MNK Mallinckrodt plc

0.97
+0.04  (+5%)
Previous Close 0.93
Open 0.85
52 Week Low 0.81
52 Week High 6.42
Market Cap $82,330,442
Shares 84,588,967
Float 83,321,317
Enterprise Value $4,521,031,422
Volume 1,953,917
Av. Daily Volume 6,165,699
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Upcoming Catalysts

Drug Stage Catalyst Date
StrataGraft skin tissue
Deep partial thickness severe burns - skin defects
PDUFA priority review
PDUFA priority review
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Drug Pipeline

Drug Stage Notes
Terlipressin
Hepatorenal syndrome (HRS) Type 1
CRL
CRL
CRL announced September 14, 2020.
MNK-6106
Hepatic Cirrhosis and Chronic Hepatic Encephalopathy (HE)
Phase 2a
Phase 2a
Phase 2 commencement of dosing announced August 12, 2019.
UVADEX (methoxsalen) and Therakos
Acute Graft Versus Host Disease
Phase 3
Phase 3
Phase 3 enrolment to stop following interim analysis February 20, 2019.
H.P. Acthar Gel
Amyotrophic Lateral Sclerosis
Phase 2
Phase 2
Phase 2 trial discontinued due to safety concerns - July 16, 2019.
CPP-1X/sulindac
Familial Adenomatous Polyposis (FAP)
Phase 3
Phase 3
Phase 3 data released May 7, 2019 did not meet primary endpoint.
MNK-812
Pain
CRL
CRL
CRL issued December 12, 2018.
VTS-270
Niemann-Pick Disease
Phase 3
Phase 3
Phase 3 trial did not show a statistically significant separation from placebo.
Stannsoporfin
Jaundice
CRL
CRL
CRL issued August 22, 2018.
RAPLIXA
Hemostasis
Approved
Approved
Approved April 30, 2015.

Latest News

  1. DUBLIN, Sept. 14, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the company's New Drug Application (NDA) seeking approval for the investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1).

    The CRL stated that, based on the available data, the agency cannot approve the terlipressin NDA in its current form and requires more information to support a positive risk-benefit profile for terlipressin for patients with HRS-1. HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis1 for which there is currently no FDA-approved treatment.2 HRS-1 is estimated to affect between 30,000 and 40,000 Americans annually,3,4 and often is a challenge to effectively diagnose in a timely manner due to its diagnosis of exclusion.5 If left untreated, HRS-1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months.5,6 U.S. discharge data in a recently published study indicated an in-hospital mortality rate of 34.2% (n=1,133), while an additional 14.4% (n=475) of patients were discharged to hospice.7

    "While we are disappointed that the FDA issued a complete response letter for terlipressin, we remain confident in the strength of the data from our Phase 3 CONFIRM study, which is the largest clinical trial ever conducted in this rare condition," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "HRS-1 is a complex disease that affects a critically ill patient population with no approved treatment in the U.S. at present. We are surprised by and disagree with the FDA's decision and remain committed to pursuing all available options as we continue working with the FDA toward approval of terlipressin in order to help address this difficult and life-threatening syndrome."

    Terlipressin is an investigational agent being evaluated for the treatment of HRS-1 in the U.S., and its safety and effectiveness have not yet been established by the FDA.

    Terlipressin is approved in many countries outside the United States, where it has been a standard of care for decades in the treatment of patients with HRS-1.8,9 Terlipressin, together with albumin, is currently the standard of care for HRS-1 in countries where it is available.10

    In 2005, terlipressin was granted Fast Track designation by the FDA, which provides for expedited review to facilitate development of drugs intended to treat serious or life-threatening conditions and fill an unmet medical need.11 In 2016, Mallinckrodt and the FDA reached agreement on the Phase 3 CONFIRM trial protocol design and data analysis under the agency's special protocol assessment (SPA) process. A SPA is an advance agreement with the FDA for the acceptability of the clinical design, endpoints and statistical data analyses for a Phase 3 trial before the start of the trial.

    On July 15, 2020, the company announced that the Cardiovascular and Renal Drugs Advisory Committee of the FDA voted to recommend approval of its investigational agent terlipressin to treat adults with HRS-1 based, in part, on results from the Phase 3 CONFIRM trial. The CONFIRM trial was the largest-ever prospective study (n=300) conducted to assess the safety and efficacy of terlipressin in patients with HRS-1 for potential use in the U.S. and Canada. Initial results were presented in a late-breaking session at The Liver Meeting® 2019, the annual meeting of the American Association for the Study of Liver Diseases (AASLD).

    About Terlipressin

    Terlipressin is a potent vasopressin analogue selective for V1 receptors being investigated for the treatment of HRS-1 in the U.S. and Canada. It is an investigational product in these countries as the safety and efficacy have not been established with, nor has approval been granted by, regulatory authorities in either country. Terlipressin is approved for use outside the U.S. and Canada.

    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, nephrology, pulmonology and ophthalmology; 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 www.mallinckrodt.com.

    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.

    CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS

    This release includes forward-looking statements with regard to terlipressin, including with regard to interactions with regulators as well as its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and 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.

    CONTACT

    Media Inquiries

    Caren Begun

    Green Room Communications

    201-396-8551

    Investor Relations

    Daniel J. Speciale

    Vice President, Finance and Investor Relations Officer

    314-654-3638

    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. © 2020 Mallinckrodt. US-2001369 09/20

    References

    1 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed September 12, 2020.

    2 Boyer TD, Medicis JJ, Pappas SC, et al. A randomized, placebo-controlled, double-blind study to confirm the reversal of hepatorenal syndrome type 1 with terlipressin: the REVERSE trial design. Open Access Journal of Clinical Trials. 2012:4. https://www.dovepress.com/a-randomized-placebo-controlled-double-blind-study-to-confirm-the-reve-peer-reviewed-article-OAJCT

    3 C Pant, B S Jani, M Desai, A Deshpande, Prashant Pandya, Ryan Taylor, R Gilroy, M Olyaee. Hepatorenal syndrome in hospitalized patients with chronic liver disease: results from the Nationwide Inpatient Sample 2002–2012. Journal of Investigative Medicine. 2016; 64:33–38.

    4 United States Census Bureau: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed September 12, 2020.

    5 Gines P, Sola E, Angeli P, et al. Hepatorenal syndrome. Nature Reviews. 2018;4:23. 

    6 Colle I and Laterre PF. Hepatorenal syndrome: the clinical impact of vasoactive therapy. Expert Review of Gastroenterology & Hepatology. 2018;12(2):173-188. DOI: 10.1080/17474124.2018.1417034. 

    7 Jamil K, Lodaya K, Tavares R, Huang X, Hayashida D. The hepatorenal syndrome patient journey: Portrait of an often-fatal path for those with liver disease. Presented at Digestive Disease Week® (DDW) Chicago, IL. May 2, 2020May 5, 2020.

    8 De Franchis R. Evolving Consensus in Portal Hypertension Report of the Baveno IV Consensus Workshop on methodology of diagnosis and therapy in portal hypertension. J Hepatol. 2005;43:167-176.

    9 Ioannou GN, Doust J, Rockey DC. Terlipressin for acute esophageal variceal hemorrhage. Cochrane Database of Systematic Reviews. 2003;1. doi: 10.1002/14651858.CD002147.

    10 European Association for the Study of the Liver (EASL). Clinical practice guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018;69(2):406-460.

    11 U.S. Food and Drug Administration (FDA). Fast Track. Available at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track. Accessed September 12, 2020.  

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    SOURCE Mallinckrodt Pharmaceuticals

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  2. New York, United States, Fri, 28 Aug 2020 03:29:23 / Comserve Inc. / -- The amphetamine drug market is anticipated to record a robust CAGR during the forecast period, i.e. 2020-2028.

    Research Nester released a report titled "Amphetamine Drug Market – Global Demand Analysis & Opportunity Outlook 2028" which delivers a detailed overview of the amphetamine drug market in terms of market segmentation by application, by demography, by distribution channel, and by region.

    Further, for the in-depth analysis, the report encompasses the industry growth drivers, restraints, supply and demand risk, market attractiveness, BPS analysis, and Porter's five force model.

    The amphetamine drug market is segmented by application, by demography, by distribution…

    New York, United States, Fri, 28 Aug 2020 03:29:23 / Comserve Inc. / -- The amphetamine drug market is anticipated to record a robust CAGR during the forecast period, i.e. 2020-2028.

    Research Nester released a report titled "Amphetamine Drug Market – Global Demand Analysis & Opportunity Outlook 2028" which delivers a detailed overview of the amphetamine drug market in terms of market segmentation by application, by demography, by distribution channel, and by region.

    Further, for the in-depth analysis, the report encompasses the industry growth drivers, restraints, supply and demand risk, market attractiveness, BPS analysis, and Porter's five force model.

    The amphetamine drug market is segmented by application, by demography, by distribution channel, and by region. Based on the application, the amphetamine drug market is segmented into ADHD, narcolepsy, obesity, depression, and others, out of which the depression segment is anticipated to dominate the market owing to the increase in the prevalence of depression among adults and children around the world. On the basis of demographics, the amphetamine drug market has been bifurcated into children and adults. Among the demographic segment, the adult is anticipated to hold the largest share in the market attributed to a large adult patient population. The amphetamine drug market is anticipated to record a robust CAGR during the forecast period, i.e. 2020-2028. This market is thriving on the back of a rising number of ADHD patients and governments' approvals and initiatives to address the health related problems. Along with this, the investments into healthcare system for the betterment of the society further are anticipated to raise the market growth. According to the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA), in 2015, there were 17.2 million individuals who used stimulants, of which 1.8 million were youth and 4.9 million were adults.Request Here For Sample Copy

    "The Final Report will cover the impact analysis of COVID-19 on this industry (Global and Regional Market)."

    Based on the regional analysis, the amphetamine drug market is segmented into five major regions including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa region. The market in North America region is anticipated to dominate the global market and accounted for rising prevalence in the number of depression and ADHD patients globally. Additionally, the continuous focus of key market players is on the consumers, encouraging them to innovate in the market. Such factors are anticipated to boost the market growth of the region. The market in Europe is anticipated to hold the second-largest share owing to the presence of massive pharmaceutical firms in the region

    The increasing number of ADHD patients worldwide

    According to the survey done by the Centers for Disease Control and Prevention (CDC), 2016, 0.388 million children aged 2–5 years, 4 million children aged 6–11 years, and 3 million children aged 12–17 years, were diagnosed with ADHD in the U.S.

    The global surge in the number of incidences is associated with ADHD due to the dearth of established treatment for this disorder. People are left with long-running medication procedures for their treatment. The medicinal treatment through CNS stimulants such as amphetamine is the most preferred way to treat the patient. This is expected to incite the growth of the global amphetamine drug market. However, the side-effects and contraindications related to amphetamine drugs are some of the factors that are estimated to limit market growth. Download a PDF copy of this report:

    "The Final Report will cover the impact analysis of COVID-19 on this industry (Global and Regional Market)."

    This report also provides the existing competitive scenario of some of the key players of the amphetamine drug market which includes company profiling of Teva Pharmaceutical Industries Ltd. (TLV: TEVA), Pfizer Inc. (NYSE:PFE), Novartis AG (SWX: NOVN), Eli Lilly and Company (NYSE:LLY), GlaxoSmithKline plc (LON: GSK), Mallinckrodt Company (NYSE:MNK), Johnson & Johnson Services, Inc. (NYSE:JNJ), Hisamitsu Pharmaceutical Co., Inc. (TYO:4530), and Purdue Pharma L.P. The profiling enfolds key information of the companies which encompasses business overview, products and services, key financials, and recent news and developments. On the whole, the report depicts a detailed overview of the amphetamine drug market that will help industry consultants, manufacturers, existing players searching for expansion opportunities, new players searching possibilities and other stakeholders to align their market-centric strategies accordingly to the ongoing and expected trends in the future.

    Research Nester is a one-stop service provider, leading in strategic market research and consulting with an unbiased and unparalleled approach towards helping global industrial players, conglomerates and executives to make wise decisions for their future investment and expansion by providing them qualitative market insights and strategies while avoiding future uncertainties. We believe in honesty and sheer hard work that we trust is reflected in our work ethics. Our vision is not just limited to gain the trust of our clients but also to be equally respected by our employees and being appreciated by the competitors.

    For more information, please contact:

    AJ Daniel

    Research Nester
    Email:
    Tel: +1-6465869123

    The post Research on Amphetamine Drug Market (impact of COVID-19) 2020-2028: Teva Pharmaceutical Industries Ltd., Pfizer Inc., Novartis AG, Eli Lilly and Company, GlaxoSmithKline plc, Mallinckrodt Company appeared first on Comserveonline.

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  3. ST. LOUIS, Aug. 24, 2020 /PRNewswire/ -- Mallinckrodt Pharmaceuticals (NYSE:MNK), a global biopharmaceutical company, today announced that its Specialty Generics business has been recognized as a Manufacturing Leadership Award winner for outstanding achievement by the National Association of Manufacturers (NAM).

    The Specialty Generics business' Hobart, N.Y. manufacturing site received awards for outstanding achievement in two categories – Operational Excellence Leadership and Engineering and Production Technology Leadership.

    Spiro Gavaris, President, Mallinckrodt Specialty Generics said, "We are extremely proud to receive the National Association of Manufacturers' prestigious manufacturing leadership awards for the third consecutive year. This recognition further demonstrates Mallinckrodt's history of innovative manufacturing solutions, our focus on being the US-based supplier of choice for specialty generic drugs and active pharmaceutical ingredients, and our commitment to providing patients access to quality medicines."

    This year, Mallinckrodt's Hobart, N.Y. manufacturing site was recognized in the Operational Excellence Leadership category for its Packaging Changeover Improvement Project that successfully reduced the changeover time of packaging lines by 50% and decreased the variability of time to completion.

    The Hobart site's Packaging Serialization Project was an award winner in the Engineering & Production Technology Leadership category for its achievement in upgrading the facility's packaging lines, which enabled production of fully serialized pharmaceutical finished product with full pallet aggregation two years ahead of FDA requirements.

    "We are very pleased that NAM's Leadership Council has recognized our Hobart site for manufacturing leadership in operational excellence, as well as engineering and production technology," said David Hollingshead, Senior Director of Manufacturing. "Achieving six awards in the last three years is testimony to our employees' dedication to the strategy development and deployment process in becoming a premier manufacturing site. Continuous improvement is core in the mindsets and behaviors of our most important asset – our people."

    Mallinckrodt will be recognized at the 16th Annual Manufacturing Leadership Awards Gala which will be held virtually on October 8, 2020.

    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, nephrology, pulmonology and ophthalmology; 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 www.mallinckrodt.com.

    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 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.

    About the Manufacturing Leadership Awards

    The Manufacturing Leadership Awards honor manufacturing companies and individual manufacturing leaders that are shaping the future of global manufacturing. Winning projects and individual manufacturing leaders have demonstrated achievement in one of a wide range of categories, and are chosen by a panel of expert judges for results that have delivered clear and compelling value, return on investment, and other tangible outcomes. For more information on the Manufacturing Leadership Awards Gala or Rethink: The Manufacturing Leadership Council Summit, please go to www.MLCRethink.com.

    About the National Association of Manufacturers

    The National Association of Manufacturers (NAM) is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states.

    The NAM's world-class staff of policy experts provide unmatched access and information on the key issues affecting your business and bottom line. It is on the front lines of a wide range of policy battles, from immigration reform and labor relations, to energy and the environment, to trade policy and taxes.

    www.nam.org 

    CONTACTS

    For Financial/Dailies Media Inquiries

    Ron Bartlett

    H+K Strategies

    Senior Vice President

    813-545-2399

     

    Investor Relations

    Daniel J. Speciale

    Vice President, Finance and IRO

    314-654-3638

    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. © 2020 Mallinckrodt. US-2000671 08/20

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/mallinckrodts-hobart-ny-site-recognized-with-two-manufacturing-leadership-awards-301116432.html

    SOURCE Mallinckrodt Pharmaceuticals

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  4. STAINES-UPON-THAMES, United Kingdom, Aug. 10, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Stratatech Biologics License Application (BLA) for StrataGraft®, an investigational regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns. The FDA granted the application priority review and assigned a Prescription Drug User Fee Act (PDUFA) target date of February 2, 2021.

    Autograft, the current standard of care for deep partial-thickness thermal burns, involves the surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, leaving the patient with more wounded areas requiring care. Each year, approximately 40,000 patients in the U.S. require hospitalization for the treatment of severe burns.1 The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), expressed interest in StrataGraft skin tissue as a medical countermeasure in response to large-scale burn incidents, and provided funding and technical support for the continued development of StrataGraft skin tissue.

    "Treatment advances are needed that can help minimize or eliminate the need for autografting. The FDA's acceptance of the BLA submission for StrataGraft skin tissue for review takes us one step closer to providing adult burn patients in the United States with a potential new treatment option for deep partial-thickness thermal burns," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We are focused on delivering solutions to patients with severe and critical conditions, and look forward to working with the FDA during the regulatory review process for StrataGraft skin tissue."

    The StrataGraft skin tissue BLA is based on data from the pivotal Phase 3 STRATA2016 clinical trial, previously published as an abstract in the Journal of Burn Care & Research and presented via a prerecorded video at the virtual American Burn Association 52nd Annual Meeting, with support from the STRATA2011 clinical trial, previously published in Burns. Top-line results from the Phase 3 trial of StrataGraft skin tissue, which met both primary endpoints in adults with deep partial-thickness thermal burns, including autograft sparing and durable wound closure, were announced in September 2019.

    The completion of the BLA rolling submission was announced on June 9, 2020. The FDA granted StrataGraft skin tissue orphan drug designation, and it was among the first products designated by the Agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act.

    About StrataGraft

    StrataGraft regenerative skin tissue is an investigational treatment being developed to reduce autograft in patients with severe thermal burns. An engineered, bilayer tissue, StrataGraft skin tissue is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers. StrataGraft skin tissue can be sutured, stapled or secured with an adhesive. StrataGraft skin tissue is cryopreserved in order to deliver viable cells upon application.

    Mallinckrodt is currently conducting a StrataGraft skin tissue continued access clinical trial (StrataCAT, NCT04123548) under an Expanded Access Program (EAP). The trial sites involved in the pivotal Phase 3 trial (STRATA2016, NCT03005106) have the opportunity to participate in this multicenter, open-label study. The company is planning to evaluate StrataGraft skin tissue for the treatment of adults with full-thickness burns (also referred to as third-degree burns). Additionally, Mallinckrodt plans to conduct a study evaluating StrataGraft skin tissue in treatment of pediatric populations. 

    StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.

    The continued development of StrataGraft skin tissue, including the pivotal Phase 3 clinical study (STRATA2016) and the BLA process for StrataGraft skin tissue in the United States, is being supported through a partnership with BARDA, under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under Project BioShield Contract No. HHSO100201500027C. These efforts are part of BARDA's strategy to build emergency preparedness in response to mass casualty events involving trauma and thermal burns by developing novel medical countermeasures for adult and at-risk populations. In the case of a mass casualty thermal burn event, the Government Accountability Office estimates that more than 10,000 patients might require thermal burn care.The limited number of specialized burn centers and related medical infrastructure in the United States creates a public health need for therapies that could be deployed quickly for use in these and other care sites.

    About Deep Partial-Thickness Thermal Burns

    Deep partial-thickness thermal burns are complex skin injuries in which the damage extends through the entire epidermis (outermost layer of skin) and into the lower part of the dermis (innermost layer of skin).

    Autograft is considered to be a standard of care by many for deep partial-thickness thermal burns. It involves the surgical harvesting of healthy skin tissue from an uninjured site on the patient and transplanting the skin graft to the injury. While this process can be effective in providing closure of the original wound, it has significant limitations related to the donor site wounds created during surgical removal of the skin tissue for grafting. Donor site wounds are painful and can create risks of additional scarring and infection. In addition, the amount of healthy skin available for harvesting is frequently limited in those patients with large burns, necessitating sequential re-harvesting of available donor sites. As a result, there is a need for alternatives to donor site harvesting for the treatment of severe burns.

    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, nephrology, pulmonology and ophthalmology; 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 www.mallinckrodt.com.

    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.

    Cautionary Statements Related to Forward-Looking Statements

    This release includes forward-looking statements concerning StrataGraft regenerative skin tissue, including the anticipated regulatory review process, its potential impact on patients, and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and 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.

    CONTACTS

    For Trade Media Inquiries

    Sheryl Seapy

    W2O

    213-262-9390

    For Financial/Dailies Media Inquiries

    Ron Bartlett

    H+K Strategies

    Senior Vice President

    813 545 2399

      

    Investor Relations

    Daniel J. Speciale

    Vice President, Investor Relations and IRO

    314-654-3638

    Government Affairs

    Mark Tyndall

    Senior Vice President, Government Affairs & Chief Counsel, Litigation

    202-459-4141

    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.

    ©2020 Mallinckrodt. US-2001226 07/20.

    ________________________

    1 American Burn Association. Burn Incidence Fact Sheet. http://ameriburn.org/who-we-are/media/burn-incidence-fact-sheet/. Accessed May 15, 2020.

    2 United States Government Accountability Office. National Preparedness: Countermeasures for Thermal Burns. https://www.gao.gov/assets/590/588738.pdf. Accessed February 12, 2020.

     

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    SOURCE Mallinckrodt plc

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  5. DUBLIN, Aug. 4, 2020 /PRNewswire/ --

    • Second quarter net sales of $166.5 million net of the retrospective one-time Acthar® Gel Medicaid liability; adjusted net sales of $700.9 million, a decline of 14.9%, due primarily to demand impacts related to COVID-19 and competitive and payer pressures on certain products
    • Diluted loss per share of $11.04 with adjusted diluted earnings per share (EPS) of $1.89, a decline of 25.3%
    • Operating cash flows of $170.9 million in the quarter with free cash flow of $159.5 million
    • Key pipeline advancements include:
      • A positive vote by the U.S. Food and Drug Administration (FDA) advisory committee for terlipressin
      • Completion of a rolling submission of a Biologics License Application (BLA) to the FDA for StrataGraft® regenerative skin tissue
    • Company continues to work to resolve outstanding issues related to opioids, Acthar Gel, and other risks, as well as address overall debt levels, and is considering with its external advisors all options to address legal and financial challenges. While no final determination has been made, it is possible that Mallinckrodt plc and most of its subsidiaries could file for Chapter 11 reorganization in the near term

    Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today reported results for the three- and six-months ended June 26, 2020. Unless otherwise noted, the quarter comparisons are to the prior year comparable three- and six-months ended June 28, 2019.

    Net sales were $166.5 million in the second quarter and adjusted net sales, following the adjustment for the retrospective one-time Acthar® Gel (repository corticotropin injection) Medicaid rebate liability, were $700.9 million, with diluted loss per share of $11.04 compared to diluted earnings per share of $0.08, following the $639.7 million impact from the retrospective Acthar Gel Medicaid rebate liability and a $63.5 million non-restructuring impairment of the OFIRMEV® (acetaminophen) injection intangible asset. Adjusted diluted EPS were $1.89 versus $2.53, a decrease of 25.3%, on lower net sales in second quarter 2020, partially offset by non-operational favorability from adjusted income tax expense and interest expense.

    "Our reported GAAP net sales were impacted by the retrospective one-time Acthar Gel Medicaid liability, and our normalized operating results also displayed a contraction this quarter due to the COVID-19 health crisis along with increased competitive and payer pressures on certain products. Amidst these challenges, we continued to operate well, which is a testament to our employees' hard work and commitment to our business, patients and customers," said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt.  "We also continue to execute on our strategic priorities – making important progress in advancing our pipeline, including a positive outcome of the recent advisory committee meeting on terlipressin and completion of a rolling submission of a Biologics License Application (BLA) to the FDA for StrataGraft® regenerative skin tissue."

    Trudeau continued, "Looking ahead, we expect our current challenges to continue in the back half of the year. We remain committed to ensuring patients have uninterrupted access to our medicines throughout the COVID-19 health crisis. We continue to be highly focused in the near term on addressing all legal and financial challenges impacting the business."

    COMPANY FINANCIAL RESULTS

    Second Quarter 2020 Results

    Gross loss was $220.2 million as compared to gross profit of $388.9 million, driven in part by the retrospective one-time Acthar Gel Medicaid liability coupled with declines in overall net sales. Adjusted gross profit was $505.0 million, compared with $603.9 million, due primarily to the decline in net sales. Adjusted gross profit as a percentage of adjusted net sales was 72.1%, compared with 73.4%, due primarily to changes in product mix.

    Selling, general and administrative (SG&A) expenses were $231.3 million or 138.9% of net sales, as compared to $225.9 million, or 27.4%, primarily impacted by legal expenses and separation costs. Adjusted SG&A expenses were $197.5 million or 28.2% of adjusted net sales, compared with $208.6 million or 25.3%. The decline in adjusted SG&A expense reflects the Company's ongoing efforts to reduce SG&A, while the percentage of net sales and adjusted net sales were impacted by lower net sales in the second quarter 2020.

    Research and development expenses were $82.9 million, or 49.8% of net sales, as compared to $79.6 million, or 9.7%. Research and development as a percentage of adjusted net sales was 11.8% versus 9.7%.

    Interest expense was $64.2 million as compared to $71.5 million, a reduction of 10.2%, driven by lower aggregate debt in 2020, a reduction in floating interest costs, and the reversal of deferred interest associated with the interest-bearing deferred tax obligations.

    Income tax expense was $161.3 million, for an effective tax rate of negative 20.4%. The adjusted effective tax rate was 4.6% in the second quarter.

    Six-Month Fiscal 2020 Results

    Net sales were $832.3 million and adjusted net sales were $1,366.7 million, down 15.3% compared with $1,613.9 million. The adjusted net sales decrease is primarily attributed to the retrospective one-time Acthar Gel Medicaid liability, increased competition on certain products and the impact of the COVID-19 pandemic.

    Net loss was $983.3 million, compared to net income of $161.7 million. Diluted loss per share was $11.66, compared to diluted earnings per share of $1.92, with adjusted diluted earnings per share of $3.53 versus $4.48.

    BUSINESS SEGMENT RESULTS

    Specialty Brands Segment

    Net sales for the segment in the second quarter 2020 were $522.8 million.

    • Acthar Gel net sales were $213.7 million, a 19.8% decrease, primarily driven by continued reimbursement challenges impacting new and returning patients; continued reduction in new patients as a result of COVID-19 pandemic, which is anticipated to impact results in the second half of the year; continued payer scrutiny on overall specialty pharmaceutical spending; and, to a partial extent, the change in the Medicaid rebate calculation.
    • INOMAX® (nitric oxide) gas, for inhalation, net sales were $154.9 million, an increase of 10.9%, or 11.0% on a constant-currency basis, driven by an overall increased consumption of nitric oxide by the Company's customers, including strong utilization within COVID-19 patients. The INOmax Total Care service offering remains a differentiating feature among competition.
    • OFIRMEV® net sales were $52.4 million, a decrease of 42.1%, impacted by the overall reduction in elective surgeries due to public health orders and institutions being focused on responding to the COVID-19 pandemic.
    • Therakos® immunology platform net sales were $47.8 million, a decrease of 21.5%, or 20.7% on a constant-currency basis, driven largely by COVID-19 stay-at-home directives impacting patients' abilities to receive treatment in hospitals or apheresis centers.
    • AMITIZA® (lubiprostone) net sales were $49.4 million, down 5.0% due to continued impact of competition in the U.S. and the biennial price reduction in Japan.

    Specialty Generics Segment

    Net sales for the segment in the second quarter were $178.1 million, as expected, with slight sequential increase from the first quarter 2020.

    LIQUIDITY

    Cash provided by operating activities in the second quarter was $170.9 million, with free cash flow of $159.5 million.  For the six-month period, operating cash flows were $224.6 million, with free cash flows of $193.3 million.

    The cash balance at the end of the second quarter was $818.3 million, and the revolving credit facility was fully drawn. Total principal debt outstanding at the end of the second quarter was $5.293 billion, with net debt of $4.475 billion.

    BUSINESS AND LITIGATION UPDATE

    The Company has identified several negative conditions and events impacting the business as of June 26, 2020. Due to pressures from the Acthar Gel Medicaid matter, the ongoing opioid litigation and the Company's existing debts and the related risk of non-compliance with its financial debt covenant over the next twelve months, the Company has been working with external advisors to explore a range of options and engage in dialogue with financial creditors and litigation claimants and their advisors, including the possibility of a filing for reorganization in bankruptcy under Chapter 11 by Mallinckrodt plc and most of its subsidiaries in the near-term.  However, these plans have not yet been finalized nor are they fully within the Company's control.  Further disclosure regarding this matter will be included within the Form 10-Q expected to be filed later today.

    CONFERENCE CALL AND WEBCAST

    Mallinckrodt will hold a conference call on Tuesday, Aug. 4, 2020, beginning at 8:30 a.m. U.S. Eastern Time. This call can be accessed in three ways:

    • At the Mallinckrodt website: http://www.mallinckrodt.com/investors/events-calendar/.
    • By telephone: For both listen-only participants and those who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is (877) 359-9508. For participants outside the U.S., the dial-in number is (224) 357-2393. Callers will need to provide the Conference ID of 5970869. Dial-in 15 minutes in advance of the call is encouraged to avoid connection delays.
    • Through an audio replay: A replay of the call will be available beginning at 11:30 a.m. Eastern Time on Tuesday, Aug. 4, 2020, and ending at 11:30 a.m. Eastern Time on Tuesday, Aug. 18, 2020. Dial-in numbers for U.S.-based participants are (855) 859-2056 or (800) 585-8367. Participants outside the U.S. should use the replay dial-in number of (404) 537-3406. All callers will be required to provide the Conference ID of 5970869.

    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, nephrology, pulmonology and ophthalmology; 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 www.mallinckrodt.com.

    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 net income, adjusted diluted earnings per share, adjusted net sales, adjusted gross profit, adjusted SG&A, net sales growth on a constant-currency basis, adjusted effective tax rate, net debt and free cash flow, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations.

    Adjusted net income, adjusted net sales, adjusted gross profit and adjusted SG&A represent amounts 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. The adjustments for these items are on a pre-tax basis for adjusted net sales, adjusted gross profit and adjusted SG&A and on an after-tax basis for adjusted net income. Adjustments to GAAP amounts include, as applicable to each measure, amortization; restructuring and related charges, net; inventory step-up expense; discontinued operations; changes in fair value of contingent consideration obligations; significant legal and environmental charges (inclusive of the CMS retrospective liability); losses on divestiture; unrealized gain on equity investment; gains on debt extinguishment, net; separation costs; tax effects of aforementioned adjustments, changes in uncertain tax positions, tax impacts related to substantial doubt about the Company's ability to continue as a going concern, legislative changes and tax impacts from certain transactions, such as acquisitions or reorganizations; and other items identified by the company. Adjusted diluted earnings per share represent adjusted net income divided by the number of diluted shares.

    The adjusted effective tax rate is calculated as the income tax effects on continuing and discontinued operations plus the income tax impact included in Mallinckrodt's reconciliation of net loss, divided by loss from continuing and income from discontinued operations plus the pre-tax, non-income, tax-related adjustments included in its reconciliation of adjusted net income (excluding dilutive share impact). The income tax adjustment included in the reconciliation of adjusted net income primarily represents the tax impact of adjustments between net loss and adjusted net income, changes in uncertain tax positions, tax impacts related to the substantial doubt about the Company's ability to continue as a going concern, tax impacts of legislative changes and tax impacts from certain transactions, such as acquisitions or reorganizations.

    Segment net sales growth 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.

    Free cash flow for the second quarter represents net cash provided by operating activities of $170.9 million less capital expenditures of $11.4 million, each as prepared in accordance with GAAP.

    Free cash flow for the year to date represents net cash provided by operating activities of $224.6 million less capital expenditures of $31.3 million, each as prepared in accordance with GAAP

    Net debt as of June 26, 2020 represents the total principal debt outstanding of $5.293 billion less cash of $818.3 million, each as prepared in accordance with GAAP.

    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 certain 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 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.

    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, legal, economic, business, competitive and/or regulatory factors affecting Mallinckrodt's businesses, and any other statements regarding events or developments the company 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 dispute between Mallinckrodt, HHS and CMS, including the lawsuit filed by Mallinckrodt and any related appeals, as well as the time and expense of litigating this dispute; the impact of this dispute on Mallinckrodt's expectations for performance, as well as the financial impact of the retrospective one-time Acthar Gel Medicaid liability on Mallinckrodt or any other related impacts; the impact of the outbreak of the COVID-19 coronavirus; the possibility that Mallinckrodt plc and/or certain of its subsidiaries will file for Chapter 11 and the potential effects of such a filing and resulting bankruptcy process on Mallinckrodt's liquidity, results of operations and business; governmental investigations and inquiries, regulatory actions and lawsuits brought against Mallinckrodt by government agencies and private parties with respect to its historical commercialization of opioids, including the non-binding agreement in principle regarding terms and conditions of a global settlement to resolve all current and future opioid-related claims; 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' 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; 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; potential indemnification liabilities to Covidien pursuant to the separation and distribution agreement; business development activities; retention of key personnel; 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; conducting business internationally; Mallinckrodt's ability to achieve expected benefits from 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 and its ability to generate sufficient cash to reduce its indebtedness; future changes to U.S. and foreign tax laws or the impact of disputes with governmental tax authorities; and the impact of Irish laws.

    These and other factors are identified and described in more detail in the "Risk Factors" section of Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended December 27, 2019 and Form 10-Q for the fiscal quarter ended March 27, 2020. 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.

    CONTACTS

    Investor Relations      

    Daniel J. Speciale

    Vice President, Finance and Investor Relations Officer

    314-654-3638

    Media

    Michael Freitag / Aaron Palash / Aura Reinhard

    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. © 2020 08/20.

    MALLINCKRODT PLC

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (unaudited, in millions, except per share data)















    Three Months Ended



    June 26,

    2020

    Percent of

    Net sales



    June 28,

    2019

    Percent of

    Net sales

    Net sales (includes a retrospective one-time charge of $534.4 million related to the Medicaid lawsuit for the three months ended June 26, 2020)

    $

    166.5



    100.0

    %



    $

    823.3



    100.0

    %

    Cost of sales

    386.7



    232.3





    434.4



    52.8



    Gross (loss) profit

    (220.2)



    (132.3)





    388.9



    47.2



    Selling, general and administrative expenses

    231.3



    138.9





    225.9



    27.4



    Research and development expenses

    82.9



    49.8





    79.6



    9.7



    Restructuring charges, net

    14.4



    8.6





    (0.2)





    Non-restructuring impairment charges

    63.5



    38.1





    113.5



    13.8



    Gains on divestiture

    (0.6)



    (0.4)









    Opioid-related litigation settlement

    8.5



    5.1









    Medicaid lawsuit

    105.3



    63.2









    Operating loss

    (725.5)



    (435.7)





    (29.9)



    (3.6)



    Interest expense

    (64.2)



    (38.6)





    (71.5)



    (8.7)



    Interest income

    1.0



    0.6





    2.2



    0.3



    Other (expense) income, net

    (0.6)



    (0.4)





    74.4



    9.0



    Loss from continuing operations before income taxes

    (789.3)



    (474.1)





    (24.8)



    (3.0)



    Income tax expense (benefit)

    161.3



    96.9





    (24.3)



    (3.0)



    Loss from continuing operations

    (950.6)



    (570.9)





    (0.5)



    (0.1)



    Income from discontinued operations, net of income taxes

    17.5



    10.5





    7.3



    0.9



    Net (loss) income

    $

    (933.1)



    (560.4)

    %



    $

    6.8



    0.8

    %













    Basic (loss) earnings per share:











    Loss from continuing operations

    $

    (11.25)







    $

    (0.01)





    Income from discontinued operations

    0.21







    0.09





    Net (loss) income

    $

    (11.04)







    $

    0.08





    Diluted (loss) earnings per share:











    Loss from continuing operations

    $

    (11.25)







    $

    (0.01)





    Income from discontinued operations

    0.21







    0.09





    Net (loss) income

    $

    (11.04)







    $

    0.08





    Weighted-average number of shares outstanding











    Basic weighted-average shares outstanding

    84.5







    83.8





    Diluted weighted-average shares outstanding

    84.5







    83.8





     

    MALLINCKRODT PLC

    NON-GAAP MEASURES

    (unaudited, in millions except per share data)































    Three Months Ended



    June 26, 2020



    June 28, 2019



    Net

    sales

    Gross

    (loss)

    profit

    SG&A

    Net

    (loss)

    income



    Diluted

    net

    (loss)

    income

    per

    share (1)



    Net

    sales

    Gross

    profit

    SG&A

    Net

    income



    Diluted

    net

    income

    per

    share (1)

    GAAP

    $

    166.5



    $

    (220.2)



    $

    231.3



    $

    (933.1)





    $

    (11.04)





    $

    823.3



    $

    388.9



    $

    225.9



    $

    6.8





    $

    0.08



    Adjustments:



























    Intangible asset amortization



    190.8



    (0.8)



    191.6





    2.26







    215.0



    (1.6)



    216.6





    2.58



    Restructuring and related charges, net







    14.4





    0.17











    (0.2)







    Non-restructuring impairment charge







    63.5





    0.75











    113.5





    1.35



    Income from discontinued operations







    (17.5)





    (0.21)











    (7.3)





    (0.09)



    Change in contingent consideration fair value





    4.9



    (4.9)





    (0.06)









    3.2



    (3.2)





    (0.04)



    Significant legal and environmental charges (2)

    534.4



    534.4



    (17.2)



    665.4





    7.86

















    Divestitures







    (0.6)





    (0.01)

















    Separation costs





    (20.7)



    20.7





    0.24









    (18.9)



    18.9





    0.22



    Gains on debt extinguishment, net





















    (62.3)





    (0.74)



    Unrealized loss on equity investment







    2.4





    0.03

















    R&D upfront payment (3)







    5.0





    0.06

















    Legal entity and intercompany financing reorganization







    (6.3)





    (0.07)











    3.0





    0.04



    Income taxes (4)







    159.9





    1.89











    (72.8)





    (0.87)



    As adjusted

    $

    700.9



    $

    505.0



    $

    197.5



    $

    160.5





    $

    1.89





    $

    823.3



    $

    603.9



    $

    208.6



    $

    213.0





    $

    2.53































    Percent of adjusted net sales

    100.0

    %

    72.1

    %

    28.2

    %

    22.9

    %







    100.0

    %

    73.4

    %

    25.3

    %

    25.9

    %

































































    (1)

    In periods where the Company reports a net loss from continuing operations, potential ordinary shares outstanding are excluded from the calculation of diluted earnings per share, prepared in accordance with GAAP, as they would be anti-dilutive. These potentially dilutive shares are included in the calculation of adjusted diluted earnings per share when dilutive. As a result, the adjusted diluted earnings per share utilized a weighted average share count of 84.7 shares and 84.1 shares for the three months ended June 26, 2020 and June 28, 2019, respectively.





    (2)

    Effective June 15, 2020, the Company was forced under protest to change the base date average manufacturer price ("AMP") for Acthar Gel, as directed by CMS. While the Company continues to pursue its appeal of the March 16, 2020 ruling by the U.S. District Court for the District of Columbia that upheld CMS' position, the Company incurred a retrospective one-time charge of $639.7 million, of which $534.4 million and $105.3 million have been reflected as a component of net sales and operating expenses, respectively, in the unaudited condensed consolidated statement of operations. The $105.3 million reflected as a component of operating expenses represents a pre-acquisition contingency related to the portion of the retrospective liability that arose from sales of Acthar Gel prior to the Company's acquisition of Questcor Pharmaceuticals Inc. in August 2014. Of the $534.4 million recorded as a component of net sales, $12.3 million represents the impact of the Medicaid rebate calculation through June 14, 2020 for the three months ended June 26, 2020. Also includes $17.2 million in opioid defense costs and an $8.5 million increase in the fair value of the opioid settlement warrants. Opioid defense costs are considered to be non-recurring as a result of the opioid-related litigation settlement announced during the three months ended March 27, 2020; therefore, such costs are included as an adjustment to net income on a go-forward basis until effectuation of the opioid-related litigation settlement.





    (3)

    Represents research and development ("R&D") expense incurred related to an upfront payment made in June 2020 to acquire product rights for terlipressin in Japan.





    (4)

    Includes tax effects of above adjustments (unless otherwise separately stated), changes in uncertain tax positions, tax impacts related to the substantial doubt about the Company's ability to continue as a going concern, legislative changes and certain intercompany transactions. 

     

    MALLINCKRODT PLC

    SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH

    (unaudited, in millions)























    Three Months Ended















    June 26,

    2020



    June 28,

    2019



    Percent

    change



    Currency

    impact



    Constant-

    currency

    growth

    Specialty Brands (1)

    $

    522.8





    $

    627.8





    (16.7)

    %



    (0.1)

    %



    (16.6)

    %

    Specialty Generics

    178.1





    195.5





    (8.9)





    (0.1)





    (8.8)



    Segment net sales

    $

    700.9





    $

    823.3





    (14.9)

    %



    (0.1)

    %



    (14.8)

    %

    Medicaid lawsuit

    (534.4)









    *



    *



    *

    Net sales

    $

    166.5





    $

    823.3





    (79.8)

    %



    (0.1)

    %



    (79.7)

    %



    *Not meaningful





    (1)

    The three months ended June 26, 2020 includes the prospective change to the Medicaid rebate calculation of $8.6 million for the period from June 15, 2020 through June 26, 2020, of which $6.8 million represents the channel impact.

     

    MALLINCKRODT PLC

    SELECT PRODUCT LINE NET SALES AND CONSTANT-CURRENCY GROWTH

    (unaudited, in millions)























    Three Months Ended















    June 26,

    2020



    June 28,

    2019



    Percent

    change



    Currency

    impact



    Constant-

    currency

    growth

    Specialty Brands



















    Acthar Gel (1)

    $

    213.7





    $

    266.4





    (19.8)

    %



    %



    (19.8)

    %

    INOmax

    154.9





    139.7





    10.9





    (0.1)





    11.0



    Ofirmev

    52.4





    90.5





    (42.1)









    (42.1)



    Therakos

    47.8





    60.9





    (21.5)





    (0.8)





    (20.7)



    Amitiza

    49.4





    52.0





    (5.0)









    (5.0)



    Other (2)

    4.6





    18.3





    (74.9)









    (74.9)



    Specialty Brands Total

    $

    522.8





    $

    627.8





    (16.7)

    %



    (0.1)

    %



    (16.6)

    %





















    Specialty Generics



















    Hydrocodone (API) and hydrocodone-containing tablets

    $

    25.4





    $

    18.1





    40.3

    %



    %



    40.3

    %

    Oxycodone (API) and oxycodone-containing tablets

    15.0





    19.6





    (23.5)









    (23.5)



    Acetaminophen (API)

    55.5





    48.4





    14.7









    14.7



    Other controlled substances

    77.8





    98.6





    (21.1)





    (0.1)





    (21.0)



    Other

    4.4





    10.8





    (59.3)









    (59.3)



    Specialty Generics Total

    $

    178.1





    $

    195.5





    (8.9)

    %



    (0.1)

    %



    (8.8)

    %

    Segment net sales

    $

    700.9





    $

    823.3





    (14.9)

    %



    (0.1)

    %



    (14.8)

    %

    Medicaid lawsuit

    $

    (534.4)





    $





    *



    *



    *

    Net sales

    $

    166.5





    $

    823.3





    (79.8)

    %



    (0.1)

    %



    (79.7)

    %







    *Not meaningful





    (1)

    The three months ended June 26, 2020 includes the prospective change to the Medicaid rebate calculation of $8.6 million for the period from June 15, 2020 through June 26, 2020, of which $6.8 million represents the channel impact.





    (2)

    The three months ended June 28, 2019 includes $13.9 million of net sales related to BioVectra prior to the completion of the sale of this business in November 2019.

     

    MALLINCKRODT PLC

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (unaudited, in millions, except per share data)















    Six Months Ended



    June 26,

    2020

    Percent of

    Net sales



    June 28,

    2019

    Percent of

    Net sales

    Net sales (Includes a retrospective one-time charge of $534.4 million related to the Medicaid lawsuit for the six months ended June 26, 2020)

    $

    832.3



    100.0

    %



    $

    1,613.9



    100.0

    %

    Cost of sales

    768.7



    92.4





    889.9



    55.1



    Gross profit

    63.6



    7.6





    724.0



    44.9



    Selling, general and administrative expenses

    462.4



    55.6





    456.1



    28.3



    Research and development expenses

    160.3



    19.3





    164.9



    10.2



    Restructuring charges, net

    12.6



    1.5





    4.0



    0.2



    Non-restructuring impairment charges

    63.5



    7.6





    113.5



    7.0



    Gains on divestiture

    (0.4)











    Opioid-related litigation settlement

    (8.3)



    (1.0)









    Medicaid lawsuit

    105.3



    12.7









    Operating loss

    (731.8)



    (87.9)





    (14.5)



    (0.9)



    Interest expense

    (138.7)



    (16.7)





    (154.2)



    (9.6)



    Interest income

    4.5



    0.5





    3.7



    0.2



    Other income, net

    1.1



    0.1





    90.7



    5.6



    Loss from continuing operations before income taxes

    (864.9)



    (103.9)





    (74.3)



    (4.6)



    Income tax expense (benefit)

    142.4



    17.1





    (229.0)



    (14.2)



    (Loss) income from continuing operations

    (1,007.3)



    (121.0)





    154.7



    9.6



    Income from discontinued operations, net of income taxes

    24.0



    2.9





    7.0



    0.4



    Net (loss) income

    $

    (983.3)



    (118.1)

    %



    $

    161.7



    10.0

    %













    Basic (loss) earnings per share:











    (Loss) income from continuing operations

    $

    (11.95)







    $

    1.85





    Income from discontinued operations

    0.28







    0.08





    Net (loss) income

    (11.66)







    1.93





    Diluted (loss) earnings per share:











    (Loss) income from continuing operations

    $

    (11.95)







    $

    1.84





    Income from discontinued operations

    0.28







    0.08





    Net (loss) income

    (11.66)







    1.92





    Weighted-average number of shares outstanding:











    Basic

    84.3







    83.7





    Diluted

    84.3







    84.3





     

    MALLINCKRODT PLC

    NON-GAAP MEASURES

    (unaudited, in millions except per share data)































    Six Months Ended



    June 26, 2020



    June 28, 2019



    Net sales

    Gross

    profit

    SG&A

    Net (loss)

    income



    Diluted

    net

    (loss)

    income

    per

    share (1)



    Net sales

    Gross

    profit

    SG&A

    Net

    income



    Diluted

    net

    income

    per

    share

    GAAP

    $

    832.3



    $

    63.6



    $

    462.4



    $

    (983.3)





    $

    (11.66)





    $

    1,613.9



    $

    724.0



    $

    456.1



    $

    161.7





    $

    1.92



    Adjustments:



























    Intangible asset amortization



    387.5



    (1.7)



    389.2





    4.60







    436.2



    (3.2)



    439.4





    5.21



    Restructuring and related charges, net







    12.6





    0.15











    4.0





    0.05



    Non-restructuring impairment charge







    63.5





    0.75











    113.5





    1.35



    Inventory step-up expense

















    10.0





    10.0





    0.12



    Income from discontinued operations







    (24.0)





    (0.28)











    (7.0)





    (0.08)



    Change in contingent consideration fair value





    5.7



    (5.7)





    (0.07)









    (2.3)



    2.3





    0.03



    Significant legal and environmental charges (2)

    534.4



    534.4



    (39.7)



    671.1





    7.92

















    Divestitures







    (0.4)





















    Separation costs





    (42.0)



    42.0





    0.50









    (30.6)



    30.6





    0.36



    Gain on debt extinguishment, net





















    (71.3)





    (0.85)



    Unrealized gain on equity investment







    (3.0)





    (0.04)

















    R&D upfront payment (3)







    5.0





    0.06

















    Reorganization of legal entity ownership







    (6.3)





    (0.07)











    (189.8)





    (2.25)



    Income taxes (4)







    138.1





    1.63











    (116.0)





    (1.38)



    As adjusted

    $

    1,366.7



    $

    985.5



    $

    384.7



    $

    298.8





    $

    3.53





    $

    1,613.9



    $

    1,170.2



    $

    420.0



    $

    377.4





    $

    4.48































    Percent of adjusted net sales

    100.0

    %

    72.1

    %

    28.1

    %

    21.9

    %







    100.0

    %

    72.5

    %

    26.0

    %

    23.4

    %





































    (1)

    In periods where the Company reports a net loss from continuing operations, potential ordinary shares outstanding are excluded from the calculation of diluted earnings per share, prepared in accordance with GAAP, as they would be anti-dilutive. These potentially dilutive shares are included in the calculation of adjusted diluted earnings per share when dilutive. As a result, the adjusted diluted earnings per share utilized a weighted average share count of 84.7 shares for the six months ended June 26, 2020.





    (2)

    Effective June 15, 2020, the Company was forced under protest to change the base date AMP for Acthar Gel, as directed by CMS. While the Company continues to pursue its appeal of the March 16, 2020 ruling by the U.S. District Court for the District of Columbia that upheld CMS' position, the Company incurred a retrospective one-time charge of $639.7 million, of which $534.4 million and $105.3 million have been reflected as a component of net sales and operating expenses, respectively, in the unaudited condensed consolidated statement of operations. The $105.3 million reflected as a component of operating expenses represents a pre-acquisition contingency related to the portion of the retrospective liability that arose from sales of Acthar Gel prior to the Company's acquisition of Questcor Pharmaceuticals Inc. in August 2014. Of the $534.4 million recorded as a component of net sales, $27.6 million represents the impact of the Medicaid rebate calculation through June 14, 2020 for the six months ended June 26, 2020. Also includes $39.7 million in opioid defense costs which are considered to be non-recurring as a result of the opioid-related litigation settlement announced during the three months ended March 27, 2020; therefore, such costs are included as an adjustment to net income on a go-forward basis until effectuation of the opioid-related litigation settlement. These costs were partially offset by a $8.3 million decrease in the fair value of the opioid settlement warrants.





    (3)

    Represents R&D expense incurred related to an upfront payment made in June 2020 to acquire product rights for terlipressin in Japan.





    (4)

    Includes tax effects of above adjustments (unless otherwise separately stated), changes in uncertain tax positions, tax impacts related to the substantial doubt about the Company's ability to continue as a going concern, legislative changes and certain intercompany transactions.The six months ended June 28, 2019 also includes certain installment sale transactions.

     

    MALLINCKRODT PLC

    SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH

    (unaudited, in millions)























    Six Months Ended















    June 26,

    2020



    June 28,

    2019



    Percent

    change



    Currency

    impact



    Constant-

    currency

    growth

    Specialty Brands (1)

    $

    1,013.4





    $

    1,232.0





    (17.7)

    %



    (0.1)

    %



    (17.6)

    %

    Specialty Generics

    353.3





    381.9





    (7.5)









    (7.5)



    Segment net sales

    $

    1,366.7





    $

    1,613.9





    (15.3)

    %



    (0.1)

    %



    (15.2)

    %

    Medicaid lawsuit

    (534.4)









    *



    *



    *

    Net sales

    $

    832.3





    $

    1,613.9





    (48.4)

    %



    (0.1)

    %



    (48.3)

    %







    *Not meaningful





    (1)

    The six months ended June 26, 2020 includes the prospective change to the Medicaid rebate calculation of $8.6 million for the period from June 15, 2020 through June 26, 2020, of which $6.8 million represents the channel impact.

     

    MALLINCKRODT PLC

    SELECT PRODUCT LINE NET SALES

    (unaudited, in millions)























    Six Months Ended















    June 26,

    2020



    June 28,

    2019



    Percent

    change



    Currency

    impact



    Constant-

    currency

    growth

    Specialty Brands



















    Acthar (1)

    $

    381.3





    $

    490.3





    (22.2)

    %



    %



    (22.2)



    Inomax

    296.6





    290.8





    2.0





    (0.1)





    2.1



    Ofirmev

    127.3





    186.1





    (31.6)









    (31.6)



    Therakos

    111.5





    122.7





    (9.1)





    (0.6)





    (8.5)



    Amitiza

    90.5





    105.0





    (13.8)









    (13.8)



    Other (2)

    6.2





    37.1





    (83.3)









    (83.3)



    Specialty Brands Total

    $

    1,013.4





    $

    1,232.0





    (17.7)

    %



    (0.1)

    %



    (17.6)

    %





















    Specialty Generics



















    Hydrocodone (API) and hydrocodone-containing tablets

    $

    51.9





    $

    35.5





    46.2

    %



    %



    46.2



    Oxycodone (API) and oxycodone-containing tablets

    31.9





    36.1





    (11.6)









    (11.6)



    Acetaminophen (API)

    99.6





    94.6





    5.3









    5.3



    Other controlled substances

    161.4





    192.8





    (16.3)





    (0.1)





    (16.2)



    Other

    8.5





    22.9





    (62.9)









    (62.9)



    Specialty Generics Total

    $

    353.3





    $

    381.9





    (7.5)

    %



    %



    (7.5)

    %

    Segment net sales

    1,366.7





    1,613.9





    (15.3)





    (0.1)





    (15.2)



    Medicaid lawsuit

    (534.4)









    *



    *



    *

    Net sales

    $

    832.3





    $

    1,613.9





    (48.4)

    %



    (0.1)

    %



    (48.3)

    %







    *Not meaningful





    (1)

    The six months ended June 26, 2020 includes the prospective change to the Medicaid rebate calculation of $8.6 million for the period from June 15, 2020 through June 26, 2020, of which $6.8 million represents the channel impact.





    (2)

    The six months ended June 28, 2019 includes $26.3 million of net sales related to BioVectra prior to the completion of the sale of this business in November 2019.

     

    MALLINCKRODT PLC

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (unaudited, in millions)











    June 26,

    2020



    December 27,

    2019

    Assets







    Current Assets:







    Cash and cash equivalents

    $

    818.3





    $

    790.9



    Accounts receivable, net

    493.3





    577.5



    Inventories

    333.0





    312.1



    Prepaid expenses and other current assets

    310.2





    150.2



    Total current assets

    1,954.8





    1,830.7



    Property, plant and equipment, net

    864.7





    896.5



    Intangible assets, net

    6,566.5





    7,018.0



    Other assets

    304.1





    593.7



    Total Assets

    $

    9,690.1





    $

    10,338.9











    Liabilities and Shareholders' Equity







    Current Liabilities:







    Current maturities of long-term debt

    $

    19.5





    $

    633.6



    Accounts payable

    86.5





    139.8



    Accrued payroll and payroll-related costs

    132.5





    105.2



    Accrued interest

    67.2





    62.9



    Medicaid lawsuit

    639.7







    Accrued and other current liabilities

    375.5





    485.4



    Total current liabilities

    1,320.9





    1,426.9



    Long-term debt

    5,223.4





    4,741.2



    Opioid-related litigation settlement liability

    1,635.1





    1,643.4



    Pension and postretirement benefits

    61.4





    62.4



    Environmental liabilities

    60.3





    60.0



    Other income tax liabilities

    220.9





    227.1



    Other liabilities

    198.6





    237.2



    Total Liabilities

    8,720.6





    8,398.2



    Shareholders' Equity:







    Preferred shares







    Ordinary shares

    18.8





    18.7



    Ordinary shares held in treasury at cost

    (1,616.0)





    (1,615.7)



    Additional paid-in capital

    5,575.7





    5,562.5



    Retained deficit

    (3,000.2)





    (2,016.9)



    Accumulated other comprehensive loss

    (8.8)





    (7.9)



    Total Shareholders' Equity

    969.5





    1,940.7



    Total Liabilities and Shareholders' Equity

    $

    9,690.1





    $

    10,338.9



     

    MALLINCKRODT PLC

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (unaudited, in millions)











    Six Months Ended



    June 26,

    2020



    June 28,

    2019

    Cash Flows From Operating Activities:







    Net (loss) income

    $

    (983.3)





    $

    161.7



    Adjustments to reconcile net cash from operating activities:







    Depreciation and amortization

    439.4





    488.6



    Share-based compensation

    13.3





    22.8



    Deferred income taxes

    314.1





    (271.2)



    Non-cash impairment charges

    63.5





    113.5



    Gains on divestitures

    (0.4)







    Other non-cash items

    (12.5)





    (76.0)



    Changes in assets and liabilities:







    Accounts receivable, net

    83.6





    95.5



    Inventories

    (27.2)





    (23.8)



    Accounts payable

    (45.7)





    7.2



    Income taxes

    (219.8)





    22.4



    Medicaid lawsuit

    639.7







    Other

    (40.1)





    (73.3)



    Net cash from operating activities

    224.6





    467.4



    Cash Flows From Investing Activities:







    Capital expenditures

    (31.3)





    (77.6)



    Proceeds from divestiture, net of cash

    (3.5)







    Other

    6.0





    8.2



    Net cash from investing activities

    (28.8)





    (69.4)



    Cash Flows From Financing Activities:







    Issuance of external debt





    200.0



    Repayment of external debt

    (129.6)





    (685.9)



    Debt financing costs

    (9.1)







    Repurchase of shares

    (0.3)





    (2.5)



    Other

    (19.2)





    (18.0)



    Net cash from financing activities

    (158.2)





    (506.4)



    Effect of currency rate changes on cash

    (0.5)





    0.8



    Net change in cash, cash equivalents and restricted cash

    37.1





    (107.6)



    Cash, cash equivalents and restricted cash at beginning of period

    822.6





    367.5



    Cash, cash equivalents and restricted cash at end of period

    $

    859.7





    $

    259.9











    Cash and cash equivalents at end of period

    $

    818.3





    $

    241.1



    Restricted cash included in other assets at end of period

    41.4





    18.8



    Cash, cash equivalents and restricted cash at end of period

    $

    859.7





    $

    259.9



     

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