MERCK & CO., INC. CONSOLIDATED STATEMENT OF OPERATIONS - GAAP (AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES) (UNAUDITED) Table 1a | | | | | 2024 | | | | | 2023 | | | % Change | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | Full | | | | | Full | | Full | | | | 1Q | 2Q | 3Q | 4Q | Year | 1Q | 2Q | 3Q | 4Q | Year | 4Q | Year | | Sales | | | | | | $ 15,775 $ 16,112 $ 16,657 $ 15,624 $ 64,168 $ 14,487 $ 15,035 $ 15,962 $ 14,630 $ 60,115 | | | | | | 7% | 7% ...

Merck on Tuesday issued full-year 2025 revenue guidance that fell short of Wall Street's expectations, as the company temporarily paused shipments of a key vaccine into China. The pharmaceutical giant anticipates 2025 sales of $64.1 billion to $65.6 billion, lower than the $67.31 billion that analysts surveyed by LSEG had expected. In a release, the company said that sales range reflects a decision to halt shipments of Gardasil into China beginning in February through and going through at least mid-2025. Ga ...

Merck (MRK) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of its 21-valent pneumococcal conjugate vaccine (PCV), Capvaxive, for the prevention of invasive pneumococcal disease (“IPD”) and pneumococcal pneumonia in individuals aged 18 years and above.The European Commission will now review the CHMP’s opinion and a final decision from the regulatory body is expected by the second quarter of 2025.The FDA approved Capvaxiv ...

Merck (MRK) has decided to stop the phase III HYPERION study early. The study evaluates MRK’s pulmonary arterial hypertension (PAH) drug, Winrevair (sotatercept), for a more advanced version of the disease.This decision is based on strong efficacy data from previously conducted studies on Winrevair. Per Meck, an external steering committee unanimously concluded that the HYPERION study has lost ‘clinical equipoise’.How Does Losing Clinical Equipoise Benefit Merck?Clinical equipoise refers to a genuine uncert ...

Wall Street analysts forecast that Merck (MRK) will report quarterly earnings of $1.69 per share in its upcoming release, pointing to a year-over-year increase of 5533.3%. It is anticipated that revenues will amount to $15.56 billion, exhibiting an increase of 6.4% compared to the year-ago quarter.Over the last 30 days, there has been a downward revision of 2.2% in the consensus EPS estimate for the quarter, leading to its current level. This signifies the covering analysts' collective reconsideration of th ...

Core Viewpoint - Merck's supplemental new drug application for Welireg has been accepted by the FDA, seeking approval for treating advanced pheochromocytoma and paraganglioma, marking a significant step in addressing a gap in treatment options for these rare tumors [1][5]. Regulatory Updates - The FDA has granted a priority review for the sNDA, with a decision expected on May 26, 2025 [2]. - The sNDA is based on data from the phase II LITESPARK-015 study, focusing on objective response rate and duration of response [2]. - The European Medicines Agency's CHMP has recommended conditional approval for Welireg for two indications, with a final decision expected in the first quarter of 2025 [8][9]. Market Performance - Merck's stock has decreased by 19.2% over the past year, contrasting with a 2.2% decline in the industry [4]. - Welireg generated sales of $349 million in the first nine months of 2024, driven by increased uptake for advanced RCC [10]. Product Development - Welireg is currently approved for advanced renal cell carcinoma and certain tumors associated with von Hippel-Lindau disease, and if approved for advanced PPGL, it will be the only treatment available for this condition in the U.S. [5]. - Merck is exploring Welireg as a monotherapy and in combination with other therapies for various rare cancer indications [9].

Core Viewpoint - Merck (MRK) is set to report its fourth-quarter and full-year 2024 earnings on February 4, with sales and earnings estimates at $15.56 billion and $1.72 per share respectively. However, earnings estimates for 2025 have seen a decline from $9.57 to $9.44 per share over the past month [1][2]. Earnings Estimates and Trends - The current earnings estimates for Q1, Q2, and 2025 are $1.72, $2.23, and $9.44 per share respectively, showing a downward trend compared to previous estimates [2]. - The earnings surprise history indicates that Merck has exceeded earnings expectations in the last four quarters, with an average surprise of 37.57% [5]. Factors Influencing Upcoming Results - Keytruda, Merck's cancer drug, is expected to drive top-line growth in Q4, supported by increased patient demand and additional indications [7]. - Keytruda's sales are estimated at $7.73 billion, with the company's own estimate at $7.62 billion, reflecting strong uptake in early-stage non-small cell lung cancer [8]. - Alliance revenues from Lynparza and Lenvima are anticipated to contribute positively to oncology sales, while sales of the HPV vaccine Gardasil may be negatively impacted by lower demand in China [9][11]. Sales Performance by Product - The pharmaceutical unit's sales estimate is $13.9 billion, with the company's estimate slightly higher at $13.97 billion [15]. - The Animal Health segment is expected to see growth, with estimates for this unit at $1.34 billion [15]. Valuation and Stock Performance - Merck's stock has declined by 19.2% over the past year, underperforming the industry and the S&P 500 [17]. - The company's shares trade at a forward P/E ratio of 10.30, which is lower than the industry average of 16.0 and its own 5-year mean of 13.28, indicating attractive valuation [19]. Investment Thesis - Merck has a strong portfolio with over six blockbuster drugs, primarily driven by Keytruda. However, the company is heavily reliant on this drug, which is set to lose patent exclusivity in 2028 [22][24]. - Despite challenges, Merck's strong cash position of $14.6 billion provides opportunities for strategic acquisitions to bolster its pipeline [24]. - Long-term growth is expected to be driven by Keytruda and new products, while short-term investors may consider selling due to potential delays in strong earnings growth [25].

Core Insights - Merck and Eisai announced data from the phase III LEAP-015 study, evaluating the combination of Keytruda and Lenvima with chemotherapy for treating gastroesophageal adenocarcinoma [1][2] - The study showed a significant improvement in progression-free survival (PFS) but failed to meet the overall survival (OS) endpoint [3] - Keytruda remains a key product for Merck, generating over $21 billion in sales in the first nine months of 2024, accounting for around 50% of the company's pharmaceutical sales [8][9] Study Results - The LEAP-015 study compared the Keytruda plus Lenvima regimen against standard chemotherapy for first-line treatment of HER2-negative gastroesophageal adenocarcinoma [2] - The interim analysis indicated a statistically significant improvement in PFS, while the final analysis did not meet the OS endpoint [3] - The combination also showed a significant improvement in objective response rate, a key secondary endpoint [4] Market Performance - Merck's stock has declined by 21.2% over the past year, contrasting with a 2.2% decline in the industry [5] - The Keytruda plus Lenvima combination is already approved in multiple regions for advanced endometrial and renal cell carcinoma [6] Future Prospects - Merck is exploring the Keytruda and Lenvima combination across various tumor types through the LEAP clinical program [7] - The company is developing strategies to sustain Keytruda's growth, including innovative immuno-oncology combinations and a subcutaneous formulation [10] - Keytruda is expected to continue its growth trajectory, particularly in early-stage non-small cell lung cancer, despite patent expiration concerns post-2028 [9]

Core Viewpoint - Merck is facing significant challenges due to the impending patent cliff for its leading cancer drug, Keytruda, but it remains a strong investment for long-term holders [2][3]. Group 1: Keytruda's Market Position - Keytruda generates over $20 billion in annual sales and has over 30 indications in the U.S. across various cancer types, which is expected to sustain revenue growth until its patent loss in 2028 [3][4]. - The competition from ivonescimab and BioNTech's PM8002 is anticipated to take time to develop and gain approval, allowing Keytruda's sales to continue growing until at least 2028 [5][6]. Group 2: Post-Keytruda Strategies - Merck is developing a subcutaneous version of Keytruda, which has shown positive phase 3 results, indicating it will continue to compete effectively in the market [6][7]. - The company is also exploring new products, including a partnership with LaNova Medicines for LM-299 and a deal with Hansoh Pharma for an oral GLP-1 medicine, indicating a proactive approach to diversify its portfolio [8][9]. Group 3: Financial Health and Dividend - Merck has a strong history of revenue growth, with an 80% increase in dividends over the past decade, and a current forward yield of approximately 3.4%, significantly higher than the S&P 500 average [12][13]. - The company’s robust pipeline of over 90 programs in mid or late-stage trials suggests potential for future revenue generation beyond Keytruda [10].

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