Q1 2020 Earnings Call

Media. Please disconnect at this time following the formal remarks, we will open the call left for your question.

Operator: Following the formal remarks, we will open the call up for your questions. Please be advised that the call is being recorded. At this time, I'd like to turn the call over to Lavina Talukdar, Head of Investor Relations at Moderna. Please proceed. Thank you, operator. Good morning, everyone.

Please be advised that's the goal is being recorded at this time I'd like to sprinkled every couple of units on the dark head Investor Relations estimate area. Please proceed.

Thank you operator, good morning, everyone welcome to mature in its conference call to discuss our first quarter 2025 cents updates and financial results you can access the press release issued this morning as well that's implied that will be reviewing by going to me investor section of our website.

Lavina Talukdar: Welcome to Moderna's conference call to discuss our first quarter 2020 business updates and financial results. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the investor section of our website. Speaking on today's call are Stphane Bancel, our CEO; Tal Zaks, our CMO; Stephen Hoge, our President; and Lawrence Kim, our CFO. Before we begin, please note that this conference call will include forward-looking statements. Please see slide two of the accompanying presentation and our SEC filings for important risk factors that

Speaking on today's call, our Stephane bunch sell our C E L Kazakhs, our CMO, even though our president and Lawrence Kim our CFO.

Before we begin please note that this conference call will include forward looking statements. Please see slide two of the accompanying presentation under SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward looking statements.

Lavina Talukdar: [inaudible] We undertake no obligation to update or revise the information provided on this call as a result of new information or future results or developments. With that, I will now turn the call over to Stephane.

We undertake no obligation to update or revise the information provided on this call as a result of new information future results, which about mix with that I will now turn the call over just stuff.

Thank you every now and good morning.

Stephane Bancel: Thank you, Lavina, and good morning or good afternoon, everyone. Thank you for joining the call. I hope you and your families are in good health. As you know, we believe mRNA has the potential to be a new class of medicines with the opportunity to address many medical needs with medicines with higher probability of technical success, with greater speed of research and clinical development versus traditional medicines, and with greater manufacturing capital efficiency and lower cost of goods than injectable recombinants. Given the unknowns of working with a new technology, we have been laser focused on managing risk, technology risk, biology risk, execution risk, and financing risk. As many of you know, 2019 was an important year for Moderna. We reported clinically validating data from key programs in two of our modalities.

Hi, everyone. Thank you for during the quarter.

Oh pure when your families are in good times.

As you know we believe involved there has a potential could be a new crescent magazines, we'd be a possibility to address many unmet medical needs.

We made that seemed to be higher probability of technical success break the speed of research and clinical development.

That's used 27 minutes teams in Britain manufacturing capital efficiency and know what percent would been injectable recombinant.

You bet, you're not walking with new technology wed been laser focused on managing risk technology risk How's your risk things are kind of risk and fun answers.

As many of you know.

What the 19 wasn't nimble, thank you fix and yet from a downturn.

We bought it couldn't you couldn't you buy dating data from P. programs in two of them with equities.

Stephane Bancel: Prophylactic Vaccines Antistatic, Secreted, and Cell Surface Therapeutics Data that we believe fundamentally changes the risk profile for each of these two modalities, which we now call core modalities. As a result, our strategy is to double down on these two core modalities with many important new development candidates. We have already announced five new development candidates in these core modalities since January 13th at the JP Morgan conference. Three new development candidates in infectious disease prophylactic vaccines, and two in the Systemic Secreted and Telso Fast Therapeutics modality. While we focus on doubling down in core modalities, we are still very interested in understanding the potential of mRNA technology in our current exploratory modalities, cancer vaccines, Infratumoral Immune Oncology, localized regenerative therapy, and systemic intracellular therapy. So when we think about

Well, let you can succeed.

And just didn't meet the secret did and sensors for projects.

They tenets, we believe fundamentally change where we spoke part will be towards these two modalities that we now called Colm will that be too.

As a result last.

I'll start if he used to double down you've used to call modalities, we have many both at new development candidates.

We have already announced five new development candidate he'd be school modalities since January testing and the JP Morgan Conference.

When you when you look back probably they couldn't use protecting vaccine.

And we just couldn't make secret did intensifies upticks and everything.

What we focus on dumping down you called modalities Rusty very interested in understanding the potential.

It's it's never easy enough currents exposed to remote licensees.

So vaccine.

Got you more immuno oncology.

Localized readdress the properties.

Thank you Stephanie interested enough robotics.

So when we think about.

Stephane Bancel: The company, we basically have two distinct areas of focus. This is a significant point in our strategy. We have core modalities.

The company, we basically have two distinct every all focused.

He is a significant balking astrology difficult modalities, we want to scale and invest.

Stephane Bancel: We want to scale and invest in exploratory modalities that continue to be a big driver of the company's future as we await clinical data to decide the path forward. So, stepping back.

Thanks extraordinary modalities.

That's what you could be a big driver off to the company's future as we await couldn't equaled exactly beside the Buffalo.

Just stepping back.

Stephane Bancel: I would like to share with you the progress of a company to award a new class of medicine. This is a strategic plan that we shared with you in February 2020. In the early days of the company, our goal was to enter the clinic safely.

I would have to should we view the progress.

Well the company to while the new custom indices.

You see this tragic plan that we should we view in February Twentytwenty.

In the early days of a company all gone with myself the clinic safety.

Stephane Bancel: We spent years investing and developing mRNA science, formulation delivery, and manufacturing technologies. The company pivoted out of that growth phase when we entered the clinic with our H10 influenza vaccine in December 2015. In the clinic, our next goal was to learn how a lot of technology was working or not. We explored our technology across six different modalities.

We spent you asked me this thing as you repeat ammonia science formulation Dave.

And manufacturing technologies.

The company people to help them doesn't roll phase when we entered the kidney we bought H. Dan you can sandboxing in December 2015.

In the clinic well next goal was to know how we're not taking or if he was working on that.

We explored all technology across six different modalities.

Stephane Bancel: We tested 16 different molecules in the clinic in a short four-year period. In 2019, we generated important data in two of the six modalities and identified our first two core modalities, infectious disease prophylactic vaccines and Systemic Secreted Antisurface Therapeutics. Early in the year, we entered a new phase of the company's development. Our goal for this next phase in our history is to file multiple BLAs while continuing our clinical programs in the four expiratory modalities and continue to invest aggressively in early research to invent new modalities such as in the ongoing collaboration with their partners. When we first presented this plan in early February this year, we had imagined that the next phase of growth for the company would have taken us three to four years.

With this did 16 different than when it comes into could.

You know shops for your parent.

You talked to 19, we generated E. Bolton data into what would you seek similarities and they'd have to fight off just to call modalities.

Pictures disease perfecting vaccines.

And systemic secret did anticipate properties.

Well either yeah, we entered a new phase of the company's development.

Well go and for this next phase in our history used to fight Multiport deal is.

Continuing all clinical programs in the Fox brokering modalities.

And keeps we invest aggressively in early reception.

We invent new modalities such as the ongoing collaboration we've got six.

When we stressed presented these plans may not be February this year, we had emagin at the next phase of growth of a company.

Thank goodness, we grew four years.

Oh vaccine against cost could be two virus and long it's about 70 agree.

Stephane Bancel: Our vaccine against the SARS-CoV-2 virus, mRNA-1273, is a major acceleration of our company's development. Today, we are very happy to announce that we received clearance yesterday from the FDA to proceed with Phase 2. It's just nine days from filing our IND, and on Monday, April 27th, the FDA gave us the green light. We intend to start the clinical trial as soon as safely possible. We also announced this morning that we are finalizing the phase 3 protocol.

He's a major acceleration of accompanies development.

Two there were very happy to announce that's we received yesterday tier ones from the every year to proceed with phase two.

He just nine this company go I envy almost 27, you give us a green light.

We tend to stop the Pinnacle trial I assume that's safe people see more.

We wish I know this morning.

Finalizing the phase three protocol.

Stephane Bancel: And our aim is to start doing phase 3 in early summer 2020. This means that we have the potential for a BLA approval for mRNA-1273 in 2021. That is an acceleration of several years. This is the plan we had just a month ago. We should be a commercial stage company in 2021, that is two to three years ahead of our previous plan. Plans we applied just months ago.

And HM East, we stopped dosing the phase three.

Early somehow twentytwenty.

This means that really potential toward being <unk> approval for him on its sort of 73 2021.

That's using next generation of several years, yes is the plan we have just months ago.

Well done actually be a commercial company sorry, one last you'd be a commercial missteps company Eattwenty four Q1.

That these two to four years ahead of operating disciplines plans, we aren't just in Mexico.

Did you unique opportunity.

Stephane Bancel: This is a unique opportunity, so we're working actively to get the company ready. To deliver on this acceleration of the company's plan, we're expanding our leadership team in areas where their expertise will be instrumental to allow us to successfully file several BLAs and be ready commercially. Today, we are announcing 3 new additions to the leadership roles of Moderna. First, Patrick Bester. Patrick Jones-Moderna, Senior Vice President, Commercial Vaccine. Patrick will report to me. Patrick Jones is from Merck & Co., where he was most recently head of global marketing and commercial operations for the entire vaccine business at Merck. Patrick, we'll start on Zoom first.

So well looking actively to get the company right.

Did you ever on these I've situation that accompanies plan.

We're expanding our leadership team in every aspect of expertise will be instrumental.

So where does the success, we filed seaboard be it is and where do you called Michigan.

To the aware in Helsinki, we know what you show.

Well leadership roles of Madonna.

Phil Patrick Destiny.

Patrick John's Madonna, that's you know Vice President Commission vaccines.

Patrick will report to me.

Patrick drugs from Milking company, where are you most percent he was head to laborde marketing and commercial production for the entire vaccine business now.

Patrick we cellphones interest.

Stephane Bancel: Patrick Legge Global Initiatives will focus on revenue growth and access expansion. A 20-year veteran in the biopharma industry, Patrick has had various leadership positions within infectious disease and global health at Merck in the US, in Europe, and in Asia. Second, Jackie Miller, Dr. Jackie Miller.

Strict like nobody initiatives, we are focused on revenue growth and access expansion.

Let's see let's see a bit they run into buying the screen I forgot to tenant diversity that she position we beneath it should be news and a good what has no in the U.S. in Europe, but they're still in Asia.

Second.

Just give me that book keeping that trucking, we'd be doing what they're not on May 11.

Stephane Bancel: Jackie will be joining Moderna on May 11, from GSK as Senior Vice President, Infectious Disease Development. Jackie joins the company from GSK, where she held a variety of leadership roles since 2005. Most recently, Jacqueline was a Vice President and Head of Clinical R&D and Epidemiology, where she built and led the Clinical and Epidemiology Research Team at the first USK Vaccine Research and Development Center in the US, and third, Dr. Charbel Haber. Charbel joined Moderna on April 21st as Senior Vice President for Regulatory Affairs. Trabel Joson, from Biogen, who has served as Vice President, Global Safety and Regulatory Science since 2017. In this role, he built and led the Global Regulatory Strategy Department, the Clinical Trial Application Group, and the Medical Writing Group.

From GSK here.

You know Vice President you Pictures these developments.

Jackie drives a company from just here, where she ended parents he or she probably since 2005.

Most recently, Jackie resident Vice President and head can you called R&D and <unk> energy, where she built and led excuse me cone and it could even if you were such Steve I discussed riskier vaccine research and development center in the U.S.

And so the shopping habits shop and drive more data on that front 20, Phil as you know Vice President Rugrats oilfields.

Trumping just some from Biogen, we still does vice President Global safety and we've got three science Cdtwenty 17.

In this role you'd be and led the report regulatory strategy development and clinical trial application group and then maybe you could have likely moves.

Probably off the Biogen the Javier.

Stephane Bancel: Prior to Biogen, Dr. Haber was head of Global Regulatory Affairs for Immunology and Neurology at EMD Serona. I am very excited to welcome Patrick, Jackie, and Charbel and look forward to their contribution at Moderna as we embark on the commercial stage phase of our company. It is a bittersweet moment to announce today the departure from the company of Dr. Lawrence Kim, our Chief Financial Officer. Lawrence joined the company in 2014 when it was private.

When we got three I fail, <unk>, even though where he and new energy at M.B. Serrano.

Hi, I'm very excited when compare trick Jackie and shopping and Fort Walton back on from shut up Madonna as we embark on the commission stage phase although companies.

He's a business with moments to announce to there the departure from the company over the next on Lawrence keep well Chief Financial Officer.

No. One has joined the company even when you talk to you and the company was probably its.

So if you remember it was a pretty unique on stage company.

Stephane Bancel: As some of you remember, it was a preclinical stage company with zero development candidates. Lawrence took a chance on Stephen Hoge and me and decided to leave a great job at Goldman Sachs to join us. The company is now public, with 23 development candidates and preparing its first phase three. Lawrence will manage with us for a smooth transition. He will do Moderna's second quarter conference call in August with us before leaving the conference. I am very thankful for Lawrence's contribution over the years and for the constructive discussion he and I had about ensuring a smooth transition. There is never a good time for a leadership position.

We have zero, you've not been candidates.

Well, that's a good chance on Stephen Hogan.

I get to lever great dropped by Goldman Sachs to join Us.

The company is not Patrick.

We've talked you freed up when candidates.

And preparing these girls phase three.

Now lets me my has reversed for a smooth transition.

You would do more than a second quarter conference call you know goes Weve us before leaving the company.

I am very thankful following thanks would be similar yes.

On a constructive discussion he and I had to both ensuring a smooth transition.

They never good time pointing to ship conditions.

Stephane Bancel: But the company is very well capitalized, with around $2.4 billion of capital to invest to create value, and we need to focus on the next phase readiness. Company to become. We have retained Russell Reynolds for the search for Moderna's next vehicle. We will focus on SDFO. We are a public company, and commercial, and Global Operations Experts. Given this is where Moderna is heading.

But the company's very well capitalized.

Weve around 2.4 billion that all capital to invest great value.

We need to focus on the next phase readiness for the company to be called nationally.

We have retained the recent rent to own <unk> from what dynamics useful.

We were focused on to see a cool with public company.

And commercial.

And grow Boral paraffin experiments.

You bet and she's where Madonna hedging.

Before I don't quite some time, Paul can you could update I.

Stephane Bancel: Before I hand over to Tal for clinical updates, I wanted to take a few minutes to frame the opportunity in our vaccine modality. We believe mRNA has the potential to be a new class of vaccine, where each of the four drivers of value apply. We are very excited about the potential of our vaccines. First, as we discussed, you need a very large report. The ability to make first-in-class vaccines that do not have products on the market today to protect as many people as we can. Second, a relatively high probability of technical success. As we discussed on our vaccine day, Dr. Andrew Lowe from MIT has shown that from the start of phase two, i.e., positive phase one, to approval, vaccines have a 42% probability of approval. This is the highest probability amongst all categories of medicine in clinical trials, and we think this is a very important value driver for this franchise. Third, we think an important driver is speed.

I wanted to make a few minutes to from your bought C. D E mail vaccine modality.

We believe in Miami has the potential to be a new class of vaccines.

Well each for dry mills are value reply.

We're very excited about the potential of on vaccines to drug use value.

Yes, that's we discuss their doctor pulse energy.

<unk> Kristine Kubacki that'd be most I've pulled back on the market today to protect as many people last weekend.

So gone or were not usually high probability or you're going to success as we just because I thought vaccine there, but I do know from MIT I shouldn't that's from the stopping a phase two.

The phase one two or pro Bono vaccines, the 42% for BT <unk>.

He's a high yes, probably t. amongst all categories I'm missing you could you go to trial.

We think the variable antibody drug up all these franchise.

Phil do we think and people think gravity speed speed in the labs, you've been we have a platform we consider the menu county that pardon me, we couldn't equal to setting.

Stephane Bancel: PID in the labs, even we have a platform, we can study many candidates in parallel in preclinical settings. Once we pick a development candidate to take into the clinic, we can do it very quickly, as we have shown recently with the SARS-CoV-2 vaccine. Going from the design of a vaccine on January 13 to injecting the first human on March 16 in as little as 63 days. Finally, we believe the capital efficiency of our platform offers significant advantages over traditional vaccines. Because the manufacturing process to make mRNA molecules is a cell-free manufacturing process, it can have a much lower capex than cis-recombinant protein manufacturing. The second dimension is capital leverage across the value chain. For example, when we decided to go after SARS-CoV-2, we did not have to buy any new equipment. Our team was able to leverage existing CapEx in a matter of days. With that overview, let me now turn it over to Tyler.

What's would be could you ever been candidates to pick a good organic.

Again, we very quickly as we have showed recently, we must cells will be two vaccine.

Going from design of a vaccine on January 15, two injecting discuss two men almost 16, you asked me to not 63 days.

Finally, we believe a Catholic Exensio platform offers significant advantages what traditional vaccines.

Because of manufacturing process to make him on the molecule syncrude manufacturing process.

Mexico, where capex, that's just we're comping that pulte manufacturing.

The second time insurance is a capex near record across the value chain.

I phone when we decide to go after Southgobi too we didn't have to buy any new machine.

Our team was able to leverage existing capex in about selling days.

We definitely have you had been outstanding balance on that.

Thank you used to fund and good morning, everyone.

Stephane Bancel: Thank you, Stephane. And good morning, everyone. I'll start with a quick reminder of the data generated to date with our vaccine. In over 1,500 healthy volunteers and seven positive phase one data sets to date, we have observed a safety profile that is consistent with the safety of adjuvanted vaccines, and we've time and again demonstrated the ability to elicit an immune response in the form of neutralizing antibodies.

I'll start with a quick reminder, on the data generated to date with our vaccine.

And over 1500 healthy volunteers and seven positive phase one data sets today, we have observed the safety profile, that's consistent with the safety of ads have entered vaccines and Weve time, and again demonstrated the ability to elicit an immune response in the form of neutralizing antibodies.

I'll start with a high level progress on M&A, Twoku 73, or vaccines against Sars group too.

Stephane Bancel: I'll start with a high-level progress on mRNA-1273, our vaccine against SARS-CoV-2, and we'll give more details shortly. As you heard from Stephane earlier, we have FDA clearance to move into our Phase 2 study, and we plan to start it shortly. This study will run in parallel with the NIH-run Phase 1 study, which has completed enrollment of the first three DOS cohorts. Our CMV Phase 2 dose confirmation study is fully enrolled, and we still expect data readout to come in the third quarter of this year. Despite having had some COVID-19 related disruptions.

We'll give more detail shortly.

As you heard from the phone earlier, we have the FDA clearance to move into our phase two study and we plan to started shortly.

This study will run in parallel with the NIH run Phase one study, which has completed enrollment of the first three dose cohorts.

Our CMB phase two dose confirmation study is fully enrolled and we still expect data read out to come into third quarter of this year.

[noise], despite having had some covert nine king related disruptions.

Stephane Bancel: At our Vaccines Day on April 14th, we announced positive interim analysis of our Phase 1 study for our Zika vaccine. At the two lower doses of 10 microgram and 30 microgram, we achieved seroconversion rates of 94 and 100%, respectively. The two higher dose cohorts of 100 microgram and 250 microgram are now saline.

At our vaccines day on April 14th we announced positive interim analysis of our phase one study for or Zika vaccine.

The two lower doses of 10 microgram 30, microgram, we achieved shearer conversion rates of 9400% respectively.

The two higher guest oversee behind it my congrats and 250 microgram are now fully role.

As a reminder, we paused or H. NPV PR three phase one be study enrollment has a cautionary measure to protect children and their caregivers due to cope with 19 disruptions.

Stephane Bancel: As a reminder, we paused our HMPV-PIV3 Phase 1b study enrollment as a precautionary measure to protect children and their caregivers due to COVID-19 disruption. However, our RSVP program with Merck continues. So this has been covered in detail, but just to quickly get everybody on the same page, our SARS-CoV-2 vaccine, mRNA-1273, which was a subject of much work and discussion in the first quarter of this year, demonstrates the kind of speed that we believe the platform can provide from the first selection of a sequence by our scientists and our collaborators at NIAID on January 13 to the production of a clinical batch on February 7, 25 days This strong collaboration between us and NIAID led to this trial opening within 63 days. And we've spoken about this before.

Our RSV program with Merck continues.

So this has been covered in detail, but just to quickly.

Face everybody on the same place our source code to vaccine and we're in a 12 73, which was the subject of much work in discussion in the first quarter. This year demonstrates the kind of speed that we believe the platform can provide from first selection of the sequence by our scientists and our collaborators at NIAD on January 13 to the production of the clinical batch onsite.

There are 725 days later.

That had been released by 20 by February 24th and by March 4th was associated with an open I'd that DNA said files.

The strong collaboration between us and NIAD led to this ER the trial opening within 63 days and we've spoken about this before.

Stephane Bancel: On April 17th, we were awarded a contract from the U.S. government agency BARDA to accelerate the development, and on April 27th, we announced an IND was submitted to the U.S. FDA for the Phase II study. Last Friday, we announced a collaboration with Lonza to manufacture mRNA-1273 at scale with the goal of producing up to 1 billion doses a year. And of course, today we announce FDA clearance to start the Phase 2 part. In parallel, we have been working on the phase three protocol, and we are finalizing that with a name to start the study in the summer of 2020. The design of the Phase 1 study is on slide 17.

On April 17th we were awarded a contract from the U.S. Government agency BARDA to accelerate the development and on April 27th We announced an idea was submitted to the U.S.F.D.A. for the phase two study.

Last Friday, we announced a collaboration with Lonza to manufacture and learn a 12 73 at scale with the goal of producing up to 1 billion doses a year.

Of course today, we announced the FDA clearance to start the phase two part.

In parallel we have been working on the phase three protocol and we're finalizing that with a big to start the study in the summer 2020.

[noise] the design of the Phase one studies on slide 17. The study started as a 45 subject Crow with three dose cohorts 25, 102 hundred 50 micrograms with each participant receiving two vaccinations a month apart.

Stephane Bancel: The study started as a 45-subject trial with three dose cohorts, 25, 100, and 250 micrograms, with each participant receiving two vaccinations a month apart. These three dose cohorts have now been fully enrolled, and the safety and immunogenicity data from them will be shared when available. The NIH is expanding the trial to include two additional age cohorts, a 56 to 70 year old cohort and a 71 and above age cohort. Each of these age cohorts will include three dose levels, also at 25, 100, and 250 micrograms at the same vaccination schedule. In terms of the late phase development for mRNA-1273, as mentioned before, the phase two study is expected to start shortly. This study will evaluate the safety, reactogenicity, and immunogenicity of two vaccinations of mRNA-1273 given one month apart. Volunteers will receive either placebo 50 or 250 micrograms at both vaccinations. This study will enroll 600 healthy participants and two cohorts of adults ages 18 to 55 and 55 years old and above.

These three dose cohorts have now been fully enrolled and the safety and Immunogenicity data from there will be shared would available.

The NIH is expanding the trial to include two additional age cohorts.

50, 60, 70 year old cohort and the 71 in a both age cohorts. Each of these age cohorts will include three dose levels also at 25 102 hundred 50 micrograms at the same vaccination schedule.

In terms of the Lake Phase development for M&A to up 73 as mentioned before the phase. Two study is expected to start shortly this study will evaluate the safety reactogenicity any units in the city of two vaccinations of M&A 12, 73, given one month apart.

With tears will receive either placebo 50, or 250 micrograms at both vaccinations.

This study will enroll 600 healthy participants and two cohorts of adults ages 18 to 55, and 55 year old and above.

Stephane Bancel: This study is meant to both increase our safety database as well as confirm the immunogenicity that we expect to see in phase one. We are finalizing, as I said, the phase three protocol, and the study is expected to begin this summer. Last week, Moderna-Lanza announced its strategic collaboration with the goal to enable the manufacturing of up to 1 billion doses a year, and this is assuming a dose of 50 micrograms. Technology transfer is expected to begin this June, and we anticipate the first batches of mRNA-1273 to be manufactured at Lonza's U.S. sites in July of this year. I would be remiss not to mention BARDA's role in this.

This study is meant to both increase our safety database as well as confirmed the immunogenicity seeking assays that we expect to see him assays work.

We are finalizing as I said the phase three protocol and this study is expected to begin this summer.

Last week, Madonna <unk> announced its strategic collaboration with the goal to enable manufacturing of up to wasn't Bill you don't see the yield and this is a seem to get those 50 Mike.

Technology transfer is expected to begin this June and we anticipate the truth batches of M&A 12, 73 could be manufactured at Lonza U.S. sites in July this year.

I would be remiss not to mention bargains rowing. The boat <unk> Award is allowing for a few move as quickly as we are with scale up both internally and with long term.

Stephane Bancel: The BARDA award is allowing us to move as quickly as we are with scale-ups, both internally and with lungs. Moving on to CMV, slide 20 reviews our late-stage development plans for CMV. As previously announced, the phase two dose confirmation study is fully enrolled, and we remain on track for data readout in the third quarter of 2020. Importantly, greater than 70% of participants have now received their second vaccine dose. A protocol amendment was submitted to expand the timeframe for the remaining participants to receive their second dose as well. As a reminder, we plan to select a dose for phase three after the first interim analysis, which is data after the second vaccination. We continue to prepare for Phase 3, which is intended to start in 2021 in the U.S. and Europe.

Moving on the C and D. Slide 20 reviews, our late stage development plans for CMV as previously announced the phase two dose confirmation study is fully enrolled and we remain on track for data read out in the third quarter of 2020.

Importantly, greater than 70% of participants had no received is second to exceed this protocol amendment was submitted to expand became senator there were many participants to receive their second goes as well.

As a reminder, we plan to selected dose for the case, we after the first entry now kids, which is the data close to the second vaccination.

We continue to prepare for the phase three which is intended to start to 2021 and the U.S.

During the first quarter 20, we also received constructive feedback from it type C. CMC meeting that we've had with the FDA.

Moving on to MBR in 80, 93 on Zika vaccine program, let me recap on slide 24, the data that we recently constructed at of vaccines day, where we reported him interim analysis of the onboard phase one trial.

Stephane Bancel: During the first quarter of 2020, we also received constructive feedback from the type C CMC meeting that we had with the FDA. Moving on to mRNA 1893, our Zika vaccine program, let me recap on slide 24, the data that we recently presented at Vaccines Day, where we reported an interim analysis of the ongoing phase one trial. This study demonstrated a fairly benign safety profile consistent with what we've seen before for other vaccines. And at the two lower doses of 10 and 30 micrograms after a two dose vaccination regimen, prime and boost, the seroconversion rates were 94 and 100%, respectively. These data are encouraging, and we are preparing to move forward with this program into a Phase 2 trial. Exploratory modalities are a critical part of our strategy, and they can continue to make up a significant part of what we do in the clinic. And on slide 26, you see a, If you scan the page, you'll see many readouts and catalysts from each of the programs, both from our core modalities as well as the exploratory. With that, I now turn the call over to Lauren.

This study has demonstrated fairly benign safety profile consistent with what we've seen before for other vaccines and at the two lower doses of tenant 30 micrograms. After two days vaccination regimen frightening do you feel conversion rates would maybe 400% respectively.

These data are encouraging and we're preparing to move forward and it's pretty good interest phase two trial.

Exploratory modalities are a critical part of our strategy and we can continue to make up a significant part of what we do in the clinic.

And on Slide 26, you see a <unk>.

If you scan to pay jewel he any read outs incredibly from each of your programs both from our core modalities as the world's get exploratory ones.

Let me now turn the call over to Lawrence.

I can tell.

Let me first cover an update on the vertex agreement in July 2016, we entered into a strategic collaboration and license agreement with vertex Indebt discovery and development of Central MRT medicines for the treatment of cystic fibrosis ixia by enabling self millions of people see have to potentially produce funky.

Lawrence Kim: Let me first cover an update on the VERTEX agreement. In July 2016, we entered into a strategic collaboration and license agreement with VERTEX aimed at discovery and development of potential mRNA medicines for the treatment of cystic fibrosis, or CF, by enabling cells in the lungs of people with CF to potentially produce functional CFTR proteins.

No, yes, you're correct.

On July 2019, the initial research term was extended next month.

And based upon promising preclinical data generated.

In March of 2020, we were pleased that very much elected to extend this collaboration for a further 18 months.

Now, let me turn to financial results in today's press release, we reported our first quarter 2020 financial results I note that these results are unaudited.

Lawrence Kim: In July of 2019, the initial research term was extended by six months. And based upon promising preclinical data generated in March of 2020, we were pleased that Virtax elected to extend this collaboration for a further 18 months. Now let me turn to financial results. In today's press release, we reported our first quarter 2020 financial results. Note that these results are unaudited.

We raised approximately $550 million net proceeds from the February public equity offering which resulted in US ending Q1 2020 with cash cash equivalents in investments of 1.72 billion.

This compares to 1.26 billion at the end of 2019.

Net cash used in operating activities was 106 nine for first quarter 2020, compared to 144 million in 2019.

And just as a reminder, that latter number includes unless something payment 22 billion, which will not recur.

Lawrence Kim: We raised approximately $550 million in net proceeds from the February public equity offering, which resulted in us ending Q1 2020 with cash equivalents and investments of $1.72 billion. This compares to $1.26 billion at the end of 2019. MedCash used in operating activities was $106 million for the first quarter of 2020, compared to $144 million in 2019, and just as a reminder, that latter number includes an in-licensing payment of $22 million, which will not. Cash used for purchases of property equipment was $6 million for the first quarter of 2020 compared to $8 million in 2019. Revenue for the first quarter of 2020 was $8 million compared to $16 million in 2019. This decrease of $8 million in revenue was mainly due to cumulative catch-up adjustments resulting from changes in our estimated costs for our future performance, coupled with the timing of amortization of deferred revenue due to the satisfaction of our performance.

Cash used for purchases of property equipment was $6 million for the first quarter 2020 compared to no into 2019.

Revenue for the first quarter 2020 was 8 million compared to 15 million in 2019. This decrease of 8 million in revenue was mainly due to cumulative catch up adjustments, resulting from changes in our estimated cost for our future performance obligation.

Coupled with the timing of amortization of deferred revenue due to the satisfaction of our performance obligations.

R&D expenses for the first quarter 2020 were 115 million compared to 139 to 20 IP.

The decrease in 15 going in R&D was mainly driven by a decrease in the lab supplies a material and clinical trial in manufacturing cost, partially offset by personnel related costs.

Do you an expenses for the first quarter 2020, or 24 million compared to 27 billion in Q1 2019.

This decrease of 3 million was primarily attributable to decreases in legal and other consulting and outside services Stan.

Net loss for calendar 2020 was 124 million compared to 133 million in Q1 20, yet.

I'll turn now to what we expected to remain or 2020.

If you look at our castle why have you can see your cash used in operating activities and purchases of property and equipment bite by quarter are laid out here in Q1 of 2020, we used 120 112 million of cash and these two items, which is inline with our expectations.

Lawrence Kim: R&D expenses for the first quarter of 2020 were $115 million compared to $130 million in 2019. The decrease of $15 million in R&D was mainly driven by a decrease in lab supplies and materials, and clinical trial and manufacturing costs, partially offset by personnel-related costs. DNA expenses for the first quarter of 2020 were $24 million compared to $27 billion in Q1 2019. This decrease of $3 million was primarily attributable to decreases in legal and other consulting and outside services spend.

If you go back to Q1 2019, we used 152 million of cash on these two items and remember again that number included that licensing payment.

Overall, you can see the decline in our quarter over quarter cashing cities happens through Q4, 2019 with a slight uptick in Q1 2020.

And so consistent with our initial 2020 guidance, which we issued back in November.

We expect our 20 claim that cash used in operating activities and purchases of property and equipment to be approximately $500 million.

While we have seen parts of our spend slowdown as a result at the impact of the 19th such as certain clinical trial expenses and laboratory supplies. We're also investing in preparedness for the late stage development potential being late filing for a code that vaccine.

Lawrence Kim: And the net loss for Q1 2020 was $124 million compared to $133 million in Q1. I'll turn now to what we expect for the remainder of 2020. If you look at our cash flow line items, you can see our cash used in operating activities and purchases of property and equipment by quarter are laid out here.

It's often bringing our cash flow guidance back to its original levels.

We recognize that much of our till the docking spend is covered by the BARDA Award note that the award is not cash up front, but rather reimbursement of expenses incurred.

We do expect to incur significant expenses this year in relation to that BARDA award will be expecting general matching expenses and reimbursements.

Lawrence Kim: In Q1 of 2020, we used $112 million of cash on these two items, which is in line with our expectations. If you go back to Q1 2019, we used $152 million of cash on these two items. And remember, again, that number included that licensing.

[noise] lets drill down next on our balance sheet strength and the composition of the 2.4 billion of cash available funding, we have to invest and create value.

We ended Q1 2020 with cash cash equivalents and investments of $1.72 billion.

On April 16 to 2020, we entered into an agreement with BARDA to accelerate development of our Marni vaccine candidates against an album run of ours.

For funding of up to 483 million over 430 million has been committed.

Lawrence Kim: Overall, you can see the decline in our quarterly-over-quarter cashings for these items through Q4 2019 with a slight uptick in Q1 2020. And so, it is consistent with our initial 2020 guidance, which we issued back in November. We expect our 2020 net cash used in operating activities and purchases of property and equipment to be approximately $500 million. While we have seen parts of our spend flow down as a result of the impact of COVID-19, such as certain clinical trial expenses and laboratory supplies, we are also investing in preparedness for late stage development and potential BLA filing for our COVID-19 vaccine. That results in bringing our cash flow guidance back to its original level, and recognize that much of our COVID vaccine spend is covered by the BARDA award. Note that the award is not cash up front but rather reimbursement as expenses are incurred.

Additionally, we are fortunate to have established strategic alliances with private and government sponsored organizations, including the Bill and Melinda Gates Foundation, DARPA and another part of the warrant compressing additional available funding of $180 million.

Together just creates multiple years of cash runway considering the cash guidance that we shared today and a strong ability to invest for the long run in many aspects of the business.

The next slide shows our pipeline and the programs through the various phases of development.

With a snapshot here.

Before I turn it back to Stefan let me just reiterate an important point for my announced departure. This morning, which is that I expect to seamlessly transition my responsibilities through August but.

But I'll make a brief remarks now.

First of all I'm, so grateful to have been invited to be a part of this company what an opportunity to contribute to return of mission of turning them Arnie into a new classes that are since I joined the company six years ago.

I'm going to story was nation fusion was full of unknowns I'm, leaving now as a company has.

Automobile late on the horizon with 23 important new potential medicine in the pipeline.

Lawrence Kim: We do expect to incur significant expenses this year in relation to that BARDA award, but we expect, in general, a matching of expenses and reimbursement. Let's drill down next on our balance sheet strength and the composition of the $2.4 billion of cash and available funding we have to invest and create value. We ended Q1 2020 with cash, cash equivalents, and investments of $1.72 billion. On April 16th, 2020, we entered into an agreement with BARDA to accelerate the development of our mRNA vaccine candidate against the novel coronavirus for funding of up to $483 million, of which $430 million has been committed. Additionally, we are fortunate to have established strategic alliances with private and government-sponsored organizations, including the Bill & Melinda Gates Foundation, DARPA, and another BARDA award comprising additional available funding of $1

Ladies and many more to come.

We've invested heavily in the platform to establish attacking the foundation for this new classes medicines and the team is growing with unbelievable new talent.

I'm personally most proud of the financial Foundation, we've built to enable the company to invest appropriately.

It's been energizing and motivating to partner with stuff on the board, that's executive team and the passionate but they're not completed.

For me I mean, you're going to take the next step in my career, and which will be to stay close to innovation the biotech.

But not as a company executive I look forward to sharing more about those plans at an appropriate time on the red with many of you on this call and with that I'll turn it over to Stephane for closing remarks.

All right. Thanks again.

Your remarks, but bugging you as my fault enough will go six yes, that's been.

Quite a critical rights.

On slide helped you fall, let me close by giving a quick update for the company's tends to their fluffy. We've all pipeline you fix I think we'll see that today, we have two candidates.

Lawrence Kim: Together, this creates multiple years of cash runway, considering the cash guidance that we shared today, and a strong ability to invest for the long run in many areas. The next slide shows our pipeline and the programs through the various phases of development with a snapshot here. But before I turn it back to Stphane, let me just reiterate an important point from my announced departure this morning, which is that I expect to seamlessly transition my responsibilities through August. But I'll make a brief remark now.

Well, which were preparing for pretty scary CMV vaccine no southgobi cool vaccine.

We have now six candidate that's I think based cool.

I'll put branco faced.

12 phase one programs and even put it the phase when we though.

What's the next to their way from seen so IPO in December 28 thing.

Oh programs are very exciting we have seven Christine klaskin vaccine.

They are no approved vaccines on them buckets against those viruses.

Most of these vaccine candidates have moved <unk> billion Doe and your peak Sanders Oculto anything.

Lawrence Kim: First of all, I'm so grateful to have been invited to be a part of this company. It's a great opportunity to contribute to Moderna's mission of turning mRNA into a new class of medicine. I joined the company six years ago when the story was nascent, and the future was full of unknowns. I'm leaving now as the company has multiple BLAs on the horizon with 23 important new potential medicines in the pipeline, and I believe many more to come.

As we shall I thought about independent station.

We believe all you know about the vaccine ugly and could be a very <unk> business from Madonna.

We belong to them.

And you eat t. like opportunities at the height EBIT margin.

Well, it's a five exciting even okurowski program, that's already in the clinic or combined with the commercial checkpoint.

Paul revenues these programs and to auto immune disease programs.

The company has never been stronger Newcastle formations, we have now those mobank files that nine on drug has people don't seals and patient you know studies.

Lawrence Kim: We've invested heavily in the platform to establish the scientific foundations of this new class of medicines, and the team is growing with unbelievable new talent. I'm personally most proud of the financial foundation we've built to enable the company to invest appropriately in the business. It's been energizing and motivating to partner with Stphane, the board, its executive team, and the passionate Moderna employee base. For me, I'm eager to take the next step in my career, which will be to stay close to innovation and biotech, but not as a company executive. I'll look forward to sharing more about those plans at an appropriate time down the road with many of you on this call. And with that, I'll turn it over to Stephane for closing remarks.

The team is strong and getting stronger every mall, we now more than 900 employees.

Got you pretty both on mission and not proud and energized by our progress and the meaning of at work.

Last week, we belong.

Agreements or manufacturing capabilities as change league.

We not only have all fully integrated GMP sites, you must I trust that who many of you know and that'd be it did.

But weve added strategic partnership we don't though.

That can enable us to up to 1 billion builds these annually fall vaccine against Southgobi too, but just so over product you know pipeline as we need to.

We have great pop nails, Weve Astrazeneca mill and the optics.

Hi, I'm very proud of a sense the progress that the team of Stephen hole and maybe some all of them in the work we've got fixed over last few years.

Well I'm very pleased the fixed decided to expand the relationship we Madonna.

Stephane Bancel: Lawrence, thanks again for not only your remarks but for having you as my partner for those six years. It has been quite an incredible ride. On slide 34, let me close by giving a quick update on where the company stands today, starting with our pipeline. It's exciting to see that today we have two candidates for which we are preparing for phase three of the CMV vaccine, North-South COVID-2 vaccine. We now have six candidates that are either in phase two or preparing for phase 3, 12 phase 1 programs, and 11 positive phase 1 results. What an acceleration since our IPO in December 2018. Our programs are very exciting. We have seven first-class vaccines where there are no approved vaccines on the market against those viruses.

But we're also very thankful for partnership we've had them over yields we bought though dapa CP and the Gates Foundation and of course, who are very thankful for the late this partnership we've called out farther than if we meet and got off to enable us to go right equal to study, especially as we go of calls.

Focusing on safety trials.

All of a soft could be to succeed.

And of course when kept alive.

From 2.4 beaten that all investing the business in costs used to be D, leading and on a company in the world.

We are very think poor falling best also got trust and partnership as we believe this unique company.

We're energized by the Opus easier ahead of us.

To be done you could ask them at the Sims.

Correct me accelerating all given up on pipeline and redeem the company to potentially filings Brlten billion.

Stephane Bancel: Most of these vaccine candidates have multi-billion dollar annual peak sales opportunities. As we shared at our Vaccine Day presentation, we believe our innovative vaccines are going to be a very large business for Moderna. We've got a long-term, Annuity-like opportunity at the High Ebit Mark. We also have five exciting immuno-oncology programs that are all in the clinic, that are all combined with a commercial check. 4 rare disease programs and 2 autoimmune disease programs. The company has never been stronger. Look at our foundations.

I'm on its way of 73.

Which would be as you can appreciate the Keystone week moment former company.

We're investing in of course, it's easy to get those there to get the right foundations for potentially many additional be any in the future something we've as he can vaccine and CMV vaccine behind the software will be two am on its website Ukraine.

We already standing up the organization to address the need to supply have to be didn't those these fall that should be felt succeed them on its going to some degree.

Well go to default investment and of course, it sees we'd be very enabling for additional vaccines and carpet seeks to come.

Stephane Bancel: We have now dosed more than 1,900 healthy volunteers and patients in our studies. The team is strong and getting stronger every month. We now have more than 900 employees who care deeply about our mission and are proud and energized by our progress and the meaning of our work. Last week, with the Lonza agreement, our manufacturing capabilities have changed leagues. We not only have a fully integrated GMP site in Massachusetts, which many of you know and have visited, but we've added a strategic partnership with Lonza that can enable us to produce up to one billion doses annually for the vaccine against SARS-CoV-2, but also other products in our pipeline as we need them. We have great partners with AstraZeneca, Merck, and Veera. I am very proud of the fantastic progress that the team of Stephen Hoge and Melissa Moore have made in the work with Vertex over the last few years. And we are very pleased that Vertex has decided to expand its relationship with Moderna.

I have never been as excited.

And optimistic but the future of Madonna in the last nine years.

We are humbled and excited by the ability to bring fault and you've got somebody just seems whole patient.

That's that's been all know Stahl since we started the company.

I would like to thank the great team well done employees working very hard every day.

And equally many of them seven days a week now since January two fights.

Southgobi tool virus.

I would have to think that many people do bulky breaking all clinical studies, including patients had people don't seal position industries.

That's correct oral thought mills.

I've worked with us to show vision, and helping us to achieve decision whether patients moved up and I'm happy to take any questions.

Oh Franco.

Certainly.

A reminder to ask a question you will need to press star one on your telephone.

So with your question, that's the pound or husky.

Please stand by what we can probably kidney roster.

Your first question comes from Matthew Harrison isn't Morgan Stanley. Please ask your question.

Great. Good morning, Thanks for taking the questions.

I guess first you highlighted the 50 microgram dose on the I'm, sorry, covey to vaccine.

Stephane Bancel: But we're also very thankful for the partnership we've had over the years with BARDA, DARPA, CEPI, and the Gates Foundation. And, of course, we are very thankful for the latest partnership with BARDA, $483 million to enable us to do the right clinical study as fast as we can go, of course, focusing on safety first for the SARS-CoV-2 vaccine. And, of course, we are well capitalized

And I think Dr. felt he and his interview also talked about on good responses in low doses in animals can you just talk about your confidence in being able to move forward and with it the right kind of immune response with with the low dose as opposed to the other doses that that you're testing.

Stephane Bancel: We are working to raise $2.4 billion to invest in the business and continue to build the leading mRNA company in the world. We are very thankful for investors for their trust. Partnership, as we build this unique company, we are energized by the opportunity ahead of us to build a new class of medicine. We are currently accelerating our development pipeline and readying the company to potentially file its first BLA for mRNA-1273, which will be, as you can appreciate, a historic moment for the company. We're investing in the processes to get us there, to get the right foundations for potentially many additional BLAs in the future, starting with the Zika vaccine and CMV vaccines behind the SARS-CoV-2 mRNA-1273. We are already scaling up the organization to address the need to supply up to a billion doses for our potential first vaccine, mRNA-1270.

Stephane Bancel: All those efforts, investments, and processes will be very enabling for additional vaccines and therapeutics to come. I have never been as excited and optimistic about the future of Moderna in the last nine years. We are humbled and excited by the opportunity to bring forward a new class of medicines for patients. That has been our North Star since we started the company. I would like to thank the great team of Moderna employees working very hard every day, and literally, many of them seven days a week now since January to fight the SARS-CoV-2 virus. I would also like to thank the many people who participate in our clinical studies, including patients, healthy volunteers, physicians, and nurses. I'd like to recognize all our partners that work with us to share our vision and help us to achieve this vision of helping patients. With that, we are now happy to take any questions. Operator.

Operator: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound or hush. Please stand by while we compile the case. Your first question comes from Matthew Harrison, and Morgan Stanley. Good. Good morning.

Matthew Harrison: Thanks for taking the questions. I guess, first, you highlighted the 50-microgram dose of the SARS-CoV-2 vaccine, and I think Dr. Fauci, in his interview, also talked about good responses and low doses in animals. Can you just talk about your confidence in being able to move forward and elicit the right kind of immune response with the low dose as opposed to the other doses that you're testing? And then, secondly, can you just update us on where the field is in figuring out what neutralizing antibody titers are and if you think they'll be available by the time you report initial data from the Phase 1 study? Thanks.

The right kind of immune response, however, you want to characterize neutralizing antibodies P.H., one versus T.H., two et cetera, the emerging data that we're seeing preclinically with a him on a 12 73 is all consistent with that.

Your final question on neutralizing empty buddies, yes, those essays are being stood up as we speak there'll be invalidated, they're being transferred to commercial vendors and the N.A.D. is actively looking that in parallel with you know the similar types of.

Stephane Bancel: So, this is Toe. Hi Matthew.

Binding anybody's, we expect to be able to report.

Stephane Bancel: Let me take that question. Two, you know, spot-on things that we're looking at. So, first of all, 50 micrograms is our current best guess. We, you know, this is short of data, and it's based, you know, as you've seen Tony Fauci's remark, on what we expect the platform could deliver. That being said, the final dose selection will really be a factor of, I think, three elements. The first is the overall sense of a dose response of, you know, how much more you get as you go up in dose. Because in the case of a pandemic, we obviously need to balance this with having enough doses available. And so, you don't want to unnecessarily overshoot.

Both kinds of data when we see the data from that phase one.

Great. Thanks for the thorough answer.

Your next question comes from <unk>, that's a J.P. Morgan.

No question.

Thanks for taking my questions I've got two of them for you as well. So I guess first can you talk more about what the phase three covert vaccine design might look like there's obviously nothing traditional about this program. So how should we be thinking about and I like the endpoints in term analyses and amount of follow up you think you need fried.

<unk> emergency use authorization or full approval.

And then my second question for you is regarding coven also regarding covert 19 there've been some conflicting reports out there on emerging mutations with the virus be very interested to hear your views on this and what it could potentially mean for the effectiveness of your vaccine. Thanks a lot.

Stephane Bancel: The second element is an understanding of what that dose could mean as you compare it to convalescent serum. And so, there's a lot of work being done on assay validation, and I'll get back to that in a minute, to understand what any given level of antibodies means, and the last. The other element that I think will enable us to connect the dots is understanding the performance of the vaccine and additional animal models of SARS-CoV-2, and then seeing, commensurate with the expected ability to protect those animals, what levels of titers do we get? The higher the species, the more reliable that data is. But ultimately, what we care about is being able to connect the dots for human disease. So it's a, it's a long story short, it's a best guess estimate for now.

Thanks, Cory this total take those questions. So.

The phase three design, let me make a couple of points any any pivotal trial in order to demonstrate advocacy as well as safety has to be placebo controlled and large enough so that.

The people among the people that you will vaccinate there will by chance occur cases, right and so it's a case driven design and you set your statistics based on what you expect to see and how many cases you expect to see him a placebo then how many fewer cases do you expect the vaccine to demonstrate.

Any such trial to be effective depends on three things how big it is when you start how good are you at predicting the attack rate in the population that you vaccinate because the data driven to design. Then you know we can vaccinate a whole lot of people, but if they end up for the month become not being exposed to the risk of.

Stephane Bancel: And based on the emerging data, and we will continue to refine it as more data becomes available. Your question about the right kind of immune response. Look, I think the data we've seen to date, both across the clinical trials, across the experience that we have in the preclinical models across the board. As I mentioned, in all the other clinical trials, we've routinely reported neutralizing antibodies as the measure of immunological success. And if you think about the kind of scientific first principles of how an mRNA technology presents an antigen from within the cell and mimics the instruction set that a virus would otherwise give the cell to make an antigen, we get the right kind of immune response, however you want to characterize it, neutralizing antibodies, Th1 versus Th2, et cetera. The emerging data that we're seeing preclinically with mRNA-1273 is

An infection. Then then we won't know whether the vaccine work and the third element is how good our vaccine or.

Is because the the higher the point estimate for the vaccine advocacy the clear their results are in the sooner you can find them.

Somewhere between those parameters, we are going to have to have a conversation it's ongoing between us or collaborators <unk> at the N.A.H. and ultimately F.D.A.

The length and follow up here and how soon can we see the data I think is a function of all those design elements as well as where you sort of set the bar for cases, and what expected benefit is.

No you asked a an interesting question on you know where does he way come into this weird as approval and what kind of interesting data one could expect.

So I think if <unk> as you get closer to it.

Stephane Bancel: Your final question on neutralizing antibodies: Yes, those assays are being set up as we speak. They're being validated. They're being transferred to commercial vendors, and the NIAID is actively looking at that in parallel with, you know, the simpler types of binding antibodies. We expect to be able to report both kinds of data when we see the data from that phase.

My sense is that we're not looking at a binary event in the sense that you know one day, we know nothing in the next day Assembly available for everybody I think as we learn more about the potential benefits first based on phase, one and two and potentially a surrogate they'd on animal models.

And an understanding what those levels could mean from convalescent germ, we will gain more confidence has the potential benefit of this vaccine we will still not be talking about in approval. We will not have a full safety database, but you start to generate in anticipation of potential benefit in the context of the raging pen.

Matthew Harrison: Your next question comes from Corey Kazimow of FGP Morgan. Please ask your question.

Corey Kazimow: Thanks for taking my questions. I've got two of them for you as well. So, I guess, first, can you talk more about what the phase three COVID vaccine design might look like? I mean, there's obviously nothing traditional about this program.

Corey Kazimow: So how should we be thinking about kind of like the end points, interim analyses, and amount of followup you think you need for either emergency use authorization or full approval? And then my second question for you is regarding COVID and also regarding COVID-19. There've been some conflicting reports out there on emerging mutations with the virus. I would be very interested to hear your views on this and what it could potentially mean for the effectiveness of your vaccine. Thanks a lot.

<unk>.

I think that's important.

The next step of data is then to get a sense that the vaccine to safe when given to a larger group of individuals and both healthy people people with gore or older with co morbidity than we need to go and build that safety database in the appropriate placebo controlled I mentioned.

And the final pieces, then to actually demonstrate clinical utility benefit and that requires to have an endpoint that's meaningful and I think that to end points that are relevant for thinking about a pivotal trial are going to be covert 19 disease. So however, you define disease, the appropriate symptom and <unk>.

Stephane Bancel: Thanks, Corey. I'll take those questions.

Stephane Bancel: So look, the phase three design, let me make a couple points. Any, any pivotal trial, in order to demonstrate efficacy as well as safety has to be placebo controlled and large enough so that, The people among the people that you will vaccinate there will by chance occur cases right and so it's a case driven design and you set your statistics based on what you expect to see and how many cases you expect to see in the placebo and then how many fewer cases do you expect the vaccine to demonstrate Now any such trial to be effective depends on three things, how big it is when you start, how good are you at predicting the attack rate in the population that you vaccinate?

G. severe already and having a <unk> biological confirmation and of course infection per se is also a relevant and point because we know that asymptomatic people.

Even if they themselves are asymptomatic. If you can prevent infection you will on a population basis actually prevent others from getting infected and them being sick. So there's that benefit to society here are preventing infection.

Even if less so to the individual <unk>.

So between the disease than point infection endpoint, I think that's where you're going to see the the pivotal trials into space emerge.

I hope that answers your question on the design as we get closer to it we lock it down with the N.A.H. and the F.D.A., we will of course be describing it in public.

Stephane Bancel: Because if it's a case-driven design, then you know, we can vaccinate a whole lot of people. But if they end up, in the months to come, not being exposed to the risk of an infection, then we won't know whether the vaccine worked. And the third element is how good our vaccine is because the higher the point estimate for the vaccine efficacy, the clearer the results are and the sooner you can find them. Somewhere between those parameters, we are gonna have to have a conversation. It's ongoing between us and our collaborators at NIAID.

Question regarding the emerging mutations we're all following that closely I would make two points here number one.

So far from what we've seen none of them mutations that have been described are expected to significantly interfere with binding or neutralizing activities.

Of Andy Buddies generated to the full length spike protein and here I would make the remind you that are important 812 73 actually in codes for the full length Spike protein.

Stephane Bancel: at the NIH and ultimately FDA. The length of follow-up here and how soon we can see the data, I think is a function of all those design elements as well as where you sort of set the bar for cases and what expected benefit is. Now you asked an interesting question on, you know, where does EUA come into this?

Ah I think the mutation that everybody kind of saw last week had to do with potentially increase miscibility, but that mutation doesn't necessarily alter the critical utilizing binding domains as we understand and so we're clearly watching this this this area closely like everybody else to assess the potential impact.

Stephane Bancel: Where does approval come from and what kind of interim data one could expect? So I think if, as you get closer to it, My sense is that we're not looking at a binary event in the sense that, you know, one day we know nothing, and the next day it's suddenly available for everybody. I think as we learn more about the potential benefits, first based on phase one and two, and potentially surrogate data and animal models, and an understanding of what those levels could mean from convalescent serum, we will gain more confidence as to the potential benefits of this vaccine. We will still not be talking about approval, and we will not have a full safety database, but you start to generate an anticipation of potential benefit. In the context of a raging pandemic, I think that's important. The next step of data is then to get a sense that the vaccine is safe when given to a larger group of individuals, both healthy people and people who are older with comorbidities. And we need to go and build that safety database and the appropriate placebo-controlled trial.

The second point, I'd say sort of with a more longer term vision should such a mutation arise and be relevant for the community of the population that's been exposed or the effectiveness of any vaccine I would contend that actually our platform is going to be uniquely suited to address that for two reasons.

Number one is as as we've demonstrated you can move very fast based on just understanding the sequence of and you mutation and you immediately generated vaccine.

Against it.

But importantly, as you look to the future one could envision a world, where if we've demonstrated advocacy and benefit against this virus and the appropriate randomized controlled trials.

If there's a slight mutation and you alter the vaccine to kinda chase the virus the past two approval and expected benefit for the next one shouldn't be much quicker and you can think of the way the world has evolved to deal with flu mutations whereby as soon as there was a new sequence that sequences actually put into production and.

Stephane Bancel: And the final piece is then to actually demonstrate clinical utility benefits, and that requires to have an endpoint that's meaningful.

Stephane Bancel: And I think the two endpoints that are relevant for thinking about a pivotal trial are going to be COVID-19 disease. So however you define disease, the appropriate symptomatology, severity, and having microbiological confirmation. And of course, infection per se is also a relevant endpoint because we know that asymptomatic people, even if they themselves are asymptomatic, if you can prevent infection, you will, on a population basis, actually prevent others from getting infected and them from getting sick. So there's a benefit to society here of preventing infection, even if less so to the individual vaccinee. So between a disease endpoint and an infection endpoint, I think that's where you're going to see the pivotal trials in this space. I hope that answers your question about design.

And and millions of doses of vaccines are generated you don't need to replicate the entire phase one through three development path every time, there's a minor mutation once you've established a platform. So as I look to the future I think we're we're in a very good place from the fundamentals of our platform to envision that that sort of a response to any rising mutations.

Okay. Thanks for the third responses and Great City impressive progress you guys are making.

Thanks for.

Again, the ladies and gentlemen, if he had a question at this time please press Taiwan on your telephone.

Yeah next question comes from.

That's okay. Please answer a question.

<unk> you might be on me.

Operator will come back to talk to them to go to the next question. Please.

Yes, Sir next question comes from solving <unk> Goldman Sachs.

Stephane Bancel: As we get closer to it, we will lock it down with the NIH and the FDA. And we will, of course, be describing it in public. Your question regarding the emerging mutations, we're all following that closely. I would make two points here. Number one: so far, from what we've seen.

Okay.

How many for.

Hello.

Well well, you're looking at challenging animal models, and then examining the the antibody levels and humans and and then the second question around you know with regard to supply and demand constraints.

Stephane Bancel: None of the mutations that have been described are expected to significantly interfere with binding or neutralizing activities of antibodies generated to the full-length spike protein. And here I would make the point that I would remind you that our mRNA-1273 actually encodes for the full-length spike protein. I think the mutation that everybody kind of saw last week had to do with potentially increased transmissibility, but that mutation doesn't necessarily alter the critical neutralizing binding domains as we understand them. So we're clearly watching this area closely, like everybody else, to assess the potential impact.

Salons that partnership.

You know really just kind of.

Where you I guess is that <unk> are you going to expand beyond that to kind of handle handle demand and supply.

This is tall, let me try and take your first question I think you got cut off but if I understood. You correctly, you asked whether we're running animal channel challenge models, and whether we will be able to connect the dots between those in what we see in human <unk> and I think the answer is yes or that work is ongoing.

It's been done in close collaboration with Ah Barney grams team at the University of the N.H. and the S.A. development work that is ongoing is being deployed so that we are able to connect the dots between the challenge models convalescent share and this year.

That we eventually expect to see from people who've been vaccinated. So I hope that answers that question Soviet let me turn it over to one to talk about doorstep entrepreneur Buffy Lonza question.

Stephane Bancel: The second point I'd say, sort of with a more longer-term view, should such a mutation arise and be relevant to the immunity of the population that's been exposed or the effectiveness of any vaccine, I would contend that actually our platform is going to be uniquely suited to address that for two reasons. Number one is, as we've demonstrated, you can move very fast based on just understanding the sequence of a new mutation, and you immediately generate a vaccine against it. But importantly, as we look to the future, one could imagine a world where if we've demonstrated efficacy and benefit against this virus and the appropriate randomized control trials, if there's a slight mutation and you alter the vaccine to kind of chase the virus, the path to approval and expected benefit for the next one should be much quicker.

[noise] Hello, This is which is what I'm, just keep technical operations and probably the officer on whether or not.

You take you then you take the second question that you have lots of brings <unk> in in supporting and manufacturing products worldwide launches capacity together with the capacity that we have you know, citing massachusetts in in the capability.

Will be a great health for for <unk> scaling up in the <unk> using the quantities. We we are going to manufacture to get it we'd loans the formulated balkanize fake that we will more partnership with existing.

Stephane Bancel: And you can think of the way the world has evolved to deal with flu mutations, whereby as soon as there's a new sequence, that sequence is actually put into production, and millions of doses of vaccines are generated. You don't need to replicate the entire phase one through three development path every time there's a minor mutation once you've established the platform. So, as I look to the future, I think we're in a very good place from the fundamentals of our platform to imagine that sort of response to any rising disease.

We think she's being C.M., most where she finished.

In distribution any if needed with anyone.

Thank you.

Thank you.

Thank you. Your next question comes from 10 10 events right. Please answer a question.

Great. Thank you can you hear me okay.

Yeah.

Great sorry about that before come running over and then.

Thank you for all of the hard work. It's been took an incredible run during the last couple of we can the companies really <unk> challenges Lawrence it's been kind of nice working with you and I'm wishing all the last two so my question.

C.M.V. and I know you guys have talked about sort of the.

Corey Kazimow: Okay, thanks for the thorough responses. It's great to see the impressive progress you guys are making. Thanks, Gordon.

Challenges tests were getting the final criticized for formal versus another thing I wanted to see if there's an update on that.

Operator: Thanks for attending. Again, ladies and gentlemen, if you have a question at this time, please press star one on your telephone. Your next question comes from Senator Piper. Please ask your question.

Whether or not there's any changes to the expectation for even the third quarter.

So how very general progress and investment in the vaccine Clark form will really help what you're doing and P.M.V. thing too much.

Stephane Bancel: Ted, you might be on mute. Operator, we'll come back to Ted. Can you go to the next question, please? Yes, your next question comes from Salveen Richter of Goldman Sachs. [inaudible] Hello, for all. Hello. Where you're looking at challenging animal models and then examining antibody levels in humans. And then a second question around, you know, with regard to supplying demand constraints is the Lonza partnership. You know, really just kind of where you are, I guess, is that are you going to expand beyond that to kind of handle demand and supply?

Thanks for the kind words. This is called let me try and take maybe both of those questions and stuff on can add on.

<unk> I believe we we remain on track and it's you can do the simple math here, if we've already vaccinated over 70% of people with the second dos and it's that critical hosts second dos interim analysis that should confirm or dose for phase three if you recall the data from the phase.

One with a much smaller numbers of subjects, we had pretty tight error bars in a pretty good understanding of the dose response curve now with a much larger study even if it ran into some <unk> sort of difficulty because of covert 19.

Stephane Bancel: This is Kyle. Let me try and take your first question. I think you got cut off, but if I understood you correctly, you asked whether we're running animal channel challenge models and whether we will be able to connect the dots between those and what we see in human vaccinees. And I think the answer is yes, that work is ongoing. It's been done in close collaboration with Barney Graham's team at the VRC of the NIH, and the assay development work that is ongoing is being deployed so that we are able to connect the dots between the challenge models, convalescent serum, and the serum that we eventually expect to see from people who've been vaccinated. So I hope that answers that question. Salveen, let me turn it over to Juan to talk about, or Stphane to talk about the Alonzo question.

We're going to be more than powered to understand the immunogenicity and the size was really driven not just by the need to understand immunogenicity, but also to validate the safety profile that we see here so confident that with the numbers of people that we manage to get into the secondary the amendment approach.

Cause mentioned for the remaining lesson 30%.

We will stay on track as we've discussed before to have the data and be able to move on.

<unk> our plans for phase three continue and remain fully on track for C.N.B. Your question on how it's preparing the platform I'll give you sort of a brief answer from approach of maybe medical in development and then I'll, let stiffen talk as it relates to the company becoming.

Juan Andres: Hello, this is Juan Andres, Chief Technical Operations and Quality Officer at Moderna. So, let me take you to the second question that you have.

Moving to its commercial life phase.

Juan Andres: Launcher brings an incredible track record of supporting and manufacturing products worldwide. Launcher's capacity, together with the capacity that we have at our site in Massachusetts, and the capability will be a great help for Moderna to scale up and also produce quantities. We are going to manufacture, together with Launcher, the formulated bulk, and I expect that we will have more partnerships with existing CMOs for fill finish and distribution, and, if needed, with new ones. Thank you.

The Kobe experience isn't it is is doing really three things for us it is accelerating or understanding of the safety and immune ingenuity at a much wider level for the platform sort of the leading edge of data, if you will and and I expect that the ability to run the large sample controlled trial.

And expand the safety database at a much more rapid manner.

Stephane Bancel: Thank you. Thank you. Your next question comes from Ted Tenev of Pfeiffer.

Then we had so far and phase ones will be informative for all of US. After the performance of this platform and here I sorta speak as a chief Medical officer with a kenai on safety profile of our platform. So far we've seen nothing unexpected and it's all been sort of consistent across the application but of course.

Stephane Bancel: Please ask your question. Great, thank you. Can you hear me okay? Yes. Great. Sorry about that before. Good morning, everyone. And thank you for all of the hard work.

Stephane Bancel: It's been just an incredible run during these last couple weeks here, and the company's really risen to the challenges.

Database of 1500 subjects will benefit greatly when we go into thousands with cope with the second element has to do with expanding or capability building up the development team that can.

Stephane Bancel: Lawrence, it's been so nice working with you and I'm wishing you all the best too. So my question actually has to do with CMV, and I know you...

Integrate and and bill to be a lay file.

Stephane Bancel: I know you guys have talked about sort of the...

Building up our competencies on the regulatory finds the pharmacovigilance et cetera. All of that ahead of a large phase three effort on C.N.B. I think is is a tremendous benefit for us.

Stephane Bancel: Challenges just with getting the final data set from the final verses and all those things I wanted to see if there was an update on that.

Stephane Bancel: [inaudible] Thanks, Ted, for the kind words. This is Paul.

Stephane Bancel: Let me try and take maybe both of those questions, and Stephane can add on. On CMV, I believe we remain on track. And you can do the simple math here.

And I was sort of let's the fun speak to all the other elements were this is accelerating the progress of our company.

<unk>, Hey, wanting to it I would just had a few things.

Stephane Bancel: We've already vaccinated over 70% of people with the second dose, and it's that critical post-second dose interim analysis that should confirm our dose for phase three. If you recall the data from phase one, with much smaller numbers of subjects, we had pretty tight error bars and a pretty good understanding of the dose response curve. Now, with a much larger study, even if it ran into some sort of difficulty because of COVID-19, we're going to be more than powered to understand the immunogenicity. And the size was really driven not just by the need to understand the immunogenicity but also to validate the safety profile that we see here. So, I'm confident that with the numbers of people that we managed to get into the second dose, the amendment of the protocol is mentioned for the remaining less than 30%, that we will stay on track as we've discussed before to have the data and be able to move on.

And I think <unk>, okay, too I used to eat to choose the power of a platform, which we create.

Some very possibly network effects, where you could take an example of something new we she had today, we cheese no we had to put it to you.

Type C. meeting.

Basketball, so around C.M.V. fall C.N.N.T. cell phone manufacturing.

As you can appreciate.

The dialogue with with the agency or on C.N.V. face cream.

Is going to be very instrumental in helping goes on the page we fall sauce coby tool among it's going to 73.

Because of.

The Oh I didn't see that the agent he has.

We've had had an amazing dialogue with the F.D. The response, even has you know seven days a week very engaged very willing to find able to wait to shave <unk>, making any self cuts on safety obviously.

So for these be any process that seems to be able to go for you know.

Stephane Bancel: And our plans for phase three continue and remain fully on track for CMV. Your question on how it's preparing the platform, I'll give you sort of a brief answer from the perspective of maybe medical and development, and then I'll let Stephane talk as it relates to the company sort of moving to its commercial life phase. The COVID experience is doing really three things for us. It is accelerating our understanding of safety and immunogenicity at a much wider level for the platform, sort of the leading edge of data, if you will, and I expect that the ability to run a large placebo-controlled trial and expand the safety database in a much more rapid manner than we have so far in phase one will be informative for all of us as to the performance of this platform. Here I So far, we've seen nothing unexpected, and it's all been sort of consistent across the application, but, of course, the second element has to do with expanding our capabilities, building up a development team that can integrate and build a BLA file.

In the next multiple from the.

Pinnacles tied and so on the manufacturing side.

Yes, we agency that'd be easy to ask a question. It's a good gratification quickly.

Oh really help us would it be interactivity keep moving the team <unk> for the digital infrastructure.

Thank God growing which is critical both on clinical and on C.M.C., then you're going to be able to use that's very quickly.

On <unk> on T.M.V.

I think that's only be very possible that we need to look in fact, I think I'll sometime.

I appreciate that because.

Most company does you know do not platforms.

As he because <unk> is what are your that'd be easy to to make more than very robust and to get tickets over next summer. So that's what we do and south would be to be a wise can be replicated much faster.

Stronger on on the cost C.M.V., an overview of a programs.

<unk>.

<unk>.

Stephane Bancel: Building up our competencies on the regulatory front, the pharmacovigilance front, etc., all of that ahead of a large phase 3 effort on CMV, I think is a tremendous benefit for us. And I will sort of let Stephane speak to all the other elements where this is accelerating the progress of our company.

We but it'd be very rapid Nina <unk> infrastructure, we'll give you updates on that's in the coming mouse.

But as you can appreciate what would that work doesn't happen very quickly on coby will help us on the of a product that's on the other company brightening standpoint, because as you got push it the more than that Brian as being transformed in the last few mouse because of the we noticed that soon as being was by companies. There's some other pulled up cover that besides me too.

Stephane Bancel: Thanks, Pat. Morning, Ted. I would just like to add a few things.

Stephane Bancel: And I think Kyle started to allude to it, which is the power of a platform, which really creates... Some very powerful network effects, where if you take an example of something new we share today, which is, you know, we are the positive. Type C meeting last quarter around CMV for CMNT, so for manufacturing. As you can appreciate, this dialogue we had with the agency around CMV phase 3. He's going to be very instrumental in helping us on phase three for SARS-CoV-2, mRNA-1273, because of the urgency that the agency has. We've had an amazing dialogue with the FDA. The responsiveness, you know, seven days a week, very engaged, very willing to find every way to shave a day off the process without making any shortcuts on safety, obviously.

Can you call around so I think the momentum of of more than that he's gonna be extremely strong and extremely enable by the sauce Kobe to be there fighting process.

That's super helpful. Thank you very much.

Thanks.

Thank you once again to ask a question you want me to press.

The phone.

Mm.

The next question comes from this <unk>.

They're supposed to answer questions.

Hi team. Thank you for the continued amazing progress that you're making day every day I'm too quick question see yeah with the first class and he is related to.

You are you defining eight caught offside interface to you mentioned there will be a cohort of patients who are 55 in about it there may be a range above what you're not going to be going up there and then if you're going to be a cool word among the fee.

Stephane Bancel: So for this BLA process that we should be able to go through, you know, in the next month, both on the clinical side and also on the manufacturing side, this access to the agency, this ability to ask questions, to get clarification quickly, will really help us really build that capability within the team, the processes, all the digital infrastructure, you know, data gathering, which is critical, both on clinical and on CMC, then you're going to be able to use that very quickly on Zika, on CMV, and I think that's going to be very powerful. The network effects, I think, are sometimes underappreciated because most companies, as you know, do not have platforms, whereas here, because mRNA being an information molecule, there's really an ability to make Moderna very robust and to take it to the next level, so that what we do on SARS-CoV-2, BLA-wise, can be replicated much faster and much stronger on Zika, CMV, and all the other programs.

<unk> three that are healthy sort of far at highest risk given that maybe they have obesity or cardiovascular disease. How are we thinking about the eastern population that right. The high stress to incorporate that into this needs to see three enrolled me.

And the second question is in regards to manufacturing.

You could help us understand what is single larger I know when it comes to scaling m., Arnie therapeutic and things and making it in your class.

Hi, This is tall, let me, let me start by entering clinical ones and then I'll that want to take the manufacturing question.

The interface to there is no upper limits I think above 55, you've seen the N.H. phase one sort of parks it out a little bit more finally, I think for US we're going to take all comers above 55 with no upper age limit in terms of your question on cohorts at higher risk for disease should they.

I didn't affected this relates to both the elderly and people with the distinct co morbidities as we build a safety database, obviously, we need to get there, but get the responsibly I think the face to the initial sort of expansion into larger numbers is people that do not have.

Stephane Bancel: I think it will be the same things around commercial, you know, with the arrival of Patriot. We are going to build a commercial infrastructure very rapidly. We'll give you updates on that in the coming months. But as you can see, all that work that's going to happen very quickly on COVID will help us on other products, not only from a company branding standpoint, because, as you know, the Moderna brand has been transformed in the last few months because of the results that the team has been able to accomplish, but also at the product level, at the scientific level, at the clinical level. So I think the momentum of Moderna is going to be extremely strong and extremely enabled by the SARS-CoV-2, the antibody process.

Hi risk of disease should they get infected in the phase three we will clearly then open it up and we will do that in a manner. That's responsible and takes the appropriate intrim looks to make sure that we expand into that population who needs. It the most of them way that so that's careful and that's.

Going discussion, obviously between us and I had an F.D.A. how to best achieve that so.

Stephane Bancel: That's super helpful. Thank you very much. Thanks, guys.

Let me that one take your manufacturing question.

Okay things are things for the question, obviously, one of the one of them gnomes with discussed before we take assumptions associated with those.

Operator: Thank you once again. To ask a question, you will need to press star 1 on your telephone.

Yasmine Rahim: Your next question comes from Yasmine Rahim, from Efrat Capital Partners. Please ask. Hi team.

And then in terms of the industrialization of the.

The product obviously, we're we're working very hard you seem bringing the equipment.

Yasmine Rahim: Thank you for the continued amazing progress that you're making day over day. Two quick questions for you. The first question is related to how are you defining the age cutoff for phase two, you mentioned there will be a cohort of patients who are 55 and above? Is there maybe a range above which you're not going to be going after?

Bringing the raw materials premium to people to delete. These together us we scale up item things that he's a a very simple unknown in those we have done these before probably not at the scale of which we are I'm going having the partnership with loans gives me a tremendous computer.

Yasmine Rahim: And then, is there going to be a cohort among phase two? And as you're thinking about phase three, which are healthy but are at highest risk, given that maybe they have obesity or cardiovascular disease, how are we thinking about this patient population that is at highest risk to incorporate that into phase two and phase three enrollment? And then the second question is in regards to manufacturing. If you could help us understand, what is the single largest unknown when it comes to scaling up mRNA therapeutics? And thank you for taking your question.

That that that we are going to be doing these very rapidly and obviously a speedy suburbia since I'm I'm, bringing these three things together he's flawed what do you still have out and.

Yeah.

Yes mean, just to to let some <unk> <unk> 12, and one and D. leadership teamwork.

As you know he and.

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I have all come from an organization.

Yeah, My not you know very dog manufacturing complex on you the action.

Have another <unk>.

They know that every extra meet again, those we can get out of all system.

We'd be helping other people so I'm very thankful for the team. They are usually working seven days a week.

Stephane Bancel: Hi, this is Carl. Let me start by answering the clinical ones, and then I'll let Juan take the manufacturing questions. In our Phase 2, there is no upper limit. I think above 55, you've seen the NIH Phase 1 sort of parse it out a little bit more finely. I think for us, we're going to take all comers above 55 with no upper age limit.

You know, putting all night tales to to shave. We then we can so that we can what are you maximize the multi outputs overseas them and I'm tremendously Thankfully program.

<unk>. So I, we were very grateful for all the work that everyone has Madonna.

Huh.

Humanity.

Thank you.

Your next question comes from just mention I think if America Professor question.

Stephane Bancel: In terms of your question on cohorts at higher risk for disease, should they get infected, this relates to both the elderly and people with distinct comorbidities. As we build a safety database, obviously, we need to get there, but we need to get there responsibly. I think the Phase 2, the initial sort of expansion into larger numbers is people that do not have a high risk of disease should they get infected. In Phase 3, we will clearly open it up, and we will do that in a manner that's responsible and takes the appropriate interim steps to make sure that we expand into that population who needs it the most in a way that's careful. That's an ongoing discussion, obviously, between us and the FDA on how to best achieve that goal. Let me let Juan take your manufacturing questions.

Hey, guys. This is Alex gone for Jeff. Thanks for taking our question and Lawrence We're sorry to see you go but assuming you're moving out in the bigger and better things. So my question is on capital allocation in the near term.

You reiterated you're 2020 expense guidance, but I was hoping you could give a bit more color and it gives and takes within that vis-a-vis affects versus cat backs and how much manufacturing belt out and commercial readiness activities for coping 19 are reflected within that.

And my second question is on the commercialization fun do you intend to take the vaccine forward yourselves or do you think they will take partnering.

Scale or with the U.S. government potentially step in as well any <unk> color you can get a here and if there's some historical context, it could point to that'd be great. Thanks.

Stephane Bancel: Okay, thanks for the question. Obviously, one of the unknowns was discussed before, which is the assumptions associated with those. And then in terms of the industrialization of the product, obviously, where we're working very hard is in bringing the equipment, bringing the raw materials, bringing the people's capabilities together as we scale up. I don't think there is a single unknown in those.

Yeah, It's Lawrence on let me handle the financial question.

Respect to the guidance and the components so.

As I mentioned around sort of the the the the pre coded business. If you will do a I'd I'd mentioned, but we're seeing a bit of a slow down and expenses IBEX related to.

Juan Andres: We have done this before, probably not at the scale at which we are going. Having the partnership with Lonza gives me tremendous confidence that we are going to be doing this very rapidly. And obviously, speed is at the essence. Bringing these three things together is what it's all about.

You know lab work and some of the clinical trials as we've noted into those those expenses will.

Will be coming down a relative to what we thought one we originally set up time.

The off that is is investments that we are making to be ready for all that's coming down the road. We've mentioned this the the rapid a acceleration of until the vaccine timelines. There's a lot of we need to do the company to be ready for potentially being commercial on 2021.

Stephane Bancel: That's something we are extremely fortunate to have one and this leadership team. As you know, he and the team have all come from large organizations. They have managed, you know, very large manufacturing complexes. We have a lot of experience. They know that every extra million doses we can get out of our system will be helping a lot of people, so I'm very thankful for the team. They are literally working seven days a week, you know, pulling all-nighters to shave every day we can, so that we can really maximize the monthly output of the system. And I'm tremendously thankful for them.

So the those offset we will continue to update you all his view as me.

The other scope those investments in I mean, that's me move forward with respect to <unk>. It is not a a huge component here right now.

Yasmine Rahim: Thank you, Stephane. And so are we.

Of the of the anticipated budget, mainly because of the leverage we've got in in the platform as well as the the the benefit of having a a great partner like logic on board.

Geoffrey Christopher Meacham: We're very grateful for all the work that everyone at Moderna is doing on behalf of humanity. Thank you. Your next question comes from Jeff Meechan of Bank of America. Please. Hey guys, this is Alec on behalf of Jeff. Thanks for taking our question. And Lawrence, we're sorry to see you go but assume you're moving on to bigger and better things. So my question is about capital allocation in the near term. You reiterated your 2020 expense guidance, but I was hoping you could give a bit more color on the gives and takes within that, vis-a-vis OPEX versus CapEx, and how much manufacturing buildout and commercial readiness activities for COVID-19 are reflected within that.

And again will continue to update that died and should anything change.

And then the last thing I I would just reiterate is that there is substantial IBEX expected with respect to the the kind of the vaccine work being funded by Barney the clinical development that scale up at that that will be paid for bye bye bar to reimburse.

On a a very rapid cycle time, and so that's why I mentioned that there would be at us nationals expensive reimbursement through the course of the year and it would substantially offsets.

Alec Warren Stranahan: and My second question is on the commercialization front.

Yes, <unk> and Alex on commercialization as you can't up where shape.

Alec Warren Stranahan: Do you intend to take the vaccine forward yourselves, or do you think it will take partnership to deliver it at scale, or would the U.S. government potentially step in as well? Any color you can give here?

As we said before the case of C.M.B.

<unk> and the K.P.B.D.T.N., you're missing to sell the product you know how their coffee countries.

Lawrence Kim: Any historical context you could point to would be great. Thanks.

Stephane Bancel: Hey, Alex, it's Lawrence. Let me handle the financial question. With respect to the guidance and the components, so, as I mentioned around sort of the pre-COVID business, if you will, I mentioned that we're seeing a bit of a slowdown in expenses, OPEX, related to, you know, lab work, and some of the clinical trials, as we've noted. And so those expenses will be coming down relative to what we thought when we originally set out guidance. The offset is investments that we are making to be ready for all that's coming down the road. We've mentioned this, the rapid acceleration of the COVID vaccine timelines, and there's a lot that we need to do as a company to be ready for it to potentially be commercialized in 2021.

Fosco be cool I think it <unk>.

To think about the product into different time horizon.

Raise a pandemic phase.

And we feel you see we all at all and then we believe as a company.

<unk> T. for this product in the endemic phase because we do not believe these viruses going away.

So from a pandemic phase.

He's going to be mostly a partnership governments.

So in that case, you know you don't that's going to send him an action.

Yeah, a complex sets of potential buyers.

Because we are going to be as we discussed at the at the global Ovelar Crosby industry, we've been there <unk> for some time.

Which is why as we sit them you keep many times we are seeing for everybody was working on the vaccine and we're hoping that many vaccines are going to finish line because if you think about it.

Stephane Bancel: And again, we'll continue to update that guidance should anything change. And then, the last thing I would just reiterate is that there is substantial OPEX expected with respect to the COVID vaccine work being funded by BARDA, the clinical development that scales up, but that will be paid for by BARDA, and reimbursed on a very rapid cycle time. And so that's why I mentioned that there would be this matching of expense and reimbursement through the course of the year, and that would substantially offset.

Actually very few companies.

<unk> manufacturing scale.

He's requiring full the task ahead.

And I already in the clinic, meaning they can have a shawl to meet them impact.

We've had a vaccine.

You know if the and they just a couple of companies I, that's those two things.

Lawrence Kim: Yes, thanks, Lawrence and Alex, for commercialization. As you can appreciate, as we've said before, with the case of CMB, you know, we did not anticipate the capability and investment to sell the products in 140 countries. For SARS-CoV-2, I think it's important to think about the product in two different time horizons. There is a pandemic phase, in which obviously we all are.

So if you think about <unk> very supply close friend World in Twentytwenty wine.

He's going to be most people knowing forgotten man so that they will be a location in the different geographies. You know we've been looking at them for example in the U.S.

To decide who gets a vaccine that's we know it'd be appropriate.

So we intensive costing you a <unk> gunmen spec, we've already done with NIAD and those companies fluoxetine fall for a few years you know can you come on recently, we've <unk> and <unk> I assume the C.D.C. to be able to supply <unk> go on my.

Stephane Bancel: And then we believe, as a company, there's an opportunity for this product in the endemic phase because we do not believe this virus is going away. So for the pandemic phase, it will be mostly a partnership with the government. So in that case, you know, you don't necessarily have to necessarily manage the complexities of potential buyers because we're going to be, as we discussed, at the global level across the industry, supply constrained for some time, which is why, as we said publicly many times, we are rooting for everybody who is working on the vaccine. We are hoping that many vaccines are going to the finish line because, if you think about it, there are actually very In my opinion, they're just a couple of companies that have those two things.

Those is fall them could beside the location that makes sense on the country.

Great. Thank you and congrats on the rapid progress.

Thank you.

Yeah.

You're an X. question comes from Alan Carers need our names.

The real question.

Hi.

Taking the question.

I had a couple of them.

Okay.

Success with vaccines.

Are you able to.

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Design.

Thursday 16 programs.

Update on 15 45 and.

I see anybody.

How long.

Hi.

Yeah.

Any other question is.

Over 19 program.

Feasible to have.

Hmm.

Yeah.

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Mm.

Oh.

Yeah.

So let me stop maybe we were first question on the B.B.N. <unk>.

As you know, we do not guide programs timelines. So the T.V.'s working on events in Grozny pulled on boxing <unk>, Oh stable, it's would've given no time lines and we will not give timeline on the weekends as you appreciate through the movie.

Alec Warren Stranahan: And so if you think about it in a very supply-constrained world in 2021, it's going to be mostly partnering with governments so that they will do the allocation in the different geographies. You know, we do not intend, for example, in the U.S., to decide who gets the vaccine. That will not be appropriate. So we intend to continue our partnership with the U.S. government, like we've already done with NIAID and Dr. Tony Farshid's team for a few years, as you know, and in the clinic more recently, with BARDA, and eventually, I assume, the CDC, to be able to supply the U.S. government with doses for them to decide on allocation. That makes sense for the country. Great, thank you, and congrats.

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Timelines, where we get close up some kind of lipsticks given up on.

And especially we've we've been soft coby too.

You end up and they make and given the suffering around the world. We think it's important to communicate all based ponds and I I hope ever we'd appreciate that when we say we aim to sell their face we are at least some other he is the best <unk>.

P. things can get <unk>.

Operator: Thank you and congrats on the rapid progress.

But silver already programs run a communicating.

Operator: Thank you.

Operator: Your next question comes from Alan Kerr of Neudem & Company. Please ask your question. All right, thanks for joining us.

Do you want to take the the <unk> data question, Yeah, Yeah, Yeah. It's a good question I believe we should be able to have a sense of the cases and a potential early look by the end of the year, but again that is a function of how soon can we start how big.

Alan Kerr: You are taking my questions and congratulations on your progress. I've got a couple of them in your increased focus and Success with Vaccines. Are you able to accelerate or what sort of extra emphasis are you putting on these early stage vaccine programs? Can you give us an update on 1345 and 1189, the RSV and EBV programs that are internal? How are those moving along? And I know you don't give high-resolution info on timelines, but to the extent you can, then the other question is around your COVID-19 program, to what extent is it feasible to have, even in an interim analysis, your new plan phase three trial in 2020?

The trial is and how good are we at Immunizing people, who are then at risk for cases occurring because as I mentioned it will end up being a a case driven designed to be able to analyze it and we'll share the day that we'll we'll show the details any expectations once we locked down the design with our partners and better.

With the the agency.

Oh.

Stephane Bancel: So, let me start maybe with your first question on EBV and RSV pediatrics. As you know, we do not guide our program's timeline. So the team is working on advancing those important vaccines as fast as possible, but we have given no timelines, and we will not give timelines. On the return, as you have appreciated over the quarters, to give timelines where we get closer to late-stage development, and especially with SARS-CoV-2. [inaudible] Kyle, we want to take the COVID interim data question.

Could be just a U.S.

Right.

You go global.

Right.

Oh.

I mean, if we're talking about.

The possibility of that.

Manager trial.

Oh.

Are you contemplating that two or is it.

The trial.

Yeah.

And they're doing everything.

Yeah.

Yeah, well so so let me take take both questions in turn.

Stephane Bancel: Yeah, yeah, yeah, it's a good question. I believe we should be able to have a sense of the cases and a potential early look by the end of the year. But again, that is a function of how soon we can start, how big the trial is, and how good are we at immunizing people who are then at risk for cases. Because, as I mentioned, it will end up being a case-driven design to be able to analyze. And we'll share the data; we'll share the details and the expectations once we lock down the design with our partners and vet it with the agency.

This first pivotal trial, there's going to be a partnership with a knife with the N.A.H. So it will be at this stage either sold or predominantly U.S. trial work in parallel looking at opportunities to launch parallel pivotal trials in Europe and globally, because I think ultimately.

More data we have here the wiser we will be.

Stephane Bancel: Do you expect this to be just a U.S. trial, or would you go global? Another follow-up to this is, to what extent? I mean, I've heard talk about the possibility of a larger trial with multiple vaccines. Are you contemplating that too, or is this the trial that you're planning to face? Candidate.

Okay.

I think can you. Please remind me your second question.

Yeah, Okay, I think you answered and that was I was wondering yeah.

Yeah.

Contemplated.

Wow.

Oh right right the multi on trial yeah.

Stephane Bancel: So let me take both questions in turn. This first pivotal trial is going to be a partnership with NIAID and the NIH. So it will be, at this stage, either a sole or predominantly U.S. trial. We're, in parallel, looking at opportunities to launch parallel pivotal trials in Europe and globally because I think, ultimately, the more data we have here, the wiser we will be. I think so, can you please remind me of your second question?

Yeah, Yeah yeah.

So there's been a lot of talk about that both on the W.H. So site as well as the in ages as you can clearly into it it's not front and center in my brain for two reasons first is we expect to be the first one out there for a pivotal trial and so we just have to get on and and and demonstrator.

Stephane Bancel: Well, I think he I think he answered it. I was wondering if she was contemplating a trial. [inaudible]

<unk>, our sex scenes potential Oh, but the second one is more fundamental I think it is important for the field to use more or less concern.

Stephane Bancel: So there's been a lot of talk about that, both on the WHO side as well as the NIH, but it's not front and center in my brain for two reasons.

[noise] case, where it actually makes sense to run many vaccines in a single trial, it's not like we're lacking for volunteers, who would line up to be immunized and understand the benefit of the vaccine and frankly the epidemic.

Stephane Bancel: The first thing is that we expect to be the first one out there for a pivotal trial. And so we just have to get on and demonstrate our trial, our vaccine's potential. But the second one is more fundamental. I think it is important for the field to use more or less [inaudible] that would make that, you know, add any scientific value. So for my, this is a personal opinion here; I question the merits of that design from a scientific and a public health need perspective. I think what's critical here is that for every vaccine candidate that Stefan alluded to, we're going to need more than one of them. It matters less whether there's a few percent difference in the apparent estimate of point efficacy. What matters is that you know it works, and you're able to scale it up and make it available to those who need it the most.

Is so unpredictable and where it shows up to what degree and how it comes down that there is no expectation of a consistency of attack rate overtime that would make that you know add any scientific value. So from my there's a personal opinion here.

I question, the merits of of that design from a scientific and public health need perspective, I think what's critical here is that for every vaccine candidate as to fund alluded to we're gonna need more than one of them but.

It matters less whether there's a a few percent difference on the appearance estimate of the point efficacy. What matters is you know it works and you're able to scale it up and make it available to those who needed the most.

Govind Singh: Okay, thanks very much. Your next question comes from Govind Singh, BMO. Please ask your question. Hi, everyone. This is Govind on for George. Just thanks for taking our questions. Two on 1273.

Okay. Thanks very much.

Yeah.

[noise] [noise]. Your next question comes from <unk> is being know disaster question.

Hi, everyone is it going on for George.

Thanks, taking our question two on the 12 73. The first one would be can you help us understand if there's any profit share agreements in place without any other parties, including that h. around the vaccine and just how do you guys see the commercial landscape evolving with so many other vaccine candidates and development.

Govind Singh: The first one would be, can you help us understand if there are any profit share agreements in place with any other parties, including the NIH, around the vaccine? And just how do you guys see the commercial landscape evolving with so many other vaccine candidates in development? And then maybe to follow up on Naya's comments about the preclinical results that they saw. I understand they're probably doing their studies separate from you guys, but maybe you can help us understand what kind of preclinical results you've seen and when this data will be presented? That'd be really helpful. Thanks a lot.

And then just to follow up maybe with a nyets comments about their preclinical result that they saw I understand they're probably doing their studies separate from you guys, but maybe you can help us understand what kind of preclinical without new scene and when might this data be prevented that'd be really helpful. Thanks a lot.

Stephane Bancel: Yes, so it's Stephane. I'm going to start, and then the team might take the pieces I dropped. So it's pretty, as Tyler said; there's preclinical work being done both in our labs and at NIAID by Dr. Tony Sparks' team. As soon as we have a body of data that makes scientific sense and is complete and holistic, we intend to publish that work. So as soon as it's public, you'll be aware. In terms of the profit share, we have not disclosed any previous arrangements. So I will not comment on that one. And what was your other question?

Yeah, So it's different I'm going to stop and then the team I think the P.C.'s I drove so.

That's pretty S.S. tested as per can you can work being <unk>, an I.D., but <unk>.

As soon as Vayser. Both you know they found that makes sense. Because then sends complete that and what do you speak we intend to publish network. So so that's one of these public year you'd be you'd be aware.

Income off the <unk> shall we have no do schools previously or any arrangement, so <unk> and what was your question.

Stephane Bancel: [inaudible]

Stephane Bancel: The commercial landscape and how other coronaviruses will affect it.

The commercial landscape and how other <unk>, yeah, I've seen yeah.

Stephane Bancel: Yeah, thank you. So on the commercial landscape, as I briefly mentioned a few minutes ago, as you know, I mean, there are 100 plus, last time I checked on Wikipedia, vaccine candidates being worked on around the world. The thing I think that is important is manufacturing scale and where those projects are in the respect of the clinic. As I said a few minutes ago, I believe that the project at this stage in research with a group that doesn't have the ability to do 10 million doses per month, ramping up to, you know, hundreds of millions per month is not going to be able to have a big damper. [inaudible] In the start lane, my sense is that very few are going to get to the finish line. With manufacturing scale, that matters. One or two million doses a year is not going to be very helpful at the global scale.

Yeah. Thank you so on the <unk>.

Mentioned, a few minutes ago.

As you know I mean that hundred plus that's not my check on we keep it yeah vaccine candidates being walked on her on the well.

But the thing I think that's valuable than ease.

You know manufacturing scale them.

And where all this project in the.

And we <unk>.

As I said, a few minutes ago.

I believe doesn't portray with these states in research, we've a group that <unk>.

Off millions of those is the mall ramping up to you know 100, <unk>, he's not going to be able to have a big Dan.

On do you spend any.

So if you use those two as a screen that.

She's with that we do I think you end up with very few number <unk>.

I began attempting to twentytwenty ones I'm pregnant.

To have an impact on <unk> I quite a ways in drug development not every company that he's going to get to we're finished line.

Govind Singh: Thank you for your help and all the progress you've made.

Operator: Your next question comes from Justin King is a. Hi, this is actually Hartaj on behalf of Justin. So one thing, first, Lawrence, thank you so very much. It was a real pleasure working with you, and I look forward to seeing you again sometime in the future. And then secondly, just to Moderna, for all the work that you're doing, I think people, a lot of people really don't understand just the compression of the timelines that you and the government are engaging in. It's really, really a thing of beauty.

And that <unk> you paid that once a few vaccines on this stage all of <unk> a lot of your L.U. project might just stopping investing because gotten Ukraine <unk>.

For something that might have no commercial and so I think what it means that other people.

Stock Lane my sense is very few of them to get to it could just flying.

We've manufacturing skin that the mattress.

Why not to me again, you know those these are yeah.

The very helpful.

Okay.

Thank you for your health and all the progress.

Thank you.

The next question comes from Justin King is okay.

Interesting request.

[noise] hi.

It's actually a hard time on for Justin So one thing first Lawrence. Thank you. So very much it was a real pleasure working with you I look forward to asking you again sometime in the future and then secondly, just them or Ghana, all the work that you're doing I think people a lot of people really don't understand just.

Justin King: So two questions. One is manufacturing, and the second is regulatory strategy worldwide. So on manufacturing, if you could just talk a little bit about, you know, going from clinical to commercial batches. I know you've talked about going from millions, tens of millions to now a billion with Lonza. Can you just talk broadly about the timing? You know, when can you go from that clinical stage?

Pressure on the timeline that that you and the government or engaging it's really really thing of beauty knock on wood. So two questions one in [noise].

And a second on regulatory strategy a worldwide. So on manufacturing if you just talk a little bit about you know going from clinical to commercial batches I know you talk.

On about going for millions tens of millions to not doing that long that can just pop broadly about the timing you know when can you go from that clinical I know you mentioned that long as I was stock manufacturing perception in July and how that maps against and B.L.A. you know that you'll be starting to file and then secondly on regulatory strategy you know Japan.

Justin King: I know you mentioned that Lonza will start manufacturing the first batches in July and how that maps against the BLA that you'll be starting to file. And then, on regulatory strategy, you know, Japan just approved Remdesivir. I guess the EU is going through an approval process, a fast approval process for Remdesivir. So how are you thinking of the worldwide approval strategy, aside from the United States, where I assume you'll file the BLA towards the end of the year? And thank you for the question.

And just approved that severe I've I guess, you isn't going to an approval process.

For hospital, plus that's where I'm guessing here, so hardly thinking of the worldwide approval strategy aside from the United States, where I assume file to be only towards the end of the in Texas for the question.

Yeah. So <unk> the money then you'd be stuck because on manufacturing, we haven't done not done and not sharing a precise.

Stephane Bancel: Good morning. Let me start quickly on manufacturing. We have not done and not shared a precise output per month. What we've said is that given we're ramping up both Norwood, which we say could do up to 100 million doses per year at the 50 microgram dose. As you can see, every month this year, every month next year, the output per month is going to increase. And so the team is working as hard as they can because they do understand, trust me, that every extra, you know, 100,000 virus we get out of the system protects more people, we will slow down the spread of this virus. And so it's not a linear, you know, process where you start now at 100 million, and those come up, of course not.

With a mall once we've said is that.

<unk> you know, both Norwood, which we think we do up to 100, <unk> Oh, yeah at the 50 micrograms those.

And then that owns outside as you can.

I appreciate 50 every mall D.C. yeah.

Next yeah, the output Kemal is going to increase.

And so the T.V.'s working as how does it can cause they <unk>. They do understand trust me that every extra you know 100000 vida, we'd we'd get out of a systemic when we protect more people are we still don't the spread of these virus and so.

No the leading the out you know process, where you stop now autonomy. Then you know those from multiple of costs not so he's just going to be an exploration process, which is why these dialog we've been going on.

Stephane Bancel: So it's just going to be an acceleration process, which is why this dialogue with the government in terms of allocation, and we're going to be hand in hand for quite some time, where as soon as the product is made, NQCD will go to the government, and then they'll decide how they allocate it, and we'll just kind of be on a regular basis. Charlie, you want to take the regulatory question, maybe?

Location, and we're gonna be hand to mouth for quite some time, where I suppose in a product is made and you see the legal.

If we're going let them and then decide to locate then we just kind of be on a regular basis.

He wants to take the regulatory question maybe.

Stephane Bancel: Yes. Thanks, Stephan, and thanks, Hartaj, for the question. Look, we're in active dialogue now with regulators beyond the U.S. I think having the partnership with Lonza is a huge enabler to imagine the ability to scale up and eventually supply the vaccine on a global scale to those who need it the most. That will take shape over the coming weeks and months. The expectation I have is that we will do more than one trial to demonstrate the benefit. That being said, at a certain point, we're going to have data both for potential benefit and ultimately for benefit. By and large, that data should be applicable for filing in other territories, and so we're actively mapping it out, and our intent is absolutely to eventually be able to make this vaccine available to those who need it the most.

Yes, thanks to find them. Thanks Hurts us for the question look we're we're we're an active dialogue now with a regulators beyond the U.S. I think having the partnership with lawns a is a huge enabler to envision the ability to scale up and eventually supply the vaccine on a global footprint to those who needs. It the most.

That will take shape over the coming weeks and months.

The expectation I have is that we will do more than one trial to demonstrate the benefit that being said.

A certain point, what was going to have data both potential benefit and ultimately for benefit.

Large that they need should be applicable for filing and other territories and so we're we're actively mapping it out in our intent is absolutely to eventually be able to make this vaccine available to those who needed most.

Stephane Bancel: Great. Thank you for all the questions. Thank you.

Thank you for all the question.

Thank you.

There are no freighter questions that'd be fine.

Operator: There are no further questions at this time. Presenters, you may continue.

<unk>.

Stephane Bancel: So thank you so much everybody for participating, and we look forward to talking to you or seeing you at the latest on June 2nd, Science Day.

So I think there's so much I've already for about two pay thing and it would've <unk> talking to you are seeing you the latest on June 2nd.

Probably not enough times there yet.

Operator: Thank you very much. Have a good day and stay safe. Bye-bye.

Oh, Thank you very much I have a good then if they have I.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now...

Ladies injunction on different <unk>, thank you for participating.

[music].

Operator: [inaudible]

Operator: BF-WATCH TV 2021