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Monday, February 28, 2022

Adams Announces End Of NYC's Controversial Vaccine Passport Rule

 At long last, New Yorkers and tourists visiting the Big Apple will soon be able to enter stores, restaurants, bars and other venues without needing to show proof of vaccination status.

That's right: Mayor Eric Adams is finally lifting his city's requirement for patrons to be vaccinated, one of the most restrictive such laws in the country. It was first implemented by his predecessor, Bill de Blasio, last year. However, he clarified Monday that there are no plans to remove requirements that workers be vaccinated.

Mayor Adams clarified that the requirement would be lifted on March 7 so long as COVID cases continue to trend downward.

NYC's indoor mask requirement for all public schools will be lifted on the same day (again, provided no unexpected spikes in infections arise).

Adams noted that more than a million students would return to public schools Monday after their February break. According to the mayor, if students can intermix this week without creating any "unforeseen spikes" in infections, then that would essentially confirm that the mask mandates are no longer necessary.

"New York City’s numbers continue to go down day after day, so, as long as COVID indicators show a low level of risk and we see no surprises this week, on Monday, March 7 we will also lift Key2NYC requirements," Adams announced. "This will give business owners the time to adapt and will allow us to ensure we are making the best public health decisions for the people of New York."

Circling back the vaccine passport rule, which was first adopted in the late summer of 2021, it's worth noting that it hasn't always been enforced. But it does still technically apply to restaurants, bars, nightclubs, coffee shops, fast food eateries, indoor fitness locations, movie theaters, music and concert venues, museums, sports arenas and stadiums, theaters and billiard halls, among other places.

Adams, who is seen as far more business-friendly than his predecessor, Mayor de Blasio, had hinted that he was eagerly awaiting the end of the vaccine passport rule during an economic development press briefing on Wednesday. Adams said at the time that he meets daily with health experts, who have provided structure and benchmarks the city should meet before it returns to pre-pandemic normalcy.

"We can't close down again, and I'm not going to do something at my anticipation to get back that's going to jeopardize closing down the city again," Adams said. "Our economy can't handle it. We don't have another $11 billion to put back in the economy. We must do it the smart way."

Adams decision follows a move by Gov. Kathy Hochul to ditch the Empire State's mask mandate (for everywhere but schools), although Hochul said over the weekend that the statewide mandate for schools would be ending on Wednesday.

The city fired more than 1,400 municipal workers over their refusal to abide by the vaccine mandate, which was extremely controversial in parts of the city like South Brooklyn and Staten Island.

https://www.zerohedge.com/covid-19/nyc-mayor-unveils-end-nycs-controversial-vaccine-mandate

Supernus Prelim 2021 Financial Results

 

  • Preliminary full year 2021 total revenues were $579.8 million; an 11% increase compared to $520.4 million in 2020

  • SPN-830 (apomorphine infusion device) NDA accepted for review by FDA; PDUFA date early October 2022

  • Completed acquisition of Adamas Pharmaceuticals, Inc. in November 2021; integration well underway

  • Qelbree® continued its growth trajectory, closing the year with 13,380 prescriptions in December 2021

Novavax revenue misses

 

  • NVX-CoV2373 is the first protein-based COVID-19 vaccine authorized in multiple major markets around the world, including the European Union, AustraliaCanada, and Great Britain; authorizations granted by 12 regulatory agencies and emergency use listing from the WHO

  • Additional filings for authorization under review, including in the United States

  • Initiated vaccine shipments globally, with doses administered in the European Union, AustraliaIndonesia and South Korea

  • Expanded clinical body of evidence for NVX-CoV2373 across several studies, including:

  • Developed Omicron-specific vaccine; GMP manufacturing ongoing with delivery expected toward the end of first quarter of 2022

  • Full year 2022 total revenue guidance of between $4 billion and $5 billion

  • Company to host conference call today at 4:30 p.m. ET

Financial Guidance

Novavax expects to achieve full year 2022 total revenue of between $4 billion and $5 billion. Total revenue reflects all sources, including product sales of Nuvaxovid by Novavax, grants revenue, royalties and other revenue.

Conference Call

Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 870-4263 (Domestic) or (412) 317-0790 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 7:30 p.m. ET on February 28, 2022 until 11:59 p.m. ET on March 7, 2022. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 2206365.

A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until May 28, 2022.

https://finance.yahoo.com/news/novavax-reports-fourth-quarter-full-210200635.html

GoodRx Earnings, Sales Increase in Q4 But Miss Consensus

 Share Slump in Late-Hours Trading

https://www.marketscreener.com/quote/stock/GOODRX-HOLDINGS-INC-112833794/news/GoodRx-Earnings-Sales-Increase-in-Q4-But-Miss-Consensus-Share-Slump-in-Late-Hours-Trading-39615994/

Cerner's 2021 revenue reaches $5.77B as pending Oracle acquisition draws pension fund lawsuit

 Two months after Oracle announced plans to buy Cerner, the health IT company is now being sued by a pension fund over concerns that the company's leadership "stymied potential bidders" while pushing forward a deal with Oracle and didn't explore other alternatives.

The lawsuit, filed by the Operating Engineers Construction Industry and Miscellaneous Pension Fund, requests files from Cerner to "investigate possible wrongdoing and/or breaches of fiduciary duty" by the company's board. 

The complaint seeks documents from Cerner under a Delaware law giving corporate shareholders broad inspection rights if they credibly suspect bad faith or self-dealing. 

In December, Oracle announced plans to buy Cerner in a deal valued at $28.3 billion, one of the software company’s biggest acquisitions ever and one of the largest takeovers this year.

In the lawsuit, first reported by Bloomberg Law, the plaintiffs argue that Cerner's board and management “expressed a clear preference for Oracle and did not follow reasonable steps to obtain a value-maximizing transaction,” according to the complaint filed Feb. 22 in Delaware’s Chancery Court.

"Despite the lack of a sales process, the board also failed to secure a 'go shop' provision in the merger agreement, which would have enabled Cerner to solicit potential counter-parties and obtain a better sales price. The board further agreed to an onerous termination fee of $950 million, virtually guaranteeing that no other potential counterparty would even attempt to acquire the company," the plaintiffs wrote in the complaint.

Cerner's board failed to conduct a meaningful market check, the suit says. “This series of events raises questions as to the board’s discharge of its fiduciary duties," the plaintiffs allege in the complaint.

The suit also says that in negotiating the merger with Oracle, Cerner’s senior management was "primarily interested not in maximizing shareholder value but in enhancing their own potential compensation packages." The suit mentions that CEO David Feinberg, CFO Marc Erceg, CTO Jerome Labat and former CEO Brent Shafer are entitled to more than $64 million in golden parachute payments should their employment be terminated post-merger.

The health IT company reported its fourth-quarter 2021 revenue came in "slightly below expectations" as a result of a COVID-related project delay and lower technology resale.

Cerner's fourth-quarter revenue came to $1.45 billion, up 4% compared to $1.39 billion in the fourth quarter of 2020, according to its financial release. The company's GAAP-diluted earnings per share was 59 cents, a 28% increase from the fourth quarter of 2020, with an adjusted diluted EPS of 93 cents.

The company reported fourth-quarter earnings of $174.8 million. On a per-share basis, Cerner said it had net income of 59 cents. Earnings, adjusted for one-time gains and costs, came to 93 cents per share, which beat Wall Street estimates.

Given the proposed acquisition by Oracle, Cerner said it would not be hosting an earnings conference call, issuing prepared remarks, providing financial guidance nor repurchasing shares.

The company's 2021 revenue grew 5% to $5.77 billion compared to $5.5 billion in 2020.

For the year, Cerner's adjusted diluted earnings per share increased 18% to $3.35. But GAAP-diluted EPS was down 27%, with net earnings also dropping from $780 million in 2020 to $555 million in 2021. 

"For the full year we delivered solid revenue growth, expanded adjusted operating margin by 180 basis points, increased adjusted diluted EPS by 18% and generated record GAAP cash flow from operating activities of $1.8 billion and free cash flow of $1.2 billion, which were up 23%and 37%, respectively, over 2020,” said Mark Erceg, executive vice president and chief financial officer, in a statement.

“In addition, we repurchased $1.5 billion of shares at an average purchase price of $74.96, increased our quarterly dividend by 23%and successfully closed and integrated Kantar Health—which is pacing well ahead of its acquisition economics," he said.

https://www.fiercehealthcare.com/health-tech/cerners-2021-revenue-reaches-58b-pending-oracle-acquisition-draws-pension-fund-lawsuit

Novavax's COVID vaccine shows long-term efficacy in UK trial

 

Novavax Inc said on Monday that an extended analysis of a late-stage study conducted in the United Kingdom showed that its COVID-19 vaccine provided long-term protection against the coronavirus.

The protein-based vaccine, NVX-CoV2373, continued to provide protection and maintained overall efficacy of 82.7% over a six-month period, the company said.

Additionally, vaccine efficacy of 82.5% was maintained against both symptomatic and asymptomatic infection, while vaccine efficacy against severe disease was 100%.

The analysis was conducted between November 2020 and May 2021 before the Delta and Omicron variants became dominant.

Novavax is working on developing an Omicron-specific vaccine and said on Monday it expects to begin manufacturing doses of the shot at a commercial scale in the first quarter.

The company did not disclose how many overall doses it expects to deliver in the first quarter, but forecast $4 billion to $5 billion in overall revenue in 2022.

Last year, Novavax reported data from its UK trial, where the vaccine was 89.3% effective in preventing COVID-19, with cases collected over three months.

"The vaccine offers protection against symptomatic and asymptomatic COVID-19 infection which may both interrupt virus transmission and prevent COVID-19 disease," said Gregory Glenn, president of research and development.

"Additionally, we are encouraged to see that our COVID-19 vaccine maintains a high level of durable efficacy and continues to exhibit a reassuring safety profile in this extended timeframe."

Earlier this month, Britain approved the two-dose COVID-19 vaccine for use in adults. The vaccine is being reviewed by the U.S. Food and Drug Administration and has received approvals from the European Union and the World Health Organization as well as countries including India, Indonesia and the Philippines.

The company earlier this month said its vaccine was about 80% effective in a late-stage trial in adolescents.

https://www.marketscreener.com/quote/stock/NOVAVAX-INC-58256108/news/Novavax-s-COVID-vaccine-shows-long-term-efficacy-in-UK-trial-39614837/

Biden administration announces new nursing home reform efforts

 The Biden administration on Monday announced a round of new measures for nursing homes aimed at ensuring adequate care for seniors. 

Citing how the pandemic "highlighted the tragic impact of substandard conditions at nursing homes," the White House announced it would be issuing new requirements through the Department of Health & Human Services (HHS) to improve the "quality and safety" of nursing homes. 

Through the Centers for Medicare & Medicaid Services (CMS), the administration will be proposing new minimum standards of care to be unveiled within the next year following a study to determine the level of care and staffing that is needed.

These new measures include reducing resident room crowding and reinforcing safeguards against unnecessary medications and treatments.

Along with these new measures, the administration will also be enhancing the government's abilities to inspect nursing homes and issue penalties against those that are found to be unsafe. President Biden called for limits on financial penalties against poor-performing facilities to be raised from $21,000 to $1,000,000.

In order to enhance transparency, CMS will be making a database of owners and operators of nursing homes across states that will highlight previous issues at facilities.

HHS is currently conducting a three-part study into how the COVID-19 pandemic impacted nursing homes. The first report from the study published last year found that two out of five nursing home residents likely contracted the coronavirus in 2020 and overall mortality rates in nursing homes rose by five percent between 2019 and 2020.

The new efforts will also include policies to encourage adequate nursing home staffing, including new requirements to make nurse aide training more affordable, possibly enhancing pay to improve workforce sustainability and launching a nursing career pathway campaign with the Department of Labor.

According to a survey released last year by the American Health Care Association and the National Center for Assisted Living, 99 percent of nursing homes said they were experiencing some staffing issues, with nearly 60 percent saying they were had "high level staffing shortages."

https://thehill.com/homenews/administration/596165-biden-administration-announces-new-nursing-home-reform-efforts