Gilead’s remdesivir could see $7 billion in annual sales on stockpiling boost: analyst

Gilead Sciences Inc potential COVID-19 treatment, remdesivir, could bring in more than $7 billion in annual sales by 2022, spurred by governments stockpiling the drug to guard against future outbreaks, SVB Leerink said on Wednesday.
Remdesivir has shown improvement in COVID-19 patients in clinical trials and has been cleared for emergency use in severely ill patients in the United States, India and South Korea. Some European nations are using it in compassionate use.
The U.S. drugmaker is yet to set a price for the drug that is currently being administered intravenously in hospitals.
SVB Leerink analyst Geoffrey Porges, who upgraded his rating on Gilead’s shares to “outperform”, estimates remdesivir to be priced at $5,000 per course in the United States, $4,000 per course in Europe and around $2,000 in other markets.
The estimate comes a month after Boston-based Institute for Clinical and Economic Review suggested a price of $4,500 per U.S. treatment course for 10 days.
Remdesivir is yet to win a formal U.S. approval and Porges said commercial sales of the drug could begin later this year. He expects government stockpiling to begin late next year and said half of the forecasted sales of nearly $7.7 billion in 2022 could come from stockpiling contracts.
“We do forecast gradual adoption of vaccination, but in our view that is unlikely to stop government stockpiling of remdesivir,” Porges wrote in a client note.
Last month, brokerage SunTrust Robinson Humphrey estimated global sales of the drug to be around $3 billion by 2022. That assumes a U.S. price of around $10,000 per treatment course, but potential competition from other therapies and vaccines.
Given the vast number of COVID-19 infections, pricing remdesivir at around $1,000 per course could still mean over $1 billion in revenue, brokerage Jefferies had said last month.

https://www.marketscreener.com/GILEAD-SCIENCES-4876/news/Gilead-s-remdesivir-could-see-7-billion-in-annual-sales-on-stockpiling-boost-analyst-30717121/?countview=0

White House picks five COVID vaccine candidates for Warp Speed initiative

Aimed at following through on its pledge to have a COVID-19 vaccine available in the next 2-3 quarters under Operation Warp Speed, the Trump administration has selected five “finalists” for development.

Moderna (MRNA +3.8%): Phase 2 study of mRNA-1273 underway.

AstraZeneca (AZN +0.5%) with Oxford University: Studies in UK underway on AZD1222.

Johnson & Johnson (JNJ -0.1%): Phase 1 study to launch in September at the latest.

Merck (MRK +1.6%): No dates yet announced for trials.

Pfizer (PFE -0.9%): “Hundreds of millions” of doses to be available this year.

MRNA, AZN/Oxford and JNJ have already received $2.2B in federal funding. All five will have access to additional financial support to quickly advance their candidates.

About 30K people will take part in Phase 3 trials, meaning that a total of 150K people could be vaccinated.

Conspicuous by their absence are GlaxoSmithKline (GSK +0.4%) and Sanofi (SNY -0.5%).

https://seekingalpha.com/news/3580124-white-house-picks-five-covid-vaccine-candidates-for-warp-speed-initiative

WHO set to resume hydroxychloroquine trial in battle on COVID-19

The World Health Organization (WHO) is set to resume its trial of hydroxychloroquine for potential use against the new coronavirus, its head Tedros Adhanom Ghebreyesus said on Wednesday, after testing was suspended due to health concerns.
Tedros also told an online media briefing he was “especially worried” about the outbreak in Central and South America, where infections have been spreading rapidly.
https://www.reuters.com/article/us-health-coronavirus-who/who-set-to-resume-hydroxychloroquine-trial-in-battle-on-covid-19-idUSKBN23A2LT

Keros At Jefferies 2020 Virtual Healthcare Conference

Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, announced that Keros’ President and Chief Executive Officer Jasbir S. Seehra, Ph.D. is scheduled to present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 9:00 am ET.
https://www.globenewswire.com/news-release/2020/05/28/2040093/0/en/Keros-Therapeutics-To-Present-At-The-Jefferies-2020-Virtual-Healthcare-Conference.html

Muddy Waters reiterates bearish view on eHealth

Online health insurance exchange operator eHealth (EHTH -1.5%) is under modest pressure on below-average volume on the heels of a second bearish report from Muddy Waters Research (MW).

The noted short seller, who released its first report in April, cites the company’s over-aggressive accounting, booking sales years ahead of actually collecting the cash. For example, it calculates that will take about nine years for cash collections to match receivables for the 2019 customer cohort. In other words, it will collect only ~64% of booked Medicare Advantage (MA) revenue during the three-year period (average “life” for a MA customer) for which it estimates revenue.

MW also claims that EHTH is also under-reporting costs associated with member retention and revenue sharing, necessary expenses to collect the cash, adding that the cash it does collect fails to meet the initial receivable booked, exclusive of its subsequent tail revenue (revenue after the three-year period) adjustments, according to its estimate.

EHTH generates cash corresponding to tail revenue only from members who remain at least 10 years, a very small percentage of each cohort (sign-ups each year). MW estimates that tail revenue cash collections are $227 per member or 22.4% of the initial receivable booked. About 2/3 of clients leave by year 3.

MW says the company books two sources of revenue, once when an application is approved by CMS [$1,013 per member last year equal to the constrained loan-to-value (LTV) amount] and revenue in excess of the LTV via from the residual tail group and increases in MA commission rates.

In Q1, the company booked $106.4M in revenue and $3.5M in net income. Cash flow ops was $8.9M.

In 2019, it recorded net income of $83.5M on revenue of $506.2M. Cash flow ops was ($71.5M).

https://seekingalpha.com/news/3580086-muddy-waters-reiterates-bearish-view-on-ehealth

Pliant Therapeutics up 55% in U.S. debut

Shares in Pliant Therapeutics (PLRX +55%) are currently exchanging hands at $24.74 on turnover of ~2.1M shares in the first day of its IPO of 9M common shares priced at $16.

The South San Francisco, CA-based biopharmaceutical firm develops treatments for fibrosis. Lead candidate is PLN-74809, a small molecule inhibitor of certain integrins (class of proteins that plays a key role in cell-extracellular matrix adhesion), for the potential treatment of ideopathic (cause unknown) pulmonary fibrosis (IPF) and a liver disorder called primary sclerosing cholangitis (PSC) characterized by inflammation and scarring of the bile ducts. Enrollment is underway in two Phase 2a studies in IPF. A Phase 2a study in PSC should launch in H2.

https://seekingalpha.com/news/3580092-pliant-therapeutics-up-55-in-u-s-debut

Novavax enlists AGC Biologics to manufacture adjuvant for COVID-19 shot

Novavax is racing against some of the world’s biggest pharmaceutical companies in its COVID-19 vaccine effort, and the biotech has now brought on a partner to manufacture its adjuvant.

The company enlisted Japanese contract development and manufacturing organization AGC Biologics to scale up and produce its Matrix-M adjuvant, a component of the novel coronavirus vaccine candidate NVX-CoV2373. The partners aim to deliver vaccine doses in 2020 and 2021, AGC says.

AGC is working to “quickly” ramp up the adjuvant supply amid the pandemic, CEO Patricio Massera said in a statement, adding that the urgency “could not be higher.”

Novavax has one of the 10 COVID-19 vaccines in human trials, and more than 120 others are in preclinical testing, according to a Tuesday update from the World Health Organization. The company has scored up to $384 million for its work from the Coalition for Epidemic Preparedness Innovations (CEPI), and last month inked a $167 buyout to bolster its manufacturing capacity.

Other big players involved in the COVID-19 vaccine race are Johnson & Johnson, Pfizer, Sanofi and AstraZeneca. Moderna, a biotech that hasn’t yet won approval for any of its therapies or vaccines, is also among frontrunners with late-stage trials planned this year.

Aside from COVID-19, Novavax is also involved in research against RSV, Ebola and other diseases. The company hasn’t yet scored any FDA approvals, but it’s getting ready to file its flu vaccine, NanoFlu, after posting positive phase 3 data back in March. The flu vaccine also uses Novavax’s Matrix-M adjuvant.

The AGC Biologics tie-up comes right on the heels of the CDMO’s purchase of a former AstraZeneca plant in Boulder, Colorado. AGC will begin commercial production there by April 2021.

The site houses two 20,000-liter mammalian cell bioreactors, with room for up to four more for potential future expansions. Aside from that site, AGC is completing expansion projects in Seattle, Copenhagen and Chiba, Japan, by the end of 2021, the company says.

https://www.fiercepharma.com/manufacturing/novavax-enlists-agc-biologics-to-manufacture-adjuvant-for-covid-19-shot