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Thursday, May 1, 2025

Tandem Diabetes jumps as overseas sales drive Q1 beat

 Shares of Tandem Diabetes Care (NASDAQ:TNDM) climbed ~20% on Thursday, marking its biggest intraday gain in nearly a year, after the insulin pump maker reported better-than-expected revenue for Q1 thanks to a record sales performance from overseas.

The San Diego, California-based MedTech posted $234.4M in revenue for Q1 with ~22% YoY growth, exceeding the consensus by $14.2M, as the company recorded its best quarter outside the U.S., adding $83.8M to the topline from overseas regions.

“The strength of our first quarter performance was driven by more than 20% worldwide sales growth, including our highest quarter ever outside the United States,” CEO John Sheridan remarked.

The maker of the t: slim X2 insulin delivery system announced over 17K pump shipments during the quarter while its ex-US pump shipments exceeded 11K.

However, the company’s net loss expanded over 200% to $130.6M, while its GAAP operating loss widened to $120.9M from $41.7M, and adjusted EBITDA narrowed to (2%) from (7%) in the prior-year period.

As for guidance, Tandem (NASDAQ:TNDM) reaffirmed its full-year outlook to reflect an adjusted EBITDA margin of nearly 3% from $997M to $1.007B in sales for the year, in line with $998.7M in the consensus.

https://www.msn.com/en-us/money/markets/tandem-diabetes-jumps-as-overseas-sales-drive-q1-beat/ar-AA1E0ljO

Blueprint Medicines ups full year revenue guidance

 -- Achieved 61% year-over-year growth with $149.4 million in AYVAKIT net product revenues in the first quarter 2025 --

-- Raising AYVAKIT net product revenue guidance to $700 - $720 million for 2025 --

--  Initiated BLU-808 proof of concept studies in allergic rhinoconjunctivitis and chronic urticaria –

https://www.prnewswire.com/news-releases/blueprint-medicines-reports-first-quarter-2025-results-and-raises-ayvakitayvakyt-avapritinib-full-year-revenue-guidance-302443541.html

Becton Dickinson downgrades

 

TodayDowngradeWilliam BlairOutperform → Mkt Perform
TodayDowngradeWells FargoOverweight → Equal Weight
TodayDowngradeBofA SecuritiesBuy → Neutral$190

HHS casts doubt on evidence supporting gender-affirming care for youth

The Trump administration questioned the evidence supporting gender-affirming health care for youth in a lengthy review published Thursday by the Department of Health and Human Services (HHS). 

The roughly 400-page, unsigned review states there is a “lack of robust evidence” supporting interventions such as puberty blockers, hormone therapy and the rare surgeries to treat gender dysphoria in minors. It advocates for a greater reliance on psychotherapy to treat the condition, which is characterized by severe psychological distress that stems from a mismatch between a person’s gender identity and sex at birth. 

The document contradicts guidance from major medical organizations including the World Professional Association for Transgender Health and the American Medical Association, which opposes statewide bans on gender-affirming care for youth. Neither group immediately returned a request for comment on the report. 

“Our duty is to protect our nation’s children — not expose them to unproven and irreversible medical interventions,” National Institutes of Health Director Jay Bhattacharya said in a news release accompanying Thursday’s report. 

The review’s release comes at the direction of an executive order President Trump issued days into his second term to end federal support for gender-affirming care for minors, which his administration has said includes children and adolescents up to 19 years old. Two federal courts blocked parts of the order that sought to withhold funding from hospitals providing transition-related services to youth. 

The names of the new review’s contributors would not initially be made public, HHS said Thursday, “in order to help maintain the integrity of this process.” A department spokesperson did not immediately return a request for additional comment on the decision to withhold the authors’ names.  

In a fact sheet released earlier this week, the White House said HHS had coordinated with “a team of eight distinguished scholars” to publish the review. The department said Thursday that contributors include medical doctors, ethicists and a methodologist and represent “a wide range of political viewpoints.” 

The report was subject to peer review before publication, the department said, and a postrelease peer review, set to begin in the coming days, will involve “stakeholders with different perspectives.” 

Transgender rights advocates decried the review as one-sided and politically motivated. Some pointed to Trump’s campaign promise to ban gender-affirming care for youth, which he has equated to child abuse.

Stanley Goldfarb, chair of the organization Do No Harm, which advocates against gender-affirming care for youth, said it “rightfully exposes a number of serious risks in the medical transition of young people,” which he called “misguided.” 

“Do No Harm, its fellows, researchers, and members have been warning about the experimental and irreversible sex change interventions on children, and we are grateful and encouraged HHS is bringing needed scrutiny to the gender industry,” said Goldfarb, a retired kidney specialist and former associate dean at the University of Pennsylvania’s medical school. 

Goldfarb and Do No Harm, which he founded in 2022, have been influential in arguing that transition-related treatments are medically harmful to minors, supplying model legislation banning such care to state lawmakers and lobbying conservative leaders in Congress. 

Half the nation since 2021 has adopted laws that ban or heavily restrict access to gender-affirming health care for transgender youths — and adults, in some cases.

Trump has called for federal legislation to that effect, telling Congress during his joint address in March to pass a bill “permanently banning and criminalizing sex changes on children and forever ending the lie that any child is trapped in the wrong body.” 

In its fact sheet released Monday, the White House said HHS had eliminated approximately 200 grants totaling $477 million in research or education on gender-affirming treatment since Trump took office in January. 

https://thehill.com/homenews/lgbtq/5277822-trump-hhs-report-transgender-youth-gender-affirming-care/

US files false claims complaint against three health insurers



US False Claims Act Complaint Against Three National Health Insurance Companies and Three Brokers Alleging Unlawful Kickbacks and Discrimination Against Disabled

The United States filed a complaint today under the False Claims Act (FCA) against three of the nation’s largest health insurance companies — Aetna Inc. and affiliates, Elevance Health Inc. (formerly known as Anthem), and Humana Inc. — and three large insurance broker organizations — eHealth, Inc. and an affiliate, GoHealth, Inc., and SelectQuote Inc. The United States alleges that from 2016 through at least 2021, the defendant insurers paid hundreds of millions of dollars in illegal kickbacks to the defendant brokers in exchange for enrollments into the insurers’ Medicare Advantage plans.

Under the Medicare Advantage (MA) Program, also known as Medicare Part C, Medicare beneficiaries may choose to enroll in health care plans (MA plans) offered by private insurance companies, such as defendants Aetna, Anthem, and Humana. Many Medicare beneficiaries rely on insurance brokers to help them choose an MA plan that best meets their individual needs. Rather than acting as unbiased stewards, the defendant brokers allegedly directed Medicare beneficiaries to the plans offered by insurers that paid brokers the most in kickbacks, regardless of the suitability of the MA plans for the beneficiaries. According to the complaint, the broker organizations incentivized their employees and agents to sell plans based on the insurers’ kickbacks, set up teams of insurance agents who could sell only those plans, and at times refused to sell MA plans of insurers who did not pay sufficient kickbacks.

The United States further alleges that Aetna and Humana each conspired with the broker defendants to discriminate against Medicare beneficiaries with disabilities whom they perceived to be less profitable. Aetna and Humana allegedly did so by threatening to withhold kickbacks to pressure brokers to enroll fewer disabled Medicare beneficiaries in their plans. The United States alleges that, in response to these financial incentives from Aetna and Humana, the defendant brokers or their agents rejected referrals of disabled beneficiaries and strategically directed disabled beneficiaries away from Aetna and Humana plans.

“Health care companies that attempt to profit from kickbacks will be held accountable,” said Deputy Assistant Attorney General Michael Granston of the Justice Department’s Civil Division. “We are committed to rooting out illegal practices by Medicare Advantage insurers and insurance brokers that undermine the interests of federal health care programs and the patients they serve.”

“It is concerning, to say the least, that Medicare beneficiaries were allegedly steered towards plans that were not necessarily in their best interest – but rather in the best interest of the health insurance companies,” said U.S. Attorney Leah B. Foley for the District of Massachusetts. “The alleged efforts to drive beneficiaries away specifically because their disabilities might make them less profitable to health insurance companies are even more unconscionable. Profit and greed over beneficiary interest is something we will continue to investigate and prosecute aggressively. This office will continue to take decisive action to protect the rights of Medicare beneficiaries and vulnerable Americans.”

The lawsuit was originally filed under the qui tam or whistleblower provisions of the FCA. Under the FCA, private parties can file an action on behalf of the United States and receive a portion of the recovery. The FCA permits the United States to intervene in and take over the action, as it has done here. If a defendant is found liable for violating the FCA, the United States may recover three times the amount of its losses plus applicable penalties.

The Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section and the U.S. Attorney’s Office for the District of Massachusetts are handling the matter, with valuable assistance from the Department of Health and Human Services (HHS) Office of Inspector General and the FBI.  The case is captioned United States ex rel. Shea v. eHealth, et al., No. 21-cv-11777.

Trial Attorneys David G. Miller, Anna H. Jugo, Diana E. Curtis, and Sara B. Hanson of the Justice Department’s Civil Division and Assistant U.S. Attorneys Charles Weinograd and Julien Mundele for the District of Massachusetts are handling the matter.

The investigation and prosecution of this matter illustrates the government’s emphasis on combating healthcare fraud.  One of the most powerful tools in this effort is the FCA.  Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to HHS at 800-HHS-TIPS (800-447-8477).

The claims asserted in the complaint are allegations only. There has been no determination of liability. 

Note: Read the complaint here

https://www.justice.gov/opa/pr/united-states-files-false-claims-act-complaint-against-three-national-health-insurance

Third Point Says It Expects to Boost Credit Exposure Amid Tumult

 


Third Point LLC expects to boost its exposure to company debt in the coming weeks, as it looks to capitalize on dislocations brought on by tariff-related volatility.

The hedge fund owns bonds from bigger companies with relatively liquid debt, and that have “more levers to pull” when markets grow tumultuous, Daniel Loeb, the firm’s chief executive officer, wrote in a letter to investors.

RFK Jr. Shatters The Measles Narrative With One Brilliant Point

 Via VigilantFox.com,

RFK Jr. is perhaps the most impactful HHS Secretary we’ve ever seen - but if you read the mainstream news, you’d think his first 100 days were a disaster.

While chronic disease drains trillions from Americans every year, the press can’t stop obsessing over measles.

Just look at these headlines:

Many Windows Users Didn't Know That They Can Now Block Ads

“As measles cases rise, some parents become vaccine enthusiasts.”

“US measles cases near 900, outbreaks reported in 10 states.”

It makes you think measles is a really big problem, but in reality, it’s not.

RFK Jr. expertly flipped this media narrative on its head in real time during his Wednesday night appearance on NewsNation—and it was so brilliant the audience gave him a round of applause.

NewsNation’s Chris Cuomo asked Kennedy:

“You weren’t saying that [get vaccinated] during COVID. That’s why people aren’t getting vaccinated. And now it’s a problem. How do you deal with that issue, and what responsibility do you have in terms of how people feel about getting vaccinated?”

Kennedy delivered a sharp, measured response. First, he pointed out that measles is a far smaller problem in the U.S. than it is globally.

He explained, “Right now we have about 842 cases, Chris. And Canada, they have about the same number. They have one-eighth of our population. Europe has ten times that number. Our numbers have plateaued.”

He noted that for years, the CDC has insisted the only way to manage measles is through universal vaccination. But Kennedy challenged that approach.

He argued that people who have concerns about the MMR vaccine—whether it’s due to aborted fetal debris or DNA particles—deserve access to treatment options.

“And that’s what we’re developing at CDC right now,” Kennedy said, “protocols for treating measles.”

Kennedy then delivered a devastating jab at the dominant measles narrative, putting everything into perspective and leaving the panel silent.

“I want to say this,” Kennedy began.

“We’ve had four measles deaths in this country in 20 years. We have 100,000 autism cases a year. We have 38% of our kids now are diabetic or pre-diabetic. That should be in the headlines,” he said.

*Applause erupted*

“When I was a kid, there were 2 million measles cases a year and none of them got headlines. And we had 400 deaths. We had deaths between 1 in 1,200 and 1 in 10,000. We have so many kids now who are afflicted by chronic disease. And the media never covers them. They only want to cover measles,” he added.

“And what I’ve been saying to people is, let’s pay attention to other illnesses as well—illnesses that are really, really damaging our country, that are existential for our country. We now spend almost a trillion dollars a year on diabetes and metabolic disorder,” Kennedy explained.

Then he drove the point home, contrasting the media’s obsession with measles to its silence on autism.

“By 2035, we’re going to be spending a million dollars a year on autism. Autism in 1970 was 1 in 10,000 Americans. Today, it’s 1 in 31. In California, it’s 1 in every 20 kids—1 in every 12.5 boys,” he said.

“This is what the media ought to be focusing on, and it’s not. And because of that, we don’t have the solutions and we don’t have the cures.”

During that 90-second stretch, the NewsNation panel sat there stunned in silence.

No pushback, no rebuttal.

That’s because they knew Kennedy was dropping undeniable truths.

Cuomo and friends understand the media’s job isn’t to inform parents or educate the public on real health solutions.

They’re only there to smear people like Kennedy and make mountains out of molehills. Because they know if they leave him unresisted, the public might get a little too close to the truth.

Watch the full video below: