Large biopharma companies will have $1.7T in dealmaking firepower next year: analyst

 Merger and acquisition activity has been rather slow in the biopharma industry so far this year. But, by one team of analysts’ calculations, large drugmakers will have big piles of cash to deploy in 2022.

Eighteen large-cap U.S. and European biopharmas will have more than $500 billion in cash on hand by the end of 2022, SVB Leerink analyst Geoffrey Porges and his team wrote in a Wednesday note. The companies could use the money to strike deals, pay down debt or offer returns to shareholders through dividends or share buybacks, the analysts said.

Because the companies can leverage their assets to borrow additional capital, the theoretical firepower of the 18 drugmakers would be enormous at more than $1.7 trillion, the analysts wrote.

Out of 18 companies Porges's team looked at, 12 are expected to have more than $20 billion in cash by the end of 2022 when excluding existing debt. Even after factoring in debt, Porges expects Pfizer, Moderna, Johnson & Johnson, Novartis and BioNTech to have net cash of more than $20 billion.

Meanwhile, the team expects Regeneron, Vertex, Novo Nordisk and GlaxoSmithKline to have between $11 billion and $18 billion in cash on hand when including debt.

Based on the companies’ cash positions and potential room to take on new debt, Porges said the 18 biopharma majors will have $1.72 trillion in M&A capacity. J&J topped the list with more than $200 billion in M&A firepower. Pfizer and Novartis followed with $175 billion and $154 billion, respectively. AbbVie, GSK, Bristol Myers Squibb and Merck will each boast more than $100 billion in firepower, the team figures.

For the analysis, Porges and team used Wall Street’s consensus estimates to come up with each company’s cash flow by the end of next year. Some companies are benefiting from major one-time events. Novartis is getting $20.7 billion from selling its 20-year investment in Roche. GSK and Pfizer are expected to get an inflow of $27.7 billion and $16.3 billion, respectively, by spinning off their consumer health joint venture, which is planned for mid-2022. The analysis didn’t seem to consider J&J’s planned spinoff of its world-leading consumer health franchise, a process the New Jersey corporation expects could take nearly two years to complete.

For their part, Pfizer, BioNTech and Moderna are getting a major windfall from sales of their COVID-19 vaccines and treatments. Pfizer, for one, could see $84 billion in total sales from its BioNTech-partnered COVID vaccine Comirnaty and its yet-to-be-authorized oral antiviral Paxlovid between 2021 and 2023, according to consensus estimates cited by Porges.

But having cash on hand doesn’t necessarily translate into busy M&A activity. Take 2021, for example: At the end of 2020, PwC estimated the biopharma industry had $1.47 trillion in firepower that it could use for M&A. But the largest buyout announced this year involving two drugmakers was Merck & Co.’s $11.5 billion acquisition of Acceleron. The only other deal that exceeded $5 billion was Jazz Pharmaceuticals' $7.2 billion takeover of GW Pharma.

By contrast, 2020’s largest deal was AstraZeneca’s $39 billion purchase of Alexion. Altogether, three M&A deals last year carried values of more than $10 billion.

https://www.fiercepharma.com/pharma/m-a-large-biotech-pharma-companies-will-have-1-7t-firepower-for-dealmaking-2022

Bristol Myers wrongfully denied exemption requests to COVID vax policy: employee lawsuit

 In response to being told that they would be fired if they did not get vaccinated against COVID-19, four Bristol Myers Squibb employees have filed a lawsuit against the company claiming the drugmaker wrongfully denied their requests for religious exemptions.

Filed Wednesday in federal district court in Manhattan, the lawsuit says BMS is violating Title VII by "systematically manufacturing" reasons for not providing employees religious exemptions to its vaccine mandate.

Title VII requires employers to provide accommodations to employees who request exemptions from workplace policies "on the basis of sincerely held religious beliefs," the suit says. The employees claim BMS is denying the sincerity of their religious beliefs because they "hold and express political beliefs too."

In September, BMS informed employees that they needed to be vaccinated by Nov. 1. In a quarterly securities filing on Oct. 27, the company revealed that 94% of its workforce was vaccinated.

Responding to the lawsuit, a BMS spokesperson said the company's "priority throughout the pandemic has been the health and safety of our communities, employees and patients, who are among the most vulnerable."

"Our policy that all eligible employees in U.S. and Puerto Rico be vaccinated against COVID-19 is consistent with this safety priority and our responsibility as a science-based company to help slow the spread of the virus," she added. "The policy includes a process for employees to request a reasonable accommodation based on, among other things, their sincerely held religious beliefs."

"The process includes interactive discussions with the employees and detailed assessments," she continued. The company has granted accommodations to "some individuals" who submitted requests, she added.

The plaintiffs in the lawsuit are highly paid professionals: Carrie Kefalas, M.D., the head of clinical trial risk management for global drug development; John Lott, the associate director of strategy and submissions lead, patient safety and epidemiology; Jeremy Beer, a senior manager for data integrity; and Kamila Dubisz, an account manager.

As BMS rolled out the vaccination requirement to employees, the company included a threat of “for cause” termination for those who failed to comply, the suit alleges.

In her filing her request, Kefalas identified herself as a non-denominational “follower of Jesus Christ,” the suit says.

Kefalas, who requested to continue to work remotely, said vaccination “would permanently destroy my relationship with My Savior, prevent eternal salvation and promise eternal damnation of my soul as it is described in the Bible because I would be accepting the Beast as my Savior,” the suit says.

On Nov. 17, BMS notified Kefalas that her request was denied because her beliefs were not “sincerely held,” according to the lawsuit. BMS also said that in previous internal company communications, Kefalas had questioned the safety of vaccinations without stating any religious objections.

Kefalas, who earns approximately $300,000 per year, was told that she would face termination on Dec. 6 if she didn’t show proof of vaccination by Nov. 29, the suit says.

Other employees in the suit were told they would be fired in December and January for not following the vaccine mandate, according to the lawsuit.

The employees are seeking a court injunction "enjoining Bristol Myers Squibb Co. from terminating them and all other similarly situated employees until the parties can be fully heard on the merit," the suit says. 

If BMS were to fire non-compliant employees, it wouldn’t be the first company to do so. In October, United Airlines said it was in the process of terminating 232 employees for not getting vaccinations. Also in October, New York’s largest healthcare provider, Northwell, revealed that it fired 1,400 employees who were not vaccinated.

According to a survey of nearly 600 employers conducted in August by global professional services firm Aon, only 7% said they would be willing to fire an employee who refused to get a vaccine, with the percentage higher among companies in industries that traditionally demand in-person work.

https://www.fiercepharma.com/pharma/four-bristol-myers-squibb-employees-set-to-be-fired-for-not-being-vaccinated-file-suit

Japan reverses request to halt reservations for inbound flights

 Japan has reversed its request to halt reservations for inbound flights, citing confusion between government agencies over the country’s efforts to halt the spread of the omicron COVID-19 variant, Reuters reported 

The country told airlines on Monday to stop allowing passengers to reserve seats on incoming flights until the end of December due to concerns around the new variant. 

Japanese Prime Minister Fumio Kishida said the move created confusion, as his Chief Cabinet Secretary Hirokazu Matsuno said Kishida asked the transportation ministry to address the needs for returning Japanese passengers, according to Reuters.

"I understand the transport ministry has cancelled its instruction for the blanket suspension of new reservations and asked airlines anew to give sufficient consideration to the needs of returning Japanese nationals," Matsuno told the media.

A Transportation Ministry official said airlines may take new flight reservations as long the number of arrivals stays between the daily limit of 3,500, which is down from last month's figure of 5,000, Reuters noted.

Japanese health officials have confirmed two cases of the omicron variant in the country, Reuters reported. 

South African first detected the new variant, formerly called B.1.1529, last week saying it is “very different” from past mutations from the virus. 

Japan followed other countries by banning foreign travel from South Africa and surrounding countries. 

A ban on foreign entrants to Japan, which was rolled back last month and reimposed on Monday, remains in place, as does a ban on foreign residents in Japan arriving from those 10 African countries, according to Reuters. 

https://thehill.com/policy/healthcare/public-global-health/584024-japan-reverses-request-to-halt-reservations-for

'Trigger' found for rare blood clots in patients after AstraZeneca vaccine

 Scientists believe they have found the trigger for the rare blood clots in people who have taken the  Oxford/AstraZeneca COVID-19 vaccine.

A study by a team of researchers from the United States and United Kingdom found a protein in the blood — known as platelet factor 4 (PF4) — that reacts to the adenovirus used by the vaccine that then causes a chain reaction involving the immune system.

This reaction can result in the dangerous clots — a condition known as vaccine-induced immune thrombotic thrombocytopenia (VITT), or Thrombosis with Thrombocytopenia (TTS).

"These data confirm that PF4 is capable of forming stable complexes with clinically relevant adenoviruses, an important step in unraveling the mechanisms underlying TTS," said an abstract of the study, conducted by researchers at Arizona State University, Cardiff University in Wales, and other institutions. 

An AstraZeneca spokesperson said that although the research is not definitive, it offers interesting insights, and AstraZeneca is exploring ways to leverage these findings in its efforts to remove the rare side effect. 

"This pre-clinical research further advances our knowledge about the potential mechanisms underlying the extremely rare condition, Thrombosis with Thrombocytopenia (TTS), which is treatable for the majority of people," the spokesperson said in a statement to The Hill.

"It is important to note that the mechanism identified does not demonstrate that it is the cause of TTS and that most individuals that will have PF4 antibodies will not develop TTS," the spokesperson added.

The spokesperson noted there is a significantly higher likelihood of developing TTS if a person is unvaccinated and develops COVID-19, than if vaccinated with the AstraZeneca vaccine.

AstraZeneca's vaccine has not been authorized to be administered in the U.S., although the company has agreed to supply 700,000 doses once an emergency use authorization is granted.

https://thehill.com/policy/healthcare/public-global-health/584017-scientists-find-trigger-for-rare-blood-clots-in

Manchin won't rule out backing GOP effort to defund Biden vaccine mandate

 Sen. Joe Manchin (D-W.Va.) declined to say Thursday how he would vote on a GOP effort to defund President Biden’s vaccine requirement for larger businesses as part of the debate over a short-term bill to fund the government.

Manchin, asked if he would vote for an amendment to block funding for the mandate, sidestepped the question by saying that he was still “working” through it.

“I’ve been very supportive of a mandate for federal government, for military ... I’ve been less enthused about it in the private sector,” Manchin said.

A small group of conservative senators are pushing for a vote on their proposal to block funding for the mandate as part of the Senate’s consideration of a short-term deal to fund the government into mid-February. Democratic leadership hasn’t publicly opened the door to an amendment vote.

The Senate took a similar vote in September as part of its debate on the first short-term funding bill. Manchin voted with all Democrats against the amendment at the time.

But the threshold for the amendment to get added into the funding bill at the time was three-fifths, meaning even if Manchin or another Democrat had voted "yes," their “no” vote wasn’t critical for Democrats.

But the GOP senators pushing for the vote say that in order for them to consider helping speed up the short-term government funding bill this week, their amendment vote has to be at a simple majority threshold.

That means if Manchin and every Republican voted for the amendment to defund the vaccine mandate, it would be inserted into the short-term government funding bill.

Sen. Roger Marshall (R-Kan.) said an amendment vote, which he stressed would have to be at a simple majority, in exchange for speeding up the government funding bill was “on the table right now.”

“Sen. Lee, Sen. Cruz and myself will be talking with leadership and seeing what that amendment opportunity looks like,” he said, referring to Sens. Mike Lee (R-Utah) and Ted Cruz (R-Texas).

Congress has until the end of Friday to fund the government and avoid a shutdown. Because of Senate rules, and the time crunch, any one senator can drag the process out past the deadline.

https://thehill.com/homenews/senate/584004-manchin-wont-rule-out-backing-gop-effort-to-defund-biden-vaccine-mandate

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