Moderna, Inc.

Good morning and welcome to Moderna's first quarter 2020 conference call. At this time, all participants are in a listen-only mode. If you are part of the press or media, please disconnect at this time. 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 Lovina Talukdar, Head Investor Relations at Moderna.

Please proceed. Thank you, operator. Good morning, everyone. Welcome to Moderna's conference call to discuss our first quarter 2020 business updates and financial results. 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. Speaking on today's call are Stefan Bonsell, our CEO, Tal Zaks, our CMO, Stephen Hogue, our president, and Lawrence Kim, our CFO. Before we begin, please note that this conference call will include forward-looking statements. 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. With that, I will now turn the call over to Stephane.

Thank you, Lavina, and good morning or good afternoon, everyone. Thank you for doing the call. I hope you and your families are in good health. As you know, we believe mRNA has the potential to be a new class of medicines with the opportunity to address many medical needs, with medicines with higher probability of technical success, with greater speed of research and clinical development versus traditional medicines, and with greater manufacturing capital efficiency and lower cost of goods than injectable recombinants. Given the unknowns of working with a new technology, we have been laser-focused on managing risk, technology risk, biology risk, execution risk, and financing risk. As many of you know, 2019 was an important infection year for Moderna. We reported clinically validating data from key programs in two of our modalities, prophylactic vaccines, antistemic, secreted, and cell surface therapeutics. Data that we believe fundamentally changed the risk profile for each of these two modalities that we now call As a result, our strategy is to double down in these two core modalities with many important new development candidates. We have already announced five new development candidates in these core modalities since January 13th at the J.P. Morgan Conference. Three new development candidates in infectious disease prophylactic vaccines and two in the systemic secreted and telsofast therapeutics modalities. While we focus on doubling down in core modalities, we are still very interested in understanding the potential of mRNA technology in our current expiratory modalities, cancer vaccines, intratumoral immune oncology, localized regenerative therapeutics, and systemic intracellular therapeutics. So when we think about the company, we basically have two distinct areas of focus. This is a significant point in our strategy. We have core modalities where we want to scale and invest, and exploratory modalities that continue to be a big driver for the company's future as we await clinical data to decide the path forward. So stepping back, I would like to share with you the progress of a company toward a new class of medicines. This is a strategic plan that we shared with you in February 2020. In the early days of our company, our goal was to enter the clinic safely. We spent years investing and developing mRNA science, formulation delivery, and manufacturing technologies. The company pivoted out of that growth phase when we entered the clinic with our H10 influenza vaccine in December 2015. In the clinic, our next goal was to learn how our technology was working or not. We explored our technology across six different modalities. We tested 16 different molecules in the clinic in a short four-year period. In 2019, we generated important data in two of these six modalities and identified our first two core modalities, infectious disease prophylactic vaccines and systemic secreted and cell surface therapeutics. Early in the year, we entered a new phase of companies' development. Our goal for this next phase in our history is to file multiple BLAs while continuing our clinical programs in the four expiratory modalities and continue to invest aggressively in early research to invent new modalities such as an ongoing collaboration with Vertex. When we first presented this plan in early February this year, we had imagined that the the next phase of growth of a company will have taken us three to four years. Our vaccine against SARS-CoV-2 virus, mRNA-273, is a major acceleration of our company's development. Today, we are very happy to announce that we received yesterday clearance from the FDA to proceed with Phase 2. It's just nine days from filing our IND on Monday, April 27th, The FDA gave us a green light. We intend to start the clinical trial as soon as safely possible. We've also announced this morning that we are finalizing the Phase III protocol, and our aim is to start dosing the Phase III in early summer 2020. This means that we have a potential for a BLA approval for mRNA-1273 in 2021. That is an acceleration of several years. This is a plan we had just months ago. Moderna should be a commercial stage company in 2021. That is two to three years ahead of our previous plans, plans we outlined just months ago. This is a unique opportunity. So we are working actively to get the company ready. To deliver on this acceleration of the company's plan, we're expanding our leadership team in areas where their expertise will be instrumental to allow us to successfully file several BLAs and be ready commercially. Today, we're announcing three new additions to the leadership roles of Moderna. First, Patrick Berchtedt. Patrick joins Moderna as Senior Vice President, Commercial Vaccines. Patrick will report to me. Patrick joins from Merck and Company, where he most recently was head of global marketing and commercial operation for the entire vaccine business at Merck. Patrick will start on June 1st. Patrick, like global initiatives, will focus on revenue growth and access expansion. A 20-plus year veteran in the biopharma industry, Patrick has held various leadership positions within infectious disease and global health at Merck in the U.S., in Europe, but also in Asia. Second, Dr. Jackie Miller. Jackie will be joining Moderna on May 11th from GS Care as Senior Vice President, Infectious Disease Development. Jackie joins a company from GS Care where she held a variety of leadership roles since 2005. Most recently, Jackie was the Vice President and Head, Clinical R&D and Epidemiology, where she built and led the clinical and epidemiology research team at the first LHK Vaccine Research and Development Center in the U.S. And third, Dr. Charbel Haber. Charbel joined Moderna on April 21st as Senior Vice President, Regulatory Affairs. Charbel Johnson from Biogen, where he served as Vice President, global safety and regulatory science since 2017. In this role, he built and led the global regulatory strategy department, the clinical trial application group, and the medical writing groups. Prior to Biogen, Dr. Haver was head of global regulatory affairs for immunology and neurology at EMD Serrano. I am very excited to welcome Patrick, Jackie, and Charvel, and look forward to their contribution at Moderna as we embark on the commercial stage phase of our companies. It is a bittersweet moment to announce today the departure from the company of Dr. Lawrence Kim, our Chief Financial Officer. Lawrence joined the company in 2014, when the company was private. As some of you remember, it was a preclinical stage company with zero development candidates. Lawrence took a chance on Stephen Hogan and I and decided to leave a graduate by Goldman Sachs to join us. The company is now public with 23 development candidates and preparing its first phase three. Lawrence will manage with us for a smooth transition. He will do Moderna second quarter conference call in August with us before leaving the company. I am very thankful for Lawrence's contribution over the years. And so a constructive discussion he and I had about ensuring a smooth transition. There is never a good time for leadership transitions. But the company is very well capitalized with around $2.4 billion of capital to invest to create value. And we need to focus on the next phase readiness for the company to be commercial. We have retained Russell Reynolds for the search for Moderna next year. We will focus on the CFO. We are a public company. and commercial, and global operation experience, given this is where Moderna is heading. Before I hand over to Tal for clinical updates, I wanted to take a few minutes to frame the opportunity in our vaccine modality. We believe mRNA has the potential to be a new class of vaccines, where each of the four drivers of value apply. We are very excited about the potential of our vaccines to drive this value. First, as we discussed, a very large opportunity, the ability to do first-in-class vaccines that do not have products on the market today to protect as many people as we can. Second, a relatively high probability of technical success. As we discussed at our vaccine day, Dr. Andrew Law from MIT has shown that from the start of a phase two, a positive phase one, to approval, Vaccines have 42% probability of approval. This is the highest probability amongst all categories of medicine in clinical trials. We think this is a very important value driver for this franchise. Further, we think an important driver is speed. Speed in the labs, even with a platform, we can study many candidates in parallel in preclinical settings. Once we pick a development candidate to take into the clinic, we can do it very quickly, as we have shown recently. with SARS-CoV-2 vaccine, going from design of a vaccine on January 13 to injecting the first human on March 16 in as little as 63 days. Finally, we believe the capsule efficiency of our platform offers significant advantages over traditional vaccines. Because the manufacturing process to make a mRNA molecule is a cell-free manufacturing process, it can drive much lower capex than just recombinant protein manufacturing. The second dimension is a CapEx leverage across the value chain. For example, when we decided to go after SARS-CoV-2, we did not have to buy any new machine. Our team was able to leverage existing CapEx in a matter of days. With that overview, let me now turn over to Tal.