Key Takeaways Moderna targets $30B market with 10 new products in four years to reduce COVID-19 sales reliance.Declining Spikevax sales drive focus on RSV and late-stage pipeline programs like CMV and influenza.Cancer therapy intismeran, with Merck, advances in phase III studies for melanoma and lung cancer.Moderna (MRNA) is focusing on launching up to 10 new marketed products over the next four years, targeting a market opportunity of over $30 billion. These launches are central to Moderna’s strategy to dr ...

Core Insights - Moderna's shares increased by 4% following the announcement of positive preliminary immunogenicity data from a phase IV study of its updated COVID-19 vaccine, Spikevax, targeting the LP.8.1 variant [1][6] - The phase IV study demonstrated that the 2025-2026 formula of Spikevax resulted in an average increase of over 8-fold in neutralizing antibodies against the LP.8.1 variant across various age groups, with a safety profile consistent with previous studies [2][6] - The FDA approved updated COVID-19 vaccines from Moderna, Pfizer/BioNTech, and Novavax for the 2025-26 vaccination season, specifically targeting the LP.8.1 strain [4] Company Performance - Year-to-date, Moderna's shares have decreased by 40.3%, contrasting with the industry's growth of 2.8% [3] Regulatory Approvals - The FDA approved Moderna's Spikevax for individuals aged 6 months to 64 years with at least one high-risk condition, and a next-generation version called mNexspike for those aged 12 to 64 years [7] - Pfizer/BioNTech's Comirnaty was approved for at-risk individuals aged 5 years and older, showing a 4-fold increase in neutralizing antibodies against the LP.8.1 variant in a phase III study [8] - Novavax's Nuvaxovid was approved for at-risk individuals aged 12 to 64 years, being the only non-mRNA-based vaccine currently available [9]

Market Overview - U.S. markets experienced a slight decline, with the Dow Jones Industrial Average falling approximately 0.3% to 45,757.90, the S&P 500 decreasing 0.1% to 6,606.76, and the Nasdaq dipping 0.07% to 22,333.96 [1] Nio Inc. (NIO) - Nio's stock surged by 8.17%, closing at $7.02, with an intraday high of $7.09 and a low of $6.48; the 52-week range is $7.71 to $3.02 [2] - The stock's rise followed UBS's upgrade from Neutral to Buy, with a price target increase from $6.20 to $8.50 [2] - Nio's shipment of a new model to dealers contributed to the positive momentum [2] Rivian Automotive, Inc. (RIVN) - Rivian's shares climbed 5.29%, ending the day at $14.32, with a high of $14.65 and a low of $13.73; the 52-week range is $17.15 to $9.50 [3] - The increase is attributed to Rivian's announcement of a new facility in Georgia, marking a significant step in their electric vehicle production [3] Moderna Inc. (MRNA) - Moderna's stock rose by 4.02%, closing at $24.84, with a day's high of $25.63 and a low of $23.91; the 52-week range is $75.37 to $23.15 [4] - This uptick followed the release of preliminary data showing an eight-fold increase in antibodies with their updated Spikevax formula targeting the LP.8.1 variant of SARS-CoV-2 [4] Meta Platforms Inc. (META) - Meta's shares increased by 1.87%, closing at $779, with an intraday high of $781.36 and a low of $765.10; the 52-week range is $796.25 to $479.80 [5] - The rise was influenced by a leak revealing Meta's next-generation smart glasses, described as a "game changer" by analyst Ross Gerber [5] BitMine Immersion Technologies Inc. (BMNR) - BitMine's stock rose by 5.31%, closing at $55.93, with a high of $57.01 and a low of $50.90; the 52-week range is $161 to $3.20 [5] - The increase follows BitMine's report of holding over 2.15 million Ethereum tokens, making it the world's largest Ethereum treasury company [5] Rivian's Performance Metrics - Rivian has a Momentum ranking in the 60th percentile and a Growth ranking in the 24th percentile, compared against Tesla and Nio [6]

Core Insights - The 2025-2026 formula of Spikevax has shown a greater than 8-fold increase in LP.8.1-neutralizing antibodies across various age groups [1] Company Summary - Moderna, Inc. announced positive preliminary immunogenicity data for the 2025-2026 formula of Spikevax, which targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19 [1] - The data comes from an ongoing Phase 4 clinical trial assessing the safety, tolerability, and immunogenicity of the new formula [1] Clinical Findings - The clinical findings indicate that individuals aged 12 to 64 years with at least one underlying condition that increases the risk for severe COVID-19 outcomes, as well as all adults aged 65 and older, experienced an average of greater than 8-fold increase in neutralizing antibodies against the LP.8.1 variant [1]

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]

Financial Performance - Total revenue for Q2 2025 was $142 million, a decrease of 41% compared to $241 million in Q2 2024[12] - Net product sales decreased by 38%, from $184 million in Q2 2024 to $114 million in Q2 2025[12] - Net loss was $825 million in Q2 2025, a 35% improvement compared to a net loss of $1279 million in Q2 2024[12] - Operating expenses decreased by 35%, a reduction of $555 million, from $1604 million in Q2 2024 to $1049 million in Q2 2025[8, 12] - Cash, cash equivalents, and investments decreased by 11%, from $84 billion as of March 31, 2025, to $75 billion as of June 30, 2025[8, 14] Pipeline and Approvals - The company received three new U S FDA approvals, expanding the commercial portfolio[9] - Positive Phase 3 data for mRNA-1010, the flu vaccine, showed superior relative vaccine efficacy compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older[9, 35] Financial Outlook and Cost Reduction - The company updated its 2025 GAAP financial framework, lowering the high end of the total revenue range from $25 billion to $15 - $22 billion, primarily due to the timing of UK COVID shipments moving from 2H25 to 1Q26[15] - The company is reducing 2025 GAAP operating expenses by approximately $04 billion and progressing toward intermediate-term cost reduction goals[16] - The company continues to target cash breakeven in 2028[55]

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].

Industry Overview - The second-quarter 2025 reporting cycle for the Medical sector is commencing, with most firms expected to release earnings results in the next two weeks, primarily consisting of pharma/biotech and medical device companies [1] - The earnings season for the drug and biotech sector began in mid-July, highlighted by Johnson & Johnson's strong performance, which exceeded earnings and sales estimates, leading to raised revenue and earnings expectations for the year [1] Company Performance - Novartis surpassed second-quarter earnings and revenue estimates, driven by a year-over-year increase in sales of key drugs, prompting an upward revision of its annual guidance for core operating income [2] - Roche experienced solid growth in the first half of 2025, with high demand for key drugs offsetting declines in legacy drug sales [2] - As of July 23, 15% of companies in the Medical sector, representing 27.2% of the sector's market capitalization, reported quarterly earnings, with 88.9% outperforming earnings estimates and 100% beating revenue estimates [3] - Overall, second-quarter earnings for the Medical sector are projected to increase by 0.9%, while sales are expected to rise by 7.9% compared to the previous year [3] Upcoming Earnings Reports - Merck, AstraZeneca, Bristol Myers, AbbVie, and Moderna are scheduled to release their quarterly results this week [4] - Merck has a strong earnings track record, beating estimates in the last four quarters with an average surprise of 3.82% [5] - AstraZeneca has a mixed earnings history, beating estimates in three of the last four quarters, with an average surprise of 4.24% [8] - Bristol Myers has consistently beaten earnings estimates, with an average surprise of 20.16% over the last four quarters [11] - AbbVie has also maintained a strong track record, beating estimates in the last four quarters with an average surprise of 2.55% [13] - Moderna has an excellent earnings history, with an average surprise of 31.60% in the last four quarters [15] Sales Drivers - Merck's growth in the second quarter is likely attributed to increased sales of its cancer drug Keytruda, driven by additional indications and patient demand [7] - AstraZeneca's sales are expected to be bolstered by strong demand for its cancer and diabetes medications [10] - Bristol Myers' revenue may be impacted by declines in legacy drug sales, but growth products are expected to partially offset this decline [12] - AbbVie's revenue is anticipated to be driven by strong sales of key drugs and contributions from newer products [14] - Moderna's revenues are expected to be influenced by sales of its COVID-19 vaccine, Spikevax, while the focus is shifting to updates on its broader pipeline [16]

Company Insights - Moderna's stock (MRNA) has surged approximately 37% in the last month but has dipped around 15% year to date, with a recent trading increase of about 7% [1] - The FDA approved Moderna's supplemental Biologics License Application for Spikevax, allowing its COVID-19 vaccine for children aged six months to 11 years at increased risk for COVID-19 [1] - Moderna's mRNA-1010, a seasonal influenza vaccine candidate, achieved a relative vaccine efficacy (rVE) of 26.6% in a Phase 3 study, with specific strain efficacies of 29.6% for A/H1N1, 22.2% for A/H3N2, and 29.1% for B/Victoria lineages [2][3] - The FDA also expanded the approval of Moderna's respiratory syncytial virus vaccine to adults aged 18-59 at increased risk for the disease [3] Industry Trends - Global healthcare stocks are currently cheaper than they have been in decades, with a slow return of investment into the sector [4] - Despite low prices, investor interest remains weak due to uncertainty around U.S. drug pricing policies, including potential revival of "most-favored-nation" rules and 200% tariffs on pharmaceutical imports [5] - Healthcare funds have seen net inflows of $7.2 billion since early 2024, although this is still 41% lower than the previous year [7] - U.S. healthcare has underperformed the S&P 500 by over 60 percentage points in the past three years, with its valuation at a near-record 27% discount compared to the S&P [8] - Investors are awaiting a clear catalyst for the sector, with ongoing policy uncertainty complicating future earnings predictions [9]

Core Insights - Moderna (MRNA) received FDA approval for its COVID-19 vaccine, Spikevax, for children aged six months to 11 years at increased risk for the disease [1][6] - The vaccine was previously available under Emergency Use Authorization [1][6] - Following the announcement, Moderna's shares increased by 4.5% [1] Group 1: FDA Approval and Vaccine Availability - Spikevax is now fully approved for adults aged 65 and above, and individuals aged six months to 64 years at increased risk for severe COVID-19 [2] - The updated Spikevax will be available for eligible patients during the 2025-2026 vaccination season in the U.S. [2][6] Group 2: Stock Performance - Year-to-date, Moderna's shares have decreased by 17.5%, while the industry has seen a growth of 0.2% [3] Group 3: Competitive Landscape - Other COVID-19 vaccines include Pfizer (PFE)/BioNTech's (BNTX) Comirnaty and Novavax's (NVAX) Nuvaxovid, with Comirnaty also using mRNA technology [4] - Novavax's Nuvaxovid is the only non-mRNA vaccine in the U.S. and has received full approval for older adults and high-risk individuals aged 12-64 [7] Group 4: Company Ranking - Moderna currently holds a Zacks Rank of 3 (Hold) [8]