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Tuesday, May 14, 2024

CVS warns it could lose up to 10% of its Medicare members next year

 Facing the wrath of upset investors following its first quarter earnings, CVS Health has promised to value margins over members going forward.

First apologizing for last quarter’s earnings, which were plagued by higher-than-expected Medicare Advantage (MA) utilization, CFO Thomas Cowhey told the Bank of America Securities 2024 Health Care Conference crowd that CVS remains a big believer in MA, but noted it will take “a couple years to get back on track."

Cowhey was tasked with reassuring investors the company would improve margin at any cost, but he didn't pass up the opportunity to say he believes the recent MA rate cut by CMS is limiting the business. Starting in 2023 and into 2025, core utilization trends are projected to remain higher than CVS is accustomed to seeing pre-pandemic, limiting growth potential to no more than 200 basis points of margin improvement.

“The goal next year is margin over membership,” he explained. “Could we lose up to 10% of our existing Medicare members? It’s entirely possible. And that’s okay, because we need to get this business back on track.”

The company was $900 million short of its health care benefits estimates on its medical cost line. Within that $900 million, about $400 million was attributed to high utilization among outpatient services, outpatient pharmacy and behavioral mental health.

CVS drew criticism for a separate $250 million of the $900 million, where Cowhey said the company incorrectly forecast seasonality. Diving deeper, inpatient services for respiratory illnesses were much higher than CVS anticipated, mirroring similar levels in 2018 and 2019, he said. They expect seasonal respiratory illnesses should subside in upcoming quarters.

Cowhey said the company is reevaluating vision, dental, OTC and flex cards, fitness and transportation benefits for its members. CVS may also look to exit markets, he added. The company is in negotiation with plan sponsors for its group business segment.

CVS lowered its full-year earnings outlook to $7 per share, $1.30 below what was previously announced. The company does not plan on doing more stock repurchases in 2024, Cowhey said.

https://www.fiercehealthcare.com/ai-and-machine-learning/bofa-cvs-warns-it-could-lose-10-its-members-next-year

Humacyte eyes strong market entry post-FDA review

 Humacyte, Inc. (HUMA), a biotechnology company specializing in regenerative medicine, has recently announced its financial results for the first quarter of 2024, alongside providing a business update that indicates a significant stride towards the commercial launch of its flagship product, the Humacyte Vascular Access Graft (HAV).

The U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application for the HAV, granting it Priority Review with a Prescription Drug User Fee Act (PDUFA) date set for August 10, 2024.

As the company prepares for potential approval, it has secured $63 million in funding, completed a budget impact model for the HAV, and is actively engaging with payers and assembling a sales team. Financially, Humacyte ended the quarter with $115.5 million in cash and cash equivalents and reported a net loss of $31.9 million, a decrease from the previous year's first-quarter loss.

Key Takeaways

  • Humacyte's Biologics License Application for the HAV in vascular trauma has been accepted by the FDA, with Priority Review status.
  • The company is preparing for the U.S. market launch, having raised $63 million in funding and engaged in commercial readiness activities.
  • No revenues were reported for the first quarters of 2023 and 2024, with a decrease in net loss from Q1 2023 to Q1 2024.
  • The company is confident in its financial position to support operations for at least 12 months.
  • Positive feedback from trauma and vascular surgeons and successful FDA interactions have been reported.

Company Outlook

  • Humacyte is focusing on commercial readiness for the anticipated launch of the HAV in the United States.
  • The company is in discussions with payers and is recruiting a sales team to support the product launch.
  • Anticipated results from the Phase 3 trial of the HAV in end-stage renal disease patients are expected in the third quarter of 2024.

Bearish Highlights

  • Humacyte reported no revenues in both the first quarter of 2023 and 2024.
  • The net loss for Q1 2024 was $31.9 million, although this was a decrease from the $37.0 million net loss in Q1 2023.

Bullish Highlights

  • The company has completed a budget impact model to demonstrate the HAV's potential economic value.
  • Promising results from the BioVascular Pancreas (BVP) in non-human primate studies and positive preclinical results for the small-diameter HAV in cardiac bypass graft surgery were reported.

Misses

  • Despite the decrease in net loss, the company is still operating at a loss with no current revenue stream.

Q&A Highlights

  • CEO Laura Niklason expressed confidence in meeting the PDUFA date following smooth FDA interactions.
  • President Dale Sander discussed the post-approval commercialization plan, including a soft launch followed by a full promotional effort.
  • COO Heather Prichard outlined the manufacturing capacity for the HAV, with current capabilities at 8,000 units per year and the potential to scale up to 40,000 units per year.
  • The company has submitted an application for an ICD-10 code for the HAV in trauma and plans to apply for a new technology add-on payment with CMS post-approval.

Humacyte's proactive engagement with the FDA and the medical community, coupled with its strategic financial and operational planning, positions the company for a potentially successful market entry pending regulatory approval.

The company's focus on commercial readiness and positive clinical study results underscore its commitment to bringing innovative treatments to patients with vascular and renal diseases. As the PDUFA date approaches, stakeholders are likely to closely monitor Humacyte's progress and the impact of its products on the healthcare market.

https://www.investing.com/news/stock-market-news/earnings-call-humacyte-anticipates-strong-market-entry-postfda-review-93CH-3437670

1000s Of Islamists Protest Against 'Censorship' After Calls For A Caliphate In Germenay Are Banned

 by Thomas Brooke via ReMix News,

The Salafist group organizers claimed unfair censorship after strict conditions were imposed on Muslims calling for a caliphate in Germany and against anti-Semitic rhetoric...

Thousands of Islamists took to the streets of Hamburg again on Saturday for what organizers called a “defense of Islamic values” in the face of political intimidation and media censorship.

The protest was organized by Muslim Interaktiv, a group under investigation by Hamburg’s domestic intelligence agency for “extremism.” It claimed on its social media accounts that over 6,000 Muslims had turned out to participate, although police estimates put the figure closer to 2,300.

The demonstration was in response to recent attempts by German politicians to restrict the group’s activities after a recent march in the port city sparked outrage amid calls for Germany to become a caliphate under Sharia Law, and participants chanted anti-Semitic slogans.

Muslim Interaktiv claimed it wanted to “set an example” to protect “Islamic identity,” and posted that the requirement for Muslims to “commit to Western values” was the “lie of the year.”

The demonstration was allowed to take place under strict conditions, which included a wholesale ban on anti-Semitic rhetoric, calls for a caliphate using any medium, and a ban on any incitement of hatred or violence.

Organizers called the conditions ahead of the march “repressive” and revealed it had been seeking legal advice to take action against the measures imposed on the group.

Attendees held placards claiming they were being censored by the German government.

After the controversial protest held last month, Germany’s Federal Interior Minister Nancy Faeser denounced the demonstration despite overseeing the country’s open borders immigration policy in recent years that has seen millions of Muslims, many of whom have originated from countries that practice fundamental Islam, arrive in Germany.

“Seeing an Islamist demonstration of this kind on our streets is difficult to bear. It’s a good thing that the Hamburg police counteracted crime with a large presence,” she told Tagesspiegel.

She told the Funke newspaper group last week the new conditions imposed on the group’s activities gave the police greater power to intervene and disperse the participants if necessary.

“Anyone who would rather live in a caliphate, and therefore in the Stone Age, is against everything that Germany stands for. We defend our constitution — with the means of our constitution,” she said.

https://www.zerohedge.com/geopolitical/1000s-islamists-protest-against-censorship-after-calls-caliphate-germenay-are-banned

Monday, May 13, 2024

Japan's Shionogi says COVID treatment did not meet endpoint in late-stage trial

 Japan's Shionogi & Co said on Monday its pill-based treatment for COVID-19 did not meet the primary endpoint of showing a statistically significant reduction of 15 common symptoms of the illness in a global, late-stage trial.

The company's pivotal Phase 3 study (SCORPIO-HR) of ensitrelvir did however demonstrate a potent antiviral effect compared to placebo, the company said.

WHY IT'S IMPORTANT

Shionogi said previously it expected the pill, known commercially as Xocova, to deliver $2 billion in annual sales if it secured U.S. approval.

Xocova would compete with Pfizer's antiviral drug Paxlovid.

Shionogi's CEO told the Nikkei newspaper in March that the company expected to be able to sell the drug in the U.S. in early 2025.

CONTEXT

Xocova was granted emergency approval by Japanese regulators in November 2022, making it the nation's first domestically produced oral treatment for COVID. It received full approval in Japan in March 2024.

The Japanese government bought 2 million courses of the drug, most of which remain unused and are set to be destroyed, according to a Kyodo report this month.

The drug was granted Fast Track designation by the U.S. Food and Drug Administration in 2023.

The SCORPIO-HR trial is a part of the U.S. National Institutes of Health's (NIH) public-private partnership for COVID treatments and vaccines.

WHAT'S NEXT

The company said it will continue working with regulatory bodies to explore routes to making ensitrelvir available, without giving further details.

https://www.yahoo.com/news/japans-shionogi-says-covid-treatment-072650957.html

'Yellen says Chinese response possible on expected US tariff action'

The United States could see a significant response from China following any U.S. tariff actions, U.S. Treasury Secretary Janet Yellen said on Monday ahead of expected new tariffs targeting certain sectors this week.

Yellen, speaking to reporters after a broadband event in rural Fredericksburg, Virginia, said she and other U.S. officials had made clear to China they could reconfigure tariffs first imposed under former President Donald Trump to be more strategic, but that any changes would be narrowly targeted.

"We've been clear that in reviewing it we may decide that it's appropriate to reconfigure what's been done in a more strategic way," she said.

She declined to give any details of expected changes in U.S. tariffs on China, but said the Biden administration would ensure Chinese officials were informed ahead of any U.S. action.

"President Biden believes that anything we do should be targeted to our concerns and not broad-based and hopefully we will not see a significant Chinese response. But that's always a possibility," Yellen told Bloomberg Television earlier Monday.

Yellen's comments, given ahead of an event on broadband, come as U.S. President Joe Biden is expected to announce new tariffs on Tuesday that will include a large hike on levies for electric vehicles.

The tariffs will also target semiconductors, solar equipment and medical supplies, sources told Reuters last week.

"I have been very clear in my engagement with the Chinese that we believe there needs to be a level playing field for competition, and that we have particular concern about clean energy, semiconductors and areas where China has, through its policies, encouraged so much investment that it's led to overcapacity," she said.

Yellen said she was hopeful that China would recognize that U.S. actions were targeted, and declined to speculate on any possible retaliatory measures by Beijing. "We're going to try to keep our actions targeted, and we'll see what happens," she said.

https://ca.finance.yahoo.com/news/yellen-says-chinese-response-possible-150620048.html

Israeli forces press Gaza offensive from north and south

Israeli forces pushed deep into the ruins of Gaza's northern edge on Monday to recapture an area from Hamas fighters, while in the south tanks and troops pushed across a highway into Rafah, leaving Palestinian civilians scrambling to find safety.

Some of the most intense fighting for weeks is raging in both the north and south. Israeli operations in Rafah, which borders Egypt, have closed a main crossing point for aid. Humanitarian groups say this has worsened an already dire situation.

Hundreds of thousands of people are fleeing again. Around half of Gaza's population took sanctuary there after Israel ordered evacuations from northern Gaza in October.

Gaza's health authority appealed for international pressure to reopen access via the southern border to allow in aid, medical supplies and fuel to power generators and ambulances.

"The wounded and sick suffer a slow death because there is no treatment and supplies and they cannot travel," it said.

A foreign U.N. security staff member was killed on Monday when a U.N.-marked vehicle travelling to a hospital in Rafah was struck - the first international U.N. fatality in the Gaza war, a U.N. spokesperson said, bringing the total death toll of U.N. personnel to around 190.

In northern Gaza's Jabalia, a sprawling refugee camp built for displaced Palestinians 75 years ago, Israeli forces pushed into an area where they claimed to have dismantled Hamas months ago.

Residents fled along rubble-strewn streets carrying bags of belongings. Tank shells landed in the centre of the camp and health officials said they had recovered 20 bodies from overnight airstrikes.

"We don't know where to go. We have been displaced from one place to the next... We are running in the streets. I saw it with my own eyes. I saw the tank and the bulldozer. It is on that street," said one woman, who did not give her name.

An Israeli air strike on a house in Al-Nuseirat refugee camp in central Gaza Strip killed at least eight people, said Mahmoud Basal, a spokesperson of the Gaza Civil Emergency Service. He said several other people were wounded and missing.

The Palestinian death toll in the war has now surpassed 35,000, with 57 killed in the past 24 hours, according to Gaza health officials, whose figures do not differentiate between civilians and fighters.

Israeli troops are seeking to wipe out Hamas. A senior U.S. State Department official on Monday said Washington did not think that goal of total victory was "likely or possible." The militant group, which has said it is committed to Israel's destruction, burst into Israel on Oct. 7, killing 1,200 and taking more than 250 hostages, by Israeli tallies.

Hamas' armed wing said because of Israeli bombardments it had lost contact with militants guarding four Israeli hostages, including U.S.-Israeli citizen Hersh Goldberg-Polin, who appeared in a video released by Hamas in late April.

Attending a Memorial Day ceremony on Monday to mark Israel's fallen soldiers, Prime Minister Benjamin Netanyahu said the war against Hamas was a struggle to secure Israel's "existence, liberty, security and prosperity".

"Our war of independence is not over yet," he said.

In Rafah, Israel stepped up aerial and ground bombardments on eastern areas, killing people in an airstrike on a house in the Brazil neighbourhood.

Residents said Israeli air and ground bombardments were intensifying and tanks had cut off the main north-south Salahuddin road.

"The tanks cut the Salahuddin road east of the city, the forces are now in the southeast side, building up near the built-up area. The situation is dreadful and the sounds of explosions never stopped," said Bassam, 57, from the Shaboura neighbourhood in Rafah.

"People continue to leave Rafah ... no place looks safe now and people do not want to escape at the last minute," he told Reuters via a chat app.

RAFAH ASSAULT SPLITS U.S. AND ISRAEL

UNRWA, the main U.N. aid agency in Gaza, estimated that about 360,000 people had fled the southern city since the Israeli military gave its first evacuation order a week ago.

They are moving to empty tracts of land, including Al-Mawasi, a small strip along the coast, designated as an expanded humanitarian area by Israel.

But Shaina Low of the Norwegian Refugee Council aid agency said it was not set up to receive uprooted families.

There was "no space to install latrines or water points. There are huge piles of solid waste. My colleague spoke about seeing donkey carcasses on top of trash, so there are all sorts of health concerns," Low said.

The assault on Rafah has caused one of the biggest splits in decades between Israel and its main ally the U.S., which paused some deliveries of weapons.

U.S. President Joe Biden, who is running for reelection this year, has faced heavy criticism from his own supporters domestically for his support of Israel. Some of those critics have accused Israel of committing genocide, a claim dismissed by the White House and Israel.

"We do not believe what is happening in Gaza is a genocide," U.S. national security adviser Jake Sullivan told reporters.

Washington says Israel must not assault Rafah without a plan to protect civilians, which it has yet to see.

Israeli Defence Minister Yoav Gallant's office said on Monday he had briefed U.S. Secretary of State Antony Blinken on the "precise operation" in the Rafah area.

The State Department said Blinken spoke with Egyptian Foreign Minister Sameh Shoukry on Monday and reaffirmed that Washington does not support a major military ground operation by Israel in Rafah.

Hamas' armed wing said its fighters were engaged in gun battles with Israeli forces in one of the streets east of Rafah, and in the east of Jabalia.

In Israel, the military sounded sirens several times in areas near Gaza, warning of potential Palestinian cross-border rocket and or mortar launches.

Israeli protesters blocked aid trucks headed for Gaza, strewing food packages on the road at Tarqumiya checkpoint, west of Hebron in the Israeli occupied West Bank.

Sullivan expressed concern about reports of Israeli settlers attacking a humanitarian aid convoy on its way to Erez Crossing in northern Gaza, the second such incident in less than a week.

"It is a total outrage that there are people who are attacking and looting these conveys," Sullivan said. "It is completely and utterly unacceptable behavior."

https://www.yahoo.com/news/israeli-forces-step-attacks-gazas-063916370.html

Wegovy weight loss sustained for four years in trial, Novo Nordisk says

Patients taking Novo Nordisk's popular Wegovy obesity treatment maintained an average of 10% weight loss after four years on the treatment, the company said on Tuesday.

Novo presented the new long-term data at the European Congress on Obesity in Venice, Italy, gleaned from a large study for which much of the results had been published last year.

"This is the longest study we've conducted so far of semaglutide for weight loss," Martin Holst Lange, Novo's head of development, said in an interview, referring to the active ingredient in Wegovy and the company's diabetes drug Ozempic.

"We see that once the majority of the weight loss is accrued, you don't go back and start to increase in weight if you stay on the drug," he added.

The data could bolster the company's case as it tries to convince insurers and governments to reimburse Wegovy and deflect notions that it is a lifestyle drug.

Wegovy was the first to market from a newer generation of medicines known as GLP-1 agonists, originally developed for diabetes, that provide a new way to address record obesity rates. Eli Lilly launched its rival drug Zepbound in the United States in December. Neither company has been able to produce enough to meet unprecedented demand.

Dr. Simon Cork, Senior Lecturer in Physiology from Anglia Ruskin University, said Britain's public health service's decision to limit coverage of the medicine to two years was "because of questionable long-term effectiveness".

The new data showing benefits continuing to four years may go some way to negating that argument, he said.

The 17,604-patient trial tested Wegovy not for weight loss but for its heart protective benefits for overweight and obese patients who had preexisting heart disease but not diabetes. Participants were not required to track diet and exercise because it was not an obesity study.

Patients in the trial called Select lost an average of nearly 10% of their total body weight after 65 weeks on Wegovy. That percentage weight-loss was roughly sustained year-on-year until the end of about four years, where weight loss stood at 10.2%, the company said.

Wegovy and Zepbound are being tested to assess their benefits in a variety of other medical uses such as lowering heart attack risk and for sleep apnea and kidney disease.

The weight loss in the heart trial was less than the average of 15% weight loss in earlier Wegovy obesity studies before the drug was launched in the United States in June 2021.

https://www.yahoo.com/news/wegovy-weight-loss-sustained-four-235536667.html