By Tamara Mathias and Michael Erman
(Reuters) - Mylan NV said on Wednesday its board had set up a committee to review possible strategic alternatives, citing a tough U.S. environment for generic drugmakers.
"We are evaluating all alternatives," Chief Executive Officer Heather Bresch said on a conference call with analysts. She declined to discuss any options under consideration, adding that the review process was just beginning.
Mylan said its U.S.-centric investor base does not properly value the importance of its international business, noting that 60 percent of its revenue comes from outside the United States.
"Mylan feels strongly about underappreciated value of its ex-US business at current stock prices," Evercore ISI analyst Umer Raffat said in a note. However, he added, "the true growth engine for Mylan going forward comes from the U.S." via biosimilar launches.
The company said it was confident it would receive by mid-October U.S. approval of its generic version Advair, GSK's big-selling asthma treatment, after a three-month regulatory delay.
Mylan reported a much smaller-than-expected second quarter profit and lowered its 2018 earnings forecast as restructuring at a large West Virginia plant impacted product production, and shortages of its EpiPen emergency allergy injectors further hurt revenue.
Shortages of the life-saving treatment continue due to ongoing manufacturing issues at a Pfizer plant responsible for the entire EpiPen global supply. Mylan said the devices may not always be available from pharmacy to pharmacy.
Mylan now expects full-year adjusted earnings per share of $4.55 to $4.90, down from its prior view of $5.20 to $5.60. Analysts were estimating $5.25 per share, according to Thomson Reuters I/B/E/S.
The low end of the new forecast represents a worst case scenario, Bresch said.
Mylan shares initially fell as much as 9 percent before recovering entirely and were up 1.5 percent at $39.13.
Generic drugmakers like Mylan and Teva Pharmaceutical Industries have suffered over the past few years as price erosion weighed heavily on their bottom lines.
But Mylan said competition was not the problem. Company executives said a U.S. healthcare system that allows insurers and pharmacy benefit managers to make deals for preferred access to prescription drugs on their formularies is hurting its business. It called for requiring formulary access for cheaper generic alternatives.
"The negative trends playing out in the U.S. marketplace are unsustainable for the healthcare system over the long term," the Mylan board said in a statement.
The Trump administration in May released a blueprint for reducing prescription drug costs for U.S. consumers. It has since suggested changes that could eliminate rebate deals between manufacturers and industry middlemen that some blame for high drug prices.
Mylan said the U.S. Food and Drug Administration had issued observations following inspection of its Morgantown, West Virginia plant that are being addressed by a restructuring program.
That revamp had a "significantly negative impact" on production, the company said, adding that it expects the impact and related expenses to continue through 2018.
Excluding items, Mylan earned $1.07 per share, well below analysts' average estimate of $1.22.
(Reporting by Saumya Sibi Joseph and Tamara Mathias in Bengaluru and Michael Erman in New York; Editing by Sriraj Kalluvila and Bill Berkrot)