Moderna, Inc.

Good morning and welcome to Moderna's second quarter earnings 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 thank you for joining us on today's call to discuss Moderna's second 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 Stephane Boncel, our Chief Executive Officer, David Moline, our Chief Financial Officer, Stephen Hogue, our President, Paul Burton, our Chief Medical Officer, Corinne Lagoff, our Chief Commercial Officer, and Jackie Miller, our Senior Vice President, Therapeutic Head of Infectious Diseases. Before we begin, please note that this conference call will include forward-looking statements made pursuant to the Safe Harbor provisions of Private 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 performance and results to differ materially from those expressed or implied in these forward-looking statements. On slide three, please see the important indication and information for our COVID-19 vaccine, which has been authorized for emergency use in the United States and in many countries around the world. I will now turn the call over to Stefan.

Thank you, Labina. Good morning or good afternoon, everyone. Welcome to our Q2 2021 conference call. Today, I will start by a quick business review of a quarter before Corinne walks you through the commercial update. David will present the key financials. Stephen and Jackie will provide the clinical update, highlighting new human data about the final analysis for COVID-19 vaccine phase three study. and human data for COVID-19 booster candidates phase two. I will then come back to close to share some thoughts about where we are heading. Let me start with Moderna COVID-19 vaccine, or SpacVax. We are pleased to announce today that our final analysis vaccine efficacy, or VE, in our phase three study is holding very nicely at 93%. We are starting to get authorizations for adolescent indication 12 to 17 years of age, receiving authorization in Japan this week, and a positive recommendation from the European Medicines Agency in July. An important step toward our vision of an annual respiratory combination booster is the start of a phase 1-2 for mRNA 1010, which is a quadrivalent seasonal flu vaccine. our teams are already preparing the Phase 2-3 for this program. We were delighted to get fast-track designation from the US FDA for RSV vaccine candidates, mRNA-1345, in adults over 60 years of age. There is no approved RSV vaccine. The burden for RSV infection is very high. In adults over 65 years of age, according to the CDC, 177,000 hospitalizations and around 14,000 deaths occur annually in the U.S. due to RSV. Our team is also preparing the Phase 2 free for this program. Our Zika vaccine has now moved to Phase 2. mRNA-3927 for Proprionic Acidemia, or PA, a rare genetic disease, has also started dosing patients in our Phase 1-2. And we are pleased to announce recently that we started dosing healthy volunteers in our first autoimmune disease program, mRNA-6231, coding for IL-2. So Moderna is now in the clinic in five large therapeutic areas, infectious diseases, cancer, cardiology, autoimmune diseases, and rare genetic diseases. We have a strong pipeline momentum, and the research teams are working hard to bring the next wave of development candidates to the clinic. Moving to slide six, we have also a strong commercial momentum. Let me start by giving you an update about Advanced Purchase Agreement, or APAs, for our COVID-19 vaccine spike docs. For fiscal year 2021, we have now signed APAs for $20 billion versus 19.2 billion announced in our Q1 call. We are now capacity constrained for 2021 and we are not taking any more orders for 2021 delivery. For Fiscal Year 2022, we have already signed APS for $12 billion. We have also signed an additional $8 billion in options. We are having numerous discussions ongoing as we speak with countries around the world to enter into new APS for 2022. We'll continue to give you updates on a regular basis. What is very interesting to see is that forward-thinking countries like Israel and Switzerland have already signed APAs for 2023 to ensure supply for the endemic market. On the financial front, we delivered $4.4 billion of revenue and $2.8 billion of net income. The cash generation in the quarter was strong at around $4 billion, bringing our cash balance to over $12 billion at the end of June. We're also announcing today our first share buyback plan. Our board of directors has authorized share repurchase for up to $1 billion. David and I will give you more color in a few minutes. For 2021, we continue to forecast supply between 800 million and a billion doses. For 2022, we forecast supply between two to three billion doses, depending on the final dose approved by the regulators for our booster. At 50 micrograms, up to 3 billion doses. At 100 micrograms, up to 2 billion doses. As we continue focusing on scaling the company, I am delighted to have three new executive committee members who joined recently. By start date of the company, Shannon Klinger as our chief legal officer and corporate secretary. She joined us from Novartis where she was the chief legal officer. as Chief Medical Officer. He joined us from Johnson Pharmaceuticals, the Johnson & Johnson company, where he was Chief Global Medical Affairs Officer. And more recently, Kate Cronin as our newly created role of Chief Brand Officer. Kate was until recently the CEO of Ogilvy Health. I look forward to working closely with Shannon, Paul, and Kate as we scale Moderna to the next level. On slide nine, you will find our usual summary slide. A few important things to note. We are now preparing phase two three for quadrivalent seasonal flow and our RSV program. Our team continues to grow as we increase manufacturing capacity for COVID-19 vaccine, as we move program from early stage clinical study to late stage clinical studies, and as we increase investment in research for the next wave of development candidate. Let me now turn to Corinne to give you a commercial update. Corinne?