Moderna at Barclays Conference: Strategic Focus on Oncology and Vaccines

On Tuesday, 11 March 2025, Moderna Inc. (NASDAQ: MRNA) presented at the Barclays 27th Annual Global Healthcare Conference. The discussion highlighted Moderna’s strategic advancements in oncology and vaccine development while acknowledging uncertainties in market dynamics and regulatory landscapes. The company remains optimistic about its financial targets despite facing challenges.

Key Takeaways

• Moderna is advancing its oncology portfolio with individualized neoantigen therapy (INT) and T-cell engagers.
• The company anticipates data readouts for melanoma and CMV vaccine trials in 2026 and 2025, respectively.
• Revenue guidance for 2025 is set between $1.5 billion and $2.5 billion, with a breakeven target in 2028.
• Operating expenses are projected to decrease significantly from $9 billion in 2023 to $5 billion by 2026.
• Moderna paused its norovirus vaccine study but expects no delays in timelines.

Financial Results

• 2025 Revenue Guidance: $1.5 billion to $2.5 billion, influenced by vaccination rates, market share, and regulatory approvals.
• Operating Expenses: Reduction from $9 billion in 2023 to $5 billion by 2026, focusing on cost efficiencies.
• Breakeven Target: 2028, driven by top-line growth and streamlined operations.
• COVID Vaccination Market Share: 40% in the U.S.

Operational Updates

• INT Program: Phase 3 trials for melanoma are fully enrolled, with data expected in 2026. NSCLC studies are ongoing.
• Oncology Pipeline: Focus on diverse mRNA applications, including T-cell engagers and cancer antigen therapies.
• Rare Disease Programs: Data for PA and MMA expected in 2026.
• CMV Vaccine: Anticipated results in 2025, with the study currently blinded.
• Norovirus Vaccine: Trial paused due to a GBS case, but timelines remain unaffected.
• RSV Vaccine: Approval awaited for the 18-59 age group, with a PDUFA date of June 12.

Future Outlook

• Guidance Factors: Vaccination rates, market share, and regulatory approvals in Canada, Australia, and the UK.
• Political Uncertainty: Awaiting confirmations of key healthcare leaders.
• Upside Possibilities: Higher-than-expected vaccination rates and competitive positioning.
• Partnerships: Open to collaborations to advance commercialization efforts.

Q&A Highlights

• BioNTech Comparison: Moderna emphasizes differences in technology and trial design.
• Oncology Focus: Efforts to expand beyond INT, with significant interest in the oncology space.
• Revenue Drivers: Key factors include vaccination rates and regulatory approvals.
• Cost Strategy: Focus on reducing clinical trial spending and operational improvements.
• Norovirus Update: Details on the voluntary trial pause and its impact on timelines.

For a more detailed understanding, readers are encouraged to refer to the full transcript.

Full transcript - Barclays 27th Annual Global Healthcare Conference:

Gina Wen, SMICCAL Biotech Analyst, Barclays: Good afternoon, everyone. My name is Gina Wen. I’m a SMICCAL biotech analyst at Barclays. Welcome to our twenty seventh Global Healthcare Conference. On stage with me, we have two senior leadership from Moderna.

We have Rose Laughlin, the Executive VP of Research. And we also have Lavita Talutiga, SVP, Head of Investor Relations with us. And so maybe I know, Rose, you don’t talk to investor too much. So I wanted to take this opportunity to take the most advantage of you. I know we talk to Laveena a lot.

So Rose, maybe thank you for joining us today. Before we get started, can you give us a brief overview of your background and your role at Moderna?

Rose Laughlin, Executive VP of Research, Moderna: Yes, absolutely. And thank you for having me. So I have been at Moderna for almost ten years. So I’ve seen many stages of our company and our pipeline. And I lead the research organization.

So that includes your therapeutic area research and your platform technology.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay. Well, thank you for that. So before we dive into the emerging oncology portfolio at the Moderna, maybe give us a recap of ongoing studies for your R and T program?

Rose Laughlin, Executive VP of Research, Moderna: Absolutely. So for INT, our individualized neoantigen therapy, we currently have three Phase three studies. So we are in adjuvant melanoma as well as adjuvant NSCLC and a perioperative NSCLC setting. And we also have Phase two studies ongoing in adjuvant renal cell carcinoma as well as muscle invasive bladder cancer and non muscle invasive bladder cancer where we’re actually testing INT as monotherapy.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay. And then maybe the melanoma part, Phase three that’s most advanced since you already fully enrolled. I understand it is event driven, but what could be like estimate timing or if you can share with us any additional color that what could be the potential data update?

Rose Laughlin, Executive VP of Research, Moderna: Sure. We completed that enrollment in September of twenty twenty four. And so looking at historical data, we are cautiously optimistic in an event driven way that we will see a data readout in 2026 for that study.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay, good. And I assume you will collaborate with Merck and then would that be a top line release and a conference call and then a full data at the medical conference?

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: It’s a little bit premature

Rose Laughlin, Executive VP of Research, Moderna: to say how we’re going

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: to release that data. We obviously would love to present all of that data at a medical conference, but you’re right, we’ll be working with Merck in terms of the disclosure plan.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay. And regarding the two Phase three studies in non small cell lung cancer, maybe give us a quick update regarding the enrollment status there?

Rose Laughlin, Executive VP of Research, Moderna: Sure. And we haven’t shared details on the enrollment status, but we are very encouraged by what we’re seeing both from clinicians who are very enthusiastic about the program and their patients enrolling. So.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay. Will you guys also give update once you complete enrollment?

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: Because it’s a major study and once we get to full enrollment, yes, with our partner Merck, we would likely update when that enrollment status is finalized.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay, good. So I did get tons of a question from investor regarding BioNTech’s approach in INP. And there’s some question on whether INP only works in melanoma or would that go beyond melanoma? And so maybe your thoughts on BioNTech’s approach and then their data read through to your platform?

Rose Laughlin, Executive VP of Research, Moderna: Yes, definitely very timely news. So in general, we are always hoping that BioNTech will bring positive readouts because we feel like that will move the entire neoantigen space forward. We do look at the two programs that we’re advancing and see some important differences. So we focus on the technology and the setting. So from a technology perspective, we use our proprietary algorithm to select the neoepitopes that we include.

We include 34 of those neoepitopes. I believe their vaccine has 20. We use our own lipid nanoparticle to deliver it and they have their own delivery vehicle. And then finally, we administer ours intramuscularly where theirs is administered intravenously. And so you can imagine that has a different antigen presentation profile.

And then when we think about setting, we have chosen to move forward in the later line patients. And we believe in adjuvant setting, when you’re having a lot of patients who are able to have their tumor resected, so you don’t have the same bulk. And also they’re much earlier in their treatment journey, so their immune systems are quite intact. And we believe that might be an ideal setting for a neoepitope based therapy. So when you put all of those pieces together, we obviously watch them closely and look forward to the results, but we don’t necessarily anticipate a one to one read through of their program and how we anticipate INT will perform.

Gina Wen, SMICCAL Biotech Analyst, Barclays: I think if they are active in a different tumor type, there will be a strong evidence that our NT should work across multiple tumor types. Right. That’s great. So, I think I had to ask you also share beyond what I and T we are focusing on, you have actually much larger oncology franchise. So, maybe if you can share with us what has been done in the past years and what should we expect in the coming years?

Rose Laughlin, Executive VP of Research, Moderna: Yes, absolutely. So obviously, we’re very excited about INT. We do have a diverse portfolio in oncology coming behind it. And what we really love about the portfolio is it demonstrates the different applications with mRNA technology and also it’s letting us get to different histologies and different stages of cancer. So as we’re looking at really strengthening our position in the oncology field, we look at the whole and they focus on antigens that are shared across patients.

We manufacture them once, pull them off the shelf when the patient is ready for it. We have T cell engagers. So within T cell engagers, we can actually target both cell surface proteins that are on cancer cells as well as intracellular antigens that are actually presented on those cancer cells. And what’s really exciting about using an mRNA based platform for a T cell engager is that it’s relatively straightforward for us to multiplex what others might call a combination, but for us it’s a single therapeutic. And so we can go after multiple targets in one therapy, which you can imagine as a more comprehensive approach and thinking about escape and tumor heterogeneity is quite the advantage in that space.

And then finally, we’re working toward in vivo cell therapies starting with CAR N.

Gina Wen, SMICCAL Biotech Analyst, Barclays: That’s really exciting. So maybe wanted to ask a little bit more about the T cell engagers, especially after we saw a few exciting data out there. I think the Genex and Via all show the T cell engager in a certain target, in their cases the PSMA target. So we do have a dual masking, single masking. So maybe your T cell engager is different because of the antibody conjugate, in your case, directly mRNA.

So maybe also elaborating like your asset compared to the traditional T cell engager, what’s the unique part there?

Rose Laughlin, Executive VP of Research, Moderna: Yes, absolutely. So because we’re encoding our T cell engagers with mRNA, we’re able to access a lot of different types of antibody formats in binding domains. And so we can design those such that you can have the same advantages you put with the recombinant protein like long circulation, but also pursue multiple targets in parallel through those binding domains. And we actually don’t have to design all of those to be on the same molecule. We can actually encode such that you actually get multiple molecules that can circulate.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay. That’s very good. And the maybe also any other so the programs that could move into the next step like a Phase II, any programs you wanted to highlight?

Rose Laughlin, Executive VP of Research, Moderna: Yes, absolutely. So of our emerging oncology portfolio, the cancer antigen therapies are our most advanced. So within cancer antigen therapies, we actually are focused on off the shelf, as I mentioned. So they’re not individualized, but we’re actually harnessing a couple of different biologies to pursue. So we are looking at immune antigens, we are looking at tumor antigens, and we’re also looking at cell therapy enhancers.

And so if you look in the immune antigen space, our lead program is our checkpoint AMT program. It actually encodes for epitopes from PD L1 and IDO. So the idea behind this vaccine is that you are training the immune system to both target cancer cells that may be over expressing those, but also immunosuppressive cells like Tregs. So you’re really sort of taking the brakes off of the immune system, but utilizing our unique approach for it. And so that program is currently in Phase II studies in metastatic settings in combination with pembro.

So that’s in melanoma as well as NSCLC. In the tumor antigen space, we are looking at both tumor specific antigens as well as tumor associated antigens. And actually our first therapy in that space, we’re looking forward to moving into Phase one later this year. And then as you move into the cell therapy enhancer concept, what we’re looking at there is actually encoding the antigen that is recognized by an ex vivo cell therapy. So our lead program there is in collaboration with Omatics, where they have an ex vivo TCR T cell and we are actually encoding the up to from PRAME that those engineered T cells will recognize within the body.

So they infuse the cells, we provide our cell therapy enhancer and look to see that it’s improving the persistence and health of those engineered T cells, which we hope will translate to improved efficacy.

Gina Wen, SMICCAL Biotech Analyst, Barclays: That’s super exciting. So should we expect also maybe at ASCO will be some data update or events at ASCO?

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: So we’re hopeful that we may be able to show some early data from some of these programs, but it’s yet to be determined.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay, good. So maybe also switch gear on the rare disease. I know those are the one maybe investor in the past was not the key focus, but I think with the evolving development those could be also become very important.

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: So the rare disease, the PA pivotal trial timing, maybe any update there? Sure. So we’re on track with our rare disease programs, both PA and MMA will either be in a pivotal study. PA is already generating data there. In MMA, we expect to start that pivotal study later this year.

And the timing of the data that you think that’s what could that be? So PA has a clinical endpoint in reduction of MDE, so it will be event driven to some degree. We do expect data sometime in 2026 for that program. In MMA, there will be both a biomarker endpoint as well as the reduction of MDE as the clinical endpoint, which could allow us to see some of the data from the biomarker dataset earlier than we do for PA, which is slowly clinical on that endpoint. But again, we think that because that study will start later this year, data most likely in 2026.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay, good. Now we switch back to the key topics we used to talk a lot. So maybe I will start with CMV because we haven’t seen the events happen yet. So maybe give us any updated thoughts there regarding the timing. Do you see actually blinded events on your end?

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: So good question. We’re still expecting the results for our CMV final analysis, event driven in 2025. And we are blinded and have been blinded since that early analysis has been has taken place earlier this year. So we do not see any of the data.

Gina Wen, SMICCAL Biotech Analyst, Barclays: But you do see blinded events, right? Right.

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: We are aware of some of the blinded events as they’re coming in, correct.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Right. Okay. And then do you see it’s coming closer to one hundred and twelve cases?

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: We do expect the data to come out sometime in 2025.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay. Okay. And then the longer we wait, should we be worried about the efficacy, the harder to hit forty nine point one percent efficacy threshold that from the statistics perspective? So I don’t think

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: the time to the one hundred and twelve events really affects whether or not we will hit that forty nine percent or roughly fifty percent on the vaccine efficacy. It could portend that the cases that we’re accruing is just a little bit slower, but we do expect that data in 2025.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay. Okay, good. And then going back to the 2025 guidance, you do give range 1,500,000,000 to $2,500,000,000 dollars. So maybe any walkout through what could be additional headwind? I think that earlier this year, you did say hopefully this is we do not you do not need to revise the guidance again, right?

So what could be

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: the headwind or tailwind that will make you have to change again? So you’re right. We gave a very wide guidance range for 2025 at the beginning of this year of $1,500,000,000 to $2,500,000,000 and what we were attempting to do with that guidance range is to really take into consideration the uncertainty that potentially could come through this year. And some of those uncertainties include vaccination

Rose Laughlin, Executive VP of Research, Moderna: rates, what the uptake

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: of vaccines will be this year, including additional S. In Canada, Australia as well as U. K. And so the timing of the licensure for those three facilities could impact the revenue we see coming in from international markets. All of that is contemplated in the low end of the guidance range.

At the higher end of $2,500,000,000 it really assumes flat vaccination rates to last year, a market share similar to what we had in COVID last year in The U. S. At forty percent, as well as timely approvals for the licensure of the three facilities in those countries I just mentioned.

Gina Wen, SMICCAL Biotech Analyst, Barclays: So given current all the political uncertainties, any thoughts there that Moderna could do something?

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: So you’re right. There’s a lot of uncertainty that we all have experienced ever since the new administration has taken place. However, we are still waiting for additional confirmations for some of the key leaders in the healthcare space. The FDA commissioner was just confirmed. We are waiting for CMS as well as the head of CDC to also be confirmed.

And we think that as these confirmations take place, you’ll start to see potentially a little bit more of a business as usual in terms of ACIP meetings and VERPAC meetings, just given FDA commissioner and some of the other confirmed individuals will likely also weigh in on those important meetings that are advisory meetings to the regulators.

Gina Wen, SMICCAL Biotech Analyst, Barclays: So in your low end guidance, do you think you had already taken enough consideration of

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: the risk assessment regarding the political uncertainty there? So vaccination rates being impacted could be for any reason, including additional political risk. Correct.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay. So what could be the upside possibility from here, your revenue guidance?

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: On the guidance range? Well, some levers are that vaccination rates are actually higher than we anticipated even on the high end, which would be flat to last year. Better competitive positioning. This year, we’ll have two products that we’ll be positioning during contracting season, our COVID vaccine as well as our RSV vaccine, whereas we were really locked out of that RSV market last year due to timing of approval and, ACIP recommendation. And also if the timely licensure of our facilities happen, that could also lead to some nice upside.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay, good. And then regarding the financial goal, like a breakeven in 2028 with potential to further reduce OpEx. So maybe if needed, so maybe what change in cost structure that could help reaching that goal?

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: Yes. Good question, Gina. So our breakeven guidance is really predicated on both the top line growing from the base that we have in just COVID really and a small amount of RSV sales from last year, as well as the intersection of that top line with our cash cost structure. And what you’ve seen us do is that we’re bringing that cash cost structure down from 2023, it was roughly $9,000,000,000 in operating expenses that came down to $6,400,000,000 last year. This year, we’re going to take that down even further on a cash cost basis of $5,500,000,000 We’ve guided to an additional $500,000,000 of cash costs out in 2026, which brings that cash cost structure in 2026 down to $5,000,000,000 So that’s the guidance we’ve given thus far.

We are and always looking at ways to run more efficiently as we kind of come off of some of the larger clinical studies in infectious diseases and anniversary through those. We should see a natural evolution of clinical trial spend coming down as well. And so stay tuned for additional updates that we may have, but we are committed to bringing our cash cost structure down. Okay, good.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Quickly on a few other pipeline assets, maybe one is a norovirus. I think during earnings call was announced the clinical hold for one single case of JVS, maybe any update so far?

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: Sure. Just so everyone knows, we did voluntarily pause that study when we saw that case of GBS out of an abundance of caution and also to update regulatory documents. So this is consent forms, investigator brochures for that trial. But in doing that, we also alerted the FDA that we were taking this action on ourselves and that’s when we were officially put on hold the sort of the norovirus study. However, the trial had already enrolled fully enrolled the Northern Hemisphere and we had started enrolling the Southern Hemisphere and that continues to happen.

So it should not affect timelines for the readout for this study. However, the clinical trial hold as we’re going back and forth with the FDA will run its course and when that comes off, we’ll have an announcement there.

Gina Wen, SMICCAL Biotech Analyst, Barclays: What did the FDA ask for the data? I mean, we’re talking about one case like what could make them feel comfortable that the trial enrollment can resume?

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: Yes. So we typically don’t talk about discussions we’re having with the FDA or Q and A back, but should they have any questions, it gives them the ability to ask us questions. I think that this was just one case in a 20,000 plus study and we also have had our technology in billions of people and we haven’t really seen GBS, which in the one case in this study doesn’t really breach the background rates of what we see in older adult populations, which is two in the one hundred thousand people who can get GBS. So I think that it’s kind of in what you would expect as background rate.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay. And I see like in a worst case scenario, if you cannot like some significant delay in the Southern Hemisphere, you only have five thousand patients additional, right? So will twenty thousand patients will be enough for the study, the powering assumption? How much impact that will be?

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: So we haven’t really said what the powering assumptions are for this study, but we do have an excess of 20,000 people enrolled in the Northern Hemisphere. And as I mentioned earlier, we’re continuing to enroll the Southern Hemisphere currently. So we don’t see any issues to the timeline and to the statistics of the study at this point in time.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay. So maybe kind of going back to the RSV vaccine, the ACE meeting delay, so how much impact do you think it will be for the I think that’s the in the high risk patient population in terms of launching?

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: So I’ll remind you that for any of the products or indications that we look to get approved in 2025 are not factored into the revenue guidance. So we’re hopeful that we’re going to get the approval later this year for the RSV eighteen to 59 year old that PDUFA date is June 12. Right. And so once that approval comes through, we’ll be in position really to compete next year on that label.

Gina Wen, SMICCAL Biotech Analyst, Barclays: So without ASA meeting, if June 12, you get approval, will you be able to launch or you have to wait until ASIP meeting to make a recommendation?

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: Once you get FDA approval, you can start having those discussions with customers. The ASIP recommendation will actually help that. And so we would and probably our customers who would want to see that ACIP recommendation, which is another reason why we didn’t put it into the guidance this year.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay. Good. We have one more minute, maybe give you opportunity to see like what which part do you think investor maybe the most disconnected either in terms of understanding or misunderstand Moderna, which one topic you think that you wanted to highlight?

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: Sure. Actually, having Rose here is one of those reasons why we wanted to talk about what’s beyond INT in therapeutics and that emerging oncology portfolio that has made a lot of headway in just a year and moving into the clinic and Phase II data potentially coming for our Check Point AMT that is in Phase II is really exciting. Those are in metastatic settings, so very distinct from what we’re doing in INT. And so I think that as that portfolio moves forward, we’re already seeing a ton of interest in the oncology space for Moderna, but really through INT and we’ve got so much more right behind INT.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay. Are you planning to carry this forward internally

Rose Laughlin, Executive VP of Research, Moderna: or you will be seeking some

Gina Wen, SMICCAL Biotech Analyst, Barclays: partnership in terms of oncology franchise? So, we are

Lavita Talutiga, SVP, Head of Investor Relations, Moderna: going to move these forward in the Phase I and Phase IIs on our own. Partnerships are we’re always open to partnerships, particularly if a partner can bring commercialization progress, for instance, in that space. And so stay tuned for that as well.

Gina Wen, SMICCAL Biotech Analyst, Barclays: Okay, great. Well, thank you very much. We look forward to the data update later this year. Thank you for having us. Thank you.

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