Thu, Dec. 8, 4:28 PM
- In a statement, Allergan (NYSE:AGN) says it will "vigorously defend" the six patents covering eye drop RESTASIS (cyclosporine ophthalmic emulsion) 0.05% that are the subject of an Inter Partes review by the USPTO's Patent Trial and Appeal Board (PTAB). Generic competitor Mylan N.V. (NASDAQ:MYL) requested the action. The patents are valid until August 2024.
- A decision from the PTAB should happen by Q4 2017.
Thu, Dec. 8, 7:30 AM
- Philip van Doorn and team at Marketwatch put together a list of 18 S&P 500 names with consensus sell-side price targets at least 30% above the current price.
- Ten of the 18 stocks are in healthcare, which has been roughed up by a combination of Obamacare, Clinton's talk about drug pricing (back when all thought she would be the next POTUS), and now Trump joining in the bashing.
- The list (in order of possible upside): Mallinckrodt PLC (NYSE:MNK) - 56% potential upside, Endo International PLC (NASDAQ:ENDP) - 52% upside, Hanesbrands (NYSE:HBI) - 45% upside, Edwards Lifesciences (NYSE:EW) - 44% upside, Mylan (NASDAQ:MYL) - 42% upside, Allergan (NYSE:AGN) - 39% upside, Alexion (NASDAQ:ALXN) - 37% upside, Activision Blizzard (NASDAQ:ATVI) - 35% upside, Salesforce.com (NYSE:CRM) 34% upside, NRG Energy (NYSE:NRG) - 34% upside, Centene (NYSE:CNC) 34% upside, Gilead (NASDAQ:GILD) 33% upside, Facebook (NASDAQ:FB) 32% upside, Boston Scientific (NYSE:BSX) - 32% upside, Pitney owes (NYSE:PBI) - 32% upside, Molson Coors (NYSE:TAP) - 30% upside, Newell Brands (NYSE:NWL) - 30% upside, Zimmer Bioment (NYSE:ZBH) - 30% upside.
Wed, Dec. 7, 9:37 AM
- In a regulatory filing, Mylan N.V. (MYL -3.4%) discloses that it has announced restructuring programs in certain locations as its streamlines its global operations. The initiatives will result in the elimination of "less than 10%" of its workforce.
- The company says it will release additional details as initiatives are finalized.
Mon, Nov. 28, 7:59 AM
- Mylan N.V. (NASDAQ:MYL) signs an agreement with United Nations-backed Medicines Patent Pool that enables it to produce and market a generic version of Bristol-Myers Squibb's (NYSE:BMY) hepatitis C med DAKLINZA (daclatasvir) in 112 low to middle income countries. The license allows Mylan to develop fixed-dose combinations for all six major genotypes of HCV.
- DAKLINZA, in combination with sofosbuvir, with or without ribavirin, is approved in the U.S. for the treatment of HCV genotypes 1 and 3 and in Europe for HCV genotypes 1,3 and 4.
Wed, Nov. 23, 3:20 PM
- The Senate Judiciary Committee has postponed its hearing on EpiPen pricing as it "considers other avenues to ensure government and company witnesses participate."
- The hearing was scheduled for November 30 but Mylan (MYL +1.2%), representatives of the Justice Department and the Centers for Medicare & Medicaid Services (CMS) stated that they would not be able to attend due to "pending matters and investigations."
- At issue is whether Mylan underpaid government healthcare plans by classifying EpiPen as generic in the Medicaid Drug Rebate Program.
Tue, Nov. 22, 3:48 AM
- Mylan (NASDAQ:MYL) won't be appearing at a November 30 Senate hearing about the EpiPen, stating its $465M settlement with the Justice Department is a "pending matter" and the DOJ will also not be attending.
- At issue is whether Mylan underpaid government healthcare plans by classifying the Epipen as generic in the Medicaid Drug Rebate Program.
Mon, Nov. 21, 3:56 PM
- Senate Judiciary Committee Chairman Chuck Grassley has sent a letter to SEC Chairperson Mary Jo White asking if her agency is investigating whether Mylan (MYL +0.5%) misled the public with its October 7 press release about the EpiPen settlement saying it "appears to go well beyond the Justice Department's position."
- The company agreed to pay $465M to the DOJ to settle the matter as it related to the Medicaid Drug Rebate Program.
Wed, Nov. 9, 6:36 PM
- Mylan N.V. (NASDAQ:MYL) Q3 results ($M): Total Revenues: 3,057.1 (+13.4%); Generics Third Party Net Sales: 2,610.8 (+16.6%); Specialty Third Party Net Sales: 418.7 (-4.6%).
- North America: 1,098.8 (+0.8%); Europe: 842.0 (+37.6%); ROW: 670.0 (+25.0%).
- Net Income: (119.8) (-128.0%); Non-GAAP Net Income: 726.4 (-1.0%); EBITDA: 294.7 (-64.7%); Non-GAAP EBITDA: 1,060.9 (+7.5%); EPS: (0.23) (-127.7%); Non-GAAP EPS: 1.38 (-3.5%); Cash Flow Ops: 1,240.5 (+10.3%).
- Consensus view was non-GAAP EPS of $1.46 on revenues of $3.1B.
- No guidance given.
- Shares are off 2% after hours on robust volume.
Wed, Nov. 9, 4:12 PM
Wed, Nov. 9, 3:03 AM
- Healthcare stocks, the weakest sector this year, may become winners, as Obamacare reforms are set to be "repealed and replaced" and major legislation Clinton proposed is unlikely to be imposed on drugmakers.
- While Trump hasn't set out a comprehensive alternative to the Affordable Care Act (which may see 22M Americans lose current coverage), he said he'll encourage competition between markets in different states.
- Insurance stocks: UNH, AET, ANTM, CI, HUM, WCG, CNC, MOH, GTS, HQY
- Drugmakers premarket: MYL +5.8%, NVS +3.4%, SNY +2.9%, AZN +2.4%, GSK +1.9%, PFE +1.8%, CELG +1%, ABBV, MRK, BMY, LLY, JNJ, ABT, ACET, ZTS, BIIB, REGN
Tue, Nov. 8, 5:35 PM
- APPS, APU, ATHX, ATO, CALL, CHMI, COTV, CPST, CSRA, CUI, CYTX, DIOD, ECPG, ECYT, EGAN, ENS, ETE, ETP, EVH, EVOK, EVRI, FF, FLO, FR, GALE, GDOT, GLF, HLIT, ICUI, INFI, JUNO, MACK, MIME, MNKD, MNTX, MRIN, MYL, NNI, NTES, NVAX, OMER, PAHC, PLKI, PRI, QHC, QNST, RBA, RELY, RPD, RTK, SEDG, SGRY, SHAK, SLF, SLW, SPTN, SPWR, SREV, SUN, SXL, TASR, TCRD, TCS, TPIC, TTEC, TTEK, TTGT, TUBE, UGI, UHAL, VRTU, VVUS, WAGE, WUBA, XON, XONE, YUME, ZLTQ
Tue, Nov. 8, 8:09 AM
- Mylan N.V. (NASDAQ:MYL) submits a Biologics License Application (BLA) to the FDA seeking approval of its biosimilar to Roche's (OTCQX:RHHBY) cancer med Herceptin (trastuzumab). This is the company's first BLA filing for a biosimilar in the U.S.
- Its trastuzumab biosimilar, co-developed with Biocon Ltd., is currently being sold in 11 countries, including India.
Mon, Nov. 7, 5:59 PM
- After a solid day, Mylan (MYL +4.5%) is giving some back in the postmarket session, -1.1%, as the Senate Judiciary Committee calls on the FTC to investigate the drugmaker's business practices for possible anticompetitive behavior.
- The committee's leadership is responding to news reports saying Mylan engaged in exclusive deals with schools, preventing them from purchasing competitors to the EpiPen auto-injector.
- In a letter to the FTC, committee Chairman Chuck Grassley and Ranking Member Patrick Leahy say “Increasing patient access to safe, effective and affordable medications has long been a shared priority of ours. We also share a strong belief that potential anti-competitive actions by drug industry participants must be aggressively investigated because of their impact on competition and drug costs."
- The committee has scheduled a hearing to look over a reported settlement between the Justice Dept. and Mylan tied to a separate issue (misclassification of EpiPen in the Medicaid Drug Rebate Program).
Fri, Nov. 4, 3:38 PM
- The major averages are flat, but the XLV is higher by 1%, and the IBB by 2.15% as pharmaceutical names rebound from yesterday's plunge.
- Sending the stocks down was word of charges about to come from the government following a two-year antitrust probe, but public outrage goes with the territory, says Zacks' Tracey Ryniec, noting the prices - with some at just four or five times earnings - are getting seriously cheap.
- Among those moving today: Endo International (ENDP +1.8%), Perrigo (PRGO +3%), Mylan (MYL +2.6%), Allergan (AGN +3.4%), Cara (CARA +23.8%), PTC (PTCT +20%), Novavax (NVAX +18.9%), Flex (FLKS +14.5%), Cerus (CERS +14.9%), LifePoint (LPNT +2.9%), and Halyard Health (HYH +3.2%).
Fri, Nov. 4, 6:00 AM
- In a note this morning, Credit Suisse addresses what exactly was new in yesterday's Bloomberg article about potential price-fixing charges against generic drugmakers:
- "The investigation itself wasn’t news, most generics manufacturers had disclosed receipt of subpoenas, but we sense most investors felt the investigation wouldn’t come to anything. This afternoon’s news that charges could be brought by year-end obviously brought immediacy to the issue and at a time when investor confidence is fragile. Investors have been concerned the consolidating purchasing consortiums of drug chains and wholesalers (top-4 buying groups now represent 84% of purchasing in the U.S.) have used their buying power at the manufacturers expense. Regardless of the outcome of the investigation, the ongoing government scrutiny could hinder generic manufacturers' counter moves especially in terms of price exploration for individual products. That said, and appreciating the matter can’t be taken lightly, we think it would be premature to conclude this signals a dramatic change in the generic drug industry’s landscape over the long-term. There continue to be regulatory and manufacturing capacity issues which work in the generic manufacturers' favor."
- Among the hardest hit were LCI (-26.6%), ENDP (-19.5%), IPXL -19.5%, AKRX -18%. Healthcare ETF XLV was down just 1%. Large-cap generic manufacturers such as MYL and TEVA were down 6-10%.
Thu, Nov. 3, 2:57 PM
- The DOJ could file charges before the end of the year in its probe over whether companies colluded on drug pricing, according to Bloomberg.
- Among those hit: Mylan (MYL -7.4%), Teva (TEVA -10.6%), and Endo International (ENDP -15.4%).
- Others include Allergan (AGN -4.1%) and Valeant (VRX -6.9%)
- Related ETFs: IBB, XLV, IYH, XBI, VHT, PJP, BBH, HQH, FBT, CURE, HQL, XPH, PBE, FXH, FHLC, IHE, RXL