Moderna, Inc.

Good morning and welcome to Moderna's 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'd like to turn the call over to Lavina Talukdar, Head of Investor Relations at Moderna. Please proceed.

Thank you, Operator. Good morning, everyone, and welcome to Moderna's second quarter 2020 conference call to discuss 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 Bonsal, our Chief Executive Officer, Kyle Zaks, our Chief Medical Officer, Stephen Hogue, our President, and David Malie, our Chief Financial 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 2 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. I will now turn the call over to Stéphane.

Thank you, Ravina. Good morning and good afternoon, everyone. I hope all of you are in good health and remain safe. Thank you for joining our future business update. We are committed to building mRNA as a new class of medicines, with Moderna's position to remain the leader in this field. As you know, we believe our mRNA medicines have a potential to address large unmet medical needs and to treat diseases that are not addressable by recombinant protein or small molecules. Due to the platform nature of mRNA, we believe our mRNA medicines provide a higher probability of technical success to commercial launch. and faster timelines to clinical trials and to the market relative to traditional medicines. We also believe that the manufacturing capital intensity of mRNA is materially lower than recombinant proteins, that our cost of manufacturing at commercial scales will be similar to small molecule injectables. Let me start by summarizing the key achievements of the company in Q2 on slide 4. mRNA 273 of COVID-19 vaccine candidates so the start of its phase two, and the team focused on the phase three design and preparation for July start. We signed a strategic long-term partnership with Lonza to have significant manufacturing capacity to make mRNA and formulate it at large industrial scale to complement our Massachusetts manufacturing site capacity in the context of the pandemic. We started the technology transfer to Lonza in Q2. We raised $1.3 billion on May 18, and as communicated in OS3, this capital was raised to enable us to scale up at risk for manufacturing capacity in anticipation of a potential approval for MRNet 1233. We started investing the proceeds for additional capital equipment at the Massachusetts plant, as well as the Lonza plant in New Hampshire and in Switzerland. ordering raw materials at large scale and hiring additional personnel to make mRNA-1273. In April, we finalized and announced an award from BARDA for up to $483 million for critical development costs for mRNA-1273. An additional award was also announced last week for up to $472 million, given the increased size of a Phase III to 30,000 participants. The total award is now up to $955 million. In a very difficult environment during the spring, given the many lockdowns across the U.S. due to COVID-19 outbreaks, our clinical team was able to continue to operate most of our clinical trials on schedule, and we remain on track to provide in Q3 the Phase 2 interim data for CMV vaccine candidate, mRNA-1647. The team continues to work relentlessly to start the Phase III study for CMV in 2021. We continue to believe that our CMV vaccine candidate annual peak sales could be $2 to $5 billion. And like mRNA-1273, our COVID vaccine candidate, we own the global commercial rights of mRNA-1647, our CMV vaccine candidate. Q2 marked a new growth phase for our company as we started to build and hire our commercial team. This is a historic moment for those of us who have worked at the company for many years since it was a breakthrough research enterprise working with small animal models. And now we are building commercial. In Q2, the team started discussions with several countries around the world about potential supply agreements for MRN1273. We saw our first deferred revenues book in Q2 on the balance sheet for $75 million of cash receipts from deposits for our first potential supply of MR-1273. As of July 37th, we have received approximately $400 million of cash deposits. For today's call, we will cover three main topics. First, Tal will review and update you on our clinical programs and share some new clinical data and our CMV and Zika vaccine candidates. Then Steven and I will share with you our value framework for vaccine COVID-19 candidates and our approach for delivering value during the pandemic. Finally, David will take you through the second quarter financials. Let me now turn the call to Tav.