Novartis May Turn Sandoz into Separate Entity Amidst Restructuring

 For months, Swiss pharma giant Novartis has been conducting a review of its generics business unit, Sandoz, even entertaining a potential sale. But rather than selling, Novartis could spin Sandoz off into a separate entity with its own listing on a stock exchange.

Citing unidentified people “familiar with the matter,” Bloomberg reported that Novartis “sees a separate listing of the $25 billion Sandoz business as increasingly likely.” However, those individuals were quick to note that no final decision has been made regarding the fate of Sandoz. 

In October 2021, Novartis began to conduct a strategic review of Sandoz. Novartis Chief Executive Officer Vas Narasimhan predicted it would be completed by the end of 2022. 

Sandoz is one of the largest generics entities in the world and is also Novartis’ leading business unit for the development of biosimilar products. Over the past several years, Sandoz has seen a significant decline in its sales within the U.S. as the generics business has become increasingly challenging. 

Earlier this year, it appeared that Sandoz began an upswing financially. In the first quarter of 2022, Sandoz saw sales growth of 8%, primarily outside of the United States. Sales for the generics and biosimilar unit benefited from what the company called the normalization of impacts of COVID-19.

The review of Sandoz comes after Novartis has undertaken a restructuring plan that includes the slashing of about 8,000 jobs by 2024. While that figure is not yet set in stone, a Novartis spokesperson told BioSpace that the company is “still working on many of the design elements of the new organization.” The restructuring plan, announced earlier this year, will see the merger of two company divisions, its oncological and pharmaceutical divisions, into one innovative medicine (IM) business unit.

As Novartis continues with its restructuring plan, Sandoz will remain in play. What its future is at this time remains to be seen. If Novartis attempts to sell off the generics business, potential suitors could be waiting. 

As BioSpace previously reported, some potential buyers have expressed interest in acquiring some or all of the Sandoz business. Last fall, European investment group EQT and the Struengmann family, who own a significant stake in BioNTech, were reportedly considering a deal for the company. According to some reports, a sale of the generics business unit could net Novartis about $21.6 billion. However, some analysts though have pegged the valuation of the company at closer to $25 billion.

Novartis has been focused on streamlining its operations. Under the leadership of Narasimhan, the company spun off its Alcon eye business as well as its animal business. The company also sold its 33% stake in Roche back to its Basel, Switzerland neighbor last year, securing an astounding $20.7 billion.

Some of the funds the company gained from those transactions will be used to acquire up to $15 billion worth of its own common shares. Novartis also plans to keep some of that money in reserve in order to fuel M&A decisions. 

https://www.biospace.com/article/amidst-restructuring-novartis-could-spin-off-sandoz-into-separate-listing/

All hail 'non-dilutive' biotech financing

 The bear market notwithstanding, biotechs continue to burn vast amounts of cash, meaning that they will need more sooner or later. But the market malaise has laid many low, and with investors suddenly unwilling to part with their money doing a secondary equity offering has become difficult. Little wonder that some are turning to debt or other forms of financing that can loosely be termed “non-dilutive”. Just yesterday Blueprint secured $575m, with another $675m available later, in a deal with Sixth Street and Royalty Pharma that mortgaged Ayvakit and Gavreto royalties and provided various lines of credit. After market close Geron added $50m to an existing $75m loan with Hercules Capital and Silicon Valley Bank, and this morning Cytokinetics priced a $450m convertible debt offering. Needs must, but gearing up businesses that are naturally loss-making is a questionable strategy, and though debt might seem cheap at one point, a subsequent collapse in market value can make it incredibly hard to service – as Dendreon and others found to their cost. This is not to say that biotech debt is always a bad idea, but its track record is decidedly mixed.

Selected highs and lows of biotech debt financing
Company	Detail	Outcome
Successes
Cubist	$450m convertible in 2010, $800m convertible in 2013	Company bought by Merck & Co in 2014
Tesaro	$500m term loan in 2017	Company bought by GSK in 2018
Human Genome Sciences	$495m convertible in 2011	Company bought by GSK in 2012
Failures
Dendreon	$620m convertible in 2011	Company became insolvent in 2014
Synergy Pharma	$300m loan in 2017	Company became insolvent in 2018
Orexigen	$172m of gross debt on balance sheet in 2018	Company became insolvent in 2018
And some where the jury is still out
Clovis	$630m debt (incl $437m convertible) on balance sheet in Mar 2022	Company has been paying off and refinancing debt, but is currently capitalised at just $260m
Bridgebio	$450m credit line in Nov 2021	Acoramidis failed in Dec 2021; company now capitalised at $1.3bn
Neurocrine	$450m convertible in 2017	Company has repurchased some debt, incl $224m for cash in May 2022
Source: company filings. The bear market notwithstanding, biotechs continue to burn vast amounts of cash, meaning that they will need more sooner or later. But the market malaise has laid many low, and with investors suddenly unwilling to part with their money doing a secondary equity offering has become difficult. Little wonder that some are turning to debt or other forms of financing that can loosely be termed “non-dilutive”. Just yesterday Blueprint secured $575m, with another $675m available later, in a deal with Sixth Street and Royalty Pharma that mortgaged Ayvakit and Gavreto royalties and provided various lines of credit. After market close Geron added $50m to an existing $75m loan with Hercules Capital and Silicon Valley Bank, and this morning Cytokinetics priced a $450m convertible debt offering. Needs must, but gearing up businesses that are naturally loss-making is a questionable strategy, and though debt might seem cheap at one point, a subsequent collapse in market value can make it incredibly hard to service – as Dendreon and others found to their cost. This is not to say that biotech debt is always a bad idea, but its track record is decidedly mixed. Selected highs and lows of biotech debt financing Company Detail Outcome Successes Cubist $450m convertible in 2010, $800m convertible in 2013 Company bought by Merck & Co in 2014 Tesaro $500m term loan in 2017 Company bought by GSK in 2018 Human Genome Sciences $495m convertible in 2011 Company bought by GSK in 2012 Failures Dendreon $620m convertible in 2011 Company became insolvent in 2014 Synergy Pharma $300m loan in 2017 Company became insolvent in 2018 Orexigen $172m of gross debt on balance sheet in 2018 Company became insolvent in 2018 And some where the jury is still out Clovis $630m debt (incl $437m convertible) on balance sheet in Mar 2022 Company has been paying off and refinancing debt, but is currently capitalised at just $260m Bridgebio $450m credit line in Nov 2021 Acoramidis failed in Dec 2021; company now capitalised at $1.3bn Neurocrine $450m convertible in 2017 Company has repurchased some debt, incl $224m for cash in May 2022  Source: company filings. https://www.evaluate.com/vantage/articles/news/snippets/all-hail-non-dilutive-biotech-financing

New Disney Show Accused Of Indoctrinating Kids To Think That Men, Too, Can Get A Period

 by Bill Pan via The Epoch Times (emphasis ours),

The Walt Disney Company, which recently sparked controversy for inserting radical sex and gender ideology into its children’s programs, has come under scrutiny again after a clip from the new series “Baymax!” showed the namesake nurse robot taking advice on menstrual products from a transgender person.

The video was obtained and shared by conservative author and filmmaker Christopher Rufo. Earlier this year, Rufo publicized video footage of an internal company call, in which Disney executives discussed the company’s “not-at-all secret gay agenda,” including a push for more LGBT cartoon characters.

“I’ve obtained leaked video from Disney’s upcoming show ‘Baymax,’ which promotes the transgender flag and the idea that men can have periods to children as young as two years old,” Rufo wrote in a Jun. 28 post on Twitter. “It’s all part of Disney’s plan to re-engineer the discourse around kids and sexuality.”

EXCLUSIVE: I've obtained leaked video from Disney's upcoming show "Baymax," which promotes the transgender flag and the idea that men can have periods to children as young as two years old.

It's all part of Disney's plan to re-engineer the discourse around kids and sexuality. pic.twitter.com/y1ATnKCEce

— Christopher F. Rufo ⚔️ (@realchrisrufo) June 28, 2022

In the 27-second clip, Baymax can be seen standing in the female hygiene product aisle of a store. When he asks a woman next to him for suggestions, the woman appears to be surprised but nonetheless recommends “the tampons I usually use,” before several other customers join in to offer advice.

“I prefer pads, they’re more comfortable for me,” a woman tells the inflatable robot.

“I always get the ones with wings,” recommends a male-sounding person wearing a transgender flag.

“Get unscented and bleach-free if you can,” another woman says.

“My daughter loves these!” a man says while showing Baymax some other product.

“These might be easier if it’s her first period,” yet another woman offers. “These are really environmentally friendly!”

Appropriateness Debated

The clip has triggered a debate on social media over whether the messaging is appropriate for an animated series directly aimed at younger viewers, with many accusing Disney of trying to normalize to children the idea that biological males can have periods.

“I have 4 kids, ages 8-15, who would watch this and it would make them all uncomfortable. What is the purpose?” journalist Nicole Russell wrote on Twitter.

Some others, however, applauded the inclusion of the period talk and dismissed Rufo’s concerns as “conspiracy theory.”

“Apparently, this is all you need to trigger Christopher Rufo into an unhinged rant and conspiracy theories,” Alejandra Caraballo, an instructor at Harvard Law School, wrote alongside a transgender pride flag.

The debate comes as the Disney-Pixar movie “Lightyear” falls short of box office expectations for two consecutive weekends.

The latest installation in the “Toy Story” franchise, “Lightyear” earned only about $51 million in North America on its opening weekend and landed 5th at the box office on the second weekend, with just $17.6 million, falling even behind the independent horror film “The Black Phone.”

Critics argue that the poor performance of “Lightyear” has to do with Disney’s focus on pushing LGBT-friendly messages rather than entertaining the audience. As the result of Disney’s insistence in keeping a same-sex kiss between two female characters in “Lightyear,” the film has been banned in 14 countries, including China and Indonesia.

“Baymax!,” a spin-off of the widely successful 2014 movie “Big Hero 6,” premiered on June 29 on Disney Plus.

https://www.zerohedge.com/political/new-disney-show-accused-indoctrinating-kids-think-men-too-can-get-period

Sanofi flu vaccines licensed and approved for 2022-2023 influenza season

 Fluzone® High-Dose Quadrivalent (Influenza Vaccine) and Flublok® Quadrivalent (Influenza Vaccine) are the only two flu vaccines proven to help prevent more cases of flu in older adults, compared to their standard-dose flu vaccine comparators as assessed in randomized controlled trials, the gold standard in evaluating clinical evidence for vaccine licensure1,2

*  Fluzone® High-Dose (Influenza Vaccine) is the first and only influenza vaccine with superior flu protection and 10 years of evidence in preventing flu-related hospitalizations in adults aged 65+2,3,a,b
*  As the leaders in flu, Sanofi is committed to protecting patients most at-risk for the flu and its related complications, including hospitalizations due to pneumonia & cardiovascular events4

https://finance.yahoo.com/news/sanofi-flu-vaccines-licensed-approved-210400123.html

White House Promotes 'AbortionFinder' Tool Helping Minors Skirt Parental Notification

The memo came from Health and Human Services, and the White House passed it along on official letterhead. “Know Your Rights: Reproductive Health Care,” read the title of the document that represents the latest effort by the Biden administration to make good on the president’s post-Roe promise to “do all in my power to protect a woman’s right” to an abortion.

The memo in question points the public to AbortionFinder.org, an online tool that provides pregnant women information on where they can terminate their pregnancy. The website also directs minors “15 or younger,” RealClearPolitics was first to report, to resources for bypassing parental notification laws.

“Some states require people under 18 to involve a parent or guardian when getting an abortion,” a pop-up window announces to minors seeking an abortion. “If you need to avoid involving a parent or guardian, contact the If/When/How Judicial Bypass (JB) Helpline for information about getting a judicial bypass.”

That hotline and the accompanying online Abortion Finder are products of Power to Decide, a pro-abortion nonprofit funded, in part, by federal grants from the Department of Health and Human Services. And for now, the White House is leaning on allied outside organizations like these to preserve access to abortion.

The regulatory landscape has already shifted with almost half of the states preparing to significantly limit or outlaw abortion altogether. Some Democrats, including Massachusetts Sen. Elizabeth Warren and New York Rep. Alexandria Ocasio-Cortez, have called on the president to build abortion clinics in federal parks and on military bases. Others want Biden to expand the number of justices on the Supreme Court, adding pro-abortion judges for the express purpose of reversing the opinion. He has rejected both those ideas. Otherwise, the president is all ears.

Biden called on Congress to codify Roe, either during this Congress or the next, if Democrats expand their majorities. And the president supports changing the Senate filibuster to ease passage.

Meanwhile, according to HHS Secretary Xavier Becerra, options are limited. “There is no magic bullet,” Becerra told reporters at a Tuesday press conference, “but if there is something we can do, we will find it and we will do it.” As of now, that includes giving minors the resources needed to find an abortion provider and, if necessary, to secure an abortion without notifying their parents.

Power to Decide has focused on reducing teen pregnancy since its founding in 1996, and the abortion advocacy organization lists Google, the Ford Foundation, and the Bayer Corporation among its many major funders. It has also received significant financial support from the federal government since 2001. Previously called the National Campaign to Prevent Teen and Unplanned Pregnancy, Power to Decide has received nearly $16 million in grants from the HHS, a figure that includes $897,585 awarded in the first year of the Biden administration.

According to public lobbying disclosures, the federally funded group also lobbied Congress in support of a number of key White House priorities. “We also worked to advance policies that would reduce barriers to abortion care,” the organization wrote in its 990 tax-exempt documents, “including the elimination of the Hyde Amendment from the president’s budget and the House-Passed FY2022 appropriations bill and the passage of the Women’s Health Protection Act.”

Power to Decide declined to comment when contacted by RealClearPolitics. The White House, meanwhile, referred RCP to HHS when asked about its efforts to shore up abortion access and, in some cases, to provide resources to minors looking to skirt parental notification laws. That agency, however, did not return repeated RCP requests for comment.

Congressional Republicans are already furious. “Here’s Joe Biden turning to a Google and Big Pharma-funded outfit to help teenagers - 15 and younger - get abortions. Priorities,” tweeted Missouri Sen. Josh Hawley. Michigan Rep. Lisa McClain blasted the Biden administration, telling Fox News that the move was "unbelievable."

Abortion advocates such as the ACLU have long argued that parental notification laws jeopardize the health of teenagers and that “the risks of delayed and denied health care far outweigh the costs of permitting teens to consent on their own to abortion services.”

Abortion opponents respond that parental notification laws are necessary safeguards to protect minors who, in some cases, may be victims of sexual assault.

“The White House instructing young girls on how to go around their parents to get abortions is radical and dangerous. Parental involvement policies are wildly popular – they protect children from exploitation by the profit-driven abortion industry and abusers and traffickers who use abortion to cover up their crimes,” said Mallory Carroll, a spokeswoman for Susan B. Anthony Pro-Life America.

Abortion opponents such as Carroll warn that the White House is overplaying its hand. “Pro-abortion Democrats have failed to learn the political and moral lesson from the Virginia elections last year that you don’t come between parents and their children,” she told RCP in a statement. “They should expect similar results.”

https://www.realclearpolitics.com/articles/2022/07/01/white_house_promotes_abortionfinder_tool_helping_minors_skirt_parental_notification__147832.html

Reining In the Agencies

 The Supreme Court saved a crucial decision for the last day of its term, ruling 6–3 in West Virginia v. Environmental Protection Agency that the Clean Air Act does not allow the EPA to move from regulating individual power plants to regulating regional emissions through its interpretation of the Clean Power Plan. The opinion, written by Chief Justice John Roberts, cited the major questions doctrine, according to which Congress must “speak clearly if it wishes to assign to an agency decisions of vast economic and political significance.”

“This decision properly keeps the EPA in its lane and rejects the agency’s efforts to usurp national energy policy from Congress,” Jones Day partner Yaakov Roth, who argued the case in front of the Supreme Court on behalf of the plaintiffs, told me. “It is a very important step toward political accountability and economic certainty” Indeed, the case has far-reaching implications for other agencies that could currently be exceeding their statutory remits. The Securities and Exchange Commission, for example, recently proposed requirements for companies to disclose their exposure to climate risk and to provide details about the climate effects of their operations. Meantime, the National Labor Relations Board is considering making franchise businesses such as McDonald’s accountable for the actions of local franchises. Such rules could find themselves on the wrong side of the Court’s approach, which found the EPA’s rulemaking to be an example of “agencies asserting highly consequential power beyond what Congress could reasonably be understood to have granted.”

The Clean Air Act allows the EPA to set maximum levels of new and existing emissions sources. However, the Clean Power Plan, proposed in 2015 under President Barack Obama, went further. If emissions exceeded the EPA’s requirements, a state, or group of states, would be required to shut down power plants or to install renewable energy sources. The plan was similar to the American Clean Energy and Security Act, introduced by Democratic congressmen Henry Waxman and Edward Markey in 2009, and the American Power Act, introduced by senators John Kerry and Joe Lieberman in 2010. Neither bill became law, despite sizeable Democratic majorities in both chambers.

Writing for the majority, Chief Justice Roberts argued that “EPA claimed to discover an unheralded power representing a transformative expansion of its regulatory authority in the vague language of a long-extant, but rarely used, statute designed as a gap filler. That discovery allowed it to adopt a regulatory program that Congress had conspicuously declined to enact itself.” The dissent, written by Justice Elena Kagan, parted ways on the grounds that “Congress . . . gives an expert agency the power to address issues—even significant ones—as and when they arise.” Given that climate change is such an issue, the dissent holds, the EPA has the authority to regulate carbon emissions and therefore reduce the environmental danger. But Justice Neil Gorsuch elaborated on the major-question doctrine in a concurring opinion, writing, “The framers believed that the power to make new laws regulating private conduct was a grave one that could, if not properly checked, pose a serious threat to individual liberty.”

Severe, government-imposed cuts in carbon emissions raise the cost of electricity and American-made goods. Under the Clean Power Plan, some states or groups of states would have had to meet EPA targets by ensuring plants cut emissions or by financing reductions in other ways, such as suppressing consumer demand or investing in more costly renewable energy. In any case, carbon emissions are declining naturally without the plan. Emissions of energy-related carbon dioxide declined by 14 percent from 2007 to 2019, according to the Energy Information Administration. Between 2014, when the Clean Power Plan was proposed, and 2019, two years after the Trump administration rescinded it, these emissions fell by 5 percent.

Cleaner air and efficient power generation are worthwhile goals. But so is the security that comes from the rule of law. The Supreme Court has just weighed in on that balance, and could weigh in further in the years ahead.

Diana Furchtgott-Roth, former acting assistant secretary for economic policy at the U.S. Treasury, is adjunct professor of economics at George Washington University.

https://www.city-journal.org/west-virginia-v-epa-ruling-analysis

DC Health Dept lays off 131 workers, ends COVID contact tracing program

 The DC Health Department ended its COVID-19 contract tracing program on Thursday, laying off 131 workers employed by the program.

“The COVID-19 Contact Trace Force has been instrumental in helping slow the spread of COVID-19 in the District of Columbia,” DC Health told The Hill. “However with COVID infection levels coming down and easier access to at-home testing kits, the COVID-19 Contact Trace Force is no longer as effective or vital a tool as it was during the peak of the pandemic.”

The District of Columbia government currently considers COVID-19 infection levels in the area “low,” the most recent weekly case rate coming in at 195.9 for the week of June 19 to 25 and the most recent hospital admission rate at 0.4 percent.

DC Health emphasized that its department gave advance notice of the end of the trace force and aided its employees in finding new roles.

“DC Health provided contact tracers with opportunities to learn more about new positions and even a career fair,” a spokesperson told The Hill, adding that many will continue to work in DC government and disease investigation.

The DC government will continue operating its mobile contact tracing system despite the closure of its overall contact tracing program, allowing DC residents to opt in for notifications about potential exposure to COVID-19.

“The DC CAN digital exposure notification system for mobile devices will remain in place and fully supported, and DC Health will continue to monitor the spread of diseases in the community, including COVID-19, and provide consultative services to high-risk facilities,” wrote the department.

https://thehill.com/homenews/state-watch/3543643-dc-health-department-lays-off-131-workers-ends-covid-contract-tracing-program/