Year Established 1970
Revenues: $11,434 (-4%)
Net Income: $353 (-49%)
R&D: $705 (-10%)
TOP SELLING DRUGS
|Glatiramer Acetate||Multiple Sclerosis||$541||372%|
|EpiPen||Anaphylaxis, General allergy indications||$218||-49%|
|Esomeprazole Magnesium||GERD, Ulcers||$202||-3%|
It was a challenging year for Mylan, plagued with valsartan recalls, remediation efforts, and ongoing drug shortages for EpiPen. Financially, the first quarter revealed the company’s tribulations are far from over, with revenues down 7% to $2.5 billion and a loss of $25 million, as compared to earnings of $87.1 million in 1Q18. North America sales were down 6% and sales in Europe were down 14% primarily driven by a competitive environment and the impact of the $58.8 million Morgantown plant remediation activities, partially offset by new product sales, including Wixela Inhuband Fulphila (biosimilar to Neulasta), and increased market share on Glatiramer Acetate Injection.
On November 20, Mylan initiated a voluntarily recall of certain valsartan-containing products due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA), (classified as a probable human carcinogen) contained in the API Valsartan, manufactured by Mylan Laboratories. Valsartan is used for the treatment of high blood pressure, heart failure, and to reduce cardiovascular mortality following a heart attack.
In December, the recall was expanded to include another 104 lots, including Amlodipine and Valsartan Tablets, Valsartan Tablets and Valsartan and Hydrochlorothiazide Tablets.
Additionally, Mylan’s manufacturing license for valsartan was suspended by European authorities after NDEA was found in some batches of the hypertension drug made at the company’s facility in Hyderabad, India.
Also in November, the company received a warning letter from the FDA relating to its manufacturing facility in Morgantown, West Virginia, citing problems with cleaning and quality control systems. As part of the ongoing restructuring and remediation activities, Mylan discontinued a number of products from the site while transferring some products to other sites. That being said, Mylan does not expect to have any significant new product launches from the site in 2019.
To top that off, May 10th 2019 marked one year of the EpiPen shortage, which is expected to drag on. According to a statement last August, Mylan’s manufacturing partner Meridian Medical Technologies, a Pfizer company, continued to experience interruptions in the production of EpiPen (epinephrine injection, USP) and EpiPen Jr. At that time, over the past few months, there was intermittent supply as the company explored several options with Pfizer to help stabilize supply. Sterile injectables require a highly complex and technical manufacturing and assembly process and despite the company’s best efforts, further supply shortages were anticipated. In June, Pfizer and Mylan announced that they are working with the FDA to extend the expiration dates by four months on all lots of EpiPen, with the exception of EpiPen Jr., in an effort to help alleviate shortages.
In more recent bad news, in May, 44 states filed a lawsuit alleging pharmaceutical companies colluded to fix the prices on their generic drugs, in which Mylan is a defendant. According to a UBS estimate, Mylan faces litigation charges of $1.1 billion.
On the bright side, Mylan and Fujifilm Kyowa Kirin Biologics Co. were granted marketing authorization from the EU for Hulio, a biosimilar to AbbVie’s Humira, for all indications. Mylan plans to launch Hulio across various markets in Europe on or after October 16. Humira is the world’s top-selling drug with nearly $20 billion in sales in 2018.