Mallinckrodt: A Valeant Clone That Has Imploded
Uncommon Profit Investor • 11 Comments
Uncommon Profit Investor • 11 Comments
Tue, Nov. 29, 6:38 PM
- Mallinckrodt (NYSE:MNK) fell 9.1% in today's trade, tumbling to the bottom of the S&P 500, despite reporting better than expected FQ4 earnings and revenues.
- In the earnings conference call, CEO Mark Trudeau said MNK's specialty generics segment fell 19% in the quarter, and management expects "significant downward pressure on this segment to persist."
- MNK also has experienced temporary "production issues" with a third-party manufacturer supporting its Therakos immunotherapy platform, and the company says the situation could continue into Q2 2017.
- The company's decision to withhold FY 2017 guidance also troubled investors, which caused concerns about lack of sales visibility for Acthar, generics and the hospital franchise to weigh on shares, Guggenheim analyst Louise Chen says.
- Barclays is one of several firms that remain optimistic, saying MNK's selloff was "outsized considering much of the disclosure on the call was largely expected, including specialty generics weakness and the 2017 outlook, which seemed relatively mild."
Tue, Nov. 29, 6:49 AM
- Mallinckrodt (MNK +0.8%) FQ4 results: Revenues: $887.2M (+13.9%); Operating Income: $147.7M (+58.8%); Net Income: $110M (+50.5%); EPS: $1.01 (+62.9%); Non-GAAP EPS: $2.04 (+21.4%).
- FY2016 results: Revenues: $3,380.8M (+15.7%); Operating Income: $617.3M (+74.5%); Net Income: $489M (+106.7%); EPS: $4.39 (+119.5%); Non-GAAP EPS: $7.85 (+15.6%); Quick Assets: $280.5M (-23.3%); CF Ops: $1,184.6M (+32.2%).
- Shares are up 4% premarket.
Tue, Nov. 29, 6:02 AM
Mon, Nov. 28, 5:30 PM
Mon, Nov. 21, 8:17 AM
- Mallinckrodt (NYSE:MNK) announces plans to initiate a Phase 2 clinical trial in the first half of next year to assess H.P. Acthar Gel (repository corticotropin injection) in patients with amyotrophic lateral sclerosis (ALS), a Fast Track designation by the FDA.
- The eight-week open-label study will evaluate four different dosing regimens of Acthar. An optional 28-week open-label extension phase will follow.
Fri, Nov. 18, 9:42 AM
- Raymond James initiates coverage of Mallinckrodt (MNK +0.9%) with an Outperform rating and $72 (29% upside) price target.
Thu, Nov. 17, 8:14 AM
- Deutsche Bank analyst Gregg Gilbert says Mallinckrodt (NYSE:MNK) did not intentionally mislead investors relative to Acthar's exposure to Medicare. He adds that yesterday's sell-off creates an "interesting" entry point. He reiterates his Buy rating and $78 (29% upside) price target.
- Shares are up a fraction premarket.
Wed, Nov. 16, 6:18 PM
- Mallinckrodt (NYSE:MNK) plunged 12% in today's trade after short seller Andrew Left accused CEO Mark Trudeau of committing securities fraud.
- "Trudeau has been caught red handed committing securities fraud - exposed by none other than the newly released Medicare drug-spending dashboard," according to Citron Research editor Left, who called into question MNK's Acthar Gel sales derived from government sources such as Medicaid and Medicare.
- Leerink analysts say the report attempts to question whether the government should be paying Acthar’s average $80K-$100K net price per patient per year and calling it to the attention of government figures who have been targeting excessive drug pricing issues, in the type of issue that became a major headache for Mylan recently with EpiPen.
Wed, Nov. 16, 3:31 PM
Fri, Nov. 4, 3:24 PM
Sat, Oct. 22, 6:37 PM
- Mallinckrodt (NYSE:MNK) and Lannett Company (NYSEMKT:LCI) are tussling with the FDA over its withdrawal of previously approved abbreviated New Drug Applications (ANDAs) for generic versions of Janssen Pharmaceuticals' (NYSE:JNJ) CONCERTA (methylphenidate HCl) for the treatment of attention deficit hyperactivity disorder (ADHD).
- The agency pulled the approvals due to the lack of bioequivalence. Although bioequivalence was the basis for the original approvals, field reports of insufficient therapeutic effect surfaced after the products were launched. In an analysis of reports from the FDA's adverse event reporting system, FAERS, the reported therapeutic failures of the generics in question were almost 10x higher than Actavis' (NASDAQ:TEVA) generic version, the reference drug. Further analyses showed differences in the rates of drug release and absorption. Specifically, the companies' products delivered the active ingredient at a slower rate 7 - 12 hours after dosing.
- Lannett has requested a hearing with the FDA on the matter. Mallinckrodt will have to do the same after an appeals court removed its pending litigation with the agency from its oral argument calendar. It has filed a Motion to Reconsider in an attempt to be put back on the docket. Both firms insist that their generic versions are safe and effective.
Fri, Sep. 23, 9:16 AM
- In an Inter Partes Review, the USPTO's Patent Trial and Appeals Board (PTAB) upholds five Mallinckrodt (NYSE:MNK) patents covering INOMAX (nitric oxide) gas for inhalation. The patents, valid until 2031, were challenged by Praxair Distribution (NYSE:PX).
- INOMAX is approved in the U.S. to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation in term and near-term (at least 34 weeks gestation) neonates with hypoxic respiratory failure associated with pulmonary hypertension in conjunction with ventilator support and other agents.
Thu, Aug. 25, 9:14 AM
- The FDA designates Mallinckrodt's (NYSE:MNK) Synacthen (tetracosactide) depot formulation (long acting) for Fast Track review for the treatment of Duchenne muscular dystrophy (DMD). A Phase 1 study is underway.
- Synacthen, a 24-amino acid melanocortin receptor agonist, is a synthetic version of the natural hormone ACTH (adrenocorticotrophic hormone). It is currently approved ex-U.S. to test if the adrenal glands are working properly and to treat adrenocortical insufficiency.
- DMD is an inherited disorder caused by the absence of a protein called dystrophin. It is characterized by progressive muscle degeneration and weakness.
- Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
- DMD-related tickers: (NASDAQ:SRPT)(NASDAQ:BMRN)(NASDAQ:SMMT)(NASDAQ:PTCT)(NYSE:PFE)(OTCQB:MRNA)(NASDAQ:CATB)
Wed, Aug. 24, 8:38 AM
- Mallinckrodt (NYSE:MNK) inks a deal to sell its Nuclear Imaging business to IBA Molecular for ~$690M, consisting of an upfront payment of $574M, contingencies of $77M and the assumption of $39M in long-term obligations.
- The unit includes a portfolio of diagnostic imaging products including the medical isotope molybdenum-99, the source of technetium-99m, used in ~80% of nuclear medicine procedures worldwide. About 2/3 of the total business is in the U.S.
- The transaction, expected to close in H1, 2017, includes 800 employees and two manufacturing facilities in Missouri and the Netherlands.
Fri, Aug. 19, 8:01 AM
- Arrowhead Pharmaceuticals (NASDAQ:ARWR) initiated with Buy rating and $15 (112% upside) price target by Cantor Fitzgerald.
- Karyopharm Therapeutics (NASDAQ:KPTI) initiated with Buy rating and $15 (92% upside) price target by H.C. Wainwright.
- Mediwound Ltd. (NASDAQ:MDWD) initiated with Outperform rating and $14 (75% upside) price target by Wells Fargo.
- SCYNEXIS (NASDAQ:SCYX) initiated with Buy rating and $15 (436% upside) price target by Guggenheim Securities.
- Patheon NV (Pending:PTHN) initiated with Neutral rating and $30 (7% upside) price target by Credit Suisse. Initiated with Buy rating and $32 (14% upside) price target by Jefferies. Initiated with Overweight rating and $31 (11% upside) price target by Morgan Stanley.
- GlycoMimetics (NASDAQ:GLYC) initiated with Outperform rating by Cowen and Company. Initiated with Outperform rating and $32.50 (306% upside) price target by Raymond James.
- Audentes Therapeutics (Pending:BOLD) initiated with an Outperform rating by Cowen and Company. Initiated with Outperform rating and $20 (33% upside) price target by Wedbush.
- Mallinckrodt (NYSE:MNK) initiated with Buy rating and $95 (19% upside) price target by Stifel Nicolaus.
- TESARO (NASDAQ:TSRO) initiated with Outperform rating and $122 (28% upside) price target by RBC Capital.
Wed, Aug. 10, 6:54 PM
- Mallinckrodt plc (NYSE:MNK) acquires privately held Stratatech for an undisclosed sum. The Madison, WI-based regenerative medicine firm develops proprietary skin substitute products.
- Its lead pipeline candidate is Phase 3-stage StrataGraft, an "off-the-shelf" skin substitute for the treatment of severe burns.
- The transaction should close later this year. According to the company, it is unable to provide guidance on the impact of the deal to EPS due to the difficulty in forecasting the timing or amount of items that would impact GAAP earnings.