Moderna, Inc.

Good morning, and welcome to Moderna's fourth quarter 2020 conference call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions. Please be advised that the call is being recorded. At this time, I would like to turn the call over to Lavina Toleduktar, Head of Investor Relations at Moderna. Please proceed.

Thank you, Operator. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's fourth quarter 2020 and full year 2020 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 Stefan Bancel, our CEO, David Moline, our CFO, Stephen Hogue, our president, and Tal Zaks, 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. We undertake no obligation to update or revise the information provided on this call as a result of new information or future results or developments. On slide three, please see the important indication and safety information for our COVID-19 vaccine, which has been authorized for emergency use in the United States and many other countries around the world. With that, I will now turn the call over to Stephane.

Thank you, Lavinia. Good morning or good afternoon, everyone. I hope all of you and your loved ones are in good health. Thank you for taking the time to join our Q4 2020 call. For the call, we propose to start first by looking back to fiscal year 2020 and then looking to fiscal year 2021. For fiscal year 2020, I will share a few slides to summarize the key elements of the year before David shares with you the 2020 financials and also how we think about 2021 financial framework. For fiscal year 2021, I will share business objectives and why we are so excited for 2021 and the infection point this year will represent in our history. Given we start with an update on our approach to variants of concern, and then Ty will provide an update on our clinical pipeline. 2020 was a historic year for Moderna. We started in January as an early stage development company. By the end of July, we had become a late stage development company. And by December, we had positive results from our phase three co-study of our COVID-19 vaccine showing efficacy around 94%. Our COVID-19 vaccine was authorized by the FDA and Canada Health in mid-December. And we shipped almost a billion doses to the U.S. government and the Canadian government by year end. We laid the groundwork for a global organization, adding commercial subsidiaries in eight countries. By the end, we had signed $11.7 billion of advanced purchase agreements for the vaccine. A team of a little over 1,000 members did all that. And we also continue to invest in science to improve further our mRNA platform. And we also advanced more than 20 programs in development across five therapeutic areas. and we did it without a large global pharmaceutical partner. The Moderna team executed swiftly and superbly in carrying out a complicated face-to-face study while achieving remarkable diversity. The Moderna team secured the authorization of the COVID-19 vaccine by regulators. The Moderna team built out our manufacturing capacity, scaling up across many manufacturing processes, partnered with Lonza, Rovi, and Catalan, and shipped across 80 million doses by ad. For context, we had made less than 100,000 doses of medicine in 2019. This was roughly a 200-time increase in 12 months, and we are on our way to produce as many as 1 billion doses in 2021 and more in 2022. In 2019, we had no authorized products. We had negative cash flows from operations every quarter, and we anticipated needing multiple capsularies over at least five years until CMB will produce sufficient revenues for Moderna to break even in terms of cash flows and become a self-sustaining company. In 2020, we had our first product authorized and we booked our first product revenues in the last two weeks of Q4. We had two quarters of positive cash flows from operation. We ended the year with a strong balance sheet and with cash generation in two quarters. Moderna has been changed forever. Moderna has been changed in a profound way. Moderna is now a commercial company with subsidiaries in eight countries and a direct presence in many more through commercial distributors and partners. mRNA is an information molecule. We have a powerful platform, and this is just the beginning. We have a scalable platform due to our investment in IT, robotics, and AI over the last seven years. We have an amazing team, as you witnessed, by what the team accomplished in the 12 short months of 2020. And we have the capital to invest and scale. On slide six, you have a summary of countries in which we received emergency use authorization or conditional approvals, and all the submission that we did. On slide seven, you get a sense for the commercial infrastructure that we built. For context, in May of 2020, Moderna did not have a single employee dedicated to commercial activities. We closed the year with eight commercial subsidiaries, an incredible commercial team, and commercial partners. We now have commercial operations in the U.S., in Canada, in Europe, in the five largest markets, Germany, France, Italy, Spain, and the U.K. We established Moderna Switzerland, where we have both commercial capabilities to serve a Swiss market, as well as manufacturing for geographies outside the U.S. with our partner Lonza. and the support teams that we need in finance, HR, digital, and legal. We are partnered with Madison in Israel and with Takeda in Japan. If you step back and think about it, this commercial network, which we started building and will expand in 2021, is an incredible asset for the entire Moderna pipeline. We now have the infrastructure to commercialize all our products. These markets on the slide are some of the largest markets in the world. So by building the commercial network for the launch of our COVID-19 vaccine and deciding not to partner, we have actually financed and built the commercial network for all of our programs. We have become a fully integrated company and in 12 months proved that we are capable of running complex phase three studies, scaling up manufacturing to commercial level, making hundreds of millions of doses per year and building our own commercial network. As I said, the Monad team did an amazing job in 2020. On slide S, you get a glimpse of what Moderna looks like in February 2021. While most people in the world think of Moderna as a COVID-19 vaccine company, this is just the first product that we are launching. We have a platform, and our molecule mRNA is an information molecule. This is just the beginning. We are going to soon start a phase three study for vaccine against CMV, Cetomegalovirus, the number one cause of birth defects. there is no approved CMV vaccine on the market. The pharma industry has strived for around 20 years to make a vaccine against CMV. This is a complex virus, a vaccine that has six mRNAs per dose, several of which have to form a complex protein called the pentamine. We believe that CMV vaccine will present potential annual peak sales between $2 and $5 billion. We have three programs in phase two, a plasmonas cancer vaccine in melanoma, or oxfocilagin in ovarian cancer, and VEGF injected in patients' heart post-heart attack to revascularize their heart with new blood vessels. We have had 12 positive phase 1 readouts. In addition to our COVID-19 vaccine, we have eight infectious disease vaccine candidates, all for first-in-class vaccines, like against CMV, or what we believe could be a best-in-class vaccine, like with influenza. But we also have a remarkable therapeutic pipeline. We have candidate therapeutics in immuno-oncology with five medicines in the clinic, four in rare disease program, two cardio program, and two autoimmune disease programs. If you think about it, Moderna is doing after a four leading cause of death by disease area, infectious disease, cancer, cardiovascular disease, autoimmune disease. The total addressable market is very large. We are not a COVID-19 vaccine company. We're investing in science and leveraging our scalable platform to take more candidates from our research labs to clinical development soon, so stay tuned for that. We announced yesterday that we are increasing our base manufacturing plan for the number of COVID-19 doses we will produce in fiscal year 2021 from 600 million to 700 million doses, given the strong start of our U.S. operation and initial ramp of our outside-the-U.S. operation. Our team is still working hard to get us up to 1 billion doses for fiscal year 2021. Now, let me turn to David for Q4 and fiscal year 2021 financial framework. David? David Morgan Okay.