Moderna, Inc.

Good morning. My name is Dee Tamara, and I will be your operator today. Welcome to Moderna's first quarter earnings call. At this time, all participants are in 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'd like to turn the call over to Lavina Tolukdar, head investor relations at Moderna. Please proceed.

Thank you, Dean Tamera. Good morning, everyone. Thank you for joining us on today's call to discuss Moderna's first quarter 2021 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 chief executive officer, David Moline, our chief financial officer, Stephen Hogue, our president, Tal Zaks, our Chief Medical Officer, Karim Laghaf, our Chief Commercial Officer, and Juan Andres, our Chief Technical and Operations Officer. Before we begin, please note that this conference call will include forward-looking statements made pursuant to the safe harbor provision 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. I will now turn the call over to Stéphane.

Thank you, Lavina. Good morning, or good afternoon, everyone. Thank you for taking the time to join our Q1 2021 conference call. We'll start by a quick business review of the quarter before Cohen walks you through commercial updates. David will then walk you through the key financials. Stephen will provide a clinical update, especially new human data, about two of our COVID-19 booster candidates, mRNA-1273, the currently authorized vaccine, and mRNA-1273.351, the variant-specific booster to B.1.351, first identified in South Africa. I will then come back to close. The Moderna COVID-19 vaccine is now available and protecting people in 37 countries around the world. And with the WHO authorization last Friday night, the number of countries where our vaccine will be available will go up significantly. In the first quarter alone, 102 million doses have been shipped and many tens of millions of people have been fully vaccinated or received their first dose. 12 months ago, in Q1 2020, Moderna had never run a phase-free clinical study, never gotten a product authorized by a regulator, and never made 100 million doses in a single quarter. Not even 10 million, not even 1 million doses. I am very proud of what the Moderna team has achieved, but most importantly, I am very thankful for their impact on the world and the incredible personal sacrifices that our team has made to help protect fellow human beings around the world. This is very humbling, and I'm fortunate to lead Moderna in this moment. I'm also thankful for Moderna scientists, engineers, doctors, and team members who have worked relentlessly over the last 10 years now to be ready for when the virus emerged in late 2019. We invented the technology to produce safe, well-tolerated mRNA vaccines, which made it possible for us to chase this virus. The company achieved revenues of $1.9 billion in Q1 2021, of which $1.7 billion were COVID-19 vaccine product sales. The net income for the period was $1.2 billion. This marks the company's first GAAP profitable quarter in its history after nine years of operating losses. At the end of 2021, we had cash and cash investments of $8.2 billion. David will give you more details in a few minutes. We increased our 2021 supply forecast once again. We now believe that we should be able to supply 800 million doses in 2021, and we are still aiming for 1 billion doses for the year. The total advance purchase agreement signed for delivery in 2021 has been increased to $19.2 billion. We are happy to report this morning an interim update to our TINCOV study, the initial interim analysis of a Phase II-III TINCOV study of mRNA-1273 showed vaccine efficacy against COVID-19 of 96%, and mRNA-1273 was generally well-tolerated with no serious safety concerns identified to date. We are also on track to start this month the filing of our rolling BLA-to-be-FDA for COVID-19 vaccine mRNA-1273. Outside of COVID, we added another first as a company. and that is the dosing of our first patient with an mRNA therapeutics candidate against a rare genetic disease, propionic acidemia, a genetic deficiency in the liver with our candidate mRNA-3927. One of the things that I'm the most excited about is where we are going. The Q1 results highlighted above are the consequence of last year's work and decisions we made. So as I look to where Moderna is going, I get very excited by the level of increased investment across the board. Using a strong balance sheet to invest to scale Moderna. Just two numbers for some color. In Q1 2021, our R&D investments were approximately four times higher than the R&D investments in Q1 of last year. Not 4%, not 40%, four times higher. For all of you who have known us for many years, Moderna has been built as a digital enterprise since the early days. But we now have the opportunity to do much more and to build new functions like clinical trial operations, pharmacovigilance, commercial, digitally from the get-go. So looking at the next five to 10 years, we're investing intensely in digital, automation, and AI. Our plan for 2021 is to invest three times more in digital than in fiscal year 2020. We announced last week that we have decided to invest to increase our 2020 supply to up to 3 billion doses. Let me share with you why we decided to recommend to our board to invest at that scale. First, let's talk about the science of SARS-CoV-2 virus. New variants of concern continue to emerge around the world. And we believe that over the next six months, at the southern hemisphere and its fall and winter, we could see more variants of concern emerge. We have said for a while now that we believe booster shots will be needed, as we believe that the virus is not going away. We also believe, from a scientific standpoint, that the highest-efficacy booster over time will be provided by a multivalent variant-specific booster. Second, the market has changed quite a lot versus what we knew six months ago. First, mRNA vaccines have emerged as the best-in-class vaccines, high-efficacy, good tolerability profile, ability to scale manufacturing, and speed to chase variants in the clinic. Many companies are still in the clinic with their first-generation vaccine, while we're in the clinic with variant-specific boosters. More importantly, as we are talking to governments around the world, in the West and in the East, in the North and in the South, we are hearing loud and clear from the market, supply us with more mRNA vaccines for primary series, and supply us with more mRNA vaccines in the future for boosters for 2022 and 2023. There is a big shift versus what the market perceived six or nine or 12 months ago, when protein vaccines or adenovaccines were thought to be the answer to the pandemic. We believe it has become an mRNA market for COVID-19 vaccines. Third is our large pipeline. We believe we will bring to market several more products in the next few years that will add to the market demand for COVID-19 boosters for years, flu vaccine, as we discussed at our vaccine day, and our goal is to have a seasonal flu vaccine combined with a COVID-19 booster in a single-dose product. We also have strong clinical data for RSV vaccine and CMV vaccine. Plus, we have seven programs in clinical studies in three therapeutics areas, and more programs to move from preclinical development to clinical studies in the months to come. So we decided to build capacity to deliver up to 3 billion doses of supply in 2022 to serve both the North and the South. We are doubling our drug substance supply in Europe and increasing by 50% our drug substance supply in the U.S. We are, of course, adding filling capacity in the U.S. and Europe at our existing partners, but also adding new ones as we speak. More to come. Another piece of feedback we're hearing from the market is that Moderna has a best-in-class mRNA vaccine. Shipment at minus 20 Celsius and storage not minus 70 Celsius. Small cartons of 100 doses. Storage up to six months in standard freezer and four weeks in regular refrigerated temperatures. the only authorized mRNA vaccine that does not require on-site dilution. We believe this is an even more important feature today, but will be more in the future in 2021, 2022, and 2023 as we move to a booster market decentralized in pharmacies and at doctors' offices. We believe we have the best mRNA vaccine authorized, and we continue to improve our product to continue to have the best in-class product of the mRNA market. We are delighted to announce this morning the start of a dosing of our first patient in our Phase 1-2 study with propionic acidemia disease. The study is called Paramount. It is yet another milestone for Moderna. Not only do we have, I believe, the most innovative infectious disease vaccine clinical pipeline, but we also have therapeutics candidates in clinical studies in oncology, in cardiology, and now in rare genetic disease. Let me close my remark on this familiar slide. We now have 1,500 employees. We have recently incorporated Moderna Japan KK, and we continue to build our commercial network with a push to Asia Pacific in 2021. And given our strong balance sheet of $8.2 billion, we are going to continue to accelerate and invest to allow Moderna to scale and maximize the impact of a broad MRNA platform to help as many people as we can. Let me share our perspective on yesterday afternoon announcement by the United States Trade Ambassador that the US government will support waiving intellectual property protection for COVID-19 vaccines. We believe this will not help supply more mRNA vaccines to the world any faster in 2021 or in 2022, which is the most critical time of a pandemic. There is no ideal mRNA manufacturing capacity in the world. There is no industry of talented individuals who are skilled in the art of making high-quality and high-purity GMP-grade mRNA vaccines. There are no companies who have developed manufacturing processes, purification processes, analytical processes that would allow them to quickly run a clinical trial. And if approved by regulators around the world, then provide hundreds of millions or billions of supply of mRNA vaccines. We have announced in a company statement issued October 8, 2020, that during the pandemic, Moderna will not enforce COVID-19-related patents. You can find that statement on our website. We believe that the best way to end the pandemic is what we are currently doing. First, to maximize supply in 2021 to protect as many people as we can. Second, to build additional capacity, which we have announced last week, to get up to 3 billion doses of authorized mRNA vaccines for 2022, 2023, and beyond. And third, to continue to adapt the vaccine to have the highest efficacy vaccine with variant-specific booster, for which we announced very encouraging clinical results yesterday. Let me now turn to Corinne to give you a commercial update. Corinne?