Shares of Mylan N.V. (MYL - Free Report) have declined 7.5% in the year so far against the industry’s growth of 6.4%.
Mylan is a global pharmaceutical company with a well-established generics business. It also has a presence in the biosimilars market.
After sailing through troubled waters in 2017, things were turning for this beleaguered generic company. However, the company suffered yet another blow.
Mylan recently suffered a major setback as rival Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) won the FDA approval for the first generic version of the former’s EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions including those that are life-threatening (anaphylaxis), in adults and pediatric patients. The approval of a generic will negatively impact EpiPen sales of Mylan as the generic will obviously be priced lower. Mylan was earlier under the scanner for high price of the product. We note that the company already has its own authorized generic for the same.
Earlier, Mylan stated that it is evaluating strategic alternatives as the generic business in North America continues to experience pricing and competitive pressure. Concurrent with its second-quarter results, the company also lowered its outlook as a result of the change in expected complex product launch, utilization assumptions, resizing of product opportunities in the United States, and the negative impact on operations of the restructuring and remediation program in Morgantown.
The company earlier suffered a setback, when the FDA refused to approve its Abbreviated New Drug Application for the generic version of GlaxoSmithKline’s (GSK - Free Report) asthma drug, Advair Diskus.
Earlier, Mylan and partner Momenta Pharmaceuticals reported disappointing results from a phase I study on the biosimilar version of Orencia. The study failed to meet primary endpoints. Any additional failures will be detrimental to the company’s growth prospects.
Mylan’s manufacturing partner, Pfizer (PFE - Free Report) earlier experienced interruptions in the production of EpiPen, and hence the latter’s supplies to Mylan are inconsistent and inadequate in meeting global demand including the United States.
While the biosimilar business continues to gain traction buoyed by new approvals, it might not be enough to combat the persistent decline in North America.
Mylan currently carries a Zacks Rank #5 (Strong Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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