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Tuesday, September 15, 2020

Working from home due to COVID continues to decline

The number of U.S. employees working from home due to COVID-19 is falling, but remains elevated, according to the Bureau of Labor Statistics.

The BLS says 24% of workers telecommuted in August, down from 26.4% in July. That’s down from the peak of 35.4% in May.

Younger workers were less likely to work from home than others. Just 11% of those under 25 teleworked because of the pandemic, compared with 27% of those between 25 to 54 and 23% of those 55 and older.

Better educated employees were more likely to work from home, with just 3% of those with a high school diploma or less teleworking.

Despite the rally in technology stocks and certain work-from-home related issues, the newly-created Direxion Work From Home ETF (WFH, +0.4%) has barely budged. It’s up 5% since its arrival on the market at the end of June.

See the WFH top 10 holdings.

https://seekingalpha.com/news/3614223-working-from-home-due-to-covid-continues-to-decline

Healthcare SPAC Montes Archimedes Acquisition files for $500M IPO

A blank check company formed by Patient Square Capital, Montes Archimedes Acquisition (MAACU) to raise up to $500M by offering 50M units at $10/unit.

Each unit consists of one share of common stock and one-half of a warrant, exercisable at $11.50.

The company plans to target the entire health care industry, including tech-enabled services, biopharmas, pharmaceutical value chain, medical devices, diagnostics, providers, digital health, and consumer health.

According to the Center for Medicare and Medicaid Services, total U.S. national health expenditure was projected to exceed $3.5T in 2019, and total health care spending is projected to grow at a 5.5% CAGR through 2027, approaching approximately 20% of total U.S. Gross Domestic Product. This pace of growth is projected to continue over the years to come, driven by favorable trends including an aging population, increased prevalence of chronic disease and improved access to health care.

Patient Square Capital LP, has agreed to purchase 12M warrants (or 13.5M warrants if the underwriters’ over-allotment option is exercised in full), each exercisable to purchase one share of Class A common stock at $11.50/share, at a price of $1/warrant in a private placement.

https://seekingalpha.com/news/3614151-healthcare-spac-montes-archimedes-acquisition-files-for-500m-ipo

Stability data on Pfizer COVID-19 vaccine support 5-day storage at point of use

At its Investor Day event, Pfizer (PFE -0.1%) reviewed its pipeline of 89 projects spread across six therapeutic areas. Four programs are in registration and 23 are in Phase 3 development.

27 key programs highlighted.

Revenue CAGR of at least 6% over the next five years.

Highlights pertaining to COVID-19:

Vaccine:

Stability data on BNT162b2 supports five-storage at refrigerated (2-8 °C) temperature.

Phase 1 data two weeks after the second shot showed neutralizing geometric mean titers higher than convalescent sera.

Limited blinded tolerability data from ongoing Phase 3 study showed mild-to-moderate tolerability profile.

Application filed with FDA to expand Phase 3 enrollment to ~44K subjects, allowing for recruitment of new populations. Current enrollment is north of 29K.

Data readout on efficacy likely by end of October.

Protease inhibitor:

Initiated a Phase 1b study of PF-07304814, an intravenously administered phosphate prodrug that metabolizes into the active compound PF-00835321 which has demonstrated to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.

Related ticker: BioNTech SE (BNTX -1.3%)

https://seekingalpha.com/news/3614258-stability-data-on-pfizer-covidminus-19-vaccine-support-five-day-storage-point-of-use

Alexion Pharma up on rumored Biogen interest

Alexion Pharmaceuticals (ALXN +6.5%) is up on double normal in apparent response to rumors that Biogen (BIIB +0.0%) may be eyeing the company.

ALXN is currently valued at $25.4B. Q2 revenues were ~$1.44B led by Soliris: $975.5M (-0.5%); Ultomiris: $251.1M (+363.3%); Strensiq: $184.3M (+30.4%) and Kanuma: $33.6M (+28.2%). Cash flow ops was up 38% to ~$1.34B.

2020 outlook: Revenues: $5.55B – 5.60B; Soliris/Ultomiris sales: $4.73B – 4.76B; non-GAAP EPS: $10.65 – 10.95.

https://seekingalpha.com/news/3614287-alexion-pharma-up-7-on-rumored-biogen-interest

Aveo announces final results from late-stage study of tivozanib in kidney cancer

AVEO Oncology (NASDAQ:AVEO) announces that final results from the Phase 3 TIVO-3 study comparing Fotivda (tivozanib) to Bayer’s (OTCPK:BAYRY) Nexavar (sorafenib) in renal cell carcinoma (RCC) patients in third- and fourth-line settings were just published in the journal European Urology.

Consistent with its announcement in May, the trial met the primary endpoint demonstrating tivozanib’s superiority in extending progression-free survival (PFS) with 27% less risk of cancer progression. Specifically, median PFS in the tivozanib arm was 5.6 months versus 3.9 months in the sorafenib arm (p=0.02; hazard ratio = 0.73).

Tivozanib failed to match sorafenib in overall survival (OS), a secondary endpoint. Median OS in the tivozanib group was 16.4 months compared to 19.2 months for sorafenib. Despite the shortfall, the company states that tivozanib’s OS hazard ratio was 0.97, meaning that there was 3% less risk of death than sorafenib.

AVEO’s U.S. marketing application is currently under FDA review with an action date of March 31, 2021. No advisory committee meeting is planned.

https://seekingalpha.com/news/3614342-aveo-announces-final-results-from-late-stage-study-of-tivozanib-in-kidney-cancer

AxoGen raises Q3 revenue guidance, stock up

AxoGen (NASDAQ:AXGN) shares spike +23% after hours following the announcement of higher revenue guidance for third quarter.

The company says it now expects Q3 revenue to be “at least” $30M, above the market estimate of $23.04M. AxoGen initially expected its Q3 revenue to remain below the prior-year levels of $28.6M.

Upside on quarterly revenue guidance points to the lower than expected impact of regional COVID-19 resurgence on the incidence of trauma and surgical procedure, told AxoGen. “The company has benefited from a catch-up of previously deferred procedures during the third quarter, primarily in July and August.”

Q3 2020 result is scheduled to be announced on October 29, after the market close.

See Q2 earnings call presentation

https://seekingalpha.com/news/3614396-axogen-raises-q3-revenue-guidance-stock-up-23-ah

Scientists isolate tiny antibody that neutralizes SARS-CoV-2

Scientists at the University of Pittsburgh School of Medicine (UPMC) have isolated an antibody, dubbed Ab8, that is 10x smaller than a full-sized antibody used in drugs and completely neutralizes the SARS-CoV-2 virus.

The data, published in the journal Cell, showed that Ab8 was highly effective in preventing and treating COVID-19 in mice and hamsters.

The scientists says Ab8’s small size increases its potential for diffusion in tissues, increasing efficacy, while being potentially suitable for alternative routes of administration such as inhalation. A bonus is that it does not bind to human cells, thereby avoiding unwanted side effects.

Ab8 was identified by “fishing” in a pool of more than 100B potential candidates using the SARS-CoV-2 spike protein as bait. It is created when the VH domain is fused to part of the immunoglobulin tail region, adding the immune functions of a full-sized antibody without the bulk.

Abound Bio, a newly formed UPMC-backed company, has in-licensed the rights to Ab8 for global development.

Selected tickers: Eli Lilly (NYSE:LLY), Gilead Sciences (NASDAQ:GILD), Vir Biotechnology (NASDAQ:VIR), Regeneron Pharmaceuticals (NASDAQ:REGN)

https://seekingalpha.com/news/3614311-scientists-isolate-tiny-antibody-neutralizes-sars-covminus-2