WHO's hydroxychloroquine trial suspended pending safety data, Bloomberg says » 18:0005/2505/25/20
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The World Health…
The World Health Organization temporarily halted tests on hydroxychloroquine in its COVID-19 drug trials pending more data because of safety concerns, Bloomberg's Corinne Gretler reports. The steering committee decided to suspend enrollment to that arm of the so-called Solidarity trials, WHO officials said Monday. That's after the Lancet published a study that said the drug, touted by U.S. President Donald Trump as a treatment, was linked to an increased risk of death and heart ailments, the author notes. Mylan (MYL), Teva (TEVA), Novartis (NVS), and Bayer (BAYRY) are among companies that had announced efforts to increase hydroxychloroquine production early in the COVID-19 outbreak. Reference Link
Week in Review: How Trump's policies moved stocks » 09:5505/2305/23/20
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Catch up on the top…
Hydroxychloroquine linked to higher death risk in COVID patients, WaPo reports » 08:4105/2205/22/20
MYL, TEVA, NVS, BAYRY
Hydroxychloroquine, the anti-malaria drug that President Trump has said that he has been taking to prevent himself from contracting coronavirus infection, has been linked to a significantly higher risk of death and patients taking it were also more likely to develop a type of irregular heart rhythm that can lead to sudden cardiac death, a study published in medical journal the Lancet concluded, reported The Washington Post's Ariana Eunjung Cha and Laurie McGinley. Mylan (MYL), Teva (TEVA), Novartis (NVS), and Bayer (BAYRY) are among companies that had announced efforts to increase hydroxychloroquine production early in the COVID-19 outbreak. Reference Link
|Over a week ago|
Trump taking hydroxychloroquine to prevent coronavirus infection, CNBC says » 16:5605/1805/18/20
President Trump said …
President Trump said that he has been taking anti-malaria drug hydroxychloroquine fo more than a week to to prevent himself from contracting coronavirus infection, reports CNBC. The Fly notes that Mylan (MYL) and Novartis (NVS) are making chloroquine tablets to fight COVID-19. Reference Link
Fly Intel: Pre-market Movers » 09:1105/1305/13/20
GILD, ROKU, JCP, JD, LVS, MYL, UNFI, CYBR, INFN, ADPT, NE, BLUE
Check out this morning's…
Mylan to supply investigational antiviral remdesivir for COVID-19 treatment » 16:1905/1205/12/20
Mylan (MYL) announced, as…
Mylan (MYL) announced, as part of its ongoing efforts to support patients and public health needs during the COVID-19 pandemic, a global collaboration with Gilead Sciences (GILD) to expand access to the investigational antiviral remdesivir for the potential treatment of COVID-19. Under the terms of the license agreement signed with Gilead, Mylan has rights to manufacture and distribute remdesivir in 127 low- and middle-income countries, including India. The agreement is non-exclusive, allowing for multiple licensees to ensure extensive access to this treatment, once approved as safe and effective for COVID-19 patients. "To ensure preparedness in this critical time of need, Mylan is confident it will be able to develop a bioequivalent version of remdesivir, including production of its own active pharmaceutical ingredient and the finished dosage form in sterile powder lyophilized vials for administration of the medicine by intravenous infusion. We will be in a position to provide product in the coming months, subject to reviews by national regulatory bodies and the Prequalification Program of the World Health Organization."
Gilead signs remdesivir licensing deals with Mylan, four other manufacturers » 14:0505/1205/12/20
Gilead (GILD) said it has…
Gilead (GILD) said it has signed non-exclusive voluntary licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir. The agreements allow the companies - Cipla Ltd., Ferozsons Laboratories, Hetero Labs., Jubilant Lifesciences and Mylan (MYL) - to manufacture remdesivir for distribution in 127 countries. "The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access," Gilead said in a statement. Under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly. The licensees also set their own prices for the generic product they produce. The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier. Reference Link
Mylan says on track to close pending Upjohn combination in second half » 08:3805/1105/11/20
Mylan CEO Heather Bresch…
Mylan CEO Heather Bresch said, "As we navigate the COVID-19 environment, our hearts and thoughts are with those who have been affected by COVID-19, and all of the healthcare workers and first responders who continue to go above and beyond to help save lives across the globe. I also would like to extend a special message of gratitude to our own Mylan family around the world. Thanks to their commitment, we have been able to continue meeting patient needs, even amid the challenges of a global pandemic. These efforts are reflected in our first quarter results, which came in with total revenues growing 5%, or 8% on a constant currency basis. We're also reaffirming revenue guidance to be in the range of $11.5B and $12.5B, absorbing approximately $200M of foreign exchange headwinds versus our previous expectations, and adjusted EBITDA to be in the range of $3.2B to $3.9B, absorbing approximately $50M of foreign exchange headwinds versus our previous expectations. These ranges account for COVID-19 impacts forecasted through the second quarter. Looking ahead, we remain on track to close the pending combination with Pfizer's Upjohn Business in the second half of the year and continue to have great confidence that Viatris will be well positioned to deliver value for all of our stakeholders as a true partner of choice."
Mylan reports Q1 revenue $2.62B, consensus $2.65B » 08:3505/1105/11/20
Reports Q1 U.S. GAAP net…
Reports Q1 U.S. GAAP net earnings of $20.8M, compared to U.S. GAAP net loss of $(25.0M) in the prior year period. Reports Q1 adjusted net earnings of $467.2M, compared to adjusted net earnings of $421.9M in the prior year period. Mylan President Rajiv Malik said, "During these trying times, I am especially inspired by the dedication of Mylan's manufacturing colleagues who, with the support of their families, are continuing to work on-site to respond to the need for critical medicines. As a result of the Mylan team's efforts, our broad and diverse manufacturing footprint of more than 40 manufacturing facilities, which is spread across 12 countries, has maintained supply continuity. The strategic locations of our plants have enabled Mylan to avoid disruptions due to logistical challenges in any one part of the world. We have further mitigated risk by having multiple API and finished dose sources where possible, and we are continuously monitoring the inventory levels of our raw materials and the finished dosage form of our products. At this time, we do not foresee any supply disruptions, which we believe is a result of our geographic spread and supplier diversity." Mylan CFO Ken Parks added, "During the first quarter, we generated $357M of adjusted free cash flow, an increase of $330M over the prior year, primarily driven by working capital velocity and timing of certain other payments. As evidenced by our strong first quarter cash flow, we are pleased with our liquidity position despite the COVID-19 pandemic and anticipate full year adjusted free cash flow generation to be consistent with 2019 levels. We continue to target approximately $1B of debt repayment during 2020 and remain fully committed to our investment grade credit rating."
Mylan backs FY20 revenue view $11.5B-$12.5B, consensus $11.74B » 08:3505/1105/11/20
Sees FY20 adjusted EBITDA…
Sees FY20 adjusted EBITDA $3.2B-$3.9B. This range accounts for COVID-19 impacts forecasted through Q2, and assumes healthcare systems around the world will begin to resume their normal functions in the second half of 2020.