, have been reported post-marketingHypersensitivity Reactions, Including Anaphylaxis: In the double-blind, placebo-controlled portions of the clinical trials in Peyronie's disease, a greater proportion of XIAFLEX-treated patients (4%) compared to placebo-treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 XIAFLEX injection procedures). The incidence of XIAFLEX-associated pruritus was similar after each injection regardless of the number of injections administeredBecause XIAFLEX contains foreign proteins, severe allergic reactions to XIAFLEX can occur. Anaphylaxis was reported in a post-marketing clinical trial in one patient who had previous exposure to XIAFLEX for the treatment of Dupuytren's contracture. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX injections. The safety of more than one treatment course of XIAFLEX is not knownRisk of Bleeding in Patients with Abnormal Coagulation: In the XIAFLEX controlled trials in Peyronie's disease, 65.5% of XIAFLEX-treated patients developed penile hematoma, and 14.5% developed penile ecchymosis. Patients with abnormal coagulation (except for patients taking low-dose aspirin, eg, up to 150 mg per day) were excluded from participating in these studies. Therefore, the efficacy and safety of XIAFLEX in patients receiving anticoagulant medications (other than low-dose aspirin, eg, up to 150 mg per day) within 7 days prior to XIAFLEX administration is not known. In addition, it is recommended to avoid use of XIAFLEX in patients with coagulation disorders, including patients receiving concomitant anticoagulants (except for low-dose aspirin)Acute Post-Injection Back Pain Reactions: Post-marketing reports of acute lower back pain reactions, sometimes accompanied by radiation to the lower extremities, chest and arms, muscle spasms, chest pain, paresthesias, headache, and dyspnea, have been received by patients treated with XIAFLEX for Peyronie's disease. These events can be mild to severe in intensity. The events typically lasted for 15 minutes and typically did not require intervention.
Administer the smallest number of treatment cycles necessary to treat the patient's curvature deformitySyncope and Presyncope: Most, but not all cases of syncope and presyncope in patients with Peyronie's disease, occurred in association with post-injection penile pain and hematoma, penile pain with spontaneous erections, and pain during micturition. These potential triggers suggest a vasovagal mechanism.  Make patients aware of the potential symptoms that could trigger syncope and presyncope after treatment with XIAFLEX. 
If presyncopal symptoms occur, patients should remain recumbent until symptoms resolve.  Syncope may be associated with bodily injuries, including concussion, head abrasion, and other accidental injuriesAdverse Reactions
Clinical trials In the XIAFLEX clinical trials for Peyronie's disease, the most frequently reported adverse drug reactions (≥25%) and at an incidence greater than placebo included: penile hematoma, penile swelling, and penile pain.Post-marketing experience Acute post-injection lower back pain reactions have occurred in close temporal proximity to XIAFLEX treatmentsCases of localized skin and soft tissue necrosis events as sequelae of penile hematoma, some of which required surgical intervention Syncope and presyncope have been reported in men treated with XIAFLEX for Peyronie's disease. Most, but not all cases occurred in the immediate treatment period or within 1-2 days following injection. Bodily injuries associated with the syncopal events have been reportedClick for full Prescribing Information, including Boxed Warning and Medication Guide.About Keenova
Keenova Therapeutics is a leading U.S.-focused branded therapeutics company that strives to help patients with rare or unaddressed conditions live happier and healthier lives.Keenova's rare disease capabilities underpin our diversified brands portfolio, which is focused across a wide range of specialty therapeutic areas of significant unmet need. These include rheumatology, ophthalmology, nephrology, neurology, pulmonology, orthopedics, urology, and neonatal respiratory critical care.Headquartered in?Dublin, Ireland, Keenova benefits from a strong?U.S.?manufacturing footprint with facilities in?Louisiana,?New Jersey,?New York,?Pennsylvania,?and?Wisconsin. To learn more, please visit?www.keenova.com.Keenova uses its website as a channel of distribution of important company information, such as press releases, investor presentations, and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission ("SEC") disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.Information Regarding Forward-Looking Statements
This release contains forward-looking statements, including with regard to XIAFLEX, the efficacy, potential treatments or indications, therapeutic outcomes or treatment responses of this product, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. 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: 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 the "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Keenova's most recent Annual Reports on Form 10-K, and other filings and furnishings with the Securities and Exchange Commission (SEC), all of which are available from the SEC's website (www.sec.gov). 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.* Based on a survey of about 7,700 U .S. adult men with a PD diagnosis, PD-related symptoms, or a history of seeking treatment for the condition.ReferencesHellstrom WJ. Int J Impot Res. 2003;15(Suppl 5):S91–S92.Stuntz M, Perlaky A, des Vignes F, et al. PLoS One. 2016;11(2):e0150157.DiBenedetti DB, Nguyen D, Zografos L, et al. Adv Urol. 2011; 2011:282503.Contacts 
Media:                                        Investors:media.relations@keenova.com       investor.relations@keenova.com  View original content to download multimedia:https://www.prnewswire.com/news-releases/keenova-announces-newly-updated-peyronies-disease-study-results-at-american-urology-association-meeting-302773494.htmlSOURCE Keenova Therapeutics Original: Keenova Announces Newly Updated Peyronie's Disease Study Results at American Urology Association Meeting

Keenova Reports First Quarter 2026 Financial ResultsMay 12, 2026 6:30 AM
PR Newswire (US) Strong First-Quarter Performance Driven by Acthar® Gel1 and XIAFLEX®2Pipeline Development, Synergy Plan Remain on TrackReaffirms 2026 Net Sales Guidance of $1.94 Billion to $2.00 Billion and Adjusted EBITDA Guidance of $730 Million to $760 MillionConference Call and Webcast Today at 8:00 a.m. ETFirst Quarter 2026 Highlights3Acthar Gel net sales of $170 millionXIAFLEX net sales of $134 millionNet sales from continuing operations of $468 millionLoss from continuing operations of $114 millionAdjusted EBITDA from continuing operations of $174 millionDUBLIN, May 12, 2026 /PRNewswire/ -- Keenova Therapeutics plc ("Keenova" or the "Company") today reported its financial results for the first quarter ended March 31, 2026. "We are pleased to report continued positive momentum, led by our two core brands—Acthar Gel and XIAFLEX," said Siggi Olafsson, President and Chief Executive Officer. "Acthar Gel's strong growth reflects increased patient demand across all treatment areas while XIAFLEX benefited from strong field execution and demand growth, which will be further supported this year by refreshed direct-to-consumer advertising campaigns.""We continue to effectively implement our growth strategy in our core brands while maximizing the value of our established brands as we prepare to pursue a listing on the New York Stock Exchange in the second half of 2026," Mr. Olafsson said. "We remain confident in our ability to make meaningful clinical and operational progress this year in support of Keenova's mission to help patients with rare or unaddressed conditions live happier and healthier lives."Impact on Financial Results Due to Completion of Mallinckrodt-Endo Merger and Subsequent Par Health Spin-OffOn July 31, 2025, the Company (formerly Mallinckrodt plc) completed its merger with Endo LP (formerly Endo, Inc.) ("Endo") and recorded Endo's assets and liabilities on its balance sheet at fair value. On November 10, 2025, the Company completed the separation of Par Health, Inc. ("Par Health"). Keenova is required to present Par Health's assets and liabilities, results of operations, and cash flows as discontinued operations retroactively in its financial statements.First Quarter 2026 Financial ResultsNet sales from continuing operations in the first quarter of 2026 were $468 million, an increase of $261 million over the same period in 2025, primarily driven by strength in sales of Acthar Gel and the inclusion of XIAFLEX net sales.Acthar Gel net sales were $170 million, an increase of 47% from the prior-year period, driven by robust growth across all therapeutic areas, resulting in an all-time high in new patient starts and the ninth consecutive quarter of growth. Year-over-year growth was supported by continued execution that drove market expansion, as well as the ongoing uptake of SelfJect. The year-over-year comparison also reflects the impact of improved patient access which began contributing to Acthar Gel growth in the second quarter of 2025. While the Company expects enhanced access to continue supporting patient demand in 2026, its contribution to Acthar Gel's growth rate is expected to moderate over the remainder of the year.XIAFLEX net sales were $134 million, driven by increased demand and price. A new Dupuytren's contracture awareness campaign launched this month, complementing a new digital campaign focused on Peyronie's disease that began rolling out in February.Loss from continuing operations was $114 million, compared to $75 million in the prior-year period. This change primarily reflects the continuing effects of costs and benefits associated with transactions that occurred in 2025. Strong performance of Acthar Gel and the inclusion of XIAFLEX net sales were more than offset by $158 million of incremental non-cash expenses related to fair value adjustments of inventory and intangible assets and the inclusion of Endo operating costs following the business combination.Adjusted EBITDA from continuing operations was $174 million, reflecting the strength in Acthar Gel and XIAFLEX along with the realization of initial merger-related synergies.XIAFLEX Pipeline UpdatePlantar Fibromatosis: Topline results for the Phase 3 study are expected in July 2026, with regulatory submission targeted for the fourth quarter of 2026.Hammer Toe: An FDA End-of-Phase 2 meeting is scheduled for June 2026, with enrollment for the Phase 3 study on track to begin in the third quarter of 2026.Synergies UpdateIn the first quarter of 2026, the Company realized $23 million in synergies. The Company remains on track to realize pre-tax merger synergies of approximately $100 million in 2026 and $150 million of annual pre-tax, run-rate synergies by the merger's three-year anniversary.Reaffirmed 2026 Financial GuidanceFor the full-year 2026, Keenova reaffirmed the guidance the Company first issued on March 31, 2026, as follows: Acthar Gel net sales growth rate in the mid-teens.XIAFLEX net sales growth rate in the mid- to high-single digits.4Net sales of $1.94 billion to $2.00 billion.Adjusted EBITDA of $730 million to $760 million.The above Adjusted EBITDA guidance incorporates anticipated merger synergies to be realized in 2026. The guidance for net sales and Adjusted EBITDA does not take into account any potential acquisition or divestiture activity, including the potential sale of the PERCOCET business.The Company does not provide comparable GAAP measures for its forward-looking non-GAAP guidance or a reconciliation of such measures because the reconciling items described in the definition of Adjusted EBITDA provided below are inherently uncertain and difficult to estimate and cannot be predicted without unreasonable effort. The variability of such items may have a significant impact on our future GAAP results.Please see "Non-GAAP Financial Measures" included in this release for a discussion of non-GAAP measures and reconciliation of GAAP and non-GAAP financial measures for the first quarter.Please see the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2026, to be filed with the U.S. Securities and Exchange Commission ("SEC") for additional information.Conference Call and WebcastKeenova will hold a conference call for investors today, May 12, 2026, at 8:00 a.m. Eastern Time.The audio webcast may be accessed through the Investor Relations section of the Company's website or through this webcast link. To access the call through a conference line, participants can register here to receive dial-in numbers and a personalized PIN to participate in the call. Participants are advised to join 10 minutes prior to the scheduled start time. A replay of the webcast will be available following the event.About KeenovaKeenova Therapeutics is a leading U.S.-focused branded therapeutics company that strives to help patients with rare or unaddressed conditions live happier and healthier lives.Keenova's rare disease capabilities underpin our diversified brands portfolio, which is focused across a wide range of specialty therapeutic areas of significant unmet need. These include rheumatology, ophthalmology, nephrology, neurology, pulmonology, orthopedics, urology, and neonatal respiratory critical care.Headquartered in Dublin, Ireland, Keenova benefits from a strong U.S. manufacturing footprint with facilities in Louisiana, New Jersey, New York, Pennsylvania, and Wisconsin. To learn more, please visit www.keenova.com.Keenova uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the SEC disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.Non-GAAP Financial MeasuresTo supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release includes certain financial information of the Company that is 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 assessing the Company's capital structure, and the Company believes that these measures will be used by certain investors to evaluate operating results and financial leverage, borrowing capacity and balance sheet risk. The Company believes that presenting these non-GAAP financial measures provides useful information about performance and financial leverage across reporting periods on a consistent basis by excluding certain items, which may be favorable or unfavorable. Despite the importance of these measures to management in goal-setting and performance measurement, 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, metrics such as non-GAAP Adjusted EBITDA from continuing operations and similar metrics (unlike GAAP measures and relevant 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. These non-GAAP financial measures should be read in conjunction with the Company's and Endo's unaudited condensed consolidated financial statements, audited financial statements, and publicly filed reports in their entirety. Reconciliations of certain of these historical adjusted financial measures to the most directly comparable GAAP financial measures are included in the tables accompanying this press release. Further information regarding non-GAAP financial measures can be found on the Company's website at www.keenova.com.Adjusted EBITDAAdjusted EBITDA represents net income or loss prepared in accordance with GAAP and adjusted for certain items that management believes are not reflective of the operational performance of the business. Adjustments to GAAP amounts include, as applicable to each measure, interest expense, net; income tax expense; depreciation and amortization; combination, integration, and other related expenses; restructuring charges, net; liabilities management and separation costs; gains/losses on debt extinguishment; gains/losses on divestitures; fresh-start inventory-related expenses; business combination inventory-related expense; share-based compensation; and other items identified by the Company.Adjusted EBITDA from Continuing OperationsAdjusted EBITDA from continuing operations represents Adjusted EBITDA (as defined above) and as adjusted for income (loss) from discontinued operations.Forward Looking StatementsStatements in this Press Release that are not strictly historical, including statements regarding the future financial condition and operating results of the Company, expected product launches, legal, economic, business, competitive and/or regulatory factors affecting Keenova's businesses and any other statements regarding events or developments Keenova believes or anticipates will or may occur in the future, may be "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties. Forward-looking statements can be identified by the use of forward-looking terminology such as the words "believe," "expect," "plan," "intend," "project," "anticipate," "approximately," "estimate," "predict," "potential," "continue," "may," "could," "should," "will" or the negative of these terms or similar expressions.There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: the expected benefits and synergies of the merger with Endo may not be fully realized in a timely manner, or at all; the Company's increased indebtedness as a result of the merger with Endo and significant transaction costs related to the merger with Endo; the expected growth opportunities, profit improvements, cost savings and other benefits as a result of the spin-off of Par Health may not be fully realized in a timely manner, or at all; loss of the benefits of services provided by Par Health or certain of its subsidiaries as a result of the spin-off of Par Health; risks associated with being a smaller, less diversified company as a result of the spin-off of Par Health; unanticipated costs, litigation and/or regulatory inquiries and investigations, including as a result of the merger with Endo or the spin-off of Par Health; the estimated fair values of the net assets acquired in the merger with Endo are preliminary and subject to change if new information becomes available; potential changes in the Company's business strategy, portfolio, capital allocation decisions, and performance; exposure to global economic conditions and market uncertainty; governmental investigations and inquiries, regulatory actions, and lawsuits, in each case related to the Company or its officers; the Company's contractual and court-ordered compliance obligations that, if violated, could result in penalties; matters related to Acthar® Gel (repository corticotropin injection), including the settlement with governmental parties to resolve certain disputes and compliance with and restrictions under the related corporate integrity agreement; the ability to maintain relationships with the Company's suppliers, customers, employees and other third parties; scrutiny from governments, legislative bodies and enforcement agencies related to sales, marketing and pricing practices; pricing pressure on certain of the Company's products due to legal changes or changes in insurers' or other payers' reimbursement practices resulting from recent increased public scrutiny of healthcare and pharmaceutical costs; the reimbursement practices of governmental health administration authorities, private health coverage insurers and other third-party payers; complex reporting and payment obligations under the Medicare and Medicaid rebate programs and other governmental purchasing and rebate programs; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; changes in or failure to comply with relevant laws and regulations; any undesirable side effects caused by the Company's approved and investigational products, which could limit their commercial profile or result in other negative consequences; the Company's and its partners' ability to successfully develop, commercialize or launch new products or expand commercial opportunities of existing products, including Acthar Gel SelfJect, the INOmax® Evolve DS delivery system, and XIAFLEX® (collagenase clostridium histolyticum); the Company's ability to successfully pursue additional indications for XIAFLEX, including the timing and outcome of clinical results and regulatory submissions; the Company's ability to successfully identify or discover additional products or product candidates; the Company's ability to navigate price fluctuations and pressures, including the ability to achieve anticipated benefits of price increases of its products; competition; the Company's and its partners' ability to protect intellectual property rights; limited clinical trial data for Acthar Gel; the timing, expense and uncertainty associated with clinical studies and related regulatory processes; product liability losses and other litigation liability; material health, safety and environmental laws and related liabilities; business development activities or other strategic transactions; attraction and retention of qualified personnel in key fields; the effectiveness of information technology infrastructure, including risks of external attacks or failures; customer concentration; the Company's reliance on certain individual products that are material to its financial performance; complex manufacturing processes; reliance on third-party manufacturers and supply chain providers and related market disruptions; conducting business internationally; new or increased tariffs and evolving trade relations and changes in trade and taxation policy; the Company's significant levels of intangible assets and related impairment testing; natural disasters or other catastrophic events; the Company's substantial indebtedness and settlement obligation, its ability to generate sufficient cash to reduce its indebtedness and its potential need and ability to incur further indebtedness; restrictions contained in the agreements governing the Company's indebtedness and settlement obligation on the Company's operations, future financings and use of proceeds; the Company's variable rate indebtedness; the Company's tax treatment by the Internal Revenue Service under Section 7874 and Section 382 of the Internal Revenue Code of 1986, as amended; future changes to applicable tax laws or the impact of disputes with governmental tax authorities; the impact of Irish laws; the comparability of the Company's financial results to historical financial statements in light of its emergence from Chapter 11 bankruptcy proceedings in 2023, the divestiture of the Therakos business, the merger with Endo and spin-off of Par Health.The "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC, its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2026, to be filed with the SEC, and other filings with the SEC, all of which are on file and available from the SEC's website (www.sec.gov) and the Company's website (www.keenova.com), identify and describe in more detail the risks and uncertainties to which the Company's businesses are subject. There may be other risks and uncertainties that we are unable to predict at this time or that we currently do not expect to have a material adverse effect on our business. The forward-looking statements made herein speak only as of the date hereof and the Company does 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. Given these uncertainties, one should not put undue reliance on any forward-looking statements.No Offer of SecuritiesThe Company's potential NYSE listing in the second half of 2026 is subject to approval by Keenova's Board of Directors and other considerations and conditions. The Company expects to conduct a public offering of Keenova's ordinary shares to facilitate the listing at that time, and no assurance can be given as to whether or when such transaction will occur or its impact.This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any such offering would be made pursuant to a registration statement to be filed with the SEC. The price and number of the ordinary shares to be sold in any such offering have not yet been determined. The timing of any such offering would be subject to market and other conditions and the completion of the SEC's review process. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.CONTACTSInvestors:
investor.relations@keenova.comMedia:
media.relations@keenova.com KEENOVA THERAPEUTICS PLCSELECT PRODUCT LINE NET SALES(unaudited, in millions)
Three Months Ended
Change
March 31, 2026
March 28, 2025
$
%Acthar Gel$           169.5
$           115.4
$             54.1
47 %Xiaflex134.4
—
134.4
— %INOmax58.8
62.5
(3.7)
(6) %Amitiza21.0
20.0
1.0
5 %Other Products78.7
9.1
69.6
NMLicense Revenues5.9
0.2
5.7
NMTotal$           468.3
$           207.2
$           261.1
NM
________NM indicates that the percentage change is not meaningful or is greater than 100%. KEENOVA THERAPEUTICS PLCCONSOLIDATED ADJUSTED EBITDA(unaudited, in millions)
Three Months Ended
March 31, 2026
March 28, 2025Net loss$          (113.5)
$           (27.7)Income from discontinued operations, net of income taxes—
(47.6)Loss from continuing operations(113.5)
(75.3)Adjustments:


Interest expense, net45.6
28.5Income tax expense (benefit)4.8
(1.7)Depreciation5.6
2.7Amortization55.4
9.7Combination, integration, and other related expenses19.8
20.5Restructuring credits, net—
(2.0)(Gain) loss on divestiture(0.2)
6.2Fresh-start inventory-related expense44.8
32.3Business combination inventory-related expenses100.2
—Share-based compensation11.0
9.0Change in fair value of contingent consideration0.6
(0.1)Change in derivative asset and liabilities fair value—
2.6Unrealized loss on equity investment0.5
6.2Other(0.6)
0.2Adjusted EBITDA from continuing operations$           174.0
$             38.8 KEENOVA THERAPEUTICS PLCCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(unaudited, in millions, except per share data)




Three Months Ended
March 31, 2026
March 28, 2025Net sales$       468.3
$       207.2Cost of sales281.7
95.1Gross profit186.6
112.1Selling, general and administrative expenses210.6
114.9Combination, integration, and other related expenses19.8
20.5Research and development expenses23.2
15.3Restructuring credits, net—
(2.0)Operating loss(67.0)
(36.6)Interest expense(51.0)
(32.6)Interest income5.4
4.1Other income (expense), net3.9
(11.9)Loss from continuing operations before income taxes(108.7)
(77.0)Income tax expense (benefit)4.8
(1.7)Loss from continuing operations(113.5)
(75.3)Income from discontinued operations, net of income taxes—
47.6Net loss$      (113.5)
$        (27.7)



Basic (loss) income per share


Loss from continuing operations$        (2.87)
$        (3.82)Income from discontinued operations—
2.42Net loss$        (2.87)
$        (1.41)Basic weighted-average shares outstanding39.6
19.7



Diluted (loss) income per share:


Loss from continuing operations$        (2.87)
$        (3.82)Income from discontinued operations—
2.42Net loss$        (2.87)
$        (1.41)Diluted weighted-average shares outstanding39.6
19.7 ________________________________________1 Repository corticotropin injection.2 Collagenase clostridium histolyticum.3 The financial results presented in this release reflect the continuing operations of Keenova Therapeutics plc.4 Compared to aggregate XIAFLEX net sales for fiscal year 2025, which is calculated based on Endo's XIAFLEX net sales of $299.7 million for the pre-merger portion of fiscal year 2025 and Keenova's XIAFLEX net sales of $246.6 million for the post-merger portion of fiscal year 2025, for a total of $546.3 million.  View original content to download multimedia:https://www.prnewswire.com/news-releases/keenova-reports-first-quarter-2026-financial-results-302769401.htmlSOURCE Keenova Therapeutics Original: Keenova Reports First Quarter 2026 Financial Results

Keenova Launches New Consumer Campaign for Dupuytren's Contracture: Don't Be a VikingMay 4, 2026 7:30 AM
PR Newswire (US)

Dupuytren's contracture, a.k.a. Viking Hand, is a progressive hand condition affecting an estimated 13 million AmericansDUBLIN, May 4, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced today the launch of its newest television commercial and disease awareness campaign, Don't Be a Viking.







The Big Idea
The bold concept taps into the condition's nickname, "Viking Hand," and follows a Viking's patient journey, from frustration and confusion in living with the symptoms to taking control and seeing a hand specialist.The campaign encourages people who may have symptoms of Dupuytren's contracture, as well as their loved ones and caregivers, to visit FindaHandSpecialist.com. The site helps individuals connect with a hand specialist who can provide an accurate diagnosis and discuss a full range of treatment options, including nonsurgical approaches."The lighthearted campaign shines a spotlight on the very real challenges people with Dupuytren's contracture face when they rely on a 'wait and see' approach or avoid treatment altogether," said Dayna Sracic, Executive Director, Consumer Marketing at Keenova. "Don't Be a Viking empowers patients to see themselves as confident, informed partners in their own care and speak with a hand specialist."Inside the Story
The condition is known as Viking Hand because of a historic genetic association with people of Northern European ancestry, although the incidence of the disease is now more geographically dispersed.1The commercial opens with a Viking in his kitchen battling a jar of pickles. He twists, strains, grunts, and finally loses his patience, smashing the jar with an axe in a burst of frustration. His wife rushes in, shocked at the sight of the mess and stunned that a simple jar has turned into a kitchen disaster.The couple then reaches out to a hand specialist who guides the Viking through diagnosis and nonsurgical treatment options. The specialist also helps him set aside his axe in favor of a modern approach. The transformation blends the rugged world of Viking lore with the landscape of contemporary healthcare, showing that even the strongest heroes sometimes need expert support.Why It Matters
The campaign concept is grounded in insights from consumer research, which shows that many Dupuytren's contracture patients delay treatment to avoid surgery and often learn to adapt to the condition instead of addressing it.2* Don't Be a Viking aims to motivate patients and those around them to take the important step of planning a visit with a hand specialist as soon as they are unable to lay their hand flat and discuss nonsurgical treatment options.Watch the commercial.Where It Shows Up
The 30- and 15-second spots will run nationwide on broadcast and cable TV, including ABC, CBS, NBC, ESPN, Golf Channel, Tennis Channel, CNN, and Fox News. It will also appear on major streaming platforms such as Hulu, Amazon, Netflix, Paramount+, and Peacock, along with additional online placements. The campaign extends across social media, digital display, online video, and search, and is supported by materials in healthcare settings.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.1,3 It affects an estimated 13 million Americans.4,5†About Keenova
Keenova Therapeutics is a leading U.S.-focused branded therapeutics company that strives to help patients with rare or unaddressed conditions live happier and healthier lives.Keenova's rare disease capabilities underpin our diversified brands portfolio, which is focused across a wide range of specialty therapeutic areas of significant unmet need. These include rheumatology, ophthalmology, nephrology, neurology, pulmonology, orthopedics, urology, and neonatal respiratory critical care.Headquartered in?Dublin, Ireland, Keenova benefits from a strong?U.S.?manufacturing footprint with facilities in?Louisiana,?New Jersey,?New York,?Pennsylvania,?and?Wisconsin. To learn more, please visit?www.keenova.com.Keenova uses its website as a channel of distribution of important company information, such as press releases, investor presentations, and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission ("SEC") disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.Information Regarding Forward-Looking Statements
This release contains forward-looking statements, including the potential of Keenova's products to improve health and treatment outcomes. 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: 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 Keenova's products; 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 Keenova's most recent Annual Report on Form 10-K, and other filings and furnishings with the Securities and Exchange Commission (SEC), all of which are available on the SEC's website (www.SEC.gov) and Keenova's website (www.keenova.com). The forward-looking statements made herein speak only as of the date hereof and Keenova does 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.* 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.† Dupuytren's contracture prevalence estimation calculation in the U.S.: Average Dupuytren's contracture prevalence in the U.S. (5%) multiplied by U.S. adult population (~258 million adults per 2020 U.S. Census data) = ~13 million.References Bayat A, McGrouther DA. Management of Dupuytren's disease--clear advice for an elusive condition.?Ann R Coll Surg Engl. 2006;88(1):3-8."Dupuytren's contracture consumer awareness trial usage online survey report." Endo USA, Inc. (a Keenova Therapeutics company); 2024.Hurst LC, Badalamente MA, Hentz VR, et al. Injectable collagenase clostridium histolyticum for Dupuytren's contracture.?N Engl J Med.?2009;361(10),968-979.MedlinePlus Genetics. Dupuytren contracture. National Library of Medicine. Accessed August 14, 2025.?https://medlineplus.gov/genetics/condition/dupuytren-contracture/#frequencyOgunwole SU, Rabe MA, Roberts AW, Caplan Z. Adult population grew faster than total population from 2010 to 2020. U.S. Census Bureau. Published August 12, 2021. Accessed August 14, 2025.?https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.htmlContacts


Media:                                        Investors:media.relations@keenova.com       investor.relations@keenova.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/keenova-launches-new-consumer-campaign-for-dupuytrens-contracture-dont-be-a-viking-302760837.htmlSOURCE Keenova Therapeutics

Original: Keenova Launches New Consumer Campaign for Dupuytren's Contracture: Don't Be a Viking

Keenova Presents a New TERLIVAZ® (terlipressin) Clinical Analysis at Digestive Disease WeekMay 1, 2026 7:30 AM
PR Newswire (US)

DUBLIN, May 1, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced today that a new presentation on hepatorenal syndrome-acute kidney injury (HRS-AKI) and TERLIVAZ® (terlipressin) will be shared at Digestive Disease Week (DDW), taking place May 2-5, 2026.







"We are pleased to share these findings with the medical community, as they expand the clinical evidence and advance our understanding of this challenging and rapidly progressive condition," said Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova. "These data improve understanding of characteristics, treatment patterns, and outcomes associated with terlipressin use in U.S. practice, helping inform efforts to support care for patients with HRS-AKI."TERLIVAZ is the first and only FDA-approved therapy indicated to improve kidney function in adults with HRS-AKI.Presentation DetailsTitle: Real-world terlipressin treatment patterns and outcomes in hepatorenal syndrome-acute kidney injury (HRS-AKI): Preliminary data from seven US hospitalsAuthors: Stevan A. Gonzalez, MD; Aanchal Kapoor, MD; A. Sidney Barritt IV, MD, MSCR; Xingyue Huang, PhD; Sneha S. Kelkar, MSc, MPH; Rishi P. Verma, MPH; Malinda Tan, PharmD; Jordana K. Schmier, MA; Mary Panaccio, PhD; R. Todd Frederick, MD; Christopher White, MD, MSPHAbout Hepatorenal Syndrome-Acute Kidney Injury
Hepatorenal syndrome–acute kidney injury (HRS-AKI) is a life-threatening condition in adults with advanced liver disease that is marked by a rapid decline in kidney function1 and is associated with high morbidity and mortality.2 It is an acute medical emergency that requires hospitalization.3 A U.S. study based on national data revealed that the projected annual number of inpatients diagnosed with HRS has increased between 2018 and 2023, from 42,930 to 63,381.4INDICATION 
TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.LIMITATION OF USEPatients with a serum creatinine >5 mg/dL are unlikely to experience benefit.IMPORTANT SAFETY INFORMATIONWARNING: SERIOUS OR FATAL RESPIRATORY FAILURETERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO2) before initiating TERLIVAZ. 
 Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO2 

Keenova Therapeutics to Report First Quarter 2026 Financial Results on May 12, 2026April 30, 2026 7:00 AM
PR Newswire (US)

DUBLIN, April 30, 2026 /PRNewswire/ -- Keenova Therapeutics plc, a leading developer and manufacturer of branded therapeutics, announced today that it will report its first quarter 2026 financial results on Tuesday, May 12, 2026, before market open. The Company will host a conference call on the same day at 8:00 a.m. ET.







The audio webcast may be accessed through the Investor Relations section of the Company's website at investor.keenova.com under Events & Presentations or through this link. To access the call through a conference line, participants can register here to receive a dial-in number and personalized PIN to participate in the call. Participants are advised to join 10 minutes prior to the scheduled start time. A replay of the webcast will be available following the event.About KeenovaKeenova Therapeutics is a leading U.S.-focused branded therapeutics company that strives to help patients with rare or unaddressed conditions live happier and healthier lives.Keenova's rare disease capabilities underpin our diversified brands portfolio, which is focused across a wide range of specialty therapeutic areas of significant unmet need. These include rheumatology, ophthalmology, nephrology, neurology, pulmonology, orthopedics, urology, and neonatal respiratory critical care.Headquartered in Dublin, Ireland, Keenova benefits from a strong U.S. manufacturing footprint with facilities in Louisiana, New Jersey, New York, Pennsylvania, and Wisconsin. To learn more, please visit www.keenova.com.Keenova uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission ("SEC") disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.ContactsInvestors
investor.relations@keenova.comMedia
media.relations@keenova.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/keenova-therapeutics-to-report-first-quarter-2026-financial-results-on-may-12-2026-302758692.htmlSOURCE Keenova Therapeutics

Original: Keenova Therapeutics to Report First Quarter 2026 Financial Results on May 12, 2026

Keenova Announces Unaudited Fourth Quarter 2025 Financial ResultsMarch 31, 2026 6:30 AM
PR Newswire (US)

Robust Fourth-Quarter Performance Driven by Strength in Acthar® Gel1 and XIAFLEX®2Financial and Operational Performance Exceeded Expectations as Company Completed Transition into Branded Therapeutics CompanyHammer Toe Trial Meets Primary Safety Endpoint and Secondary, Exploratory Efficacy EndpointsProvides 2026 Net Sales Guidance of $1.94 Billion to $2.00 Billion and Adjusted EBITDA Guidance of $730 Million to $760 MillionConference Call and Webcast Today at 8:00 a.m. ETFourth Quarter 2025 Highlights3Acthar Gel net sales of $205.6 millionXIAFLEX net sales of $156.5 millionNet sales from continuing operations of $543.0 millionLoss from continuing operations expected to be between $105.0 million and $115.0 millionAdjusted EBITDA from continuing operations expected to be between $210.0 million and $220.0 millionDUBLIN, March 31, 2026 /PRNewswire/ -- Keenova Therapeutics plc ("Keenova" or the "Company") today announced unaudited financial results for the fourth quarter ended December 31, 2025.







"2025 was a transformational year for Keenova. We completed our evolution into a purpose-driven branded therapeutics company and delivered financial results above our expectations. We also began executing on our synergy plans and remain on track to meet our targets," said Siggi Olafsson, President and Chief Executive Officer. "Our performance underscores the positive momentum in the business and our team's disciplined execution. We have now delivered two consecutive years of double-digit growth in Acthar Gel, fueled by increasing patient demand and continued uptake of SelfJect™. XIAFLEX also performed well in the fourth quarter, and today we announced a significant milestone in our hammer toe clinical program."Mr. Olafsson added, "We have a strong foundation in place and meaningful value-creation opportunities ahead as we prepare to pursue a listing on the New York Stock Exchange in the second half of the year. Our team has embraced Keenova's mission to help patients with rare or unaddressed conditions live happier and healthier lives, and I am proud of their dedication to positioning our Company for sustainable growth and long-term success."Impact on 2025 Financial Results Due to Completion of Mallinckrodt-Endo Merger and Subsequent Par Health Spin-OffOn July 31, 2025, the Company (formerly Mallinckrodt plc) completed its merger with Endo LP (formerly Endo, Inc.) ("Endo") and recorded Endo's assets and liabilities on its balance sheet at fair value. On November 10, 2025, the Company completed the separation of Par Health. Keenova is required to present Par Health's assets and liabilities, results of operations, and cash flows as discontinued operations retroactively in its financial statements.Unaudited Fourth Quarter 2025 Financial ResultsNet sales from continuing operations in the fourth quarter of 2025 were $543.0 million, an increase of $277.3 million over the same period in 2024, primarily driven by momentum in Acthar Gel and the inclusion of XIAFLEX:Acthar Gel net sales were $205.6 million, an increase of 48%, primarily driven by higher demand and continued momentum in SelfJect uptake due to commercial investments and strong execution that drove category awareness and expansion.XIAFLEX net sales were $156.5 million.Loss from continuing operations is expected to be between $105.0 million and $115.0 million in the fourth quarter of 2025, compared to income from continuing operations of $566.4 million in the prior year period. This change reflects costs and benefits associated with transactions that occurred in 2025 and 2024, including:In the fourth quarter of 2024, the Company recognized a non-recurring pre-tax gain of $754 million on the sale of its Therakos® business; andIn the fourth quarter of 2025, strong performance of Acthar Gel and the inclusion of XIAFLEX net sales were more than offset by $185.8 million of incremental non-cash expenses related to fair value adjustments of inventory and intangible assets, the absence of a tax expense associated with the Therakos sale recognized in the prior year period, the inclusion of Endo operating costs following the business combination, and $11.8 million of integration-related costs.Adjusted EBITDA from continuing operations is expected to be between $210.0 million and $220.0 million, primarily driven by growth in Acthar Gel and the inclusion of XIAFLEX net sales, together with the realization of initial merger-related synergies.Merger Synergies UpdateKeenova realized $13 million in pre-tax merger synergies in the fourth quarter of 2025. The Company expects to realize pre-tax merger synergies of approximately $100 million in 2026 as it remains on track to achieve $150 million of annual pre-tax, run-rate synergies by the merger's three-year anniversary.XIAFLEX Pipeline UpdateHammer Toe: Proof-of-concept study enrollment was completed ahead of schedule in November 2025. Topline data demonstrated a favorable safety profile and met secondary and exploratory efficacy endpoints, enabling progression of the program into a registrational Phase 3 study. An FDA end-of-Phase 2 meeting is planned for the second quarter of 2026, with the start of the Phase 3 study expected in the fourth quarter of 2026.Plantar Fibromatosis: Patient enrollment for the Phase 3 study was completed on March 5, 2026. Topline results are expected in the third quarter of 2026; regulatory submission is targeted for the fourth quarter of 2026.Capital Allocation PrioritiesKeenova's capital allocation priorities for 2026 include investing in organic growth to support commercial execution for Acthar Gel and XIAFLEX and fund targeted R&D to enhance the durability of the Company's portfolio.Additionally, the Company is exploring opportunities to enhance its portfolio. This includes bolt-on acquisitions that leverage Keenova's existing capabilities to add to growth, as well as opportunistic divestitures, including a potential sale of the PERCOCET® business.2026 Financial GuidanceFor the full-year fiscal 2026, Keenova expects to deliver:Acthar Gel net sales growth rate in the mid-teens.XIAFLEX net sales growth rate in the mid- to high-single digits.4Net sales of $1.94 billion to $2.00 billion.Adjusted EBITDA of $730 million to $760 million.The above Adjusted EBITDA guidance incorporates anticipated merger synergies to be realized in 2026. The guidance for net sales and Adjusted EBITDA does not take into account any potential acquisition or divestiture activity, including the sale of the PERCOCET business, which is expected to generate approximately $65 million in net sales and approximately $64 million in Adjusted EBITDA in full-year 2026.The Company does not provide comparable GAAP measures for its forward-looking non-GAAP guidance or a reconciliation of such measures because the reconciling items described in the definition of Adjusted EBITDA provided below are inherently uncertain and difficult to estimate and cannot be predicted without unreasonable effort. The variability of such items may have a significant impact on our future GAAP results.Please see "Non-GAAP Financial Measures" included in this release for a discussion of non-GAAP measures and reconciliation of GAAP and non-GAAP financial measures for the fourth quarter.Please see the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, to be filed with the U.S. Securities and Exchange Commission ("SEC") for additional information.Conference Call and WebcastKeenova will hold a conference call for investors today, March 31, 2026, at 8:00 a.m. Eastern Time to discuss its fourth quarter and full-year 2025 financial and operational results and outlook for 2026.The audio webcast may be accessed through the Investor Relations section of the Company's website or through this webcast link. To access the call through a conference line, participants can register here to receive dial-in numbers and a personalized PIN to participate in the call. Participants are advised to join 10 minutes prior to the scheduled start time. A replay of the webcast will be available following the event.About KeenovaKeenova Therapeutics is a leading U.S.-focused branded therapeutics company that strives to help patients with rare or unaddressed conditions live happier and healthier lives.Keenova's rare disease capabilities underpin our diversified brands portfolio, which is focused across a wide range of specialty therapeutic areas of significant unmet need. These include rheumatology, ophthalmology, nephrology, neurology, pulmonology, orthopedics, urology, and neonatal respiratory critical care.Headquartered in Dublin, Ireland, Keenova benefits from a strong U.S. manufacturing footprint with facilities in Louisiana, New Jersey, New York, Pennsylvania, and Wisconsin. To learn more, please visit www.keenova.com.Keenova uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the SEC disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.Explanatory Notes and Non-GAAP Financial MeasuresThe unaudited financial results presented in this press release reflect Keenova's continuing operations. Such unaudited financial results are subject to completion of the Company's financial closing procedures. Actual results may differ materially from these unaudited financial results.As disclosed in the Company's Form 8-K furnished today with the SEC, the Company will file a Form 12b-25 with the SEC on April 1, 2026, which will have the effect of extending the deadline for its Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the "2025 Form 10-K") until April 15, 2026. The Company intends to file the 2025 Form 10-K on or prior to April 15, 2026. Please see the Company's Form 8-K for additional information.To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release includes certain financial information of the Company that is 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 assessing the Company's capital structure, and the Company believes that these measures will be used by certain investors to evaluate operating results and financial leverage, borrowing capacity and balance sheet risk. The Company believes that presenting these non-GAAP financial measures provides useful information about performance and financial leverage across reporting periods on a consistent basis by excluding certain items, which may be favorable or unfavorable.Despite the importance of these measures to management in goal-setting and performance measurement, 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, metrics such as non-GAAP Adjusted EBITDA from continuing operations and similar metrics (unlike GAAP measures and relevant 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. These non-GAAP financial measures should be read in conjunction with the Company's and Endo's unaudited condensed consolidated financial statements, audited financial statements, and publicly filed reports in their entirety. Reconciliations of certain of these historical adjusted financial measures to the most directly comparable GAAP financial measures are included in the tables accompanying this press release. Further information regarding non-GAAP financial measures can be found on the Company's website at www.keenova.com. Adjusted EBITDAAdjusted EBITDA represents net income or loss prepared in accordance with GAAP and adjusted for certain items that management believes are not reflective of the operational performance of the business. Adjustments to GAAP amounts include, as applicable to each measure, interest expense, net; income tax expense; depreciation and amortization; combination, integration, and other related expenses; restructuring charges, net; liabilities management and separation costs; gains/losses on debt extinguishment; gains/losses on divestitures; fresh-start inventory-related expenses; business combination inventory-related expense; share-based compensation; and other items identified by the Company.Adjusted EBITDA from Continuing OperationsAdjusted EBITDA from continuing operations represents Adjusted EBITDA (as defined above) and as adjusted for income (loss) from discontinued operations.Forward Looking StatementsStatements in this Press Release that are not strictly historical, including statements regarding the future financial condition and operating results of the Company, expected product launches, legal, economic, business, competitive and/or regulatory factors affecting Keenova's businesses and any other statements regarding events or developments Keenova believes or anticipates will or may occur in the future, may be "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties. Forward-looking statements can be identified by the use of forward-looking terminology such as the words "believe," "expect," "plan," "intend," "project," "anticipate," "approximately," "estimate," "predict," "potential," "continue," "may," "could," "should," "will" or the negative of these terms or similar expressions.There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: the risk that the completion and filing of the Company's 2025 Form 10-K will take longer than expected and any related consequences thereof, including triggering an event of default with respect to the Company's credit agreement for its revolving credit facility and term loan facility and the indenture related to certain senior secured notes, which could result in substantially all of the indebtedness under such agreements becoming immediately due and payable if the Company does not file within the grace periods defined in such agreements; the expected benefits and synergies of the merger with Endo may not be fully realized in a timely manner, or at all; the Company's increased indebtedness as a result of the merger with Endo and significant transaction costs related to the merger with Endo; the expected growth opportunities, profit improvements, cost savings and other benefits as a result of the spin-off of Par Health may not be fully realized in a timely manner, or at all; loss of the benefits of services provided by Par Health or certain of its subsidiaries; risks associated with being a smaller, less diversified company as a result of the spin-off of Par Health; unanticipated costs, litigation and/or regulatory inquiries and investigations, including as a result of the merger with Endo or the spin-off of Par Health; potential changes in the estimated fair value of the net assets acquired in the merger with Endo; potential changes in the Company's business strategy and performance; exposure to global economic conditions and market uncertainty; governmental investigations and inquiries, regulatory actions, and lawsuits, in each case related to the Company or its officers; the Company's contractual and court-ordered compliance obligations that, if violated, could result in penalties; matters related to Acthar® Gel (repository corticotropin injection), including the settlement with governmental parties to resolve certain disputes and compliance with and restrictions under the related corporate integrity agreement; the ability to maintain relationships with the Company's suppliers, customers, employees and other third parties; scrutiny from governments, legislative bodies and enforcement agencies related to sales, marketing and pricing practices; pricing pressure on certain of the Company's products due to legal changes or changes in insurers' or other payers' reimbursement practices resulting from recent increased public scrutiny of healthcare and pharmaceutical costs; the reimbursement practices of governmental health administration authorities, private health coverage insurers and other third-party payers; complex reporting and payment obligations under the Medicare and Medicaid rebate programs and other governmental purchasing and rebate programs; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; changes in or failure to comply with relevant laws and regulations; any undesirable side effects caused by the Company's approved and investigational products, which could limit their commercial profile or result in other negative consequences; the Company's and its partners' ability to successfully develop, commercialize or launch new products or expand commercial opportunities of existing products, including Acthar Gel SelfJect, the INOmax® Evolve DS delivery system, and XIAFLEX® (collagenase clostridium histolyticum); the Company's ability to successfully pursue additional indications for XIAFLEX, including the timing and outcome of clinical results and regulatory submissions; the Company's ability to successfully identify or discover additional products or product candidates; the Company's ability to navigate price fluctuations and pressures, including the ability to achieve anticipated benefits of price increases of its products; competition; the Company's and its partners' ability to protect intellectual property rights; limited clinical trial data for Acthar Gel; the timing, expense and uncertainty associated with clinical studies and related regulatory processes; product liability losses and other litigation liability; material health, safety and environmental laws and related liabilities; business development activities or other strategic transactions; attraction and retention of qualified personnel in key fields; the effectiveness of information technology infrastructure, including risks of external attacks or failures; customer concentration; the Company's reliance on certain individual products that are material to its financial performance; complex manufacturing processes; reliance on third-party manufacturers and supply chain providers and related market disruptions; conducting business internationally; new or increased tariffs and evolving trade relations and changes in trade and taxation policy; the Company's significant levels of intangible assets and related impairment testing; natural disasters or other catastrophic events; the Company's substantial indebtedness and settlement obligation, its ability to generate sufficient cash to reduce its indebtedness and its potential need and ability to incur further indebtedness; restrictions contained in the agreements governing the Company's indebtedness and settlement obligation on the Company's operations, future financings and use of proceeds; the Company's variable rate indebtedness; the Company's tax treatment by the Internal Revenue Service under Section 7874 and Section 382 of the Internal Revenue Code of 1986, as amended; future changes to applicable tax laws or the impact of disputes with governmental tax authorities; the impact of Irish laws; the comparability of the Company's financial results to historical financial statements in light of its emergence from Chapter 11 bankruptcy proceedings in 2023, the divestiture of the Therakos business, the merger with Endo and spin-off of Par Health.The "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 27, 2024, its Quarterly Report on Form 10-Q for the quarterly period ended March 28, 2025, its Quarterly Report for the quarterly period ended June 27, 2025, its Quarterly Report for the quarterly period ended September 26, 2025, its Registration Statement on Form S-4, as amended, filed with the SEC, and other filings with the SEC, all of which are on file with the SEC and available from the SEC's website (www.sec.gov) and the Company's website (www.keenova.com), identify and describe in more detail the risks and uncertainties to which the Company's businesses are subject. There may be other risks and uncertainties that we are unable to predict at this time or that we currently do not expect to have a material adverse effect on our business. The forward-looking statements made herein speak only as of the date hereof and the Company does 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. Given these uncertainties, one should not put undue reliance on any forward-looking statements.No Offer of SecuritiesThe Company's potential NYSE listing in the second half of 2026 is subject to approval by Keenova's Board of Directors and other considerations and conditions. The Company expects to conduct a public offering of Keenova's ordinary shares to facilitate the listing at that time, and no assurance can be given as to whether or when such transaction will occur or its impact.This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any such offering would be made pursuant to a registration statement to be filed with the SEC. The price and number of the ordinary shares to be sold in any such offering have not yet been determined. The timing of any such offering would be subject to market and other conditions and the completion of the SEC's review process. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.CONTACTSInvestors:
investor.relations@keenova.comMedia:
media.relations@keenova.comorAura Reinhard / Catherine Simon
Joele Frank, Wilkinson Brimmer Katcher
212-355-4449 KEENOVA THERAPEUTICS PLCSELECT PRODUCT LINE NET SALES(unaudited, dollars in millions)




Change
4Q25
4Q24
$
%Acthar Gel$           205.6
$           138.9
$             66.7
48 %Xiaflex156.5
—
156.5
— %INOmax61.5
60.8
0.7
1 %Therakos—
48.6
(48.6)
NMAmitiza14.4
9.5
4.9
52 %Other Products81.2
7.9
73.3
NMLicense Revenues               23.9
—
23.9
— %Total$           543.0
$           265.7
$           277.3
104 %




_________

NM indicates that the percentage change is not meaningful or is greater than 100%. KEENOVA THERAPEUTICS PLCCONSOLIDATED ADJUSTED EBITDA(unaudited, in millions)


Estimated 4Q25
4Q24Net (loss) income$          (173.4)
$           612.8Net loss (income) from discontinued operations63.4
(46.4)(Loss) income from continuing operations before taxes(1)               (110.0)
566.4Adjustments:


Interest expense, net48.9
45.1Income tax expense0.3
116.4Depreciation5.2
2.1Amortization56.5
10.7Combination, integration, and other related expenses11.8
—Liabilities management and separation costs(1.0)
11.7Loss on debt extinguishment, net0.1
19.8Gain on divestiture—
(754.4)Fresh-start inventory-related expense54.5
39.7Business combination inventory-related expenses125.3
—Share-based compensation9.9
3.3Change in fair value of contingent consideration11.3
(0.4)Change in derivative asset and liabilities fair value0.8
(13.4)Unrealized (gain) loss on equity investment(0.9)
18.8Other2.3
2.0Adjusted EBITDA from continuing operations(1)$           215.0
$             67.9
____________(1) Loss from continuing operations before taxes reflects the midpoint of the estimated range of $105 million to $115 million.
Adjusted EBITDA from continuing operations reflects the midpoint of the estimated range of $210 million to $220 million. ________________________________________1 Repository corticotropin injection.2 Collagenase clostridium histolyticum.3 The unaudited financial results presented in this release reflect the continuing operations of Keenova Therapeutics plc. For an explanation of these measures and comparisons against prior periods, please see "Explanatory Notes and Non-GAAP Financial Measures" below.4 Compared to aggregate XIAFLEX net sales for fiscal year 2025, which is calculated based on Endo's XIAFLEX net sales of $299.7 million for the pre-merger portion of fiscal year 2025 and Keenova's XIAFLEX net sales of $246.6 million for the post-merger portion of fiscal year 2025, for a total of $546.3 million.



View original content to download multimedia:https://www.prnewswire.com/news-releases/keenova-announces-unaudited-fourth-quarter-2025-financial-results-302729822.htmlSOURCE Keenova Therapeutics

Original: Keenova Announces Unaudited Fourth Quarter 2025 Financial Results

Keenova Presents a New TERLIVAZ® (terlipressin) Clinical Analysis at the SHM ConvergeMarch 27, 2026 7:30 AM
PR Newswire (US)

DUBLIN, March 27, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced today that a new presentation on hepatorenal syndrome-acute kidney injury (HRS-AKI) and TERLIVAZ® (terlipressin) will be shared at the Society of Hospital Medicine (SHM) Converge, taking place March 29-April 1, 2026.







"We are pleased to share these findings with the medical community, as they help deepen our understanding of this challenging and rapidly progressive condition," said Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova. "Expanding the clinical evidence base is essential, and this analysis provides fresh insight into how clinicians are using TERLIVAZ in practice and how we can continue to support patients affected by HRS-AKI."TERLIVAZ is the first and only FDA-approved therapy indicated to improve kidney function in adults with HRS-AKI.Presentation DetailsTitle: Real-World Utilization Patterns and Outcomes in Hospitalized U.S. Adults With Hepatorenal Syndrome-Acute Kidney Injury Treated with Terlipressin: A Retrospective Cohort StudyAuthors: A. Sidney Barritt IV, MD; Kavish R. Patidar, DO; Robert J. Wong, MD, MS; Xingyue Huang, PhD; Rachel Black, PharmD; Mary Panaccio, PhD; Jonathan Lilley, BA; Nisha Wadhwani, PhD; Rahul Rajkumar, MD, MPH; Christopher White, MD, MSPHAbout Hepatorenal Syndrome-Acute Kidney Injury
Hepatorenal syndrome–acute kidney injury (HRS-AKI) is a life-threatening condition in adults with advanced liver disease that is marked by a rapid decline in kidney function1 and is associated with high morbidity and mortality.2 It is an acute medical emergency that requires hospitalization.3 A U.S. study based on national data revealed that the projected annual number of inpatients diagnosed with HRS has increased between 2018 and 2023, from 42,930 to 63,381.4INDICATION
TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.LIMITATION OF USEPatients with a serum creatinine >5 mg/dL are unlikely to experience benefit.IMPORTANT SAFETY INFORMATIONWARNING: SERIOUS OR FATAL RESPIRATORY FAILURETERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO2) before initiating TERLIVAZ. 
 Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO2 

Keenova Unveils Clinical Data from Phase 2 Plantar Fibromatosis Study at the ACFAS Annual MeetingFebruary 24, 2026 7:30 AM
PR Newswire (US)

Previously unpublished clinical data support the potential long-term safety and efficacy of collagenase clostridium histolyticum (CCH) for plantar fibromatosis.The findings will be presented at the ACFAS Annual Meeting, highlighting progress toward a potential nonsurgical treatment option for a painful condition.Keenova's Phase 3 clinical trial is currently underway, with results expected mid-2026.DUBLIN, Feb. 24, 2026 /PRNewswire/ -- Keenova Therapeutics plc is presenting clinical data on plantar fibromatosis at the American College of Foot and Ankle Surgeons (ACFAS) Annual Meeting, taking place February 24–27, 2026.







Why It MattersPlantar fibromatosis is a progressive condition with no FDA-approved nonsurgical treatment options. Keenova is investigating collagenase clostridium histolyticum (CCH) as a potential therapy. CCH is not approved for treating plantar fibromatosis.News You Should KnowNew findings from Study 306, an open-label extension of Keenova's phase 2 trial analysis show:Patients receiving initial treatment or re-treatment with CCH demonstrated a safety profile consistent with the earlier phase 2 study.Data support the potential long-term safety, efficacy, and durability of CCH in plantar fibromatosis.Keenova's Phase 3 clinical trial evaluating CCH for plantar fibromatosis is currently underway, with results expected mid-2026.CSO Perspective"We are pleased to share with the medical community these important data that help advance our understanding of this burdensome condition," said Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova. "We are progressing our program to pivotal Phase 3 study to advance a potential nonsurgical treatment option for patients with plantar fibromatosis, reinforcing our commitment to bring new therapies for challenging conditions."Zoom in: About Study 306Builds on earlier phase 2 results showing improvements in nodule hardness, consistency, and other clinical measures, including the reduction of pain associated with the condition.Participants entered a 180-day observation period without treatment, followed by an optional treatment phase for new or previously treated nodules.Participants who chose not to be retreated continued in long-term observation without receiving additional treatment.The primary endpoint was safety.Additional efficacy was evaluated using patient- and investigator-reported outcomes.Presentation DetailsTitle: Long-term safety, efficacy, and durability of collagenase clostridium histolyticum (CCH) in the treatment and re-treatment of plantar fibromatosis (PFI)Authors: C. James Anderson, DPM; Jason Levy, DPM, FACFAS; Sara E. Suttle, DPM, FACFAS; Nigel Jones, PharmD; Luis Ortega, MD; Gongfu Zhou, PhD; Joseph Caporusso, DPMAbout Plantar Fibromatosis
Plantar fibromatosis or Ledderhose disease is a hyperproliferative fibrous tissue disorder resulting in the formation of collagen nodules along the plantar fascia, the thick connective tissue that supports the arch of the foot, which is often painful. There is no cure for plantar fibromatosis. Symptom management options include custom insoles (orthotics), topical treatments, over-the-counter pain and anti-inflammatory medications, radiation therapy and steroid injections, and ultimately, surgery may be required to remove the nodules.About Keenova 
Keenova Therapeutics is a leading global developer and manufacturer of branded therapeutics that strives to help patients with rare or unaddressed conditions live happier and healthier lives.The Company's diversified brands portfolio is focused across a wide range of therapeutic areas of significant unmet need, including endocrinology, gastroenterology, hepatology, immunology, neonatal respiratory critical care, nephrology, neurology, pulmonology, ophthalmology, orthopedics, rheumatology and urology. Globally headquartered in Dublin, Ireland, Keenova benefits from a strong U.S. manufacturing footprint with facilities in Louisiana, New Jersey, New York, Pennsylvania and Wisconsin. To learn more, please visit www.keenova.com.Keenova uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission ("SEC") disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.Information Regarding Forward-Looking Statements
There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: the expected benefits and synergies of the business combination with Endo ("Business Combination") may not be fully realized in a timely manner, or at all; the Company's increased indebtedness as a result of the Business Combination and significant transaction costs related to the Business Combination; the expected growth opportunities, profit improvements, cost savings and other benefits as a result of the spin-off of Par Health may not be fully realized in a timely manner, or at all; unanticipated costs, litigation and/or regulatory inquiries and investigations as a result of the spin-off of Par Health; risks associated with being a smaller, less diversified company as a result of the spin-off of Par Health; potential changes in the Company's business strategy and performance; exposure to global economic conditions and market uncertainty; governmental investigations and inquiries, regulatory actions, and lawsuits, in each case related to the Company's or its officers; the Company's contractual and court-ordered compliance obligations that, if violated, could result in penalties; compliance with and restrictions under the global settlement to resolve all opioid-related claims; matters related to Acthar Gel, including the settlement with governmental parties to resolve certain disputes and compliance with and restrictions under the related corporate integrity agreement; the ability to maintain relationships with the Company's suppliers, customers, employees and other third parties; scrutiny from governments, legislative bodies and enforcement agencies related to sales, marketing and pricing practices; pricing pressure on certain of the Company's products due to legal changes or changes in insurers' or other payers' reimbursement practices resulting from recent increased public scrutiny of healthcare and pharmaceutical costs; the reimbursement practices of governmental health administration authorities, private health coverage insurers and other third-party payers; complex reporting and payment obligations under the Medicare and Medicaid rebate programs and other governmental purchasing and rebate programs; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; changes in or failure to comply with relevant laws and regulations; any undesirable side effects caused by the Company's approved and investigational products, which could limit their commercial profile or result in other negative consequences; the Company's and its partners' ability to successfully develop, commercialize or launch new products or expand commercial opportunities of existing products, including Acthar Gel (repository corticotropin injection) SelfJect, the INOmax Evolve DS delivery system, and XIAFLEX; the Company's ability to successfully identify or discover additional products or product candidates; the Company's ability to navigate price fluctuations and pressures, including the ability to achieve anticipated benefits of price increases of its products; competition; the Company's and its partners' ability to protect intellectual property rights, including in relation to ongoing and future litigation; limited clinical trial data for Acthar Gel; the timing, expense and uncertainty associated with clinical studies and related regulatory processes; product liability losses and other litigation liability; material health, safety and environmental laws and related liabilities; business development activities or other strategic transactions; attraction and retention of key personnel; the effectiveness of information technology infrastructure, including risks of external attacks or failures; customer concentration; the Company's reliance on certain individual products that are material to its financial performance; the Company's ability to receive sufficient procurement and production quotas granted by the U.S. Drug Enforcement Administration; complex manufacturing processes; reliance on third-party manufacturers and supply chain providers and related market disruptions; conducting business internationally; the Company's significant levels of intangible assets and related impairment testing; natural disasters or other catastrophic events; the Company's substantial indebtedness and settlement obligation, its ability to generate sufficient cash to reduce its indebtedness and its potential need and ability to incur further indebtedness; restrictions contained in the agreements governing the Company's indebtedness and settlement obligation on the Company's operations, future financings and use of proceeds; the Company's variable rate indebtedness; the Company's tax treatment by the Internal Revenue Service under Section 7874 and Section 382 of the Internal Revenue Code of 1986, as amended; future changes to applicable tax laws or the impact of disputes with governmental tax authorities; the impact of Irish laws; the comparability of the Company's post-emergence financial results and the projections filed with the U.S. Bankruptcy Court for the District of Delaware and the lack of comparability of the Company's historical financial statements and information contained in its financial statements after the adoption of fresh-start accounting following emergence from Mallinckrodt's and Endo's respective bankruptcy proceedings.The "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 27, 2024, its Quarterly Report on Form 10-Q for the quarterly period ended March 28, 2025, its Quarterly Report for the quarterly period ended June 27, 2025,  its Quarterly Report for the quarterly period ended September 26, 2025, its Registration Statement on Form S-4, as amended, filed with the SEC, and other filings with the SEC, all of which are on file with the SEC and available from the SEC's website (www.sec.gov) and the Company's website (www.keenova.com), identify and describe in more detail the risks and uncertainties to which the Company's businesses are subject. There may be other risks and uncertainties that we are unable to predict at this time or that we currently do not expect to have a material adverse effect on our business. The forward-looking statements made herein speak only as of the date hereof and the Company does 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. Given these uncertainties, one should not put undue reliance on any forward-looking statements.Contacts:


Media:Investors:


media.relations@keenova.cominvestor.relations@keenova.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/keenova-unveils-clinical-data-from-phase-2-plantar-fibromatosis-study-at-the-acfas-annual-meeting-302694691.htmlSOURCE Keenova Therapeutics

Original: Keenova Unveils Clinical Data from Phase 2 Plantar Fibromatosis Study at the ACFAS Annual Meeting

Keenova Announces New Manuscript on Plantar Fibromatosis Treatment Patterns in Peer-Reviewed Journal of Foot and Ankle SurgeryFebruary 16, 2026 7:30 AM
PR Newswire (US)

Plantar fibromatosis is a rare condition, and most newly diagnosed patients receive conservative (nonsurgical) treatments.Real-world treatment patterns suggest symptoms may persist or return, creating an opportunity for more research on long-term outcomes and effectiveness.Keenova is actively evaluating a nonsurgical treatment option for plantar fibromatosis, with a Phase 3 clinical trial currently underway.DUBLIN, Feb. 16, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced the publication of a new manuscript presenting real-world evidence on treatment patterns for patients with plantar fibromatosis. The peer-reviewed article appears in The Journal of Foot and Ankle Surgery, available here.







Why It MattersPlantar fibromatosis is a progressive condition with no FDA-approved nonsurgical treatment options. With no official treatment guidelines available, Keenova and its clinical partners are working to better understand how healthcare providers manage the condition in real-world practice. Keenova is also investigating collagenase clostridium histolyticum (CCH) as a potential nonsurgical therapy. CCH is not approved for treating plantar fibromatosis.CSO Perspective"We believe patients with this rare condition deserve more treatment options, especially those seeking alternatives to surgery," said Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova. "That's why we are actively investigating a nonsurgical approach in our Phase 3 clinical trial, with the goal of supporting patient care and helping to improve quality of life for the people who need it most."What We LearnedFindings from the manuscript show:Plantar fibromatosis is rare, but it appears consistently in real-world data, indicating that it is regularly diagnosed and treated despite its low overall prevalence.Most patients receive treatments such as injectable corticosteroids, oral corticosteroids, and physical/occupational therapy.Although surgery is infrequent, conservative treatments often continue after surgery, which may suggest disease recurrence or persistent symptoms.These patterns indicate a need for more research to understand long-term outcomes and identify effective treatments for people with refractory plantar fibromatosis.Phase 3 StatusKeenova's Phase 3 clinical trial evaluating CCH for plantar fibromatosis is currently underway.Manuscript DetailsTitle: Real-World Treatment Patterns Among Newly Diagnosed Patients With Plantar Fibromatosis in the United StatesAuthors: Jill Davis, MS; Aimee Near, MPH; Jenny Tse, MS; Riddhi Doshi, PhD, MBBS, MPH; Elizabeth Wang, MS; Luis Ortega, MD; David Hurley, MD; David G. Armstrong, MD, PhD, MSAbout Plantar Fibromatosis
Plantar fibromatosis or Ledderhose disease is a hyperproliferative fibrous tissue disorder resulting in the formation of collagen nodules along the plantar fascia, the thick connective tissue that supports the arch of the foot, which is often painful. There is no cure for plantar fibromatosis. Symptom management options include custom insoles (orthotics), topical treatments, over-the-counter pain and anti-inflammatory medications, radiation therapy and steroid injections, and ultimately, surgery may be required to remove the nodules.About Keenova
Keenova Therapeutics is a leading global developer and manufacturer of branded therapeutics that strives to help patients with rare or unaddressed conditions live happier and healthier lives.The Company's diversified brands portfolio is focused across a wide range of therapeutic areas of significant unmet need, including endocrinology, gastroenterology, hepatology, immunology, neonatal respiratory critical care, nephrology, neurology, pulmonology, ophthalmology, orthopedics, rheumatology and urology. Globally headquartered in Dublin, Ireland, Keenova benefits from a strong U.S. manufacturing footprint with facilities in Louisiana, New Jersey, New York, Pennsylvania and Wisconsin. To learn more, please visit www.keenova.com.Keenova uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission ("SEC") disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.Information Regarding Forward-Looking Statements
There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: the expected benefits and synergies of the business combination with Endo ("Business Combination") may not be fully realized in a timely manner, or at all; the Company's increased indebtedness as a result of the Business Combination and significant transaction costs related to the Business Combination; the expected growth opportunities, profit improvements, cost savings and other benefits as a result of the spin-off of Par Health may not be fully realized in a timely manner, or at all; unanticipated costs, litigation and/or regulatory inquiries and investigations as a result of the spin-off of Par Health; risks associated with being a smaller, less diversified company as a result of the spin-off of Par Health; potential changes in the Company's business strategy and performance; exposure to global economic conditions and market uncertainty; governmental investigations and inquiries, regulatory actions, and lawsuits, in each case related to the Company's or its officers; the Company's contractual and court-ordered compliance obligations that, if violated, could result in penalties; compliance with and restrictions under the global settlement to resolve all opioid-related claims; matters related to Acthar Gel, including the settlement with governmental parties to resolve certain disputes and compliance with and restrictions under the related corporate integrity agreement; the ability to maintain relationships with the Company's suppliers, customers, employees and other third parties; scrutiny from governments, legislative bodies and enforcement agencies related to sales, marketing and pricing practices; pricing pressure on certain of the Company's products due to legal changes or changes in insurers' or other payers' reimbursement practices resulting from recent increased public scrutiny of healthcare and pharmaceutical costs; the reimbursement practices of governmental health administration authorities, private health coverage insurers and other third-party payers; complex reporting and payment obligations under the Medicare and Medicaid rebate programs and other governmental purchasing and rebate programs; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; changes in or failure to comply with relevant laws and regulations; any undesirable side effects caused by the Company's approved and investigational products, which could limit their commercial profile or result in other negative consequences; the Company's and its partners' ability to successfully develop, commercialize or launch new products or expand commercial opportunities of existing products, including Acthar Gel (repository corticotropin injection) SelfJect, the INOmax Evolve DS delivery system, and XIAFLEX; the Company's ability to successfully identify or discover additional products or product candidates; the Company's ability to navigate price fluctuations and pressures, including the ability to achieve anticipated benefits of price increases of its products; competition; the Company's and its partners' ability to protect intellectual property rights, including in relation to ongoing and future litigation; limited clinical trial data for Acthar Gel; the timing, expense and uncertainty associated with clinical studies and related regulatory processes; product liability losses and other litigation liability; material health, safety and environmental laws and related liabilities; business development activities or other strategic transactions; attraction and retention of key personnel; the effectiveness of information technology infrastructure, including risks of external attacks or failures; customer concentration; the Company's reliance on certain individual products that are material to its financial performance; the Company's ability to receive sufficient procurement and production quotas granted by the U.S. Drug Enforcement Administration; complex manufacturing processes; reliance on third-party manufacturers and supply chain providers and related market disruptions; conducting business internationally; the Company's significant levels of intangible assets and related impairment testing; natural disasters or other catastrophic events; the Company's substantial indebtedness and settlement obligation, its ability to generate sufficient cash to reduce its indebtedness and its potential need and ability to incur further indebtedness; restrictions contained in the agreements governing the Company's indebtedness and settlement obligation on the Company's operations, future financings and use of proceeds; the Company's variable rate indebtedness; the Company's tax treatment by the Internal Revenue Service under Section 7874 and Section 382 of the Internal Revenue Code of 1986, as amended; future changes to applicable tax laws or the impact of disputes with governmental tax authorities; the impact of Irish laws; the comparability of the Company's post-emergence financial results and the projections filed with the U.S. Bankruptcy Court for the District of Delaware and the lack of comparability of the Company's historical financial statements and information contained in its financial statements after the adoption of fresh-start accounting following emergence from Mallinckrodt's and Endo's respective bankruptcy proceedings.The "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 27, 2024, its Quarterly Report on Form 10-Q for the quarterly period ended March 28, 2025, its Quarterly Report for the quarterly period ended June 27, 2025, its Quarterly Report for the quarterly period ended September 26, 2025, its Registration Statement on Form S-4, as amended, filed with the SEC, and other filings with the SEC, all of which are on file with the SEC and available from the SEC's website (www.sec.gov) and the Company's website (www.keenova.com), identify and describe in more detail the risks and uncertainties to which the Company's businesses are subject. There may be other risks and uncertainties that we are unable to predict at this time or that we currently do not expect to have a material adverse effect on our business. The forward-looking statements made herein speak only as of the date hereof and the Company does 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. Given these uncertainties, one should not put undue reliance on any forward-looking statements.Contacts:Media: Investors:media.relations@keenova.cominvestor.relations@keenova.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/keenova-announces-new-manuscript-on-plantar-fibromatosis-treatment-patterns-in-peer-reviewed-journal-of-foot-and-ankle-surgery-302688006.htmlSOURCE Keenova Therapeutics

Original: Keenova Announces New Manuscript on Plantar Fibromatosis Treatment Patterns in Peer-Reviewed Journal of Foot and Ankle Surgery

I'll keep my eyes on it......you too please.

Doesn’t look like they issued new stock, news says their lenders now own the company.

MNKT: DEC 1st, 2023 SEC Cease and Desist Order:

https://www.sec.gov/files/litigation/admin/2023/33-11256.pdf

https://www.sec.gov/enforce/33-11256-s

Mallinckrodt Plc emerged from Ch. 11 bankruptcy with new equity. *****I spent 25 minutes looking for the ticker but could not find any references, so, I'll simply submit a ticker change from MNKTQ back to MNKT. If anyone finds any other reference to a ticker change please post it on this board.

https://www.sec.gov/Archives/edgar/data/1567892/000110465923116529/tm2330452d1_ex99-2.htm

MNKTQ: BK PLAN effective. All shares cancelled. ***PPS rose 71% from .07 to .12 on 39,227 volume. Someone got a bit lucky, knowing the stock would be cancelled.

https://otce.finra.org/otce/dailyList?viewType=Deletions

How much is the tender offer?

Finally looking good $MNKTQ

Glad you got out

GLTU

i left a long time ago but didnt see this just took my profits.. didnt think the bk thing was coming here ..until your post i forgot i was even heree glta

Opioid scapegoat here

SERIOUSLY??????

Nope

Not looking likely......

150 million dollars out of the 250 million was granted approval for access. With the short the way it is it could be absolutely insane or it will get ignored

Now will squeeze MAYBE .... could be massive squeeze from these levels.

MNK changed to MNKTQ, bankruptcy. Delisted from the AMEX to the OTC:

https://otce.finra.org/otce/dailyList?viewType=Additions

MNK new 52 week low

and maybe another Rally the biggest one yet ?

this is not just a monstrous squeeze in yhr msking. there is value here that that is worth a long term hol

3500 at 1.12 i flipped the coin ..it came up heads

1.13

$MNK short of the century bankruptcy pumper.

MNK Mallinckrodt's Potential Bankruptcy: Hedge Funds' New Path to Dodge Opioid Settlement Debt?
BENZINGA 12:28 PM ET Jul-26-2023

https://stockcharts.com/h-sc/ui?s=MNK

Last year, Mallinckrodt Plc (NYSE:MNK) pledged to pay $1.7 billion to settle numerous lawsuits by governments and individuals impacted by the opioid crisis, who argued the company had a hand in sparking the public health disaster.

The settlement, expected to be disbursed through 2030, was intended to finance overdose reversal drugs and cover the treatment expenses of opioid users.

Nevertheless, hedge funds that backed Mallinckrodt support a plan for the company to pull out of the agreement with roughly $1.3 billion still outstanding, Wall Street Journal reported.

Several hedge funds, including Silver Point Capital, are negotiating with Mallinckrodt's board to assume control of the business via a bankruptcy declaration. Other funds, such as Bracebridge Capital and Alta Fundamental Advisers, are discussing its potential Chapter 11 filing.

The funds argue that Mallinckrodt was overgenerous in its settlement commitment and that the company's funds should primarily belong to top-tier lenders, such as themselves, rather than to victims or state governments.

They believe Mallinckrodt's continued contributions to the opioid trust could harm the company's financial stability and breach its legal obligations to investors.

The report also noted that the hedge funds suggest that Mallinckrodt should restructure through bankruptcy due to declining business.

In response, Mallinckrodt confirmed its ongoing discussions with "its financial stakeholders" to determine the best way forward considering their debt and opioid settlement commitments.

It is a controversial move, as Mallinckrodt was the first opioid manufacturer to globally settle with state attorneys general, municipal governments, and countless individuals who accused the company of downplaying the addictive risks of its prescription opioids.

Upon settling the lawsuits, Mallinckrodt and its executives were exempted from future liabilities for opioid sales, and the company was allowed to continue producing the drugs.

Price Action: MNK shares are up 61.40% at $0.71 on the last check Wednesday

1.87

Like I said close the gap at 2.40

exit 2.21 resistance

MNK 2.35 NUTS

HERE COMES 2,21

TRIMMING ABOVE 1.76

MNK..WATCH THAT 2.21 AS TOP

MNK BREAKING RESISTANCE IN PRE MARKET

MNK: Benzinga breaks-down the most BIZARRE story in the history of Wall Street??? If not, a good candidate for such. OLD NEWS??? Well, read it again:
https://www.benzinga.com/news/23/07/33393811/federal-reserve-to-follow-through-with-0-25-rate-hike-wednesday-likely-another-next-meeting-says-for
////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////

So many many stocks with repeat rallies - missed this one again

Check your broker. its easy to borrow with Etrade.

MNK 1.77 NO SHARES AVAILABLE TO SHORT

I TRIED

Hmmm gap to fill at 2.40

MNK: If you want your Company's stock to SOAR, well, simply get SUED or INVESTIGATED for FRAUD or otherwise misleading your investors!!! Works every time!!!

Second times a charm

Rocket’s

Doing similar moves after hours