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Mylan N.V. (NASDAQ: MYL) reported its financial results for Q2 and the first half of 2020. Total revenues reached $2.73 billion in Q2, a 4% decline year-over-year, while revenues for the first half stood at $5.35 billion, showing little change. North America net sales increased by 2%, but the Europe and Rest of World segments faced declines of 6% and 10%, respectively. U.S. GAAP net earnings for Q2 were $39.4 million, a significant recovery from a loss of $(168.5) million in Q2 2019. Adjusted net earnings rose to $574.3 million compared to $532.8 million in the prior year.
Mylan N.V. (NASDAQ: MYL) will announce its second quarter 2020 financial results on August 6, 2020, prior to the opening of U.S. markets. A live webcast to discuss these results is scheduled for 10:30 a.m. ET on the same day, accessible via phone or through their investor website. Mylan operates globally, providing over 7,500 products in more than 165 countries, including essential antiretroviral therapies for approximately 40% of people receiving treatment for HIV/AIDS worldwide. Focused on improving healthcare access, Mylan employs around 35,000 people.
Mylan and Upjohn, a division of Pfizer, have announced the unveiling of the branding and logo for their upcoming joint company, Viatris. This new entity aims to leverage both companies' strengths, offering a Global Healthcare Gateway with access to over 1,400 therapeutic molecules across 165 countries. The transaction is anticipated to close in Q4 2020, following overwhelming shareholder approval on June 30, 2020. Viatris seeks to enhance patient access to essential medicines while creating value for stakeholders.
Mylan N.V. and Fujifilm Kyowa Kirin Biologics have received FDA approval for Hulio (adalimumab-fkjp), a biosimilar to Humira, targeting various inflammatory conditions. This product is set to launch in July 2023, enhancing patient access to affordable treatments. The approval follows successful clinical trials showing no significant safety or efficacy differences compared to Humira. With Humira's U.S. sales at approximately $14.9 billion for 2019, Hulio presents a significant market opportunity for Mylan.
Mylan N.V. (NASDAQ: MYL) has issued a voluntary nationwide recall of one lot of Daptomycin for Injection, 500 mg/vial, due to the presence of particulate matter in a single-dose vial. This recall affects products distributed to wholesalers and retail pharmacies from April to May 2020, with the specific lot number being 7605112, which expires in October 2021. Although intravenous use of this product may lead to serious adverse events, Mylan reports no adverse event reports related to this issue. Consumers and distributors are advised to cease usage and return the product.
Mylan N.V. (NASDAQ: MYL) announced the approval of remdesivir 100 mg/vial for restricted emergency use in India by the Drug Controller General of India (DCGI), addressing urgent COVID-19 treatment needs. The drug, branded as DESREM™, will launch in July at INR 4,800, over 80% less than the branded version in developed countries. Mylan aims to expand access across 127 low- and middle-income countries, marking their first approval in this region. The company emphasizes its commitment to public health and collaboration with Gilead Sciences in tackling COVID-19.
Mylan N.V. (Nasdaq: MYL) announced that its shareholders have overwhelmingly approved the merger with Upjohn, a division of Pfizer, with 99.6% voting in favor. Executive Chairman Robert J. Coury emphasized that this approval reflects confidence in the transaction's potential to unlock value and drive growth. The new company, Viatris, is expected to launch in Q4 2020 with a focus on shareholder returns and a commitment to a dividend of at least 25% of free cash flow. The merger now awaits final regulatory approvals.
Mylan N.V. (NASDAQ: MYL) announced a significant legal victory as the U.S. District Court for the Northern District of West Virginia invalidated Biogen's Tecfidera® patent (U.S. Patent No. 8,399,514), which protects methods for treating multiple sclerosis (MS). This ruling facilitates Mylan's entry into the generic market for dimethyl fumarate, pending FDA approval. Mylan aims to launch its product, potentially being the first oral generic MS treatment in the U.S., as it expects 180 days of marketing exclusivity post-approval, with a target date of November 16.
