-=Biogen (BIIB) : major patent win against Mylan (MYL)

•  Biogen  won a long-awaited decision in a patent case defending its multiple sclerosis drug Tecfidera against a challenge by Mylan.
• In a decision issued Wednesday, administrative patent judge Sheridan K. Snedden wrote that Mylan (MYL) had failed to show that parts of a key patent protecting Tecfidera were unpatentable, as the company had claimed.

Biogen stock rocketed Wednesday after reports suggested U.S. patent officials agreed to uphold the patent covering Tecfidera, an important multiple sclerosis drug.

In midday trading on the stock market today, shares of Biogen (BIIB) surged 22.7%, near 347.60. That pushed Biogen stock into a breakout, above a buy point at 318.10 out of a consolidation.

Mylan (MYL) and Biogen have been engaged in a patent battle over Tecfidera for years. So, the patent decision by U.S. officials has been a major point of contention for Biogen stock. According to various posts on Twitter, officials upheld the patent on Tecfidera for another eight years.

As a result, Mylan won't be able to launch a generic challenger to the blockbuster drug until 2028, according to various reports. This would be a huge boon for Biogen stock. Meanwhile, Mylan stock rose 3.4%, near 23.

-=Mylan N.V. (MYL) to combine with Pfizer's (PFE) off-patent branded and generic established medicines business

• Hiving off the generics business is part of Pfizer’s ongoing effort to become leaner and more focused on finding new medicines. Pfizer recently shed its consumer health unit by creating a joint venture with GlaxoSmithKline that will eventually be spun off as a stand-alone company.
• Pfizer is meanwhile beefing up its research engine and innovative drug portfolio. In June, it agreed to pay $10.6 billion for Array BioPharma, a purchase that brought it two marketed oncology drugs, Braftovi and Mektovi. The deal also added a highly skilled, small-molecule-focused research team that has generated for its partners a pipeline of 17 drug candidates in preclinical or clinical studies. A month earlier, Pfizer added rare-disease-focused Therachon for $340 million.
• The merger ends a yearlong strategic review by Mylan, which has struggled with pricing pressure and scandals, including a federal price-fixing probe and lawsuits over its opioid sales. CEO Heather Bresch, who became a face of pharma greed during congressional hearings over the price of the EpiPen, will retire when the merger is complete. Upjohn president Michael Goettler will be the CEO of the merged firm.

Mylan N.V. confirms agreement to combine with Pfizer's (PFE) off-patent branded and generic established medicines business

Under the terms of the agreement, which is structured as an all-stock, Reverse Morris Trust transaction, each Mylan share would be converted into one share of the new company. Pfizer shareholders would own 57% of the combined new company, and Mylan shareholders would own 43%. The Boards of Directors of both Mylan and Pfizer have unanimously approved the transaction.

• The new company is expected to have pro forma 2020 revenues of $19 to $20 billion. Pro forma 2020 adjusted EBITDA is anticipated to be in the range of $7.5 to $8.0 billion, including phased synergies of approximately $1 billion annually to be realized by 2023. Pro forma free cash flow for 2020 is expected to be more than $4 billion. The new company will be focused on returning capital to shareholders, while maintaining a solid investment grade credit rating. It expects to achieve a ratio of debt to adjusted EBITDA of 2.5x by the end of 2021. In addition, the new company intends to initiate a dividend of approximately 25% of free cash flow beginning the first full quarter after close and the potential for share repurchases once the debt to adjusted EBITDA target is sustained.
• The new company, which will be renamed and rebranded at close, will be led by Mylan's current Chairman Robert J. Coury, who will serve as Executive Chairman of the new company; Michael Goettler, current Group President, Upjohn, who will serve as Chief Executive Officer (CEO); and Rajiv Malik, current Mylan President, who will serve as President. Ken Parks, currently CFO of Mylan, has agreed to depart the company at closing. Heather Bresch, Mylan's current CEO, will retire from Mylan upon the close of this transaction.

The transaction is anticipated to close in mid-2020, subject to approval by Mylan shareholders and customary closing conditions, including receipt of regulatory approvals.

Mylan N.V. beats by $0.08, beats on revs; reaffirms FY19 EPS guidance, revs guidance

Reports Q2 (Jun) earnings of $1.03 per share, excluding non-recurring items, $0.08 better thanthe S&P Capital IQ Consensus of $0.95; revenues rose 1.5% year/year to $2.85 bln vs the $2.82 bln S&P Capital IQ Consensus.

Coreaffirms guidancefor FY19, sees EPS of $3.80-4.80 vs. $4.28 S&P Capital IQ Consensus; sees FY19 revs of $11.5-12.5 bln vs. $11.63 bln S&P Capital IQ Consensus.

-=Mylan N.V. (MYL) reported earnings on Mon 5 Nov 2018 (a/h)

Mylan N.V. beats by $0.06, misses on revs; committed to FY guidance

Reports Q3 (Sep) earnings of $1.25 per share, excluding non-recurring items, $0.06 better than the S&P Capital IQ Consensus of $1.19; revenues fell 4.2% year/year to $2.86 bln vs the $2.91 bln S&P Capital IQ Consensus. Rest of World segment net sales of $773.7 million, up 4%, up 11% on a constant currency basis. Europe segment net sales of $1.04 billion, flat, up 2% on a constant currency basis. North America segment net sales of $1.01 billion, down 14%, down 13% on a constant currency basis, primarily due to the combined impact of the implementation of new accounting standards, lower volumes including EpiPen Auto-Injector sales, the divestiture of certain contract manufacturing assets, the loss of exclusivity of a product and actions associated with the restructuring and remediation program at the Morgantown manufacturing facility. 

"We remain committed to our full-year 2018 guidance, and this confirmation is not dependent on any single product approval or launch. As we look ahead, we're very optimistic about our long-term growth prospects as we have secured almost all regulatory approvals necessary for our key 2019 product drivers around the world."

Upgraded to Buy (from Neutral) at BofA/Merrill Lynch, which suggests that the Q3 report may help to reveal that some concerns regarding co's broader portfolio appear overdone.

Earnings this week : November 5 - 9, 2018 (wk 45)

Notable earnings out this week

Monday (Nov 5) 

• Morning: CNA CYOU DEA DO DXPE FOLD HRTX HUD INVH KMPR KOS L NS OHI PCG PEGI PGRE RACE RBC SEAS SHO SOGO SOHU  SYY
• Afternoon: ACHC AEL AKCA ANDE APLE APTS ATRO ATUS AVD AWR BE BHF BKD BKH BKNG CAR CBT CDEV CIR COHU CRZO CTRE CXW DCO DCP DRH DVAX ELF EVBG FMC FN FNV FRGI FRPT FTDR HHC IFF INSY IPAR ITRI IVC JCOM KMT LASR LDL LMNX LPI MAR MATX MOS MTW MWA MYL NBIX NTR NVRO OAS OTTR OUT OXY P PDCE PEN PLOW PTCT RARE RCII REN RNG RYAM SBAC SNHY STRL SYKE TBI TCMD THC TROX TRTX TVTY TWOU VVC VVV WTR 

Tuesday (Nov 6)

• Morning:  AAC ABC ADM AES AFI ANIP APD AVNS BCC BCPC BDX BHC BIOS BLD BR CBM COL CORE CTLT CVS DSKE ELAN EMES EMR ETM EXPD FI FRTA FSS GCP GLDD GLT GOGO GSKY GTN GTX HAE HLNE HPT HSIC IONS IRWD JELD JLL KEYW LABL LGIH LLY LPX LXP MBUU MFA MIDD MLCO MLM MNK MYE NHI NOVT NWN OCN ONCE ONDK ORA PINC PNM PQG PRIM REGN RHP RL SAGE SERV SNH STE SUM SYNH TAST TDG TRI UNT UNVR USAC USFD VER VPG VRTV WLK WLKP ZBRA
• Afternoon:  AAXN ACAD AIMT AIZ APEI ASH BEL BOLD BWXT CCS CGBD CHUY COHR CPE CSLT CUTR CWH DAR DATA DIOD DK DOOR DPLO DVN DXC DXCM EGN ENLC ENLK ENPH ETSY EVH EVRI FANG FIVN FTK FTR G GDDY GHDX GLUU HALO HEAR HCKT IAG ICHR INFN INGN INSP IOSP JAZZ JKHY KAR KTOS LC LNT MB MBI MED MODN MTCH MXWL MYGN NEWR NP OR PAA PAAS PAGP PAHC PLNT PLT PLYA PRA PRI PRMW PSEC PUMP PXD PZZA QDEL QHC QTWO RLJ RPD RRGB SCSC SEND SIEN SUPN SWX TAHO TRUE TSLX TWLO TWO UCTT VSLR VSM WEN WSC WTTR XEC XOG ZAGG ZG 

Wednesday (Nov 7)

• Morning: ALNY AMRX ANDX ASC AVA CARS CDK CLNY CNDT CNHI COTY CRL CSTE CSWI DF DISH DLPH ENBL FOXA GEO GIB GRPN HUM HZNP ITG KELYA KORS MDP MGLN MIDD MNTA NSIT ODP PFGC RCM RDWR ROK SBGI SGRY SMG SMI SO SPNS SRE TPB TSG VAC VGR VIRT WAAS WWW
• Afternoon: AAOI ADT ALB ALRM AMBC ANGI AYX CARG CTRP  CVNA CYBR FOSL FTD GDOT IAC KDP MCHP NUS NWSA OSTK QCOM ROKU SAIL SQ TIVO TLND TRIP TTWO UPWK WYNN ZAYO

Thursday (Nov 8)

• Morning: CAH CROX DISCA EBIX ENDP HAIN HII JCI SBH SGMS
• Afternoon:  ACB AGO AGS AL ALTR AMBR AMC AMPH AQN ARA ASRT ATVI BOJA BPI BRS BW CBPX COLD COLL CTL CYRX DBX DIS DOX ECOM EGAN EPAY ERI FGEN FNKO FOE FSCT FSM FTCH GMED HDP HTZ ICUI IMPV JAG JJSF LGF.A LOPE LPSN MCFT MIME MRAM MTD NNI NTRA OSTK PDFS PRAA RBA RDFN SCOR SENS SGMO SGYP SPPI SSRM SWIR SWKS SYNA TERP TRUP TRXC TSE TTD UEPS UIS UPLD VRAY VRTU WOW WPRT WSC XON XRAY YELP ZGNX

Friday (Nov 9)

• Morning:  ADNT ERF ESNT MGI MPAA OMER OXFD PBPB RDNT SSP STWD SUP TRCO UBNT
• Afternoon: ATHN GNC OPK   

This week's biggest % winners & losers : Oct. 2 - 6, 17 (wk 40)

The following are this week's top 20 percentage gainers and top 20 percentage losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top 20 % gainers

• Healthcare: MNKD (5.04 +132.26%), ELGX (5.74 +28.7%), NTLA (30.88 +24.27%), FLXN (29.72 +22.89%), MYL (38.27 +22%), ICPT (70.12 +20.81%), ATRS (3.89 +20.06%), SGYP (3.47 +19.66%), CFMS (4.13 +17.33%), FMI (46.98 +16.85%)
• Materials: TROX (25.31 +19.95%)
• Industrials: THR (20.83 +15.79%), GOL (24.33 +15.09%), BW (3.81 +14.41%)
• Consumer Discretionary: HOV (2.25 +16.58%), PNK (24.41 +14.55%)
• Information Technology: SNCR (14.19 +52.09%), VNET (7.16 +25.83%)
• Consumer Staples: OME (22.05 +32.43%)
• Telecommunication Services: I (6.54 +39.15%)

This week's top 20 % losers

• Healthcare: MNTA (12.95 -30%), MCRB (11.92 -25.69%), IMMU (11.65 -16.67%), SCMP (10.5 -11.02%)
• Consumer Discretionary: TTS (8.6 -32.28%), ODP (3.95 -13%), ASNA (2.19 -10.82%), GPRO (9.89 -10.17%), HELE (87.45 -9.75%)
• Information Technology: SHOP (97.92 -15.94%), NPTN (4.96 -10.79%), PI (37.12 -10.78%), AAOI (58.2 -10%),
• Financials: NAVI (12.6 -16.11%), MBI (7.65 -12.07%)
• Energy: PDS (2.77 -11.22%), CIE (1.27 -11.19%), HLX (6.63 -10.28%), NE (4.13 -10.22%)
• Consumer Staples: FIZZ (109.23 -11.95%)

Mylan N.V. (MYL) receives FDA approval for Copaxone 40 mg /ml generic

  

Mylan N.V. receives FDA approval for Copaxone 40 mg /ml generic

• Co announced the FDA has approved Mylan's Abbreviated New Drug Applications for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic version of Teva's Copaxone 40 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection, an AP-rated, substitutable generic version of Teva's Copaxone 20 mg/mL, which are indicated for the treatment of patients with relapsing forms of multiple sclerosis, a chronic inflammatory disease of the central nervous system. Mylan will begin shipping imminently.
• The FDA approved Mylan's Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection and 20 mg/mL for once-daily injection as therapeutic AP-rated equivalents to Copaxone 40 mg/mL and Copaxone 20 mg/mL, respectively, meaning if they are substituted for their branded counterpart they can be expected to have the same clinical effect and safety profile. As part of its ANDAs, Mylan submitted rigorous side-by-side analyses, including characterization data, which demonstrated that Mylan's Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL have the same active ingredient, dosage form, route of administration and strength as their branded counterpart. Mylan's Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL are available by prescription only.

=Mylan N.V. (MYL) reported earnings on Wed 1 March 17 (b/o)

Mylan N.V. beats by $0.14, beats on revs; guides FY17 EPS in-line, revs towards the high end:

• Reports Q4 (Dec) earnings of $1.57 per share, excluding non-recurring items, $0.14 better than the Capital IQ Consensus of $1.43; revenues rose 31.2% year/year to $3.27 bln vs the $3.18 bln Capital IQ Consensus. Third party net sales for the current quarter were $3.22 billion compared to $2.47 billion for the prior year period, representing an increase of $746.8 million, or 30%. North America segment third party net sales of $1.57 billion, up 22% Europe segment third party net sales of $927.4 million, up 50% Rest of World segment third party net sales of $729.2 million, up 28%.
• Co issues in-line guidance for FY17, sees EPS of $5.15-5.55, excluding non-recurring items, vs. $5.35 Capital IQ Consensus Estimate; sees FY17 revs of +17% to $12.25-13.75 bln vs. $12.64 bln Capital IQ Consensus Estimate.
• "We also continue to advance toward our long-stated 2018 adjusted EPS target of $6.00."

====Adamis Pharmaceuticals (ADMP) may benefit from rival Mylan's (MYL) pricing fiasco of EpiPens

Adamis Pharmaceuticals (ADMP) could benefit from rival Mylan's (MYL) high price of EpiPens as its own product is reportedly close to approval. Adamis has an epinephrine pre-filled syringe that may be better than the EpiPen, even apart from the price controversy.
Price target: $10