Friday, 18 August, 2017

Mylan pushes back all 2017 U.S. drugs launches to next year

Drugs developer "We have elected to defer all major US launches from our full year 2017 financial guidance to 2018
Marlene Weaver | 10 August, 2017, 02:55

The launches include Mylan's generic version of GlaxoSmithKline's blockbuster Advair asthma treatment and Teva's multiple sclerosis drug, Copaxone.

But delays in drug approvals and increased competition from new generic versions of its own drugs forced Mylan to reassess and lower its forecast, she said.

Rival generic drugmakers such as Teva, and Irish-based pair Mallinckrodt and Endo International have also lowered their 2017 forecasts, hurt by continued generic drug price erosion.

On a call with investors, the company blamed the delays on restructuring at the FDA and said that it didn't expect the agency to require any more clinical or device-related studies. "Looking ahead, we continue to have great confidence in our underlying business in every region and the opportunities we have for long-term growth", said Heather Bresch, the chief executive officer of Mylan.

This is providing investors an opportunity to differentiate between pharmaceutical companies focused exclusively on generics and/or specialty medicines and those capable of delivering a broad and diverse portfolio across multiple channels in various geographies, which remains Mylan's strategy. But Mylan President Rajiv Malik told investors Wednesday that the FDA seems more focused on quickly approving subsequent versions of generics.

Mylan executives said Wednesday that the company planned to submit a response to the FDA's concerns regarding Advair in the next few weeks.

Drugmakers have cited exactly that FDA shift in explaining why their generics businesses have been hurting, an industry trend that slammed generic drugmakers' and drug distributors' shares late last week.

China, Vietnam meeting cancelled amid South China Sea tensions
China has used land reclamation to build up islands and construct airports to back its claim of much of the waters off its coast. He said the framework is an outline and countries can put in more substantive aspects of the code when the negotiations start.

Sales of its signature EpiPen autoinjector, used to treat anaphylaxis, fell 9 percent in the second quarter of 2017 as generic versions came on the market, even though the market segment saw a 4 percent increase in sales. North American sales slid 9% overall in the quarter ended June 30; excluding EpiPen sales, they grew 4%.

The firm also trimmed its second quarter earnings per share and revenue estimates to $1.15 and $2.92 billion, respectively, both of which are below the consensus estimates. It also cut a long-standing 2018 earnings per share target of $6 to at least $5.40.

Mylan lowered its 2017 earnings per share estimate by 5% from $5.17 to $4.93 and its 2018 estimate by 10% from $5.78 to $5.21.

Revenue jumped 16% to $2.96 billion.

Mylan's quarterly net earnings rose 76.4 per cent to $297 million, or 55 U.S. cents per share, helped by demand for products it gained through the acquisition of Swedish drugmaker Meda previous year. On an adjusted basis, earnings fell to $1.10 a share from $1.16 a share.

Shares closed at $32.08, up 29 cents, after opening 5.9% lower.

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