Neogen Cuts Guidance

 On Tuesday, Neogen Corporation (NASDAQ:NEOG) shares are trading lower after the company reported worse-than-expected third-quarter 2024 earnings and cut 2024 guidance.

The company reported sales of $228.8 million, up 4.8% year over year, missing the consensus of $230.01 million. Core revenue growth was 6.2%.

Neogen’s third quarter adjusted EPS was $0.12 flat Y/Y but below the consensus of $0.14.

Gross margin was 51.1% in the third quarter of fiscal 2024, compared to 49.5% in the same quarter a year ago. This increase is primarily due to increased sales of higher-margin products in the Company’s Food Safety segment.

Third-quarter Adjusted EBITDA was $52.7 million, representing an Adjusted EBITDA Margin of 23.0%, compared to $51.3 million and a margin of 23.5% a year ago.

This drop in margin was primarily due to higher operating expenses compared to the prior-year period, reflecting additions to accommodate the integration of the former 3M Food Safety Division.

Guidance: Neogen cuts its fiscal year 2024 sales guidance to $910 million—$920 million, down from prior guidance of $935 million—$955 million versus the consensus of $938.16 million.

The lower guidance reflects a slower-than-anticipated recovery of order fulfillment rates, impacting the ability to meet end-market demand.

Neogen lowers adjusted EBITDA guidance to $210 million-$215 million versus prior guidance of $230 million-$240 million.

William Blair writes that the revised guidance will lower investor confidence in the company’s ability to meet its original pro forma targets, a key tenet of their bullish thesis.

While there are a few positives (Petrifilm seems to be leading growth and animal safety rebounded after quarters of declines), William Blair says the small miss combined with another period of lowered expectations will put the stock further in the penalty box, especially since key metrics like EBITDA are sequentially worsening rather than improving despite the high margin contributions of the 3M business.

https://finance.yahoo.com/news/food-animal-safety-focused-neogen-164057976.html

Exercise Option for Hip OA

 Neuromuscular exercise was as effective as progressive resistance training (PRT) for helping people with osteoarthritis (OA) of the hip improve functional ability and reduce pain, a cluster-randomized trial showed.

Patients assigned to neuromuscular exercise, which emphasizes balance and postural control, averaged 1.5 more chair stands performed in 30 seconds (30s-CST) after 12 weeks -- the exact same increase seen with 12 weeks of resistance training in the unblinded 160-patient trial, according to Troels Kjeldsen, MSc, of Aarhus University in Denmark, and colleagues.

Additionally, mean Hip Disability and Osteoarthritis Outcome Score (HOOS)opens in a new tab or window values for pain increased by 9.3 points with neuromuscular exercise versus 8.6 points with resistance training (difference -0.7, 95% CI -5.3 to 4.0), reflecting decreases in pain intensity, the researchers reported in Annals of Internal Medicineopens in a new tab or window.

HOOS measures of hip-related quality of life also showed the programs to be equivalent, Kjeldsen and colleagues indicated.

This appears to be the first study to compare neuromuscular exercise with other types of physical therapy for mild-moderate hip OA.

"Of note, PRT is considered the most potent intervention for increasing muscle mass, strength, and power, features that are markedly hampered in hip OA and closely related to physical function," the researchers explained, such that this form of exercise could be expected to be more effective than less intensive programs such as neuromuscular exercise. On the other hand, previous studies had found improvements in pain and function with neuromuscular exercise. One of theseopens in a new tab or window was a randomized trial comparing neuromuscular exercise with usual care, but it was structured as "prehabilitation" for patients scheduled for joint replacement and thus had relatively advanced OA.

In the new trial, candidacy for hip arthroplasty was one of the exclusion criteria (along with severe obesity and morning stiffness regularly lasting 30 minutes or more). Inclusion criteria were a clinical diagnosis of hip OA with a pain episode within the previous 2 weeks that patients rated at 3 or more on a 10-point scale.

Patients were recruited from five hospitals and 10 physical therapy clinics in Denmark. As this was an open-label, cluster-randomized trial, randomization was performed at the site level. In the end, 78 patients were assigned to neuromuscular exercise and 82 to PRT.

Just under two-thirds of participants were women. Mean patient age was about 65, and body mass index values averaged 28. Some 55% had symptoms lasting more than 2 years. About half had received no prior treatment other than over-the-counter medications. Approximately 40% reported that they still engaged in at least moderate physical activity totalling 150 minutes or more per week.

Each intervention was delivered in twice-weekly, hour-long sessions. Neuromuscular exercise comprised 10 different exercises "emphasizing sensorimotor control and functional stability," the authors explained, with progression through four difficulty levels. Resistance training involved five exercises targeting muscles in the knee and hip joints, also progressively more intense as the program continued. At the third level, participants were instructed to continue until they literally could not perform the exercise anymore; if the target number of repetitions was completed, the intensity was raised 2%-10%.

At baseline, mean 30s-CST totals were 11.6 in the neuromuscular exercise group and 11.3 among those assigned to PRT. Other performance capabilities at baseline included (all means):

• 40-meter fast walking time: 24.4 and 24.9 seconds, respectively
• 9-step stair climb time: 10.4 seconds for both
• Affected leg extension power: 1.67 and 1.50 W/kg
• HOOS pain: 58.9 and 57.5
• HOOS quality of life: 47.1 and 43.7
• HOOS activities of daily living: 64.7 and 63.4

For all of these, and other secondary measures, patients in both groups showed modest improvements, and the differences did not approach statistical significance, although numerical trends generally favored resistance training. No safety issues were identified with either program.

Only about half of patients showed at least 80% adherence and fidelity to the scheduled programs -- slightly more in the PRT group than those assigned to neuromuscular exercise -- but improvements were only a little greater in a per-protocol analysis versus the primary intention-to-treat population, Kjeldsen and colleagues reported.

Limitations to the study included the specific content of each program, any of which could be modified with potentially improved (or worsened) results. "Future trials should identify responders to exercise in hip OA and investigate the underlying mechanisms, which are largely unknown," Kjeldsen's group concluded. "High-quality trials exploring optimal content of exercise are also warranted."

The study's conduct in Denmark (racial-ethnic distributions were not reported but it's probable that participants were overwhelmingly white) and its open-label design were additional limitations.

Disclosures

The trial was funded by the Independent Research Fund Denmark, Fysioterapipraksisfonden, Helsefonden, Aarhus University, Region Zealand, the Association of Danish Physiotherapists, Andelsfonden, and Familien Hede Nielsens Fond.

Authors reported relationships with Biogen Idec, Sanofi, Nestlé Health Science, and Stryker, all unrelated to the current work.

Primary Source

Annals of Internal Medicine

Source Reference: opens in a new tab or windowKjeldsen T, et al "Progressive resistance training or neuromuscular exercise for hip osteoarthritis: A multicenter cluster randomized controlled trial" Ann Intern Med 2024; DOI: 10.7326/M23-3225.

https://www.medpagetoday.com/rheumatology/arthritis/109564

New WIC Rules Include More Money for Fruits, Veggies, and Expand Food Choices

 The federal program that helps pay for groceries for millions of low-income mothers, babies, and young kids will soon emphasize more fruits, vegetables, and whole grains

opens in a new tab or window, as well as provide a wider choice of foods from different cultures.

The final rule changes for the program known as the Supplemental Nutrition Program for Women, Infants, and Children (WICopens in a new tab or window) were announced Tuesday by the Food and Nutrition Service, and will take effect within 2 years with some exceptions.

Last updated a decade ago, the new WIC rules make permanent a bump in monthly cash vouchers for fruits and vegetables -- something first enacted during the COVID-19 pandemic. Shoppers can also add canned fish, fresh herbs, and lactose-free milk to their carts, among other changes. The voucher piece will take effect by June, officials said.

"It places a heavy emphasis on fruits and vegetables, which we think is an important component of a healthy diet," Agriculture Secretary Tom Vilsack said in an interview. "It's designed to fill the nutrition gaps that are often in the diets of many of us."

The WIC program served an average of about 6.6 million low-income Americans a month in 2023 at a cost of a little more than $7 billion. It's designed to supplement the food budgets for pregnant, nursing, and postpartum women, as well as to feed babies and young kids up to age 5. That's done by providing vouchers to mothers and children who qualify and specifically listing the amount and types of food they can buy.

But officials have said only about half of those eligible are enrolled in WIC.

Under the new rules, fruits and vegetable vouchers in 2024 will provide $26 per month for kids ages 1 through 4; $47 per month for pregnant and postpartum women; and $52 for breastfeeding women. The changes also expand access to whole grains like quinoa, wild rice, and millet and to foods such as teff and whole wheat naan. They also remove or reduce monthly allowances for juice and cut back on allowances for milk.

Food plans in the program are based on recommendations from the National Academies of Science, Engineering, and Medicine and the federal 2020-2025 Dietary Guidelines for Americans.

The plan failed to include a change requested by top allergists in the U.S. that would have added peanut products to foods allowed for babies ages 6 months to 11 months to help prevent peanut allergies.

Researchopens in a new tab or window published in 2015 showed early introduction to peanut foods can reduce the chance of allergy development in kids who are at high risk, and several U.S. guidelines suggest exposing high-risk children to peanuts as early as 4 months.

Adding peanut to the WIC guidelines may have prevented more than 34,000 infants from developing a peanut allergy, said Gideon Lack, MBBCh, of King's College London, who led the study. But federal nutrition officials concluded that the change was "outside the scope" of the final rule.

Ruchi Gupta, MD, MPH, a pediatrics professor and child allergy expert at Northwestern University, called the omission "disappointing." She noted that WIC enrollees often include children of color who are at higher risk of developing dangerous peanut allergies.

The decision "can only increase disparities we are already seeing in food allergy prevalence," she said.

https://www.medpagetoday.com/primarycare/dietnutrition/109570

Accelerated Aging Linked to Recent Increase in Early-Onset Solid Tumors

 Levels of aging-associated biomarkers increased significantly in people born in 1965 or later, coinciding with subsequent increases in early-onset cancers, a large prospective-cohort study showed.

As compared with people born from 1950 through 1954, individuals born in 1965 or later had a 17% higher likelihood of accelerated aging. Accelerated aging had a significant association with early-onset solid tumors, particularly lung, gastrointestinal, and uterine cancers. The data showed little association between accelerated aging and late-onset cancers.

The findings suggest accelerated aging may contribute to recent increases in early-onset cancers, defined as occurring in adults younger than 55, reported Ruiyi Tian, MPH, of Washington University in St. Louis, at the American Association for Cancer Research (AACR)opens in a new tab or window annual meeting.

"Accelerated aging may emerge as a risk factor for early-onset solid cancers, especially lung, gastrointestinal, and uterine cancers," Tian said during an AACR press briefing. "These findings require validation in diverse populations. Mechanistic studies are needed to understand the association between accelerated aging and early-onset cancers. Future studies should also help guide the development of novel preventive and therapeutic modalities."

Describing the findings as "obviously very concerning information," press briefing moderator Shivaani Kummar, MD, of Oregon Health and Science University in Portland, questioned Tian about the study's limitations. Specifically, she asked whether investigators looked at the relationship between accelerated aging and other diseases, besides cancer. Kumar also wondered about factors or behaviors that might alter the results, such as smoking and tobacco cessation.

The study was limited to early-onset cancer, said Tian. Investigators adjusted for multiple confounders, including alcohol use, tobacco use, and demographic variables. With respect to lung cancer, an age-adjusted model resulted in an even stronger association with accelerated aging, which was not altered by adjustment for smoking.

"One concern is that we would like to validate the findings in more diverse populations, because right now we're using data limited to people in the U.K.," said Tian. "We would like to see this validated in other countries, other cohorts, especially in minorities, who are not normally well represented in these large population databases."

In response to another question, Tian said accelerated aging is a biological process and does not translate into a chronological number, such as 5 years older.

By way of background, Tian said interest in accelerated aging and cancer risk evolved from recent worldwide increases in early-onset cancers. From 1990 to 2019, global incidence of early-onset cancersopens in a new tab or window increased substantially. The increase has been more prominent in recent birth cohortsopens in a new tab or window. The increased frequency of early-onset cancers has coincided with an increased prevalence of accelerated aging, but the association between the two has not been extensively studied.

To investigate the potential link between accelerated aging and early-onset cancers, Tian and colleagues analyzed data from the U.K. Biobankopens in a new tab or window, a long-term prospective study of the contributions of genetics and environmental exposures to the development of diseases. The analysis included 148,724 participants ages 37 to 54.

To calculate biological age, investigators determined baseline values of nine serum biomarkers: albumin, alkaline phosphatase, creatinine, C-reactive protein, glucose, mean corpuscular volume, red cell distribution width, white blood cell count, and lymphocyte proportion. They analyzed the biomarker values by means of the PhenoAge algorithmopens in a new tab or window to quantify accelerated aging by birth cohort and then examined associations with early-onset cancers.

The analyses showed that people born after 1965 had a 17% increased likelihood of accelerated aging as compared with those born from 1950 through 1954. By multivariable analysis, accelerated aging was associated with a small, but significantly increased risk of early-onset cancers (HR per standard deviation 1.08, 95% CI 1.04-1.12, P<0.001). The overall result was driven by lung (HR 1.42, 95% CI 1.19-1.70), gastrointestinal (HR 1.22, 95% CI 1.11-1.34), and uterine (HR 1.36, 95% CI 1.13-1.64) cancers.

After stratifying accelerated aging values into tertiles, investigators found that the risk of lung, gastrointestinal, and uterine cancers increased with higher aging values. Comparison of the highest and lowest tertiles resulted in the following hazard ratios:

• Lung: HR 2.02 (95% CI 1.13-3.62)
• Gastrointestinal: HR 1.62 (95% CI 1.27-2.08)
• Uterine: HR 1.83 (95% CI 1.10-3.04)

Accelerated aging had weaker associations with late-onset gastrointestinal (HR 1.16) and uterine cancers (HR 1.23), and no association with late-onset lung cancer.

"By examining the relationship between accelerating aging and the risk of early-onset cancers, we provide a fresh perspective on the shared etiology of early-onset cancers," said Tian. "If validated, our findings suggest that interventions to slow biological aging could be a new avenue for cancer prevention."

Disclosures

Tian reported no relevant relationships with industry.

Kummar disclosed relationships with Bayer, Genome & Co., Genome Insight, Gilead Sciences, Harbour BioMed, Mundipharma, Oxford Bio Therapeutics, Seagen, SpringWorks Therapeutics, Mirati Therapeutics, and PathomIQ.

Primary Source

American Association for Cancer Research

Source Reference: opens in a new tab or windowTian R, et al "Rising accelerated aging in recent generations associated with elevated risk of early-onset cancers" AACR 2024; Abstract 846.

https://www.medpagetoday.com/meetingcoverage/aacr/109586

Enliven Therapeutics Well-Positioned, With Conservative Trading Levels: Mizuho

 Mizuho Securities initiated coverage on Enliven Therapeutics Inc ELVN, a clinical-stage precision oncology company focused on discovering and developing next-generation small molecule kinase inhibitors.

The company’s lead product, ELVN-001, is under development for Chronic myelogenous leukemia (CML), a slow-progressing blood cancer that begins in the bone marrow.

Thursday, Enliven Therapeutics will host a webcast to discuss initial proof of concept data on ELVN-001.

Additional Phase 1 data is expected in 2025, but Mizuho expects late 2024 could also be possible.

Mizuho writes that the CML tyrosine kinase inhibitors (TKI) market is established, ~$13 billion-$14 billion worldwide, and it has been growing since 2001 when Novartis AG’s NVS Gleevec (imatinib) became the first TKI to receive regulatory approval. 

Over the last two decades, there have been four generations of TKIs approved for this disease. 

However, approved TKIs are still limited in their design and, therefore, still produce various safety/tolerability issues. 

The analyst writes that Enliven is well-positioned to address these shortcomings, and if it succeeds in doing so, this should garner an alpha opportunity for investors. 

Mizuho initiates with a Buy rating and a price target of $34.

Mizuho says that in the past two decades, even the least successful CML TKI has consistently generated at least $500 million in sales at its peak. 

Additionally, the prevalence of CML is increasing, with the global market currently valued at around $13-14 billion in branded sales. 

Considering this, the current trading value of ELVN, at around 1x its projected minimum peak sales in this market, appears to be quite conservative. 

Typically, investors are comfortable with multiples of 2-4x the expected peak sales for biotech companies showing growth potential. Therefore, the trading levels for ELVN-001 seem cautious.

https://www.benzinga.com/analyst-ratings/analyst-color/24/04/38170122/enliven-therapeutics-well-positioned-with-conservative-trading-levels-analyst-says

Over 500,000 Democratic Voters Have Cast Primary Protest Votes Against Biden

 There are clear indicators that large swathes of prior Biden voters don't intend to vote for him this next time around versus Trump. The latest example is that the "uncommitted" campaign is gaining steam, having garnered the support of more than a half-million Democrat voters.

The initiative organized by dissident Democrats outraged over President Biden's handling of the Israel-Gaza war has sent a powerful shot across the bow of his presidential campaign, and the movement didn't even exist at the start of the 2024 primary season. Yet The Nation says that so far in total 530,502 people have voted "uncommitted" or "uninstructed" where it’s available on the ballot.

The initiative was first implemented in the key swing state of Michigan, resulting in over 100,000 people there registering their vote as "uncommitted". The state has a huge Arab and Muslim demographic.

The Nation has documented that the movement is spreading fast, and it should be a huge worry for Biden campaign strategists: 

The campaign has won enough votes to secure Democratic National Convention delegates from Minnesota (14), Hawaii (7), Michigan (2), and, according to local news reports, Washington (2). And notable levels of support for the effort in must-win battleground states such as Wisconsin signal that the president’s campaign cannot neglect the fact that a substantial portion of the base that must be mobilized this fall is crying out for the United States to back an immediate, permanent cease-fire in Gaza, where Israel’s assault has cost more than 33,000 lives.

According to more from AntiWar.com, which has been closely following the movement:

Last week, 48,091 votes were cast for “uninstructed” in the Wisconsin primary. The turnout far exceeded organizers’ expectations, as their goal was to secure 20,682, the margin of victory for Biden in Wisconsin for the 2020 election.

The opposition to Biden was strongest in the area of Wisconsin where University of Wisconsin–Madison students reside, historically a Democratic stronghold. In that area, 30% of voters cast ballots for “uncommitted,” something Rep. Mark Pocan (D-WI) called “a big, f**king deal.”

Meanwhile, there's also been an intensifying divide among Democrats over whether to halt defense aid to Israel,  a debate which only intensified in the wake of the Israel Defense Forces (IDF) attack on the World Central Kitchen convoy in Gaza, which left seven international workers dead, including an American.

This increased fragmentation of Biden's base has been on display in recent days too, given former House Speaker Nancy Pelosi - still very influential among Dems - has publicly come out against Biden's policy to continue arming Israel. The issue is entering the heart of the Democratic establishment, threatening unity.

Axios reported that she "signed onto a call by progressive members of Congress for the U.S. to stop transferring weapons to Israel over a strike that killed seven aid workers in Gaza."

https://www.zerohedge.com/geopolitical/over-500000-democratic-voters-have-cast-primary-protest-votes-against-biden

‘Social and emotional learning’ is another reason why we need school choice

 According to the Collaborative for Academic, Social and Emotional Learning (CASEL), social and emotional learning (SEL) is “the process through which all young people and adults acquire and apply the knowledge, skills, and attitudes to develop healthy identities, manage emotions and achieve personal and collective goals, feel and show empathy for others, establish and maintain supportive relationships, and make responsible and caring decisions.” This alleged “process” can also “help to address various forms of inequity and empower young people to and adults to co-create thriving schools and contribute to safe, healthy, and just communities.”  

Several words in CASEL’s definition of SEL should alarm those who are skeptical about the wisdom of allowing the public school system to establish itself as the primary actor in the social and emotional formation of our children. The development of “healthy identities” and “supportive relationships,” the co-creation of “thriving schools,” and the lionization of “just communities” are buzz words for leftist ideology.  

Of course, we all want health, support and justice for our children. But the majority of American parents define these goods differently than today’s SEL activists and educators do. 

For those endorsing and implementing SEL in schools, healthy identities involve obsession with race and gender; supportive relationships are ones in which feelings trump facts and the feelings of “the oppressed” trump those of “the oppressor;” and “just communities” are ones that sacrifice the real interests of victims to the perceived interests of victimizers. These ideas are based on ideologically biased definitions of health, support and justice that are endemic in today’s universities—which do ever less educating (especially of future K-12 educators) and ever more indoctrination in unpopular lies. 

Of course, I want my children to be confident in who they are; but like most American parents of all races, I believe that true confidence comes from an identity predicated on virtues and capabilities, not on immutable characteristics. Yes, I want my children to feel supported; but like most American parents, I believe that supportive relationships are those that inspire the growth of strengths, not the codification of and identification with weaknesses. Absolutely, I want my children to pursue and expect justice for themselves and others; but, like most American parents, I believe that there can be no justice without order.  

My understanding of true social and emotional learning reflects my values. I teach my values to my children at home. I also, like most families with the capacity to do so, send my children to a school that, more or less, reflects those values. This means opting out of public school in my deep blue zip code. I fear that it would also mean opting out of public school in many red zip codes today, as too many public schools in all zip codes are more reflective of teachers’ unions values than of parents’ values.   

The problem with SEL, beyond its total opposition to the true social and emotional wellness that we all want for our children, is its imposition upon children whose parents do not agree with its premises or aims. That these families are disproportionately minority and low-income—and therefore forced to rely on schools run by teachers’ unions led by people who have not only no interest in children learning math but also great interest in integrating the unpopular values of SEL into math class—is a national disgrace.  

It’s a disgrace that can only be ended by freeing those parents without means from the insult that the teachers unions are currently adding to injury: not only will we fail to teach your child anything about reading, but we will furthermore introduce, among the materials that we won’t teach them to read, ideas you do not agree with about why reading is for wealthy white people anyway.  

So long as teachers’ unions retain their stranglehold on the K-12 education system and the politicians that control it, this will never happen. So much for just communities.  

Elizabeth Grace Matthew is a visiting fellow at Independent Women’s Forum. Her work has appeared in outlets including USA Today, Deseret News, Law and Liberty, and The Dispatch.  

https://thehill.com/opinion/4583074-social-and-emotional-learning-is-another-reason-why-we-need-school-choice/