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When Take-Two hit $12B Zynga deal in 2022, casual games peaked, Apple introduced ATT, but mobile game market fell

—  Video-game giant’s push into smartphone titles was expensive and late. 

 

 

Cecilia D’Anastasio / Bloomberg:

 

—  Excitement over the upcoming release of Grand Theft Auto VI is letting publisher Take-Two Interactive Software Inc. deflect investor attention from a big problem: its $12 billion foray into the shrinking mobile-games business.

With just a small presence in the fastest-growing segment of video games — titles played on smartphones — Take-Two splurged last year on Zynga, known originally for Facebook games like FarmVille and Words With Friends. It was the biggest deal ever in video games and boosted revenue from mobile titles to half of Take-Two’s $5.3 billion in annual sales.

 

Unfortunately for Take-Two and longtime Chief Executive Officer Strauss Zelnick, the deal closed just as the mobile-games business was heading into a downturn. With the end of Covid-19 restrictions, consumers who had embraced casual games during the pandemic turned to other diversions. At the same time, Apple Inc. built new privacy features into its software that made it harder for Zynga to attract new players.

“They closed the deal, and the mobile industry spent the next 18 months correcting,” said Doug Creutz, an analyst at Cowen Group who nonetheless recommends buying Take-Two shares because of its other titles, including prospects for GTA VI.

Since the spring of 2022, sales from Zynga’s five highest-grossing games have fallen 23%, according to researcher SensorTower. It’s part of a broad decline in the $90.4 billion mobile-games market that began in 2021 and is expected to let up starting next year, according to researcher NewZoo. Based on Take-Two’s own estimates, Zynga will finish this fiscal year with sales down about 5% from 2021.

 

Mobile Gaming Hits the Skids

Mobile gaming sales will recover slowly from a post-Covid hangover

Source: NewZoo

Zynga’s pipeline offers little encouragement. After putting out an average of seven games a year over the last decade, the company released just three titles in 2023. And just two new releases are on the calendar for the next 12 months, according to Take-Two’s latest earnings report. That includes a Star Wars smartphone game that’s been delayed at least three times

“Our vision for mobile is to be the largest mobile gaming company in the world, based on market share,” Alan Lewis, a company spokesman, said in an email. Take-Two is investing in new intellectual property and has a growing mobile ad business that, he said, “enables us to monetize nearly all of our players, which is a distinguishing characteristic vs. other mobile companies.”

Take-Two was among the last of the major publishers to scoop up a mobile-games company. The Zynga purchase, financed with cash and stock, provided a stable of proven titles. The goal was to prepare the company for the coming hegemony of mobile gaming.

But after soaring to new highs during the pandemic, mobile-gaming revenue fell by 7% industrywide in 2022, according to NewZoo, and is expected to finish 2023 with another 2% drop. Take-Two has lowered projections for Zynga this year, saying in November the division would account for 49% of total bookings — a measure of sales — down from a projected 53% six months earlier.

In May, the company reported $465 million in impairment charges related to Zynga, reflecting the declining outlook for a few titles.

Sheep Parade Through New York City Streets In Celebration Of The Global Launch Of Zynga's FarmVille English Countryside
English farmers and their sheep parade through New York City in celebration of Zynga’s first major FarmVille release, FarmVille English Countryside, in 2011.Photographer: Michael Loccisano/Getty Images

Zynga’s debut in gaming was electric. FarmVille, in which players operate digital farms, shot to internet fame after its release on Facebook in 2009. Some 32 million aspiring farmers logged in every day at the peak. In 2011, FarmVille, Words With Friends and Zynga’s other browser games accounted for 12% of Facebook revenue, according to a filing. Players recruited friends, creating small armies of ad watchers. They could buy tractor fuel or seeds in the game’s general store with FarmVille currency.

But investors couldn’t see a sustainable business model that extended beyond volatile social media or advertising. And Zynga’s games weren’t sticky enough to keep users long term. The company’s initial public offering came off at less than half the $20 billion market value some analysts said was possible. In an Ars Technica report, developers complained that the company’s focus on acquiring new customers and getting them to spend money made the games less fun.

To counter those concerns, Zynga began buying undervalued game companies and moved into mobile. Smartphones were the perfect platform for the company’s strategy of targeting and attracting new players, and eventually encouraging them to buy things in games. From 2015 to 2016, as smartphone ownership swelled, mobile-gaming revenue leapt by $11 billion to $43 billion, according to NewZoo.

Zynga pushed out mobile versions of Words With Friends, FarmVille, and eventually, casino and puzzle games, with the goal of creating “forever franchises.”

Take-Two, meanwhile, had been left behind. In an interview on the Invest Like the Best podcast in October, Zelnick said he underestimated the importance of mobile gaming early on and was focused on Take-Two’s core business of games for consoles.

“I missed the boat,” Zelnick said.

Star Wars: Hunters has been in development since at least 2018 under a team of about 150 — a timeline more typical of a blockbuster console game. Zynga’s BossAlien subsidiary previously made only car-racing games for mobile phones. A complicated arena combat game, Star Wars: Hunters was their first of such scope. And under a multiyear licensing deal with Walt Disney Co., Star Wars: Hunters must clear a certain quality bar while operating on both mobile devices and the Nintendo Switch.

Star Wars: Hunters “continues to hit important milestones as we approach its planned release date in calendar 2024,” Take-Two’s Lewis said, adding that the team developing it has an array of expertise, including in developing console games.

“Profitability in mobile gaming is highly driven by the scale of the game,” Creutz said. “Rather than being dominated by one or two very big games like King, Zynga’s profile has always consisted of about a dozen or so small-to-medium games.”

US-TECHNOLOGY-INTERNET-GAMES-GTA
Zynga’s struggles are overshadowed by the enthusiasm for Grand Theft Auto VI.Photographer: Chris Delmas/AFP/Getty Images

At the same time, the industry is still coping with the privacy changes enacted by Apple. They allowed iPhone users to stop companies like Zynga from tracking their activities. That made it especially hard to identify future players and target them with pitches. Many companies dependent on such marketing tactics were stunned.

“Everyone was freaking out and very concerned about the future of advertising and marketing,” said Eric Kress, host of the Deconstructor of Fun podcast and principal at Gossamer Consulting Group. “Zynga wasn’t ready. They were gonna lose. Take-Two saved them.”

While analysts say the damage from Apple’s move will persist, Zynga said it has adjusted its user acquisition strategy.

But the mobile-game industry has been consolidating ever since. Electronic Arts Inc. acquired Glu Mobile for $2.4 billion in 2021, Take-Two purchased Zynga in 2022 and Savvy Gaming Group bought Scopely for $4.9 billion this past April. And in October, Microsoft Corp. completed the $69 billion purchase of Activision Blizzard Inc., gaining a strong lineup of mobile games in a deal first proposed in 2022.

When analysts ask about Zynga on earnings calls, Zelnick has acknowledged the challenges. Late last year, he described the mobile industry as “soft.” This year, he said, it’s “more challenging than we anticipated.”

Zelnick plans to adapt Take-Two’s most popular franchises to mobile, prompting speculation about a smartphone version of Grand Theft Auto VI. Analysts question whether that’s possible, considering the delays for the Star Wars game. After the acquisition, Zelnick projected $100 million of cost savings within two years, and over $500 million of additional revenue down the line, in part from marketing the mobile games to some of Take-Two traditional customers.

The good news for Take-Two is that Zynga’s struggles are overshadowed by the enthusiasm for Grand Theft Auto VI. Take-Two shares were up 52% this year through Wednesday’s close in New York, triggered by announcements about the new game. They were 1.3% higher at midday Thursday.

“Shareholders were asking, ‘What’s up with Zynga or this downturn in mobile?’” said Joost van Dreunen, a lecturer at New York University’s business school. “Then all of the sudden, Strauss pushes the big, red button in his office and starts issuing Grand Theft Auto commands into the ether.”

(Updates shares. The market value estimate in the 12th paragraph was corrected in an earlier version of this story.)

 

 

— Techmeme

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Elon Musk is fielding complaints about Grok giving liberal responses on diversity, transgender rights, and inequality, despite promising an ‘anti-woke’ chatbot

—  Grok, launched this month on X, has angered conservatives by endorsing diversity.  Musk says he’s trying to fix it.

 

Will Oremus / Washington Post:

 

 

Decrying what he saw as the liberal bias of ChatGPT, Elon Musk earlier this year announced plans to create an artificial intelligence chatbot of his own.

 

In contrast to AI tools built by OpenAI, Microsoft and Google, which are trained to tread lightly around controversial topics, Musk’s would be edgy, unfiltered and anti-“woke,” meaning it wouldn’t hesitate to give politically incorrect responses.

 

That’s turning out to be trickier than he thought.

Two weeks after the Dec. 8 launch of Grok to paid subscribers of X, formerly Twitter, Musk is fielding complaints from the political right that the chatbot gives liberal responses to questions about diversity programs, transgender rights and inequality.

“I’ve been using Grok as well as ChatGPT a lot as research assistants,” posted Jordan Peterson, the socially conservative psychologist and YouTube personality, on Wednesday. The former is “near as woke as the latter,” he said.

The gripe drew a chagrined reply from Musk. “Unfortunately, the Internet (on which it is trained), is overrun with woke nonsense,” he responded. “Grok will get better. This is just the beta.”

Grok is the first commercial product from xAI, the AI company Musk founded in March. Like ChatGPT and other popular chatbots, it is based on a large language model that gleans patterns of word association from vast amounts of written text, much of it scraped from the internet.

Unlike others, Grok is programmed to give vulgar and sarcastic answers when asked, and it promises to “answer spicy questions that are rejected by most other AI systems.” It can also draw information from the latest posts on X to give up-to-date answers to questions about current events.

Artificial intelligence systems of all kinds are prone to biases ingrained in their design or the data they’ve learned from. In the past year, the rise of OpenAI’s ChatGPT and other AI chatbots and image generators has sparked debate over how they represent minority groups or respond to prompts about politics and culture-war issues such as race and gender identity. While many tech ethicists and AI experts warn that these systems can absorb and reinforce harmful stereotypes, efforts by tech firms to counter those tendencies have provoked a backlash from some on the right who see them as overly censorial.

Touting xAI to former Fox News host Tucker Carlson in April, Musk accused OpenAI’s programmers of “training the AI to lie” or to refrain from commenting when asked about sensitive issues. (OpenAI wrote in a February blog post that its goal is not for the AI to lie, but for it to avoid favoring any one political group or taking positions on controversial topics.) Musk said his AI, in contrast, would be “a maximum truth-seeking AI,” even if that meant offending people.

So far, however, the people most offended by Grok’s answers seem to be the people who were counting on it to readily disparage minorities, vaccines and President Biden.

Asked by a verified X user whether trans women are real women, Grok answered simply, “yes,” prompting the anonymous user to grumble that the chatbot “might need some tweaking.” Another widely followed account reposted the screenshot, asking, “Has Grok been captured by woke programmers? I am extremely concerned here.”

A prominent anti-vaccine influencer complained that when he asked Grok why vaccines cause autism, the chatbot responded, “Vaccines do not cause autism,” calling it “a myth that has been debunked by numerous scientific studies.” Other verified X accounts have reported with frustration about responses in which Grok endorses the value of diversity, equity and inclusion programs, which Musk has dismissed as “propaganda.”

The Washington Post’s own tests of the chatbot verified that, as of this week, Grok continues to give the responses illustrated in the screenshots.

David Rozado, an academic researcher from New Zealand who examines AI bias, gained attention for a paper published in March that found ChatGPT’s responses to political questions tended to lean moderately left and socially libertarian. Recently, he subjected Grok to some of the same tests and found that its answers to political orientation tests were broadly similar to those of ChatGPT.

“I think both ChatGPT and Grok have probably been trained on similar Internet-derived corpora, so the similarity of responses should perhaps not be too surprising,” Rozado told The Post via email.

Earlier this month, a post on X of a chart showing one of Rozado’s findings drew a response from Musk. While the chart “exaggerates the situation,” Musk said, “we are taking immediate action to shift Grok closer to politically neutral.” (Rozado agreed the chart in question shows Grok to be further left than the results of some other tests he has conducted.)

Other AI researchers argue that the sort of political orientation tests used by Rozado overlook ways in which chatbots, including ChatGPT, often exhibit negative stereotypes about marginalized groups.

A recent Securities and Exchange Commission filing showed that xAI is seeking to raise up to $1 billion in funding from investors, though Musk has said that the company isn’t raising money right now.

Musk and X did not respond to requests for comment as to what actions they’re taking to alter Grok’s politics, or whether that amounts to putting a thumb on the scale in much the same way Musk has accused OpenAI of doing with ChatGPT.

 

 

 

— Techmeme

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PureTech founded entity Karuna Therapeutics to be acquired by Bristol Myers Squibb for $14 billion

Transaction Delivers KarXT, a First-in-Class M1 / M4 Muscarinic Receptor Agonist, with Differentiated Efficacy and Safety

KarXT Is a Potential First-in-Class Treatment for Schizophrenia and as an Adjunctive Therapy, and First-in-Disease Treatment for Alzheimer’s Disease Psychosis, with Promise in Additional Neuropsychiatric and Neurodegenerative Indications

KarXT Is Expected to Launch in the U.S. for the Treatment of Schizophrenia in Adults with a Prescription Drug User Fee Act Date of Sept. 26, 2024

Bristol Myers Squibb to host a conference call today at 8 a.m. ET

 

Bristol Myers Squibb strengthens neuroscience portfolio with acquisition of Karuna Therapeutics

 

PRINCETON, N.J. & BOSTON — Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) Friday announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired. The transaction was unanimously approved by both the Bristol Myers Squibb and Karuna Boards of Directors.

 

Karuna is a biopharmaceutical company driven to discover, develop and deliver transformative medicines for people living with psychiatric and neurological conditions. Karuna’s lead asset, KarXT (xanomeline-trospium), is an antipsychotic with a novel mechanism of action (MoA) and differentiated efficacy and safety. Karuna’s New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults was accepted for review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) date of Sept. 26, 2024. KarXT is also in registrational trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease. Bristol Myers Squibb believes KarXT represents a significant revenue contribution opportunity. Bristol Myers Squibb also sees potential from Karuna’s early-stage and pre-clinical pipeline.

 

“There are tremendous opportunities in neuroscience, and Karuna strengthens our position and accelerates the expansion and diversification of our portfolio in the space. We expect KarXT to enhance our growth through the late 2020s and into the next decade,” said Christopher Boerner, Ph.D., Chief Executive Officer of Bristol Myers Squibb. “This transaction fits squarely within our business development priorities of pursuing assets that are strategically aligned, scientifically sound, financially attractive, and have the potential to address areas of significant unmet medical need. We look forward to welcoming the talented Karuna team to Bristol Myers Squibb.”

 

“Schizophrenia and Alzheimer’s disease psychosis affect millions of people worldwide, with limited to no treatment options. KarXT’s novel mechanism has resulted in a transformational profile in schizophrenia, with compelling efficacy and a differentiated safety profile,” said Samit Hirawat, M.D., Executive Vice President, Chief Medical Officer, Drug Development of Bristol Myers Squibb. “KarXT also has the potential to deliver meaningful benefits to patients as an adjunctive treatment for patients with schizophrenia and as a first treatment for Alzheimer’s disease psychosis.”

 

Bill Meury, President and Chief Executive Officer of Karuna Therapeutics, said, “Karuna’s portfolio offers advancements in treatment not seen in many years. With Bristol Myers Squibb’s long-standing expertise in developing and commercializing medicines on a global scale and legacy in neuroscience, KarXT and the other assets in our pipeline will be well-positioned to reach those living with schizophrenia and Alzheimer’s disease psychosis. This announcement is a testament to the Karuna team’s talent, hard work, and innovation.”

 

Delivering Meaningful Benefits to Patients with KarXT

KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. KarXT has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments, including no meaningful weight gain, extrapyramidal symptoms, increased prolactin levels, akathisia and/or sedation.

 

Given this differentiated profile, KarXT has meaningful and expanding revenue potential in schizophrenia and with upside in additional indications and geographies:

  • Schizophrenia: KarXT is expected to launch in late 2024 in the U.S. as a treatment for schizophrenia in adults. There are approximately 1.6 million1 people treated for schizophrenia in the U.S., a significant portion of whom do not respond to currently available therapies and experience unacceptable side effects.
  • Adjunctive schizophrenia: A registrational clinical trial is currently underway evaluating KarXT as adjunctive treatment with current standard of care agents for the treatment of schizophrenia, with data expected in 2025.
  • Alzheimer’s disease psychosis: Registrational clinical trials are currently underway evaluating KarXT for the treatment of Alzheimer’s disease psychosis, with data expected in 2026. There are more than 6 million2 people living with Alzheimer’s disease in the U.S. There are currently no approved treatments for Alzheimer’s disease psychosis.
  • Additional indications: Bristol Myers Squibb believes KarXT also has potential in additional indications, including Bipolar I disorder, which impacts approximately 1.4 million1 people in the U.S., and Alzheimer’s disease agitation.

 

The transaction is expected to be dilutive to Bristol Myers Squibb’s non-GAAP diluted earnings per share by approximately $0.30 in 2024 from the financing cost of the transaction, as Bristol Myers Squibb expects to offset the operational expenses of the transaction through continued resource allocation, cost efficiencies and portfolio prioritization. The accounting treatment as a business combination or asset acquisition will be determined upon the expected close of the transaction. Bristol Myers Squibb expects to finance the acquisition with primarily new debt issuance. Bristol Myers Squibb’s cash flows and strong financial profile enable continued commitment to strong investment-grade credit ratings and investment for growth through business development opportunities and distributions to shareholders through ongoing dividends and share repurchases.

 

Transaction Terms and Financing

Under the terms of the merger agreement, Bristol Myers Squibb will acquire all outstanding shares of Karuna common stock for $330.00 per share in cash representing an approximately 53.4% premium to Karuna Therapeutic’s closing stock price on Dec. 21, 2023, for a total equity value of approximately $14.0 billion, or $12.7 billion net of estimated cash acquired.

 

The transaction is expected to close in the first half of 2024, subject to customary closing conditions, including approval of Karuna stockholders and receipt of required regulatory approvals.

 

Conference Call Information

Bristol Myers Squibb will host a conference call today, Friday, Dec. 22, 2023, at 8:00 a.m. ET during which company executives will review discuss the transaction and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at http://investor.bms.com.

 

Investors and the public can register for the live conference call here. Those unable to register can access the live conference call by dialing in the U.S. toll-free 1-866-777-2509 or international +1 412-317-5413. Materials related to the call will be available at http://investor.bms.com prior to the start of the conference call.

 

A replay of the webcast will be available at http://investor.bms.com approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on December 22, 2023, through 11:30 a.m. ET on Jan. 4, 2024, by dialing in the U.S. toll free 1-877-344-7529 or international +1 412-317-0088, confirmation code: 3194180.

 

Advisors

Gordon Dyal & Co. and Citi are serving as financial advisors to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel. Goldman Sachs & Co. LLC is serving as exclusive financial advisor to Karuna, and Simpson Thacher & Bartlett LLP is serving as legal counsel.

 

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

 

About Karuna Therapeutics

Karuna Therapeutics is a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions. At Karuna, we understand there is a need for differentiated and more effective treatments that can help patients navigate the challenges presented by serious mental illness. Utilizing our extensive knowledge of neuroscience, we are harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples’ lives. For more information, please visit www.karunatx.com.

 

Additional Information and Where to Find It

In connection with the proposed acquisition of Karuna Therapeutics by Bristol Myers Squibb, Karuna Therapeutics intends to file a preliminary and definitive proxy statement. The definitive proxy statement and proxy card will be delivered to the stockholders of Karuna Therapeutics in advance of the special meeting relating to the proposed acquisition. This press release is not a substitute for the proxy statement or any other document that may be filed by Karuna Therapeutics with the SEC. KARUNA THERAPEUTICS’ STOCKHOLDERS AND INVESTORS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY EACH OF BRISTOL MYERS SQUIBB AND KARUNA THERAPEUTICS WITH THE SEC IN CONNECTION WITH THE PROPOSED ACQUISITION OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED ACQUISITION AND THE PARTIES TO THE PROPOSED ACQUISITION. Investors and security holders will be able to obtain a free copy of the proxy statement and such other documents containing important information about Bristol Myers Squibb and Karuna Therapeutics, once such documents are filed with the SEC, through the website maintained by the SEC at www.sec.gov. Bristol Myers Squibb and Karuna Therapeutics make available free of charge at Bristol Myers Squibb’s website at www.bms.com/investors and Karuna Therapeutics’ website at https://karunatx.com/, respectively, copies of materials they file with, or furnish to, the SEC.

 

Participants in the Solicitation

This press release does not constitute a solicitation of a proxy, an offer to purchase or a solicitation of an offer to sell any securities. Bristol Myers Squibb, Karuna Therapeutics and their respective directors, executive officers and certain employees may be deemed to be participants in the solicitation of proxies from the stockholders of Karuna Therapeutics in connection with the proposed acquisition. Information regarding Bristol Myers Squibb’s directors and executive officers is contained in Bristol Myer Squibb’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the SEC on February 14, 2023, and its definitive proxy statement for the 2023 annual meeting of stockholders, which was filed with the SEC on March 23, 2023. Information regarding Karuna Therapeutics’ directors and executive officers is contained in Karuna Therapeutics’ definitive proxy statement for the 2023 annual meeting of stockholders, which was filed with the SEC on April 27, 2023. To the extent holdings of Bristol Myers Squibb’s or Karuna Therapeutics’ securities by their respective directors or executive officers have changed since the amounts set forth in such 2023 proxy statements, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the identity of potential participants, and their direct or indirect interests, by security holdings or otherwise, will be included in the definitive proxy statement relating to the proposed acquisition when it is filed with the SEC. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov, Bristol Myers Squibb’s website at www.bms.com and Karuna Therapeutics’ website at https://karunatx.com/.

 

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding, among other things, the proposed acquisition of Karuna Therapeutics by Bristol Myers Squibb, the expected timetable for completing the transaction, future opportunities for the combined businesses, the expected benefits of Bristol Myers Squibb’s acquisition of Karuna Therapeutics and the development and commercialization of Karuna Therapeutics’ product candidates, including the therapeutic and commercial potential of KarXT and Karuna Therapeutics’ other technologies and products in development. These statements may be identified by the fact they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance, although not all forward-looking statements contain such terms. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. These statements are only predictions, and such forward-looking statements are based on current expectations and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them, that are difficult to predict, may be beyond our control and could cause actual outcomes and results to differ materially from those expressed in, or implied by, the forward-looking statements. Actual results may differ materially because of numerous risks and uncertainties including with respect to (i) the approval of Karuna Therapeutics’ stockholders of the proposed acquisition, which may be delayed or may not be obtained, (ii) the risk that the expected benefits or synergies of the acquisition will not be realized, (iii) the risk that legal proceedings may be instituted related to the merger agreement, (iv) any competing offers or acquisition proposals for Karuna Therapeutics, (v) the possibility that various conditions to the consummation of the acquisition may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the acquisition and (vii) unanticipated difficulties or expenditures relating to the proposed acquisition, including the response of business partners and competitors to the announcement of the proposed acquisition or difficulties in employee retention as a result of the announcement and pendency of the proposed acquisition. The actual financial impact of this transaction may differ from the expected financial impact described in this press release. In addition, the compounds described in this press release are subject to all the risks inherent in the drug development process, and there can be no assurance that the development of these compounds will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2022, and Karuna Therapeutics’ business, particularly those identified in the risk factors discussion in Karuna Therapeutics’ Annual Report on Form 10-K for the year ended December 31, 2022, as well as other documents that may be filed by Bristol Myers Squibb or Karuna Therapeutics from time to time with the SEC. Neither Bristol Myers Squibb nor Karuna Therapeutics undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. The forward-looking statements made in this press release relate only to events as of the date on which the statements are made and readers are cautioned not to place undue reliance on such statements.

 

Use of Non-GAAP Financial Information and Financial Guidance

In discussing financial guidance, Bristol Myers Squibb refers to financial measures that are not in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The non-GAAP financial measures are provided as supplemental information to the financial measures presented in this communication that are calculated and presented in accordance with GAAP and are presented because management has evaluated the company’s financial results both including and excluding the adjusted items or the effects of foreign currency translation, as applicable, and believes that the non-GAAP financial measures presented portray the results of the company’s baseline performance, supplement or enhance management, analysts and investors overall understanding of the company’s underlying financial performance and trends and facilitate comparisons among current, past and future periods.

 

Non-GAAP earnings and related EPS information are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because Bristol Myers Squibb believes they neither relate to the ordinary course of Bristol Myers Squibb’s business nor reflect Bristol Myers Squibb’s underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods.

 

Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to or as a substitute for the related financial measures that are prepared in accordance with GAAP and are not intended to be considered in isolation and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.

 

A reconciliation of the forward-looking non-GAAP measures presented in this communication is not provided due to the inherent difficulty in forecasting and quantifying items that are necessary for such reconciliation. Namely, we are not able to reliably predict the impact of specified items such as unwind of inventory purchase price adjustments, accelerated depreciation and impairment of property, plant and equipment and intangible assets and stock compensation resulting from acquisition-related equity awards, or currency exchange rates beyond the next twelve months. As a result, the reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is not available without unreasonable effort. In addition, Bristol Myers Squibb believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. The variability of the specified items may have a significant and unpredictable impact on our future GAAP results. In addition, the non-GAAP financial guidance in this communication excludes the impact of any potential additional future strategic acquisitions and divestitures and any specified items that have not yet been identified and quantified. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this communication.

 

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases.

Contacts

PureTech
Public Relations

publicrelations@puretechhealth.com
Investor Relations

IR@puretechhealth.com

EU Media
Ben Atwell, Rob Winder

+44 (0) 20 3727 1000

ben.atwell@FTIconsulting.com

U.S. Media
Nichole Sarkis

+1 774 278 8273

nichole@tenbridgecommunications.com

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HealthEC, LLC data event impacts companies nationwide, including Corewell Health

GRAND RAPIDS, Mich. — (BUSINESS WIRE) — Please replace the release with the following corrected version due to multiple revisions.

 

The updated release reads:

HEALTHEC, LLC DATA EVENT IMPACTS COMPANIES NATIONWIDE, INCLUDING COREWELL HEALTH

 

Population health management platform HealthEC, LLC, is notifying people nationwide of a data security event that happened earlier this year. For more information, please see HealthEC’s news release.

 

The company enables value-based health systems to identify high-risk patients, close gaps in care and recognize barriers to optimal care. HealthEC is a vendor for Corewell Health in Southeast Michigan.

 

The information of approximately 1 million patients of Corewell Health in Southeast Michigan could be impacted by the HealthEC data event. HealthEC is sending letters to every person who was impacted.

 

Not all individuals have the same data impacted, but the possible impacted data could include: Name; address; date of birth; Social Security number; medical record number; medical information like diagnosis, diagnosis code, mental/physical condition, prescription information, and provider’s name; health insurance information including beneficiary number, subscriber number, Medicaid and/or Medicare identification; billing and claims information including patient account number, patient identification number, treatment cost information. This event did not impact platforms such as Epic and MyChart and they are safe to use.

 

HealthEC is offering 12 months of credit monitoring and identity protection services through TransUnion. Instructions on how to activate these services is being sent to all impacted people.

 

Those seeking additional information can contact HealthEC toll-free at 1-833-466-9216 or visit the HealthEC website. People can also write to HealthEC at Attn: Compliance Officer, 343 Thornall St., Suite 630, Edison, NJ 08837.

Contacts

Ellen Bristol, Ellen.Bristol@corewellhealth.org

Categories
Business Healthcare Lifestyle Perspectives Regulations & Security Science

Patritumab Deruxtecan granted Priority Review in the U.S. for certain patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer

  • Submission based on HERTHENA-Lung01 results showing patritumab deruxtecan demonstrated clinically meaningful and durable responses in patients with advanced EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies
  • Application being evaluated under FDA Real-Time Oncology Review
  • If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients

 

 

BASKING RIDGE, N.J. & RAHWAY, N.J. — (BUSINESS WIRE) — Daiichi Sankyo (TSE: 4568) and Merck (known as MSD outside of the United States and Canada) (NYSE: MRK) announced today that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.

The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is June 26, 2024. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in December 2021.

 

The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The BLA is being reviewed under the Real-Time Oncology Review (RTOR) program, an initiative of the FDA which is designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application.

 

Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and Merck.

 

The BLA is based on the primary results from the HERTHENA-Lung01 pivotal phase 2 trial and data results presented at the IASLC 2023 World Conference on Lung Cancer (#WCLC23), which were simultaneously published in the Journal of Clinical Oncology.

 

In HERTHENA-Lung01, patritumab deruxtecan was studied in 225 patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR TKI and platinum-based chemotherapy, which demonstrated an objective response rate (ORR) of 29.8% (95% CI: 23.9-36.2), including one complete response and 66 partial responses. The median duration of response was 6.4 months (95% CI: 4.9-7.8). The safety profile of patritumab deruxtecan observed in HERTHENA-Lung01 was consistent with previous phase 1 clinical trials in NSCLC with a treatment discontinuation rate of 7.1% due to treatment-emergent adverse events (TEAEs). Grade 3 or higher TEAEs occurred in 64.9% of patients. The most common (≥5%) grade 3 or higher TEAEs were thrombocytopenia (21%), neutropenia (19%), anemia (14%), leukopenia (10%), fatigue (6%), hypokalemia (5%) and asthenia (5%). Twelve patients (5.3%) had confirmed treatment-related interstitial lung disease (ILD) as determined by an independent adjudication committee. One grade 5 ILD event was observed.

 

“The FDA’s prioritization of the BLA submission reflects the strength of the data from HERTHENA-Lung01 and emphasizes the need to provide new options to patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “If approved, patritumab deruxtecan could become the first HER3 directed medicine approved in the US and the second DXd antibody drug conjugate approved from Daiichi Sankyo’s oncology pipeline.”

 

“The acceptance of the BLA submission of patritumab deruxtecan marks an important step in potentially bringing this new medicine to previously treated patients with EGFR-mutated non-small cell lung cancer who often experience recurrence and have few remaining treatment options,” said Marjorie Green, MD, Senior Vice President and Head of Late-Stage Oncology, Global Clinical Development, Merck Research Laboratories. “Today is the first of many important milestones from our collaboration with Daiichi Sankyo, as we work together to bring new and potentially first-in-class antibody drug conjugates to people living with cancer.”

 

About HERTHENA-Lung01

HERTHENA-Lung01 is a global, multicenter, open-label, two-arm phase 2 trial evaluating the safety and efficacy of patritumab deruxtecan in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR TKI and platinum-based chemotherapy. Patients were randomized 1:1 to receive 5.6 mg/kg (n=225) or an uptitration regimen (n=50). The uptitration arm was discontinued as the dose of 5.6 mg/kg of patritumab deruxtecan was selected following a risk-benefit analysis conducted from the phase 1 trial assessing the doses in a similar patient population.

 

The primary endpoint of HERTHENA-Lung01 was ORR as assessed by blinded independent central review (BICR). Secondary endpoints included duration of response, progression-free survival (PFS), disease control rate, and time to response – all assessed by both BICR and investigator assessment – as well as investigator-assessed ORR, overall survival, safety and tolerability.

 

HERTHENA-Lung01 enrolled patients in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

 

About EGFR-Mutated Non-Small Cell Lung Cancer

Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide.1 NSCLC accounts for approximately 85% of all lung cancers – 55% having distant spread at diagnosis – with EGFR mutations occurring in 14% to 38% of all NSCLC tumors worldwide.2,3,4

 

About HER3

HER3 is a member of the EGFR family of receptor tyrosine kinases.5 It is estimated that about 83% of primary NSCLC tumors and 90% of advanced EGFR-mutated tumors express HER3 after prior EGFR TKI treatment.6,7 There is currently no HER3 directed therapy approved for the treatment of any cancer.

 

About Patritumab Deruxtecan

Patritumab deruxtecan (HER3-DXd) is an investigational HER3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, patritumab deruxtecan is composed of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

 

Patritumab deruxtecan was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in December 2021 for the treatment of patients with EGFR-mutated locally advanced or metastatic NSCLC with disease progression on or after treatment with a third-generation TKI and platinum-based therapies.

 

Patritumab deruxtecan is currently being evaluated as both a monotherapy and in combination with other therapies in a global development program, which includes HERTHENA-Lung02, a phase 3 trial versus platinum-based chemotherapy in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression on or after treatment with a third-generation EGFR TKI; a phase 1 trial in combination with osimertinib in EGFR-mutated locally advanced or metastatic NSCLC; and a phase 1 trial in previously treated patients with advanced NSCLC. A phase 1/2 trial in HER3 expressing metastatic breast cancer also has been completed.

 

About the Daiichi Sankyo and Merck Collaboration

Daiichi Sankyo and Merck entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply.

 

About the DXd ADC Portfolio of Daiichi Sankyo

The DXd ADC portfolio of Daiichi Sankyo currently consists of six ADCs in clinical development across multiple types of cancer. ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

 

Designed using Daiichi Sankyo’s proprietary DXd ADC technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

 

Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan and DS-3939 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

 

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com.

 

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

 

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

 

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

 

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

References

1 World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Accessed September 2023.

2 Economopoulou P, et al. Ann Transl Med. 2018; 6(8):138.

3 Chen R, et al. J Hematol Oncol. 2020; 13(1):58.

4 Zhang Y-L, et al. Oncotarget. 2016; 7(48):78985-78993.

5 Mishra R, et al. Onco Rev. 2018; 12(355):45-62.

6 Scharpenseel H, et al. Scientific Reports. 2019; 9:7406.

7 Yonesaka K, et al. Clin Cancer Res. 2022; 15:28(2):390-403.

Contacts

Daiichi Sankyo
Global/US Media:
Jennifer Brennan

Daiichi Sankyo, Inc.

jbrennan2@dsi.com
+1 908 900 3183 (mobile)

Japan Media:
Koji Ogiwara

Daiichi Sankyo Co., Ltd.

Ogiwara.koji.ay@daiichisankyo.co.jp
+81 3 6225 1126 (office)

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

Merck
Media:
Robert Josephson

+1 203 914 2372

robert.josephson@merck.com

Investors:
Peter Dannenbaum

+1 732 594 1579

peter.dannenbaum@merck.com

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Organon to present at the 42nd Annual J.P. Morgan Healthcare Conference

JERSEY CITY, N.J. — (BUSINESS WIRE) — Organon (NYSE: OGN), announced on Thursday that Kevin Ali, Chief Exec. Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 9, 2024, at 1:30 p.m. PT.

 

Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at: https://jpmorgan.metameetings.net/events/healthcare24/sessions/49500-organon/webcast?gpu_only=true&kiosk=true

 

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

 

Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

 

For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formally known as Twitter) and Facebook.

Contacts

Media:

Karissa Peer

(614) 314-8094

Kate Vossen

(732) 675-8448

Investor:

Jennifer Halchak

(201) 275-2711

Alex Arzeno

(646) 430-2028

Categories
Business Culture Lifestyle Perspectives Regulations & Security

AM Best assigns Credit Ratings to Federal Life Insurance Company

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance—AM Best has assigned a Financial Strength Rating of A- (Excellent) and a Long-Term Issuer Credit Rating of “a-” (Excellent) to Federal Life Insurance Company (Fed Life) (Riverwoods, IL). The outlook assigned to these Credit ratings (ratings) is stable.

The ratings reflect Fed Life’s balance sheet strength, which AM Best assesses as very strong, as well as its adequate operating performance, neutral business profile and appropriate enterprise risk management (ERM).

 

The ratings also reflect AM Best’s assessment that, based on Fed Life’s business plan, the company will build and maintain a balance sheet assessment of very strong supported by risk-adjusted capitalization also at the very strong level, as measured by Best Capital Adequacy Ratio (BCAR). Capital contributions in 2023 and retained earnings through the forecast period are expected to support net premium growth. Direct premium growth is expected to be relatively rapid based on projections, but capital at Fed Life is anticipated to be managed through affiliated reinsurance and capital infusions as necessary. Financial flexibility is viewed as positive as the company has access to additional capital at the holding company level (Federal Life Group, Inc.), and from its ultimate parent organization, Insurance Capital Group, LLC (ICG). The holding company has access to additional capital from the ultimate owner, ICG. Investment risk is projected as low but may increase to moderate depending on the evolution of the liability profile of the company, which could impact future balance sheet metrics.

 

The adequate operating performance assessment and the neutral business profile assessment are based on Fed Life’s business plans presented to AM Best. The plan includes an expectation of rapid premium growth and improving operating profitability that supports an adequate operating performance assessment. In addition, it also includes the introduction of additional products, which in combination with a larger and more geographically diversified premium base, would support a neutral business profile assessment. Should Fed Life materially underperform its business plan these assessments would no longer be supported. An ERM structure has been established and is expected to evolve alongside the product risks and operational complexity of the business.

 

Fed Life, originally incorporated in 1899 and mutualized in 1962, was demutualized in 2018 and under its new ownership is focused now on a portfolio of accident and health, as well as life and annuity (L/A) products, which it plans to market nationwide. The company engaged with a largely new management team in 2022 and 2023 to support the plan, and introduced its first new product, a hospital indemnity product, in 2022. Additional new products are in development to supplement the company’s hospital indemnity product and legacy L/A book of business. Rapid premium growth in 2022 and 2023 evidence early successes of the plan; however, successful launches of new products and further development of distribution are key to realizing the growth and expansion milestones presented to AM Best. AM Best will monitor the performance of Fed Life against key milestones set out in the business plan and internal expectations to evaluate if ongoing performance remains supportive of the adequate operating performance and neutral business profile assessments.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

John McGlynn

Senior Financial Analyst
+1 908 882 2106
john.mcglynn@ambest.com

Joseph Zazzera
Director
+1 908 882 2442
joseph.zazzera@ambest.com

Christopher Sharkey
Associate Director, Public Relations
+1 908 882 2310
christopher.sharkey@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 882 2318
al.slavin@ambest.com

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United Natural Foods releases ‘Better for All’ environmental, social, and governance report for fiscal year 2023

Details significant progress on the Company’s key areas of focus – delivering positive impact, operational efficiency, and reinforcing its value proposition to stakeholders.

 

PROVIDENCE, R.I. — (BUSINESS WIRE) — United Natural Foods, Inc. (NYSE: UNFI) (the “Company” or “UNFI”) today released its 13th annual Better for All Report detailing UNFI’s progress on its social, environmental, and governance objectives during the Company’s 2023 fiscal year, ended July 29, 2023.

 

The report demonstrates the success of the Company’s enhanced focus on its most pressing impact areas – safety, well-being, waste, climate, sourcing, and community. It underscores that UNFI’s initiatives benefitting the planet, society, and the food industry can also directly benefit the Company’s business performance, resulting in enhanced value for all of its stakeholders.

 

UNFI’s Better for All strategy continues to focus on establishing the Company as a key connector within the food system value chain, creating and growing critical linkages among farmers, suppliers, manufacturers, retailers, and consumers.

 

“UNFI is building a company that creates sustainable value for stakeholders and shareholders, and a better food system for all,” said Sandy Douglas, President and CEO of UNFI. “In FY2023, we issued new responsible sourcing policies and position statements, expanded supplier diversity efforts, reaffirmed our broader commitment to diversity, equity, and inclusion (DEI), started work on our ninth and largest on-site solar array, completed LED lighting conversions across all of our distribution centers (DCs), and deployed a new system that helps us reduce food waste in our DCs.”

 

As a result of these efforts across the Company during fiscal 2023, UNFI reported the following milestones toward its goal to build a food system that is better for its people, its communities, and the planet:

  • Published, in connection with the Company’s new Supplier and Vendor Code of Conduct, both a formal policy designed to support the goal of zero deforestation across our primary deforestation-linked commodities by 2025, and a position statement and action plan for animal welfare standards in our supply chain. These have allowed the Company to work more efficiently and effectively with suppliers and vendors in pursuing these goals.
  • Completed a roof-mounted solar array installation, the Company’s largest to date, at its Howell, New Jersey distribution center, with a new, even bigger roof-mounted solar array at its Riverside, CA distribution center slated for the near future. UNFI’s solar array initiatives lower the Company’s carbon footprint and provide an excellent return on investment while also reducing the energy cost of operating a distribution center.
  • Launched the Climate Action Partnership to encourage suppliers to make credible climate commitments and provide innovative and scalable resources specific to the food system. This forum allows the Company to share best practices with suppliers who have common goals and drive more collaboration and efficiency across supply chains.
  • Reaffirmed its commitment to DEI and continued to build a diverse, high-performing, and agile workforce by delivering more DEI programming to employees. These initiatives help UNFI recruit talented associates and benefit from their diverse perspectives, whether they work in Company distribution centers or corporate offices.
  • Successfully completed an electric vehicle (EV) Blueprint that outlines how the Company plans to transition to zero-emission vehicles in the state of California. This reduces fuel and maintenance costs while also improving air quality.
  • Completed LED lighting conversions in all distribution centers, which not only decreases greenhouse gas (GHG) emissions and lowers cost but also improves safety by increasing lighting and limiting maintenance work throughout the facility.
  • Deployed a Reverse Logistics Disposition Reporting (RLDR) system at all UNFI distribution centers that increases inventory visibility, improves operating efficiency, reduces food waste, and minimizes waste disposal costs, contributing to lower shrink in distribution centers.
  • Supported the “Acres: Cultivating Equity in Black Agriculture” program, launched by The National Minority Supplier Development Council (NMSDC), to improve the Company’s relationships with an excellent source of high-quality producers.

 

Mr. Douglas added, “Our associates can be very proud of the solid progress on company sustainability and operational efficiency goals. I look forward to what we’ll accomplish together in 2024.”

 

About UNFI

UNFI is North America’s premier grocery wholesaler delivering the widest variety of fresh, branded, and owned brand products to more than 30,000 locations throughout North America, including natural product superstores, independent retailers, conventional supermarket chains, eCommerce providers, and foodservice customers. UNFI also provides a broad range of value-added services and segmented marketing expertise, including proprietary technology, data, market insights, and shelf management to help customers and suppliers build their businesses and brands. As the largest full-service grocery partner in North America, UNFI is committed to building a food system that is better for all and is uniquely positioned to deliver great food, more choices, and fresh thinking to customers. To learn more about how UNFI is delivering value for its stakeholders, visit www.unfi.com.

 

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding the Company’s business that are not historical facts are “forward-looking statements” that involve risks and uncertainties and are based on current expectations and management estimates; actual results may differ materially. The risks and uncertainties which could impact these statements include those described in the Company’s filings under the Securities Exchange Act of 1934, as amended, including its annual report on Form 10-K for the year ended July 29, 2023 filed with the SEC on September 26, 2023 and other filings the Company makes with the SEC. Any forward-looking statements are made pursuant to the Private Securities Litigation Reform Act of 1995 and, as such, speak only as of the date made. The Company is not undertaking to update any information contained in this press release to reflect subsequently occurring events or circumstances. Any estimates of future results of operations are based on a number of assumptions, many of which are outside the Company’s control and should not be construed in any manner as a guarantee that such results will in fact occur. These estimates are subject to change and could differ materially from final reported results.

Contacts

For UNFI Investors:
Kristyn Farahmand

401-213-2160

kristyn.farahmand@unfi.com
-or-

Steve Bloomquist

952-828-4144

steve.j.bloomquist@unfi.com

For Media:
UNFI
Charles Davis

215-539-1696

cdavis@unfi.com

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Amneal to participate at the 42nd Annual J.P. Morgan Healthcare Conference

BRIDGEWATER, N.J. — (BUSINESS WIRE) — Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced today that Chirag Patel, Co-Chief Exec. Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate in the 42nd Annual J.P. Morgan Healthcare Conference on Jan. 9 to 10, 2024.

 

Chirag will present on Jan. 10 at 11:15 a.m. PST, and a live webcast will be accessible on the Company’s website at https://investors.amneal.com. A replay of the webcast will be available for 30 days following the event.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of approximately 270 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars.

 

In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

Contacts

Investor
Anthony DiMeo

Head of Investor Relations

anthony.dimeo@amneal.com

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Merck provides US regulatory update on gefapixant

RAHWAY, N.J. — (BUSINESS WIRE) — $MRK #MRK — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.

 

In the CRL, the FDA concluded that Merck’s application did not meet substantial evidence of effectiveness for treating RCC and UCC. The CRL was not related to the safety of gefapixant. Merck is reviewing the FDA’s feedback to determine next steps.

Chronic cough is defined as a cough lasting longer than 8 weeks. In adults with RCC, the cough persists despite appropriate treatment of underlying conditions such as asthma or gastroesophageal reflux disease, and UCC is a cough where the underlying cause cannot be identified despite a thorough evaluation.

 

“We thank our clinical trial participants and investigators for their important contributions that add to the body of knowledge related to chronic cough and help to raise awareness about the significant unmet medical need and the impact of RCC and UCC on patients,” said Dr. Joerg Koglin, senior vice president, global clinical development, Merck Research Laboratories. “Acknowledging the absence of any approved treatments for refractory or unexplained chronic cough, we are disappointed in the FDA’s response to our application for gefapixant.”

 

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

 

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

 

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

 

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Media Contacts:

Julie Cunningham

(617) 519-6264

Deb Wambold

(215) 779-2234

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Damini Chokshi

(732) 594-1577