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Sunday, August 1, 2021

SPAC AfterNext HealthTech Acquisition lowers deal size by 17% ahead of $250 million IPO

 AfterNext HealthTech Acquisition, a blank check company formed by TPG targeting healthcare technology, lowered the proposed deal size for its upcoming IPO on Friday.


The Fort Worth, TX-based company now plans to raise $250 million by offering 25 million units at $10. The company had previously filed to offer 30 million units at the same price. Each unit consists of one share of common stock and one-third of a warrant, exercisable at $11.50. At the revised deal size, AfterNext HealthTech Acquisition will raise -17% less in proceeds than previously anticipated.

AfterNext HealthTech Acquisition is led by CEO and Chairman Halsey Wise, the former CEO of MedAssets and Integraph; President and Director Anthony Colaluca, the former CFO of MedAssets and Integraph; and CFO Martin Davidson, a Partner and CAO of TPG Capital. The company aims to leverage management's experience to target businesses that lie at the intersection of healthcare and technology.

AfterNext HealthTech Acquisition was founded in 2021 and plans to list on the NYSE under the symbol AFTR.U. Goldman Sachs, Deutsche Bank, and BofA Securities are the joint bookrunners on the deal.

Heart disease biotech Tenaya Therapeutics prices upsized IPO at $15 midpoint

 Tenaya Therapeutics, a preclinical biotech developing multiple therapies to treat heart disease, raised $180 million by offering 12 million shares at $15, within the range of $14 to $16. The company offered 2 million more shares than anticipated.


The company's multi-modality drug discovery platform targets both genetic and non-genetic forms of heart disease, and consists of a gene therapy program using AAVs, a cellular regeneration program which also uses viral vectors to deliver gene combinations to regenerate cardiomyocytes in the heart, and a precision medicine program using human induced pluripotent stem cell-derived cardiomyocytes. The company plans to submit INDs for its gene therapy and precision medicine platforms in 2022.

Tenaya Therapeutics plans to list on the Nasdaq under the symbol TNYA. Morgan Stanley, Cowen, and Piper Sandler acted as joint bookrunners on the deal.

Biopharma royalty firm Healthcare Royalty sets terms for $750 million IPO

 Healthcare Royalty, which buys royalty interests in marketed and late-stage biopharmaceuticals, announced terms for its IPO on Thursday.


The Stamford, CT-based company plans to raise $750 million by offering 46.9 million shares (33% secondary) at a price range of $15 to $17. At the midpoint of the proposed range, Healthcare Royalty would command a fully diluted market value of $3.4 billion.

Healthcare Royalty claims it is the leading mid-market royalty acquisition company by number of transactions and aggregate value of capital deployed since 2016. The company's portfolio contains 35 products across 12 therapeutic categories, including Shingrix, Krystexxa, and Xpovio. From its 2006 inception through June 30, 2021, Healthcare Royalty has deployed approximately $4.7 billion across 76 royalty-related transactions involving 79 products.

Healthcare Royalty was founded in 2006 and booked $263 million in revenue for the 12 months ended March 31, 2021. It plans to list on the NYSE under the symbol HCRX. Goldman Sachs, Citi, Credit Suisse, Jefferies, Cowen, SVB Leerink, Truist Securities, BMO Capital Markets, Stifel, and Raymond James are the joint bookrunners on the deal. It is expected to price during the week of August 2, 2021.

WCG Clinical sets terms for $720 million IPO

 WCG Clinical, which provides ethical review services and other clinical trial solutions to biopharmas and CROs, announced terms for its IPO on Tuesday.


The Princeton, NJ-based company plans to raise $720 million by offering 45 million shares at a price range of $15 to $17. At the midpoint of the proposed range, WCG Clinical would command a fully diluted market value of $6.1 billion.

WCG believes that it is a leading provider of clinical trial solutions, which enable biopharmaceutical companies, contract research organizations (CROs), and institutions to accelerate the delivery of new treatments and therapies to patients. The company's proprietary suite of technology-enabled solutions provides ethical review services as well as broader clinical trial solutions including study planning and optimization, patient engagement, and scientific and regulatory review services. Since its founding, its end-to-end solutions have benefitted over 5,000 biopharmaceutical companies and CROs, and 10,000 research sites.

WCG Clinical was founded in 1968 and booked $498 million in revenue for the 12 months ended March 31, 2021. It plans to list on the Nasdaq under the symbol WCGC. Goldman Sachs, Morgan Stanley, BofA Securities, Barclays, Jefferies, William Blair, and BMO Capital Markets are the joint bookrunners on the deal. It is expected to price during the week of August 2, 2021.

Nutraceutical maker The Better Being Co. sets terms for $200 million IPO

 The Better Being Co., which sells vitamins and supplements under the Solaray, KAL, and other brands, announced terms for its IPO on Monday.


The Salt Lake City, UT-based company plans to raise $200 million by offering 12.5 million shares at a price range of $15 to $17. At the midpoint of the proposed range, The Better Being Co. would command a market value of $843 million.

Close comp The Bountiful Company (BTFL), maker of Nature's Bounty products, filed for a US IPO in April 2021 before announcing its core brands would be acquired by Nestle for $5.75 billion (16.8x trailing EBITDA).

The vertically integrated company manufactures and sells nutritional vitamins and supplements, beauty products, and other natural products under numerous brands, including Solaray, KAL, Zhou Nutrition, Nu U, Heritage Store, Zand, and Life Flo. 

The Better Being Co. was founded in 1993 and booked $344 million in sales for the 12 months ended March 31, 2021. It plans to list on the NYSE under the symbol BBCO. Goldman Sachs, Credit Suisse, Jefferies, Deutsche Bank, Piper Sandler, and Guggenheim Securities are the joint bookrunners on the deal. It is expected to price during the week of August 2, 2021.

Overdose data, often scattered and siloed, challenge researchers racing to predict risk

 As fatal overdoses once again rise — accounting for 92,183 deaths in 2020, a 30% increase from the year before — public health researchers are racing to develop better tools to prevent them.

Some see promise in models that pull in data and spit out predictions about who is at highest risk of developing opioid use disorder or overdosing, giving health officials and physicians an idea of where to target strained prevention resources. But experts say that a scattered and siloed system to collect data on overdoses and outcomes is hamstringing efforts to further develop and deploy those models.

“These are public health datasets which were never designed for research,” said Scott Weiner, an emergency medicine physician at Brigham and Women’s Hospital in Boston and the director of the hospital’s Comprehensive Opioid Approach and Education Program. “It really is in many cases, an issue of garbage in, garbage out.”

Predictive disease models are designed to warn patients of their health risks, project disease progression, and help insurers predict costs. But turning data on opioid prescribing, substance use disorder diagnoses, and overdoses into useful models presents a unique set of challenges.

“Cancer models have the advantage that the tumor is like a law of nature. It’s like the airflow over an airplane wing or gravity,” said Benjamin Linas, an associate professor of epidemiology at Boston University School of Public Health. A tumor can be biopsied, the cells grown in a lab, and models produced from the measurable development of those cells. “There’s no analogy for opioid use disorder,” Linas said, “which doesn’t exist outside of the context of society.”

By that, he means that the many complexities of the health care system — and in particular, the treatment of opioid use disorder and the stigma still surrounding the condition — shape what data can be collected and how it can be shared. To protect patient privacy, for example, federal regulations stipulate that certain substance use disorder treatment records be kept separate from a patient’s other health care records.

“Because there’s so much stigma … we need a lot of protection around the privacy of people who have substance use disorders,” he said. “But then the other consequence of that is it hides the problem; it makes it impossible to study.”

Opioid prescriptions can provide some data, but the use of illicit drugs is far harder to track. And medical records on overdoses sometimes don’t specify the drugs involved, which would be valuable for modelers. Different hospitals also use different electronic health record systems that can’t always talk to one another, which can make collecting data on a single patient across more than one system exceedingly difficult.

“If you’re at my hospital and you have an overdose, I mean, you go across the street to [another] hospital, you have an overdose. I don’t know that unless I really specifically dig into and access their records,” Weiner said.

The data shortcomings start before a patient ever reaches the hospital. Weiner said the details collected when an ambulance crew arrives to treat a critically ill patient who has overdosed — information that could be used for public health modeling — is often understandably scattershot. Emergency services data often doesn’t include information on a patient’s past medical history, or often even the drugs involved, Weiner said.

“They’re taking care of this critically ill patient, maybe they had an overdose, they’re giving them Narcan, they’re resuscitating them. And then the ambulance has to just quickly fill out some form or put in standard of care before they have to go back out and do another call, right?” he explained.

“We’re relying on that data that’s quickly put into a computer between these two calls to then determine predictive analytics,” he said.

Taken together, those gaps have created what Weiner calls a “black hole” in valuable patient data. That makes it difficult for modelers like Muhammad Noor E Alam, an assistant professor of mechanical and industrial engineering at Northeastern University, to gather enough useful data to develop models that can actually improve treatment outcomes or help curb overdose rates.

Alam’s team at the university’s Decision Analytics Lab is working on predictive models to identify and account for the various factors that contribute to the development of opioid use disorder. The researchers are also analyzing big datasets to determine why some patients discontinue their opioid use disorder treatment.

Alam’s research uses claims data that holds information on doctors’ appointments, hospital bills, insurance coverage, and other information collected when a patient interacts with a provider.

But data restrictions, built as guardrails to protect patient privacy, also make it difficult to gather enough information to power a predictive model. ZIP codes, for instance, are often removed from datasets, Alam said. But that information is also valuable for analyzing community-level trends in opioid use disorder and overdose risk.

“So when you nail down … those who have all the information available, the patient total becomes very, very little. And so sometimes the power of your analyses diminishes,” Alam said.

Linas said the claims data that Alam and other researchers use can be valuable for certain modeling, especially given that it’s one of the more accessible types of data. But it will never line up perfectly with a patient’s actual outcomes.

“These are administrative records. We’re trying to use them as basically measures of clinical outcomes. We’re taking the track that there was a claim for an admission with opioid use disorder on it as some sort of measure of a more direct clinical outcome. And it was never intended for that purpose,” said Linas. “We do that a lot.”

As a result, while predictive opioid models have potential, their promise won’t be realized until the data itself becomes more accessible and robust. In a recent review paper published in The Lancet, experts examined the existing evidence on predictive modeling for the opioid crisis and emphasized better data is crucial to furthering the field.

“Data linkage should involve datasets that cover most major health and social agencies and a range of indicators of social functioning and disadvantage,” said Chrianna Bharat, a research associate at the National Drug and Alcohol Research Centre in Australia and co-author of the paper. Syncing those different datasets — which would take policy changes and a cultural shift in how health data is shared — would broaden the kind of work modelers could do.

Bharat and others also stressed that if predictive opioid models stand any chance of entering a clinical setting, they need to be developed alongside the health care workers who may eventually put their recommendations in action.

“I think that’s really important to ensure that they’re not only useful and practical,” Bharat said, “but that they’re understandable for [clinicians].”

https://www.statnews.com/2021/07/30/overdose-data-often-scattered-and-siloed-pose-challenges-for-researchers-racing-to-predict-risk/

States could get billions from opioid lawsuits. They have to decide how to spend it

 The endgame of the sprawling mass of opioid lawsuits is starting to come into focus: Already, a settlement with Johnson & Johnson and three major drug distributors will pour billions of dollars into communities to combat the addiction crisis, with more to come.

But what that looks like, exactly, will vary from place to place. States are likely to see lump sums of money doled out for years, and they will be left to decide how to spend it under the guideposts set up in the settlements. It could easily become subject to competing interests: Legislatures could squabble with governors over priorities, while in some places, counties could demand more autonomy. Some public health experts are also raising questions about the quality of addiction programs to which states could allocate funding.

“This is extremely complicated, and getting it right is going to be tough,” said Kelly Dineen, the director of the health law program at Creighton University’s law school.

The attorneys spearheading the suits are promising that the bulk of the billions will be dedicated to preventing and treating addiction. They say they’re building safeguards into the agreements to guarantee the money goes to the root of the problem that led states, cities, counties, and tribes to file these cases in the first place — a crisis that has only reached new depths during the Covid-19 pandemic.

It’s a direct response to the historic 1998 tobacco settlement worth more than $200 billion, in which money advocates argued should go to smoking cessation and prevention was instead dropped into states’ general funds — and used, in some places, for services as unrelated as filling potholes.

“This money must go down and address addiction,” Louisiana Attorney General Jeff Landry said last week as a group of state attorneys general announced the $26 billion pact with the three distributors and Johnson & Johnson. “We’re here because of addiction.”

More agreements could be coming, as plaintiffs and the defendants in the opioid supply chain — including manufacturers, distributors, and pharmacies — negotiate ways to resolve the thousands of lawsuits alleging the companies helped ignite the country’s opioid epidemic.

State officials often look for any available revenue source to bolster their constrained budgets. If the settlements outline that the money should go to abatement programs, perhaps a state might siphon some of the funds to build a general hospital that includes addiction care, even if it’s not just a facility for opioid addiction, some experts speculated.

“There is always room in these things for states to perhaps wriggle out of what the original intent was,” said Nicolas Terry, the executive director of the Hall Center for Law and Health at Indiana University’s law school.

And as the money starts moving, different parties could spar over how to spend it.

When Oklahoma settled an individual case against Purdue Pharma in 2019, the money helped establish an addiction treatment center at Oklahoma State University, in an initiative steered by Attorney General Mike Hunter. But members of the state legislature were outraged that the money had not been placed in the state’s treasury for them to decide what to do with. They’ve since changed the law so they get authority over divvying up money from future settlements.

Other states are trying to get ahead of the process. Tennessee has established an opioid abatement council that will help direct any funding, while New York set up a “lock box” for money from the settlements to ensure it goes to addiction services.

“Yes, we’ve reached a settlement after many months and years of negotiation, but it will not bring back the loss of life,” New York Attorney General Letitia James said last week. “What it will do is prevent this tragedy from happening again. What it will do is provide prevention and education and abatement and beds to those organizations and hospitals who need it now more than ever.”

New York also established a board to advise the legislature on allocating the money, consisting of health officials as well as people who’ve experienced addiction themselves or in their families, which Melissa Moore, the state director for the Drug Policy Alliance, called “a really crucial degree of accountability.”

In Oregon, county officials are arguing that most of the settlement money the state receives should be directed to them, since county governments are largely responsible for addiction services, said Brad Anderson, the senior assistant counsel in Washington County, the state’s second largest.

“These were local government-initiated lawsuits,” Anderson said. “Local governments have disproportionately felt the implications of the opioid epidemic, and are best suited to being part of the solution.”

The county has plans to devote the funding it receives to help build its planned Center for Addictions Triage and Treatment.

“Folks are going to emergency rooms, they’re going to jail a lot of the time,” said Kristin Burke of the county’s health department. “But what we really want is to get people treatment.”

There are still lots of details to be worked out before much of the money starts arriving in state coffers. More states and communities are reviewing the deal with the distributors and Johnson & Johnson and have the option to sign on, but Washington state Attorney General Bob Ferguson has already rejected the compact, arguing the $26 billion over 18 years — and the estimated $527.5 million the state would get over that period — isn’t sufficient for the toll of the addiction crisis. (Nearly $24 billion from the agreement will go to the states, with the remaining $2 billion covering fees and costs, attorneys general said.)

Public health experts have credited lawyers with delineating the types of addiction programs to which the settlement money can go. In the deal struck last week with the distributors and Johnson & Johnson, the agreement lists a number of abatement strategies that align with public health approaches to addressing addiction, including distributing the opioid overdose reversal medication naloxone; providing medication-assisted treatment to people without insurance and to incarcerated people; and expanding syringe exchange programs.

Still, experts have raised concerns about how exactly states will allocate their dollars, with worries about which types of programs they will or won’t fund. Political and law enforcement officials sometimes oppose some of the most effective treatments for opioid addiction — the medications methadone and buprenorphine — because they are opioids themselves, and instead favor programs that promote abstinence but have less evidence of success and are not backed by addiction medicine specialists.

“We want opportunities for states to be able to tailor the settlement dollars to the needs of the population in their state,” said Creighton’s Dineen. “But we also know that, especially when it comes to drug policy, states don’t always make health decisions that go with the evidence.”

In Louisiana, for example, the legislature passed a bill backed by Landry to steer any settlement money to drug courts. (The governor vetoed the measure, saying it had too vaguely defined an acceptable use of the money.) Many public health advocates argue that drug courts are an extension of the criminal justice system that often don’t help people get evidence-based treatments, and instead call for medical experts to guide addiction care.

While the settlement agreement points to what experts say are the best types of interventions, the deals are also expected to start doling out millions of dollars at a time when officials in some states are rolling back harm-reduction programs. Local officials in Indiana and New Jersey communities have recently voted to shutter syringe exchange programs, which can be conduits to addiction treatment and have been shown to reduce the transmission of viruses like hepatitis C and HIV among people who inject drugs.

“They have to put their money where their mouth is,” Dineen said of the officials who will oversee settlement dollars. “If they really want to help people who have an opioid use disorder, or help prevent it, then they have to get behind programs and services that have a track record of working.”

https://www.statnews.com/2021/07/30/states-could-get-billions-from-opioid-lawsuits-they-have-to-decide-how-to-spend-it/