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 up the call for your questions. Please be advised that the call is being recorded. At this time, I'd now turn the call over to Lavine Talukdar, Head, Investor Relations at Moderna. Please proceed.

Thank you. Good morning, everyone, and welcome to Moderna's third 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 Stephane Boncel, our chief executive officer, Tal Zaks, our chief medical officer, Stephen Hogue, our president, and David Moline, 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 Security 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 revise the information or provided on this call as a result of new information or future results or development. I will now turn the call over to Stephan.

Thank you, Lavina. Good morning or good afternoon, everyone. I hope all of you and your loved ones are in good health and remain safe. Thank you for joining our Q3 Business Update Conference Call. I will start with reviewing key highlights. I would like to focus on three topics. First, our COVID-19 vaccine. Second, our broader development pipeline. And finally, key financials. As many of you know, we completed enrollment of our phase three COVID study for mRNA-1273. 30,000 participants have been enrolled in the study, 37% of whom are from diverse communities. Tal will give you some details in a few minutes. We are grateful for the participants in the study and for our principal investigators. I would like to also thank PPD and NIAD for a great job and collaboration. It is very important to the Moderna team that we have a high bar for quality and transparency to ensure the public has trust in COVID-19 vaccines. We have reported weekly enrollment progress over co-op study and have reported weekly enrollment numbers from diverse communities. When we were not happy with the representation of these diverse communities, given the high burden of disease in these populations, we decided to slow down the overall co-op study enrollment process in order to recruit more people from diverse communities. As you can imagine, It was not an easy decision to slow down, but it was the right decision. We signed the Biopharma Pledge to not submit for regulatory approval for mRNA-1273 until we have adequate safety and efficacy data. We were also the first company to file the full, unredacted version of our Phase III protocol online to ensure clinicians around the world could see In full transparency, how the COV study is being run. We were pleased to set the standard and have others in the industry follow all it. We continue to expect our first interim analysis to read out in November. The Independent Data Safety Monitoring Board, or DSMB, will carry out this interim analysis and then inform Moderna. we should have a post-second dose two-month safety follow-up after the second vaccination of the 15,000 or million participants in the second half of November. As many of you know, this is what the US FDA has asked as part of the EUA submission in their latest guideline published ahead of the October 22 VIRTAC meeting. We are working closely with the US FDA to file chemistry manufacturing control, or CMC, components as soon as they are available to ensure CMC is not on the critical path to an EU approval. In addition to the ongoing dialogue with the U.S. FDA, we have announced rolling submissions for MRN 273 in the U.K. and Canada and received confirmation of eligibility for submission of marketing authorization application to the EMA for the EU. We are very pleased to announce this morning that we have signed a partnership in Japan with Takeda for an order of 50 million doses for the Ministry of Health, Labor, and Welfare of Japan. In the third quarter, we have received $1.1 billion of cash payments from governments around the world, and those are accounted in our financials as deferred revenues. Let me now turn to our broader pipeline. We announced at R&D Day in September the positive phase two readout for mRNA-1647, our CMV vaccine. We are on track to start the pivotal phase three registration study for CMV in 2021. I will refer you to our April Vaccine Day presentation in which we communicated that we believe Our CMV vaccine has a potential for annual peak sales between $2 and $5 billion. There is no approved vaccine against CMV, and it is the number one cause of birth defect in the U.S. and the developed world. Moderna owns global rights to CMV 1647. Our intratumoral OX40 ligand program that many of you have heard about at our recent R&D day is not doing patients, in a Phase II expansion study. In rare disease, startup activities under an amended protocol for a Phase I propionic acidemia, or PA, study are underway. All of our pipeline programs that were enrolling and dosing patients also continue and are ongoing. Let me finish this slide with a few words about financials. David will go through the financial numbers in a few minutes, but I wanted to share a few thoughts. As I mentioned earlier, we reported this morning that we booked $1.1 billion of deferred revenues in Q3 for supply agreements for MR-1273. This cash has been received by the company. These cash receipts have enabled the company to generate $893 million of cash flow provided by operating activities in the third quarter after investment of approximately $300 million in the business. If you turn to slide four, I am pleased to report that this is the first quarter in the company's story in which we reported positive cash flow provided by operating activities coming from product supply agreements. It has been 10 years after inception and after investing billions of dollars in science and product development. Thank you to all our employees, scientists, of course to our investors, and to all of you that have believed in Moderna. Let me turn to slide five. for my closing remarks. As a snapshot of Moderna in October 2020, we have accomplished a lot and continue to have a broad pipeline that continues to progress well. We have fully enrolled phase three program with mRNA-1273. We now have four phase two trials with CMV, personalized cancer vaccine, VHF with AstraZeneca, and now Vox40 ligand. Seven ongoing phase one programs. and 12 positive Phase I studies. Our vaccine franchise has six programs in development addressing the major and med needs. We have five immuno-oncology programs in the clinic, four programs in rare disease, and two programs in autoimmune disease. Our foundations have never been stronger, with 32,000 participants and patients in our trials. We have now over 1,200 employees, We have an international manufacturing capacity and capabilities with our partner, Lonza, who will be in Catalan. And we have strategic partnerships with companies like Merck, AstraZeneca, and Vertex. At the end of September, we have a strong balance sheet of $4 billion. I am very proud of what we have accomplished so far and where we stand as a company. The next few weeks and months are going to be quite historic for Moderna. I will now turn it over to Tal to talk about clinical updates.