Latest news with #mNEXSPIKE
Yahoo
02-08-2025
- Business
- Yahoo
Moderna Inc (MRNA) Q2 2025 Earnings Call Highlights: Navigating Challenges with Strategic Cost ...
Revenue: $0.1 billion for Q2 2025. Net Loss: $0.8 billion for Q2 2025. Cash and Investments: $7.5 billion at the end of Q2 2025. Cost Reduction: 35% reduction in cost of sales, R&D, and SG&A combined compared to Q2 2024. Operating Expenses Reduction: $581 million reduction in Q2 2025 versus Q2 2024, a 40% year-over-year reduction. Net Product Sales: $114 million, primarily driven by COVID vaccine sales. Total Revenue: $142 million for Q2 2025. Cost of Sales: $119 million, representing 105% of net product sales. R&D Expenses: $700 million, down 43% from last year. SG&A Expenses: $230 million, down 14% year over year. Loss Per Share: $2.13, an improvement from a loss of $3.33 in 2024. 2025 Revenue Projection: Updated to $1.5 billion to $2.2 billion. 2025 R&D Expense Forecast: Lowered to $3.6 billion to $3.8 billion. 2025 Capital Expenditures Projection: Lowered to $300 million. Headcount Reduction: Approximately 10% reduction announced. Warning! GuruFocus has detected 2 Warning Sign with MRNA. Release Date: August 01, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Moderna Inc (NASDAQ:MRNA) secured three FDA approvals, including mNEXSPIKE, a next-generation COVID vaccine, and mRESVIA for high-risk individuals. The company reported a 35% reduction in combined costs of sales, R&D, and SG&A compared to the second quarter of 2024. Moderna Inc (NASDAQ:MRNA) ended the quarter with $7.5 billion in cash and investments, maintaining a strong financial position. Positive Phase III efficacy data for their flu vaccine was announced, which supports the advancement of their flu and flu-COVID combination programs. The UK Court of Appeal upheld the validity of Moderna's EP'949 patent, which was found to be infringed by Pfizer and BioNTech. Negative Points Moderna Inc (NASDAQ:MRNA) reported a net loss of $825 million for the quarter, although this was an improvement from the previous year. Product sales declined by 38% compared to the second quarter of 2024, primarily due to lower COVID vaccine sales. The company announced a 10% workforce reduction to align costs with current business conditions. There was a $300 million reduction in the high end of their 2025 projected revenue range due to a timing shift of UK COVID shipments. Cost of sales represented 105% of net product sales this quarter, up from 62% in the prior year, driven by lower volume. Q & A Highlights Q: Can you explain the rationale behind adding secondary endpoints to the CMV study and provide an update on the individualized neoantigen therapy data cadence? A: Stephen Hoge, President: The addition of secondary endpoints in the CMV study aims to capture more comprehensive data on the vaccine's potential value, such as virus presence in bodily fluids. This is done while the study remains blinded to ensure integrity. Regarding the individualized neoantigen therapy, we expect a consistent cadence of results from randomized studies over the next year or two, starting with the Phase III adjuvant melanoma study. Q: How should we think about COVID vaccine pricing in the US this year compared to last year? A: James Mock, CFO: The US COVID vaccine sales are projected between $1 billion to $1.5 billion, factoring in competitive pressures and vaccination rates. Contracting and pricing are complete, and we are confident in our range, though specific pricing details are not disclosed. Q: What are your expectations for the CMV vaccine's positive readout, and how do you view the regulatory environment with recent FDA and ACIP changes? A: Stephen Hoge, President: A positive CMV readout would show vaccine efficacy above 49.1%, which would significantly impact public health. We continue to have productive dialogues with the FDA and ACIP, and we are grateful for the timely approvals of our recent products. Q: Do you have any early indications of COVID vaccine demand for the upcoming fall and winter season? A: Joseph Stringer, Analyst: Outside the US, demand is stable due to advanced purchase agreements. In the US, the spring booster campaign showed solid uptake, particularly among the 65+ demographic. We remain cautiously optimistic for the fall, but the true demand will be clearer by the end of September. Q: How are you balancing the need to bring late-stage infectious products to market with cost-cutting measures? A: James Mock, CFO: We continue to invest significantly in our late-stage pipeline, focusing on diversification beyond seasonal products. We are balancing the completion of our respiratory portfolio with investments in oncology and rare diseases, while adjusting our cash costs from $9 billion to $4 billion. Q: What does the decision to start the first-line metastatic melanoma trial for Intismeran suggest about the program's potential? A: Stephen Hoge, President: The decision reflects our optimism based on the adjuvant melanoma study results. We believe in the potential of Intismeran in both adjuvant and metastatic settings, supported by our progress in manufacturing efficiency. Q: Can you discuss the flu-COVID combo submission requirements and the timeline for CMV data release? A: Stephen Hoge, President: We are consulting with the FDA on flu-COVID combo requirements, likely needing flu efficacy data first. For CMV, we are updating the statistical analysis plan and expect to release data this fall, though exact timing depends on completing necessary approvals. Q: How are you approaching business development, particularly in oncology, and what are your plans for the COVID-flu combo filing? A: Stephane Bancel, CEO: We focus on partnering for non-mRNA assets and are open to collaborations that enhance our oncology capabilities. For the COVID-flu combo, we may proceed with flu approval first, but concurrent submissions are possible depending on regulatory guidance. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
02-06-2025
- Health
- Yahoo
What you need to know about Moderna's new COVID vaccine, just approved by the FDA
Moderna, over the weekend, announced that the U.S. Food and Drug Administration had approved its second-generation COVID vaccine, but only for specific populations: all adults 65 and over and those between 12 and 64 with at least one underlying risk factor as defined by the Centers for Disease Control and Prevention. Moderna's COVID shot had previously been approved for everyone 12 and older. The narrower approval follows the FDA announcing it was likely to limit access to immunizations among healthy children and adults under 65 this fall—as well as an announcement by Health Secretary Robert F. Kennedy Jr. (who, in 2021, called mRNA shots the 'deadliest vaccine ever made') about how COVID shots would be removed from the federal vaccine schedule for children and pregnant women. Still, days later, the CDC issued its own updated advice, going against Kennedy's announcement by keeping the shots on the schedule for healthy children 6 months and older. The mNEXSPIKE vaccine, which is meant to be a booster but will not immediately replace the Moderna's original COVID shot, was found through a Phase 3 clinical trial of 11,400 participants to be superior to the original; it showed a 9.3% higher relative vaccine efficacy (rVE) in individuals 12 and older and a 13.5% higher rVE in adults 65 and older. It will be available to those in the eligible populations—including those with risk factors such as asthma, chronic lung or kidney disease, or diabetes, according to the CDC—in the 2025–2026 respiratory virus season. The limits worry some physicians, including Dr. Jennifer Nayak, associate professor of pediatrics, microbiotics, and immunology at the University of Rochester, who told Rochester First, 'We know that [of] children who are hospitalized with COVID-19, about 41% of them don't have a known preexisting condition,' Nayak said. 'When you limit vaccination to only children who have preexisting conditions, you're going to miss some of the children who will get more seriously ill with this virus.' This updated mRNA shot still works by teaching the body to make a specific protein that helps your immune system ward off certain diseases. But instead of targeting the entire spike protein on the virus's surface, reports Medical Xpress, the new vaccine focuses on just two segments. This helps it last longer when refrigerated, making it easier to distribute in certain parts of the world, and more effective at lower doses. In the clinical trial, the new vaccine was found 'to have a similar safety profile' to the original, with 'fewer local reactions and comparable systemic reactions,' the most common being injection site pain, fatigue, headache, and myalgia. Still, other possible risks listed by Moderna, which 'may not be all the possible side effects,' include: Severe allergic reaction (which would occur within one hour) that could cause trouble breathing, face or throat swelling, body rash, fast heartbeat, or dizziness Myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the heart's outside lining, especially in males age 12–24; symptoms include chest pain, shortness of breath, and feelings of a fluttering or pounding heart) Such reactions, Moderna suggests, can be reported to the Vaccine Adverse Event Reporting System (VAERS). 'The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,' said Stéphane Bancel, chief executive officer of Moderna, in a company news release. 'COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone.' More on vaccines: The new COVID strain, NB 1.8.1, is an Omicron variant. Here's all you need to know Researchers uncover a link to autism—and it isn't vaccines The shingles vaccine could be the next best tool to prevent dementia, new study finds This story was originally featured on
Yahoo
02-06-2025
- Automotive
- Yahoo
Top Stock Movers Now: Ford, Cleveland-Cliffs, Moderna, and More
U.S. equities were mixed at midday after China accused the U.S. of violating a trade deal the two countries reached last month. Shares of the "Big Three" U.S. automakers tumbled after President Donald Trump said late Friday he planned to double tariffs on steel imports to 50%. Shares of Moderna climbed after the FDA approved the drugmaker's new COVID-19 vaccine, mNEXSPIKE, "for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor."U.S. equities were mixed at midday after China hit back at the U.S. and accused Washington of violating a trade deal the two countries reached last month. President Donald Trump said on Friday that China had "totally violated" the truce they struck in Geneva. The Dow Jones Industrial Average was down 0.5% and the S&P 500 slipped 0.1%. The Nasdaq was up 0.2%. Science Applications International Corp. (SAIC), or SAIC, shares dropped after the technology firm reported fiscal 2026 first-quarter profit and free cash flow below analysts' expectations. Shares of "Big Three" U.S. automakers General Motors (GM), Ford (F), and Chrysler parent Stellantis (STLA) tumbled after Trump said he planned to double tariffs on steel imports to 50%. By contrast, Cleveland-Cliffs (CLF), Steel Dynamics (STLD), and Nucor (NUE) were among U.S. steelmakers whose stocks jumped on Trump's plan to lift steel tariffs. Shares of Moderna (MRNA) gained after the Food and Drug Administration (FDA) approved the drugmaker's new COVID-19 vaccine, mNEXSPIKE, "for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor." Blueprint Medicines (BPMC) shares jumped after French drugmaker Sanofi (SNY) agreed to buy the Cambridge, Mass.-based biopharma firm for up to $9.5 billion. Oil and gold futures surged. The yield on the 10-year Treasury note gained. The U.S. dollar lost ground to the euro, pound, and yen. Major cryptocurrencies were mixed. Read the original article on Investopedia
Gulf Insider
02-06-2025
- Health
- Gulf Insider
Moderna Disables Comments On X Post Announcing New Covid Shot Amid Backlash
Moderna shares rose in premarket trading after the company announced FDA approval of its new lower-dose Covid-19 vaccine, mNEXSPIKE, for adults aged 65 and older, as well as individuals 12–64 with underlying health conditions. However, the approval sparked backlash on X, with many questioning the Trump administration and Health Secretary Robert F. Kennedy Jr.'s 'MAHA' (Make America Healthy Again) agenda. Moderna said in a Saturday morning X post that the mNEXSPIKE (mRNA-1283) vaccine should be available in the U.S. in time for the 2025-26 respiratory virus season, which starts later this year. 'The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,' CEO Stéphane Bancel stated in a press release. Bancel noted, 'COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health.' Last month, the FDA announced that Covid vaccines would not be offered this fall to healthy children and adults. At the same time, the Trump administration stated that any new Covid vaccines must undergo clinical trials using an inert placebo—such as saline—rather than being tested against existing approved vaccines. Moderna's X post was met with heavy backlash, as many users voiced outrage over the FDA's approval, under Health Secretary RFK Jr., of yet another round of Covid vaccines. Moderna's social media team disabled comments on the post. Bottom line: people are furious: X user KAS14599753: ' When your products are so safe and effective, you turn off the comments.' X user Dr Aseem Malhotra: ' Complete and total madness. This company ( like Pfizer ) should be under investigation.' X user Gadsden2020: ' Gee, I wonder why they don't let everyone comment on this? Could it be that they know people aren't buying their bullshit anymore? We know it's only about the $$$.' X user DocAhmadMalik: ' Thank you, Donald Trump, Bobby, Jay, and Aseem, for proving that you are in on the game or totally hopeless.' Click here to read more…
Yahoo
02-06-2025
- Business
- Yahoo
Moderna Stock Climbs as FDA Approves New COVID-19 Vaccine
Moderna said the FDA approved its new COVID-19 vaccine "for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor." Shares of the pharmaceutical giant rose Monday morning but are still down by nearly 35% this year. Moderna's original COVID-19 vaccine generated $3.1 billion in sales last of Moderna (MRNA) climbed Monday after the Food and Drug Administration (FDA) approved the drugmaker's new COVID-19 vaccine. Moderna said its new vaccine, mNEXSPIKE, showed a higher relative efficacy in a clinical trial than its first FDA-approved COVID-19 vaccine and was approved "for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC)." The Cambridge, Mass.-based company said it "expects to have mNEXSPIKE available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA, the Company's approved respiratory syncytial virus (RSV) vaccine." Moderna's original COVID-19 vaccine, Spikevax, generated $3.1 billion in sales last year. Moderna shares rose 2% soon after markets opened but have lost nearly 35% of their value in 2025. Read the original article on Investopedia Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
