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Friday, January 5, 2024

Axogen Preliminary Unaudited Revenue Tops Views

 Preliminary Unaudited Fourth Quarter and Year-End Performance and Business Highlights

  • Fourth quarter revenue is expected to be approximately $42.7 million, which represents an 18% increase over the fourth-quarter of 2022 driven by solid performance across the product portfolio.
  • Full-year 2023 revenue is expected to be approximately $158.8 million, which represents a 15% increase over the full-year of 2022. This growth is attributed to the effective implementation of sales strategies and the performance of our diverse product portfolio including the launch of Axoguard HA+ Nerve ProtectorTM, mirroring the positive trends observed in our fourth-quarter results.
  • Revenue from Core Accounts for the full-year 2023 is expected to represent approximately 65% of revenue. We ended the fourth quarter with Core Accounts at 375, an increase of 13% over prior year, indicating solid growth and strengthened relationships within this important customer base.
  • At the end of the fourth quarter, our team demonstrated efficient sales growth with 116 direct sales representatives, compared to the 115 representatives recorded as of December 31, 2022.
  • In 2023, we achieved a significant milestone by surpassing 100,000 Avance® Nerve Graft implants since its launch. This achievement reflects the growing trust and preference for Avance in the healthcare community.
  • We continue our commitment to drive innovation by the introduction of Axoguard HA+ Nerve ProtectorTM and the strategic roll-out in Q2 of 2024 of Avive+ Soft Tissue MatrixTM, a resorbable nerve protection product that provides temporary protection and tissue separation during the critical phase of healing for nerve injuries. This application was previously addressed by Avive Soft Tissue membrane. These initiatives reflect our ongoing dedication to advancing our product offerings and enhancing value for our patients and stakeholders.

Pacira Preliminary Unaudited Fourth Quarter and Full-Year 2023 Revenues Above Views

 

  • Fourth quarter EXPAREL net product sales of $143.9 million in 2023, compared with $138.0 million in 2022. Fourth quarter net product sales were comprised of average daily volume growth of 4 percent. Pacira reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. There were 61 selling days in each of the fourth quarters of 2023 and 2022.
  • Fourth quarter ZILRETTA net product sales of $28.7 million in 2023, compared with $28.0 million in 2022.
  • Fourth quarter iovera° net product sales of $6.0 million in 2023, compared with $4.6 million in 2022.
  • Other revenue, including sales of bupivacaine liposome injectable suspension and royalties, was $2.6 million in the fourth quarter of 2023, compared with $1.4 million in the fourth quarter of 2022.

2023 Full-Year Preliminary Unaudited Revenue Highlights

  • Full-year EXPAREL net product sales of $538.1 million in 2023, compared with $536.9 million in 2022. Full-year net product sales were comprised of average daily volume growth of 5 percent, which was offset by a lower net selling price primarily due to the implementation of 340B Drug Pricing in October 2022 and other contracted relationships. There were 250 selling days in 2023 and 252 selling days in 2022.
  • Full-year ZILRETTA net product sales of $111.1 million in 2023, compared with $105.5 million in 2022.
  • Full-year iovera° net product sales of $19.7 million in 2023, compared with $15.3 million in 2022.
  • Other revenue, including sales of bupivacaine liposome injectable suspension and royalties, was $6.1 million in 2023, compared with $9.1 million in 2022.

Merck seeks GLP-1 drugs with benefits beyond weight loss - CEO

 Merck & Co is seeking GLP-1 treatments with benefits beyond weight loss, CEO Robert Davis said on Thursday at a conference.

Newer diabetes and weight-loss drugs of the GLP-1 class like Novo Nordisk's Wegovy and Ozempic and Eli Lilly's Mounjaro and Zepbound are expected to together generate annual sales of over $100 billion by the end of the decade.

Merck's experimental drug efinopegdutide, which belongs to the GLP-1 class and is being developed as a treatment for non-alcoholic steatohepatitis (NASH), also showed a "compelling" weight-loss benefit.

Showing benefits beyond weight loss will potentially make it easier to get reimbursement for the drugs, Davis said.

"I think everyone recognizes weight management is a hard thing to get reimbursed. But if you can show cardiovascular outcome, if you can show diabetes outcome, which you're starting to see data for, if you can see fatty liver disease benefits...that is an area where we think there's opportunity," he said.

GLP-1 drugs, which work by helping control blood sugar levels and triggering a feeling of fullness, are also being studied to see whether they can improve health in other ways.

Data from last year suggested that semaglutide, the active ingredient of Wegovy and Ozempic, may also cut the risk of stroke or heart attack, and may delay the progression of kidney disease in diabetes patients.

https://finance.yahoo.com/news/1-merck-seeks-glp-1-205910540.html

Thursday, January 4, 2024

Inflation Reduction Act re-routes Medicare savings into tax credits for electric vehicles

 The Biden administration took an unprecedented step of rolling its climate agenda into a health care concern with the passage of the Inflation Reduction Act (IRA). According to critics, it makes climate change a priority. In both cases, they say, it’s not accomplishing anything with either goal.

Diverted funds

Medicare provisions within the IRA are siphoning funds into green energy policies, Isabelle Morales, federal affairs manager for Americans For Tax Reform, told Just The News. The IRA, Morales explained, grants the Secretary of Health and Human Services the ability to negotiate the price of prescription drugs on behalf of Medicare.

“The negotiation is basically, if a company doesn’t comply, they’re subject to 90% tax on all of their earnings. So, it’s really not a negotiation,” Morales said.

Writing in the Wall Street Journal, Mark Merritt, president of Proactive Strategies Group, said that only about 15% of the $280 billion in savings from the program goes into Medicare. The bulk of the savings, Merritt explained, are going to support the $7,500 electric-vehicle tax credit.

Morales said the siphoned funds are also supporting the $4,000 used electric-vehicle tax credit, and tax credits for energy efficiency items, such as doors. The tax credits on these vehicles, Merritt said, are items that wealthier Americans purchase. In 2019, half of those enrolled in Medicare earn less than $30,000 per year, whereas the typical Tesla buyer earns around $150,000 per year.

According to Merritt, the savings that go into Medicare pay for some “relatively inexpensive new benefits,” such as a $2,000 annual cap on pharmacy spending. The overall Medicare program's budget is projected to rise from $1 trillion in 2023 to $1.8 trillion in 2031.

Melting glaciers to asthma

Over the past decade, climate activists have pushed to make climate change a health-care issue. In 2013, journalist Courtney Subramanian argued in Time that climate change should be rebranded a health issue, because people could connect with fears of infectious diseases and childhood asthma more than they could melting glaciers.

The rhetoric on climate change since then has spilled over into health issues, even into medical journals. In 2021, as people were dying of COVID-19, 200 medical journals published an opinion piece by a group of medical journal editors that called climate change the “greatest threat to public health.” That same year, Harvard and U.K. universities produced a study claiming that fossil fuels were responsible for 1 in 5 deaths – 8 million people annually.

Energy expert and author Alex Epstein criticized the study for ignoring the strong correlations between fossil fuels use and markers of human improvement, such as increased standard of living, access to clean water, life expectancy, and infant mortality. Since 1980, Epstein wrote on “Energy Talking Points,” India’s fossil fuel use grew 700% and China’s fossil fuel use increased 600%, citing BP Statistical Review of World Energy. Between 1980 and 2020, according to World Bank data, life expectancy in India increased by 16 years, and life expectancy in China increased by 10 years, Epstein wrote.

With the popular merging of concerns about climate change and health issues, the IRA was promoted as a sweeping climate and health care bill. Jeff Reynolds, senior investigative researcher with Restoration of America, told Just The News that the IRA does nothing for health care. “It reminds me a lot of Obamacare. It wasn’t anything they claimed it was going to be,” he said.

Instead of truly lowering drug prices, which are skyrocketing, Reynolds said, the IRA diverts funding into electric vehicles and that the combination of climate change and health issues follows a similar pattern to what was seen during the COVID pandemic, where fears of deadly infections were used by politicians to justify restrictions that were unnecessary and ultimately harmful.

“That’s exactly what they’re doing with climate change,” he said.

Minimal impact

The IRA will grant the Secretary of Health and Human Services in 2026 authority for price controls on 10 separate drugs, and over time, that increases to 20. Morales said that these price controls will ultimately disincentivize drug innovations, as it can take 15 years and billions of dollars to develop a drug and bring it to market.

Citing a 2021 University of Chicago study, Morales said the IRA’s price controls will lower research and development on new drugs and result in 135 fewer drugs entering the market. This will, according to the study, result in a loss of 331.5 million life years in the U.S., which is more than the first two years of the pandemic. For cancer treatments alone, the IRA will reduce research and development spending by $18.1 billion annually.

Critics of the IRA also point out it will have minimal impact on global warming.

Preston Brashers, senior policy analyst for the Heritage Foundation, testified at a House subcommittee hearing in September on the impacts of the IRA a year after its passage. Even if the U.S. eliminated 100% of its greenhouse gas emissions today, by the end of the century, Brashers said, global temperatures would be reduced by no more than 0.2 degrees Celsius. “Of course, the IRA’s green tax credit provisions will come nowhere near eliminating U.S. emissions,” Brashers said.

Writing in the Federalist, Reynolds points out the massive losses automakers are taking on the EVs they sell, as well as all the difficulties drivers face — from depreciation to charging issues — which have slowed the pace of sales of the vehicles in the past few months, will result in a lot of wasted taxpayer dollars.

“The Biden administration is more interested in pet projects, unsustainable green schemes, and ideological revenue redistribution than in the core functions of government — and seniors hoping for relief on drug prices get screwed once again,” he said.

https://justthenews.com/politics-policy/energy/provisions-inflation-reduction-act-send-medicare-savings-tax-credits

A COVID CODA

 As covid recedes into history–we hope–a new study from Washington University sheds some retrospective light. (The link goes to an article in SciTechDaily, apparently by the authors of the study. The full report is here.) The study compared long-term adverse impacts from covid and seasonal flu, and found that covid was in most respects more damaging. However:

The statistical analysis spanned up to 18 months post-infection and included a comparative evaluation of risks of death, hospital admissions, and 94 adverse health outcomes involving the body’s major organ systems.
***
During the overall 18-month study period, patients who had COVID-19 faced a 50% higher risk of death than those with seasonal influenza. This corresponded to about eight more deaths per 100 persons in the COVID-19 group than among those with the flu.

That’s all? It means that of 100 people who had seasonal flu, 16 died in the next year and a half. (With respect to fatalities, we are talking almost exclusively about an elderly and severely ailing population; not reported is how many died in the next year and a half absent either disease.) Whereas, of 100 who had covid, 24 out of 100 died in the ensuing 18 months.

That is a difference, certainly, but a difference worth sacrificing our younger generation for? Worth destroying hundreds of thousands of small businesses and turning our economic and social lives upside down for? No sane person would say so.

Then there is this; the authors enthusiastically endorse vaccination:

“For both COVID-19 and seasonal influenza, vaccinations can help prevent severe disease and reduce the risk of hospitalizations and death. Optimizing vaccination uptake must remain a priority for governments and health systems everywhere. This is especially important for vulnerable populations such as the elderly and people who are immunocompromised.”

However:

Regarding both viruses, patient vaccination status did not affect results.

I don’t know whether the authors of the study tried to reconcile those statements, and if so, how they did it. There is no obvious path to consistency.

https://www.powerlineblog.com/archives/2024/01/a-covid-coda.php

Only Citizens Should Vote In America: Gingrich

 by Newt Gingrich via RealClear Wire,

The next step in radically changing America is now underway. City officials in our national capital plan to allow non-citizens to vote next year.

President Joe Biden let millions of illegal immigrants cross the border. Then he bussed them to Washington DC. The city’s Democratic machine now wants to let them vote – knowing they will almost certainly vote Democrat for all the support and assistance.

This policy is a clear threat to American nationalism.

Three characteristics define a survivable national identity.

There must be a border which defines the nation. There must be a broad sense of history and common culture which enables people to see themselves as belonging to a common community. And there must be meaningful citizenship which gives people a stake in the larger national community (in our case, citizenship allows us to vote).

The American left has been working overtime to erase all three of these characteristics.

The left believes in open borders – and has done everything to make America open to millions of Biden’s illegal immigrants. This has not been the result of incompetence or lack of resources. This is deliberate policy. And, from the left’s standpoint, it is successful.

The left hates American history. It despises the great men and women who sacrificed and worked to make America the most successful, prosperous, and freest country in the world. For three generations, the left has been brainwashing children into an anti-American worldview. The anti-American prejudice now infects most of our newsrooms and many of our larger corporations.

Now that the left has been getting Biden’s illegal immigrants into the country, its members want to start letting illegal immigrants vote. In effect, the non-citizens would offset Americans with whom the left doesn’t agree. They are especially committed to getting new non-citizens to vote. Their dream of a huge American Latino-Democratic majority has been destroyed by the radicalism and real-world failures of Bidenism (Trump is now running ahead of Biden among American Latinos).

A key test case for getting Biden’s illegal immigrants to vote in 2024 will be the City of Washington DC. Our national capital’s left-wing politicians are totally failing to protect residents from runaway crime (there were 959 car-jackings in DC in 2023). The city bureaucracy is driving sports teams out of town. The roads are decaying, and American citizens must visit their own national capital with a sense of concern for their own safety. Now, the DC City Council has decided its next contribution to American decay is to disenfranchise its own residents and allow non-citizens to vote.

Now, the left – as they always do – will shout that being concerned about the votes of U.S. citizens being cancelled out by the votes of non-citizens is (you guessed it) racist. This is a ham-fisted attempt to shout down any discussion of what is an absurd, self-destructive policy that would make the entire concept of American citizenship meaningless.

This is nothing but a fringe political position which is totally rejected by the American people.

In a national survey from February 2021, Americans deeply opposed allowing non-citizens to vote in American elections. Further, they support requiring citizenship verification during voter registration.

In Arizona, 81 percent support allowing only American citizens to vote and requiring citizenship verification to register to vote in federal elections. Only 15 percent oppose. In Maine, 75 percent support a ban on non-citizen voting and only 19 percent oppose. In Montana, the figures are 86 percent support and 11 percent oppose, and in West Virginia, they are 84 percent to 13 percent.

In another national poll by McLaughlin & Associates from May 2021, 61 percent disapproved of “new laws in places such as California and Vermont that allow non-citizens to vote in U.S. elections.” Only 30 percent approved.

Congress should move this month to block the DC politicians’ effort to let non-citizens vote in our national capital. Congress should also pass a law making it illegal for non-citizens to cast ballots in federal elections.

The effort to let non-citizens overrule Americans must be stopped.

https://www.zerohedge.com/political/only-citizens-should-vote-america-gingrich

Character.ai: Young people turning to AI therapist bots

 Harry Potter, Elon Musk, Beyoncé, Super Mario and Vladimir Putin.

These are just some of the millions of artificial intelligence (AI) personas you can talk to on Character.ai - a popular platform where anyone can create chatbots based on fictional or real people.

It uses the same AI tech as the ChatGPT chatbot but, in terms of time spent, is more popular.

And one bot has been more in demand than those above, called Psychologist.

A total of 78 million messages, including 18 million since November, have been shared with the bot since it was created by a user called Blazeman98 just over a year ago.

Character.ai did not say how many individual users that is for the bot, but says 3.5 million people visit the overall site daily.

The bot has been described as "someone who helps with life difficulties".

The San Francisco firm played down its popularity, arguing that users are more interested in role-playing for entertainment. The most popular bots are anime or computer game characters like Raiden Shogun, which has been sent 282 million messages.

However, few of the millions of characters are as popular as Psychologist, and in total there are 475 bots with "therapy", "therapist", "psychiatrist" or "psychologist" in their names which are able to talk in several languages.

Some of them are what you could describe as entertainment or fantasy characters like Hot Therapist. But the most popular are mental health helpers like Therapist which has had 12 million messages, or Are you feeling OK?, which has received 16.5 million.

Psychologist is by far the most popular, with many users sharing glowing reviews on social media site Reddit.

"It's a lifesaver," posted one person.

"It's helped both me and my boyfriend talk about and figure out our emotions," shared another.

The user behind Blazeman98 is 30-year-old Sam Zaia from New Zealand.

"I never intended for it to become popular, never intended it for other people to seek or to use as like a tool," he says.

"Then I started getting a lot of messages from people saying that they had been really positively affected by it and were utilising it as a source of comfort."

The psychology student says he trained the bot using principles from his degree by talking to it and shaping the answers it gives to the most common mental health conditions, like depression and anxiety.

He created it for himself when his friends were busy and he needed, in his words, "someone or something" to talk to, and human therapy was too expensive.

Sam has been so surprised by the success of the bot that he is working on a post-graduate research project about the emerging trend of AI therapy and why it appeals to young people. Character.ai is dominated by users aged 18 to 30.

"So many people who've messaged me say they access it when their thoughts get hard, like at 2am when they can't really talk to any friends or a real therapist,"

Sam also guesses that the text format is one with which young people are most comfortable.

"Talking by text is potentially less daunting than picking up the phone or having a face-to-face conversation," he theorises.

Theresa Plewman is a professional psychotherapist and has tried out Psychologist. She says she is not surprised this type of therapy is popular with younger generations, but questions its effectiveness.

"The bot has a lot to say and quickly makes assumptions, like giving me advice about depression when I said I was feeling sad. That's not how a human would respond," she said

Theresa says the bot fails to gather all the information a human would and is not a competent therapist. But she says its immediate and spontaneous nature might be useful to people who need help.

She says the number of people using the bot is worrying and could point to high levels of mental ill health and a lack of public resources.

Character.ai is an odd place for a therapeutic revolution to take place. A spokeswoman for the company said: "We are happy to see people are finding great support and connection through the characters they, and the community, create, but users should consult certified professionals in the field for legitimate advice and guidance."

The company says chat logs are private to users but that conversations can be read by staff if there is a need to access them, for example, for safeguarding reasons.

Every conversation also starts with a warning in red letters that says: "Remember, everything characters say is made up."

It is a reminder that the underlying technology called a Large Language Model (LLM) is not thinking in the same way a human does. LLMs act like predicted text messages by stringing words together in ways in which they are most likely to appear in other writing on which the AI has been trained.

Other LLM-based AI services offer similar companionship such as Replika, but that site is rated mature because of its sexual nature and, according to data from analytics company Similarweb, is not as popular as Character.ai in terms of time spent and visits.

Earkick and Woebot are AI chatbots designed from the ground up to act as mental health companions, with both firms claiming their research shows the apps are helping people.

Some psychologists warn that AI bots may be giving poor advice to patients, or have ingrained biases against race or gender.

But elsewhere the medical world is starting to tentatively accept them as tools to be used to help cope with high demands on public services.

Last year an AI service called Limbic Access became the first mental health chatbot to secure a UK medical device certification by the government. It is now used in many NHS trusts to classify and triage patients.

https://www.bbc.com/news/technology-67872693