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MRNA Beats on Q2 Earnings & Sales, Stock Down on Lowered Sales View
ZACKS· 2025-08-01 18:26
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]
Moderna(MRNA) - 2025 Q2 - Earnings Call Presentation
2025-08-01 12:00
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]
Moderna to Report Q2 Earnings: Is a Beat in Store for the Stock?
ZACKS· 2025-07-29 13:31
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].
Will These 5 Pharma/Biotech Bigwigs Surpass Q2 Earnings Forecasts?
ZACKS· 2025-07-28 15:31
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]
What's Going On With Moderna Stock Wednesday?
Benzinga· 2025-07-23 19:14
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]
MRNA Stock Up on Full FDA Nod for COVID-19 Jab in Pediatric Patients
ZACKS· 2025-07-11 16:01
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]
FDA Grants Complete Approval To Moderna's COVID-19 Vaccine For Children As Young As 6 Months
Benzinga· 2025-07-10 18:13
Group 1: Moderna's Vaccine Approval - The U.S. FDA has 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 disease [1] - Moderna's CEO emphasized the importance of vaccination for protecting children against severe disease and hospitalization, expressing appreciation for the FDA's review and approval [2] - The updated Spikevax vaccine is expected to be available for eligible populations in the U.S. for the 2025-2026 respiratory virus season [2] Group 2: Legal Challenges and Patent Issues - Pfizer and BioNTech have requested a reversal of a court ruling that found their COVID-19 vaccine infringed on a Moderna patent, while a previous ruling declared one of Moderna's patents invalid [3] - The companies argue that Moderna's mRNA technology is a continuation of earlier research, questioning the validity of the patent [4] - Moderna maintains that the court's decision to uphold the patent is correct and should remain [4] Group 3: FDA's Vaccine Approval Decisions - The FDA's top vaccine official overruled agency scientists to limit the approval of two COVID-19 vaccines, despite recommendations for broader use [6] - The official restricted the vaccines to higher-risk individuals, citing declining hospitalization and death rates from COVID-19 as a factor in the decision [7] - Following the news, Moderna's stock price increased by 3.60% to $33.97 [7]
Why Moderna Stock Was So Healthy This Week
The Motley Fool· 2025-07-04 19:07
Core Viewpoint - Moderna has experienced a significant increase in stock value, gaining over 12% recently, driven by positive developments in its vaccine research [1]. Group 1: Vaccine Development - Moderna published results from a late-stage study of its seasonal flu vaccine, mRNA-1010, which demonstrated a stronger immune response compared to standard flu vaccines [2]. - The company plans to resubmit its application for a combination COVID-19/flu vaccine, following the withdrawal of its previous application in May [4]. - CEO Stéphane Bancel highlighted the trial results as a significant milestone in reducing influenza burden in older adults [5]. Group 2: Market Sentiment - Despite the positive news regarding the flu vaccine, there is skepticism about whether this development alone will make Moderna's stock a compelling buy [5]. - The company has a robust pipeline of development programs, which could enhance the attractiveness of its shares if any show promise [6].
Moderna Secures FDA Nod for Next-Gen COVID-19 Vaccine mNexspike
ZACKS· 2025-06-03 17:21
Core Insights - Moderna (MRNA) received FDA approval for its next-generation COVID-19 vaccine, mRNA-1283, branded as mNexspike, with a narrower usage label than initially sought [1][8] - The approval aligns with the FDA's updated guidance focusing on vaccinating high-risk populations, specifically older adults aged 65 and individuals aged 12-64 with underlying health conditions [2][8] - mNexspike is Moderna's third FDA-approved product, joining Spikevax and mResvia [3] Product Details - mNexspike offers improved shelf life and storage benefits, making it advantageous for distribution in areas with limited cold-chain infrastructure [4] - Clinical data indicates that a 10 μg dose of mNexspike has a 9.3% higher relative vaccine efficacy compared to a 50 μg dose of Spikevax [4] Market Launch - Moderna plans to commercially launch mNexspike during the 2025-26 vaccination season [5] Stock Performance - Year-to-date, Moderna's stock has decreased by 35%, contrasting with a 4% decline in the industry [6] Recent Developments - Negative sentiment surrounds Moderna's stock due to the U.S. government terminating contracts worth $766 million for the development of an mRNA-based bird flu vaccine [9] - The FDA's new guidelines for COVID-19 vaccine boosters limit eligibility for healthy individuals under 65, potentially reducing demand [10] - Moderna voluntarily withdrew a regulatory filing for its COVID-19/influenza vaccine after the FDA requested additional efficacy data, delaying potential approval [10] Competitive Landscape - Other players in the COVID-19 vaccine market include Pfizer (PFE) with its mRNA vaccine Comirnaty and Novavax (NVAX) with its non-mRNA vaccine Nuvaxovid [11][12] - Novavax's Nuvaxovid has received full FDA approval for older adults and high-risk individuals aged 12-64, but is not yet approved for those under 12 [12]
MRNA Seeks FDA Nod for Updated COVID-19 Vaccine
ZACKS· 2025-05-26 14:46
Group 1 - Moderna has submitted a regulatory filing to the FDA for an updated version of its COVID-19 vaccine Spikevax, targeting the LP.8.1 variant [1] - The FDA's recent guidance recommends vaccine-makers to update their COVID-19 shots to target strains from the JN.1 lineage, with a preference for LP.8.1, which currently accounts for about 70% of total cases in the U.S. [2] - The FDA has also mandated that vaccine makers conduct randomized, placebo-controlled clinical studies to demonstrate the real-world benefits of yearly COVID-19 vaccine boosters for individuals under 65 years [3] Group 2 - Year to date, Moderna's stock has decreased by 37%, while the industry has seen a decline of 6% [4] - Other COVID-19 vaccines in the market include Pfizer/BioNTech's Comirnaty and Novavax's Nuvaxovid, with no recent updates from these companies regarding their vaccines [6] - Currently, only Moderna and Pfizer/BioNTech's vaccines are approved for individuals aged six months and above, while Novavax's vaccine is restricted to specific age groups and conditions [7]