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Tag: Kenvue

  • Tylenol, Kleenex, Band-Aid and more put under one roof in $48.7 billion consumer brands deal

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    Kimberly-Clark is buying Tylenol maker Kenvue in a cash and stock deal worth about $48.7 billion, creating a massive consumer health goods company.

    Shareholders of Kimberly-Clark will own about 54% of the combined company. Kenvue shareholders will own about 46% in what is one of the largest corporate takeovers this year. The deal must still be approved by the shareholders of both companies.

    The combined company will have a huge stable of household brands under one roof, putting Kenvue’s Listerine mouthwash and Band-Aid side-by-side with Kimberly-Clark’s Cottonelle toilet paper, Huggies and Kleenex tissues. It will also generate about $32 billion in annual revenue.

    Kenvue has spent a relatively brief period as an independent company, having been spun off by Johnson & Johnson two years ago. J&J first announced in late 2021 that it was splitting its slow-growth consumer health division from the pharmaceutical and medical device divisions.

    Kenvue has since been targeted by activist investors unhappy about the trajectory of the company and Wall Street appeared to anticipate some heavy lifting ahead for Kimberly-Clark.

    Kenvue’s stock jumped 12% Monday afternoon, while shares of Kimberly-Clark, based outside of Dallas, slumped by nearly 15%.

    Kenvue shares have shed nearly 50% of their value since approaching $28 in the spring of 2023. Morningstar analyst Keonhee Kim said Kenvue’s volatile journey as a public company may have been driven in part by poor execution and a lack of experience operating as a stand-alone business.

    He said the leadership of a more-established consumer products company like Kimberly-Clark could help unlock some of Kenvue’s value.

    He also noted that Kenvue brands include Neutrogena, Benadryl and other names that have been in store consumer health aisles for decades. Kim said he thinks Kimberly-Clark may have seen upside in adding those products.

    “I think that may have made the deal a lot more attractive … especially after the past couple of months of Kenvue’s stock price decline,” he said.

    Kenvue and Tylenol have been thrust into the national spotlight this year as President Donald Trump and Health Secretary Robert F. Kennedy Jr. promoted unproven and in some cases discredited ties between Tylenol, vaccines and the complex brain disorder autism.

    Trump then urged pregnant women against using the medicine. That went beyond Food and Drug Administration advice that doctors “should consider minimizing” the painkiller acetaminophen’s use in pregnancy — amid inconclusive evidence about whether too much could be linked to autism.

    Kennedy reiterated the FDA guidance during a press conference last week. He said that there isn’t sufficient evidence to link the drug to autism.

    “We have asked physicians to minimize the use to when it’s absolutely necessary,” he said.

    Kenvue has continued to push back on the Trump administration’s public statements about Tylenol and acetaminophen, the active ingredient it contains.

    “We strongly disagree with allegations that it does and are deeply concerned about the health risks and confusion this poses for expecting mothers and parents,” Kenvue said in a statement on its website.

    The merger could face other hurdles. Citi Investment Research analyst Filippo Falorni said he is concerned about the deal’s size given the recent history in the sector, particularly given the challenges faced by Kenvue.

    In July, Kenvue announced that CEO Thibaut Mongon was leaving in the midst of a strategic review, with the company under mounting pressure from activist investors unhappy about growth. Critics say Kenvue has relied too much on its legacy brands and failed to innovate.

    Industry analysts also point out the poor track record for mergers involving consumer packaged goods companies. In September, Kraft Heinz said it would break up its decade-old merger. Its net revenue has fallen every year since 2020.

    Kimberly-Clark and Kenvue, like Kraft Heinz, are facing increasing competition from cheaper store brands. In 2024, 51% of toilet paper and other household paper products sold in the U.S were store brands, according to Circana, a market research company, while store brands held a 24% share of sales of health products, including medications and vitamins.

    On Monday, a bottle of 100 extra-strength Tylenol caplets cost $10.97 on Walmart’s website. A bottle of 100 extra-strength acetaminophen caplets from Walmart’s Equate brand cost $1.98.

    Inflation drove some of that buyer behavior, Circana said. Shoppers are also shifting their purchases to stores with more private-label brands, like Aldi and Costco. And stores are improving their offerings and adding more of them; last year, Walmart and Target both launched new store brands to complement their existing ones.

    Still, both Kimberly-Clark and Kenvue make name-brand products in segments where consumers are less likely to shift to store brands, including hair care, skin care, feminine products and mouth care, according to Circana. Kenvue owns brands like Aveeno and Neutrogena, for example, while Kimberly-Clark makes Kotex and Depend.

    Kimberly-Clark Chairman and CEO Mike Hsu will be chairman and CEO of the combined company. Three members of the Kenvue’s board will join Kimberly-Clark’s board at closing. The combined company will keep Kimberly-Clark’s headquarters in Irving, Texas, but there will be significant operations around Kenvue facilities and locations as well.

    The deal is expected to close in the second half of next year. It still needs approval from shareholders of both both companies.

    Kenvue shareholders will receive $3.50 per share in cash and 0.14625 Kimberly-Clark shares for each Kenvue share held at closing. That amounts to $21.01 per share, based on the closing price of Kimberly-Clark shares on Friday.

    Kimberly-Clark and Kenvue said that they identified about $1.9 billion in cost savings that are expected in the first three years after the transaction’s closing.

    ___

    AP Health Writer Tom Murphy contributed to this report.

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  • Texas attorney general sues Tylenol makers, claiming links to autism

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    (CNN) — Texas Attorney General Ken Paxton has filed a lawsuit against the companies Johnson & Johnson and Kenvue, claiming that they “deceptively” marketed Tylenol to pregnant mothers and that the medication is tied to an increased risk of autism. Kenvue said in a statement that the medication is safe and the company will “vigorously defend” against the claims.

    The lawsuit, dated Monday and filed in the District Court of Panola County, Texas, comes about a month after President Donald Trump publicly claimed that the use of Tylenol during pregnancy can be associated with an increased risk of autism in the child, despite decades of evidence that the medication is safe.

    “Big Pharma betrayed America by profiting off of pain and pushing pills regardless of the risks. These corporations lied for decades, knowingly endangering millions to line their pockets,” Paxton, the state’s Republican attorney general, who is also running for US Senate, said in a news release Tuesday. “By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.”

    The lawsuit claims that Johnson & Johnson and Kenvue violated the Texas Deceptive Trade Practices-Consumer Protection Act because they knew that acetaminophen, the active ingredient in Tylenol, “is dangerous to unborn children and young children” and “they hid this danger and deceptively marketed Tylenol as the only safe painkiller for pregnant women,” according to the lawsuit.

    The state’s lawsuit has requested a jury trial and, in part, calls for the companies to “destroy any marketing or advertising materials in their possession that represent, directly or indirectly, that Tylenol is safe for pregnant women and children.” The lawsuit also calls for the companies to pay civil penalties to the state in the amount of $10,000 per violation.

    “Nothing is more important to us than the health and safety of the people who use our products. We are deeply concerned by the perpetuation of misinformation on the safety of acetaminophen and the potential impact that could have on the health of American women and children,” Kenvue said in an emailed statement Tuesday.

    “We will vigorously defend ourselves against these claims and respond per the legal process. We stand firmly with the global medical community that acknowledges the safety of acetaminophen and believe we will continue to be successful in litigation as these claims lack legal merit and scientific support,” the statement said in part. “We also encourage expecting mothers to speak to their health professional before taking any over-the-counter medication, including acetaminophen, as indicated on our product label for Tylenol®.”

    In a statement, a Johnson & Johnson company spokesperson said it “divested its consumer health business years ago, and all rights and liabilities associated with the sale of its over-the-counter products, including Tylenol (acetaminophen), are owned by Kenvue.”

    Texas Attorney General Ken Paxton filed a lawsuit that says makers of Tylenol “deceptively marketed” the medication as the “only safe painkiller for pregnant women.” Credit: Mandel Ngan/AFP / Getty Images via CNN Newsource

    Experts have said there are multiple causes of autism, and the science showing a connection between autism and Tylenol is not settled.

    “Suggestions that acetaminophen use in pregnancy causes autism are not only highly concerning to clinicians but also irresponsible when considering the harmful and confusing message they send to pregnant patients, including those who may need to rely on this beneficial medicine during pregnancy,” Dr. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, said in a statement in September.

    “Acetaminophen is one of the few options available to pregnant patients to treat pain and fever, which can be harmful to pregnant people when left untreated. Maternal fever, headaches as an early sign of preeclampsia, and pain are all managed with the therapeutic use of acetaminophen, making acetaminophen essential to the people who need it,” he said. “The conditions people use acetaminophen to treat during pregnancy are far more dangerous than any theoretical risks and can create severe morbidity and mortality for the pregnant person and the fetus.”

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    Jacqueline Howard and CNN

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  • Tylenol’s maker pushes back against possible label change linking pain reliever’s use in pregnancy to autism

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    (CNN) — Kenvue, the American company that makes Tylenol, says the US Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible connection between its use in pregnancy and diagnoses of autism or ADHD in children.

    Kenvue says that acetaminophen, the generic name for the painkiller and fever reducer also known as paracetamol, is “one of the most studied medicines in history” and that “adoption of the proposed labeling revisions would be arbitrary, capricious, and contrary to law.”

    Tylenol generates $1 billion annually for the company and is considered the company’s biggest-selling brand, according to the brokerage Morningstar.

    The current label instructs people who are pregnant or breastfeeding to “ask a health professional before use.”

    The push for a label change came after President Donald Trump held a news conference last month in which he told pregnant women who are in pain to try to “tough it out” instead of taking Tylenol, even though acetaminophen is the one over-the-counter pain reliever considered safe for pregnant people to take.

    The president claimed without evidence that Tylenol use during pregnancy was linked to a “very increased risk of autism.”

    “Fight like hell not to take it,” Trump urged.

    Most people use acetaminophen at some point during their pregnancy, studies show. Other common pain or fever treatments like ibuprofen or regular-dose aspirin can increase the risk of serious complications when used during pregnancy.

    Untreated pain or fever can be dangerous for the mother and the fetus, possibly leading to problems like miscarriage, birth defects or high blood pressure.

    Beginning the process to change the safety label on acetaminophen products was just one action the Trump administration planned to take.

    US Health and Human Services Secretary Robert F. Kennedy Jr. said at the news conference last month that his agency would launch a public service campaign about the issue.

    The FDA also sent a letter to physicians saying that the choice to take Tylenol “still belongs with parents” but that use during pregnancy may cause an “increased risk of neurological conditions such as autism and ADHD in children.”

    However, the letter also noted that “a causal relationship has not been established” and that studies about a link are “contradictory.”

    The Informed Consent Action Network, an anti-vaccine nonprofit with close ties Kennedy, said in a letter dated the day of Trump’s news conference that it had filed a citizen’s petition with the FDA. Such filings are a way for individuals, industry or consumer groups to ask the agency to take action on a specific issue.

    The petition says that because of the “urgent public health implications,” the FDA should act quickly to add a more detailed warning to the labels of over-the-counter drug products that contain acetaminophen to spell out that “studies show that frequent use of this product during pregnancy may increase your child’s risk of neurodevelopmental disorders, including autism spectrum disorder and attention-deficit/hyperactivity disorder.”

    On Friday, Kenvue asked the FDA to deny the petition, saying that suggested changes to the label are unsupported by scientific evidence “and would represent an unexplained departure from FDA’s longstanding position on acetaminophen during pregnancy.”

    The company said it met with Kennedy in early September, after the HHS secretary reached out to say he believed there was a connection between acetaminophen use during pregnancy and autism, and it told him there was no such link.

    An HHS spokesperson said Monday that the FDA doesn’t comment on product-specific matters.

    The FDA website on acetaminophen has not changed to reflect the Trump administration’s views. It says it was last updated in August and specifies, “to date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.”

    Acetaminophen has been studied for decades to find any problems it may cause in pregnancy, according to the American College of Obstetricians & Gynecologists. Not one reputable study has concluded that acetaminophen use in any trimester of pregnancy causes neurodevelopmental disorders in children.

    That group points to a study published last year of more than 2 million children that found no significant associations between acetaminophen use during pregnancy and children’s risk of autism, ADHD or intellectual disability.

    Another study published in August analyzed 46 studies on acetaminophen use during pregnancy and neurodevelopmental disorders. Six of the studies specifically examined acetaminophen use and autism. Overall, the analysis concluded that there was “strong evidence of an association” between acetaminophen use during pregnancy and autism, but the authors were careful to say that the paper could only show an association, the research could not show that acetaminophen caused autism.

    “We recommend judicious acetaminophen use — lowest effective dose, shortest duration — under medical guidance, tailored to individual risk–benefit assessments, rather than a broad limitation,” the researchers wrote in that analysis.

    After the Trump news conference, medicine regulatory agencies for the European Union and the United Kingdom and Health Canada quickly issued statements confirming that taking the over-the-counter pain-reliever during pregnancy remains safe.

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    Jen Christensen and CNN

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  • In meeting with RFK Jr., CEO of Tylenol maker stresses there is no clear link between medication and autism, WSJ reports

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    (CNN) — The interim CEO and director of drugmaker Kenvue, which makes the common pain reliever Tylenol, met with US Health and Human Services Secretary Robert F. Kennedy Jr. privately this week in an attempt to dissuade him from including the drug as a potential cause of autism in an upcoming report, the Wall Street Journal reported Friday.

    HHS officials have announced that the department is conducting a study of the causes of autism, and recent reports suggest that HHS will issue an analysis that links the development of autism to the mother’s use of Tylenol during pregnancy, among other potential causes. The report is expected to be released this month.

    Tylenol is a brand name for the pain reliever acetaminophen.

    The American College of Obstetricians and Gynecologists has said that there is no proof of a causal link between Tylenol use in pregnancy and a child’s diagnosis of autism.

    In a statement Friday, a spokesperson for HHS said that officials routinely meet with stakeholders for their perspectives.

    “We are using gold-standard science to get to the bottom of America’s unprecedented rise in autism rates. HHS officials regularly meet with stakeholders to get their perspective about our agenda to Make America Healthy Again. Any claims regarding this or any other specific meeting, however, are nothing more than speculation unless officially discussed by HHS,” HHS spokesperson Andrew Nixon said.

    Kenvue said in its own statement Friday that it engaged in a “scientific exchange” with HHS officials but that it is concerned about the forthcoming HHS report potentially causing confusion.

    “As we would with any regulator who reaches out to us, we engaged in a scientific exchange with the Secretary and members of his staff as it relates to the safety of our products. Our position remains the same: in evaluating available science, we continue to believe that taking acetaminophen does not cause autism, and global health regulators, independent public health organizations, and medical professionals agree,” Kenvue said.

    “We are concerned about the potential for consumer confusion and misinformation about the safety of taking acetaminophen during pregnancy, particularly as cough, cold and flu season approaches,” the statement said. “We encourage regulators to continue to objectively review the scientific evidence on this issue, as they have done for many years. FDA has been looking at this issue for over a decade and has conducted multiple reviews since 2014 and continues to recommend acetaminophen in pregnancy and maintain the same labeling requirements.”

    The company also recommended that expecting mothers speak to their health care provider before taking any over-the-counter medications, including acetaminophen, which is also indicated on the product label.

    Tylenol is widely used in the US, including during pregnancy. The US Food and Drug Administration recommends against using other common pain relievers, nonsteroidal anti-inflammatory drugs, in pregnancy at 20 weeks or later because they can result in low amniotic fluid.

    “There is no clear evidence that proves a direct relationship between the prudent use of acetaminophen during pregnancy and fetal developmental issues,” Dr. Christopher Zahn, chief of clinical practice for the American College of Obstetricians and Gynecologists, said in a statement this month. “Neurodevelopmental disorders, in particular, are multifactorial and very difficult to associate with a singular cause. Pregnant patients should not be frightened away from the many benefits of acetaminophen, which is safe and one of the few options pregnant people have for pain relief.”

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    Jacqueline Howard, Deidre McPhillips and CNN

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  • J&J Dividend Decision Shows Power of Free Cash Flow

    J&J Dividend Decision Shows Power of Free Cash Flow

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    Johnson & Johnson


    plans to maintain its quarterly dividend at $1.19 a share even after separating its


    Kenvue


    over-the-counter drug and pers…

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  • Johnson & Johnson Maintains Dividend After Kenvue Spinout

    Johnson & Johnson Maintains Dividend After Kenvue Spinout

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    Johnson & Johnson


    on Wednesday issued new financial guidance after spinning out the consumer-health company


    Kenvue


    While its earnings and sales projections were lowered on an absolute basis, the company is maintaining its dividend and expects to increase its revenue at a faster pace.

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  • J&J Investors Can Convert Only a Fraction of Shares Into Kenvue Stock

    J&J Investors Can Convert Only a Fraction of Shares Into Kenvue Stock

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    Johnson & Johnson


    $35 billion exchange offer for


    Kenvue


    that expired last Friday was substantially oversubscribed. The result is that participating J&J holders will be able to convert only a fraction of their shares for Kenvue stock.

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  • J&J’s Kenvue Deal Could Be Too Popular. What Happens if It Is.

    J&J’s Kenvue Deal Could Be Too Popular. What Happens if It Is.

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    Johnson and Johnson


    $40 billion exchange offer for shares in


    Kenvue


    is likely to generate strong interest from the healthcare company’s shareholders, resulting in participants being able to swap only a portion of their J&J stock. 

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  • J&J Investors Must Decide If They Want Kenvue Stock

    J&J Investors Must Decide If They Want Kenvue Stock

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