Tue, Jun. 21, 12:48 PM
Tue, Jun. 21, 11:00 AM
Tue, Jun. 21, 9:12 AM
Tue, Jun. 21, 7:54 AM
- Impax Laboratories (NASDAQ:IPXL) acquires a group of 15 generic drugs from Teva Pharmaceutical Industries (NYSE:TEVA) and affiliates of Allergan (NYSE:AGN) for total consideration of $586M. The transaction also includes the return of the rights to the pending abbreviated New Drug Application (ANDA) for a generic version of Johnson & Johnson's (NYSE:JNJ) Concerta (methylphenidate hydrochloride) to Impax.
- The deal will be immediately accretive to Impax's earnings. The group generated ~$150M in sales and ~$100M in gross profit in 2015. Per IMS, the U.S. market for the portfolio is ~$3.1B.
- Impax will finance the acquisition with cash on hand and $400M in term loans.
- Teva divested the products to satisfy U.S. Federal Trade Commission conditions for its planned acquisition of Allergan's generics business.
Fri, Jun. 10, 7:19 AM
- Boston Scientific (NYSE:BSX) initiated with Buy rating and $26 (13% upside) price target by Guggenheim Securities.
- Zimmer Biomet Holdings (NYSE:ZBH) initiated with Neutral rating and $140 (18% upside) price target by Guggenheim Securities.
- Edwards Lifesciences (NYSE:EW) initiated with Neutral rating and $120 (18% upside) price target by Guggenheim Securities.
- Oncobiologics (Pending:ONS) initiated with Buy rating and $15 (218% upside) price target by Cantor Fitzgerald.
- Walgreens Boots Alliance (NASDAQ:WBA) reinstated with Buy rating and $95 (20% upside) price target by Bank of America.
- Goldman Sachs initiates coverage of specialty pharma with a Neutral rating: Buy: Jazz Pharma (NASDAQ:JAZZ) - $196 (26% upside) price target, Horizon Pharma (NASDAQ:HZNP) - $24 (30% upside) price target; Neutral: Endo International (NASDAQ:ENDP) - $20 (11% upside) price target, Mallinckrodt (NYSE:MNK) - $73 (17% upside) price target, Momenta Pharmaceuticals (NASDAQ:MNTA) - $14 (19% upside) price target; Concordia Healthcare (NASDAQ:CXRX) - $32 (31% upside) price target; Sell: Impax Laboratories (NASDAQ:IPXL) - $33 (2% downside risk) price target.
- Biocept (NASDAQ:BIOC) initiated with Buy rating and $1.20 (71% upside) price target by Roth Capital.
- Seres Therapeutics (NASDAQ:MCRB) initiated with Outperform rating and $40 (22% upside) price target by Cowen & Company.
- Omeros (NASDAQ:OMER) initiated with Buy rating and $21 (94% upside) price target by Cantor Fitzgerald.
- Glaukos (NYSE:GKOS) initiated with Buy rating and $35 (30% upside) price target by Cantor Fitzgerald.
- Shire plc (NASDAQ:SHPG) initiated with Overweight rating and GBX5,600 (34% upside) price target by Morgan Stanley.
Tue, May 10, 6:41 AM
Mon, May 9, 5:30 PM| Mon, May 9, 5:30 PM | 1 Comment
Wed, May 4, 12:55 PM
- Turing Pharmaceuticals' post-Martin Shkreli fallout continues with a lawsuit filed by Impax Laboratories (IPXL -4%) accusing the company of breaching their Daraprim (pyrimethamine) contract and soiling its and the drug's reputation with payers, patients and investors with its behavior and outrageous 5,000% price hike.
- Under the terms of their agreement, Impax allowed Turing to use its drug ID code to sell Daraprim which meant that Impax would be responsible for filing certifications and Medicaid payments. Turing was supposed to provide monthly pricing data to Impax for the government notifications and to pay it for the rebates owed to Medicaid. It did neither. Impax says Turing owes it $30M as of this month, with more accruing. According to Impax, the tab is exorbitant because Turing's sky-high price has forced it to pay more than 50x the Medicaid rebate it expected when it sold the drug to Turing.
- The lawsuit also accuses Turing of damaging its reputation by virtue of the notorious price increase and specifically tarnishing its image with the Centers for Medicare and Medicaid Services over its failure to file timely and accurate reports.
- On another front, Mr. Shkreli is apparently about to face another as-yet-undisclosed indictment. A hearing is set for June 6.
- Previously: Turing's Shkreli bows to pressure and drops price of Daraprim (Sept. 23, 2015)
Thu, Mar. 31, 10:10 AM
- The U.S. Federal Trade Commission (FTC) has filed a complaint in federal court accusing Endo International (ENDP -4.3%) unit Endo Pharmaceuticals and several other drug firms of using pay-for-delay deals to block the market launch of lower-cost generic versions of pain med Opana ER (oxymorphone HCl) and shingles pain patch Lidoderm (lidocaine patch 5%).
- The FTC's suit alleges Endo paid the first filers, Impax Laboratories (IPXL -1%) and Watson Laboratories (AGN -0.2%), to delay the launches of their versions of the two products. The complaint seeks a court judgement declaring that the defendants' conduct violated antitrust laws, the disgorgement of their ill-gotten gains and a permanent injunction barring them from future anti-competitive behavior.
- In 2010, Endo alleged paid Impax more than $112M to delay the launch of its generic version of Opana ER until January 2013. Opana ER sales in 2012 were more than $250M. In May 2012, Endo and its partners Teikoku Seiyaku Co. Ltd. and Teikoku Pharma USA allegedly paid Watson hundreds of millions of dollars, including $96M of free Lidoderm product, to delay the launch of its generic version of Lidoderm, a $1B business at that time, until September 2013. For the first 7 1/2 months after September 2013, Endo made a deal with Watson not to market its own generic version which enabled Watson to be the only generic supplier on the market.
- The charges against the Japanese firms has been settled via a stipulated order for permanent injunction that prohibits the Teikoku entities from engaging in certain types of reverse-payment agreements for 20 years.
Wed, Mar. 9, 6:53 AM
- In a regulatory filing, Impax Laboratories (NASDAQ:IPXL) reports that its board has approved a restructuring plan with the aim of reducing costs, improving operating efficiencies and beefing up its competitive position.
- The plan includes the closure of its Middlesex, New Jersey manufacturing and packaging site and the elimination of ~213 positions at the facility over the following 24 months. The products made at the site will be transferred to other company locations or third party manufacturers. The R&D activities at Middlesex will be unaffected.
- The plan is expected to save $23M - 27M per year beginning in 2017. The company expects to record aggregate pre-tax charges of ~$45M - 53M over the next two years, with $22M - 25M to be booked in 2016. Total cash charges will be $26M - 31M.
- Separately, the company discloses that it received a Civil Investigative Demand (CID) on March 8 from the U.S. Attorney's Office, Southern District of New York, Civil Frauds Unit. The CID requests information related to the company and any pharmacy benefit manager (PBM) concerning migraine nasal spray Zomig (zolmitriptan), specifically any contracts between the parties and any services performed by and payments to the PBMs under the contracts. Impax intends to cooperate fully with the inquiry.
Mon, Feb. 22, 7:07 AM
- Impax Laboratories (IPXL) Q4 results: Revenues: $282.1M (+115.0%); R&D Expense: $26.4M (+56.2%); SG&A: $56.5M (+33.9%); Operating Income: $30.8M (+999%); Net Income: $11.4M (+999%); EPS: $0.16; Non-GAAP EPS: $0.62 (+287.5%).
- FY2015 results: Revenues: $860.5M (+44.4%); R&D Expense: $77M (-2.0%); SG&A: $201.3M (+44.4%); Operating Income: $69.6M (-21.6%); Net Income: $39M (-32.1%); EPS: $0.54 (-33.3%); Non-GAAP EPS: $1.45 (+9.8%); Quick Assets: $340.4M (-18.0%).
- 2016 Guidance: Revenues: Company expects revenues to increase at least 15% over FY2015; Adjusted R&D Expense across the generic and brand divisions: ~$100M - 105M; Adjusted SG&A Expense: ~$200M - 210M; CAPEX: ~$40M; Company expects Adjusted EPS to increase at least 10% over FY15 adjusted diluted EPS.
Mon, Feb. 22, 6:31 AM
Sun, Feb. 21, 5:30 PM
Wed, Feb. 17, 11:02 AM
- The FDA approves Impax Laboratories' (IPXL +12.9%) abbreviated New Drug Application (ANDA) for attention deficit hyperactivity disorder (ADHD) med dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (mixed salts of a single-entity amphetamine product) extended-release capsules in range of strengths.
- The company plans to transition to the ANDA product from the current generic Adderall XR.
- U.S. annual sales of branded and generic mixed amphetamines are $1.8B.
Tue, Feb. 2, 8:20 AM
- The FDA grants preliminary approval of Impax Laboratories' (NASDAQ:IPXL) generic version of Merck's (NYSE:MRK) cholesterol med VYTORIN (ezetimibe and simvastatin) in the 10/10, 10/20, 10/40 and 10/80 mg strengths. According to IMS Health, U.S. sales for the four strengths in 2015 were $714M.
- Preliminary approval means that the New Drug Application meets all the quality, safety and efficacy standards for clearance but is subject to an automatic stay of final approval for up to 30 months pending the resolution of a patent infringement suit.
- Shares are up 19% premarket but only on turnover of 100.
Fri, Jan. 15, 7:55 AM
- The FDA approves Impax Laboratories' (NASDAQ:IPXL) supplemental New Drug Application (sNDA) for EMVERM (mebendazole) 100 mg chewable tablets for the treatment of pinworm, roundworm and hookworm, in single or mixed infections. Pinworm, three times more common than head lice, is a highly contagious parasite that infects 40M Americans each year.
- Commercial distribution will commence next quarter.
Impax Laboratories, Inc. operates as a technology based specialty pharmaceutical company, which engages in the development, manufacture and marketing of controlled-release and niche generics. It operates through two segments: Global Pharmaceuticals and Impax Pharmaceuticals. The Global... More
Industry: Drug Manufacturers - Major
Country: United States
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