Dear Seeking Alpha readers, I want to start by apologizing that since the publication of my article "Merck: Seriously Undervalued At Peak Pessimism (Rating Upgrade)," Merck & Co., Inc. (NYSE: MRKWith over two decades of dedicated experience in investment, Allka Research has been a guiding force for individuals seeking lucrative opportunities. Its conservative approach sets it apart, consistently unearthing undervalued assets within the realms of ETFs, commodities, technology, and pharmaceutical companies.Al ...

Regulatory Approvals - The company received FDA approval in January 2024 for a treatment related to Stage III-IVA cervical cancer based on the KEYNOTE-A18 trial[31]. - In February 2024, the company obtained China's NMPA approval for a first-line treatment of locally advanced or metastatic biliary tract carcinoma based on the KEYNOTE-966 trial[31]. - The company achieved FDA full approval in January 2024 for a treatment of HCC secondary to hepatitis B, transitioning from accelerated to full approval based on the KEYNOTE-394 trial[31]. - The FDA issued a Complete Response Letter (CRL) for the BLA of MK-1022 due to findings from a third-party manufacturing facility inspection, with no issues identified regarding efficacy or safety data[104]. - The FDA accepted a supplemental NDA for MK-6482 for priority review, with a target action date set for May 26, 2025[105]. - V116, a 21-valent pneumococcal conjugate vaccine, is under review in the EU and Japan, with a recommendation for approval expected by the second quarter of 2025[106]. - Keytruda (MK-3475) is under review in the EU and Japan for first-line treatment of unresectable advanced malignant pleural mesothelioma, with a positive opinion from EMA's CHMP[110]. - The FDA accepted the BLA for MK-1654 (clesrovimab) with a PDUFA date set for June 10, 2025, aimed at protecting infants from RSV[108]. Market and Pricing Pressures - The company reported that global health care cost containment pressures negatively impacted sales performance in 2024, affecting pricing and market access[37]. - The company anticipates ongoing pricing pressures from managed care organizations and government programs, which could adversely affect sales and profit margins[40]. - The Company faces increasing pricing pressure due to consolidation among health care entities, which enhances purchasing strength and may adversely affect revenue[42]. - Legislative changes from the IRA will impose financial penalties for drugs with price increases exceeding inflation rates, affecting the Company's pricing strategy starting in 2026[43]. - The Company anticipates a decline in U.S. sales of Keytruda after government price setting takes effect on January 1, 2028[43]. - The American Rescue Plan Act eliminates the cap on Medicaid rebates starting January 2024, potentially increasing rebate payments for the Company[46]. - In China, the recent NRDL update resulted in an average price reduction of 63% for new entries, indicating significant pricing pressure[60]. - The volume-based procurement (VBP) program in China has led to average price reductions of over 50% for mature products in recent rounds[60]. - The EU's Health Technology Assessment Regulation will begin in 2025, influencing pricing and reimbursement decisions for new products[54]. - The Company is subject to government-mandated annual price reductions in Japan, with the next reduction scheduled for April 2025[59]. - The Company expects ongoing pricing pressures and market access challenges in emerging markets due to government price controls[61]. Competition and Market Strategy - The company is facing increasing competition from generic and biosimilar products, which may impact sales of existing products[34]. - The company is refining its sales and marketing efforts to adapt to changing industry conditions and competition[35]. - The company is well-positioned to respond to evolving health care environments and market forces through continuous evaluation and adaptation of its business practices[39]. - The company has received multiple product approvals in 2024 and 2025, indicating a strong pipeline of new treatments[30]. - Merck is diversifying its oncology portfolio with numerous Phase 3 programs focused on immuno-oncology, precision molecular targeting, and tissue targeting[111]. - The company focuses on breakthrough science for unmet medical needs, prioritizing research and development resources on candidates with clear advantages for patients and payers[89]. - The company maintains a strategy of supplementing internal research through acquisitions and external alliances across the entire spectrum of collaborations[89]. - The company is actively pursuing acquisitions and external alliances to complement its internal research capabilities[481]. - Merck's recent transactions reflect a strategic focus on expanding its product pipeline and market presence through significant investments[481]. Research and Development - As of December 31, 2024, approximately 23,500 employees were engaged in the company's research and development activities[88]. - The company is pursuing multiple candidates in its clinical pipeline across various disease areas, including cancer, cardiovascular diseases, and infectious diseases[90]. - Research and development expenses decreased significantly to $17,938 million in 2024 from $30,531 million in 2023[432]. - The company’s research and development model aims to increase productivity and improve the probability of success in drug development[89]. - The company is committed to ensuring that externally sourced programs remain an important component of its pipeline strategy[89]. - Merck's MK-7962 (Winrevair) shows positive topline results in Phase 3 ZENITH study for PAH, leading to early termination due to overwhelming efficacy[107]. - The clinical development program for favezelimab was terminated after evaluation of data from the clinical program[120]. - The Phase 2b trial for MK-8189 did not meet its primary efficacy endpoint, halting further development in schizophrenia and related indications[120]. - Merck announced the discontinuation of the Phase 3 KeyVibe trials for MK-7684A due to meeting pre-specified futility criteria for overall survival[120]. - The company has several drug candidates under review with anticipated patent expirations extending into the 2040s, indicating a robust pipeline for future products[83]. Financial Performance - The Company achieved sales of $64,168 million in 2024, a 6.8% increase from $60,115 million in 2023[432]. - Net income attributable to Merck & Co., Inc. rose to $17,117 million in 2024, compared to $365 million in 2023[432]. - Cash dividends declared on common stock increased to $3.12 per share in 2024, up from $2.96 per share in 2023 and $2.80 per share in 2022, totaling $7,943 million in 2024[436]. - Net cash provided by operating activities rose to $21,468 million in 2024, compared to $13,006 million in 2023 and $19,095 million in 2022[438]. - The company reported a decrease in inventories by $835 million in 2024, following a decrease of $816 million in 2023[438]. - The total comprehensive income for 2024 included a net increase of $216 million, contrasting with a loss of $393 million in 2023[436]. - The company’s cash, cash equivalents, and restricted cash at the end of 2024 amounted to $13,318 million, up from $6,909 million in 2023[438]. - The U.S. provision for aggregate customer discounts covering chargebacks and rebates was $13.3 billion in 2024, up from $12.5 billion in 2023 and $12.3 billion in 2022[454]. Environmental Sustainability - The company is committed to reducing energy usage, water use, and greenhouse gas emissions as part of its environmental sustainability strategy[134]. - The Company aims to reduce Scope 1 and 2 operational GHG emissions by 46% by 2030, and Scope 3 GHG emissions by 30% by 2030, both from a 2019 baseline[135]. - The Company has set a net-zero target for GHG emissions across its global operations by 2045[135]. - Expenditures for environmental remediation were $4 million in 2024, with an estimated total of $26 million for 2025-2029[140]. - The company is committed to achieving its 2025 waste diversion goal of no more than 20% of global operational waste sent to landfills[142]. - The Environmental, Health and Safety Council oversees the company's environmental sustainability strategy and monitors performance against its goals[133]. Workforce and Employee Engagement - As of December 31, 2024, the company had approximately 75,000 employees worldwide, with 31,000 in the U.S. and 15,000 third-party contractors[124]. - The company's voluntary turnover rate was approximately 4.6% in 2024, down from 5.6% in 2023[124]. - In 2024, the company hired approximately 7,300 employees globally through various recruitment channels[127]. - Women comprise 52% of the company's workforce, and 39% of the senior management team are women[124]. - The company's benefits rank in the top quartile of Fortune 100 companies under the Aon 2024 Benefits Index[129]. - The company has been included in the Seramount 100 Best Companies ranking for 38 consecutive years[129]. - The company offers a minimum standard of 12 weeks of paid parental leave globally[129]. - The company received accolades such as the Business Group on Health's Best Employers Excellence in Health & Well-being in 2024[130]. Data Protection and Compliance - The company is subject to the EU General Data Protection Regulation (GDPR), which can impose penalties of up to 4% of global revenue for non-compliance[70]. - The GDPR requires strict obligations for processing personal health data, including consent and notification to data protection authorities, adding complexity to data management[71]. - Merck has entered into EU-approved Standard Contractual Clauses to facilitate lawful data transfers from the EU to the U.S. following the Schrems II decision[71]. - The Personal Information Protection Law (PIPL) in China requires compliance for processing personal information, similar to GDPR but with unique requirements[75]. - The company has adopted a comprehensive global privacy program to manage evolving data protection requirements across multiple jurisdictions[76]. Acquisitions and Collaborations - Merck will acquire WuXi Vaccines' facility in Dundalk, Ireland for approximately $440 million, expected to close in Q1 2025[482]. - Merck recorded a charge of $588 million for the upfront payment related to the exclusive global license of MK-2010, with potential future payments totaling up to $2.8 billion[483]. - Merck acquired the aqua business of Elanco for $1.3 billion, enhancing its Animal Health portfolio with innovative products[487]. - Merck acquired EyeBio for $1.2 billion, with future contingent payments potentially reaching $1.7 billion[487]. - Merck's acquisition of Harpoon Therapeutics for $765 million included a charge of $656 million to R&D expenses, with no future contingent payments[492]. - In 2023, Merck acquired Prometheus Biosciences for $11 billion, with a charge of $10.2 billion to R&D expenses[494]. - Merck's collaboration with Daiichi Sankyo includes three ADC candidates, enhancing its development and commercialization capabilities[493]. - Merck entered a collaboration with Kelun-Biotech, making an upfront payment of $175 million for exclusive rights to develop up to seven investigational preclinical ADCs for cancer treatment[495]. - Merck paid $38 million to Kelun-Biotech for exercising a license option for one candidate, with potential future payments of up to $540 million in development-related payments and $1.5 billion in regulatory milestones[496]. - Merck's collaboration with Orna Therapeutics included an upfront payment of $150 million and potential future payments of up to $3.1 billion in sales-based milestones[500].

Investors often turn to recommendations made by Wall Street analysts before making a Buy, Sell, or Hold decision about a stock. While media reports about rating changes by these brokerage-firm employed (or sell-side) analysts often affect a stock's price, do they really matter?Before we discuss the reliability of brokerage recommendations and how to use them to your advantage, let's see what these Wall Street heavyweights think about Merck (MRK) .Merck currently has an average brokerage recommendation (ABR) ...

NEW YORK, Feb. 25, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Merck & Co., Inc. ("Merck" or the "Company") (NYSE: MRK) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Merck investors who were adversely affected by alleged securities fraud between February 3, 2022 and February 3, 2025. Follow the link below to get more information and be contacted by a member of our team:https://zlk.com/pslra-1/merck-co-inc-lawsuit-submission-form? ...

Core Viewpoint - A class action securities lawsuit has been filed against Merck & Co., Inc. due to alleged securities fraud impacting investors between February 3, 2022, and February 3, 2025 [1] Group 1: Lawsuit Details - The lawsuit aims to recover losses for investors affected by misleading information regarding Merck's expected revenue of $11 billion from Gardasil sales by 2030 [2] - The complaint highlights that Merck's optimistic forecasts were based on anticipated consumer activation and education efforts, particularly in China [2] - On February 4, 2025, Merck announced it would not meet the $11 billion sales target for Gardasil, citing a need to reduce inventory due to lower-than-expected demand in China, leading to a stock price drop of over 9% in one day [2] Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until April 14, 2025, to request appointment as lead plaintiff, although participation does not require this role [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees [3] Group 3: Firm Background - Levi & Korsinsky has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years [4] - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as a leading securities litigation firm in the United States [4]

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Merck & Co., Inc. regarding a class action lawsuit related to misleading statements about Gardasil's expected revenue, which has led to significant stock price decline [1]. Group 1: Allegations and Impact - The lawsuit alleges that Merck provided investors with material information indicating expected revenue of $11 billion from Gardasil sales by 2030, driven by consumer activation and education efforts [1]. - On February 4, 2025, Merck announced it would not achieve the projected $11 billion in sales due to ceasing shipments to China, resulting in a stock price drop from $99.79 to $90.74, a decline of over 9% in one day [1]. Group 2: Class Action Details - Shareholders who purchased MRK shares between February 3, 2022, and February 3, 2025, are encouraged to register for the class action, with a deadline of April 14, 2025, to seek lead plaintiff status [2]. - Registered shareholders will receive updates through portfolio monitoring software throughout the case lifecycle, with no cost or obligation to participate [2]. Group 3: Law Firm's Mission - The Gross Law Firm aims to protect investors' rights against deceit and fraud, ensuring companies adhere to responsible business practices [3].

Company Overview - Merck (MRK) is a pharmaceutical company based in Rahway, operating in the Medical sector, with a year-to-date share price change of -11.86% [3] Dividend Information - Merck currently pays a dividend of $0.81 per share, resulting in a dividend yield of 3.7%, which is higher than the Large Cap Pharmaceuticals industry's yield of 2.31% and the S&P 500's yield of 1.52% [3] - The annualized dividend of $3.24 represents a 3.8% increase from the previous year, with Merck having increased its dividend five times over the last five years, averaging an annual increase of 5.95% [4] - The company's current payout ratio is 42%, indicating that it pays out 42% of its trailing 12-month earnings per share as dividends [4] Earnings Expectations - Merck is expected to see earnings growth this fiscal year, with the Zacks Consensus Estimate for 2025 at $9.03 per share, reflecting a year-over-year earnings growth rate of 18.04% [5] Investment Considerations - Dividends are favored by investors as they enhance stock investing profits, reduce overall portfolio risk, and offer tax advantages [6] - High-yielding stocks may face challenges during periods of rising interest rates, but Merck is considered a compelling investment opportunity due to its strong dividend profile and current Zacks Rank of 3 (Hold) [7]

Core Viewpoint - The Merck & Co., Inc. class action lawsuit alleges that the company and its executives made misleading statements regarding the company's revenue outlook and growth prospects for Gardasil, leading to significant stock price declines when the truth was revealed [3][4][5]. Group 1: Allegations of Misleading Statements - The lawsuit claims that Merck created a false impression of reliable information about its revenue outlook and growth of Gardasil while downplaying competition risks and drug approval developments [3]. - It is alleged that Merck's optimistic reports regarding growth and demand in China were not reflective of the actual situation, which showed diminished ability to drive demand for Gardasil [3]. Group 2: Stock Price Impact - Following the announcement on July 30, 2024, regarding a significant drop in shipments from its distributor, Merck's stock price fell nearly 10% [4]. - On February 4, 2025, after disclosing a 3% decline in Gardasil sales to $8.6 billion, Merck's stock price dropped more than 9% [5]. Group 3: Class Action Process - Investors who purchased Merck securities during the class period can seek appointment as lead plaintiff, representing the interests of the class [6]. - The lead plaintiff can choose a law firm to litigate the case, and participation as lead plaintiff does not affect the ability to share in any potential recovery [6]. Group 4: About Robbins Geller - Robbins Geller Rudman & Dowd LLP is a leading law firm specializing in securities fraud cases, having secured $6.6 billion for investors in class action cases [7]. - The firm has a strong track record, being ranked 1 in securing monetary relief for investors in six out of the last ten years [7].

Core Viewpoint - A class action securities lawsuit has been filed against Merck & Co., Inc. due to alleged securities fraud affecting investors between February 3, 2022, and February 3, 2025 [1] Group 1: Lawsuit Details - The lawsuit aims to recover losses for Merck investors who were impacted by the company's misleading statements regarding expected revenue of $11 billion from Gardasil sales by 2030 [2] - The complaint highlights that Merck's optimistic forecasts for Gardasil's growth in China were based on the company's confidence in consumer activation and education efforts [2] - On February 4, 2025, Merck announced it would not meet the $11 billion sales target for Gardasil by 2030, citing a halt in shipments to China to reduce inventory due to lower-than-expected demand [2] Group 2: Stock Impact - Following the announcement on February 4, 2025, Merck's stock price dropped from $99.79 per share to $90.74 per share, representing a decline of over 9% in one day [2] Group 3: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until April 14, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require serving as lead plaintiff [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees [3] Group 4: Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years [4] - The firm has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Merck & Co., Inc. securities between February 3, 2022, and February 3, 2025, of the April 14, 2025, deadline to serve as lead plaintiff in a class action lawsuit [1] Group 1: Class Action Details - Investors who purchased Merck securities during the specified Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [1] - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by April 14, 2025 [2] - The Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions [3] Group 2: Case Background - The lawsuit alleges that throughout the Class Period, Merck provided investors with optimistic revenue expectations of $11 billion from Gardasil sales by 2030 while concealing adverse facts about demand in China [4] - Defendants reportedly made materially false and misleading statements regarding Gardasil's demand, leading to inflated inventory levels for its distributor, Zhifei [4]