Q3 2021 Moderna Inc Earnings Call

November 4, 2021

This time I'd like to turn the call over to Levina Talukdar, Head of Investor Relations. Please go ahead, ma'am.

Operator: I'm going to go over to Lavina Talukdar, Head of Investor Relations at Moderna. Please go ahead, ma'am.

Please go ahead ma'am.

Lavina Talukdar: Thank you, operator. Good morning, everyone, and thank you for joining us on today's call.

Thank you, operator, good morning, everyone and thank you for joining us on today's call to discuss Moderna's third quarter 2021 financial results and business update.

Lavina Talukdar: Today's call is to discuss Moderna's third quarter 2021 financial results and business update.

Lavina Talukdar: You can access the press release we issued this morning as well as the slides that we'll be reviewing by going to the investor section of our website.

You can access the press release, we issued this morning as well as the slides that we'll be reviewing by going to the investors section of our website.

Lavina Talukdar: On today's call is Stphane Bancel, our Chief Executive Officer.

On today's call are Stefan Bancel, our Chief Executive Officer, David Levine, Our Chief Financial Officer, Stephen Hoge, Our President and Paul Burton, Our Chief Medical Officer.

Lavina Talukdar: Officer, David Milleen, Chief Financial Officer, Stephen Hoge, President, and Paul Burton

Lavina Talukdar: Chief Medical Officer. Before we begin, please note that this conference call will include

Before we begin please note that this conference call will include forward-looking statements made pursuant to the Safe Harbor provision of the Private Securities Litigation Reform Act of 1995. Please see slide two of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance.

Lavina Talukdar: Pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995.

Lavina Talukdar: For the accompanying presentation and our STC filings on important risk

Lavina Talukdar: [inaudible]

Lavina Talukdar: to differ materially from those expressed or implied in these forward-looking statements.

And results to differ materially from those expressed or implied in these forward-looking statements.

Lavina Talukdar: On slide 3, please see the important indications and safety information for our COVID-19 vaccine, which has been approved for emergency use in the United States and many other countries.

On slide three, please see the important indication and safety information from our COVID-19 vaccine, which has been authorized for emergency use in the United States and many other countries around the world. I will now turn the call over to Stephen.

Lavina Talukdar: Transcription by CastingWords. I will now turn the call over to Stephane. Thank you.

I will now turn the call over to Stephane.

Stephane Bancel: Thank you, Lavina. Good morning or good afternoon, everyone.

Thank you and good morning all. Good afternoon, everyone. Welcome to our Q3, 2021 conference call. Today I'll stop by quickly to review of the quarter before David presents the key financials.

Stephane Bancel: Welcome to our Q3 2021 conference call. Today I will start with a quick business review of the quarter before David presents the key financials. Paul will then walk you through some real-world evidence updates, and Stephen will provide a clinical development update. I will then come back to close to share some thoughts about where we are heading.

Welcome to our Q3, 2021 conference call.

So there was topped by quickly it has to review of the quarter before David presents the key financials.

We then will confer some real-world evidence uptake, and Stephen will provide the clinical development update. I will then come back to close to share some thoughts about where we are heading. We have a holistic pipeline update. First, respiratory vaccines.

Come back to close to shut some thoughts about where we are heading.

Stephane Bancel: Test lab on site 5 with a holistic pipeline update. First, the respiratory vaccine. We are pleased to have filed the BLA for COVID-19 vaccine with FDA and have now received a priority review designation. Additionally, we received our first full approval for SPIKEVAX in Canada. We received EUA from the FDA for the 50-microgram booster, and mix-and-match has been authorized, will still receive the authorization for boosters from other major geographies, such as EMA UK, and so on.

Yes.

Part of a holistic part behind us.

Respiratory vaccines.

We are pleased with filing the BLA for COVID-19 vaccines wherever the year and have now received a priority review designation. We received our first four spiked back in Canada. We received EUA from the FDA for a 15 microgram booster and mix and match has been authorized.

We received our first four spiked back in Canada.

Well received EUA from the FDA for a 15 microgram booster and mix and match has been authorized.

We also received before the sharp we still from all of our major geographies EMEA, UK and so on.

Stephane Bancel: We were informed recently that FDA may take until January 2022 to review the EUA request for 12 to 17 years of age. Turning now to flu, mRNA-1010 is fully enrolled in Phase 1, and we expect human data soon. For RSV, mRNA-1345, after very positive data in Phase 1, with high neutralizing antibody levels after one dose, our teams are finalizing the preparation of a Phase 2 trial in older adults. This study should stop.

We went from recycling it may take until January '22 to review the EUA request false, whereas some 17 years of age. Turning now to flu. 1 out of 10 is fully enrolled phase one and we expect human data sooner. For OSB and mountain discussing 45.

Turning now to flu.

10, 10 is fully enrolled phase one and we expect human data sooner.

For OSB and mountain discussing 45.

After very positive data in that phase, where we were high neutralizing antibody levels after one dose. All teams are finalizing the proportion of our phase II <unk>. This study should start soon.

This study should start soon.

Stephane Bancel: We also announced our development candidate for COVID booster plus flu booster in a single dose, mRNA 1073, which we anticipate will be in the clinic soon. Let me now turn to the vaccine against latent viruses. As many of you know, latent viruses are a major cause of health problems. Latent viruses are mainly made of DNA viruses, and once a human is infected by a latent virus, that virus will stay in the body

We also announced our development candidate for Covid booster plus [subooster] in the single dose among the 10-73 which we anticipate will be in the clinic soon. Let me now turn to vaccine against latent viruses.

Let me now turn to vaccine against latent viruses.

As many of you know latent viruses are major cause of health problems. Latent viruses are mainly made up of DNA viruses and once the human use infected by a latent virus, that virus will stay in the body. You are familiar with some latent viruses like HIV and HPV. There are many of them that help humans.

Latent viruses are mainly made up of DNA viruses and west of human use infected burleson virus.

We stay in the body.

Stephane Bancel: You are familiar with some latent viruses, like HIV and HPV. There are many others that have helped you. As a company, we are committed to developing a portfolio of first-in-class vaccines and therapeutics against this latent virus. Our first programs are CMV vaccines, EPV vaccine, and EPV therapeutic vaccine.

You are familiar with some latent viruses like HIV and HPV.

There are many of them that helps humans.

As a company we are committed to developing a portfolio of first in class vaccines and therapeutics against these latent viruses.

Our first program, our CMV vaccine, EBV vaccine and EBV for Zika vaccine. We are also putting that to work on two HIV vaccines.

<unk> vaccine and EBV for Zika vaccine.

Stephane Bancel: We have also partnered to work on two HIV vaccines. Last week marked a big milestone for Moderna. We started those things in the clinic, the first participants of our Phase 3 Pivotal Registration Study for CMV Vaccine mRNA 1647. This marks the second phase 3 study that the company has started and brings us one step closer to getting another important vaccine to millions of people around the world. For the EBV vaccine, mRNA 1189 should start dosing for its phase 1 variance, and our new development candidate, an EBV therapeutic vaccine, mRNA 1195, is moving toward the clinic.

We are also putting that to work on to HIV vaccines.

Last week marked a big milestone for Moderna.

We started dosing in the clinic the first participants of our phase III people Sone registration study for CMV vaccine mRNA 1647.

This marks the second phase III study that the company has started and brings us one step closer to getting another important vaccine to millions of people around the world.

Our EBV vaccine amounted to $11.89. Should start closing phase one very soon and on new development candidate in the EBV therapeutic vaccine. And on the 1195 is moving toward the clinic.

<unk> always phase one very soon and on new development candidate in the EBV therapeutic vaccine.

And on the 1195 is moving toward the clinic.

Stephane Bancel: Lavina Talukdar, Our personalized cancer vaccine is in Phase 2, heading to S30 with Ketudra. Monotherapy is fully enrolled, and we expect data in the back end of 2020. Our rare genetic programs continue to progress well in the clinic. P.A.

Let me not talk to therapeutics. Our personalized cancer vaccine is in phase II study with kids will drop, monotherapy is fully enrolled and we expect data in the back end of 2022.

Our personalized cancer vaccine is in phase II study with Keytruda monotherapy is fully enrolled and we expect data in the back end of 2022.

Our residency programs continue to progress well in the clinic. As it is phase one dose call fully enrolled. MMA <unk> patient these phase one GSE1A has an open IND and has received orphan drug designation by FDA.

Stephane Bancel: has its phase one dose cohort fully enrolled. MMA is losing patients in its phase 1. GSD-1A has an open IND and has received drug designation by FDA often. So, as you can see, we have three rare genetic disease programs in the clinic or soon to be in the clinic. So we look forward to sharing clinical data in the coming months. We are very proud to have found a way to get Triglonazure Type 1, or CN1, to patients through a donation of our IP and assets to the Institute for Life-Changing Medicine. CN1 disease is an ultra-rare disease with very few patients afflicted around the world.

As it is phase one dose call fully enrolled MMA.

<unk> patient these phase one GSE <unk> has an open IND and has received orphan drug designation by FDA.

As you can see our free residency disease programs in the clinic or soon to be in the clinic. So we look forward to showing clinical data in the coming months.

We are very proud to have found a way to get figured out that type one-off CN1 to patients through a donation of IP and the assets to the institute for life-changing medicines.

CN1 is either neutral or were these with very few patients afflicted around the world.

Stephane Bancel: The model that we support is one in which just the cost of clinical development will result in a very high price for a few patients around the world that could benefit. So instead of developing a drug and charging a very high price, we decided to give the drug away and innovate through a creative partnership. We provide the drug to the patients, and we pay for clinical trial materials. The Institute pays for the clinical trial costs.

What we found out that it is just the cost of clinical development will result in the very high price for a few patients around the world that could benefit.

This model is not one that we support. So instead of developing a drug and shoving a very high price, we decided to give the drug away and innovate through a creative partnership. We provide the drug to be institutes, we pay for clinical trial material.

So instead of developing a drug in chartering to very high price, we decided to give the drug away and innovate through a creative partnership we provide the drug to be institutes, we pay for clinical trial material the.

The Institute pays for clinical trial costs. If the drug is approved, we'll provide the medicine to the kids and their families for free.

Stephane Bancel: If a drug is approved, we'll provide the medicines to the kids and their families for free, and we will not charge any royalty or milestone to the institution. We believe this is the right thing to do to continue to contribute to society for ultra-rare diseases where our mRNA platform can help. One of the important news items announced today is the introduction of a new modality to our existing six modalities. We are very pleased to announce that Vertex and Moderna are now in GLP-PLOC studies for the Cystic Fibrosis Program VXE5.0.

If the drug is approved we'll provide the major seems to have kids and their families for free.

And we will not charge any royalty or milestone to the institutes. We believe this is the right thing to do to continue to contribute to society. What we've tried to do is where I'm Mani platform can have. One of the important news item announced today is the introduction of a new modality to our existing six modalities.

We believe this is the right thing to do to continue to contribute to society. What we've tried to do is where I'm Mani platform can have.

One of the important news item announced today is the internet.

Auction of a new modality to our existing six modalities.

We're very pleased to announce that vertex and Waddell now I'll know in GOP Tox studies for cystic fibrosis program VXC522.

Stephane Bancel: This marks our first in-health pulmonary therapeutics program. I would like to congratulate and thank our scientific team as well as the Vertex team for having been able to develop a novel lipid formulation to allow inhaled pulmonary delivery. This is really exciting for patients. As I have communicated previously, in addition to doing therapeutics using mRNA coding for human proteins, like the ones I just described, we want to use our mRNA plus lipid technologies to develop therapeutics using mRNA coding for gene editing enzymes. We are pleased to announce our first partnership in that field.

This marks our first inhaled preliminary for a particular program. I would like to congratulate and thank our scientific team as well as the [graphics] team for having been able to develop a novel liquid formulation to allow in head from the early delivery. This is really exciting for patients.

I would like to congratulate and thank our scientific team as well as the <unk> team for having been able to develop a novel liquid formulation to allow in head from the early delivery. This is really exciting for patients.

As we communicated previously in addition to doing for a particular using mRNA coding for human proteins like the ones I just described will want to use our mRNA sleepy technologies to develop therapeutics using embryonic coding for gene-editing enzymes.

We are pleased to announce our first partnership in the theater. We announced earlier this week that we entered into a licensing collaboration with Mr. Jerome based in California to use their next generation gene editing enzymes.

Stephane Bancel: We announced earlier this week that we entered into a licensing collaboration with Metagenome, based in California, to use their next-generation gene-editing enzymes. We believe that their technology, coupled with our mRNA plus lipid technologies and our manufacturing infrastructure, will produce some exciting new medicines to take into the clinic. I am very pleased with the progress of the company. We are increasing depth in vaccines and, at the same time, increasing breadth of application with our seventh modality in the lung and gene editing.

Right now earlier this week that we entered into a licensing collaboration with Mr. Jeremy Best in California to use their next generation gene editing enzymes.

We bring the best technology, coupled with [inaudible] technologies, and our manufacturing infrastructure, we'll produce some exciting new medicine to take into the clinic.

I am very pleased with the progress of the company. We are increasing depth in vaccines and at the same time, increasing breadth of application. We've also given similarity in the lung and gene editing.

We are increasing depth in vaccines and at the same time, increasing breadth of application. We've also given similarity in the lung and gene editing.

Jacqueline Miller: On slide six, you will find financial highlights. For Q3, we reported revenue of around $5 billion, enabled by delivering 208 million doses of our COVID-19 vaccine. Net income of $3.3 billion. Our cash and cash equivalents position was $15 billion at the end of September. Since the end of the quarter, we have been working to gain better visibility into those variables that will impact our full-year results, and we have much better visibility today than we did a month ago.

On slide six you will find the financial highlights. For Q3, we reported revenue of around $5 billion enabled by delivering 208 million doses of our COVID-19 vaccine.

Net income of $3.3 billion of cash and cash equivalents position was $15 billion at the end of September.

Since the end of the quarter, we have been working to gain better visibility into those variables that will impact our full year results.

And we have much better visibility to where they've been and we did a month ago. For fiscal year 2021 we are updating the range of those is we plan to deliver to 700 to 800 million doses.

Jacqueline Miller: For fiscal year 2021, we are updating the range of doses we plan to deliver to 700 to 800 million doses. The key variables of this updated volume range are, first, a longer lead time for exports to countries outside the U.S. and for international shipments in general. In Q3, we shipped more deliveries to a new international market and expect Q4 to also have more international deliveries. As we deliver to these countries for the first time, we expect the process to become more routine, and delivery times to shorten.

Fiscal yes, why do you want to you why we are updating the range of those is we plan to deliver two 700 to 800 million doses.

The key variable of this update volume range are, first, longer lead time for exports to countries outside the US and for international shipments in general.

First longer lead time for exports to countries outside the U S and international shipments in general in.

In Q3, we shipped more deliveries to a new international market and expect Q4 to also have more international deliveries. As we deliver to these countries for the first time, we expect the process to become more routine and delivery time to shorten. However, some Q4, Dave Reese and ask you to move to early 2022 as a result.

More information on deliveries.

As we deliver to these countries for the first time, we expect the process to become more routine and delivery time to short term. However, some Q4, Dave Reese and ask you to move to early 2022 as a result.

Jacqueline Miller: However, some Q4 deliveries may still move to early 2022 as a result. Second, in Q3, we expanded our Filipino capacity with our manufacturing partners, which had a temporary impact on our shipment. That work is complete now, and we should see a positive impact from this expansion very soon.

Second, in Q3, we have expanded our fill finish capacity with our manufacturing partners, which has a temporary impact on our shipments.

Work is complete now and we should see a positive impact from this expansion very soon. Third, the bottleneck of production has moved down the manufacturing line to production release.

Jacqueline Miller: Third, the bottleneck of production has moved down the manufacturing line to product release. We have added additional resources and skilled personnel to the release and of the manufacturing line, and we expect to increase the weekly number of doses released. We believe resolution of these factors will put us in a good position heading into Q4 and 2022.

Phil the bottleneck of production as we move down the manufacturing line to production release.

We added additional resources skilled personnel to valleys Andover manufacturing line and we expect to increase the weakening in both of those is waste.

We believe our resolution of these factors put us in a good position heading into Q4 and 2022. Now if I turn to revenue for '2021, the updated revenue ranch problems is you do one is $15 billion to 18 billion.

Jacqueline Miller: Now if I turn to revenue for 2021, the updated revenue range for 2021 is $15 billion to $18 billion. This range reflects the updated delivery schedule with fewer doses delivered in 2021, as some doses are pushed into 2022, and also the pricing impact of prioritizing delivery to COVAX and the African Union, which have lower tiered pricing. On slide 7, let me start by summarizing the scale-up operational challenges that the team had to work through as we scale from making less than 100,000 doses in 2029 to hundreds of millions of doses in 2021. Q1 scale-up challenges were around drug substance and making mRNA in lipids.

Now if I turn to revenue for 'twenty one the updated revenue ranch problems is you do one is $15 billion to 18 billion.

This range reflects updated delivery schedule with fewer of those these deliveries in 2021 and some doses as push into 2022.

So the pricing impact of prioritisation of [inaudible] and African Union, that have a lower-tier pricing.

On slide seven let me start by similar I think the scale up of operational challenges that the team had to work through. As we scale for making less than 100000 builds in 2009 to hundreds of millions of doses in 2021.

As we scale for making less than 100000 builds in 2009 to hundreds of millions of those easy in 'twenty you're talking about.

Q1 scale-up challenges were around the drug substance, making mRNA and lipid. Could you to scale up challenges were on drug product and ensuring we could feel enough parts.

Jacqueline Miller: Q2 scale-up challenges were around drug products and ensuring we could fill in our piles. In the first half of the year, we made great progress on these challenges, as you can see from the numbers on the right. We now have 901 million doses of drug substance that have been formulated and a large volume bag of mRNA products, and we have 770 million doses of drug products already in vials. CUPRI scale-up challenges were around product release as the supply chain became more complex with increased deliveries to many countries around the world.

Could you to scale up challenges, we're wrong drug product and ensuring we could feel enough parts.

In the first half of the year, we made great progress in these challenges as you can see from the numbers on the right. We now have 901 million doses of drug substance that there've been formulated in a large volume backs of mRNA product.

We now have 901 million doses of drug substance that there've been formulated.

Large volume backs of mrna product.

And we have 717 million doses of drug products already in the base. Q2 scale-up challenges, where our own product release. Our supply chain became more complex with increased deliveries to many countries around the world.

<unk> scale up challenges, where our own product release.

Supply chain became more complex with increased deliveries to many countries around the world at.

Jacqueline Miller: At the beginning of the year, we supplied just a few large... As mentioned before, we are working through these challenges, and as of November 3rd, we have shipped 566 million doses around the world. With the progress here to date, we expect to be able to deliver 700 to 800 million doses for a full year in 2021. We were pleased to be named last week, for the seventh year in a row, as one of the top 20 biotech and pharmaceutical companies in the world by Science.

At the beginning of a year, we supply just a few large countries. As mentioned before, we are working through these challenges and as of November 3rd we actually found 66 million doses around the world. With the progress year to date, we expect to be able to deliver 700 to 800 million doses for our full year 2021.

As mentioned before we are working through the strategy in <unk> and Thats November Phil we actually found that $66 million is around the world with a progress yesterday, we expect to be able to deliver 700 million dose. So our full year 2021.

We were pleased to be named last week for the seventh year in a row as one of the top 20 biotech and pharmaceutical company in the world by Science. We continue to invest in science and the culture of our team.

We continue to invest in science and the culture of our team.

We are building, the best mRNA science in the World and the culture of baldness, collaboration, curiosity and relentlessness.

On slide nine you will find out usual summary, slide which describes some of the key high-level attributes of the company as of today. Now let me [inaudible] to David.

Jacqueline Miller: We continue to invest in science and the culture of autonomy. We aim to build the best mRNA science in the world in a culture of boldness, collaboration, curiosity, and relentlessness. On the timeline, you will find our usual summary slides which describe some of the key high-level attributes of a company as of today. Now, let me turn over to David. Okay. Thank you, Stephane.

Okay. Thank you, Stephen. We are providing today the analysis of actual 2021 third-quarter results along with an updated view of key drivers of financial performance going forward.

We are providing today the analysis of actual 2021 third quarter results along with an updated view of key drivers of financial performance going forward.

Turning now to slide 11, starting with an overview of our sales performance before commenting more broadly on our financial results.

Total product sales in the third quarter were $4.8 billion, representing 208 million doses delivered to our customers. This compares to sales of $4.2 billion and 199 million doses in Q2. And sales of $1.7 billion in 102 million doses in Q1 of this year. Sales to the US government were $1.2 billion in the third quarter, reflecting 73 billion doses delivered compared to $2.1 billion in 126 million doses in Q2 and sales of $1.4 and 88 million doses in Q1. Sales to the rest of the World were $3.6 billion in the third quarter, reflecting 136 million doses delivered compared to sales of $2.1 billion and 73 million doses in Q2, and $.4 billion of sales and 14 million doses in Q1.

Jacqueline Miller: We're providing today the analysis of the actual 2021 third quarter results along with an updated view of key drivers of financial performance going forward. Turning now to slide 11, starting with an overview of our sales performance before commenting more broadly on our financial results. The total product sales in the third quarter were $4.8 billion, representing 208 million doses delivered to our customers. This compares to sales of 4.2 billion and 199 million doses in Q2 and sales of 1.7 billion and 102 million doses in Q1 of this year.

Year.

Sales to the U S government were $1 2 billion in the third quarter, reflecting 73 billion doses delivered compared to $2 1 billion in 126 million doses in Q2 and sales of $1 4.088 billion doses in Q1.

Jacqueline Miller: Sales to the U.S. government were $1.2 billion in the third quarter, reflecting 73 million doses delivered, compared to 2.1 billion and 126 million doses in Q2 and sales of 1.4 billion and 88 million doses in Q1. Sales to the rest of the world were $3.6 billion in the third quarter, reflecting 136 million doses delivered, compared to sales of 2.1 billion and 73 million doses in Q2 and 0.4 billion of sales in 14 million doses in Q1.

Sales to the rest of the World were $3 6 billion in the third quarter, reflecting a 136 million doses delivered compared to sales of $2 1.073 billion doses in Q2, and <unk> 4 billion of sales and 14 million doses in Q1.

This reflects the significant manufacturing ramp up outside the US over the last two quarters. The relatively modest increase of delivered doses in Q3 versus Q2 was driven by the factors that Stephen just explained.

The relatively modest increase of delivered doses in Q3 versus Q2 was driven by the factors that Stefan just explained.

Jacqueline Miller: This reflects the significant manufacturing ramp-up outside the U.S. over the last two quarters. The relatively modest increase in delivered doses in Q3 versus Q2 was driven by the factors that Stephane just explained. We continue to scale our production network and are working to achieve an increased quarter over quarter improvement starting in Q4. Turning to slide 12.

We continue to scale, our production network and we're working to achieve an increase quarter over quarter improvement starting in Q4.

Turning to slide 12. The transformation of Moderna from an R&D focused biotech to a commercial company continue to be very apparent when reviewing our financial results.

The transformation of <unk> from an R&D focused biotech to a commercial company.

To be very apparent when reviewing our financial results.

Comparison of the third quarter of 2021 to prior year is not meaningful due to our growth, which is why I will primarily focus on the quarter over quarter comparison relative to Q2 on the slide.

Jacqueline Miller: The transformation of Moderna from an R&D-focused biotech to a commercial company continues to be very apparent when reviewing our financial results. The comparison of the third quarter of 2021 to the prior year is not meaningful due to our significant growth, which is why we'll primarily focus on the quarter over quarter comparison, relative to Q2 on the slide. Total revenue was $5 billion in the third quarter of 2021 compared to $4.4 billion in the second quarter and $0.2 billion in the prior year period.

Difficult growth, which is why I will primarily focus on the quarter over quarter comparison.

Relative to Q2 on the slide.

Total revenue was 5 billion in the third quarter of 2021 compared to $4 4 billion in the second quarter and .2 billion in the prior year period.

The increase of total revenue is driven by the sale of the company's COVID-19 vaccine. Product sales in Q3 were $4.8 billion compared to $4.2 billion in the second quarter, an increase of 15%.

Jacqueline Miller: The increase in total revenue is driven by the sale of the company's COVID-19 vaccine. Product sales in Q3 were $4.8 billion compared to $4.2 billion in the second quarter, an increase of 15%. Cost of sales was $722 million, or 15% of the company's product sales in the third quarter compared to $750 million, or 18% of product sales in the second quarter. The quarter over quarter percentage improvement is driven by higher average selling, as a result of shifts in our customer mix, and to a smaller extent by favorable manufacturing costs.

Cost of sales was $722 million or 15% of the company's product sales in the third quarter compared to $750 million or 18% of product sales in the second quarter.

The quarter over quarter percentage improvement is driven by higher average selling price as a result of shifts in our customer mix and to a smaller extent by favorable manufacturing cost.

Research and development expenses were $521 million in the third quarter up from $421 million in Q2, and 344 million in the same period in 2020.

The higher spend versus prior quarter and prior year was driven by increased COVID-19 vaccine clinical development activities, including our announced efforts around booster variants specific and multi bail in vaccine candidates.

Jacqueline Miller: Research and development expenses were $521 million in the third quarter, up from $421 million in Q2 and $344 million in the same period of 2020. The higher spend versus prior quarters and prior years was driven by increased COVID-19 vaccine clinical development activities, including our announced efforts around booster variant specific and multivalent vaccine candidates. Headcount increases as well as external costs to support a growing and maturing development pipeline beyond the COVID-19 vaccine activities have also contributed to the expense increase.

Head count increases as well as external cost to support our growing and maturing development pipeline beyond the COVID-19 vaccine activities also contributed to the expense increase.

Selling general and administrative expenses were 168 million for Q3 compared to 121 million in the prior quarter and 48 million for the same period in the prior year.

The growth in spending was driven by the commercialization of our COVID-19 vaccine globally with continued investments in personnel and outside services and supported the accelerated company Buildout.

Jacqueline Miller: Selling general and administrative expenses were $168 million for Q3, compared to $121 million in the prior quarter and $48 million for the same period in the prior year. Growth in spending was driven by the commercialization of our COVID-19 vaccine globally, with continued investments in personnel and outside services in support of the accelerated company build-out. Provision for income taxes was $219 million in the third quarter, following $283 million in Q2 and an insignificant amount in the prior year.

Provision for income taxes was $219 million in the third quarter following 283 million in Q2.

Insignificant amount in the prior year.

Our effective tax rate for the third quarter was 6%.

Separately, let me remind you of the fact that we had a net operating loss carryforward of $2 3 billion at the end of 2020.

This year, we started to release the valuation allowance against the related deferred tax assets, which results in an estimated nonrecurring full year benefit to our effective tax rates of about five percentage points.

Jacqueline Miller: Our effective tax rate for the third quarter was six percent. Let me remind you of the fact that we have a net operating loss carry forward of $2.3 billion at the end of 2020. This year, we started to release the valuation allowance against the related deferred tax assets, which results in an estimated non-recurring full-year benefit to our effective tax rates of about 5%. Our Q3 effective tax rate was lower than the US statutory rate primarily due to the just described benefit related to the release of the valuation allowance. The Foreign Derived Intangible Income Deduction and an Excess Tax Deduction Related to Stock-Based Compensation

Our Q3 effective tax rate was lower than the U S statutory rate primarily due to the just described benefit related to the release of the valuation allowance.

The foreign derived intangible income deduction.

Excess tax deduction related to stock based compensation.

This last item drove the quarter over quarter reduction due to the increase in our share price in Q3 versus Q2.

Jacqueline Miller: This last item drove the quarter over quarter reduction due to the increase in our share price in Q3 versus Q2. We recorded net income of $3.3 billion in Q3 compared to $2.8 billion in Q2, an increase of 20%. This compares to a loss of $0.2 billion in Q3 of last year. Diluted earnings per share for Q3 2021 were $7.70.

We recorded net income of $3 3 billion in Q3 compared to $2 8 billion in Q2, an increase of 20%. This compares to a loss of <unk> 2 billion in Q3 of last year.

Diluted earnings per share for Q3, 2021 were $7 72.

Turning now to year to date financial results compared to prior year on slide 13.

Total revenue was $11 3 billion for the first nine months of this year compared to <unk> 2 billion for the same period in 2020.

Jacqueline Miller: Turning now to year-to-date financial results compared to the prior year, on slide 13, total revenue was $11.3 billion for the first nine months of this year, compared to $0.2 billion for the same period in 2020. The significant growth was driven by the sales of 510 million doses of the company's COVID-19 vaccine.

The significant growth was driven by the sales of 510 million doses, the company's COVID-19 vaccine.

Revenue of $473 million in the first nine months of 2021, an increase of $286 million compared to the prior year was primarily driven by increases in revenue from BARDA related to the company's COVID-19 vaccine development.

Jacqueline Miller: Grant revenue of $473 million in the first nine months of 2021, an increase of $286 million compared to the prior year, was primarily driven by increases in revenue from BARDA related to the company's COVID-19 vaccine development. Cost of sales was $1.7 billion, or 16% of the company's product sales for the year-to-date period as of September 30th, including third-party royalties of $400 million. The portion of the inventory costs associated with this year's product sales was expensed as pre-launch inventory costs in 2020. If inventory sold for the first nine months of this year was valued at cost, our cost of sales for the period would have been 17% of product sales.

Cost of sales was $1 7 billion or 16% of the company's products sales for the year to date period.

September 30 of <unk>.

Including third party royalties of $400 million.

A portion of the inventory costs associated with this year's product sales was expense does prelaunch inventory cost in 2020.

It's inventory sold for the first nine months of this year was valued at cost our cost of sales for the period would have been 17% of the product sales.

Research and development expenses were $1 $3 billion for the nine months ended September 30 of this year.

<unk> <unk> 6 billion for the same period in 2020.

Jacqueline Miller: Research and development expenses were $1.3 billion for the nine months ended September 30th of this year, compared to $0.6 billion for the same period in 2020. The growth in spending in 2021 was mainly due to an increase in clinical trial expenses, to a lesser extent, personnel-related costs, manufacturing expenses, and consulting and outside services, primarily driven by increased mRNA-1273 clinical development activity. Selling general and administrative expenses were $0.4 billion for the first nine months of this year, compared to $0.1 billion for the same period in 2020.

The growth in spending in 2021 was mainly due to increase in clinical trial expenses and to a lesser extent personnel related costs manufacturing expenses and consulting and outside services, primarily driven by increased mrna 12 73 clinical <unk>.

Development activities.

Selling general and administrative expenses were <unk> 4 billion for the first nine months of this year compared to <unk> 1 billion for the same period in 2020.

The growth in spending in 2021 was mainly due to increases in consulting and outside services personnel related costs and marketing expenses, primarily attributable to the company's COVID-19 vaccine commercialization related activities and increased head count.

Jacqueline Miller: The growth in spending in 2021 was mainly due to increases in consulting and outside services, personnel-related costs, and marketing expenses, primarily attributable to the company's COVID-19 vaccine commercialization, related activities, and increased headcount. For the nine months ended September 30th, we recorded a provision for income taxes of $541 million compared to insignificant amounts in the same period in 2020. Our effective tax rate for the first nine months of this year was 7%.

For the nine months ended September 30th we recorded a provision for.

For income taxes of 541 billion compared to insignificant amounts in the same period in 2020.

Our effective tax rate for the first nine months of this year was 7% it was lower than the U S statutory rate, primarily due to nonrecurring benefits related to the release of the valuation allowance the ongoing benefit of the foreign derived intangible income deduction as well as <unk>.

Screed items for excess tax deductions related to stock based compensation.

Net income was $7 3 billion for the nine months ended September 30th of this year compared to a net loss of <unk> 5 billion for the same period in 2020.

Jacqueline Miller: It was lower than the U.S. statutory rate, primarily due to non-recurring benefits related to the release of the valuation allowance, the ongoing benefit of the foreign-derived intangible income deduction, as well as a discrete item for excess tax deductions related to stock-based compensation.

Diluted earnings per share were $17 for the first nine months of 2021.

Turning to cash in selected cash flow information on slide 14.

Jacqueline Miller: That income was $7.3 billion for the nine months ended September 30th of this year compared to a net loss of $0.5 billion for the same period in 2020. The cash and earnings per share were $17 for the first nine months of 2021. Turning to cash and selected cash flow information on slide 14, we ended Q3 2021 with cash and investments of $15.3 billion compared to $12.2 billion at the end of Q2.

We ended Q3, 2021 with cash and investments of $15 $3 billion compared to $12 2 billion at the end of Q2.

The increase was driven by our commercial sales and additional customer deposits received in the third quarter for future purchases of our COVID-19 vaccine.

Net cash provided by operating activities was $3 3 billion in Q3.

$4 1 billion in Q2.

Jacqueline Miller: The increase is driven by our commercial sales and additional customer deposits received in the third quarter for future purchases of our COVID-19 vaccine. Net cash provided by operating activities was $3.3 billion in Q3 after $4.1 billion in Q2. The quarterly reduction is driven by a lower amount of cash deposits for future product supply received in Q3 compared to Q2.

The quarter over quarter reduction is driven by a lower amount of cash deposits for future products supply received in Q3 compared to Q2.

On a year to date basis net cash provided by operating activities was $10 3 billion compared to <unk> 8 billion in the prior year.

Cash used for purchases of property and equipment was $164 million for the nine months ended September 30th compared to $44 million for the same period in 2020.

Jacqueline Miller: On a year-to-date basis, net cash provided by operating activities was $10.3 billion, compared to $0.8 billion in the prior year. Cash used for purchases of property and equipment was $164 million for the nine months ended September 30th, compared to $44 million for the same period in 2020, reflecting continuous investments in our manufacturing infrastructure. Now turning to slide 15.

Reflecting continuous investments in our manufacturing infrastructure.

Now turning to slide 15.

Let me briefly expand further on our cash and investment position and the net balance of cash deposits for future product supply.

This is an important point when modeling future cash flows the.

Cash and investment balance reported as of September 30th was $15 3 billion up from $12 2 billion as of June 30th.

Jacqueline Miller: Let me briefly expand further on our cash and investment position and the net balance of cash deposits for future product supply, as this is an important point when modeling future cash flows. The cash and investment balance reported as of September 30th was $15.3 billion, up from $12.2 billion as of June 30th. The increase is driven by our commercial activities, including cash receipts from product sales and Customer Deposits for Future Product Supply. The net balance of cash deposits for future product supply was $6.7 billion at the end of Q3, at a similar level to the balance in Q2 of this year.

The increase was driven by our commercial activities, including cash receipts from product sales.

Customer deposits for future products supply.

The net balance of cash deposits for future product supply was $6 7 billion at the end of Q3 at a similar level to the balance in Q2 of this year.

Turning now to the 2021 updated financial framework on slide 16.

For the full year 2021, we expect to product sales range of 15 to 18 billion.

We now expect to be able to deliver seven to 800 million doses at the 100 microgram dose level to our customers. This compares to the prior outlook of 800 to 1 billion doses.

Jacqueline Miller: Turning now to the 2021 updated financial framework on slide 16. For the full year 2021, we expect a product sales range of $15 to $18 billion. Additionally, we now expect to be able to deliver 7 to 800 million doses at the 100 microgram dose level to our customers. This compares to the prior outlook of 800 to a billion doses.

Our total cost of sales includes the cost of goods manufactured third party royalties as well as logistics and warehousing costs.

Given the favorability we have observed in the year to date period. We now expect total cost of sales as a percent of product sales between 16% to 17% for the full year 2021. This.

Jacqueline Miller: Our total cost of sales includes the cost of goods manufactured, third-party royalties, as well as logistics and warehousing costs. Given the favorable favorability we have observed in the year-to-date period, we now expect total cost of sales as a percent of product sales between 16 to 17% for the full year 2021. This compares to our previous outlook of 18 to 20% of product sales. In 2022, we currently expect the cost of sales ratio to exceed 20% driven by customer mix and multiple presentation types.

This compares to our previous outlook of 18% to 20% of product sales.

For 2022, we currently expect the cost of sales ratio to exceed 20% driven by customer mix and multiple presentations types.

On the R&D and SG&A expense side, we continue to plan for an increase on a quarter over quarter basis and expect this trend to continue for the remainder of 2021 and beyond.

Driven by our maturing development portfolio and the scale up over our commercial activities.

Based on further increased visibility of utilization of our accumulated net operating loss carryforward.

Jacqueline Miller: On the R&D and SG&A expense side, we continue to plan for an increase on a quarter over quarter basis and expect this trend to continue for the remainder of 2021 and beyond, driven by a maturing development portfolio and the scale-up of our commercial activity. Based on further increased visibility of the utilization of our accumulated net operating loss carry forward, expected global sales mix, and the mentioned discrete benefits in the first nine months of this year, we now expect our all-in 2021 tax rate to be in the high single-digit range.

Expected global sales mix and the mentioned discrete benefits in the first nine months of this year.

We now expect our all in 2021 tax rate to be in the high single digit range. This compares to our previous four previous forecast of approximately 10%.

Since we won't have a material benefit from our valuation allowance in future years, we expect our reported 2022 effective tax rate will increase relative to 2021 right.

It's also too early to further comment on impacts from a potential tax reform.

Jacqueline Miller: This compares to our previous forecast of approximately 10%. Since we won't have a material benefit from our evaluation allowance in future years, we expect our reported 2022 effective tax rate will increase relative to our 2021 rate. It's also too early to further comment on the impacts of a potential tax reform. Finally, regarding capital investments, we are now planning for approximately $0.4 billion of capital investment. Fall into the 2021 calendar year compared to our previous range of $450 to $550 million.

Finally regarding capital investments, we are now planning for approximately <unk> 4 billion of capital investment to fall into the 2021 calendar year compared to our previous range of $450 million to $550 million.

We are strongly committed to a further buildout over manufacturing in general company infrastructure, and hence predict capital investment in 2022 will be meaningfully above 2021 levels.

This concludes my remarks concerning the financial performance and I'll now turn the call over to Paul Burton.

Thank you David and good morning, good afternoon, everyone with more than 150 million people worldwide now having received two doses around vaccine. We are humbled to be able to see the positive impact it is having on people's lives around the world.

Jacqueline Miller: We're strongly committed to a further build out of manufacturing and general company infrastructure and hence predict capital investment in 2022 will be meaningfully above the 2021 level. This concludes my remarks concerning financial performance, and I now turn the call over to Paul Berkley.

We are reminded of the fact that almost 250 million people have been infected with COVID-19 globally and 5 million people have lost their lives.

Our profound thanks as always go out to those on the Frontlines working tirelessly to keep us safe and this ongoing fight.

Paul Burton: Thank you, David, and good morning, good afternoon, everyone. With more than 150 million people worldwide now having received two doses of our vaccine, we are humbled to be able to see the positive impact it is having on people's lives around the world. We are reminded of the fact that almost 250 million people have been infected with COVID-19 globally, and 5 million people have lost their lives. Our profound thanks, as always, go out to those on the front lines working tirelessly to keep us safe in this ongoing fight.

Through numerous independent studies time and time again, we see consistent findings showing that mrna 12, 73 is highly effective in saving lives and reducing hospitalizations and reducing the risk of COVID-19 infection.

I will highlight a few of these independently conducted studies in this morning. On slide 18, I will begin with some of the data from the United States government.

Slide 18.

I will begin with some of the data from the United States government.

Paul Burton: Through numerous independent studies, time and time again, we see consistent findings showing that mRNA-1273 is highly effective in saving lives, reducing hospitalizations, and reducing the risk of COVID-19 infections. I will highlight a few of these independently conducted studies this morning. Slide 18.

These data come from the CDC and show through September of this year the difference in COVID-19 cases.

Fully vaccinated and unvaccinated populations.

In Unvaccinated person has an 11 fold greater risk of dying from COVID-19.

Paul Burton: I will begin with some of the data from the United States government. These data come from the CDC and show, through September of this year, the difference in COVID-19 cases between fully vaccinated and unvaccinated populations. An unvaccinated person has an 11-fold greater risk of dying from COVID-19, underscoring the importance that getting vaccinated plays in our protection and ending this pandemic. The data show that vaccination with mRNA-1273 provides the greatest protection, not only against COVID-19 infection but also death due to COVID-19. In fact, even during the surge of the Delta virus variant during the summer months this year, Moderna's vaccine had the lowest reported deaths associated with breakthrough infection, as these CDC data demonstrate.

Underscoring the importance of getting vaccinated plays an hour.

Protection ending this pandemic.

Paul Burton: Approximately 160 million doses of the Moderna vaccine have been administered in the United States. And on the next slide, I want to show you some further government-generated data on a country where the Moderna vaccine has also had extensive use. And that country is

Hit it with the Moderna vaccine and 1.9 million people have been fully vaccinated with the Pfizer Bion Tech vaccine.

These government generated data from the federal office of public health in Switzerland, again, Ah clear and show the vaccination with somebody done the vaccine is highly effective reducing infections hospitalizations and deaths due to COVID-19 infection.

Paul Burton: You can see the exposure data on the left. Approximately 3.6 million people have been fully vaccinated with the Moderna vaccine, and 1.9 million people have been fully vaccinated with the Pfizer-BioNTech vaccine. These government-generated data from the Federal Office of Public Health in Switzerland again are clear and show that vaccination with the Moderna vaccine is highly effective in reducing infection.

But every 1 million people vaccinated use of mrna 12 73.

Would be expected to result in 643 <unk>.

Paul Burton: Hospitalizations and Death due to COVID-19 infection. For every one million people vaccinated, use of mRNA-1273 would be expected to result in 643, fewer COVID-19 breakthrough infections, 78 hospitalizations, and 38 fewer deaths.

<unk> COVID-19 breakthrough infections.

78, hospitalizations and 38 fewer deaths.

Next inside 20 Ah data from two of a recent independent studies that build on the results I just showed you from Switzerland.

The first study on the left side of this slide followed 38 million vaccinated people in the United States, Iceland and South Korea.

Paul Burton: Next, on slide 20, are data from two other recent independent studies that build on the results I just showed you from Switzerland. The first study, on the left side of this slide, followed 38 million vaccinated people in the United States, Iceland, and South Korea and again found that those people vaccinated with mRNA 1273 are at 53% reduced risk of a COVID-19 infection and 33% reduced risk of a COVID-19 hospitalization compared to those vaccinated with the alternate mRNA vaccine.

Followed 38 million vaccinated people in the United States.

Iceland and South Korea.

And again found that those people vaccinated with mRNA 1273 were at 53% reduced risk of a COVID-19 infection. And 33% reduced risk of a COVID-19 hospitalization. Compared to those vaccinated with the alternate mRNA vaccine.

We're at 53% reduced risk of of COVID-19 infection.

And 33% reduced risk of of COVID-19 hospitalization.

Compared to those vaccinated with the alternate mRNA vaccine.

The data on the right-hand slide are from a recent publication by Nordstrom and colleagues in Sweden and Norway. Showing the mRNA 12 73 delivered 87% vaccine effectiveness during a time of high Delta variant circulation in those countries.

Paul Burton: The data on the right hand of the slide are from a recent publication by Nordstrom and colleagues in Sweden and Norway, showing that mRNA-1270 delivered 87% vaccine effectiveness during a time of high delta variant circulation in those countries. The data I've shared so far are all from the general population.

Showing the mrna 12 73.

Delivered 87% vaccine effectiveness during a time of high Delta ovarian circulation in those countries.

The data I've shared so far are from the general population. Let me turn now to the effectiveness of the Moderna vaccine in particularly vulnerable populations the immunocompromised.

Paul Burton: Let me turn now to the effectiveness of the Moderna vaccine in particularly vulnerable populations, the immunocompromised. These data were published just two days ago by the United States CDC Vision Network and examine the vaccine's effectiveness at preventing COVID-19 hospitalization, which is so critically important, in individuals with a variety of immunocompromised medical conditions between January and September of this year. As the authors of this study note, with the exception of those individuals with rheumatic disorders, Vaccine effectiveness point estimates were generally higher for the Moderna vaccine than for the Pfizer-BioNTech vaccine, and the difference in effectiveness in these hard-to-immunize populations is shown in the column on the right.

Let me turn now to the effectiveness of the Mcdonough vaccine in particularly vulnerable populations the immuno compromised.

These data were published just two days ago again by the United States CDC Vision network.

And examine vaccine effectiveness of preventing COVID-19, hospitalization, which is so critically important.

And individuals with a variety of immuno compromised medical conditions between January and September of this year.

As the authors of the study note, with the exception of those individuals with rheumatic disorders. Vaccine effectiveness point estimates would generally higher for the Moderna vaccine then for the Pfizer biotech vaccine.

Vaccine effectiveness point estimates would generally higher for the Mcdonough vaccine then for the funds up biotech vaccine.

And the difference in effectiveness in these hard to immunize populations. As shown in the column on the right.

As shown in the column on the right.

I want to turn now to the topic of myocarditis and to put it in the context of the clinical benefits of explanation that I've just described with mrna 12 73.

Paul Burton: I want to turn now to the topic of myocarditis and put it in the context of the clinical benefits of vaccination that I've just described with mRNA-1273. It is important to recognize that the cases of myocarditis reported to occur following mRNA vaccination are rare, generally mild, typically respond to conservative treatment, and are self-limited. Health authorities have reviewed many data sets, and the U.S. CDC and WHO have concluded that there is a risk of myocarditis and pericarditis after receiving any mRNA vaccine.

It is important to recognize that the cases of myocarditis reported to occur following mrna vaccination of rat generally mild typically respond to conservative treatment and a self limiting.

Health authorities have reviewed many data sets in the U S. C D C and W. H I have concluded that there is a risk of myocarditis and pericarditis after receiving any mrna vaccine.

Paul Burton: The WHO's Advisory Committee on Vaccine Safety notes that myocarditis can occur following SARS-CoV-2 infection or COVID-19 disease. However, mRNA vaccines have a clear benefit in preventing hospitalization and death from COVID-19. Analyses from our Global Safety Database show that the events of myocarditis are very rare.

Whose advisory committee on vaccine safety notes myocarditis can occur following sounds Kobe to infection of COVID-19 disease.

And the mrna vaccines have a clear benefit and preventing hospitalization and death from COVID-19.

Analyses from Al Global Safety database show that the events of myocarditis are very rare.

Paul Burton: Overall, we observe 9.5 cases of myocarditis per million vaccinated individuals, compared to an expected rate of 21 cases per million individuals. Now, in common with other reports of mRNA vaccines in individuals aged 18 to 24, we see an increased rate of myocarditis of 40 cases versus 17 expected cases per million individuals. These data from our own safety database are consistent with the findings from safety databases evaluated by the CDC and other global health authorities, and the link to the CDC analysis is provided on the slide below. mRNA-1273 has been authorized for use in adolescents age 12 to 18 in multiple countries around the world. Moderna's Global Safety Database, has information on an estimated 1.5 million patients. This gives us an opportunity to look at the rate of myocarditis in those individuals, and those data are shown in this table.

Overall, we observe nine five cases of myocarditis per million vaccinated individuals too.

Compared to an expected rate of 21 cases per million individuals.

Now in common with other reports of mrna vaccines individuals aged 18 to 24, we see an increased rate of myocarditis of 40 cases versus 17 expect it to cases per million individuals.

These data from our own safety database Ah consistent with the findings from safety databases evaluated by the C. D C.

And other global health authorities.

And the link to the CDC analysis is provided on the slide below.

[noise] mrna 12, 73 has been authorized for use in adolescents, aged 12 to 18 in multiple countries around the world.

<unk> Global safety database has information on an estimated 1.5 million of them, providing us an opportunity to look at the ratio of myocarditis in those individuals.

And those data are shown in this table.

We see this small absolute well described risk of increased market access rates in males, aged 18 to 24 that I just described to you.

Paul Burton: We see the small, absolute, well-described risk of increased myocarditis rates in males aged 18 to 24, as I just described. But we do not see an increased risk in adolescents, neither in boys nor in girls.

But we do not see an increase risk in adolescence, neither in boys and girls.

Paul Burton: These data are reassuring and important as we continue to offer mRNA-1273 to adults and adolescents and as we file for authorization in children. So, in summary, the data I've shared with you today from independent government reports in the United States and in Switzerland, countries with high vaccination rates of Moderna's vaccine, show that mRNA-1273 is associated with the lowest breakthrough infection, hospitalizations, and deaths due to COVID-19.

These data are reassuring and important as we continue to offer mrna 12 73 to adults adolescents and as we filed for authorization in children.

So in summary, the data I've shared with you today from independent government reports and the United States in Switzerland.

Countries with high vaccination rates of modern this vaccine.

So the mrna 12 73 is associated with the lowest breakthrough infections.

Specializations and deaths due to COVID-19.

Other independent studies and millions of individuals continue to show that mrna 12, 73 is highly effective in reducing the risk of breakthrough COVID-19 as.

Paul Burton: Other independent studies in millions of individuals continue to show that mRNA-1273 is highly effective in Reducing the Risk of Breakthrough COVID-19, as well as hospitalizations and deaths. And importantly, this is also true in those vulnerable and hard-to-vaccinate immunocompromised patient populations. The Global Safety Database, of 151 million vaccinated individuals, shows a rate of myocarditis in males aged 18 to 24 that is consistent with analyses by CDC and others. Moderna's global safety database does not show an increased risk of myocarditis in 1.5 million individuals below the age of 18, and vaccinated with Spike.

As well as hospitalizations and that.

And importantly, this is also true and those are vulnerable and hard to vaccinate immuno compromised patient populations.

Modern this global safety database of 151 million vaccinated individuals shows a ratio of myocarditis in males, aged 18 to 24 that is consistent with analyses by CDC and others.

Modern this global safety database does not show an increased risk of myocarditis.

In 1.5 million individuals.

Below the age of 18.

And vaccinated with Spike tracks.

Paul Burton: So this concludes my quick overview of some recent analyses of mRNA-1273 effectiveness data and a review of data from our Global Safety Database. And I will now turn the call over to Paul. Thank you, Paul, and good morning or good afternoon, everyone.

So these this concludes my quick overview of some recent analyses of mrna 12, 73 effectiveness data and review of data from Mount Global Safety database and I will now turn the call over to Steven.

Thank you Paul and good morning, or good afternoon, everyone. Today I'll review the progress we've made across our vaccines and therapeutics pipeline.

Stephen Hoge: Today I'll review the progress we've made across our vaccines and therapeutics pipeline. Let me start with our COVID-19 vaccine, mRNA-1273, for adults ages 18 and above, where there are a number of important regulatory updates. First, we announced that the FDA granted priority review to Moderna's COVID-19 vaccine BLA. In October, we also received an EUA from the FDA and the European Commission's approval for a booster dose of our COVID-19 vaccine at the 50-microgram dose level for the adult cohort ages 18 and above.

Let me start with our COVID-19 vaccine mrna 12, 73 for adults ages 18, and above where there are a number of important regulatory updates <unk>.

First we've announced that the FDA granted priority review <unk> COVID-19 vaccine BLA.

In October we also received an E Bay from the FDA and the European Commission's approval for a booster dose of the hour COVID-19 vaccine at 115 microgram dose level, the adult cohort ages 18 and above.

Stephen Hoge: Turning to the adolescent and pediatric settings, as a reminder, there are two clinical trials for each of these groups. Teen Cove is our study in the adolescent population, 12 to 17-year-olds, and Kid Cove is the study in the pediatric population, age 11 and younger.

Turning to the adolescent in pediatric settings. As a reminder, there are two clinical trials for each of these groups Teen Cove is our study in the adolescent population 12 to 17 year olds and Kid Cove is this study in the pediatric population age 11 and younger but.

Stephen Hoge: For the adolescent population 12 to 17 years old, our vaccine is authorized in a number of countries worldwide, including the United Kingdom, the European Union, Canada, Switzerland, Japan, Thailand, Taiwan, Saudi Arabia, and Argentina, to name a few. We've submitted data from our KTENCO study to the FDA in the United States, as well as to other countries. We were recently notified by the FDA that the agency will require additional time to evaluate our proposed amendment due to recent analysis of the risk of myocarditis after vaccination in some populations.

But the adolescent population 12 to 17 years old or vaccine is authorized in a number of countries worldwide, including the United Kingdom European Union, Canada, Switzerland, Japan, Thailand, Taiwan, Saudi Arabia, and Argentina to name a few.

We've submitted data from our <unk> study to the FDA in the United States as well as to other countries were recently notified by the FDA that the agency will require additional time to evaluate our proposed amendment due to recent analysis of the risk of myocarditis after vaccination in some populations. The agency expects this evaluation may.

Stephen Hoge: The agency expects this evaluation may extend until January 2022. As Paul noted, Moderna's global safety database includes an estimated 1.5 million adolescents who've received the Moderna COVID-19 vaccine, most outside of the United States. And to date, we have not observed a rate of myocarditis from those younger than 18 years in our safety database that points to an increased risk of myocarditis in that population.

Extend until January 2022.

As Paul noted Madonna's Global safety database includes an estimated 1.5 million adolescents, who received the Moderna COVID-19 vaccine most outside of the United States and to date, we have not observed a rate of myocarditis from those younger than 18 years in our safety database that points to an increased risk of Margaret.

That is in that population.

Stephen Hoge: We continue to believe the benefits of vaccination significantly outweigh the risks. In a pediatric setting, our study, known as KIDCOVE, is ongoing and is focused on three age groups, a group with children 6 to 11 years of age, a group of 2 to less than 6, and a group of children 6 months to less than 2. The trial consists of a dose escalation phase for each group followed by an expansion phase once the dose has been selected.

We continue to believe the benefits of explanation significantly outweigh the risks.

And the pediatric setting our study known as Kid Cove is ongoing and is focused in three age groups a group with children six to 11 years of age a group of two to less than six and a group of children six months to lessen too.

The trial consists of a dose escalation phase for each group followed by an expansion phase once the dosage been selected.

Stephen Hoge: Last week, we shared positive top-line data from the oldest of the age groups in Kid Cove, the 6- to 11-year-old cohort, showing that two 50-microgram doses of mRNA-1273 were generally well-tolerated and that the primary immunogenicity endpoints were met. We will submit our results soon to the EMA and other global regulatory agencies. For the other two age groups in KIDCO, the two to less than six years old group and the six-month to less than two-year-old group, our dose selection studies are ongoing. On the next slide, let me share with you some of the data we have in children ages 6 to less than 12 years of age.

Last week, we shared positive top line data from the oldest of the age groups and Kid Cove. The six 211 year old cohort showing that 215 microgram doses of mrna 12, 73 were generally well tolerated and that the primary immunogenicity endpoints where Matt.

We will submit our results soon to the email and other global regulatory agencies.

For the other two age groups and Kitco, the two to less than six years old group in the six months to less than two year old group or dose selection studies are ongoing.

On the next slide let me share with you some of the data we have and children ages six to less than 12 years of age.

Stephen Hoge: This data is after dose one, as we are waiting for additional follow-up time to share the post-dose two data. As a reminder, the study was randomized two to one. Vaccine vs.

This data is after dos one as we are waiting for additional follow up time to share the post those two days.

As a reminder, the study was randomized two to one for vaccine versus placebo.

Stephen Hoge: Placebo: Based on the case definition of COVID-19 that we used in the Phase 3 adult study, the observed interim vaccine efficacy was 100% in this analysis, starting two weeks after the first dose and using that case definition. Vaccine efficacy against SARS-CoV-2 infection was also high at 80%, and vaccine efficacy against asymptomatic SARS-CoV-2 infection was 65%, both endpoints that we think are Turning now to our booster and next generation COVID-19 vaccine programs on slide 28.

Based on the case definition of COVID-19 that were used in the phase III adult study the observed interim vaccine efficacy was 100% in this analysis starting two weeks after the first dose and using that case definition.

Vaccine efficacy against Sars Kobe to infection was also high at 80% and vaccine efficacy against symptom asymptomatic starts Privy to infection was 65% both endpoints that we think are incredibly important as we seek to end the pandemic.

Turning now to our booster and next generation COVID-19 vaccine programs on slide 28. As a reminder, we are evaluating multiple COVID-19 vaccines as potential boosters to provide the broadest range of countermeasures to the virus as it continues to evolve.

Stephen Hoge: As a reminder, we are evaluating multiple COVID-19 vaccines as potential boosters to provide the broadest range of countermeasures to the virus as it continues to evolve. We were granted an EUA for the 50-microgram dose of our current vaccine as a booster, as mentioned previously.

We were granted you a for the 50 microgram dose of our current vaccine as a booster as mentioned previously.

Stephen Hoge: And we are currently evaluating two variant-specific vaccines and two multivalent vaccine candidates, which are combinations of different variants of concern in an effort to stay ahead of the evolving virus. In addition, we're also evaluating mRNA-1283 as a next-generation refrigerator-stable vaccine, which is in a Phase I study. The interim analysis of that phase one data has been completed at three different dose levels and indicates that a lower dose of mRNA-1283 can achieve similar neutralizing antibody responses as a primary in primary series as our authorized vaccine mRNA-1270. mRNA-1283 also had an acceptable safety and tolerability profile, and we're moving forward towards a Phase 2 booster study for that candidate. This will also evaluate even lower doses of mRNA-1283 given the strong boosting performance seen in phase one.

And we are currently evaluating to various specific vaccines and two multi valent vaccine candidates, which are combinations of different variance of concern in an effort to stay ahead of the evolving virus.

In addition, we are also evaluating mrna 12 83 is a next generation refrigerator stable vaccine, which is in a phase one study.

The interim analysis of that phase one data has been completed at three different dose levels and indicates that a lower dose of mrna 12 83 can achieve similar neutralizing antibody responses as a primary in primary series as are authorized vaccine mrna 12 73.

And more than a 12 83 also had an acceptable safety and Tolerability profile and we're moving forward towards a phase two booster study for that candidate. This will also evaluate even lower doses of mrna 12 83, given the strong boosting performance scene in phase one.

While the start of our booster strategy in late while.

While the start of our booster strategy in late January of this year was in response to the threat of newly identified variants at that time, our booster strategy has continued to evolve as the pandemic unfolds.

Stephen Hoge: While the start of our booster strategy in late January of this year was in response to the threat of newly identified variants at that time, our booster strategy has continued to evolve as the pandemic unfolds. Slide 29 is a slide we shared at our Vaccine Day in April of this year. At the time, the graph on the left was illustrative of our view of the likely path for the pandemic, based on our perspective on respiratory virus evolution and epidemiology, including prior coronavirus pandemics. Today, it's becoming clear that the SARS-CoV-2 virus is following the footsteps of other respiratory viruses and is on its way to becoming a seasonal endemic threat. So where are we now?

Slide 29 is a slide we shared at our vaccines day in April of this year at the time the graph on the left was illustrative of our view of the likely path for the pandemic based on our perspective on respiratory virus evolution in epidemiology, including Pryor Coronavirus Pandemics.

Today, it's becoming clear that the Sars Kobe to virus is following the footsteps of other respiratory viruses and is on its way to becoming a seasonal epidemic endemic threat. So where are we now.

With Delta and the potential for other variance the winter of 2021, 2022 still looks to be a time of moderating, but persistent variant epidemic waves infection.

Infection, and reinfection continue to cause morbidity and mortality during this phase, but hopefully and fewer people.

Stephen Hoge: With Delta and the potential for other variants, the winter of 2021-2022 still looks to be a time of moderating but persistent variant epidemic. Infection and reinfection continue to cause morbidity and mortality during this phase, but hopefully in fewer people. The focus will remain on suppressing the rate of viral evolution and emergence. Primary vaccination is critical. But given the high rate of background transmission, booster vaccines will also be important in all. Looking ahead, we expect 2022 to be the beginning of the seasonal endemic phase.

The focus will remain on suppressing the rate of viral rubble evolution and emergence primary vaccination is critical but given the high rate of background transmission booster vaccines will also be important in all countries.

Looking ahead, we expect 2022 will be the beginning of the seasonal endemic phase.

Re infections and individuals who are at high risk, including older adults immune compromised or healthy adults with more rapidly waning immunity due to <unk> nation with potentially less effective vaccines will be at the greatest risk for severe outcomes.

As with the recent Delta wave. This will include some risk of hospitalization and unfortunately, some risk of death as well as social disruption.

Stephen Hoge: Reinfections in individuals who are at high risk, including older adults, the immune compromised, or healthy adults with more rapidly waning immunity due to under-vaccination with potentially less effective vaccines will be at the greatest risk for severe outbreaks. As with the recent Delta wave, this will include some risk of hospitalization and, unfortunately, some risk of death, as well as social disruption. We believe this will become the primary population for whom seasonal boosting will provide a significant and enduring benefit.

We believe this will become the primary population for whom seasonal boosting will provide a significant and enduring benefit.

In summary, as we described earlier this year, we believe Sars Kobe too is following a familiar path that will ultimately become a seasonal threat to a large population of higher risk adults, perhaps the biggest unknown in the near term is the extent to which further viral evolution in the coming northern hemisphere winter in southern Hemisphere winter in 2020.

Two will create fertile ground for new newly transmissible, an immune evading variance to emerge if so rapid boosting may become necessary.

We will need to remain vigilant throughout this time as we fight the pandemic and we are ready to advanced updated boosters rapidly if they become needed.

Stephen Hoge: In summary, as we described earlier this year, we believe SARS-CoV-2 is following a familiar path that will ultimately become a seasonal threat to a large population of higher risk adults. Perhaps the biggest unknown in the near term is the extent to which further viral evolution in the coming northern hemisphere winter and southern hemisphere winter in 2022 will create fertile ground for new, newly transmissible, and immune-evading variants to emerge If so, rapid boosting may become necessary.

Now moving from Covid on slide onto Slide 30, we announced in September that the phase one portion of our quadrivalent seasonal flu vaccine mrna 10, 10 is fully enrolled and we look forward to sharing data from that trial and moving to phase too soon.

We also announced positive phase one interim data from our RSV vaccine in older adults in September and we plan to start a pivotal phase III three RSV vaccine trial before the end of 2021.

Stephen Hoge: We will need to remain vigilant throughout this time as we fight the pandemic, and we are ready to advance updated boosters rapidly if they become needed. Now moving from COVID onto slide 30, we announced in September that the phase one portion of our quadrivalent seasonal flu vaccine, mRNA 1010, is fully enrolled, and we look forward to sharing data from that trial and moving to phase two. We also announced positive phase one interim data from our RSV vaccine in older adults in September.

Separately the pediatric RSV program continues to move forward with cohorts enrolling well in our phase one study.

Our Hmp's PIV three study in Pediatrics is also currently enrolling in toddlers.

We were very excited to announce last week that our phase III CMV vaccine trial has dose. It's first participants the started the phase III trial CMV cm victory is an important step in evaluating our CMV vaccine against congenital CMV.

As a reminder, CMV is the number one cause of birth defects in the United States and we are evaluating the safety and efficacy of mrna 16, 47, and women ages 16 to 40 at 100 microgram dose level.

Stephen Hoge: And we plan to start a pivotal phase two, three RSV vaccine trial before the end of 2021. Separately, the pediatric RSV program continues to move forward with cohorts enrolling well in our Phase I study. Our HMPV-PIV-3 study in pediatrics is also currently enrolling in toddler care.

The trial is starting in the U S. And will include 105th approximately 150 sites globally, and we will rule approximately 6900 women of childbearing age.

Importantly, inclusion criteria of the trial includes women at high risk of CMV exposure through direct exposure in the home socially or occupationally to children under five years of age.

Stephen Hoge: We were very excited to announce last week that our Phase 3 CMV vaccine trial dosed its first participant. The start of the Phase 3 trial, called CM Victory, is an important step in evaluating our CMV vaccine against congenital CMV. As a reminder, CMV is the number one cause of birth defects in the United States, and we are evaluating the safety and efficacy of mRNA 1647 in women ages 16 to 40 at the 100 microgram dose level. The trial is starting in the U.S. and will include approximately 150 sites globally and will enroll approximately 6,900 women of childbearing age.

Diversity in our clinical trials is also extremely important to us and we are proud to continue our commitment from last year on clinical trial diversity, we believe setting targets and measuring ourselves against them remains one of the most important ways. We can work to address the health care and equity and clinical research for.

For the Cm victory Phase III study our goal is to have 42% of the trial participants in the United States come from communities of color many of which are disproportionately impacted by the CMP virus.

Moving on from vaccine. This slide highlights are mrna therapeutics pipeline at R&D day, we describe how our modality and therapeutic areas overlap and oncology are PCV phase two trial is now fully enrolled and we expect a readout for that as early as the fourth quarter of next year.

Stephen Hoge: Importantly, inclusion criteria for the trial include women at high risk of CMV exposure through direct exposure in the home, socially, or occupationally to children under five years of age. Diversity in our clinical trials is also extremely important to us, and we are proud to continue our commitment from last year to clinical trial diversity. We believe setting targets and measuring ourselves against them remains one of the most important ways we can work to address healthcare inequity in clinical research.

Separately and expansion cohort in head and neck cancer in phase in our phase one trial is ongoing.

We also have phase one trials ongoing for our <unk> vaccine, which has partnered with Mark the triplet program and the Isle 12 enter terminal program, which has partnered with Astrazeneca.

And cardiovascular or veg. A program is also partnered with Astrazeneca has completed the enrollment of a low dose cohort and phase two study and <unk> will be providing updates at a presentation of the data at the American Heart Association meeting in two weeks.

Stephen Hoge: For the CM Victory Phase 3 study, our goal is to have 42% of the trial participants in the United States come from communities of color, many of which are disproportionately impacted by the CMT virus. Moving on from vaccines, this slide highlights our mRNA therapeutics pipeline.

With an auto immune R. IL two program is in a phase one trial and dosing.

And within rare diseases, or <unk> and MMA trials are ongoing in phase one and our GSD. One a program has an open Indy and is expected to start of phase. One study. Soon I'm also very excited to announce that our first cystic fibrosis program has moved into preclinical development with Indian Ambling studies now under.

Stephen Hoge: At R&D Day, we will describe how our modalities and therapeutic areas overlap. In Oncology, our PCV Phase 2 trial is now fully enrolled, and we expect a readout for that as early as the fourth quarter of next year. Separately, an expansion cohort in head and neck cancer in our Phase 1 trial is ongoing.

Way, we and our partners at vertex are pleased to announce that development candidate <unk> 522.

Stephen Hoge: We also have phase one trials ongoing for our KRAS vaccine, which is partnered with Merck, the triplet program, and the IL-12 intratumoral program, which is partnered with AstraZeneca. In cardiovascular, our VEGF program, which is also partnered with AstraZeneca, has completed the enrollment of a low-dose cohort in its Phase 2 study, and AAV will be providing updates at a presentation of With an autoimmune disease, our IL-2 program is in phase one trial and dosing.

This program marks our first program in a brand new modality inhaled therapeutics as a reminder of Moderna modality income encompasses a new method for utilizing our proprietary libert nanoparticle technologies and mrna technologies to bring forward medicines.

A double clicking for a moment on the CF programs and research recall that we have two partnerships with vertex. Our first collaboration targets. The CFT are protein and trying to produce it using mrna and LNP technologies. This is where we are advancing our candidate <unk> 522.

We also have a collaboration with vertex using mrna for gene editing and gene therapy. Both collaborations are focused on treating this 10% of CF patients with disease that Unfortunately is not addressable with currency FTR modulators.

Stephen Hoge: And within rare diseases, our PA and MMA trials are ongoing in Phase I, and our GSD-1A program has an open IND and is expected to start a Phase I study soon. I'm also very excited to announce that our first cystic fibrosis program has moved into preclinical development with IND and AML studies now underway. We and our partners at Virtex are pleased to announce that our development candidate, VXC522.

For this 10% of the population alternate purchase are absolutely necessary and.

And it would be exciting update today as I said, a moment ago is that we're announcing the first development candidate to move into development from that collaboration described on the left hand side of this line.

In this collaboration we're delivering messenger RNA that encodes foresee FTR protein that is missing or nonfunctional in patients who suffer from cystic fibrosis.

Stephen Hoge: This program marks our first program in a brand new modality, Inhaled Therapeutics. As a reminder, a Moderna modality encompasses a new method for utilizing our proprietary lipid nanoparticle technologies and mRNA technologies to bring forward medicine. If you double-click for a moment on the CF programs in research, recall that we have two partnerships with Vertex. Our first collaboration targets the CFTR protein and is trying to produce it using mRNA and LNP technology.

We plan to target that 10% that I mentioned a moment ago.

We've been working incredibly hard with vertex to advance a candidate and we're very excited that that has now moved into IMD, enabling studies as vertex announced recently they expect to submit an iron in 2022 paving the path for clinical studies in these patients.

And to close I would like to just highlight our pipeline on the following <unk> lines, starting on slide 35, which concluded includes our respiratory vaccines in development.

Stephen Hoge: This is where we are advancing our candidate, VXC 522. We also have a collaboration with Vertex using mRNA for gene editing and gene therapy. Both collaborations are focused on treating the 10% of CF patients with disease that, unfortunately, is not addressable with current CFTR modules. For this 10% of the CF population, alternative approaches are absolutely necessary.

Slide 36 summarizes are large portfolio of latent virus vaccines and vaccines against other viruses.

And on slide 37, you'll see the extensive mrna therapeutics pipeline that we have in development.

With that I'll hand, it back to Stefan to close accuracy of them.

<unk> 59 is from Ah September 9th R&D, there and summarizes the product franchise, we focus on that some Obama.

Stephen Hoge: And the exciting update today, as I said a moment ago, is that we're announcing the first development candidate to move into development from that collaboration described on the left hand side of this. In this collaboration, we're delivering messenger RNA that encodes for CFTR protein that is missing or non-functional in patients who suffer from cystic fibrosis. We plan to target that 10% that I mentioned a moment ago. We've been working incredibly hard with Vertex to advance the candidate, and we are very excited that it has now moved into IND-enabling studies.

<unk> number one is a patent respiratory annual booster franchise.

Number two is a first in class vaccines for Laythan viruses.

The number for Ya is arthropathy based on the amount of the encoding proteins and crossing them before the <unk> based on the amount of encoded Jean editing enzymes.

As we have simple several quarters now soft coffee to Louisiana state and will evolve from a pandemic too endemic setting.

We believe that Twenty-twenty, it's already see pandemic in low income countries throughout the year, but that high income countries via would be up to house pandemic priming for children and boosting fathers wouldn't endemic boosting campaign a photo of 22.

Stephen Hoge: As Virtex announced recently, they expect to submit an IND in 2022, paving the path for clinical studies in these patients. And to close, I'd like to just highlight our pipeline on the following three slides, starting on slide 35, which includes our respiratory vaccines in development. Slide 36 summarizes our large portfolio of latent virus vaccines and vaccines against other viruses. And on slide 37, you'll see the extensive mRNA therapeutics pipeline that we have in development. With that, I'll hand it back to Stphane to close.

Yeah.

All types 42, you can see the revenue drivers that we anticipate we pay out in 2020 tool.

We believe they are free components that will drive of COVID-19 vaccine revenues for next year first signed Apa's.

We have already assigned a $17 billion off of advanced purchase agreements are full.

For delivery in 2022.

Seconds AP auctions.

Two free billions of Apa's at auctions, some options are being conducted EQ free from options to <unk> although.

Stephane Bancel: Thank you, Stephen. Slide 39 is from September 9th, R&D Day, and summarizes the product franchise we focused on at Moderna. Priority No. 1 is our pan-respiratory annual booster franchise. Priority No. 2 is our first-in-class vaccines for latent viruses. Priority No. 3 is our therapeutics based on mRNA-encoded proteins, and Priority No. 4.

Fair up the phone of 22 commercial markets, where so believed that the photo was wanted tool assuming a BLA grunted fault with sales will grab a commercial with the markets of up to to be turned off.

So in total at this point, we believe that 2022 revenues could be between 17 billion and taught it will be the ended up.

We have cost continue to have discussions all 20, guys, who apa's governments and organizations you can you kovach's the pan-american half over the issue of Powell and the African Union.

Stephane Bancel: 4 is our therapeutic based on mRNA-encoded gene-editing enzymes. As we have said for several quarters now, SARS-CoV-2 is here to stay and will evolve from a pandemic to an endemic certainty. We believe that 2022 will see a pandemic in low-income countries throughout the year, but in high-income countries, the year will be of two halves, pandemic priming for children and boosting for others with an endemic boosting campaign in the fall of 2022. On flight 42, you can see the revenue drivers that we anticipate will pay out in 2022.

For these patents primary franchise our goal is to be involved with COVID-19 vaccine primary series.

Four of 21, and booster, which is happening as we speak and then photo so I need to boost dose and then add to appropriate booster fubu stuff and a single dose and then.

Two kobe them through Ozzy booster in a single dose of flu vaccine human date should be out soon and the team is already preparing the phase 244 through and.

<unk> <unk> is moving fast to face to free.

If one looks at the heck damage over Lincoln viruses it is profound.

EBV as a major cause of infectious mononucleosis.

<unk> has been reported to increase risk of multiple sclerosis.

<unk> associated with something cancels, an auto immune disease.

<unk> associated with a higher risk of long Kobe.

CMV associated with being the leading cause of birth defect <unk> as a major driver of immune dysfunctions with aging CMV associated with cardiovascular disease, CMV associated with cancer and cognitive impairments.

Stephane Bancel: We believe there are three components that will drive our COVID-19 vaccine revenues for next year. First, signed APS. We have already signed around $17 billion of advance purchase agreements or APS for delivery in 2022. Seconds, AP options. There are up to $3 billion of APS that are in option. Some options have been converted in Q3 from options to film orders.

For not Ochlocracy CMV EBV in the Chevy, but while developing in the labs vaccine against overly can viruses, which just you might have.

Our goal is to eliminate these viruses.

As we discussed audio several cats are in residency programs iron the clinic actual provide can you put without soon on November 15, 80, when presented faced with data inpatients from a VEGF program at the America, how those vision.

Stephane Bancel: Third, the fall of 22 commercial markets. We also believe that the 422, assuming a BLA is granted for our boosters, will drive a commercial booster market of up to $2 billion. So, in total, at this point, we believe that 2022 revenues could be between $17 billion and $22 billion.

And we are pleased to announce a new morality will help primary for our politics.

More than I can.

To expand the use of a platform to create more drugs to help patients are.

While strategy to invest internally endeavor leadership of a crank, but dedicated team.

And two sets up the license agreement with next generation Janine companies submit that Jeremy partnership is a first step into that workshop.

This project part of our company is very pretty unexciting.

We want to stop people, great singles Brutalized from a respiratory infection.

Stephane Bancel: We of course continue to have discussions for 2022 APAs with governments and international organizations, including COVAX, the Pan American Health Organization or PAHO, and the African Union. For this pan-respiratory franchise, our goal is to evolve the COVID-19 vaccine primary series. It will follow 21 boosters, which is happening as we speak, and then follow 22 boosters and then add to a COVID booster a flu booster in a single dose, and then add to COVID and flu an RRG booster in a single dose. The flu vaccine human data should be out soon.

We won't stop until these glories achieved.

We want to stop a photo of human beings from suffering from these laythan policies.

We want to bring to market.

<unk> protein for apathy and oncology cargo review or watching a DVD that payment.

To bring rapid using <unk> anthems, we believe more than that could become the most impactful drug company in the world.

As we scale, we realized that's when it hits will cover in setting the right framework.

<unk>.

But that's made modano although.

So we worked from Q2 and Q free to aptitude, Ethel mindsets, how we behave and make decisions as Madonna.

Stephane Bancel: And the team is already preparing phase two, three, four, and RIV is moving fast to phase two, for instance. If one looks at the health damage of a latent virus disease, it is profound. EBV is a major cause of infectious mononucleosis.

Face more information on our website and we'll be happy to spend time with those of you will also learn more about them. Let me just summarize them high level.

At the modem that we act urgency.

Action to their compounds are a lifesaver tomorrow.

Plus your options in parallel to make the best choice later, we accept risk as the only path to impact.

Stephane Bancel: EBV has been reported to increase the risk of multiple sclerosis. EBV is associated with certain cancers and autoimmune diseases, and DPVs are associated with higher risk of long-term COVID. CMV is associated with being the leading cause of birth defects. CMV is a major driver of immune dysfunctions with age.

We obsess overall earnings we don't have to be a a smart this we have to run the fastest.

With provoked jealously in the face of data with question Convention because program will delsanto with fewer future.

We pushed past placebo.

We'd be able to act on us the solar shuns, we're building go beyond any job description.

Stephane Bancel: CNB's Associated with Cardiovascular Diseases, CMV associated with cancer and cognitive impairment. For now, our focus is CMV, EBV, and HIV, but we are developing in the labs vaccines against other latent viruses which hurt human health. Our goal is to eliminate this virus. As we discussed earlier, several cancer and rare genetic programs are in the clinic and should provide clinical readouts. On November 15, Haiti will present phase 2 data in patients from the VEGF program at the American Heart Association, and we are pleased to announce a new modality will be inhale pulmonary therapy.

We actually with dynamic range driving strategy and execution at the same time and at every step of away we were movies because it needs to encourage corrective action, we prioritize a platform of any single product, we utilized everything placebo using the power of the show information to maximize my inbox on patients.

Well I want to be the most impactful drug company in the world, we cared deeply about doing it the right way.

Being a great company to work full as exemplified about seventh consecutive year ranked as the best company to work for by Science, but it also means building a company. It is responsible and minimizing all impact on the planet, where perhaps we have announced earlier. This week that we will work to achieve net zero carbon emission for operations globally by 2000.

Stephane Bancel: In the effort to expand the use of our platform to create more innovative drugs to help patients, our strategy is to invest internally under the leadership of Dr. Eric Hwang with a dedicated team and to set up license agreements with next-generation gene editing companies. The MetaGemE partnership is the first step in that direction. The strategic path of the company is very clear and exciting. We want to stop people getting hospitalized for respiratory infections.

Team.

I want to thank the modern that team for a commitment to what mission and that relentless work to beat the best special on whether or not we have an excellent two years before we drove into Q&A as we wanted to share the dates of annual invest all events. Both wanted wanted to back in there on most wonderful signs there almost 17 and all of you there on <unk>.

Eight a predator will not be happy to take any questions.

Stephane Bancel: We won't stop until this goal is achieved. We want to stop all human beings from suffering from this latent virus. We want to bring mRNA encoded protein therapeutics to market for oncology, cardiology, rare genetic diseases, and autoimmune diseases.

Thank you for instruments to ask that question.

Need to print or one.

Once you fat Doobie doing a Christian rest of balance.

Our first question comes from the line of Salving Richter from Goldman Sachs. Your line is open.

Good morning, Thanks for taking my question for.

For 2022 key one.

Stephane Bancel: We want to bring therapeutics using gene editing enzymes to the world. We believe Moderna could become the most impactful drug company in the world. As we scale, we realize that we need to go further in setting the right framework for our team to understand what has made Moderna Moderna. So we work through Q2 and Q3 to articulate our mindsets, how we behave, and make decisions at Moderna. There is more information on our website, and we would be happy to spend time with those of you who want to learn more about them. But let me just summarize them at a higher level.

Supply aspects are you still dining came up to 3 billion doses hearing and can you also speak to demand dynamics is there upside to the guidance <unk> commented on today for future signed Apa's and then secondly, how confident are you that you can fix.

Supply issues and over what timeframe.

Greg <unk>, So let me take those those those different questions.

So let me start with a short term yes. We were you believe we can.

Fixed those short term supply issues as.

Stephane Bancel: At Moderna, we act with urgency. Action today compounds the life saved tomorrow. We pursue options in parallel to make the best choice later. We accept risk as the only path to impact. We obsess over learning. We don't have to be the smartest; we have to learn the fastest. We pivot fearlessly in the face of new data. We question convention because proven models don't always fuel the future. We push past the possible.

As I as I've tried to explain in my remarks.

Those up with I will qualify us television problems of scanning groups so fast.

Q1 and.

It was all about making enough drug substeps and rarely Trina waiting to have enough trucks substantial few device and the team's skill very nicely in kutuzova change, we have been filling and he was all about feeding vials and.

And the complexity of Giuffre is what are you move to go out to the back of a supply chain, which is we're losing product and shipping products and the complexity as being the wrong just in both markets. We have two sails beginning there yeah. It was mostly shipping too CVC U S and Europe and as well but.

Stephane Bancel: We behave like owners. The solutions we are building go beyond any job description. We act with dynamic range, driving strategy and execution at the same time and at every step of the way. We remove viscosity to encourage collective action. Prioritizing our platform over any single product, we digitalized everything possible using the power of digital information to maximize our impact on patients. We want to be the most impactful drug company in the world.

But then as we increase in above coffees, two menu built them by now with the complexity is just increasing any even farewell now that's growing most shoving kovach's, where you to go through Bicone free. So that's just what type of television programs that we are experiencing right now we have increased gusler, where we visited in digital towards the teams so Audi.

Stephane Bancel: We care deeply about doing it the right way. It means being a great company to work for, as exemplified by our seventh consecutive year ranked as the best company to work for by science. But it also means building a company that is responsible and minimizes our impact on the planet. We are proud to have announced earlier this week that we will work to achieve net zero carbon emissions for operations globally by 2030.

Expect this to be resolved black will result.

The drug sub sub strategies in Q1 of the drug product charges in queue tool.

The 20th what it's will eat some of drugs substance, yes, we could see makeup to forbid on building some of mozzarella as you know.

That number was worthy depending on the Boost-start goes and now that we're on the other side of that decision over 50 microgram dose, we can't make up to Freeboot uncles EBIT wasn't in the voice.

Stephane Bancel: I want to thank the Moderna team for their commitment to our mission and their relentless work to build the best version of Moderna over the next 20 years. Before we jump into Q&As, we wanted to share the dates of our annual investor event for 2022: Vaccine Day on March 24th, Science Day on May 17th, and R&D Day on September 8th.

The challenge in 2022 is going to be around to know for the fall because as the market moves whenever they make market you're going to need basically advice to be able to go to less number of dose provider again independent existing as you know we don't return bills provided which we think was what he has update.

The low income offered we've been up more into right now because we think about the endemic market in with Frank yourself pandemic. Another because of some final we just need to keep our deeper ambition.

Operator: Operator will not be happy to take any questions. Please ask participants to press star 1 on your telephone keypad. Thank you. Do I have a question? Our first question comes from the line of Salveen Richter from Goldman Sachs. Your line is open.

To be relevant to healthcare walk girls X webcast systems around the world So drug substance will not be an issue.

There's of course as I've described perpetual upcycle goes in umbrella.

Salveen Richter: Good morning, thanks for taking my question. For 2022, can you walk through the supply aspects? Are you still guiding to up to 3 billion doses here? And can you also speak to demand dynamics? Is there upside to the guidance that you are giving?

We still have quite a number of AP is being discussed.

Countries around the world.

We don't know what will happen in somewhere epidemiology.

Is that new variant coming.

<unk> well the current vaccine.

Salveen Richter: Medicare, M.D., Pfizer, Moderna, Moderna, Moderna, Moderna, Moderna, Moderna, Moderna,

You still have full although we need STM, describing the new booster.

Stephane Bancel: And then secondly, you know, how confident are you that you can fix the supply issues and over what time frame? Great, Salveen.

Of course, it would be a question of Mafia, that's where all following demonology literally on a daily basis and then there are so many for boosting people.

Around the world.

No pneumonia vaccines.

As everybody knows there's a problem with waning immunity overtime. So what time is not the frame as people <unk> going down and as we have new violence like desktop hope eventually of else, but we should not forget that must be put her on the planet up north had pneumonia vaccine injected into body to date and so we.

Stephane Bancel: Let me take those different questions. Let me start with the short term. Yes, we really believe we can fix those short-term supply issues. As I try to explain in my remarks, those are what I would qualify as the teething problems of scaling up so fast. You know, in Q1 it was all about making enough drug substance, and we are literally now waiting to have enough drug substance to fill vials, and the teams scaled very nicely.

Base of unimportant need to boost people.

Among the vaccine and thus porch short the wheel of evidence secreting the data from CDC in Switzerland there.

Stephane Bancel: In Q2, the challenge we had internally was all about filling vials, and the complexity of Q3 has really moved to the back end of the supply chain, which is releasing products and shipping products. And the complexity has been around just a number of markets we have to serve. Beginning in the year, it was mostly shipping to CDC in the U.S. and Europe, and that was it.

More we get data and the more time, you said B two C. We see a net differentiation between products and this doesn't go unnoticed by governments around the world, while working really hard to preventing hospitalization in depth.

And so there's upcycle that again, it's a very.

Unpredictable environment, none of US has worked for a pandemic before thankfully.

Stephane Bancel: But then as we increase the number of countries to many dozens by now, the complexity is just increasing. And it's even more complex now that we are serving COVAX. We need to go country by country.

But b S show that.

Keeps getting up manufacturing, we keeping getting will go on months. So that we can maximize how we can help people and they are more of a neutral photo from that.

Stephane Bancel: So that's just the type of teaming problems that we are experiencing right now. We have increased our personnel. We have invested in digital to help the teams, so I really expect this to be resolved like we resolved the drug substance challenges in Q1 and the drug product challenges in Q2. In 2022, in terms of drug substance, yes, we could still make up to $3 billion in terms of materials. As you know, that number was really depending on the booster dose.

Thank you.

Thank you sorry.

Your next questions from Matthew Harrison with Morgan Stanley. Your line is open.

Great. Good morning, Thanks for taking the question to for me. This morning. So first can we just spend a moment on on myocarditis.

And I think that the over line question here is.

Why do you think the regulators is more concerned with your vaccine in younger age groups compared to Pfizer, which is obviously already been approved in younger age groups, and then and related to that how much of an impact is this having on uptake and distribution of your vaccine given that we see Pfizer continue to highlight.

Stephane Bancel: And now that we're on the other side of that decision with a 50 microgram dose, we confirm we could make up to $3 billion if there was a need for it. The challenge in 2022 is going to really be around, you know, product form.

Potential differences.

And bringing that to governments attention.

And then secondly on flu can you just comment on how you are going to interpret these results. Obviously, we're just going to get tighter results.

Stephane Bancel: Because as the market moves to an endemic market, you're going to need vials to be able to go to a lower number of doses per vial. Again, in the pandemic setting, as you know, we launched with 10 doses per vial, which we think was really appropriate. In low-income countries, we even have more into vials now. But as we think about the endemic market, and we're trying to serve both the pandemic and the endemic at the same time, we just need to keep adding presentation to be relevant to healthcare workers and to healthcare systems around the world. So drug substances will not be an issue.

But I think it's your premise that you can achieve a much higher efficacy flu vaccine compared to traditional flu vaccines. So do you think there is a clear correlation and titers to efficacy and what level of titers would demonstrate very high efficacy. Thanks.

Thank you Matthew so Steven I'll take I'll take try and take those questions.

So so first look I think is most important to say that what what we communicated in a desire to be maximally transparent last week was that the FDA. Unlike other regulators has asked for some more time to review emerging recent data and that might take though January.

Stephane Bancel: There's, of course, as I described, potential upside to those numbers. We still have quite a number of APS being discussed with countries around the world. You know, we don't know what will happen in terms of epidemiology. You know, is there a new variant coming?

I think your question is how is that different vis-a-vis what happened with the Pfizer vaccine I think the most important thing to recognize is that the Pfizer adolescent vaccine was authorized prior to any substantial discussion about myocarditis as a benefit or is a risk.

Stephane Bancel: Is it a variant where the current vaccine is still helpful, or do we need, as Stephen described, you know, a new booster? There's, of course, a big question mark here that we're all following epidemiology literally on a daily basis. As everybody knows, there's a problem of waning immunity over time. So time is not our friend as people see their levels of antibody going down. And as we have new variants like Delta or potentially others,

In fact, the the signal emerged a few weeks later just before we made our filing and I think Ah.

<unk> approach.

There was too.

The verbeck conducted there was an ongoing discussions.

But what we've continued to see over the course of the.

Over the last four or five months is that for both mrna vaccines. There is a question of.

Stephane Bancel: But we should not forget that most people around the planet have not had an mRNA vaccine injected into their bodies today. And so we believe there's an important need to boost people with mRNA vaccines. And as Paul showed the real-world evidence, including the data from CDC and Switzerland, the more we get data and the more time we spend looking at it, we see a net differentiation between products. And this doesn't go unnoticed by governments around the world who are working really hard to prevent hospitalization and death. And so there's a side to that.

Whether it's an increased rate of myocarditis above background in 18 to 24 year old males, a relatively small population, but an important one.

And I think it's in the face of those continuing emerging questions that the FDA is being diligent and appropriately conservative in their approach and making sure. They have the time to review those and they have continued to come out over time, and so I think principally what we're seeing here is a difference as a function of.

<unk>.

Which is that the the other vaccine had been authorized prior to this concern and there has been continued emerging data around that we are very grateful for the FDA for that diligence I would note that the same information are available to other regulators and.

Stephane Bancel: Again, it's a very, you know, unpredictable environment; none of us have worked with a pandemic before, thankfully. But you can be assured that we will keep scaling up manufacturing, we'll keep engaging with government so that we can maximize how we can help people, and the revenues should follow. Thank you for having me. Your next question is from Matthew Harrison with Morgan Stanley. Your line is open. Great. Good morning. Thanks for taking the time to answer the question. Two for me this morning.

As I said before we are authorized for.

For that population.

Internationally.

Fortunately as Paul characterized we have not seen an increased rate of myocardial listen talk 17 year olds, when we think over time.

The substantial benefits of our vaccine.

Will will ultimately went out here and.

So we look forward to to.

Continuing to work with.

Thus version of what I think we heard from them last week.

The.

The question about how we see that evolving over time.

Matthew Harrison: So first, can we just spend a moment on myocarditis? And I think that the overlying question here is, you know, why do you think the regulators are more concerned with your vaccine in younger age groups compared to Pfizer, which has obviously already been approved in younger age groups? And then related to that, how much of an impact is this having on uptake and distribution of your vaccine, given that we see Pfizer continue to highlight potential differences and bring that to the government's attention?

Obviously internationally, we we are participating that market in the United States adolescent vaccinations have substantially tailed off as we all would note.

And so the extent that there is an ongoing needed in the United States for vaccination. It is a diminishing market for sure and again. This is a primary series vaccine and so we do hope that most people in the world will cero convert and not need a primary series looking forward.

The the question of what is that endemic market going forward that is of greatest import and I've tried to summarize that in our view of the evolution of this virus and what that will be it is it is we believe in the future a booster market and to boost your market targeted at those populations that are higher risk of respiratory disease.

Matthew Harrison: And then secondly, on flu, can you just comment on how you're going to interpret these results? Obviously, we're just going to get tighter results. But I think it's your premise that you can achieve a much higher efficacy flu vaccine compared to traditional flu vaccines. So do you think there is a clear correlation between titers and efficacy? And And what level of titers would demonstrate very high efficacy?

Populations tend to be older adults in the new compromise places, where we think and morning 12, 73 is demaree, demonstrating really remarkable efficacy differentiate and perhaps but public data publicly reported data is is really encourage you on that dimension and I would note that is not a population is associated to date.

Stephen Hoge: Thanks. Thank you, Matthew. So, Stephen, I'll take, I'll try and take those questions.

Stephen Hoge: So first, look, I think it's most important to say that, in a desire to be maximally transparent last week, the FDA, unlike other regulators, has asked for some more time to review emerging recent data, and that might take till January. I think your question is, how is that different vis-a-vis what happened with the Pfizer vaccine? I think the most important thing to recognize is that the Pfizer adolescent vaccine was approved prior to any substantial discussion about myocarditis as a benefit or as a risk.

With any of the vaccines and have an increased rate of myocarditis and so the benefit risk. There we think even swings more favorably to 12 73, but will allow data to continue to develop and ultimately drive this behavior. So we are quite.

Quite incur encouraged by the performance of the vaccine in the population that we think is going to be most important in the years ahead.

The last question was on flu.

Which is what do we think about the data obviously as you pointed to there are correlates of protection that have that have been used previously with Hai titers and influenza vaccine, we will be looking at that.

Stephen Hoge: In fact, the signal emerged a few weeks later, just before we made our filing, and I think a prudent approach there was to the VRBPAC conducted, there were ongoing discussions, but what we've continued to see over the course of the last four or five months is that for both mRNA vaccines, there's a question of whether there's an increased rate of myocarditis above background in 18 and 24-year-old males, And I think it's in the face of those continuing emerging questions that the FDA is being diligent and appropriately conservative in its approach and making sure that they have the time to review them. And they have continued to come out over time.

As I'm sure everybody will as well as other responses in the immune system as we continue to try and identify the optimal dose.

I am I am not going to.

Put out their review of what I think our view of success will look like I would just say that we have very high expectations for our platform now we do believe that our performance in older adults, including with the coven vaccine, but also over more recently with the RSV booster starting in phase one demonstrates that our platform does incredibly well.

In those at highest risk of these rest parental diseases and so we are optimistic that we will continue to show strong performance hopefully strongest performance in those populations.

But I won't give you a specific title number today.

Just to let some Stevens point from a few I think we should not forget the company's strategy, which is around combination.

Stephen Hoge: And so I think principally what we're seeing here is a difference in timing, which is that the prior, the other vaccine had been authorized prior to this concern, and there has been continued emerging data around that. We are very grateful for the FDA for that diligence. I would note that the same information is available to other regulators and, as I said, for that population internationally, and fortunately, as Paul characterized, we have not seen an increased rate of myocarditis in 12- to 17-year-olds, and we think over time the substantial benefits of our vaccine will ultimately win out here, and so we look forward to continuing to where we get the AMF. The question about how we see that evolving over time is obviously In the United States, adolescent vaccinations have substantially tailed off, as we all would note.

We believe that combining flu and cove, it will styles and the single those and then adding.

Is the critical central part of all strategy, we think industrial and this value for compliance or protection.

Stramineous values of convenience to the consumers I cannot believe that most people will walk a fruit truck and a coffee shop and Aussie show up every fall and.

And as we both from a pay on that catwalk best value of a product. So so we believe a combination is really critical success Arco.

Thank you.

Next question is from.

Huh.

<unk> your line.

Great. Thank you very much and congratulations on all the progress.

My question has to do with the.

The uhm emerging.

Orphan disease pipeline.

Really impressed by the progress that you guys are making there is is important.

Patient Lezsek B M or are they technology just suits ideally here. So what do you see as sort of the plans over the next couple of years kind of tickets forward a little bit.

Stephen Hoge: And so to the extent that there is an ongoing need in the United States for vaccination, it is a diminishing market for sure. And again, this is a primary series vaccine. And so we do hope that most people in the world will zero convert and not need a primary series looking forward.

What could this pipeline look like.

Maybe you can just give us a sense of where where do you think look over will be illegal. So disease. Southern you a a couple of years. Thank you.

Stephen Hoge: The question then is, what is that endemic market going forward that is of greatest import? And I tried to summarize that in our view of the evolution of this virus and what that need will be. It is, we believe in the future, a booster market, and it's a booster market targeted at those populations that are at higher risk of respiratory disease. Those populations tend to be older adults and immune compromised. Places where we think mRNA-1273 is demonstrating really remarkable efficacy differentiated perhaps, but public data, publicly reported data is really encouraging on that dimension. And I would note that this is not a population that's associated to date with any of the vaccines that have an increased rate of myocarditis.

Okay.

Thank you said.

I'll take take that so so first I think we're very excited about the programs that are already in the clinical space either already dosing patients who are about to start and.

And so I think the most important thing is looking forward to next year the.

The demonstration we would hope of proof of concept in that rare disease modality.

As you know we are dosing quite a large number of folks inappropriate on accursed EMEA and we've been dosing and met the monarch esteem in with the opening of the GST one a.

We'd hope to be following in short order there. So all three of those are potentials for us to demonstrate the real proof that this this technology can be used to correct inborn errors of metabolism.

In these populations I'll also note that.

Stephen Hoge: And so the benefit risk there, we think it even swings more favorably to 1273 but will allow data to continue to develop and ultimately drive this behavior. So we are quite encouraged by the performance of the vaccine in the population that we think is going to be most important in the years ahead. The last question was on flu, which is, what do we think about that data? Obviously, as you pointed out, there are correlates of protection that have been used previously with HAI titers in influenza vaccines.

Quite wide range of disease going down to his youngest two years of age and some of the metal in some of the organic epidemiologist not the older adults and some of the GST when any program. So we're going to be demonstrating quite a lot there.

Cleveland Jar presents another opportunity for that proof of concept as well as well as the PKU program when that restored but those are still in preclinical.

So the question is what do we do on the back of that proof of concept from any one or all of those programs.

What you've seen is due in in respiratory vaccines and vaccine generally is probably the best predictor of how we will respond which is as you know there are a very very large number of.

Stephen Hoge: We will be looking at that, as I'm sure everybody will, as well as other responses in the immune system as we continue to try and identify the optimal dose. But I'm not going to put out there a view of what I think our view of success will look like.

Metabolic diseases that could be addressed through deliver through a morning therapy.

We have we could list off large groups, but the degree of sexual disorders, other or do the Cassidy Miss so many beyond that and even in moving into more broadly present metabolic diseases. So what we would do is we would define that systemic intercellular therapeutic modality is a core modality just like we did with vaccine.

Stephen Hoge: I will just say that we have very high expectations for our platform. Now, we do believe that our performance in older adults, including with the COVID vaccine, but also more recently with the RSV booster study in Phase 1, shows that our platform does incredibly well in those at highest risk of these respiratory viral diseases. And so we're optimistic that we will continue to show strong performance, hopefully the strongest performance, in those populations. But I won't give you a specific title number.

<unk> a couple of years ago, and that would cause us to dramatically expand that pipeline I can assure you were looking at those programs and research right now, but we will we have held back on moving them into preclinical development and putting them on our pipeline until we saw seen the modality perform so that is probably the most important thing for me looking at the.

They're an orphan disease space over the course of.

The coming year is when do we crossed that threshold and then ultimately when do we expand dramatically that pipeline of programs.

That would be cool on the phone can I really appreciate it seemed the new pulmonary.

Disney's areas. So thanks for all the updates.

Stephane Bancel: Yeah, and we just got to Stephen's point, Matthew. I think we should not forget the company strategy, which is around combination. We believe that combining flu and COVID boosters in a single dose and then adding RSV is the critical central part of our strategy. We think it has tremendous value in terms of compliance or protection. It also has tremendous value in terms of convenience for consumers. I do not believe that most people will want the flu shot and the COVID shot and the RSV shot every fall. And as we heard from the pay and healthcare workers, that's the value of a product. So we believe the combination is really a critical success factor.

Thank you.

We have a question from Mike Leigh from.

Your line is open.

Hi, good morning, Thanks for the questions. Two questions. One is just trying to clarify guidance I think there's some confusion around guidance over the love to understand simply.

Some clarification, you lowered 2021, a little bit I think by $5 billion that range 2022, 2022 by $5 billion is that a timing shift of deliveries and how much of that is just option contracts.

As you think about 2022, because you've talked about EPA as firm commitments I am just trying to understand how mature commitments versus acceptances and how to how to think about those two and then on flu following up on the flu question. I think people are looking at labels and looking that fold increases and sure conversion rates are four to seven times in 50 to 60.

Edward Andrew Tenthoff: The next question is from Ted Penthoff with Piper Sander. Your line is open.

Stephen Hoge: Great. Thank you very much and congratulations on all the progress. My question has to do with the emerging Orphan Disease Pipeline, and I've been really impressed by the progress that you guys are making in these important patients.

<unk> sure conversion rates are those accurate numbers are those numbers, we shouldn't be looking at and comparing to maybe you could just help us qualify that because I think that's what people are trying to do thank you so much.

Edward Andrew Tenthoff: And I think the mRNA technology just suits ideally here. So what do you see as sort of the plans over the next couple of years? Kind of take us forward a little bit. You know, what could this pipeline look like? And maybe you can just give us a sense of where you think Moderna will be in the ulcer disease setting in a couple of years. Thank you. Thank you, Seth.

So good morning, like Stephane I would take the first one and give some to Stephen So I think you already highlighted some of.

Of a dry vials. So on 21, so that's two finger thing that is driving.

Trustees of course, the lower volume.

And the second one is is price.

Stephen Hoge: I'll take that. First, I think, you know, we're very excited about the programs that are already in the clinical space, either already dosing patients or about to start. And so I think the most important thing is looking forward to next year, the demonstration, we would hope, of proof of concept in that rare disease modality. As you know, we are dosing quite a large number of folks with proprionic acidemia, and we've been dosing with methylmalonic acidemia.

As you know we are working very hard we have several months to Santa although.

Both for high income country like the us to low income.

This side of Christmas and so if you think about just V. U S V. U S. We see that when we announce software getting in partnership the U S decided to delay too cute too.

The delivery of December also that volume is going to Africa junior at the look just price so.

In fact on the tone of just by doing the mouth over lower price on the same volume right there and some Waldorf I'm moving from December through January.

Stephen Hoge: And with the opening of the GSD1A IND, we'd hope to be following a short order there. So all three of those are potential opportunities for us to demonstrate the real proof that this technology can be used to correct inborn errors of metabolism in these populations. I'll also note that there's quite a wide range of disease going down to as young as two years of age in some of the organic acidemias and also older adults in some of the GSD1A programs. So we're going to be demonstrating quite a lot there.

On the on the supply volume Psycho things. So when you're also taught it to where the increase of voting moved from December to January that these one we've sat and uhm since the last numbers and as I say, but.

Some option that being exercise one of them was kovacs option. That's was exercise at the end of two free.

He is now confident as a full AP because it's on a steam coming to mind us on prepayment in song and all those other dynamics happening this team or so is.

Stephen Hoge: Kregman-Najjar presents another opportunity for that proof of concept as well, as well as the PKU program when that moves forward. But those are still in preclinical, as I said. So the question is, what do we do on the back of that proof of concept from anyone or all of those programs? What you've seen us do in respiratory vaccines and in vaccines generally is probably the best predictor of how we will respond, which is, as you know, there are a very, very large number of metabolic diseases that could be addressed through the liver through mRNA therapy. We could list off large groups, but the urea cycle disorders, other organic acidemias, so many beyond that, and even when moving into more broadly present metabolic diseases.

Starting to spend a lot of Thunder commercial team on focusing on the four of 22, because we think that's going to be a nipple thumps moment the mix and match. We think is critical that these now allowed in most places in some countries that you can just mix and match or fallen off time, but the U S market for causes impulse is that all we can mix and match.

And as you know.

Just shout, we believe that as time will go the things that we show that what we believe is that we have on August duration efficacy of vaccines on the market.

And two there if you look at data market reception very few cove in the us know that.

If you pull a valley things with this call no that'd be because you repay pros and always any babies.

50 point Derisks.

Stephen Hoge: So what we would do is we would define that systemic intracellular therapeutic modality as a core modality, just like we did with vaccines a couple years ago. And that would cause us to dramatically expand that pipeline. Now, I can assure you, we're looking at those programs and research right now, but we have held back on moving them into preclinical development and putting them on our pipeline until we see the modality perform.

We believe it or not.

Possibility for us.

Between now and next summer to make sure that people understand the facts on the staff of the real world evidence. So that they can make an informed decision and that includes a head count wolkoff, the pharmacies that doctor all and they'll save that include the consumers directly.

So this is why as we starting to suffer an offensive employees spending a lot of time walking towards the photo so it'd be too we believe that's another piece.

Stephen Hoge: So that is probably the most important thing for me, looking at the rare and orphan disease space over the course of the coming year, is when will we cross that threshold? And then, ultimately, when will we dramatically expand that pipeline of programs?

Not to go back to a previous novels, we only disclosed.

And options of Aps.

Commercial opportunities for us towards what we think is going to be on the pulse of vector October 22 six.

Steven on for sure. So I'll try I'll try and clarify that answer on Seroconversion rates. So we.

Edward Andrew Tenthoff: That made a lot of sense, and I really appreciated seeing the new pulmonary disease area.

It is a phase one study and so we're looking at a range of doses and I have not got access to the data. So I just don't I don't want to presuppose the specific answer yet as soon as we have the data we will provide our thorough interpretation of it however.

Edward Andrew Tenthoff: Pulmonary Disease Area. So thanks for all the updates. Thank you. We have a question from Michael Yee, from Geoffrey's. Your line is open.

Michael Yee: Hi, good morning. Thanks for the questions. Two questions. One is just trying to clarify guidance. I think there's some confusion around guidance, so I would love to understand some clarification. You lowered 2021.

As you point out generally seroconversion is defined as a fourfold ryzen titers of a baseline and we've done that in some of our other studies and we will be looking at in the percentage of people, who would see that serial conversion of most important to me will be looking at the consistency of that percentage across agents in particular, the older adults where you often don't.

Michael Yee: a little bit, I think by 5 billion, but it raised 2022 by.

Michael Yee: Is that a timing shift in deliveries, and how much of that is just option contracts as you think about 2022? Because you've talked about that a lot.

Achieve that type of the same level of Immunogenicity, but we believe with our platform. While there are other endpoints as well in terms of sheer protection different defined as absolute titers again greater than 40 is accepted we will look how high that goes because that can also be reassuring, but I don't think right now we're ready to get on a specific target that we will declare a success other than looking again at that or fold rise.

Michael Yee: We talked about APA's as firm commitments; I'm just trying to understand how much commitments versus acceptances are and how to think about those two.

Michael Yee: and then on the flu, following up on the flu question,

Michael Yee: I think people are looking at labels and looking at fold increases and seroconversion rates of 4-7 times and 50-60% seroconversion rates. Are those accurate numbers? Are those the numbers we should be looking at and comparing to? Maybe you could just help us qualify that because I think that's

Measuring so a conversion across the reach of agents that will be studying study.

Got it thank you.

Thank you Michael.

Next question is from Chino right from Barclays Reclining sofa.

Thank you for taking my questions I Q regarding the Cove.

Stephane Bancel: Thank you so much. So, good morning, Mike, and Stphane. I'll take the first one and give it through to Stephen. So, I think you have already highlighted some of the drivers. So, on 21, there's two things I think are driving it. First is, of course, the lower volume. And the second one is price. As you know, we're working very hard with several governments to send products that they have bought for high-income countries like the US to low-income countries this side of.

Maxine and the first question is Keith.

Keeping the supply must change and do you see in Hungary microgram dose is being used.

215, microgram doses and then also any hesitance due to safety concerns we did see a few countries put a cautionary action.

Oh, My God No vaccine and my second question is in the U S.

Stephane Bancel: And so we think about just the US; the US, we've said that publicly, when we announced our African Union partnership, the US decided to delay the delivery of a December order. That volume is going to Africa at a low tiered price. So you have an impact on the turnover just by doing the math of a lower price on the same volume right there.

We do the math you completed delivery of a 300 million doses and then use to exercise total doses of 410.

420, 21, and a 90 million doses.

2022, so just wondering how much of the remaining 110 million doses. The info Q21 will flow too.

Stephane Bancel: And some others that are moving from December to January on the supply volume side of things. So when you're on 2.22, where you have the increase of volume move from December to January, that is one. We've signed new APAs since the last numbers. And, as I said, some options have been exercised. One of them was a COVAX option that was exercised at the end of Q3, and it is now counted as a full APA because of some firm commitment and some prepayment, and so on.

Yeah.

So I can try and take the first question, although invited Paul as well.

So.

I think in terms of you referenced some of the more recent communications that have happened from public health officials for instance.

<unk> and elsewhere.

I would note that those same communications.

Literally often the same documents and include reference to the fact that there is very strong efficacy for them. It uncovered 19 vaccine and in fact some of those Nordic country Communications include referenced the fact that it looks to be potentially greater in terms of protection as emphasis for why the vaccine not only is still recommended and.

Stephane Bancel: And so those are the dynamics that are happening. The team is also starting to spend a lot of time, the commercial team, focusing on the fall of 2.22 because we think that's going to be an important moment. The mix-and-match, we think, is critical, that is now allowed in most places. In some countries, they're even just doing mix-and-match for a long time.

Many of those jurisdictions, but ultimately provide very favorable benefit risks and so we continue to believe that that whole picture looking at the benefit.

And quantifying that benefit, which we think is substantial and larger than any risks contemplated here is really important and we again look to those communications that clearly state that all anything you would add to that only Stephen that recently I think last week, the who gave updated guidance continue.

Stephane Bancel: But the U.S. market, of course, is important and is allowing mix-and-match. The data will show that what we believe is that we have the longest duration efficacy vaccine on the market. And today, if you look at data and market research, very few consumers in the US know that. People that are listening to this call know that because they read the papers on a daily basis. There are a few people in the US who do not

Continuing to endorse.

The vaccines and mrna 12, 73, and I think as they do.

Doing their analysis of these data sets of said that they need to think about potential biases occur in in general practice.

Stephane Bancel: We believe there's an opportunity for us, you know, between now and, let's say, next summer, to make sure that people understand the facts, understand the real world evidence, so that they can make an informed decision. And that includes the healthcare workers, the pharmacists, the doctors, the nurses, and that includes the consumers directly. And so this is why, as we started to sharpen our pencils, and we spent a lot of time working towards the fall of 22, we believe that's another piece that was not to go back to our previous numbers.

Looking at the the primary vaccination schedule.

And the difference in timing, we know the vaccine to use differently.

Times and that May account for these but I think clear standing behind.

The data Steven.

I've been just as a closing comment I would just reference we've entered in some of these markets into a very interesting phase of the pandemic, which is that we are in the lower risk populations.

And we are providing vaccination to them.

As as appropriate.

But so as we do that.

Stephen Hoge: So we discussed APS and options for APS, the commercial opportunities for fall of 22, which we think is going to be an important vector for 22 sales. So I'll try and clarify that answer on seroconversion rates. So this is a phase one study, and we are looking at a range of doses, and I have not got access to the data yet, so I just don't want to presuppose the specific answer yet. As soon as we have the data, we will provide our thorough interpretation of it.

We're looking at that are at risk and in.

In the most cautious and increasingly cautious ways and that's appropriate but.

But as we look forward to next year, and we start thinking about boosting.

In particular, the seasonal marketed protecting those that are highest risk I think that that calculus, obviously changed pretty dramatically.

And so I think we are in a period of time, where.

Where we are again looking at the lowest risk populations.

And I think that that is transient period of time ultimately because it is high risk populations that are of greatest concern looking forward from 2022.

Stephen Hoge: However, as you point out, generally, seroconversion is defined as a fourfold rise in titers above baseline, and we've done that in some of our other studies. And we will be looking at that, the percentage of people who experience that seroconversion, and, most importantly to me, we'll be looking at the consistency of that percentage across ages. In particular, older adults where you often don't achieve the same level of immunogenicity, but we believe our platform does well.

Yeah, maybe just to others, just because I have a chance to speak with a couple of estimates sales across the world in the last week or two.

And I think people are very clear.

Risk is at all that it is very manageable as Paul safe and its way in the mail 18 to 24.

And doors has many styles with a cap of going back to the risk profile us directors metro that care about having to go with that.

Stephen Hoge: There are other endpoints as well in terms of seroprotection defined as absolute titers; again, greater than 40 is accepted. We will look how high that goes because that can also be reassuring, but I don't think right now we're ready to guide on a specific target that we will declare a success, other than looking again at that fourfold rise for measuring seroconversion across the range of ages that we'll be studying in the study.

Films exploding again, and this is driven by the <unk> of faults you have evolve where they know the vaccine as Paul mentioned, we have a data from the US also had so many of the countries that the 12 70 per vaccine seems to be the vaccine and providing the longest protection of efficacy and that's what the camera and so I think people are.

Getting educated Kevin data, they just like to look at the facts and figure out a very practical way of 80 vehicle amies running Covington people or other hospitals and very focused on the the high proportion that's very many countries that we're still not approved in in.

Stephen Hoge: Got it. Thank you. Thank you, Michael. The next question is from Gena Wang from Barclays. Thank you for taking my question.

In the younger population.

Gena Wang: Thank you for taking my questions. I have two regarding the COVID vaccine. The first question is, given the supply restraints, do you see 100 microgram doses being used as 250 microgram doses? And then also any hesitance due to safety concerns? And we did see a few countries put a cautionary action on the Moderna vaccine. And my second question is, in the U.S., if we do the math, you completed delivery of 300 million doses.

They are being already advertised and promoted in the older population. So the people that get posted and I'll get sick and hospitalized discontent.

On the U S government.

Optical math wrong on volume.

He has a private contracts with the government.

But in Vps, some shifts from <unk> to next year of <unk>.

Okay. Thank you.

Next question is from coral reefs Asimow with JP Morgan your line so.

Hey, good morning, guys. Thank you for taking my questions too for me as well. So first of all in terms of 2022, Apa's that you outlined or the $17 billion worth of existing contracts constructed as his firm commitments or do countries have contracts have optionality.

Stephen Hoge: So I can try and take the first question, although I'll invite Paul as well. So, in terms of you referencing some of the more recent communications that have happened from public health officials, for instance, in the Nordics and elsewhere. You know, I would note that those same communications, literally often the same documents, include reference to the fact that there is very strong efficacy for the Moderna COVID-19 vaccine. And in fact, some of those Nordic country communications include reference to the fact that it looks to be potentially greater in terms of protection, as an emphasis for why the vaccine not only is still recommended in many of those jurisdictions but ultimately provides very favorable benefit risk.

Embedded in them wearing countries don't necessarily have to take the full amount depending on the evolution of the pandemic and then my second question is given your comments on the call about potentially moving into the endemic phase by the second half of next year should we think about 2022.

Stephen Hoge: And so we continue to believe that the whole picture of looking at the benefit and quantifying that benefit, which we think is substantial and larger than any risks contemplated here, is really important. And we, again, look to those communications that clearly state that. Paul, anything you would add to that?

Revenue has been weighted towards the first half of the year. Thank you.

Thank you Corey So let me let me take this path.

The apa's due north of options. When we say 17, if you didn't have apa's was out all day, all signed although and auto Ips payment.

Payments, David did a nice job working for the cash upfront square overseeing for those contracts.

Paul Burton: Only Steven that, you know, recently, I think last week, the WHO gave updated guidance, continuing to endorse the vaccines and mRNA-1273. And I think as they are doing their analyses of these data sets, they have said that they need to think about potential biases that occur in general practice, looking at the primary vaccination schedule and the difference in timing. We know that vaccines are used differently sometimes, and that may account for this, but I think there is clear standing behind the data. Steven?

It's one of a way that we are on the casino business, but we want people to be very committed and whoever material.

Upfront.

The total value of a deal when design.

The options component that we talked to rise up to <unk> as of two they're both actual options many people at our resolve incapacity.

And sometimes for financing rhythm because again as I said, we do not do Apa's revolt upfront.

And one of the Best example, that so the Republican Kovacs.

To do a quarterly option, we've kovach, so as I said it just exercised at Q2 option.

Stephen Hoge: Yeah, I mean, just as a closing comment, I would just reference that we have entered some of these markets into a very interesting phase of the pandemic, right, which is that we are in the lower risk population, and we are providing vaccination to them as appropriate. But, you know, as we do that, if, you know, we're looking at benefit risk in the most cautious and increasingly cautious ways, and that's appropriate.

At the end of Q free.

But Q free 20th allergic to went through false migrated to go back a few options and it's mostly because of a funding issue. They don't have a cash they get cash from value from from barrels, which almost be go on us and foundation on the cover.

Month to month basis.

And so we did that two heads kovach's into Google right think to help a planet.

As we don't tactical options, we say if you want the vaccine revenue sign a contract and you pay on a pole.

Stephen Hoge: But as we look forward to next year, and we start thinking about boosting, and in particular, the seasonal market for protecting those at our highest risk, I think that calculus obviously changes pretty dramatically. And so I think we are in a period of time when we are, again, looking at the lowest-risk populations.

But we've kovacs, we've got to do so we put it towards the right thing to do.

And so we expect ebay won't be free volume that in queue under Whillikers as we options. Although we end of Q for both of the options.

We'll go to active.

On the.

Stephane Bancel: And I think that is a transient period of time, ultimately, because it is high-risk populations that are of greatest concern looking forward from 2022. Yeah, maybe just to add some color, I've had the chance to speak with a couple of health ministers across the world in the last week or two. And I think people are very clear that the risk is low, that it's very manageable, as Paul said, and it's right in the mail 18 to 24.

And the.

The ventilation of a sales of over a year I think it would be dangerous to assume at this stage one way all nowhere income over first off I am so going out because of volume and also pricing as.

As you get the science the Kovach's.

For Kenyan young and somebody at the only things, we have lower prices and they didn't mention that to your pricing and so they might be.

A large volume, but the price might be way lower than what the commercial market could drive, which we believe he's going to be about what has been the pandemic price again because of the volume and so we must not people stocking.

Stephane Bancel: And those health ministers, what they care about, going back to the risk profile, as Stephen just mentioned, they care about having a winter where they don't have hospitals exploding. And this is driven by the 50 and above, the 40 and above, where they know the vaccine, as Paul mentioned, with data from the US or Switzerland or many other countries, that the 12th century vaccine seems to be the vaccine providing the longest protection of efficacy. And that's what they care about.

Ahead of when they need to injecting pharmacies.

I would be caution that assuming <unk> is a bit too early.

Okay. Thank you that's helpful.

At your car.

The next question is from Jeff Mission from Bank of America. Your line is open.

Hey, guys.

So much for taking my question.

I just had one more than the flu program maybe for for Steven It's highly likely that you will see an increase in antibody titers.

I was just thinking for the combo study, though was 12 73, what other factors do.

Stephane Bancel: And so I think that people are getting educated and looking at the data. They just like to look at the facts and figure out, in a very practical way, how do they keep their economies running, how do they keep people out of hospitals, and very focused on the high population.

Do you need to address to Derisks that study I'm, just I guess I'm trying to determine how to optimize the regimen by things like those titration or even selecting.

Selecting the population by more urgent need for the Covid booster side of things.

Stephane Bancel: As you know, in many countries, the boosters are not approved for the younger population, whereas they are being really advertised and promoted for the older population so that people get boosted and don't get sick and hospitalized. On the U.S. government, Gena, we don't comment on volume because it is a private contract with the government.

<unk>.

Thank you for the question, it's a great. One so we're going to be looking at in the combinations are actually the things that you just wanted to.

And so in particular.

We do believe the the most of the value of respiratory vaccination in the near term boosting will be an older adults.

Stephane Bancel: But indeed, there are some shifts from Q4 to next year for Q1 and Q2. OK, thank you. The next question is from Corey Casimo with JP Morgan. Hey, good morning, guys. Thank you for taking my questions. Two for me as well.

Plus or 60, plus depending upon how you want to look at it very similar to the RSV population certainly for the flu population recommendations globally, and we think COVID-19 moves that direction as well and so as we look to the first part of the question, where do we where do we intend to optimize that ratio immunogenicity. It really is towards those higher risk populations that.

Corey Casimo: So first of all, in terms of the 2022 APAs that you outlined, are the $17 billion worth of existing contracts constructed as firm commitments? Or do countries have the contracts have optionality embedded in them, wherein countries don't necessarily have to take the full amount depending on the evolution of the pandemic? And then my second question is, given your comments on the call about potentially moving into the endemic phase by the second half of next year, should we think about 2022 revenue as being weighted towards the first half of the year? Thank you. Thank you, Corey. So, let me let me take this apart. The APAs do not have many options.

Do need we think a respiratory booster every year.

When it comes to looking at the what are the what are the combination of things that we're going to be doing in selecting that ratio and dose obviously, it's mostly going to be immunogenicity and the tolerability profile.

Fortunately these vaccines have been very safe to date in these older adult populations and none of the concerns that we're having about my part of it is really exist in the $50 $60 populations.

And so we feel very confident on the overall safety profile, but the question will be where are we in optimizing the immunogenicity against endpoints that are pretty well valeted now in Covid and where are we against the Immunogenicity against then points that are also broadly accepted influenza we will be doing this for a range of different.

Stephane Bancel: When we say 17 billion APAs, those are firm orders, signed orders, and all our APAs have upfront payments. Now David did a nice job walking you through the cash upfront we are receiving for those contracts. It's one of the ways that we are conducting our business. We want people to be very committed and to have a material amount of the total value of a deal when they sign.

Four strained seasonal strained vaccine and so.

Will want to make sure there's no interference between those in that we're able to achieve strong balance immunity across the four flu strains plus the COVID-19 vaccine.

Stephane Bancel: The option component that we characterize as up to $3 billion as of today, those are true options, meaning people are reserving capacity, and sometimes it's for financing reasons because, again, as I said, we do not do APAs without upfront. And one of the best examples that's totally public is COVAX. We've had to do a quarterly option with COVAX. As I said, they just exercised their Q2 option at the end of Q3.

I think.

We have approximate targets based on the Immunogenicity results in phase III and Immunogenicity, we're seeing in the booster studies, but the open question is are we going to need all of that for the COVID-19 portion of our vaccine going forward.

And so we will continue to fall over time, whether we see more durable protection and therefore, you might be able to optimize further that goes if there was a reason to do so.

Stephane Bancel: But Q3 2022 and Q4 2022, COVAX is still an option. And it's mostly because of a funding issue; they don't have the cash, they get cash from very different funders, which are mostly government and foundation on the kind of a month to month basis.

And then the second part is with the seasonal annual flu component, we just want to understand particularly in the older adult population, where flu vaccines have had less.

Less clear efficacy every season is maybe a way I'll say it.

And there is an opportunity for improvement by raising those titers, we're going to want to look too whether or not we need to get those titers above that would've been achieved by others and I'll note that there is a precedent even for high dose flu vaccines in that market that have been differentiate on price and grabbing market share and so it could cause us to looking at 60, plus or 50 plus population it at re.

Stephane Bancel: And so we did that to help COVAX and to do the right thing to help the planet. As you know, we don't have to do options; we say if you want the vaccine, when you sign a contract, and you pay upfront, but with COVAX, we have to do so. We thought it was the right thing to do. And so we expect that if they want their Q3 volume, that in Q1 they will exercise the options, or, sorry, at the end of Q4 they will exercise the options, and I think it will go like this.

Really indexing more to those flu antigens and making sure that we.

Exceed or at least achieve that similar hydrea seroconversion. There. So those are the factors that will look at around the 10 73 program that we've announced we're looking at a range of ratios fortunate. We have we're going to a experienced we already have experienced and flew in cogan from our prior work.

And it will be a demonstration we hope of the ability to combine vaccines I will note as a final comment we have done combination respiratory vaccines in the past, including in adults with a 16 53 program and so we do have.

Stephane Bancel: On the endemic and the ventilation of sales over the year, I think it would be dangerous to assume, at this stage, one way or another, in terms of first half and second half, because of volume and also price. As you get a sense, COVAX, the African Union, and some bilateral deals we have are at lower prices, and David mentioned that. And so there might be a large volume, but the price might be way lower than what the commercial market could drive, which we believe is going to be above what has been the pandemic price, again because of volume.

Basis for beginning to think about how we might combine those antigens going forward, but ultimately will let that the 10 73 study in the early clinical experiences there'll be confirmatory around this.

Great. Thank you very much.

We have a question from Joseph Stringer from you than your line is open.

Hi, good morning, Thanks for taking our questions to for months just curious on the.

The guidance for the 2 billion guidance for the U S fall 2022.

Stephane Bancel: And so we've also seen people stocking ahead of when they need to inject in pharmacies. I would be cautioned that assuming Q1 is going to be lower than Q2 is a bit too early. Okay, thank you. That's helpful. Thank you, Cora. The next question is from Geoff Meacham from Bank of America. Your line is open.

Booster market can you help us understand what what.

Assumptions are sort of built into that that number is that does that based on sort of your internal expectations around.

Geoffrey Christopher Meacham: One more on the flu program, Abe. Optimizer. Thank you for the question there. It's a great one.

A relative percentage of of individuals that would.

Fully vaccinated individuals that would get a booster works.

Stephen Hoge: So what we're going to be looking at in the combinations are actually the things that you just pointed out. And so in particular, you know, we do believe the most value of respiratory vaccination in the near term boosting will be in older adults, you know, 50 plus or 60 plus, depending upon how you want to look at it. Very similar to the RSV population, certainly for the flu population recommendations globally.

Just trying to handicap, what what the variance could be Ah.

Around that and then.

C M D.

Can you give us a sense for the relative timelines for enrollment of that please through trial and when we could see the initial data from that thank you.

So on the fall of 20 to solve a professional team I spent quite a lot of time in the modeling the front assumption itself volume of people would also boost.

Market share and of course pricing.

Stephen Hoge: And we think COVID moves that direction as well. And so as we look to the first part of the question, where do we intend to optimize that ratio and immunogenicity? It really is towards those higher risk populations that do need, we think, a respiratory booster every year. When it comes to looking at the whole picture, what are the what are the combination of things that we're going to be doing in selecting that ratio and dose?

I cannot comment further for competitive Arizona right now is to Sheldon price increase but wound with that in Utah, but indeed, I mean, typically commercial and that it is the team that first on the many times before in over companies around for the last few months.

Great and on the enrollment of CMV. Thank you for the question so where the.

The answer it from our target perspective as fast as we can because we ultimately think there's just such a huge unmet need here and we're excited too.

Stephen Hoge: Obviously, it's mostly going to be immunogenicity and the tolerability profile. Fortunately, these vaccines have been very safe to date in these older adult populations. And none of the concerns that we're having about myocarditis really exist in the 50 plus 60 plus populations. And so we feel very confident about the overall safety profile.

Get this study going there are some caveat that I should put around that which is it probably won't be as fast as we did COVID-19, which was obviously in a couple of months.

Because we are we are targeting a population at high risk of of disease. In in this case, we're looking for women women of childbearing age who are exposed to serve conversion of covenant.

Stephen Hoge: But the question will be, where are we in optimizing the immunogenicity against endpoints that are pretty well valid now in COVID? And where are we against the immunogenicity against endpoints that are also broadly accepted in influenza? We will be doing this for a range of different, you know, it's a four-strain seasonal flu vaccine. And so we'll want to make sure there's no interference between those and that we're able to achieve a strong balance of immunity across the four flu strains plus the COVID vaccine.

Start with CMV and that is often those that are exposed to children because that's the primary vector for those infections.

And so we want to make sure that we get the right population and that matters. Because this is a case driven study as we're kind of familiar with based on Kobe 19 at the number of cases that we achieve that will ultimately dictate those interim analyses that we're looking for in the time ahead.

And so it makes sense to try and enrich for the at risk population. So you might see a slower enrollment curve or it might go really fast we're going to work as hard as we can go really fast, but the most important thing is that we need to be enrolling those that are at highest risk because we think that will ultimately generate the cases that accelerates the interim readout.

Stephen Hoge: I think, you know, we have approximate targets based on the immunogenicity we saw from phase three and the immunogenicity we're seeing in the booster studies. But the open question is, are we going to need all of that for the COVID portion of our vaccine going forward? And so we'll continue to follow over time whether we see more durable protection, and therefore, you might be able to optimize that dose further if there is a reason to do so.

Because it is an interim read out this driven on cases I can't predict when that will happen. What I can do is I can try and enrich for those cases no way I just described.

Great. Thanks, So general questions.

Next question is from among the top of that he's from the whole shebang.

Amount of milk I with that Construe 90, Susan.

Stephen Hoge: And then the second part is with the seasonal annual flu component. We just want to understand, particularly in the older adult population, where flu vaccines have had less, you know, less clear efficacy every season is maybe a way I'll say it. And there is an opportunity for improvement by raising those titers. We're going to want to look at whether or not we need to get those titers above what would have been achieved by others.

We can go to the next question operated.

Okay and next is from many for new Huh.

Your line is open.

Hey, guys. Thanks for taking my question.

A couple of quick ones can you give us a sense of.

When we might see is any the.

The impact of pricing shifts to increase deliveries to low and middle income countries with Stefan mentioned is that something that we can start to see a little bit of early next year that more of a <unk> phenomenon in terms of the budgetary timing so quarterly contract with Stefan talked about Uhm secondarily I have a few small <unk>.

Stephen Hoge: And I'll note that there is precedent even for high-dose flu vaccines in that market that have been differentiated on price and grabbed market share. And so it could cause us to look at the 60 plus or 50 plus population at really indexing more to those flu antigens and making sure that we exceed or at least achieve that similar high degree of zero conversion there. So those are the factors that we'll look at in the 1073 program that we've announced. We're looking at a range of ratios.

That question, though the numbers you on slide 15 to $6 7 billion in deposits that was really all for Apa's for 21, or 22 or to some of that apply to <unk>.

Joseph Springer: Fortunately, we're going to have experience. We already have experience with flu and COVID from our prior work, and it will be a demonstration, we hope, of the ability to combine vaccines. I will note as a final comment that we have done combination respiratory vaccines in the past, including in adults with the 1653 program. And so we do have a basis for beginning to think about how we might combine those antigens going forward. But ultimately, we'll let the 1073 study and the early clinical experiences there be confirmatory around. We have a question from Joseph Springer from Leedham, your line.

I'm sorry for contracts for 2023.

Thirdly, you you're Catholic guys, a little lower than it was last year with that is that 50 to 150 million that you took out of that that absolute savings or that just gonna get pushed into next year as some of the contract revenues, where and then finally, a little more substantive up a question.

How how <unk> how much.

Perspective can you give us an you are able to potentially compete for sure contracting and you the competitor Pfizer me onto his locked in pretty large contracts on volume for the next two years music, there's an opportunity for guys to start capturing more share the transfer relevant to the E U and laugh.

Jacqueline Miller: Hi, good morning. Thanks for taking our questions. Two from us are curious about the guidance for the 2 billion guidance for the US fall 2022 booster market. Can you help us understand what assumptions are sort of built into that number? Is that based on sort of your internal expectations around the relative percentage of individuals that would, as a fully vaccinated individual that would get a booster, or just trying to handicap what the variance could be around that? And then for CMV, can you give us a sense for the relative timelines for enrollment in that Phase 3 trial and when we could see the initial data from that? Thank you.

And finally, we talked on the last quarter about potentially access the China market, where you guys are essentially non-existent at this point and you guys mentioned going to V. H. A V can you give us an update on status your bill would be able to access that market discussion of a J D to compete with bounce exposed on sorry for the barrage.

Questions and thanks for taking my questions.

So I'll take a few in a and David.

If you can sure okay. So.

Stephen Hoge: So in the fall of 2022, the commercial team has spent quite a lot of time modeling different assumptions in terms of, you know, the volume of people who want a booster, market share, and, of course, pricing. I cannot comment further for competitive reasons right now, especially on the pricing piece, but we will do that in due time. But indeed, I mean, it's typical commercial analysis that the team that has done that many times before in other companies has run through in the last few months. Great.

We already know actually be could go back to product.

And the African Union would be December I wasn't going to get it in a press release.

Uhm and it's gonna be a big wrapped into into next year all goofy.

Anytime of European share, which was one of your question. So if you look at it as a few things in Europe. If you remember we had the late and slow launch in Europe, because we have no manufacturing capacity in Europe into your record when we started the pandemic we had novel that'd be calling me up there and.

And we went up it up to expel through the survey with market. So long as that came on nine a bit late to have anal with because we have nothing and no one's attitude vis update you know sometime in the summer to just get machines, and and and get the first you're you're ready and so indeed in Europe with a list of shaving we have in the U S.

Joseph Springer: And on the enrollment of CMV, thank you for the question. So the answer from our target perspective is as fast as we can because we ultimately think there's just such a huge unmet need here, and we're excited to get this study going. There are some caveats I should put on that, which is that it probably won't be as fast as we did COVID, which was obviously in a couple of months, because we are targeting a population at high risk of disease.

Except for that but if all Switzerland, Vectra like you sort out here and so as a country get more and more of an understanding <unk>. That's M. Only vaccines off superego. The the oil got back into it ended up in Bosnia almost what he used any more it's my understanding that must be given for kovacs I think we have an interesting.

Joseph Springer: And in this case, we're looking for women of childbearing age who are exposed to seroconversion of COVID-19, sorry, with CMV. And that is often those that are exposed to children, because that's the primary vector for those infected. And so we want to make sure that we get the right population, and that matters because this is case-driven.

Buffy T V code that that goes Shirley no as you'd think you talk to <unk> <unk>.

Helping yourself as you get more and more of a date that for sure we had the better and better understanding that to a million vaccines are not the same.

And so again as we look into why he went with what we already have a contract with Europe with you too.

And we are we are discussing or so we've got feedback on free on the data and what I'm, saying the benefits of them without a vaccine verses.

Stephen Hoge: Great, thanks for taking our questions.

Stephane Bancel: Next question is from Emmanuel Papadakis from Doshi Bank. Your line is open. Emmanuel Pavelakis, your line is open. We can go to the next question operator. Okay, and the next question is from Mani Foroohar from SVB Lyric. Your line is open.

<unk> do you have a one and then the other question is gonna stay in Europe, which is today.

Contract southern at the European level, because this was organized and a great by Europe because of a pandemic. The big question is gonna be out there is wendell countries felt to be buying by themselves.

Because we have to make a gift of.

Mani Foroohar: Hey guys, thanks for taking the questions. A couple quick ones. Can you give us a sense of when we might see, if any, the impact of pricing shifts to increase deliveries to low and middle-income countries that Stephane mentioned? Is that something that you know we're starting to see a little?

Of supply when they set the 21 of those two agreements that might not meet the needs that they have as we understand bits of a different profiles of a vaccine and so I think there's going to be quite interesting to see the the shelf alternative.

Europe, but as soon as we built teams you want but we have no infrastructure in Europe zero, not one with an employee and commercial we have now teams you know in several countries in Europe, and the UK Spaniard policy in Germany.

Mani Foroohar: [inaudible] As I mentioned, going there via JV, can you give us an update on the status of your ability to access that market, and the discussion of a JV to compete with BioNTech's Foson? Sorry for the barrage of questions, and thanks for taking our questions.

Building the <unk> team as we speak so I think that sometimes so has because we get people in the Bronx to be able to get the message.

We already have you done state, though David do you want to take a couple of furniture Shaw.

Yeah. So in terms of the deposit so 6.7 billion, we have in hand, I would just say the preponderance of those deposits for for delivers either in 21 and and 22.

Stephane Bancel: So I'll take a few and David, if you can take the financials, that would be great. So in Q4, we already, you know, actually picked COVAX products and the African Union will be in December, as we communicated in the press release. And there's going to be a big ramp up into next year, obviously, in terms of European share, which was one of your questions. So if you look at it, there are a few things.

There may be some small amounts and twenty-three, but it's it's pretty early in terms of contracting there.

Secondly in terms of count that I think the answer is yes, you can expect as I said, we're gonna see.

Stephane Bancel: First, in Europe, if you remember, we had a late and slow launch in Europe because we had no manufacturing capacity in Europe. If you recall, when we had the pandemic, we had Norwood that we converted, and we were not allowed to export, so we sold it to the US market. So Lomza came online a bit later than Norwood because we had nothing in Lomza until they started, you know, sometime in the summer to just get machines and get the facility ready.

You know a notable increase in her Cup X next year, but but generally in terms of the reduction this year. It's a combination of things moving into the first quarter of next year and also we're running in some cases add or below the estimated you know investment requirements.

Stephane Bancel: And so indeed, in Europe, we have a smaller share than we have in the US. [inaudible] On screen now are suggestions for March 19th for American subscription. And so again, as we look into 2022, we already have a contract with Europe for 2022, and we are also discussing, country by country, the data, and I'm saying the benefit of the Moderna vaccine versus the other one. And then the other question that's going to stay in Europe, which is today: contracts are done at the European level because this was organized and agreed by Europe because of a pandemic.

So it's a combination of those two.

Oh, great and on and on and on potential China J V. I know you guys have mentioned that in the last call I know there's been any progress.

Yeah, So nothing too two announced with it but.

We didn't know about it though if you put in China.

[laughter] alright, thanks for taking the question Uhm I'll, let you guys check on check on a manual.

Okay. Thank you.

There are no forgiveness Tonight at this time I would now like to turn the conference back to Mister Stefan themselves.

Stephane Bancel: The big question that's going to be out there is when will countries start to buy by themselves? Because they have to make guesses of supply when they set up the 21 and 22 agreements that might not meet the needs that they have as they understand better the different profiles of a vaccine.

Well. Thank you very much for joining us and if you have any kind of a question where do we know what to which Levine habits, you have a great day bye.

This concludes today's conference call. Thank you phone 20, you may now disconnect.

Stephane Bancel: And so I think it's going to be quite interesting to see the share of opportunities that we have in Europe. So as we built our teams, you remember, we had no infrastructure in Europe at zero, not one Moderna employee in commercial. Now, we have teams, you know, in several countries in Europe, you know, in the UK, Spain, France, Germany, building the Italian team as we speak.

[music].

Stephane Bancel: So I think that's one of the things that will also help because we'll get feet on the ground to be able to get the message that we are well-evidenced data. David, do you want to take a couple of financial questions? Yeah, so in terms of the deposit, I would just say the preponderance of those deposits are for deliveries either in 2021 or in 2022. There may be some small amounts in 2023, but it's pretty early in terms of contracting there.

Stephane Bancel: Secondly, in terms of CapEx, I think the answer is yes, you can expect, as I said, we're going to see, you know, a notable increase in our CapEx next year. But generally, in terms of the reduction this year, it's a combination of things moving into the first quarter of next year. And also, we're running, in some cases, at or below the estimated investment requirements. So it's a combination of those two.

Jacqueline Miller: Great, and on potential Chinese JVs.

Stephane Bancel: Potential Chinese JV. I know you guys mentioned that in the last call. I don't know if there's been any progress. Yes, so nothing to announce today, but... We do know about other people in China. Great, thanks for taking the questions. I'll let you guys check on them. Thank you. There are no further questions at this time. I would now like to turn the call office back to Mr. Stephane Bancel.

Stephane Bancel: Well, thank you very much everybody for joining us, and if you have any further questions, well, you know when to reach Lavina and the team. Have a great day. Bye. This concludes today's conference call. Thank you for joining us.

Operator: [inaudible] ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ???

Q3 2021 Moderna Inc Earnings Call

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