Mon, Nov. 23, 9:19 AM
Mon, Nov. 23, 6:28 AM
- Mallinckrodt (MNK +1.5%) FQ4 results: Revenues: $882.4M (+31.0%); R&D Expense: $53.9M (+19.8%); SG&A: $302.9M (+20.3%); Operating Income: $42.7M (+124.3%); Net Income: $75.2M (+121.3%); EPS: $0.76 (+137.3%); Non-GAAP EPS: $1.84 (+15.7%).
- FY2015 results: Revenues: $3,346.9M (+60.8%); R&D Expense: $185.1M (+13.2%); SG&A: $1,169.8M (+57.0%); Operating Income: $461.8M (+708.4%); Net Income: $308.2M (+314.3%); EPS: $2.61 (+217.6%); Non-GAAP EPS: $7.37 (+66.0%); Quick Assets: $365.9M (-48.3%).
- No guidance given.
Mon, Nov. 23, 6:02 AM
Sun, Nov. 22, 5:30 PM
Thu, Nov. 19, 9:22 AM
- Mallinckrodt's (NYSE:MNK) board authorizes an additional $500M in share repurchases. $200M was authorized in January. The board also authorizes management to reduce its outstanding debt at its discretion.
- The board's actions are based on the expectation that the company will be able to generate durable earnings and $1B in cash flow from operations each year.
Mon, Nov. 16, 12:09 PM
- The FDA approves Mallinckrodt's (MNK -1.3%) INOmax DSir Plus MRI device for the delivery of INOMAX (nitric oxide) for inhalation during MRI procedures.
- Neonatologist and Professor of Pediatrics Stephen Welty, M.D., says, "Neonates being treated with INOmax frequently have multiple medical concerns that may need diagnostic imaging, such as an MRI scan, to guide medical management. Before INOmax DSir Plus MRI, physicians had to make the difficult decision to take the risk of interrupting INOmax treatment so that imaging could be done. Now, we can deliver uninterrupted inhaled nitric oxide treatment during diagnostic imaging, which will facilitate clinical decision-making and patient care."
- Mallinckrodt obtained the rights to INOmax via its $2.3B acquisition of Ikaria in March. INOmax, a vasodilator (opens blood vessels) that improves oxygen uptake and blood flow, is used in conjunction with ventilator support and other agents.
- Previously: Mallinckrodt buys critical care firm for $2.3B (March 5)
Tue, Nov. 10, 1:30 PM
- On CNBC, Mallinckrodt (MNK +7.9%) CEO Mark Trudeau said the cost of Acthar Gel is a good value compared to the alternative treatments for the (19) indications on the product's label considering the limited treatment options for patients. The costs of the treatments are far greater than the cost of Acthar which, according to Mr. Trudeau, is the view of payers. He also says his firm's business model is unique and should not be compared to Valeant's (VRX -0.9%).
- The stock spiked upward (undoubtedly due to short covering) during Andrew Left's interview during CNBC's Halftime Report today after he failed to provide more "smoking gun" evidence on MNK despite saying that "MNK is worse than VRX."
- Citron Research's has yet to publish its report on the company. Shares dropped 17% yesterday in response to a Citron tweet that stated MNK had significantly more downside risk than VRX.
Mon, Nov. 9, 3:06 PM
- "At these prices Mallinckrodt (MNK -17.3%) has significantly more downside than Valeant," tweets Citron Research. "Far worse offender of the reimbursement system ... more to follow. Valeant can't live in a vacuum."
- "The market has been so focused on Valeant that they forgot about other platform companies who are levered and face the same headwinds in reimbursement," Citron's Left tells BI. "While Valeant has been taking all the heat, the business model of Mallinckrodt is just as, if not more in danger of unraveling."
Mon, Nov. 9, 7:26 AM
- A pilot study run by Mallinckrodt (NYSE:MNK) assessing H.P. Acthar Gel in patients with persistently active Systemic Lupus Erythematosus (SLE) on corticosteroid therapy failed to meet its primary endpoint of a clinical response defined by complete resolution of skin or joint activity as measured by the hybrid SLE Disease Activity Index (hSLEDAI) with no new organ system disease as measured by the British Isles Lupus Assessment Group-2004 (BILAG). The data were presented at poster session during the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting in San Francisco.
- The company-sponsored study, "Repository Corticotropin Injection (H.P. Acthar Gel) Attenuates Disease Activity in Patients with Persistently Active Systemic Lupus Erythematosus (SLE) Requiring Corticosteroids" was an eight-week, double-blind, randomized placebo-controlled trial that assessed the clinical efficacy of repository corticotropin injection (RCI) in 38 patients with persistently active SLE involving skin and/or joints despite moderate dose corticosteroids. Subjects were randomized 2:1 to receive RCI 40 units subcutaneously every day, RCI 80 units subcutaneously every other day or volume-matched placebo gel.
- Although the study failed to achieve its primary efficacy endpoint, treatment with RCI did show improvement in secondary endpoints versus placebo, including reduction in total hSLEDAI, BILAG and CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) Activity scores, decreased tender and swollen joint count and increased proportion of subjects achieving response as defined by a composite index called SRI (SLE responder index).
- Most patients in the study were on multiple therapies so the clinical outcomes may not be solely attributable to Acthar, which has not been formally studied in combination with other commonly used SLE treatments.
- SLE, affecting more than 1.5M Americans, is an autoimmune disease in which the immune system produces antibodies to cells within the body that leads to widespread inflammation and tissue damage.
- H.P. Acthar Gel is currently FDA-approved for 19 indications but generates almost all of its sales in five areas: proteinuria in nephrotic syndrome, multiple sclerosis, infantile spasms, exacerbation or maintenance treatment of SLE and systemic dermatomyositis.
- Mallinckrodt obtained the rights to Acthar Gel via its $5.6B acquisition of Questcor Pharmaceuticals in August 2014.
Fri, Oct. 30, 8:25 AM
- Regulatory authorities in Australia and Japan approve an expanded label for Mallinckrodt's (NYSE:MNK) INOmax (nitric oxide), originally approved in 2007 and 2008, respectively, for the treatment of newborns with hypoxic respiratory failure.
- The Australian Therapeutic Goods Administration (TGA) clears INOmax for peri- and post-operative pulmonary hypertension in conjunction with cardiovascular surgery in neonates through adolescents up to age 17.
- The Japanese Ministry of Health, Labour and Welfare (MHLW) clears INOmax (marketed as INOflo/INOvent in country) for peri-operative pulmonary hypertension in conjunction with cardiovascular surgery for use in neonates through adults.
- INOmax, a vasodilator (opens blood vessels) that improves oxygen uptake and blood flow, is used in conjunction with ventilator support and other agents.
Fri, Oct. 16, 12:32 PM
- Opko Health (OPK +2.5%) initiated with Overweight rating and $14 (47% upside) price target by JP Morgan.
- Jazz Pharmaceuticals (JAZZ +1.7%) initiated with Outperform rating and $200 (44% upside) price target by Northland Capital Markets.
- Mallinckrodt (MNK) initiated with Outperform rating and $92 (37% upside) price target by Northland Capital Markets.
- Shire (SHPG +1.1%) initiated with Outperform rating and $288 (38% upside) price target by Northland Capital Markets.
- Nabriva Therapeutics (NBRV +2.2%) initiated with Outperform rating and $19 (90% upside) price target by Leerink.
- Penumbra (PEN -0.2%) initiated with Buy rating and $48 (20% upside) price target by Canaccord Genuity.
- REGENXBIO (RGNX -3.6%) initiated with Overweight rating and $36 (100% upside) price target by Piper Jaffray.
- Dyax (DYAX -0.9%) upgraded to Outperform from Market Perform by Leerink. Price target raised to $36 (29% upside) from $25.
- Eli Lilly (LLY +1.5%) upgraded to Outperform from Neutral by Credit Suisse. Price target raised to $105 (30% upside) from $89.
- Athenahealth (ATHN -4.6%) downgraded to Underperform from Buy by Jefferies. Price target lowered to $105 (22% downside risk) from $125.
- Halyard Health (HYH -1.5%) downgraded to Underweight from Equal Weight by Morgan Stanley. Price target lowered to $27 (6% downside risk) from 38.
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
Mallinckrodt PLC along with its subsidiaries operates in a specialty biopharmaceutical and nuclear imaging business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and nuclear imaging agents.
Other News & PR