Moderna, Inc.

Good morning. My name is Kevin, and I'll be your operator today. Welcome to Moderna's fourth quarter and full year 2021 earnings call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for questions. Please be advised that this call is being recorded. At this time, I'd like to turn the call over to Levina Tulukdar, Head of Investor Relations at Moderna. Please proceed.

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 2021 financial results and business updates. You can access the press release we 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 Bancel, our Chief Executive Officer, David Moline, our Chief Financial Officer, Stephen Hogue, our President, and Paul Burton, our Chief Medical 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 it over to Stephane.

Thank you, Lavina. Good morning or good afternoon, everyone. Welcome to our Q4 2021 conference call. Today, I will start by a quick business review of Fiscal Year 2021 before Paul walks you through some real-world evidence data. Even we then review our clinical programs before David presents our financial results. I will then come back to close to share some thoughts about where we are heading. We are pleased to report today $18.5 billion of revenues for fiscal year 2021 and a gap net income of $12.2 billion, translating into a gap diluted earnings per share of $28.29 billion, with a cash balance at the end of the year of $17.6 billion. We announced this morning that we have completed our August 2021 $1 billion share buyback plan, which reduced our average checkout during the fourth quarter for the first time in the company history. I am very proud of the team's ability to advance as well as expand with new programs our development pipeline. In respiratory vaccines, for COVID, as you know, we received full BLA approval from the U.S. FDA for Spikevax. With authorization for 12 to 17 years old in key markets globally, we are running a 50-microgram dose study in the U.S. for adolescents following discussions with the FDA. We are pleased to report that we have also started to receive authorization for children aged 6 to 11 years of age, beginning in Australia last week, with more countries expected in the days and weeks to come. We also dose our first participants in the Omicron-specific vaccine trial, mRNA-1273.529. And today we are announcing that we plan to bring mRNA-1273.214, a bivalent vaccine combining the wild-type vaccine, mRNA-1273, and the Omicron vaccine, mRNA-1273.529, into one single-dose booster into the clinic with a total mass of 50 micrograms. We are very excited that now RSV is in Phase 3. This is our third vaccine starting the Phase 3. And for flu, we are waiting the Phase 2 data for mRNA 1010. As soon as we have them, we will pick a dose and we'll initiate our Phase 3 for flu, and we will start our Phase 1 for COVID plus flu program, mRNA 1073. For latent viruses, CMV is enrolling in Phase 3. EBV and HIV are now in Phase 1, and we are very excited to announce last week that we are adding two new latent virus programs to our development pipeline, one vaccine against HSV and one vaccine against VZB. More latent viruses vaccines are in the works in our labs. In therapeutics, PA and MMA are in the clinic dosing and recruiting more patients. We announced a new checkpoint cancer vaccine, mRNA-4359, and Merck has informed us that they are returning the rights to the KRAS vaccine. We are evaluating future steps for this program. The company continues to expand at a rapid pace. We now have one approved medicine, two in Phase 3, RSV and CMV, and five in Phase 2, a total of 44 programs. We are deploying capital to accelerate and expand the pipeline. The company now has 3,000 team members across the world with a great culture and 11 commercial subsidiaries across Americas, Europe, and Asia-Pacific. Our $17 billion cash balance at the end of the year is enabling us to scale across research, development, manufacturing, commercial, and GM. With this, let me now turn to Paul.