Moderna, Inc.

Good day and thank you for standing by. Welcome to Moderna fourth quarter 2025 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised, today's conference is being recorded. I would now like to hand the conference over to your speaker today, Lavina Talukdar, head of IR. Please go ahead.

Thank you, Kevin. Good morning, everyone. And thank you for joining us on today's call to discuss Moderna's fourth quarter 2025 financial results and business updates. You can access the press release issued this morning, as well as the slides that we'll be reviewing by going to the investor section of our website. On today's call are Stéphane Boncel, our chief executive officer, Stephen Hogue, our president, and Jamie Moth, our chief financial officer. Before we begin, please note that this conference call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Please see slide two of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. With that, I will turn the call over to Stephane.

Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us. I will start with a quick review of 2025. Jamie will present our financial results and 26 outlook. Stephen will review our commercial outlook and clinical programs. And then I will come back and share our key value drivers as we look ahead before we take your questions. Let me start with a review of 2025. Our revenues were $1.9 billion, driven by sales of our COVID vaccines, Spikevax, and NMX Spike. We continue to make tremendous progress on cost in 2025. Operating expenses were down $2.2 billion, or 30% for the year. I would like to thank the entire Moderna team for this great accomplishment in 2025. I'm very proud of this. Net loss for the year was $2.8 billion, and we ended the year with $8.1 billion in cash and investments. Before I start a review of 2025, I want to express our disappointment to the FDA, who refused to file a letter on our full program MR-1010. The current uncertainty in the US FDA regulatory environment creates real challenges for businesses, patients, and the broader innovation ecosystem. When expectations and review timelines are unpredictable, companies face greater risk and can hesitate to invest, slowing the development of breakthrough medicines. This delays patient access and increases overall healthcare costs. Sustain regulatory uncertainty threatens U.S. leadership in innovative medicines. This can also result in transformative medicine developed by U.S. companies becoming available to patients outside the U.S. before reaching American patients. Turning now to the execution on commercial and pipeline. On the commercial side, in 2025, we have three products on the market, SPACVAX, MNEXPAC, and MRSVIA. MNEXPAC was approved in the U.S. in 2025. It has an excellent launch. Quickly became our leading product in the U.S. In the past two weeks, we announced two commercial agreements. First, an agreement with Ricardati for the global commercialization of our proprionic acidemia rare disease candidate, currently in a pivotal study. We call that it brings deep rare disease commercial expertise in an established global infrastructure with a proprionic acidemia community. We also announced earlier this week a five-year strategic agreement with the government of Mexico for respiratory vaccine supply. We currently have two products under regulatory review in multiple countries. Our seasonal flu vaccine is filed under the review in Europe, Canada, and Australia. Our flu plus COVID combination vaccine is filed and under review in Europe and Canada. Additionally, we've made strong programs across the pipeline. For intramural or individual cancer therapy developed in partnership with Merck, we recently reported positive five-year phase two data in adjuvant melanoma, demonstrating the durability of clinical benefit and reinforcing our confidence in the program's long-term potential. I am very happy to announce that we have completed enrollment in our Phase 2 study in muscle-invasive bladder cancer. This marks three late-stage studies in three different cancer types that are now fully enrolled. Adjuvant melanoma, adjuvant renal cell carcinoma, and now muscle-invasive bladder cancer. We look forward to the data we get from these studies. For cancer antigen therapy, mRNA-4059, we announced positive Phase 1b data, and the problem is now in Phase 2. Our phase three norovirus program is now fully enrolled, so we could see phase three data in 2026. And our peer program is also fully enrolled in this registration study, and we could see data in 2026. I am pleased to welcome to Moderna our new chief development officer and executive committee member, Dr. David Berman. He has contributed to the development of more than a dozen clinical stage immunotherapies at BMS and AstraZeneca. His expertise will serve Moderna well as we continue to expand our oncology pipeline. David served most recently as head of R&D of ImmunoCorp. We very much look forward to David joining one of our team on March 2nd. I would like, of course, to take this opportunity to thank Jackie Miller for her many contributions in the last five years of the company, especially her tremendous leadership during the pandemic. With this, I would like to take over to Jimmy.