Healthcare Roundup – White House not on board with CDC reopening guidelines, Gilead confirms remdesivir approval in Japan for severe COVID-19

Published on: May 7, 2020
Author: Amy Liu

White House not on board with CDC reopening guidelines

The NYT reports that the White House has rejected the guidelines from the Centers for Disease Control and Prevention (CDC) for reopening the U.S. economy calling the plan “too prescriptive” per administration officials.

According to a person familiar with the matter, Chief of Staff Mark Meadows perceives that the guidelines are too uniform and regressive for areas with relatively few cases.

President Trump is keen to get things back on track after the COVID-19 shutdowns which have decimated economic activity and left millions jobless. Unemployment is as high as 25% in some places.

More than half of states have started reopening their economies or plan to do so soon, although most fail to meet criteria to resume business and social activities per the White House’s nonbinding guidelines.

Gilead confirms remdesivir approval in Japan for severe COVID-19

Under exceptional (emergency use) status, Japan’s Ministry of Health, Labor and Welfare has approved Gilead Sciences’ (GILD +0.4%) remdesivir, branded as Veklury, for the treatment of severely ill COVID-19 patients.

Moderna cleared for Phase 2 study of COVID-19 vaccine

Alongside Q1 results, Moderna (NASDAQ:MRNA) says the FDA has given the green light to begin the Phase 2 study on its novel coronavirus vaccine (mRNA-1273).

It’s expected to start imminently, with the goal of a Phase 3 study to begin in early summer, and approval as soon as 2021.

Shares are up 10.5% premarket.

Herbalife EPS beats by $0.22, revenue in-line

Herbalife (NYSE:HLF): Q1 Non-GAAP EPS of $0.83 beats by $0.22; GAAP EPS of $0.32 misses by $0.17.

Revenue of $1.26B (+7.7% Y/Y) in-line.

Shares +1.03%.

Bristol-Myers Squibb affirms guidance, sees 20% earnings growth in 2021

Bristol-Myers Squibb (NYSE:BMY) Q1 results:

Revenues: $10,781M (+13.1%) (includes Celgene).

Top sellers: Revlimid: $2,915M (+13.1%); Eliquis: $2,641M (+37.2%); Opdivo: $1,766M (-1.9%); Orencia: $714M (+11.6%).

Growth remains elusive for Opdivo, sales were down 2% in Q4 2019 as well. Growth peaked at 45% in Q3 2018.

Net loss: ($766M) (-145.3%); non-GAAP net income: $3,956M (+119.3%); EPS: ($0.34) (-132.7%); non-GAAP EPS: $1.72 (+56.4%).

2020 guidance: revenues: $40.0B – 42.0B (unch); EPS: $0.37 – 0.57 from $0.75 – 0.95; non-GAAP EPS: $6.00 – 6.20 (unch).

2021 guidance: Non-GAAP EPS: $7.15 – 7.45.

Shares up 2% premarket on light volume.

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