Core Insights - Moderna is planning to launch up to 10 new marketed products over the next four years, targeting a market opportunity exceeding $30 billion, which is crucial for driving revenue growth and reducing reliance on the COVID-19 vaccine Spikevax [1][8] Product Portfolio and Market Strategy - Spikevax, Moderna's first marketed product, significantly boosted its profitability but has seen a sharp decline in sales as pandemic demand wanes. The company introduced a second product, the RSV vaccine mResvia, but its uptake was weaker than anticipated. Recently, Moderna received approval for a third product, mNexspike, a next-generation version of Spikevax [2][8] - To counteract declining COVID-19 vaccine sales, Moderna is advancing a late-stage pipeline focused on respiratory, infectious diseases, and oncology. Key vaccine programs include mRNA-1647 for CMV, mRNA-1083 for COVID-19 plus influenza, and mRNA-1010 for standalone influenza, with data expected from the CMV study and a regulatory resubmission for the COVID/flu combination vaccine by the end of 2025 [3][8] Cancer Therapy Development - A significant candidate in Moderna's pipeline is intismeran autogene (formerly mRNA-4157), a personalized cancer therapy developed in collaboration with Merck. This therapy is undergoing evaluation in three pivotal phase III studies for melanoma and non-small cell lung cancer, with additional mid-stage studies for high-risk bladder cancers and other indications. A potential launch is targeted for 2027 [4][8] Competitive Landscape - Moderna faces stiff competition from Pfizer and BioNTech, both of which have experienced revenue fluctuations due to declining demand for their jointly developed COVID-19 vaccine, Comirnaty. These companies are also diversifying into adjacent vaccine and therapeutic areas, including a COVID-19 and influenza combination vaccine [5][6] - BioNTech is focusing on oncology as a long-term growth driver, with key candidates like BNT327, an investigational antibody targeting PD-1 and VEGF, being evaluated across various cancer indications [7]

Core Insights - Merck's Keytruda (pembrolizumab) has received FDA approval for a subcutaneous formulation, Keytruda Qlex, which is expected to launch commercially later this month [1][2] - The subcutaneous version offers improved patient convenience, reducing administration time from at least 30 minutes for the IV version to as little as one minute [2] - The approval is backed by pivotal studies showing that Keytruda Qlex is at least as effective as the IV formulation, with a regulatory filing for the SC version also under review in Europe [3] Group 1: Keytruda Qlex Approval and Market Impact - The approval of Keytruda Qlex is timely as Merck faces the potential loss of exclusivity for Keytruda IV in 2028, which currently accounts for over 48% of the company's revenue [4] - Keytruda IV generated over $15 billion in sales during the first half of 2025, reflecting an 8% year-over-year increase [4] - The new SC version comes with its own patents that extend protection beyond 2028, allowing Merck to manage Keytruda's lifecycle effectively [5] Group 2: Challenges and Competitive Landscape - Merck is experiencing a decline in sales of its second-largest product, Gardasil, which has dropped 48% year over year due to weak demand in China [6] - Competitive pressure for Keytruda may increase from dual PD-1/VEGF inhibitors like Summit Therapeutics' ivonescimab, which has shown potential to outperform Keytruda [9][10] - Merck is actively pursuing innovative combinations and partnerships, including a collaboration with Moderna to develop a personalized mRNA therapeutic cancer vaccine [8] Group 3: Financial Performance and Valuation - Merck's shares have underperformed the industry year to date, with a current price/earnings (P/E) ratio of 8.67, lower than the industry average of 14.88 and its 5-year mean of 12.70 [11][13] - Movements in EPS estimates for 2025 and 2026 have been mixed over the past 60 days, indicating uncertainty in future earnings [15] - Merck currently holds a Zacks Rank 3 (Hold), reflecting a cautious outlook [16]

Core Insights - Moderna reported a Q2 2025 loss of $2.13 per share, which was better than the Zacks Consensus Estimate of a loss of $2.99, and an improvement from a loss of $3.33 in the same period last year [1][7] - Total revenues for the quarter were $142 million, exceeding the Zacks Consensus Estimate of $127 million, but reflecting a 41% year-over-year decline due to lower net product sales [1][2] - The company revised its total revenue guidance for 2025 to a range of $1.5 billion to $2.2 billion, a reduction of $300 million from the previous guidance [5][9] Revenue Breakdown - Product sales decreased by 38% year over year to $114 million, primarily due to lower sales of the COVID-19 vaccine Spikevax, with minimal contribution from the newly launched RSV vaccine mResvia [2][3] - Moderna generated $28 million from grants, collaborations, licensing, and royalty revenues, down 51% year over year, typically derived from partnerships with major pharma companies [3] Cost Management - Selling, general and administrative (SG&A) expenses were $230 million, a 14% decrease year over year, attributed to cost-cutting measures [4] - Research and development (R&D) expenses fell by 43% to $700 million, influenced by reduced clinical spending across respiratory programs [4][9] Future Outlook - The company anticipates generating the majority of its guided revenue in the second half of 2025, with a revenue split of 40-50% expected in Q3 [8] - Moderna expects to end 2025 with nearly $6 billion in cash, cash equivalents, and investments [10] Pipeline Developments - Moderna received three regulatory approvals from the FDA, including full approval for Spikevax in pediatric patients and label expansion for mResvia [11] - The company is evaluating several late-stage pipeline candidates, including a promising influenza vaccine candidate, mRNA-1010, which showed superior efficacy compared to an approved flu shot [12][13] - A significant candidate in development is intismeran autogene, a personalized cancer therapy being evaluated in collaboration with Merck [14][16] Legal Developments - The U.K. Court of Appeal upheld the validity of Moderna's EP'949 patent, affirming the infringement by Pfizer/BioNTech's COVID-19 vaccine Comirnaty [17]

Core Viewpoint - Moderna (MRNA) is expected to exceed earnings expectations for Q2 2025, with a prior earnings surprise of 13.70% in the last quarter. The consensus estimates for sales and earnings are $127 million and a loss of $2.99 per share, respectively [1][9]. Factors Shaping MRNA's Upcoming Results - A significant portion of Moderna's revenue is anticipated to come from the COVID-19 vaccine, Spikevax, with estimated sales of $59 million, reflecting a notable decline from the previous year due to reduced demand [2]. - Minimal sales are expected from the RSV vaccine, mResvia, with projections of only $2 million, which is considerably lower than competing products from GSK and Pfizer. This is attributed to the later approval and recommendation of the vaccine [3]. Regulatory Developments - The FDA has expanded the label for mResvia to include high-risk adults aged 18-59, and the CDC has updated its recommendations for RSV vaccines to include high-risk adults aged 50-59. Investors are looking for updates on marketing strategies for both vaccines [4]. - A regulatory filing is under FDA review to update Spikevax for the LP.8.1 variant for the 2025-26 vaccination season, with a similar filing also under review by the EMA. Investors are keen on updates regarding these regulatory processes [5]. Pipeline Candidates - Moderna is advancing several late-stage pipeline candidates, including the influenza vaccine candidate mRNA-1010, which has shown superior efficacy compared to an approved flu shot. This supports potential approval for a standalone flu shot and strengthens the case for the combination vaccine mRNA-1083 [6]. - An important candidate is intismeran autogene, a personalized cancer therapy developed in collaboration with Merck, currently evaluated in pivotal phase III studies for various cancer indications. Investors are interested in updates on this therapy's progress [7]. Earnings Surprise History - Moderna has consistently beaten earnings estimates over the past four quarters, achieving an average surprise of 31.60% [8]. Market Performance - Year to date, Moderna's shares have declined by 18%, contrasting with a 2% growth in the industry [10].

Core Viewpoint - Moderna's first-quarter results for 2025 show a mixed performance, with improved bottom-line figures due to streamlining efforts, but a significant decline in revenues raises concerns about the company's future [1][2]. Sales Performance - Sales of Moderna's marketed products, primarily the COVID-19 vaccine Spikevax and the newly launched RSV vaccine mResvia, declined nearly 50% year-over-year to $86 million in Q1 2025, missing estimates [4]. - Spikevax sales were $84 million, falling short of the model estimate of $112 million, attributed to lower demand in the post-pandemic market [5]. - mResvia sales totaled $2 million, significantly below the model estimate of $70 million, due to late approval and recommendations affecting customer orders [5]. - The overall decline in RSV vaccine sales is noted across the industry, with competitors like Pfizer and GSK also experiencing significant drops [6]. Cost Management - Moderna is focusing on cost efficiency and has set a target to save approximately $300-$500 million in operating expenses next year [7]. - The company expects to incur $4.7-$5.0 billion in operating costs in 2027, a reduction of $1.4-$1.7 billion compared to 2025 estimates, marking the third consecutive quarter of double-digit year-over-year cost reductions [8]. Product Pipeline and Future Plans - Moderna plans to launch 10 new products over the next three years to diversify its revenue base beyond Spikevax [9]. - The company has submitted three regulatory filings to the FDA, including for a next-generation COVID-19 vaccine and a combination vaccine for COVID-19 and influenza, with decisions expected soon [10][11]. - Moderna is advancing over 40 mRNA-based investigational candidates, including vaccines for cytomegalovirus and influenza, as well as cancer therapies in collaboration with Merck [12][13][14][15]. Conclusion - Despite the challenges posed by declining revenues, Moderna's strategic focus on product launches and a robust pipeline of mRNA-based therapies positions the company for long-term growth beyond the COVID-19 era [16].

Core Viewpoint - Moderna reported a narrower loss of $2.52 per share in Q1 2025, compared to a loss of $3.07 in the same period last year, but total revenues of $108 million fell short of expectations and declined approximately 35% year over year due to lower product sales [1][2][3] Financial Performance - Total revenues for Q1 2025 were $108 million, missing the Zacks Consensus Estimate of $127 million [1] - Product sales decreased by 49% year over year to $86 million, primarily due to lower sales of the COVID-19 vaccine Spikevax [2] - Spikevax sales were $84 million in the quarter, down from $167 million in the previous year, attributed to lower vaccination rates and the normalization of COVID into a seasonal market [3] - mResvia sales were only $2 million, significantly below the estimated $70 million, due to late approval and recommendations [4] - The company generated $22 million from grants, collaborations, licensing, and royalty revenues, with no revenues recorded in the year-ago period [6] Cost Management - Selling, general and administrative (SG&A) expenses were $212 million, down 23% year over year due to cost-cutting measures [7] - Research & development (R&D) expenses decreased by 19% to $856 million, driven by reduced clinical spending [7] Financial Guidance - Moderna reiterated its total revenue guidance for 2025, expecting revenues between $1.5 billion and $2.5 billion, with around $0.2 billion expected in the first half of the year [8] - Full-year R&D expenses are projected to be around $4.1 billion, while SG&A expenses are expected to be approximately $1.1 billion [9] - Capital expenditure is anticipated to be around $0.4 billion in 2025 [9] Pipeline Developments - Moderna submitted three regulatory filings to the FDA in Q4 2024, including for mRNA-1283 (next-generation COVID-19 vaccine) and mResvia for high-risk adults [12] - A third filing for the COVID-19 and influenza combination vaccine, mRNA-1083, is pending further data, which may delay launch plans [13] - The company has over 40 mRNA-based investigational candidates in various clinical stages, including cancer therapies [16] - Moderna is co-developing intismeran autogene with Merck, evaluating it in pivotal phase III studies for melanoma and non-small cell lung cancer [17][18] - The company plans to start a registrational study for mRNA-3705, a therapeutic candidate for methylmalonic acidemia, later this year [19]