Q3 2020 Moderna Inc Earnings Call

Good morning, and welcome to my during this conference call.

Unknown Executive: Good morning, and welcome to Moderna's conference call. At this time, all participants are in a listen-only mode.

At this time all participants are in a listen only mode.

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

Following the formal remarks, we'll open up the call for your questions.

Please be advised that the call is being recorded.

At this time I'd now turn the call over to Levine to loop.

Okay Investor Relations I'm wondering please proceed.

Thank you good morning.

Any everyone and welcome to the journalist third quarter 2020, <unk> conference call to discuss financial results and business update you.

Unknown Executive: And welcome to Moderna's third quarter 2020 conference call to discuss financial results and business. You can access the press release issued this morning, as well as the slides that we'll be reviewing, by going to the investors section of our website. On today's call are Stphane Bancel, our Chief Executive Officer; Dr. Chauzak, our Chief Medical Officer; Stephen Hoge, our President, and David Mouin, our Chief Financial Officer.

You can access the press release issued this morning as one of the slides that will be if you're feeling by going to the investors section.

Right.

On today's call are defined bombshell water seeps Executive officer child tax, our Chief Medical Officer, Stephen Holt, President and David Windley, Our Chief Financial Officer.

Unknown Executive: Before we begin, please note that this conference call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Security Litigation Reform Act of 1996. Please see slide 2 of the accompanying presentation and our FTC filings for important... that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. We undertake no obligation to revise the information provided on this call as a result of new information or future results or developments. Thank you, Lavina. Good morning or good afternoon, everyone.

Before we begin please note that this conference call will include forward looking statements made pursuant to the safe Harbor provisions of the pie.

The Securities Litigation Reform Act of 1995, please see slide two of the accompanying presentation in our FCC findings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied.

Looking state.

We undertake no obligation to revise the information provided provided on this call as a result of new information future results for development I will now turn the call over to Stefan.

Thank you let me know.

Morning.

Hi, everyone.

Stphane Bancel: I hope all of you and your loved ones are in good health and remain safe. Thank you for joining our Q3 Business Update conference call. I will start by reviewing key highlights. I would like to focus on three topics.

I hope all of you and your loved ones are in good hands and women site.

Thank you for joining Aqua free business update conference call.

I will start we will retain key highlights.

I would like to focus on three topics so it'll.

Stphane Bancel: First, our COVID-19 vaccine. Second, our broader development pipeline. And finally, funding.

I'll be 19 vaccine second.

Well, Doug people up month pipeline and finally.

Coupon interest.

Stphane Bancel: As many of you know, we completed enrollment in our Phase III Co-Study for mRNA-1275. 30,000 participants have been enrolled in the study, 37% of whom are from diverse communities. I will give you some details in a few minutes.

As many of you know we completed enrollment of offerings free cope study for and on its website at <unk>.

So if you follow them, but sometimes I'd been enrolled in the study.

57%, Oh poop off from diverse communities.

I will give you some details in a few minutes.

Stphane Bancel: We are grateful for the participants in the study and for our principal investigators. I would also like to thank PPD and NIAID for a great job and collaboration. It is very important to the Moderna team that we have a high bar for quality and transparency to ensure the public has trust in COVID-19 vaccines. We have reported weekly enrollment progress in a core study and have reported weekly enrollment numbers from diverse communities. When we were not happy with the representation of these diverse communities, given the high burden of disease in this population, we decided to slow down the overall cost of the enrollment process in order to recruit more people from various communities.

We are grateful for.

Participants in the study and fall principal investigator calls.

I would like to also think PPD and that's all great job and collaboration.

He is very important to have more than a team. That's we have a high ball for quality and transparency to ensure the public ups Trust in COVID-19 vaccine.

We have rippled through the wiki enrollment progress, although close study endeavour posted wiki enrollment numbers.

I guess communities.

Well, we're not happy with what they shouldn't be I guess communities you've been to high burden of disease in these populations.

We decided to slow down deal bone called study enrollment process.

Got to recruit more people from those communities.

Stphane Bancel: As you can imagine, it was not an easy decision to slow down, but it was the right decision. We signed the Biopharma Pledge to not submit for regulatory approval for mRNA-1273 until we have adequate safety and efficacy data. We were also the first company to file the full, unredacted version of our Phase 3 protocol online to ensure clinicians around the world could see, in full transparency, how the cough study is being run. We were pleased to set the standard and have others in the industry follow along. We continue to expect our first interim analysis to read out in November. The Independent Data Safety Monitoring Board, or DSMB, will carry out this interim analysis and then inform Moderna.

As you can imagine it was not an easy decision to slow down but.

It was the right decision.

We signed the Biopharma pledge not suddenly.

Definitely a prolonged and body twin 73.

T., we have adequate safety and efficacy data.

We were also the first company to fund the phone.

And with that good.

<unk> phase three protocol online to ensure continued trends around the world, we see in food cost proxy public.

Public called studies being run.

We were pleased to set the stendal and that overall in the industry.

<unk>.

We continue to expect cross into everybody's east to weed out in November.

The independent data safety monitoring board or the SMB we.

We carry out before everybody here and then eat for Madonna.

Stphane Bancel: We should have a post-second dose, two-month safety follow-up after the second vaccination of 15,000 or median participants in the second half of November. As many of you know, this is what the U.S. FDA has asked as part of the EUA submission in their latest guidelines published ahead of October 22 via FACT. We are working closely with USFDA to find chemistry, manufacturing control, or CMC, components as soon as they are available to ensure CMC is not on the critical path to an EU airport.

We should have a positive so going those two more safety follow up after the Sugammadex mission over 15000, a million bucks to keep them in the second half of November.

As many of you know this is what the U.S.M.D. valves I spoke to the U.S. submission in the latest guidelines probably should have October 22, yeah back anything.

We are working closely with the U.S.M.D. into fine chemistry manufacturing control Oh CMC components as soon as that was really a ball winch, you'll see him. He is not on the critical path to anywhere pool.

Stphane Bancel: In addition to the ongoing dialogue with the US FDA, we have announced rolling submissions for mRNA-1273 in the UK and Canada and received confirmation of eligibility for submission of a marketing authorization application to the EMA for the EU. We are very pleased to announce this morning that we have signed a partnership in Japan with Takeda for an order of 50 million doses for the Ministry of Health, Labor, and Welfare of Japan. In the third quarter, we received $1.1 billion in cash payments from governments around the world, and those are counted in our financials as deferred revenue. Now, I will now turn to our brother Parker.

In addition to be ongoing dialogue, where U.S. every year.

But now it's rolling submissions for him on its west 73 in the UK and kinda, though.

And received confirmation of eligibility for submission of marketing authorization application to the economy.

Thank you.

We are very pleased to announce this morning that we have signed a partnership with <unk>.

Japan, we stuck it out for another 50 million doses for the Ministry of Health for label and welfare in Japan.

In the fourth quarter, we have received $1.1 billion of cash payment from governments around the world.

And we'll talk on did you know financials I'd be federal menus.

Let me now turn to a brother parking.

Stphane Bancel: We will announce at R&D Day in September the positive phase 2 readout for mRNA 1647, or the CMV vaccine. We are on track to start the pivotal phase 3 registration study for CMV in 2021. I will refer you to our April Vaccine Day presentation, in which we communicated that we believe our CMV vaccine has a potential for annual peak sales between $2 and $5 billion. There is no approved vaccine against CMV, and it is the number one cause of birth defects in the U.S. and the developed world. ViroMed owns global rights to CMV 1647.

We're now at the R&D day in September the positive phase two readout for M&A 16, 47 Oh.

C N b vaccine.

We are on track to start the people told phase three registration study for C.N. V 2021.

I would refer you to a pretty vaccine day presentation, which were communicated that we believe all CMV vaccine as a potential of <unk> annual peak sales between two and $5 billion.

There is no approved vaccine against CMV.

And he is the number one cause of death defect in the U.S. and the developed world.

They're not all global rights to C.N.B. 16 47.

Stphane Bancel: Our intrathemal OX40 ligand program, that many of you heard about at our recent R&D day, is now enrolling patients in a Phase II expansion study. In rare diseases, start-up activities under an amended protocol for a Phase I proprionic acidemia or PA study are underway. All of our pipeline programs that we're enrolling and dosing patients also continue and are ongoing. Let me finish this slide with a few words about finances. David will go through the financial numbers in a few minutes, but I wanted to share a few thoughts. As I mentioned earlier, we reported this morning that we booked $1.1 billion of deferred revenues in Q3 for supply agreements for MRNA 1274. This cash has been received by the company.

Oh <unk> program.

Many of you I grew up about outdoor we sent aldi there he's not doing patients in the phase two extension study.

In rare disease stuff that that can be keys, I don't I'm not the proper corner for phase. One program you guys. He didn't yelp here studies are underway.

One of the top end programs, that's we're enrolling and dosing patients that should continue and the ongoing.

Let me can you just slightly with few world financial they've either way to grow food and financial numbers in a few minutes.

I wanted to share a few Forbes.

As I mentioned earlier, we reported this morning that we booked 1.1 billion over the card revenues in Q3 from supply agreements for him on its one of 73.

These cash has been received by the company.

Stphane Bancel: These cash receipts have enabled the company to generate $893 million of cash flow provided by operating activities in the third quarter after investing approximately $300 million in the business. Turning to slide four, I am pleased to report that this is the first quarter in the company's history in which we have reported positive cash flow provided by operating activities coming from product supply agreements. It has been 10 years since inception and after investing billions of dollars in science and product development. Thank you to all our employees, scientists, and, of course, our investors, and to all of you that have believed in Moderna. Let me turn to slide 5 for my closing remarks.

Its cash receipts have enabled the company to generate 890, if we meet and got all of the.

Cash flow provided by operating activities in the field quarter after investment of approximately 300 million, but all in the business.

You could talk insightful I am pleased to report that this is a fairly squawk, though in the company's story, even before we bought it probably keep cash flow provided by operating activities coming from product supply agreement.

It has been 10 years after inception, and after investing billions of dollars in science and product development.

Thank you to all employees scientist of Costco in crystals, and what have you that I believed in Waddell.

Let me talk to strike five fold my closing remarks.

Stphane Bancel: As a snapshot of Moderna in October 2020, we have accomplished a lot and continue to have a broad pipeline that continues to progress well. We are fully enrolled in the Phase 3 program, moving on to Phase 73. We now have four phase two trials with CMV, personalized cancer vaccine, VEGF with AstraZeneca, and now FOX 40 LIGAND. 7 Ongoing Phase 1 Program; It were positive Phase 1 studies. Our vaccine franchise has six programs in development addressing the major and met; We have five immuno-oncology programs in the pipeline, four programs in rare disease, and two programs in autoimmune disease. Our foundations have never been stronger with 32,000 participants and patients in our trials. We now have over 1,200 employees.

That's not a couple of them all down though you know put about 2020, we have accomplished a lot in coffee to love a broad pipeline that continues to progress well.

We are fully enrolled phase three programs and on its website before you.

We now have four phase two trials, which CNB, that's nice cancer vaccine rejecting best present, ECA and now look something like that.

They've been on grain phase one programs and.

Play positive phase one studies.

Oh vaccine franchise about six programs in development addressing major unmet needs yeah.

We have five immuno oncology programs in the clinic, hopefully I'm getting ready to eat into programs in a three minute disease.

Oh foundations I've never been stronger we started 2000 policies she bent and patients you know trials, we have now what about with employees.

Tal: We have international manufacturing capacity and capabilities with our partner, Lonza, and Roving Catalan. And we have strategic partnerships with companies like Merck, AstraZeneca, and Verte. At the end of September, we had a strong balance sheet of $4 billion. I am very proud of what we had accomplished so far and where we stand as a company. The next few weeks and months are going to be quite historic for Moderna. I will now turn it over to Tal to talk about clinical updates. Tal?

We have an international manufacturing capacity and capabilities move up but no long ball Rabin cutbacks.

And what's kind of your partnerships with companies like know Astrazeneca and optics.

At the end of September we have a strong balance sheet $4 billion.

I'm very proud of what we've accomplished so far and where we stand as a company.

The next few weeks and most are going to be quite the story for Madonna.

I will now turn it over to Tom to talk about can you got a big Uh huh.

Tal: Thank you, Stephane, and good morning, everybody. Let me give you a quick overview of our pipeline progress. Starting with our COVID vaccine, the phase two study looking at safety and immunogenicity in 600 participants is ongoing. Dosing has been completed, but we remain blinded while the final immunological testing is being conducted. Once we have the results, we'll share them.

Thank you just a fun and good morning, everybody let.

Let me give you a quick overview of our pipeline progress starting with our covert vaccine phase two study looking at safety and Immunogenicity and 600 participants is ongoing dosing has been completed or we remain blinded while the final immunological testing is being conducted once we have the results will show them.

Tal: As a reminder, the safety data from this trial have, of course, been shared with regulators prior to the start of our phase three COVID study. That is now fully enrolled, and I will share some details shortly. For our CMV vaccine, mRNA1647, we shared positive phase 2 data at our annual R&D day in September, and the data enabled us to select the 100-microgram dose to take forward in our pivotal phase 3 trial, which is expected to begin in 2021. For our Zika vaccine, we shared positive phase 1 results and are preparing for phase 2. On the pediatric front, I'm happy to announce that our HMPV-PIV3 Phase 1D age de-escalation study has resumed dosing toddlers aged 12 to 36 months following a pause that was related to COVID-19 disruption. This is the first mRNA vaccine to be given to toddlers.

A reminder of the safety data from this trial have of course been shared with regulators prior to the start of our phase three Coke study.

That is now fully enrolled and I will share some details shortly.

For our CMV vaccine Marni 16, 47, we shared positive phase two data at our annual R&D day in September and the data enabled us to select the 100 microgram dose to take forward in our pivotal phase three trial, which is expected to begin in 2021 or.

Arsynco vaccine, we showed the positive phase one results and are preparing for phase two.

On a pediatric front I'm happy to announce that our HPV PSV three phase one b H de escalation study has resumed dosing pardon learners age 12 to 36 months. Following a pause that was related to cope with 19 disruptions.

This is the first MRT back seem to be given to Carlos.

Tal: In addition, the first cohorts of adult participants in the Phase 1 study of our RSV vaccine, mRNA-1345, have now been fully enrolled. As a reminder, this is also an age de-escalation study, similar to the HMPV-TIV3 study, and the plan is ultimately to also dose toddlers. In another core modality, systemic secreted and cell surface therapeutics, we showed positive phase one data from additional cohorts of the chikungunya antibody program during our annual R&D day in September. Importantly, we demonstrated not only potentially therapeutic levels of the secreted systemic protein but that a two dose regimen with a week between doses was safe and well tolerated and led to the predicted increase in chikungunya antibody production.

In addition, the first cohorts of adult participants in this phase one study of our RSV vaccine Airborne a 30 to 45 has now been fully enrolled.

As a reminder, this is also an h. de escalation study similar to the H. MPV PSV three study and the plan is ultimately to offset those partners.

And then other core modality, the systemic secreted in cell surface Therapeutics, we show the positive phase one data from additional cohorts of the chicken Goodyear antibody program during our annual R&D day in September.

Importantly, we demonstrated not only potentially therapeutic levels of a secreted systemic protein, but that is to do a spread.

Regimen with the week between doses were safe and well tolerated and led to the predicted increase in chicken Junior anybody productions. This demonstrates our platforms ability for repeat dosing, but further note that as a result of rapid systemic clearance no significant accumulation of are lifted nanoparticle, we'll see after administration of the second weekly dose.

Tal: This demonstrates our platform's ability for repeat dosing. I'd further note that as a result of rapid systemic clearance, no significant accumulation of our lipid nanoparticles was seen after administration of the second weekly dose. Moving to slide eight in the updates from our pipeline of candidates across the four exploratory modalities, and starting with our personalized cancer vaccine, the PCV, a randomized head-to-head trial of PCV with Keytruda versus Keytruda alone in the adjuvant setting, reminder that our Phase 1 study continues with patients in the various tumor types who were treated in the Monotherapy Cohort A and Combination Cohort B are in follow-up Gohar D in the adjuvant melanoma is also ongoing.

Moving to slide eight and the updates from our pipeline of candidates across the four exploratory modalities and starting with our personalized cancer vaccine. The PCB randomized head to head trial of PCB with Keytruda versus Keytruda alone and the different melanoma setting is ongoing.

A reminder, that our phase one study continues with patients in the various tumor types, who were treated in the monotherapy cohorts cohort and the combination covert VR and follow up and the <unk>.

Phase one expansion cohorts of corporate C is enrolling patients.

Oh, we're deep in the edge when bilodeau, most also I'm doing.

Tal: For Intra-Tumor Immuno-Oncology, I'm happy to report that we have dosed several patients in the Ovarian Phase 2 Expansion Study. Recall that we initiated this part of the study just last month, and I believe the team's focus on moving this trial forward, along with the support of our clinical investigators, has been very productive. Our triplet program in this modality also continues to enroll in-dose patients in Phase 1. In our systemic intracellular therapeutics modality, study startup activities have resumed for the PA program following disruptions due to COVID-19. In addition, Nature published a preclinical study on this program.

For the intra tumor immune oncology I'm happy to report that we have done several patients in the ovarian phase two extension study recall that we initiated this part of the study just last month and I believe the team's focus on moving to stroke forward along with the support of our clinical investigators has been very productive.

Well the triplet program and this modality also continues to enroll and dose patients in phase one.

In our systemic intra cellular therapeutic modality study startup activities have resumed for the P.A. program following disruptions due to COVID-19.

In addition nature published a preclinical study on this program.

Tal: For the MMA program, recall that we announced at R&D Day that we would take forward a next-generation development candidate, mRNA 3705, which recently received a rare pediatric disease designation from FDA. And finally, regarding our partner-led programs, the Phase I KRAS with Merck and the Phase I interleukin-12 and Phase IIa VEGF studies with AstraZeneca are all ongoing. So slide nine is a snapshot of our development pipeline, and please note that eight preclinical programs across three different modalities that we didn't touch upon during the clinical review, bringing the total number of programs in development currently to 21. Now, let me move into more detail on mRNA-1273, our vaccine against COVID-19. Slide 10 is a broad overview of where we are. mRNA-1273 elicits a robust immune response across species and can protect murine and non-human primates from the virus taking hold in both the nose and the lung.

For the M&A program recall that we announced at R&D day that we would take forward a next generation development candidate him.

Hi, Marni 37 outside which recently received a rare pediatric disease designation from the FDA.

And finally regarding or partner led programs the phase one k. rest with Merck in the phase one interleukin 12 in phase two they digest studies with Astra Zeneca are all ongoing.

So slide nine is a snapshot of our development pipeline and please note that a preclinical programs across three different modalities that we didn't touch upon during the clinical review, bringing the total number of programs in development currently to 21.

So let me move into more detail to M&A 12, 73, our vaccine against COVID-19 Slide 10 is a broad overview of where we are and Barney 12, 73, elicits a robust immune response across species and can protect and you're in a non human primates from the vars, taking hold in both the nose of the lungs.

Tal: In the clinic, at the 100 microgram dose, we observed consistently high levels of neutralizing antibody titers across all adult age groups, and these titers were higher than those seen on average in convalescent sero. And the PHEDES-3 COVE trial has completed enrollment, meeting our expectations. And I'll give you more details on the demographics in a moment.

In the clinic at the 100 microgram dose, we observe consistently high levels of neutralizing antibody titers across all adult age groups of these charters were hard than those seen on average in convalescence zero and the city's three code trial has completed enrollment meeting our expectations and I'll give you more details on the demographics in a moment.

Tal: Let me briefly review the phase one results that were published in the New England Journal of Medicine. mRNA-1273 has been generally safe and well tolerated, as the phase one safety data at 100 microgram across the adult age cohorts demonstrate. As it relates to tolerability, the most common solicited adverse events were headaches, fatigue, myalgia, chills, and injection site pain, the majority of which were mild to moderate in severity and self-limited. Of note, local and systemic reactogenicity were more common and more frequently moderate in severity after the second dose. One severe solicited systemic adverse event occurred after the second dose, and that was fatigue in the above-age 71 age cohort who received the 100 microgram dose. What is important is that these flu-like symptoms are expected, they're transient, and generally mild to moderate in nature, and I believe they correlate with the underlying potency to stimulate an immune response and high levels of neutralizing antibodies.

Let me briefly review the phase one results that were published in the New England Journal of Medicine, and burning 12, 73 has been generally safe and well tolerated as the phase one safety data at 100 microgram across the adult age cohorts demonstrate.

As it relates to Tolerability. The most common solicited adverse events were headache fatigue lay out your children injection site pain, the majority of which were mild to moderate in severity and self limited.

Local and systemic reactogenicity were more common in more frequently moderate in severity. After the second dose one severe solicited systemic adverse event occurred after the second dose and that whats fatigue and the above age 71 age cohort who received the 100 microgram dose what.

It is important is that these flu like symptoms are expecting their transient than generally mild to moderate in nature and I believe they correlate with the underlying potency to stimulate an immune response and high levels of neutralizing antibodies.

Tal: Importantly, there were no vaccine-related serious adverse events in this trial and no patterns of concern for any clinical labs. And while these numbers are still small, we did not see a difference in safety or reactogenicity profile between younger and older adults. As it relates to immunogenicity, I would make three points regarding the data. First, we see the same level of neutralizing antibodies in younger and older adults. Second, we see these levels consistently in everybody who received the vaccine. And finally, these levels are higher than those seen on average in the blood of people who have been ill with COVID-19 and whom we expect, by and large, to be immune to a second infection. Now, if you follow the timeline, you see that high levels of antibodies are achieved quickly upon boost, and I believe the speed and quality of this immune response speaks to the T cell support and puts us in a good place to have durable protection. Slide 13 shows an overview of our Phase 3 co-study, which is now fully enrolled with 30,000 participants. The full protocol can be found on our website.

Importantly, there were no vaccine related serious adverse events in this trial I know patterns of concern for any clinical labs and while these numbers are still small we did not see a difference in safety or reactogenicity profile between younger and older adults.

As it relates to the Immunogenicity I wouldn't make three points regarding the data.

First we see the same level of neutralizing antibodies in younger and older adults.

Second we see these levels consistently and everybody who received the vaccine.

And finally these levels are higher than those seen on average in the blood of people, who had been ill with Cobian, 19, and whom we expect by and large to be immune to a second infection.

Now if you follow the current when you see that the high levels of anti bodies are cheap quickly upon boost and I believe the speed and quality of this immune response speaks to the team still supports and puts us in a good place to have durable protection.

Slide 13 shows an overview of our phase three clinical study, which is now fully enrolled with 30000 participants before.

Protocol can be found on our website at.

Noteworthy points from this slide include the one to one randomization between 100 micrograms emerging in the vaccine or placebo.

Tal: The noteworthy points from this slide include the one-to-one randomization between 100 micrograms of mRNA in the vaccine arm and placebo. Moreover, every participant in this study was expected to be at higher risk than average of infection. That was inclusion criteria number one, and a significant proportion of subjects were stratified as being at risk of worse outcomes from COVID-19 should they get infected. These are people over 65 years old or those under 65 years old but with chronic conditions that are risk factors for disease.

Every participant in the study was expected to be at higher risk for an average of infection that was inclusion criteria number one.

The significant proportion of subjects were stratified as being gris at risk of worse outcomes from COVID-19 should they get infected. These are people over 65 years old or those under 65 years old, but with chronic conditions that are risk factors for disease.

So why did we do in terms of demographics, we're very proud of the hard work of our clinical team our collaborators at <unk> and our clinical trial sites that led to the successful recruitment of a diverse and representative study population, which is similar to the census of our country with 37% of study participants coming from diverse communities and you can.

Tal: So how did we do in terms of demographics? We're very proud of the hard work of our clinical team, our collaborators at NIAID, and our clinical trial sites that led to the successful recruitment of a diverse and representative study population, which is similar to the census of our country, with 37% of study participants coming from diverse communities. And you can see the breakdown on the left side of this slide. We've enrolled 6,000 Hispanic or Latinx participants and 3,000 Black or African American participants. The age distribution is shown in the middle, and of note, about two-thirds of the trial participants are older than 45, as the gender distribution was close to evenly split, as is seen on the right. So what about risk factors for severe COVID-19 disease?

See the breakdown on the left.

Right of this slide.

We'd be enrolled 6000 Hispanic or less and that's participants and 3000 Blocker African American participants.

Its distribution is shown in the middle and of note about two thirds of the trial participants are older than 45.

As the gender distribution was close to even lease fleet as seen on the right.

So what about risk factors persevered COVID-19 disease. The greatest risk factor is age and a quarter participants were over the age of 65.

In addition, 17% were younger but still at risk of severe disease by virtue of co morbid conditions, such such that 42% of trial participants are in the high risk strata of having worse outcomes should they get infected.

There is another way of looking at it which looks at the breakdown of the chronic conditions that put people at risk shown on the right.

These include diabetes at 36% severe obesity is 25% significant cardiac disease at 19% and 18% with chronic lung disease.

I would note that all that all in all over 8000 of the participants in our study are living with these chronic conditions. If you do the math, you'll realize that a significant proportion of participants in the current study have the independent risk factors of both an older age and co morbid conditions.

Tal: The greatest risk factor is age, and a quarter of participants were over the age of 65. In addition, 17% were younger but still at risk of severe disease by virtue of comorbid conditions, such that 42% of trial participants are in the high risk strata of having worse outcomes should they get infected. There's another way of looking at it, which looks at the breakdown of the chronic conditions that put people at risk, as shown on the right. These include diabetes at 36%, severe obesity at 25%, significant cardiac disease at 19%, and 18% with chronic lung disease. I would note that, all in all, over 8,000 of the participants in our study are living with these chronic conditions. If you do the math, you'll realize that a significant proportion of participants in the COVE study have the independent risk factors of both an older age and a comorbid condition. Slide 16 sums it up.

Slide 16 sums it up our phase three Coke study is representative of the many diverse populations that make up our nation and by extension many parts of the world and many people could identify with our study and can find themselves in it.

As it were anticipating the results of our COVID-19 vaccine study, let me take a few minutes to review the statistical analysis plan and what happens next as many of you know we have two interim analyses at 53, and 106 events and a final analysis triggered at 151 events at the first interim analysis.

Based on the statistical plan in order to cover the success, we will need to show vaccine efficacy of 74% or greater from the graph on the left you can see that there's a 50% probability of meeting that hurdle, assuming a vaccine efficacy rate of 75%. So there's an element of chance here as well.

The second interim analysis vaccine efficacy of 57% or greater is required to meet the statistical hurdle and the probability of meeting this is actually 95% if the actual true vaccine efficacy in 75%.

Tal: Our Phase 3 COVE study is representative of the many diverse populations that make up our nation and, by extension, many parts of the world. And many people could identify with our study and can find themselves in it. As we're anticipating the results of our COVID-19 vaccine study, let me take a few minutes to review the statistical analysis plan and what happens next. As many of you know, we have two interim analyses at 53 and 106 events and a final analysis triggered at 151 events. At the first interim analysis, based on the statistical plan, in order to call it a success, we will need to show a vaccine efficacy of 74% or greater. From the graph on the left, you can see that there's a 50% probability of meeting that hurdle, assuming a vaccine efficacy rate of 75%.

For the final analysis has brought up the guidelines.

At least a 50% efficacy is required and again the probability of meeting that primary endpoint in the final analysis is in the high Ninetys, assuming that our true vaccine efficacy rate is 75% or higher.

But we also need to remember is what's not on this route all of these assumptions are driven by the imperative to ensure that we have a high degree of confidence and I'm talking about statistical confidence that once one of these boundary conditions are across not only do we have an initial point estimate about the vaccine efficacy, but we have a 95% car.

Two dogs interval that the true efficacy not the point estimate of the sample exclude 30% or is higher than 30%.

And I'm sure, we'll be coming back to this crucial point in the future.

So each interim analysis there are three potential outcomes I did this study meets the statistical hurdle, which is 74% at the first interim and greater than 57% at the second enable us to trigger the full analysis required to evaluate whether to proceed with a regulatory submission and of course the trial remains blinded data can.

Tal: So there's an element of chance here as well. At the second interim analysis, vaccine efficacy of 57% or greater is required to meet the statistical hurdle. And the probability of meeting this is actually 95% if the actual true vaccine efficacy is 75%. For the final analysis, as per FDA guidelines, at least 50% efficacy is required. And again, the probability of meeting that primary endpoint in the final analysis is in the high 90s, assuming that our true vaccine efficacy rate is 75% or higher. But what we also need to remember is what's not on this graph. All of these assumptions are driven by the imperative to ensure that we have a high degree of confidence. And I'm talking about statistical confidence that once one of these boundary conditions is crossed, not only do we have an initial point estimate about the vaccine efficacy, but we have a 95% confidence interval that the true efficacy, not the point estimate of the sample, excludes 30% or is higher than 30%.

I need to accrue at this time.

The study may not meet the statistical hurdle that would continue to the next milestone for this study is determined to be futile.

As we've committed to and have been transparent throughout the phase three clinical program. Today, we released the informed consent form of our phase three study on our web site and we will continue to be transparent we will announce the results of next that once the first interim analysis has occurred.

The pressure there was also driven by the fact that from a distribution standpoint, we're ready.

We expect that money, so many pretty be distributed within existing infrastructure. There's nothing you require that hasn't already been used for years with many other vaccines.

Specifically the advantages of M&A 12, 73 that allows us to do this include the ability to package and ship boxes in any configuration housing small or large quantities of vaccine.

Storage conditions of minus 20 degrees Celsius for six month refrigeration temperatures have to do a true up to a week and room temperature is conditions for up to 12 hours after thought.

No special handling or dilution is required prior to vaccination with their Murray 12, 73 and by the end of this year, we expect to have approximately 20 million doses ready to ship in the U.S.

Tal: And I'm sure we'll be coming back to this crucial point in the future. So in each interim analysis, there are three potential outcomes. Whether the study meets the statistical hurdle, which is 74% at the first interim and greater than 57% at the second, will enable us to trigger the full analysis required to evaluate whether to proceed with regulatory submission. And, of course, the trial remains blinded, and data continue to accrue at this time. The study may not meet the statistical hurdle and then would continue to the next milestone, or the study is determined to be futile.

With that let me turn it over to David to take you through the financials.

Okay. Thank you Tony.

Turning to slide 21 in the duck.

We ended Q3 2020 with cash and investments of 3.97 billion compared to 3.07 billion at the end of Q2.

The increase is primarily driven by 1.1 billion of customer deposits received in the third quarter for potential supply them or Nay 12 73.

Net cash provided by operating activities was 763 million for the nine months ended September 2020, compared to net cash used of 360 million for the same period in 2019.

Tal: As we have committed to and have been transparent throughout the Phase 3 clinical program, today we released the informed consent form for our Phase 3 study on our website, and we will continue to be transparent. We'll announce the results and the next step once the first interim analysis has occurred. Now the pressure we're under is also driven by the fact that, from a distribution standpoint, we're ready. We expect mRNA-1273 to be distributed within existing infrastructure. There's nothing you require that hasn't already been used for years with many other vaccines. Specifically, the advantages of mRNA-1273 that allow us to do this include the ability to package and ship boxes in any configuration, housing small or large quantities of vaccine, Storage conditions of minus 20 degrees Celsius for six months, refrigeration temperatures of 2 to 8 for up to a week, and room temperature conditions for up to 12 hours after thaw. No special handling or dilution is required prior to vaccination with mRNA-1273, and by the end of this year, we expect to have approximately 20 million doses ready to ship in the U.S. With that, I will turn it over to David to take you through the financials. Okay, thank you, Tal. Turning to slide 21 in the deck.

The reversal from cash used to cash provided by operating activities was driven by total customer deposits for the nine months ended September Thirtyth of 1.2 billion received for potential supply them or in a 12 73.

Cash used for purchases of property and equipment was $44 million for the nine months ended September 2020, compared to 25 million in 2019.

Total revenue was 158 million for Q3 2020 compared to 17 million for the same period in 2019.

Total revenue was 233 million for the nine months ended September 2020, compared to 46 million for the same period in 2019.

Total revenue increase for both the three and nine month periods in 2025.

Primarily due to increases in grant revenue from BARDA to accelerate development of EM are nay 12 73.

Research and development expenses were 344 million for Q3 2020 compared to 120 million for the same period in 2019.

David: We ended Q3 2020 with cash and investments of $3.97 billion compared to $3.07 billion at the end of Q2. The increase is primarily driven by 1.1 billion of customer deposits received in the third quarter for a potential supply of mRNA-1273. Net cash provided by operating activities was $763 million for the nine months ended September 2020, compared to net cash used of $360 million for the same period in 2019. The reversal from cash used to cash provided by operating activities is driven by total customer deposits for the nine months ended September 30th of $1.2 billion received for a potential supply of mRNA-1273. Cash used for purchases of property and equipment was $44 million for the nine months ended September 2020, compared to $25 million in 2019.

Research and development expenses were 612 million for the nine months ended September 2020, compared to 370 million 78 million for the same period in 2019.

The increases for both three and nine month periods. In 2020 were mainly due to increased M&A 12, 73 clinical development activities and head count and pre launch inventory buildup.

Overall in both periods, we saw a significant increase in expenses for for the prophylactic vaccines modality as a result of a focus on them or are they 12 73.

General and administrative expenses were 49 million for Q3 2020 compared to 28 million for the same period in 2019.

Expenses were 109 million for the nine months ended September 2020, compared to 84 million for the same period in 2019 [noise].

David: Total revenue was $158 million in Q3 2020 compared to $17 million for the same period in 2019. Total revenue was $233 million for the nine months ended September 2020, compared to $46 million for the same period in 2019. Total revenue increased for both the three and nine month periods in 2020, primarily due to increases in grant revenue from BARDA to accelerate the development of mRNA-1273. Research and development expenses were $344 million for Q3 2020 compared to $120 million for the same period in 2019.

The increases for both periods were mainly driven by increases in personnel outside services and setup costs associated with preparation for commercialization of them are in a 12 73 globally.

Turning to selected cash flow information on slide 22.

On the top half of the page we present the information from our 10-K and 10-Q filings and on the bottom part we provide the quarterly trend and also items to take into consideration.

When assessing the evolution of this trend in particular for Q2 and Q3 of this year.

Cash provided by operating activities and for purchase of property and equipment was 719 million for the nine month period ended September Thirtyth.

And $874 million in the third quarter alone.

David: Research and development expenses were $612 million for the nine months ended September 2020, compared to $378 million for the same period in 2019. The increases for both the three and nine-month periods in 2020 were mainly due to increased mRNA-1273 clinical development activities, headcount, and pre-launch inventory buildup, overall, in both periods. We saw a significant increase in expenses for the prophylactic vaccine modality as a result of our focus on mRNA-1273. General and administrative expenses were $49 million for Q3 2020 compared to $28 million for the same period in 2019.

Excluding deposits received for potential supply about marinade, 12, 73, and the vertex upfront payment cash used in operating activities and for purchase of property and equipment was 296 million in the third quarter. This.

This compares to 118 million in the second quarter of this year, excluding customer deposits received in Q2.

The increased cash used of around 200 million in Q3 compared to previous quarters, it's consistent with our expectation as we were making substantial investments in manufacturing and potential global commercialization activities for our in a 12 73.

Coal, but vaccine candidate.

David: Expenses were $109 million for the nine months ended September 2020 compared to $84 million for the same period in 2019. The increases for both periods were mainly driven by increases in personnel, outside services, and setup costs associated with preparation for commercialization of mRNA-1273 globally. Turning to selected cash flow information on slide 22. On the top half of the page, we present the information from our 10-K and 10-Q filings. And on the bottom part, we provide the quarterly trend and also items to take into consideration when assessing the evolution of this trend, in particular for Q2 and Q3 of this year. Cash provided by operating activities and for the purchase of property and equipment was $719 million for the nine-month period ended September 30th and $874 million in the third quarter alone.

Let me now give you an overview about where we stand with regard to commercial organization activities. Please turn to slide 23.

On slide 23, you see lift could supply agreements that we have announced publicly today.

As a reminder, these include the agreement with the U.S. government for 100 million doses and options for an additional 400 million doses.

We just announced a deal with Japan for 50 million doses.

Canada has confirmed 20 million doses with an option for an additional 36 million.

We have also signed agreements with Switzerland, Israel and Qatar.

And there are several other countries that have signed agreements that have not been publicly disclosed.

We are thankful for the trust the governments around the world that placed in house to deliver a vaccine for the country.

All of these agreements contained provisions for deposits and have contributed to our three Q twangy deferred revenue value of $1.2 billion, including 600 million from the U.S. government.

David: Excluding deposits received for potential supply of mRNA-1273 and the vertex up from payment, cash used in operating activities and for the purchase of property and equipment was $296 million in the third quarter. This compares to $118 million in the second quarter of this year, excluding customer deposits received in Q2. The increased cash used of around $200 million in Q3 compared to previous quarters is consistent with our expectation as we are making substantial investments in manufacturing and potential global commercialization activities for mRNA-1273 COVID vaccine candidates. Let me now give you an overview of where we stand with regard to commercialization activities. Please turn to slide 23. On slide 23, you see the supply agreements that we have announced publicly today. As a reminder, these include the agreement with the U.S. government for 100 million doses and options for an additional 400 million doses. We just announced a deal with Japan for 50 million doses. Canada has confirmed 20 million doses with an option for an additional 36 million. We have also signed agreements with Switzerland, Israel, and Qatar, and there are several other countries that have signed agreements that have not been publicly disclosed.

We continue to work with the European Union, where we are in advance discussions to supply 80 to 160 million doses.

No. She patients with other countries are also ongoing including with cold box on a tiered pricing proposal.

As a reminder, pricing for agreements with smaller volume were executed at $32 per dose or $64 for two vaccination course $37 per dose or $74 per course.

We remain on track to fulfill these contracts with anticipated supply between 500 million at a billion doses in 2021.

Turning now to our 2020 financial update on slide 24.

On an overall basis, we now expect net cash provided by operating activities and purchases of property and equipment in 2020 in the range of positive point $1.3 billion, but.

The change compared to our update in Q2 is primarily driven by the increase in customer deposits for the potential supply available on a 12 sub Q3 as well as upfront payments for recently announced collaboration agreements with vertex and key age [noise].

Let me provide you more color on the individual components of our financial outlook.

David: We are thankful for the trust governments around the world have placed in us to deliver a vaccine for their country. All of these agreements contain provisions for deposits and have contributed to our 3Q20 deferred revenue value of $1.2 billion, including $600 million from the U.S. government. We continue to work with the European Union, where we are in advanced discussions to supply 80 to 160 million doses. Negotiations with other countries are also ongoing.

With regard to the ongoing investment in our portfolio, excluding our coal that vaccine candidate and associated activities.

We remain on track to our prior outlook.

We expect net cash used in operating activities and purchases of property and equipment to be approximately point 4 billion in 2020, reflecting an improvement of 1.1 billion from prior outlook.

This change is entirely driven by business development activities and related upfront payments as investment levels remain consistent with prior outlooks.

David: Including with COVAX on the tiered pricing proposal. As a reminder, pricing for agreements with smaller volumes was executed at $32 per dose or $64 for a two vaccination course to $37 per dose or $74 per dose. We remain on track to fulfill these contracts with anticipated supply between 500 million and a billion doses in 2021. Turning now to our 2020 financial update on slide 24. On an overall basis, we now expect net cash provided by operating activities and purchases of property and equipment in 2020 in the range of positive 0.1 to 0.3 billion dollars. The change compared to our update in Q2 is primarily driven by the increase in customer deposits for the potential supply of mRNA-1273, as well as upfront payments for recently announced collaboration agreements with Vertex and KeyAZ.

Turning now to the financial impacts of a rapidly advancing our late 12 73 cobot vaccine.

First.

Expenses that fall under the scope of our BARDA agreement.

These are primarily research and development activities to drive the coldest vaccine to licensure and scale up activities on the technical development and manufacturing side as we expect a relatively close matching of expenses and reimbursement we do not expect these activities to materially impact.

Our cash flow and hence these are not shown separately on slide 24.

Next looking out the cobot vaccine related bad investments, primarily for manufacturing a product to be commercialized in the us and internationally.

We expect the cash impact of cobot related investments to be 0.5 to <unk> 0.6, 5 billion and 2020.

David: Let me provide you more color on the individual components of our financial outlook. With regard to the ongoing investment in our portfolio, excluding our COVID vaccine candidate and associated activities, we remain on track to our prior expectations. I suspect net cash used in operating activities and purchases of property and equipment to be approximately $0.4 billion in 2020, reflecting an improvement of $0.1 billion from the prior outlook. This change is entirely driven by business development activities and related upfront payments as investment levels remain consistent with the prior outlook.

This includes approximately 2.2 billion in capital investments with the balance of the expenses related to raw materials and production activity in our network.

Additionally, this investment includes initial commercial infrastructure buildout and costs related to our supply agreements the.

The sum total of net cash used in operating activities for all of modern as business is currently expected to total 0.9 to 1.05 billion before consideration of customer deposits.

Including the customer deposits received by the end of September.

David: Turning now to the financial impacts of a rapidly advancing mRNA-1273 COVID vaccine. First, expenses that fall under the scope of our BARDA agreement. These are primarily research and development activities to drive the COVID vaccine to licensure and scale up activities on the technical development and manufacturing side. As we expect a relatively close matching of expenses and reimbursement, we do not expect these activities to materially impact our cashflow, and hence these are not shown separately on slide 24. Next, looking at the COVID vaccine related med investment, primarily for manufacturing a product to be commercialized in the US and internationally. We expect the cash impact of COVID-related investments to be 0.5 to 0.65 billion in 2020. This includes approximately $0.2 billion in capital investments, with the balance of the expenses related to raw materials and production activity included in our net income. Additionally, this investment includes initial commercial infrastructure build out and costs related to our supply. The total of net cash used in operating activities for all of Moderna's business is currently expected to total $0.9 to $1.05 billion before consideration of customer deposits.

Some of the 1.2 billion, we expect a total net contribution from cash provided by operating activities and used for purchase of property and equipment of positive point 1.3 billion fixed.

In the third quarter of 2020, we expense pre launch inventory of $52 million largely raw materials.

The costs associated with purchases of property and equipment or leased assets related to our M&A 12, 73 program are evaluated for all.

David: Including the customer deposits received by the end of September, which sum to $1.2 billion, we expect a total net contribution from cash provided by operating activities and use for the purchase of property and equipment of positive $0.1 to $0.3 billion. We expect this number to increase as we continue to receive further deposits. Turning now to slide 25.

Yeah.

Assets with alternative use will be capitalized example of these assets include tea and general production infrastructure.

Assets acquired to meet the current production needs of them are in a 12 73 and before product approval will be expensed immediately as costs are incurred. This reflects the fact that moved down the does not yet have other platform products approved or commercialized after a regulatory.

David: As we progress towards approval and commercialization of mRNA-1273, there is heightened interest in several areas of accounting that will increasingly impact our reported results as we move forward. Slide 25 highlights some key areas which will change with an approval event, for example, an emergency use authorization in the United States. Costs associated with pre-launch inventory are currently fully expensed as R&D expense in the period incurred. This includes costs for acquired raw materials as well as production costs.

Oreo approval event.

When PND at least assets are no longer required to be assessed for alternative use such assets will be capitalized in.

In Q3, we recorded $10 million of PPD as expense.

On product sales customer deposits for potential supply of them are in a 12 73.

A recorded as deferred revenue and will be recognized as revenue when control of approved product has been transferred to the customer and customer acceptance has occurred.

David: After an approval event, we will capitalize our inventory to the extent that commercialization is determined to be probable, and we expect future economic benefits from sales to be realizable. In the third quarter of 2020, we expensed pre-launch inventory of $52 million, largely raw materials. Next slide, please. The costs associated with purchases of property and equipment or leased assets related to our mRNA-1273 program are evaluated for alternative use, and assets with alternative use will be capitalized. An example of these assets include IT and general production infrastructure.

In Q3, we recorded $1.1 billion of incremental deferred revenues associated with potential future supply of Edmar Nay 12 73.

No product revenue was recognized in the quarter.

Accounting for the BARDA Grant follows a reimbursement model, where we will recognize revenue as we perform services and closely match expenses as they are incurred.

David: Assets acquired to meet the current production needs of mRNA-1273 and before product approval will be expensed immediately as costs are incurred. This reflects the fact that Moderna does not yet have other platform products approved or commercialized. After a regulatory approval event. When PP&E and leased assets are no longer required to be assessed for alternative use, such assets will be capitalized.

David: In Q3, we recorded $10 million of PP&ES expense. On product sales, customer deposits for potential supply of mRNA-1273 are recorded as deferred revenue and will be recognized as revenue when control of the approved product has been transferred to the customer and customer acceptance has occurred. In Q3, we recorded $1.1 billion of incremental deferred revenue associated with potential future supply of mRNA-1273. No product revenue was recognized in the quarter.

David: Accounting for the BARDA grant follows a reimbursement model where revenue will be recognized as we perform services and closely match expenses as they are incurred. As of 12-31-2019. We had $982 million of federal and state accumulated net operating loss carry forward and $471 million of net deferred tax assets, which were fully reserved as we concluded that realization of our net deferred tax assets was not yet more likely than not to be realized.

The next few weeks for the next few years.

And if you look at the big picture not only through kind of Madonna.

I believe Madonna and terrible 2020 in a strong position.

With a strong cash position of approximately 1.3 billion, though.

With a diverse pinnacle portfolio of vaccines and therapeutics across six different modalities.

We have always focused on the portfolio approach to reduce technology risk.

We had 20 development candidates.

We had sustained over a nine year conception large investments in platform science and money and then the formulation.

Stphane Bancel: After regulatory approval and as we expect to utilize the NOLs, we will reverse and release the valuation allowance or portion of the allowance, which will result in a tax benefit in our income state. This concludes the financial update, and I turn the call back to Stephane. Thank you, Tyler and David. In closing, I would like to step back for a few minutes, across the world.

We have established a very broad and strong IP portfolio.

With sustained largely investment in process development.

We on the fully integrated plan that allowed us to grow from raw materials to feed vials for all of us can equal needs at scale and posted at that speed.

As I look at the end of Twentytwenty one.

Stphane Bancel: We are all, rightly so, very focused on the pandemic and the race against the virus, both with therapeutics and vaccines. The Moderna team has been incredibly focused in 2020 on getting mRNA-1273 to the market in record time. But an important part of my role is to look into the future.

18 months from now.

I believe that if we launch and on the Twitter 73.

Who would exist because we depend emmy crises in the unique position.

We should have a strong cash balance at the end of Twentytwenty one.

It will be made over $4 billion at hand as of September 15th Twentytwenty.

Plus the cash flow that we should generate in fiscal year Twentytwenty one.

Stphane Bancel: Not only in the next few weeks but the next few years, and to look at the big picture, not only to look at Moderna. I believe Moderna entered 2020 in a strong position, with a strong cash position of approximately 1.3 billion dollars, and a diverse clinical portfolio of vaccines and therapeutics. Of course, six different modalities. We have always focused on a portfolio approach to reduce technology risk.

The U.S. government as to getting a very thoughtful approach real production waps speed or whatever U.S.

They decided to support for your vaccine technologies, including amounting to diversify risk to ensure we got several vaccines to finish line for the U.S. citizens.

They decided to Buck only two companies got technology.

Well that was one of the two companies that the U.S. government, although the 100 million doses from.

Stphane Bancel: We have 20 development candidates. We have sustained over nine years since inception large investments in platform science, mRNA, and LNP formulation. We have established a very broad and strong IP portfolio, with sustained large investments in process development.

That is a very important market access.

We are grateful for the trust of U.S. government placed in us or the learning process and our technology and we're very thankful for their head.

Madonna with fans worldwide rights to develop and commercialize them on its one of 73.

We have out of the culprits off now.

Although that weve realized corporate profits from a COVID-19 vaccine.

Stphane Bancel: We own the fully integrated plant that allows us to go from raw materials to field vials for all of our clinical needs at scale and with unprecedented speed. As I look at the end of 2021, 14 months from now, I believe that if we launch mRNA-1273, we will exit the COVID pandemic crisis in a unique position. We should have a strong cash balance at the end of 2021. It will be made over $4 billion at hand as of September 30, 2020, plus the cash flow that we should generate in fiscal year 2021. The U.S. government has taken a very thoughtful approach with Operation Warp Speed, or OWS.

We intend to reinvest the returns from a sales of a vaccine into our pipeline development.

And hope to bring them all mid to high teens to the market.

I believe that the long term strategic implication ouch.

We should have a unique cash position at the end of Twentys on Q1.

More than that as we didn't mean to scare because and on there he didn't information on what occurred.

We invested would effortlessly and science upscale that Nova company could have thought in robotics in digital in four says even augment.

Lost manufacturing plant.

We have always been limited in the last five years with cash.

I believe that this is about to change in a very material away during fiscal year Twentytwenty one.

The approval of M&A, It's worth 70 free for commercialization would provide a unique de risking of the entire Madonna vaccine platform.

Stphane Bancel: They decided to support three vaccine technologies, including mRNA, to diversify risk to ensure they got several vaccines to the finish line for U.S. citizens. They decided to back only two companies for technology, and One of the two companies that the U.S. government ordered 100 million doses from. That is a very important market, actually. We are grateful for the trust the US government has placed in us, our development process, and our technology, and we are very thankful for their help. Moderna retains worldwide rights to develop and commercialize mRNA-1278.

We used the same chemistry to make each ammonia production.

We just sent manufacturing process to make them on it.

We use the same chemistry.

<unk>.

To send manufacturing process to formulate the amount you know obviously.

Think about what this team could do over an expected 10, youre talking from a growing cash guidance now forbidden, though and the knowledge that topic now as she leads to approved vaccine.

I believe 2021 would be the most important inflection year in Madonna history.

Stphane Bancel: Without a Corporate Partner, we will realize all the profits from a COVID-19 vaccine. We intend to reinvest the returns from the sales of the vaccine into our pipeline development, and we hope to bring more medicines to the market. I believe that the long-term strategic implications are clear. We should have a unique cash position at the end of 2021, and it has been built to scale because mRNA is an information molecule. We invested relentlessly in science at scale that no other company could afford, in robotics, in digital, in process development, and in a large manufacturing plant. But we have always been limited in the last five years with cash.

Early on we recognized that them out and they could be an entire new class of medicine.

We always said since day one.

That he made no sense that this would be a one product company.

It would be zero, if we fail to make safe and efficacious product.

Oh, it's would be a new class of medicine, changing medicine flavor.

Our mission to deliver on the promise of him on his science to create a new generation of course on the T. medicine for patients.

He is why don't we strive for every single there.

He 2020. We do then two weeks alone we had many partners. The NIH bother you on viral we kept on PPD.

The clinicians that exactly the clinical trials and they'll keep.

I'm very thankful for the clinical trial participants have interest and their participation you know trials.

Stphane Bancel: I believe that this is about to change in a very material way during fiscal year 2021. The approval of mRNA-1273 for commercialization would provide a unique de-risking of the entire Moderna vaccine platform. We use the same chemistry to make each mRNA vaccine, with the same manufacturing process to make the mRNA. We use the same chemistry for lipids, and the same manufacturing process to formulate the mRNA in our lipid

With that we'll now be happy to take your questions. Thank you operator.

Thank you and as.

As a reminder, ladies and gentlemen to ask a question do we need to press star one of your telephone.

Withdraw your question. Please press the pound key please.

Please stand by we compile the kuni roster.

And our first question comes from the line of Salveen Richter with Goldman Sachs. Your line is now.

'cause it 19 vaccine so just given the commentary from the recent ft AD com on uncovered 19, I'm just like your thoughts here about how you intend to unblind potentially on the first interim or you know post that the fall three looks in the study.

Stphane Bancel: Think about what this team could do over the next five to 10 years, starting from a growing cash balance of $4 billion and the knowledge that our technology leads to approved vaccines. I believe 2021 will be the most important inflection year in Moderna history. Early on, we recognized that mRNA could be an entire new class of medicine. We always said, since day one, that it made no sense that this would be a one product company.

And then secondly, just timelines around our vaccine either way just given some of the commentary and I think after Hao-chi talking about January green light for for vaccines. Thank you.

Yes, Hi, this is Tom let me try and take that I'd say.

Stphane Bancel: It will be zero if we fail to make safe and efficacious products, or it will be a new class of medicine, changing medicine forever. Our mission is to deliver on the promise of mRNA science to create a new generation of transformative medicine for patients. But in 2020, we didn't do it alone.

The bottom line here is the <unk>.

We feel.

I think an obligation to the participants of the coast study, especially those for whom you way will be appropriate for that there is a way for them to ultimately benefit from what they themselves have contributed to that of course I think we all listened intently their birkbeck last week, there was a balance to be had here the.

Stphane Bancel: We have many partners, the NIH, BARDA, Lonza, Rovi, Catalan, PPD, and the clinicians that have executed our clinical trials and our team. I'm very thankful for the clinical trial participants, for their trust and their participation in our trial. With that, we'll now be happy to take your questions. Thank you. Operator.

Well I think this is going to happen at the end of the day. Unfortunately, the cases are accruing.

You know, we're we're in a period of a increasing transmission and so I expect that there will be some time between knowing that the bar has been crossed for efficacy doing the analysis and discussing with S.D.A. and part of that conversation.

Unknown Executive: And as a reminder, ladies and gentlemen, to ask a question, you will need to press star one on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. And our first question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.

He is finding the right balance of.

Along do you continue to collect blinded data and what is the type of data that one can collect post blinding, but still on trial I mean, if you do the math if you're looking for very very rare safety events. For example, then then.

Paul: COVID-19 vaccine. So just given the commentary from the recent FDA adcom on COVID-19, I just would like your thoughts here about how you intend to unblind potentially on the first interim or, you know, post the full three looks in the study. And then secondly, just timelines around a vaccine EUA, given some of the commentary, and I think Dr. Fauci is talking about a January green light for vaccines. Thank you. Yeah, hi, this is Paul.

An unblinded study actually could.

I could give you powered to detect that even.

Even more than a blinded trial. So a lot of these elements I think are going to go into of the conversation that we're having with FDA and.

I'm confident that together with them, we will find the right balance as to how to operationalize. This as it relates to the timing.

I think we're on track to have a the first interim in November I think I expect.

Paul: Let me try and take that. I think the bottom line here is that we feel, I think, an obligation to the participants of the COVE study, especially those for whom an EUA will be appropriate, that there is a way for them to ultimately benefit from what they themselves have contributed to. Now, of course, I think we all listened intently to BIRPAC last week. There's a balance to be had here. The way I think this is going to happen at the end of the day, unfortunately, the cases. You know, we're in a period of increasing transmission. And so I expect that there will be some time between knowing that the bar has been crossed for efficacy, doing the analysis, and discussing with FDA.

Unfortunately that we're going to be on track for additional cases occurring in December and beyond and so the totality of data in the coming months I think we'll we'll cross that threshold I anticipate for efficacy and the rest will be a dialogue with the FDA and other regular.

Three agencies on the right process by which to.

Ensure we demonstrate the safety and efficacy and ultimately make the vaccine available.

Thanks, Tom.

Thank you and.

And our next question comes from the line of Matthew Harrison with Morgan Stanley. Your line is now open.

Paul: And part of that conversation is finding the right balance of how long do you continue to collect blinded data? And what is the type of data that one can collect post-blinding but still on trial? I mean, if you do the math, if you're looking for very, very rare safety events, for example, then an unblinded study actually could give you the power to detect that, even more than a blinded trial.

Probably information that's my guess.

Two related questions from me.

How can you comment at all about the attack rate that you're seeing in the study I think given the Pfizer comments earlier. This week there was a lot of.

Confusion among among investors about whether the attack rate in these studies mirrors, what we're seeing in the general population orphan somehow lower than than what we're seeing in the general population and then.

Paul: So a lot of these elements, I think, are going to go into the conversation that we're having with FDA. And, you know, I'm confident that, together with them, we will find the right balance as to how to operationalize this. As it relates to the timing, I think we're on track to have the first interim approval in November.

A related question something else that I think has come up a lot is this.

Concern about functional unblinding potentially due to people recognizing.

Some of the features of the boost.

Paul: I think I expect, unfortunately, that we're going to be on track for additional cases occurring in December and beyond. And so the totality of data in the coming months will cross that threshold I anticipate for efficacy. And the rest will be a dialogue with FDA and other regulatory agencies on the right process by which to ensure we demonstrate the safety and efficacy and ultimately make the vaccine. Thanks, tell. Thank you. And our next question comes from the line of Matthew Harrison with Morgan Stanley. Your line is now, this morning.

And that may be leading towards a certain people taking on different behavior, which may lead to this lower event rate. So I was wondering if you could talk about if you have a concern about functional unblinding and especially related to the fact that you obviously have the placebo data from the phase two studies do you have a much better idea of placebo at you.

That.

Tolerability versus what we've seen from an open label study. Thanks.

Hey, Matthew let me try and give you a sense of how I see the data first of all my sense from the emerging data is that the attack rates of our trial participants do mirror, what we see in those ZIP codes, where the subjects are coming from.

Paul: I guess two related questions from Tal: can you comment at all about the attack rate that you're seeing in the study? I think given the Pfizer comments earlier this week, there's a lot of, [inaudible] Studies that mirror what we're seeing in the general population, somehow lower than what we see in the population. A related question, something else that I think has come up a lot is, I'm concerned about functional blinding, potentially due to people recognizing some, and that may be leading to certain people taking on different behaviors.

It's not a surprise.

Because if you look at the demographics of what we've been able to achieving the Coke study, having so many people are minorities older with comorbid conditions.

So it's it's it's it's on par with expectations I think writ large.

Paul: I was wondering if you could talk about whether you have a concern about functional and blinding, especially related to the fact that you obviously have the placebo data from the phase two study, so you have a much better idea of placebo-adjusted tolerance. Thanks, Matthew. Let me try and give you a sense of how I see the data. First of all, my sense from the emerging data is that the attack rates of our trial participants do mirror what we see in those zip codes where the subjects are coming from. It's not a surprise because if you look at the demographics of what we've been able to achieve in the COBE study, having so many people of minorities older with comorbid conditions, So it's on par with expectations, I think, writ large.

Unfortunately, with the current attack rates not slowing down the math that were doing you know, it's this paradox sort of more attack rates out there are worse off for four or subjects. Unfortunately, but the data we'll we'll we'll get there. So that's my sense.

No. There is a balance to be had which I think is I've tried to address and the first question, but not just us, but but everybody in the field is struggling with which is the.

The accumulation of data versus the eventual unblinding of participants and how does that all play into regulatory expectations tenet.

And I think we'll continue to have this dialogue in the coming weeks.

Paul: And unfortunately, with the current attack rates not slowing down, the math that we're doing, you know, it's this paradox of more attack rates out there, worse off for our subjects, unfortunately, but the data will get there. So that's my sense. Now there is a balance to be had, which I think is, I've tried to address in the first question that not just us but everybody in the field is struggling with, which is the accumulation of data versus the eventual unblinding of participants and how does that all play into regulatory expectations. Your concern you raised about functionality and blinding, Yes, I share that. I think we all do to a certain degree.

New York that concern you raise about functional unblinding.

Yes, I share that I I think we all do to a certain degree we chose a dose that we believe is optimal in the sense that people may get some trends in flu like symptoms, but it's worth it for the opportunity to prevent this this disease.

[music].

I don't think this leads to lower his venture rates for.

Per se I think my biggest concern is that if anything it would bias us against the vaccine efficacy right. If people behave because they think they got something and that modifies their behavior are they and if anything you would expect that the behaviors would be such that the.

Paul: We chose a dose that we believe is optimal in the sense that people may get some transient flu-like symptoms, but it's worth it for the opportunity to prevent this disease. I don't think this leads to lower event rates for, [inaudible] If anything, it should hurt us. But I don't expect this ultimately to be significantly changing the event rates. And, you know, if I look at the macro picture, as I've said, I think we're going to be on track, unfortunately, for where we anticipate. Thanks. Thanks very much. Thank you. And our next question comes from the line of Ted Tenthoff, with Piper Sandler. Your line is now.

Placebo recipients would be less at risk of getting infected in the vaccine recipients would be more at risk of getting infected.

So at least from a statistical and robustness of the data it it shouldn't have any adverse effect if.

If anything it should hurt us, but I don't expect this ultimately to be significantly changing the event rates and if I look at the macro picture as I've said I think we're going to be on track Unfortunately for where we anticipate being.

Thanks, Thanks very much.

Thank you.

And our next question comes from the line of Ted Tenthoff.

With Piper Sandler Your line is now open.

Great. Thank you very much and thank you for all of your hard work in bringing total 73 for me to see the company turning cash flow positive for a huge milestone I wanted to get a sense who were.

Paul: Great. Thank you very much. And thank you for all of your hard work in bringing 1273 forward. Amazing to see the company turning cash flow positive, a huge milestone. I'm going to get a sense for, (inaudible) Ted, it's Stephane.

Part of that.

Clean.

The prices were at the quantities that you're talking about for next year with clogs up thank you.

Ken it's defined as we've said in the past to know we're not disclosing costs of would call obvious competitive reasons. So ER I wouldn't be able to answer that question.

Stphane Bancel: As we've said in the past, you know, we are not discussing the cost of goods for obvious competitive reasons, so I won't be able to answer that question. Fair enough. Looking forward to the data coming up. Thank you. Thanks, Dave. And our next question comes from the line. Michael. You're on mute.

Fair enough looking forward to data coming up thanks.

Thanks, Dan.

Thank you.

And our next question comes from the line.

Hello.

Michael.

Your line is now.

What do you think.

Paul: What do you think is going on with the event rates? I know that you actually believe you're on time. So maybe it's a question more in part based on the competitor. And related to that, do you actually know your actual event rates?

Yes going on with the event rates.

I know that you said you actually believe your on time. So maybe it's a question more in part based on the competitor and related to that do.

Do you actually know your actual event rates and therefore, you do feel every day that you are seeing the numbers and feel very confident about November.

Paul: And therefore, you do feel every day that you're seeing the numbers and feel very confident about November, and you know, your competitor missed that timeline. So I think everybody's nervous about that. So maybe just make a comment about what you think is going on in general.

Your competitor Miss that timeline. So I think everybody is nervous about that maybe just make a comment about.

What do you think it's going on channel and then secondly, because stop.

Paul: And then secondly, because the NRM is actually a pretty high interim, and I think you've actually commented on that. Maybe just make a comment about if we don't hit that, what that will mean for folks. And I think it has to do mostly with the alpha spend, so that's why I'm not too concerned. But maybe just make a comment on that as well. Thank you.

DNR, there's actually a pretty high interim and I think you've actually commented on that maybe just make a comment about if we don't hit that.

What that will mean for fall and I think it has to do with that alpha spend shelf, that's why I'm not too concerned, but maybe just make a comment about that as well.

Thank you Yeah. This is Tom So look I can't I can't comment about our competitors I don't know their data. So I leave that to them I can repeat what I said about our sense. We do of course see the data coming in a there was a small team.

Paul: Look, I can't I can't comment about our competitors. I don't know their data. I leave that to them. I can repeat what I said about our senses. We do, of course, see the data coming in. There's a small team at Moderna that's aware of the cases that's following up. The numbers, of course, are being kept confidential, to minimize speculation here.

Madonna that's aware of the cases, that's following up that number is of course are being kept confidential to minimise speculation here, but.

Paul: Since we are following the zip codes and the counties from which these participants come, we have pretty sophisticated models of what to expect, and I think we're on track for those expectations. So I think we should be on track for that first interim sometime in November, as we have articulated. You raise a valid point about the interim, and thank you for asking that. Hitting that interim is going to be a function of what the actual vaccine efficacy is and an element of luck in the distribution of the first batch of data you see. Not hitting it doesn't mean the vaccine doesn't work, and in fact, it doesn't even mean that the vaccine has a less than 75% efficacy. We could easily not hit it and yet come back on the second interim and demonstrate an 80 or 85% efficacy. That's kind of the chance of how the stats work.

But I can tell you that overall it since we are following the ZIP codes in the counties from which these participants come we have pretty sophisticated models of what to expect and I think we're on track for those expectations. So I think we should be on track for.

That first interim sometime in November as we have articulated.

You raise a a valid points about the interim and thank you for asking that.

Hitting that interim is going to be a function of what the actual vaccine efficacy isn't an element of luck on a you know the distribution of the first batch of data you see not hitting it doesn't mean the vaccine does work in fact doesn't even mean that the vaccine has a less than 75% efficacy, we could easily not edit and yet come.

Back on the second interim and demonstrate an 80 or 85% efficacy. That's the kind of the chance of how the stats work I think the alpha spend et cetera. You are correct. This is a conservative design and I you.

Paul: I think the alpha spend, et cetera; you're correct. This is a conservative design, and maybe it's an opportunity to dispel a notion. The fact that we crossed the boundary at an interim doesn't mean it's less powerful than a final from a pure statistical standpoint. Once you cross that boundary, you have the same statistical conviction that you would have had on the final. Now, the way I think about the data here is that, irrespective of the point at which we cross the boundary, the trial will continue blinded for a period of time. Data will continue to accrue, and as long as the trial continues blinded, we will get better and better with more and more data to increase the level of certainty we have on all the endpoints of the trial.

You know, maybe it's an opportunity to to dispel the notion. The fact that we cross the boundary added interim doesn't mean, it's less powerful than a final from a pure statistical standpoint. Once you cross that boundary you have the same statistical conviction that you would have had on the final no I think the the way.

I think about the data here is irrespective of the point at which we cross the boundary. The trial will continue blinded for a period of time data will continue to accrue and as long as the trial continues blinded, we will get better and better with more and more data.

To increase the level of certainty we have on all the endpoints of the trial so in that regard.

Paul: So in that regard, In that regard, for me, this first crossing of the interim is just the basis that allows us to go and have confidence to start doing analyses and proceed down the path of regulatory interaction so that we ensure that ultimately access is not delayed to people when there's such a high need out there in our communities. Thank you. Thank you. And our next question comes from the line of Gena Wang with Barclays. Your line is.

In that regard for me. This this first crossing of the interim is just the basis that allows us to go and have confidence to start doing analyses and and price.

Proceed down the path of regulatory interactions. So that we ensure that ultimately access is not delayed to people. When there is such a high need out there in our communities over.

Thank you.

Thank you and our next question comes from the line of Geno way with Barclays. Your line is now open.

Okay.

Do you also see safety in a blinded format. If so how does that compare to the phase one profile and then two questions regarding the interim analysis.

Tal: Do you also see safety in a blinded format? If so, how's that compared to the phase one profile? And then two questions regarding the interim analysis. So for the first interim, if you miss the first interim, is it still four to eight weeks to hit the second interim? And then for the first interim, what is the fertility boundary?

Yes first interim.

If you Miss the first interim is just do four to eight weeks to hit the second interim and.

And then for the first interim wouldn't versatility bundling.

Tal: Let me take that. Thank you. Okay. The safety, yes, we see the totality in a blinded fashion.

Uh huh.

Let me take that.

The safety, yes, we see.

The totality in a blinded fashion.

Tal: I would remind you that the independent Data Safety Monitoring Board that's been appointed by the NIH and sees not just our trial, but also the other U.S. OWS sponsored trials in parallel, sees both the blinded and the unblinded data, writ large, I can tell you that so far, we're not seeing anything unexpected. So the talk continues. And in that regard, I don't expect surprises when we eventually unblind Your second question around the timing is, I think it's a matter of weeks between the first and the second interim months. Now, I can't be more precise because obviously it's a function of the future transmission rates in areas, and I hope that they go down. But for now.

I would remind you that the independent data safety monitoring board that's been appointed by the NIH and sees not just our trial, but also the other us Oh W.S. sponsored trials.

In parallel sees both the blinded and the unblinded data.

Writ large I can tell you that so far we're not seeing anything unexpected so the trial continues and.

In that regard I don't expect surprises when we eventually on blind.

Your second question around the timing is.

I think it's a matter of weeks between the first and the second interim not months.

No I can't be more precise because obviously, it's a function of the future transmission rates and areas and I hope that they go down.

But for now this.

Tal: [inaudible] In terms of futility, I think the boundary is to show that this is going the wrong way, specified to the degree that we felt it was appropriate to specify in the protocol. Beyond that, I can say that the reason you have a Data Safety Monitoring Board is that you've got on that panel several statisticians and several experienced clinicians, so it is where I expect them to exercise their judgment and experience, and they're looking at it closely Okay, thank you. Thank you.

I'm sorry.

For weeks not longer interest.

In terms of futility or I think the boundary is to show that this is going the wrong way.

Hey, it's you know specified to the degree that we felt it was appropriate to specify in the protocol beyond that I can say that.

The reason you have a data safety monitoring board you've got on that panel several statisticians and several experienced clinicians. So it is where I expect them to exercise their judgment and experience and they're looking at of course over.

Okay. Thank you.

Thank you.

Tal: And our next question comes from the line of Corey Kazama, from J.P. Morgan. Your line is now: Thanks, guys, for taking my question. This is Matthew on behalf of Corey.

Our next question comes from the line of Cory 'cause CASM.

From JP Morgan your line is now.

Okay.

Thanks, guys for taking my question. This is knocking on for Corey just on the Cove trial and in light of subject to mix and commentary that it that rates are tracking geographically with infections I'm wondering what your assumptions are for the proportion of patients. The Sars covert to infection that you expect to ultimately go on to become symptomatic.

Matthew: Just on the COVE trial, and in light of subject mix and commentary that event rates are tracking geographically with infections, I'm wondering what your assumptions are for the proportion of patients with SARS-CoV-2 infection that you expect to ultimately go on to become symptomatic. Let me make, let me answer that in maybe a simplified form. The tracking is first and foremost of symptomatic cases because we're not routinely swabbing people just to check PCRs. People self-identify

Yes.

So.

Let me make.

Let me answer that in and maybe a simplistic form the tracking is first and foremost of symptomatic cases.

Because we're not routinely swabbing people.

Just to check PCR as people self identify the asymptomatic infection rate will be determined based on Suralco G that distinguishes between infection in immunology immunization by later comparing antibodies against nuclear capsid versus spot protein. So.

Tal: The asymptomatic infection rate will be determined based on serology that distinguishes between infection and immunization by later comparing, you know, antibodies against nuclear capsid versus spec protein. So we are primarily aware of the symptomatic infections to begin with, and that is the parameter that we're primarily tracking as it relates to the epidemiology. I hope that answers the question. Um, yeah, I guess maybe just to follow up. So when you say that rates are tracking zip codes, what is the data that you're gathering from outside the trial to benchmark it?

We are primarily aware of the symptomatic infections to begin with and that is the parameter that were primarily tracking as it relates to the PD meteorology.

Hope that answers the question.

Yes, I guess, maybe just a follow up so when you say that rates are tracking the zip codes what is.

The data that you're gathering from outside the child, a bunch market.

Teams there.

The reporting of a case rates and infection rates together, it's a we've got we've got a couple of independent X.

Tal: [inaudible] expert panels and teams here that compile the totality of the data that emerges from the various surveillance programs and sophisticated models to create those predictions. Thank you. If you're asking me to describe what's under that hood, you know, it's a complicated black box for me, but I can tell you that the number that it spits out ultimately looks very close to the number that we see on a daily and weekly basis at this stage.

Expert panels and teams here that compile the totality of the data as it emerges from the various surveillance programs and and sophisticated models to create those predictions.

Okay. Thank you I, if you're asking me to describe what's under that Hood. It. It's a complicated black box for me, but I can tell you that the number that it spits out ultimately looks very close to the number that we see on a daily and weekly basis at this stage and that's what gives me the confidence.

Tal: And that's what gives me confidence. Got it, thanks. Thank you. Our next question comes from the line of Jeff Leach, with Bank of America. Your line is now open. Hey guys, this is Alec on for Jeff.

Got it thanks.

Thank you. Our next question comes from the line of Geoff Meacham with Bank of America. Your line is now open.

Hey, guys. This is Alex on for Geoff Thanks for taking my questions.

Alec: Thanks for taking our questions. Can you talk a bit more about the tiered pricing proposal with COVAX? What will this look like?

And can you talk a bit more about the tiered pricing proposal to kovacs AMOLED. This looks like and if you can't talk about the agreement specifically, what's the logic of a tiered structure versus just a set price for a certain amount of dose that seen in the other supply agreement.

Stphane Bancel: And if you can't talk about the agreement specifically, what's the logic of a tiered structure versus just a set price for a certain amount of doses seen in the other supply agreements? And on the Japan supply agreement, and I suppose on most of the OUS supply agreements, how do you plan to allocate manufacturing between your plants and lances? And are there any logistics or technical constraints that would limit the vaccine produced in Norwood geographically? And, I guess, just lastly, what's being done to ensure consistency of the vaccine produced between both your own internal and external manufacturing sites? Thanks. Hey Alex, Stphane, so there are a lot of questions. If I forget some, let me know.

And on the Japan supply agreement and I suppose on most of the U.S. supply agreements and how do you plan to allocate manufacturing between your plants in licenses and are there any logistical constraints that would limit the vaccine produced in Norwood geographically and I guess, just lastly, what's being done to ensure consistency of vaccine produced.

I mean, both your own internal and external manufacturing sites. Thanks.

Hey, Alex Stephanie So it's another question if I forget something let me know so on kovacs.

Stphane Bancel: So, on COVAX... What we want to do is to make sure that the vaccine is available around the world. As you know, we believe, based on early development data, that the vaccine has a chance to be protective across different age ranges, and we think that's very important. And so we want the vaccine to be available to help as many people as we can. The tier pricing is very typical of what GAVI has done in the past. As I'm sure you are aware, COVAX is being run by GAVI and CEPI. And so the idea here is to propose to low-income countries and middle-income countries a price that is lower than the price being paid by developed countries or high-income countries.

What we want to do or east to make sure that the vaccine ease available around the world as.

As you know we believe are based on a quick I mean on the early development data.

That the vaccine has a chance to be productive across you know different H H range and we think it's very important that so we wonder vaccines will be available to help as many people as we can.

The chip pricing is very typical of what Gabby has done in the past as I'm sure you're aware kovacs is being run by Gavi and safety.

And so the idea here is to propose to low income countries and middle income countries, a price that is lower vendor price being paid by developed countries or high income countries and so thats basically the idea and so of course, we're not in a position to disclose those prices to there.

Stphane Bancel: And so that's basically the idea. And so, of course, we're not in a position to disclose those prices today because the discussions are ongoing with COVAX. But what we want to make sure as a company is that we are able to provide vaccines at a lower cost for low-income and middle-income countries. In terms of quality across the board, I would say it's very typical of what is done in any biopharmaceutical company when you have several sites, in terms of a quality organization, technology transfer, validation, and so on, to ensure that the product that is made, you know, at And then in terms of allocation, so as we said in the past, you know, we set up the supply chain with the US supply chain, you know, Moderna, Massachusetts, and London, New Hampshire, to focus initially on the US.

Because the discussions ongoing we've kovacs, that's what we want to make sure. The companies that we are able to provide vaccines I to lower cost following com MBT come country.

In sum of quality across the board I would say, it's very typical of what is done.

You know in any biopharmaceutical companies when you have several sites in some of the quality organization kicking off she transfer validation and so on to ensure that a product that is made you know I'd lonza in visco at Lonza in New Hampshire, all at Madonna MSS was at ease over the same.

42 in the same spec.

And then they come about location. So as we said in the past we set up a supply channel we've.

We have a U.S. supply chain, you know more than I'm, especially sad and as long as our new Hampshire to focus initially on the U.S. we.

Stphane Bancel: We set up the supply chain in Lanzarvisp to be initially focused outside the U.S. As, and I think this is going to really hold for the first, I would say, two quarters after launch. After such a time, we're going to set up the supply chain in terms of regulatory filing so that products can be moved around. So if we get to a point where, you know, we have kind of sold over products in the U.S. that make sense to be sold in the U.S., we will be able to ship products from the U.S. to international markets, and vice versa. We want to set up a supply chain so that at some stage, we need more product in the U.S.

We said that the supply chain loans I've east to be initially focus outside the U.S. ER.

As and I think this is going to really hold call. It feels I would get two quartiles after launch.

After such a time, we're going to set up the supply chain in terms of regulatory filing. So that's products can be moved around so if we get to a point, where we know we have kind of sold over products in the us that makes sense to be sold in the U.S., we'd be able to ship products from the U.S. twin connection on.

And vice versa, we want to set up a supply chain. So that you've got some stage, we need more product in the U.S., we can call from Switzerland to more products into the U.S.. So we're trying to to setup a subtraction that that allows us to be very flexible and nimble to react to the needs of the marketplace.

Stphane Bancel: We can import more products from Switzerland into the US. So we're trying to set up a supply chain that allows us to be very flexible and nimble to react to the needs of a market. I hope that was a good question, Alex. Yes, very helpful. Thanks.

I hope that answers the question Alex.

Yes very helpful. Thanks.

Hartaj Singh: Thank you. Thank you. And our next question comes from the line of Hartaj Singh with Oppenheimer. Great, thank you. Thanks for all of the data presented. Just a couple of quick questions.

Thank you.

Thank you and our next question comes from the line of Hartaj Singh with Oppenheimer. Your line is now.

Okay.

Great. Thank you thanks for all the.

The data presented on just a couple of quick questions one is not.

Stphane Bancel: One is a non-COVID related virus called CMV 1647. You know, you've got worldwide rights to it, I was asked if you have worldwide rights to it. How are you thinking in terms of as you grow the organization, Stphane, on a worldwide basis with 1273? Can you just talk a little bit about how that will help you with 1647 when the time comes?

Non core related on CMB 16, 40.

47.

You've got a worldwide.

So to have worldwide rights to how are you thinking in terms of as you grow the observations to fall on.

On a worldwide basis tall 73.

Can you just talk a little bit on how that will help you with that 60 47, when the time comes to launch not even prepared for worldwide trial with 16.7, and then secondly.

Stphane Bancel: To launch that and even, you know, prepare for a worldwide trial with 1647. And then secondly, you know, is it just wrong for us to assume that part of your initial revenues from 1273 to COVID-19 vaccine could be sort of one-offs, you know, depending on how governments order them versus a kind of a more, you know, life-for-life comparison on a year-for-year basis? Any way to think about that going forward? Thanks for the question. Thank you, Hartaj.

Is it just long plus to assume that part of your initial revenues from 12 73 to call. It 19 vaccine could be sort of one offs, depending on how governments all of them are versus kind of a more.

Like for like basis comparison on a year from your basis any way to think about that going forward. Thanks for the questions.

Thank you I'll touch so.

Stphane Bancel: So on the, I would say, non-COVID organization, you know, Stephen Hoge has spent a lot of time since the beginning of a pandemic really focusing on that one of the things we've done to allow us as a company to both deliver 1273 at a kind of historic record time and not slow down the rest of the pipeline, which is, of course, very important for Moderna and Moderna's future and for patients It's basically, you know, Tyler has refocused most of his time on 1273 and taking this product from literally, you know, a computer into phase one, into phase two, and into successfully completing the co-study and all the interaction with regulatory agencies around the world on the one hand, and then Stephen has refocused on the non-COVID portfolio. And so, what we have done is we've been hiring quite a lot.

On the I would say non covey organization you know.

Steven Hog I spend a lot of time.

Since the beginning of a penny to refocus on that's one of the thing we've done that.

To allow us as a company to boss.

Then you got 12 70 free at a kind of historically call time.

And not slow down the rest of our pipeline, which of course is very important for Madonna.

And with that must future on for patients is basically no tyler's refocus most of his time on 12 cents you frame.

And taking this product.

You know from literally you know computer into phase one into phase two any two competing successfully you've heard the cost study.

And it will be interaction, we've really got three agencies around the world on the one end and then Stephen as we are focused on.

Stphane Bancel: If you look at our headcount numbers, we've been hiring quite a lot, and we're going to continue to do so into the next quarters so that we can have the right scale in terms of development so that we don't slow down the development pipeline of a great asset like CMV or PCV or other assets because we don't have the right teams on the ground. And as we get, you know, closer to commercialization, we'll, of course, hire people dedicated to that. We've already hired the head of marketing for CMV because it's very important.

Stphane Bancel: We believe, [inaudible] And given the similarity of outcome between Zika and CMV, and given what happened in Latin America a few years ago, everybody is highly aware of Zika. And so I think there's a great opportunity for us to actually prepare the market to increase the speed of the uptake of CMV by preparing the market a few years before launch, which is what we are doing. In terms of revenues, as we described in a Q2 call, we really believe there is a pandemic phase for the COVID vaccine and then an endemic phase, which will be, you know, set up mostly on boosting. But, as has been discussed a lot in the medical community, we do not know across the different vaccines, you know, how long we're going to be working for. And so we believe most probably, especially the elderly, or people at high risk, we're going to want to boost their immune profile. We do not know yet if it's going to be, you know, once a year, once every two years, once every four years, but it will probably depend on the different populations. We really have no way to know that.

And you know how long, they're gonna be walking fall and so we believe most probably be especially the elderly people at high risk. We're gonna want to boost their that you mean profiling, we do not know yet if he's gonna be no one's a yeah. Once every two years. Once every four yelled at most probably would depend on the Prime Corporation, we have.

Nobody wait who knows that's about to run the clinical experiments, which we are all doing across the industry.

Stphane Bancel: But to run the clinical experiments, which we are all doing across the industry, I couldn't see pay that different vaccines would have different durations of protection. And so, indeed, I think you're thinking about it the right way, which I think there will be for quite a while, you know, pandemic contracts that are going to be set up like some that we have set up to actually start vaccinating people. And then there's going to be a follow-up contract that I can anticipate for the boost. So that's kind of how we think about it. Does that make sense, Hartaj?

Couldn't see paid that different vaccines will have different duration of protection.

And so in these I think are you thinking about the the rights away, which I think there's gonna be for quite a while you know pandemic contract because I'm gonna be set up like some that we have to set up to get actually started vaccinating people and then there's gonna be for a contract with that kind of itchy painful but boy.

So that's kind of how we think about it but I'm gonna cancel that.

Yeah, no that helps a lot too thank you.

Stphane Bancel: Yeah, no, that helps a lot. Thank you. Thank you. And our next question comes from the line of George Farmer with BMO Capital Markets. Your line is now open. Hi, good morning.

Yankees and our next question comes from the line of George form would be M. O capital market Chelan is now.

Hi, good morning, Thanks for taking my questions.

I Wonder if you could comment on you know what happens if.

You don't hit the primary endpoint of this study at the Cove study and you do hit meaningfully on second any secondary endpoints, which could be quite important I mean, certainly reduce the severity of disease could be something regarded as as as as meaningful have you thought about that and my second question.

George Farmer: Thanks for taking my questions. I was wondering if you could comment on what happened, and you do hit meaningfully on secondary endpoints, which could be quite important. I mean, certainly reducing the severity of. [inaudible] QA. And I hope you have a great day. And I'll see you next time.

Is if you do get an E way.

Does it does the existing supply agreement have have haven't come into play do you start start drawing down on your inventory commitments phone U E way or do you wait until you get full approval. Thanks very much.

Paul: Does the existing supply agreement come into play? Do you start drawing down on your inventory commitments following EUA, or do you wait until? George, this is Paul, an interesting point you raised: typically, if you don't hit the primary, you don't get to get credit from secondaries, the way the stats are laid out. I think in this case, if there's biological plausibility, then of course, we'd go and discuss with the agency what the data are looking like And if we fail to hit it, but the trial continues blinded, given I think the exigent circumstances, we can go and have a dialogue with the agency and discuss what we've seen so far. But I'd say the Proximal answer would still be the conservative one, which is if you don't hit the primary, it's very hard to take credit for secondaries.

[noise]. So George this is <unk>, it's an interesting point you raise typically if you don't hit the primary you don't get to get credit from secondary is the way. The stance are laid out I think in this case, if there's biological plausibility. Then of course, you know we'd go and discuss with the agency.

<unk>.

The data are looking like.

Cause I anticipate we will actually have the opportunity to cross. It early we may have those discussions ahead of time, while more data is accumulating and if we fail to hit it but the trial continues blinded given I think the exigent circumstances, we can go and have a dialogue with the agency and what we've seen so far but I'd say the.

The proximal answer would still be the conservative one which is if you don't get the primary it's very hard to take credit for secondary it's gonna be up to the regulators I think the answer to your second question is an easier one Ah yes, the the supply agreement kicks in and U S government.

Paul: It's going to be up to the regulators. I think the answer to your second question is an easier one. Yes, the supply agreement kicks in, and the U.S. government, I would expect, would start to take credit for the supplies once we have an emergency use authorization.

I would expect would start to take.

The supplies once we have an emergency use authorization.

George Farmer: Great, thanks very much. Our next question comes from Alan Carr with Needham and Company. All right, thanks for taking my questions, to revive that flu program, or if you could give us some more. Seasonal flu vaccine or something, and if you can give us any updates on timelines around that. First, Stephen, I'll take that.

Great. Thanks very much.

Thank you.

Question comes from a line of Alan Carr with need him accompany your mother's milk.

Hi, Thanks for taking my questions.

Definitely from Covid.

You all mentioned in a month or last month, it you'd like to revive that flew program.

I mean, if you could give me some more uhm details around that is this something that.

It's gonna be able to set a seasonal flu vaccine or something that.

C. As it is a universal vaccine.

And and if you can give us any update on timelines around that.

Sure, Steve I don't think that yeah.

Yeah.

Stephen: So what we announced last month is that we're looking at it strategically, and we're going to begin building a business in seasonal influenza. I'll remind you that we already have clinical data for pandemic influenza from two different programs. And so we've shown the ability to generate a productive immune response to the influenza virus as well. We haven't provided clarity yet on when we expect that program to move into the clinic.

I've got a we announced last month is that we're we're looking at a strategically and we're going to begin building a business in seasonal influenza Uhm I'll remind you that we do have already clinical data in pandemic influenza from two different programs and so we send the ability to generate a productive immune response.

Two influenza virus as well.

We haven't provided clarity yet on when we expect that program to move into the clinic Uhm, we will in the future provide those updates as we get closer to that time, but we have suggested you know both it it's an interesting market to try and do better on because there's a substantial still unmet need an influenza and we do think our platform.

Stephen: We will in the future provide those updates as we get closer to that time. But we have suggested, you know, both that it's an interesting market to try and do better on because there's a substantial still unmet need for influenza. And we do think our platform can be differentiated for a couple of reasons. One is, obviously, that we can bring many antigens to bear. And second, the opportunity to do combinations, you know, potentially combinations even with other viruses that might need seasonal boosting. And so we'll provide an update as soon as we declare the development candidate as we normally do and move forward toward clinical development. But We're quite excited by that opportunity at this time.

Can be differentiated for a couple of reasons, one obviously that we can bring many antigens to bear and the second the opportunity to do combinations potentially combinations, even with other viruses that might need seasonal boosting.

And so we'll we'll provide an update uhm as soon as we declared the development count as we normally do and move forward towards clinical development, but we're quite excited by that opportunity at this time.

Stephen: Great. Thanks for taking the questions. Thank you. And our next question comes from the line of Umar Rafat with EvoCorp. Your line is now open. Hi guys, thanks so much for taking my questions. I had a couple, if I may.

Alright, thanks for taking questions.

Thank you.

And our next question comes from the line of <unk> with Evercore. Your line is now.

Hi, guys. Thanks, so much for taking my question that a couple if I may 1st maybe starting from an easier one what's the cycled threshold you're using for the P. C. R. Positivity is it about 34 second if you could confirm if there have been any one off cases of Covid infection for participants who got 12 seventy-three in phase one.

Umar Rafat: First, maybe starting from an easier one, what's the cycle threshold you're using for PCR positivity? Is it about 34? Second, if you could confirm if there have been any one-off cases of COVID infection for participants who got 1273 in phase one or phase two. And then, finally, I know the slides mentioned rapid protection in the lung and nose of non-human primates, but in the New England Journal data, we did see at least one primate at the 100 dose with detectable RNA on the nasal swab. So I guess what I'm getting at is, as a base case, despite the requirement for symptoms, is it reasonable to assume that we could actually see one-off cases of nasal swab testing positive for COVID? Thank you very much. Hi Omar, let me take those questions.

Or face too and then finally I know the slides mention rapid protection and long and knows of nonhuman primate [noise].

But in the New England Journal data, we did see him at least one primate at the hundred dose would detectable iron down the nasal swab. So I guess, what I'm getting at is as a base case. Despite the requirement of symptoms is it reasonable to assume that we could actually see one off cases of nasal swab test positive for Covid. Thank you very much.

Alright, let me take those questions cycled fresh hold I don't think the numbers meaningful because it's not the same number on different essays, it's part of the I'll say characteristics or I can't really comment because I don't believe you can compare those numbers across different assays.

Paul: Cycle threshold: I don't think the number is meaningful because it's not the same number on different assays. It's part of the assay characteristics. So I can't really comment because I don't believe you can compare those numbers across different assays. For the participants in Phase 2, I think we've had a case or two, but since we're still blinded, I can't really comment on what that means. The question on nasal swabs. Yes, well, first of all, in the primate, you're right, there was one primate with transient and relatively low levels in the nose, and the rest were sterile.

On the participants in.

Phase two I think we've had a case or two but since we're still blinded I can't really comment on on what that means.

The question on nasal swabs.

Yes, well first of all in the prime it you're right. There was one appointment with transient and relatively low levels and the nose and the rest were stir Oh I think that would we talk about sterilizing immunity I think that concept is confused by the.

Paul: I think that when we talk about sterilizing immunity, I think that concept is confused by the... high sensitivity that we have. So, what do I mean by that? Well, if I'm immune and I've got IgGs and I've got IgAs, as our data show we do, and I'm walking down the street and somebody sneezes a whole bunch of SARS-CoV-2 on me, and I'm on 49th Street, well, if somebody stops me on 50th Street and sticks a sw It doesn't mean that the antibodies aren't kicking in, and the virus isn't getting cleared. It's a question of timing and sensitivity.

The high sensitivity that we have so what do I mean by that well, if I'm immune and I've got I G. G. As in I've got Iga as as our data show, we have and I'm walking down the street and somebody sneezes on me a whole bunch of Sars Cove too.

You know when I'm on 49th Street, well, if somebody stops me I'm 50th Street in <unk> Ah swab of my nose, they're probably gonna see some detectable virus from that cloud I, just inhaled a block ago. It doesn't mean that anybody's aren't kicking in in the bars isn't getting cleared it's a question of time and getting sensitivity.

Paul: So it depends on how you measure and when you measure and what the triggers for measuring are. In our trial, we test people who raise their hand to say they've got a symptom and a reason to be tested. The only asymptomatic testing that occurs is really at day one and day 29 to make sure that we're excluding the right people and not confounding adverse events with actual disease. But short of that, we're not just randomly doing swab tests. So I hope that that answers your question as it relates to detection. Thank you very much. Our next question comes from the line of Mani Foroohar with SVD lettering.

So it depends on how you measure on when you measure and what are the triggers for measuring in our trial, we test people, who raised their hands to say they've got a symptom and a reason to be tested the only asymptomatic testing that occurs is really a day, one and day 29 to make sure that we're excluding the right people and not confounding adverse events with actual disease, but.

Short of that we're not just randomly doing swap test so I hope that that answers your question as it relates to detection.

Rover.

Thank you very much.

Thank you.

And our next question comes from the line of money for <unk>, how surreal with S. V dealer rate. Your line is now.

Mani Foroohar: Hey, guys, thanks for taking my questions. I know there are a lot of folks on the COVID-19 program. Specifically, I wanted to dive in on math and finances a little bit.

Hey, guys. Thanks for taking my question I know, there's been a lot of folks on the COVID-19 firm specifically I wanted a dive in on a massive financial is a little bit uhm. So did I hear right the quarter by 10 million P of what would otherwise be P. P. N E more expensive and so we're moving that back to Capex give us the base for.

David: So did I hear right that for the quarter, about 10 million of what would otherwise be PP&E were expensed? And so would moving that back to CapEx give us the base from which we'd go here? And secondarily, on that, how should I think about the tempo of CapEx growth over the next 12 to 24 months, presuming a successful EUA and global commercialization? And then I have a follow-up question after that. Yeah, so in terms of the capital deployment, if you look at quarter three, we had $10 million, which I mentioned was 1273 related, that was expense. What we also invested was $12 million in the quarter, which was capitalized, so 22 in total.

Which would go here uhm and secondarily on that how should I think about the tempo of.

Capex growing over the next 12 to 24 months presuming a successful you and global commercialization Uhm and then I have a follow up question out of this.

Yeah. So in terms of the capital deployment, if you look at the quarter three.

We had $10 million, which I mentioned that was 12 73 related that was expensed. What all so we invested was $12 million in the quarter, which was capitalized so twenty-two in total and I think that's a reasonable run right you'll see some increase here.

David: And I think that's a reasonable run rate. You'll see some increase here as we finish the year and we trend up on investing in preparation for launch and the full capacity that we're putting in place. As that continues into next year, I think it's fair to understand that the capital deployment is going to increase somewhat, including the possibility in the fourth quarter of additional expense. Capital, to the extent it's deployed prior to the approval, which we do expect more to happen. And then, if I may... Also keep in mind inventory expensing, which is not strictly capital investment but the acquisition of raw materials and the cost of production. And, of course, we're ramping that production in anticipation of an approval.

As we finished the year and we trend up on investing in preparation for launch and and the full capacity that we're putting in place.

As that continues into next year.

I think it's fair to understand that the capital deployment is going to increase somewhat including the possibility in the fourth quarter of additional expenses capital to the extent it's deployed prior to the approval, which we do expect more to happen.

And then if I may.

Also keep in mind, the the inventory expensing, which is not strictly capital investment, but the acquisition of raw materials and the cost of production and of course, we're ramping the production in anticipation of an approval and therefore, it's it's quite likely that.

David: And therefore, it's quite likely that we'll have a fairly significant amount of expensed inventory occurring in Q4 prior to approval. And as you would understand, the impact of that is that as we start commercializing the product post-approval, the cost of that product will be essentially zero from a cost of goods perspective until we've sold through that inventory that we produced prior to approval. Okay, that's really helpful.

We'll have a fairly significant amount of expense inventory occurring in queue for prior to approval.

And as you would understand the impact of that is that as we.

Stark commercializing product post approval the cost of that product will be essentially zero from a cost of goods perspective until we've sold through that inventory that we produce prior to approval.

Okay. That's really helpful and then popping over onto the non Covid pipeline I made a mistake. If we've mentioned what's the timeline to get the next slug of data from the Oxford log in programs and when should we think about having a reasonable number of patients.

Stephen: Um, and then popping over onto the non-COVID pipeline, I may have missed it if it was mentioned, what's the timeline to get the next slug of data from the Oxford Ligand Program? And when should we think about having a reasonable number of patients with that asset on top of a PD on top of a PD one on top of an approved PD one therapeutic? Let me try and take that. This is tall.

Uhm with that asset on top of a P. D on top of a P. D. One hung up and approve P. One therapeutic.

Let me try and take care of this is tall. So you know it's oncology and date I think is determined by not just patient accrual, but the events that happened on trial and so it's really hard for me to predict which is why we've been very clear on how many patients we have and where are we I think the next.

Tal: So, you know, it's oncology, and data, I think, is determined by not just patient accrual but the events that happen on trial. And so it's really hard for me to predict, which is why we've been very clear about how many patients we have and where we are. I think the next tranche of data, I would anticipate, will be once we have a sufficient number of these patients with ovarian cancer on trial, and that is already in combination with PD-L1 blocker. So that should be informative for response rates once we have sufficient patients with sufficient follow-up. Over and done. Great, that's very helpful. And as a final question, I'll go back to financials. Obviously, the stock has been, you know, quite volatile over the course of this year, as have many of your peers.

Tranche of data I would anticipate will be once we have a sufficient number of these patients with ovarian cancer on trial and that is already in combination with the P. D O one block or so that should be informative for a response rates once we have sufficient patients with.

Sufficient follow up over.

Great that's helpful and as a final question on pop back to financials, obviously, a stock has been quite volatile over the course of this year as have many of your peers uhm.

Tal: Given that, and given that you continue to build out your infrastructure and headcount, anticipation of expanding the pipeline and launching commercially, presuming an EUA for COVID-19, how should I think about modeling, or how should we think about modeling stock-based compensation relative to the overall R&D expense and SG&A expense? Will the portion go up as you start to have more of a sales force, or will it go down as you get scale?

Given that and given that you continue to build out your infrastructure in headcount anticipation of expanding the pipeline and launching commercially for them to do I'm going to U a for COVID-19, how should I think about modeling how should we think about modeling stock-based compensation uhm relative to the overall are.

And do you experience SG&A expenses portion go up as you start to have more of a sales force will go down and you get scale just how should we think about that either absolute terms as a proportion of took a proportion of spend just has between my modeling. It next say 12 months.

Mani Foroohar: Just how should we think about that, either in absolute terms or as a proportion of spend? How should we think about modeling it in the next, say, 12 months? That's a very good question. And I guess I'd have to get back to you. I guess I'd start with the point of view that the trend would be stable. But you know, we'll have to get back to you on that. All right, thanks for taking the questions, and congratulations on all. Thank you. Our last question comes from the line of Nazeem Jacob with UBS. Your line is now open.

That's a very good question and and I guess I'd to help to get back to you I guess I'd start with the point of view about the trend would be stable, but we'll have to get back to you on that.

Alright, thanks for taking the questions and congratulations Donald's.

Okay.

Thank you Alaska.

Our last question comes to an online magazine Jacob UBS, Vermont is now.

Nazeem Jacob: Hi, this is Alana on behalf of Naveen. Thank you for taking our question. So from what you've seen in your non-human primate studies, what impact on prevention of infection through viral colonization and viral transmission do you expect to see from 1273? And then, secondly, sort of a broader question is, do you think that your vaccine or any vaccine in general will be able to deliver sterilizing immunity? Yeah, so that's a good question.

Hi, This is Atlanta on Bernadene. Thank you for taking our question I assume from what you've seen on in your nonhuman Primate studies, what impact on prevention of infection, sorry, the viral colonization and viral transmission do you expect to see from 12 73 and then.

And secondly, sort of a broader question is do you think that you're a vaccine or any vaccine in general we'll be able to deliver sterilizing immunity.

Yeah. So that's a good question, let me tell you how I think about it.

Tal: Let me tell you how I think about it. Again, as I alluded before, I think the concept of sterilizing immunity is a function of how you actually test for it. Will we be able to demonstrate prevention of infection, at least as measured by serology, which is to say, maybe somebody saw a little bit of the virus, but actually, the antibodies kicked in, and they never established enough to demonstrate antibodies against the other parts of the virus, the nuclear capsid? That's actually what we will be measuring in phase three, as a way to show protection from asymptomatic infection. I'm hopeful that we will be able to demonstrate that. I anticipate that I mean, just on first principles, what is the hardest thing for a vaccine to do? sterilize. What's the next hardest? It's to prevent asymptomatic. What's the easiest?

Again as I as I alluded before I think the concept of sterilizing immunity is a function of how you actually test for it.

We'll be able to demonstrate prevention of infection at least as measured by serology, which is to say maybe somebody saw a little bit of the virus, but actually the antibodies kicked in and they never established enough to demonstrate antibodies against the other parts of the virus the nuclear caps and that's actually what we will be measuring in the phase three.

As a way to show protection for me some dramatic infection I'm hopeful that we will be able to demonstrate that I anticipate that.

Mean, just on first principles what is the hardest thing for a vaccine to do it's to sterilize. What's the next hardest it's to prevent asymptomatic, what's the easiest it's probably to prevent the most severe disease and so that's how I think about the order of expectations, but I think what you're really getting at.

Tal: It's probably to prevent the most severe disease. And so that's how I think about the order of expectations. But I think what you're really getting at is what the ability of this vaccine is going to be to prevent transmission. And I think because I don't anticipate any easy direct measure of this, we're going to have to do some math once we see the data. I expect that if people get less sick, and certainly less severely sick, they will be spreading less, because I think there is, while we have asymptomatic spread, we also have symptoms. And so, and in fact, I think, the higher the symptoms, at least early in the disease, potentially, the more viral shedding you see. So that's a complicated equation that I think, in a nutshell, is going to be very hard to answer directly through some concrete measurement in the trial.

Is what is going to be the ability of this vaccine to prevent transmission and I think because I don't anticipate any easy direct measure of this we're gonna have to do some some math once we see the data I expect that if people get less sick and certainly less severe sick they will be spreading.

<unk> cause I think there is why we have asymptomatic spread we also have symptomatic spread.

And so.

And in fact, I think the higher the symptoms at least early in the disease potentially the more.

Horrible shedding you see so that's a complicated equation that I think in a nutshell is gonna be very hard to answer directly through some concrete measurement in the trial, what we will hope to show is that we prevent asymptomatic infection based on serology, we will clearly hope to show prevention of symptomatic infection. That's the primary endpoint.

Tal: What we will hope to show is that we prevent asymptomatic infection based on serology; we will clearly hope to show prevention of symptomatic infection. That's the primary end point. And, you know, based on first principles, which, by the way, Phil Krause from FDA alluded to and agreed with last Thursday, one would anticipate that if you prevent symptomatic disease, it should be even clearer that you're preventing the more severe manifestations. Thank you. And that concludes today's question and answer session. I would now like to turn the call back to Stephane for his closing remarks. Right?

And you know based on first principles, which <unk> by the way so across from F. D. A alluded to an agreed with Ah last Thursday, when would anticipate that if you prevent symptomatic disease, you should it should be even clearer that you're preventing the more severe manifestations.

Thank you.

<unk>.

And that concludes today's question and answer session when I like summer cold that's to Stefan for any closing remarks.

Stphane Bancel: Thank you, operator. Well, thank you, everybody, for your time and your questions and your support. Have a wonderful day and speak soon. Stay safe, everybody. Bye. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. Thank you.

Alright, Thank you alright, so I Wanna. Thank you how about you for your time and your question and then you'll see Paul have a wonderful day and speak some safe everybody bye.

Ladies and gentlemen. This concludes today's conference call. Thank you for participating you may know just.

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