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Mylan NV (MYL.OQ)

MYL.OQ on NASDAQ Stock Exchange Global Select Market

20.86USD
23 Sep 2019
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Latest Key Developments (Source: Significant Developments)

Revance Therapeutics Inc - Co & Mylan Ireland Amended Collaboration & License Agreement Dated Feb 28, 2018
Tuesday, 27 Aug 2019 

Aug 27 (Reuters) - Revance Therapeutics Inc ::REVANCE THERAPEUTICS INC - CO & MYLAN IRELAND AMENDED COLLABORATION & LICENSE AGREEMENT DATED FEB 28, 2018.REVANCE- WILL EXTEND TIME PERIOD FOR MYLAN TO DECIDE ON CONTINUATION OF DEVELOPMENT OF BIOSIMILAR TO BRANDED BIOLOGIC PRODUCT (ONABOTULINUMTOXINA).REVANCE THERAPEUTICS INC - MYLAN HAS AGREED TO PAY CO $5 MILLION INCREMENTAL TO PREVIOUSLY AGREED NON-REFUNDABLE UPFRONT PAYMENT OF $25 MILLION.  Full Article

Pfizer Says Upjohn Unit Has No Opioid Liabilities Which Will Transfer To New Company
Monday, 29 Jul 2019 

July 29 (Reuters) - Mylan NV ::PFIZER SAYS MANUFACTURING SUPPLY ISSUES CONTINUE TO AFFECT STERILE INJECTABLES BUSINESS; EXPECTS SIGNIFICANT IMPROVEMENT BY END OF 2019 - CONF. CALL.PFIZER SAYS TARGETING A U.S. REGULATORY SUBMISSION IN LATE Q4, 2019 OR EARLY 2020 FOR TANEZUMAB - CONF. CALL.PFIZER CEO SAYS CANNOT SUPPORT SENATE BILL ON DRUG PRICING AS IT IS WRITTEN ALTHOUGH THERE ARE SOME POSITIVES - CONF. CALL.PFIZER SAYS UPJOHN HAS NO OPIOID LIABILITIES WHICH WILL TRANSFER TO NEW COMPANY- CONF. CALL.  Full Article

Mylan Reports Q2 Loss Per Share $0.33
Monday, 29 Jul 2019 

July 29 (Reuters) - Mylan NV ::MYLAN REPORTS SECOND QUARTER 2019 RESULTS.Q2 GAAP LOSS PER SHARE $0.33.QTRLY TOTAL REVENUES OF $2.85 BILLION, UP 2% COMPARED TO PRIOR YEAR PERIOD.Q2 ADJUSTED EARNINGS PER SHARE $1.03.FOR FULL YEAR 2019, REAFFIRMING GUIDANCE RANGES FOR TOTAL REVENUE OF $11.5 BILLION TO $12.5 BILLION.QTRLY NORTH AMERICA SEGMENT NET SALES OF $1.02 BILLION, UP 2% ON AN ACTUAL AND CONSTANT CURRENCY BASIS.QTRLY EUROPE SEGMENT NET SALES OF $989.6 MILLION, FLAT, UP 6% ON A CONSTANT CURRENCY BASIS.Q2 EARNINGS PER SHARE VIEW $0.95, REVENUE VIEW $2.83 BILLION -- REFINITIV IBES DATA.REMAIN ON TRACK TO DELIVER ON 2019 GUIDANCE.FOR FY REAFFIRMING GUIDANCE RANGES ADJUSTED EPS, ADJUSTED FREE CASH FLOW RANGE.DURING SECOND QUARTER OF 2019, RECORDED A NET CHARGE OF $20.9 MILLION IN LITIGATION SETTLEMENTS AND OTHER CONTINGENCIES, NET.DURING THREE MONTHS ENDED JUNE 30, RECOGNIZED EXPENSE OF ABOUT $18.0 MILLION FOR SETTLEMENT IN PRINCIPLE RELATED TO MODAFINIL ANTITRUST MATTER.FY2019 EARNINGS PER SHARE VIEW $4.26, REVENUE VIEW $11.63 BILLION -- REFINITIV IBES DATA.  Full Article

Pfizer Nears Deal To Combine Off-Patent Drug Business With Mylan - WSJ
Saturday, 27 Jul 2019 

July 27 (Reuters) - :PFIZER NEARS DEAL TO COMBINE OFF-PATENT DRUG BUSINESS WITH MYLAN - WSJ.PFIZER & MYLAN DISCUSSED STOCK DEAL IN WHICH MYLAN SHAREHOLDERS WOULD OWN LITTLE MORE THAN 40% OF NEW ENTITY & PFIZER SHAREHOLDERS THE REMAINDER - WSJ.PFIZER WOULD RECEIVE ABOUT $12 BILLION IN PROCEEDS FROM A NEW SALE OF DEBT- WSJ.  Full Article

Theravance Biopharma and Mylan Expand YUPELRI Development and Commercialization Agreement to Include China and Adjacent Territories
Friday, 14 Jun 2019 

June 14 (Reuters) - Mylan NV ::THERAVANCE BIOPHARMA AND MYLAN EXPAND YUPELRI® (REVEFENACIN) DEVELOPMENT AND COMMERCIALIZATION AGREEMENT TO INCLUDE CHINA AND ADJACENT TERRITORIES.MYLAN NV - EXPANSION OF DEVELOPMENT & COMMERCIALIZATION DEAL FOR NEBULIZED REVEFENACIN TO INCLUDE CHINA & SOME ADJACENT TERRITORIES.MYLAN NV - THERAVANCE BIOPHARMA WILL RECEIVE AN UPFRONT PAYMENT OF $18.5 MILLION UNDER TERMS.MYLAN NV - MYLAN WILL BE RESPONSIBLE FOR ALL ASPECTS OF DEVELOPMENT AND COMMERCIALIZATION IN PARTNERED REGIONS.MYLAN NV - THERAVANCE BIOPHARMA ALSO TO BE ELIGIBLE TO RECEIVE ADDITIONAL POTENTIAL DEVELOPMENT AND SALES MILESTONES TOTALING $54 MILLION.  Full Article

Mylan NV Reports Q1 Adj EPS Of $0.82
Tuesday, 7 May 2019 

May 7 (Reuters) - Mylan NV ::MYLAN REPORTS FIRST QUARTER 2019 RESULTS AND REAFFIRMS 2019 GUIDANCE.QTRLY TOTAL REVENUES OF $2.50 BILLION, DOWN 7% COMPARED TO PRIOR YEAR PERIOD.QTRLY LOSS PER SHARE $0.05.REMAIN POSITIONED TO REAFFIRM OUR GUIDANCE FOR 2019.Q1 ADJUSTED EARNINGS PER SHARE $0.82.MYLAN IS NOT PROVIDING FORWARD LOOKING GUIDANCE FOR U.S. GAAP REPORTED FINANCIAL MEASURES.Q1 EARNINGS PER SHARE VIEW $0.79, REVENUE VIEW $2.69 BILLION -- REFINITIV IBES DATA.IN U.S. INDUSTRY CONTINUES TO EXPERIENCE VOLATILITY.INTEND TO REPAY $1.1 BILLION OF DEBT DURING 2019.ON BOTTOM LINE, CAME IN AHEAD OF EXPECTED AT $0.82 OF QTRLY ADJUSTED. EPS, MAINLY DUE TO GROSS MARGINS COMING IN AT HIGH END OF GUIDANCE RANGE.FY2019 EARNINGS PER SHARE VIEW $4.41, REVENUE VIEW $11.96 BILLION -- REFINITIV IBES DATA.RECOGNIZED A U.S. GAAP INCOME TAX BENEFIT OF $89.5 MILLION IN QUARTER, VERSUS $76.6 MILLION LAST YEAR.MYLAN - NORTH AMERICA NET SALES DOWN 6%, DUE PRIMARILY TO LOWER VOLUMES ON EXISTING PRODUCTS, DRIVEN BY MORGANTOWN PLANT REMEDIATION ACTIVITIES IMPACT.IN QUARTER, RECORDED NET CHARGES OF $0.7 MILLION IN LITIGATION SETTLEMENTS AND OTHER CONTINGENCIES, NET.IN Q1, RECOGNIZED LITIGATION RELATED CHARGES OF ABOUT $4.8 MILLION.  Full Article

TB Alliance And Mylan Announce Pact To Commercialize Investigational Tuberculosis Drug
Thursday, 18 Apr 2019 

April 18 (Reuters) - Mylan NV ::TB ALLIANCE AND MYLAN ANNOUNCE GLOBAL COLLABORATION TO COMMERCIALIZE INVESTIGATIONAL DRUG PRETOMANID AS PART OF TWO REGIMENS TO TREAT TUBERCULOSIS (TB).MYLAN - TB ALLIANCE GRANTED LICENSE TO CO TO MANUFACTURE AND COMMERCIALIZE PRETOMANID FOR XDR-TB AND TREATMENT-INTOLERANT OR NON-RESPONSIVE MDR-TB.MYLAN NV - TB ALLIANCE HAS LICENSED PRETOMANID TO MYLAN FOR DS- AND MDR-TB.MYLAN NV - TB ALLIANCE GRANTED A SUBLICENSE FOR BEDAQUILINE TO MYLAN, FOR ITS DEVELOPMENT AND COMMERCIALIZATION FOR USE IN DS-TB ONLY.  Full Article

Mylan Wins FDA Approval For Generic Atazanavir-Cobicistat Drug
Thursday, 28 Mar 2019 

March 27 (Reuters) - Mylan NV ::MYLAN PHARMS INC WINS FDA'S TENTATIVE APPROVAL FOR GENERIC ATAZANAVIR-COBICISTAT DRUG - FDA WEBSITE.  Full Article

Mylan Sees 5 Of Co's Top 50 & 1 Of Top 10 Gross Margin Generating Products To Be Manufactured In Morgantown In 2019
Wednesday, 27 Feb 2019 

Feb 27 (Reuters) - Mylan NV ::MYLAN SAYS SEES ONLY 5 OF CO'S TOP 50 & ONLY 1 OUT OF TOP 10 GROSS MARGIN GENERATING PRODUCTS TO BE MANUFACTURED IN MORGANTOWN IN 2019 - SEC FILING.  Full Article

Mylan Says U.S. Court Denied Sanofi's Motion Regarding Court Filing In Parties' Litigation On Sale, Marketing Of Epipen
Wednesday, 27 Feb 2019 

Feb 27 (Reuters) - Mylan NV ::MYLAN SAYS ON JAN. 23, U.S. COURT DENIED SANOFI’S MOTION REGARDING SANOFI'S NOV. 1, 2018 COURT FILING IN PARTIES' LITIGATION ON SALE, MARKETING OF EPIPEN.MYLAN SAYS U.S. COURT DENIES SANOFI'S NOV. 1, 2018 MOTION FOR SUGGESTION OF REMAND OF CASE TO U.S. DISTRICT COURT FOR DISTRICT OF NEW JERSEY - SEC FILING.  Full Article

U.S. FDA approves Mylan generic of Lilly lung cancer drug Alimta

The U.S. Food and Drug Administration on Thursday granted Mylan NV tentative approval for its generic version of Eli Lilly and Co's lung cancer drug Alimta.