- While investors have long criticized Mylan’s new product yield, a generic Advair and Restasis could finally be coming to market before the end of the year.
- In terms of recently launched drugs, gCopaxone has had a slow start but could be starting to pick up. Fulphila continues to do well, and Yupelri was approved by the FDA earlier this month.
- 3Q outperformance was helped in part by strong margin expansion due to new product launches and continued integration efforts
- Mylan still has issues, including a difficult generic environment and the ongoing Morgantown remediation. However, expectations are low, and the risk/reward could be favorable Read More
- Mylan's recently received approval of Fulphila, their Neulasta biosimilar. Analysts expect the drug to contribute to management's guidance and importantly, demonstrates the company's ability to bring complex generics and biosimilars to the market
- Investor focus now shifts to two upcoming, and sizable, opportunities: gAdvair on June 27, and gRestasis on July 31. Read More
Mylan has drifted down by about 14% since early March as institutional investor concerns have grown over that time. Concerns have specifically centered around risk to 2017 and 2018 guidance due to approval delays in the company's new product pipeline. Additionally, the company's core business (generics and Epipens) have had new developments that have raised concerns over their outlooks as well. Read More
The company received a CRL (complete response letter), which is essentially a non-approval from the FDA. Mylan stated that they would review the letter and provide an update after reviewing and discussing with the FDA.
What does this mean for the stock? Read More
Many of us know of Mylan due to the EpiPen controversy, which became the poster child for healthcare and its out-of-control pricing in America. In late August of 2016, the media began reporting on the significant price increases on the EpiPen, which had increased from $100 in 2007 to $609 in mid-2016. Up to that point, the drug had become the primary component of Mylan's earnings, with a significant portion of profitability coming from the business (with some estimates placing it at 40% of its operating profit). Read More