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Sunday, October 23, 2022

FTC and DOJ have vowed to scrutinize private equity deals

 The Biden administration has been keen to take on corporate consolidation, appointing a new generation of antitrust officials to the Department of Justice (DOJ), the Federal Trade Commission (FTC) and the White House that has promised to pay closer attention to private equity deals.

One area of focus is healthcare. For years, PE firms have been buying up healthcare players. In 2018, for the first time, there were more physicians who were employees than owners of their practices. While PE can help drive operational efficiencies, there is growing concern—and evidence—that their motive for profit can conflict with maintaining quality care. 

Recent studies and investigative reporting have found that after PE takes over a nursing home, patients die more often. PE firms have been investigated for their role in surprise bills and slashing benefits for emergency room doctors early in the pandemic; they have been known to push clinical staff out of important decisions. They are also linked to higher Medicare and private insurance spending

While critics claim the DOJ and FTC are not following traditional interpretations of antitrust laws, the agencies argue there is a need to more closely scrutinize these deals and the impact they have on competition. 

The DOJ has recently indicated a particular focus on rollup transactions that consolidate market share and, with it, negotiating power. Payers and providers have been merging for years, even throughout the pandemic, spurring concerns about price gouging. The FTC’s own study has found that several recent hospital mergers have resulted in significant price hikes and reduced quality care. 

The agency is also concerned about filing deficiencies and conflicts of interest related to board appointments of PE representatives at competing companies. In September, the DOJ began digging into antitrust concerns in the New England fishing industry. That’s an indicator that probe efforts are ramping up, Austin Ownbey, an antitrust attorney at D.C.-based law firm Foley Hoag, told Fierce Healthcare. 

“Given the fact that they are obviously looking at corners of the market that they haven’t traditionally looked at,” Ownbey said, “my advice would be don’t assume that you can just look at the standard antitrust concerns you’ve looked at for years.” Any PE involvement, including in smaller markets, seems “ripe for potential investigation.”

In particular, Ownbey suspects, those being targeted will include verticals with promising returns from consolidation, namely outpatient services like gastroenterology, ambulatory and wound care centers. 

Or, regulators might target areas where the patient population is especially vulnerable, such as nursing homes, explained Arman Oruc, co-chair of Goodwin’s antitrust practice. Though there haven’t been any enforcement actions that he has seen so far, Oruc says parties need to be prepared to answer a lot of questions. 

“It’s something that any healthcare executive should consider if they’re looking at any transactions,” Oruc said.

Funds will likely reconsider what companies they go after and in what order, according to Matt Simpson, an M&A lawyer at Mintz. They will be thinking of higher priority targets first, and likely those they have expertise in already. 

Healthcare markets tend to be large, fragmented and localized—so “a lot of this comes down to how you define competition and where does the competition actually occur,” Simpson said. “It is a very fact-specific analysis in these transactions.”

Though it is helpful to have a business run by someone with prior investments in the same space, “you’ve got to weigh the fact that we don’t want to see consolidation reach the point where prices are going up,” Ownbey explained. If investors decide to avoid scrutiny by sticking to one investment per market, “it makes capital more expensive.” A company may need to look for other sources of funding; if that fails, it may need to pull out altogether, which could harm competition.

In Oruc’s view, PE provides needed capital to underfunded businesses; it doesn’t go in to crush them. If added regulatory scrutiny has a chilling effect on activity in the sector, “it’s only going to harm consumers and patients out there,” Oruc said. 

Healthcare entities should be mindful of this shift in enforcement. “Even if the focus of the investigation is on the private equity fund,” Ownbey noted, “a DOJ investigation will be incredibly disruptive.” The agency might seek months' worth of documents and interviews —and ultimately, might not approve the deal. Investors might decide to scrap a deal themselves for the same reasons. It would be “way better” to avoid getting into a deal with a fund that will draw scrutiny, Ownbey added. 

The safest path forward is to seek antitrust legal counsel and identify the risks ahead of time. Transaction costs may go up; prices may go down. But ultimately, Simpson believes dealmaking will adjust: “Innovation and regulation—they can coexist.” 

https://www.fiercehealthcare.com/regulatory/ftc-doj-promise-heavier-scrutiny-pe-deals-healthcare

Tenet cuts outlook for surgical center business after Hurricane Ian closures

 Tenet Healthcare Corp. lowered its financial outlook for its surgical center subsidiary United Surgical Partners International due to more spikes in COVID-19 cases.

The major hospital chain posted $131 million in net profits for the third quarter of the year and $4.8 billion in net operating revenue. The chain also announced Friday a $1 billion share repurchase program that will expire Dec. 31, 2024. 

Tenet's stock sank 30% Friday after its earnings report. Bloomberg reported that stocks of hospital operators plunged Friday after earnings reports from Tenet and HCA Healthcare underwhelmed investors, wiping out more than $5 billion in market value across the group.

In the third quarter, the system worked to “recover from our cyber attack and dealt with a very active COVID spike among our employees, but our operating discipline across our business units allowed us to adapt to the environment and drive strong results,” said CEO Saum Sutaria in a statement. 

The system increased its financial outlook for adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) by $25 million, at the midpoint of its financial range. However, the chain lowered the outlook for EBITDA for its outpatient business USPI by $75 million. 

“In the third quarter, multiple things came together, and when performance did not meet our expectations subsequently, we decided now is the time to reduce our guidance in the segment,” Sutaria said during an investor call Friday. 

He added that the impact on USPI is “mostly due to short-term disruption” and that Tenet isn’t shifting its long-term plans for the key subsidiary. 

One of the obstacles USPI faced in the third quarter was disruptions caused by Hurricane Ian. The storm, which battered Florida and South Carolina, impacted 60 USPI centers, and there remain four that are still not fully operational, according to the company.

Another issue is lingering spikes from COVID-19 that have further strained staff and availability at doctors’ offices. Sutaria said that case cancelations spiked to 20% in July, above the normal cancelation rate of around 15%. 

Sutaria added that there is likely to be a seasonal demand for healthcare services in the fourth quarter. 

In the hospital segment, Tenet once again faced higher labor expenses as it relied on contract staff to plug vital holes caused by a spike in COVID-19 cases in July. 

“Nearly 10% of our clinical staff were out at some point in the month due to COVID,” Sutaria said. “These dynamics led to compressed patient volumes in July and for us increased our procurement of contract labor staff.”

Tenet leaders noted that the chain has tried to be judicial in how it applies contract labor in order to negate the exorbitant cost in workers' rates.

However, the chain admitted that such rates did not go down as much as the chain expected back in February when the financial outlook was released.

https://www.fiercehealthcare.com/providers/tenet-healthcare-lowers-2022-outlook-uspi-after-hurricane-ian-closures

19 States To Investigate Banks For ESG-Style Commitment To UN Alliance

 by Nathan Worcester via The Epoch Times (emphasis ours),

The war between states and banks over environmental, social, and governance (ESG) investing and similar practices has reached the doorstep of the U.N. A total of 19 state attorneys general have launched investigations of major financial institutions’ commitment to the U.N.-convened Net-Zero Banking Alliance.

The alliance’s website states that its members control roughly 40 percent of the world’s banking assets and are “committed to aligning their lending and investment portfolios with net-zero emissions by 2050.”

The Net-Zero Banking Alliance is a massive worldwide agreement by major banking institutions, overseen by the U.N., to starve companies engaged in fossil fuel-related activities of credit on national and international markets,” Missouri Attorney General Eric Schmitt said in a statement regarding the investigations.

A May statement from the alliance states that it “does not support the financing of fossil fuel expansion” but notes that it “believes that immediate divestment from existing fossil fuel positions will not necessarily bring about the required real economy decarbonization that the world needs.”

We are leading a coalition investigating banks for ceding authority to the U.N., which will only result in the killing of American companies that don’t subscribe to the woke climate agenda. These banks are accountable to American laws–we don’t let international bodies set the standards for our businesses,” Schmitt said.

Arizona, Arkansas, Indiana, Kansas, Kentucky, Louisiana, Mississippi, Montana, Nebraska, Oklahoma, Tennessee, Texas, and Virginia are among the states now investigating the banks through a powerful tool known as a civil investigative demand.

One demand encompasses the following requests: “Describe Your involvement in each Global Climate Initiative in which You participate, including the date You first began participating; any promises, pledges, or other commitments You made to the Global Climate Initiative; or any actions You made or took pursuant to, or consistent with, such commitments, or Your initial or on-going participation, and the employee(s) responsible for managing Your relationship with each Global Climate Initiative.”

Schmitt’s announcement is the latest salvo in a long-running conflict between major financial institutions and individual U.S. states regarding ESG.

State treasurers, such as West Virginia’s Riley Moore, have sought to move their state’s money from financial institutions that follow ESG principles.

https://www.zerohedge.com/geopolitical/19-states-investigate-banks-esg-style-commitment-un-alliance

Summit makes case for changes to antibiotic R&D after sharing data from failed phase 3 trial

 Ten months after revealing a phase 3 flop, Summit Therapeutics has shared data from an antibiotic trial and framed it as evidence of a potential need to change how anti-infectives are developed and assessed. 

In December, Summit reported that its targeted-spectrum antimicrobial ridinilazole performed no better than the approved vancomycin in terms of the clinical response rate in Clostridioides difficile infection. The biotech spoke to the FDA over the summer, leaving the meeting with the impression that a path to market is still open for ridinilazole—if it runs at least one more clinical trial.

Summit used the infectious disease event IDWeek 2022 to present data from the failed Ri-CoDIFy phase 3 study. The sustained clinical response rate in the ridinilazole arm came in at 73% compared to 70.7% in the vancomycin active control cohort. The small numerical difference fell short of the level needed to show ridinilazole is superior to vancomycin.

While the lack of impact on response rates caused the study to miss its primary endpoint, Summit made the case that ridinilazole has an edge in other regards, notably in terms of the rate of recurrence. The recurrence rate in the ridinilazole arm was 8.1% versus 17.3% in the vancomycin cohort. Summit framed the difference as a result of the effects of the two molecules on the microbiome. \\

The biotech found ridinilazole had minimal impact on gut microbiome diversity compared to vancomycin and is less likely to promote resistance to antibiotics. Summit thinks such factors should be factored into assessments of the merits of antibiotics.

“We believe that this study may be indicative as to the need to change the way in which anti-infective agents are developed and assessed going forward, including the need for monitoring the impact of treatments on the gut microbiome,” Summit CEO Robert Duggan said in a release. “A diverse microbiome is critical to human health and protecting it must be a focus going forward.” 

Summit’s statement provides no update on its plans for ridinilazole. The company said it planned to explore the possibility of running further studies to support approval after getting feedback from the FDA earlier in the year.

https://www.fiercebiotech.com/biotech/summit-makes-case-changes-antibiotic-rd-after-sharing-data-failed-phase-3-trial

Nicotine-degrading gut bacteria could protect against NASH

 Scientists have discovered that nicotine accumulation in the intestines of tobacco smokers drives the progression of non-alcoholic statohepatitis, or NASH—and that a nicotine-degrading gut bacterium could be useful in treating the disease.

In a study published Oct. 19 in Nature, a research team led by Frank Gonzalez, Ph.D., of the National Cancer Institute reported that they had characterized the mechanism by which nicotine interacts with compounds in the intestine and ultimately leads to NASH, one of several conditions classified as “non-alcoholic fatty liver disease”.

The team also showed that the bacterium Bacteroides xylanisolvens is capable of breaking down nicotine particles, and that NASH-afflicted mice with the microbe in their gut had both lower concentrations of nicotine in their intestines and less severe disease.

The researchers built upon previous work showing an association between nicotine and NASH, along with studies that posited bacterial enzymes as a solution for removing nicotine from the organs of smokers. While a relationship between smoking and non-alcoholic fatty liver disease has been clear for some time, this was the first time scientists had pinpointed a possible mechanism. It was also the first time they had verified the presence of gut microbiota that are capable of breaking down nicotine.

First, to confirm that nicotine does indeed build up in the intestines of smokers, the scientists analyzed stool, gut lining, and serum samples from 30 smokers and compared them with samples from 30 non-smokers. As expected, nicotine levels were higher in the smokers’ samples. Those findings were then replicated in mice: A group that received nicotine orally, via smoke exposure, or through subcutaneous injection had much more nicotine in their intestines and other organs than the control group.

Next, the researchers sought to find out if the composition of the gut microbiome could influence nicotine levels. To that end, they gave nicotine-infused drinking water to two sets of mice—one group without any bacteria in their microbiome, also known as “germ-free” mice, and a control group that was clear of select bacterial pathogens. More nicotine accumulated in the organs of the germ-free mice than in the controls, suggesting that the gut bacteria were eliminating it.

To figure out which microbes were doing the job, the scientists screened a public genome database for bacteria that contained the genes for enzymes that were known to break down nicotine. After further analysis of stool and serum samples from human smokers, one microbe stood out: B. xylanisolvens, which was plentiful in samples with the lowest amounts of nicotine.

Colonizing B. xylanisolvens in mice who were subsequently exposed to nicotine confirmed what the scientists had seen in the samples—the bacterium was capable of breaking nicotine down in vivo. Further experiments revealed that an enzyme called NicX was doing the work; expressing the NicX gene in fellow bacteria E. Coli gave it nicotine-degrading powers. Meanwhile, knocking out the gene for NicX in B. xylanisolvens took away their ability to break it down.

The scientists then set up mouse experiments to see if B. xylanisolvens colonization was enough to ward off NASH. It was: Mice who were fed a high-fat, high-fructose diet and given nicotine in their water—conditions that mimic those that lead to NASH in humans—had less liver hardening, inflammation and fibrosis if their gut microbiota were colonized with B. xylanisolvens.

But how was nicotine leading to NASH in the first place? To answer this, the scientists focused on intestinal AMP kinase alpha-1, a cellular “sensor” involved in maintaining energy homeostasis that had previously been shown to interact with nicotine. A series of experiments revealed that nicotine activates AMP kinase alpha-1, which then activates another enzyme, SMPD3. SMPD3 regulates the production of ceramides, a type of lipid.

Earlier studies had already associated high SMPD3 levels with the progression of metabolic disease. The same was true for NASH. Suppressing the enzyme in mice who were given nicotine ameliorated the NASH progression, the current study showed.

Finally, the researchers assessed whether B. xylanisolvens might be useful against NASH in a clinical setting. Examining samples from 83 smoking and non-smoking patients with biopsy-proven non-alcoholic fatty liver disease, they found that higher levels B. xylanisolvens levels in the smoking patients were associated with lower disease severity. However, those findings didn’t extend to non-smoking patients, suggesting that the bacteria’s nicotine-degrading properties were specifically responsible for protecting smokers against NASH.

“This study indicates that interventions with either microbial nicotine degraders or other targets based on the intestinal AMPKα–SMPD3–ceramide axis show translational potential for the treatment of nicotine-associated NASH,” the researchers wrote in their paper.

https://www.fiercebiotech.com/research/nicotine-nomming-bacteria-could-protect-against-nash

Quest catches ‘tailwind’ as plummeting COVID test sales send base diagnostic business to new heights

 Though countless diagnostic developers struck it rich at the height of the COVID-19 pandemic, many of those that were relatively new to the testmaking game are now struggling to make up for lost sales as the spread of the virus slows down.

Not so for established testing giants like Quest Diagnostics, which has seen its base business rebound in direct relation to dropping COVID-related earnings.

“There is a correlation between COVID volumes and our base business, and so as COVID improves, we believe that could help our base business,” Steve Rusckowski, the company’s outgoing CEO, said during a call with investors Thursday. “To some extent, as we’ve talked before, we have somewhat of a natural hedge, because if COVID goes up and base softens, we have seen that in the past. Therefore, the improving COVID situation should be a tailwind on base growth going forward.”

That seesaw effect was on display in Quest’s third-quarter earnings. According to a release, the company’s COVID testing revenues dropped more than 55% year over year—from $709 million in the third quarter of 2021 to $316 million this year. That number also marked a drop of about 11% from the preceding quarter of this year, CEO-elect Jim Davis said on the call, explaining that the decline came after a “plateau” in June and July.

Meanwhile, non-COVID-related earnings—which Quest refers to as its base business—rang in at nearly $2.2 billion, up more than 5% from the same period last year. That upswing occurred in direct correlation with the COVID-related downswing, with Davis singling out August and September as the base business’ strongest months after a “softer” start to the year.

In fact, he added, “before Hurricane Ian hit in September, we were seeing some of the highest base testing volumes we have ever experienced.”

That growth helped buoy Quest’s overall earnings: Despite the major drop in COVID test sales, the company’s total quarterly revenues sank only about 10% year over year, to around $2.5 billion.

With its base business picking up speed, Quest is now taking a more optimistic view toward the rest of the year. It’s now expecting full-year revenues as high as $9.86 billion, which would represent a year-over-year decrease of 8.6%, compared to previous forecasts that topped out at $9.75 billion and assumed a decline of at least 9.6%.

COVID testing-wise, the company is predicting that its 2022 revenues will be slashed approximately in half compared to 2021’s haul. But as it shifts focus back to the base testing business, Quest isn’t leaving its COVID-related developments behind.

“As COVID-19 volumes have declined, we’ve begun to repurpose some of our COVID-19 testing platforms to enhance our quality and reduce costs,” Davis said on Thursday’s call.

The improved appointment and scheduling system that Quest introduced throughout the pandemic, for example, has reduced wait times to “approximately five minutes, which is roughly half the level since 2019,” per Davis. It has also increased the number of patients who arrive at a Quest testing center with an appointment—now up to 75% from 2019’s below-25% rate—which “allows us to flex our workforce to meet demand within a particular geography, which enables us to serve our patients faster,” he said.

https://www.fiercebiotech.com/medtech/quest-catches-tailwind-plummeting-covid-test-sales-send-base-diagnostic-business-new

GSK's HIV franchise could reach £7B in 2026, analyst says

 GSK is banking on long-acting cabotegravir for growth in its HIV department. At least one team of analysts believes the company has the winning formula, and real-world evidence has started backing the case.

GSK’s entire HIV business could reach about £7 billion in sales by 2026, and the cabotegravir franchise—which currently includes Cabenuva treatment and Apretude for PrEP—could reach peak sales of around £3 billion in 2030, ODDO BHF analysts estimated in a Friday note.

The ODDO team confirmed their forecast after speaking with HIV expert Christine Katlama in France. The takeaway? Long-acting HIV treatments are a “real game-changer for patients as they enable a significant improvement in quality of life and better treatment observance,” the team wrote. GSK’s cabotegravir is leading the space with no real competitor in the near future, the ODDO analysts said.

Last year, GSK’s HIV drugs brought in £4.8 billion in global sales. The British pharma itself has projected that cabotegravir-based therapies could reach over £2 billion at peak.

The only notable competitor in sight in the long-acting space is Gilead Sciences’ lenacapavir. The capsid inhibitor can be given every six months, whereas the dosing interval for cabotegravir is currently two months at the longest. However, lenacapavir, like cabotegravir, must be paired with another antiretroviral drug, and Gilead right now doesn’t have a long-acting partner.

Lenacapavir was originally paired with Merck & Co.’s potentially long-acting islatravir. But a recent clinical setback has forced Merck to revisit the proper dosing strength of the drug with a new phase 3 program launched in September.

Still, changing the HIV treatment paradigm from daily pills to an injection given once every two months won't be an easy feat. Meanwhile, questions are circling about Cabenuva’s antiviral strength and whether its dosing schedule is convenient enough to change patient behaviors. 

Real-world data by GSK’s HIV-focused ViiV Healthcare and academics have started to offer more answers to those questions, and so far the evidence is in support of cabotegravir.

At IDWeek 2022, researchers presented an analysis of electronic health records from a database called Observational Pharmaco-Epidemiology Research and Analysis (OPERA). The data showed that in a group of U.S. patients who had viral loads below 200 copies/mL after their first Cabenuva injection, 99% of patients remained virologically suppressed after a median follow-up of 3.4 months.

In patients who had over 200 copies/mL at first prescription, with a median viral load of 16,400 copies/mL, 91% of them achieved virologic suppression, defined as having fewer than 200 copies/mL.

While the data only followed patients for a very short time, the observations suggest that Cabenuva is effective among virologically suppressed individuals, the researchers concluded.

Cabenuva won U.S. approval in January 2021. The fact that real-world studies already exist “shows how much enthusiasm there is around Cabenuva,” Kimberly Smith, M.D., ViiV’s head of R&D, said in an interview with Fierce Pharma.

Despite strong data from Cabenuva’s clinical trials, market watchers still wanted to know if the experience would play out in the same way in the real world. So far, the data are “showing the same thing that we saw in our pivotal studies, that people are doing well, they’re tolerant, and they’re happy,” Smith said.

HIV doctors are used to prescribing pills but not injections. In a separate observational study of healthcare professionals across 24 U.S. sites, 79% of doctors reported they were “extremely” or “very” positive about administering Cabenuva, according to results shared at IDWeek 2022. About 87% of responders said injection visits take less than 45 minutes, including waiting time. Altogether 75% of responders estimated that at least a quarter of their existing patients are eligible for Cabenuva.

https://www.fiercepharma.com/marketing/gsks-hiv-franchise-could-reach-ps7b-2026-analyst-says-real-world-data-start-backing-long