Moderna, Inc.

Good day, and thank you for standing by. Welcome to the Moderna fourth quarter 2023 conference call. At this time, all participants are in 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 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 Tulukdar, 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 and full year 2023 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 investors section of our website on today's call are stefan boncel our chief commercial executive officer Stephen Hogue, our President, and Jamie Mock, 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'll turn it over to Stephane.

Thank you, Lavina. Good morning, or good afternoon, everyone. Thank you for joining us today. I will start with a review of 2023. Jamie will then present our financial results. Steve will then review our late-stage clinical programs. And I will close by sharing our 2024 priorities. Let me start with our mission. Moderna's commitment to deliver the greatest possible impact to people through mRNA medicine. In 2023, every member of the Moderna team helped to advance our mission, which is a driving force that motivates our team every single day. We impacted more than 100 million people around the world, and we advanced our development pipeline across all of our franchises, including infectious disease, oncology, and where it is. 2023 was a difficult year as we transitioned from a pandemic to a seasonal endemic market. We reported sales of $6.1 billion for 2023, which was at the low end of our financial framework range. These sales exclude the recognition of $600 million of deferred revenue from GAVI. In the US, the vaccination rate was down year over year. We were pleased that our US commercial team drove an increase in our retail market share from 37 to 48%. Outside of the US, we were not able to compete in the EU market in the second half of 2023 due to a competitor contract, and our performance led to a low market share in Japan. We did have a strong performance in Israel, Switzerland, and Taiwan. We took several important actions in 2023 that we set our commercial COVID business up for success. We resized the manufacturing footprint, which has been established to support capacity at pandemic levels. We exited contract manufacturing relationships and reduced inventory levels. These initiatives will improve cash flow from our COVID business moving forward. We also flattened the commercial structure. All regions report directly to me now for more targeted sales execution and also better integration with global teams. We focused our R&D spending and our SG&A expenditures towards near-term growth and higher return on investment projects. While sales were challenging in 2023, Our development team had a great year, with excellent progress across many of our late-stage pipeline programs. In 2023, we advanced our pipeline and now have nine late-stage programs. Let's start with respiratory vaccine. For RSV, we filed for approvals around the world. We reported positive data from a flu P303 study. And we are fully enrolled in the Phase III studies for our next-gen COVID, mRNA-1283, and flu plus COVID combination vaccine, mRNA-1083. In our latent franchise, we are very excited that our phase three CMV trial is now fully enrolled. In our individualized new antigen therapy program, or IMT, where we partner with Merck, phase three studies in adjuvant melanoma and no small cell lung cancer are enrolled. We purchased and are currently building out a manufacturing site in Marlborough, Massachusetts to enable commercialization of our INC program. Our rare disease therapeutic programs continue to progress well. We are in due selection for the research study of our propionic acidemia program. In MMA, we are pleased to see improvement in biomarkers and clinical outcomes. In research, we made six external investments including one acquisition, which we expect will increase the strategic reach and also the breadth of our MRNA platform. Now turning to our 2023 financial summary, we reported GAAP revenue of $6.8 billion, a net loss of $4.7 billion, primarily driven by mostly non-cash charges of $3.7 billion related to resizing of manufacturing and the tax valuation allowance. We are pleased to end the year with cash and cash investments of $13.3 billion. Let me turn to Jamie for more color on our financials.