Welcome to the Sanofi's Third Quarter 2021 earnings call. I would now like to turn the call over to Eva Schaefer-Jansen, Head of Sanofi Investor Relations. Please go-ahead Eva..

Good morning, good afternoon and good evening to everyone. Thank you for joining us to review Sanofi's 2021 third quarter results, followed by a Q&A session. As usual, you can find the slides to these earnings call on the Investors page of our website at sanofi.com.

Moving to slide 2, I would like to remind you that information presented in this call contain forward-looking statements that involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially.

I refer you to our Form 20-F document on file with the SEC and also our Document d'Enregistrement Universal for a description of these risk factors. With that, please advance to Slide 3.

Our speakers on the call today are Paul Hudson, Chief Executive Officer; John Reed, Global Head of R&D; the Global Business Unit Heads Bill Sibold, Thomas Triomphe, Olivier Charmeil, and Julie Van Ongevalle; and Jean-Baptiste de Chatillon, Chief Financial Officer. For the Q&A, you have two options to participate.

Option 1, click the raise hand icon at the bottom of your screen or option 2, submit your question by clicking the Q&A icon at the bottom of the screen. With that, I'd like to turn the call over to Paul..

Thank you, Eva and thanks to everyone for joining our call today. We are truly excited about the outstanding results in the third quarter. The strong performance of our businesses exceeded expectations with double-digit growth with on top line and bottom line up 10% and 19% respectively.

Just about two years into executing on our fleet to win strategy, the strong set of third quarter results marks another proof point of our focus on growth. And puts us on a clear trajectory to deliver on our midterm financial targets. Dupixent was again the number one driver with a 55% increase in sales. Growth came from the U.S.

and increasingly from global markets as the rollout of this uniquely successful medicine continues across additional geographies, younger patient populations, and new indications. In the recent months, we've reported on 3 positive Phase 3 readouts in prurigo nodularis, eosinophilic esophagitis and in atopic dermatitis patients as young as 6 months.

It's truly outstanding and speaks volumes about the game changing quality of this medicine and the hard work done by all the teams. Bill will tell you more about how we're working on accelerating clinical milestones in our pursuit of the greater than 10 billion cells ambition for Dupixent (ph.).

In vaccines, we delivered record fee sales of the quarter, reaching 2.4 billion euros, an increase of 17%. One key to success is our differentiated offering, which demonstrate our leadership in flu and our continuous efforts to improve the standard of care.

In the quarter, 2/3 of our global flu sales were generated by our differentiated high-dose flu brands, impressively reflecting their value for better protection which is also recognized by payers and providers.

So, in conclusion, these results give us confidence in our growth outlook for the remainder of the year, allowing us to gain raise our full-year guidance to around 14% on business earnings per share. Moving on to Slide 5, let me turn to our targeted M&A activities in the quarter.

In line with our existing M&A priorities, we announced 2 bolts on acquisitions which strengthen synergies growth areas. Both are a perfect fit with our strategic priorities as outlined at our Capital Markets Day in December 2019. Our deals have followed the same objective. Adding exciting science and first-in class technologies to our pipeline.

We're looking for growth opportunities in areas where we have existing capabilities and where incremental cost to succeed with commercialization are low and hence, accretion can be reached quickly.

Starting on the left, our collaboration we translate buyer wants always focused on the development of next-generation vaccines and to leverage TBIO's expertise in messenger RNA technology.

Then in June of last year, well before any COVID MRNA vaccines were fully validated, we saw the opportunity to gain full access to TBIO's targets, assets, and tech transfer. The acquisition provides us with a fully-owned platform, an important pillar in building our center of excellence in MRNA.

We're now moving full speed ahead with the first positive clinical data in COVID in hand already, we're committed to have the first modified quadrivalent flu MRNA vaccine enter the clinic in 2022, and to deliver a pipeline of at least 5 other clinical candidates by 2025.

Thomas and the team will talk more about this at our upcoming vaccines day on December the 1st. Last month, we also announced our intention to acquire Kadmon. This will bring a recently FDA approved and launched transplant medicine to Sanofi.

This first-in-class science which addresses a high-end met medical need of global scale and existing expertise in transplant will allow us to fully unlock the potential of this attractive asset. Olivier will provide additional details about the significant growth opportunity in just a moment.

We were absolutely delighted to find Rezurock fitting into our transplant portfolio and we remain focused on delivering on our commitments, considering capital allocation priorities as outlined in Capital Markets Day in 2019. And now, hand over to John, our Global Head of R&D, to give us a quick update on our pipeline. John..

Thanks, Paul. As indicated on the left side of slide number 6, we continue to deliver strong progress on pipeline execution despite the ongoing pandemic environment and made advances with a number of important late-stage clinical studies.

Five positive pivotal readouts were reported for our pipeline over the last 3 months, including 4 additional indications for Dupixent, 3 in dermatology, and now showing clear benefits in the gastroenterology disease.

Our anti - PD1 medicine, Libtayo, also delivered a competitive Phase 3 performance in front line non -small cell lung cancer in combination with chemotherapy.

A small Phase 3 study of our reversible covalent BTK inhibitor known as Rilzabrutinib fail to meet the target endpoint in Pemphigus vulgaris likely due to impart to effects of background medications in the placebo arm, but we will share encouraging Phase 2 data for the ITP indication at a major medical congress later this year and we also expect a publication sharing the details of our ITP data in the near future.

With regards to recent approvals, we're proud to have launched [Indiscernible] in the U.S. and Japan, establishing a new standard of care for patients living with Pompe disease.

On the right side of slide number 6, I draw your attention to some of our upcoming milestones over the next 6 to 9 months, including submissions to bring benefits to infants, namely Dupixent an infant atopic dermatitis, and Nirsevimab, the potential first all infant protection against RSV, respiratory syncytial virus.

Pivotal trial readouts expected in the next few months include the much anticipated recombinant COVID-19 vaccine and AMEERA-3 for amcenestrant in second-line and third-line breast cancer. The amcenestrant trial is event-driven, now expected to occur end of Q4 or in Q1 based on the latest update on projected event rates.

As of now, approximately 90% of the required number of events have accumulated, suggesting that we will have data soon.

Also, in oncology, the event-driven Imroz trial, which investigates Sarclisa in newly diagnosed transplant in eligible myeloma patients combined with Revlimid, Velcade, and dexamethasone, is expected to read out in the first half of 2022.

Initial data for frontline myeloma patients who are eligible for transplant will be shared at a major hematology congress later this year. In hemophilia, FNS Oktika Galpha (ph.), our long-acting factorate therapy, with the potential to transform replacement therapy for people living with hemophilia A, is expected to read out in Q1.

With regards to Fitusiran, our first-in-class SIRNA targeting anti - thrombin 3 that rebalances the deficient coagulation cascade with a convenient subcutaneous small volume injection delivered once monthly or even every other month, we will share data later this year at an upcoming medical congress for patients treated for nine months with the original 80 milligram dose on a monthly schedule.

Seeking to optimize the coagulation rebalancing effects of Fitusiran, a lower dose has been recently introduced into the protocol and we will continue to collect data to provide longer efficacy and safety follow-up data for patients with hemophilia A and B with or without inhibitors.

Conversations with health authorities continue about the registration requirements, but altogether, timelines have likely shifted by around 18 months. Now, moving to slide 7.

If you attended our R&D day last year, EUROAPI described Sanofi as an immunology Company with strong core competencies and immune -science that stretch into multiple therapeutic areas, including autoimmune and inflammation, immuno -oncology, and hematology.

Today, I would like to provide some insights into our work in neuro -immunology with that based on 2 molecules. First, tolebrutinib, the brain penetrates BTK inhibitor, which is expected to be disease modifying for multiple sclerosis and potentially other neuro -inflammatory diseases.

We initiated 4 Phase III trials for tolebrutinib immediately following achieving proof-of-concept. I'm delighted to say that despite the pandemic, patient enrollment in this program is progressing well. Earlier this month, we presented encouraging data at ECTRIMS from the Phase II long term extension program.

Those data demonstrated a low annualized relapse rate over the 48-week treatment period, with 98% of patients remaining in the study. These data indicate that Tolebrutinib has a potential to slow disability accumulation and thus bring renewed hope to the people suffering with difficult to treat MS.

Unlike other non-brain penetrate BTK inhibitors, Tolebrutinib has 2 mechanisms. Number 1, inhibiting B-cells in the periphery and in the brain. And number 2, inhibiting inflammatory microglial cells inside the brain which sets total Tolebrutinib apart from all other BTK inhibitors.

Our scientists are continuing to build the body of data showing the impact of Tolebrutinib on human microglia, which supports the thesis that brain penetrant, Tolebrutinib, modulates neuroinflammatory processes directly within the central nervous system.

A second example of Sanofi's emerging strengths in neuro -inflammation is found in SAR'820, a brain penetrant RIP kinase inhibitor, which targets necroptotic cell death, cytokine release, and inflammatory pathways. Besides exploring its potential activity in progressive MS, this molecule has recently received U.S.

fast-track designation for the treatment of ALS. A Phase 2 study is set to start early next year. With that, I hand over to Bill Sibold, Sanofi's biggest fan of medicine is tackling neuro inflammation, following his experience developing and launching our MS franchise.

Bill?.

Thank you, John. Indeed, it is exciting for me personally to see the progress we are making towards practice changing new medicines for MS, ALS and other neurological disorders. Continuing with the theme of translating excellence in immunoscience into transformative medicines, I'll start with an update on Dupixent on slide number 8.

Dupixent, our mega brand, delivered an excellent quarter with worldwide growth of 55% and added EUR500 million in sales compared to the same quarter last year. As Paul mentioned earlier, Dupixent strong performance in the U.S.

was further accelerated by impressive sales growth across other geographies, where we continue to expand in our new country markets and younger age groups. In the third quarter, 25% of sales came from markets outside the U.S. supported by the strong contribution from growth around the globe.

Dupixent sales nearly tripled over the period of the last 2 years when compared with the third quarter of 2019. Annualizing at close to EUR6 billion and well on its trajectory to achieve our greater than EUR10 billion peak sales ambition. Dupixent, reached for the first time the EUR1 billion sales milestone in a single quarter in the U.S.

At the same time, in office visit remained below pre COVID levels, but are now steadily recovering. While we are executing on the tremendous commercial potential of Dupixent across approved indications and geographies, we remain focused on delivering milestones for future growth, which I will explain in more detail on my next slide.

Moving to slide 9, I want to highlight a number of important achievements since Q2. We have consistently delivered on multiple milestones for growth even during the challenging times of the of the pandemic.

In atopic dermatitis, we have recently announced positive pivotal phase 3 results in 6 month - to 5-year - old after a 10-month trial acceleration and we are about to unlock growth beyond the adult population in China following the swift approval of AD in adolescents.

In asthma, our second core indication, we continue to emphasize our strong safety and efficacy profile by receiving approval of the pediatric indication in asthma.

Encouraged by the recent positive data readouts in CSU, POE and PN, we're optimistic that Dupixent has the potential to become a new treatment option for patients suffering from the burden of these debilitating and undeserved diseases.

In 2022, we will continue to execute on the robust clinical development program and our agenda of planned submissions in multiple adjacent type two indications, all of which are expected to become future growth drivers. As a reminder, the indications mentioned on the slide combined have the potential to address a population of almost 0.5 million U.S.

patients, further adding to the greater than 3 million patients already addressable today. Advancing to slide 10 and turning to the other Specialty Care franchises, we saw good business momentum in the quarter.

In rare diseases, our Pompe franchise grew double-digit in the period with strong performance across all geographies, primarily driven by patient accruals. In August, we launched Nexviazyme in the U.S. and we are now working on establishing Nexviazyme as the next standard of care for the treatment of Pompe disease in global markets.

Nexviazyme was also approved in Japan in September. Strong growth of Kevzara was mainly driven by the inclusion of the interleukin-6 receptor blockers in the updated July WHO guidelines for the treatment of patients with severe or critical COVID-19.

Kevzara is not approved or authorized for emergency use for the treatment COVID-19 anywhere in the world and we will continue to prioritize access for indicated patients with rheumatoid arthritis. As a result of the continued increase in worldwide demand for IL-6 receptor blockers, suppliers expected to be constrained until early 2022.

The uptake of our new oncology portfolio is progressing well with the launches of Sarclisa and Libtayo. For Sarclisa, we saw a strong performance, particularly in Japan, France, and Germany.

The highlight of the quarter was the presentation of the Phase 3 trial of Libtayo combination data in patients with first-line advanced non-small cell lung cancer with a submission plan for later this year.

Where blood disorder grew 7% when excluding the industrial supply sales of hemophilia products to Sobi, strong sales growth of Cablivi from new country launches in Europe was the key driver for the franchise in the quarter. With that, I hand over to Thomas to update you on the vaccines business..

Thank you, Bill. In the third quarter, vaccines reached a new record with EUR2.4 billion in sales, the highest quarterly sales in our history. This strong Q3 performance was largely driven by our influenza franchise. In the U.S.

thanks to our newly licensed facility producing [Indiscernible] [Indiscernible] we were able to ship larger quantities in a record time. Europe grew 88% due to successful influenza expansion, many resulting from sticker recommendation in Germany.

Influenza is also recognized by the European Center for Disease Prevention and Control, as superior to standout influenza vaccine. Let me associate good news regarding Nirsevimab. Our investigational long-acting antibody under development with AstraZeneca, which is designed to protect all infants for the first RSV season with one single-dose.

During the Idea Week Congress, we presented the positive results of the middle trial. In this pivotal phase 3 study, a single dose of Nirsevimab showed a 74.5% reduction in lower respiratory tract infections caused by RSV and requiring medical care in healthy infants.

The safety profile of Nirsevimab was favorable and similar to placebo in these infants. We will show more data on the safety results of the Melody study for which we already announced similar safety and tolerability compared to [Indiscernible] at the ResViNet conference in November. So, stay tuned for more exciting data on Nirsevimab.

Moving on to Slide 12, it's important to remember that evidence accumulated over 10 years, as demonstrated year after year, that Flu zone (ph.) High dose Efluelda provides protection beyond flu. Which means protection against cardiovascular events, as well as protection against pneumonia hospitalization.

This extensive body of evidence is clearly the driver of our flu franchise success. In Q3, our differentiated flu sales amount to close to EUR900 million and represent 2/3 of the total franchise sales when it was less than EUR400 million just 2 years ago. This quarter, we launched a new DTC campaign in the U.S.

to communicate the unique benefits of Flu zone High-Dose. And we're very glad to see that further as GAAP partners recognizes the [Indiscernible] of this product as illustrated by the Walgreens Communication on the right side of the slide.

To conclude with flu, we recently announced our [Indiscernible] Melanie quadrivalent flu vaccine in the clinic in 2022. For this new program, the benchmark in terms of clinical benefit for the elderly is Flu zone High Dose, as it is becoming the standard of care for seniors.

Simply demonstrating immunogenicity versus [Indiscernible] vaccine will not be sufficient in this fast-evolving market. Let's now look at Slide 13 and talk about Sanofi COVID-19 vaccine program developed with the adjuvant of our partner GSK.

The upper part of this slide describes the ongoing Phase III safety and efficacy study conducted over 4 continents. Now that the enrollment stage of Stage 1 part of this study, testing a 10-microgram dose of the parent strain is about to complete. We do expect to have our efficacy readout by year-end, when we have accrued a sufficient number of cases.

In parallel, the enrollment of Stage 2 of the study, testing of Biovail and formulation of 5 microgram parent strain and 5 microgram beta strain has started this month. Let's now turn on the booster study at the lower part of the slide.

It will assess the immune response in adults previously immunized with the vaccine using either MRNA, protein, or adinovictor (ph.) technologies. The first arm of the study is testing a 5-microgram dose parent strain.

And we do expect that that will also be available by year-end as previously mentioned, our aspiration is to develop a practical universal booster vaccine. [Indiscernible] normal refrigeration temperature and agnostic to which vaccine technology was previously used in the primary series. With that, I now hand over to Olivier..

Thank you, Thomas. Moving to General Medicine on Slide 14, we are very pleased with our performance in the third quarter. The execution of our strategy continues to deliver and to focus on our core assets as generated consistently positive results in recent quarters.

General Medicine sales reached EUR 3.6 billion with our core asset of 5%, supported by the solid performance of cardiovascular and diabetes brands in our portfolio.

We saw demand-driven strong double-digit growth of Toujeo and SOLIQUA across most geographies in the quarter, while Plavix growth of 6% was mainly due to higher volumes in China, where the products included in the GDP program are ready for the second year.

[Indiscernible] sales increased strongly, mainly as a result of the performance in Europe and due to the ongoing launch in China. When you exclude the effect of [Indiscernible] sale to Regeneron in the U.S., which ended beginning of 2021, the brand grew 64% in the quarter.

Lovenox, our largest co-assets by sales grew 4% and continued to benefit from inclusion in WHO guidelines for the treatment of hospitalized severe COVID-19 patients. As a lightened last quarter, gross of Lovenox started to slow in the period due to the high base of comparison in the third quarter of 2020.

We expect sales will slightly decrease during the remainder of the year. Sales of non-core assets of the general medicine business, we are lower in the quarter. In line with expectations is a decline of 6% reflected the impact from divesture of products, which are part of our ongoing strategy thought for your streamlining efforts.

We are consequently reducing the number of smaller product families with the objective to drive efficiencies and to increase profitability. I will provide more insights into reducing the complexity of the portfolio in just a minute.

Now, on Slide 15, Paul has already mentioned the compelling strategic fit and strong rationale of the announced Kadmon acquisition. Transplant is a well-established growth area for our general medicine business, driven by expertise in this market and anchored on our core assets Mozobil and Thymoglobulin.

Both brands reported solid growth in the last 9 months, 14% and 16% respectively. The acquisition of Kadmon adds a significant gross of opportunities for us and build on our experience in the transplant arena. Where we intend to further expand our harvest, commercial presence, with a complementary portfolio.

You and I had seen that Kadmon 's key asset consumer was approved by the U.S. FDA only in December. It is a first-in-class treatment for adults and pediatric patients 12 years and older with clinic half versus US disease were failed at least two prior lines of systemic therapy steroids.

As a current standard of care in frontline chronic GVHD treatment scarcely behalf of the patient are estimated to fail on steroid therapy. While later lines of therapy for additional efficacy, adverse events mean patient often fail to tolerate.

Rezurock puts in Sanofi's hand with an established and leading constant expertise, we believe we can get it to mock patient faster. Initial market feedback has been very positive and we anticipate to close a Kadmon deal soon in November, subject to approval by Kadmon stockholders. The expectation is that the deal will be accepted in 2022.

On my slide 16, I want to highlight the progress we are making on our commitment to transform our general medicine business through streamlining the portfolio of established products as well as reducing our geographic footprint and simplifying the go-to-market model.

On our past forward are more resilient, are more profitable general medicine business. We have been steadily reducing the number of non-strategic product families of the recent years, mainly with divestures. These streamlining efforts have resulted in almost EUR1 billion of cash proceeds.

To reduce the complexity of our business, we have already drastically reduced our footprint in non-strategic markets and transferred distribution activities to serve parties, covering already more than 40 countries. We are also making significant progress in advancing in our digital transformation.

Digitalization of healthcare has been accelerated due to the pandemic. We are engaging with doctors and patients who are [Indiscernible] approach, which leverage our increasing capabilities in data, digital, and AI, positioning Sanofi as a preferred partner to HCPs.

More than 60% of our HCP interaction are now supported by digital platform, compared to only 30% in 2019. To conclude, we are making solid progress with implementation of our strategic priorities, which keeps us on track to deliver on our objective. With that, I hand over the call to Julie..

Thank you, Olivier. Following our return to growth last quarter, I'm very glad to report continuous growth in the third quarter. It's a result of good performance from all geographies and almost all categories. These positive results show that the execution of our strategic roadmap is starting to deliver.

I want to specifically highlight that on cutting and embracing complexity, we've been successful in our simplification efforts knowing that out of our 250 plus brands, we have already discontinued the production or announced divestments for 111 brands or 45% of our brands.

We're also continuing our simplification endeavor at many other levels to further increase our focus on our priorities. At the same time, to prioritization of our wellness categories continues to pay off with the digestive wellness brands and [Indiscernible] Buscopan performing very strongly, as well as our magnesium brand and mental wellness.

And in Q3, the good performance of Pain received an additional boost with consumer purchasing dirty plan and IV while getting their COVID-19 vaccination. Lastly, I'm pleased to report that cough and cold is back to growth, although from a low 2020 base.

On our second strategic priority of becoming a true fast-moving consumer healthcare Company, the creation of our standalone is a key business enabler. And I'm happy to report we are progressing as planned, with more than half of the legal entities created as of today, and with the next significant wave expected on January 1st, 2022.

More importantly, we are already seeing great benefits of the progress made to-date, allowing our teams to adapt new processes, policies, and overall ways of working, and as a result, to move faster and be more consumer centric.

We've also been able to successfully reallocate [Indiscernible] investments to our must win brands and countries to accelerate growth. As a conclusion, you might remember that historically our gap versus market growth has been substantial. In 2020, this gap was close to five points.

On a rolling 12 months, we have reduced this gap to less than two points. And I'm very happy to share that year-to-date, we divided this gap by four. To less than 0.5 point. With that, I hand it over to our CFO, Jean-Baptiste..

Thank you very much. Thank you, Julie. On slide 18, turning to our Financial Performance, Company sales increased 10.1% in the third quarter, driven by excellent growth of Dupixent, differentiated flu, and consumer health. We said we would be improving on our gross margin. And we are delivering.

Based on the favorable portfolio shifts to Specialty Care products on efficiencies within industrial affairs. This quarter, the vaccine business contributed also strongly to the improvement of more than 200 bps due to partial recovery of the meningitis. vaccine business in the U.S.

We are committed to science on our R&D spend increased during the quarter, driven by advancements of our priority assets. We also continue to add R&D spend from recent acquisitions. In SG&A, spend was driven mainly by commercial investments behind specialty care, growth drivers on flu vaccine, partly offset by continued streamlining of G&A.

Other operating income benefited from net gains from disposal of around EUR130 million versus around EUR60 million last year, contributing to a BOI margin of 34.1% in the quarter. I just think first, this in both years, BOI clearly outgrowth sales.

On slide 19, we have achieved around 2.1 billion of cumulative savings, 2 billion in OpEx as shown on this slide, but also 100 million in COGS. We already achieved our target of 500 million savings in R&D due to prioritization of specialty care on exiting diabetes on cardiovascular.

In addition, permanent efficiencies were generated by consolidating functions across site, improving our trials logistic and reducing cycle time through more gibed governments.

In the same period spending in R&D increased by 500 million behind our priority assets on due to recent acquisitions such as Principia [Indiscernible] [Indiscernible] We have a similar picture on HGNA, where we invested around 1 billion more behind our growth drivers in specialty care on vaccines.

This was partly offset by permanent savings achieved in Gen Med as explained by Olivier as these decomplexifying the business, focusing on key markets, on employing a digitally-enabled go-to-market model.

General and administration across all areas of Sanofi contributed in July 10, 2021, EUR400 million through smart spending initiatives, real estate efficiencies, preferred supplier model on digitalization.

So, we remain, we are on track to achieve our target of EUR2.5 billion savings by 2022, with most of these years on next year savings to be reallocated beyond our growth drivers on key programs in R&D. So, slide 20, we summarize expected dynamics for Q4 of 2021.

So, for Pharma, we expect continued growth from Dupixent, GenMega core assets are expected to grow with Lovenox for coming to stable. Divestures will have a negative effect on established products. The latest round of China DBP will be implemented late Q4 this year on an uncertainty remain around the future mechanism for insulin class inclusion.

For vaccines, we expect Q4 sales to be in line versus last year with flu vaccine sales growth driven by Europe compensated by continued weakness of trouble vaccines on lower U.S. PPM sales following the vaccines loans.

We expect Consumer Health to grow in line with market in Q4 and OpEx will grow, especially with the impact on R&D of TBIO and potentially Kadmon closing. So, on Slide 21, based on the strong results during the first 9 months of this year, we are raising our full-year guidance for 2021 business EPS.

We now expect business EPS to grow around 14% at constant exchange rate. The outlook regarding foreign exchange impact continues to be negative by minus 3.5 to minus 4.5 based on October average exchange rate. And with that, I hand the call back to Paul with an important update on our ESG roadmap..

Well, thanks, J.B. Today we announced our ambition to strengthen our commitment to the planet, with a target to reach carbon neutrality by 2030. This marks a 20-year acceleration versus our previous targets. We're building on great work done across organization that has allowed us to already reduce submissions of our activities by 27% since 2015.

Most importantly, we now introduce our next zero target by 2050. We will take the opportunity of [Indiscernible] 26 to set of common initiatives within the industry. Let's have a quick look at a few key initiatives we're rolling out. We have set the clear ambition of a 100% renewable electricity across our operations by 2030.

We're moving full speed ahead and delighted to highlight that all our sites in France are now entirely powered by renewable activity.

We're taking decisive actions to reduce the environmental footprint of our products and as an industry-leading global manufacturer of hundreds of millions of vaccines every year, we have made recyclable, eco -friendly product packaging a priority with the aim to reduce list of free vaccines by 2027.

We've reached the first milestone with approximately 25% of all flu vaccines packaged in sustainable materials, already this year. The Pharma Industry itself is heavily regulated and they would be easy to hide behind complex supply chains, interactions with the regulators, and regulatory agencies, etc.

But the reality is that climate change is already here so the time for sustainable action is simply now. With that, I think its time to open up for Q&A and I hand back to Eva..

We will now open the call to your questions. As a reminder, we would ask you to limit your questions to 2 each. [Operator Instructions] Your question will be read by our panelists. And now we'll take the first question from Simon Muhtar at [Indiscernible]. Simon..

I was just un -muting my line. Thanks for taking my questions. I got two, please. One on the outlook and secondly on [Indiscernible]. Firstly, you delivered a very strong operational execution once again for the quarter. And if you look at nine months, you've already exceeded your 2022 margin target of 30%.

And this quarter, significantly exceeded your 32% 2025 target.

I'm just wondering, can you help us understand why we shouldn't assume upward pressure to both the near and mid-term targets? Especially considering the previous comments that you've made that Dupixent is going to be margin increase have been 2022, I guess, with that, is there anything specific you'd call out 2022 in terms of pushing calls if need to consider.

And then secondly, on Amira three, does the recent data from Merinies (ph.) Emerald trial increase your level of optimism around the positive outcome. But given the similarities in the 2 trial designs. And can you just say the opportunity to remind us of the key differentiating factors amongst investment versus the competitive part in some,.

Unless it was two questions. But we'll do our best thinking and thank you for taking us off. So, the question of course, some were chucking ahead. What does it mean for now and on would see 2022 in the guidance that we've already given and I think it'd be good if you share your view..

Simon, thank you very much for your kind words about our operational execution. And I think you're perfectly right to think that there's no operational reasons to change that trend.

As there are no reasons to change our -- the way we manage the Company, which is really each time we can why we are respecting the guidance for 2022 [Indiscernible] 2025, we take the opportunity to add to the science, to add to our pipeline. You see what we're doing with [Indiscernible] value we see what we are trying to do with Kadmon.

I mean, all of those operations, we aim to go on each time we have room to do it. It's not about beating expectations on our BOI margin guidance, it's really about reallocating from our cost savings into the science to our element moment evaluation of our pipelines. We're ready, and it's a very simple, and we have not changed since December 19..

[Indiscernible]. We gave you some guidance for 2022, 2025 should look like and to get ahead when credit tend to buy new by accelerating or doubling down on our own science [Indiscernible] It's a great position to be in to be honest.

John read a comment on AMEERA-3 and [Indiscernible] I think you've already said, but then more importantly, the data from I think it was medium radius and what that means..

Simon, thanks for the question. Indeed, the positive result for elacestrant does increase our confidence in AMEERA-3 because the field was really lacking robust data from a CDK4/6 experience patient population and now we have it through those data.

And we'll look forward to the details of the data at the San Antonio Breast Cancer Conference, but that is encouraging for our study.

And even more so, I think, because elacestrant seems to prefer the mutant form of the estrogen receptor and not so active against the wild-type form, whereas our molecule amcenestrant is equally active against both forms.

And, of course, the safety profile is really best-in-class for amcenestrant, whereas the Radius' compound has a history of Grade 3 safety events. We're even more bullish I think after seeing those data..

Thanks, John. Very clear I think for everybody. Maybe we get to the next question..

The next question is from Pete Verdult at Citi..

Yes. Thanks. Pete Verdult of Citi. Two topics that you don't get much air time.

But despite being 50% of sales, consumer, and Gen Med, Julie just following up from your prepared remarks, I mean if you were to characterize Q3, how much of it is just a function of easy comps versus clear evidence of the measures that you've put in place coming through? And I think you've hinted at this, but it sounds to me that you believe the Sanofi Consumer Business can deliver or can get back to industry-leading growth in 2022.

Just wanted to circuit the ties there. And if you could very quickly, just remind us what the timelines are that your work continue for these RX to OTC launches on [Indiscernible]. And then something similar for Olivier again, I noted you prepared remarks but can I just push you on VBP insulin ballpark quantification of the likely impact.

And then on Rezurock, lots of enthusiasm, consensus for Kadmon was about a billion. Is that something that you feel is fair or do you internally, at Sanofi, have higher expectations in terms of the peak sales expectations for Rezurock? Thank you..

Okay. Good. We're really getting into it. Julie, how much of it is favorable comps, I think [Indiscernible] said.

How much of it is just sheer excellence execution, which bodes well for the future?.

First, Pete. Thank you for your question. I think our growth is really coming from 3 sources. Yes, there is an additional boost of COVID vaccination and Pain specifically, but basically representing only 40% over Pain growth. Some categories there's a low base. Some other categories there's a very high base, talking about cough and cold.

And also, as I mentioned earlier, indeed, clearly improved brand activations resulting from increased consumer eccentricities already, which is for me a key component of our strategic roadmap and also guarantee for our future success.

So, when you asked about lots of questions, actually, our future growth and outlook for next year, I mean, our goal is to continue to reduce our GAAP versus market as we also share the Capital Markets Day and I shared earlier, and grow our priority brands through the above-market as early as 2022.

So as early as next year, in key geographies, again, by delivering our strategic priorities, which are -- I mean, we have multiple proof points. And I think you had.

There was another question?.

The RX to OTC switches timeline, just like some of the timelines..

Well, I'll pick that one up before we hand to liberate, but I wanted to jump in because I want to say it's quite extraordinary the transformation that's going on in the consumer business and I feel like it's gaining momentum and it's got strong staying power what's going on. So, I know you paid close attention to that. That's really cool.

Much of it you don't see because saving the numbers at some point. The switches that no much has changed around the middle of the decade, I think because we talked about telephones, around about the same time. One little nugget that I think is we haven't shared yet, is that we've completed one of our self-selection studies successfully.

And it's just the digital piece of fun, we got another one to go before we get talking to the regulators again, but as steps go, we continue to make good progress behind the scenes. And although we have a way to go, of course, we've never said anything other than that. That was a good milestone for us to show that we know how to do these things.

Of course, there's a lot to happen between now and, but we were pleased to get that first. Olivier, so over to on VBP insulin..

So, Peter, thank you for your question. We have said that of course in our plan we had incorporated the insulin VBP impact starting in 2022.

So, although the policy has not yet been fully disclosed, and we probably be released in the course of the month of November and we are expecting the bidding process to start either at the end of November or beginning of December. For an implementation, that is going to start in '22.

So really no surprise, in line with our expectation, I would add that we are very happy with the continued performance of Plavix that shows our ability to grow volume. Not only the first year, remember 91% for Plavix of first-year up to implementation of VBP.

But also, we'll continue to grow on a nice space and we continue to sing especially in the field of diabetes, there's still a lot of potential to grow our volume. With regard to your question with on edge work, we are very excited by Kadmon. We hear very positive anecdotal feedback coming from key opinion leaders.

We are expecting as a closing, to take place for us to stockholder approval beginning of November. We are very much looking forward to be in the field. And when we look to the upcoming years, 2022 is going to be a very exciting year and I can tell you is that we are seeing that in 2020 the Rezurock is going to be elusive.

And we are very much looking forward to enter into 2022 for Rezurock..

Not expecting it to be diluted in 2022..

Thank you..

I will say, and it's with timing that what we've done and we've mentioned few times [Indiscernible] in my comments. But, you've heard me mentioned Capital Markets Day 2019 a few times because we're trying to keep delivering on our commitments and promises even when we're anticipating quite far ahead.

I think we're doing that really brilliantly actually, but Feb 5th was the other landmark versus the consumer. And Gen Med and close immunology have been brought consumer in Gem had can be equally effusive about transformation that's underway in Gen Med.

I think we're just underappreciated what we're going to be able to do on such a large piece of business that you said it's selling how far revenue at the upfront or few questions.

And frankly, the work that's being done and the breakthrough work gives us huge confidence in what we have ahead of us in fueling everything else that we're doing some delight to adapt. So next question..

The next one is from Wimal Kapadia of Bernstein. Wimal..

Oh, great. Thank you very much for taking my questions.

The first guy just asked about the [Indiscernible] Maybe it's a little bit of an unfair question, but typically, when a target that looks highly prevalent across multiple tumor types, you would see several players focused on the target despite the failures that we -- some of the failures that we've seen.

Is this Sanofi being ahead of the competition or is it because of the strength of the molecule? So just curious to hear your thoughts there. And then, just tied to that, how do you think about the potential competition from [Indiscernible] to target, with respect to the [Indiscernible] camp...

[Indiscernible] And then my second question, sorry I pronounce the name, so I'm just going to say BV001.

Just in terms of efficacy, should we expect to see a better clinical outcome versus existing Factor 8 or is duration of usage the most likely key advantage? And then just on commercialization, how should we think about the launch trajectory? That just given the stickiness of patients versus -- to previous factor 8 launches, but now it's been several years.

So maybe there's a little bit more appetite for switches versus the past. So just curious to hear your thoughts there as well. Thank you..

Thanks, Wilmal. Loving it, that we're getting into the pipeline conversation. So, John, maybe to [Indiscernible] that we, ahead of everybody else, and how's it compared to the other mechanisms with similar targets..

Yes, we are that class of targets to CEA Carcinoembryonic Antigen is complex, but fortunately, our scientists really able to focus on a variant, the CKM5 that is very tumor specific in its expression scarcely expressing any normal tissues.

And that really, I think turned out to be the key attribute here of the molecule that's allowed us to succeed where perhaps others have not. So, we're very excited about the current molecule, and I think we've also shared that we want to do more with it and put different payloads on that molecule for different kinds of cancers.

so, we're very eager to generate the date around that.

We will next year have I think 4 Phase 2 studies that will deliver data next year, including in gastric cancer, including a combo study in lung cancer together with Ramucirumab, Cyramza, including data in breast and pancreatic, as well as some data in frontline long together with the PD-1 inhibitor.

So next year will be a rich year for some readouts while we continue to Phase 3 journey with a pivotal study. And in terms of the comparison with Trop-2, we like this better than Trop-2, because according to.

our data, Trop-2 is not as clean in terms of expression in normal tissue versus tumor tissues compared to CKM -5. So, we think our therapeutic index will be superior..

Thanks, John.

Maybe build your comments on efanesoctocog or BIVV001?.

Yeah. Why don't we just call it Efa? That makes it a lot easier for me, I can certainly tell you that. But we're really, really excited about it. And this is not only going to bring longer dosing interval, but a degree of higher protection. And I'll just -- from the September 2020 New England Journal of Medicine publication,.

It was there that it was referenced as a potential new class of factor rate replacement therapy, with a weekly treatment interval that would transform severe Hemophilia A into a mild disease. That's the promise, this is a game changer in Hemophilia and we believe there is no reason that anyone who is on factor isn't on EFA. That's how good it is.

It's going to get people back to a more normal level. So yeah, we're really excited. Now, there has been a lot of change in the market, obviously with different mechanisms coming in which increased the switch rate that slowed down a little bit during COVID 19. We expect though and a lot of the market still remains a factor market.

We're excited about getting out there and really seeing it becoming the leading factor..

Great. Thank you. Thanks, Bill..

The next question is from Geoff Porges at Leerink..

Geoff, we can't hear you..

So, in the meantime, we can take -- Okay. Yes, we can hear you now..

Thanks very much. First of all, I just want to say congratulations on making the commitment on climate change, Paul. I think that's pretty impressive and encouraging. So, a couple of questions. First on Relza, Paul, could you just give us a sense of -- John, sorry.

Could you give us a sense of what you saw in the reels of pemphigus data because you were pretty clear that primary and secondary endpoints were not met but now you've announced additional studies. So is Relza something that we should see a future value driver and contributor or not, could you help us understand that.

And then secondly, on Dupe, you're annualizing at EUR6 billion a year right now, you're growing at better than 50%. It looks like you'll hit the EUR10 billion target in about 18 months if that growth continues. You've got three new indications, you're just getting started around the world.

And yet, the street really is tethered to that EUR10 billion number, Paul.

Are you willing to update it? And why isn't that EUR15 or EUR20 billion?.

Hey, great questions indeed. Thanks for the coming up front about climate change. There's a lot of responsibilities come with this -- with the role that I have. And one of the privileges of being here is that, it’s got a Company that perhaps not well publicized but was doing an incredible amount to -- in the benefit of our contract with society.

We're doubling down a few places, been very excited about that. We will declare some other shared industry perspective of CAP 26, which is not that far away, but we have an absolute responsibility as I said up front to do something. And it's not just for a post about the elevator, it's real work being done by whole organization on a daily basis.

So really proud of the organization. Long way to go, like everybody, long way to go, but really proud..

John, Wills, I think you touched on upfront.

Maybe there was some factors in the placebo arm, with other treatments and things like that but to be candid, we -- how do you feel about how we performed and what the opportunity could be around the corner?.

Yes. Thanks for the question, Jeff. In that study, there was a background glucocorticoid, high levels of those that patients were on in both the placebo and the treatment arm. And then one of the -- it was a complex endpoint but part of it was, how quickly can patients get to lower dose of steroids. And we saw a couple of things.

One was that the response rate in the placebo arm was 3 to 4 times higher than has been seen in any other PVI study. So, evidentially, those high doses of glucocorticoids and the control arm, really interfere with the ability to see the signal. Also, the trial which we inherited from Principia was ongoing when we bought the Company.

The criteria for physicians treating patients on the study in terms of determining what threshold would meet the requirements for reducing steroid doses were not very strenuous, so there was quite a bit of heterogeneity in terms of when physicians decided to titrate down background steroids.

That and some other lessons learned from the study lead us to believe that we could have had a better design study and at that indication we would have approached in a different way going forward. As I said, the other data we have coming from ITP though on the other hand, is very encouraging so that boosts our confidence that the molecule has merit.

Those data showed a good response rate, a very competitor response rate, excellent durability as well. We're in the Phase 3, it's progressing well. We'll have an opportunity to share details of the Phase 2 data at upcoming congresses, as well as in a publication. And we are pursuing real Xa and other indications.

So, we have high hopes that molecule, given the importance of the BTK target across a number of autoimmune allergic diseases will be a big player in our portfolio on a go-forward basis..

Thanks, John. Bill, it's a question we're getting a lot, so it'd be good to share your view, our view on potential peak for Dupixent..

Well, first of all, Jeff, thanks for the question and for the stats that you gave leading into it. It's really been impressive what we've been able to do and in the last quarter, it's been incredibly impressive as well. Just since Q2, we've had 6 milestones, which is just really an unbelievable pace which we're going.

And the thing that I find really reassuring is this is a global brand truly, with 25% of the sales now coming from outside of the U.S. And it is not a U.S. product by any means, it is a global brand. Now, if you look towards what was in that EUR10 billion plus forecast that we gave, COPD wasn't in that.

So naturally, you may think that after we announced that, in 2023 would be a time to change our guidance. But given the rocket ship performance and the distance to 2023, we think it is important to update prior and we're currently discussing the timing of that. So, I would say stay tuned for the moment..

Great. Thanks very much..

Thank you. Great questions.

Maybe where do we go next?.

The next question is from Graham Parry of Bank of America. Graham..

Can you hear me okay? Brilliant. And so, I'm going to follow-up at you on AMEERA-3. If you can just remind us when recruitment was complete.

And so how long actually have you had patients on drug in that study for now? And to what extent do you see it as an encouraging sign that you're taking longer for accrual events? And does it change the statistical analysis plan at all? And John, on the second-quarter call, I think you said that just looking at how events were occurring, you were looking at 4 to 6 months PFS.

Just wondered, was that for all patients or was that referring to the control arm or the drug arm in the study? And then a second question for John, investors often say just that post AMEERA-3, there's not a lot going on in Sanofi R&D until 2023. So perhaps you could just help us, in what date in 2022, you're most looking forward to? Thanks..

A 100 gentlemen, nobody has seen any of the data, right? Where if the difference of close end Q2 is we're excited because we've seen the Marine radio status. So that's a good indicator. But we haven't seen any of the data.

The only thing that we've shared in fact is that 90% of the events have been accrued and we haven't even declared how many events we're actually expecting to see. So, John, I don't know whether you want to add anything, but I'm not sure there's much, but I'll leave it to you..

Yeah, I don't know if there's a lot more to add. One should always be cautious about over-interpreting the fact that an event-driven study is continuing on and on.

We'll just have to wait for the date, and we're not planning at this point to change the statistical analysis plan, but we'll take a look at what we learned from the data of radius when they presented at the San Antonio meeting and see if there's any second thought we have around that.

But right now, we're staying the course and waiting for the events. And as I said, 90% of them approximately have occurred, so we are hopeful in the next few weeks that we may get there. I think we all just have to remain patient while we wait for the curtain to open here and to see -- turn over the card here.

In terms of events for next year, there's a number of things that we could be excited about.

I mentioned some of the front-lines that there will be front-line data for Sarclisa next year with the most modern backbone therapy that'll be an important opportunity for us to move into the frontline space and see if we continue to demonstrate the best-in-class profile among the CD-38 class in myeloma so far 2 out 2, there's going to be more data presented at an upcoming congress at the end of this year, which will get further insight.

I think that's certainly something we'll be watching. I mentioned there will be some face to reach out on two submit map, and additional indications or in combinations with other medicines. So, I think that's going to help further establish the level of excitement to have in that molecule based on what we see in those studies.

Data will be trickling in for SAR 245 or non - alc IL-2 throughout the year next year. We have started in four indications at least now and so those data will be accruing in this signal-seeking studies across dermatology, across lung, across GI and head and neck cancers.

We'll be getting more and more insights into that molecule in combination with PD-1. FNS occupied was mentioned. We're going to have the readout on that next year, so that's really exciting.

So those are a few off-the-tops of the head, we can refer you to the backup slides to show other readouts next year and we think it's going to be a good year for us..

Thank you. Thank thanks, John for that summary. That list is getting longer, I noticed. I just want to come back so on no misunderstanding from anybody on AMEERA-3 never seen any data with 90% accrued. We've been confident throughout the process. We believe in the pathway. We have a great medicine with the great balance of safety and efficacy.

And to recent data from Menarini RADIAS gives us even more confidence. So, we will turn the cards over as always, that's our game. But we're optimistic about turning them over. So, let's see where we get to, right? Okay. Next question..

So, the next question is from Matt Weston at Credit Suisse..

Thank you. Two questions please. Sticking with the pipeline. Firstly, on Fitusiran, it's had a checkered history. We've now got an 18-month delay to the readout. Is there anything that we'll see between now and 2023, 2024 that will allow our investors to understand your continued optimism for the molecule.

And then just a quick one on the COVID Universal Booster strategy, can you tell us whether now the pricing for that program if it's profitable -- if it's positive, apologies, would be for profit or whether it would remain one where you would aim not for profit pricing? Thank you..

Okay, Matthew. Thank you. I'll toss it to Bill for fitusiran, but since I joined the Company I've been with a lot of I did a lot of diligence turning the Company and then early days when it got in-house was able to see the data and was always excited about Fitusiran cause we'd seen what [Indiscernible] had done.

We saw how fickle the market was, how quickly it would move. We look ahead of what Fitusiran, will compete with the even with the delay. As a managing team, we looked at that and can we still thread the needle on an exclusive profile. And we know that we will have to go to a lower dose probably and we'll experience that.

And we also know that our interval to stretch further. So, and there isn't that much excitement in follow-on some other companies. So, it's a needle to thread but if we get it done, that's why we stick at it. I think we can really make ourselves a very successful medicine ASR.

It is one of those things where I think we are a little bit a way from where we need to be, but we keep making progress, will keep learning. We're excited about the profile on this at every turn, in any data we picked up, there are patients that have responded like they're living disease-free.

So, we know that we just have to balance those things and that journey, so far, is still worth the trade for us. And we feel that way to this point. I don't know if John or Bill wants to add anything else..

Paul, just to echo all your comments. This has a really unique profile. Whether you're looking at any gene therapy or anything else, a potential every other month, so 6 injections per year, it's a great profile, small sub-Q administration.

So, let's see, I think John mentioned in his statements that in upcoming meeting this year we'll be reporting at some of the 80-milligram mild dosing. So, stay tuned..

Alright..

Yeah, that's right. You were asking what data or what we might be able to provide the investor community to help understand why we remain excited about the asset and indeed, there'll be a presentation of data at an upcoming Congress later this year and probably in the next year as well.

We have the full dataset on the original 80 milligram Q monthly dose for the two main phase three studies. One of those was with patients with inhibitors and the other was without, so those data will be shared with the community in the next few weeks and months.

And then, we go from there and further up with the studies we're doing now to explore the lower dose in the more -- the less frequent dosing intervals.

The one thing I would just say because this is an SRNA drug, we have to all remember that that class of drugs has nontraditional pharmacology, right? They have whatever color depot like effect and doing some titration of that is perhaps not unexpected.

We know what levels we have to get of antithrombin 3 reduction to get that sweet spot and we're just dialing into that right now..

Okay. Thank you both. Thomas, boosters..

Thank you, Matt, for the question on COVID-19 boosters. Let me start quickie saying, but our strong engagement on the COVID-19 pandemic, is not about the financial. Be it for the COVID-19 booster, or for the orphan under a viewed 500-million disease vaccines that were manufacturing from 3 different manufacturers, on top about one to government.

Now, back to your initial question. As we committed before, it's clearly going to be an affordable pricing and we have not changed the way we're from that at all, that's the strategy. We've already said before it will be start of EUR10, no change there. Now it's up to the Phase 3 readout that's coming pretty soon..

Great. Thank you..

Okay..

Thank you..

I'm going to take the next question from the jets and Luisa Hector from Berenberg. The first question on [Indiscernible] it's actually a 3-in-1. Can you provide the USS split by indication, how is the China launch progressing? You continue to note fewer in-person physician visits in the US.

So, you remain slightly below quicker with when do you expect this to normalize? And the second is on Flu - COVID combo vaccine.

Do you continue to believe that demand for such a combo would be low or are you positioned to move forward on this, despite ending your COVID mRNA development?.

Okay, good. I count four questions but okay. Bill, sales split. I'm not sure, frankly, how much we share on that beyond the geographies that you've already said. And China update, in person visits, numbers of tours, and then Tom, I'll come to you for quick comment in a moment on Flu and COVID..

So, thanks for the question. Maybe starting in the reverse order there about pace of opening and we were encouraged actually to see between last quarter and this quarter, a trend up closer at 85% and that varies obviously by specialty.

As far as when does it get back to normal? It's really a question of COVID, right? If we could predict that we can predict when we're going to open up. And again, we think that we see some really encouraging signs. I will just reiterate that not all specialties were affected the same through the pandemic as it relates to Dupixent.

We saw with pulmonologists and any of the respiratory physicians that it was -- they were harder hit.

Oftentimes we had pulmonologists being pulled into ICUs and so forth to take care of patients there and also patients with any respiratory illness because they were so susceptible were really hunkering down at home, so you didn't see the same exacerbation rates, etc. and I think that reach through in asthma as well as COPD as well.

So just a little bit of context there. We're not going to break out the indication split within the U.S. or anywhere for that matter, but I can say that there is a strong growth across all of the -- all the indications.

You had a specific question about China, and we've been really, really impressed with the work that the team has done in China since getting the NRDL listing in March. This is tracking to be one of the most successful immunology launches in China ever.

And as we've stated, we think this is going to be a blockbuster in China on its own and will become a real leader in I&I. In the next 3 years, the labeled population in China will expand, children AD 6 to 11 in 2022, but then we also expect infant AD in 2023 and asthma in 2024.

We really are at the beginning with Dupixent in China, so we're building a strong foundation, a strong base. We're accelerating hospital listings, we're doing policy shaping, we're growing the number of prescribers, and we're really accelerating access to patients.

So, this is a long-term story, it's off to a great start, and we look forward to reporting more on it in time..

Well said, Bill, thank you. Thomas, flu, COVID approach..

So, your question is about the flu COVID-19 in combination, interest need versus clinical profile, for any combination and you know that we know commissions fairly well as we are. The worldwide Europe VFA commission, will always looking at what's the need for it, with problems are we trying to solve versus the clinical benefit themselves need.

We always look at what's the convenience, on convenience innovate today. In most of the countries in the world in one single disease, you can receive COVID-19 boosters. And fluid in the same visit. So, you you're not saving.

any visit. Now on the second path is from clinical profile perspective, whether we're looking for -- and as we've shared before and that's shown by the success of our growth of influenza differentiate vaccines. Clearly people are looking at superior influenza vaccines So that's the bar to reach in terms of both safety and efficacy.

So, as I mentioned today in the presentation, that something we want to look at. We'll be able to Melanie to read the best clinical safety and efficacy bar and then we'll move on. But there's a lot to go there. We're very confident with the first strategy we have in place and we're looking forward to share it with you on December 1st..

Yeah, I was going to have that and I think the December 1st meeting, you will get to share some interesting insights, perspectives, and data which I think will help bring some clarity to the flu landscape and in general to the vaccine landscape. So, make sure you are available for that is all I would say..

Okay, good. Next question..

The next question is from Richard Vosser at JPMorgan. Richard..

Just on Nirsevimab, obviously strong headline data in the April, but the hospitalizations. I think on the primary look at that, didn't meet statistical significance. Just your thoughts on whether that impact any the of sort of reimbursement or recommendations that payers or their An ICP might make.

And then second question just on vacillates and just thoughts on the uptake there and what's going on with the PPH vaccines. Thanks very much..

Thank you, Richard. Okay. Over to you, Tom..

Thank you, Richard. On the first part on [Indiscernible] Important to clarify that the hospitalization specifically in the middle of the trial was not a primary endpoint so the city was not powered for that. Very important to say that a specified pooling of hospitalization across the Phase 2B and Phase 3 medalist trial was pre -specified.

And we've made that cut area with the ability to prevent 3 out of 4 hospitalizations so we're not worried at all by the [Indiscernible] perspective on this. I think very good profile of Nirsevimab, again, 3 out of 4 hospitalization in a set up. We're pretty much is the number one hospitalization custody in new bonds in the world.

So that's from the midstream at an event for the second question on vaccine. You know that we've launched Vasileios in the U.S. in June 2021, we're still in the early stage of these. The launch is doing very well, but you probably know that when you are switching vaccines from one can be a tricky pediatrician can do to another.

It takes for pediatricians to go through their existing vaccines and move onto the next one. there what we see in the Vassilis launch, of course, I remind everyone that as we've discussed last time, vaccine sales are booked in the sales line. They are shared.

The AR books, sorry [Indiscernible]Merck with some of your best there? And it's at the [Indiscernible] line, but you [Indiscernible] the [Indiscernible] Overall, I would say, vaccine is good launch, going well. Most importantly, PPA sale is doing well.

As we noticed before, we are an institution where we have a decreasing birth cohort, despite that, you see that we are doing very well on PPFSH?.

Thank you for that. I think we'll please the launch, but also at the same time, you see when you in an established vaccine marketplace with good standard of care, it takes time to educate and to change, and that's fine for us, we're used to doing this, that's why we're the leader.

These are thoughts to have at the back of your mind as you think about what happens in the future if other platforms, including our own by the way, are successful in MRNA in flu. What motivates in a pandemic is very different in peace time. Let's just get deeper into his conversations on December the 1st, which I keep trying to advertise. Okay.

Any other questions?.

The next question is from Keyur Parekh at Goldman Sachs. Keyur? Okay. In the meantime, we can probably have [Indiscernible] at Q - Bryan Garnier [Indiscernible].

Yeah. Can you hear me? 2 questions. First for Tom (ph.). If I understand correctly, your recombinant COVID vaccine is presented in two vials. One for the antigent and one for adjuvant.

Therefore, don't you think that this presentation could seriously slow down the use of your vaccine being in a pandemic or booster -- or primary vaccination or booster, sorry.

And do you plan to improve this presentation if not already done, to have, for example, a ready-to-use syringe? That's my first question and the second one is for Jean-Baptiste, you full-year guidance for EPS growth appears to imply significant slowdown for EPS growth in Q4.

How to interpret that, what could be the reason for this slow down? Thank you..

Okay. Thank you so much. JB, let's start with you.

What about the rest of the year and what does that mean?.

I think it's important to have in mind the very specific phasing of our BOI on EPS growth during the year quarter-on-quarter. You notice that on the fourth quarter, the average in looking at the past years, 8-9% point below the average of the first-quarter. So, it's very normal to have this trend. And nothing will make us slow down.

Of course, we want to accelerate, but we want to accelerate in science and in innovation. So that's where we are looking at and that's why we will be closing of [Indiscernible] has occurred and that will be of course, maybe it's Kadmon it's closed before your end. You will see some more R&D costs picking up in Q4, which is expected..

It's great. Thank you. And Thomas, maybe help clarify what role we actually think we'll play in primary before you get into some of the mechanics..

So indeed, COVID-19, the situation is evolving and we're supplying and where we are needed, we're trying to be relevant. What does that mean concretely? It means that the product we are developing is developed with our partners in Europe and North America. The express demand has clearly been, but booster doses, not primarily vaccination doses.

And of course. back to your question. Jack, in terms of presentation, of course it will our partner knew very well, but this is the? value of an empty Gen and evade of adjuvants at our premixed a bit, say debit.? So that's very clear. It didn't prevent them at all.

As I mentioned previously, to place orders so that we can move forward in 2022 as soon as we have our Phase 3 readout. But I remind everyone again that as I mentioned initially, our contribution and our engagement in COVID-19 is not about the financial, it's about getting an impact on the pandemic..

Yes. Thanks for that. And I think that in addition, there is an opportunity to do. So just to play our part and that's our focus, but whilst, we think, the method of administration is really not a complication at all. It's also important to remember things that would term a stable.

And so, I think with the pandemic nobody's really getting into those details, but they are important details for what happens next in the roles of the established platforms and MRNA and different things like that. But if we if we get good data as a booster then we will be making some 75 million doses have been pre -ordered by European countries.

So, if we get there and this profile firmer stable and we're playing a part, that will just be a great thing to do. And I think it'll be a great foreign organization to see us do it too. So, thank you for that. Maybe it's the last question..

Yes, we'll take the final question from Peter Welford, at Jefferies. Peter.

Hi, yes. Thanks for taking my questions. Firstly, just on [Indiscernible] mix-and-match, just regarding the timing of that. I think it looks as though the [Indiscernible] may have got into 2023 from '22. These clarifies the event driven or due to enrollment and similarly, it depicts in COPD. It looks like that may not be filed '24.

Is that also due to one of the studies being shifted? And then the second one just to [Indiscernible] we're obviously saying that the B cell therapies, and the CD20 antibodies are taking a lot of market share and being widely adapted and curious what your view is, at this point on Sanofi's presence in multiple scleroses? Are you looking at getting into the B-cell segment with the biologic? Do you think you'd need that to compete long-term in multiple scleroses or has 11 charger and the experience of that frequent dose put you off having the pilot should give me on? Thank you..

Okay. I think I'm going to ask Bill in a moment to comment on why we think we have the winning proposition. All again, CD20 s and also to comment on the CFDA. I think I heard you correctly, which was the move by a quarter on COPD. Nothing special on that. But you can comment if you like, and John, to some minimum..

Yeah, it's really COVID -related. And the original readout was going to be tail-end of 2023 and so it just slipped by a couple of months into 2024, but these pipeline delays are very -- they're COVID -related.

And in the COPD one, as Bill, I think, referenced, with social distancing, etc., patients are having fewer exacerbations and we have criteria for a certain number of exacerbations to be eligible for the study. Otherwise, that being the primary endpoint, there's going to be very little to measure.

It's sort of a secondary consequence of the COVID as well. So those are really pandemic-related delays..

Okay.

And then, Bill, MS? As you are the godfather of Aubagio and everything else, what do you want to say?.

Well, thanks for the question. Look, Tolebrutinib is we consider the best in disease potential -- has best in disease potential across the whole MS disease continuum. And why is that? Well, it's brain [Indiscernible] at a level that actually makes a difference, we believe.

We had a lot of people tried to come into the space and say they've got a BTKI that does this or does that, but we're not concerned at the moment. We believe that ours is the first. We think it's going to be the best. We have an incredibly comprehensive development program. And when we've talked about this asset, you brought up the B-cell deplete.

We don't think jumping into a second or third version of Rituxan or over-delivers Ocrelizumab. I should say, would be the thing for us to do. And when we've been comparing Tolebrutinib, we've been comparing it to the CD20 s in the sense that if you look at the impact that we have on MRI, it's consistent with those products.

And if you let the recent data that we announced that ECTRIMS, which looks at relapse rate, is consistent. So that's the comparator. The difference is that we believe that's important for progressive disease to get inside the brain, rather knocking on the outside in the periphery.

And so, we believe that this is really the product and being an oral once today that can be the winner in this space. I'll leave it at that..

That's a good place to leave at. So, I think we've come to the end. Just to remind everybody, as some travel is returning to normal in many places, the Vaccines Day, which I'm not sure I mentioned on December the 1st, will be in Paris. So, I'm hopeful that those who can, I feel able, I motivated you to come.

I can assure you it will be a very interesting and compelling day. We look forward to that. Thanks to the team. Great progress by Sanofi through Q3. It's just the beginning and we look forward to updating its full-year. So, thank you very much..