Shares of Mylan N.V (MYL - Free Report) are up 8.1% in after-market trading, after the company beat on earnings in the third quarter. Mylan’s stock has lost 25.8% so far this year compared with the industry’s decline of 6.6%.
Adjusted earnings of $1.25 per share beat the Zacks Consensus Estimate of $1.17 and were up from $1.10 in the year-ago quarter.
However, third-quarter revenues of $2.86 billion missed the Zacks Consensus Estimate of $2.87 billion and were down 4% from the prior-year quarter.
Quarter in Detail
The company posts results in three segments on a geographic basis, namely North America, Europe and Rest of World.
North America segment’s net sales came in at $1.01 billion, down 14%. This decline was primarily due to lower volumes on existing products like the EpiPen Auto-Injector. This was partially offset by new product sales, including the recent launch of Fulphila, a biosimilar of Neulasta. The decline in volumes was primarily driven by the timing of purchases of products by customers, divestiture of certain contract manufacturing assets, loss of exclusivity of a product, and actions associated with the restructuring and remediation program at the Morgantown manufacturing facility.
The FDA completed an inspection at Mylan's plant in Morgantown, West Virginia earlier this year and made observations through a Form 483. Thereafter, Mylan submitted a comprehensive response to the FDA. During the second quarter of 2018, Mylan started a restructuring and remediation program to reduce complexity at the Morgantown manufacturing facility, which led to the discontinuation and transfer of a number of products to other manufacturing sites, a reduction of the workforce and extensive remediation activities. These actions have led to a temporary disruption in supply of certain products.
Net sales in the Europe segment were $1.04 billion in the quarter, an increase of $0.5 million, which was primarily driven by new product sales and higher volumes on existing products.
Rest of World segment’s net sales of $773.7 million were up 4%, driven by new products.
Adjusted gross margin of 55% was slightly down from 53% in the year-ago quarter.
2018 Outlook Reiterated
Mylan expects 2018 total revenues of $11.25-$12.25 billion. The company anticipates adjusted EPS around $4.55-$4.90.
Mylan’s third-quarter results were mixed as the company’s earnings beat estimates but revenues missed the same.
Mylan proactively discontinued a number of products, while also transferring some to other sites. These have led to a temporary disruption in supply of certain products and reduced volumes in North America generic sales.
Nevertheless, Mylan continues to gain traction with its biosimilar portfolio. The company has launched nearly 475 new products year to date across its segments, including a record number of complex generics and biosimilars. In August 2018, Mylan completed an agreement with certain subsidiaries of Novartis AG (NVS - Free Report) to purchase worldwide rights to their global cystic fibrosis products, consisting of the TOBI Podhaler and TOBI solution. This should further broaden the company’s portfolio.
Mylan and partner Biocon obtained the FDA approval for Fulphila. The company earlier received the FDA approval for a biosimilar version of Roche Holdings’ (RHHBY - Free Report) Herceptin.
Meanhwile, the company expects an approval of the generic version of GlaxoSmithKline’s (GSK - Free Report) asthma drug, Advair Diskus, Wixela. The FDA had earlier issued a complete response letter (CRL) for the same. Nevertheless, Mylan is in discussions with the FDA, regarding the progress of its review. Based on our latest update from the agency, the FDA is in the final stage of the labeling review.
However, these new approvals might not be enough to combat the persistent decline in North America.
Mylan carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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