Moderna at Jefferies Conference: Strategic Growth and Challenges

On Thursday, 05 June 2025, Moderna Inc (NASDAQ:MRNA) presented at the Jefferies Global Healthcare Conference 2025, outlining its strategic roadmap amid both opportunities and challenges. The company reaffirmed its revenue targets and cost management strategies while addressing concerns about regulatory changes and cash burn. The discussion highlighted Moderna’s commitment to advancing its vaccine pipeline and exploring new therapeutic areas.

Key Takeaways

• Moderna reaffirmed its 2025 revenue guidance of $1.5 billion to $2.5 billion.
• The company plans to reduce operational expenses, targeting a $4 billion cash cost base by 2027.
• Approval of the next-generation COVID vaccine, Nexpike, and plans to resubmit the flu COVID combo vaccine for approval.
• Moderna is investing in cancer therapeutics, with promising developments expected by 2026.
• The company’s strategic focus includes launching new vaccines and managing costs to drive future growth.

Financial Results

• Revenue Guidance:

- 2025 revenue is expected to range between $1.5 billion and $2.5 billion.

• Cost Management:

- Aiming for a $4 billion cash cost base by 2027.

- Reduced costs by 20% year-over-year in Q1 2025.

- Plans to cut costs by 20% to 30% annually.

- Anticipates using $5.5 billion in cash for 2025.

• Cash Position:

- Expects to end 2025 with approximately $6.6 billion in cash.

• Future Cost Targets:

- 2026: Targeting $4.7 billion in cash costs.

- 2027: Targeting $4.2 billion in cash costs.

Operational Updates

• COVID Vaccine:

- Nexpike (mRNA-1283) has been approved, with plans for label expansion through a placebo-controlled study.

- Current label covers individuals aged 65+ and those aged 12-64 with comorbidities.

• Flu COVID Combo Vaccine:

- Withdrew the BLA, planning resubmission pending efficacy data.

• Norovirus Vaccine:

- Resolved FDA clinical hold; enrollment resumed for a phase three study.

• CMV Vaccine:

- Awaiting final analysis including virologic shedding data.

• Pipeline Updates:

- No further investments in respiratory vaccines beyond current projects.

Future Outlook

• Revenue Growth Drivers:

- Growth expected from RSV, flu, flu COVID, norovirus, and CMV vaccines.

- Potential launches in rare diseases and cancer therapies.

• Cash Flow:

- Continued focus on cost-cutting and aligning costs with revenue.

• Cancer Program:

- Individualized Neoantigen Therapy (INT) and new cancer therapeutic (4359) are key focus areas.

• Regulatory Clarity:

- Positive momentum with FDA approvals and regulatory clarity.

Q&A Highlights

• COVID Vaccine Label and Recommendations:

- Acknowledged narrowing of the recommended population but emphasized the larger indicated population.

• Placebo-Controlled Studies:

- Commitment to conducting placebo-controlled studies for label expansion and other vaccines.

• CMV Vaccine Interim Analysis:

- Clarified timing and endpoints for the final analysis.

For more in-depth details, please refer to the full transcript below.

Full transcript - Jefferies Global Healthcare Conference 2025:

Mike, Interviewer, Jefferies: Everyone, thank you. Good morning, and thank you for joining us on our next discussion here at the Jefferies Healthcare Conference. I have the pleasure of having the President of Moderna, Stephen Hoag, up here with us. Obviously, timely. A lot’s going on in the world, both from a regulatory administrative standpoint.

We had Marty Makary here yesterday. Obviously, a lot going on with your commercial business, the pipeline, all of that. So I look forward to getting into some of that. Maybe it would just be a great place for Steven to start about the outlook for 2025. At the beginning of this year, there was some guidance.

I think a lot of people are trying to think about the outlook for 2025 and thinking about the changes that are going on with the administration, how that’s going to change things. So maybe just make some opening statements about how you feel about this year and the guidance, and obviously what’s weighing on people’s minds, which is what’s going on with the administration, is that going to impact your business starting with this year, like hitting numbers?

Stephen Hoag, President, Moderna: Yeah, for sure. So first, Mike, thanks for having us. It’s always a pleasure and a privilege. So yeah, in terms of 2025, it’s pretty important to separate where we are from maybe how we got there. Okay.

In some ways, I think where we are in our last quarterly call just a few weeks ago, we reaffirmed our revenue range and our cost range for this year for what we’re trying to We did indicate that there are we thought we were making progress with our next generation COVID vaccine approval, mRNA twelve eighty three.

Mike, Interviewer, Jefferies: We also And you got it.

Stephen Hoag, President, Moderna: And we got it. Yeah. We also indicated that the FDA had let us know we would probably need to file efficacy on the flu for the flu COVID combo. I think the discussion at the time would be whether we withdraw or try to do a major amendment to that file. I think that ended about where we expected, which is, as you know, we withdrew that BLA.

Mike, Interviewer, Jefferies: Actually pulled that BLA.

Stephen Hoag, President, Moderna: Okay. Waiting for the efficacy data now this summer, so very soon. And then we will resubmit hopefully later this year. And in terms of overall sort of business and financial performance, I think the thing that we went into the year with the most anxiety about, probably most investors, was just the uncertainty of what would the change in administration mean for our products, for getting them approved, recommendations around COVID vaccines. And I feel like in the last month, a lot of that uncertainty has clarified.

And now we have a clear path forward for strain selection, clear indication of what populations are gonna be recommended for COVID vaccines this year and hopefully going forward, And a clear set of expectations around what data we’re expected to generate if we want to expand that population. I know you mentioned Commissioner McCary was here in the New England Journal article that he authored with the head of CBR, Vinay Prasad. They indicated that there’s one to two hundred million Americans that should be getting a COVID booster in that in that New England Journal piece. And and we only had forty million last year. And so we see this as an opportunity for us to do a better job making sure we communicate around the value of COVID vaccination because there’s a large untapped market there.

So you put it all together, and I think what we feel like is a lot of the uncertainty that we had maybe in the first half of the year has started to crystallize and And honestly, from a company perspective, what we need is predictability. What we need is that clarity because whatever is necessary, we’ll go off and then do.

Mike, Interviewer, Jefferies: You’ll be able to adjust and plan based on that. So just starting for this year, the latest development was that they approved the new COVID vaccine for a specific label. I mean, I can maybe get some of the exact there, but 65 and over and then people understood what, 12 to 64 but with a comorbidity. Yeah. And so that’s the label.

And then we understand that, without following every detail, the ACIP and the CDC, CDC, they had some recommendations, but you can still sort of get it if you talk to your doctor. Can you just try to triangulate what happened in the last couple of weeks, and does that impact the guidance and the utilization of COVID vaccines for 2025?

Stephen Hoag, President, Moderna: Yeah. So, we didn’t update our guidance a couple weeks ago. I won’t do that here except to say that the news of the last few weeks is broadly consistent with what we expected to have happen. And so, know, what we see is a narrowing of the recommended population for COVID vaccines. Whether that was done through the ACIP or through the FDA label, you know, Again, was a bit of a dealer’s choice, I guess, for the administration how they wanted to do that.

We

Mike, Interviewer, Jefferies: did think think a label is a label. It’s like cancer label, whatever. It’s a label. But recommendation is a recommendation and whether payers pay for it or whatnot. All of that is, you know, people are sophisticated enough.

But a label is the label and the recommendation would be rich.

Stephen Hoag, President, Moderna: That’s correct.

Mike, Interviewer, Jefferies: And that most people who are getting the vaccine anyway, generally speaking, fit within the Are in the label.

Stephen Hoag, President, Moderna: Yeah. If you look at the majority of doses given last year, even before any of this change, that was in the sixty five plus population. That’s clearly on label. And if you look at the balance of what’s left, the majority of that, overwhelming majority of the overall number of doses are to people 12 with some risk factor, or sixty Bear in mind that the risk factors that were listed in that framework and that the ACIP has presented on cover seventy four percent of Americans. And that’s why when you look at the total, you’re talking about

Mike, Interviewer, Jefferies: How seventy four percent is what? Sixty five and up? Seventy

Stephen Hoag, President, Moderna: four percent of the population 65 has a risk factor for severe COVID-nineteen because everything from obesity to physical activity, blood pressure issues, a whole range

Mike, Interviewer, Jefferies: of And the definition of comorbidity is fairly broad.

Stephen Hoag, President, Moderna: Very broad. Very broad. And so if you actually look at the indicated population, I’ll come back to it, the indicated population, even for our new product or the Novavax product or where these recommendations are headed, it is still four to five times larger than the number of doses that happened last year. So we think this is an opportunity for us to focus on growing the market or at least stabilizing it through this cycle. But what’s great is a lot of the uncertainty that maybe existed before this news has now kind of fallen away.

Mike, Interviewer, Jefferies: But they are making a clear statement about how they want to, either through the label or their own commentary that they just don’t want a super broad indication and tell everyone, young kids, all this other stuff going on, that they can. But you can still get it if you want if you talk to

Stephen Hoag, President, Moderna: For sure. If you look at the recent CDC publication on children, that said shared clinical decision making. Which really means talk to your physician, talk to

Mike, Interviewer, Jefferies: your health provider. How about going forward, two things have come up. One is in order to get COVID vaccines approved, you to placebo controlled studies. How does that impact the COVID vaccine? And then other vaccines like the flu vaccine or other things, how did that commentary coming out, we got a lot of questions about that, how that’s going to change the ability for Moderna to get either the COVID vaccine, new ones, or other other non COVID vaccines.

Stephen Hoag, President, Moderna: Yeah. Well, I’d start by saying our COVID vaccine at 12 80 3, now Nexpike, was approved just a week ago. And so that’s somewhat settled as a question. We did as a part of that agree to a post marketing commitment to run a placebo controlled study, not in the indicated population,

Mike, Interviewer, Jefferies: but

Stephen Hoag, President, Moderna: in a population that would expand the label to healthy people under the age of 60 four, 50 to 64. That’s consistent

Mike, Interviewer, Jefferies: with to 64. Correct. And

Stephen Hoag, President, Moderna: that’s consistent with, frankly, a framework that was published by the commissioner, and with the Novavax label, and we understand now to be the rules of the game. And from our perspective, we are not public health officials. We are a company. Our responsibility are to generate data to allow them to make the decisions they want. And at the end of the day, if the FDA feels they need data to know whether they can expand our labels into healthy people, then it’s our obligation to go get that.

So

Mike, Interviewer, Jefferies: that’s the COVID situation. Let’s take some of the other upcoming COVID flu. COVID flu is when you said you think you can get approved because the flu infection data is coming later this summer. Help set our expectations about that should be positive and then you’re gonna file that. Now that would be a vaccine that’s a combination Mhmm.

But you’re kind of using flu data and COVID data

Stephen Hoag, President, Moderna: Yeah.

Mike, Interviewer, Jefferies: But that vaccine study was not the two together. I mean, could come up with a million Yeah. Scenarios. You know? So what are the

Stephen Hoag, President, Moderna: Well, combination products generally get approved through a different mechanism. You wanna show that you can put the two products together and they don’t interfere with each other. But if they’re separately licensed products, not just with vaccines, but with medicines, generally that path is a little bit different. So we have an approved COVID component now because it’s the same component in Nexpike. And the flu study that you just referenced, we’ve run a 40,000 person randomized controlled trial phase three study.

And generally, flu guidance hasn’t changed to our knowledge. And so we’ll expect if that data is positive, that we’ll be able to get the flu product approved. Once you have the flu product and the COVID product approved and you’ve run a phase three showing you combine them, I think we believe we have a pretty straight

Mike, Interviewer, Jefferies: So let me go, flu, if it’s positive, you want to file that one as a monotherapy or is filed, or you want to get it approved, that one?

Stephen Hoag, President, Moderna: Correct. We would

Mike, Interviewer, Jefferies: intend to do both with mono And because you withdrew the combo. Good color for that.

Stephen Hoag, President, Moderna: So, would still think there’s going be a market for mono COVID. We still think there’s going to be a market for mono flu. We think the bigger market’s going to be for the combo. And so we will intend to register all three products. If the flu is positive, we’ve already got the COVID approved.

If the flu is positive, we would then expect the end of this year or the second half of this year to file flu for approval and flu COVID combo for approval because we’d want both options available. There may be some people who still want to do them separately

Mike, Interviewer, Jefferies: or the labor And what would expect the label and all these types of things are probably going to be something similar to the COVID label? That’s a reasonable expectation.

Stephen Hoag, President, Moderna: For the COVID component, I think the FDA has

Mike, Interviewer, Jefferies: been very clear about that. Yeah, the label, this combination is probably going to reflect the COVID label.

Stephen Hoag, President, Moderna: JASON Yeah, I think the FDA has been very clear on that. JASON Okay.

Mike, Interviewer, Jefferies: What else? So then with this administration and more clarity over the last few months, how does that change the development plans? Is Moderna, yeah, we go forward. We got it. We got it.

So, norovirus, CMV, others, and we just keep going because don’t worry, nothing has changed. It’s administration focused on it, they’re still going to be able to approve all these things. Don’t worry.

Stephen Hoag, President, Moderna: Yeah, well, think it’s important to note that for all the rest of our products, including by the way our COVID product, we’ve run placebo controlled efficacy studies. Norovirus right now is twenty five, thirty thousand people as a placebo controlled efficacy study. There’s over some By

Mike, Interviewer, Jefferies: the way, restarted, right? It’s back up? Was a pause and then

Stephen Hoag, President, Moderna: Yes, so FDA removed the clinical hold from a couple of months ago. And so that’s been resolved. And it is enrolling in the Southern Hemisphere, Panama Australia and a few other countries, because like flu, it bounces Northern Southern Hemisphere different seasons. And so norovirus, we think we’re right in line with expectations in that regard. And then I would say CMV, same thing.

It is a placebo controlled, 7,000 person, very large, phase three study. Should answer all the questions both about safety and efficacy. And our follow on vaccines after that, whether you want to talk about Epstein Barr virus or Lyme or any of them, we would expect to be placebo controlled. And so, that perspective, because there’s not an approved therapy to compare it to, it doesn’t feel like this framework change in COVID impacts our path in the other programs.

Mike, Interviewer, Jefferies: Because you’re going be running placebo controlled studies.

Stephen Hoag, President, Moderna: Correct, we already are.

Mike, Interviewer, Jefferies: With CMV, can I just ask, you know, we care about things coming up and news flow and things that are going to say, hey, see, there’s new products coming, we’re going to get to P and L and revenue and cash flow? That’s important. That for CMV, that it had hit at least one or two of the first interim analyses. And then now it’s been many months. And so I can assure you, and you probably look at, read investor reports, I don’t if you do, that Wall Street is like, well where is the final analysis?

And people hang on every word because it was like it’s coming and, but then it’s just this year. So it doesn’t make any sense to me because it’s not really a seasonal infection. So how could you have a bunch of interim analyses that didn’t stop or didn’t hit?

Stephen Hoag, President, Moderna: If you

Mike, Interviewer, Jefferies: said that, that’s public. Yeah. But again, the final one, here we are in June.

Stephen Hoag, President, Moderna: Yeah. So to be clear, one sort of point, we only have had one It was conducted at the very end of last year. And the reason is, you want to preserve as much alpha, as much statistical power for the final analysis. And so there was only ever one.

At that point, we didn’t have all the number of cases. You’re right, it’s not seasonal, but it’s event driven, you accrue cases. And at that point, we didn’t meet the threshold for declaring early success, early efficacy. But the study was powered, our label expectations really are based on that final analysis. And at this point, I can tell you we are still blinded.

There haven’t been other data. We haven’t slow walked anything. We are literally just waiting for cases to accrue, events to happen, so that we can trigger the process of conducting that analysis, that

Mike, Interviewer, Jefferies: final You can that, just to be clear, that a certain number of events happened. People tracked that. That was by the end of twenty twenty four. Mhmm. Here we are in the June.

If you look at the accrual of the events, and I remember it’s like 58%, and then final analysis around 50 or We’ve gone six months, and we haven’t gotten to those number of events.

Stephen Hoag, President, Moderna: Yeah, I mean it was, in the previous eighteen months, we got there, no, appreciate it. In the preceding eighteen months, or two years, we’d accrued about two thirds of it. And we expect it this year, is all I can say at this point.

Mike, Interviewer, Jefferies: We have working very well. No one’s trimming the events. That would be a possibility.

Stephen Hoag, President, Moderna: It’s possible. But the other thing, to point to on that, Mike, which is fair, is that there are a lot of other endpoints in that final analysis. So, I don’t want to lose this. The first interim analysis only looked at immunogenicity as a surrogate for infection. But if you look to the final analysis, there are many things that matter in a latent virus vaccine.

One of them things like virologic shedding, The presence of, in the urine or the blood of the virus, because that’s ultimately what will lead to transmission, in this case from a mother to a baby. And a whole other host of things that we’ll want to look at and capture. So the final analysis is not just an unblinding or a repeat of that same interim. It actually is this much more robust set of information about whether the vaccine was effective. It’s possible the vaccine didn’t prevent, let’s say, you from generating little antibodies, but it prevented you from becoming latently infected and shedding the virus.

And those sorts of endpoints, we’ve got more data to collect, more data to pull together. And once you unblind in the final analysis, you unblind for all of them. And so you can imagine it’s much more labor intensive and robust process to conduct that final analysis.

Mike, Interviewer, Jefferies: I mean, I’m good at interpreting words, but if you basically have an analysis which is just looking at seroconversion, that seems pretty straightforward. You’re telling me there’s, in the final analysis, there’s all sorts of other endpoints that would require more blood work or urine work, that’s what you’re saying. But you would say if the events have been hit, wouldn’t you? The events have been hit, then I would just say, Okay, it’s been hit and we still have many months of work to go look at all the urine analysis and all these other things.

Stephen Hoag, President, Moderna: Generally, we will complete the work before we trigger the DSMB process. And so we have an obligation. It’s not a we have an update on our event count, but we want to make sure we deliver a robust final analysis, all of the endpoints, including the key other endpoints like shedding. And as you just said, that’s a lot more testing, a lot more work. You’ve got to get it done right.

And so we’re completing that. We’re going to get it in the hands of the DSMB. And once the DSMB has rendered their verdict, of course we will share it.

Mike, Interviewer, Jefferies: One of the big things that continues to be a point for investors is that the company’s revenues are guidance of 1.5. Give me the exact

Stephen Hoag, President, Moderna: 1.5 to 2.5.

Mike, Interviewer, Jefferies: Five to 2.5. The OpEx guidance or the formal guidance, but you have cash burn guidance for this year. Correct. Yes. Guidance year end of $6,000,000,000

Stephen Hoag, President, Moderna: and Year end cash of about 6,000,000,000 Cash of 6,600,000,000.0 And we expect cash use this year, cash investment in the business, that’s OpEx plus cost of goods. So our cash use of about $5,500,000,000 that’s the guidance. So it’s net use of about three.

Mike, Interviewer, Jefferies: Okay. And so it’s basically nine at the end of ’20 ’4 going around six further into ’25. Analysts have various estimates for ’27 and people basically believe that the revenues are could grow, but you know there’s some guesses as to what that is. And then expenses are we can guess what that is. And when you do that math, that’s still another negative x billions of dollars.

So six is going down. So the question is, Wall Street doesn’t believe that the revenue streams are gonna pick up significantly Yeah. And the cost basis is the cost basis, so the cash burn is going down. How do you respond to that math? And do you believe that that Wall Street doesn’t understand that it’s gonna be okay because it’s you know, the cash burn is going down and people see this as a problem?

Stephen Hoag, President, Moderna: Look, Respond

Mike, Interviewer, Jefferies: to that.

Stephen Hoag, President, Moderna: Yeah. No, it’s a fair question. It’s a very fair question. Look, our goal should be, and I think our track record is, that we want to make or beat our cost guidance. Okay.

And then we hope over the course of this year to show where we’ve stabilized COVID as a business and we’ll grow from there. But we want to make or beat our revenue guidance. If you look at the cost numbers, we have decreased this year, we’ve got it to $5,500,000,000 If you look at the first quarter, that is a year over year decrease, actual cost reductions of 20%. And that is the second or third year in a row that we’ve done that. We’ve been eliminating 20% or 30% of cost per year.

In fact, if you look at where we were through the first quarter, we’re actually ahead of what you’d predict for current year. So, are trending favorable to our $5,500,000,000 cost guidance. We’ve indicated that the midpoint of our range is 4.7 for next year and 4.2 for the year after, and that means we’re settling into about a $4,000,000,000 cash cost base, inclusive of cost of goods in that. And I hope what we’ve shown is our ability to regularly meet or exceed our cost targets, take that 20% cost out if necessary year over year is there. We have to pick a number to aim at in ’28, and we do think four is the right number.

But, if the number has to be 3,000,000,000, then it will be three.

Mike, Interviewer, Jefferies: How do you get there? Is very helpful. So, yeah, we agree. Four is where you’re kind of aiming at, but if they’re based on revenues minus expenses is cash burn, If you need to get to three because revenues are only one or whatever it’s gonna be, you think you can get there?

Stephen Hoag, President, Moderna: Again, we’ve reduced about a billion dollars a year for the last couple of years. We’re looking forward to reducing another 708 hundred million dollars for next year. It is the same path, the same types of discipline that we’ve been executing. For the most part, what you see happening is that, as you’ll remember a couple years ago, said, or about a year and a half ago, said, we’re not going to start any new phase threes. And what you will see is a rundown of our R and D investment for these 10 products that we intend to launch and grow our revenue.

And if we don’t start new phase threes, that R and D line is just going to, every year, come down by a sizable chunk. And that’s essentially what’s been happening. That is what’s driving, you know, over the next eighteen months, us going from whatever is $5,500,000,000 in ’25 to $4.4.2 in ’27. And if we need to continue that trajectory, just straight line it. We will avoid The

Mike, Interviewer, Jefferies: three that you could get to that’s COGS, SG and A, and R and D?

Stephen Hoag, President, Moderna: All cash costs.

Mike, Interviewer, Jefferies: Could get that.

Stephen Hoag, President, Moderna: All cash costs. So when we say 4.2 for ’27, that is all of it. That is all cash used in the business, inclusive of cost of goods. So sometimes people think it’s OpEx. I actually think that’s a people get twisted on that one.

Because actually, the OpEx number, if you back into it, is probably more like three, two and a half to three, because the rest is in the cost of sales. And sales, look, if sales is down, cost of sales comes down with it. And we will continue to hold on starting any new phase threes, which does not lead to any growth in r and d in ’27 and beyond, it actually leads to this decline, we will hold until we have confidence on that revenue trajectory that we’re all

Mike, Interviewer, Jefferies: Let’s take it one step further. So let’s say you could get down to three. Revenues have to be above three in order to be profitable and people are not seeing anywhere in the next couple of years that this is going to happen. So therefore, the cash is going from six and you can do your own math. Do, do, what is that, how does that work?

Stephen Hoag, President, Moderna: Yeah, well I think we would, I would disagree, I guess, that there’s not opportunities to grow revenue. So midpoint of our range is

Mike, Interviewer, Jefferies: have new vaccines coming.

Stephen Hoag, President, Moderna: Midpoint of our range is two this year. We have very little RSV in it. A lot of that is because it’s still the first contract year. We’re not into the second year of contracting in RSV. That starts in July of this year.

And we do think we will grow over time to a share of RSV. Our flu and flu COVID product launches are both we hope to file them later this year, and that would mean that they would be approvals and contributing by ’27 for sure, ’27, ’20 ’8. And then you have norovirus, which we spoke about, and CMV.

Mike, Interviewer, Jefferies: Pfizer is not anywhere in the COVID flu game. Are they still there? Because if that does happen, that’s a material change that could

Stephen Hoag, President, Moderna: be worse.

Mike, Interviewer, Jefferies: People do believe that would be a value proposition to take two.

Stephen Hoag, President, Moderna: Yeah, I think we believe strongly in flu COVID. It is clear from the FDA guidance the market really is in that older adult and high risk populations. I don’t believe Pfizer’s currently in a pivotal study in any of those areas. And so I think they focus more on younger and healthier populations, which obviously is not consistent with the FDA guidance now. So anyway, I just listed RSV moving forward, but then flu and flu COVID, norovirus and CMV.

That’s five products. We additionally expect to launch two rare diseases and have, we would hope, our first launch of our INT and Tismarin Cancer program with Merck, which would be three more products. And so, if at the end of the day, if we’re heading towards two this this year, midpoint of the 1.5 to 2.5, and we launch five to seven products, depending on your handicapping of that, by 2728, we would hope that that has grown to a number bigger than three. And that four seems quite reasonable. That’s where we’re planning to.

But again, we’re going to match cost and revenue in the future, and we have, I think, shown, I do think that we haven’t gotten maybe all the credit about how we’ve been able to control consistently those costs and bring them down on a glide path.

Mike, Interviewer, Jefferies: You definitely have, and I think we have to definitely congratulate and give credit to the fact that the company has been doing that. I think Wall Street is, you know, with can they do it fast enough, do it more, and then one thing is where’s the revenue growth, the other thing is managing expenses. Both of those things have to happen. I think the reality is We’re trying to get that in That’s totally fair.

Stephen Hoag, President, Moderna: And I think the reality of those seven products is seeing them through to their approvals is actually the biggest driver of that cost now.

Mike, Interviewer, Jefferies: Let’s tie that together then because you mentioned INT, is individualized neoantigen therapy, otherwise to some people known as cancer vaccine. But first, is that a data readout that could happen next year? Talk about the probability of that happening because I feel like you’re saying, I think that was my question last earnings call, about the timing of that. And then secondly, one of the differences or one of the options between you and another peer, BioNTech, is that they have very much pivoted or spent a lot of time focusing on cancer programs, which seems to be hotter these days. And so there’s a question as to whether Moderna, given the administration, given the environment we’re in, would make more portfolio strategic decisions, appreciating we also want to keep costs down, but more pivoting towards areas where they might not be so much about respiratory vaccines.

So,

Stephen Hoag, President, Moderna: great question. So, first of all On the cancer vaccine timing question Cancer overall. We still expect that interim analysis, that readout on efficacy next year, in 2026. It is an event driven analysis, so my ability to predict when people’s cancers relapse is imperfect, and yet, we still feel like 2026 is the year we’ll see.

Mike, Interviewer, Jefferies: You know the event track rate. We top of ’25, so it’s early. We do. But you’re tracking along.

Stephen Hoag, President, Moderna: And again, we’re standing behind. We think ’26 is the year that that happens. Okay. If you look to the portfolio question, I’ll point to the fact that in the second quarter, we did update as a part of our annual portfolio review. We actually removed the tenth product on our 10 product launches, was a younger adult combination flu COVID vaccine.

And we removed it and said, we’re going to take that money and invest it in a new cancer therapeutic, something called four thousand three hundred fifty nine, that we’re quite enthusiastic about the early clinical data we’re

Mike, Interviewer, Jefferies: seeing What is four thousand three and fifty nine?

Stephen Hoag, President, Moderna: It is a combination, it used to be called Check Point as a therapy approach. We’ll say more about it in the future, but it is a combination immunotherapy that expands T cell responses against your immunosuppressive tumor microenvironment. We’ve been testing it in a phase one study in multiple histologies. We’ve seen some early, we’re quite encouraged, they’re early, I don’t want to overstate this target? It is a novel approach to generating T cell immunity against immune suppressive signals.

Mike, Interviewer, Jefferies: Right, it’s an mRNA that creates an antigen, creates antibodies against some target that you think is right.

Stephen Hoag, President, Moderna: So we’re looking forward to sharing that data in an upcoming medical meeting, but it was sufficient for us as a strategic decision to say, we’re going to take one of these respiratory vaccines away, take that money, and allocate it to another cancer therapy. So to your question, I think we’ve already started making those And in fact, at the end of these next couple of vaccines, respiratory vaccines, there are no more coming in our pipeline. And so we are completing the work. We do expect we’ll have a really strong portfolio commercially at that point, but we don’t expect to continue investing in respiratory beyond that.

Mike, Interviewer, Jefferies: We’ve got a lot of great FDA and regulatory clarity recently. You got the COVID vaccine approved a week or so ago. So you can see that the agency is pushing forward and reasonably rational. You heard about that from Marty yesterday. And the recommendations and things, these are not surprising.

In fact, the stock went up anyways after that. And you’re working on the on the cost structure and you’ve got some more things coming. So we continue to look forward to the progress this year. People are watching this and and trying to and trying to obviously figure it out. And so we appreciate your time and giving us the outlook.

So thank you very much, Steve.

Stephen Hoag, President, Moderna: Thank you, Mike.

Mike, Interviewer, Jefferies: Okay. Thank you.

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