Earnings Labs

Moderna, Inc. (MRNA)

Q3 2020 Earnings Call· Thu, Oct 29, 2020

$47.16

-3.17%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-5.35%

1 Week

+0.28%

1 Month

+97.83%

vs S&P

+86.90%

Transcript

Operator

Operator

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

Lavina Talukdar

Management

Thank you. Good morning, everyone, and welcome to the Moderna’s Third Quarter 2020 Conference Call to discuss Financial Results and Business Update. You should 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 Stéphane Bancel, our Chief Executive Officer; Tal Zaks, our Chief Medical Officer; Stephen Hoge, our President; and David Meline, our Chief Financial Officer. Before we begin, please note that this conference call will include forward-looking statements made pursuant to safe harbor provision of the Private Securities Litigation Reform Act of 1995. 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 revise the information or provide - 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. 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 product development pipeline. And finally, key financials. As many of you know, we completed enrollment of our Phase 3 COVE 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 participants in the study and for our principal investigators. I would like to also thank…

Tal Zaks

Management

Thanks you, Stéphane. And good morning, everybody. Let me give you a quick overview of our pipeline progress and starting with our COVID vaccine. The Phase 2 study looking at safety and immunogenicity in 600 participants is ongoing. Dosing has been completed, but we remain blinded while the final immunological testing is being conducted. Once we have the results, we will share that. As a reminder, the safety data from this trial have of course been shared with regulators prior to the start of our Phase 3 COVE study. That is now fully enrolled, and I will share some details shortly. For our CMV vaccine, mRNA-1647, we shared positive Phase 2 data at our annual R&D Day in September and the data enabled us to select the 100 microgram dose to take forward in our pivotal Phase 3 trial, which is expected to begin in 2021. For our Zika vaccine, we showed the positive Phase 1 results and are preparing for Phase 2. On the pediatric front, I'm happy to announce that our hMPV/PIV3 Phase 1b age de-escalation study has resumed dosing toddlers aged 12 to 36 months following a pause that was related to COVID-19 disruptions. This is the first mRNA vaccine to be given to toddlers. In addition, the first cohorts of adults participants in the Phase 1 study of our RSV vaccine, mRNA-1345, has now been fully enrolled. As a reminder, this is also an age de-escalation study similar to the hMPV/PIV3 study and the plan is ultimately to also those toddlers. In another core modality, the systemic secreted and cell surface therapeutics, we showed the positive Phase 1 data from additional cohorts of the Chikungunya antibody program during our annual R&D Day in September. Importantly, we demonstrated not only potentially therapeutic levels of a secreted systemic…

David Meline

Management

Okay. Thank you, Tal. Turning to Slide 21 in the deck. We ended Q3 2020 with cash and investments of $3.97 billion compared to $3.07 billion at the end of Q2. The increase was primarily driven by $1.1 billion of customer deposits received in the third quarter for a potential supply of mRNA-1273. Net cash provided by operating activities was $763 million for the nine months ended September 2020 compared to net cash used of $360 million for the same period in 2019. The reversal from cash used to cash provided by operating activities is driven by total customer deposits for the nine months ended September 30 of $1.2 billion received for a potential supply of mRNA-1273. Cash used for purchases of property and equipment was $44 million for the nine months ended September 2020 compared to $25 million in 2019. Total revenue was $158 million for Q3 2020 compared to $17 million for the same period in 2019. Total revenue was $233 million for the nine months ended September 2020 compared to $46 million for the same period in 2019. Total revenue increased for both the three month and nine month periods in 2020, primarily due to increases in grant revenue from BARDA to accelerate development of mRNA-1273. Research and development expenses were $344 million for Q3 2020 compared to $120 million for the same period in 2019. Research and development expenses were $612 million for the nine months ended September 2020 compared to $378 million for the same period in 2019. The increases for both three month and nine month periods in 2020 were mainly due to increased mRNA-1273 clinical development activities and headcount and pre-launch inventory buildup. Overall, in both periods, we saw a significant increase in expenses for the prophylactic vaccines modality as a result of…

Operator

Operator

Thank you. [Operator Instructions] And our first question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.

Salveen Richter

Analyst

[Technical Difficulty] COVID-19 vaccine. So just given the commentary from the recent FDA Adcom on COVID-19, just would like your thoughts here about how you intend to unblind potentially on the first interim or post the full three looks in the study? And then secondly just timelines around a vaccine EUA, just given some of the commentary, and I think Dr. Fauci talking about at January green light for vaccines? Thank you.

Tal Zaks

Management

Yeah. Hi, this is Tal. Let me try and take that. I think the bottom line here is that we feel I think an obligation to the participants of the COVE study, especially those for whom an EUA will be appropriate that there is a way for them to ultimately benefit from what they themselves have contributed to. And of course, I think we all listened intently to Vertex last week. There is a balance to be had here. The way I think this is going to happen at the end of the day, unfortunately, the cases are accruing. We are in a period of increasing transmission. And so I expect that there will be some time between knowing that the bar has been crossed for efficacy, doing the analysis and discussing with FDA. And part of that conversation is finding the right balance of how long do you continue to collect blinded data and what is the type of data that one can collect post blinding, but still on trial. I mean if you do the math, if you're looking for very rare safety events for example, then an unblinded study actually could give you power to detect that even more than a blinded trial. So a lot of these elements I think are going to go into of the conversation that we're having with FDA. And I'm confident that together with them we will find the right balance as to how to operationalize this. As it relates to the timing, I think we're on track to have the first interim in November. I think I expect unfortunately that we're going to be on track for additional cases occurring in December and beyond. And so the totality of data in the coming months I think will cross that threshold I anticipate for efficacy and the rest will be a dialog with FDA and other regulatory agencies on the right process by which to ensure we demonstrate the safety and efficacy and ultimately make the vaccine available.

Salveen Richter

Analyst

Thanks, Tal.

Operator

Operator

Thank you. And our next question comes from the line of Matthew Harrison with Morgan Stanley. Your line is now open.

Matthew Harrison

Analyst · Morgan Stanley. Your line is now open.

[Technical Difficulty] all the information this morning. I guess two related questions from me. Tal, can you comment at all about the attack rate that you're seeing in the study? I think given the Pfizer comments earlier this week, there is a lot of confusion among investors about whether the attack rate in these studies mirrors what we're seeing in the general population or if it's somehow lower than what we're seeing in the general population? And then a related question, something else that I think has come up a lot is this concern about functional unblinding potentially due to people recognizing some of the features of the boost and that may be leading towards certain people taking on different behavior, which may lead to this lower event rate. So I was wondering if you could talk about if you have a concern about functional unblinding? And especially related to the fact that you obviously have the placebo data from the Phase 2 study, do you have a much better idea of placebo-adjusted tolerability versus what we've seen from an open label study? Thanks.

Tal Zaks

Management

Thanks, Matthew. Let me try and give you a sense of how I see the data. First of all, my sense from the emerging data is that attack rates of our trial participants do mirror what we see in those zip codes where the subjects are coming from. It's not a surprise because if you look at the demographics of what we've been able to achieve in the COVE study, having so many people, minorities older with co-morbid conditions, so it's on par with expectations, I think writ large. And unfortunately with the current attack rates not slowing down, the math that we're doing, it's this paradox of more attack rates out there worse off for our subjects unfortunately, but the data will get there. So that's my sense. Now there is a balance to be had, which I think is -- I've tried to address in the first question that not just us but everybody in the field is struggling with, which is the accumulation of data versus the eventual unblinding of participants and how does that all play into regulatory expectations, and I think we'll continue to have this dialog in the coming weeks. The concern you raised about functional unblinding, yes, I share that. I think we all do, to a certain degree. We chose a dose that we believe is optimal in the sense that people may get some transient flu-like symptoms, but it's worth it for the opportunity to prevent this disease. I don't think this leads to lower event rates, per se. I think my biggest concern is that, if anything, it would bias us against vaccine efficacy rate. If people behave because they think they got something and that modifies their behavior, then if anything, you would expect that the behaviors would be such that the placebo recipients would be less at risk of getting infected and the vaccine recipients would be more at risk of getting infected. So at least from a statistical and robustness of the data, it shouldn't have any adverse effect. If anything, it should hurt us. But I don't expect this ultimately to be significantly changing the event rates. And if I look at the macro picture, as I've said, I think we're going to be on track, unfortunately, for where we anticipate being.

Matthew Harrison

Analyst · Morgan Stanley. Your line is now open.

Thanks. Thanks very much.

Operator

Operator

Thank you. And our next question comes from the line of Ted Tenthoff with Piper Sandler. Your line is now open.

Ted Tenthoff

Analyst · Piper Sandler. Your line is now open.

Great. Thank you very much, and thank you for all of your hard work in bringing 1273 forward. Amazing to see the company turning cash flow positive. A huge milestone. Let me get a sense for cost of vaccine at the price or at the quantities that you're talking about for next year with Lonza? Thank you. Stéphane Bancel: Ted, it's Stéphane. As we've said in the past, we are not disclosing cost of goods for obvious competitive reasons. So I won't be able to answer that question.

Ted Tenthoff

Analyst · Piper Sandler. Your line is now open.

Fair enough. Looking forward to data coming up. Thanks. Stéphane Bancel: Thanks, Ted.

Operator

Operator

Thank you. And our next question comes from the line of Michael Yee. Your line is now open.

Unidentified Analyst

Analyst

[Technical Difficulty] what do you think is going on with the event rates? I know that you said you actually believe you're on time, so maybe it's a question more in part based on the competitor. And related to that, do you actually know your actual event rates, and therefore, you do you feel every day that you're seeing the numbers and feel very confident about November? Your competitor missed that timeline, so I think everybody is nervous about that. So maybe just make a comment about what you think is going on in general? And then secondly, because if the NRM is actually pretty high interim, and I think you've actually commented on that. Maybe just make a comment about if we don't hit that what that will mean for folks? And I think it has to do mostly with the alpha spend, so that's why I'm not too concerned. But maybe just make a comment about that as well?

Tal Zaks

Management

Thank you. Yeah, this is, Tal. Look, I can't comment about our competitors. I don't know their data. So I'll leave that to them. I can repeat what I said about our sense. We do of course see the data coming in. There is a small team at Moderna that's aware of the cases that's following up. That number is of course being kept confidential to minimize speculation here. But I can tell you that overall since we are following the zip codes and the counties from which these participants come, we have pretty sophisticated models of what to expect, and I think we're on track for those expectations. So I think we should be on track for that first interim some time in November, as we have articulated. You raised a valid point about the interim, and thank you for asking that. Hitting that interim is going to be a function of what the actual vaccine efficacy is and an element of luck on the distribution of the first batch of data you see. Not hitting it doesn't mean the vaccine doesn't work. And in fact, it doesn't even mean that the vaccine has a less than 75% efficacy. We could easily not hit and yet come back on the second interim and demonstrate an 80% or 85% efficacy. That's kind of the chance of how the stats work. I think the alpha spend, etc., you're correct. This is a conservative design and maybe it's an opportunity to dispel a notion. The fact that we crossed the boundary at an interim doesn't mean it's less powerful than a final from the peer statistical standpoint. Once you cross that boundary, you have the same statistical conviction that you would have had on the final. Now I think the way I think about the data here is irrespective of the point at which we cross the boundary, the trial will continue blinded for a period of time. Data will continue to accrue. And as long as the trial continues blinded, we will get better and better with more and more data to increase the level of certainty we have on all the endpoints of the trial. So in that regard, for me, this first crossing of the interim is just the basis that allows us to go and have confidence to start doing analysis and proceed down the path of regulatory interactions so that we can ensure that ultimately access is not delayed to people when there is such a high need out there in our communities.

Unidentified Analyst

Analyst

Thank you.

Operator

Operator

Thank you. And our next question comes from the line of Gena Wang with Barclays. Your line is now open.

Gena Wang

Analyst · Barclays. Your line is now open.

[Technical Difficulty] do you also see safety in a blinded format? If so, how is that compared to the Phase 1 profile? And then two questions regarding the interim analysis. So if first interim -- if you missed the first interim, is this due four to eight weeks to hit the second interim? And then for the first interim, what is the futility boundary?

Tal Zaks

Management

Let me take that. The safety, yes, we see the totality in a blinded fashion. I would remind you that the Independent Data Safety Monitoring Board that's been appointed by the NIH and sees not just our trial, but also the other U.S. OWS-sponsored trials, in parallel sees both the blinded and the unblinded data. Writ large, I can tell you that so far we're not seeing anything unexpected, so the trial continues. And in that regard, I don't expect surprises when we eventually unblind. Your second question around the timing is I think it's a matter of weeks between the first and the second interim, not months. Now I can't be more precise because obviously it's a function of the future transmission rates in areas, and I hope that they go down. But for now this is four weeks, not longer. In terms of futility, I think the boundary is to show that this is going the wrong way. It's specified to the degree that we felt it was appropriate to specify in the protocol. Beyond that, I can say that the reason you have a Data Safety Monitoring Board, you've got on that panel several statisticians and several experienced clinicians. So it is where I expect them to exercise their judgment and experience when they're looking at it closely.

Gena Wang

Analyst · Barclays. Your line is now open.

Okay. Thank you.

Operator

Operator

Thank you. And our next question comes from the line of Cory Kasimov from J.P. Morgan. Your line is now open.

Unidentified Analyst

Analyst

Thanks guys for taking my question. This is Matthew on for Cory. Just on the COVE trial in light of subject mix and commentary that event rates are tracking geographically with infections. I'm wondering what your assumptions are for the proportion of patients with SARS-CoV-2 infection that you expect to ultimately going to become symptomatic?

Tal Zaks

Management

Yeah. So let me make -- let me answer in maybe a simplistic form. The tracking is first and foremost of symptomatic cases because we're not routinely swabbing people just to check PCR as people self-identify. The asymptomatic infection rate will be determined based on serology that distinguishes between infection and immunization by later comparing antibodies against nuclear capsid versus spike protein. So we are primarily aware of the symptomatic infections, to begin with. And that is the parameter that we're primarily tracking as it relates to the epidemiology. Hope that answered the question?

Unidentified Analyst

Analyst

Yeah. I guess maybe just to follow-up. So when you say that rates are tracking the zip codes, what is the data that you are gathering from outside the trial to benchmark it to zip codes?

Tal Zaks

Management

Reporting of case rates and infection rates together. It's -- we've got a couple of independent expert panels and teams here that compile the totality of the data that emerges from the various surveillance programs and sophisticated models to create those predictions.

Unidentified Analyst

Analyst

Great. Thank you.

Tal Zaks

Management

If you're asking me to describe what's under that hood, it's a complicated black box for me. But I can tell you that the number that it spits out ultimately looks very close to the number that we see on a daily and weekly basis at this stage, and that's what gives me the confidence.

Unidentified Analyst

Analyst

Got it. Thanks.

Operator

Operator

Thank you. And our next question comes from the line of Geoff Meacham with Bank of America. Your line is now open.

Unidentified Analyst

Analyst · Bank of America. Your line is now open.

Hey, guys. This is Alec on for Geoff. Thanks for taking our questions. Can you talk a bit more about the tiered pricing proposal with COVAX? What would this look like? And if you can talk about the agreement specifically, what's the logic of a tiered structure versus just a set price for a certain amount of doses seen in the other supply agreements? And on the Japan supply agreement, and I suppose on most of the OUS supply agreements, how do you plan to allocate manufacturing between your plants and launches? And are there any logistical constraints that would limit the vaccine produced in Norwood geographically? And I guess, just lastly. What's being done to ensure consistency of vaccine produced between both your own internal and the external manufacturing sites? Thanks. Stéphane Bancel: Hey, Alec. It's Stéphane. So it's a lot of questions. If I forget something, let me know. So on COVAX, what we want to do is to make sure that the vaccine is available around the world. As you know, we believe based on -- I mean on the early development data that the vaccine has a chance to be protective across different age range, and we think it's very important. And so we want the vaccine to be available to help as many people as we can. The tiered pricing is very typical of what Gavi has done in the past. As I'm sure you are aware, COVAX is being run by Gavi and CEPI. And so the idea here is to propose to low-income countries and middle-income countries a price that is lower than the price being paid by developed countries or high-income countries. And so that is basically the idea. And so of course, we're not in a position to disclose those prices…

Unidentified Analyst

Analyst · Bank of America. Your line is now open.

Yes, very helpful. Thanks. Stéphane Bancel: Thank you.

Operator

Operator

Thank you. And our next question comes from the line of Hartaj Singh with Oppenheimer. Your line is now open.

Hartaj Singh

Analyst · Oppenheimer. Your line is now open.

Great. Thank you. Thanks for all of the data presented. Just a couple of quick questions. One is a non-COVID-related on CMV-1647. You've got a worldwide -- since you have worldwide rights to, how are you thinking in terms of as you grow the organizations, Stephane, on a worldwide basis with 1273? Can you just talk a little bit about how that will help you with 1647 when the time comes to launch that, even prepare for worldwide trial with 1647? And then secondly, is it just wrong for us to assume that part of your initial revenues from 1273, the COVID-19 vaccine, could be sort of one-offs depending on how governments order them versus kind of a more like-for-like basis comparison on a year-for-year basis. Any way to think about that going forward? Thanks for the questions. Stéphane Bancel: Thank you, Hartaj. So on the, I would say, non-COVID organization, Stephen Hoge has spent a lot of time since the beginning of the pandemic to refocus on that one. I think we've done to allow us as a company to both deliver 1273 at the kind of historic record time and not slowdown the rest of our pipeline, which of course is very important for Moderna and Moderna's future and for patients. Tal has refocused most of this time on 1273 and taking this product from literally in a computer into Phase 1 into Phase 2 and into competing successfully over the COGS study and all the interaction with regulatory agencies around the world on the one hand. And then Stephen has refocused on the non-COVID portfolio. And so what we have done is, we've been hiring quite a lot. If you look at our headcount numbers, we've been hiring quite a lot and we're going to continue to…

Hartaj Singh

Analyst · Oppenheimer. Your line is now open.

Yeah. No, that helps a lot, Stéphane. Thank you.

Operator

Operator

Thank you. And our next question comes from the line of George Farmer with BMO Capital Markets. Your line is now open.

George Farmer

Analyst · BMO Capital Markets. Your line is now open.

Hi. Good morning. Thanks for taking my questions. I was wondering if you could comment on what happens if you don't hit the primary endpoint of this study, of the COVE study? And you do hit meaningfully on secondary endpoints, which could be quite important, I mean, certainly reducing severity of disease could be something regarded as meaningful. Have you thought about that? And my second question is, if you do get an EUA, does the existing supply agreement having come into play, do you start drawing down on your inventory commitments following EUA or do you wait until you get full approval? Thanks very much.

Tal Zaks

Management

So, George, this is Tal. Interesting point you raised. Typically if you don't hit the primary, you don't get to get -- take credit from secondary is the way the stats are laid out. I think in this case, if there is biological possibility, then of course we'd go and discuss with the agency what the data are looking like. Because I anticipate we will actually have the opportunity to cross it early, we may have those discussions ahead of time while more data is accumulating. And if we fail to hit it, but the trial continues blinded given I think the exigent circumstances, we can go and have a dialog with the agency on what we've seen so far. But I'd say the proximal answer would still be the conservative one, which is if you don't hit the primary, it's very hard to take credit for secondaries. It's going to be up to the regulators. I think the answer to your second question is an easier one. Yes, the supply agreement kicks in and U.S. government I would expect would start to take the supplies once we have an Emergency Use Authorization.

George Farmer

Analyst · BMO Capital Markets. Your line is now open.

Great. Thanks very much.

Operator

Operator

Thank you. And our next question comes from the line of Alan Carr with Needham & Company. Your line is now open.

Alan Carr

Analyst · Needham & Company. Your line is now open.

Hi. Thanks for taking my questions. Stepping away from COVID, you all mentioned in a months or last month that you'd like to revive that flu program. I'm wondering if you could give us some more details around that? Is it something going to be both as a seasonal flu vaccine or something that we see as a universal vaccine? And if you can give us any updates on timelines around that?

Stephen Hoge

Analyst · Needham & Company. Your line is now open.

This is Steve. I'll take that. Stéphane Bancel: Yeah. Go ahead, Steve.

Stephen Hoge

Analyst · Needham & Company. Your line is now open.

So we announced last month is that we're looking at it strategically and we're going to begin building a business in seasonal influenza. I'll remind you that we do have already clinical data in pandemic influenza from two different programs. And so we're still in the ability to generate a productive immune response to influenza virus as well. We haven't provided clarity yet on when we expect that program to move into the clinic. We will in the future provide those updates as we get closer to that time. But we have suggested both it's an interesting market to try and do better on because there is a substantial still unmet need an influence, and we do think our platform can be differentiated for a couple of reasons. One, obviously, that we can bring many antigens to bear. And the second, the opportunity to do combinations, potentially combinations even with other viruses that might need seasonal boosting. And so we'll provide an update as soon as we declare the development candidates we normally do and move forward towards clinical development. But we're quite excited by that opportunity at this time.

Alan Carr

Analyst · Needham & Company. Your line is now open.

Great. Thanks for taking the questions.

Operator

Operator

Thank you. And our next question comes from the line of Umer Raffat with Evercore. Your line is now open.

Umer Raffat

Analyst · Evercore. Your line is now open.

Hi, guys. Thanks so much for taking my questions. I had a couple if I may. First, maybe starting from an easier one. What's the cycle threshold you're using for the PCR positivity? Is it about 34? Second, if you could confirm if there have been any one-off cases of COVID infection for participants who got 1273 in Phase 1 or Phase 2? And then finally, I know the slides mentioned rapid protection in lung and nose of non-human primates. But in The New England Journal data, we did see at least one primate at the 100 dose with detectable RNA on the nasal swab. So I guess what I'm getting at is, as a base case, despite the requirement of symptoms, is it reasonable to assume that we could actually see one-off cases of nasal swab test positive for COVID? Thank you very much.

Tal Zaks

Management

Hi, Umer. Let me take those questions. Our cycle threshold, I don't think the number is meaningful because it's not the same number on different assays. It's part of the assay characteristics, so I can't really comment because I don't believe you can compare those numbers across different assays. On the participants in the Phase 2, I think we've had a case or two. But since we're still blinded, I can't really comment on what that means. The question on nasal swabs, yes. Well, first of all on the primate, you're right, there was one primate with transient and relatively low levels in the nose and the rest were sterile. I think that when we talk about sterilizing immunity, I think that concept is confused by the high sensitivity that we have. So what do I mean by that? Well, if I am immune and I've got IgGs and I've got IgAs as our data show we have and I'm walking down the street and somebody sneezes on me a whole bunch of SARS-CoV-2, and I'm on 49th Street, well, if somebody swabs me on 50th Street and sticks a swap up my nose, they're probably going to see some detectable virus from that cloud I just inhaled a block ago. It doesn't mean that the antibodies aren't kicking in and the virus isn't getting clear, that's a question of timing and sensitivity. So it depends then on how you measure and when you measure and what are the triggers for measuring. In our trial, we test people who raised their hand to say they've got a symptom and a reason to be tested. The only asymptomatic testing that occurs is really at day one and day 29 to make sure that we're excluding the right people and not confounding adverse events with actual disease. But short of that, we're not just randomly doing swab tests. So I hope that answers your question as it relates to detection?

Umer Raffat

Analyst · Evercore. Your line is now open.

Thank you very much.

Operator

Operator

Thank you. And our next question comes from the line of Mani Foroohar with SVB Leerink. Your line is now open.

Mani Foroohar

Analyst · SVB Leerink. Your line is now open.

Hey, guys. Thanks for taking my questions. I know there has been a lot of focus on the COVID-19, but specifically I wanted to dive in on massive financials a little bit. So did I hear right that for the quarter about $10 million of what would otherwise be PP&E were expensed? And so would moving that back to CapEx give us the base from it would go here? And secondarily on that, how should I think about the tempo of CapEx growing over the next 12 to 24 months presuming a successful EUA and global commercialization? And then I have a follow-up question out of this.

David Meline

Management

Yeah. So in terms of the capital deployment, if you look at the quarter three, we had $10 million, which I mentioned, that was 1273-related that was expensed. What also we invested was $12 million in the quarter, which was capitalized. So $22 million in total. And I think that's a reasonable run rate. You will see some increase here as we finish the year and we trend up on investing in preparation for launch and the full capacity that we're putting in place. As that continues into next year, I think it's fair to understand that the capital deployment is going to increase somewhat, including the possibility in the fourth quarter of additional expensed capital to the extent it's deployed prior to the approval, which we do expect more to happen. And then if I may, also keep in mind the inventory expensing, which is not strictly capital investment, but the acquisition of raw materials and the cost of production, and of course we're ramping that production in anticipation of an approval. And therefore, it's quite likely that we'll have a fairly significant amount of expensed inventory occurring in Q4 prior to approval. And as you would understand, the impact of that is that as we start commercializing product post-approval, the cost of the product will be essentially zero from a cost of goods perspective until we've sold through that inventory that we've produced prior to approval.

Mani Foroohar

Analyst · SVB Leerink. Your line is now open.

Okay. That's really helpful. And then hopping over on to the non-COVID pipeline. I may have missed it if it was mentioned. What's the timeline to get the next slug of data from the OX40 ligand program? And when should we think about having a reasonable number of patients with that asset on top of a PD-1 -- on top of an approved PD-1 therapeutic?

Tal Zaks

Management

Let me try and take that. This is Tal. So it's oncology, and data I think is determined by not just patient accrual, but the events that happen on trial. And so it's really hard for me to predict, which is why we've been very clear on how many patients we have and where are we. I think the next tranche of data I would anticipate will be once we have a sufficient number of these patients with ovarian cancer on trial, and that is already in combination with the PD-L1 blocker. So that should be informative for our response rates once we have sufficient patients with sufficient follow-up.

Mani Foroohar

Analyst · SVB Leerink. Your line is now open.

Great. That's helpful. And as a final question, bought back to financials. Obviously the stock has been quite volatile over the course of this year, as have many of your peers, given that you continue to build out your infrastructure and headcount anticipation of expanding the pipeline and launching commercially for them to zoom in EUA for COVID-19, how should I think about modeling or how should we think about modeling stock-based compensations relative to the overall R&D expense, SG&A expense? Will the portion go up as you start to have more of a sales force? Will it down as you get scale? Just how should we think about that, either in absolute terms, as a proportion of spend? Just how should we think our modeling it in the next say 12 months?

David Meline

Management

That's a very good question. And I guess I'd have to get back to you. I guess, I'd start with the point of view that the trend would be stable. But we'll have to get back to you on that.

Mani Foroohar

Analyst · SVB Leerink. Your line is now open.

All right. Thanks for taking the questions, and congratulations on all the success.

Operator

Operator

Thank you. Our last question comes from the line of Navin Jacob with UBS. Your line is now open.

Unidentified Analyst

Analyst

Hi. This is Elana on for Navin. Thank you for taking our question. So from what we've seen in your non-human primate studies, what impact on prevention of infection through the viral colonization and viral transmission do you expect to see from 1273? And then secondly, sort of a broader question is, do you think that your vaccine or any vaccine in general will be able to deliver sterilizing immunity?

Tal Zaks

Management

Yeah. So that's a good question. Let me tell you how I think about it. Again, as I alluded before, I think the concept of sterilizing immunity is a function of how you actually test for it. We'll be able to demonstrate prevention of infection, at least as measured by serology, which is to say maybe somebody saw a little bit of the virus, but actually the antibodies kicked in and they never established enough to demonstrate antibodies against the other parts of the virus, the nuclear capsid. That's actually what we will be measuring in the Phase 3 as a way to show protection from asymptomatic infection. I'm hopeful that we will be able to demonstrate that. I anticipate that -- I mean, just on first principles, what is the hardest thing for a vaccine to do? It's to sterilize. What's the next hardest? It's to prevent asymptomatic. What's the easiest? It's probably to prevent the most severe disease. And so that's how I think about the order of expectations. But I think what you're really getting at is what is going to be the ability of this vaccine to prevent transmission. And I think because I don't anticipate any easy direct measure of this, we're going to have to do some math once we see the data. I expect that if people get less sick and certainly less severe sick, they will be spreading less because I think there is -- while we have asymptomatic spread, we also have symptomatic spread. And so -- and in fact, I think the higher the symptoms at least earlier in the disease, potentially the more the viral shedding you see. So that's a complicated equation that I think in a nutshell is going to be very hard to answer directly through some concrete measurement in the trial. What we will hope to show is that we prevent asymptomatic infection based on serology. We will clearly hope to show prevention of symptomatic infection, that's the primary endpoint. And based on first principles, which by the way, Phil Krause from FDA alluded to and agreed with last Thursday, one would anticipate that if you prevent symptomatic disease, you should -- it should be even clearer that you're preventing the more severe manifestation.

Operator

Operator

Thank you. And that concludes today's question-and-answer session. I would now like to turn the call back to Stéphane for any closing remarks. Stéphane Bancel: Great. Thank you, operator. Well, thank you everybody for your time and your question and your support. Have a wonderful day, and speak soon. Stay safe everybody. Bye.

Operator

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.