ModernaMRNA
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Moderna Morgan Stanley 24th Annual Global Healthcare Conference

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PeriodFY 0Duration34 minParticipants2

Transcript

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Terence FlynnU.S. Biopharma Analyst

Thanks for joining us everybody. I'm Terence Flynn, Morgan Stanley's U.S. Biopharm analyst. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. Very pleased to be hosting Moderna this morning. From the company, we have Stephen Hoge, the company's President. Stephen, thanks so much for being here. Really an opportunity to get to speak with you today. I guess first what I wanted to start off with is INT program is front and center.

Terence FlynnU.S. Biopharma Analyst

Congratulations on the positive phase III adjuvant melanoma data. Maybe just talk to us about the implications of that data for the broader strategy at Moderna in terms of what does this mean for additional indications, what does this mean for leaning in on the program? Just high level before we dig into some of the data questions that I have.

Stephen HogePresident

Yeah. Of course. Well, first, thank you again for having us. Always a pleasure to be here. Look, we're obviously thrilled by the results that were announced. The idea of a T-cell priming approach, a vaccine, if you will, approach to treating cancer, has been long promised, but this is the first time that we've been able to see a statistically significant and clinically meaningful result, as we said in our press release. It was also the first time anybody's ever achieved that kind of benefit over KEYTRUDA in the adjuvant setting in melanoma. That's not because there wasn't a lot of attempts. We think it bodes really well for the hypothesis, the scientific hypothesis, that we've been working on ourselves for over 10 years, which is if you can prime T-cells to see the tumor, are they able to mobilize a substantial response?

Stephen HogePresident

Not just in combination with KEYTRUDA, which helps with T-cell exhaustion, but actually against new and more diverse sets of tumors. The phase II results that we had from five years ago were exciting. We recently provided some scientific updates at ASCO, and we're looking forward to sharing more, and we're quite optimistic about the large book of work we've got with ongoing studies right now.

Terence FlynnU.S. Biopharma Analyst

Great. Do these data at all change the investment opportunity? As you ramp investments, are you guys going to lean in? Does that change the break-even target at all? I imagine you have a certain number of indications you are already looking at, but how do you think about a broader rollout of this in the future?

Stephen HogePresident

Yeah. Look, I think we are still targeting break even 2028, and that has been based on the strength of our infectious disease vaccines business. We now have five products approved, and I am sure we will talk more about it, but with approval of our flu product in the U.S., our combination product outside the U.S., in Europe. So we are looking forward to building that franchise. We have been investing in INT, in intismeran, underneath that. We currently have a very large book of work with our partner, Merck, that includes nine ongoing clinical trials, multiple phase IIIs, in fact, three randomized phase IIIs in lung cancer, as well as melanoma, as well as studies we may talk about in renal cell carcinoma and bladder cancer, both muscle invasive and non-muscle invasive.

Stephen HogePresident

All of that is actually investments we have really made over the last few years and is baked into that perspective. The caveat becomes then, as this data comes out from INT, how do we respond to it? In particular, where are the places we might go next? Those include looking at monotherapy opportunities, earlier stage disease, stage 1. Of course, where the data directs us, we will want to be in a position to make those investments. We are in a strong financial position thanks to the convertible debt we recently put in that we will have more than enough on our balance sheet if the data directs us to make those investments, but we want to be responsible about it. So we are going to wait and look for data and then respond to that as we go forward.

Terence FlynnU.S. Biopharma Analyst

Okay. Makes sense. Maybe we will dig into the melanoma data a little bit here, but just wondering, I think there is an expectation we could see the full phase III data at ESMO. Do you think that is a fair venue for this type of data?

Stephen HogePresident

You know how these things go. We look forward to sharing it at an upcoming medical meeting, and that medical meeting will determine when they want to announce.

Terence FlynnU.S. Biopharma Analyst

Okay. We hosted a KOL a couple of weeks ago, and he stated that he'd consider a hazard ratio of less than 0.75 as exciting, but ideally looking for 0.65. As we think about that, do you think that's a fair characterization from what clinically meaningful is for this data set?

Stephen HogePresident

We would agree with that. I think those are reasonable. Again, I'd come back to KEYTRUDA itself, in the adjuvant melanoma setting is a very effective drug. Obviously, Nobel Prize winning innovation, but a product that has had a huge impact on how we treat cancer. That standard is really what we compare ourselves against in this phase III trial. It's a very active comparator. We would want to provide a meaningful benefit, and as ourselves and Merck put out in the press release, we think we have provided a clinically meaningful benefit based on this first interim analysis. But ultimately, we look for the field to look at that data and make their own determinations. We also hope that that data matures. We look forward to it over time.

Stephen HogePresident

If you think about that phase II result from five years ago, we saw continued maturation over the full five years. We'll look forward to that. But can't wait to get the first round of this data out there so that people can start responding to that directly.

Terence FlynnU.S. Biopharma Analyst

Okay. We're looking forward to it. The other question we get a lot is just read-through potential from this trial to other tumor types. I know you and Merck have a broad program, as you mentioned.

Terence FlynnU.S. Biopharma Analyst

Yeah. What are some of the other data points we should look for in this phase III presentation?

Terence FlynnU.S. Biopharma Analyst

That will give us insights into likelihood of success in these other tumor types that you're conducting right now.

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