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Moderna CEO on COVID-19 vaccine effectiveness, emergency use period

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

Video Transcript

JULIE HYMAN: We have been talking this morning about the news out from Moderna-- that its coronavirus vaccine trial showed a 94 and 1/2% efficacy rate, and also does not need to be stored in as cold conditions as the Pfizer vaccine. We got very positive news on that front last week. To talk about this, we are joined by the CEO of Moderna-- that's Stéphane Bancel-- as well as our Anjalee Khemlani, who covers the industry for us. And Anjalee, I'm going to toss it over for you-- to you to begin the conversation.

ANJALEE KHEMLANI: Thanks, Julie. And thank you, Stéphane, for joining us again. I know that you just got off the call with all the government officials who were touting the results. I want to jump in to the efficacy right now. We know that that's a key metric that you sort of outshone the competitor at this point. But what would you say is sort of the key right now, when it comes to who this best benefits in the broader population. We know that each vaccine is obviously going to have a different forte. Who do you feel is going to be best suited by your vaccine right now?

STÉPHANE BANCEL: Well, good morning, and thank you for having me back. It's a bit too early to tell exactly the population because the data is blinded to us as a company. As you know, this is run by an independent NIH investigator group and safety board.

But what we know so far as this first kind of cut of the data as of, you know, 95 participants. We know that 90 of those participants were on placebo and got disease. And five that were on the vaccine got disease as well. That is how [INAUDIBLE] team determined the 94.5%. We were very good kind of statistical strength.

The other piece that is much more exciting to me is for secondary endpoint with the severe disease. As we know with vaccination, what are we trying to do? We're trying to prevent people from getting disease. And if they get disease, you want to prevent them to get to the hospital. And those are where the severe disease case are very important.

And so out of 95 cases, were 11 cases of severe disease. 11 were on placebo and zero were on the vaccine now. Which means that if you get the vaccine, based on the data we have so far, is your very high chance of getting protected-- of having no disease. That's been 94%. But if you get disease, most probably you will get mild disease, not severe disease. And that's, of course, a game changer.

If we could have a vaccine that will prevent people from getting severe disease that would lead to hospitalization. That would lead-- in a worst case scenario-- to ICU, and the worst outcome-- to death, that would be a game changer in term of, of course, reducing hospitalization and death. The impact on the economy. And so this is why we are now getting ready to prepare in the coming weeks the filing to the EUA-- to the FDA.

We want to finish the study-- the final analysis has always been set up at 151 cases. We have 95 as of last Wednesday. And given the number of cases in the country, it's going to be a matter of days-- not weeks-- that we get the full data set.

Because it's very important to your question, we'd be able to analyze the elderly, African-American, Latino-- Latinx, and to really understand is our vaccine working across the board. We have a good demographic sampling at 95 participants, so we are cautiously optimistic. But it's only when we'll have a final analysis filed to the FDA, that we are able to sit down with the CDC to figure out who is best for Moderna vaccine.

ANJALEE KHEMLANI: Thanks. And I know that one of the things you were previously asked-- is there an update on the timeline right now? Because you are looking at producing 20 million doses by the end of the year with more than 40 million, I believe, per month after that. So as it stands right now, is there an update to the timeline based on who can get this vaccine first, and when you anticipate the general public will be able to receive doses.

STÉPHANE BANCEL: Yes. So this would be the timeline by the CDC, when this receive a full data set from the different vaccines, when they would be submitted to regulators, i.e., to the FDA. So we are a few weeks away from the data being available to the FDA-- for when the CDC being able to determine who should get the vaccine first.

So we think that in the EUA period, this would be mostly used for elderly person, for people with high risk like, you know, diabetes, people that are obese. As you have seen, those are comorbidity factors that have been reported by the CDC.

And then what when [INAUDIBLE] managed to file for full BLA, a full product approval-- where anybody above the age of 18 could get access to a product. I think this is more kind of a late Q1 time frame, where any Americans who want vaccinations can get access to it.

And then the next piece is the young. We are going to start very soon a study in teenagers. As typical with vaccine, you want to wait to have safety, but also efficacy of a vaccine. To have a good sense that the vaccine can drive the benefits, before you start those in the teenagers.

And so we'll start teenagers very soon. I'm hoping we'll get teenager data by the end of June, so that in the July-August time frame, teenagers can be vaccinated. So they can go back to a normal school year, with their teachers and their staff being vaccinated in the spring-- the students, you know, in the summer.

And then we are also going to go down early next year in age, by going down to younger children down to toddlers. But those-- you have to be very, very careful for obvious safety reasons. You have to start at a lower dose and you go down slowly in age, as you get the validation that the vaccine is well-tolerated and makes enough antibodies. So that will take a bit of a while. I anticipate this maybe more toward the end of 2021 for younger children.

ANJALEE KHEMLANI: Absolutely. And heading to the stock right now, up more than 10% on this news-- obviously, a very exciting day. But in the recent past, we've seen a little bit of focus on some of that share activity-- sales of shares by executives like yourself and others-- across the board. Not just with Moderna, but there have been other companies. Do you have any thoughts on that-- on the criticism and sort of the focus on that right now?

STÉPHANE BANCEL: I mean, if you think about it, Moderna has been private for eight years. I invested in every private [INAUDIBLE] of a company. I'm actually the only investor in the world who put cash at the same financial terms, as a [INAUDIBLE] investors across those things.

And when the company became public in December '18, we set up plans to provide a little bit of liquidity. And that's basically what you are seeing. So because of a success of a company, I think there's a lot of scrutiny. But if you look at the plans that are happening, they have been happening when the stock was at 20. We had no idea that the stock was going to be at this place, because none of us anticipated the pandemic, obviously, in December '18, when we went public.

And so I think it's very typical. I think there's just a lot of focus on it right now. I hope people realize, at least in my case, most of my worth is still in Moderna stock and will remain for a long time. I think it's just the beginning. As I've said on our last earning call, 2021 is going to be an inflection year for our company.

We now know that Moderna can make effective vaccine. This was proven today. Moderna is a platform and mRNA is an information molecule.

We have a CMV vaccine, for example, that's going to start phase three next year. We believe it's a 2 to 5 billion annual peak sales product. There is no CMV vaccine approved on the market. There are 10,000 kids in this country every year that are going to be born with birth defects, because their mom will get CMV infection during pregnancy. No vaccine on the market. We have a high probability of success of this product now.

And now Moderna at the end of Q3 had $4 billion of cash. So think about what we can do by now, and knowing that the technology is the risk, and investing in more product to scale up the company. This is just the beginning-- big inflection point next year.

JULIE HYMAN: Stéphane, it's Julie again, here. I want to ask about what the coronavirus vaccine specifically-- obviously, it would be great news for society and humankind, whoever comes up with a successful vaccine. Talk to me more about what it means for Moderna. Is this going to be a profitable product for you?

STÉPHANE BANCEL: So I think it means two things for Moderna. The short term-- in term of product sales and profits, and then the long term, which is the validation of a platform. Because unlike other pharmaceutical products, if you look at big pharmaceutical companies, there is no correlation between the products in the pipeline.

In our case, it is not the same. The CMV vaccine uses exactly the same technology than the COVID vaccine. So in the risking of a platform, I think the value is really incredible. In the short term, what we've said is we're going to make a reasonable profit on the vaccine.

We have been selling recently our vaccine around $37 per dose. For all others-- I'm talking millions of doses-- when governments place very large order-- like the US government placed a $100 million order, as you recall, a month or two ago-- the price was at $25 per dose because of volume discount.

And so if you think about it, you know, we generated a billion dollar of cash from operation in Q3. We went from, I think, lost money for ATLs to our first quarter, to, I think, operating cash flow of a billion dollar generated in the quarter. So I think next year is going to be an interesting year, where I believe we're going to generate a lot of cash. We have $4 billion of cash and no debt at the end of Q3.

So I think the company's going to be extremely well positioned by the end of 2021. We'll have a lot of products in the pipeline, a very strong cash buy-in, so that we can scale Moderna to where we maximize [INAUDIBLE] you of this platform in the next 5 to 10 years.

BRIAN SOZZI: Stéphane, will you be speaking to President-elect Joe Biden today? And how concerned are you that President-elect Joe Biden is not getting the information he needs from President Trump, and will that impact the distribution of your vaccine?

STÉPHANE BANCEL: So the distribution of our vaccine is being currently handled by Operation Warp Speed-- you know, Dr. Slaoui and General Perna. We are talking to them almost on a daily basis. We are coordinating with the CDC. We have [INAUDIBLE] on the-- who, as you know, has been selected by the US government to do the distribution.

But the next big step is really going to be around data. The FDA data that the CDC will use to decide who gets what vaccine. So all that process is clearly ongoing. And I know there are daily discussions with different members of a government.