Moderna (NasdaqGS:MRNA) Q4 2025 Earnings call February 13, 2026 08:00 AM ET Company ParticipantsAdi Jayaraman - Senior Managing DirectorElizabeth Webster - Biotech Equity ResearchJamey Mock - CFOLavina Talukdar - Head of Investor RelationsMatthew Guggenbiller - Equity Research AssociateMichael Yee - Global Head of Biotechnology Research and Managing DirectorShelby Hill - Senior Equity Research AssociateStephen Hoge - PresidentStéphane Bancel - CEOConference Call ParticipantsCourtney Breen - Senior AnalystEl ...

Moderna (NasdaqGS:MRNA) Q4 2025 Earnings call February 13, 2026 08:00 AM ET Company ParticipantsAdi Jayaraman - Senior Managing DirectorElizabeth Webster - Biotech Equity ResearchJamey Mock - CFOLavina Talukdar - Head of Investor RelationsMatthew Guggenbiller - Equity Research AssociateMichael Yee - Global Head of Biotechnology Research and Managing DirectorShelby Hill - Senior Equity Research AssociateStephen Hoge - PresidentStéphane Bancel - CEOConference Call ParticipantsCourtney Breen - Senior AnalystEl ...

Moderna (NasdaqGS:MRNA) Q4 2025 Earnings call February 13, 2026 08:00 AM ET Speaker9Good day, and thank you for standing by. Welcome to Moderna Fourth Quarter 2025 conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. To ask a question during the session, you'll need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please p ...

来源：经济观察网 在罕见病领域，针对丙酸血症（PA）的疗法mRNA-3927的注册研究已达成目标入组，预计2026年可能 会有数据发布。诺如病毒疫苗mRNA-1403的临床三期研究也将在2026年进行中期分析。 经济观察网 莫德纳（MRNA.US）在2026年有多项关键事件值得关注，涉及财务业绩、疫苗审批及临床 数据发布。 以上内容基于公开资料整理，不构成投资建议。 在季节性疫苗领域，公司预计其独立流感疫苗mRNA-1010将于2026年在多个地区获批上市。此外， RSV疫苗mRESVIA的一项三期临床试验数据也预计在2026年获得。 产品研发进展 在肿瘤治疗领域，莫德纳与默沙东联合开发的个性化癌症疫苗mRNA-4157（针对黑色素瘤）可能在 2026年宣布三期临床试验数据。公司独立研发的mRNA-4359（癌症疫苗）的潜在二期临床数据也有望 在2026年公布。同时，双方在非小细胞肺癌等适应症上的多项二期/三期临床试验将继续推进。 公司项目推进 业绩经营情况 公司计划于2026年2月13日发布2025年第四季度及全年财报。 公司项目推进 ...

In RSV, Moderna's mRESVIA vaccine generated $2 million in sales during the quarter and is now approved for adults aged 60 and older in 40 countries, including approval for high-risk adults aged 18 to 59 in 31 of those countries. Despite these developments, total revenue fell 45% year-over-year (YOY), owing mostly to decreased COVID vaccination rates and the lack of a $140 million prior-year adjustment that had increased prior-year quarter figures. Retail channels accounted for 72% of vaccinations in the fal ...

Core Viewpoint - Moderna has faced challenges in maintaining revenue growth from its coronavirus vaccine but has shown a strong start in 2026 with a 58% increase in stock price, raising questions about a potential sustained bull run for the company [1]. Group 1: Recent Developments - Moderna's recent data from a five-year follow-up study on intismeran autogene, in combination with Merck's Keytruda, demonstrated a 49% reduction in disease recurrence or death for advanced melanoma patients compared to Keytruda alone [3]. - Intismeran autogene is currently in a phase 3 study and is being investigated across multiple cancer types, with a total of eight phase 2 or phase 3 studies ongoing [4]. Group 2: Market Position and Opportunities - Moderna has established itself as a leader in mRNA-based therapies and the coronavirus vaccine market, with recent clinical progress and the launch of mRESVIA, a vaccine for respiratory syncytial virus [5]. - The partnership with Merck for intismeran autogene presents a significant commercial opportunity, potentially leading to blockbuster status, despite profit-sharing with Merck [6]. Group 3: Future Prospects - Moderna is expected to make sustained clinical and regulatory progress with several candidates in mid or late-stage clinical trials, which could diversify its lineup of approved products in the next three years [7].

Core Insights - Merck is set to report its Q4 and full-year 2025 results on February 3, with a focus on the sales performance of its cancer drug Keytruda, which accounted for over 50% of pharmaceutical sales in the first nine months of 2025 [2][11] - Keytruda's sales increased by 8% year over year in Q3 2025, but were below expectations, prompting attention on Merck's non-oncology drugs, particularly Capvaxive and Winrevair, which are expected to drive long-term growth [3][5] Sales Performance - Keytruda's sales performance is critical, with a noted increase of 8% year over year in Q3 2025, but weaker than anticipated [3] - Capvaxive and Winrevair have shown strong sales, with Capvaxive generating $480 million and Winrevair $976 million in the first nine months of 2025 [5][11] - The Animal Health business is also contributing to top-line growth, with expected revenue increases in Q4 [6] Product Approvals and Market Competition - Capvaxive was approved in the U.S. in June 2024 and in the EU in March 2025, while Winrevair was approved for PAH treatment in 2024 [4] - Enflonsia, a new RSV antibody, recorded sales of $79 million in Q3 2025, with its performance in Q4 still uncertain as it moves into broader clinical use [7] - Winrevair faces competition in the PAH market from United Therapeutics and Johnson & Johnson, while Enflonsia competes with AstraZeneca/Sanofi's Beyfortus [8][10] Financial Performance and Valuation - Merck's shares have increased by 30.6% over the past six months, outperforming the industry and the S&P 500 [13] - The company's price/earnings ratio stands at 15.61, which is lower than the industry average of 18.36 but higher than its 5-year mean of 12.48 [14] - The Zacks Consensus Estimate for 2025 earnings per share has slightly decreased from $8.98 to $8.95, and for 2026 from $8.81 to $6.94 over the past 60 days [15]

Summary of Moderna's Presentation at the JPMorgan Healthcare Conference Company Overview - **Company**: Moderna - **Event**: 44th Annual JPMorgan Healthcare Conference - **CEO**: Stéphane Bancel Key Points Industry and Company Strategy - Moderna aims to build a respiratory vaccine franchise to generate cash for investments in oncology and rare disease assets [2][3] - The company has three FDA-approved products and two products submitted for regulatory approval (flu and flu plus COVID) [2][3] - A focus on diversifying away from COVID-19 vaccines to ensure future growth [3] Financial Performance - Sales guidance for 2025 was initially $1.62 billion, but the company expects to achieve around $1.9 billion, exceeding the midpoint of the range by $100 million [3] - Cash costs have been significantly reduced from $6.3 billion in 2024 to an expected $4.3-$4.5 billion by the end of 2025, a reduction of nearly $2 billion [5][6] - The company ended 2025 with a cash balance of $8.1 billion, including a credit facility providing liquidity of $9 billion [7] Growth Drivers - **Geographic Diversification**: Partnerships in the U.K., Canada, and Australia to build dedicated factories, ensuring long-term volume commitments [8] - **New Product Launches**: Introduction of mRESVIA, a higher efficacy COVID vaccine, which has achieved a 24% market share in retail and 32% in the elderly segment [9] - Anticipation of re-entering the European market for COVID vaccines post-2026 due to the expiration of Pfizer's partnership with the EU [10][11] Pipeline and R&D - A robust oncology pipeline with 10 clinical studies ongoing for mRNA-4157 combined with Keytruda, including three phase three studies [14][15] - Potential for significant breakthroughs in oncology with mRNA-4359 and mRNA-2808, targeting metastatic settings and multiple myeloma, respectively [15][37] - Upcoming readouts expected in 2026 for various oncology products, including phase three data for mRNA-4157 [18][23] Market Dynamics - The company anticipates a potential sales growth of up to 10% in 2026, driven by both U.S. and international markets [38] - The U.S. market is experiencing a decrease in COVID vaccine volume, but the introduction of new products and partnerships is expected to stabilize sales [39][40] - The flu vaccine (mRNA-1010) is expected to launch in 2027, with minimal sales anticipated in 2026 due to regulatory timelines [44][45] Cost Management and Profitability - Continued focus on cost discipline to achieve cash break-even by 2028, with a reduction in R&D costs as existing phase three commitments sunset [21][22] - Gross margin improvements expected through increased volume, productivity enhancements, and internal manufacturing capabilities [50][51] Conclusion - Moderna is positioned for growth through strategic diversification, innovative product launches, and effective cost management, with a strong focus on oncology and respiratory vaccines as key areas for future development [22][25]

Core Insights - Respiratory Syncytial Virus (RSV) is a significant respiratory virus that poses health risks, particularly to children, the elderly, and immunocompromised individuals. In the U.S., nearly all children are infected by age two, leading to approximately 58,000 hospitalizations annually for children under five. Globally, RSV affects 64 million people and results in 160,000 deaths each year [2] Group 1: RSV Overview - RSV is an RNA virus that spreads through the air and is classified under the Pneumoviridae family. It has a genome consisting of 10 genes encoding 11 proteins, which can be categorized into target and non-target proteins [4] - The F protein is crucial for the fusion of the virus with host cells, while the G protein aids in viral attachment to host cell receptors. Both proteins are highly glycosylated and are considered primary targets for vaccine development due to their genetic and antigenic conservation [6][7] Group 2: Vaccine Development - The RSV vaccine market has seen significant advancements, with three new vaccines approved globally in 2023, all targeting the pre-F glycoprotein. GSK's Arexvy and Pfizer's Abrysvo have been launched, with Moderna's mRESVIA expected to be approved in 2024 [9] - Several companies, including domestic firms like Adimab and Clover Biopharmaceuticals, are actively developing RSV vaccines. Clover's SCB-1019, a bivalent recombinant pre-F candidate vaccine, has shown comparable neutralizing antibody levels to Arexvy in older adults during Phase I trials [9] Group 3: Ongoing Research and Clinical Trials - Ongoing RSV projects are primarily focused on vaccine development, with various candidates in different clinical trial phases. For instance, SP-0125 is in Phase III for infants, while several others are in Phase II and I for older adults [10] - The RSV research landscape includes a range of vaccine types, such as live attenuated, recombinant protein, and mRNA vaccines, indicating a diverse approach to combating RSV [9][10] Group 4: Antibody Development and Research Solutions - Yiqiao Shenzhou has developed stable trimeric constructs of RSV pre-F and post-F proteins, which are essential for antibody screening and vaccine development. Their product library includes various RSV targets and antibodies, supporting multiple research applications [13]

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.