Mallinckrodt PLC

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Mallinckrodt Plc engages in the development, manufacture, market, adn distribution of both branded and generic specialty pharmaceutical products and medical imaging agents. It operates through the Specialty Brands and Specialty Generics segments. The Specialty Brands segment includes innovative specialty pharmaceutical brands. The Specialty Generics segment relates to niche specialty generic drugs and active pharmaceutical ingredients. The company was founded by Gustavo Mallinckrodt, Otto Mallinckrodt and Edward Mallinckrodt in 1867 and is headquartered in Blanchardstown, Dublin.

NEW YORK & RARITAN, N.J. & DUBLIN--(BUSINESS WIRE)--CVC, a leading global private markets manager, today completed the previously announced acquisition of the Therakos business from Mallinckrodt plc (“Mallinckrodt”), a global specialty pharmaceutical company. The investment in Therakos from CVC Capital Partners Fund IX will provide the resources and expertise to further develop the business and its services which improve the lives of patients. Therakos is the leading company in Extracorporeal P.

CVC Completes Acquisition of Therakos from Mallinckrodt

Net Proceeds to Reduce the Company's Net Debt by More Than 60% DUBLIN , Dec. 2, 2024 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today announced that it has completed the previously announced sale of its Therakos business to CVC Capital Partners Fund IX for a purchase price of $925 million before customary adjustments. Siggi Olafsson, President and Chief Executive Officer, said, "We are pleased to complete this transaction, which provides Therakos with an ideal partner to invest in its continued growth and advances our strategic priorities to optimize our capital structure and concentrate on our key strengths and capabilities.

Mallinckrodt Completes Divestiture of Therakos® Business

– Poster evaluates potential impact of waiting until Day 4 (and after 12 doses of TERLIVAZ) before assessing outcomes in adult patients with HRS with rapid reduction in kidney function1 – DUBLIN , Nov. 18, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced a poster presentation on TERLIVAZ® (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), taking place in San Diego, CA, from November 15-19, 2024. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2 HRS involving rapid reduction in kidney function1 is estimated to affect more than 42,000 Americans annually, approximately 0.01% of the U.S. population,3 making it a very rare condition; and rates of hospitalizations are increasing.4 Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.

Mallinckrodt Presents Data on TERLIVAZ® (terlipressin) for Injection in Patients with Hepatorenal Syndrome (HRS) at the 2024 American Association for the Study of Liver Diseases (AASLD) Annual Meeting

DUBLIN , Nov. 14, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced that Siggi Olafsson, President and Chief Executive Officer, will present at Jefferies London Healthcare Conference on Tuesday, November 19, 2024 at 9:30 a.m. GMT/4:30 a.m.

Mallinckrodt to Present at Jefferies London Healthcare Conference

Achieves Third Quarter Net Sales of $505.5 Million, Reflecting 1.7% Year-Over-Year Growth Reaffirms Full Year Net Sales Guidance and Raises Full Year Adjusted EBITDA Guidance After Adjusting Both Metrics for the Therakos Transaction Delivers Third Consecutive Quarter of Acthar® Gel Growth, Underscoring Increase in Patient and Prescriber Demand; Expects Brand to Grow Approximately 10% in Full Year 2024 Successfully Launched Acthar Gel SelfJect™ Device and Expanded the Rollout of INOmax ® EVOLVE™ DS Delivery System to U.S. Hospitals Nationwide Specialty Generics Segment Maintains Momentum with Seventh Consecutive Quarter of Year-Over-Year Growth Net Proceeds from Sale of Therakos ® Business Expected to Reduce Net Debt by More Than 60% in the Fourth Quarter DUBLIN , Nov. 5, 2024 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported its financial results for the third quarter ended September 27, 2024.1 "Our third quarter results demonstrate the successful execution of our strategy to stabilize the base business and position Mallinckrodt for long-term growth. We are pleased to reaffirm our full year net sales guidance and again raise our Adjusted EBITDA guidance, even after adjusting for the Therakos transaction," said Siggi Olafsson, President and Chief Executive Officer.

Mallinckrodt plc Reports Third Quarter 2024 Financial Results and Raises Full Year Guidance

– Four posters highlight TERLIVAZ research on the potential impact of dosing and outcomes in key subpopulations of adults with HRS with rapid reduction in kidney function 1  – DUBLIN , Oct. 30, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the presentation of four posters on TERLIVAZ® (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) taking place in San Diego from November 15-19, 2024. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2 HRS involving rapid reduction in kidney function1 is estimated to affect more than 42,000 Americans annually, approximately 0.01% of the U.S. population,3 making it a very rare condition; and rates of hospitalizations are increasing.4 Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection at the 2024 American Association for the Study of Liver Diseases (AASLD) Annual Meeting

– Evaluation of real-world trends and outcomes in hospitalized U.S. HRS-AKI patients treated with TERLIVAZ – DUBLIN , Oct. 29, 2024 /PRNewswire/ --  Mallinckrodt plc, a global specialty pharmaceutical company, today announced a poster presentation on TERLIVAZ® (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 at the annual meeting of the American College of Gastroenterology (ACG), taking place in Philadelphia from October 25-30, 2024. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2 HRS involving rapid reduction in kidney function1 is estimated to affect more than 42,000 Americans annually, approximately 0.01% of the U.S. population,3 making it a very rare condition; and rates of hospitalizations are increasing.4 Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.

Mallinckrodt Presents Data on TERLIVAZ® (terlipressin) for Injection in Patients with Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI) at the American College of Gastroenterology (ACG) Annual Meeting

– Pooled analysis from Phase 3 clinical trials highlights liver transplant rates in adult patients with HRS with rapid reduction in kidney function treated with TERLIVAZ 1  – DUBLIN , Oct. 26, 2024 /PRNewswire/ --  Mallinckrodt plc, a global specialty pharmaceutical company, today announced a poster presentation on TERLIVAZ® (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 at Kidney Week 2024, the annual meeting of the American Society of Nephrology (ASN) taking place in San Diego from October 23-27, 2024. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2 HRS involving rapid reduction in kidney function1 is estimated to affect more than 42,000 Americans annually, approximately 0.01% of the U.S. population,3 making it a very rare condition; and rates of hospitalizations are increasing.4 Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.

Mallinckrodt Presents Data on TERLIVAZ® (terlipressin) for Injection in Patients with Hepatorenal Syndrome (HRS) at Kidney Week 2024

DUBLIN , Oct. 24, 2024 /PRNewswire/ -- Mallinckrodt plc  ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today announced that it will report third quarter 2024 earnings results for the period ended September 27, 2024, on Tuesday, November 5, 2024.  A conference call for investors will begin at 8:30 a.m.

Mallinckrodt to Report Earnings Results for Third Quarter 2024

–  The INOmax EVOLVE DS is our next-generation nitric oxide delivery system that combines mini-cylinder technology, automation, integration, and interaction into one device1 – – The INOmax EVOLVE DS is now available for contracting and distribution for use in U.S. hospitals – DUBLIN , Oct. 10, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the rollout of the U.S. Food and Drug Administration (FDA) cleared INOmax® EVOLVE™ DS delivery system for the delivery of INOmax® (nitric oxide) gas, for inhalation. This nationwide rollout follows the successful introduction of the INOmax EVOLVE DS Pilot program.

Mallinckrodt Announces an Expanded Rollout of the INOmax® EVOLVE™ DS Delivery System in U.S. Hospitals

– Findings from nine human factors studies, assessing design and user interface, suggest SelfJect functions as an effective delivery device when used as intended1 – – The SelfJect delivery device received the Arthritis Foundation's Ease of Use certification –  DUBLIN , Sept. 17, 2024 /PRNewswire/ --  Mallinckrodt plc, a global specialty pharmaceutical company, today announced the publication of findings from seven formative and two validation human factors studies of recently launched Acthar Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector ("SelfJect").2 The manuscript, describing the formative and human factor outcomes, was recently published online in Expert Opinion on Drug Delivery.

Mallinckrodt Announces Publication of Human Factors Studies and Arthritis Foundation Ease of Use® Certification of Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector

Achieves Second Quarter Net Sales of $514.3 Million, Reflecting 8.3% Year-Over-Year Growth on a Reported Basis and 8.4% on a Constant Currency Basis Reports Net Loss of $43.3 Million, Reflecting a 94.2% Year-Over-Year Improvement; Delivers Adjusted EBITDA of $174.0 Million, Reflecting 20.8% Year-Over-Year Growth Raises Full Year Net Sales Guidance Range to $1.9 Billion to $2.0 Billion and  Adjusted EBITDA Guidance Range to $585 Million to $615 Million Launches Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector Reached Agreement to Sell Therakos ® Business for $925 Million; Net Proceeds to Reduce Net Debt by More Than 50% DUBLIN , Aug. 6, 2024 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported its financial results for the second quarter ended June 28, 2024.1 "Our second quarter results reflect continued positive momentum across the business as we again delivered net sales and Adjusted EBITDA growth and achieved meaningful milestones," said Siggi Olafsson, President and Chief Executive Officer. "In Specialty Generics, we reported our sixth consecutive quarter of double-digit net sales growth, driven by our relentless focus on consistently delivering high-quality products in a marketplace facing persistent and ongoing disruptions.

Mallinckrodt plc Reports Second Quarter 2024 Financial Results and Raises Full Year Guidance

– Acthar Gel is the first and only medication in its class of adrenocorticotropic hormone products available in a self-injection device to treat a range of chronic and acute inflammatory and autoimmune conditions1 – DUBLIN , Aug. 6, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the availability of the Acthar Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector (herein referred to as "SelfJect"), offering a new administration option for Acthar Gel for appropriate patients with a range of chronic and acute inflammatory and autoimmune conditions.1 The U.S. Food and Drug Administration (FDA) previously approved Mallinckrodt's supplemental New Drug Application (sNDA) for SelfJect in February 2024. Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9111652-mallinckrodt-selfject-launch/ Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone (ACTH) analogs and other pituitary peptides.1 Acthar Gel is approved by the FDA for the treatment of several autoimmune disorders and medical conditions known to cause inflammation.1 Please see Indications and Important Safety Information for Acthar Gel below.

Mallinckrodt Announces Availability of Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector in the U.S.

Divestiture Advances Mallinckrodt's Strategic Priorities to Optimize Capital Structure and Focus on Core Areas of Expertise Mallinckrodt to Use Net Proceeds to Reduce Net Debt by More Than 50% CVC Brings Resources and Expertise to Further Develop and Commercialize Therakos DUBLIN and LUXEMBOURG , Aug. 5, 2024 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, and CVC Capital Partners ("CVC"), one of the world's leading investment firms, today announced that they have entered into a definitive agreement1 under which CVC Capital Partners Fund IX will acquire the Company's Therakos business for a purchase price of $925 million, subject to customary adjustments. Therakos is a fully integrated extracorporeal photopheresis (ECP) delivery system for autologous immunomodulatory therapy.

Mallinckrodt Reaches Agreement to Sell Therakos® Business to CVC for $925 Million

DUBLIN , Aug. 1, 2024 /PRNewswire/ -- Mallinckrodt plc  ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today announced that it will report second quarter 2024 earnings results for the period ended June 28, 2024, on Tuesday, August 6, 2024.  A conference call for investors will begin at 8:30 a.m.

Mallinckrodt to Report Earnings Results for Second Quarter 2024

– Three posters highlight  research on outcomes of TERLIVAZ treatment in key subpopulations of adults with HRS with rapid reduction in kidney function1 – DUBLIN , June 5, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the presentation of three posters on TERLIVAZ® (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 at the 2024 European Association for the Study of the Liver (EASL) Congress taking place in Milan, Italy from June 5-8, 2024. The posters include a retrospective chart review that examined the potential relationship of serum creatinine (SCr) levels and treatment outcomes in support of earlier diagnosis;2 data analyzing clinical response to TERLIVAZ in HRS patients with a mean arterial pressure (MAP) of

Mallinckrodt Presents Data on TERLIVAZ® (terlipressin) for Injection in Patients with Hepatorenal Syndrome (HRS) at the 2024 European Association for the Study of the Liver (EASL) Congress

– Two poster presentations of Mallinckrodt's research for adults with HRS with rapid reduction in kidney function1 provide further insight into treatment with TERLIVAZ for appropriate patients – DUBLIN, May 18, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the presentation of two posters on TERLIVAZ® (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 at the 2024 Digestive Disease Week® (DDW) taking place in Washington, DC from May 18-21, 2024. The posters feature a post-hoc analysis of data from the pivotal Phase III CONFIRM trial, analyzing the impact of dose interruptions on treatment response to TERLIVAZ in patients with hepatorenal syndrome-acute kidney injury (HRS-AKI),2 and a pooled analysis of three Phase III clinical studies assessing the impact of TERLIVAZ treatment on patients with HRS and a baseline serum creatinine (SCr)

Mallinckrodt Presents Data on TERLIVAZ® (terlipressin) for Injection in Patients with Hepatorenal Syndrome (HRS) at the 2024 Digestive Disease Week® (DDW)

Achieves First Quarter Net Sales of $467.8 Million, Reflecting 10.2% Year-Over-Year Growth on a Reported and  Constant Currency Basis Reports Net Loss of $65.4 Million, Reflecting a 73.8% Year-Over-Year Improvement; Delivers Adjusted EBITDA of $144.9 Million, Reflecting 17.3% Year-Over-Year Growth Initiated Rollout of INOmax ®  EVOLVE™ DS Delivery System in Select Hospital Systems Anticipates Launch of Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector (SelfJect) in Third Quarter of 2024 DUBLIN , May 9, 2024 /PRNewswire/ -- Mallinckrodt plc  ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported its financial results for the first quarter ended March 29, 2024.1 "Mallinckrodt had a strong start to the year, delivering year-over-year growth in both net sales and Adjusted EBITDA as we continued to advance our key business priorities," said Siggi Olafsson, President and Chief Executive Officer. "In Specialty Brands, we achieved net sales growth, driven by increasing Acthar Gel sales as demand continued to stabilize and by meaningful progress in our ongoing launch of Terlivaz®, which is now focused on appropriate early patient identification and further adoption.

Mallinckrodt plc Reports First Quarter 2024 Financial Results and Reaffirms Full Year 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.

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

DUBLIN , March 4, 2024 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today announced that Paul O'Neill has been appointed Executive Vice President, Quality & Operations, Specialty Brands, effective immediately. Mr. O'Neill previously served as the Company's Senior Vice President, Quality & Operations, Specialty Brands.

Mallinckrodt Announces Appointment of Paul O'Neill as Executive Vice President, Quality & Operations, Specialty Brands

– Acthar Gel Single-Dose Pre-filled SelfJect Injector is a self-controlled, pre-filled delivery device1 for appropriate patients with a range of chronic and acute inflammatory and autoimmune conditions2 – – This first-in-class delivery device reduces the steps required for patients and caregivers to administer Acthar Gel treatment1 and underscores Mallinckrodt's mission by advancing Acthar Gel therapeutic modernization efforts to address patient needs – – Acthar Gel Single-Dose Pre-filled SelfJect Injector is expected to launch in the U.S. in the second half of 2024 – DUBLIN , March 1, 2024 /PRNewswire/ --  Mallinckrodt plc, a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Mallinckrodt's supplemental New Drug Application (sNDA) for the Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector (herein referred to as "SelfJect"), a new delivery device for Acthar Gel for appropriate patients with a range of chronic and acute inflammatory and autoimmune conditions.2 SelfJect is intended to provide the appropriate subcutaneous dose of Acthar Gel, as prescribed by a healthcare professional, and is designed to help give patients control of their administration.1,3 Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides.2 Acthar Gel is approved by the U.S. FDA for the treatment of several autoimmune disorders and medical conditions known to cause inflammation.2  Please see Indications and Important Safety Information for Acthar Gel below. "We're excited to bring this innovation to U.S. patients with chronic and acute inflammatory and autoimmune conditions.

Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector

Four Directors Added to Board Bring Seasoned Experience in Pharmaceuticals, Healthcare, Finance and Operations Paul Bisaro Returns as Board Chair Siggi Olafsson Will Continue as President, CEO and Board Member DUBLIN , Feb. 2, 2024 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today announced the appointments of Paul Bisaro , Katina Dorton, Abbas Hussain and Wesley Wheeler to its Board of Directors, effective immediately. Mr. Bisaro has also been reappointed to his previous role as Board Chair.

Mallinckrodt Announces Board of Directors and Leadership Updates

– Oral presentation of a post hoc analysis of the Phase 3 CONFIRM trial details the therapeutic effect of TERLIVAZ in adult patients with hepatorenal syndrome (HRS) and alcoholic hepatitis (AH)1 – DUBLIN , Jan. 22, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the presentation of findings from a post hoc analysis of the Phase 3 CONFIRM clinical trial. In this analysis, treatment with TERLIVAZ® (terlipressin) for injection was associated with improvements in verified hepatorenal syndrome (HRS) reversal and HRS reversal vs.

Mallinckrodt Presents New Data on TERLIVAZ® (terlipressin) for Injection at the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress

Drugmaker Mallinckrodt said on Tuesday it has completed its financial restructuring and emerged from bankruptcy.

Drugmaker Mallinckrodt emerges from bankruptcy

Moving Forward as a Stronger Company With a Significantly Improved Balance Sheet and Increased Financial Flexibility  David Stetson and Jon Zinman Appointed to New Board of Directors DUBLIN , Nov. 14, 2023 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today announced that it has completed its financial restructuring, emerged from Chapter 11 following an expedited court-supervised process and completed the Irish Examinership Proceedings. Supported by an enhanced capital structure, Mallinckrodt will continue to focus on advancing its business across its portfolio and executing on recent and planned product launches.

News for Mallinckrodt PLC Stock (MNKTQ)