Anorectal manometry and high-resolution anorectal manometry (HRAM) are becoming the investigation of choice for understanding the pathophysiology of chronic constipation with or without fecal incontenance in children in many institutions. In high resolution anorectal manometery we are able to gain information whether the symptoms are related to sphincter dysfunction, impaired sensation, or pelvic floor dyssynergia

Start Date07 Sep 2024

Sponsor / Collaborator

Ain Shams University

ChiCTR2400088155 / SuspendedPhase 4IIT

Evaluating lubiprostone for effective in colonoscopic bowel preparation

Start Date15 Aug 2024

Sponsor / Collaborator-

100 Clinical Results associated with Lubiprostone

100 Translational Medicine associated with Lubiprostone

100 Patents (Medical) associated with Lubiprostone

364

Literatures (Medical) associated with Lubiprostone

01 Oct 2024·Journal of Managed Care & Specialty Pharmacy

A real-world study of persistence and adherence to prescription medications in patients with chronic idiopathic constipation in the United States

Article

Author: Terasawa, Emi ; Du, Shawn ; Terreri, Brian ; Lu, Mei ; Moshiree, Baharak ; Boules, Mena ; Cash, Brooks D. ; Feuerstadt, Paul ; Ayyagari, Rajeev ; Nguyen, Linda ; Westermeyer, Ben ; Lembo, Anthony ; Pi, Selina

BACKGROUNDAt present, 4 prescription therapies have been approved by the US Food and Drug Administration for the treatment of chronic idiopathic constipation (CIC) in adults.OBJECTIVESTo compare persistence with and adherence to prucalopride vs 3 other prescription medications for CIC in a US population.METHODSThis retrospective, observational cohort study used data from the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental Databases (January 2015-June 2020). Inclusion criteria were patients (aged ≥18 years) with at least 1 prescription fill for prucalopride, lubiprostone, linaclotide, or plecanatide on or after April 2, 2019 (commercial availability of prucalopride), and at least 1 constipation-related diagnosis code. Persistence was assessed by time to discontinuation, and adherence was assessed by the proportion of days covered (PDC) and the proportion of patients who achieved PDC of at least 80%. Adjusted hazard ratios (HRs) for discontinuation and odds ratios for adherence were calculated.RESULTSA total of 14,700 patients (mean age = 48.3 years; female = 81.9%) were included (prucalopride, n = 675; lubiprostone, n = 1,591; linaclotide, n = 11,105; plecanatide, n = 1,329). After adjusting for confounding factors, the HRs for discontinuation were significantly higher for all comparator medications compared with prucalopride after 2 months (HR [95% CI]: lubiprostone, 1.70 [1.48-1.95]; linaclotide, 1.25 [1.10-1.41]; plecanatide, 1.31 [1.13-1.51], all P < 0.001). The unadjusted mean (SD) PDC was 0.53 (0.32) with prucalopride compared with 0.41 (0.31); P less than 0.001 with lubiprostone, 0.48 (0.31), P less than 0.05 with linaclotide, and 0.48 (0.29), P = 0.98 with plecanatide. The comparator medications were all associated with lower odds of achieving PDC of at least 80% relative to prucalopride (odds ratio [95% CI]: lubiprostone, 0.52 [0.40-0.69], P < 0.001; linaclotide, 0.73 [0.58-0.93], P = 0.009; plecanatide, 0.70 [0.53-0.93], P = 0.015).CONCLUSIONSThe findings of this study indicate that prucalopride has higher treatment persistence and adherence compared with other CIC prescription medications. This research represents the first instance of a real-world claims study showcasing such outcomes.

01 Sep 2024·Expert Opinion on Pharmacotherapy

Emerging therapies for opioid-induced constipation: what can we expect?

Review

Author: Roostaei, Ghazal ; Khoshnam Rad, Niloofar ; Fakhri B, Maryam S. ; Abdollahi, Mohammad ; Nikfar, Shekoufeh

INTRODUCTIONThe rise in opioid use for managing chronic and oncologic pain has led to a significant increase in opioid-induced constipation (OIC) that impacts patient quality of life and pain management.AREAS COVEREDIn this study, emerging therapies for OIC were criticized for refining advancements and novel treatment options. Key topics included the efficacy of peripherally acting mu-opioid receptor antagonists (PAMORAs) such as methylnaltrexone, naloxegol, and naldemedine, which specifically target opioid-induced gut dysfunction. Other treatment options, including intestinal secretagogues like lubiprostone and linaclotide, selective 5-HT receptor agonists such as prucalopride, and emerging adjunctive therapies like transcutaneous electrical nerve stimulation (TENS) and electroacupuncture were mentioned. Current guidelines from the American Gastroenterological Association (AGA) and the European consensus were criticized.EXPERT OPINIONExperts stress the importance of a stepwise approach to managing OIC, considering patient-specific factors and the efficacy of various treatments. While PAMORAs have demonstrated effectiveness in improving bowel function, their high cost and lack of extensive head-to-head comparisons with traditional laxatives are significant concerns. Emerging therapies and adjunctive treatments offer promising results but require further validation through rigorous studies. Future research should focus on long-term outcomes, cost-effectiveness, and comparative effectiveness to better address the complex needs of patients with OIC and refine treatment protocols.

01 Sep 2024·The British Journal of Psychiatry

Association between a selective 5-HT₄ receptor agonist and incidence of major depressive disorder: emulated target trial

Article

Author: Cowen, Philip J ; Harrison, Paul J ; de Cates, Angharad N ; Harmer, Catherine J ; Emmanuel, Anton ; Murphy, Susannah E ; Travis, Simon ; Taquet, Maxime

BackgroundThe serotonin 4 receptor (5-HT4R) is a promising target for the treatment of depression. Highly selective 5-HT4R agonists, such as prucalopride, have antidepressant-like and procognitive effects in preclinical models, but their clinical effects are not yet established.AimsTo determine whether prucalopride (a 5-HT4R agonist and licensed treatment for constipation) is associated with reduced incidence of depression in individuals with no past history of mental illness, compared with anti-constipation agents with no effect on the central nervous system.MethodUsing anonymised routinely collected data from a large-scale USA electronic health records network, we conducted an emulated target trial comparing depression incidence over 1 year in individuals without prior diagnoses of major mental illness, who initiated treatment with prucalopride versus two alternative anti-constipation agents that act by different mechanisms (linaclotide and lubiprostone). Cohorts were matched for 121 covariates capturing sociodemographic factors, and historical and/or concurrent comorbidities and medications. The primary outcome was a first diagnosis of major depressive disorder (ICD-10 code F32) within 1 year of the index date. Robustness of the results to changes in model and population specification was tested. Secondary outcomes included a first diagnosis of six other neuropsychiatric disorders.ResultsTreatment with prucalopride was associated with significantly lower incidence of depression in the following year compared with linaclotide (hazard ratio 0.87, 95% CI 0.76–0.99; P = 0.038; n = 8572 in each matched cohort) and lubiprostone (hazard ratio 0.79, 95% CI 0.69–0.91; P < 0.001; n = 8281). Significantly lower risks of all mood disorders and psychosis were also observed. Results were similar across robustness analyses.ConclusionsThese findings support preclinical data and suggest a role for 5-HT4R agonists as novel agents in the prevention of major depression. These findings should stimulate randomised controlled trials to confirm if these agents can serve as a novel class of antidepressant within a clinical setting.

News (Medical) associated with Lubiprostone

26 Mar 2024

·www.prnewswire.com

Mallinckrodt plc Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Provides 2024 Guidance

Exceeds High End of Guidance Range on Net Sales and Adjusted EBITDA for Fiscal Year Received U.S. Food and Drug Administration (FDA) Approval of Supplemental New Drug Application for Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector (SelfJect) With Launch Planned for 2024 Accomplished Key Milestones in Specialty Brands in 2023, Including Successful Launch of Terlivaz® (terlipressin) and FDA Clearance of INOmax® EVOLVE™ DS Delivery System With Rollout in 2024 Appointed New Board Members With Expertise in Pharmaceuticals, Healthcare, Finance and Operations Provides 2024 Adjusted EBITDA Guidance of $520 Million to $560 Million DUBLIN, March 26, 2024 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported its financial results for the fourth quarter and fiscal year ended December 29, 2023.1 "We are pleased with the meaningful progress we made in 2023 as we exceeded the high end of our annual net sales and Adjusted EBITDA guidance, drove significant growth in Specialty Generics, achieved key milestones in Specialty Brands, and strengthened Mallinckrodt's financial foundation," said Siggi Olafsson, President and Chief Executive Officer. "As we entered 2024, we welcomed four experienced directors to our Board, reflecting our ongoing commitment to building a stronger Mallinckrodt for the benefit of our patients, customers, partners, employees and investors." Mr. Olafsson continued, "Ongoing growth in our Specialty Generics segment underscores the reliability and quality of our manufacturing and supply capabilities, the benefits of our vertically integrated manufacturing base and focused execution by our team. We expect strong performance to continue in the new year as we continue to meet market needs with accessible, high-quality medicines. In Specialty Brands, we are well-positioned to continue the momentum we achieved last year with the successful launch of Terlivaz, consistent growth in Therakos ® and signs of stabilization in Acthar Gel. With the FDA's clearance of our INOmax EVOLVE delivery system in December, we are pleased that the rollout of this innovative product in hospitals has begun. In addition, we were pleased to receive FDA approval of the Supplemental New Drug Application for SelfJect, which we plan to launch later this year. We are excited for the opportunities ahead as we continue advancing our strategic priorities and delivering for our patients." Fourth Quarter 2023 Financial Results Mallinckrodt's net sales in the fourth quarter of 2023 were $469.3 million, comprising $226.3 million in the Predecessor period and $243.0 million in the Successor period, as compared to $489.3 million in the fourth quarter of 2022. This reflects a decrease of 4.1% on a reported basis and 4.3% on a constant currency basis. The Company's Specialty Brands segment reported net sales of $270.7 million, comprising $130.9 million in the Predecessor period and $139.8 million in the Successor period, as compared to $320.7 million in the fourth quarter of 2022. The decreases of 15.6% on a reported basis and 15.8% on a constant currency basis are primarily due to the impact of competition, including the loss of exclusivity for Amitiza® in the U.S., and continued pressure on overall specialty pharmaceutical spending, partially offset by the launch of Terlivaz and return to growth of Therakos. Mallinckrodt's Specialty Generics segment reported net sales of $198.6 million, comprising $95.4 million in the Predecessor period and $103.2 million in the Successor period, as compared to $168.6 million in the fourth quarter of 2022, reflecting an increase of 17.8% on a reported and constant currency basis. This increase was primarily due to growth in finished-dosage products as the broader market experienced ongoing disruptions in product quality and supply. The Company's net income for the fourth quarter of 2023 was $1,052.4 million, comprising net income of $1,090.6 million in the Predecessor period offset by a net loss of $38.2 million in the Successor period, as compared to a net loss of $249.5 million in the fourth quarter of 2022. The increase was driven primarily by the reorganization impacts of the Chapter 11 and liabilities management processes, certain non-restructuring intangible asset impairments, and the application of fresh start accounting. Mallinckrodt's Adjusted EBITDA in the fourth quarter of 2023 was $123.8 million, comprising $55.5 million in the Predecessor period and $68.3 million in the Successor period, as compared to $175.5 million in the fourth quarter of 2022, a decrease of 29.5%. This decrease was primarily due to the impact of competition, including generic competition in the U.S. Amitiza market, and a shift in the Company's overall product mix as the Specialty Generics segment increased to approximately 42.3% of overall net sales in the fourth quarter of 2023 versus 34.5% of net sales in the fourth quarter of 2022. This was partially offset by strength in the Specialty Generics segment, growth in Therakos and the launch of Terlivaz. In addition, the Company continued to invest in the launch of Terlivaz, and included in Adjusted EBITDA are approximately $15 million of non-recurring compensation costs in the fourth quarter of 2023 and approximately $30 million of non-recurring compensation costs year-to-date related to the Company's Chapter 11 process. Adjusted gross profit as a percentage of sales was 62.3% for the fourth quarter of 2023, as compared to 65.9% for the fourth quarter of 2022. The decline in gross profit was primarily due to the Company's shift in overall product mix. Mallinckrodt's cash balance at the end of the fourth quarter of 2023 was $262.7 million. During the fourth quarter, Mallinckrodt repaid the outstanding principal amount of $100.0 million on its up to $200 million revolving accounts receivable financing facility, ending the quarter with approximately $460 million in liquidity including availability under that facility. Total principal debt outstanding at the end of the fourth quarter of 2023 was $1,647.8 million, with net debt of $1,385.1 million outstanding. Fiscal Year 2023 Results Mallinckrodt's net sales for fiscal 2023 were $1,865.9 million, comprising $1,622.9 million in the Predecessor period and $243.0 million in the Successor period, as compared to $1,914.3 million for fiscal 2022, comprising $874.6 million for the period January 1, 2022 through June 16, 2022 and $1,039.7 million for the period June 17, 2022 through December 30, 2022. The Company's net loss for fiscal 2023 was $1,669.5 million, comprising $1,631.3 million in the Predecessor period and $38.2 million in the Successor period, as compared to $911.2 million for fiscal 2022, comprising $313.1 million for the period January 1, 2022 through June 16, 2022 and $598.1 million for the period June 17, 2022 through December 30, 2022. Mallinckrodt's Adjusted EBITDA for fiscal 2023 was $571.9 million, comprising $503.6 million in the Predecessor period and $68.3 million in the Successor period. Fourth Quarter and Fiscal Year 2023 Business Segment Update Specialty Brands Segment Acthar Gel reported net sales of $104.4 million for the fourth quarter of 2023, comprising $47.4 million in the Predecessor period and $57.0 million in the Successor period. While fiscal 2023 net sales were slightly below guidance, fourth quarter net sales reflected positive momentum and underlying business strength, with improved performance in three out of five therapeutic areas versus the fourth quarter of 2022. In addition, the Company remains on track to launch SelfJect in the second half of 2024 following FDA approval. Mallinckrodt expects fiscal 2024 Acthar Gel net revenue to decline in the low single digits, compared with fiscal 2023. This represents significant progress toward net revenue stabilization for the brand. In addition, Mallinckrodt expects Acthar Gel net sales performance to improve over the course of fiscal 2024, as prescribing momentum within the category continues to grow. Terlivaz reported net sales of $5.6 million in the fourth quarter of 2023, comprising $3.3 million in the Predecessor period and $2.3 million in the Successor period, and $15.6 million in fiscal 2023, comprising $13.3 million in the Predecessor period and $2.3 million in the Successor period, reflecting a strong first full year of product launch as Mallinckrodt exceeded its formulary access targets. The Company received more than 200 formulary approvals during the year, setting a firm foundation for continued momentum as the product moves into its next phase. In fiscal 2024, the Company will continue to invest in marketing for Terlivaz to drive hospital adoption and early patient identification. INOmax (nitric oxide) gas sales grew outside of the U.S. in the fourth quarter of 2023, driven largely by volume growth in Japan, while persistent competitive pressures continued to impact U.S. sales. Mallinckrodt received FDA clearance of the INOmax EVOLVE DS Delivery System in the fourth quarter of 2023. The next-generation nitric oxide delivery system combines mini-cylinder technology, automation, integration and interaction into one device, representing an important contribution to serve the needs of NICU patients. The Company is focused on the rollout of this system, which is currently underway in select U.S. hospitals participating in the EVOLVE DS Pilot program, with wider rollout planned later this year. Therakos sales grew year over year for the third consecutive quarter, driven by strong performance in the U.S. and international markets. Therakos growth reflects the continued need for a safe and efficacious immunomodulatory therapy in an evolving market. Total product net sales for the fourth quarter of 2023 grew 14.8% on a reported basis and 13.5% on a constant currency basis, or $9.2 million, as compared to the fourth quarter of 2022. Mallinckrodt continues to expect the product to grow in the mid-single digits over the next several years. Specialty Generics Segment The Company delivered strong growth in its Specialty Generics segment in fiscal 2023 versus prior years, with year over year net sales growth of 20.5%. Performance was driven by the finished-dosage products business, manufacturing excellence in the Acetaminophen (APAP) business and three successful new product launches, including generic Mydayis® and generic Vyvanse® capsules for ADHD and morphine sulfate tablets. The business also gained regulatory approval in the fourth quarter of 2023 for a reformulation of the Company's fentanyl patch product, which it reintroduced to the market in multiple strengths in the first quarter of 2024. Mallinckrodt's Specialty Generics business will continue to be differentiated as a reliable, consistent supplier, creating stable pricing dynamics and a competitive advantage with customers amidst ongoing shortages and supply chain constraints. 2024 Financial Guidance For the full-year fiscal 2024, Mallinckrodt expects: The Company does not provide a reconciliation of forward-looking non-GAAP guidance to the comparable GAAP measures as these items are inherently uncertain and difficult to estimate and cannot be predicted without unreasonable effort. Please see the "Reconciliation of Non-GAAP Financial Guidance" included in this release for a reconciliation of GAAP and non-GAAP financial measures for the fourth quarter of 2023 and fiscal 2023. Board Updates On February 2, 2024, Mallinckrodt announced that Paul Bisaro has been reappointed to his previous role as Board Chair and Katina Dorton, Abbas Hussain and Wesley Wheeler have been appointed to the Company's Board of Directors, which now comprises seven directors. These new board members bring seasoned experience in pharmaceuticals, healthcare, finance and operations. For full biographies of each director, please visit . About Mallinckrodt Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The Company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit . Mallinckrodt 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. NON-GAAP FINANCIAL MEASURES This press release contains financial measures, including Adjusted EBITDA, adjusted gross profit, adjusted SG&A expenses, adjusted R&D expenses, and net sales growth (loss) on a constant-currency basis, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. Adjusted EBITDA represents net income or loss prepared in accordance with accounting principles generally accepted in the U.S. ("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 taxes; depreciation; amortization; restructuring charges, net; non-restructuring impairment charges; inventory step-up expense; discontinued operations; changes in fair value of contingent consideration obligations; significant legal and environmental charges; divestitures; liabilities management and separation costs; changes in fair value of derivative assets and liabilities; gains on debt extinguishment, net; unrealized gain or loss on equity investment; reorganization items, net; share-based compensation; fresh-start inventory related expenses; and other items identified by the Company. Adjusted gross profit, adjusted SG&A expenses and adjusted R&D expenses represent amounts prepared in accordance with GAAP, 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, the aforementioned items in the Adjusted EBITDA paragraph. The adjustments for these items are on a pre-tax basis for adjusted gross profit and adjusted SG&A expenses. Segment net sales growth (loss) on a constant-currency basis measures the change in segment net sales between current- and prior-year periods using a constant currency, the exchange rate in effect during the applicable prior-year period. The Company has provided these adjusted financial measures because they are used by management, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance. In addition, the Company believes that they will be used by investors to measure Mallinckrodt's operating results. Management believes that presenting these adjusted measures provides useful information about the Company's performance across reporting periods on a consistent basis by excluding items that the Company does not believe are indicative of its core operating performance. These adjusted measures should be considered supplemental to and not a substitute for financial information prepared in accordance with GAAP. The Company's definition of these adjusted measures may differ from similarly titled measures used by others. Because adjusted financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management strongly encourages investors to review the Company's unaudited condensed consolidated financial statements and publicly filed reports in their entirety. A reconciliation of certain of these historical adjusted financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release. Further information regarding non-GAAP financial measures can be found on the Investor Relations page of the Company's website. Predecessor and Successor Periods Mallinckrodt's financial results presented in this press release include Successor and Predecessor periods. The Company reports its results based on a "52-53 week" year ending on the last Friday of December. The period November 15, 2023 through December 29, 2023 reflects the Successor period, while the period December 31, 2022 through, and including, November 14, 2023 reflects the Predecessor period. The combined periods of December 31, 2022 through November 14, 2023 (Predecessor) and November 15, 2023 through December 29, 2023 (Successor) ("fiscal 2023") and the combined periods of January 1, 2022 through June 16, 2022 (Predecessor) and June 17, 2022 through December 30, 2022 (Predecessor) ("fiscal 2022") consisted of 52 weeks, while the fiscal year ended December 31, 2021 (Predecessor) ("fiscal 2021") consisted of 53 weeks. Upon emergence from Chapter 11 on each of November 14, 2023 (the "2023 Chapter 11 Cases") and June 16, 2022 (the "2020 Chapter 11 Cases"), we adopted fresh-start accounting in accordance with the provisions of Financial Accounting Standards Board Accounting Standards Codification Topic 852 - Reorganizations ("ASC 852"), and became a new entity for financial reporting purposes as of the effective dates of the 2023 and 2020 Chapter 11 Cases. References to "Successor" relate to the financial position as of December 29, 2023 and results of operations of the reorganized Company subsequent to November 14, 2023, while references to "Predecessor" relate to the financial position as of December 30, 2022 and results of operations of the Company for the period from December 31, 2022 through November 14, 2023, the period from June 17, 2022 through December 30, 2022, and for the periods prior to, and including June 16, 2022. All emergence-related transactions related to the effective dates of the 2023 and 2020 Chapter 11 Cases were recorded as of November 14, 2023 and June 16, 2022, respectively. Accordingly, the consolidated financial statements for the Successor are not comparable to the consolidated financial statements for the Predecessor periods and the consolidated financial statements for the combined predecessor period from June 17, 2022 through November 14, 2023 are not comparable to the consolidated financial statements for the predecessor period prior to, and including June 16, 2022. Mallinckrodt's results of operations as reported in its consolidated financial statements for the Successor and Predecessor periods are in accordance with GAAP. The comparison of the Predecessor and Successor periods for the periods presented herein is not in accordance with GAAP. However, the Company believes that the comparison is useful for management and investors to assess Mallinckrodt's ongoing financial and operational performance and trends. CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS Statements in this press release that are not strictly historical, including statements regarding future financial condition and operating results, expected product launches, legal, economic, business, competitive and/or regulatory factors affecting Mallinckrodt's businesses, the ongoing strategic review, and any other statements regarding events or developments Mallinckrodt 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. 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 effects of Mallinckrodt's recent emergence from bankruptcy; changes in Mallinckrodt's business strategy and performance; the uncertainties inherent in strategic review processes, and the challenges in effecting related transactions; Mallinckrodt's tax treatment by the Internal Revenue Service under Section 7874 and Section 382 of the Internal Revenue Code of 1986, as amended; Mallinckrodt's repurchases of debt securities; the liquidity, results of operations and businesses of Mallinckrodt and its subsidiaries; governmental investigations and inquiries, regulatory actions and lawsuits, in each case related to Mallinckrodt or its officers; historical commercialization of opioids, including 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 Mallinckrodt's suppliers, customers, employees and other third parties following emergence from the 2023 Chapter 11 Cases as well as perceptions of the Company's increased performance and credit risks associated with its constrained liquidity position and capital structure, which reflects a recently increased risk of additional bankruptcy or insolvency proceedings; the possibility that Mallinckrodt may be unable to achieve its business and strategic goals following emergence from the 2023 Chapter 11 Cases; the non-dischargeability of certain claims against Mallinckrodt as part of the bankruptcy process; developing, funding and executing Mallinckrodt's business plan and the Company's ability to continue as a going concern; Mallinckrodt's post-bankruptcy capital structure; scrutiny from governments, legislative bodies and enforcement agencies related to sales, marketing and pricing practices; pricing pressure on certain of Mallinckrodt'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; Mallinckrodt's and its partners' ability to successfully develop or commercialize new products or expand commercial opportunities; Mallinckrodt's ability to navigate price fluctuations; competition; Mallinckrodt's and its partners' ability to protect intellectual property rights, including in relation to ongoing litigation; limited clinical trial data for Acthar Gel; clinical studies and related regulatory processes; product liability losses and other litigation liability; material health, safety and environmental liabilities; business development activities; attraction and retention of key personnel following emergence from the 2023 Chapter 11 Cases; the effectiveness of information technology infrastructure including cybersecurity and data leakage risks; customer concentration; Mallinckrodt's reliance on certain individual products that are material to its financial performance; Mallinckrodt's ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration; complex manufacturing processes; reliance on third-party manufacturers and supply chain providers; conducting business internationally; Mallinckrodt's ability to achieve expected benefits from prior or future restructuring activities; Mallinckrodt's significant levels of intangible assets and related impairment testing; labor and employment laws and regulations; natural disasters or other catastrophic events; Mallinckrodt's substantial indebtedness, its ability to generate sufficient cash to reduce its indebtedness and its potential need and ability to incur further indebtedness; restrictions on Mallinckrodt's operations contained in the agreements governing Mallinckrodt's indebtedness; actions taken by third parties, including the Company's creditors and other stakeholders; Mallinckrodt's variable rate indebtedness; future changes to applicable tax laws or the impact of disputes with governmental tax authorities; and the impact of Irish laws. The "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended December 29, 2023, to be filed with the SEC, and its Quarterly Reports on Form 10-Q for the quarterly periods ended September 29, 2023, June 30, 2023 and March 31, 2023, and other filings with the SEC, all of which are on file with the SEC and available on Mallinckrodt's website at and , respectively, identify and describe in more detail the risks and uncertainties to which Mallinckrodt'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 Mallinckrodt 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 Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 [email protected] Media Michael Freitag / Aaron Palash / Aura Reinhard / Catherine Simon Joele Frank, Wilkinson Brimmer Katcher 212-355-4449 Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2024. Exhibit 99.1 SOURCE Mallinckrodt plc

Executive ChangeDrug ApprovalFinancial StatementBiosimilar

06 Mar 2024

·www.prnewswire.com

ENDO REPORTS FOURTH-QUARTER 2023 FINANCIAL RESULTS

DUBLIN, March 6, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) today reported financial results for the fourth-quarter ended December 31, 2023. __________ CONSOLIDATED FINANCIAL RESULTS Total revenues were $498 million in fourth-quarter 2023, a decrease of 10% compared to $556 million in fourth-quarter 2022. This decrease was primarily attributable to decreased revenues from the Generic Pharmaceuticals and Sterile Injectables segments, partially offset by increased revenues from the Branded Pharmaceuticals segment. Reported loss from continuing operations in fourth-quarter 2023 was $2,441 million compared to reported loss from continuing operations of $245 million in fourth-quarter 2022. This change was driven by adjustments to our estimated allowed claims, including with respect to certain litigation matters and debt obligations. The allowed claims will be reduced to reflect actual payments upon Chapter 11 emergence, which is expected to occur in second-quarter 2024. Adjusted income from continuing operations in fourth-quarter 2023 was $151 million compared to $190 million in fourth-quarter 2022. This change was primarily driven by decreased revenues. BRANDED PHARMACEUTICALS SEGMENT Fourth-quarter 2023 Branded Pharmaceuticals segment revenues were $246 million compared to $224 million during fourth-quarter 2022. Specialty Products revenues increased 16% to $188 million in fourth-quarter 2023 compared to $162 million in fourth-quarter 2022. This change was primarily due to an increase in XIAFLEX® revenues, partially offset by a decrease in SUPPRELIN® LA revenues mainly driven by lower volumes. Fourth-quarter 2023 XIAFLEX® revenues were $148 million, a 29% increase compared to fourth-quarter 2022 driven by increased net selling price and increased volumes. The increase in net selling price was primarily attributable to reversing approximately $14 million of reserves recorded during the first three quarters of 2023 following application of the final Inflation Reduction Act vial-wastage rebate determination. STERILE INJECTABLES SEGMENT Fourth-quarter 2023 Sterile Injectables segment revenues were $96 million, a decrease of 11% compared to $108 million during fourth-quarter 2022. This decrease was primarily attributable to competitive pressure on VASOSTRICT® and ADRENALIN®. GENERIC PHARMACEUTICALS SEGMENT Fourth-quarter 2023 Generic Pharmaceuticals segment revenues were $139 million, a decrease of 32% compared to $205 million during fourth-quarter 2022. This decrease was primarily attributable to competitive pressure on varenicline tablets, the generic version of Chantix®, and lubiprostone capsules, the authorized generic of Mallinckrodt's Amitiza®, partially offset by revenue from dexlansoprazole delayed release capsules, the generic version of Dexilant®, which launched during fourth-quarter 2022. INTERNATIONAL PHARMACEUTICALS SEGMENT Fourth-quarter 2023 International Pharmaceuticals segment revenues were $17 million, a decrease of 14% compared to $20 million during fourth-quarter 2022. This decrease was primarily attributable to competitive pressure on several products. 2024 FINANCIAL EXPECTATIONS Endo is providing financial guidance for the full-year ending December 31, 2024, which contemplates key uncertainties, including competitive assumptions related to VASOSTRICT® ready-to-use, ADRENALIN ® and generic Dexilant ® products. All financial expectations provided by Endo are forward-looking, and actual results may differ materially from such expectations, as further discussed below under the heading "Cautionary Note Regarding Forward-Looking Statements." CASH, CASH FLOW AND OTHER UPDATES As of December 31, 2023, the Company had approximately $778 million in unrestricted cash and cash equivalents. Fourth-quarter 2023 net cash provided by operating activities was approximately $115 million compared to approximately $110 million net cash provided by operating activities during fourth-quarter 2022. Amitiza® is a registered trademark of a Mallinckrodt company. Dexilant® is a registered trademark of Takeda Pharmaceutical U.S.A., Inc. Chantix® is a registered trademark of Pfizer Inc. __________ __________ SUPPLEMENTAL FINANCIAL INFORMATION To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial measures. For additional information on the Company's use of such non-GAAP financial measures, refer to Endo's Current Report on Form 8-K furnished today to the U.S. Securities and Exchange Commission, which includes an explanation of the Company's reasons for using non-GAAP measures. The tables below provide reconciliations of certain of the Company's non-GAAP financial measures to their most directly comparable GAAP amounts. Refer to the "Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures" section below for additional details regarding the adjustments to the non-GAAP financial measures detailed throughout this Supplemental Financial Information section. Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures Non-GAAP Financial Measures The Company utilizes certain financial measures that are not prescribed by or prepared in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP net income and its components and diluted net income per share amounts. Despite the importance of these measures to management in goal setting and performance measurement, the Company stresses that these are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. Because of the non-standardized definitions, non-GAAP adjusted EBITDA and non-GAAP adjusted net income from continuing operations and its components (unlike GAAP net income from continuing operations and its components) 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. Investors are encouraged to review the reconciliations of the non-GAAP financial measures used in this press release to their most directly comparable GAAP financial measures. However, the Company does not provide reconciliations of projected non-GAAP financial measures to GAAP financial measures, nor does it provide comparable projected GAAP financial measures for such projected non-GAAP financial measures. The Company is unable to provide such reconciliations without unreasonable efforts due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations, including adjustments that could be made for asset impairments, contingent consideration adjustments, legal settlements, gain / loss on extinguishment of debt, adjustments to inventory and other charges reflected in the reconciliation of historic numbers, the amounts of which could be significant. See Endo's Current Report on Form 8-K furnished today to the U.S. Securities and Exchange Commission for an explanation of Endo's non-GAAP financial measures. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation, including, but not limited to, statements with respect to financial guidance, expectations or outlook, bankruptcy court hearings or approvals, Chapter 11 emergence, and any other statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "outlook," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: the Company's restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the Company's strategy; risks and uncertainties associated with Chapter 11 proceedings; the negative impacts on the Company's businesses as a result of filing for and operating under Chapter 11 protection; the time, terms and ability to obtain approval and consummate the proposed Plan or Reorganization or a sale under Section 363 of the U.S. Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results while in Chapter 11 proceedings; the Company's ability to discharge claims in Chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in Chapter 11 proceedings; the Company's ability to conduct business as usual; the Company's ability to continue to serve customers, suppliers and other business partners at the high level of service and performance they have come to expect from the Company; the Company's ability to continue to pay employees, suppliers and vendors; the ability to control costs during Chapter 11 proceedings; adverse litigation; the risk that the Company's Chapter 11 Cases may be converted to cases under Chapter 7 of the Bankruptcy Code; the Company's ability to secure operating capital; the Company's ability to take advantage of opportunities to acquire assets with upside potential; the impact of competition and the timing of competitive entrants; the Company's ability to satisfy judgments or settlements or pursue appeals including bonding requirements; the Company's ability to adjust to changing market conditions; the Company's ability to attract and retain key personnel; supply chain interruptions or difficulties; changes in competitive or market conditions; changes in legislation or regulatory developments; the Company's ability to obtain and maintain adequate protection for intellectual property rights; the timing and uncertainty of the results of both the research and development and regulatory processes, including regulatory decisions, product recalls, withdrawals and other unusual items; domestic and foreign health care and cost containment reforms, including government pricing, tax and reimbursement policies; technological advances and patents obtained by competitors; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; the Company's ability to integrate any newly acquired products into its portfolio and achieve any financial or commercial expectations; the impact that known and unknown side effects may have on market perception and consumer preference for the Company's products; the effectiveness of advertising and other promotional campaigns; the timely and successful implementation of any strategic initiatives; unfavorable publicity regarding the misuse of opioids; the uncertainty associated with the identification of and successful consummation and execution of external corporate development initiatives and strategic partnering transactions; the Company's ability to advance its strategic priorities, develop its product pipeline and continue to develop the market for XIAFLEX® and other branded and unbranded products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. In addition, U.S. and international economic conditions, including consumer confidence and debt levels, inflation, taxation, changes in interest and currency exchange rates, international relations, capital and credit availability, the status of financial markets and institutions and the impact of continued economic volatility, can materially affect the Company's results. Therefore, the reader is cautioned not to rely on these forward-looking statements. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as public periodic filings with the U.S. Securities and Exchange Commission (the "SEC") and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the SEC. Copies of the Company's press releases and additional information about the Company are available at or you can contact the Endo Investor Relations Department at [email protected]. SOURCE Endo International plc SOURCE Endo International plc

Financial StatementBiosimilar

07 Nov 2023

·www.prnewswire.com

Mallinckrodt plc (in Examinership) Reports Third Quarter 2023 Financial Results

Third Quarter Net Sales of $497.0 Million Reflects 6.8% Growth Compared to the Prior Year Quarter Acthar® Gel (Repository Corticotropin Injection) Delivery Device Supplemental New Drug Application Accepted by U.S. Food and Drug Administration Financial Restructuring Plan Approved by U.S. Bankruptcy Court; Company Poised to Complete Irish Examinership and Emerge from Chapter 11 in the Near Term DUBLIN, Nov. 7, 2023 /PRNewswire/ -- Mallinckrodt plc (in examinership) (OTCMKTS: MNKTQ) ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported its financial results for the third quarter ended September 29, 2023. "Mallinckrodt's results underscore our relentless focus on stabilizing the business. While net loss increased, largely due to reorganization impacts, we achieved year-over-year revenue growth for the second consecutive quarter and year-over-year adjusted EBITDA growth. As a result of our continued commitment to executing on our strategic priorities and solid performance, we now expect to land near the top end of our prior full-year guidance ranges for both net sales and Adjusted EBITDA," said Siggi Olafsson, President and Chief Executive Officer. "Our Specialty Generics business continued to deliver strong growth, reflecting the core strength of our vertically integrated business. With three FDA abbreviated new drug application approvals this quarter, including lisdexamfetamine dimesylate capsules (generic form of Vyvanse®), we are proud of the role Mallinckrodt plays in addressing market supply shortages and delivering high-quality medicines that patients need. In Specialty Brands, we achieved a key regulatory milestone with FDA acceptance of our Acthar® Gel (repository corticotropin injection) delivery device Supplemental New Drug Application (sNDA) submission. Our launch and adoption of Terlivaz® (terlipressin) reflected further positive momentum in the medical community. While we continue to face headwinds from significant competitive pressures, our performance this quarter is another clear indicator of the tangible progress we have made." Mr. Olafsson continued, "The Chapter 11 proceedings we initiated in August will meaningfully enhance our financial foundation and better position the business for the future, and we are pleased the process is moving on an expedited basis, as anticipated. Our financial restructuring plan was approved by the U.S. Bankruptcy Court in early October, and we expect to complete the Examinership in Ireland and formally emerge from the restructuring process in the near term as a stronger organization." Third Quarter 2023 Financial Results Mallinckrodt's net sales in the third quarter of 2023 were $497.0 million, as compared to $465.4 million in the third quarter of 2022. This reflects an increase of 6.8% on a reported basis and 6.6% on a constant currency basis. The Company's Specialty Brands segment reported net sales of $286.2 million, as compared to $303.5 million in the prior year quarter, a decrease of 5.7% on a reported basis and 6.0% on a constant currency basis. This decline is primarily due to the impact of competition, including the loss of exclusivity for Amitiza® in the U.S., and continued pressure on overall specialty pharmaceutical spending. Mallinckrodt's Specialty Generics segment reported net sales of $210.8 million, as compared to $161.9 million in the prior year quarter, reflecting an increase of 30.2% on a reported and constant currency basis. This increase is primarily due to growth in finished-dosage products as the broader market has experienced disruption in product quality and supply, coupled with the successful launch of lisdexamfetamine dimesylate capsules, used to treat attention-deficit/hyperactivity disorder (ADHD). The Company recorded a net loss for the third quarter of $1,724.8 million, as compared to $284.9 million in the third quarter of 2022. This was driven primarily by the reorganization impacts of the Chapter 11 and liabilities management process and certain non-restructuring intangible asset impairments. Mallinckrodt's Adjusted EBITDA in the third quarter was $180.6 million, as compared to $166.1 million in the third quarter of 2022, an increase of 8.7%. This increase is primarily due to strength in the Specialty Generics segment, growth in Therakos ® and the launches of lisdexamfetamine dimesylate capsules and Terlivaz, partially offset by overall product mix. In addition, the Company continued to invest in the launch of Terlivaz, which was partially offset by other reductions in selling, general and administrative (SG&A) expenses and research and development (R&D) expenses as Mallinckrodt continues to improve its overall cost structure. The Company incurred approximately $7.0 million of incremental compensation costs in the third quarter, and approximately $15.0 million year to date, related to the Chapter 11 process, for which no adjustment was made to Adjusted EBITDA. The Company expects to incur an incremental $15.0 million of compensation costs through emergence. Adjusted gross profit as a percentage of sales was 66.3% for the third quarter of 2023, as compared to 66.2% for the third quarter of 2022. Nine -Month 2023 Results 1 Mallinckrodt's net sales were $1,396.6 million for the nine months ended September 29, 2023, as compared to $1,425.0 million for the nine months ended September 30, 2022, comprising $874.6 million in the predecessor period and $550.4 million in the successor period. The Company recorded a net loss of $2,721.9 million, as compared to $661.7 million for the nine months ended September 30, 2022, comprising $313.1 million in the predecessor period and $348.6 million in the successor period. Mallinckrodt's Adjusted EBITDA was $448.1 million, as compared to $499.4 million for the nine months ended September 30, 2022, comprising $303.0 million in the predecessor period and $196.4 million in the successor period. Third Quarter 2023 Business Segment Update Specialty Brands Segment Acthar Gel net sales declined 2.9% on a reported and constant currency basis, or $3.6 million, as compared to the comparable quarter of the prior year. Acthar Gel net sales improved sequentially, and the product continues to be a top choice for prescribers. In addition, Mallinckrodt's sNDA submission for its Acthar Gel delivery device was accepted by the FDA, and the Company remains focused on the launch of this innovation in the second half of 2024. Terlivaz's launch continued to exceed initial expectations and track ahead of the product's anticipated launch curve. The Company has gained formulary inclusion for Terlivaz at more than 200 hospitals and is pleased with the utilization seen to date. Mallinckrodt's success with this launch further demonstrates the strength of its engagements with hospitals and the broader medical community. INOmax® (nitric oxide) gas sales grew outside of the U.S., although sales in the U.S. continued to be impacted by competitive pressures. Mallinckrodt continues to anticipate receiving clearance for INOmax Evolve in late 2023. Therakos® sales grew year over year, driven by strength in the U.S. Total product net sales grew 13.8% on a reported basis and 11.6% on a constant currency basis, or $8.0 million, as compared to the comparable quarter of the prior year. In addition, the Company launched Therakos CELLEX® Photopheresis System in Japan at the beginning of the fourth quarter and is pleased with initial uptake. Mallinckrodt continues to believe the product will grow in the mid-single digits moving forward. Specialty Generics Segment Mallinckrodt's Specialty Generics segment experienced another quarter of strong growth, underscoring the benefits of vertical integration as the high performance of the Company's U.S.-based manufacturing plants supported market share gains in key product families. Beyond growing volumes and creating value realization opportunities, Mallinckrodt's ability to maintain consistent, stable supply of medicines helps serve a public health need amid ongoing shortages in the marketplace. The Company received FDA approvals for three products in the Specialty Generics segment during the quarter and successfully launched one, lisdexamfetamine dimesylate capsules. Mallinckrodt expects to launch the other two in the fourth quarter. 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 third 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 quarter ended September 29, 2023 to be filed with the Securities and Exchange Commission for additional information concerning the Company's Chapter 11 proceedings, liquidity and related risks. 2023 Financial Guidance Update For the full-year 2023, Mallinckrodt expects to be near the top end of the guidance ranges for both net sales and Adjusted EBITDA, even while assuming approximately $30 million of incremental bankruptcy-related compensation costs for key employee incentive and retention programs through emergence. The Company is also narrowing the range of its 2023 net sales expectations for Acthar Gel and now expects the product to decline by approximately 15% for the fiscal year. The Company does not provide a reconciliation of forward-looking non-GAAP guidance to the comparable GAAP measures as these items are inherently uncertain and difficult to estimate and cannot be predicted without unreasonable effort. About Mallinckrodt Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The Company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit . Mallinckrodt 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. NON-GAAP FINANCIAL MEASURES This press release contains financial measures, including adjusted EBITDA, adjusted gross profit, adjusted SG&A expenses, adjusted R&D expenses, and net sales growth (loss) on a constant-currency basis, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. Adjusted EBITDA represents net income or loss prepared in accordance with accounting principles generally accepted in the U.S. ("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 taxes; depreciation; amortization; restructuring charges, net; non-restructuring impairment charges; inventory step-up expense; discontinued operations; changes in fair value of contingent consideration obligations; significant legal and environmental charges; divestitures; liabilities management and separation costs; gains on debt extinguishment, net; unrealized gain or loss on equity investment; reorganization items, net; share-based compensation; fresh-start inventory related expenses; and other items identified by the Company. Adjusted gross profit, adjusted SG&A expenses and adjusted R&D expenses represent amounts prepared in accordance with GAAP, 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, the aforementioned items in the Adjusted EBITDA paragraph. The adjustments for these items are on a pre-tax basis for adjusted gross profit and adjusted SG&A expenses. Segment net sales growth (loss) on a constant-currency basis measures the change in segment net sales between current- and prior-year periods using a constant currency, the exchange rate in effect during the applicable prior-year period. The Company has provided these adjusted financial measures because they are used by management, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance. In addition, the Company believes that they will be used by investors to measure Mallinckrodt's operating results. Management believes that presenting these adjusted measures provides useful information about the Company's performance across reporting periods on a consistent basis by excluding items that the Company does not believe are indicative of its core operating performance. These adjusted measures should be considered supplemental to and not a substitute for financial information prepared in accordance with GAAP. The Company's definition of these adjusted measures may differ from similarly titled measures used by others. Because adjusted financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management strongly encourages investors to review the Company's unaudited condensed consolidated financial statements and publicly filed reports in their entirety. A reconciliation of certain of these historical adjusted financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release. Further information regarding non-GAAP financial measures can be found on the Investor Relations page of the Company's website. Predecessor and Successor Periods Mallinckrodt's financial results presented in this press release include Successor and Predecessor periods. The Successor period runs from June 17, 2022 through September 29, 2023, while the Predecessor period includes June 16, 2022 and prior. As a result of the application of fresh-start accounting, the Company's financial statements for periods prior to June 16, 2022 are not comparable to those for periods subsequent to June 16, 2022. Operating results for the Successor and Predecessor periods are not necessarily indicative of the results to be expected for a full fiscal year. Mallinckrodt's results of operations as reported in its unaudited condensed consolidated financial statements for the Successor and Predecessor periods are in accordance with GAAP. The comparison of the Predecessor and Successor periods for the periods presented here is not in accordance with GAAP. However, the Company believes that the comparison is useful for management and investors to assess Mallinckrodt's ongoing financial and operational performance and trends. CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS Statements in this document that are not strictly historical, including statements regarding future financial condition and operating results, expected product launches, legal, economic, business, competitive and/or regulatory factors affecting Mallinckrodt's businesses, and any other statements regarding events or developments Mallinckrodt 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. 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 ability of Mallinckrodt and its subsidiaries to obtain approval from the U.S. Bankruptcy Court (the "Bankruptcy Court") with respect to motions or other requests made to the Bankruptcy Court throughout the course of the Chapter 11 Cases (the "2023 Chapter 11 Cases") initiated on August 28, 2023 by Mallinckrodt and certain of its subsidiaries (collectively, the "2023 Debtors"); the ability of Mallinckrodt and its subsidiaries to consummate the Chapter 11 plan of reorganization (as may be amended or supplemented from time to time in accordance with its terms, the "2023 Plan") and emerge from Chapter 11 within its currently expected timeline or at all; the effects of the 2023 Chapter 11 Cases, including increased professional costs, on Mallinckrodt's liquidity, results of operations and businesses; the ability of the 2023 Debtors to operate their business during the pendency of the 2023 Chapter 11 Cases; the consummation of the transactions contemplated by the restructuring support agreement dated as of August 23, 2023, by and among the Company, certain of its subsidiaries, certain creditors and the Opioid Master Disbursement Trust II (the "RSA"), and the 2023 Plan, including the ability of the parties to negotiate definitive agreements with respect to the matters covered by the term sheets included in the RSA, the 2023 Plan or otherwise, the occurrence of events that may give rise to a right of any of the parties to terminate the RSA, and the ability of the parties thereto to satisfy the other conditions of the RSA or the 2023 Plan, as applicable, including satisfying the milestones specified in the RSA and completion of the Irish Examinership Proceedings; the comparability of Mallinckrodt's post-emergence financial results to its historical results and the projections filed with the Bankruptcy Court; changes in Mallinckrodt's business strategy and performance; Mallinckrodt's tax treatment by the Internal Revenue Service under Section 7874 and Section 382 of the Internal Revenue Code of 1986, as amended; Mallinckrodt's repurchases of debt securities; the effects of the emergence from the 2023 Chapter 11 Cases on the Company's liquidity; the liquidity, results of operations and businesses of Mallinckrodt and its subsidiaries; governmental investigations and inquiries, regulatory actions and lawsuits, in each case related to Mallinckrodt or its officers; historical commercialization of opioids, including 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 Mallinckrodt's suppliers, customers, employees and other third parties as a result of, and following, the emergence upon completion of the 2023 Chapter 11 Cases as well as perceptions of the Company's increased performance and credit risks associated with its constrained liquidity position and capital structure, which reflects a recently increased risk of additional bankruptcy or insolvency proceedings; the possibility that Mallinckrodt may be unable to achieve its business and strategic goals even after the 2023 Plan is successfully consummated; the non-dischargeability of certain claims against Mallinckrodt as part of the bankruptcy process; developing, funding and executing Mallinckrodt's business plan and the Company's ability to continue as a going concern; Mallinckrodt's post-bankruptcy capital structure upon completion of the 2023 Chapter 11 Cases; scrutiny from governments, legislative bodies and enforcement agencies related to sales, marketing and pricing practices; pricing pressure on certain of Mallinckrodt'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; Mallinckrodt's and its partners' ability to successfully develop or commercialize new products or expand commercial opportunities; Mallinckrodt's ability to navigate price fluctuations; competition; Mallinckrodt's and its partners' ability to protect intellectual property rights, including in relation to ongoing litigation; limited clinical trial data for Acthar Gel; clinical studies and related regulatory processes; product liability losses and other litigation liability; material health, safety and environmental liabilities; business development activities; attraction and retention of key personnel in light of the 2023 Chapter 11 Cases; the effectiveness of information technology infrastructure including cybersecurity and data leakage risks; customer concentration; Mallinckrodt's reliance on certain individual products that are material to its financial performance; Mallinckrodt's ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration; complex manufacturing processes; reliance on third-party manufacturers and supply chain providers; conducting business internationally; Mallinckrodt's ability to achieve expected benefits from prior or future restructuring activities; Mallinckrodt's significant levels of intangible assets and related impairment testing; labor and employment laws and regulations; natural disasters or other catastrophic events; Mallinckrodt's substantial indebtedness, its ability to generate sufficient cash to reduce its indebtedness and its potential need and ability to incur further indebtedness; restrictions on Mallinckrodt's operations contained in the agreements governing Mallinckrodt's indebtedness; actions taken by third parties, including the Company's creditors, the Trust and other stakeholders; Mallinckrodt's variable rate indebtedness; future changes to applicable tax laws or the impact of disputes with governmental tax authorities; and the impact of Irish laws. The "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended December 30, 2022 and Quarterly Reports on Form 10-Q for the quarterly periods ended September 29, 2023, June 30, 2023 and March 31, 2023, and other filings with the SEC, all of which are on file with the SEC and available on Mallinckrodt's website at and respectively, identify and describe in more detail the risks and uncertainties to which Mallinckrodt'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 Mallinckrodt 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 Investor Relations Daniel Speciale Senior Vice President, Finance 314-654-3638 [email protected] Derek Belz Vice President, Investor Relations 314-654-3950 [email protected] Media Michael Freitag / Aaron Palash / Aura Reinhard / Catherine Simon Joele Frank, Wilkinson Brimmer Katcher 212-355-4449 Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2023. Exhibit 99.1 SOURCE Mallinckrodt plc

Financial StatementDrug ApprovalBiosimilar

100 Deals associated with Lubiprostone

External Link

KEGG	Wiki	ATC	Drug Bank
D04790	Lubiprostone	A06AX03	DB01046

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Opioid-Induced Constipation	US	Sucampo Pharma Americas LLC	19 Apr 2013
Chronic constipation	JP	Mylan LLC	29 Jun 2012
Chronic constipation	JP	Viatris Pharmaceutical GK	29 Jun 2012
Irritable bowel syndrome with constipation	US	Sucampo Pharma Americas LLC	29 Apr 2008
Chronic idiopathic constipation	US	Sucampo Pharma Americas LLC	31 Jan 2006

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic idiopathic constipation	Phase 2	KR	Takeda Pharmaceuticals Korea Co. Ltd.	17 May 2019
Chronic constipation	Phase 2	US	Takeda Pharmaceuticals U.S.A., Inc.	01 Jun 2012
Opioid-Induced Bowel Dysfunction	Phase 2	CA	Sucampo Pharma Americas LLC	01 Aug 2007
Opioid-Induced Bowel Dysfunction	Phase 2	US	Sucampo Pharma Americas LLC	01 Aug 2007
Constipation	Phase 2	-	Takeda Pharmaceutical Co., Ltd.	01 May 2005
Constipation	Phase 2	-	Sucampo Pharma Americas LLC	01 May 2005
Irritable bowel syndrome with constipation	Phase 2	-	Sucampo Pharma Americas LLC	01 May 2005
Irritable bowel syndrome with constipation	Phase 2	-	Takeda Pharmaceutical Co., Ltd.	01 May 2005

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW	Not Applicable	-	277	Lubiprostone	(uuinbogtgf) = szfwuacusc mnfctehiis (gimkptxkjg, 0.99)	Positive	15 Oct 2023
				Control (Bisacodyl, lactulose, or Sodium Picosulfate)	(uuinbogtgf) = aactwbahlo mnfctehiis (gimkptxkjg, 1.04)
NCT00645801 (PEG, CTgov)	Phase 4	-	158	lubiprostone (Amitiza) (Ingested 4 Tablets of Lubiprostone in Divided Doses + 1 Gallon of Polyethylene Glycol)	jnbjzcmcqt(ydcklyljfl) = cmpwhklmkt dhrtgdjlca (iqidtcsocg, jzqsplyxiu - laxozpapvw) View more	-	01 Jun 2023
				Placebo (Ingested 4 Tablets of Placebo in Divided Doses + 1 Gallon of Polyethylene Glycol)	jnbjzcmcqt(ydcklyljfl) = dcxzfanlrx dhrtgdjlca (iqidtcsocg, brafizeofr - xbfdkirlgq) View more
NCT02766777 (Pubmed) Manual	Phase 3	Constipation - functional	87	lubiprostone (12 mcg)	(rjzprmbmkr) = TEAEs were mostly mild in intensity, with gastrointestinal disorders (diarrhea, vomiting) most frequently reported. pkxdkgfqcg (bztntjocwl )	Positive	01 Nov 2021
				lubiprostone (24 mcg)
NCT02138136 (Pubmed \| Clin Gastroenterol Hepatol) Manual	Phase 3	Constipation - functional	606	Lubiprostone	(jmspfcqbxq) = oegwteohra maxyztjvaf (mhxhyivoso )	Negative	07 Apr 2021
				Placebo	(jmspfcqbxq) = sksjzvrltm maxyztjvaf (mhxhyivoso )
NCT01096290 (CTgov)	Phase 4	Constipation	23	lubiprostone (Lubiprostone 24mcg BID for 30 Days)	fvzdarjumw(qszwkqepid) = dgoefjndfp zprdaopxsb (tvgilkewgx, uzjwbumkqm - yaasewrczf) View more	-	09 Sep 2020
				Matched placebo (Placebo)	fvzdarjumw(qszwkqepid) = hszxoqfayg zprdaopxsb (tvgilkewgx, aophykeyyw - fohjbriyka) View more
NCT02042183 (CTgov)	Phase 3	Constipation - functional	606	Lubiprostone (Lubiprostone)	qtrpwwwxeq(ssdwbcvvir) = dtfkmxvlzz vjodnhdjyx (wdxlnukrju, wcsxuzpclz - plporfdsur) View more	-	21 Jul 2020
				Placebo (Placebo)	qtrpwwwxeq(ssdwbcvvir) = agoqmcnfmx vjodnhdjyx (wdxlnukrju, eznbtipvaz - ijgckvhpfi) View more
NCT02766777 (CTgov)	Phase 3	Constipation - functional	87	Lubiprostone	qcamzoxvua(fznapmwhdj) = uhtxzuvfbl irsxkqzypz (cnabzdnspg, hlmmvimbtx - gphjbqompr) View more	-	15 May 2020
NCT02138136 (CTgov)	Phase 3	Constipation - functional	419	lubiprostone	bzqqalecdd(abfbzctdox) = yskotwviyr ttldtxznwy (qjjxulspnh, zaohbkfxgy - pniqtxqvdl) View more	-	21 Jan 2020
NCT03097861 (CTgov)	Phase 3	Chronic idiopathic constipation	552	Placebo (Placebo)	qdzmbzahqp(crqdjrrbho) = opoogsgstf yvesrancie (klirqhrbjx, gpniiimtpf - afjppoqwei) View more	-	14 Jan 2020
				Lubiprostone (Lubiprostone Sprinkle)	qdzmbzahqp(crqdjrrbho) = srpciaowqf yvesrancie (klirqhrbjx, nukahruonk - gfsmqcfesd) View more
NCT00620061 (CTgov)	Phase 3	Opioid-Induced Bowel Dysfunction	439	Lubiprostone 24	uczognousp(sdrucjnfor) = ushuyrlwds ltscpvuqzi (mjveglfxth, bxgjkfelpq - kqbmuiboor) View more	-	30 Dec 2019

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis