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.
Sep. 23, 2014, 3:45 AM
- Under Treasury Secretary Jack Lew’s crackdown on inversions, the Treasury Department announced new tax rules late yesterday to deter U.S. companies from moving their domicile to countries with lower tax rates.
- The tax changes make it harder for companies to complete overseas mergers, and should they choose to invert, companies will face a hard time using the cash accumulated abroad.
- The new rules are effective immediately and apply to all deals that have not closed by yesterday.
- Related M&A: MDT, COV, SLXP, MYL, CQB, OTC:FYFFF,BKW, THI
Sep. 13, 2014, 1:53 PM
- The FDA grants tentative approval for Mylan's (NASDAQ:MYL) emtricitabine and tenofovir disoproxil fumarate combination tablets (200 mg/300 mg) co-packaged with nevirapine tablets (200 mg) for the treatment of patients with HIV-1. The product is cleared for use alone or in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and pediatric patients at least 12 years old and weighing at least 38 kg.
- Tentative approval means that the product meets the quality, safety and efficacy standards for regulatory clearance, but is not eligible for marketing in the U.S. due to patent protections, although it clears the product for sale ex. U.S. under the PEPFAR program (President's Emergency Plan for AIDS Relief).
- The branded Emtricitabine/tenofovir (200 mg/300 mg) product is Gilead Sciences' (NASDAQ:GILD) Truvada. Nevirapine (200 mg) tablets are sold under the brand name Viramune by Boehringer Ingelheim.
Sep. 10, 2014, 7:42 AM
- Mylan (NASDAQ:MYL) acquires the U.S. rights to Arixtra (fondaparinux sodium) Injection and the authorized generic of Arixtra from Aspen Global Inc. Arixtra is indicated for the prophylaxis of deep vein thrombosis (DVT).
- Mylan is already selling Arixtra via an interim distribution agreement. Apotex is currently selling generic Arixtra but will transition it to Mylan by year end.
- Under the terms of the agreement, Mylan will pay Aspen $225M when the transaction is finalized. An additional $75M will be held in escrow pending the satisfaction of certain conditions. Aspen will supply Arixtra and its generic to Mylan.
- According to IMS Health, U.S. sales of branded Arixtra were $18.8M for the 12-month period ending June 30, 2014. Generic Arixtra sales were $95.3M over the same time frame.
Sep. 8, 2014, 1:33 PM
- The U.S. District Court for the District of Maryland rules that sales of generic versions of Hospira's (HSP -2.1%) proprietary sedative, Precedex (dexmedetomidine HCL injection), may proceed. The Court initially granted the company's motion for a temporary restraining order against the FDA, Mylan (MYL +2.1%) and Par Sterile Products against the introduction of generic formulations. Hospira has filed an appeal of the decision and a motion for injunction pending appeal before the U.S. Court of Appeals for the Fourth Circuit. Not known for waiting, Mylan restarts the launch of its generic version.
- Despite the adverse ruling, Hospira reaffirms its 2014 EPS guidance of $2.30 - 2.50.
- Precedex generated ~$440M in revenues in 2013. The company previously stated that the encroachment of generic Precedex competitors may force it to lay off sales personnel.
Aug. 30, 2014, 12:05 PM
- In the largest study of its kind ever done, Novartis' (NYSE:NVS) investigational heart failure drug candidate, LCZ696, demonstrated superiority over the ACE-inhibitor enalapril on several key endpoints.
- LCZ696 reduced the risk of death from cardiovascular disease by 20%, reduced heart failure hospitalizations by 21% and reduced the risk of all-cause mortality by 16%. All the results were highly statistically significant.
- The twice-daily tablet acts to enhance the protective neurohormonal systems of the heart while simultaneously suppressing the harmful system. Current therapies act only to block the harmful effects.
- Novartis intends to submit its NDA to the FDA by the end of 2014 and its MAA to the EC in early 2015.
- Related tickers: (NYSE:VRX) (NYSE:TEVA) (NASDAQ:MYL) (NYSE:TARO) (NYSE:RDY)
MYL vs. ETF Alternatives
Other News & PR