Second quarter earnings season is drawing to a close with most major companies having reported results. This week, companies like Endo, Mylan (MYL - Free Report) , Novo Nordisk and Perrigo (PRGO - Free Report) presented their second quarter results.
Recap of the Week’s Most Important Stories
A Look at Q2 Earnings Results: Mylan’s second quarter results were disappointing with the company missing on both earnings and revenues and cutting its outlook (Also read: Mylan Misses on Q2 Earnings & Sales, Lowers View). Mylan has pushed back all major product launches in the U.S. from 2017 to 2018 reflecting ongoing challenges and the uncertain U.S. regulatory environment. These product launches include generic versions of Advair and Copaxone. Escalating price erosion in the generics market remains a major challenge. Meanwhile, Mylan got a subpoena from the U.S. Department of Justice (“DOJ”) in late Jul 2017 seeking information relating to opioids manufactured, marketed or sold by the company from Jan 1, 2013 to Dec 31, 2016. Mylan has lost 15.4% of its value year to date versus the 15.8% decline of its industry.
Perrigo’s second quarter results were better-than-expected with the company raising its outlook (Also read: Perrigo Q2 Earnings & Sales Top, 2017 View Raised). Novo Nordisk also topped earnings estimates and raised its outlook. Meanwhile, Endo, which topped earnings and revenue estimates, lowered its outlook (Also read: Endo Beats Q2 Earnings & Sales, 2017 Guidance Lowered). Endo stock has lost 54.2% of its value year to date versus the 1.8% decline of its industry.
Perrigo is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Esperion Up on Positive Mid-Stage Data: Esperion’s (ESPR - Free Report) shares were up 15.4% on positive top-line data from a study evaluating the company’s bempedoic acid and Zetia (ezetimibe) combination plus Lipitor versus placebo in patients with hypercholesterolemia. The mid-stage triplet oral therapy study met its primary endpoint of greater LDL-C lowering compared to placebo. The company intends to conduct additional studies next year and expects to file for FDA approval of the combination by the first quarter of 2019.
Zynerba Plunges as STAR 1 Fails to Shine: Zynerba (ZYNE - Free Report) saw its shares plunging 55.7% on disappointing mid-stage data on the company’s experimental cannabinoid treatment, ZYN002. Results from the double-blind placebo controlled STAR 1 study in adult epilepsy patients with focal seizures showed that both doses of ZYN002 failed to meet the endpoints compared to placebo. Focus has now shifted to a couple more studies being conducted with ZYN002 – osteoarthritis (top-line data expected in Aug 2017) and Fragile X syndrome (top-line data expected in Sep 2017).
Valeant Gets CRL for Eye Drop: Valeant , which reported second quarter results this week (Also read: Valeant Beats Q2 Earnings, Sales in Line, Trims View), got a complete response letter (“CRL”) from the FDA for its new drug application (“NDA”) for Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%). The company is looking to gain approval for the use of the intraocular pressure lowering single-agent eye drop in patients with open angle glaucoma or ocular hypertension. While no safety or efficacy concerns were raised by the FDA, the CRL referred to a Current Good Manufacturing Practice (“CGMP”) inspection at Bausch + Lomb's manufacturing facility in Tampa, FL. Valeant is working on resolving manufacturing quality issues at the Tampa plant and will be working with the agency to determine the path forward.
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index declined 1.9% over the last five trading sessions. Among major stocks, Bristol-Myers (BMY - Free Report) was up 1.9% while Glaxo lost 3.2%. Over the last six months, J&J was up 17% while Merck (MRK - Free Report) declined 1.7% (See the last pharma stock roundup here: Mixed 2Q Results from Pfizer, Bristol-Myers Announces IO Deals).
What's Next in the Pharma World?
Watch out for the usual pipeline and regulatory updates.
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