Moderna, Inc.

Good morning. My name is Kevin, and welcome to Moderna's third quarter 2022 earnings call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call for your questions. To ask a question during the session, please press star 1-1. Please be advised this call is being recorded. At this time, I'd like to turn the call over to Levina Talukdar, 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 third quarter 2022 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 investors section of our website on today's call are stefan boncel our chief executive officer stephen hogue our president arpa garay our chief commercial officer and Jamie Mock, our Chief Financial Officer. After prepared remarks, we will take your questions through 9.15 a.m. this morning. 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 the call over to Stéphane.

Thank you, Lavina. Good morning, or good afternoon, everyone. Welcome to our Q3 2022 conference call. Today, I will start with a quick business review of the quarter before Stephen reviews our clinical programs. Papa will then take you through commercial dynamics, and Jamie will present financials. I will then come back to close before we take your questions. In the quarter, we reported $3.4 billion in revenues. We reported net income of $1 billion and cash investments totaling $17 billion. We now expect deliveries under advanced purchase agreements in the range of $18 to $19 billion in 2022, due to delayed deliveries from our 50-inch contract manufacturers, resulting in $2 billion to $3 billion of revenue deferrals into 2023. In Q3, we had to deal with a lot of complexity, launching two products, 1273.214 and 1273.222 at the same time, and also moving products from 10-dose vials to 5-dose vials. Q3 was actually our greatest delivery amount in terms of vial produced and was up over 20% the average for the previous three quarters. I'll probably share my thoughts on 2023 in a moment. In the first quarter, we repurchased over 7 million shares. The $3 billion share repurchase program we announced in February 2022 was completed. Since the start of our first share repurchase program in 2021, through the end of the first quarter, we have repurchased more than 23 million shares. Our third share repurchase program announced in August 2022 for an additional $3 billion in repurchase is ongoing. Let me now review the pipeline highlights and advances since our last update. I am very pleased with the important progress the Moderna team has made on advancing the pipeline closer to product launches, and at the same time, increasing the breadth of the pipeline. We've continued to progress our COVID booster programs and have received authorization around the world for both our COVID-1273.214 program, which targets Omicron BA.1, and 1273.222, which targets BA.45. We have, as you know, two respiratory vaccine phase three trials as we speak that continue to progress quickly. For flu vaccine, attended in September, we announced the first phase three immunogenicity study was fully enrolled. We expect now data in the first quarter of 2023. As a reminder, we plan to pursue an accelerated approval pathway for seasonal flu vaccine. We also started a phase three efficacy study with a flu vaccine and that trial is enrolling quickly. For phase three HIV vaccine, we are on track for data without this winter season. We were pleased to announce that Merck exercised their option to develop and commercialize a personalized cancer vaccine, mRNA-4157, paying Moderna $250 million in Q4. We and Merck will share costs and profit 50-50 for this program moving forward. We continue to expect data from our Phase 2 study for PCV in Q4 this year. In rare diseases, we are pleased to share at the R&D Day that we saw encouraging early sign of clinical benefit above PA and GSD1A, and announced a new development candidate for OTC. On slide six, you see our usual snapshot of Moderna in November 2022, showing the breadth of the pipeline. We have now 48 programs in development across vaccines and therapeutics. The company continues to grow, and we now have more than 3,700 Moderna team members. Last week, we were very pleased to announce as the top employer by science for the eighth consecutive year. We have now 15 commercial subsidiaries globally and a strong balance sheet of $17 billion to fund our continued growth. With this, I will now turn it over to Stephen to review the pipeline. Stephen? Thank you, Stéphane.