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Mylan NV (MYL.OQ)

MYL.OQ on NASDAQ Stock Exchange Global Select Market

19.29USD
6 Dec 2019
Change (% chg)

$0.39 (+2.06%)
Prev Close
$18.90
Open
$19.02
Day's High
$19.34
Day's Low
$19.01
Volume
1,552,648
Avg. Vol
1,918,625
52-wk High
$32.65
52-wk Low
$16.64

Latest Key Developments (Source: Significant Developments)

Biocon And Mylan Launch Trastuzumab Biosimilar, Ogivri In The U.S.
Monday, 2 Dec 2019 

Dec 2 (Reuters) - Biocon Ltd ::BIOCON AND MYLAN LAUNCH TRASTUZUMAB BIOSIMILAR, OGIVRI (TRASTUZUMAB-DKST), IN U.S..  Full Article

Mylan Issues Statement Regarding FDA's Warning Letter To Co’S API Manufacturer
Wednesday, 13 Nov 2019 

Nov 12 (Reuters) - Mylan NV ::MYLAN ISSUES STATEMENT REGARDING U.S. FOOD AND DRUG ADMINISTRATION'S WARNING LETTER TO MYLAN’S API MANUFACTURER.NO INTERRUPTION IN MANUFACTURING OR DISTRIBUTION IS ANTICIPATED AT MYLAN LABORATORIES LIMITED, UNIT 8, BASED ON FDA WARNING LETTER.NO SIGNIFICANT COMMERCIAL IMPACT IS EXPECTED AND NO SIGNIFICANT LAUNCHES ARE PLANNED FOR UNIT 8 IN 2020.CONCERNS CITED BY FDA IN WARNING LETTER BASED ON INSPECTION CONDUCTED IN UNIT 8 FROM MAY 27, 2019, TO JUNE 5, 2019.FDA'S CONCERNS CITED BASED ON INSPECTION CONDUCTED FROM MAY 27 TO JUNE 5, WHICH PLACED A PRIMARY FOCUS ON THE MANUFACTURING OF VALSARTAN API.EXTENSIVE TESTING OF APIS MANUFACTURED & DISTRIBUTED BY UNIT 8 WAS PERFORMED FOR PRESENCE OF NITROSAMINE IMPURITIES AND NONE WERE DETECTED.  Full Article

FDA Says Sent Warning Letter To Mylan After Inspecting Andhra Pradesh Plant In India
Wednesday, 13 Nov 2019 

Nov 12 (Reuters) - FDA::FDA SAYS SENT WARNING LETTER TO MYLAN AFTER INSPECTING ANDHRA PRADESH PLANT IN INDIA.FDA SAYS SENT WARNING LETTER TO MYLAN SUMMARIZES SIGNIFICANT DEVIATIONS FROM CURRENT GOOD MANUFACTURING PRACTICE FOR ACTIVE PHARMACEUTICAL INGREDIENTS.  Full Article

Mylan And Pfizer Announce Viatris As The New Company Name In The Planned Mylan-Upjohn Combination
Tuesday, 12 Nov 2019 

Mylan NV ::MYLAN AND PFIZER ANNOUNCE VIATRIS AS THE NEW COMPANY NAME IN THE PLANNED MYLAN-UPJOHN COMBINATION.MYLAN NV - IT IS EXPECTED THAT IN COMING MONTHS, SHAREHOLDERS OF MYLAN WILL VOTE ON PROPOSED COMBINATION OF MYLAN AND UPJOHN.MYLAN NV - NEW NAME WILL BE EFFECTIVE UPON CLOSING OF COMBINATION, WHICH IS EXPECTED TO OCCUR IN MID-2020.  Full Article

Mylan Reports Third Quarter 2019 Results And Updates 2019 Guidance
Tuesday, 5 Nov 2019 

Nov 5 (Reuters) - Mylan NV ::MYLAN REPORTS THIRD QUARTER 2019 RESULTS AND UPDATES 2019 GUIDANCE.SEES FY 2019 ADJUSTED EARNINGS PER SHARE $4.20 TO $4.40.NOT PROVIDING FORWARD-LOOKING GUIDANCE FOR U.S. GAAP REPORTED FINANCIAL MEASURES.QTRLY TOTAL REVENUES OF $2.96 BILLION, UP 3%, UP 6% ON A CONSTANT CURRENCY BASIS, COMPARED TO PRIOR YEAR PERIOD.Q3 GAAP EARNINGS PER SHARE $0.37.QTRLY NORTH AMERICA SEGMENT NET SALES OF $1.09 BILLION, UP 8% ON AN ACTUAL AND CONSTANT CURRENCY BASIS."CONTINUE TO MAKE PROGRESS TOWARD A SUCCESSFUL DEAL CLOSE WITH PFIZER'S UPJOHN BUSINESS, WHICH WE CONTINUE TO EXPECT WILL OCCUR IN MID-2020".Q3 ADJUSTED EARNINGS PER SHARE $1.17.Q3 REVENUE VIEW $3.01 BILLION -- REFINITIV IBES DATA.FOR FULL YEAR 2019, WE ALSO ARE NARROWING CERTAIN OF OUR FINANCIAL GUIDANCE RANGE METRICS.Q3 EARNINGS PER SHARE VIEW $1.13, REVENUE VIEW $3.01 BILLION -- REFINITIV IBES DATA.NOW EXPECT 2019 TOTAL REVENUES TO BE IN RANGE OF $11.5 BILLION TO $12.0 BILLION.FY2019 EARNINGS PER SHARE VIEW $4.29, REVENUE VIEW $11.61 BILLION -- REFINITIV IBES DATA.SEES 2019 ADJUSTED EPS TO BE IN RANGE OF $4.20 TO $4.40.QTRLY NET SALES WERE UNFAVORABLY IMPACTED BY EFFECT OF FOREIGN CURRENCY TRANSLATION.UNFAVORABLE IMPACT OF FOREIGN CURRENCY TRANSLATION ON CURRENT PERIOD NET SALES WAS ABOUT $62.0 MILLION.  Full Article

Pfizer Sees Upjohn Revenue In China Growing By Mid To High Single Digits For 2019
Tuesday, 29 Oct 2019 

Oct 29 (Reuters) - Pfizer ::PFIZER SAYS EFFORTS TO IMPROVE DIAGNOSIS RATES OF RARE HEART DISEASE HAS HELPED DRIVE SALES OF RECENTLY APPROVED DRUG VYNDAQEL - CONF. CALL.PFIZER EXPECTS STERILE INJECTABLES BUSINESS TO BE A SOLID GROWTH CONTRIBUTOR IN FUTURE - CONF. CALL.PFIZER CEO EXPECTS 5 YEAR REVENUE CAGR OF ABOUT 6% TO BEGIN IMMEDIATELY ON CLOSE OF MYLAN TRANSACTION - CONF. CALL.PFIZER NOW EXPECTS UPJOHN REVENUE IN CHINA TO GROW OPERATIONALLY BY MID TO HIGH SINGLE DIGITS FOR THE FULL YEAR OF 2019 COMPARED WITH 2018 - CONF CALL.PFIZER CEO SAYS "THINGS HAVE IMPROVED" SINCE THE SECOND QUARTER THAT SIGNAL A POSITIVE FOR 2020 GUIDANCE; HOWEVER CO DOES NOT PROVIDE FORECAST NUMBERS - CONF. CALL.PFIZER CEO SAYS NOT LOOKING FOR LARGER MERGERS OR ACQUISITIONS AT PRESENT - CONF. CALL.PFIZER CEO SAYS BUSINESS DEVELOPMENT STRATEGY WILL FOCUS ON MID-STAGE TRIAL ASSETS THAT WILL PROVIDE REVENUE POST 2026 WHEN PATENT PRESSURES WILL RESURFACE FOR CO - CONF. CALL.  Full Article

Mylan Expands Oncology Portfolio With Launch Of Generic Faslodex Injection
Tuesday, 17 Sep 2019 

Sept 17 (Reuters) - Mylan NV ::MYLAN EXPANDS ONCOLOGY PORTFOLIO WITH LAUNCH OF GENERIC FASLODEX® INJECTION, A TREATMENT FOR ADVANCED BREAST CANCER.MYLAN - ANNOUNCED U.S. LAUNCH OF FULVESTRANT INJECTION, A GENERIC VERSION OF ASTRAZENECA'S FASLODEX INJECTION.  Full Article

Mylan NV Says Director Robert Coury Reports Open Market Purchase Of 49,859 Ordinary Shares At Average Price Of $20.06Per Share On August 2
Monday, 5 Aug 2019 

Aug 5 (Reuters) - Mylan NV ::MYLAN NV SAYS DIRECTOR ROBERT COURY REPORTS OPEN MARKET PURCHASE OF 49,859 ORDINARY SHARES AT AVERAGE PRICE OF $20.06PER SHARE ON AUGUST 2 - SEC FILING.  Full Article

Mylan to begin search for CFO of new company
Monday, 29 Jul 2019 

July 29 (Reuters) - Mylan NV ::MYLAN SEES POTENTIAL FOR SHARE REPURCHASES BY THE END OF 2021 - CONF. CALL.PFIZER CEO SAYS MYLAN HAS BEEN "SIGNIFICANTLY UNDERVALUED", EXPECTS NEW COMBINATION TO ADDRESS THIS - CONF. CALL.MYLAN SAYS WILL BEGIN SEARCH FOR CFO FOR NEW COMPANY, WHOSE APPOINTMENT WILL BE AGREED UPON WITH PFIZER- CONF. CALL.HEAD OF NEW COMPANY, MICHAEL GOETTLER, SAYS WILL BE OPERATING THROUGH GLOBAL CENTERS IN PITTSBURGH, PENNSYLVANIA; SHANGHAI, CHINA AND HYDERABAD, INDIA- CONF. CALL.HEAD OF NEW COMPANY MICHAEL GOETTLER SAYS ONLY ABOUT A THIRD OF NEW COMPANY REVENUE TO COME FROM GENERICS- CONF. CALL.HEAD OF NEW COMPANY MICHAEL GOETTLER SAYS ROUGHLY 55% OF ITS REVENUE WILL COME FROM NORTH AMERICA AND EUROPE, REST FROM ASIA AND EMERGING MARKETS - CONF. CALL.MYLAN PRESIDENT RAJIV MALIK SAYS NEW COMPANY EXPECTS ABOUT $3 BILLION IN REVENUE FROM PRODUCTS EXPECTED TO LAUNCH BY 2023- CONF. CALL.OUTGOING MYLAN CFO KEN PARKS SAYS IN NEAR TERM, NEW COMPANY ANTICIPATES TOTAL REVENUE TO GROW MODESTLY AS GROWTH WILL OFFSET EXPECTED PRICING PRESSURE - CONF. CALL.MYLAN EXPECTS EXPECT "STRONG CASH FLOWS" IN THE SECOND HALF OF THE YEAR- CONF. CALL.PFIZER CFO EXPECTS GROWTH WILL START "EARLIER" POST CLOSING MYLAN DEAL, SOME TIME IN 2020 - CONF. CALL.ROBERT COURY, EXECUTIVE CHAIRMAN OF NEW COMPANY, SAYS LOOKING FOR SOMEONE WHO IS AN EXISTING PUBLIC COMPANY CFO WITH "QUITE A BIT OF EXPERIENCE" TO FILL ROLE OF FINANCE CHIEF FOR NEW COMPANY- CONF. CALL.  Full Article

FDA Says Approved Mylan’S Generic Diclofenac Sodium
Wednesday, 19 Jun 2019 

June 19 (Reuters) - FDA::FDA SAYS APPROVED MYLAN’S GENERIC DICLOFENAC SODIUM.  Full Article

UPDATE 3-Mylan shares slide after warning of hit to revenue

Nov 5 Generic drugmaker Mylan NV said on Tuesday reevaluation of its portfolio of medicines will continue next year and cautioned of a hit to revenue, and its shares nearly 6%.