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Moderna CEO 'tap dancing' after company announces 94% vaccine efficacy

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Yahoo Finance’s Julie Hyman, Myles Udland, and Brian Sozzi speak with Moderna CEO Stéphane Bancel about the company’s COVID-19 vaccine updates.

Video Transcript

JULIE HYMAN: Stéphane, we were just starting to talk about the sort of steps that are taken here. How do you decide that you're at the point where you can ask for the EUA and now what happens next. What's your expected timeline?

STÉPHANE BANCEL: Great, so thank you for having me back. So like there companies, we were waiting for two things. First to have a final analysis of phase 3 efficacy, which we got yesterday.

When we filed the protocol for phase 3 backing June, July with the FDA, we agree with them that from a statistical standpoint we needed to reach 151 cases of disease to be able to have a robust analysis. What we show this morning is actually an analysis at 196 cases, showing a 94% efficacy.

But as Anjalee was saying, the piece that got me the most excited that I was almost tap dancing in the house yesterday when I heard it from the team, is we had 30 cases of severe disease. And of those 30, 30 were on placebo and zero were on no vaccine.

So if you think about what was happening in the country, people are getting infected. If they get a severe disease, they end up in the hospital. And if you get, you know, a bad case, we end up into the ICU and the worst case outcome of course, is death if you can stop that whole cascade, that is I believe a game changer.

And so we've got efficacy data and FDA had been very clear through EUA guidelines back in October, if you recall, wanting two months of safety data for at least half of the participants. We crossed that threshold in the second half of November, as we had communicated.

And so today we have all the pieces we need. We have been working with FDA very closely now for several months to file all of the information on manufacturing. So that they have everything to be able to make a decision.

And so Rafael is going to go today. The team is finalizing the quality control as we speak, they spent the whole weekend of Thanksgiving checking and checking and rechecking all of the data. Is going today, the FDA has indicated to us that we likely have all advisory board for mRNA-1273 on December 17.

And that could anticipate within I would say 24 to 72 hours after this for potential approval. What we're also doing today is to file in many countries outside the US. We're filing in Canada, in Europe, in the UK, in Switzerland, in Israel, and Singapore. And we've been doubly sure to help access in low and middle income countries.

ANJALEE KHAMLANI: Stéphane, I wish that you had recorded the tap dancing so we could share that on air. That would have been very interesting. So next time, please do that.

One of my questions for you really is, now that you have-- now that you have the filings set to go in, this really sets the company up to validate a product that would be the first on the market in the history of the company. But in addition to your point about manufacturing, and especially since you're looking at globally for approval, also includes sort of an infrastructure that's being set up that could play a role later on down the line.

As it stands right now, do you intend for the relationships that you have with the manufacturers, as well as the infrastructure being set up for distribution, do you think that's going to outlast the product itself?

STÉPHANE BANCEL: Yeah, that's a great point. I mean, as I shared with our investors third quarter call on my very last light is I believe 2021 is going to be the most important inflection point in the company history. If you think about it, we had $4 billion of cash at the end of Q3. We have to date 20 products in development.

And because this is a platform. I think that's a thing that's very new, that a lot of people don't appreciate yet. For hundred plus years that the pharmaceutical industry has been around, there is zero correlation between drug one and drug two in any big pharma pipeline. Since now 50 years of the biotech industry has existed, there's also no correlation.

But we use mRNA. mRNA is an information molecule. And so now with these efficacy data, and I hope in a few weeks with these first approval, it has an incredible rate across all of our vaccine pipeline.

We have six products in the pipeline. Some of them are $2 to 5 billion annual peak sales pro vaccine, like our CMV vaccine starting its phase 3 next year. We've announced recently, we're going to go after flu.

As you know, the efficacy of flu vaccine is pretty bad. You know in the 30 to 60%. Based on the good data we had in the elderly, which is the population the most at risk with flu, we're going to after flu business.

And so as you said the infrastructure we're building for COVID is going to be useful for the entire pipeline. So 2021 I think is going to be the most important year in the company's history. I could see us finish the year with a very strong balance sheet. We know for $4 billion of cash on the balance sheet. We have no debt.

I could see us, I think, you know maybe 25, 30 productions in development. On our way to 40 plus products. That's kind of a pipeline like the size of an Amgen. That's what Moderna is gearing up to do.

And this validation by the regulators, in a few weeks I hope, after this success phase for data has an incredible rate across the entire pipeline.

ANJALEE KHAMLANI: What time do you expect that filing today. And then going forward for the December 17th meeting, are there things that you anticipate being asked. Because obviously, this nugget about severe COVID prevention is really exciting for you and generally health experts, but does that matter to the population broadly?

STÉPHANE BANCEL: I think it matters tremendously, especially in term of psychology. You know, you don't always know if you have an underlying disease. And some people know diabetes starting, they are not aware. Some people might have genetic variation in their genes that might make them more susceptible to a disease.

So if you think about the psyche and the impact that's had on the economy. If you could get a vaccine and know that you have a 94% chance to have no disease and 6% chance to have minor disease, where you would not have anything severe happening to you. I think you would have an enormous impact on psychology.

And which is why I think if you think about the economy as a whole. Once we get enough Americans vaccinated, which I could see happening for people with severe risk in Q1, the rest of the population in Q2. I think by the end of Q2 you might be in a place in the US, where basically you have any American who is willing to get vaccinated have access to a vaccine and goes back to a normal life.

Go back traveling, go back to see friends, go back to movie theaters, and trips and so on. I think we're seeing the light at the end of the tunnel.

ANJALEE KHAMLANI: And what time do you expect that filing today. Is it going to be later today, or sometime soon this morning?

STÉPHANE BANCEL: It's going to be I think that in the afternoon. The team is working on it. We need to make sure that a every T's crossed every I's dot, as you can imagine. This is very important for credibility. So far, I think the FDA that they have everything they need squared away. So it will happen today, but by the time we go to bed tonight, it'll be at the FDA.

BRIAN SOZZI: Stéphane, is all your capacity for 2021 in terms of the vaccine, is that sold out. And how close do you think you can get to producing 1 billion doses of the vaccine next year?

STÉPHANE BANCEL: So it's a good question. So we've already sold out a lot. We have not communicated publicly. So I need to respect Reg FD. But if you look how many of those to the US government. 18 million in Europe, 50 million in Japan, and many, many other teams across the world.

And so we already starting to see a lot of capacity sold out. As we've said, we feel very confident that we can make half a billion doses. We are working toward a billion. The piece that is hard for me to know today, is given we are running 24/7 now, is will I have in 2021 every day all the raw material we need.

Because if I need one plastic bag, or I need one raw material, we cannot stop production. And so that's the swing factor that is still a bit unknowable today. But you need to be assured we're working as hard as we can. We've got partners, or suppliers, to get closer to a billion dose.

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