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Thursday, August 8, 2024

Insulet inventory pressures cloud annual revenue forecast raise

 Insulet Corp on Thursday raised its annual revenue growth forecast but pressures over unutilised inventory clouded the upbeat outlook, sending shares of the insulin device maker down about 3.5% in extended trading.

The company said it recorded a charge of $13.5 million in the second quarter ended June 30 relating to some unutilised inventory, which hurt gross margin by about 280 basis points.

Its adjusted profit of $0.55 per share for the reported quarter was just shy of analysts' average estimate of $0.56.

The company manufactures and sells insulin delivery devices under the brand Omnipod, which eliminate the need for multiple daily injections using syringes or insulin pens for people with insulin-dependent diabetes.

It did not give further details in its statement over the inventory write-down.

In July, Insulet's larger peer Dexcom had slashed its annual revenue forecast, prompting investor concerns over changing trends in the diabetes market.

However, Massachusetts-based Insulet now expects its annual revenue to grow between 16% and 19%, up from its earlier forecast of 14%-18%, encouraged by the strong sales of its Omnipod devices.

It expects Omnipod revenue growth in the range of 18% to 21% this year, higher than previous forecasts of 15%-19% growth.

The company's total revenue stood at $488.5 million for the quarter, compared with analysts' estimate of $463.09 million.

https://finance.yahoo.com/news/insulet-inventory-pressures-cloud-annual-000726870.html

'X's handling of UK riots could influence EU probe'

 An ongoing European Commission investigation into social media platform X could take its handling of harmful content related to the recent UK riots into account, a spokesperson said.

Last month, European Union officials issued charges against X, owned by tech billionaire Elon Musk, under the Digital Services Act (DSA), which requires very large online platforms to do more to tackle illegal content and risks to public security.

While Britain has not been a member of the EU since 2020, harmful content in breach of DSA rules shared in Britain may have been seen by users in Europe, constituting a potential breach of the law.

Disinformation and calls to violence spread on social media in Britain in recent days, after far-right and anti-Muslim groups seized on the fatal stabbing of three young girls.

"What happens outside of the EU is not covered by the DSA, but what happens in the UK is visible here. If there are examples of hate speech or incitements to violence, they could be taken into account as part of our proceedings against X," a Commission spokesperson told Reuters.

X did not immediately respond to a request for comment.

https://finance.yahoo.com/news/xs-handling-uk-riots-could-153023285.html

Gilead quarterly profit beats Street estimates, revenue up 5%

 Gilead Sciences on Thursday reported second-quarter profit that handily beat Wall Street estimates, driven by lower operating expenses and higher product sales, and the drugmaker raised its outlook for full-year earnings.

The Foster City, California-based company posted a quarterly profit of $2.01 per share excluding items, on revenue of $7 billion, up from $1.34 a share and revenue of $6.6 billion in the year-ago quarter.

Wall Street analysts had expected an adjusted profit of $1.60 per share on revenue of $6.72 billion, according to LSEG data.

It was a "mixed albeit solid quarter unlikely to dramatically change perceptions," RBC Capital Markets analyst Brian Abrahams said in a research note.

He said Gilead's solid tumor oncology franchise continues to face commercial and developmental challenges, but HIV remains steady and the success of long-acting agents has lifted sentiment.

Gilead shares, which rose 2% in regular Nasdaq trading on Thursday, were little changed at $75.60 after hours.

“It was a very strong quarter of commercial execution," CEO Daniel O'Day told Reuters in an interview, citing recent data showing that the company's long-acting injectable drug lenacapavir was more effective in preventing HIV infection in women compared to a daily pill.

He said the company also looks forward to a potential U.S. launch of seladelpar, a liver drug acquired with Gilead's purchase earlier this year of CymaBay, for primary biliary cholangitis. The U.S. Food and Drug Administration is slated to decide on the drug's approval by next Wednesday.

Quarterly sales of HIV drug Biktarvy rose 8% to $3.2 billion, which was in line with analysts' estimates. Sales of its COVID-19 treatment Veklury fell 16% to $214 million, but still came in well above Wall Street expectations of $190 million.

Oncology sales rose 15% to $841 million, while sales of liver disease drugs rose 17% to $832 million.

For full-year 2024, Gilead said it still expects product sales of $27.1 billion to $27.5 billion, but raised its adjusted profit estimate to $3.60 to $3.90 a share from a previous $3.45 to $3.85 a share.

Analysts have projected 2024 earnings per share of $3.75 on revenue of $27.58 billion.

https://finance.yahoo.com/news/gilead-quarterly-profit-beats-street-200538338.html

Detransitioners sue Planned Parenthood for gender malpractice— as our tax dollars fund it

 Planned Parenthood was once considered a “women’s health” organization.

But women are out — now it’s up for debate what a woman even is anymore — and something very different is in.

A nonprofit generally associated with abortion on demand, recently Planned Parenthood has gotten into a different game: Luring people into the idea that they can change their gender.

The number of people, particularly young women, being “treated” at PP for gender dysphoria and given drugs in the mistaken belief a girl can become a boy or vice versa has skyrocketed.

With the increase in numbers has come the inevitable trauma.

disturbing report Thursday in The Free Press identified Cristina Hineman as the first detransitioner to sue Planned Parenthood for medical malpractice.

She had just turned 18 when Planned Parenthood prescribed her a cocktail of hormonal drugs.

Hineman, like many other young women who believe they can become men, has autism, per the report — and “had been battling a cluster of mental health problems: self-harm, depression and anxiety.”

A second woman, identified as Anna in the story, has filed a separate lawsuit against PP after being given hormonal drugs at age 19 without any discussion of the many possible painful side effects. She’s seeking $50,000 in damages.

Cristina Hineman was prescribed hormonal drugs at Planned Parenthood at 18 years old.
Cristina Hineman was prescribed hormonal drugs at Planned Parenthood at 18 years old.Independent Women's Forum

It’s not just young adults: The Free Press cites insurance-claim data indicating that about 12,000 youths under age 17 sought gender-related care at PP clinics between 2017 and 2023.

Meanwhile, ever-more Americans have rightly focused on the distressing trend of children being put on hormones or undergoing surgical procedures in a fruitless attempt to change their gender.

Parents’ rights groups are fighting on behalf of mothers and fathers who’ve been kept in the dark about their own children’s mental health.

Alliance Defending Freedom, for example, has seven active cases representing parents suing school districts that secretly transitioned their children behind their backs.

But unhappy or depressed 18-year-olds, who can’t legally have a drink of alcohol, place a bet in most casinos or rent a car, also shouldn’t be handed life-destroying drugs when they’re having a low moment.

While plenty of parents in Hollywood seem only too happy to parade their gender-confused children around, most of the rest of us understand that what these kids are going through is largely a phase, much like when they wanted to be Batman as a toddler.

A groundbreaking 15-year study from the Netherlands released in April found just this — that feelings of “gender non-contentedness” collapsed with age.

Hineman was battling a "cluster of mental health problems" during her transition, according to the lawsuit.
Hineman was battling a “cluster of mental health problems” during her transition, according to the lawsuit.Independent Women's Forum

Hineman decided to transition at 17, but her parents’ opposition made her wait until she became a legal adult.

A troubled 18-year-old is in no position to make life-altering decisions. This should be obvious.

Detransitioner lawsuits are rising across the country. It turns out that many people feel that they were lied to and coerced into making damaging and irreversible changes to their bodies.

Hineman had her breasts removed after what she described as a “superficial consult” — a troubling example of how the deeply abnormal has been normalized in our health-care system.

How can we simply accept that healthy breasts can be removed without any trauma following? It makes no sense.

But the larger question is this: Why are we taxpayers supporting these procedures?

Planned Parenthood gets $670 million a year in government funding. Its latest annual report touts that 41 PP affiliates provide “gender-affirming hormone therapy.”

Why is taxpayer money going to this bizarre kind of medicine that takes advantage of vulnerable people in a state of distress?

It’s one thing to look away — and quite another to be funding it.

Other countries are facing the reality that gender transition is false, and that pushing this concept is causing more problems than it solves.

On Wednesday, Britain’s National Health Service launched a new program for detransitioners — because so many of them need specialized care after botched attempts to change their birth sex.

The UK, as well as Denmark, Sweden and other countries in Europe, have limited hormone treatments for minors after realizing the harm they have caused.

Yet the United States is still full speed ahead.

Planned Parenthood has always asserted that its federal funding doesn’t directly pay for the abortions its clinics provide.

But money is fungible: By supporting the organization, that $670 million indirectly subsidizes all of PP’s services.

Now the organization is supporting extremely controversial gender procedures with the help of our tax dollars.

Why should we pay for any of it? Defunding Planned Parenthood is an easy call — and politicians should be braver in making it.

Karol Markowicz is the author of the book “Stolen Youth.”

https://nypost.com/2024/08/08/opinion/detransitioners-are-suing-tax-funded-planned-parenthood/

Over Half in US Buy Food Online

 According to Statista's Consumer Insights, more than half of Americans have ordered groceries online for delivery in the past 12 months before the survey was carried out between July 2023 and June 2024. 53 percent said they had ordered items to their house in this way.

Infographic: Every Second American Buys Food Online | Statista


The most popular category of food ordered online for delivery was one fitting this rather lazy method of shopping: snacks and candy at 24 percent.

However, all categories of groceries ordered online for delivery were very close together. The healthier fruits and vegetables category follows close behind at 23 percent, ahead of frozen food and rice & pasta, both at 22 percent. A similar number of Americans had ordered breakfast cereal, meats & sausages as well as dairy and bread.

The survey also showed that Walmart was the most popular store to order groceries from online, followed by Amazon, Costco and Instacart.

https://www.zerohedge.com/personal-finance/every-second-american-buys-food-online

Does Roche have buyer's remorse for Flatiron takeover?

 Roche is reported to be considering the sale of its cancer data specialist Flatiron Health, just a few years after it bought the company for $1.9 billion.

The Financial Times first revealed the rumour, citing people familiar with the matter who suggested that, while Roche had deliberately kept Flatiron as an independent entity, its ownership has been a brake on other drugmakers using its technology platform.

New York City-based Flatiron – which was founded in 2012 with backing from Google's parent firm Alphabet – manages electronic health records for cancer patients at community oncology practices and academic medical centres across the US, and offers the anonymised data as a resource for cancer researchers. According to the FT, two-thirds of its revenues come from selling data to pharma companies.

The firm caught Roche's eye after working with pharma companies and regulators to develop new approaches for how real-world evidence may be used in regulatory decision-making, including the design and validation of novel endpoints for clinical trials. It bought the company amid a major push into the digital health arena around that time alongside other deals, including a clinical data partnership with GE Health and genetic profiling specialist Foundation Medicine.

The Swiss pharma group – which has seen a complete change of top management in the intervening years – is reportedly working with Citigroup to look into various options for Flatiron, which could include the sale of all or part of the business. Neither company has been prepared to comment on the rumour.

When it bought Flatiron in 2018, Roche's former pharma chief executive Daniel O'Day said: "This is an important step in our personalised healthcare strategy for Roche, as we believe that regulatory-grade real-world evidence is a key ingredient to accelerate the development of, and access to, new cancer treatments."

The data company has continued to forge plenty of partnerships in the intervening years, including a wide-ranging alliance with the FDA, which was extended for another five years last year. However, the company's partnership deals since the takeover – at least those announced publicly – have featured a lot more academic and healthcare organisations than pharma companies. Pfizer and Bristol-Myers Squibb feature among its publicised pharma collaborations.

Flatiron has over 2,500 employees across the UK, Germany, Japan, and the US.

https://pharmaphorum.com/news/does-roche-have-buyers-remorse-flatiron-takeover

AI biotechs Exscientia and Recursion agree $688m merger

 In one of the biggest M&A deals involving artificial intelligence-focused drug developers to date, Recursion Pharma has agreed to join with Exscientia in an all-stock transaction valued at $688 million.

Salt Lake City, US-based Recursion will absorb its smaller UK counterpart as a result of the deal, which it said would create a "full-stack technology-enabled small molecule discovery platform" powered by AI and with 10 programmes in clinical testing.

Under the terms of the deal Exscientia shareholders stand to receive 0.7729 Recursion shares for each share they own in the UK firm and – if the deal goes through as planned – will end up owning around 26% of the combined company.

Recursion chief executive Chris Gibson said that combining the two companies' technologies will create a platform that can "meaningfully improve the efficiency of drug discovery in the coming decade" and lead to "the broader availability of high-quality medicines and lower prices for consumers."

In a statement, Recursion said the marriage would combine its "scaled biology exploration and translational capabilities with Exscientia's demonstrated precision chemistry tools and capabilities, including its newly commissioned automated small molecule synthesis platform."

The size of the deal means that, if it is consummated, it will top prior M&A deals involving AI in drug discovery companies. Those include BioNTech's $540 million acquisition of InstaDeep last year, Cadence Designs Systems' $500 million takeover of OpenEye Scientific and Ginkgo Bioworks' purchase of Zymergen for $300 million – both completed in 2022 – and Roivant's $450 million play for Silicon Therapeutics in 2021.

The merger comes after a turbulent period for Oxford-based Exscientia. Last year, the company announced a contraction of its R&D activities to focus on cancer after several years of rapid expansion, and also sacked its founder and CEO, Dr Andrew Hopkins, over what was described as "inappropriate relationships" with two employees.

On the plus side, in between those events, the company secured a $674 million discovery alliance with German group Merck KGaA covering up to three small-molecule projects, with a $20 million upfront payment, and an expansion of an existing alliance with Sanofi that brought in $45 million upfront with up to $300 million in the offing if all goes to plan.

Recursion meanwhile has partnerships in place with Roche/Genentech and Bayer, and the company said that the tally across both companies is worth more than $20 billion, not including royalties on products that may reach the market, with $200 million in milestones possible within the next two years.

The combined pipeline has little overlap – spanning programmes in rare diseases and cancer – and consists of seven clinical-stage candidates from Recursion and three from Exscientia.

The UK firm's lead project is CDK7-targeted GTAEXS617, currently in the phase 1/2 ELUCIDATE trial in advanced solid tumours, while Recursion has four candidates in phase 2 trials including REC-994 for cerebral cavernous malformation, REC-2282 for neurofibromatosis type 2, and REC-4881 for familial adenomatous polyposis.

If the deal proceeds to completion – expected early next year – Gibson will be CEO of the combined company while Exscientia's chief scientific officer (and currently interim CEO) will take on the same role.

https://pharmaphorum.com/news/ai-biotechs-exscientia-and-recursion-agree-688m-merger