Q4 2019 Earnings Call

Good morning, and welcome to Madrid fourth quarter, and full year 2019 conference call, but they're fine all participants are going to listen only mode.

Operator: Good morning, and welcome to Moderna's fourth quarter and full year 2019 conference. At this time, all participants are in the listen-only mode. Following the formal remarks, we will open the call up for your questions. Please be advised that the call is being recorded. At this time, I'd like to turn the call over to Lavina Talukdar.

Moving to formal remarks, we will open the call for your question. Please be advised it's always being recorded.

Finally, I'd like to turn the call little girls either sell it.

Lavina Talukdar: Talukdar, Ted Invesh.

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Operator: Please proceed. Thank you, Operator.

Please proceed.

Thank you operator, good morning, everyone on today's call, we will discuss the journal fourth quarter and full year 2019, this update and financial results.

Lavina Talukdar: Good morning, everyone.

Stphane Bancel: On today's call, we will discuss Moderna's fourth quarter and full year 2019 business updates and financial results. You can access the press release issued this morning, as well as the slides that we'll be reviewing, by going to the investor section of our website. Speaking on today's call are Stphane Bancel, our Chief Executive Officer, Kyle Vack, our Chief Medical Officer, Stephen Hoge, our President, and Lawrence Kim, our Chief Financial Officer. Before we begin, I would like to remind everyone that this conference call will include forward-looking statements. Please see slide two of the accompanying presentation and our SEC filings for important risk factors that 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 update or revise the information provided on this call as a result of new information or future results or developments. I will now turn the call over to Stephane.

You can access the press release issued this morning, as well slides that would be reaching back onto the investor section of our website speaking on today's call I step on box out our Chief Executive Officer, Callback, Our Chief Medical Officer, Steven Coke, our President and Mark Kim Our Chief Financial Officer.

Sure.

Before we begin.

I'd like to remind everyone that this conference call will include forward looking statements. Please see slide two of the accompanying presentation and our FTC filings for important risk factors that could cause actual performance and results to differ materially from those expressed or implied in these forward looking statement, we undertake no obligation.

Turning to update or revise the information provided on this call as a result of new information for future results for development.

Now turn the call over to Stefan.

Stphane Bancel: Thank you, Lavina, and good morning, everyone. As you know, we believe mRNA has the potential to be a new class of medicines with the opportunity to address many unmet medical needs. Given the announcement of working with a new technology, we have been laser focused on managing risk. Technology risk, biology risk, execution risk, and financing risk. 2019 was an important inflection year for Moderna.

Thank you and every now and good morning, everyone.

As you know we've really been on has the potential to be a new Praful Mehta seems real policy to address many unmet medical needs.

Given the unknowns walking through the new technology, we have been laser focused on managing risk.

The yard your risk powered here is exactly on risk and financing risk.

2019, with a NIPT bolt on your picture and yet from a bit on them.

Well, we bought it can you give anybody they think they though from keep programs into other modalities, reflecting about seems on the left.

Stphane Bancel: We reported clinically validating data from key programs in two of our modalities, prophylactic vaccines on the left and systemic secreted and cell surface therapeutics on the right, data that we believe fundamentally change the risk profile of each of these two modalities, which we now call core modalities. As a result, our strategy is to dabble in these two core modalities with many important methods. We have already announced five new development candidates in this core modality since January 13 at the JPMorgan conference. Three new development candidates in infectious disease prophylactic vaccines and two in the systemic secreted and cell surface therapeutic modality

Interest it makes you cricket instead of surplus property mix on the right.

They said that we believe fundamentally change of every spring <unk> Oh, Bishop with these two modalities that we now covered call modalities.

As a result, Australasia <unk> that was down in these two commodities with many both in medicine.

We have already announced five and you would you ever been calling to discriminate used since January 15 at the JP Morgan Conference.

When you never been county that any picture did he is projecting vaccines.

And to win the systemic scripted and sensor based therapeutic modalities.

Why would that went down increment that you will see molded are interested in understanding the potential of I'm on the technology, you know extraordinary modalities cancer vaccines interest you more immuno oncology localized perhaps you've put up a dick and systemic interests your property.

Stphane Bancel: While we double down on core modalities, we are still more than ever interested in understanding the potential of mRNA technology in our exploratory modalities, cancer vaccines, intracerebral immune oncology, localized regenerative therapeutics, and systemic intracellular therapeutics. So when we think about it, we have two distinct businesses.

So when we're thinking about the we have two distinct businesses.

His significant balky knows tradition.

Stphane Bancel: This is a significant point in our strategy. Commodities, we want to scale invest in; exploratory modalities, where we are waiting for clinical data to decide on the path forward. So, we are stepping back.

Accommodate you walk is getting better.

Extraordinary piece, where we are waiting for peak will they definitely cycle not profitable.

So stepping back I.

Stphane Bancel: I would like to share with you the progression of the company towards a new class of managers. In the early days of Moderna's history, our goal was to enter the clinic safely. We spent years investing and developing mRNA science, formulation delivery, and manufacturing. The company pivoted out of that growth phase when we entered the clinic with our H10 influenza vaccine in December 2015. In the clinic, our next goal was to learn how well our technology was working or not. We explored our technologies across six different modalities. We tested 16 different molecules in the clinic over a short four-year period.

Well, that's Michelle we view the portion of the company cobalt and you've got something at the same.

In the only did something we've done a history of good West went public safety.

We spent yells investing and you would you get monocytes formulation day rate and manufacturing.

The company people did outcomes that growth phase when we entered the clinic, we will extend your friends at vaccine in December 20 feet Jim.

In the clinic or next go to what's going wrong, how wearable technology wasn't working on up.

We expect all picking allergies across six different modalities.

15, 16 different when excluding the clinic in their shelf for your parity of.

Stphane Bancel: In 2019, we generated important data in two of these six modalities, and I've identified our first two core modalities: Infectious Disease Prophylaxis Vaccines and Systemic, Secreted, and Cell-Surface Therapeutics. We're entering a new phase of the company's development. Our goal for this next phase of our history is to find multiple DLAs while continuing to explore our clinical programs in our four exploratory modalities. We will also continue to invest aggressively in our science, including inventing new modalities, such as our ongoing collaboration with Vertex. We are fortunate to have closed the financing earlier this year, so we can maximize our potential to create value and manage risk. Once we find capable BLAs, our goal will be to scale the company and commercialize a large portfolio of mRNA materials. Now Tyler will take you through the Probiotic Vaccine Program.

In 2019, which everything you pull than they thought you'd toward these six modalities and I I don't you fight off Piste took almost every piece you picture. The these prophylactic vaccines.

She said mixi corrected instead of suffice for everything.

We're entering the new phase of a company's development.

Well go for these next phase of all history.

Finally people would be really well continuing to EXPAREL. Although can you go programs you know folks about 30 modalities.

We're still get from Investec reoccupied all fine if we didn't get inventing new modalities <unk> ongoing collaboration we've got six.

Well to need to be able to close a financing earlier. This year. So we can mckee mother potential to create value and.

And at risk.

Once we find that you wouldn't yet is oh, what do we kind of a company and commercialize loss portfolio by Mount Emmons listings.

No Paralympic who for prophylactic vaccine programs.

Kyle Vack: Thank you, Stephane, and good morning, everyone. I'll start with a quick reminder on the data generated today with our. In over 1,000 healthy volunteers and six positive Phase 1 datasets to date, we've observed a safety profile consistent with the safety of marketed vaccines and the ability to elicit an immune response in the form of neutralizing antibodies. Updates for the ongoing programs are shown on this slide. The CMV phase 2 dose confirmation study is enrolling well. We have completed the second dose cohort and are close to completing the third. We now expect data readout to come in the third quarter of this year. Our HMPV-PIV3 combination respiratory vaccine has started the age de-escalation study, and Merck is on track with their RSV program in adults.

Thank you for foreign and good morning, everyone I'll start with a quick reminder, on the data generated to date with our vaccines in over 1000 healthy volunteers in six positive phase one data sets to date, we've observed the safety profile consistent with the safety of marketed vaccines and the ability to elicit an immune response in the form of neutralizing antibodies.

Updates for the ongoing programs are shown on this slide the CMB phase two dose confirmation study is enrolling well we completed the second dose cohort at or close to completing the third one we now expect data read out to come in the third quarter. This year.

All right to PDP I'd be three combination respiratory vaccine has started the age de escalation study and Merck is on track with their RSV program in adults Zika is also going well as three of the for dose cohorts have completed enrollment.

Kyle Vack: Speaker is also going well, as three of the four donors.

Stephen Hoge: Our three new development candidates announced recently are vaccines against pediatric RSV, mRNA 1345; Epstein-Barr virus or EBV, mRNA 1189; and our vaccine against the novel 2019 coronavirus, mRNA 1273. Stephen will take you through each of these candidates.

Our three new development candidates announced recently or vaccines against pediatric RSV MRT 30, 45, Epstein Barr virus or you'd be V., MRT 11, 89, and our vaccine against the noble 2019, krona bars emerged a 12 73, Stephen will take you through each of these candidates in a minute.

Stephen Hoge: Stephen will take you there.

To be isn't the unmet need as there aren't any approved vaccines in the burden of disease from CMV infection is significant.

Stephen Hoge: CMV is an unmet need as there aren't any approved vaccines and the burden of disease from CMV infection is significant. Of the 25,000 newborns in the U.S. affected each year, 20% will have permanent neurodevelopmental disabilities, and the spectrum of sequelae ranges from hearing loss, vision loss, microcephaly, and even mortality in 10 to 30% of newborns.

The 25000 your burns in the U.S. affected each year, 20% will have permanent euro developmental disabilities, and the second this spectrum of sick well arranged from hearing loss vision loss microcephaly, and even mortality intend to 30% of the severely affected infants. We believe RGB in pentameter vaccine has the potential to pro.

Stephen Hoge: We believe our GB and pentamer vaccine has...

Stephen Hoge: We believe in our GBM...

Even CMV infection and help thousands of newborns avoid these equivalent.

Stephen Hoge: Infection, and help thousands of newborns avoid these sequelae. On slide 16, I'll review the most recent data from our CMV program. In January of this year, we shared the seven-month interim data. The safety has been generally well-tolerated, and we've not seen any related serious adverse events. Immunogenicity data continues to confirm earlier interim data from the trial and continues to exceed our expectations. Specifically, we continue to see higher neutralizing antibody titers in seronegatives and seropositives in both epithelial and fibroblast assays. If you look at those who have never had CMV, the seronegative group, after the third vaccination, they had neutralizing titers against epithelial cells that were more than tenfold higher than the level seen in seropositives at baseline, which

On Slide 16, I'll review the most recent data from our CMP program in January of this year, we shared the seven month interim data. The safety has been generally well tolerated and we've not seen any related serious adverse events.

Immunogenicity data continues to confirm earlier interim data from the trial and continues to exceed our expectations. Specifically, we continue to see higher neutralizing antibody titers ensure a negative ENSPIRIT positive in both the peculiar when fiberglass assays.

If you look at those who have never had CMV seronegative group after the third vaccination they hadn't neutralizing titers against it we feel yourselves that were more than 10 fold higher than the level seen since your positives that baseline.

We also saw nice increase in titers against the fiberglass.

Stephen Hoge: We also saw a nice increase in titers.

Stephen Hoge: Even in zero positives, people who have been infected, our vaccine is able to boost them 20 to 40 fold higher above baseline after the third vaccination, and we see early evidence of durability out to 12 months. These data are what's behind our optimism and belief that we can take this vaccine all the way through to prevent infections in newborns. As mentioned earlier, our Phase 2 dose confirmation study is enrolling well and is currently enrolling the last dose cohort. We now expect data from the first interim analysis in the third quarter of this year. Preparation for the Phase 3 trial, which we anticipate will include less than 8,000 participants, including women of childbearing age, is underway. An early estimate of the cost of this trial is in the range of $200 to $250 million.

Given its your positive people, who have been infected orbit scene is able to boost them 20 to 44 higher above baseline level. After the third vaccination and we see early evidence of durability out to 12 months.

These data are what's behind our optimism and believe that we can take this vaccine all the way through to prevent infections in newborn.

As mentioned earlier, our phase two dose confirmation study is enrolling well and is currently enrolling the last dose cohort. We now expect data from the first interim analysis in the third quarter of is your preparation for the phase three trial that we anticipate will include less than 8000 participants, including women of childbearing age are underway.

An early estimate of the cost to this trial it was in the range of $200 million to $250 million.

That was an opportunity for us CMBS clearly a blockbuster opportunity we estimate annual peak sales for CMV vaccine to be in the range of $2 billion to $5 billion inline with the estimates of others in the field, assuming an average selling price like artist. So relevant comparator here, we estimate gross margins of about 90% and EBIT margins of approximately 50.

Stephen Hoge: Now, as an opportunity for us, CMV is clearly a blockbuster opportunity. We estimate annual peak sales for a CMV vaccine to be in the range of $2-5 billion, in line with the estimates of others in the field. Assuming an average selling price like Gardasil, a relevant comparator here, we have to make gross margins of about 90% and EBIT margins of approximately 50%. We're excited about the progress towards this opportunity, supported by the fact that just one of the antigens in our vaccine, GB, when encoded for in a traditional recombinant technology in the past, had already shown 50% efficacy, which was demonstrated by Sanof We believe that targeting both pentamer and GB antigens, as our CMV vaccine does, will be additive to the vaccine's efficacy. As a reminder, our CMV vaccine, mRNA-1647, is wholly owned by us. Let me transition it to Stephen to talk about our new development candidates. Thank you, y'all.

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We're excited about the progress towards this opportunity supported by the fact that just want to be antigens and our vaccine the GB when encoded for into traditional recombinant technology in the past that already shown at 50% efficacy, which was demonstrated by Sanofi several years ago, we believe the targeting both and tumor and GB antigens as our CMV vaccine does.

We'll be additive to the vaccines efficacy.

As a reminder, or CMV vaccine Marni 16, 47 is wholly owned by us.

Let me transition at the Stephen to talk about her new Feldman Kennedy.

Thank you Tony.

Stephen Hoge: I want to start by introducing three development candidates in our vaccine, prophylaxis, prophylaxis vaccine modality that we recently announced earlier this year. The first is against the Epstein-Barr virus, and I just want to pause for a moment and give you an overview of that. So Epstein-Barr virus is a member of the herpes family that includes CMV, and it's spread through bodily fluids. EBV is a major cause of a wide range of but is the leading cause of infectious mononucleosis in the United States, accounting for almost one million cases annually. Infected mononucleosis can debilitate patients for weeks to months and, in rare cases, can lead E.B.V.

I want to start by introducing three development candidates in our vaccine people like Texas prophylactic vaccines modality that Weve recently announced earlier this month the first it against Epstein Barr virus and just want a pause for a moment and give you an overview of the disease.

So Epstein Barr virus is a member of the herpes them family includes DMV and spreads for bodily fluids, mostly in the young children adolescents CBD is a major cost of a wide range of diseases, but is the leading cause of infectious mononuclear doses in the United States accounting for almost 1 million cases annually.

In fact as money, yes. This can debilitate patients for weeks tomorrow, and a rare cases can lead to hospitalization and even spawning rupture.

He BB infection is also associated with a range of other disorders, including Liberal proliferative disorders cancers and auto immune diseases.

Stephen Hoge: For instance, it is associated with a significant increase in the risk of multiple sclerosis. There are currently no approved vaccines for EBC. So our vaccine candidate, mRNA 1189, is designed to provide broad protection against EBV infection and infectious mild. EBV has a number of surface proteins on its envelope, including GP350, a trimeric complex of GP42, GH, and GL, a dimeric complex, and also. All of those antigens are important for infecting a range of different cell types, but particularly B-cells and epithelial Now, vaccination against only one of those antigens, GP350, which provides only partial B cell protection, reduced the rate of infection in a prior study by up to seven times, and reduced the rate of infectious mononucleosis in a prior study by up to 78%.

For instance, it is associated with a significant increase in risk and multiple sclerosis.

There are currently no approved vaccines for Ltd.

So our vaccine candidate and warranty 11, 89 is designed to provide fraud protection against CBD infection infectious mononuclear says.

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Including GP 350, a try Merrick complex set of GP 42, GH NGL die Merrick complex and also GB.

All of those antigens are important for infecting a range of different cell types, but particularly b cell and epithelial cells.

Now vaccination against only one of those antigens GP 350, which provides only partial b cell protection reduce the rate of infection in a prior study by up to seven <unk> reduced the rate of infectious mononucleosis in a prior study I have to 78%, but does not prevent the rate of infection.

Stephen Hoge: But it did not prevent the rate of infection. We believe that the combination of multiple antigens, GP350 plus antigens for GP42, GH, GL, and GB will provide an opportunity for broader protection, both of B cells and epithelial cells. Very analogous to our approach with the cytomegalovirus vaccine. Now, we estimate that the opportunity is quite substantial. Worldwide direct costs of EBV-linked infectious mononucleosis reach almost $500 million annually, and the indirect costs could exceed $1 billion. But prevention of infection, EBV infection, in addition to the prevention of infection of mononucleosis, could represent a much more significant upside because of the associated increased risk for cancers and multiple sclerosis. These would represent long-term potential but are not currently...

We believe that the combination of multiple antigens GP 350, plus antigens procure GBP 42, G.H. GL and GB will provide an opportunity for broader protection, both a b cells antipathy themselves very analogous to our approach with a cytomegalovirus vaccine.

Now we estimate that the opportunity is quite substantial worldwide direct cost of <unk> de linked in Texas, one nucleo assist reach almost $500 million annually and the indirect cost could exceed $1 billion.

But prevention of infection NPV infection. In addition to the prevention infection money goes this could represent a much more significant upside because of the associated increase for skin cancers in multiple sclerosis. These are people that represent a long term potential but are not currently a focus of our current clinical development plan.

Stephen Hoge: These would represent

Putting now to our second recently announced program, which is for respiratory syncytial virus in the pediatric population I want to pause and provide a little bit of an overview of the disease again.

Stephen Hoge: Pivoting now to our second recently announced program, which is for respiratory syncytial virus in the pediatric population, I want to pause and provide a little bit of an overview RSV is the leading cause of severe lower respiratory tract disease and hospitalization in infants and young children worldwide. It's a major cause of hospitalization in this country, accounting for up to 86,000 hospitalizations a year and over 2 million medically attended RSV infections in children under the age of five. Globally, the burden of disease is even more substantial, with over 30 million episodes of acute lower respiratory tract infection.

RSV is the leading cause of unaddressed severe lower respiratory tract disease, and hospitalization and infants and young children worldwide. It's a major cost hospitalization in this country accounting for up to 86000 hospitalizations, a year and over 2 million medically attended RSV infections in children under the age of five globally. The burden of disease is even more.

Substantial with over 30 million episodes of acute lower respiratory tract infection annually.

Stephen Hoge: We estimate that the direct cost associated with pediatric RSV disease in children under the age of 5, exceeds $2 billion annually. So our target population for this vaccine is the young, under the age of five, children who are at highest risk for respiratory syncytial virus. There is currently no approved RSC vaccine in that population. Our candidate, mRNA1345, encodes for a stabilized prefusion F-glycoprotein, analogous to our other efforts in RSV-X. MRNA1345 will use the same proprietary lipid nanoparticle as our HMPV-PIV3 vaccine, mRNA1653, as well as the CMV vaccine that Tal just mentioned. We believe that neutralizing antibodies elicited by 1345 will lead to a reduction of medically attended RSV disease in the very young. And while that's exciting, we actually intend to combine 1345 with mRNA 1653 to create a combined pediatric vaccine, respiratory vaccine, which will affect over 3 million.

Well, we estimate that the direct cost associated with pediatric RSV disease, and the children age five exceed 2 billion annually. So our target population for this vaccine is the young under the age of five children for rest person just parse. There is currently no approved RSV vaccine in that population.

Our candidate MRT 13, 45 encodes for a stabilized profusion f. glycol protein analogous to our other efforts in RSV vaccine and warranty 30, or 13 45, we'll use the same proprietary lip and nanoparticle as our H M. P. D. P. I'd be three vaccine Marni 16, 53, as well as the CMV vaccine intelligence describes.

We believe that neutralizing antibodies and listen to by 13 45 will lead to a reduction of medically attended RSV disease in the very.

Now, while that's exciting we actually intend to combine 13 45 with a morning 16 53 to create a combination pediatric vaccines respiratory vaccine, which will address over 3 million medically attended a low risk protecting our first prototype infections annually in the U.S. along that combination of M. ornate 13 45 in 16.

Stephen Hoge: Medically Attended Lower Respiratory Tract and Upper Respiratory Tract Infections Annually in the U.S. alone. That combination of mRNA 1345 and 1653 would represent a significant opportunity to address unmet needs. The current plan is to develop 1345 and 1653 independently in the near term through their initial clinical studies, but we would combine them prior to registrational studies and ultimately, Now, the third vaccine that we announced earlier this month is our mRNA vaccine against the SARS-CoV-2 virus, recently named the novel coronavirus that's associated with COVID, mRNA-1273 is an mRNA vaccine that encodes a pre-fusion stabilized form of the spike protein of that novel coronavirus that had been selected by Moderna in collaboration

The three would represent a significant opportunity address unmet need.

The current plans to develop 13, 45, and 16 53 independently in the near term through their initial clinical studies, but we would combine them prior to Registrational studies and ultimately advanced joint product.

A third vaccine that we announcement earlier this month is our MRT vaccine against the stars Koby to virus recently named the novel Corona virus, that's associated with Covidien 18 disease.

Good morning, 12, 73 isn't MRT vaccine that encodes for a pre fusion stabilized form of the spike protein Oh that novel Krona virus that had been selected by Madonna and collaboration with the National Institutes of allergy and infectious diseases, the vaccine reset and vaccine Research center, which are part of the NIH.

Stephen Hoge: has been selected by

Stephen Hoge: Cervarix Diseases and the Vaccine Research Center, which are both part of the NIH. The first clinical batch for our Phase 1, including finishing and filling in vials, was completed on February 7th, and earlier this week, that batch was shipped to the NIH for phase 1. NIAID will conduct that Phase 1 study under its own IND. Now pivoting to our second core modality, earlier this year we did announce two additional programs in the autoimmune therapeutic area for our systemic, secreted, and cell surface therapeutics. And as we described them at J.P. Morgan, I won't go into great detail, but I will briefly recap them here.

The first clinical batch for phase, one, including finishing and filling involves was completed on February 7th and earlier this week that batteries shipped to the AD age for the phase one study.

Hi, I D will conduct that phase one study under their own I Indian near term.

[laughter] pivoting to our second core modality earlier this year, we did announce two additional programs in the auto immune therapeutic area in our systemic secreted and cell surface therapeutics and as we described them at JP Morgan I won't go into great detail, but to briefly recap than here.

I hope to our I O. Two program MRT 62, 31 encodes for a long acting polarizing aisle too as you can see in the lower right hand corner on this page we've demonstrated a non human primates that a single subcutaneous injection of at more in a 62 31 can lead to a substantial increase in T reg cells without increasing our.

Stephen Hoge: Our IL-2 program, mRNA-6231, encodes for a long-acting, tolerizing IL-2. As you can see in the lower right-hand corner on this page, we've demonstrated in non-human primates that a single subcutaneous injection of mRNA-6231 can lead to a substantial increase in Treg cells without increasing activator, and that provides an opportunity to re-establish immune balance across There are a number of different recombinant IL-2 based therapeutics that have shown potential, and we will be advancing this program into the clinic in the near future. The second program we announced earlier this year was PD-L1 mRNA-6981. It's an mRNA-encoded PD-L1 to send a tolerizing signal to immune cells. In this case, we are expressing PD-L1 on the myeloid antigen-presenting cell.

Conveyed itself.

Provides an opportunity to reestablish immune balance across it that might be relevant for a wide range of auto immune diseases.

There are a number of different recombinant IL two based therapeutics that have shown potential and we will be advancing this program into the clinic in the near term.

Second program, we early we announced earlier this year with PDL one more in a 69 81, it's an MRT encoded PDL one to send a taller rising signal to immune cells.

In this case, we are expressing PD one on the myeloid antigen presenting cells and the purpose of that is to drive a tolerant genic phenotype, a reestablishment of immune homeostasis effector cells, including T cells and T cells.

Stephen Hoge: And the purpose of that is to drive a tolerogenic phenotype, a reestablishment of immune homeostasis in effector cells, including T cells and P cells. mRNA-6981 will be an IV infusion using the same LNP as our mRNA-encoded antibody, mRNA-1944, that has previously been described. And in preclinical disease models across a wide range of autoimmune As you can see in the lower right-hand corner, one example, which is collagen-induced arthritis. The first indication for which we're going to be bringing the PD-L1 program forward is autoimmune hepatitis, a disease we see of compelling unmet need.

Good morning, sticking on any one will be a ivy infusion using the same LMP as our morning coated antibody and morning 1944 that had previously described and preclinical disease models across a wide range of autoimmune conditions, we've demonstrated ability to modify the disease as you can see in the lower rate in quarter. One example, which is college and induced arthritis.

The first indication, which we're going to be bringing the PDL. One program forward is in autoimmune hepatitis a disease, we see of compelling on.

Now with that I'll turn it back over to talk to talk about our other work in the exploratory modalities.

Thank you Steven.

Stephen Hoge: Thank you, Stephen. Let me just briefly review these modalities that we consider exploratory, but obviously make up a significant part of what we do in clinical research and give you a sense of where we are in the prosecution of these programs. Starting with the cancer vaccines, our personalized cancer vaccine, mRNA-4157, is in a randomized phase 2 trial for the treatment of adjuvant melanoma, the combination of PCV with Keytruda against Keytruda alone, and it's recruiting well. KRAS vaccine, mRNA-5671, is an ongoing phase 1 study, and this one is led by Merck, and it has a monotherapy as well as a combination with Keytruda-R. Our intra-tumor immuno-oncology therapeutics, we have three programs in this modality, all of them are in combination with PD-1 inhibitors, dosing of patients is ongoing and I look forward to the future to being able to demonstrate whether the ability to influence the immune system in this manner will be helpful to these patients.

Let me just briefly review these modalities that we consider exploratory, but obviously make up a significant part of what are we doing clinical research and give you a sense, where we are on the prosecution of these programs.

Starting with a cancer vaccines are personalized cancer vaccine them or in a 41 57 isn't a randomized phase two trial for the treatment of as you've been melanoma. The combination of PCB with Keytruda against Keytruda alone and its recruiting will KRS Oh vaccine them on a 50 671 is an ongoing phase one study in this one is led by Merck and it has.

Monotherapy as well as a combination with keytruda or.

Or intra tumor immune oncology therapeutics, a we have three programs in this modality all of them or in combination with PD. One inhibitors dosing of patients is ongoing and I look forward to the future to being able to demonstrate whether the ability to influence the immune system. In this matter will be helpful to these patients.

On the regenerative therapeutic modality astrazenecas conducting a phase two a in patients.

With our M&A that encodes for vascular to fuel our growth factor and that's in patients that are undergoing cabbage coronary artery bypass grafting that study continues to enroll.

Stephen Hoge: On the regenerative therapeutics modality, AstraZeneca is conducting a Phase IIa study in patients with rMRNA that encodes for vascular endothelial growth factor, and that's in patients that are undergoing CABG, coronary artery bypass grafting. That study continues to enroll. In systemic intracellular therapeutics, we have two INDs open now in both MMA and TA, methylmalonic acidemia and propionic acidemia. I'm pleased to announce that the first patient with MMA has enrolled in this trial. They're in the observation period right now. This trial is now open at seven institutions in the United States, and we're continuing to look for additional patients to enroll while we follow this first patient closely. With that, I turn it over to Lawrence to describe the rest of our pipeline and where we go from here.

And this systemic intra cellular therapeutics Oh, we have two lines. These open now in both M.A.N.P. Macmillan against anemia propionic acid. The me up I'm pleased to announce at the first patient minimum me as enrolled in this trial there in the observation period right. Now. This trial is now open at seven institutions in the United States and we're continuing to look for additional patients.

Enroll while we follow this first patient closely.

With that let me turn it over to learns to describe the rest of our pipeline, where we go from here.

Thank you talk so on slide 29, you say graphic that represents our whole development pipeline and stands today first and foremost we're focused on the advancement in execution around this development pipeline.

Here are three significant things from us today around CMV vaccine, where the phase III preparation is very much underway you had the fees to enrollment for that CMV vaccine is ahead of schedule and importantly in phase one never may has enrolled as for subject. So we're really.

Focused on executing across the entire breadth of the pipeline.

And then the other keeping you heard today that the preclinical programs continue to grow.

Lawrence Kim: Thank you all. On slide 29, you see a graphic that represents our whole development pipeline as it stands today. First and foremost, we're focused on the advancement and execution around this development pipeline. You heard three significant things from us today about the CMV vaccine, where the phase 3 preparation is very much underway. You heard that phase 2 enrollment for that CMV vaccine is ahead of schedule, and importantly, in phase 1, MMA has enrolled its first subject. So we're really focused on executing across the entire And then the other key thing you heard today is that the preclinical programs continue to grow, and you will have heard that we announced in the first two months of the year five new development candidates.

And you will you will have heard that we announced in the first too much of the or five new development candidate. This is.

Indicative of the productivity that we expect out of the research platform.

But at least on the next slide is or a bus list of clinical data next steps across the pipeline you did scanned the page you'll see a lot of readouts coming in the near term we've guided for the CMB read out in the phase two data with a three month interim analysis in the third quarter of this year and a phase three start in 2021 and with the rest of the vaccines, you'll see a number of additional phase one read outs.

We would expect to occur as well as advancement of these new newly nominated development candidates toward the clinic [noise].

If you look the next category of systemic secret therapeutics or anybody gets to continue we'll continue to progress through further development of a dose cohort and we'll continue to advance preclinical work.

Lawrence Kim: This is indicative of the productivity that we expect out of the research platform. What this leads to on the next slide is a robust list of clinical data and next steps across the pipeline. If you scan the page, you'll see a lot of readouts coming in the near future. We've got it for the CMV readout, phase two data with a three-month adrenaline analysis in the third quarter of this year, and phase three start in 2021. And with the rest of the vaccines, you'll see a number of additional phase one readouts that we would expect to occur as well as advancement of these newly nominated development candidates toward the clinic. If you look at the next category of systemic secreted therapeutics or antibodies against chikungunya, we'll continue to progress through further development of a dose cohort, and we'll continue to advance preclinical work toward IND filing.

Work towards 90 filings.

And you just heard from column the rest of our programs will be more aggressively moving forward here towards clinical data.

On slide 31 in today's press release, we report our fourth quarter and full year 2019 financial results. Please note. These results are unaudited. After this call we'll be filing audited financial shortly with the 10-K.

We ended 2019 with cash cash equivalents and investments of $1.26 billion. This compares to $1.69 billion at the end of 2018.

Net cash used in operating activities that was 459 million for 2019 compared to 331 million in 2018 and cash used for purchases of property and equipment was 32 million for 2019 significant drop versus $106 million in 2018, we placed our Norwood Moderna technology Center manufacturing facility in.

Service in mid 2018.

[laughter] revenues for Q4, 2019 was $14 million compared to 35 million for Q4 2018 and for the full year revenue was 60 million compared to 135 million in 2018, I recall that in January 2019, we adopted the mandated revenue recognition standard assay six six using a modified retrospective trends.

Lawrence Kim: And you just heard from Kyle that the rest of our programs will be progressively moving forward towards clinical data. On slide 31 in today's press release, we reported our fourth quarter and full year 2019 financial results. Please note these results are unaudited as of this call. We'll be filing audited financials shortly with the 10K. We ended 2019 with cash, cash equivalents, and investments of $1.26 billion. This compares to $1.69 billion at the end of 2018. Net cash used in operating activities was $459 million for 2019, compared to $331 million in 2018. And cash used for purchases of property and equipment was $32 million for 2019, a significant drop versus $106 million in 2018. We placed our Norwood Moderna Technology Center manufacturing facility in service in mid-2018.

Looking back at applied those contracts, which weren't completed as of January 1st 2019 until the decreases in revenue were largely attributable to the adoption of this new revenue scattered together with the completion of the initial for your research period under the 2016 Merck agreement.

Total revenue under the previous.

Revenue recognition standard would have been $15 million for Q4, 2019, and 95 million for full year 2019.

R&D expenses for Q4, 2019 were $119 million compared to 159 for Q4 2018 and for the full year 2019, R&D dollars were 496 million compared to 454 million. In 2018 are the decrease in Q4 was mainly due to a decrease in there in licensing payments to sell script minutes affiliate and a read.

Lawrence Kim: Revenue for Q4 2019 was $14 million compared to $35 million for Q4 2018, and for the full year, revenue was $60 million compared to $135 million in 2018. Recall that in January of 2019, we adopted the Mandated Revenue Recognition Standard ASC-606 using a modified retrospective transition method applied to those contracts which weren't completed as of January 1, 2019, and so the decreases in revenue are largely attributable to the adoption of this new revenue standard together with the completion of the initial four-year research period under the 2016 Merck Agreement. Total revenue under the previous revenue recognition standard would have been $15 million for Q4 2019 and $95 million for full year 2019. R&D expenses for Q4 2019 were $119 million compared to $150 million for Q4 2018, and for the full year 2019, R&D dollars were $496 million compared to $454 million in 2018.

Never lab supplies materials.

The increase for the full year 2019 was mainly driven by an increase in personnel related costs, including stock based comp driven by an increase the number of employees as well as higher clinical trial and manufacturing costs.

[laughter] DNA expenses for Q4 were 26 million compared to 38 million in Q4 2018 and for the full year digging expenses were 110 million compared to 94 million in 2018.

The decrease in Q4 was primarily driven by a decrease in stock based comp mainly attributable to certain performance based equity awards with best carrying commencement contingent on the IPO in 2018.

The increase for the full year 2019 was mainly due to the additional cost operating as a publicly traded company, including the increases insurance consulting and outside services and facility costs.

The next slide we show the progression of selected cash flow line items, namely our net cash used in operating activities and our purchases of property and equipment at the table shows you. Our GAAP results by period with a total operating cash flow plus PPD I'd point, you primarily to the bar chart, which shows a quarter by quarter progression of this metric and you'll.

Lawrence Kim: The decrease in Q4 was mainly due to a decrease in our in-licensing payments to Sellscript and its affiliates and a reduction of our lab supplies and materials. The increase for the full year 2019 was mainly driven by an increase in personnel related costs, including stock based comp, driven by an increase in the number of employees, as well as higher clinical trial and manufacturing, G&A expenses for Q4 were $26 million compared to $38 million in Q4 2018, and for the full year, G&A expenses were $110 million compared to $94 million in 2018. The decrease in Q4 was primarily driven by a decrease in stock-based comp, mainly attributable to certain performance-based equity awards with vesting or commencement contingent on the IPO in 2018, and the increase for the full year of 2019 was mainly due to the additional Consulting & Outside Services & Facility, On the next slide, we show the progression of selected cash flow line items, namely our net cash used in operating activities and our purchases of property and equipment.

See that our cash is shows a steady production through 2019 I would note. The Q1 contained the impact of the last of the three licensing milestone payments, we odell script, which is $22 million.

I don't expect as downward trend to continue to decline quarterly in 2020, but for the full year you can see how we ended up overall flat versus 2019, only thought about expectations, even with the advancement of our pipeline for the clinic and so as a result will reiterate our guidance for 2020.

Which is that net cash used in operating activities and purchases BPMI will total.

490 and $510 million.

[noise] that approximate 500 million a patent diamond or into our business is put into context in the next slide.

Versus the cash that's available to us for investment.

Here, you see our yearend cash balance of 1.26 billion.

And on top of that is a net proceeds of approximately 550 million from our equity offering which included the exercise in the underwriters option to purchase additional shares that we anticipate close later today and.

And then as we've mentioned before we have approximately $185 million and potential future grants available to us as well and so these amounts sum up to $2 billion and available cash, which we expect to invest in our business and that represents a significant cash runway of multiple years.

Lawrence Kim: The table shows you our gap results by period with a total operating cash flow plus PP&E. I'd point you primarily to the bar chart, which shows the quarter by quarter progression of this metric. And you'll see that our cash use shows a steady reduction through 2018. I would note that Q1 contained the impact of the last of the three licensing milestone payments we owed Selscript, which is $22 million. I don't expect this downward trend to continue to decline quarterly in 2020, but for the full year, you can see how we ended up overall flat versus 2019 when we thought about expectations, even with the advancement of our

I'll now hand, it back to used to fund to close.

Extra Lawrence Cotton zero.

On slide 35, you can see in a bit on us profile.

Our company has never been stronger.

Our pipeline.

We are grateful to have you faced spray foam. It is seen in upward Branco face to the event phase one trial is ongoing and thankful to keep can you go to weed out.

Oh programs in development.

Seven vaccines, where they are no approved vaccines on the market.

Lawrence Kim: for the Clinic. And so, as a result, we'll reiterate our guidance for 2020, which is that net cash used in operating activities and purchases of PP&E will total between $490 and $510 million. That approximate $500 million of cash investment into our business is put into context in the next slide versus the cash that's available to us for investment. Here you see our year-end cash balance of $1.26 billion, and on top of that is the net proceeds of approximately $550 million from our equity offering, which includes the exercise of the underwriter's option to purchase additional shares that we anticipate to close later today. And then, as we've mentioned before, we have approximately $185 million in potential future grants available to us as well. And so these amounts sum up to $2 billion in available cash, which we expect to invest in our business. And that represents a significant cash runway for multiple years, and I'll hand it back to Stphane to close.

Most of these vaccine candidates have Mickey began thought all annual peak sales of alternative.

As I showed you know fucking 19 showed all its here. We believe all I know you vaccines are going to be varied out for bid and ask Madonna.

We've looked on long term and you'll see like football team at a high EBIT margin.

Five even though I'll provide you drugs in the clinic.

I've read these programs, we fulfilled phase one stop if I mean to auto immune disease program.

The foundation on will now have ended up being stronger.

Can you could experience is now more than one of them several entre had people don't deals and patients.

The team is strong we moved in its current employees, who care deeply about a mission and I'm proud of and energized ball progress.

I will talk to think Oh entitled team I.

I would have to extend this fisher fin Q2, those who made the criminal virus.

Vaccine from sequence to shipping to an age for phase one goes inc. in only 42 days.

And were proud to be coded weibos many companies working on the placebo response to these cotton in global have emergency.

No it would.

These are fully digits or fully integrated facility that enabled us to be executable pipeline all the way from raw materials to finish bogs ready to ship to a panic.

Stphane Bancel: Thanks for your time. Thank you for your time.

Stphane Bancel: On slide 35, you can see an update on Moderna's profile. Our company has never been stronger. Our pipeline, preparing for CMU Phase 3, 4 medicines in or preparing for Phase 2, the event that phase 1 trials are ongoing, and 10 positive clinical readouts. 7 vaccines where there are no approved vaccines on the market.

We have great button that was 8 million gsix, but there are so dapa valda CP and the Gates Foundation.

As we sit on November quality core well walking on expanding that network of partners as we speak.

We have a financing ahlgren capital and current finance, where in the fortunate position, we invest up to 2 billion, though to a building the linking him on the company.

Stphane Bancel: Most of these vaccine candidates have multi-billion dollar annual peak sales opportunities. As I shared in our 2019 shareholder letter, we believe our innovative vaccines are going to be a very large business for Moderna, with long-term, long-term, annuity-like opportunities and a high bit margin. Five immuno-oncology drugs in the clinic.

We are thankful drawing best also got trust and partnership as we beat this unique company.

Couple of things, what's your product either very clear pricing number one execute on I'll give up and pipeline weve, especially our focus on team you faced restarts.

Quoting them, but tool is creating new development candidates into two call modalities.

We are with yet five less too much.

And probably the number of free.

Stphane Bancel: Five rare disease programs, with our first phase one started for MMA, and two autoimmune diseases programs. The foundations of Moderna have never been stronger. Our clinical experience is now more than 1,700 healthy volunteers and patients. The team is strong. We have more than 800 employees who care deeply about our mission and are proud of and energized by our progress. I would like to thank our entire team, I would like to extend a special thank you to those who made the coronavirus vaccine from sequence to shipping to NIH for phase one dosing in only 42 days, and we are proud to be included with those many companies working on the possible response to this continuing global health emergency. Norwood.

Good luck.

Today, you might view.

Stay tuned here.

As a reminder, though.

These are the events. We also see finally, saying you're just talking twentytwenty.

Well first manufacturing and do so there is next week on the Wednesday, I don't know with Pepsi BTD, Massachusetts, a webcast would be if any born on our website.

Hi, My address any steam we show many new insights, including how the team did even growing about what vaccine 42 days from sequence to shipping.

Not sure that many andys team, we show progress since opening though with indirect when she 18 on the digital front, including use cases of up to trying to digest and machine learning.

Stphane Bancel: This is a fully digital, fully integrated facility that enables the execution of a pipeline all the way from raw materials to finished valves ready to ship to the planet. We have great partners with AZ, Merck, Vertex, but also DARPA, Parda, CEPI, and the Gates Foundation. As we said on the November quarterly call, we are working on expanding that network of partners as we speak. With the final theme, our grand capital and our cash balance. We're in a fortunate position to invest up to $2 billion towards building the leading mRNA company. We are thankful to our investors for their trust and partnership as we build this unique company. For 2020, our priorities are very clear. Priority number one, execute on our development pipeline with a special focus on CMV phase three style. Project number two is creating new development candidates in the two core modalities. We already have five in the last two months. And priority number three is to develop new development candidates in new modalities. Stay tuned.

We hope to US menu of Q4 felt vaccine day in New York City on if we felt team for a deep dive into a money vaccine will they team.

We'll discuss some of our fingers clinical data I'd be this more than I would think with value creation kept application and probability of success of I'm on the vaccines.

In June we look forward to asking all felt saying there to be able to shall we view the menu progress. The team has made on them honest science and degree seen finds its way into 19.

In September we just select welcome you fall fall off on today, well Here's your water in New York review in detail to clinical data.

As I shared the mine production.

Well then they have entering a new phase of development as a company.

All goes up clear.

One fighting to keep will it be Elliot and ultimately you put them into team, which we own commercially and to continue to explore modalities in the clinic investing science.

We have to come with every teeth and I'm not laser focused on finding people wouldn't get it and vans kitting will that to maximize went back on patients.

Were continuing to realize Oh vision, we woke up swearing about the you've made a seems currently in the clinic.

We are only getting started.

Stphane Bancel: As a reminder, these are the events we are hosting for analysts and investors in 2020. Our first Manufacturing and Digital Day is next week on Wednesday at our Norwood facility in Massachusetts. A webcast will be available on our website. Juan Andres and his team will share many new insights, including how the team delivered the coronavirus vaccine in 42 days from sequence to shape. Marcello Damiani and his team will share the progress since opening Norwood in July 2018 on the digital front, including use cases of artificial intelligence and machine learning.

And on the isn't information when acuity.

Because of that we believed that the probability of picking listed success for made US you assemble lab to approval, we must already how you have and traditional medicines.

Speed.

Our truck for Gulf speaks louder than words crowing about rose sequentially shipping can you go to work product faulty to this.

Maybe that's a greater capital efficiency, we're lucky food traditional recombinant technology is becoming got parents.

We can't do annuity see Lucky BP in pediatric RSV, we felt that additional technical invested.

I have never been more optimistic about them without future and put controller since joining us I'm putting them into in 2011.

I believe Amazon is going to be a new vessel medicines.

Stphane Bancel: Thank all of you for the first Vaccine Day in your city on April 14th for a deep dive into our mRNA vaccine modality. We'll discuss, among other things, clinical data, the business model, how we think about value creation, capital allocation, and the probability of success of our mRNA vaccine.

And I believe more than that is the leading company that Steve.

We have to begin that ought to reinvest.

Great team.

Science.

IP and the manufacturing sites I'm not one.

We will work to accelerate falling to shipping them mumps and qualify system.

Stphane Bancel: In June, we look forward to hosting our third Science Day.

We're excited by the ability to bring for a while the new pessimism is for patient I'd like to finish the Gretzky moving well down the employees working hard every day at some time every weekend to make decision that we haven't seen.

Stphane Bancel: To be able to share with you the progress the team has made on mRNA science and delivery since Science Day 2019. In September, we'd also like to welcome you to our fourth R&D day, where, as usual, in New York, we'll review in detail clinical data. As I shared in my introduction, Moderna is entering a new phase of its development as a company. All the goals are clear. 1. File multiple PLAs and launch multiple medicines which we own commercially. 2.

Correct to think that many people do participate you know clinical studies screening patients as people until the end physicians.

I would select to Rick when as commercial professionals, all commercial buff nails, who work with us and shell BG and then you've got transformative medicines for patients with that we're not happy to take any questions.

Thank you as a reminder, if you'd like to ask a question Chris car telephone Keypad. My first question is from Matthew Harrison from Morgan Stanley Go ahead. Your question. Please Oh.

Stphane Bancel: Continue to explore modalities in the clinic and invest in science. We have two core modalities and are now laser focused on filing multiple BLAs and then scaling Moderna to maximize our impact on patients. We are continuing to realize our vision. We have over 12 innovative medicines currently in the clinic. We're only getting started.

Hey, good morning, Thanks for taking the questions.

I guess two for me. So so one on Corona virus and I think this is just so people understand could could you just broadly comment it sounded like.

And I age needs to file and I, Andy and then they would obviously start the clinical study what is your involvement at this point.

Stphane Bancel: Because of that, we believe that the probability of technical success for our medicines from the lab to approval will be materially higher than for traditional medicines. Our track record speaks louder than words.

And are you, taking any steps related to ramping manufacturing or any other steps related to this and then secondly, maybe just on.

Stphane Bancel: Sequence Shipping, Clinical Web Product, 42 days. Evidence of greater capital efficiency relative to traditional recombinant technology is becoming apparent. We can do new ideas like EBV and pediatric RSV without additional capital investment. I have never been more optimistic about Moderna's future and potential since joining as Employee No. 2 in 2011.

On on CMD, well actually on M&A.

Can you just talk about how enrollment is going for additional patients you know what sort of lead you to be able to get that first patient and and if you see promised in terms of being able to rapidly enroll additional patients. Thanks.

Stphane Bancel: I believe mRNA is going to be a new platform in the, and I believe Moderna is the leading company in that field, with $2 billion to invest. A great team of Science, or IP, and the manufacturing site are now. We will work to accelerate our leadership in the months and quarters to come.

Thanks might give this a tall, let me take both of these questions as it relates to Corona of ours are part here was to manufacture in ship. It I think the ER the trial and I will be run by the NIH and I defer to them to provide updates when they will.

Stphane Bancel: We are excited by the opportunity to bring forward a new class of medicines for patients. I would like to thank the great team of Moderna employees working hard every day and sometimes every weekend to make this vision a reality. I would like to thank the many people who participated in our clinical studies, including patients, university volunteers, and physicians. I would also like to recognize all our commercial partners and commercial partners who work with us and share our vision to deliver transformative medicine for patients. With that, we are now happy.

You asked about scale up you know I think we're looking at everything that it would take in how to actually get it done, but you know well update everybody. Once we have a clear picture that obviously this is a rapidly changing environment.

And in mid May enrollment or.

So right now we've got one patient enrolled we do not yet have the second and third but we're actively working with sites to find them. The age barrier I think continues to be a difficult. One we only have to find the first three so and then we can go down in age. So I am confident that we will event.

Operator: Thank you. As a reminder, if you'd like to ask a question, you can press star 1 on your telephone keypad. Our first question is for Matthew Harrison from Morgan Stanley. Go ahead. Your question, please. Hey, good morning.

Actually but I continue to have a dialogue with the agency on trying to a reduced that needs to that enrollment can be on hooked from that and we can get into the age population, where we believe the greatest unmet need and potential for benefit is so I'll update everybody as soon as we have.

Matthew Harrison: Thanks for taking the questions. I guess two for me. So one on coronavirus, and I think this is just so people understand, could you just broadly comment? It sounded like NIH needs to file an IND, and then they would obviously start the clinical study. What is your involvement at this point? And are you taking any steps related to ramping up manufacturing or any other steps related to this? And then secondly, maybe just on CMB, well, actually on MMA.

Progress in that field.

Thank you.

Okay.

Thank you. Our next question is from Ted Tenthoff the of Piper Sandler Your line is open.

Great. Thank you very much and just following up on Matts question first what maybe you can just remind us again, so that everybody understands that because we've been getting a lot of questions on those what is the process for license for all of a.

Matthew Harrison: Can you just talk about how enrollment is going for additional patients? You know, what sort of led you to be able to get that first patient in and whether you see any promise in terms of being able to rapidly enroll additional patients? Thanks.

Bio Rad or a pandemic vaccines, such as chroma virus and then with respect to.

Ptolemy: Thanks, Maria. This is Ptolemy.

Ptolemy: I'll take both of these questions. As it relates to the coronavirus, you know, our part here was to manufacture and ship it. I think the trial will now be run by the NIH, and I defer to them to provide updates when they do. You asked about scale-up.

CMV again, great progress just across the board here [noise].

You know ultimately.

What do you see is sort of the vaccination paradigm.

Or timing of vaccinations for women of childbearing age. Thanks, so much.

Ptolemy: I think we're looking at everything that it would take and how to actually get it done. But we'll update everybody once we have a clear picture, because obviously, this is a rapidly changing environment. On MMA enrollment. So right now, we've got one patient enrolled. We do not yet have the second and third, but we're actively working with sites to find them. The age barrier, I think, continues to be a difficult one. We only have to find the first three, so then we can go down in age. So I am confident that we will eventually, but I continue to have a dialogue with the agency on trying to reduce that need so that enrollment can be unhooked from that, and we can get into the age population where we believe the greatest unmet needs potential for benefit is. So I'll update everybody as soon as we make progress in that field. Thank you.

[laughter]. Thanks, Ted it's so let me take that I think what does it take to get licensure is an evolving feel though I mean, the pathways to licensure are well understood and they encompass everything from findings targets of protection to demonstrating efficacy.

What is it going to take care I don't think anybody knows I think all options are currently open but it's a rapidly evolving field and you can imagine that there actually is not yet so we're going to protection because it's a very you have arson involved people are still working to develop those as isn't models I I wouldn't give and takes a lot of credit for being at the forefront of.

That effort and work closely collaborating with them on these efforts.

As it relates to a the vaccination paradigm for CMV I think the starting point here is clearly going to be a in women of childbearing age a that's where you would anticipate the greatest benefit and I think of the next phase is going to be to get into a gardasil like population of adolescence, because obviously you want.

Edward Andrew Tenthoff: Thank you. Our next question is from Ted Tenthoff of Piper Sandler. The line is open.

Started protection as early as possible given that's what are the disease were trying to prevent here is ultimately going to be infants.

Edward Andrew Tenthoff: Great. Thank you very much.

Edward Andrew Tenthoff: And just following up on Matt's question first, maybe you can just remind us again so that everybody understands it because we've been getting a lot of questions on this. What is the process for the approval of a biothreat or pandemic vaccine such as the coronavirus? And then with respect to CMV. Again, great progress just across the board here. You know, ultimately... What do you see as sort of the vaccination paradigm or timing of vaccinations for women of childbearing age?

Born to women. So so we're going to try and get down to that age group as we develop this vaccine.

Okay.

Great. Thank you very much.

Thank you. Our next question is from Salveen Richter of Goldman Sachs. Please go ahead. Please.

Thanks for taking the question its Ross on first I'll being just a few here for me. So just quickly on current of Irish what's the potential monetary opportunity here do you guys have any details around agreements with the NIH about you know funding for you guys. So just talking about the monetary opportunity there to Madonna and then on the chicken good antibody program.

Edward Andrew Tenthoff: Thanks so much.

Kyle Vack: Thanks, Ted. Let me take that.

Kyle Vack: I think what it takes to get licensure is an evolving field. I mean, the pathways to licensure are well understood, and they encompass everything from finding surrogates of protection to demonstrating efficacy. What is it going to take here?

How much just follow up time exists since like the initial patient was first dose and then since he was since he was he just second dose and are you guys see any signs if I can meet immune response, and then I've a follow up.

Kyle Vack: I don't think anybody knows. I think all options are currently open, but it's a rapidly evolving field. And you can imagine that there actually is not yet a surrogate for protection because this is a very new virus, and people are still working to develop those assays and models. I would give NIH a lot of credit for being at the forefront of that effort, and we're closely collaborating with them on these efforts. As it relates to the vaccination paradigm for CMV, I think the starting point here is clearly going to be in women of childbearing age. That's where you would anticipate the greatest benefit, and I think the next phase is going to be to get into a Gardasil-like population of adolescents, because obviously you want to start protection as early as possible, given that the disease we're trying to prevent here is ultimately going to be infants born to women

[noise] cookbooks, depending on subsequent festival I'm, calling up only for because as a team is probably Kelly you put our secret of a pilot people I think that these are only focus is to get a vaccine, especially as we can safely button right you pointed to give them.

[noise], let me answer a if I understood correctly. Your question on that you can get a monoclonal antibody.

You know these data are emerging a we're giving you an an execution update on too in terms of where we are once I have a full sense of the data set there of course update everybody.

Gray and then just lastly, so outside of the phase two CMB update in Threeq you what programs are expected to have data this year.

We are you had you know we don't guide to specific timing on on various milestones I'd refer back to the slide which had the rich catalyst calendar and clinical data calendar that we referred to.

That list of events that included data read outs as well as advancement of programs is listening across all the next steps that some of those have advanced fairly far along.

Salveen Richter: Great, thank you very much. Thank you. Our next question is from Salveen Richter of Golden Saks. Go ahead, please. Thanks for taking the question. It's Ross.

Ross: I'm for Salveen. Just a few here for me. So just quickly on coronavirus, what's the potential monetary opportunity here? Do you guys?

For instance, I would note that the phase one.

Vaccine studies for RSV, and Zika running since last year and other instances, you'll recall that any other as you pointed out the trick in Guinea antibody program is.

Ross: Do you guys have any details around agreements with the NIH about, you know,

Ross: Funding to you guys, so just thinking about the monetary opportunity there for Moderna. And then on the chicken goonie antibody program, how much follow-up time exists since the initial patient was first dosed and then since he received his second dose? And are you guys seeing any signs of like an innate immune response? And then I have a question.

Relatively small study in healthy volunteers.

But again, where we're focused on advancing all these programs as rapidly as we kind of words towards data.

Great. Thanks.

[noise] next question is from Geoff Meacham of Bank of America go ahead. Please.

Hey, guys. This is out like on for Jeff. Thanks for taking our questions. Two questions from me. So my first is on your PCV program and I guess, the the care S. vaccine as well have you guys seen any updated data from these studies, including the ongoing phase one for the PCV since ASKO I'm, just trying to get a sense of.

Stphane Bancel: So, Stphane, I'm going to start with the first one.

Stphane Bancel: On Corona, our only focus as a team is public health. People are sick all over the planet. People are dying. That is our only focus: to get the vaccine as fast as we can, safely, partnering with the right people to get it.

Why this modality hasn't made the cut for your core franchises given its one of the more advanced in terms of clinical development and then I've got one more.

Stphane Bancel: Let me answer, if I understood correctly, your question on the chicken giga monoclonal antibody.

Stphane Bancel: You know, these data are emerging. We're giving you an execution update.

Thanks, Alex it's called look on the personalized cancer vaccine. It's a phase one so a you know data continues to come in once we have a cool cogent data set there we will be disclosing it as the question away. We don't consider this a core I think across core is one that we have.

Stphane Bancel: These data are emerging.

Stphane Bancel: [inaudible]

Ross: Great, and then just lastly, so outside of the Phase 2 CMV update and 3Q, what programs are you expecting to have data for this year?

Gotten the requisite pharmacology to believe it will translate into a clinical benefit and I think thats true both for the vaccines clearly and it's also true for this accreted and the surface protein expression because that you can get in monoclonal anybody actually reached what would otherwise be therapeutic levels of protein. So so thats why its course I think in oncology until you are.

Ross: As you know, we don't guide to specific timing for various milestones.

Ross: different programs. I would note that the Phase 1 vaccine studies for RSV and Zika have been running since last year. In other instances, you'll recall that, as you pointed out, the Tricogon antibody program is a relatively small study in healthy volunteers. But again, we're focused on advancing all these programs as rapidly as we can.

Actually show that you're a the pharmacology that you're describing in this case immunology and peaceful immunology until you actually demonstrate that that translates into a clinical benefit for patients. It's hard for me to call with core.

Ross: [inaudible]

Geoffrey Christopher Meacham: Great, thanks. The next question is from Jeff Meacham of Bank of America. Go ahead. Hey guys, this is Alec on for Jeff.

Got it that's very helpful. Thanks, and then secondly, I'm do you have any updates on the CF partnership with vertex we've seen vertex partner with some other gene therapy approaches from CRISPR therapeutics someone others I'm. So any color you can give on this partnership would be great. Thanks.

Alec: Thanks for taking our questions. I have two questions. First, on your PCV program and, I guess, the KRS vaccine as well. Have you guys seen any updated data from these studies, including the ongoing phase one for the PCV since ASCO? Just trying to get a sense of why this modality hasn't made the cut for your core franchises, given it's one of the more advanced in terms of clinical development.

Yeah, Yeah, we don't generally I comment on researcher we continue to work with vertex. We're pleased to be working them 50, our space, but we don't any updates at this time.

All right. Our next question is from Cory Kasimov from JP Morgan go ahead. Please.

Alec: Thanks, Alec. It's a call.

Kyle Vack: Look, on the personalized cancer vaccine, it's phase one. So, you know, data continues to come in. Once we have a full, cogent data set there, we will be disclosing why we don't consider this a core...

Hi, guys. Thanks for taking my questions on two of them for you first is another one on Corona virus is thinking a little bit further out just curious what kind of manufacturing capacity you anticipate having to say looking out to 2021 have you been should you need to manufacture at marinade 12, 73, four Corona virus and then secondly for the.

Kyle Vack: I think that's all.

Kyle Vack: gotten the requisite pharmacology to believe it will translate into a clinical benefit. And I think that's true, both for the vaccines clearly, and it's also true for the secreted and the surface protein expression because the gene monoclonal antibody actually reached what would otherwise be therapeutic levels of a protein. So, that's why it's core, I think, in oncology, until you actually show that the pharmacology that you're describing, in this case, immunology and T cell immunology, until you actually demonstrate that that translates into a clinical benefit for patients, it's hard for me to call it that.

C M. B program I mean, she gets kind of broadly talk about what a when would look like in that interim update for the phase two will get in Threeq. You is this more or less it's kind of looking to replicate the phase one results in a larger group of patients or other nuances, we should be thinking about thanks.

Kyle Vack: Got it. That's very helpful. Thanks. And then, secondly, do you have any updates on the CF partnership with Vertex? We've seen Vertex partner with some other gene therapy approaches from CRISPR Therapeutics, and others.

So corey wanting to the front so I'll take the first one on manufacturing capacity I think the Pakistan is just too early to know precisely because we don't have it those are very few finishing no. There's no samuel capacity, especially new sites. So just with regard to comment on that but we are working I'll forget as much as we can.

Kyle Vack: Yeah, we don't generally comment on research, or we continue.

Kyle Vack: That we don't generally comment on research.

Operator: Thank you for joining us today. We appreciate it. Thank you.

Like or so let me answer your question on seem to be phase two so I think in a nutshell. The goal here is as you say to replicate what we saw in the phase one.

Corey Casimo: All right, our next question is from Corey Casimo from J.P. Morgan. Go ahead, please. Morning, guys. Thank you for taking my questions. Two of them for you.

I'd like to be able to do that of course in the larger data set so that our confidence in picking the right. Those for phase three is there that has to do both within with replicating the the nice immunogenicity that we've seen a but being able to kind of clinically reflect on what we expect in terms of the safety and tolerability profile that would enable us to go into phase three trial.

Corey Casimo: First, is another one on coronavirus. Thinking a little bit further out, just curious, what kind of manufacturing capacity you anticipate having, say, looking out to 2021, even, should you need to manufacture mRNA-1273 for coronavirus? And then, secondly, for the CMV program, could you just kind of broadly talk about what a win would look like in that interim update for the Phase 2, we'll get in 3Q. Is this more or less kind of looking to replicate the Phase 1 results in a larger group of patients or other nuances we should be thinking about? Thanks.

Okay. Thank you.

Our next one is from hard times since Oppenheimer and company go ahead. Please.

Great. Thank you. That's just a question on that one CMB with the phase two results coming up in the third quarter and then the sees forgetting going how could you talk a little bit about how you could speed to market I know, that's all along with it depended on the phase two results.

Cori: So Cori, good morning to the fans. So I'll take the first one on manufacturing capacity. I think the punchline is just too early to know precisely. First, we don't know the dose. Then till finish, you know, there is Norwood, CMO capacity. It's actually a new site, so just way too early to comment on that. But we are working hard to get as much as we can.

Can you give us some sort of.

The conference in a role as to when you think the phase three Oh could read out by which time you could be on the market 2024, 25, 26, and then just to follow on to that which is that you took the opportunity [noise].

Kyle Vack: Hi Corey, it's Kyle. Let me answer your question about CMV phase 2. So I think, in a nutshell, the goal here is, as you say, to replicate what we saw in phase 1. But I'd like to be able to do that, of course, with a larger data set so that our confidence in picking the right dose for phase 3 is there. And that has to do both with replicating the nice immunogenicity that we've seen, but being able to kind of plant a clear flag on what we expect in terms of the safety and tolerability profile that would enable us to go into phase 3. Okay, thank you.

5 billion, Oh, which seems to make a lot of sense, because as you get to broader and broader immunity can you just brought me walk us through what kind of patient populations would you want to sort of have though vaccine broaden into to get to that higher a point off that Oh stephanopoulos that range. Thank you very much.

Hartaj Singh: Our next one is from Hartaj Singh of Oppenheimer. Go ahead, Tracey.

Well I heard the this is Paul let me start by answering.

The first question. So look the timeline a first CMV roughly speaking once we get in we anticipate a fairly aggressively to be able to complete enrollment within 18 months I anticipate the duration of the trial to be a two years or no that still needs of course, a vetting with regulatory authorities. So.

Hartaj Singh: Great, thank you. I have just one question on CMV. You know, with the Phase 2 results coming up in the third quarter and then the Phase 3 getting going, could you talk a little bit about, you know, how you could speed it to market? I know that a lot will be dependent on the Phase 2 results, but can you give us some sort of, you know, kind of a confidence interval as to when you think the Phase 3, you know, could read out and by which time you could be on the market, And then just to follow on to that, which is that, you know, you don't see the opportunity of 5 billion, which seems to make a lot of sense because as you get to broad.

I want to make sure I caveat that appropriately once or that we have two years on everybody. On study then it's a matter of analyzing looking at the results and filing and that's where I think.

The timelines are pretty well understood for what's achievable in our industry. So you can do the math from there.

Yes, and stuff and then pick the second one on C.M.B. once we take to get to 5 billion I put a number I think if your things infested monies as we explained at the R&D day in September we take it to get indication approve or in a woman in child bearing age, which as you know first one dan to get into another philosophical approach.

Hartaj Singh: Can you just broadly walk us through what kind of patient populations you would want to sort of have the vaccine broadened into to get to that higher point of that vaccine?

Hartaj Singh: [inaudible]

Hartaj Singh: The first question.

Hartaj Singh: So, look, the timeline for CMV, roughly speaking, once we get in, we anticipate fairly aggressively being able to complete enrollment within 18 months. I anticipate the duration of the trial to be two years. Now, that still needs, of course, vetting with regulatory authorities, so I want to make sure I caveat that appropriately. Once that we have two years for everybody in study, then it's a matter of analyzing, looking at the results, and filing, and that's where I think the timelines are pretty well understood for what's achievable in our industry, so you can do the math from there.

Like the HPV got to Sue.

Phil just looking for pediatric as we shared.

Yeah, you meant that there was no up of CMV. We believe is it a very important but be careful both GT here to vaccinate new ball.

Definitely setting that that's been done as you know success, we were better to eradicate the virus and to make sure that humans won't get section are infected by these virus, which has a lot of lump them or the negative impact on have <unk> population over the last four individuals on day, one you mean system and I don't have.

Another that much of course is competitive landscape I wouldn't be the only when the market for next time, you have all going to be Weve, one company called committed to affect company itself.

Stphane Bancel: Yes, and Stphane, I'll take the second one on CMV. What will it take to get to 5 billion? I think a few things.

Okay, I'm going back on that you feel like trusted we feel though and then he spoke British didn't grow or there's a lot offer a emerging markets. That's all nobody growing sagicor publishing girl persuade them off or did I Miss that I can that be tempted to speak about five yet then you have 15 that timeframe and that's where you back then we'll then have to be helpful and get teams who are on February.

Stphane Bancel: The first one is, as we explained at R&D Day in September, it will take getting an indication approval for a woman in childbearing age, which, as you know, is our first one. Then to get an adolescent approval, like the HPV vaccine Gardasil. And third is to get into pediatrics.

Stphane Bancel: As we shared, humans are the reservoir for CMV, so we believe it's a very important public health opportunity here to vaccinate newborns in the pediatric setting. That has been done, as you know, successfully with rubella to eradicate the virus and to make sure that humans don't get infected by this virus, which has a lot of long-term negative impacts on health, both at the population level as well as for individuals and their own immune systems and their own health.

So I know, Texas.

Great. Thank you.

Our next question is from yes men Rahimi of Roth Capital Partners go ahead. Please.

Hi team. Thank you for taking my questions and thank you for their tremendous progress. They do you make in quarter over quarter few questions for you all related on T. M. B. The first one is can you give us a little bit more color on line [laughter].

So we think about how her into numbers or in your cards you infection rate. If there are differences between you and in Europe, how currency or as a guide you sort of for powering assumption in your phase three and then my second question not offering that is.

Yasmin Rahimi: Another dimension, of course, is the competitive landscape. Are we going to be the only one on the market for the next 10 years? Are we going to be with one competitor, two competitors, or five competitors? And then there's population growth. There are a lot of emerging markets that are not only growing in size but in population growth. So in terms of dollars invested in inhabitants, if you think about a 5-year, 10-year, 15-year time frame, that's what impacts the model that we have for getting to around $5 billion annually.

Right now.

Part of being able to scale up when we're going to learn more in manufacturing on March four can you might not what our <unk> back that are unique linear scaling up and I'm Arnie therapeutic versus other R&D modality, just we have a little or no critical what Keith Thank you.

Yasmin Rahimi: Our next question is from Yasmin Rahimi of Roth Capital Partner. Go ahead, please.

Yasmin Rahimi: Hi team, thank you for taking my questions and thank you for the tremendous progress that you're making quarter over quarter. I have a few questions for you all related to CMV. The first one is, can you give us a little bit more color on how we think about how current the numbers are in regards to infection rates, if there are differences between U.S. and Europe, how current they are as it guides you sort of for powering assumptions in your phase three. And then the second question that we often get is, as you're in the predominant part of being able to scale up, and we're going to learn more about manufacturing Just so we have a little bit of color and nuances that you're looking through, and thank you again for taking the questions.

Taking a question.

Hi, its minutes. So let me take your first question. It's a it's a great question and ones that obviously, a keeps me up at night I think the the literature is is out there in terms of incidence rates and infections, but it's also clear from the literature that there's a high level of variability and it's not just on the continental.

Well you as versus Europe is actually local geography socioeconomic status lot of things that play into that so how are we thinking about it in terms of designing the trial, which is obviously a you know I think where your question is going to I think the go here is to design, both large trial and a broad enough trial in terms of sites and population.

And so that on average we are able to hit the incidence rate that people have described and I'm pretty confident in the ballpark of where we are powering the study to be able to reach it and finally I would note that in the trial of this type you have the ability to actually on an ongoing basis monitor the incidence in real time, so that.

Saul: Hi Yasmeen, it's Saul. Let me take your first question. It's a great question and one that obviously keeps me up at night. I think the literature is out there in terms of incidence rates and infections, but it's also clear from that literature that there's a high level of variability.

The only risk you're really taking if you're missing. It is you follow subjects for longer and you catch up the cases, so it'll ultimately the trial size will come down to the number of cases and that's one that you can monitor and almost real time.

Saul: So how are we thinking about it in terms of designing the trial, which is obviously I think where your question is going to go? I think the goal here is to design both a large trial and a broad enough trial in terms of sites and population so that, on average, we are able to hit the incidence rate that people have described, and I'm pretty confident in the ballpark of where we are driving the study to be able to reach it. And finally, I would note that in a trial of this type, you have the ability to actually, on an ongoing basis, monitor the incidence in real time so that the only risk you're really taking if you miss it is that you follow subjects for longer, and you catch up on the cases. So ultimately, trial size will come down to the number of cases, and that's one that you can monitor in almost real time.

So money that's means to fund or on the manufacturing process and why your mom <unk>.

<unk> molecule I mean, if you're being I mean, the first thing Eve are you pretty quick pace process to make him on it which is set up for you.

So that drives to a very small to react also compared to walk up technologies, especially because that's a recombinant. These are most staggering changes.

Them to fall given up would just besides overreact calls which of course as would be impact on your capex, including all your pure condition picking interviews could you just have a less lead built to go from a cut on then song. So everything is much much cheaper across the ball as we've talked in the past because him on his new position and wanting to use a san process all the cow policy NVO fall Carl.

Stphane Bancel: So, morning Yasmin and Stphane. On the manufacturing process and why mRNA is such a... Powerful Molecule. I think a few things.

Virus, so drives incredible flexibility and the incredible tens of a chronic because do not have to invest the process for every vaccine Oh I don't want occur as the team as shown in the last few weeks Weve, calling a virus. If we have had like a traditional peculiarities to invent the new process just four corner, we should be working out you've as we speak.

Stphane Bancel: I mean, the first thing is, it's a liquid-based process to make ammonia, which is cell-free. So that drives to very small reactors compared to other technologies, especially compared to recombinant. It's the most staggering change. Thank you for giving output just the size of a reactor, which of course has a big impact on your capex, including all your purification technologies, because you just have less leaf cells to go through the columns and so on. So everything is much, much cheaper across the board.

Rick.

We must probably not even ups topic to make the product you know case, we're able to just do a tiny bit though a few they shouldn't fall varied off my Trued up a these m. on the east and then go back into production. Thanks.

Aspect of a platform that we have and therapy that he is time achieve the second time to make him on these days.

Stphane Bancel: As we have talked in the past, because mRNA is an information molecule, it is the same process for Zika or for CMV or for coronavirus. So it drives incredible flexibility and incredible time to the clinic because you do not have to invent the process for every vaccine or every molecule, as the team has shown in the last few weeks with coronavirus.

Two weeks and so when you think about type you can use an asset I mean once you make whatnot you can basically a change with these pleasant would equipment and use the same room with the same team to make another product and so if you can go in a few days, making money or best use a few weeks to macro comments before you're going to go into a few finished.

Stphane Bancel: If we had traditional technologies to invent a new process just for corona, we'd still be working on it as we speak, and we would most probably not even have started to make the product. In our case, we're able to just do a tiny bit of optimization for the very large molecule that this mRNA is and then go right into production, thanks to this aspect of the platform that we have. And the repeat time is time, which is the cycle time to make mRNA is days, not weeks. And so when you think about that, you can use an asset. I mean, once you make one lot, you can basically change to disposable equipment and use the same room with the same team to make another product. And so if you can go in a few days to make mRNA, let's use a few weeks to make a recombinant before you're going to go into fill finish. That's a massive use of your capital infrastructure in terms of just capex turnover.

That's a must see a use of your capstead infrastructure and come up just a capex Sonora.

Thank you team, that's worth saying, you're Lucky Queen [noise].

Right.

[noise]. Thank you she would like to ask a question that you could press star one and your telephone keypad again start running a telephone keypad to ask a question next one is from Alan Carr of Needham. Please go ahead.

Hi, Thanks for taking my questions and a couple of one of them is can you can you clarify.

Between your exploratory your korma modalities. She does this mean that you don't plan to add anymore, and new programs cheer exploratory until either.

I'm core.

Then also around Aristide Thirteenforty fibers in Atlanta, 72, how many different and how does this fall outside.

The agreement you journey Hamlin aren't ground honesty and the last thing is can you go for the your overall manufacturing capacity at the ethanol like facility right now across all programs until capacity in.

Yasmin Rahimi: Thank you, Tim, and we look forward to seeing you in Boston next week. Thank you. If you would like to ask a question, you could press star 1 on your telephone. Again, press star 1 on your telephone keypad to ask a question. And the next question is from Alan Carr of Needham.

Without regard to cranberries would worry or what are your long term plans in terms is your needs for capacity in terms of.

Stephane Bancel: Please go ahead. Hi, thanks for taking my questions on a couple of them. One of them is that can you clarify? This is a question about the difference between your Exploratory and your Corma modalities. Does this mean that you don't plan to add any more new programs to your Exploratory until they've been completed? become core. And then also around RSV, 1345 versus 1172. How are they different? And how does this fall outside?

Hmm any manufacturing capacity in a long term thanks.

She could you go commercial.

Good thanks for those free question. So let me take the first one on exploratory and call. So yes. If you go back to the strategy.

We are stuff that weve six month, using the chronic to say, we cannot them and atrophy and on and on and so because well be expecting a pulse mean pizza corrected you've got some as Jim we're very focused on managing the I know technology risk and so we try them dose sixtyk energy and power it.

Stephane Bancel: of the agreement that you already have with Mark around RSV. And the last thing is, can you go over the your overall manufacturing capacity at the at the Norwood facility right now across all programs, the total capacity and without regard to Coronavirus, what were your what are your long term plans in terms of your needs for capacity in terms of adding manufacturing capacity in the long term? Thanks. As you go commercial.

Queued up probably Nick where to invest more because im on either informationweek, making it the platform and where are you want it to fix if you're not talking about this time to fix that I have you can all these site that's U.S. stuff investing in that opportunity you want to do you probably have capital wisely, where you know, but technology is working so I was kind of a premise as we said.

Stephane Bancel: Good. Thanks for those three questions. So let me take the first one on exploratory and core. So yes, if you go back to the strategy. We started with six modalities in the clinic, to say. We cannot manage the unknown unknown. And so because of the exciting opportunity to create a new class of medicine, we are very focused on managing the unknown technology risk. And so we tried all those six technologies in parallel. So we could learn from the clinic where to invest more, because mRNA is an information molecule, making it a platform, and wherever you want it to go, if you learn something about the science, improve that science if you can, or decide that you are stopping investing in that opportunity, you want to deploy your capital wisely, where you know the technology is working. So that was kind of the premise as we started.

Also as to what is happening with these people out in a company history that now we have a clinical light that we've got real fall prophylactic vaccine and see STEMI fabrics, we bring it goes off color I you know opinion.

We believe the technology risk is up a table it meaning we want to deploy that capital to making about you've made to see if it goes to the chronic because it's exactly what them technology send manufacturing process or Dan the ones or whether you have been positive clinical data on the extra authority from yes, we want to be very cautious and if that's been the case.

Yes, we say do we only watch Aramco extraordinary modality seems too risky for us because your Bowers your risk and there's always about your risk, but we always say the fuel.

Two free program is kind of make sense for us as what you see so.

Stphane Bancel: And so what is happening with this pivot in the company's history is that now we have clinical data. We believe the technology risk is off the table, meaning we want to deploy our capital to make innovative medicine and take those to the clinic because it's exactly the same technology, same manufacturing process, and the ones who already have positive clinical data. On the exploratory front, yes, we want to be very cautious, and that has been the case for years. We say doing only one program per exploratory modality seems too risky for us because you have the biology risk, and there's always biology. But we always say the few, two, three programs kind of make sense for us. That's what you will see. So, do we intend to invest more shareholder capital in more interesting roles, for example, as an example of one of the four exploratory right now?

The we intend to invest more shareholder capital out on more interesting more for example, as an example of one of a false brought Laurie right now yeah. So he's got you know.

We want to see whether we get from most faulty arts way and the triplet.

But like we would doesn't.

It goes to what I see that that migrated from expressway for calling the last few months or if we get signal or the team as well, although I either what over things, we could do and of course and goes program, where we get post you've seen though we take all that stuff as we tend to be area.

Because those medicine would be needed for patients.

Stephen you want to talk about always be yeah, just quickly on our speed. So Alan as you as you referenced we have a partnership with Merck and rest person official virus just a monotherapy vaccine. There are two candidates in phase one study. The one seven too is the one that is currently being conducted.

And those are targeting the elderly target product profile and so there is a nearly equal burden of disease in the elderly 170000 hospitalizations here in this country, we're excited to be working with Merck in the elderly population.

Stphane Bancel: The answer is clearly no. We want to see what we get from OX40, IL-12, and the triplets, but... Like we've done with those two modalities that have migrated from exploratory to core in the last few months, if we get signal, the team has a lot of ideas of what other things we could do. And of course, in those programs where we get positive signals, we'll take those as fast as we can to BLA, because those medicines will be needed for patients.

We have a right in our agreements as we disclosed to.

Conduct a development of an RSV vaccines towards the rest for a combination and that has been our intent.

And so we are that is separate from merck's prerogatives NRC.

Thanks to an end on the last question on manufacturing capacities, so maybe that meets tracked with teeth about.

Stephen Hoge: Yeah, just quickly on RSV. So, Alan, as you referenced, we have a partnership with Merck on respiratory syncytial virus, just a monotherapy vaccine. There are two candidates in phase one studies. V172 is the one that is currently being conducted.

Free calling the virus world, which we talked about in previous calls or improve his discussion with cheese.

All manufacturing long term plan east to use nodes to make you will find somebody stereo like we are doing two there.

Stephen Hoge: And those are targeting the elderly target product profile. And so there is a nearly equal burden of disease in the elderly, 170,000 hospitalizations a year in this country. We're excited to be working with Merck in that elderly population. We have a right in our agreements, as we disclosed, to conduct the development of an RSV vaccine towards a respiratory combination. And that has been our intent. And so we are, that is separate from Merck's prerogatives in RSV.

And too long for commercial products at Acxiom, VZ cotton, the or else out of a novel or because of hut no with white design, we're going with David to my next financing rates, we do not want to investing a big manufacturing capacity commercial glass.

Peter we have a feel it's beautiful.

Cody risk management.

But to be one within our lump them between these two I have no would focus on developments.

So, let's get a commercial site that $40 or does it was kind of company several on the.

Stephen Hoge: Good. Thanks, Stephen.

Stephen Hoge: And on the last question on manufacturing capacity, maybe I can try to teach you about a pre-coronavirus world which we talked about in the previous course, in the previous discussion, which is our manufacturing long-term plan is to use now to make development material like we are doing today, and to launch our commercial products like CMV, Zika, and the others out of Norwood. Because of Norwood's design, we've always said to manage the financing risk, we do not want to invest in a big manufacturing capacity commercial plant until we have our first VLAO. Curley Risman, But we've always said our long-term vision is to have Norwood focus on development. So that we have a commercial site, and hopefully, down the road, as we scale the company, several around the planet that are just focused on commercial products.

That's up just focused on commercial products. We believe they don't know experience in previous pharmaceutical companies that that being dedicated focus first side is really important for success development, we quite nimbleness.

Commercial requires scale and efficiency is very different worlds.

So that's kind of a pre growing up a virus world I.

Our previous plans.

And the post call I've always find the last few weeks I go back to buy for your sense, a few minutes ago, which is a well looking other options.

Both internally externally CMO pulp mills to figure out what so right Buffalo then when we have a bit something show where we shared.

Great. Thanks for taking my questions.

Thank you that answered you any session I would now like to hand, the call back just defined by itself.

Stephen Hoge: We believe, based on our experience in previous pharmaceutical companies, that having dedicated focus per site is really important for success. However, development requires nimbleness. Commercial requires scale and efficiency. It's very different in the world. So that's kind of a pre-corona virus world. And the post-corona virus world, in the last few weeks. I go back to my previous answer a few minutes ago, which is that we are looking at a lot of options, both internally and externally, with CMO partners, to figure out what's the right path forward, and when we have a better picture, we will share it.

Thank you for your question I appreciate your Vancouver, <unk> your trust or into our ability to make him on it are an important new.

So medicines, we hope to see menu of your next week, you know for what I believe would be an exciting manufacturing and just okay. Thank you.

Thank you. This concludes today's conference call. Thank you all for attending you may now disconnect.

[music].

Stphane Bancel: Great, thanks for taking my questions. Thank you, that ends our Q&A session. I would now like to hand the call back to Stphane Bancel.

Stphane Bancel: Well, thank you for your question, and especially thank you for your trust in our ability to make mRNA an important new class of medicines. We hope to see many of you next week in Norwood for what I believe will be an exciting manufacturing and digital day. Thank you.

Operator: Thank you. This concludes today's conference call. Thank you all for attending. You may now [inaudible] ??? ??? ??? ???