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Mylan NV (MYL.OQ)

MYL.OQ on NASDAQ Stock Exchange Global Select Market

22 Sep 2017
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Latest Key Developments (Source: Significant Developments)

Mylan gives details on genric approval processes
Wednesday, 9 Aug 2017 10:25am EDT 

Aug 9 (Reuters) - Mylan NV :Says disappointed with the execution by FDA on approval process of generic Copaxone.Says no further clinical or device-related studies are required for generic Advair approval process.Says will be opportunistic on deal opportunities to fill product or geographic gaps.  Full Article

Terex names John Sheehan, Chief Financial Officer
Monday, 13 Feb 2017 12:20pm EST 

Terex Corp : Terex names John D. Sheehan, Chief Financial Officer . Sheehan will assume his duties as Chief Financial Officer of Terex on February 27, 2017 . Sheehan most recently served as Executive Vice President and Chief Financial Officer of Mylan, Inc . Bradley will then continue with company until mid-March to assist with transition after which time he will be leaving company . Kevin Bradley will remain in his current role until Sheehan assumes duties of Chief Financial Officer .Kevin Bradley to resign as Chief Financial Officer.  Full Article

Mylan CEO sees EpiPen accounting for 6 pct of 2017 sales
Wednesday, 9 Nov 2016 01:47pm EST 

Mylan :Mylan sees generic drugs price erosion in mid single digits for rest of year.Mylan says believes authorized generic EpiPen at wholesale cost of $300 will generate cost savings for customers.Mylan CFO says continues to work with U.S. government to finalize EpiPen settlement over Medicaid rebates.CEO says future business development to emphasize bolt-on deals.Mylan CEO sees EpiPen accounting for 6 percent of 2017 sales.Mylan says has 16 biosimilars and insulin products in development.  Full Article

Mylan reports Q3 loss per share $0.23
Wednesday, 9 Nov 2016 12:05pm EST 

Mylan Nv -:We continue to see pricing across very broad generics portfolio to be in line with expectations.Remain committed to recently updated full year 2016 adjusted eps guidance range of $4.70 to $4.90.Effective October 1, 2016, we are expanding reportable segments.Change in segment reporting will begin with consolidated financial statements for year ending December 31, 2016.Remain committed to $6.00 adjusted earnings per share target in 2018.Comparative segment financial information will be recast for prior periods to conform to revised segment structure.In specialty segment, epipen auto-injector scripts grew quarter-over-quarter, volumes were down due to lack of wholesaler purchases in quarter.Though epipen auto-injector scripts grew q-o-q, volumes were down due to lack of wholesaler purchases in quarter in anticipation of generic launch."Continue to anticipate price erosion in mid-single digits for remainder of year".FY2016 earnings per share view $4.78 -- Thomson Reuters I/B/E/S.Mylan reports third quarter 2016 results.Q3 adjusted earnings per share $3.31.Q3 gaap loss per share $0.23.Q3 earnings per share view $1.46 -- Thomson Reuters I/B/E/S.Sees FY 2016 adjusted earnings per share $4.70 to $4.90.Sees FY 2018 adjusted earnings per share $6.00.  Full Article

Mylan NV sees 2016 sales for EpiPen in U.S. of $1,100 mln - SEC Filing
Monday, 26 Sep 2016 01:03pm EDT 

Mylan Nv : Mylan NV sees 2016 sales for EpiPen in U.S. $1,100 MLN - SEC Filing . Says in U.S., sees EpiPen 2016 estimated gross profit of $825 million - SEC Filing . For EpiPen , sees 8 million U.S. Pens sold in 2016 . Sees 2016 EpiPen operating profit in U.S. (not all regions) of $671 million versus reported 2015 operating profit of $498 million . "Does not intend in the future to provide product level profitabilty analysis for EpiPen " .Sees 2016 EpiPen net product profitability in U.S. (not all regions) of $419 million versus reported net product profitability for EpiPen of $312 million in 2015.  Full Article

BRIEF-Mylan says pre-tax Epipen profits are actually 60 pct higher than what it told Congress last week - CNBC, citing Dow Jones
Monday, 26 Sep 2016 09:05am EDT 

Sept 26 (Reuters) - • Mylan says pre-tax Epipen profits are actually 60 pct higher than what it told Congress last week - CNBC, citing Dow Jones:.  Full Article

New York probes Mylan over Epipen sales to schools
Tuesday, 6 Sep 2016 12:39pm EDT 

Mylan NV : New York attorney general says he launches antitrust investigation into Mylan over epipen . Nyag eric schneiderman says preliminary review identifies potential anticompetitive terms in epipen sales contracts with schools.  Full Article

NYC Comptroller Scott Stringer urges Mylan to name independent board chair
Thursday, 1 Sep 2016 03:24pm EDT 

New York City Comptroller Scott Stringer to Mylan: New York City Comptroller Scott Stringer writes to Mylan's Chair, Nominating and Governance Committee regarding effects of EpiPen price hikes . Urges Mylan board to name an independent board chair . "Express alarm" with Mylan's "exorbitant" price hikes for EpiPen . Asks Mylan to remove non-independent directors from the audit committee and nominating and governance committee . "Mylan's gross mismanagement of its EpiPen pricing strategy exacerbates the company's protracted history of weak board oversight" . "Mylan has failed to establish independent board leadership" . Urges Mylan to ensure each key board committee is comprised exclusively of independent directors with no material relationship to co . Urge co to establish clear and robust board-level oversight of the risks inherent by co's drug price strategy . Urges Mylan to provide clearer disclosure of co's drug pricing risks by annually detailing process and oversight co follows ((Bangalore.newsroom@thomsonreuters.com;)).  Full Article

U.S. Representatives seek details from Mylan on EpiPens price rise
Monday, 29 Aug 2016 02:36pm EDT 

: Representatives Jason Chaffetz, Elijah Cummings Of U.S. House Committee On Oversight And Government Reform Send Letter To Mylan CEO . Representatives Jason Chaffetz, Elijah Cummings Of U.S. House Committee On Oversight And Government Request Documents On Mylan's EpiPen's Price Rise Further company coverage: [MYL.O] ((Bangalore.newsroom@thomsonreuters.com;)).  Full Article

Mylan to launch first generic to EpiPen® auto-injector at a List Price of $300 per Two-Pack Carton
Monday, 29 Aug 2016 06:00am EDT 

Mylan NV : To launch first generic to EpiPen® auto injector at a list price of $300 per two-pack carton, a more than 50% discount to the brand product . Mylan also intends to continue to market and distribute branded epipen . Mylan nv says intends to initiate a direct ship program in conjunction with launch of generic at $300 generic list price . Expects to launch launch epipen auto-injector in several weeks, pending completion of labeling revisions .Both augmented patient assistance program and $300 savings card announced last week will remain in place for brand product.  Full Article

Indivior settles addiction treatment case with Mylan for undisclosed terms

Sept 25 Indivior's U.S. subsidiary, together with Monosol Rx, has settled a patent dispute with U.S. drugmaker Mylan related to generic versions of its opioid addiction treatment Suboxone, which generates 80 percent of the Indivior's revenue.