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Monday, May 6, 2024

Investors Piled Into Amgen in Search of Next Obesity Drug Payout

 Investors who may have missed out on the blistering rally in Eli Lilly & Co. and Novo Nordisk A/S are once again taking a chance with Amgen Inc.

The shares surged 12% Friday, the biggest one-day jump for Amgen in nearly 15 years, fueled by fresh optimism about the company’s future in the lucrative market for weight-loss drugs after upbeat commentary from the chief executive officer.

Although it could take years for a drug to come to market, investors who are looking for new ways trade into the hype are betting that the Amgen’s anti-obesity entrant, MariTide, could compete against current blockbusters. Wall Street’s enthusiasm for medicines tied to weight loss has supercharged Lilly, which is now the biggest health-care company in the world by market value. Likewise, Novo is the most valuable listed company in Europe and other runners up have also notched healthy gains.

Read more: Here Are the Obesity Drug Hopefuls Vying to Unseat Lilly, Novo

“There’s a clear enthusiasm to get more things on market and try to have something that is differentiated so that even if you are three or four years behind getting to market, you can gain meaningful market share,” said William Blair analyst Matt Phipps, who upgraded his rating on the stock to outperform after the CEO’s comments.

It’s not the first time that investors have ridden the weight-loss wave when it comes to Amgen. Market exuberance in late 2022 sent the stock skyrocketing after early data on the drug’s potential, but the sentiment soon faded. Investors roused again at the beginning of 2024 ahead of another batch of data. But the results raised safety concerns, dampening optimism, and the stock’s climb.

The Thousand Oaks, California-based company’s shares have climbed about 27% in the past three years while Lilly and Novo have both more than trebled. Amgen’s valuation premium sits at a five-year average of about 15 times forward earnings, below Novo’s and well short of Lilly’s 51.

“These pile-ins tend to be short lived,” said Mizuho analyst Salim Syed, who remains neutral on Amgen. “Now is the third time we’re seeing this, and every single time, the stock tends to cool off afterward.”

With detailed data from a mid-stage study not expected until the end of the year, Syed doesn’t see anything that could take the stock even higher.

“The onus is going to be on Amgen to prove that they have a compound that people are willing to ascribe this much value to,” Syed added. “If that data does not pan out, the stock is likely going to go substantially lower.”

Most on Wall Street are more enthusiastic — more than half of the analysts tracked by Bloomberg recommend buying the stock. William Blair’s Phipps sees MariTide as having “multi-blockbuster” potential despite Lilly and Novo’s current dominance, and a cadre of would-be competitors racing to develop newer treatments.

“There is that kind of ability to see real meaningful upside from one product like this and that can give you significant longer term growth and revenue and earnings upside,” Phipps said.

https://finance.yahoo.com/news/investors-pile-amgen-search-next-111503450.html

Integra posts mixed Q1 results as Boston distribution facility faces another setback

 Integra LifeSciences (Nasdaq: IART)

 today announced first-quarter results that beat the revenue consensus on Wall Street and matched earnings estimates.

The Princeton, N.J.-based company reported profit losses of $3.3 million, or -4¢ per share, on sales of $368.9 million for the three quarters ended March 31, 2024. Sales for Q1 were down slightly from the same period in 2023 when it reported $380.8 million. Profits were also down from $24.2 million in Q1 2023.

Adjusted to exclude one-time items, earnings per share were 55¢, in-line with The Street, where analysts were looking for sales of $361.96 million.

“We are pleased with our strong first quarter financial performance, which reflects the strength of our diversified portfolio and the unwavering commitment of our colleagues worldwide to our customers and patients,” President and CEO Jan De Witte said in a news release. “As we look to the rest of the year, we remain focused on executing our key priorities, particularly on enhancing quality, reliability and resilience of our manufacturing operations and supply chain, advancing our new product pipeline, and integrating the Acclarent business and welcoming our new colleagues.”

Integra’s Codman Specialty Surgical segment drove revenues for the quarter, accounting for 70% of revenues. Revenues for the segment were up 3.3% year-over-year. In particular, neurosurgery devices sales were the highest revenue generator, accounting for $202.3 million for the quarter.

For the full-year 2024, the company updated its revenue and adjusted EPS expectations to $1.672 to $1.687 billion and $3.01 to $3.11, respectively.

The revenue range reflects reported growth of 8.4% to 9.4%. Integra Lifesciences also anticipates organic growth of 3.3% to 4.3% to reflect the completion of the Acclarent acquisition and the removal of approximately $10 million of revenue from the SurgiMend and PriMatrix relaunch.

As reported in April, Integra Lifesciences acquired Acclarent from Johnson & Johnson MedTech for $275 million upfront. The deal included an additional $5 million upon achieving regulatory milestones. Acclarent, part of J&J MedTech’s Ethicon unit, enhances Integra’s position in the ear, nose and throat (ENT) treatment market.

Integra also provided an update about the temporary closure of its TEI Biosciences plant in Boston, which makes its SurgiMend, PriMatrix, Revize and TissueMend products. In August last year, an internal investigation found deviations with endotoxin testing. The result was a release of products with higher levels of endotoxins than permitted by the product specifications. Higher levels of endotoxins can induce an immune response, including a postoperative fever.

In today’s earnings release, the company said a third-party audit yielded more findings than anticipated. It is currently evaluating the timeline to address the findings and resume commercial distribution. As a result, Integra removed SurgiMend and PriMatrix from the 2024 guidance.

Shares in IART were down 17.48% to $23.84 apiece in mid-morning trading.

https://www.massdevice.com/integra-lifesciences-posts-mixed-bag-q1-results-as-boston-distribution-facility-faces-another-setback/

'Psychiatrist online prescribed me Prozac, punched the air in celebration, suggested I have a beer. Normal?

 'I processed a $50 copay, and attended my appointment with the psychiatrist. It went fast, and every time I asked a question about antidepressants, he popped a medical study in the chat box'

Dear Quentin,

I recently went through a pretty bad breakup with my boyfriend, who cheated on me. I signed up for a telemedicine service. I looked through a lot of psychiatrists and psychologists online, and those who took insurance and were in-network had a long wait list. Hence, my choosing a Zoom appointment with a psychiatric nurse on a Friday night. She then couldn't make it and rescheduled my appointment with an actual psychiatrist. I didn't mind the change so much, as long as it was not canceled.

I processed a $50 copay, and attended my appointment with the psychiatrist. It went fast, and every time I asked a question about antidepressants, he popped a medical study in the chat box. For every study that says Prozac (fluoxetine) or Celexa (citalopram) does not have a certain side effect, there is another to say that they do. It's confusing. When I told him I thought about taking fluoxetine, he threw his arms in the air in celebration. I wonder if he is getting a commission.

He prescribed the medication, and sent the prescription to my local pharmacy. Now I'm getting regular emails about future appointments with warnings that the price of the sessions could fluctuate. If I were asked to use a word to describe this therapist, it would definitely be "pushy." The way he tells it, SSRIs are the perfect antidote to my anxiety and depression, and have almost no side effects. He knew this after speaking to me for all of 10 minutes.

At the end of our last call, I said I was going out with friends, and he told me, "Have a beer for me!" Now I'm wondering, is it my anxiety that is making me second-guess everything he says? I had addiction issues in my 20s in New York, but they are in the past. Am I being extra sensitive to every little comment? Or was this whole experience too rushed and, frankly, inappropriate? (The cheering when I suggested Prozac and his hoping that I have a beer on him.)

My mental health is fragile, and I'm now being hounded by emails to pay for upcoming sessions.

What do you think?

Depressed & Disillusioned

Dear Depressed & Disillusioned,

Finding a good boyfriend is hard, but finding a good doctor is sometimes even harder. Your first appointment, the telehealth psychiatric nurse, probably had plans herself that Friday night.

Telemedicine gives both the client and the professional flexibility, but it's tricky doing your due diligence on your psychiatrist or psychiatric nurse practitioner if you don't have their name in advance. Throwing his arms in the air when you suggested Prozac does not seem like a normal response. It certainly does not sound like a professional response to prescribing an SSRI. After all, he is prescribing medication and not handing out candy to a child for good behavior.

Taking antidepressants does not appear to deter people from also drinking alcohol, and doctors warn against mixing the booze and pills. Alcohol is a depressant, so drinking can counteract the benefits of taking an SSRI in the first place. The Mayo Clinic gives a litany of reasons why you should avoid doing both: They can worsen any side effects, and make you feel less alert and more sleepy, drowsy and foggy, which could impede your ability to work or even drive.

His attitude to prescribing antidepressants seems very cavalier. You told him you had a preference for a particular medicine - not that you (or he) won the lottery. Antidepressants can also lead to suicidal thoughts, a lower sexual drive, more sleep - the list goes on. The psychiatrist, whether you connected with him online or in person, should have explained the risks to you and made sure you would contact him if your feelings of anxiety and depression got worse.

Federal law strictly prohibits doctors from receiving a commission for prescribing a specific drug. However, pharmaceutical companies may offer other, legal incentives. "Travel and accommodation to conferences are permitted, which allows for pharma companies to create incentives for doctors to be invited to lavish conferences," says the Kaufman Law Group, which is based in Los Angeles. (You can report also your doctor to the state medical board. Read more here.)

Federal law on commissions

Some doctors may have financial incentives: The Physician Payments Sunshine Act, which was part of the Affordable Care Act, requires that pharmaceutical and/or medical-device companies should report any payments made to teaching hospitals and individual physicians, and quantified industry payments made to psychiatrists. Still, that's not always clear to patients; if in doubt, ask. You will hopefully get an honest response, but that's not a guarantee.

At the best of times, it's a gray area. At the worst, it's a pretty complex (or murky) business. "The law allows for pharmaceutical companies to give money to doctors in multiple ways, which means that a doctor might feel pressure or incentive toward prescribing certain drugs or medicines," Kaufman Law Group adds. "And even if there's no overt pressure, these kinds of benefits can prejudice a doctor in a certain direction when it comes to prescribing drugs"

Psychologists usually provide cognitive/talk therapy, but they can only prescribe medication in a handful of states. Psychiatrists can prescribe medication in every state, but the law is more complex for psychiatric nurses, who typically have graduate and/or postgraduate degrees. "Each state has different requirements to prescribe medication from full practice authority to needing a supervising psychiatrist," according to the American Psychiatric Nurses Association.

Some background: Telemedicine services were expanded in the wake of the COVID-19 emergency, which allowed them to prescribe controlled substances (currently until Dec. 31, 2024). The U.S. Drug Enforcement Administration does not consider fluoxetine, citalopram and other SSRIs as at a high risk for misuse or addiction by patients - at least not like opioids, for instance. (But don't try coming off an SSRI overnight and/or without medical supervision.)

The good, bad and unreliable

There are good, bad and unreliable actors in every industry. We expect a certain level of care from mental-health professionals, but trust needs to be earned. In the wake of the pandemic, telehealth was booming and companies faced strict competition to boost profits. Some had to hire practitioners at an inordinately fast pace to meet the demand; in other egregious cases, companies shared sensitive data and made it overly complicated for clients to cancel.

Many telehealth companies have spent millions of dollars on social-media advertisements and, in at least one high-profile case, one such company was the subject of a Drug Enforcement Administration investigation for allegedly overprescribing stimulants and for using misleading advertising practices. In the wake of the pandemic, many of these companies were also using actors masquerading as patients in ads with zero mention of side effects, and worse.

But the industry has also helped millions of Americans. This study published last year, in the peer-reviewed Journal of Affective Disorders, found that both in-person and telehealth patients with major depressive disorder "were highly satisfied with treatment and reported a significant reduction in symptoms from admission to discharge. Both groups also reported a significant improvement in positive mental health, general well-being, coping ability, and functioning."

Don't see a doctor if you don't like him and/or he makes you feel uncomfortable, and don't allow one swaggering cowboy to deter you from seeking out mental-health services from trusted companies and psychiatrists online or in-person. Now that you have a prescription, you could make an in-person appointment first, and have follow-up sessions online. Never take such medications unless you are under medical supervision, and never come off them on your own either.

And today? Your ex-boyfriend has done you a favor. He has made it possible for others to get to know you - and experience all the great qualities you have to offer.

Other resources for people with family members with addiction issues: The Center for Motivation and Change published this book, "Beyond Addiction: How Science and Kindness Help People Change." by Robert Meyers, who has been working in the field for four decades.

https://www.morningstar.com/news/marketwatch/2024050624/i-wonder-if-hes-on-commission-a-psychiatrist-online-prescribed-me-prozac-punched-the-air-in-celebration-and-suggested-i-have-a-beer-is-this-normal

Novavax's top shareholder Shah Capital ramps up efforts for board shakeup

 Hedge fund Shah Capital on Monday urged Novavax shareholders to vote against the re-election of three directors and proposals related to executive compensation, ramping up its efforts for a board shakeup at the COVID-19 vaccine maker.

Shah Capital, which currently owns a near 7.5% stake in Novavax and is its third-largest shareholder, reiterated that the company was "undervalued and continues to suffer from poor profitability."

Novavax last year had raised doubts about its ability to remain in business, hurt by manufacturing snags and regulatory hurdles that delayed the entry of its protein-based vaccine to the market.

Last month, the top shareholder expressed concerns over mismanagement at the Maryland-based biotech and nominated two of its own candidates for the board. It had also urged Novavax to adopt a marketing strategy to target consumers who are hesitant to receive mRNA vaccines.

The hedge fund said in a regulatory filing on Monday that it plans to vote against directors Richard Douglas, Margaret McGlynn and David Mott at Novavax's shareholder meeting in June.

"We believe that fresh perspectives are desperately needed in the boardroom to steer Novavax towards sustainable profitable growth," it said in a statement.

McGlynn and Mott have served on Novavax's board since 2020 and Douglas since 2010.

Novavax said it welcomes the perspectives of its shareholders and values their input.

"We believe we have the right board in place to oversee Novavax's strategy," the company said in its response.

Shares of the biotech fell 1.6% to $4.85 in early trading.

In April, Shah Capital nominated Suresh Katta, founder and CEO of biotech firm Saama, and Venkat Peri, CEO of Quantiva Health, to Novavax's eight-member board, saying the duo had the experience required to set the company's strategic direction.

Shah Capital also plans to vote against three other proposals, including one related to the compensation of some of Novavax's executives. 

https://www.marketscreener.com/quote/stock/NOVAVAX-INC-58256108/news/Novavax-s-top-shareholder-Shah-Capital-ramps-up-efforts-for-board-shakeup-46636474/

Microsoft readies new AI model to compete with Google, OpenAI, The Information reports

  Microsoft is training a new, in-house AI language model large enough to compete with those from Alphabet's Google and OpenAI, the Information reported on Monday.

https://www.marketscreener.com/quote/stock/ALPHABET-INC-24203373/news/Microsoft-readies-new-AI-model-to-compete-with-Google-OpenAI-The-Information-reports-46637763/

Massachusetts top court to hear challenges to gig worker ballot measures

 The top Massachusetts court on Monday is set to consider whether the state's voters will get to decide two ballot proposals in November that would redefine the relationship between app-based companies like Uber Technologies and Lyft and their drivers - one backed by industry and the other by labor.

The Massachusetts Supreme Judicial Court first will hear arguments in a labor-backed challenge to a ballot proposal by an industry-supported group that would ask voters to declare that the drivers for the companies are not employees but rather independent contractors entitled to some new benefits.

The court then will hear a challenge by a conservative think tank to a proposed ballot measure supported by the Service Employees International Union's Local 32BJ that would ask voters to allow Uber and Lyft drivers to unionize.

Using contractors can cost companies as much as 30% less than using employees, according to various studies. A ballot victory for the companies in a state with some of the most employee-friendly laws could embolden them to pursue similar measures in other states, according to labor activists.

Uber and Lyft, along with app-based delivery services Instacart and DoorDash, have spent millions of dollars to support the ballot proposal that would cement the status of their drivers as contractors under state law.

The proposal by Flexibility and Benefits for Massachusetts Drivers, a ballot measure committee whose contributors include the four companies, also would establish an earnings floor equal to 120% of the state's minimum wage for app-based drivers, or $18 an hour in 2023 before tips.

Drivers would receive healthcare stipends, occupational accident insurance and paid sick time under the proposal.

The same court in 2022 blocked a similar industry-backed ballot measure, finding that it contained an unrelated proposal that ran afoul of a state constitutional requirement that ballot questions be limited to related subjects.

To hedge its bets, Flexibility and Benefits for Massachusetts Drivers is gathering signatures for five different versions of the current ballot question, only one of which would be put before voters on Nov. 5.

Uber and Lyft also are preparing to face a May 13 trial in a civil lawsuit filed in 2020 by the state. The state's Democratic attorney general, Andrea Joy Campbell, is asking a judge to conclude that the two companies have been unlawfully classifying their drivers as contractors, not employees.

Should Uber and Lyft lose that trial and fail to win over voters at the ballot box, the companies have said they could be forced to cease operations in Massachusetts due to the economics.

If the industry-backed ballot measure passes but the state wins in the trial, Campbell's office has said the new law would control for the future but that Uber and Lyft could be subject to penalties for the past misclassification of their drivers.

https://www.marketscreener.com/quote/stock/UBER-TECHNOLOGIES-INC-57860975/news/Massachusetts-top-court-to-hear-challenges-to-gig-worker-ballot-measures-46634944/

J&J’s ‘Pretzel’ Drug-Device Combo Scores in Mid-Stage Bladder Cancer Study

 Johnson & Johnson on Friday unveiled updated data from its Phase IIb SunRISe-1 study, which found that its investigational drug-device combination TAR-200 can induce rapid complete response in patients with high-risk non-muscle invasive bladder cancer.

Friday’s readout, which was presented at the American Urological Association’s annual meeting, came from 85 patients with high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ and who are either ineligible for or decline radical cystectomy. Results demonstrated a centrally confirmed complete response rate of 82.8%, as quantified by biopsies or urine cytology.

Almost all incidences of complete response were achieved within 12 weeks of treatment, according to J&J.

SunRISe-1 also had an estimated 1-year duration of response of 74.6%, with 85% of all responders still showing complete treatment response as of the data cutoff on January 2, 2024. None of the responders progressed to muscle-invasive or metastatic disease.

Christopher Cutie, J&J’s vice president and disease area leader for bladder cancer, in a statement called these findings “a significant step” in the pharma’s quest to provide patients with new treatment options focused on “bladder preservation and long-term survival.”

“These results reinforce the potential of TAR-200 to transform the treatment landscape” in NMIBC, Cutie said.

Designed to be easily installed, TAR-200 is an investigational targeted drug releasing system that allows for the controlled dosing of gemcitabine into the bladder. The drug-device system prolongs the exposure of the bladder to the anti-cancer drug. TAR-200’s installation procedure only takes three to five minutes and can be completed in a physician’s office without anesthesia.

In SunRISe-1, J&J is testing TAR-200 as a monotherapy or in combination with the intravenous PD-1 blocker cetrelimab. The trial has so far enrolled 200 patients and is designed to evaluate complete response as its primary endpoint. Key secondary outcomes include duration of response, overall survival and quality of life.

J&J is also running the Phase III SunRISe-3 and SunRISe-5 studies of TAR-200 in NMIBC, as well as SunRISe-2 and SunRISe-4 in muscle-invasive bladder cancer.

Friday’s readout adds another bladder cancer victory for J&J. In January 2024, the pharma won the FDA’s approval for its FGF kinase inhibitor Balversa (erdafitinib) for locally advanced or metastatic urothelial carcinoma.

The regulator also recently approved ImmunityBio’s first-in-class IL-15 superagonist Anktiva (nogapendekin alfa inbakicept-pmln), in combination with Bacillus Calmette-GuĂ©rin, for NMIBC.

https://www.biospace.com/article/j-and-j-s-pretzel-drug-device-combo-scores-in-mid-stage-bladder-cancer-study/