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Wednesday, May 4, 2022

After Falling More Than 56% in a Year, Where Is STAAR Surgical Going?

 With its share price down 56% in the past 12 months, STAAR Surgical's (STAA 5.75%) stock has clearly seen better days. Judging by its collapse, it'd be reasonable to assume the implantable lens company is facing major headwinds -- but it isn't. In fact, there's not much standing in the way of its continued growth over time.

So is there another issue that should dissuade investors from approaching this stock? Perhaps, but rumors of STAAR's rolling demise are quite overblown, and here's why.

The first thing to know about STAAR Surgical is that it sells implantable refractive lenses for vision correction.

That means it competes with laser vision-correction surgery as well as more mundane products like glasses and contact lenses. As you might have guessed, the advantage of having vision correction in an implantable format is that there's none of the hassle associated with cleaning smudged lenses or dealing with dry eyes after wearing contacts for too long.

There's no shortage of people needing vision correction. Right now, there are at least 90 million people worldwide that fall within STAAR's target market, and the company has a market share of around 9% globally. In 2021, selling implantable lenses to those people brought it $230.4 million in revenue, but that's likely just the start. Management is banking on making around $295 million in 2022, and even more beyond this year.

By 2050, the company estimates that more than 50% of the global population will be myopic, meaning that they'll need help to see things that are far away, which will make its market even larger.

The catch is that (thankfully) nearsightedness isn't exactly going viral, despite becoming more prevalent over time. In other words, penetrating the market faster than the market's base rate of growth is more likely to be a marathon than a sprint. See below:

STAA Revenue (Annual) Chart

STAA REVENUE (ANNUAL) DATA BY YCHARTS

As you can see, STAAR's annual revenue growth over the past five years hasn't been too shabby, but it hasn't been very rapid either. Given the ongoing, strong uptake of its implantable lenses in major markets like China and Japan, it's reasonable to expect similar rates of growth over the next few years.

Plus, the U.S. Food and Drug Administration (FDA) just approved one of STAAR's next-generation lenses for sale, which is sure to deliver even more growth. And assuming total expenses continue their slow decline as a share of sales, investors can also expect to see earnings continue to rise at a rapid pace, and expanding margins are plausible too. 

Furthermore, the company's debt load of near $32 million is negligible, given 2021's free cash flow (FCF) in excess of $30.3 million.


So STAAR Surgical is very far from being doomed. The only issue is that investors are going to need to pay a hefty toll to own this stock. Consider the following:

STAA PE Ratio Chart

STAA PE RATIO DATA BY YCHARTS

As you can see, the stock's valuation has taken quite a parabolic trajectory over the last three years. But even after its sharp decline in recent months, it's still very pricey with a price-to-earnings (P/E) multiple of 120 and price-to-book (P/B) multiple of about 11.

By contrast, the medical equipment industry's average P/E multiple is close to 49 and its average P/B multiple is nearly 6.9. That doesn't mean the stock isn't worth buying, but it does mean that there's an ongoing valuation risk.

undefined Stock Quote

NASDAQ: STAA

STAAR Surgical Company
Today's Change
(5.75%) $3.49
Current Price
$64.21
 STAA

KEY DATA POINTS

Market Cap
$3B
Day's Range
$58.13 - $64.36
52wk Range
$54.29 - $163.08
Volume
447,249
Avg Vol
562,995
P/E (ttm)
117.00

If investors know that they can get similar earnings growth with another stock while paying significantly less for the privilege, they might even sell their shares. And at its current valuation, it wouldn't be too surprising to hear that value investors are staying far away from STAAR Surgical. 

Nonetheless, in the long-term, the stock's valuation won't matter as much as the company's ability to keep efficiently penetrating the global market as it expands. Therefore, while I wouldn't be comfortable with buying STAAR at its current price, it's probably going to be a lucrative company to own over the next decade and beyond.

https://www.fool.com/investing/2022/05/04/after-falling-more-than-56-in-a-year-is-staar-surg/

Association of Health Policy With Payment, Regional Shifts in Gender-Affirming Surgery

 Sacha C. Hauc, MPH1Aaron S. Long, BS1Mohammad Ali Mozaffari, MD1et al

doi:10.1001/jamasurg.2022.1053

Important insurance coverage policy changes for gender-affirming care (GAC) occurred in the past decade. Several states added Medicaid coverage for GAC, and Medicare lifted its ban on gender-affirming surgery (GAS) in 2014.1 In 2016, the Department of Health and Human Services ruled that the ACA prohibits discrimination based on gender identity in federally funded insurance plans.2 Although this measure was blocked by court injunction, similar state-level measures were increasingly seen.3 Little is known about the association of these changes with access to GAS. We examined shifts in GAS by region and insurance use during periods when key antidiscrimination policies took effect.

Methods

This retrospective cohort study used data extracted from the National Inpatient Sample from 2008 to 2017. The data set included 6627 transgender patients, of whom 603 underwent GAS. Statistical models describe 3 periods when state and federal policies supporting GAS access were implemented: 2008-2013, 2014-2015, and 2016-2017. Data were analyzed from June to August 2021. This study used deidentified data and was exempted from review by the Yale University institutional review board. The study followed the STROBE reporting guideline.

Multivariate logistic regression models examined associations between GAS and patient and hospital characteristics. Characteristics were analyzed using t tests for continuous variables and χ2 tests for categorical variables; individual variables were evaluated with the Wald χ2 statistic. Analyses were conducted using SAS, version 9.4. Two-sided P < .05 was considered significant.

Results

Among the 603 patients, 277 (46.0%) were assigned female at birth (mean [SD] age, 36 [13.3]). During 2008-2013, self-pay was the most common method of GAS payment compared with Medicare (odds ratio [OR], 0.02; 95% CI, 0.00-0.05), Medicaid (OR, 0.02; 95% CI, 0.01-0.05), or private insurance (OR, 0.29; 95% CI, 0.20-0.43) (all P < .001) (Figure 1). Differences between self-pay and Medicare (OR, 0.27; 95% CI, 0.13-0.58; P < .001), Medicaid (OR, 0.13; 95% CI, 0.06-0.25; P < .001), and private insurance (OR, 0.57; 95% CI, 0.33-0.98; P = .04) decreased in 2014-2015; by 2016-2017, there was no significant difference between methods (Figure 1).

Before 2013, GAS was more common in the West compared with the Northeast (OR, 0.11; 95% CI, 0.06-0.19), Midwest (OR, 0.07; 95% CI, 0.04-0.15), and South (OR, 0.09; 95% CI, 0.05-0.19) (all P < .001) (Figure 2). By 2014-2015, differences decreased (ORs: Northeast, 0.18 [95% CI, 0.10-0.32]; Midwest, 0.11 [95% CI, 0.05-0.22]; South, 0.24 [95% CI, 0.13-0.44]; all P < .001) and decreased further by 2016-2017 (ORs: Northeast, 0.57 [95% CI, 0.37-0.87; P = .009]; Midwest, 0.27 [95% CI, 0.15-0.47; P < .001]; South, 0.53 [95% CI, 0.34-0.85; P = .007]) (Figure 2).

Discussion

This study found nationwide increases in GAS and a payer shift from self-pay to private or government insurance after state and federal policy changes favorable to GAS. By 2017, there was no significant difference between private or government insurance and self-pay.

Geographic disparities in GAS access diminished during the study period. Early predominance of cases in the West may be associated with state policies favorable toward GAS coverage. California was the first state to broadly expand Medicaid coverage for GAC in 2013 and had policies against discrimination in private insurance coverage.1,4 During the study period, Medicaid coverage for GAS was introduced in 12 states and state private insurance laws became more inclusive.1,3,5

This study is limited by reliance on ICD-9 and ICD-10 diagnosis and procedure codes, which may not represent the full range of GAS. GAS is often the final step in transition with the most stringent insurance preauthorization requirements, limiting generalizability of our results to other forms of GAC.

Despite recent improvements, access to GAS remains limited. Less than half of state Medicaid programs provide for GAC, and in 2020, only 18% of the 3 largest private health plans by state had policies favorable for facial feminization surgeries.1,6 Policies supporting insurance coverage for GAC may have a role in expanding access to GAS.

https://jamanetwork.com/journals/jamasurgery/fullarticle/2791958

Europe still can reverse obesity 'epidemic': WHO

 The new WHO European Regional Obesity Report 2022, published on 3 May by the WHO Regional Office for Europe, reveals that overweight and obesity rates have reached epidemic proportions across the Region and are still escalating, with none of the 53 Member States of the Region currently on track to meet the WHO Global Noncommunicable Disease (NCD) target of halting the rise of obesity by 2025.

New data on obesity and overweight

The report, launched at a press event on 3 May and presented at the European Congress on Obesity, reveals that in the European Region, 59% of adults and almost 1 in 3 children (29% of boys and 27% of girls) are overweight or living with obesity. Obesity prevalence for adults in the European Region is higher than in any other WHO region except for the Americas.

Overweight and obesity are among the leading causes of death and disability in the European Region, with recent estimates suggesting they cause more than 1.2 million deaths annually, corresponding to more than 13% of total mortality in the Region.

Obesity increases the risk for many NCDs, including cancers, cardiovascular diseases, type 2 diabetes mellitus and chronic respiratory diseases. For example, obesity is considered a cause of at least 13 different types of cancer, and is likely to be directly responsible for at least 200 000 new cancer cases annually across the Region, with this figure set to rise further in the coming years. Overweight and obesity are also the leading risk factor for disability, causing 7% of total years lived with disability in the Region.

Overweight people and those living with obesity have been disproportionately affected by the consequences of the COVID-19 pandemic. There have been unfavourable shifts in food consumption and physical activity patterns during the pandemic that will have effects on population health in the years ahead, and will need significant effort to reverse.

Obesity in Europe: an ongoing “epidemic”

To address the growing epidemic, the report recommends a suite of interventions and policy options that Member States can consider to prevent and tackle obesity in the Region, with an emphasis on building back better after the COVID-19 pandemic.

“Obesity knows no borders. In the Europe and Central Asia, no single country is going to meet the WHO Global NCD target of halting the rise of obesity,” said Dr Hans Henri P. Kluge, WHO Regional Director for Europe. “The countries in our Region are incredibly diverse, but every one is challenged to some degree. By creating environments that are more enabling, promoting investment and innovation in health, and developing strong and resilient health systems, we can change the trajectory of obesity in the Region.”

Obesity is a disease – not only a risk factor

Obesity is a complex disease that presents a risk to health. Its causes are much more complex than the mere combination of unhealthy diet and physical inactivity. This report presents the latest evidence, highlighting how vulnerability to unhealthy body weight in early life can affect a person’s tendency to develop obesity.

Environmental factors unique to living in modern Europe’s highly digitalized societies are also drivers of obesity. The report explores, for example, how the digital marketing of unhealthy food products to children, and the proliferation of sedentary online gaming, contribute to the rising tide of overweight and obesity in the European Region. However, it also looks at how digital platforms might also provide opportunities for the promotion and discussion of health and well-being.

Policy measures: what can countries do?

Addressing obesity is critical to achieving the Sustainable Development Goals and is a priority echoed in WHO’s European Programme of Work 2020–2025.

The new WHO report outlines how policy interventions that target environmental and commercial determinants of poor diet at the entire population level are likely to be most effective at reversing the obesity epidemic, addressing dietary inequalities and achieving environmentally sustainable food systems.

Obesity is complex, with multifaceted determinants and health consequences, which means that no single intervention can halt the rise of the growing epidemic.

Any national policies aiming to address the issues of overweight and obesity must have high-level political commitment behind them. They should also be comprehensive, reaching individuals across the life course and targeting inequalities. Efforts to prevent obesity need to consider the wider determinants of the disease, and policy options should move away from approaches that focus on individuals and address the structural drivers of obesity.

The WHO report highlights a few specific policies that show promise in reducing levels of obesity and overweight:

  • the implementation of fiscal interventions (such as taxation on sugar-sweetened beverages or subsidies for healthy foods);
  • restrictions on the marketing of unhealthy foods to children;
  • improvement of access to obesity and overweight management services in primary health care, as part of universal health coverage;
  • efforts to improve diet and physical activity across the life course, including preconception and pregnancy care, promotion of breastfeeding, school-based interventions, and interventions to create environments that improve the accessibility and affordability of healthy foods and opportunities for physical activity.

Can pill prescriptions overcome U.S. state abortion bans?

 

If the U.S. Supreme Court reverses its landmark 1973 Roe v. Wade decision guaranteeing abortion rights nationwide, demand for abortion pills, which can be prescribed through online telemedicine visits, will likely rise. Conservative states have already rushed to restrict the practice, and if Roe falls, they will be able to ban it altogether, experts say.

WHAT IS A MEDICATION ABORTION?

In a medication abortion, a patient takes a drug called mifepristone, also known as RU-486, followed by a second drug called misoprostol, to end a pregnancy rather than having a surgical procedure. Over half of abortions in the United States are medication abortions, according to the Guttmacher Institute, an abortion rights advocacy research group.

HOW DOES THE FEDERAL GOVERNMENT REGULATE MEDICATION ABORTIONS?

The U.S. Food and Drug Administration approved mifepristone in 2000, but until very recently, the FDA mandated that patients get it at a doctor's office, clinic or hospital. After easing those restrictions during the COVID-19 pandemic, the agency in December permanently did away with the requirement that it had to be dispensed in person, allowing patients to consult with healthcare providers via telemedicine appointments and receive the pills by mail. That increased access to abortion for patients living in remote areas without providers nearby and women unable to take time off from work or not able to get to clinics for other reasons. The drugs are approved for use through the 10th week of pregnancy.

DO STATES RESTRICT MEDICATION ABORTION?

Medication abortions have become a target of anti-abortion politicians and activists. At least 116 restrictions, including eight measures that ban the practice outright, have been introduced this year, according to the Guttmacher Institute.

Thirty-two states allow only physicians to dispense abortion pills, according to the Kaiser Family Foundation. Six states, including Texas and Missouri, ban any use of telemedicine for medication abortion. Another 21 states do not have blanket bans but require at least one in-person visit, meaning patients cannot simply have a telemedicine appointment and receive the pills by mail, according to the foundation.

WHAT IS THE IMPACT ON MEDICATION ABORTIONS IF ROE V. WADE IS OVERTURNED?

If the Supreme Court overturns Roe, conservative states are poised to ban or sharply restrict abortion altogether, including 13 with so-called "trigger laws" that would take effect immediately or soon after the court acts. They would apply to medication abortions. Some trigger laws ban abortions almost
completely, while others would outlaw abortion after six weeks or 15 weeks https://tmsnrt.rs/3sbQQEp.

CAN A PATIENT IN A STATE WHERE MEDICAL ABORTION IS ILLEGAL GET THE PILLS FROM AN OUT-OF-STATE PROVIDER WHERE IT IS LEGAL?

That depends. It is illegal for a medical professional to prescribe the pills via a telemedicine appointment to a woman in a state where they are illegal, legal experts say.

    "The laws around telemedicine generally say that the location of the patient controls," said Amanda Allen, senior counsel at the Lawyering Project, an organization that represents abortion providers. Doctors who prescribed abortion pills to a patient in a state where they are illegal could lose their licenses in that state, or even face criminal charges, she said.   

A woman who lives in a state where abortion is illegal could travel to a state where it is legal, have a telemedicine visit, and have the medication mailed to an address there.

    "In some cases, that's somewhat less burdensome and costly than to travel all the way to a brick-and-mortar clinic in a neighboring state," she said, noting that patients who travel to clinics in other states have sometimes faced weeks-long waits for appointments.

ARE THERE CURRENTLY LAWSUITS CHALLENGING STATE RESTRICTIONS ON MEDICAL ABORTION?

Yes. GenBioPro Inc, a company that sells mifepristone, has already challenged Mississippi restrictions on telemedicine by arguing that they are "preempted" by the FDA, meaning that the federal approval of the drug overrides any state law. There has not been a ruling in that case, which is pending in Mississippi federal court.

    Similar challenges have succeeded before. In 2014, a Massachusetts federal judge struck down a state law seeking to regulate opioid drugs more stringently than federal law on the grounds that it was preempted.

Those challenges, though, could ultimately end up at the Supreme Court, which is unlikely to strike down the state restrictions.

CAN PATIENTS GET ABORTION PILLS FROM OTHER COUNTRIES?

Yes. Women in states cracking down on telemedicine abortion have increasingly turned to ordering pills online from overseas.

While the practice is not legal, state authorities have said they have no effective way of policing orders from foreign doctors and pharmacies.

https://www.marketscreener.com/news/latest/Explainer-Can-pill-prescriptions-overcome-U-S-state-abortion-bans--40271800/

Transcript: LivaNova earnings call

 https://www.marketscreener.com/quote/stock/LIVANOVA-PLC-24530529/news/LivaNova-PLC-Q1-2022-Earnings-Call-May-04-2022-40271201/

CVS boosts outlook as prescription demand outweighs COVID vaccine dip

 CVS Health boosted its annual forecast after processing more prescriptions and adding hundreds of thousands of customers to its health insurance business in the first quarter. 

During the first three months of the year, the number of prescriptions filled increased 5.1% on a 30-day equivalent basis compared with the same time last year, which was "primarily driven by increased utilization and the impact of a weaker cough, cold and flu season experienced in the prior year," the company announced in its earnings report Wednesday.  

TickerSecurityLastChangeChange %
CVSCVS HEALTH CORP.98.60+2.60+2.71%

At the same time, 674,000 members were added to its health insurance businesses since the end of last year. However, the company noted that its adjusted operating income dropped slightly in the first quarter, partly because medical costs are returning to normal levels.

Still, these factors in part offset the decrease in administering coronavirus vaccines and diagnostic testing. 

Although the company administered more than 8 million COVID-19 vaccines in the first quarter, it was still a significant drop from the 20 million it administered in the last quarter of 2021, when customers sought boosters and many children began getting the shots.

CVS also administered 6 million tests in the first quarter, down from more than 8 million COVID-19 tests in the last quarter of 2021. 

Still, the company's drugstores got a boost from customers buying additional tests as the omicron surge of the virus peaked at the start of the quarter.

Quarterly net income climbed 89% to $2.31 billion. But operating income slipped due to a $484 million settlement the company reached with the state of Florida to settle opioid-related litigation.

Revenue was $76.8 billion, topping Wall Street’s expectations for $75.54 billion. The company said it now expects per-share earnings of between $8.20 and $8.40 this year.

https://www.foxbusiness.com/markets/cvs-boosts-outlook-as-prescription-demand-outweighs-covid-testing-dip