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Wednesday, August 2, 2023

Nevro Q2 Misses

 Company Takes Proactive Steps to Improve Commercial Execution and Maximize Growth Opportunities

Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today reported its second quarter 2023 financial results. The company also provided third quarter guidance and updated its full-year 2023 guidance.

Recent Business Highlights and Guidance

  • Second Quarter 2023 Worldwide Revenue of $108.8 Million Grew 4% As Reported and Constant Currency Compared to Second Quarter 2022

  • Painful Diabetic Neuropathy (PDN) Indication Sales of Approximately $19.0 Million Grew 73% Compared to Second Quarter 2022

  • Second Quarter 2023 U.S. Trial Procedures Increased 4% Compared to Second Quarter 2022, while U.S. PDN Trial Procedures Represented 23% of Total U.S. Trials in the Quarter

  • Second Quarter 2023 Net Loss from Operations of $25.6 Million; Second Quarter 2023 Non-GAAP Adjusted EBITDA Loss of $3.1 Million

  • Greg Siller Named as New Chief Commercial Officer

  • SENZA-PDN Randomized Controlled Trial Data Presented at the American Diabetes Association 83rd Scientific Sessions Demonstrated Positive Correlation Between Use of High-Frequency (10 kHz) Spinal Cord Stimulation and Reductions in HbA1c (A1C) and Body Weight in Subgroup of Patients with Type 2 Diabetes at 24 Months

  • Two Significant Payer Coverage Wins: Florida Blue, the Largest Commercial Payer in Florida Representing 4.6 Million Covered Lives, Updated Their Medical Policy to Include Coverage for Painful Diabetic Neuropathy, Effective June 15, 2023; and Medicare Administrative Contractors Novitas and First Coast Service Options (FCSO) now cover PDN and Non-Surgical Back Pain following the Medicare National Coverage Determination, Effective July 13, 2023

  • Provides Third Quarter 2023 Revenue Guidance of $95 Million to $97 Million; Updates Full-Year 2023 Revenue Guidance to $410 Million to $415 Million, or 1% to 2% Constant Currency Growth Over 2022

  • Provides Third Quarter 2023 Non-GAAP Adjusted EBITDA Guidance of Negative $8 Million to Negative $10 Million; Updates Full-Year 2023 Non-GAAP Adjusted EBITDA Guidance to Negative $25 Million to Negative $28 Million

FSD to Launch UNBUZZD, a Revolutionary Rapid Alcohol Detoxification Drink

Launch in the Consumer Market to be Led by Former Executives from Coca-Cola and Celsius Holdings

FSD Pharma Inc. (NASDAQ:HUGE)(CSE:HUGE)(FRA:0K9A) ("FSD Pharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders, is pleased to announce that it has executed a definitive agreement, signed July 31, 2023, with Celly Nutrition Inc. to grant exclusive rights to recreational applications for FSD Pharma's alcohol misuse technology and launch UNBUZZD, a revolutionary rapid alcohol detoxification drink.

UNBUZZD is created by scientists and expert clinical research team at FSD Pharma. According to Grand View Research, Inc., the global hangover cure products market size is expected to reach $6.18 billion by 2030, representing a CAGR of 14.8% from 2021 to 2028 (as per Report Scope by Grand View Research's Market Analysis 2017-2030 on Hangover Cure Products).

https://finance.yahoo.com/news/fsd-pharma-signs-definitive-agreement-113000280.html

Advanced Health Intelligence to re-enter China

 

  • AHI executes a binding exclusive, perpetual license with Shanghai-based Changlin Network Technology Ltd.

  • Changlin is backed by founders with 50 years of global health insurance sector experience.

  • The license agreement includes an upfront payment of USD$10 million to AHI.

  • AHI will receive an annual license fee of USD$5m.

  • AHI will receive 25% revenue share of gross sales.

  • Changlin targeting Initial Public Offering in 2024 (IPO).

  • Changlin will issue an initial 50% holding to AHI. which is expected to reconstruct to 25% but not less than 20% of its common shares to AHI at the IPO.

SMART Prices Act Deserves a Failing Grade

Sen. Amy Klobuchar of Minnesota recently introduced legislation called the SMART Prices Act, short for Strengthening Medicare and Reducing Taxpayer Prices.

Unfortunately, her cleverly named proposal isn't "smart" at all. In fact, by accelerating and expanding the drug pricing provisions in last year's Inflation Reduction Act,  the legislation would usher in a medical Dark Age for patients.

What lawmakers in favor of the bill fail to grasp is that any short-term benefits of capping prices for existing medicines are quickly swamped by the rapid decline in new drug development that ensues. A lifesaving new drug -- no matter the price -- is always better than no drug at all.

According to a new study by health research firm Vital Transformation, if the bill is passed, the Food and Drug Administration would approve about 230 fewer new treatments than it normally does over a decade, with the impacts heavily felt in rare disease, neurology, and cancer treatment.

Common sense implies that government price setting has a chilling effect on pharmaceutical research. Drug development is expensive and risky. Each new FDA-approved medicine requires an average investment of more than $2 billion, and the process can take more than 10 years.

The prospect of price controls at the end of that lengthy process sends a message to drug companies that they won't be able to generate sufficient revenues to justify such a large, uncertain investment. That will often leave them little choice but to cut back on research. Lawmakers often criticize the price of successful FDA-approved drugs, but they fail to understand that these "winners" have to fund the roughly 90% of drug candidates that never reach the market.

The Inflation Reduction Act -- which doesn't go nearly as far as the SMART Prices Act would go to set drug prices -- has already started to impact the industry. Novartis recently announced it is curtailing research efforts on promising new cancer medicines because of the act's price-setting provisions. Eli Lilly also cited the act when it scrapped plans to work on a new blood cancer drug. And Alnylam Pharmaceuticals paused a clinical trial for its drug candidate vutrisiran, which is designed to treat a rare eye disorder. Many other pharmaceutical companies have made similar announcements.

My own research suggests how this will play out over time. A colleague and I modeled a price control scheme very similar to the one in the Inflation Reduction Act. We calculated that research and development spending would likely decline by 18% through 2039, resulting in 135 fewer new drug approvals -- and more than 330 million life-years lost.

In another paper, I found that the Inflation Reduction Act could result in cuts to cancer research that are nine times greater than the amount by which President Joe Biden seeks to increase cancer research under his Moonshot initiative.

The SMART Prices bill would cause even more damage to patient health.

The Inflation Reduction Act guarantees that new medicines will not be subject to price controls for at least nine years following FDA approval, and limits the number of drugs that can be targeted each year. But the proposed bill would reduce the exemption period to just five years, with no limits on how many drugs can be subject to price controls.

The SMART Prices legislation would cause around 223,000 job losses in the biopharmaceutical industry and up to 1.1 million across the economy. Many highly-skilled workers would be forced to leave lifesaving industries, and patient health would surely suffer. In addition, many labs would close nationwide, drastically weakening our ability to deal with another public health emergency.

These dire projections apparently haven't given progressive lawmakers any pause. Democratic House members recently introduced a companion to the SMART Prices Act, known as the Lowering Drug Costs for American Families Act. The bill would go even further than the SMART Prices Act by extending innovation-killing price controls to private health insurance plans. This could jeopardize access for almost 200 million Americans while forcing biopharmaceutical firms to make even steeper cuts to R&D.

In the end, the result of these misguided bills would be to increase healthcare spending overall. Innovative new drugs help patients avoid surgeries, long hospital stays, and complications. With that pipeline slowed down, more patients would need expensive and lengthy medical interventions.

Lest we need further evidence, we can look abroad to gauge the impact of price controls on drugs. When price controls gained popularity across Europe, patient access to new medicines plummeted. Today, American patients have access to 87% of all new medicines, whereas patients in Japan, Canada, and France can access just under half.

The lawmakers pushing the SMART Prices Act and the new House bill may believe they're helping patients get a better deal. A closer look suggests serious negative side effects that will harm those same patients. For the American people, passing the SMART Prices Act or similar legislation is not the smart choice.

Tomas Philipson, an economist at the University of Chicago, was a member of the White House Council of Economic Advisers, 2017-20, and its acting chairman, 2019-20.

https://www.realclearhealth.com/blog/2023/07/31/the_smart_prices_act_deserves_a_failing_grade_969722.html

Suspect source WaPo: 'Marijuana addiction is real'

Courtney took her first marijuana puffs at 17. Two decades later, she was raising a toddler son and hiding her dependence from most family members. She would light her pipe more than a dozen times a day, sneaking to the garage of her Missouri home while her son napped.
She still loves the earthy smell. But weed long ago stopped making her giggly. It was not unusual for the 37-year-old to lose her train of thought mid-conversation or zone out while playing with her son. Many times, Courtney said, she tried to quit, flushing her stash and dumping her pipe to no avail, except for the nine months she was pregnant. Courtney felt she was addicted.
“It’s been frustrating because you’re not taken seriously,” Courtney said. “People say it’s not as severe as meth, or alcohol, that it’s not that bad. They think it’s not an addiction.”
At a time when marijuana has been legalized for recreational and medicinal use in more than 20 states — and the potency of the drug has been increased — many experts believe that most people can use it without significant negative consequences, not unlike enjoying occasional alcoholic drinks. But for users like Courtney, the struggles to quit are real and complicated by the powerful cultural perception that marijuana is natural and therapeutic, not a substance that can be addicting.
Courtney’s story reflects broader tensions about marijuana’s health consequences.
For decades, weed’s deleterious health effects were exaggerated, experts said, leading to excessive criminalization. But as legal recreational sales have expanded — Maryland in July became the latest state to permit sale of marijuana products for recreational use — the suggestion that marijuana is addictive has often met with derision, especially because science isn’t always clear on the benefits and harms. There can be reluctance to seek treatment. And other substances stir deeper fears and greater attention: Opioids are driving an overdose crisis killing more than 100,000 people each year in the United States.
“Because there are so many mixed messages in our society about cannabis, I think it’s very easy for people to minimize and rationalize problematic use of cannabis,” said Aaron Norton, a Florida mental health counselor who supports legalization of recreational and medical marijuana but believes it should be more tightly regulated.
Courtney and other marijuana users interviewed by The Washington Post spoke on the condition that only their first name or initials be used because they fear being stigmatized or because relatives or employers are not aware of their use.
Twenty-three states and D.C. have legalized recreational marijuana, and all of those states except for Virginia and Minnesota have recreational sales up and running. Medical use is lawful in 38 states.
The number of regular users has increased. According to a 2019 federal government survey, an estimated 31.6 million people age 12 or older used marijuana within the past month, up from 22.2 million five years earlier. The estimate rose to 36.4 million in 2021, although the numbers are not directly comparable because researchers changed how they collect data.
Medical experts and even many proponents of legalized marijuana acknowledge it can be addictive — akin to alcohol or some prescription drugs. Estimates vary on the prevalence of what is known as cannabis use disorder. One study from researchers at Columbia University and the National Institute on Alcohol Abuse and Alcoholism found that nearly 3 in 10 users in 2012-2013 experienced cannabis use disorder.
“The majority of people who use cannabis products in general can handle it,” said Adrianne Trogden, a Louisiana addiction counselor. “But there are still people who cannot — and they need help.”
Darren Weiss, president of Verano, a cannabis company operating in 14 states, agreed that public health and industry officials should not dismiss the potential for cannabis to be abused, but maintained that concerns are often overwrought.
“Addiction is a fact of life,” Weiss said. “There are folks who are addicted to caffeine, to sex, to all sorts of different things.”
The rise in marijuana use among teens has been highly publicized, along with concerns about the effects of more potent products on the developing adolescent brain. In May, the National Institute on Drug Abuse published a study asserting that young men with cannabis-use disorder have an increased risk of developing schizophrenia, although critics have pointed to other studies that cast doubt on the extent of the role marijuana plays in psychotic episodes.
Further fueling concerns among some experts: In the 1990s, THC, the psychoactive compound responsible for inducing a high, constituted about 5 percent of a typical joint or smoke from a bong or pipe, according to the Drug Enforcement Administration. Today, the THC content in smokable marijuana in recreational products can range between 15 and 21 percent, while products popular with young people such as edibles and oils can contain well over 50 percent.
Higher THC levels could increase the risk the brain will get conditioned to want more of the high-potency marijuana, said Nora Volkow, NIDA’s director. Last year, a study published in the journal Lancet Psychiatry found that higher potency THC was associated with an increased risk of cannabis use disorder.
Weiss questioned claims that higher potency marijuana is more likely to cause addiction. Still, he acknowledged that companies market to cannabis enthusiasts who will pay more for higher-potency products — because of the economics of the industry.
If marijuana could be sold by pharmacy chains or liquor stores, Weiss said there would be more incentive to sell lower-potency products marketed at casual consumers. More sales of lower-octane marijuana to a broader customer base would equal higher revenue, he said.
“There are a lot of people who demonize industry and think we are pushing high potency, similar to what the tobacco industry did, as a way of hooking consumers … and it couldn’t be further from the truth,” Weiss said.
The Substance Abuse and Mental Health Services Administration estimates at least 16.3 million people in the United States had a cannabis-use disorder in 2021, putting it behind only alcohol. The agency’s yearly estimates rose in 2020 after it incorporated broadened American Psychiatric Association criteria on diagnosing substance use disorders.
Most cannabis-use disorder cases were characterized as mild, which means patients experience just two or three of 11 benchmark symptoms, such as increased tolerance, intense cravings or repeated attempts to stop marijuana use. An estimated 26 percent of cases are considered moderate, while 16 percent are severe, according to SAMHSA’s National Survey on Drug Use and Health.
“It’s the second-most common addiction Americans are struggling with, but nobody hears about it,” said James H. Berry, a psychiatrist and addiction expert at West Virginia University.
Still, experts caution that mild cases of cannabis-use disorder may not fit under what the public generally considers “addiction.” The effect on users’ lives may be less severe — perhaps marijuana smoking has merely caused friction with a spouse. For those patients, interventions are typically geared toward minimizing the drug’s harm, said Trogden, the Louisiana counselor: “Maybe some counseling sessions, [introducing] some coping strategies, or education on how to use responsibly,” she said.
For people who consume medical marijuana, the risk of being misdiagnosed with a use disorder is a real threat, said Tammy Chung, an addiction researcher at Rutgers University. They can meet criteria for a use disorder, such as developing withdrawal symptoms and a higher tolerance for THC, despite being under the supervision of a medical provider.
“The threshold for cannabis-use disorder is relatively low,” said Chung, who has recommended revamping how the disorder is diagnosed.
E.H., a 44-year-old San Francisco-area schoolteacher, was never formally diagnosed with cannabis use disorder but had a medical marijuana card for years. He believes his decades of smoking marijuana day and night affected his life in profound ways. His habit was costing up to $300 a week, and he obsessed about needing to stay high. E.H. stopped using marijuana for a few years — until California legalized recreational marijuana in 2016. He waited in line at a dispensary for hours to buy a celebratory joint, then quickly spiraled back into daily use.
Today, he said he has been sober for nearly a year after joining Marijuana Anonymous. But he’s sheepish about telling people about his struggle lest they chide him for betraying the California counterculture cool of his youth.
“It feels like if you don’t smoke marijuana, you’re one of the sellouts,” E.H. said.
It’s not unusual for people to turn to recreational marijuana products, believing they treat assorted ailments — and doing so without a doctor’s guidance. Smita Das, an addiction psychiatrist at Stanford University, said she encounters patients who use marijuana to treat anxiety.
“But what we know is that actually [the marijuana] is probably worsening their anxiety over time,” Das said.
People with more serious addiction issues confront challenges in seeking care, including a lack of affordable treatment and few beds in rehabilitation centers, said Eric A. Voth, a retired addiction specialist and member of the International Academy on the Science and Impact of Cannabis, an organization of doctors that educates about the potential harms of marijuana.
Voth said that while criminal courts often mandate treatment, for others living on the streets, “there’s really no one pressing you to get into treatment.”
He recalled a 24-year-old man in Colorado living under a bridge and dealing with psychiatric problems exacerbated by marijuana. He was finally accepted into a rehabilitation program that specializes in the intersection of addiction and mental health disorders and improved, but later relapsed on cannabis and then fentanyl.
The man’s mother said early recovery was complicated by doctors dismissive of THC playing a role in her son’s mental health crises.
“He gets mixed messages in the recovery world and in society, he sure does, too,” said the mother, who spoke on the condition of anonymity to protect her son’s privacy. “Young people are being told it’s totally safe.”
Ben Cort, who leads the Colorado center where the man was treated, acknowledged that activists sounding alarms about the health consequences of cannabis have a credibility problem following a history of racially disparate enforcement of drug laws and exaggerated claims about marijuana’s harmful effects.
“‘Reefer Madness’ comes out, then the stiff penalties and everybody’s like, ‘It’s weed. What’s the big deal?’” Cort said. “You went from this huge overstatement of risk to this dramatic understatement of risk.”
Unlike with opioidsalcohol and even tobacco use disorders, no medication exists to treat marijuana addiction — although that could soon change. On June 8, French biopharmaceutical company Aelis Farma announced promising research on a drug that blocks harmful signals sent by THC to key receptors in the brain, without disrupting those receptors enough to cause harmful psychiatric effects.
Volunteers taking the drug reported marijuana had less of an effect, without experiencing withdrawal, said Meg Haney, director of the Cannabis Research Laboratory at Columbia University Irving Medical Center, who ran the NIDA-funded study. She said the drug could one day help compulsive users. “There’s evidence to show if you can go from being a daily smoker down to two, three, even four days a week, you already show important changes in your quality of life,” Haney said.
For now, treatment revolves around behavioral therapy. The Veterans Health Administration offers patients gift cards for canteen services if they forgo marijuana, a treatment known as contingency management. Health records show the rate of veterans under age 35 diagnosed with the disorder more than doubled between 2005 and 2019.
M.B., a 24-year-old from Southern California, credits her recovery to Marijuana Anonymous, modeled after 12-step programs such as Alcoholics Anonymous. Even within those groups, M.B. said, people with marijuana addictions aren’t always taken seriously.
“The problems that come up with cannabis-use disorder are very real. This was not always something that was talked about,” she said. “We were sort of laughed out of 12-step spaces.”
She smoked daily throughout her teen years before she was diagnosed with cannabis-use disorder when she was about 20. At rock bottom, M.B. said, she smoked or used a vape pen roughly every hour, often waking up at night to take hits. M.B. said she believes her habit led to at least one psychotic episode and to the draining of her finances, even as she lived at home with her parents. She spent so much buying weed that she stole money from family to pay bills.
M.B. joined the program online in 2020 during the height of the pandemic, although the withdrawals weren’t easy. For about a week, she couldn’t keep down food, suffered intense headaches and felt so uncomfortable that she showered constantly.
“I was really angry, crying all the time,” M.B. said. “I had really intense dreams that I was smoking.”
For Courtney, the young mother from Missouri, quitting wasn’t made easier after the state in fall 2022 became the 21st to legalize recreational marijuana. Missouri’s nascent weed industry has boomed — combined sales of recreational and medical marijuana could top $1 billion this year.
“You smell it in the air when you’re sitting at a stoplight,” Courtney said.
She tried Marijuana Anonymous meetings online, but it wasn’t the right fit. She considered an outpatient treatment center, but the nearest was 45 minutes away — too far to drive while raising a toddler.
Instead, her group therapy came in the form of a Reddit forum dedicated to supporting people who want to stop consuming marijuana products. The forum is dotted with stories on the effects of withdrawal, including panic attacks, insomnia and bouts of crying, but also triumphs: long anxiety-relieving walks, regular yoga, improved family time.
A few days after detailing her struggles to a reporter, Courtney reflected on the future. Did she want her son growing up to see her smoking marijuana so often? So she smashed her glass pipe and flushed her remaining weed.
The cravings weren’t as bad as she feared. But she has suffered irritability, headaches, a loss of appetite, night sweats and vivid dreams. “I still feel like the worst is ahead of me,” Courtney said after five days without using.
She and her husband earlier bought tickets to attend a three-day music festival, where the smell of marijuana wafting in the air would be a certainty. They decided to forge ahead with a plan: If she felt uncomfortable, they would leave.
The last night of the festival, Courtney relapsed with a smoke. But since then, Courtney says, she has been clean for two months.
“I’m doing really well,” she said. “I feel clearheaded and more present.”

US Plans $103 Billion Debt Sale, as Issuance to Keep Rising

The US Treasury boosted the size of its quarterly sale of longer-term debt for the first time in over 2 1/2 years, testing dealers’ appetites amid an increase in government borrowing needs so alarming it spurred Fitch Ratings to cut the US sovereign rating from AAA.

The Treasury said it will sell $103 billion of longer-term securities at its so-called quarterly refunding auctions next week, which span 3-, 10- and 30-year Treasuries. That’s up from a $96 billion total last time, and slightly larger than most dealers had expected.

The bump in issuance showcases the rising borrowing needs that contributed to Tuesday’s decision by Fitch Ratings to lower the sovereign US credit rating by one level, to AA+. Fitch said it expects US finances to deteriorate over the next three years. That’s from an already enlarged position — the Treasury is penciling in some $1 trillion worth of issuance in all this quarter.

Ahead of the announcement, dealers had also laid out expectations for stepped-up issuance of other securities, and for the boosts in sales to stretch into 2024, which the Treasury confirmed on Wednesday.

“While these changes will make substantial progress towards aligning auction sizes with intermediate- to long-term borrowing needs, further gradual increases will likely be necessary in future quarters” the department said in a statement.

Part of that deterioration is thanks to higher interest the Treasury now pays on its debt. The Treasury has also said its tax receipts have been weaker than expected. And in the meantime, the Federal Reserve’s continuing runoff of its holdings of Treasuries, of up to $60 billion a month, requires the government to sell more to the public.

The scale of future increases of longer-term debt issuance will depend on the fiscal picture and on how long the Fed keeps shrinking its bond portfolio, the Treasury said Wednesday.

US debt managers also detailed plans over coming months to lift sales of nominal Treasuries of all other maturities, in differing amounts depending on the security.

Part of the rationale for boosting sales of coupon-bearing debt — as notes that pay interest are known — is to ensure that the share of debt made up by bills, which mature in short-term spans of up to a year, doesn’t exceed the recommended range.

The Treasury said on Monday it’s targeting an increase in its cash balance to $750 billion at year-end. According to Barclays Plc strategist Joseph Abate, that would cause T-bills to exceed the 20% ceiling of overall debt suggested by the Treasury Borrowing Advisory Committee, a panel of bond-market participants.

Bill Sales

Indeed, the Treasury said Wednesday that it “anticipates further moderate increases in Treasury bill auction sizes in the coming days” as it keeps rebuilding its cash pile.

In a statement released Wednesday, the TBAC indicated that exceeding the recommended share of bills for a time wouldn’t pose a problem.

“The committee expressed comfort with the possibility that the Treasury bill share as percentage of total marketable debt outstanding might temporarily rise above their recommended range, given robust demand for bills,” the panel said.

Issuance plans for Treasury Inflation-Protected Securities, or TIPS, were held steady except for the 5-year maturity, where October’s new-issue auction will go up by $1 billion. Floating-rate note auction sizes were increased by $2 billion.

As for next week’s refunding auctions, they break down as follows:

  • $42 billion of 3-year notes on Aug. 8, compared with $40 billion at the May refunding and at the last auction in July

  • $38 billion of 10-year notes on Aug. 9, compared with $35 billion last quarter

  • $23 billion of 30-year bonds on Aug. 10, versus $21 billion in May

  • The refunding will raise about $19 billion in new cash

The Treasury also detailed increases to nominal debt of other maturities over coming months as follows:

  • Sales of 2- and 5-year note auctions will each be hoisted by $3 billion per month over the next three months

  • Issuance of 3-year notes will rise by $2 billion a month

  • Increases for 7-year notes by $1 billion per month over the next three months

  • Lifts to both the new and reopened 20-year bond auction sizes by $1 billion, starting in August

  • Increases both the new and reopened 10-year note auction sizes by $3 billion, starting in August

  • Boosts both the new and reopened 30-year bond auction sizes by $2 billion, starting in August

Separately, after announcing in May that it would launch a buyback program in the calendar year 2024, the Treasury said “significant progress” has been made in designing it, with further public updates pending in future quarterly refunding announcements.

The buybacks have a two-fold aim, one being to bolster liquidity in some pockets of the market and the other to help smooth the volatility of bill issuance as it manages its cash balance.

https://finance.yahoo.com/news/us-plans-103-billion-debt-123000519.html