Moderna, Inc.

Good day and thank you for standing by. Welcome to Moderna first 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'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, you can press star 1-1 again. Please be advised that this 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 first quarter 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 investor section of our website. On today's call are Stephane Boncel, our chief executive officer, Stephen Hogue, our president, Arpa Gouray, our chief commercial officer, 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 will turn the call over to Stefan.

Thank you, Lavina. Good morning or good afternoon, everyone. Today, I will start with a business review. Stephen will then review our clinical programs before Arpa gives an update on our commercial progress and plans. Jamie will present our financial results, and I will come back to close. So in the first quarter, we recorded revenues of $1.9 billion, GAAP net income of $79 million, and GAAP deleted earnings per share of 19 cents. Cash and cash investment of $16.4 billion at the end of the quarter. We continued in Q1, executing on our capital allocation strategy, prioritizing investment in our business. In the first quarter, we invested $1.1 billion in R&D, continuing investment in late-stage clinical programs and progressing our entire pipeline. SQ&A costs were approximately $300 million in the quarter, which included investment in digital, and also AI infrastructure, and approximately $100 million in capital investments. In 2023, our team has been very active. This includes the acquisition of OriZero in Japan, collaborations with CitumX, LifeEdit, and Generation Bio. All of these investment opportunities further expand the reach of Moderna's MR&A technology. we are growing Moderna MRNA operating system. $536 million were returned to shareholders who share purchase of 3.6 million shares in the quarter. Let me turn to commercial in the first quarter. We continue to expect $5 billion in COVID vaccine deliveries in 2023 from already signed advanced purchase agreements. With $1.8 billion of COVID sales in Q1, We are well on our way to achieve $5 billion in APAs. The commercial team is actively negotiating to sign new contracts with customers in major markets to finalize additional orders that will add to the $5 billion. The U.S. team is negotiating with pharmacy chains, hospital networks, and other customers. As a reminder, the $5 billion of signed APAs does not include any fall 2023 U.S. contracts. So these new U.S. commercial contracts are important to the business as they are additional. The team is also making progress in Japan, in Europe, and other countries in Asia, Middle East, and also Latin America. We recently signed a new contract with Australia for 2023. Our commercial organization is also preparing for the launch of RSV in 2024, our next respiratory commercial product. They are educating the medical community on the health burden of RSV Our medical team is participating in major infectious disease medical congresses and sharing new data that show the strong profile of our RSV vaccine. To prepare for RSV launch, our manufacturing teams have already begun producing drug substance, the mRNA molecule, for RSV vaccine. That vaccine will be supplied as a pre-filled syringe. We believe that will help drive adoption by pharmacists and doctors We assist some of our RSV products. In oncology, for mRNA 4157, now called individualized neoantigen therapy, or INT, we are scaling up manufacturing to support clinical development and commercial markets. Our commercial team is also working to prioritize tumor types to select for additional phase 3 studies in addition to melanoma and lung. Turning to the pipelines. At Vaccine Day, we discussed detailed data from our RRZ vaccine that were presented at recent medical meetings. We believe the profile of our RRZ vaccine is potentially best in class. We shared top-line data on the flu program, announcing the initiation of Phase 3 of 3, the Phase 3 study that we intend to use for accelerated approval, as well as strategy for our next-generation flu programs. We also announced the start of Phase 3, For our next-gen COVID vaccine, amounted to 1,283, we should be refrigerator stable. Today, we're also announcing a new program for pandemic readiness for influenza H5. In latent vaccine, our CMV phase 3 trial continued progress and is greater than 50% enrolled. I'm also very pleased to announce progress in our early stage program, EBV and HIV. EBV, as you know, has two programs. The EBV phase 1 trials to prevent mononucleosis with mRNA 1189 are fully enrolled in adults and also in adolescents. Our EBV trial for the treatment of long-term complications for EBV infection has now started enrolling. And for HIV, we share interim analysis from a phase 1 study at VaccineNet. We also introduced new programs. We are working on vaccines for norovirus and Lyme disease. Lyme is the first bacterial pathogen we are targeting with the Armani platform with a vaccine. In therapeutics, we participated in AFTR meeting where we presented detailed phase 2 data from our RNC program partnered with Merck. Later on the call, Stephen will take you through the data presented there. Our rare disease pipeline is also making progress. we're excited to announce a new milestone for our PA program. The Phase 1-2 trial in proprionic acidemia, or PA, is now in dose expansion phase. And additional data from this study will be presented at the American Society for Gene and Cell Therapy later this month in May. The company continues to expand at a rapid pace. We have 47 programs underway, which now reflects the inclusion of new programs announced in the quarter and removes programs that are not continuing to develop. The full updated pipeline can be seen in the appendix of this presentation or obviously on our website. We now have more than 4,000 team members and 17 commercial subsidiaries across America, Europe, and Asia Pacific. In addition to our commercial subsidiaries, we also announced we're opening a Seattle office as a technology hub where we're hiring data scientists and engineers who will help digitize our business and expand our AI capabilities. I'm also happy to announce Moderna was officially recognized in March as a Great Place to Work by the Great Place to Work Institute. Our $16.4 billion of cash at the end of the quarter is enabling us to scale across research, development, manufacturing, commercial, and G&A. With that introduction, Let me now talk to Stephen.