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Mallinckrodt PLC (MNK)

  • Aug. 14, 2014, 7:10 PM
    • S&P MidCap 400 constituent Mallinckrodt (MNK +1.8%) will become the newest member of the S&P 500 after the close of trading on Monday, August 18.
    • Shares are up 2% AH on modest volume.
    | 1 Comment
  • Aug. 7, 2014, 9:21 AM
  • Aug. 7, 2014, 7:30 AM
    • Mallinckrodt (MNK -1.7%) fiscal Q3 results: Net Sales: $653.1M (+14.6%); Gross Profit: $284.3M (+7.0%); Operating Loss: ($4.4M) (-633.3%); Net Loss: ($24.1M) (+13.6%); Loss Per Share: ($0.41) (+14.6%); Quick Assets: $327.9M (+19.0%): CF Ops (9 mo.): $168.1M (+999%).
    • Fiscal 2014 Guidance: Net sales: $2.35B from $2.45B from $2.28 - 2.38B; Specialty Pharma sales: $1.425B - 1.500B from $1.38B - 1.43B; Global Medical Imaging sales: $850M - 900M (unch); Methylphenidate sales: at least $190M from at least $160M; non-GAAP EPS: $4.00 - 4.30 from $3.30 - 3.60.
  • Aug. 7, 2014, 7:14 AM
    • Mallinckrodt (NYSE:MNK): FQ3 EPS of $1.20 beats by $0.35.
    • Revenue of $653.1M (+14.6% Y/Y) beats by $374.3M.
    • Press Release
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  • Aug. 6, 2014, 5:30 PM
  • Aug. 4, 2014, 10:26 AM
    • The FDA approves Lannett Company's (LCI +4.1%) generic oxycodone 5 mg. Product shipments will commence in the next several months.
    • Related tickers: (ZGNX -4.3%) (TEVA -0.5%) (MNK +0.3%) (ALKS -0.6%)
    | 1 Comment
  • Jul. 24, 2014, 10:23 AM
    • Questcor (QCOR +0.8%) Q2 results: Net Sales: $278.8M (+51.0%), Pharmaceuticals: $261.4M (+47.7%); COGS: $23.2M (+34.9%); Gross Profit: $255.7M (+52.7%); R&D Expense: $22.0M (+80.3%); SG&A Expense: $83.6M (+63.9%); Operating Income: $147.8M (+43.4%); Net Income: $96.4M (+39.5%); EPS: $1.54 (+37.5%); Quick Assets: $392.8M (+60.3%).
    • Acthar vials shipped: 8,850 (+25.5%); new paid Acthar prescriptions: 2,775 - 2,800 (+~23%), new paid Nephrotic Syndrome prescriptions: 480 - 490 (+~20%).
    • No guidance given.
  • Jul. 24, 2014, 9:14 AM
    • Questcor Pharmaceuticals (NASDAQ:QCOR): Q2 EPS of $1.85 beats by $0.11.
    • Revenue of $278.8M (+42.2% Y/Y) beats by $17.78M.
    • Press Release
  • Jul. 23, 2014, 5:33 PM
    • The FDA approves Purdue Pharmaceuticals' Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) for the treatment of severe pain requiring around-the-clock long-term opioids where alternative treatment options are inadequate.
    • Targiniq incorporates abuse deterrent technology. When a pill is crushed and/or dissolved (for snorting or injecting) the naloxone blocks the euphoric effects of oxycodone making it less desirable for abusers than oxycodone alone.
    • The agency requires a postmarket study to assess the risks of long-term use beyond 12 weeks and the effects of the abuse deterrent features.
  • Jul. 14, 2014, 8:07 AM
    • The SEC declares the Form S-4 (joint proxy statement/prospectus) effective on July 11 regarding Mallinckrodt's (NYSE:MNK) acquisition of Questcor Pharmaceuticals (NASDAQ:QCOR). Both firms have scheduled shareholder meetings on August 14, 2014 for shareholders of record on July 9, 2014 to vote on the transaction.
  • Jul. 11, 2014, 7:44 AM
    • For the first time, Questcor (QCOR) is reporting adverse events of patients treated with Acthar Gel (repository corticotropin injection) are ~5%, notes The New York Times. The information is disclosed in a regulatory filing submitted yesterday.
    • 8-K (see paragraph 3 under "Product Safety")
  • Jul. 11, 2014, 7:23 AM
    • Sun Pharmaceutical Industries voluntarily recalls 41,127 bottles of antidepressant venlafaxine hydrochoride in the U.S. because the pills do not meet dissolution specifications. The recall is classified as Class II which means that the use of the drug may cause temporary or medically reversible adverse health consequences.
    • Pfizer (PFE) recalled 104,000 bottles of the same drug several months ago after a pharmacist noticed that one of the bottles contained a heart medication. It sells in the U.S. under the brand name Effexor XR.
    • Sun is also recalling 200 vials of the chemo drug gemcitabine in the U.S. due to a lack of assurance of sterility.
    • Related tickers: (TEVA) (RDY) (MYL) (MNK) (PRGO)
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  • Jul. 8, 2014, 3:59 PM
  • Jul. 8, 2014, 7:16 AM
    • The FDA grants Priority Review to Purdue for its tamper-resistant pain medication that competes with Zogenix's (ZGNX) Zohydro. The agency's review of the company's hydrocodone tablet should take ~six months.
    • Purdue's chronic pain offering is hard for abusers to crush so it makes it more difficult to snort or inject. The FDA has stated that Zohydro could be pulled from the market if another manufacturer gets an abuse-deterrent version approved. Zogenix plans to submit an sNDA for an abuse-deterrent formulation of Zohydro in October. Two other competitors are in Phase 3 trials with their product candidates.
    • Related tickers: (TEVA) (ABBV) (ALKS) (MNK) (PFE)
  • Jul. 3, 2014, 8:28 AM
    • In response to a request from the FDA, (TEVA) files a citizen petition (CP) on the approvability of generic versions of Copaxone (glatiramer acetate injection). The agency wanted a CP in order to facilitate public review and comment on new scientific data on gene expression. This will allow Teva to comment publicly on the views and opinions of others and will create an administrative record that the FDA may use as a basis for future decisions.
    • Teva's CP provides new scientific data on gene expression and evidence to support arguments that active ingredient sameness, immunogenicity and bioequivalence in generic offerings are similar but not the same as Copaxone. The company says that competitive offerings should use the same gene expression markers and biological pathways to demonstrate sameness and be evaluated in full-scale clinical trials.
    • One possible outcome of Teva's aggressive efforts to maintain a moat around Copaxone is that it may give it more empathy for branded drug makers when it goes after incumbent products with its own generic versions.
    • Related tickers: (MNK) (ACT) (JNJ) (MYL) (MNTA) (NVS)
    | 1 Comment
  • Jul. 2, 2014, 7:54 AM
    • Zogenix (ZGNX) plans to submit an sNDA by October 2014 for a next-generation version of Zohydro (hydrocodone bitartrate) Extended-Release Capsules that incorporates unspecified abuse deterrent technology designed to make it more difficult to abuse via injection or snorting. If approved, the new formulation will be available in early 2015.
    • The company has also selected the final tablet formulation for clinical development in its collaboration with Altus Formulation. The product will incorporate abuse deterrent technology that maintains the extended-release properties of Zohydro when the tablet is crushed or chewed. This minimizes one on the ways that opioids are abused. It will have additional features that addresses abuse by injection or nasal administration.  Zogenix plans to submit an NDA in H1 2016.
    • Related tickers: (TEVA) (ABBV) (ALKS) (MNK)
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Company Description
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.