COVID-19 antibody sales of $804M help Regeneron trounce expectations in third quarter

 Three months ago, when Regeneron revealed $2.59 billion in second-quarter sales of its COVID-19 antibodies, the company warned investors not to expect further sales of the treatment to the United States in the third quarter.

But that was before Regeneron realized the full impact of the delta variant and the increased demand it would create for REGEN-COV. Another lucrative deal followed and on Thursday the company revealed another $804 million for COVID-19 antibody sales in the third quarter.

Of the 1.4 million doses Regeneron agreed to supply the U.S. in mid-September, the company delivered more than 300,000 by the end of the month at a cost of $2,100 per dose. The company has until the end of January of next year to provide the contract’s remaining doses. The contract will produce a total haul of $2.94 billion, with its international distribution partner on the drug, Roche, supplying a portion of the doses to the U.S., the company said.

With the surprisingly high sales figure for REGEN-COV, Regeneron reported overall third-quarter revenue of $3.45 billion, an increase of 51% year over year and well beyond the analyst consensus estimate of $2.79 billion. Adjusted earnings per share were at $15.37, trouncing the estimate of $9.49.

“We anticipate an ongoing role for REGEN-COV,” CEO Len Schleifer said on a conference call. “If global demand warrants, we have the capacity to produce between four to five million 1.2 gram doses in 2022, excluding any further supply contributions from Roche.”

Regeneron’s chief scientific officer George Yancopoulos sees an expanded role for REGEN-COV in the future as a prophylaxis for immunocompromised. The company has begun a trial to evaluate extended dosing for this population, Yancopoulos said. A novel anti-spike protein antibody cocktail also remains in development.

“If ever variants would arise that would raise problems for our current cocktail, we would have a complementary cocktail that ... would hopefully be unaffected by the same types of mutations,” Yancopoulos said. 

Meanwhile, as opposed to this summer when Regeneron dominated the COVID-19 antibody market, there is more competition. Earlier this week, Eli Lilly—which saw its antibodies sidelined for two months because of their ineffectiveness against variants—revealed a $1.29 billion deal to supply 614,000 doses to U.S. for mild to moderate COVID or as a post-exposure prophylaxis. Another antibody treatment, produced by GlaxoSmithKline and Vir Biotechnology, has made agreements to supply 420,000 doses, including some to the U.S., it said in a September SEC filing.

Sales of atopic dermatitis treatment Dupixent, which are recorded by Sanofi, reached $1.66 billion in the quarter, a 55% increase year over year, and 4% over the previous quarter. Macular degeneration drug Eylea had sales of $1.47 billion in the third quarter, a 12% increase year over year.

“We see the strength of Eylea and opportunity for steady growth continuing despite upcoming potential competition from which we don’t see any disruptive or game-changing new entrants,” Schleifer said.  

https://www.fiercepharma.com/pharma/surprise-antibody-sales-804-million-help-regeneron-exceed-revenue-expectations-third-quarter

Vaccine mandates could exacerbate truck driver shortage

 Federal vaccine mandates to be imposed on companies with more than 100 employees may exacerbate a truck driver shortage across the U.S. that could contribute to further supply chain delays, industry stakeholders warned the House Agriculture Committee on Wednesday.

Vaccine hesitancy is chief among the reasons drivers may not want to get the required shots, said Jon Samson, an executive director at the American Trucking Association. Samson said one reason for the COVID-19 vaccine hesitancy in this industry is that truck drivers don’t feel the need to get shots due to spending the bulk of their working hours on long drives alone.

“The trucking industry is not anti-vaccination, we are anti-supply chain inefficiency,” Samson told lawmakers at Wednesday’s committee hearing. “A lot of larger truck lines have drivers with vaccine hesitancy.”

The Biden administration published its vaccination mandate for businesses Thursday, setting a Jan. 4 deadline for companies to comply. It is expected to cover 84 million people.

Samson said there were 80,000 open truck driver jobs in the U.S., warning that larger trucking firms fear they could lose a significant portion of their workforce in part because some drivers may leave larger trucking companies for smaller ones or leave the industry entirely.

One area the truck driver shortage could contribute to supply chain issues is the distribution of agricultural products, which lawmakers on the committee warned could eventually result in food not making its way to store shelves should the shortage continue.

House Agriculture Committee Chairman David Scott (D-Ga.) called the driver shortage “a tremendous challenge” to the agricultural product supply chain.

“They hold the key as to whether or not we will have a food supply shortage,” Scott said. “We don’t have a food shortage, but the supply is in the hands of our truck drivers.”

While agricultural production has largely remained stable throughout the pandemic, the cost of transporting agricultural goods has increased substantially —  due in part to the driver shortage.

Jon Schwalls, executive officer of Southern Valley Fruit and Vegetable, a produce growing and packing firm that operates in the U.S. and Mexico, said that outbound freight costs for his company have risen by 40 percent since the start of the pandemic.

“Now we find ourselves in the middle of a supply chain crisis,” Schwalls told the committee. “Once unloaded, there are not enough drivers, warehouses and shipping containers to keep the products moving to their intended customer.”

The shortage impacts certain areas of the country more than others, according to a recent U.S. Department of Agriculture report. 

Truck availability in 18 of 20 regions reported by the USDA is listed as a “shortage” or “slight shortage” in the report released this week. West Coast routes, including the border crossing at Nogales, Ariz., are among the most significantly impacted, according to the report. Only two regions, Mississippi and the Mexico crossing with South Texas, are listed as adequate. No region is listed as surplus, or slight surplus.

There’s no easy way to explain the driver shortage, Samson said, but the Trucking Association hopes that increased flexibility and financial incentives will help the industry attract new drivers.

One possible explanation is that the industry misses out on recruiting high school graduates since Commercial Driver’s License holders must be 21 years of age to drive across state lines. Other blue collar jobs have historically offered more flexibility for similar salaries, Samson said.

 “We’re looking at recruiting younger drivers right now,” Samson said. “We’re starting to see an increase in hourly wages and we still haven’t seen a lot of those workers come back.”

https://thehill.com/homenews/house/580085-officials-warn-vaccine-mandates-could-exacerbate-truck-driver-shortage

NYC mayor-elect wants to 'revisit' vaccine mandate

 New York City Mayor-elect Eric Adams says he wants to "revisit" the city's COVID-19 vaccine mandate for city workers, which has drawn resistance from some unions.

"We need to revisit how we're going to address the vaccine mandates," Adams said on MSNBC on Wednesday.

While saying he did not want to "Monday morning quarterback" current Mayor Bill de Blasio, who put the mandate for city workers into effect, Adams said, "what I'm going to encourage him to do is to sit down with the unions."

"We can work this out," Adams added. "This is a very difficult moment, but there's an opportunity to sit down with the unions. I communicated with some of the union leaders yesterday and they are open to sit down, and this is a good opportunity to do so and I'm going to encourage him to make that happen."

De Blasio has defended the mandate, saying that it has helped raise the vaccination rate among city workers, after voluntary measures reached their limits.

"We tried voluntary approaches," de Blasio said Tuesday on CNN. "We tried incentives. It wasn't moving enough. Since we put this mandate into place, October 20, 24,000 more City employees have gotten vaccinated in just about 10 days. So, there's the proof in the pudding."

He said the city workforce's vaccination rate is now at 92 percent.

Some of the most controversy has come from police officers and firefighters.

De Blasio expressed concern that some firefighters were calling in sick in a "sickout" in protest of the mandate.

"If you're not sick, get to work, protect your fellow New Yorkers, be there for your fellow firefighters, stop playing this game," de Blasio said.

https://thehill.com/policy/healthcare/580015-nyc-mayor-elect-wants-to-revisit-vaccine-mandate

Assisted living providers sound the alarm over lack of COVID-19 aid

 Senior living providers are mounting a last-ditch effort to secure pandemic aid in Democrats’ $1.75 trillion social spending bill after they were largely excluded from previous relief packages.

Industry trade group Argentum says that assisted living facilities, which care for around 2 million seniors, have lost $30 billion during the pandemic due to increased expenses and low occupancy rates compounded by staff shortages. But these operators have only received $640 million in COVID-19 relief, a sliver of the $178 billion Provider Relief Fund that has favored hospitals and nursing homes.

Argentum is pushing lawmakers to allow senior living facilities to access the reconciliation package’s massive caregiving grants and benefit from its workforce development programs. They are excluded under the current bill that House Democrats aim to pass soon. 

“It’s so incredibly frustrating,” said Maggie Elehwany, Argentum’s senior vice president of public policy. “It feels like we keep going to Capitol Hill, and everyone agrees this is an injustice, and they’ll make sure we’re included in the next bill, and the next bill … and it just doesn’t seem to happen.”

The group recently launched an ad campaign targeting President Biden and key Democratic senators in Arizona, Delaware, New Hampshire, Pennsylvania, Virginia and West Virginia. 

“Our most vulnerable citizens in assisted living centers need your help as they recover from COVID-19,” one ad tells Biden. “Don’t leave us behind, again.”

Because assisted living facilities are regulated at the state level and don’t interact much with federal programs like Medicare and Medicaid, they haven’t historically had a large presence in Washington, D.C. That’s become evident in meetings with lawmakers. 

“People literally assumed we were getting funding, but we weren’t,” Elehwany said.

Prior to the pandemic, Argentum never spent more than $200,000 on lobbying in a single year, far less than other health sector groups that routinely shell out millions, according to OpenSecrets. Argentum increased its lobbying spending to $380,000 through the first three quarters of 2021. 

The industry has some high profile allies in Sens. Kyrsten Sinema (D-Ariz.) and Joe Manchin (D-W.Va.), who joined a bipartisan letter to Health and Human Services Secretary Xavier Becerra in August urging him to correct the uneven distribution of relief funds.

“Some provider types, such as senior care facilities, have been underrepresented in previous rounds of funding,” the senators wrote. 

The next round of relief funds, amounting to $25 billion, will be made available to senior living facilities. But they don’t expect to receive significant sums, as nearly all kinds of providers, including dentists, therapists and chiropractors, are eligible to apply for aid.

The reconciliation package, which makes massive investments in senior care, is the last chance for assisted living providers that largely missed out on $6 trillion in COVID-19 relief. President Biden previously called on Congress to provide support for senior living facilities, but the current bill doesn’t do so. 

“It just makes absolutely no sense that we’re not included in probably the biggest expenditure that Congress has ever made on allowing seniors to age where they choose to,” Elehwany said.

https://thehill.com/business-a-lobbying/business-a-lobbying/580042-assisted-living-providers-sound-the-alarm-over-lack

Cassava Soars as Journal of Neuroscience Backs it on Alzheimer’s Study

 Cassava Sciences stock (NASDAQ:SAVA) climbed more than 56% Thursday after the company said the Journal of Neuroscience had found no evidence of data manipulation in an article it published in July 2012 describing a new approach to treating Alzheimer's disease.

The criticism against the company, posted online in August, questioned the scientific integrity of the company.

The peer-reviewed article was co-authored by scientists and academic collaborators for Cassava Sciences and is foundational to simufilam, the company’s lead drug candidate for treating Alzheimer’s disease.

Disputing the validity of Cassava’s clinical biomarker data and the integrity of Western Blot Analysis, a ‘statement of concern’ was posted requesting the Food and Drug Administration to halt the current clinical study of simufilam.

Cassava said the biomarker data of Alzheimer’s patients was generated by Quanterix (NASDAQ:QTRX), an independent company, and presented at the Alzheimer’s Association International Conference.

The company said Western Blot Analysis is foundational to the biotechnology industry and is a standard lab technique used worldwide to detect a protein of interest.

“We remain focused on conducting a Phase 3 clinical program of simufilam in people with Alzheimer’s disease,” said CEO Remi Barbier in a statement today.

The company had lost more than a third of its market cap on August 25, the day criticisms became public even as it rebutted all of them point-by-point. More than two months later and accounting for the session's gains so far, it is now trading over the lows of that day.

https://finance.yahoo.com/news/cassava-soars-journal-neuroscience-backs-103819070.html

New U.S. COVID Testing/vaccine Rule Excludes Outdoor Workers

 A new U.S. workplace rule that requires tens of millions of Americans to get vaccinated for COVID-19 or submit to weekly testing will exclude employees who work exclusively outdoors, according to regulatory filing by the Occupational Safety and Health Administration.

An estimated 2.4 million healthcare workers will need to be vaccinated or replaced under a related rule issued by Centers for Medicare & Medicaid Services.

https://www.usnews.com/news/top-news/articles/2021-11-04/new-us-covid-testing-vaccine-rule-excludes-outdoor-workers

Biden COVID-19 Vaccine Mandate for Private-Sector Workers to Begin Jan. 4

 President Joe Biden will enforce a federal mandate that workers at U.S. companies with at least 100 employees be vaccinated against COVID-19 or be tested weekly starting on Jan. 4, a reprieve to businesses facing labor shortages during the holiday season, U.S. officials said on Thursday.

Biden's separate vaccine requirement for federal contractors has been delayed a month to Jan. 4, officials added, while workers in healthcare facilities and nursing homes participating in the Medicare and Medicaid government healthcare programs will need to get their shots by the same date.

The action on the private-sector vaccinations was taken under the U.S. Occupational Safety and Health Administration's (OSHA) emergency authority over workplace safety, the officials said. The mandate applies to 84.2 million workers at 1.9 million private-sector employers. Another 18.5 million workers for those employers are exempt because they either work remotely or outside all the time, OSHA said.

OSHA estimates 31.7 million of those covered workers are unvaccinated and that 60% of employers will require vaccinations, up from 25% today, resulting in another 22.7 million employees getting vaccinated.

The Chamber of Commerce, the largest U.S. business group, said Biden's administration "made some significant adjustments" in the rule that reflect concerns raised by the business community.

The mandate is likely to trigger legal challenges https://www.reuters.com/world/us/bidens-covid-19-strategy-thwarted-by-anti-vaxxers-delta-variant-2021-07-29 and a legal battle hinging upon on the rarely used law on which the action was based and questions over federal power and authority over healthcare practices.

The 490-page regulation https://public-inspection.federalregister.gov/2021-23643.pdf is known as a Emergency Temporary Standard (ETS). Senate Republicans said they would try to repeal the rule using a law known as the Congressional Review Act.

Biden in September unveiled plans to impose the mandate, with his administration seeking to increase vaccination rates amid a dangerous surge in COVID-19 cases and get more people back to work. In numerous meetings with companies and industry groups representing retailers, logistics companies, construction workers, executives asked the administration to delay the implementation deadline after the New Year, citing concerns about worker shortages.

Employers will also not be required to provide or pay for tests. The rule offers medical and religious exemptions and it estimates that about 5% of employees will seek and receive religious or medical accommodations.

Failure to comply with the mandate will result in an approximately $14,000 fine per violation with a scale that increases with several violations, officials said. They did not offer clarity on whether workers will be fired if they refuse to get the shot or tested.

"It is important to understand that there are still so many workers who are not protected and remain at risk from being seriously ill or dying from COVID-19," said a senior administration official, speaking on condition of anonymity.

Biden initially set a deadline for 70% of U.S. adults to get at least one shot by July 4, but the White House missed the deadline as it underestimated the anti-vaccine sentiment among some Americans fueled by right-wing talk show hosts, anti-vaxxers, online disinformation campaigns and resistance from many Republicans.

A recalcitrant minority of Americans has refused to accept free vaccinations despite a major rollout and incentive campaign from the administration involving 42,000 pharmacies, dozens of mass vaccination sites, free rides and even free beer.

The latest data shows that about 70% of U.S. adults have been fully vaccinated and 80% have received at least one shot. An average of 1,100 Americans are still dying daily from COVID-19, the vast majority of them unvaccinated. COVID-19 has killed more than 745,000 Americans.

The Biden administration said it stopped short of requiring the further workplace measures recommended by OSHA and the Centers for Disease Control and Prevention "including distancing, barriers, ventilation and sanitation."

"The new emergency temporary standard is well within OSHA's authority under the law. ... There is a well established legal precedent for OSHA's authority," a senior administration official said, explaining OSHA's the legal authority to issue the rule.

Along with Biden's executive order that requires all federal workers and contractors be vaccinated, the administration vaccine rules cover 100 million people, about two-thirds of the U.S. workforce, the White House estimates.

The rule for healthcare workers covers 17 million employees across 76,000 healthcare facilities even though a majority of them are already vaccinated, data from the Centers for Medicare and Medicaid Services (CMS) shows.

The administration estimates the rule will prevent more than 250,000 hospitalizations and save thousands of lives during the six months after it is implemented.

https://www.usnews.com/news/top-news/articles/2021-11-04/bidens-vaccine-mandate-to-be-enforced-after-the-new-year-offering-us-companies-relief