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Thursday, May 4, 2023

TD Bank and First Horizon Mutually Agree to Terminate Merger

 TD Bank Group (TSX and NYSE: TD) ("TD") and First Horizon Corporation (NYSE: FHN) ("First Horizon" or "the Company") today announced that they have entered into a mutual agreement to terminate their previously announced merger agreement, originally announced on February 28, 2022.  TD informed First Horizon that TD does not have a timetable for regulatory approvals to be obtained for reasons unrelated to First Horizon.  Because there is uncertainty as to when and if these regulatory approvals can be obtained, the parties mutually agreed to terminate the merger agreement.

Under the terms of the termination agreement, TD will make a $200 million cash payment to First Horizon.  This payment is in addition to the $25 million fee reimbursement due to First Horizon pursuant to the merger agreement.  The shares of First Horizon Series G Preferred Stock that TD Bank purchased will continue to reflect a conversion price of $25 per share.  Neither party will pay any other fees or have any other liabilities to each other related to the merger agreement.

https://finance.yahoo.com/news/td-bank-first-horizon-mutually-100000980.html

Sensus Healthcare Misses Views

 Lower demand for SRT systems reflects the impact of inflation on dermatologists’ cash flow from fewer elective aesthetic procedures and higher operating costs

Sensus expects to ship more than 60 SRT units during 2023 and return to profitability in the second half of the year

https://finance.yahoo.com/news/sensus-healthcare-reports-first-quarter-200500907.html

Lantheus ups guidance

 

  • Worldwide revenue of $300.8 million for the first quarter 2023, representing an increase of 44.0% from the prior year period

  • GAAP net loss of $2.8 million for the first quarter 2023, compared to GAAP net income of $43.0 million in the prior year period

  • GAAP fully diluted net loss per share of $.04 for the first quarter 2023, compared to GAAP fully diluted net income per share of $0.61 in the prior year period; adjusted fully diluted net income per share of $1.47 for the first quarter 2023, compared to adjusted fully diluted net income per share of $0.97 in the prior year period

  • Net cash provided by operating activities was $108.5 million for the first quarter 2023. Free cash flow was $99.3 million in the first quarter 2023

  • The Company provides second quarter 2023 revenue and adjusted diluted earnings per share guidance; increases full year guidance

Company will host a conference call and webcast on Thursday, May 4, 2023, at 8:00 a.m. ET. To access the conference call or webcast, participants should register online at https://investor.lantheus.com/news-events/calendar-of-events.

A replay will be available approximately two hours after completion of the webcast and will be archived on the same web page for at least 30 days.

The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.

https://finance.yahoo.com/news/lantheus-reports-first-quarter-2023-110000624.html

ZimVie ups guidance; call

 Full Year 2023 Financial Guidance:

We are updating our 2023 net sales and adjusted EPS guidance and reaffirming our 2023 adjusted EBITDA margin guidance as follows:

Projected Year Ending December 31, 2023

Prior Guidance

Updated Guidance

Net sales

$825M - $850M

$835M to $860M

Adjusted EBITDA margin[2]

13.5% - 14.0%

13.5% - 14.0%

Adjusted EPS[2]

$0.30 to $0.50

$0.40 to $0.60


Conference Call

ZimVie will host a conference call today, May 3, 2023, at 4:30 p.m. ET to discuss its first quarter 2023 financial results. To access the call, please register online at https://investor.zimvie.com/events-presentations/event-calendar. A live and archived audio webcast will also be available on this site.

About ZimVie

ZimVie is a global life sciences leader in the dental and spine markets that develops, manufactures, and delivers a comprehensive portfolio of products and solutions designed to support dental tooth replacement and restoration procedures and treat a wide range of spine pathologies. In March 2022, the company became an independent, publicly traded spin-off of the dental and spine business units of Zimmer Biomet to breathe new life, dedicated energy, and strategic focus to its portfolio of trusted brands and products. 

https://finance.yahoo.com/news/zimvie-reports-first-quarter-2023-200500359.html

Soligenix: Positive Results in Cutaneous T-Cell Lymphoma Trial

 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive clinical results from a compatibility study evaluating HyBryte™ (synthetic hypericin sodium) in the treatment of cutaneous T-cell lymphoma (CTCL) using the commercially ready Daavlin Series 7 visible light device, which recently received 510(k) clearance from U.S. Food and Drug Administration (FDA). The open-label study (protocol HPN-CTCL-02) enrolled 9 patients to receive 8 weeks of HyBryte™ treatment of their cancerous lesions, with an assessment of treatment response conducted at week 10 using the Composite Assessment of Index Lesion Severity (CAILS) score. All subjects were enrolled by Brian Poligone, MD, PhD, at the Rochester Skin Lymphoma Medical Group.

The purpose of the study was to establish that any light device capable of producing visible light of an appropriate and consistent wavelength (500 to 650 nm) was suitable for use with HyBryte™ and extend the pharmacokinetic profile using a recently developed, more sensitive hypericin assay. In addition to meeting these objectives, the efficacy demonstrated strongly substantiates the results of the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study. The treatment response data of 22% following 8 weeks of twice weekly HyBryte™ therapy recapitulates the results of the FLASH trial, despite the fact that patients in the current study were specifically selected to have more extensive disease consistent with its potential commercial use. Additionally, in this study all patients had improvements in their cumulative CAILS score (average improvement of 36.4%, range 8 to 100%). Results in individual lesions showed that 7 of the 27 index lesions (25.9%) had at least a 50% improvement in their CAILS score and 4 of the 27 index lesions (14.8%) were completely resolved after as little as 8 weeks of treatment. Other key evaluations included measurements of systemic exposure and cardiac output, which yielded extremely low and limited levels of systemic hypericin (plateau concentration of approximately 0.00013 μg/mL) detected in the blood and no observable impact to normal sinus rhythm, reinforcing the safety of HyBryte™.

Wednesday, May 3, 2023

Worried About the Possible Envision Bankruptcy? You Should Be

 Envision, a private equity-backed clinician staffing firm that also manages ambulatory surgical centers and care after hospitalization, is expected to file Chapter 11 bankruptcy if reports from the Wall Street Journal

opens in a new tab or window prove true.

If Envision goes bankrupt, it could impact emergency departments, hospitalist services, anesthesia, radiology, and services for women and children.

While Envision did not make perfect business decisionsopens in a new tab or window over the past few years -- it has received criticismopens in a new tab or window for its out-of-network billing practices, for example -- it will not be the only healthcare provider who could suffer this fate. In fact, if the growth and power of private payers like UnitedHealthcare, Cigna, and Aetna is unchecked by new government regulations, we could see a slew of care providers go bankrupt in the coming months.

Lawmakers and regulators need to protect patients, hospitals, and providers from this dramatic shift in power and influence.

Bankruptcy in Healthcare

Bankruptcy in healthcare is not newopens in a new tab or window, and it accelerated during and after the COVID pandemic due to inflation costs and staffing challenges.

But Envision's bankruptcy still could have significant ripple effects on the industry. And it is different.

While organizations may use bankruptcy to restructure their financial obligations, and can continue operations while they do so, the uncertainty of Chapter 11 could harm employees and clients as they wait to hear about potential layoffs, renegotiated contracts, services, and altered benefits.

Additionally, of the 46 healthcare bankruptcies filled in 2022, only five had liabilitiesopens in a new tab or window over $500 million. Envision's financial collapse would likely be more significantopens in a new tab or window -- and it could be one of the first canary in the provider services and hospital-based coal mine.

Antecedents to the Balance Sheet Problem

We can blame COVID and its lingering effects for rising provider expenses and declining revenues. We also can blame the No Surprises Act implementation

opens in a new tab or window, gumming up the arbitration system, which is difficult to access and often costlyopens in a new tab or window for providers.

But providers were in trouble long before COVID, inflation, and the No Surprises Act.

There has been a steady declineopens in a new tab or window in reimbursement from both government and non-government payers over the last several years.

For example, the Medicare Physician Fee Scheduleopens in a new tab or window and PAYGOopens in a new tab or window ties increases and decreases to provider reimbursement to sustainable funding for the program -- even though funding is not keeping up with inflation. Currently, the Medicare coverage rate for a relative value unit (RVU) sits at $33.89opens in a new tab or window, which, if it had been adjusted for inflationopens in a new tab or window, would be significantly higher. Allocations that increased RVU amounts for services in non-hospital-based practices also shift dollars away from hospital-based services.

Moreover, the Emergency Medical Treatment & Labor Act (EMTALA) -- the unfunded mandate -- compels emergency doctors to treat patients regardless of insurance coverage. Though crucial, this law burdens physicians with hefty costs. For uninsured patients, doctors' groups receive minimal or no compensation from Medicare, despite shouldering the expenses of patient care. For a company like Envision, which has heavy penetration in hospital-based services and emergency services specifically, these cuts and mandates are likely especially challenging.

However, one of the biggest drivers of Envision's revenue declineopens in a new tab or window allegedly came from one of the nation's largest health insurers: UnitedHealthcare.

UnitedHealthcare's first quarter revenuesopens in a new tab or window grew 13% to $70.5 billion and its operating earnings grew 14% to $4.3 billion. Most of the revenue was derived from their Optum provider services, Medicare Advantage plan participation, and pharmacy benefits managers. However, in late April 2023, United Healthcare lost a legal battleopens in a new tab or window with Envision, which had sued the insurance giant in 2018 over billing practices. While this may not change Envision's reportedly impending bankruptcy, it emphasizes the role of private payers in the declining revenues of care providers.

Notably, UnitedHealthcare is not the only payer amassing major revenues and profits.

We Have a Payer Problem

CVS Health's revenue topped $300 billionopens in a new tab or window in 2022 -- even before news broke that the company will snap up more primary care clinics. Aetna, CVS Health's insurance wing, brought in $91.4 billion in revenue in 2022, an increase of almost $10 billion from 2021. By the end of 2022, both UnitedHealthcare and CVS had revenues of $330 billion. Add Cignaopens in a new tab or window and the three companies combined made nearly $1 trillion in revenue in 2022, an amount more than the GDPs of more than 160 countries.

Not all the money is coming from insurance premiums and membership growth. Each of these companies has expressed a keen interest in value-based care models due to their involvement in managed Medicare plans like Medicare Advantageopens in a new tab or window. (Medicare Advantage plans pay taxpayer dollars to private insurers up front for the care and management of patients.)

These companies also have amassed power by creating vertically-integratedopens in a new tab or window conglomeratesopens in a new tab or window in the market, which are going unchecked.

UnitedHealthcare, for example, is made up of the nation's largest health insurance company

opens in a new tab or window, the largest provider network through Optum (more than 60,000 physiciansopens in a new tab or window), and Optum RX (a pharmacy benefit manager). CVS Health, the world's largest healthcare companyopens in a new tab or window by revenue, owns CVS retail pharmacies, Aetna (the country's sixth-largestopens in a new tab or window health insurer), CVS Caremark pharmacy benefits manager, CVS MinuteClinics, and, now, Oak Street Healthopens in a new tab or window.

Consolidation may ensure integrated, coordinated care of patients, but that benefit cannot come at the risk of access and choice for patients and negotiating power for hospitals and providers.

While we march towards value-based care, we must ensure we aren't incentivizing the creation of monopolies.

FTC Asleep at the Wheel

Despite concerns, the Federal Trade Commission (FTC) has continued to approve mergers. We are now seeing the results.

Since these models encourage patients to remain within tight networks, patients generally have fewer choices. Additionally, other businesses that interface with these giants have reduced ability to negotiate.

While payers profit, around 50% of hospitals

opens in a new tab or window finished 2022 in the red. Hospital closures mean less patient accessopens in a new tab or window, which often leads to worse outcomes for patients.

If Envision could not make it in this environment, how can smaller providers? When I speak with CEOs and CMOs of hospitals and provider groups, the number one reason for financial woes are continued concerns with reimbursement challenges with payers.

In a market-based economy, UnitedHealthcare is doing what is expected of them: making a profit. But that does not mean they are above regulation or enforcement.

We must address the issue of market domination by a limited number of powerful entities.

In order to tackleopens in a new tab or window vertical integration and consolidation, it is crucial for state legislatures to take measures to enhance and back the antitrust enforcement powers of state attorneys general and federal regulators (the FTC), ensuring patients are safeguarded from increased expensesopens in a new tab or window and limited options.

The federal government also must enforce the Affordable Care Act 80/20 Medical Loss Ratio rule

opens in a new tab or window for insurers and define more clearly what "quality improvements" mean under that rule. Lawmakers must invest in Medicare, shifting the PAYGO rules and adjusting fee-schedule rates.

On the care provider side, clinicians must better educate themselves about what is happening in healthcare and develop the business knowledge to meet the challenge. To my fellow physicians I say: Understand the issues, and the financial incentives, and advocate for patients and yourselves.

As a country, we cannot watch private payers-provider conglomerates amass power while hospitals close, healthcare outcomes worsen, provider groups shutter, and physicians burn out.

If we don't act, the whole system will bankrupt.

N. Adam Brown, MD, MBA,opens in a new tab or window is a practicing emergency medicine physician, founder of ABIG Healthopens in a new tab or window, and a professor of practice at the University of North Carolina's Kenan-Flagler Business School. Previously he served as president of emergency medicine and chief impact officer for one of the nation's largest national medical groups.

https://www.medpagetoday.com/opinion/prescriptionsforabrokensystem/104320

Why Is One Dose Suddenly Enough for the mRNA COVID Vaccines?

 The FDA and CDC recently announced

opens in a new tab or window that previously unvaccinated Americans can now receive only a single dose of the bivalent Moderna or Pfizer mRNA vaccines. To be clear, this is not saying they can choose to have one or two doses and be considered fully vaccinated either way -- only one dose is available to them. The CDC made a related decision in respect to international travelers who fly into the U.S. Theyopens in a new tab or window "will now be considered fully vaccinatedopens in a new tab or window 2 weeks after getting a single dose of either the Pfizer or Moderna mRNA vaccine any time after August 16, 2022, when bivalent formulations first became available." However, a more recent decision from the White House made this announcement moot by eliminatingopens in a new tab or window any vaccination requirements for arriving travelers.

In practice, these policy changes will probably not affect many people. The approximately 30%

opens in a new tab or window of Americans who have refused all COVID-19 vaccines for over 2 years -- often for political reasons and because of widespread misinformation -- are unlikely to change their attitudes merely because they are now limited to receiving only a single bivalent vaccine dose. And there would have been few international travelers, particularly foreigners, whose only vaccine experience would have been a single bivalent mRNA vaccine. Even so, it's worth exploring what lies behind what just happened.

Since the mRNA vaccines were first rolled out in late 2020, the standard primary series always has been two doses, which remains the legal definition of "fully vaccinated." Indeed, CDC recommends that Americans receive multiple mRNA vaccine doses, either three or four depending on age and health statusopens in a new tab or window. Why, then, do FDA and CDC suddenly consider one dose of the bivalent vaccines to be sufficient for unvaccinated people? What data underlie the decisions, and how were those decisions made? The simplest answers are: None and who really knows?

FDA official Peter Marks, MD, PhD, has referred to "simplifying

opens in a new tab or window" vaccine administration as being the driver for the recent change and "believes" that allowing unvaccinated people to receive only a single dose will "help encourage future vaccination." Given the reasons behind vaccine refusalopens in a new tab or window, that belief seems quite naïve. Marks also refers to how "most of the U.S. population" has been either infected by the virus, already vaccinated, or both. The unstated implication is that an unvaccinated person now needs only a single vaccine dose to boost immunity conferred by prior infection. Indeed, several science reporters have told me that's what FDA officials are saying in private briefings. While there is solid science behind the hybrid immunityopens in a new tab or window argument, there are also ethical concerns.

I will say again that few unvaccinated Americans will now change their minds -- but some might. However, not all of those mind-changers will have been previously infected, so some will lack any prior immunity. It's not possible to estimate the number of people that fall into this category, but it won't be zero. After all, the FDA is still seeking, rightly, to "encourage future vaccination."

There is literally no data on how well a single dose of a bivalent mRNA vaccine will protect anyone. But we have known for over 2 years that a single dose of the original vaccines was not good enough

opens in a new tab or window. The human immune system has not suddenly changed -- I think that giving only a single vaccine dose, of whatever composition, to immunologically naïve people (i.e., no prior infection or vaccination) will leave them perilously under-vaccinated, and hence at future risk of COVID-19. It's particularly problematic if those people believe they are now "fully protected" and increase their exposure to infection. The new one-dose policy is letting these people down.

A better, more humane policy would be to continue to allow every previously unvaccinated person access to two bivalent vaccine doses. Their own knowledge and input from their physicians could guide them as to whether they prefer one dose or two. But they should have the choice -- it's the ethical option.

When flawed policy changes like this one are made, we must ask whether it's appropriate for FDA officials to have that kind of decision-making capacity. In my opinion, FDA has botched several aspects

opens in a new tab or window of COVID-19 vaccine policyopens in a new tab or window over the past year. It's time for a shake-up at the agency, particularly with the winding down of any oversight from the White Houseopens in a new tab or window. "Follow the science" has always been the Biden administration's guiding principle on COVID-19 topics. It should remain so.

John P. Moore, PhD, is a professor of microbiology and immunology at Weill Cornell Medicine in New York City.

https://www.medpagetoday.com/opinion/second-opinions/104295