00:00You know, last week, we were very happy to have the advisory committee of the FDA voting 9 to 0
00:06in favor of a recommendation for a vaccine.
00:09Now, of course, everything is in the hands of the FDA.
00:12Our teams are on almost daily communication with the FDA working team to get the product moving forward.
00:19So we are cautiously optimistic that we should be able to finalize this.
00:22And assuming that you do get that final approval decision from the FDA itself by August 5th, that would be
00:28just in time for the next flu season.
00:31It seems like the consensus out there, though, is that this flu vaccine wouldn't be impactful for your revenues until
00:382027 or so.
00:40So what are you modeling for in Moderna?
00:42You know, when do you expect to see sales from this actually meaningfully hit your bottom line?
00:48Yes. So basically, when we launch a product, because it's mid-season and because there's still uncertainty because it's not
00:54approved yet, we don't put that into the guidance for the year.
00:57We are still going to work on launching the product this year.
01:01As you know, the retailers, the pharmacies have to order products from all the manufacturers before the season to be
01:08ready to have product in stock to vaccinate people.
01:11So we don't expect a big season, but it's going to help us to oil the machine to make sure
01:16people are well-educated about the product.
01:18As you know, it's not an egg-based technology.
01:21It's mRNA-based technology allowing us to have more precision for the strains circulating in the U.S.
01:27And we think that that's going to have a huge impact on vaccine efficacy.
01:31And so all that education is going to happen this year.
01:34And as you said, we expect this to be a meaningful contribution to our growth in 27.
01:38I am curious, though, Stefan, I mean, even if you do get the approval on August 5th, last time I
01:44checked, we still don't have an advisory committee in place on immunization,
01:48which, of course, would be the primary pathway to getting the insurance pickup.
01:52If for some reason there is not an advisory committee there, what options do you have to make sure that
01:58this vaccine is actually covered by insurance in the U.S.?
02:02So, I mean, if you look what happened last year with COVID, it was kind of a similar situation in
02:07terms of timing of launch versus timing of advisory board.
02:10I think a lot of states have decided to go their own ways in terms of making sure vaccines are
02:16available to protect their populations.
02:18So we'll be working with the federal government, of course, as always.
02:21We'll be working with states as well and with retailers to make sure that products are available.
02:26Is there a sense, though, particularly through the lens of Wall Street and their expectations for the potential impact on
02:32revenue, is there any risk that you miss out on this flu season coming up?
02:39Yes, I mean, there's always risk, of course.
02:42First, the product is not approved yet.
02:43But as I just mentioned, this is not in the guidance for the year.
02:47So there's no downside from a sales guidance standpoint because we have put zero for flu this year.
02:52And I do want to talk a little bit about your relationship with the FDA.
02:56You and I spoke at the beginning of May.
02:58And since that time, FDA Commissioner Marty McCary has vacated that role.
03:03We also saw another top FDA official, Vinay Prasad, leaving the FDA as well.
03:08And I wonder what that has meant with your relationship with the agency.
03:12Has it changed?
03:13Have you noticed a direct impact of that change, particularly since Commissioner McCary left?
03:20If you think about the FDA, most of our interactions are from the Moderna working team to the FDA working
03:27team.
03:28That's the teams that are making the review happen.
03:31It's not specific to Moderna.
03:32It's how the industry works and has worked for many, many decades.
03:36And so if you think about it, those leadership positions you described are already in charge of new policy.
03:43So while those jobs are vacant, what's happening for the countries, there's no new policy to move the agenda forward.
03:50But from a program standpoint, for Moderna specifically to your question, there is no impact.
03:56The FDA working team is made of professional doctors, scientists who are working actively, are reviewing the file.
04:03They are talking to our teams.
04:05If we need more data, if we have more questions.
04:07And that process is going regardless of the leadership situation.
04:10I hear what you're saying, and especially when it comes to, you know, this isn't just Moderna.
04:15And to that point, I mean, we have seen some pretty interesting reversals coming from the FDA.
04:20When you think about decisions that have been made on rare disease drugs, such as Huntington's, a drug coming out
04:27there, or rather a decision reversal.
04:29We also saw a reversal when it comes to a rare child disease as well, which will now be resubmitted
04:35just weeks after it was rejected by the FDA.
04:39So I'm curious, I mean, in your view, and it's early days, but do you think that there is a
04:44bit of a thawing of the hardline attitude that the FDA, under McCary, had taken towards some of these drug
04:50study designs?
04:52If you look at our own situation, as you know, we had a refuse to file letter, which was a
04:56huge surprise earlier this year.
04:59Our team had met with the FDA last year to discuss the flu file and say, can we submit it?
05:04And we got the answer back, yes, you can submit it.
05:07We did submit it in December.
05:09And then we got the surprise of a refuse to file letter.
05:12As you know, this was resolved over time.
05:15And again, with a positive advisory vote last week, we are optimistic.
05:20So I think as we get the system working through the working teams, looking at the science and the data,
05:26things are moving forward, which is great for patients.
05:28I am curious, though, Stefan, and this kind of builds off Katie's questions about the relationship with the U.S.
05:35regulators.
05:35Last year, the majority of revenue did come from the U.S.
05:39In the first quarter of this calendar year, the majority of your revenue came from Europe, the U.K., to
05:44be specific.
05:45Are we going to see potentially a little bit more of a diversification geographically where the revenue stack is either
05:54evenly split between Europe and the U.S.
05:56or more heavily weighted towards Europe and the U.K.?
06:00So the U.S. will always be a very important market for Moderna.
06:04This is a home market.
06:05You know, we do research in America.
06:07We manufacture in America.
06:08We do clinical trial here.
06:09And it's a very important market.
06:11So it's always going to be a very important piece.
06:13What we've said a few years ago is we wanted to diversify the product revenue from a geographic standpoint.
06:19We made investment in Canada, in the U.K., in Australia.
06:22You know, soon Europe will reopen for COVID for us.
06:25We just got the flu plus COVID vaccine approved in Europe.
06:28So international market is going to be very important for Moderna's acceleration of growth.
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