Summary of Moderna FY Conference Call (December 02, 2025) Company Overview - **Company**: Moderna (NasdaqGS:MRNA) - **Industry**: Biotechnology, specifically focusing on messenger RNA vaccines and medicines Key Points and Arguments Current Challenges and Market Dynamics - Moderna's shares have faced pressure due to decreasing immunization rates post-COVID pandemic [1][2] - The company is experiencing scrutiny regarding the safety of mRNA vaccines, particularly in light of claims related to children's deaths [2][4][6] - Vaccination rates for COVID vaccines are down approximately 27% to 30% compared to the previous year [6][9] Financial Outlook - For FY 2025, Moderna projects revenues of $1.6 to $2 billion, with $1 to $1.3 billion expected from the U.S. and $600 to $700 million from international markets [7][9] - The company anticipates that COVID-related revenues will dominate until flu and norovirus vaccines are fully integrated into their portfolio [7][10] Product Development and Pipeline - Moderna is preparing to file for regulatory approvals for seasonal flu vaccines by January 2026, targeting a market entry in 2027 [13][15] - The company has seen significant market share for its MNEXP spike vaccine, capturing 55% of the market compared to Spikevax at 45% [11] - The RSV vaccine, mRESVIA, has had a slow market entry due to competition and the need for clearer public health guidelines on revaccination [27][28] Future Growth Drivers - Moderna identifies ten growth drivers for the next three years, with a focus on expanding its vaccine portfolio, including flu and norovirus vaccines [10][12] - The company is optimistic about the potential for a combination vaccine that could increase both flu and COVID vaccine uptake [19] - The oncology segment is a significant area of investment, with ongoing trials for individualized neoantigen therapy in collaboration with Merck [38][40] Financial Strategy - Moderna ended Q3 2025 with $6.6 billion in cash and has entered a credit facility to ensure financial flexibility as it aims for break-even by 2028 [46][48] - The company is confident in its financial strategy, emphasizing low-cost, non-dilutive financing options to support its growth initiatives [46][48] Market Position and Competitive Landscape - Moderna faces competition from established players like Pfizer and GSK in the RSV market, which has seen a contraction since its peak [27][28] - The company is also exploring opportunities in the oncology space, with promising data from ongoing trials [40][42] Additional Important Insights - The company is optimistic about the future growth of its vaccine portfolio, particularly with the anticipated approval of new products and the expansion of existing ones [12][30] - There is a strong emphasis on the importance of bundling vaccines to enhance market penetration and customer engagement [16][19] This summary encapsulates the critical insights from Moderna's FY conference call, highlighting the company's current challenges, financial outlook, product pipeline, growth strategies, and competitive positioning in the biotechnology industry.

Financial Performance - Moderna's 3Q25 revenue was approximately $1.0 billion[7], with total revenue for the first three quarters of 2025 reaching approximately $1.3 billion[13] - The company experienced a net loss of $0.2 billion in 3Q25[8] - Operating expenses decreased by 34%, a reduction of $656 million, from 3Q24 to 3Q25[8] - Cash and investments stood at $6.6 billion as of September 30, 2025[8], a decrease of $0.9 billion or 12% compared to June 30, 2025[19] Revenue Outlook - The projected total revenue for FY 2025 is expected to be in the range of $1.6 billion to $2.0 billion[15] - Expected 4Q revenue from U S is projected between $0.1 billion and $0.4 billion[15] - Expected 4Q revenue from RoW (Rest of World) is projected between $0.3 billion and $0.4 billion[15] Cost Management - The company anticipates a $0.5 billion improvement in 2025 projected cash costs compared to the 2Q25 projection, and a $0.9 billion improvement compared to the January 2025 projection[11] - Moderna is ahead of plan on cash cost reduction, with a $0.9 billion improvement in the 2025 projection year-to-date[49] - The company is increasing its ending 2025 cash range to $6.5 billion - $7.0 billion, up by $0.5 billion - $1.0 billion from the prior framework[49] Product Development - The updated 2025-26 formula for Spikevax has been approved in 40 countries[9, 35] - mRESVIA has been approved in 40 countries for adults 60 years and older, and also approved in 31 of those countries for high-risk adults aged 18-59[10, 35]

Core Viewpoint - The FDA is considering an independent evaluation of DNA levels in COVID-19 vaccines due to concerns raised about potential contamination and safety issues related to residual DNA found in the vaccines [1][4][12]. Group 1: FDA and CDC Actions - The FDA's advisory panel discussed the potential for higher-than-allowed levels of DNA in COVID-19 vaccines and the implications of mRNA persistence in the body [4][12]. - The CDC's vaccine advisory panel unanimously recommended rolling back COVID-19 vaccine recommendations amid growing concerns [4][12]. - The FDA has withdrawn the emergency authorization for COVID-19 vaccines but approved them for limited groups, indicating a shift in focus towards investigating safety concerns [12][13]. Group 2: Scientific Concerns - Concerns have been raised about the presence of residual DNA in Pfizer and Moderna vaccines, with some studies indicating levels exceeding FDA regulatory limits [8][18]. - Experts have warned that residual DNA could integrate into the human genome, potentially leading to autoimmunity issues [7][18]. - The FDA has stated that no safety concerns related to the residual DNA have been identified despite the ongoing discussions [8][12]. Group 3: Company Responses - Moderna and Pfizer representatives defended their testing methods, claiming that their assays are specific for residual DNA and validated to meet FDA standards [16][17]. - The companies acknowledged the presence of residual DNA but asserted that it was within acceptable limits as defined for their specific products [17][18]. - A Moderna executive criticized outside testing methods as flawed, emphasizing the company's adherence to industry-standard testing protocols [16]. Group 4: Advisory Panel Recommendations - The advisory panel recommended that individuals consult healthcare providers before receiving COVID-19 vaccines, considering personal health factors [20]. - Members suggested that the CDC should enhance information about potential risks associated with prolonged exposure to vaccine components, including spike proteins and mRNA [21].

Main Argument - The speaker discusses the feeling of being "doubly lonely" when keeping separate aspects of one's identity, specifically faith and science [1][2][10][18] - The core message is that trust is essential for accepting truths, whether scientific or faith-based [8][17] - The speaker advocates for a personal approach in communicating science, especially to communities of faith, emphasizing respect and relationships over data and degrees [17][18] Supporting Evidence & Logic - The speaker uses the example of DNA's double helix structure, which was understood through data and equations before it could be directly observed, to illustrate belief in unseen scientific truths [3][4][5][6] - The genealogy of Jesus from the Bible is presented as an example of a faith-based truth accepted by millions, even if its accuracy cannot be verified [6][7] - The historical conflict between science and faith, exemplified by Galileo's experience, is mentioned to highlight the existing tensions [8] - The speaker shares a personal experience of creating a video explaining mRNA vaccines in a Christian context, demonstrating an attempt to bridge the gap between science and faith [11][12][13] Implications & Call to Action - The speaker suggests that skepticism towards science in communities of faith is understandable, given the reliance on trust in both domains [16][17] - The speaker encourages individuals who feel "doubly lonely" due to conflicting identities to recognize the value of their unique perspective [18]

Vaccine Hesitancy and Political Polarization - The discussion revolves around vaccine hesitancy, particularly concerning COVID-19 vaccines, and its entanglement with political polarization [2][10] - The report highlights a shift in the anti-vaccine stance from left-leaning groups to the far-right, impacting political discourse and public health [11][13] - The piece criticizes figures like RFK Jr for spreading misinformation about vaccines, despite evidence of their own families being vaccinated [2][10] Government and Public Health - The report mentions the HHS pulling back $500 million in funding for mRNA vaccine development, raising concerns about government support for vaccines [2] - The discussion questions the consistency of the HHS secretary's statements regarding mRNA vaccines and their availability [2] - The report references Florida's actions regarding public health measures, specifically pulling out of established public health practices [8] Public Opinion and Mandates - A Harvard School of Public Health poll indicates that 80% of Americans support vaccine mandates for children attending school [15] - This support includes 68% of Republicans and 66% of MAGA supporters, suggesting a broader consensus than political rhetoric might indicate [16]

Public Health & Vaccine Concerns - Robert F Kennedy Jr testified that the CDC had been lying to the American public during the pandemic and mRNA vaccines were dangerous [1][2] - Health agencies and experts globally affirm vaccines are safe and effective, saving countless lives [5] - Concerns raised about diminishing the credibility of the CDC and the US government in keeping kids safe [9] - Secretary Kennedy is accused of misrepresenting data and outright lying about conversations [39][40] - Secretary Kennedy is accused of stripping funding from mRNA vaccine research, potentially hindering future pandemic preparedness [45] Political & Governmental Reactions - Bipartisan backlash against Secretary Kennedy's statements and actions regarding vaccines and public health [1][5][40] - Democrats called for Secretary Kennedy's resignation, highlighting criticisms from Republicans [5][24] - The White House issued a statement supportive of Secretary Kennedy, focusing on fixing the "broken system" and addressing the chronic disease crisis [31] - Republican senators expressed concerns about Secretary Kennedy's leadership and its impact on public trust in vaccines [8][19][25] Healthcare Policy & Oversight - Secretary Kennedy struggled to answer questions about healthcare costs for seniors, including Medicare Part D and Part B premiums [50][51] - Concerns raised about policies approved by Secretary Kennedy causing chaos in the healthcare system and increasing costs for seniors [54][55] - Senator Cortez Masto highlighted the issue of prescription drug negotiation for Medicare, particularly regarding cancer drugs like Kruda [57][58][59] - Accusations that the Trump administration's policies are already causing harm to healthcare access and funding [72]

COVID-19 Vaccine Development & Impact - Operation Warp Speed is considered a significant achievement in politics and military-like procedures, with global recognition, including from Putin [1] - The COVID-19 vaccine development is viewed as one of the greatest medical and scientific achievements, achieved in approximately 9-10 months [1] - Government-funded research, including mRNA technology, played a crucial role in the rapid vaccine development [1][4] - The COVID-19 vaccine opened up businesses and schools globally and saved millions of lives [1] Political & Public Perception - Former President Trump's administration faced skepticism from its base regarding the COVID-19 vaccine [1] - RFK Jr is considering banning the COVID-19 vaccine and cutting mRNA vaccine research [1] - Overstating the vaccine's capabilities initially led to a loss of public confidence [3] Scientific & Medical Perspective - mRNA vaccines utilize technology that bacteria have used for billions of years to fight viruses [4] - Side effects from COVID-19 were far greater than those from the vaccine, with studies suggesting the vaccine was safer than taking aspirin [1]

Healthcare Policy & Funding - US Health Secretary's department cuts appear to extend beyond mRNA vaccines for respiratory infections [1]

Joining me now is Dr. . Paul Offett. He is the director of the vaccine education center at Children's Hospital of Philadelphia.Welcome Dr. . Offett. >> Thank you.>> If we remember the timeline of the development of the COVID vaccine, we went into lockdown in March of 2020. I believe the first shot in arms of healthcare workers was December of that year if I wasn't mistaken. That's less than a year.A traditional vaccine takes four to five years of development. Why is it so much faster. The typical production ...

Funding & Research - HHS Secretary Kennedy is cutting almost $500 million in grants and contracts for mRNA vaccine development [1] - Experts call the statement that mRNA vaccines don't perform well against upper respiratory viruses wildly incorrect [2] - Scientists are calling Kennedy's funding cuts an attack on promising research after its use in rapidly developing COVID vaccines [2] - The cancellation of contracts is considered dangerous and bad policy [3] - The action is removing the capacity to do critical research that will help deal with all kinds of viruses in the future [5] - Research institutions require large-scale government support to do their work [6] National Security & Global Competition - The funding cut is a national security risk because other nations will get ahead with their vaccination plans using mRNA technology [7] - The US may have to beg to use other countries' vaccines later when the next crisis occurs [7] Political & Scientific Implications - The governor disagrees with Secretary Kennedy on vaccinations [9] - The governor was a minority testifier on a Senate panel where the majority testifiers were handpicked to demonize vaccinations [10] - The governor states that mRNA vaccinations decreased the severity of disease [12] - The governor believes the Secretary of Health's actions are a mistake from a science standpoint [13]