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Friday, January 27, 2023
Novartis sees no benefit of Adakveo for sickle cell
HCA results and 2023 guidance
HCA Healthcare, Inc. (NYSE: HCA) today announced financial and operating results for the fourth quarter ended December 31, 2022.
Key fourth quarter metrics (all percentage changes compare 4Q 2022 to 4Q 2021 unless otherwise noted):
Revenues totaled $15.497 billion
Net income attributable to HCA Healthcare, Inc. totaled $2.081 billion, or $7.28 per diluted share
Adjusted EBITDA totaled $3.179 billion
Cash flows from operating activities totaled $2.527 billion
Same facility admissions increased 2.9 percent while same facility equivalent admissions increased 5.4 percent
2023 Guidance
Today, the Company issued the following estimated guidance for 2023:
2023 Guidance Range | |
Revenues | $61.5 to $63.5 billion |
Net Income Attributable to HCA Healthcare, Inc. | $4.525 to $4.895 billion |
Adjusted EBITDA | $11.8 to $12.4 billion |
EPS (diluted) | $16.40 to $17.60 per diluted share |
Capital expenditures for 2023, excluding acquisitions, are estimated to be approximately $4.3 billion.
The Company’s 2023 guidance contains a number of assumptions, including, among others, the Company’s current expectations regarding the impact of the COVID-19 pandemic as well as general economic conditions, including inflation, and excludes the impact of items such as, but not limited to, gains or losses on sales of facilities, losses on retirement of debt, legal claims costs and impairment of long-lived assets.
Adjusted EBITDA is a non-GAAP financial measure. A table reconciling forecasted net income attributable to HCA Healthcare, Inc. to forecasted Adjusted EBITDA is included in this release.
https://finance.yahoo.com/news/hca-healthcare-reports-fourth-quarter-120000531.html
argenx PDUFA Date Extension for SC Efgartigimod
argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the review of the Biologics License Application (BLA) for subcutaneous (SC) efgartigimod (1000mg efgartigimod-PH20) for the treatment of adult patients with generalized myasthenia gravis (gMG) to June 20, 2023.
The FDA notified argenx on January 26, 2023 that information submitted in connection with the ongoing review of the SC efgartigimod BLA constituted a major amendment and requires an extension to allow sufficient time to review. No additional data or studies have been requested at this time.
https://finance.yahoo.com/news/argenx-receives-notification-pdufa-date-060000390.html
CDC still looking at potential stroke risk from Pfizer bivalent COVID shot
New data from one U.S. Centers for Disease Control and Prevention (CDC) database shows a possible stroke risk link for older adults who received an updated Pfizer/BioNTech COVID-19 booster shot, but the signal is weaker than what the agency had flagged earlier in January, health officials said on Thursday.
U.S. Food and Drug Administration officials said they had not detected a link between the shots and strokes in two other safety monitoring databases.
The new data was presented at a meeting of outside experts that advise the FDA on vaccine policy.
Earlier this month, U.S. health officials said they had detected the possible link to ischemic strokes in people over age 65 who received the newer booster shots in its Vaccine Safety Datalink (VSD) database. They said at the time it was very unlikely to represent a true clinical risk.
Dr. Nicola Klein of healthcare company Kaiser Permanente, which maintains VSD data for the CDC, said the rate of strokes observed in the database had slowed in recent weeks, but the signal was still statistically significant, meaning likely not by chance.
Most of the confirmed cases had also received a flu vaccine at the same time, which might be a factor, she said.
FDA scientist Richard Forshee said the agency plans to study whether there is any increased risk of stroke from receiving the two shots at the same time.
Both agencies still recommend older adults receive the booster shots, now tailored to target Omicron variants as well as the original coronavirus.
Dr. Walid Gellad, professor of medicine at University of Pittsburgh, said the issue required further investigation.
"Sometimes signals are not clear," Gellad said in an email. "It makes sense to look into it more, and it doesn't make sense to change practice given the known benefits (of getting the booster) in this age group."
https://www.yahoo.com/news/u-cdc-still-looking-potential-182541506.html