Earnings Labs

Moderna, Inc. (MRNA)

Q3 2022 Earnings Call· Thu, Nov 3, 2022

$47.16

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Transcript

Operator

Operator

Good morning. My name is Kevin. And welcome to Moderna's Third Quarter 2022 Earnings Call. [Operator instructions] Please be advised that this 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.

Lavina Talukdar

Analyst

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 update. 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 Stéphane Bancel, our Chief Executive Officer; Stephen Hoge, our President; Arpa Garay, our Chief Commercial Officer; and Jamey 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 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. With that, I will turn the call over to Stéphane. Stéphane Bancel: 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 a quarter before Stephen reviews or clinical programs. Arpa will then take you through commercial dynamic and Jamey 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 billion to $19 billion in 2022, due to delay deliveries from our fill-finish contract manufacturers resulting in $2 billion to $3 billion of revenue deferrals into 2023. In Q3, we had to deal with lots of…

Stephen Hoge

Analyst

Thank you, Stéphane. Good morning or good afternoon everyone. This morning I'll review our clinical progress. We've launched two vaccine boosters for the current fall winter season to meet different market demands and have received authorizations or approvals worldwide for these vaccines. We previously shared that mRNA-1273.214, which targets Omicron BA.1 induce significantly higher titers than 1273 against the BA1 and BA4/5 sub-lineages in the clinical trial. mRNA-1273.214 is now authorized in United Kingdom, Switzerland, Canada, Australia, European Union, Japan, and other countries. For mRNA-1273.222, which targets the Omicron BA.4 BA.5 variants, the Phase 2/3 study is ongoing and we expect data later this quarter. mRNA-1273.222 is authorized in the United States and now also in the United Kingdom, Switzerland, Australia, Canada, the European Union, Japan, and other countries. Now moving to Slide 9. I'll review our respiratory vaccines pipeline. I will cover the Phase 3 studies in detail in the next slide. Here I want to highlight the progress in the earlier stage studies with our respiratory vaccines. mRNA-1020, mRNA-1030 for seasonal influenza is in a Phase 1/2 study and is now fully enrolled. mRNA-1345, for RSV, is in the pediatric population, is now fully enrolled in our Phase 1 study. Moving now to our combination respiratory pipeline where we have made meaningful progress mRNA-1073, our combination vaccine for COVID and flu is in Phase 1/2, and is fully enrolled. I'm very pleased to announce that our combination COVID, flu and RSV vaccine or mRNA-1230 has also started enrolling in its Phase 1/2 study. We announced a new development candidate, mRNA-1045. This one targeting combination of RSV and influenza and that has started in its Phase 1/2 study. And lastly, in our combination vaccine pipeline, we also have a pediatric vaccine covering hMPV and PIV3. That study is ongoing…

Arpa Garay

Analyst

Thank you, Stephen. And good day to everyone. I will start with a review of sales on Slide 16. Sales to the U.S. were $1 billion in the third quarter and were mainly from deliveries of mRNA-1273.222 our bivalent booster targeting Omicron BA.4 BA.5. Sales to Europe of mRNA-1273.214 were also $1 billion and the rest of the world totaled $1.1 billion. Through the first three quarters of the year, U.S. sales were $3.4 billion; sales to Europe were $4.5 billion and sales to the rest of the world accounted for $5.7 billion. In both the three and nine month periods, we saw geographical diversification of sales across these key regions. We recognized there are questions regarding the 2023 market and long-term COVID booster potential and we wanted to walk you through how we are thinking about it. As we transition into an endemic market, there are important factors we considered in our commercial outlook. These include the ongoing medical need for COVID boosters and the potential size of the annual booster market. We use the seasonal flu market to frame the opportunity and I will take you through our thinking on that in the next couple of slides. I will also detail some of the factors underlying the transition to the commercial market in the U.S. in 2023. I will then wrap up the COVID section with an overview of our currently signed contracts and our outlook for additional expected contracts in 2023. Finally, I'll close with a reminder what's coming in 2023 from our respiratory vaccine franchise, a potential launch timings that we shared recently at our R&D Day in September. So starting with the medical need for COVID boosters, the chart on Slide 18 compares hospitalizations and deaths associated with the seasonal flu and COVID over a…

Jamey Mock

Analyst

Thank you, Arpa, and hello everyone. It's a pleasure to be here with you today. After two months at Moderna I'm even more excited about our company's future and the role we are playing in bringing in new generation of medicines to patients. For those of you whom I haven't had the pleasure of meeting yet, I look forward to working with you in the month and years ahead. Today I will start by providing additional color on our third quarter results and capital allocation priorities and finish with the view on the key drivers on our remaining 2022 financial performance. Turning now to Slide 25, total product sales in the quarter $3.1 billion decreased 35% year-over-year. The decrease was driven by lower sales volumes due to the timing of market authorizations for our updated COVID-19 booster vaccines, and the related manufacturing ramp-up with our CMO partners. As a reminder, we received the marketing authorization for the U.S. on August 31st, for the European Union on September 2nd and Japan on September 12th. We anticipate that product sales will be higher in the fourth quarter of 2022 than in the third quarter as we continue to deliver against our supply contracts for booster vaccines. Cost of sales was 35% of product sales compared to 15% of product sales last year. This includes a charge of $333 million for inventory writedowns related to excess and obsolete COVID-19 products and expense for unutilized manufacturing capacity of $209 million, and a loss on firm purchase commitments and related cancellation charges of $102 million. These charges are driven by a shift in product demand to our Omicron targeting COVID-19 bivalent boosters and cost associated with surplus production capacity. Research and development expenses were $820 million, an increase of 57% versus the prior year. The…

Q - Salveen Richter

Analyst

Good morning, thanks for taking my questions. On pricing here for the COVID vaccine, Pfizer's guiding to price of 110 to 130 in the private market. Is this in line with what your discussions thus far suggested, and when do you think the private market will emerge next year? And then a second question here; you were talking about some of the cost burden for next year with distribution costs and building out the commercial infrastructure around flu, RSV and trials. Could you just give us some directional color on the OpEx situation as we look – to look forward?

Arpa Garay

Analyst

So I can take the pricing question. So first I'm not in a position to comment on competitor pricing, but as we think about our pricing as we evolve from a pandemic setting to an endemic setting, the real focus for us is on ensuring that our vaccines are priced based on the value that they provide to the healthcare system and reflect the cost effectiveness guidelines that are set by public health authorities around the world. So for here in the U.S. that would be ACIP. I think it's important to note that some of the pricing guidance that has been released in the past is really at a growth level and we do anticipate some discounting across different channels. Additionally here in the United States as we evolve into the commercial setting, it's also important to remember that for all ACIP recommended vaccines there is a zero out of pocket cost for consumers. So from a consumer access perspective, we do expect that the pricing will not be a barrier to uptake.

Jamey Mock

Analyst

And Salveen, maybe I'll take the cost part of that. So yes, our cost will change in endemic mode. Number one, there are presentation preferences moving more to prefilled syringe and single dose files that I think will be different year-over-year. We have to continue to invest in bivalent vaccines as well as Moderna will now pick-up the distribution costs moving forward, particularly in the United States. And so yes, our cost profile will change and we'll come out and update in terms of what that means at a later date.

Salveen Richter

Analyst

Thank you.

Operator

Operator

One moment for our next question. Our next question comes from Matthew Harrison with Morgan Stanley. Your line is open.

Matthew Harrison

Analyst · Morgan Stanley. Your line is open.

Great. Good morning. Thanks for taking the question. I was hoping to ask on PCV; just given that this is a Phase 2 study that's proof of concept a p-value grayer than 0.05 could be considered a success in this study. So maybe you could just help us think about how you're thinking about success in the study and then just given that it's an open label study, how much data is available to you internally? Thanks. Stéphane Bancel: Great. Thanks Matthew for the question. So as you said it's a Phase 2 study, but it's actually a quite sizable one. Its 150 patients and they were randomized two-to-one, so 100 patients have received the combination therapy in 50. The standard of care, which in this case is KEYTRUDA, that's actually quite a sizeable sample and does allow for us to look at efficacy. Now it is a Phase 2 study and so we didn't pre-specify a statistical threshold that we'd want to hit, but we are looking at hazard ratios across that and we will get p-values. I won't comment on a specific p-value or hazard ratio at this time. It's a premature to do so, but obviously we are looking against standard of care and demonstrate a significant benefit over that standard of care. It's just important to note that the study wasn't powered for that at 150 participants. And so we will be looking to that hazard ratio and the p-value as indicative. And then depending upon the strength of that result, if it is in fact, as you said a p-value less than 0.05 and there's a very strong result we will then make our subsequent decisions about how to proceed forward with development. Obviously, the stronger the benefit in terms of hazard ratio and the lower the p-value, the more we'll want to move very quickly towards advancing that program.

Operator

Operator

Thank you. One moment for our next question. Our next question comes from Edward Tenthoff with Piper Sandler. Your line is open.

Edward Tenthoff

Analyst · Piper Sandler. Your line is open.

Great. Thank you very much and congrats on all the progress. Appreciate all the detail on sort of the outlook both for the COVID market and as we move forward. Questions back to my favorite topic, the orphan diseases with this proof of concept I assume [ph] from the first programs, is there a desire to be expanding the pipeline similar to what you did with vaccines upon proof of concept with COVID? Thank you very much. Stéphane Bancel: Thanks Ed for the question. And so I think the short version is absolutely. In any of our modalities whether they're cancer vaccines or our infectious disease vaccines or now our orphan disease where we believe we've achieved a technological proof of concept. Where we've achieved what we wanted to in patients, we look to rapidly expand the number of diseases and implications that we can bring forward that technology in. And in the case of orphan rare diseases as we shared, we are extremely encouraged by the data across two different diseases using two different medicines that now suggest we have obviously acceptable safety and tolerability profile, which is of primary importance. But more importantly for efficacy we're starting to see really encouraging results in terms of biomarkers or even from the dynamic readout, a potential of benefit for patients. And so given the strength of those two pre prior results, we've actually moved quickly to expand our pipeline. We have a number of other programs that are already publicly disclosed and moving forward in clinical trials. Some including MMA are already in clinical studies. And as I mentioned at our R&D day we're looking to substantially expand that pipeline of programs. And so we announced the OTC program as one instance of that just a month ago but you can expect that we'll be adding substantially to that. Our goal will be to more than double that pipeline in the years ahead as we expand our investments in rare diseases on the back of that de-risk clinical data.

Edward Tenthoff

Analyst · Piper Sandler. Your line is open.

Great. Excellent. Thank you, Stéphane.

Operator

Operator

One moment for our next question. Our next question comes from Michael Yee with Jefferies. Your line is open.

Michael Yee

Analyst · Jefferies. Your line is open.

Hi, good morning. Thanks for the questions. Maybe a question for Stéphane. In RSV we've had two players read out results; I think one is 80% plus or minus 166%, plus or minus, depending on the endpoints. So I wanted to ask you how you view the bar in terms of being competitive and where there is some differentiation opportunity for RSV vaccine that could read out soon. So talk a little bit about that? And then just as a follow-up to PCV, again just to clarify Merck had opted in; can you comment on, I guess the idea of the timing just before the data whether they had sufficient information or just talk a little bit about the implications of that opt in [ph] just before the data? Thank you. Stéphane Bancel: Good. Thank you for the question, Michael. So first on RSV, obviously we're incredibly encouraged by the results that are been seen by other vaccines. Given our platform has previously demonstrated its potential in COVID specifically in respiratory vaccines, we think it bodes well for us in terms of that study. There's a bar that's been established in terms of severe disease as you referenced in the 80% range. We are looking at three-symptom or "severe disease". It's hard to compare between the studies. They're not conducted the exact same time and they don't always have exactly the same definition as you know. But we would absolutely hope and expect that the type of efficacy we're going to see against severe disease will be on par with, and I would even hope for better than what's been seen by others. It's certainly been the case with our platform technology compared to others in terms of COVID that we've been able to see those sorts of potential benefits.…

Michael Yee

Analyst · Jefferies. Your line is open.

Thanks. Very helpful. Appreciate it.

Operator

Operator

One moment for our next question. Our next question comes from Gena Wang with Barclays. Your line is open.

Gena Wang

Analyst · Barclays. Your line is open.

Thank you. Steve, maybe just follow what you comment on Merck, just want to confirm that Merck does see in the open label data for the recurring free survival rate? And then also wanted to confirm that the control arm, the PD1 model that will be in line with historical data that's in the low-70s that would be the rate? And also how would you share the data for the PCV Phase 2 data? Another question is regarding Slide 19, the global COVID market opportunity. Since we expect significant increase in price in the U.S. what is your expectation for the ex-U.S. price change across major market since you're giving like $20 to $40 price range? Stéphane Bancel: Gena, thanks for that question. So again, it was not a continuous data set. It was an open label study and so per our agreement with Merck they had the right to know what we know about the program at that point in which they were had to make their decision about whether to opt-in or not. And so of course what we did is we provided them the access to the data of the study at that point in time and as you all have noted they elected to opt-in to that program and we are encouraged by that decision on their part. They obviously do have a tremendous amount of experience and so in terms of the control arm you obviously have the Keynote-054 study, which is their prior registrational studies, they have experience of what to expect in a control arm. And I think you can infer whatever you'd like from their decision to just say that they believe it's worth opting into that program and proceeding to the primary analysis that we're conducting right now. We will obviously be able to compare the control arm, the 50 patients who just received KEYTRUDA as standard of care against the registrational studies that others have, and actually the many years of patient experience that companies like Merck and others have, just to be confident that in fact if we are seeing a difference between and we are seeing a hazard ratio difference, that it's not a difference in terms of that control arm, which will board well because again patients were randomized in this study. Now in terms of the data we'll haven't share, at this point all we'd expect to share this quarter once we've completed the analysis. The primary analysis on efficacy and the study is just the top line data in terms of PCV, which as I mentioned previously is looking at the hazard ratio and then a characterization statistically of that. In subsequent and appropriate for including meetings and otherwise we will look to then share the older data set over time.

Arpa Garay

Analyst · Barclays. Your line is open.

And then I can take the pricing question. Your question was primarily around ex-U.S. pricing and our expectations. A couple of factors are coming into play here. The first is the timing of where and how quickly ex-U.S. markets are going to be shifting from more of a central procurement pandemic setting to an endemic setting. So we are looking at how different regions and countries are going to be shifting back towards a more endemic or a commercial approach. When we get to that position, we will be again pricing the vaccine according to the value that it provides in different healthcare systems around the world. And again following established systems around cost effectiveness guidelines based on the country regulations and the public health authority guidance. The overall global average price we do anticipate will be largely driven by the regional mix. So it is hard to predict what that price will end up being, but we'll continue to share more as we see evolving demand as well as evolving pricing.

Gena Wang

Analyst · Barclays. Your line is open.

Thank you.

Operator

Operator

One moment for our next question. Our next question comes from Tara Bancroft with Cowen. Your line is open.

Tara Bancroft

Analyst · Cowen. Your line is open.

Hi guys, thanks for taking the questions. So is it fair to say that the 2023 signed APAs of the $4.5 billion to $5.5 billion is the floor? And what minimum revenue do you think could be added from the geographies that you're expecting contracts from? And related to this then to what extent does it include sales in the key markets that were mentioned in the press release like for example, does it include the option from the latest U.S. agreement? Thanks.

Arpa Garay

Analyst · Cowen. Your line is open.

Thank you for the question. So the $4.5 billion to $5.5 billion is the floor sales that we anticipate in 2023 as we already have signed APAs as well as deferrals from 2022 into 2023. This number does not include options from the U.S. government and we do anticipate additional sales coming from key markets such as the US, EU, Japan, Australia as well as regional sales in Latin America, Asia-Pacific, Middle East and COVAX. So again to answer your question specifically, this is what we anticipate to be the floor, but still unknown in terms of the total opportunity as we evolve particularly in the U.S. market into a commercial setting.

Operator

Operator

Thank you. One moment for our next question. Our next question comes from Jessica Fye J.P. Morgan. Your line is open.

Jessica Fye

Analyst

Hey guys, good morning. Thanks for taking my question. Are the short-term supply constraints mentioned is a reason for delivery delays resolved at this point? How does bivalent booster uptake so far this fall compare to your expectations? And as it relates to China's potential orders of Western mRNA vaccines, what's your level of optimism that that could come to fruition within some reasonable time timeline, say the next year or so? Thank you. Stéphane Bancel: Sure. So it’s Stéphane. I'm going to take the first question on supply and then I'll turn to Arpa for the commercial PCs. As I shared in my remarks, we actually had to deal with very complex third quarter from a manufacturing standpoint, not launching one product, but two doing this kind of in the work hard times as you are aware, we have FDA informed us at the end of June that they wanted [indiscernible] products for the U.S. and that product was available in pharmacy label at weekend. And the shift from 10 dose per vial per provide, which is what we sold with 1273. And for a first time selling five dose per vial, basically doubling the number of vials needed, the same number of doses. And so we've had quite a number of pain points with fill-finish manufacturers. We are working through a lot of those issues. A lot are solved, a lot are still being, as we speak. There are many lessons to be learned that we are working on to put robust fixes for the end of the year, so that we are in a much better place for the fall of 2023. Arpa?

Arpa Garay

Analyst

Sure. So the first question around vaccine uptake we are seeing some variability around the world in terms of vaccination rates with the best data thus far really coming from the U.S. market. As we look at 2022 vaccination uptake versus 2021 specifically for COVID boosters, we're actually tracking a similar pattern. And it's a little bit early to see what November, December, and the rest of the fall and winter season will look like. But the early rates in absolute terms, are fairly low. They are tracking the trends that we expected compared to last year. Around the world, we are seeing some markets with very high uptake of vaccination rates really driven by public health authorities. And in other markets we're still looking at sort of the dynamics that have played out this year with populations have recently gotten their fourth booster in the summertime and regulatory bodies recommending that they wait a few months before they get their fifth booster. So I think more to come as we continue to track around the world. But the early signs of uptake are encouraging. Your last question on China, we continue to look at the opportunities in China. Nothing new to report here as of now, but it is certainly a key market of interest for us commercially.

Jessica Fye

Analyst

Thank you.

Operator

Operator

One moment for our next question. Our next question comes from Geoff Meacham with Bank of America. Your line is open.

Geoff Meacham

Analyst · Bank of America. Your line is open.

Good morning guys. Yes, thanks for the question. Just had a couple. Just one to follow- up on your last comment. You mentioned booster adoption has been mixed depending on geographies. Is this something that Moderna expects to further invest in with regard to value of boosters, additional follow-up and studies? That's the first question. The second one, maybe more for Stéphane, the balance sheet remains pretty strong, you guys have done some buybacks, but we haven't seen sort of a cluster of acquisitions or any sort of real capital allocation yet. Where would M&A sort of fall in your priority list with uses of cash? And does that change as COVID continues to sort of wind down with regard to the revenue base 2023 over 2022 and maybe even more modest going forward. Thank you.

Arpa Garay

Analyst · Bank of America. Your line is open.

So to the first question on if we are investing in a vaccination rates, as I shared earlier today, the medical need continues to be clear for COVID booster vaccination, especially as we compare it to the hospitalizations and deaths compared to flu. So what we're really doing is partnering with governments and public health agencies to share the data that we have in terms of the ongoing medical need at a country level, as well as the value of COVID booster vaccination in their populations. And it's this partnership with the public health authorities that's really driving increased urgency and action around vaccinations. So that's our approach as we believe public health authorities are in the best position to encourage a vaccination for their populations. Stéphane Bancel: Thanks, Arpa. And on the balance sheet side, I mean, our biggest strategy as Jamey noted in his remarks, isn't changed. As you know we are looking, and have already signed deals in terms of technology licenses and also looking at M&A. As we've said before, we stay focused on nucleic acid. We don't really think it's a good strategic use of our capital to buy small molecule asset or large molecule or cell therapy, or else we really want to stay nucleic acid. The BT team is very active as Jamey knows, and this team knows they are doing a lot of work where we're doing a lot of things. As I've said in the past, we will remain disciplined in term of understanding the risk either on the technology side, or on the biology side, understanding value. We're here to create value not to manage press release. But the team is very active. We are looking at diligence on a regular basis. But not everything that we look at comes out to be something we think we can create a lot of value with. But we will continue to look and I would not be surprised if we continue to add partnerships in the monsoon quarter to come.

Geoff Meacham

Analyst · Bank of America. Your line is open.

Great. Thank you guys.

Operator

Operator

One moment for our next question. Our next question comes from Eliana Merle with UBS. Your line as open.

Eliana Merle

Analyst · UBS. Your line as open.

Hey guys, thanks so much for taking the question. Just another one on RSV. In terms of thinking about mRNA as a vaccine modality in the context of RSV as we move beyond COVID vaccines, I guess how are you thinking about the potential for mRNA and potential advantages relative to other more traditional vaccine modalities in the context of RSV? And I guess what we could learn from some of the upcoming readouts, both, I guess for the opportunity in RSV, but also what it could tell us about mRNA potential and vaccines relative to other modalities more broadly? Thanks. Stéphane Bancel: Great. Well, thank you for the question. So, first we have previously demonstrated with our platform in COVID and in fact in some recent publications, even in flu that we're we generally see a really broad based and balanced immune response. So we tend to see very high T-cell and cell mediated immunity. And I would argue some of the highest if not the always the highest antibody neutralizing titers. And both of those are really important as you start talking about older adults and respiratory infections, which is probably why we tended to see higher efficacy with the mRNA platform than other approaches in that high risk population, including in COVID, over the last couple of years. And so those features of the platform, the ability to generate really strong cell mediated immunity, boost T cells, which are important for preventing severe disease, but also pair that with achieving very high titers for a seasonal protection where again, you get high neutralizing titers, which provide a barrier to the amount of infection that you're going to get, which is really, really important for older adults because their cell-mediated responses, their innate immune system just isn't as…

Eliana Merle

Analyst · UBS. Your line as open.

Great. Thanks.

Operator

Operator

One moment for our next question. Our next question comes from Joseph Stringer with Needham, your line is open.

Joseph Stringer

Analyst · Needham, your line is open.

Hi, good morning. Thanks for taking our questions. Just clarification on the deferrals from the 2022 contracts, that $2 billion to $3 billion, are those locked in signed APAs and they are just being deferred to 2023 or is there any optionality built into that? And then the second question is just broader based pipeline. You are expanding pipeline 48 programs, 35 clinical trials. But what I was curious if you could comment on the relative mix of the pipeline respiratory vaccines, immuno-oncology, rare disease, where it stands now and how you sort of see that evolving in that relative mix of the pipeline programs over time? Stéphane Bancel: So maybe I'll take the first one quickly. So yes, those are locked in advanced purchase agreements for 2023, and so they are just shifting to the right from 2022.

Stephen Hoge

Analyst · Needham, your line is open.

Great. And on the broader question of the pipeline, as you mentioned, we've got 48 programs now multiple Phase 3s ongoing with some we hope to be quite eminent readouts. As you look at it right now most of our late-stage pipeline is respiratory vaccines for sure. Right? We have four programs there. And we expect the flu and RSV data to come up quickly. And we will then move rapidly in respiratory into combination vaccines. And so we have three adult combination vaccines in clinical studies. We have two pediatric respiratory combination vaccines that are moving forward and that you should expect to expand into very quickly. We would hope registrational studies over the coming period which will allow us to then build out what we hope will be the best respiratory portfolio both from a monovalent vaccine perspective, but most importantly from combinations against the viruses that matter in the different populations that we really want to protect, particularly older adults and the very young. So respiratory will be a growth area for us for the near term. But we will start to see some diversification. Again, talking about the late stage, we already have a CMV Phase 3 program, which is up and running and enrolling, it has been. And you should expect us in our latent virus vaccines to add additional late-stage programs. We're quite passionate about Epstein–Barr virus, as you all know. And we expect to move that in. And so you will start to see some first diversification in terms of our latent virus portfolio, some that's already happened with CMV. The couple of things that will come quickly as well are we hope that the readout from our personalized cancer vaccine therapeutic vaccine program, and it's a really a therapeutic because we are…

Joseph Stringer

Analyst · Needham, your line is open.

Great. Thanks for taking our questions.

Operator

Operator

One moment for our next question. Our next question comes from Mani Foroohar with SVB Securities. Your line is open.

Unidentified Analyst

Analyst · SVB Securities. Your line is open.

Hi, and good morning, this is [indiscernible] for Mani Foroohar. I just have a question related to volume to be expected. So I know that your volume production, you had mentioned that you would exclude 2023 based on because of the variability there, but I was wondering for 2023, how much of COVID volumes or I would say probably [indiscernible] do you anticipate to be driven by the APAs? And also as you move to our northern endemic model for locally vaccine, do you continue to anticipate APAs in the future? Thank you.

Arpa Garay

Analyst · SVB Securities. Your line is open.

Sure. Thank you for that question. As I outlined in terms of the volume expectations for next year outside of the signed APAs, we are looking at a number of variables that could impact the total volume. So in the long term, we do believe we should approach a 500 to 600 million volume comparable to the flu volumes that exist today. In 2023, there will be a range depending on the viral evolution, the ongoing medical need across different regions where we see public health authorities coming out with recommendations as well as just a broader consumer appetite to vaccinate. So the reason for the sensitivity on the volume that I shared earlier is we still have a number of variables as we're continuing to transition into an endemic stage. And so in the short term we don't have a clear picture of that total volume and what that could look like, but we do believe from a medical perspective, over time, we should be approaching at least the same volumes as the flu market.

Unidentified Analyst

Analyst · SVB Securities. Your line is open.

Thank you.

Operator

Operator

And I'm not showing any further questions at this time. I like to turn the call back over to Stéphane Bancel for any closing remarks. Stéphane Bancel: Well, thank you everybody for joining the call today and for your thoughtful questions. We look forward to speaking to many hours to come, days to come. And also we’re welcoming you next week or our first ESG Day. Have a great day. Bye.

Operator

Operator

Ladies and gentlemen, that concludes today's presentation. You may now disconnect and have a wonderful day.