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Tuesday, February 2, 2021

DURECT: FDA OKs POSIMIR® For Post-Surgical Pain

 POSIMIR is the only approved sustained-release bupivacaine product indicated for up to 72 hours of post-surgical analgesia from a single application

Conference Call Today, February 2, 2021 at 4:30pm ET

The DURECT management team will host a conference call to discuss the contents of this press release today at 4:30pm ET / 1:30pm PT:

Toll Free: 877-407-0784
International: 201-689-8560
Conference ID: 13716187
Webcast: http://public.viavid.com/index.php?id=143426

The conference call will also be available by webcast on DURECT's homepage at www.durect.com under the "Investors" tab.  If you are unable to participate during the webcast, the call will be archived on DURECT's website under "Event Calendar" in the "Investors" section.

https://investors.durect.com/news-releases/news-release-details/durect-corporation-announces-us-fda-approval-posimirr-post

Cassava Simufilam Improves Cognition, Behavior in Alzheimer’s Interim Analysis

  Patients’ Cognition Improved 1.6 Points on ADAS-Cog11 -


- Patients’ Behavior Improved 1.3 Points on NPI -

- Improvements Maintained at 6 Months -

- Results Support Advancing Simufilam into Phase 3 Clinical Program -

https://finance.yahoo.com/news/cassava-sciences-simufilam-improves-cognition-133000630.html

BTIG Upgrades Prothena Corp (PRTA) to Buy

Target $29 

https://www.streetinsider.com/Hot+Upgrades/BTIG+Upgrades+Prothena+Corp+%28PRTA%29+to+Buy/17899250.html

McKesson Reports Fiscal 2021 Third-Quarter Results

 Third-Quarter Highlights, Year-over-Year:

  • Total revenues of $62.6 billion, reflecting 6% growth.
  • McKesson recorded a pre-tax charge of $8.1 billion related to opioid litigation, resulting in third-quarter Loss per diluted share of ($39.03).
  • Adjusted Earnings per diluted share of $4.60, an increase of 21%.
  • Board of Directors authorized an additional $2.0 billion share repurchase program.

Fiscal 2021 Guidance:

  • Increased fiscal 2021 Adjusted Earnings per diluted share guidance range to $16.95 to $17.25, from the previous range of $16.00 to $16.50.
  • Fiscal 2021 Adjusted Earnings per diluted share guidance assumes $0.25 to $0.35 related to COVID-19 vaccine distribution and $0.20 to $0.30 related to the kitting and distribution of ancillary supplies for COVID-19 vaccines.

Catalent Fiscal 2Q Earnings

 Catalent Inc. (CTLT) on Tuesday reported fiscal second-quarter net income of $88.4 million.

On a per-share basis, the Somerset, New Jersey-based company said it had profit of 45 cents. Earnings, adjusted for one-time gains and costs, were 63 cents per share.

The average estimate of eight analysts surveyed by Zacks Investment Research was for earnings of 56 cents per share.

The maker of drug delivery technologies posted revenue of $910.8 million in the period, also exceeding Street forecasts. Six analysts surveyed by Zacks expected $895.9 million.

Catalent expects full-year revenue in the range of $3.8 billion to $3.95 billion.

https://www.timesunion.com/business/article/Catalent-Fiscal-2Q-Earnings-Snapshot-15917646.php

HCA Healthcare Q4 profit jumps 33% on inpatient admissions

 Hospital operator HCA Healthcare Inc reported a 33% rise in fourth-quarter profit on Tuesday, helped by higher revenue from hospital admissions.

Net income attributable to HCA rose to $1.43 billion, or $4.13 per share, in the quarter ended Dec. 31, from $1.07 billion, or $3.09 per share, a year earlier.

https://finance.yahoo.com/news/hca-healthcare-q4-profit-jumps-123641411.html

Pfizer sees ~ $15B in 2021 sales from Covid vaccine

 Pfizer expects to sell about $15 billion in coronavirus vaccine doses this year, the company announced in releasing its fourth-quarter earnings Tuesday.

The company’s Covid-19 vaccine, which it’s making with German partner BioNTech, was the first approved for emergency use in the U.S. It forecasts between $59.4 and $61.4 billion in revenue this year.

The company also raised its full-year earnings guidance to between $3.10 to $3.20 from $3.00 to $ 3.10, citing “additional refinements” of its vaccine revenue forecast.

Here’s how Pfizer performed in the fourth quarter compared with what Wall Street expected, according to average estimates compiled by Refinitiv.

  • Adjusted EPS: 42 cents versus 48 cents, expected.
  • Revenue: $11.68 billion versus $11.43 billion, expected.

Revenue rose 12% to $11.68 billion from $10.44 billion during the same quarter last year — better than analysts expected.

Shares of Pfizer were essentially flat in premarket trading.

“As a company, we saw the culmination of Pfizer’s decade-long conversion into a pure-play, science and innovation-focused company,” Pfizer CEO Albert Bourla said in a press release. “Right away, our ability to move quickly and utilize cutting-edge science to help address the world’s most important medical challenges was put to the test by the COVID-19 pandemic.”

Pfizer, like other Covid-19 vaccine makers, has been struggling to meet the demand for shots that will help bring an end to the pandemic. Pfizer has said it expects to deliver 200 million doses of its two-shot vaccine to the U.S. by July 31. It recently enlisted the help of French drugmaker Sanofi to help produce doses.

The company also said Tuesday it is “prepared to respond” if a Covid variant demonstrates evidence of evading its vaccine. In recent weeks, U.S. health officials, including Dr. Anthony Fauci, have said they are concerned that vaccines currently on the market may not be as effective in guarding against new, more contagious strains of the virus.

Novavax said Thursday that its vaccine was only 49% effective against B.1.351, the highly contagious strain found in South Africa. Johnson & Johnson also said its vaccine was less potent against the strain, saying on Friday the one-shot vaccine was 66% effective overall but just 57% effective against the South Africa strain.

A study conducted by Pfizer found that the new, highly contagious Covid-19 strains found in the U.K. and South Africa had only a small impact on the effectiveness of its vaccine. Still, Pfizer is developing a booster shot to help protect against the new variants. Moderna and Novavax are also developing modified vaccines.

https://www.cnbc.com/2021/02/02/covid-vaccine-pfizer-expects-about-15-billion-in-2021-sales-from-shots.html