Mon, Oct. 5, 5:15 PM
- Biopharma Mallinckrodt (NYSE:MNK), down 1.8% after hours, is planning a business and financial guidance update for tomorrow morning.
- The company will give recast historical info showing its reclassification of its contrast media and delivery systems (CMDS) business as discontinued operations after agreeing to sell it to Guerbet for $270M in July. That deal is set to close in fiscal Q1 2016.
- A conference call to discuss the guidance, featuring a Q&A session, is set for 7:30 a.m. ET tomorrow.
- Shares fell 6.8% during market hours today.
Tue, Sep. 22, 1:51 PM
- The market's down day notwithstanding, thinly traded small cap ANI Pharmaceuticals (ANIP -16.2%) gets no help from Leerink analyst Jason Gerberry. Based on discussions with ANI and Mallinckrodt (MNK -1.3%), he says ANI's Acthar-similar won't pose much of a competitive threat to the latter's brand. He says ANI told him that it plans to market its version with a small sales force and offer only a modest discount to Acthar.
- Mr. Gerberry also cites the uncertainty about whether ANI's offering will be cleared for the same indications as Acthar since the package insert for the NDAs it acquired from Merck is not publicly available and the company is not making the documents available to investors. He says more clarity of ANI's development pathway won't be coming until mid-2016, after its meeting with the FDA.
- Previously: ANI Pharma picks up two NDAs from Merck for $75M (Sept. 21)
Thu, Sep. 10, 6:54 AM
- Mallinckrodt (NYSE:MNK) enters into an agreement to privately place $750M aggregate principal amount of 5.625% senior unsecured notes due October 2023 on September 24. The debt will help finance the company's previously announced acquisition of TGG Medical Solutions for $1.325B, which includes subsidiary Therakos.
- Previously: Mallinckrodt takes out Therakos for $1.3B (Aug. 10)
Mon, Aug. 10, 8:00 AM
- Mallinckrodt (NYSE:MNK) acquires privately-held West Chester, PA-based Therakos for $1.325B. The transaction is expected to close in Q3.
- Therakos develops autologous immune cell therapies delivered through extracorporeal photopheresis via its CELLEX and UVAR XTS systems. It employs extracorporeal (outside the body) photopheresis (certain components of the blood are separated and treated with a photosensitizing agent) to treat leukocyte-enriched blood for the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma in patients that have not responded to other treatments. Specifically, the systems irradiate extracorporeally circulating blood with ultraviolet-A in the presence of the photoactive drug 8-methoxypsoralen.
- The deal is expected to add at least $0.10 per share to MNK's non-GAAP EPS in fiscal 2016 and increasingly accretive thereafter. Therakos' top line contribution will be $185M - 195M in fiscal 2015 with high single-digit growth going forward.
- MNK will fund the transaction with cash on hand plus debt.
Tue, Aug. 4, 9:35 AM| Tue, Aug. 4, 9:35 AM | 2 Comments
Tue, Aug. 4, 6:56 AM
Mon, Aug. 3, 5:30 PM
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Tue, Jul. 28, 7:16 AM
- As part of its plan to streamline its portfolio and focus on higher-growth, higher-margin opportunities in specialty pharmaceuticals, Mallinckrodt (NYSE:MNK) sells its contrast media and delivery systems (CMDS) business to French firm Guerbet for $270M. In H1, the CMDS unit generated $210M in sales.
- Beginning in Q4, MNK will report the business as a discontinued operation. This will reduce fiscal year revenues between $415M - 425M and reduce non-GAAP EPS between $0.35 and 0.45.
- The transaction should close in the next few months.
Tue, Jun. 30, 10:08 AM| Tue, Jun. 30, 10:08 AM | 3 Comments
Fri, May 29, 5:41 PM
- Orexigen Therapeutics (NASDAQ:OREX) enters into a supply agreement with Mallinckrodt (NYSE:MNK) for naltrexone, one of the active ingredients in its obesity pill Contrave. Orexigen will buy naltrexone at fixed prices, subject to certain limitations. The agreement will be effective through December 2018.
Thu, May 21, 10:58 AM
- Thinly traded nano cap Intellipharmaceutics (IPCI +17.3%) heads north on a 10x surge in volume in response to its announcement that the FDA may not require a Phase 3 study for its abuse-deterrent opioid candidate, Rexista Oxycodone XR, if bioequivalence to Purdue Pharma's Oxycontin is demonstrated. The company believes that its previously completed Phase 1 trials fulfill this criterion.
- The firm intends to file its New Drug Application (NDA) within the next 6 - 12 months. Approval is not guaranteed, however. After reviewing the data, the FDA may still require further studies.
- Rexista Oxycodone XR's formulation deters abuse by instantaneously coagulating and entrapping the drug in a viscous hydrogel when pulverized and hydrated. It is also designed to prevent dose dumping if taken with alcohol.
- Related tickers: (PTIE -1.9%)(DRRX)(COLL +1.9%)(ZGNX)(MNK -0.3%)(ACT +1.1%)(TEVA +1.6%)(ABBV -0.7%)(LCI -0.7%)(ALKS -1%)(EGLT -0.1%)(PFE -0.2%)(ACUR -2.4%)
Tue, May 5, 9:10 AM
- Mallinckrodt (MNK +0.7%) FQ2 results: Revenues: $909.9M (+63.1%); COGS: $421.4M (+42.8%); R&D Expense: $47M (+13.5%); SG&A: $343.5M (+77.0%); Operating Income: $95.2M (+999%); Net Income: $76.5M (+553.8%); EPS: $0.66 (+230.0%); Quick Assets: $1,053.5M (+48.8%); CF Ops: $365.5M (+158.9%).
- 2015 Guidance: Sales: $3.75B - 3.85B; Adjusted EPS: $7.10 - 7.50; Non-GAAP effective tax rate: 18 - 20%.
Tue, May 5, 6:57 AM
Mon, May 4, 5:30 PM
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Mon, Apr. 27, 11:19 AM
- Drug manufacturers have long defended their pricing by citing the need to recoup ultra-high development costs. Now another price-raising scheme is drawing attention. In a report by the Wall Street Journal, there are a growing number of examples where companies acquire drugs they perceive as undervalued and then significantly raise the prices.
- In February, Valeant Pharmaceuticals (VRX -1.5%) purchased the rights to two heart drugs, Isuprel and Nitropress, from privately-held Marathon Pharmaceuticals for an undisclosed sum. It then immediately raised the prices 525% and 212%, respectively, based on the recommendations of a consultant who researched the price/benefit of each. According to Truven Health Analytics, the cost of a 1mL vial of Isuprel went from $215.46 to $1,346.62 while a 2mL vial of Nitropress went from $257.80 to $805.61.
- Last year, Mallinckrodt (MNK -0.7%) bought Cadence Pharmaceuticals to gain access to its Ofirmev pain meds. A short time later, the list price for a package of 24 vials jumped 2.5-fold to over $1,019.52.
- In 2013, Horizon Pharma increased the price of Vimovo pain tablets, after acquiring the rights from AstraZeneca, almost 600% to $959.04.
- Valeant is apparently leading the price-raising pack. It has boosted list prices by at least 20% about 122 times since early 2011.
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Mallinckrodt PLC develops, manufactures, markets & distributes generic specialty pharmaceutical products, active pharmaceutical ingredients and diagnostic imaging agents. It operates in two segments; Specialty Pharmaceuticals & Global Medical Imaging.
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