Good morning and welcome to Moderna's Fourth Quarter and Full-Year 2019 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, Investor Relations at Moderna. Please proceed.

Thank you, operator. Good morning, everyone. On today’s call we will discuss Moderna's fourth quarter and full-year 2019 business update 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 Investors section of our website. Speaking on today’s call are Stéphane Bancel, our Chief Executive Officer; Tal Zaks, our Chief Medical Officer; Stephen Hoge, our President; and Lorence Kim, our Chief Financial Officer. Before we begin, I would like to remind everyone that this conference call will include forward-looking statements. 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. Stéphane Bancel: Thank you, Lavina, and good morning, everyone. As you know, we believe mRNA has a potential to be a new class of medicines with the opportunity to address many unmet medical needs. Given the unknowns of working with a new technology, we have been laser focused on managing risk, technology risk, priority risk, execution risk and financing risks. 2019 was an important inflection year for Moderna. We reported clinically validating data from key programs in two of our modalities, prophylactic vaccines on the left and systemic secreted & cell surface therapeutics on the right. Data that we believe fundamentally change the risk profile of each of these two modalities that we now call core modalities. As a result, our strategy is to double down in these two core modalities with many imported medicines.…

Thank you, Stéphane, and good morning, everyone. I'll start with a quick reminder on the data generated to date with our vaccines. In over 1,000 healthy volunteers and 6 positive Phase 1 datasets to date, we've observed the safety profile consistent with the safety of marketed vaccines and the ability to elicit an immune response in the form of neutralizing antibodies. Updates for the ongoing programs are shown on this slide. The CMV Phase 2 dose confirmation study is enrolling well. We completed the second dose cohort and are close to completing the third one. We now expect data readouts to come in the third quarter of this year. Our hMPV/PIV3 combination respiratory vaccine has started the age de-escalation study and Merck is on track with their RSV program in adults. Zika is also going well as 3 of the 4 dose cohorts have completed enrollment. Our three new development candidates announced recently are vaccines against pediatric RSV, mRNA-1345, Epstein-Barr virus or EBV, mRNA-1189 and our vaccine against the novel 2019 coronavirus mRNA-1273. Stephan, will take you through each of these candidates in a minute. CMV is an unmet need as there aren't any approved vaccines and the burden of disease from CMV infection is significant. Of the 25,000 newborns in the U.S. affected each year, 20% will have permanent neurodevelopmental disabilities. And the spectrum of sequelae range from hearing loss, vision loss, microcephaly and even mortality in 10% to 30% of the severely affected infants. We believe our gB and pentamer vaccine has the potential to prevent the infection and help thousands of newborns avoid these sequelae. On Slide 16, I'll review the most recent data from our CMV program. In January of this year, we show the 7-month interim data. The safety has been generally well tolerated and…

Thank you, Tal. I want to start by introducing three development candidates in our vaccine -- prophylactic vaccine modality that we've recently announced earlier this month. The first to begin Epstein-Barr virus. And just what to pause for a moment and give you an overview of the disease. So Epstein-Barr virus is a member of the herpes family that includes CMV and it spreads through bodily fluids, mostly in the young children and adolescents. EBV is a major cause of a wide range of diseases, but is the leading cause of infectious mononucleosis in the United States, accounting for almost 1 million cases annually. Infectious mononucleosis can debilitate patients for weeks to months and in rare cases can lead to hospitalization and even splenic rupture. EBV infection is also associated with a range of other disorders, including lymphoproliferative disorders, cancers and autoimmune diseases. For instance, it is associated with a significant increase in risk of multiple sclerosis. There are currently no approved vaccines for EBV. So our vaccine candidate mRNA-1189 is designed to provide broad protection against EBV infection and infectious mononucleosis. EBV has a number of surface proteins on its envelope, including gp350, a trimeric complex of gp42/gH/gL, a dimeric complex and also gB. All of those antigens are important for infecting a range of different cell types, but particularly B-cells and epithelial cells. Now vaccination against only one of those antigens, gp350, which provides only partial B-cell protection, reduce the rate of infection in a prior study by up to -- reduce the rate of infectious mononucleosis in a prior study by up to 78%. But it does not prevent the rate of infection. We believe that the combination of multiple antigens, gp350 plus antigens for gp42/gH/gL and gb will provide an opportunity for broader protection both of…

Thank you, Stephen. Let me just briefly review these modalities that we consider exploratory, but obviously make up a significant part of what we do in clinical research and give you a sense where we are in the prosecution of these programs. Starting with the cancer vaccines, our personalized cancer vaccine mRNA-4157 is in a randomized Phase 2 trial for the treatment of adjuvant melanoma. The combination of PCV with KEYTRUDA against KEYTRUDA alone and its recruiting well. KRAS, vaccine mRNA-5671 is an ongoing Phase 1 study and this one is led by Merck and it has a monotherapy as well as a combination with KEYTRUDA arm. Our intratumoral immuno-oncology therapeutics, we have three programs in this modality. All of them are in combination with PD-1 inhibitors. Dosing of patients is ongoing and I look forward to the future to being able to demonstrate whether the ability to influence the immune system in this matter will be helpful to these patients. On the regenerative therapeutics modality, AstraZeneca is conducting a Phase 2a in patients with our mRNA that encodes for vascular endothelial growth factor. And that's in patients that are undergoing CABG, coronary artery bypass grafting. That study continues to enroll. In the systemic intracellular therapeutics, we have two INDs open now in both MMA and PA methylmalonic acidemia and propionic acidemia. We are pleased to announce that the first patient in MMA has enrolled in this trial. They’re in the observation period right now. This trial is now open at seven institutions in the United States and we're continuing to look for additional patients to enroll, while we follow this first patient closely. With that, let me turn it over to Laurence to describe the rest of our pipeline where we go from here.

Thank you, Tal. So on Slide 29, you see a graphic that represents our whole development pipeline as it stands today. First and foremost, we're focused on the investment and execution around this development pipeline. There are three significant things from us today around the CMV vaccine, where the Phase 3 preparation is very much underway. You’ve had the Phase 2 enrollment for that. CMV vaccine is ahead of schedule and importantly in Phase 1 of MMA has enrolled its first subject. So we're really focused on executing across the entire breadth of the pipeline. And then the other key thing you heard today is that the preclinical programs continue to grow. And you will heard that we announced in the first two months of the year five new development candidates. This is indicative of the productivity that we expect out of the research platform. If you will flip through the next slide, it's a robust list of clinical data, next steps across the pipeline. If you scan the page, you'll see a lot of readouts coming in the near-term. We've got it for the CMV read out the Phase 2 data with a 3-month interim analysis in the third quarter of this year and a Phase 3 start in 2021. The rest of the vaccines you'll see a number of additional Phase 1 readouts that we would expect to occur, as well as advancement of these new -- newly nominated devolvement candidates toward the clinic. If you look at the next category of systemic secreted therapeutics or antibody against Chikungunya will continue to progress through further development of a dose cohort and will continue to advance preclinical work towards IND filings. And you just heard from Tal the rest of our programs will be progressively moving forward here towards…

Thank you. [Operator Instructions] Our first question is from Matthew Harrison from Morgan Stanley. Go ahead with your question please.

Hey, good morning. Thanks for taking the questions. I guess, two from me. So, one, on coronavirus and I think this is just so people understand. Could you just broadly comment. It sounded like NIH needs the file on IND and then they would obviously start the clinical study. What is your involvement at this point? And are you taking any steps related to ramping manufacturing or any other steps related to this? And then secondly, maybe just on CMV -- well, actually on MMA. Can you just talk about how enrollment is going for additional patients? What sort of led you to be able to get that first patient in? And if you see, promise in terms of being able to rapidly enroll additional patients. Thanks.

hanks, Mike. This is Tal. Let me take both of these questions. As it relates to coronavirus, our part here was to manufacture and ship it. I think the trial now will be run by the NIH and I defer to them to provide updates when they will. You asked about scale-up. I think we're looking at everything that it would take and how to actually get it done. But we'll update everybody once we have a clear picture of that. Obviously, this is a rapidly changing environment. On MMA enrollment, so right now, we've got one patient enrolled. We do not yet have the second and third, but we're actively working with sites to find them. The age barrier, I think, continues to be a difficult one. We only have to find the first three. So -- and then we can go down in age. So I am confident that we will eventually, but I continue to have a dialogue with the agency on trying to reduce that need, so that enrollment can be unhooked from that. And we can get into the age population where we believe the greatest unmet needed potential for benefit is. So I'll update everybody as soon as we have progress in that field.

Thank you.

Thank you. Our next question is from Ted Tenthoff of Piper Sandler. Your line is open.

Great. Thank you very much. And just following up on Matt's question first. What -- maybe you can just remind us again so that everybody understands it because we've been giving a lot of questions on this. What is the process for licensure of a bio threat or pandemic vaccine such as coronavirus? And then with respect to CMV, again, great progress just across the board here. Ultimately, what do you see as sort of the vaccination paradigm or timing of vaccinations for women of childbearing age? Thanks so much.

Thanks, Ted. It's Tal. Let me take that. I think what does it take to get licensure is an evolving field. I mean, the pathway to licensure are well understood and they encompass everything from finding surrogates of protection to demonstrating efficacy. What is it going to take here? I don't think anybody knows. I think all options are currently open, but it's a rapidly evolving field. And you can imagine that there actually isn't not yet a surrogate of protection because this is a very new virus and now people are still working to develop those assays and models. I would give NIH a lot of credit for being at the forefront of that effort and work closely collaborating with them on these efforts. As it relates to the vaccination paradigm for CMV, I think the starting point here is clearly going to be in women of childbearing age. That's where you would anticipate the greatest benefit. And I think the next phase is going to be -- to get into a [indiscernible] population of adolescents, because obviously you want to start protection as early as possible, given that's what the disease we're trying to prevent here is ultimately going to be infants born to women. So we're going to try and get down to that age group as we develop this vaccine.

Okay, great. Thank you very much.

Thank you. Our next question is from salving Salveen Richter of Goldman Sachs. Go ahead, please.

Thanks for taking the question. It's Ross on for Salveen. Just a few here from me. So just quickly on coronavirus, what's the potential monitory opportunity here? Do you guys have any details around agreements with the NIH about, funding to you guys? So just thinking about the monetary opportunity there to Moderna. And then on the Chikungunya antibody program, how much follow-up time exists since like the initial patient was first dosed and then since he was -- since he receive the second dose? And are you guys seeing any signs that they can meet immune response? And then I have a follow-up. Stéphane Bancel: It's Stéphane. I will talk about first of all on corona, only focus as a team is public health. People are sick all over the planet. People are dying. But it's our only focus is to get a vaccine as fast as we can, safely, partnering with the right people to get it done.

Let me answer -- if I understood correctly your question on the Chikungunya monoclonal antibody, these data are emerging. We're giving you an execution update on to in terms of where we are, once I have a full sense of the data set there, I will, of course, update everybody.

Great. And then just lastly, so outside of the Phase 2 CMV update in 3Q, what programs are you expecting to have data this year?

We -- as you know, we don't guide to specific timing on various milestones. I'd refer back to the slide which had the rich catalyst calendar and clinical data calendar that we referred to. That list of events that included data readouts as well as advancement of programs is a list that comprises all the next steps. Some of those have advanced fairly far along. For instance, I would note that the phase one vaccine studies for RSV and Zika running since last year. And other instances you'll recall that as you pointed out, the Chikungunya antibody program is a relatively small study in healthy volunteers. But again, we're focused on advancing all these programs as rapidly as we can towards data.

Great. Thanks.

Next question is from Geoff Meacham of Bank of America. Go ahead, please.

Hey, guys. This is Alec on for Jeff. Thanks for taking our questions. Two questions for me. My first is on your PCV program and I guess the KRAS vaccine as well, have you guys seen any updated data from these studies, including the ongoing Phase 1 for the PCV since ASCO? Just trying to get a sense of why this modality hasn't made the cut for your core franchises, given it's one of the more advanced in terms of clinical development? And then I've got one more.

Thanks, Alec. It's Tal. Look, on the personalized cancer vaccine, it's a Phase 1. So, data continues to come in once we have a full cogent dataset there, we will be disclosing it. And the question of why we don't consider this a core? I think for us core is one that we have gotten the requisite pharmacology to believe it will translate into a clinical benefit. And I think that's true both for the vaccines clearly, and it's also true for the secreted and the surface protein expression, because that you can give the monoclonal antibody actually reached what would otherwise be therapeutic levels of a protein. So that's why it's core. I think in oncology, until you actually show that you’re -- the pharmacology that you're describing in this case immunology, in T cell immunology, until you actually demonstrate that, that translates into a clinical benefit for patients. It's hard for me to call it core.

Got it. That's very helpful. Thanks. And then secondly, do you have any updates on the CF partnership with Vertex? We've seen Vertex partner with some other gene therapy approaches from CRISPR Therapeutics and others. So any color you can give on this partnership would be great. Thanks.

You know, we don't generally comment on research. We continue to work with Vertex, we're pleased to be working with them in the CFTR space, but we don't have any updates at this time.

All right.

Our next question is from Cory Kasimov from JPMorgan. Go ahead, please.

Good morning, guys. Thank you for taking my questions. Two of them for you. First is another one on coronavirus. Thinking a little bit further out, just curious what kind of manufacturing capacity you anticipate having, say, looking out to 2021 event? Should you need to manufacture mRNA-1273 for coronavirus? And then secondly for the CMV program. I mean, if you guys could kind of broadly talk about what a win would look like in that interim update for the Phase 2 we will get in 3Q? Is this more or less kind of looking to replicate the Phase 1 results in a larger group of patients or other nuances we should be thinking about? Thanks. Stéphane Bancel: So, Corey, good morning. It's Stéphane. So I will take the first one on manufacturing capacity. I think the [indiscernible] is just too early to know precisely. First, we don’t have those, then fill finish, there's Norwood CMO capacity actually new sites. So just way too early to comment on that. But we’re working out to get as much as we can.

Hi, Corey, it's Tal. Let me answer your question on CMV Phase 2. So I think in a nutshell, the goal here is, as you say, to replicate what we saw in the Phase 1, but I'd like to be able to do that, of course, in the larger data set so that our confidence in picking the right dose for Phase 3 is there. And that has to do both with replicating the nice immunogenicity that we've seen, but being able to kind of plan a clear flag on what we expect in terms of the safety and tolerability profile that would enable us to go into Phase 3 trial.

Okay. Thank you.

Our next one is from Hartaj Singh of Oppenheimer and Company. Go ahead, please.

Great. Thank you. I’ve just a question on CMV. With the Phase 2 results coming up in the third quarter and then the Phase 3 getting going, could you talk a little bit about how you could speed it to market? I know that a lot will be depending on the Phase 2 results. But can you give us some sort of -- kind of a confidence interval as to when you think the Phase 3 could read out and by which time you could be in the market, 2024, '25, '26? And then just a follow on to that, which is that, you've [indiscernible] as [technical difficulty] $5 billion, which seems to make a lot of sense because as you get to broader and broader immunity, can you just broadly walk us through what kind of patient populations would you want to sort of have the vaccine brought into to get to that higher point of that range? Thank you very much.

Hi, Hartaj. This is Tal. Let me start by answering the first question. So, look, the timeline for CMV roughly speaking, once we get in, we anticipate fairly aggressively to be able to complete enrollment within 18 months. I anticipate the duration of the trial to be 2 years. Now, that still needs, of course, vetting with regulatory authorities. So I want to make sure I caveat that appropriately. Once that we have 2 years on everybody on study, then it's a matter of analyzing, looking at the results and filing and that's where I think the timelines are pretty well understood for what's achievable in our industry. So you can do the math from there. Stéphane Bancel: Yes. And -- Stéphane, I will take the second one on CMV, what we take to get to $5 billion number. I think a few things. The first one is, as we explained, the R&D Day in September, it will take -- get an indication approval in women in childbearing age, which, as you know, is a first one. Then to getting to an adolescent approval like the HPV GARDASIL. And third is to getting to pediatric. As we shared, humans are [indiscernible] for CMV. We believe it is a very important public health opportunity here to vaccinate newborns in the pediatric setting. That has been done, as you know, successfully, with Rubella to eradicate the virus and to make sure that humans don't get infected by this virus, which has a lot of long-term negative impact on health at a population as well as for individuals and their own immune system and their own health. Another dimension, of course, is competitive landscape. We will be the only one on market for next 10 years or we’re going to be with one competitor, or two competitor or five competitors. I can come back on that if you adjust it moving further. And then it's the population growth. There is a lot of emerging markets that's not only growing in size with our population growth, but also in terms of dollar invested in [indiscernible], if you take about 5-year, 10-year, 15-year timeframe. And that’s what impact the model that we’ve for getting to around $5 billion annual peak sales.

Great. Thank you.

Our next question is from Yasmeen Rahimi of ROTH Capital Partners. Go ahead, please.

Hi, team. Thank you for taking my questions and thank you for the tremendous progress that you're making quarter-over-quarter. Few questions for you, all related on CMV. The first one is can you give us a little bit more color on how we think about how current the numbers are in regards to infection rate? If there are differences between U.S. and Europe, how current they are as it guides you sort of for powering assumptions in your Phase 3? And then a second question that was often that is, as you’re in a predominant part of being able to scale up and we’re going to learn more in manufacturing on March 4. Can you enlighten us what are aspects that are unique when you're scaling up in mRNA therapeutics versus other R&A modality? Just we have a little bit of color, do you want [indiscernible] here. And thank you for taking the questions.

Hi, Yasmeen. It's Tal. Let me take your first question. It's a great question and one that obviously keeps me up at night. I think the literature is out there in terms of incidence rates and infections. But it's also clear from that literature that there a high level of variability. And it's not just on a continental level, U.S. versus Europe, that is actually local geography, socio economic status, a lot of things that play into that. So how are we thinking about it in terms of designing the trial, which is obviously, I think where your question is going to, I think the goal here is to design both a large trial and a broad enough trial in terms of size and population, so that on average we are able to hit the incidence rate that people have described. And I'm pretty confident in the ballpark of where we are powering this study to be able to reach it. And finally, I would note that in the trial of this type, you have the ability to actually on an ongoing basis, monitor the incidence in real time. So that the only risk you're really taking if you're missing it is you follow subjects for longer and you catch up the cases. So it will -- ultimately the trial size will come down to the number of cases. And that's one that you can monitor in almost real time. Stéphane Bancel: So -- good morning, Yasmeen. It's Stéphane. On the manufacturing process and why mRNA is such a powerful molecule. I think a few things. I mean the first thing is, it's a liquid based process to make mRNA, which is cell free. So that drives to a very small reactors compared to other technologies, especially compared to recombinant…

Thank you, team and look forward to seeing you in Boston. Stéphane Bancel: Right.

Thank you. [Operator Instructions] And next one is from Alan Carr of Needham. Please go ahead.

Hi. Thanks for taking my questions. A couple of them. One of them is, can you clarify between your exploratory and your core modalities? Does this mean that you don't plan to add any more new programs to your exploratory until they become core? And then also around RSV, 1345 versus 1172, how are they different and how does this fall outside of the agreement that you already have with Merck around RSV? And the last thing is, can you get over the -- your overall manufacturing capacity at the Norwood facility right now across all programs, the total capacity? And without regard to coronavirus, what were your -- what are your long-term plans in terms of your needs for capacity, in terms of adding manufacturing capacity in the long-term? Thanks. As you go commercial. Stéphane Bancel: Good. Thanks for those three questions. So let me take the first one on exploratory and core. So, yes, if you go back to the strategy, we started with six modalities in the clinic to say we cannot manage the unknown, unknown. And so because of the exciting opportunity to create a new class of medicine, we are very focused on managing the unknown technology risk. And so we tried those six technology in parallel. So we could learn from a clinic where to invest more, because mRNA is a new formation molecule making it to platform. And wherever you wanted to fix, if you learn something about the science, fix that science if you can or decide that you’re stop investing in that opportunity, you want to deploy your capital wisely, where you know the technology is working. So that was kind of a premise as we started. And so what is happening with this pivot in the company history that now…

Yes. Just quickly on RSV. So, Alan, as you reference, we have a partnership with Merck in respiratory syncytial virus, just a monotherapy vaccine. There are two candidates in Phase 1 study. V172 is the one that is currently being conducted and those are targeting the elderly target product profile. And so there is a nearly equal burden of disease in the elderly, 170,000 hospitalizations a year in this country. We're excited to be working with Merck in that elderly population. We have a right in our agreements as we disclose to conduct the development of an RSV vaccines towards a respiratory combination and that has been our intent. And so we are -- that is separate from Merck's progress in RSV. Stéphane Bancel: Thanks, Stephen. And on the -- last question on manufacturing capacity. So let me try to [indiscernible] pre-coronavirus world, which we talked about in previous calls, in previous discussion, which is our manufacturing long-term plan is to use Norwood to make development material like we are doing today and to launch our commercial product like CMV, Zika and the others out of Norwood, because of [indiscernible] Norwood design we’ve always said to manage financing risks, we do not want to invest in the big manufacturing capacity, commercial plant until we have, of course, BLA approved, clearly a risk management. But we’ve always said, our long-term vision is to have Norwood focus on development. So that we have a commercial site and hopefully down the road as we scale the company several around the planet that are just focused on commercial products. We believe, based on our experience in previous pharmaceutical companies, that there is dedicated focus per site is really important for success. Development requires nimbleness. Commercial requires scale and efficiencies, very different worlds. So that’s kind of a pre-coronavirus world, our previous plans. And the post coronavirus, while in the last few weeks I go back to buy [indiscernible] a few minutes ago, which is we are looking at the law options, both internally and externally, CMO partners to figure out what's the right path forward and when we have a better picture, we will share it.

Great. Thanks for taking my questions.

Thank you. That ends our Q&A session. I would now like to hand the call back to Stéphane Bancel. Stéphane Bancel: Well, thank you for your question, especially thank you for your trust into our ability to make mRNA an important new class of medicines. We hope to see many of you next week in Norwood for what I believe will be an exciting manufacturing and Digital Day. Thank you.

Thank you. This concludes today's conference call. Thank you all for attending. You may now disconnect.