Mon, Mar. 2, 5:01 PM
- Mylan (NASDAQ:MYL) Q4 results ($M): Total Revenues: 2,082.7 (+15.2%); Generics: 1,815.0 (+12.2%); Specialty: 242.7 (+37.8%); Gross Profit: 969.0 (+21.7%); Operating Expenses: 576.5 (+10.3%); Net Income: 189.2 (+5.0%); Quick Assets: 225.5 (-22.6%); CF Ops (12 mo.): 1,533 (-8.9%).
- 2015 Guidance: Total Revenues: $9.6B - 10.1B; EBITDA: $2.9B - 3.3B; Non-GAAP Net Income: $1.975B - 2.150B; Non-GAAP EPS: $4.00 - 4.30; Non-GAAP CF Ops: $1.6B - 1.8B.
Mon, Mar. 2, 4:13 PM
Sun, Mar. 1, 5:35 PM
Mon, Feb. 23, 12:18 PM
- Gilead Sciences (GILD +2.2%) enters into an exclusive distribution agreement with Mylan's (MYL -0.1%) India-based subsidiary, Mylan Pharmaceuticals Private Limited, for the exclusive distribution of branded Sovaldi (sofosbuvir 400 mg tablets) and Harvoni (ledispasvir 90 mg/sofosbuvir 400 mg tablets) in India. Mylan expects to commence distribution in Q2.
- The agreement is in addition to the licensing and technology transfer agreements that Gilead signed with Mylan and seven other Indian generic drug makers for the non-exclusive rights to manufacture and distribute generic sofosbuvir, ledipasvir/sofosbuvir and, when approved, the investigational NS5A inhibitor, GS-5816 and a single tablet regimen of sofosbuvir/GS-5816 in 91 developing countries.
- Previously: Gilead adds investigational NS5A inhibitor to generic licensing agreements (Jan. 26)
Fri, Feb. 6, 9:20 AM
- According to some observers, Pfizer's (NYSE:PFE) $17B takeout of Hospira (NYSE:HSP) is only a prelude to a bigger deal(s) considering that it was prepared to spend $120B for AstraZeneca (NYSE:AZN).
- According to Gabelli analyst Kevin Kedra, Actavis Plc (NYSE:ACT) is an attractive target, especially since nabbing Allergan (NYSE:AGN) and its fast-growing drug portfolio. A Pfizer takeover would be big enough to overcome the U.S. Treasury's stricter rules on inversions and lower its tax bill.
- John Boris of SunTrust Banks says GlaxoSmithKline (NYSE:GSK), AbbVie (NYSE:ABBV), Bristol-Myers Squibb (NYSE:BMY) and Mylan (NASDAQ:MYL) may be on the radar as well.
- Pfizer had $33B in cash at the end of September which it will use a portion of plus debt to pay for Hospira.
Wed, Jan. 28, 12:38 PM
- The European Commission clears Mylan's (MYL -0.1%) $5.3B acquisition of Abbott's (ABT +0.7%) non-U.S. Developed Markets Specialty and Branded Generics Business. The EC is concerned that the transaction would potentially reduce competition so its approval is contingent upon the divestment of some of Mylan's businesses in Germany, the U.K., France, Ireland and Italy.
Dec. 10, 2014, 7:15 AM
- Mylan (NASDAQ:MYL) will accelerate the equity vesting for certain executives ahead of its planned exit from the U.S. pursuant to its deal to purchase Abbott Labs' European assets. It will also pick up the tax bill for them that was instituted by the U.S. government to discourage inversion deals.
- The total value of the accelerated vesting and tax assistance will be $32.5M and $20.5M, respectively.
- The company's move to the Netherlands will reduce its tax rate from ~25% to the high teens.
- The new rules instituted by President Obama's Treasury Department making inversions more expensive was successful in stopping the flow of deals, although Medtronic will follow through with its acquisition of Covidien.
Dec. 1, 2014, 10:52 AM
- Gilead Sciences (GILD +1%) will allow Mylan (MYL -0.8%) subsidiary Mylan Laboratories Limited to manufacture and distribute its HIV drug tenofovir alafenamide (TAF) as either a single agent or in an approved combination. The license covers 112 countries and 30M HIV sufferers.
- TAF is currently in Phase 3 development. Gilead currently manufactures drugs containing tenofovir under the brand names Viread and Truvada.
Nov. 18, 2014, 12:06 PM
- The U.S. Court of Appeals for the Federal Circuit rules in favor of generic firms, including Teva Pharmaceutical Industries (TEVA), in Roche's and Warner-Chilcott's (ACT +6.5%) patent infringement suit over Roche's branded osteoporosis med Actonel at a monthly dose of 150 mg (Warner licensed the product from Roche).
- From August 2008 to February 2011, Teva, Apotex, Mylan Pharmaceuticals (MYL +1.7%) and Sun Pharma all filed ANDAs to sell generic Actonel 150 mg tablets.
Oct. 31, 2014, 12:38 PM
- Mylan (MYL +3.1%) Q3 results: Revenues: $2,084M (+17.9%); COGS: $1,071.6M (+11.8%); R&D Expense: $158.2M (+38.8%); SG&A: $418.3M (+19.6%); Operating Income: $495M (+45.7%); Net Income: $499.1M (+214.1%); EPS: $1.26 (+215.0%); Quick Assets: $199.6M (-31.5%); CF Ops: $888.0M (+28.9%).
- 2014 Guidance: Total revenues: $7.7B - 7.8B from $7.8B - 8.0B; Gross margin: 52% - 53% from 51 - 53%; EBITDA: $2.35b - $2.41B from $2.2B - 2.4B; Net income: $1.4B - 1.44B from $1.265B - 1.370B; Non-GAAP EPS: $3.54 - $3.60 from $3.44 - $3.54; CF Ops: $1.2B - $1.3B from $1.2B - $1.4B; CAPEX: $300M - 350M from $350M - 400M.
- Q4 Guidance: EBITDA: $660M - $720M: Net income: $410M - $450M; Non-GAAP EPS: $1.03 - $1.09.
Oct. 30, 2014, 4:36 PM
Oct. 28, 2014, 9:43 AM
- A U.S. District Court rules in favor of The Medicines Company (MDCO +12.7%) in its patent infringement suit against generic med firm Mylan (MYL +0.6%). The judge rules that Mylan's ANDA for a generic version of MDCO's Angiomax (bivalirudin) infringes on the latter's U.S. Patent No. 7,582,727, which is valid until 2028.
Oct. 22, 2014, 12:24 PM
- In response to the changes in the tax code related to inversions, Abbott (ABT -1.1%) and Mylan (MYL -2.5%) adjust the terms of their $5.3B all-stock deal. The pricing terms related to product manufacturing and supply have been changed in favor of New Mylan and the number of shares of stock to be issued to Abbott have been increased to 110M from 105M.
- Former shareholders of Mylan will own ~78% of New Mylan and Abbott and its affiliates will own ~22%. The transaction is expected to close in Q1 2015.
Oct. 15, 2014, 4:13 AM
- The Supreme Court is due to hear oral arguments today over a patent for Teva's (NYSE:TEVA) top-selling multiple sclerosis drug Copaxone, which accounts for 50% of its profit.
- The patent was due to expire in September 2015, although in July 2013, the U.S. Court of Appeals for the Federal Circuit ruled that the patent was invalid. Copaxone has no IP protection at the moment.
- Two consortia are developing generic versions of Copaxone, with one involving Novartis (NYSE:NVS) and Momenta (NASDAQ:MNTA), and the other Mylan (NASDAQ:MYL) and Natco. The companies risk having to pay Teva hundreds of millions of dollars if they introduce Copaxone and then lose in the Supreme Court.
Oct. 3, 2014, 9:10 AM
Oct. 3, 2014, 7:34 AM
- Citing a stronger-than-expected Q3, Mylan (NASDAQ:MYL) increases its Q3 and full-year guidance. For Q3, it now expects non-GAAP EPS to be $1.12 - 1.16 compared to its previous forecast of $0.90 - 0.95. The revised guidance includes $0.14 per share from an agreement with Strides Arcolab Limited. Myan recognized earnings for lost revenues in 2014 that arose from supply disruptions due to quality enhancement efforts initiated at certain Agila locations prior to Mylan's acquisition of Agila from Strides in 2013.
- Mylan ups its 2014 full-year non-GAAP EPS guidance to $3.44 - 3.54 from $3.25 - 3.45.
- The company will report Q3 results on October 30 after the close. The conference call will begin at 4:30 pm ET. Consensus view on revenue is $2.04B.
- Shares are up 4% premarket on light volume.
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