Q3 2025 Sanofi SA Earnings Call

October 24, 2025

Hello, everyone. This is Thomas goes down from this and all the IR team.

Thomas Kudsk Larsen: Hello, everyone. This is Thomas Kudsk Larsen from the Sanofi IR team. Welcome to the Q3 2025 Conference Call for investors and analysts. As usual, you can find the slides on sanofi.com. Please turn to slide 3. Here we have the usual forward-looking statements. We would like to remind you that information presented in this call contains forward-looking statements that are subject to substantial risk and uncertainty that may cause actual results to differ materially. We encourage you to read the disclaimer in our slide presentation. In addition, we refer you to our Form 20-F on file with the US SEC and our French universal registration document for a description of these risk factors. As usual, we'll be making comments on our performance using constant exchange rates and other non-IFRS measures.

Welcome to the Q3 2025 conference call for investors and analysts.

As usual you can find the slides on <unk> dot com.

Please turn to slide number three.

And we have the usual forward looking statements, we would like to remind you that information presented in this call contains forward looking statements.

Object to substantial risks and uncertainties that may cause actual results to differ materially.

We encourage you to read the disclaimer in our slide presentation.

In addition, we refer you to our form 20-F on file with the U S ACC French universal registration time, but.

A description of these risk factors.

As usual, we'll be making comments on our performance using constant exchange rates and other non various measures.

<unk> are usually in millions of euros and for Q3 2020 clients unless we state otherwise.

Thomas Kudsk Larsen: Numbers used are usually in millions of euros and for Q3 2025, unless we state otherwise. Please turn to slide number 4. First, we have the presentation, and then we take your questions. As usual, we aim at keeping it all to one hour, including questions. In Q&A, we have Olivier, Brian, and Thomas to cover our global businesses, as well as Roy, our general counsel, and Brendan, head of manufacturing and supply. For the Q&A, you have two options in Zoom. Raise your hand. Submit your question using the Q&A function. With this, I'll hand you over to Paul on my left-hand side.

Please turn to slide number four.

First we have the presentation and then we'll take your questions as usual, we aim at keeping it all to one hour including questions in.

One of them.

As usual you can find the slides on the telecom piece.

For Q&A, we have pretty good Brian and Tom Mr Cola, our global businesses as well as Roy our general counsel and Brendan it will affect reining in supply.

Sure.

Okay.

Statements.

To remind you that in 14% in both the Haynesville and savings.

And for the Q&A you have two options in June basically hand submit your question using the Q&A function.

Subject to substantial risks and uncertainties that may cause.

Actual results to differ materially.

With this I'll hand, you over to Paul on my left hand side.

We encourage you to read the disclaimer in our activities.

Thomas.

In addition, we refer you to form 20-F on file with the U S. S friends Universal registration document.

Thank you everyone for joining us today.

[Company Representative] (Sanofi): Thomas. Thank you everyone for joining us today. Our growth momentum continued in Q3 with EUR 12.4 billion in sales, up 7% over last year's high base of comparison. Sales growth was primarily driven by our new launches and the performance of Dupixent, which reached EUR 4 billion in quarterly sales for the first time. After the Q3 performance, we are confident in the business outlook for the remainder of the year and reiterate our full year 2025 sales guidance. This positive outlook includes our expectations for the business in the US, our largest market by sales. We continue to work with the administration and policymakers in the US around the world on policies that improve access to treatments, lower prices for patients, and improve health systems and protect science.

Paul Hudson: Thomas. Thank you everyone for joining us today. Our growth momentum continued in Q3 with EUR 12.4 billion in sales, up 7% over last year's high base of comparison. Sales growth was primarily driven by our new launches and the performance of Dupixent, which reached EUR 4 billion in quarterly sales for the first time. After the Q3 performance, we are confident in the business outlook for the remainder of the year and reiterate our full year 2025 sales guidance. This positive outlook includes our expectations for the business in the US, our largest market by sales. We continue to work with the administration and policymakers in the US around the world on policies that improve access to treatments, lower prices for patients, and improve health systems and protect science.

Momentum continued in Q3 with $12 4 billion yards themselves.

For a description of these risk factors.

7% of Alaska is high base of comparison sales growth was primarily driven by our new launches on the performance of 2%, which reached 4 billion euros in quarterly sales for the first time.

As usual my comments on our performance using constant exchange rates and northern.

These measures.

<unk>, usually in millions of euros and for Q3 2025, unless we state otherwise.

After our third quarter performance, we are confident in our business outlook for the remainder of the year and reiterate our full year 2025 sales guidance. This positive outlook includes our expectations for the business in the U S. Our largest market by sales we continue to work with the administration and policy makers in the U S and around the world on policy.

Please turn to slide in before.

First we have the presentation and then we'll take your questions.

With Keith it all to one hour, including questions for Q&A, we have believe it Brian and Tom <unk> to cover our global businesses as well as Roy our general counsel and Brendan head of manufacturing and supply.

Is that improve access to treatments lower prices for patients and improve health systems and protect science a recent announcement on expansion of our patient affordability program offerings improved access to all our insolence is a great example of this work, which I'll discuss in a little more detail later in the presentation.

And for the Q&A you have two options in June basically hand submit your question using the Q&A function.

With this I'll hand, you over to Paul on my left I'm sorry.

[Company Representative] (Sanofi): Our recent announcement on the expansion of our patient affordability program, offering improved access to all our insulins, is a great example of this work, which I'll discuss in a little more detail later in the presentation. Let me highlight the contribution of our new launches, which have been a significant driver of this quarter's strong performance. Our launches delivered EUR 1.8 billion this quarter, grew more than 40%, and now represent 15% of our total sales. To put this in perspective, our launches represent almost half of Dupixent sales this quarter, demonstrating their significant contribution to our growth. We've strengthened our commercial portfolio with three new additions. Ayvakit, our medicine for both advanced and indolent systemic mastocytosis. The first Sanofi sales of Nuvaxovid, offering an important protein-based and non-mRNA alternative for COVID-19 vaccination. Wayrilz, our new BTK inhibitor designed as a multi-immune modulator.

Paul Hudson: Our recent announcement on the expansion of our patient affordability program, offering improved access to all our insulins, is a great example of this work, which I'll discuss in a little more detail later in the presentation. Let me highlight the contribution of our new launches, which have been a significant driver of this quarter's strong performance. Our launches delivered EUR 1.8 billion this quarter, grew more than 40%, and now represent 15% of our total sales. To put this in perspective, our launches represent almost half of Dupixent sales this quarter, demonstrating their significant contribution to our growth. We've strengthened our commercial portfolio with three new additions. Ayvakit, our medicine for both advanced and indolent systemic mastocytosis. The first Sanofi sales of Nuvaxovid, offering an important protein-based and non-mRNA alternative for COVID-19 vaccination. Wayrilz, our new BTK inhibitor designed as a multi-immune modulator.

Thomas.

Thank you everyone for joining us today.

Growth momentum continued in Q3 with $12 4 billion, new orders and sales up 7% over last year's high base of comparison sales growth was primarily driven by our new launches on the performance of 2%, which reached 4 billion euros in quarterly sales for the first time.

Now, let me highlight the contribution of our new launches, which have been a significant driver of this quarter's strong performance.

<unk> delivered $1 8 billion orders this quarter grew more than 40% and now represents 15% of our total sales.

After the third quarter performance, we are confident in the business outlook for the remainder of the year and reiterate our full year <unk> guidance is a positive outlook includes our expectations for the business in the U S. Our largest market by sales we continue to work with the administration and policy makers in the U S and around the world on policy.

To put this in perspective, our launches represent almost half of duplex in sales this quarter, demonstrating a significant contribution to our growth.

We've strengthened our commercial portfolio with three new additions advocate a medicine for both the bias in indolent systemic mastocytosis.

First one I b cells of <unk> offering an important protein based on known mrna alternative for COVID-19 vaccination.

Is that improved access to treatments lower prices for patients and improve health systems and protect science.

Our recent announcement on the expansion of our patient affordability program offering improved access to all our insolence is a great example of this work, which I'll discuss in a little more detail later in the presentation.

<unk> on mute PTK inhibitor designed as a multi immune modulator. This innovative medicine provides a new option for patients with immune thrombocytopenia that extends beyond that platelet count needs to addressing culture blackbirds.

[Company Representative] (Sanofi): This innovative medicine provides a new option for patients with immune thrombocytopenia that extends beyond their platelet count needs to addressing quality of life burdens. We're seeing good attack across our portfolio of new medicines and vaccines. BEYFORTUS, which achieved blockbuster status last year in its first full year of sales, continues its expansion into new geographies. ALTUVIIIO is on track to reach blockbuster status this year, Ayvakit will become our next blockbuster in 2026. Dupixent has reached a new milestone this quarter, exceeding EUR 4 billion in quarterly sales for the first time. More than eight years after its initial launch in atopic dermatitis, we saw an increase of over 30% in the number of patients during the last 12 months. In the US, we've surpassed the EUR 3 billion quarterly sales mark, maintaining leadership in both new and total prescriptions across established indications.

Paul Hudson: This innovative medicine provides a new option for patients with immune thrombocytopenia that extends beyond their platelet count needs to addressing quality of life burdens. We're seeing good attack across our portfolio of new medicines and vaccines. BEYFORTUS, which achieved blockbuster status last year in its first full year of sales, continues its expansion into new geographies. ALTUVIIIO is on track to reach blockbuster status this year, Ayvakit will become our next blockbuster in 2026. Dupixent has reached a new milestone this quarter, exceeding EUR 4 billion in quarterly sales for the first time. More than eight years after its initial launch in atopic dermatitis, we saw an increase of over 30% in the number of patients during the last 12 months. In the US, we've surpassed the EUR 3 billion quarterly sales mark, maintaining leadership in both new and total prescriptions across established indications.

Now, let me highlight the contribution of our new launches, which have been a significant driver of this quarter's strong performance our launches delivered $1 8 billion orders this quarter grew more than 40% and now represents 15% of our total sales.

We're seeing good uptake across our portfolio of new medicines and vaccines by Fortis, which achieved blockbuster status last year in its first full year of sales continues its expansion into new geographies.

To put this in perspective, our launches represent almost half of duplex in sales this quarter, demonstrating a significant contribution to our growth.

<unk> is on track to reach blockbuster status. This year, an advocate to become our next blockbuster in 2026.

We've strengthened our commercial portfolio with three new additions <unk>, our medicine for both advanced and indolent systemic mastocytosis.

Two picks and has reached a new milestone this quarter exceeding 4 billion euros in quarterly sales for the first time.

Years after its initial launch in atopic dermatitis, we saw an increase of over 30% in the number of patients at joined in the last 12 months.

First one I b cells of <unk> offering an important protein based and non M&A alternatives for COVID-19.

In the U S. We surpassed the 3 billion euros quarterly sales month, maintaining leadership in both new and total prescriptions across established syndications.

And <unk>, our new PTK inhibitor designed as a multimedia modulator. This innovative medicine provides a new option for patients with immune thrombocytopenia that extends beyond that platelet count needs to addressing quality blockbusters.

The launches and the recently approved indications COPD CSU and BP are progressing as planned.

[Company Representative] (Sanofi): Our launches in the recently approved indications, COPD, CSU, and BP, are progressing as planned. Outside the US, sales grew 21%, exceeding EUR 1 billion in the quarter. We continue our efforts to make Dupixent available to more patients, helped by the positive CHMP recommendation for CSU in the EU and regulatory submission for CSU in children in the US and the EU. Turning to our vaccine business, Q3 sales were EUR 3.4 billion. This performance compares to a high base in the previous year and reflects the competitive price pressure as well as the lower flu immunization rate in the US. A new highlight among our respiratory vaccines is the early start of Nuvaxovid, the only non-mRNA COVID-19 vaccine available in the US and from our collaboration with Novavax. The shipments of Nuvaxovid were delivered in the US in September.

Paul Hudson: Our launches in the recently approved indications, COPD, CSU, and BP, are progressing as planned. Outside the US, sales grew 21%, exceeding EUR 1 billion in the quarter. We continue our efforts to make Dupixent available to more patients, helped by the positive CHMP recommendation for CSU in the EU and regulatory submission for CSU in children in the US and the EU. Turning to our vaccine business, Q3 sales were EUR 3.4 billion. This performance compares to a high base in the previous year and reflects the competitive price pressure as well as the lower flu immunization rate in the US. A new highlight among our respiratory vaccines is the early start of Nuvaxovid, the only non-mRNA COVID-19 vaccine available in the US and from our collaboration with Novavax. The shipments of Nuvaxovid were delivered in the US in September.

Outside of the U S sales grew 21% exceeding 1 billion euros in the court.

We continue our efforts to make <unk> available to more patients helped by the positive <unk> recommendation for <unk> in the EU and regulatory submission policy issue in children in the U S and the EU.

<unk> is on track to reach blockbuster status this year and advocate to become our next blockbuster in 2026.

Turning to our vaccine business Q3 sales were $3 4 billion euros. This performance.

Two picks and has reached a new milestone this quarter exceeding 4 billion euros in quarterly sales for the first time more than eight years. After its initial launch at a topic dermatitis, we saw an increase of over 30% in the number of patients at joined the last 12 months.

<unk> compares to a high base in the previous year and reflects the competitive price pressure as well as the level of flu immunization rate in the U S.

Our new highlights among the respiratory vaccines is the early start of <unk> of it the only non mrna COVID-19 vaccine available in the U S and from our collaboration with Novavax.

In the U S. We have surpassed the 3 billion euros quarterly sales month, maintaining leadership in both new and total prescriptions across established indications.

Shipments of Novak submitted with delivered to in the U S. In September.

Launches and the recently approved indications COPD.

<unk> and BP are progressing as planned.

And RSV by Fortis continues its impressive expansion of 20% this quarter and now available in 40 countries.

Outside the U S sales grew 21% exceeding 1 billion euros in the course.

[Company Representative] (Sanofi): In RSV, BEYFORTUS continues its impressive expansion of 20% this quarter and now available in 40 countries. As you may have seen in our press release this morning, we decided to discontinue our RSV toddler program. While the safety profile was acceptable, the predetermined criteria for efficacy was not met in the planned futility analysis. The PPH and booster franchise remains an important contributor to our vaccine business, with the performance in Q3 reflecting phasing in the first half of the year. Sanofi has a proud legacy in flu vaccines, and we remain committed on bringing innovation to strengthen our leadership in flu and to provide better protection for patients. Our flu FLUNITY-HD study, published in The Lancet last week, demonstrated that our high-dose flu vaccine, Efluelda, known as Fluzone High-Dose in North America, provided superior protection versus standard dose vaccine on the sometimes devastating consequences of flu.

Paul Hudson: In RSV, BEYFORTUS continues its impressive expansion of 20% this quarter and now available in 40 countries. As you may have seen in our press release this morning, we decided to discontinue our RSV toddler program. While the safety profile was acceptable, the predetermined criteria for efficacy was not met in the planned futility analysis. The PPH and booster franchise remains an important contributor to our vaccine business, with the performance in Q3 reflecting phasing in the first half of the year. Sanofi has a proud legacy in flu vaccines, and we remain committed on bringing innovation to strengthen our leadership in flu and to provide better protection for patients. Our flu FLUNITY-HD study, published in The Lancet last week, demonstrated that our high-dose flu vaccine, Efluelda, known as Fluzone High-Dose in North America, provided superior protection versus standard dose vaccine on the sometimes devastating consequences of flu.

As you may have seen in our press release. This morning, we decided to discontinue our RSV toddler program, while the safety profile was acceptable the predetermined criteria for efficacy was not met in the planned futility analysis.

We continue our efforts to make <unk> available to more patients helped by the positive <unk> recommendation for <unk> in the EU and regulatory submission.

Children in the U S and EU.

The PPA and boost our franchise remains an important contributor to our vaccine business with the performance in Q3, reflecting phasing in the first half of the year.

Turning to our vaccine business Q3 sales were $3 4 billion euros. This performance compares to a high base in the previous year and reflects the competitive price pressure as well as the level of flu immunization rates in the U S.

Certainly as a proud legacy flu vaccines, and we remain committed on bringing innovation to strengthen our leadership in flu and to provide better protection for patients are fluid ADHD study published in the lancet last week demonstrated on our high dose flu vaccine. After the elder known as Fluzone high dose in North America provided street.

Our new highlight among the respiratory vaccines is the early start of <unk>. The only non mrna COVID-19 vaccine available in the U S and from our collaboration with Novavax.

Shipments of <unk> were delivered to in the U S. In September.

Barrier protection versus standardized vaccine on the sometimes devastating consequences of flu.

And RSV by photos continues its impressive expansion up 20% this quarter and now available in 40 countries. As you may have seen in our press release. This morning, we decided to discontinue our RSV toddler program, while the safety profile was acceptable the predetermined criteria for efficacy was not met in the planned futility.

Data showed an eight 8% reduction in earlier or flu hospitalizations and an important 32% reduction in laboratory confirmed flu hospitalizations versus standardized exits.

[Company Representative] (Sanofi): Data showed an 8.8% reduction in pneumonia or flu hospitalizations, and an important 32% reduction in laboratory-confirmed flu hospitalizations versus standard dose vaccines. We're expanding access to this beneficial protection with positive phase 3 data that support a label update extending the age down to 50 years for Efluelda Fluzone High-Dose. Looking ahead, we're advancing our flu pandemic preparedness with 2 programs while improving vaccination convenience with positive data on flu COVID-19 combination vaccines. These achievements underscore our commitment to delivering enhanced protection against respiratory viruses to more people worldwide. In addition to our unwavering commitment to innovation and respiratory viruses, we're also steadfast in our commitment to improve patients' access to healthcare. Our Global Health unit has reached a remarkable milestone, 1 million patients treated for non-communicable diseases across more than 40 low and middle-income countries since 2021.

Paul Hudson: Data showed an 8.8% reduction in pneumonia or flu hospitalizations, and an important 32% reduction in laboratory-confirmed flu hospitalizations versus standard dose vaccines. We're expanding access to this beneficial protection with positive phase 3 data that support a label update extending the age down to 50 years for Efluelda Fluzone High-Dose. Looking ahead, we're advancing our flu pandemic preparedness with 2 programs while improving vaccination convenience with positive data on flu COVID-19 combination vaccines. These achievements underscore our commitment to delivering enhanced protection against respiratory viruses to more people worldwide. In addition to our unwavering commitment to innovation and respiratory viruses, we're also steadfast in our commitment to improve patients' access to healthcare. Our Global Health unit has reached a remarkable milestone, 1 million patients treated for non-communicable diseases across more than 40 low and middle-income countries since 2021.

Spanning access to this beneficial protection with positive phase III data to support a label update extending the age 10 to 50 years left of Alta Tucson Hydro's looking ahead, we're advancing our pre pandemic preparedness with two programs, while improving vaccination dominion's with positive data on flu Covid combination vaccine.

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The PPA and boost the franchise remains an important contributor to our vaccine business with the performance in Q3, reflecting phasing in the first half of the year.

So that gives a proud legacy and food vaccines and we remain committed on bringing innovation to strengthen our leadership in blue and to provide better protection for patients are fluid ADHD study published in the lancet last week demonstrated that our high dose flu vaccine after the elder known as Fluzone high dose in North America provided.

These achievements underscore our commitment to delivering enhanced protection against respiratory viruses to more people worldwide.

In addition to our unwavering commitment to innovation and respiratory viruses, where also steadfast in our commitment to improve patient access to health care, a global health unit reached a remarkable milestone a million patients treated for noncommunicable diseases across more than 40, low Midland contemporaries since 2021.

Superior protection versus standardize vaccine on the sometimes devastating consequences of flu.

Data showed an eight 8% reduction in pneumonia or flu hospitalizations and an important 32% reduction in laboratory confirmed flu hospitalizations versus standard dose vaccines.

Putting us on track to reach 2 million patients by 2030.

And we're expanding access to this beneficial protection with positive phase III data to support a label update extending the age down to 50 years left the Wilder Tucson high dose looking ahead, we are advancing our flu pandemic preparedness with two programs, while improving vaccination dominion's with positive data on flu Covid combination vaccine.

[Company Representative] (Sanofi): Putting us on track to reach 2 million patients by 2030. We trained over 27,000 healthcare workers and reached 4 million people through our partnership programs during the same period. We're not stopping there. In the US, we're expanding our Insulin Value Savings program to ensure every American has access to our insulins at just $35 per month. This initiative builds on Sanofi's long-standing efforts to provide patients access to a reliable and affordable supply of critical medicines. Thank you, and I will now hand over to Francois, our CFO, for more details on the financials.

Paul Hudson: Putting us on track to reach 2 million patients by 2030. We trained over 27,000 healthcare workers and reached 4 million people through our partnership programs during the same period. We're not stopping there. In the US, we're expanding our Insulin Value Savings program to ensure every American has access to our insulins at just $35 per month. This initiative builds on Sanofi's long-standing efforts to provide patients access to a reliable and affordable supply of critical medicines. Thank you, and I will now hand over to Francois, our CFO, for more details on the financials.

We trained over 27000 health care workers and reached 4 million people through our partnership programs. During this same period.

I will not stopping that in the U S. We're expanding our insulins bodies savings program.

Every American has access to our insurance at just $35 per month.

This initiative builds on lungs are sort of his long standing efforts to provide patients access to reliable and affordable supply of critical medicines.

Yes.

These achievements underscore our commitment to delivering enhanced protection against respiratory viruses to more people worldwide.

In addition to our unwavering commitment to innovation and respiratory devices. We're also steadfast commitment to improve patient access to health care.

Thank you and I will now hand over to Francois CFO for more details on the financials. Thank you Paula and Hello to everyone. In Q3, our Nexsan grew by 7% at constant exchange rates. This growth was primarily driven by pharma and more specifically by mineralogy on recent balance sheets.

Francois: Thank you, Paul. Hello to everyone. In Q3, our net sales grew by 7% at constant exchange rates. This growth was primarily driven by pharma, and more specifically by immunology and recent launches. Our new launches demonstrating a strong momentum with 41% sales growth, while Dupixent sales grew by 26% this quarter. Vaccine sales were down, primarily due to flu as expected. This decrease resulted from a combination of competitive price pressure, mainly in Germany, and lower vaccination rates. At published rates, net group sales increased by 2% impacted by a negative foreign exchange effect. These solid results highlight our ability to drive growth against headwinds. Our business gross margin increased by 2.3 percentage points this quarter, with a continued improvement in product mix, enhanced by productivity gains.

François-Xavier Roger: Thank you, Paul. Hello to everyone. In Q3, our net sales grew by 7% at constant exchange rates. This growth was primarily driven by pharma, and more specifically by immunology and recent launches. Our new launches demonstrating a strong momentum with 41% sales growth, while Dupixent sales grew by 26% this quarter. Vaccine sales were down, primarily due to flu as expected. This decrease resulted from a combination of competitive price pressure, mainly in Germany, and lower vaccination rates. At published rates, net group sales increased by 2% impacted by a negative foreign exchange effect. These solid results highlight our ability to drive growth against headwinds. Our business gross margin increased by 2.3 percentage points this quarter, with a continued improvement in product mix, enhanced by productivity gains.

And has reached a remarkable milestone a million patients treated for noncommunicable diseases across more than 40, lower Midland contemporaries since 2020, we'll.

Launcher, demonstrating our strong momentum with 41% gross wide boutiques incentives grew by 26% this quarter.

Putting us on track to reach 2 million patients by 2030.

We trained over 27000 health care workers.

It's 4 million people through our partnership programs. During this same period.

Vaccine sales were down primarily due to few flu as expected. The decrease resulted from a combination of competitive price pressure, mainly in Germany, and lower vaccination rates.

I'm going to have stopping that in the U S. We're expanding our insulins values savings program to ensure every American has access to our incidence at just $35 per month.

At published rates net group sales increased by 2% impacted by the negative foreign exchange effects.

This initiative builds on launched <unk> has longstanding efforts to provide patients access to reliable and affordable supply of critical medicines.

These solid results highlight our ability to drive growth against headwinds.

Our business gross margin increased by 2% two three percentage points. This quarter with the continued improvements in product mix enhanced by productivity gains. We now capture the full benefit of duplex and improved manufacturing process.

Thank you and I will now hand over to Francois CFO for more details on the financials. Thank you Paula and Hello to everyone. In Q3, our Nexsan has grew by 7% at constant exchange rates. This growth was primarily driven by pharma and more specifically by immunology and recent launches.

Francois: We now capture the full benefit of Dupixent improved manufacturing process, as well as the contribution from Ayvakit since the Blueprint closing in mid-July. As we move into 2026, the growth margin profile will return to its fundamental growth as a step-up from Dupixent C3 manufacturing transition is now complete. Operating expenses grew by 6%. Excluding the impact of the Blueprint acquisition, operating expenses grew by low single digits, highlighting our cost discipline. R&D expenses increased by 5%, broadly reflecting the underlying activity level. We continue to invest in sales and marketing to support our launches, and G&A costs were slightly down in line with our objective to keep them broadly stable going forward. Other operating income and expenses are moving up, primarily due to the increased share of profits paid to Regeneron as Dupixent continues its strong growth trajectory.

François-Xavier Roger: We now capture the full benefit of Dupixent improved manufacturing process, as well as the contribution from Ayvakit since the Blueprint closing in mid-July. As we move into 2026, the growth margin profile will return to its fundamental growth as a step-up from Dupixent C3 manufacturing transition is now complete. Operating expenses grew by 6%. Excluding the impact of the Blueprint acquisition, operating expenses grew by low single digits, highlighting our cost discipline. R&D expenses increased by 5%, broadly reflecting the underlying activity level. We continue to invest in sales and marketing to support our launches, and G&A costs were slightly down in line with our objective to keep them broadly stable going forward. Other operating income and expenses are moving up, primarily due to the increased share of profits paid to Regeneron as Dupixent continues its strong growth trajectory.

As well as the contribution from <unk> since the blueprint closing in mid July.

As we moved into 2026, the gross margin profile would return to its fundamental growth as the step up from <unk> manufacturing transition is now complete.

New launches demonstrating our strong momentum with 41% gross while duplex incentives grew by 26% this quarter.

Vaccine sales were down primarily due to few flu as expected. The decrease resulted from a combination of competitive price pressure, mainly in Germany, and lower Opex addition rights.

Operating expenses grew by 6%.

Excluding the impact of the blueprint acquisition operating expenses grew by low single digits, highlighting our cost discipline.

At published rates net group sales increased by 2% impacted by the negative foreign exchange effects.

R&D expenses increased by 5% broadly, reflecting the underlying activity level.

These solid results highlight our ability to drive growth against headwinds.

We continue to invest in sales and marketing to support launches.

Our business gross margin increased by 2% two three percentage points. This quarter with the continued improvement in product mix enhanced by productivity gains. We now capture the full benefit of duplex and improved manufacturing process.

G&A costs were slightly down in line with our objective to keep them broadly stable going forward.

Outside of operating income and expenses are moving up primarily due to increased share of profits paid titration regimen, Iran as duplex and come to use its strong growth trajectory.

Well as a contribution from <unk> since as a blueprint closing in mid July.

Business EPS reached $2 91, new roles and robust growth of 19.

As we moved into 2026, the gross margin profile would return to its fundamental growth as the step up from <unk> three manufacturing transition is now complete.

Francois: Business EPS reached EUR 2.91, a robust growth of EUR 0.19 and 13% compared to Q3 2024. This strong performance reflects our compelling sales growth and increasing growth margin combined with cost discipline. Looking at our year-to-date progress, we are maintaining stronger earnings momentum with 9% sales growth and business EPS growing faster at 12%. It fully supports our guidance for the full year and demonstrate our ability to deliver profitable growth consistently. Based on our year-to-date performance, we reiterate our full-year guidance of high single-digit sales growth and low double-digit business EPS growth at constant exchange rates. We have now completed the acquisitions of Dren Bio's DR-0201, Vigil Neuroscience, and Blueprint, and their associated costs are fully factored in our guidance.

François-Xavier Roger: Business EPS reached EUR 2.91, a robust growth of EUR 0.19 and 13% compared to Q3 2024. This strong performance reflects our compelling sales growth and increasing growth margin combined with cost discipline. Looking at our year-to-date progress, we are maintaining stronger earnings momentum with 9% sales growth and business EPS growing faster at 12%. It fully supports our guidance for the full year and demonstrate our ability to deliver profitable growth consistently. Based on our year-to-date performance, we reiterate our full-year guidance of high single-digit sales growth and low double-digit business EPS growth at constant exchange rates. We have now completed the acquisitions of Dren Bio's DR-0201, Vigil Neuroscience, and Blueprint, and their associated costs are fully factored in our guidance.

13% compared to Q3 2024.

This performance reflects a compelling set of growth and increasing gross margin combined with cost discipline.

Operating expenses grew by 6%.

Excluding the impact of the blueprint acquisition operating expenses grew by low single digits, highlighting our cost discipline.

Looking at our year to date progress, while maintaining strong earnings momentum with 9% growth on business EPS growing faster at 12%.

R&D expenses increased by 5% broadly, reflecting the underlying activity level.

It fully supports our guidance for the full year and demonstrate our ability to deliver profitable growth consistently.

We continue to invest in sales and marketing to support our balance sheet.

First I know you have to that performance, we reiterate our full year guidance of high single digit sales growth and low double digit business EPS growth at constant exchange rates.

And G&A were slightly down in line with our objective to keep them broadly stable going forward.

As operating income and expenses are moving up primarily due to the accretion of profit paid but tied to the regimen of rins as duplex to use its current growth trajectory.

We have now completed the acquisitions of <unk> 0201, VGL neuroscience and blueprints and their associated costs are fully factored into our guidance.

Business EPS reached <unk> 91 in euros and robust growth of 19.

While we typically provide full year guidance at the beginning of each year, we can share a few business trends for next year, which you can which you may find useful for modeling purposes.

17% compared to Q3 2024.

Francois: While we typically provide full-year guidance at the beginning of each year, we can share a few business trends for next year, which you may find useful for modeling purposes. R&D next year is expected to increase moderately. We will continue investing in sales and marketing to support our product launches, as well as our strong set of momentum. At the same time, we will remain disciplined on G&A costs, with the objective to keep them broadly stable. We expect to achieve around half a billion EUR of capital gains from divestment, similar to what we anticipate for 2025. Regarding AMVUTTRA royalties, based on the latest EvaluatePharma sales consensus, the implied royalties are now expected around EUR 700 million for next year. You will find a slide with the updated AMVUTTRA royalty considerations reflecting current external consensus in the appendices of this presentation.

François-Xavier Roger: While we typically provide full-year guidance at the beginning of each year, we can share a few business trends for next year, which you may find useful for modeling purposes. R&D next year is expected to increase moderately. We will continue investing in sales and marketing to support our product launches, as well as our strong set of momentum. At the same time, we will remain disciplined on G&A costs, with the objective to keep them broadly stable. We expect to achieve around half a billion EUR of capital gains from divestment, similar to what we anticipate for 2025. Regarding AMVUTTRA royalties, based on the latest EvaluatePharma sales consensus, the implied royalties are now expected around EUR 700 million for next year. You will find a slide with the updated AMVUTTRA royalty considerations reflecting current external consensus in the appendices of this presentation.

This strong performance reflects a compelling set of growth and increasing gross margin combined with disciplined.

R&D next year are you expecting to increase moderately.

Looking at two.

That progress without maintaining strong earnings momentum with 9% growth of business EPS growing faster at 12% it.

We will continue investing in central marketing to support our product launches.

A strong set of momentum.

It fully supports our guidance for the full year and demonstrates our ability to deliver profitable growth consistently.

At the same time, we will remain disciplined on G&A costs with the objective to keep them broadly stable.

We expect to achieve around half a billion euro of capital gains from divestments similar to what we anticipate for 2025.

Based on our year to date performance, we reiterate our full year guidance of high single digit sales growth and low double digit business EPS growth at constant exchange rates.

Regarding <unk> royalties based on the latest evaluate pharma sales consensus <unk>.

We have now completed the acquisitions of <unk>, 0201, Vg neuroscience and blueprints and their associated costs are fully factored in items.

Implied royalties are now expected to around 700 million euros for next year, you will find the slides music updated <unk> royalty considerations, reflecting current external consensus in the appendices of this presentation.

While we typically provide full year guidance at the beginning of each year, we can share Oculus transform next year, which you can which you may find useful for modeling purposes.

Another indicator for 2020, Cts a reduction of approximately.

Francois: Another indicator for 2026 is a reduction of approximately EUR 300 million reimbursement from Regeneron for the R&D balance. Both item and AMVUTTRA gains and reduced Regeneron R&D reimbursements will offset each other next year. We continue to execute our capital allocation policy. We remain disciplined and balanced across four priorities: Investing in organic growth drivers, pursuing selective bolt-on acquisitions, maintaining our policy of progressive dividends, and executing opportunistic share buybacks. Based on our projected trajectory for 2026 and beyond, we remain confident in our ability to sustain our profitable growth momentum for the next few years. I now hand over to Houman to provide an update on the progress of our innovative pipeline.

François-Xavier Roger: Another indicator for 2026 is a reduction of approximately EUR 300 million reimbursement from Regeneron for the R&D balance. Both item and AMVUTTRA gains and reduced Regeneron R&D reimbursements will offset each other next year. We continue to execute our capital allocation policy. We remain disciplined and balanced across four priorities: Investing in organic growth drivers, pursuing selective bolt-on acquisitions, maintaining our policy of progressive dividends, and executing opportunistic share buybacks. Based on our projected trajectory for 2026 and beyond, we remain confident in our ability to sustain our profitable growth momentum for the next few years. I now hand over to Houman to provide an update on the progress of our innovative pipeline.

100 million reimbursements from region around the R&D balance.

R&D next year are you expecting to increase moderately.

We will continue investing in sales and marketing to support our product launches as.

Both <unk> and <unk> gains and reduce our regimen around R&D reimbursements will offset each other next year.

Whereas a strong set of momentum.

At the same time, we will remain disciplined on G&A costs with the objective to keep them broadly stable.

We continue to execute our capital allocation policy, and we remain disciplined and balanced across four priorities.

We expect to achieve around half a billion euro of capital gains from divestments similar to what we anticipate for 2025.

Investing in organic growth drive aisles pursuing selective bolt on acquisitions, maintaining our policy of progressive dividends and executing opportunistic share buybacks.

Regarding <unk> strong royalties that based on the latest evaluate pharma sales consensus is the implied royalties are now expected to around 700 million euros for next year, you will find the slides with the updated <unk> royalty considerations, reflecting current external consensus in the appendices of the year.

Based on our projected trajectory for 2026 and beyond we remain confident in our ability to sustain our profitable growth momentum momentum for the next few years.

I'll now hand over to Matt to provide an update on the progress of our innovative pipeline.

Some patients.

And those are in 2026 is a reduction of approximately.

Thank you Francois and lead to share our Q3 pipeline achievements with progress in mini program.

Houman Ashrafian: Thank you, Francois. I'm pleased to share our Q3 pipeline achievements with progress in many programs. We received regulatory approval for Wayrilz in the United States and ITP and T-heal in China. We received regulatory submission acceptances for Dupixent CSQ in children in the US and in the EU. The FDA nominated T-heal to the new Commissioner's National Priority Voucher Program to speed up the review. Wayrilz ITP was submitted in Japan, and Sarclisa subcutaneous was accepted globally in myeloma. Our phase 3 programs have delivered successful readouts, with amlitelimab meeting the primary endpoint in the phase 3 study in atopic dermatitis, test one, and Fluzone High-Dose in people 50 years and above. We also commenced dosing first patients in new phase 3 studies, either the 2 studies for linzecumig in COPD and Wayrilz in sickle cell disease and warm autoimmune hemolytic anemia.

300 million reimbursements from registered around property R&D balance.

We received regulatory approvals for <unk> in the United States and ICP in seed yield in China. Further we received regulatory submission acceptances the depiction CSU in children in the U S and in the EU the knowing that the economic yield for the new commissioners national priority voucher program to speed up.

Both sides <unk> gains and reduce our R&D reimbursements will offset each other next year.

We continue to execute our capital allocation policy and we remain disciplined on balance across four priorities investing in organic growth drive aisles pursuing selective bolt on acquisitions, maintaining our policy of progressive dividends.

To review <unk> ATP resubmitted in Japan, Takeda subcutaneous is accepted globally in myeloma.

Executing opportunistic share buybacks.

Our phase III programs have delivered successful readout.

But he has done a projected trajectory for 2026 and beyond we remain confident in our ability to sustain our profitable growth momentum momentum for the next few years.

With Amylin Telematic meeting the primary endpoint in the phase III study in atopic dermatitis case, one and fleet on high days and people 50 years and a half.

We also commenced dosing the first patient in new Phase III studies the.

I'll now hand over to Matt to provide an update on the progress.

The two studies for <unk>, secondly, can COPD and <unk> in sickle cell disease, and warm autoimmune hemolytic anemia.

<unk> pipeline.

Thank you Francois and lead to share our Q3 pipeline achievements with progress in many program.

Finally way relative to the margin as multimedia modulation platform and rare diseases with an approval in the U S.

We received regulatory approvals for <unk> in the United States, and ICP and peak yield in China. Further we received regulatory submission acceptances the depiction CSU in children in the U S and in the EU to nominate the SBA nominal yield for the new national priority voucher program to speed up.

Houman Ashrafian: Finally, Wayrilz is emerging as a multi-immune modulation platform in rare diseases with an approval in the US and a positive recommendation in the EU for ITP. Multiple designations across new indications, further strengthening our rare disease portfolio. Please turn to the next one. Moving to dermatology, amlitelimab met all primary and secondary key endpoints in the first phase 3 study in AD. Data demonstrated clinically meaningful improvement in several measures of skin clearance. As an example, looking at the vIGA measure, the efficacy progressively increased and showed no plateau at 24 weeks. Further, amlitelimab offers patient-friendly quarterly dosing. There were no new safety concerns identified in this study. OCEANA AD is a comprehensive program including 5 phase 3 studies in adults and adolescents, biologic experienced patients, and across different geographies. We anticipate full data to report out throughout 2026.

Positive recommendation in the EU for IPP multiple designations across new indications such as strengthening our rare disease portfolio. Please.

Please turn to the next.

Moving to dermatology and the telecom met all primary and secondary key endpoints.

<unk>.

<unk> ITT submitted in Japan.

<unk> III <unk>.

The subcutaneous is accepted globally.

Data demonstrated clinically meaningful improvement in several measures of skin clearance as an example, working with Iga measure the efficacy progressively increase and showed no plateau at 24 weeks.

Our phase III programs have delivered successful readouts.

Ambulatory not meeting the primary endpoint in the phase III study in atopic dermatitis scopes, one and fleet on high days and people 50 years and above.

Further I'm going to tell my pop is patient friendly quarterly dosing.

We also commenced dosing the first patient in new Phase III studies, one of the two studies and second making sure PD and <unk> in sickle cell disease, and warm autoimmune hemolytic anemia.

No new safety concerns identified in this study.

As Shannon.

Hence it program, including five phase III study in adults and adolescence.

Finally way relative to emerging as multi immune modulation platform and rare diseases with an approval in the U S and a positive positive recommendation in the EU for IPP multiple designations across new indications further strengthening our rare disease portfolio.

<unk> experienced patients and across different geographies, we anticipate full data to report out throughout 2026.

For us that can make our TNF alpha and ox 40 ligand antibody achieved its primary objective and our phase Iia study NHS, we observed clinically meaningful improvements in both primary and secondary endpoints and biologically 90 patients at week 16 or that can make was well tolerated data were presented at AAD in Paris in September where I also.

Houman Ashrafian: Brevecamig, our TNF alpha and OX40 ligand Nanobody, achieved its primary objective in a phase 2a study in HS. We observed clinically meaningful improvements in both primary and secondary endpoints in biologically naive patients at week 16. Brevecamig was well tolerated. Data were presented at EADV in Paris in September, where I also had the pleasure to meet many of you at our IR roundtable. Our phase 2b study is now starting its recruitment. Please turn to the next slide. Moving to respiratory, amlitelimab is showing intriguing efficacy in its phase 2 study in asthma, thinking in a difficult-to-treat subgroup. While the primary endpoint of annualized asthma exacerbation rate reduction at week 48 did not reach statistical significance at the highest dose, notable improvements were observed in key secondary.

Please turn to the next.

Moving to dermatology and literally have met all primary and secondary key endpoints first phase III study.

Data demonstrated clinically meaningful improvement in several measures of skin clearance as an example, looking at the <unk> the efficacy progressively decreased and showed no.

I've had the pleasure to meet many of you at our IR Roundtable I'll pay TV study now starting gets recruited.

Please turn to the next slide.

2014.

Moving to respiratory and the Telemark wish him intriguing efficacy in its phase two study in asthma and kind of difficult to treat type group, while the primary endpoint annualized asthma exacerbation rate reduction at week 48 did not reach statistical significance at the highest dose notable improvements were observed and Keith.

Not all patients.

Patient friendly quarterly dosing.

Safety concerns identified.

Okay.

A comprehensive program, including five phase III study in adult and adolescent biologic experienced patients and across different geographies, we anticipate full data to report out throughout 2026.

The heterogeneous inflammation subgroup of patients with high blood eosinophils greater than 300 cells per microliter and elevated neutrophil at greater than 4000 cells per microliter showed the greatest benefit treatment was well tolerated with no new safety concerns were still analyzing the study data, including Biomarkers next.

Houman Ashrafian: The heterogeneous inflammation subgroup of patients with high blood eosinophils greater than 300 cells per microliter and elevated neutrophil at greater than 4,000 cells per microliter showed the greatest benefit. Treatment was well tolerated with no new safety concerns. We're still analyzing this study data, including biomarkers. Next steps will be subject to prioritizations within our overall respiratory portfolio. We're pleased by the recent efdoralprin alfa data, which showed superiority to the standard of care in the phase 2 study to alpha-1 antitrypsin deficiency emphysema. The recombinant protein has a longer half-life and could provide higher AAT serum levels with less frequent dosing of either once every 3 or 4 weekly. A phase 2 open-label study is currently ongoing, which will add to the safety data.

That can make our TNF alpha and ox 40 like antibody achieved its primary objective and our phase Iia study NHS, we observed clinically meaningful improvements in both primary and secondary endpoints and biologically naive patients at week 16 or that can make was well tolerated data were presented at ATV in Paris in September where I also.

That will be subject the prioritization within our overall respiratory failure.

Had the pleasure to meet many of you at our IR round table I'll pay TV study is now starting its recruiting.

We are pleased by the recent.

<unk> Alpha data, which showed superiority to the standard of care in phase III study to have one antitrypsin deficiency emphysema. The recombinant protein has a longer half life and to provide high service levels with less frequent dosing.

Please turn to the next slide.

Moving to respiratory and <unk> intriguing efficacy in its phase two study in asthma C kind of difficult to treat sub group, while the primary endpoint of annualized asthma exacerbation rate reduction at week 48 did not reach statistical significance at the highest dose.

He's a once every three or four weekly.

Our phase II open label study is currently ongoing which will add to the safety data. We will now engaged in discussions with regulatory lag and regulatory agencies to see if we can move ahead based on the data we have supported by the upcoming safety studies.

Improvements were observed and Keith.

The heterogeneous inflammation subgroup of patients with high blood eosinophils, Brexit and 300000 per microliter and elevated future sale at greater in the South for Mike really showed the greatest treatment was well tolerated.

Houman Ashrafian: We will now engage in discussions with regulatory agencies to see if we can move ahead based on data we have, supported by the upcoming safety studies. Please turn to the next slide. 212Pb-DOTAMTATE, our radioligand, showed intriguing overall response rate in patients with SMARCAkten receptor-positive, gastroenteropancreatic neuroendocrine tumors, otherwise known as GEP-NETs, a group of difficult to treat rare and metanological cancers. In peptide receptor radio-NUPI-naive patients, the overall response rate was 57.1%, and in PRRT-exposed patients, the overall response was 19.2%. Both measures were based on blinded independent central review. We observed a manageable safety profile that was similar across both cohorts.

It tends to next slide.

Net to <unk> 2008 already ligand showed intriguing overall response rates in patients with somatostatin receptor positive.

No new safety concerns were still analyzing that data and creating fire market next steps will be subject to provide physicians with an overall restructuring of the complaint.

Gastro and pancreatic neuroendocrine tumors, otherwise known as GAAP net group a difficult to treat rat and the technological cancers and peptide receptor radio nuclides FRP naive patients. The overall response rate was 57, 1% and in PRT expectations, Yes.

We are pleased by the recent.

Our friend Alpha data, which showed superiority to the standard of care.

Study, 106% deficiency emphysema.

Pricing has long life.

<unk> response was 19, 2% both measures were based on blinded independent Central review, we observed the manageable safety profile that was similar across both companies.

Hi.

Serum levels with less frequent testing either 143.

I'd say to labels that is currently ongoing.

Immunology overall cannot ton didn't meet the predefined primary endpoint ACR 20, but showed clinically meaningful efficacy in phase II study and uncontrolled advanced treatment naive rheumatoid arthritis patients.

The safety data, we will now engaged in discussions with regulatory regulatory agency to see if we can.

Houman Ashrafian: Immunology, our oral TNF alpha balinatunfib didn't meet the predefined primary endpoint of ACR20, but showed clinically meaningful efficacy in the phase 2 study in uncontrolled advanced treatment-naive rheumatoid arthritis patients on background methotrexate across endpoints requiring a deeper disease control, including ACR15, ACR17. This oral treatment has potential to use it as a combination backbone therapy with internal and external oral medicines, with the next step currently being evaluated. Finally, we are placed to initiate two replicate phase 3 studies of duvakitug in both Crohn's disease and ulcerative colitis. This treatment offers patient-friendly subcutaneous dosing with a potential competitive safety and efficacy by select clearly targeting VC3 receptor. This follows the positive phase 2 data that read out last year and were presented in the ECHO meeting this year. Next slide, please.

Can move ahead based on the data we have supported by the upcoming safety studies.

Please turn to next slide.

Methotrexate across endpoints recording packages can grow in <unk>.

Led to 212 <unk> already answered it intriguing April response rates in patients with somatostatin receptor positive cash.

<unk> ACL 15, Asia 17, oral this oral treatment has the potential to use it.

Castro.

And your endocrine tumors, otherwise known as GAAP.

A combination background therapy, but internal and external medicines for the next debt currently being evaluated finally were placed initiative to replicate phase III study that you are accurate in both crohn's disease, and ulcerative colitis as treatment of this patient friendly subcutaneous dosing with a potential competitor safety and efficacy.

Difficult to treat.

Logical cancers and peptide saturated not radio UK on Saturday night patients. The overall response rate was 57, 1% and in <unk> patients. The overall response was 19, 2%. Both measures were based on blinded independent Central review, we observed the manager.

Are you targeting.

D C D C III receptor with Polaris the positive phase two data read out last year and were presented at that meeting.

<unk> safety profile was similar across both counties.

Monology oral TNF alpha ton didn't meet the predefined primary endpoint ACR 20, but showed clinically meaningful efficacy in our phase II study and uncontrolled advanced treatment naive rheumatoid arthritis patients on background methotrexate across endpoints, requiring a deeper disease control, including ACR 15 ACI.

Next slide please as a completion, let me share a stay.

<unk>.

Houman Ashrafian: As a conclusion, let me share a status of our key mid and late-stage development projects. Our immunology pipeline includes medicines with available data such adalimumab's Phase 3 program in AD, with further potential lifecycle management. Secukinumab in Phase 2 in different asthma patient subgroups and potential LCM such as COPD, as well as brivekimig in HS and others in mid-stage development, some of which I covered earlier, like alemtansib and duvelisib. On itolizumab, I can share that a decision to move forward in COPD will be made subject to regulatory discussions and in collaboration with our valued partner, Regeneron. In rare diseases, Waylivra is now approved for ITP in the US, with potential for multiple new indications. venglustat currently in Phase 3 for Fabry disease and Gaucher disease type 3.

Key mid and late stage development projects.

Our immunology pipeline includes medicines with enabled data such analytical maps phase III program in <unk> with further potential lifecycle management second make in phase III and different asthma patient subgroups and potential LCM, such as COPD as well as for vacuum make in Hs and others and this take development some of which I covered earlier.

So all this oral treatment has the potential to use it.

As a combination.

<unk> therapy with internal and external oral medicines for the next step currently thinking that way.

Like elements uncertainty Patrick.

Finally, we have placed initial two replicate phase III study with <unk> and both Crohn's disease, and ulcerative colitis as treatment of this patient friendly subcutaneous dosing with a potential competitor safety and efficacy by selectively targeting.

On the Quebec, Matt I can share that a decision to move forward and CFPB will will be made subject to regulatory discussions and in collaboration with our valued partner Regeneron and rare diseases. <unk> is now approved in the U S with potential for multiple new indications Bengal.

Deep Sea <unk>.

<unk> three receptor.

Currently in phase III for Fabry disease, and Kashi the tax rate and lastly at dollar print outside successful in phase III for half one antitrypsin deficiency with encouraging update just the other day.

You guys hit around last year and were presented at that time.

Next slide please.

Houman Ashrafian: Lastly, F-dolaprin alpha successful in Phase 2 for alpha-1 antitrypsin deficiency with encouraging update just the other day. Sarclisa is well underway with a subcutaneous formulation already approved across different lines and combination regimens in multiple regions, and 212Pb-DOTAMTATE in GEP-NET with data this week at ESMO. In neurology, tolebrutinib is on review for SPMS with a revised PDUFA date of 28 December, and in Phase 3 for primary progressive multiple sclerosis with a readout before the end of the year. Lastly, frexalimab is in Phase 3 for relapsing-remitting multiple sclerosis and SPMS 2. riliprubart in 2 Phase 3 studies for chronic inflammatory demyelinating polyneuropathy. In vaccines, we have multiple Phase 3 programs underway, such as rabies, V 21, yellow fever vaccine, and broad opportunities in flu. Flu COVID-19 combinations and pandemic flu right behind, as Paul covered earlier in his.

Sure.

David.

He mid and late stage development projects.

So please as well underway and the subcutaneous formulation already approved across different lines in combination regimen in multiple regions and led to unseat automate and get matched with data this week.

Our immunology pipeline includes medicines with available data such analytical match phase III program in <unk> with further potential lifecycle management second make in phase III and different asthma patient subgroups and potential LCM, such as COPD as well as prevent can make in Hs and others in mid stage development, some of which I covered earlier.

And the neurology Halliburton to become review for CMS with a revised <unk> date of December 28, and then phase III primary progressive multiple sclerosis, with a retail readout before the India, France Allomap is in phase III for relapsing remitting multiple sclerosis, and Spi two and lastly, really pre bought in two phase III studies.

Like Albert <unk>.

On the topic I'm happy to share that a decision to move forward in COPD will be made subject to regulatory discussions and <unk> in collaboration with our valued partner Regeneron and rare diseases. <unk> is now approved in the U S with potential for multiple new indications Bengal is currently.

Nick inflammatory demyelinating Polyneuropathy finally in vaccines, we have multiple phase III programs underway such as Randy.

Currently in phase III for Fabry disease, and Kashi the tax rate and lastly at dollar print alpha successful in phase III for Alpha one antitrypsin deficiency with encouraging update just the other day.

The 21, yellow fever vaccine a broad opportunity in flu.

Fluid Covid combination and pandemic flu right behind as Paul covered earlier.

So please it is well underway and the subcutaneous formulation already approved the different mines in combination regimens.

Next slide.

On my last slide I plan to cover my usual news flows.

Houman Ashrafian: Next slide, please. On my last slide, I plan to cover my usual newsflow of newsflow slide for the remaining three months of the year and all of 2026. The last significant items for 2025 are US decisions on tolebrutinib in SPMS, a phase 2 readout in PPMS, and multiple regulatory decisions. Next year, we expect the remaining phase 3 readouts for adalimumab in AD. In rare diseases, we also expect venglustat phase 3 readouts in 2 indications. In all cases, if positive, regulatory submissions will follow later in the year. In addition, we anticipate multiple regulatory submissions based on data we've already received this year, as well as regulatory decisions for medicines and vaccines under review.

News for a slide for the remaining three months EMEA and all of 2026.

Regions led to unseat automate and getting that data.

Lost significant access to 25 in the U S decisions on Britain, Netherlands.

And in urology calibrating the EMS.

Good day to December 2000.

Phase III readouts in Pts and multiple regulatory decisions.

And in phase III for primary progressive multiple sclerosis, where the <unk> readout for the India, France Allomap is in phase III for lapsing remitting multiple sclerosis, and ESPN, two and lastly, really pre bought in two phase III studies the chronic inflammatory.

Next year, we expect our manufacturing and.

<unk> and <unk>, we also expect Tango stat since you Readouts in two indications in all cases its positive regulatory submissions will follow later in the year. In addition, we have multiple regulatory submission based on data. We have already received this year on the regulatory decisions the medicines and vaccines under review.

Before I close my sincere thanks.

Or color you can sign up your R&D, who share my commitment to improve science and therapy and help advance our pipeline further.

Houman Ashrafian: Before I close, my sincere thanks to all colleagues in Sanofi R&D who share my commitment to improve science in Sanofi and help advance our pipeline further, from new initiatives in re-research all the way to regulatory approval. With this, I hand back to Paul.

New initiatives research all the way through regulatory approval with this I hand back to Paul.

Okay. Thank you, we'll now open the call to your questions. As a reminder, we would ask you to limit your questions to one or two equal.

[Company Representative] (Sanofi): Okay. Thank you, Eamonn. We'll now open the call to questions. As a reminder, we would ask you to limit your questions to one or two each. You'll be notified when your line is open to ask your question. At that time, please make sure you unmute your microphone. Or option 2, submit your question by clicking the Q&A icon at the bottom of the screen. Your question will be read by our panelists. We will take the first question. Please go ahead.

Paul Hudson: Okay. Thank you, Eamonn. We'll now open the call to questions. As a reminder, we would ask you to limit your questions to one or two each. You'll be notified when your line is open to ask your question. At that time, please make sure you unmute your microphone. Or option 2, submit your question by clicking the Q&A icon at the bottom of the screen. Your question will be read by our panelists. We will take the first question. Please go ahead.

You'll be notified when your line is open to ask your question at that time, Please make sure you unmeet microphone.

Our option to submit your questions by clicking the Q&A button at the scale. The question will be read by a panelist.

We will take the first question. Please go ahead first question from Sachin Jain from wholesale.

Operator: Yes. First question from Sachin Jain from BofA. Sachin?

<unk>.

Thanks for taking my questions. So first one I wonder if you just update us on a quarterly estimates are recognizing debates and confidence are solving any questions. The FDA has had what about tonight.

Sachin Jain: Hi there. Thanks for my questions. First one, I wonder if you could update us on the tolebrutinib SPMS regulatory debates and confidence resolving any questions the FDA has had with that delayed PDUFA? The second one, just to make sure there's no confusion in the market given the debates at Q2, can we assume that your wording of profitable growth for 26 means EBIT and EPS ahead of sales? Thank you.

And the second one just to just to make sure. There's no confusion in the market given the debates at Teekay can we assume that you're avoiding of profitable growth for 2000 sites means EBIT and EPS ahead of sales.

Okay. Thank you.

John will provide some clarity on the regulatory piece in Sps.

[Company Representative] (Sanofi): Okay, thank you. Do you want to provide some clarity on the regulatory piece on the SPMS tolebrutinib?

Paul Hudson: Okay, thank you. Do you want to provide some clarity on the regulatory piece on the SPMS tolebrutinib?

Yeah. Thanks for the question pretty straightforward as we reported earlier in the year the FDA.

Houman Ashrafian: Yeah. Thanks for the question. Pretty straightforward. As we reported earlier in the year, the FDA requested an extension. We've submitted datasets with the FDA, continue conversations, and look forward to the PDUFA 28 December.

Requested an extension we've submitted datasets with the FDA continue conversations and look forward to.

Additionally December 28 <unk>.

This unprofitable barrels I confirm that the idea is to have.

[Company Representative] (Sanofi): Thank you. Francois?

Paul Hudson: Thank you. Francois?

Francois: Yes, on profitable growth, I confirm that the idea is to have, as we go down through the P&L, all items growing faster than the upper end of the P&L, which means basically gross margin growing faster than sales growth, BOI growing faster than gross margin, and EPS growing faster than BOI. We have achieved that each and every single quarter this year. We'll do it in 2025. We expect to get there in 2026, and we are working in the same to deliver the same objective for the following years as well.

François-Xavier Roger: Yes, on profitable growth, I confirm that the idea is to have, as we go down through the P&L, all items growing faster than the upper end of the P&L, which means basically gross margin growing faster than sales growth, BOI growing faster than gross margin, and EPS growing faster than BOI. We have achieved that each and every single quarter this year. We'll do it in 2025. We expect to get there in 2026, and we are working in the same to deliver the same objective for the following years as well.

As we go down through the P&L or items growing faster than the upper end of the P&L, which means basically gross margin growing faster than sales growth.

Total gross margin and EPS growing faster than supply, we have achieved that each and every single quarter doesn't share with doing it in 2025, we expect to get there in 2006, and we are working in the summer, but there you go the same objective for the following years as well.

That's very clear. Thank you pencil last question next question is coming we think that from the hand back now.

[Company Representative] (Sanofi): That's very clear. Thank you, Francois. Next question.

Paul Hudson: That's very clear. Thank you, Francois. Next question.

Operator: Next question is from Luisa Hector from Berenberg. Luisa?

Thank you.

The obligatory U S policy question do you have any update on your conversations with the U S administration.

Luisa Hector: Thank you. Perhaps I could ask the obligatory US policy question. Do you have any updates on your conversations with the US administration? Is it more complex for you with shared assets like Dupixent? Should we be concerned about a degree of silence right now, or is it simply that there is more of a bottleneck in terms of a long queue to speak with the administration, maybe Trump's busy agenda? Just any color on that sort of ability to communicate. I'll stop there. Thank you.

Is it more complex you would shed assets like it makes sense.

And then should we be.

About a degree of silence right now or is it simply that.

More of a bottleneck and pass it along to Steve for the administration may be chumps busy agenda, just any color on that sort of ability to communicate.

After that thank you.

Thank you.

I think our answer is pretty straightforward, which is we've had ongoing dialogue with the U S government R&D multiple governments since before we received a letter.

[Company Representative] (Sanofi): Thank you. I think our answer is pretty straightforward, which is we've had ongoing dialogue with the US government and indeed multiple governments since before we received the letter, back at the end of July, I think it was. You know, we focus on making sure that people understand the value we can bring. Those conversations have continued throughout this whole process. So

Paul Hudson: Thank you. I think our answer is pretty straightforward, which is we've had ongoing dialogue with the US government and indeed multiple governments since before we received the letter, back at the end of July, I think it was. You know, we focus on making sure that people understand the value we can bring. Those conversations have continued throughout this whole process. So can't really comment on bottleneck, or other implications. You know, I think that's probably as much as we can say at this point.

Back at the end of July I think it was.

We focus on making sure that people understand the value we can bring.

And those conversations have continued throughout this whole process, so probably comment on bottlenecks or other applications, but.

[Company Representative] (Sanofi): Can't really comment on bottleneck, or other implications. You know, I think that's probably as much as we can say at this point. Okay. Thank you, Luisa. Next question, please.

No I think that's probably as much as we can say at this point.

Okay. Thank you Lisa next question. Please next question Charlie Chen from Barclays.

Paul Hudson: Okay. Thank you, Luisa. Next question, please.

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Operator: Yes. Next question, Xue Chen from Barclays. Shirley?

I can't go Tammy.

Yes.

Hi, Thank you so much for taking my questions.

Xue Chen: Hi. Can you guys hear me?

Emily Field: Hi. Can you guys hear me?

[Company Representative] (Sanofi): Yeah.

Paul Hudson: Yeah.

Xue Chen: Hi. Thank you so much for taking my question. I have a question on BEYFORTUS. As you guys said, the Q3 orders have been impacted by inventory carryover from last season. Could you please give us a sense of how Q4 ordering trends are tracking so far? Are we still expecting a 3 Q, 4 Q equal split? Given the competition that is ongoing, like, how do we see the trastuzumab competition is gonna impact the 4 Q number given we know that, Merck actually entered the market, late-ish in 3Q? We saw very strong growth in ex-US market, and what do you see the opportunities there? What is your overall perspective for BEYFORTUS in 2026? Thank you.

Emily Field: Hi. Thank you so much for taking my question. I have a question on BEYFORTUS. As you guys said, the Q3 orders have been impacted by inventory carryover from last season. Could you please give us a sense of how Q4 ordering trends are tracking so far? Are we still expecting a 3 Q, 4 Q equal split? Given the competition that is ongoing, like, how do we see the trastuzumab competition is gonna impact the 4 Q number given we know that, Merck actually entered the market, late-ish in 3Q? We saw very strong growth in ex-US market, and what do you see the opportunities there? What is your overall perspective for BEYFORTUS in 2026? Thank you.

Have a question all day.

So you guys said.

Q3 orders have been impacted by inventory carryover from last season.

Could you please give us a sense of how Q4 ordering trends are tracking so far and we still.

<unk> equal.

And also given the competition that is ongoing.

Let me see the SaaS program that competition is going to impact the <unk> number.

But we know that.

Mark actually entered the market.

Thank you.

And also we saw very strong growth in ex U S market.

And what do you see the opportunity there and what is the overall.

Four two.

In 2026.

Thank you.

Okay. So the poll questions Tom for you.

[Company Representative] (Sanofi): Okay. The four questions, Thomas, for you.

Paul Hudson: Okay. The four questions, Thomas, for you.

Rich question. Thank you very much Julie.

[Company Representative] (Sanofi): Great question. Thank you very much, Xue Chen. Maybe a couple of points to address these different elements. Thanks for giving an eye to the BEYFORTUS performance in Q3. As usual, there's a few points of highlight. First of all, overall for BEYFORTUS, you saw that we increased our performance versus last year. We have done that notably by extending the penetration to about 40 countries. Now, in your question, there were some geographic elements to it. On the US part, yes, absolutely. You're correct on what's going on in the US. Yes, we do confirm the guidance that we had provided at last quarter, at Q4.

Thomas Triomphe: Great question. Thank you very much, Xue Chen. Maybe a couple of points to address these different elements. Thanks for giving an eye to the BEYFORTUS performance in Q3. As usual, there's a few points of highlight. First of all, overall for BEYFORTUS, you saw that we increased our performance versus last year. We have done that notably by extending the penetration to about 40 countries. Now, in your question, there were some geographic elements to it. On the US part, yes, absolutely. You're correct on what's going on in the US. Yes, we do confirm the guidance that we had provided at last quarter, at Q4.

Maybe a couple of points to address these different emmet.

So getting a 92.

And in Q3.

It's a few points of highlights first of all overall.

You saw that we increased our performance versus last year.

And we have done that to notably by extending the penetration to about 40 countries now.

Question <unk>.

Geographic elements to it.

The U S. Part, yes, absolutely you are correct on that.

What's going on in the U S and yes, we do confirm the guidance provided last quarter.

Q4, we expect it to be roughly in the same order of magnitude that your sweet spot they sell to some of the order.

[Company Representative] (Sanofi): We expect it to be roughly in the same order of magnitude by Q3 for BEYFORTUS overall, for global BEYFORTUS performance. The second point, I think you wanted to mention a couple of points on the environment and the competition. Without talking about the competition specifically, because we don't do that, maybe I can say a few words on the fact that actually, if you look at last year, 2024, first year of full supply and BEYFORTUS was a blockbuster. You remember that if you look at the US performance, the total IV coverage rate of all babies in the US was around 55% for all RSV solutions available. Roughly 55% of babies were getting some form of RSV protection.

Thomas Triomphe: We expect it to be roughly in the same order of magnitude by Q3 for BEYFORTUS overall, for global BEYFORTUS performance. The second point, I think you wanted to mention a couple of points on the environment and the competition. Without talking about the competition specifically, because we don't do that, maybe I can say a few words on the fact that actually, if you look at last year, 2024, first year of full supply and BEYFORTUS was a blockbuster. You remember that if you look at the US performance, the total IV coverage rate of all babies in the US was around 55% for all RSV solutions available. Roughly 55% of babies were getting some form of RSV protection.

So global fulfillment. This thing on the point that you wanted to mention it.

On the environment.

And the competition without talking about the comprehensive specifically because we don't do that maybe I can say a few words on the fact that actually if you look at.

Last year 2024.

First year of full supply and <unk> was a blockbuster you'll remember that if you look at the U S. The total level coverage rate of all babies in the U S was around 55% all RSV solutions available roughly 55% of baby, we're getting some some pharma R&D reputation we read.

<unk> in 2025, and I think we will be focused in 2018 to increasing that definition colored rate, we expect 2025 to land around 70% adhesion COVID-19 in the U S and thats.

[Company Representative] (Sanofi): We're really focused in 2025, I think we will be focused in 2026 to increasing that vaccination coverage rate. We expect 2025 to land around 70% vaccination coverage rate in the US. That's, therefore, we're welcoming all efforts from everywhere to make sure that we increase the importance of awareness. What we are seeing in the signals in the US is that by far, BEYFORTUS is the favored product, the favored prescription from US prescribers simply due to the fact that it's highly differentiated with an extended half-life of 71 days. It makes it by far the longest-acting monoclonal antibodies for the prevention of RSV. It has an incredible real-world evidence behind it. That's very important going forward.

Thomas Triomphe: We're really focused in 2025, I think we will be focused in 2026 to increasing that vaccination coverage rate. We expect 2025 to land around 70% vaccination coverage rate in the US. That's, therefore, we're welcoming all efforts from everywhere to make sure that we increase the importance of awareness. What we are seeing in the signals in the US is that by far, BEYFORTUS is the favored product, the favored prescription from US prescribers simply due to the fact that it's highly differentiated with an extended half-life of 71 days. It makes it by far the longest-acting monoclonal antibodies for the prevention of RSV. It has an incredible real-world evidence behind it. That's very important going forward.

Hello and welcome.

Efforts from everywhere to make sure that we increase the importance of O&M, what we're seeing in the signal in the USA, but by far.

<unk> is a FINRA.

The attention on the U S.

The bird simply due to the timing highly differentiated with an extended half life of 71 days. It makes it by far the longest acting antibodies for the prevention of RSV.

<unk> 20 billion in real World evidence.

So that's very important.

Okay. Thanks.

Thank you.

Next question. Please next question, Matt Weston from UBS Matthew.

[Company Representative] (Sanofi): Okay. Thank you. Next question, please.

Paul Hudson: Okay. Thank you. Next question, please.

Operator: Yes. Next question, Matthew Weston from UBS. Matthew?

Thank you two questions. Please.

Matthew Weston: Thank you. Two questions, please. Francois, I'm gonna buck the trend. Most people ask 2026 guidance questions, I'm gonna ask a 2027 guidance question. Slide 29 flags the Regeneron R&D reimbursement stepping down. It's something that's been familiar, I think, for many people for a while, but maybe not fully reflected in consensus. The step-down is actually much greater in 2027 than in 2026, and your slide implies about a half a billion EBIT gap in 2027. I'm just trying to understand, are there any additional levers within manufacturing gross margin or the business that could help mitigate that? Or that's something that we've just gotta get prepared for, even though it's a year and a half away. Then one for Houman. You set out your enthusiasm for amlitelimab.

So I'm going to Buck that trend by people. After 2026 guidance question. So I'll go after 2027 guidance question.

Slide 29, flex and reach their own R&D.

R&D reimbursements stepping down its something thats been familiar I think for many people for a while but maybe not fully reflected in consensus.

The step down is actually much greater than 2007 than in 2006 in your slide implies about a half a billion EBIT gap in 2007, I'm just trying to understand are there any additional levers with a manufacturing gross margin of the business that could help mitigate that or that's something that we just got to get prepared for even better.

Year and a half away.

And then one for human.

You set out your enthusiasm for our <unk>.

Lilly has just reported findings from the phase III adjoining extension study at cliffs, which looks like Q eight week dosing and shared very limited erosion and efficacy I'd be very interested if you think that limits. The differentiation primarily telematics why you are aiming for your 12 weeks could be differentiated thank you.

Matthew Weston: Lilly has just reported the findings from the phase 3 ADJOINT extension study for Ebglyss, which looked at Q 8-week dosing and showed very limited erosion in efficacy. I'd be very interested if you think that limits the differentiation for amlitelimab, where you were aiming for your 12-week to be differentiated. Thank you.

Okay. Thank you Francois you want to catch that and then maybe Brian on human dependent.

[Company Representative] (Sanofi): Okay, thank you. Francois, you wanna catch that? Maybe Brian and Houman, depending. Yeah.

Paul Hudson: Okay, thank you. Francois, you wanna catch that? Maybe Brian and Houman, depending. Yeah.

But you I think that this is a good question for 2027, Indeed, and which is what I presented in the last call at the end of July. The fact, Thats moved 2026, we will have we will lose about <unk> <unk>.

[Company Representative] (Sanofi): Yes, Matthew. I think that this is a good question for 2027 indeed, which is what I presented in the last call at the end of July. The fact that in 2026, we will lose about EUR 300 million of R&D reimbursement from Regeneron. As I said a few minutes ago, it will be entirely offset by the additional royalties that we will receive from AbbVie. In 2027, indeed, we will have a much more significant amount of R&D reimbursement in terms of decrease, because we will lose EUR 800 million from one year to the other. This will not be fully offset in 2027 by the additional AbbVie royalty, which will be around EUR 300 million, which is in one of my appendices in this presentation as well.

François-Xavier Roger: Yes, Matthew. I think that this is a good question for 2027 indeed, which is what I presented in the last call at the end of July. The fact that in 2026, we will lose about EUR 300 million of R&D reimbursement from Regeneron. As I said a few minutes ago, it will be entirely offset by the additional royalties that we will receive from AbbVie. In 2027, indeed, we will have a much more significant amount of R&D reimbursement in terms of decrease, because we will lose EUR 800 million from one year to the other. This will not be fully offset in 2027 by the additional AbbVie royalty, which will be around EUR 300 million, which is in one of my appendices in this presentation as well.

R&D reimbursement from rental demand and as I said, a few minutes ago, it's going beyond totally offset by the additional royalty that we would receive from a food hall in 2027, Indeed, we will have a much more significant amount of.

R&D reimbursement.

When we lose 800 million from one year to the other and this will not be fully offset in 2027 five.

The shortfall in Bhutan royalties, which would be around from $5 million, which is one of my.

<unk> in this presentation as well so we'd have a gap indeed up about half a billion.

[Company Representative] (Sanofi): We'll have a gap indeed of about EUR half a billion. Will we be able to cover it with other exceptional items or, let's say, non-recurring item? The answer is no. That being said, I mean, we will continue growing at a reasonable pace as well, so. I said it last time that.

We'd be able to cover it with other exceptional items, though that's a nonrecurring item. The answer is no that being said I mean, we will continue growing at a reasonable pace as well so and I said it last time that.

François-Xavier Roger: We'll have a gap indeed of about EUR half a billion. Will we be able to cover it with other exceptional items or, let's say, non-recurring item? The answer is no. That being said, I mean, we will continue growing at a reasonable pace as well, so. I said it last time that.

There was one year, where we weren't sure about increasing our profitability and deliver profitable growth.

[Company Representative] (Sanofi): If there was one year where we were not sure about increasing our profitability and deliver this profitable growth, it would be 2027 for that same reason. That being said, I repeat what I said last quarter, which is we expect our BOI to increase in absolute value in 2027 in spite of this impact. We will be able, in absolute value, to cover the gap, the EUR 500 million gap. Most probably, I believe that we may be in a position, it's still early to say, to even increase our profitability in terms of BOI in 2027 as well. I say we may be. Still very early. We have not even completed our 2026 budget, so I want to be careful.

François-Xavier Roger: If there was one year where we were not sure about increasing our profitability and deliver this profitable growth, it would be 2027 for that same reason. That being said, I repeat what I said last quarter, which is we expect our BOI to increase in absolute value in 2027 in spite of this impact. We will be able, in absolute value, to cover the gap, the EUR 500 million gap. Most probably, I believe that we may be in a position, it's still early to say, to even increase our profitability in terms of BOI in 2027 as well. I say we may be. Still very early. We have not even completed our 2026 budget, so I want to be careful. Directionally, there is probably a possibility, largely as a consequence of the gross leverage that we will get from superior growth.

2027.

Same reason ethane.

Said and I will repeat what I said last quarter, which is we expect our <unk> to infringe in absolute value in 2007. Despite these impacts will be dearborn in absolute value to cover the gaps you $500 million gap and most probably I believe that we may be in a position still early to say to even increase our profitability.

In terms of BYD in 2007 as well.

So we may be still very early we have not even completed about 2026 budge. So I won't to careful but directionally there was probably a possibility largely as a consequence of.

[Company Representative] (Sanofi): Directionally, there is probably a possibility, largely as a consequence of the gross leverage that we will get from superior growth.

The gross leverage that we would get from Chicago growth.

Okay. Thank you maybe Brian first amendment, yes.

[Company Representative] (Sanofi): Okay, thank you. Maybe Brian first and then Houman.

Paul Hudson: Okay, thank you. Maybe Brian first and then Houman.

Yes, I think for Great question. Thank you very much I think as you look at the marketplace. We've always said this is a marketplace is going to continue to grow the bio penetration rates extremely low at just over 14% so more assets coming into the marketplace will only help the marketplace grow as you can see from our growth today than it takes in a market that product it's already on the marketplace. It's benefiting from other therapies come into the marketplace.

[Company Representative] (Sanofi): Great question. Thank you very much. I think as you look at the marketplace, we've always said, this is a marketplace that's going to continue to grow. The biopenetration rate's extremely low, just over 14%. More assets coming into the marketplace will only help the marketplace grow. As you can see from our growth today in Dupixent, a market, a product that's already on the marketplace is benefiting from other therapies coming into the marketplace. That said, one thing that we've said consistently for a very long time, these IL-13s are incomplete therapies, and we've seen them on the market now. Actually, if you look at Lebry, that's been on the market for nearly a year now, has single-digit share. We're seeing while it's helping grow the marketplace, it's really not taking very much share from Dupixent.

Brian Foard: Great question. Thank you very much. I think as you look at the marketplace, we've always said, this is a marketplace that's going to continue to grow. The biopenetration rate's extremely low, just over 14%. More assets coming into the marketplace will only help the marketplace grow. As you can see from our growth today in Dupixent, a market, a product that's already on the marketplace is benefiting from other therapies coming into the marketplace. That said, one thing that we've said consistently for a very long time, these IL-13s are incomplete therapies, and we've seen them on the market now. Actually, if you look at Lebry, that's been on the market for nearly a year now, has single-digit share. We're seeing while it's helping grow the marketplace, it's really not taking very much share from Dupixent.

That said one thing that we've said consistently for a very long time. These io thirteen's are incomplete therapies and we've seen them on the market now actually if you look elaborate thats been on the market for nearly a year now as single digit share. So we're seeing while it's helping grow the marketplace rollout taking very much share from depicts it depicts we believe still has a very strong profile.

In each to the still have these dosing ranges that are either two weeks or at best four weeks is what we're seeing right. Now. So we think that there is a lot of room for a much more durable dose in the marketplace, assuming we finish the regulatory trials and get it to the marketplace.

[Company Representative] (Sanofi): Dupixent, we believe, still has a very strong profile. Each of these still have these dosing ranges that are either 2 weeks or, at best, 4 weeks is what we're seeing right now. We think that there's a lot of room for a much more durable dose in the marketplace, assuming we finish the regulatory trials and get it to the marketplace for Nina or for.

Brian Foard: Dupixent, we believe, still has a very strong profile. Each of these still have these dosing ranges that are either 2 weeks or, at best, 4 weeks is what we're seeing right now. We think that there's a lot of room for a much more durable dose in the marketplace, assuming we finish the regulatory trials and get it to the marketplace for Nina or for.

Sure.

Hey, Matt.

Just Matt to answer the question as well as the pipeline.

[Company Representative] (Sanofi): Houman, yeah, no.

Paul Hudson: Houman, yeah, no.

Houman Ashrafian: Just, Matt, to answer your question as well as the BiPen comment, which is important. This is a totally novel mechanism, an apical node in immune response with not only durability but multiple differentiating factors. We remain based on the data, actually, the sort of the case study, encouraged by the potential for Hamlin.

Comment which is important.

Totally novel mechanism.

In April, noting the immune response with not only driving multiple differentiating factors, we remain based on the data actually the PK.

On the study.

Encouraged by the potential for.

Great. Thank you next question, Yes next question from Seamus Fernandez from Guggenheim Seamus.

[Company Representative] (Sanofi): Great. Thank you. Next question.

Paul Hudson: Great. Thank you. Next question.

Operator: Yes. Next question from Seamus Fernandez from Guggenheim. Seamus?

Oh, thanks, very much so just a couple of quick questions.

Seamus Fernandez: Thanks very much. Just a couple of quick questions. Can you just update us on rilzabrutinib and just kind of timing dynamics around that? It's unclear if that's still on track for second half of 2026 readout in CIDP. Just wanted to clarify that. You know, more broadly, just hoping to get a better understanding of when we're going to learn more about the programs that have had kind of unfortunate outcomes, and where a number of programs are under review, including the oral TNF, including itepekimab. It just seems like there's a lot of secondary analysis exploration going on and holding on to assets as part of the pipeline.

Can you just update us on a really prudent art.

And just kind of timing dynamics around that.

It's unclear if that's still on track for second half of 2026 readout and see IDP. So I just wanted to clarify that.

And then more broadly.

Just hoping to get a better understanding of when we're going to learn more about the programs that have had kind of unfortunate outcomes.

And where a number of programs are under review, including the oral TNF, including it.

Any factors, we remain based on the data actually so it's a case study.

Paul Hudson: Hello everyone, this is Thomas Gusladen from.

Houman Ashrafian: The Sanofi IR team.

Paul Hudson: Welcome to the Q3 2025 conference call for investors and analysts. As usual, you can find the slides.

At a pack them out it just seems like there's a lot of secondary analysis exploration going on and holding on to assets as part of the pipeline.

Encouraged by the potential for Hamlin.

Thank you next question, Yes next question from Seamus Fernandez from Guggenheim Seamus.

Houman Ashrafian: On Zenovi.com, please turn to slide number three.

Paul Hudson: Here we have the usual forward-looking statements. We would like to remind you that information presented in this call contains forward-looking statements that are subject to substantial risks and uncertainties that may cause actual.

And I'm, just trying to get a better understanding of when we're going to know the advancement or elimination of some of those assets that haven't quite lived up to at least investor expectations. Thanks.

Oh, thanks, very much. So just a couple of quick questions can you just update us on.

Seamus Fernandez: I'm just trying to get a better understanding of when we're going to know the advancement or elimination of some of those assets that haven't quite lived up to at least investor expectations. Thanks.

A real up regard.

And just kind of timing dynamics around that it's unclear. If that's still on track for second half of 2026 readout can see I D. P. So I just wanted to clarify that and then more broadly.

Houman Ashrafian: Results to differ materially.

Paul Hudson: We encourage you to read the disclaimer in our slide presentation. In addition, we refer you to our.

Okay.

Yes.

François-Xavier Roger: Form 20-F on file with the U.S. SEC.

I'll try and be succinct on this one really pretty boss.

[Company Representative] (Sanofi): Okay. Houman?

Paul Hudson: Okay. Houman?

Houman Ashrafian: Thanks, Seamus Fernandez. I'll try and be succinct on this one. On really three parts, we've updated the timelines at this Q3. The reality is that the outcomes for the two phase 3 studies for CIDP are just creeping over the year. This is purely a patient recruitment phenomenon. And we look forward to seeing the results of those studies. You'll remember the phase 2 studies were extremely encouraging. On your second point about when you will see the data and when we'll make decisions, obviously, those datasets will all be presented at the relevant scientific congresses. I've already announced today that we will go forward subject to regulatory approval with our partners in itepekimab. There's no tardiness there.

Paul Hudson: to our French Universal Registration Document for a description of these risk factors. As usual, we'll be making comments on.

Updated the timelines.

Yes.

Just hoping to get a better understanding of when we're going to learn more about the programs that have had kind of unfortunate outcomes and where a number of programs are under review, including the oral TNF, including at a pack of Mab. It just.

Q3, and the reality is that.

Houman Ashrafian: Our performance using constant exchange rates.

The outcomes of the two phase III studies, plus the IBP I'd, just creeping over the year purely a patient recruitment phenomenon.

Paul Hudson: Other non-IFRS measures. Numbers used are usually in millions of euros and for Q3 2025 unless we state otherwise. Please turn to slide number 4. First we have the presentation and then we take your questions. As usual, we aim at giving it all to one hour, including questions in Q&A. We have Olivier, Brian Foard, and Thomas Gusladen to cover our global businesses, as well as Roy, our General Counsel, and Brendan, Head of Manufacturing and Supply. For the Q&A you have two options in Zoom. Raise your hand.

And we look forward to seeing the results of those studies that Youll remember the phase II studies were.

Extremely encouraging and then.

Seems like there's a lot of secondary analysis exploration going on and holding on to assets as part of the pipeline.

On your second point about when.

When youll see the data room, and we'll make decisions obviously days will.

It will be presented at the relevant scientific Congresses.

I've already announced today.

We will go forward subject to regulatory approval with our partners and it's tech map.

François-Xavier Roger: Submit your question using the Q&A function.

<unk>.

Tardiness that obviously we have to.

Paul Hudson: With this, I'll hand you over to.

Houman Ashrafian: Paul on my left-hand side.

Okay human.

Paul Hudson: Thomas, thank you everyone for joining us today. Our growth momentum continued in Q3 with €12.4 billion in sales, up 7% over last year's high base of comparison. Sales growth was primarily driven by our new launches and the performance of Dupixent, which reached €4 billion in quarterly sales for the first time after the third quarter performance. We are confident in the business outlook for the remainder of the year and reiterate our full year 2025 sales guidance. This positive outlook includes our expectations for the business in the U.S., our largest market by sales. We continue to work with the administration and policymakers in the U.S. and around the world on policies that improve access to treatments, lower prices for patients, improve health systems, and protect science.

Taking regulatory opinion before we move forward.

Houman Ashrafian: Obviously, we have to take a regulatory opinion before we move forward into a replication phase 3. For the other study, I've already alluded to the fact that we will take a portfolio view on asthma with a number of our assets and figure out what we take forward in asthma. On balinatunfib, we've just had access to the results. I've outlined the importance of ACL 50 and 70 and the fact they're clinically meaningful. We'll figure out, as we've always said, we've been consistent in our view that we'll figure out exactly the role of balinatunfib in mono and combination therapy, both with our own molecules and partners.

James.

I'll try and be succinct on this one I'm really pretty vast we've updated the timelines.

<unk> patient phase III, and then to the other studies.

Added to the fact that we will take a portfolio view on asthma with a number of assets and figure out what we take for the vast map and about in the <unk>. We just have access to the results.

Yes.

Q3, and the reality is that.

The outcomes of the two phase III studies for <unk>.

I just creeping over the year. This is purely a patient recruitment phenomenon.

<unk> outlined the importance of ICL $50, <unk> and the fact that clinically meaningful and we'll figure out as we've always said we've been consistent in our view that we'll figure out exactly the wrong balance in mono and combination.

And we look forward to seeing the results of those studies that you'll remember the phase II studies.

Extremely encouraging and then.

Combination therapy, and small molecules and honest.

On your second point about when when when Youll see the data room, and we'll make decisions obviously those datasets when will be presented at the relevant scientific Congresses.

Thank you and thank you Sherry was so great questions.

I think we've seen it with many of our.

[Company Representative] (Sanofi): Thank you. Thank you, Seamus. They're great questions. You know, we've only seen it with many of our competitors having hits and misses in immunology over the last months. That these extra levels of thinking actually are worth doing and stand doing with step because you really do pick the right patient population. Taking time, I think, is wise for us. Next question.

Paul Hudson: Thank you. Thank you, Seamus. They're great questions. You know, we've only seen it with many of our competitors having hits and misses in immunology over the last months. That these extra levels of thinking actually are worth doing and stand doing with step because you really do pick the right patient population. Taking time, I think, is wise for us. Next question.

Competitors, nothing hits and misses in immunology over the last months.

I've already announced today.

Going forward subject to regulatory approval with our partners and it's tech map So theres no.

These extra levels of thinking actually are worth doing the standard stuff.

Paul Hudson: Our recent announcement on the expansion of our patient affordability program offering improved access to all our insulins is a great example of this work, which I'll discuss in a little more detail later in the presentation. Now let me highlight the contribution of our new launches, which have been a significant driver of this quarter's strong performance. Our launches delivered €1.8 billion this quarter, grew more than 40%, and now represent 15% of our total sales. To put this in perspective, our launches represent almost half of Dupixent sales this quarter, demonstrating their significant contribution to our growth. We've strengthened our commercial portfolio with three new additions: Avakit, our medicine for both advanced and indolent systemic mastocytosis; the first cenobi cells of Nuvaxovid, offering an important protein-based and non-mRNA alternative for COVID-19 vaccination; and WAYLIVRA, our new BTK inhibitor designed as a multi-immune modulator.

Tardiness that and obviously we have to.

Because you really do pick the right patient populations.

Taken regulatory opinion before we move forward.

Tom I think it is wise for US next question next question from Simon Baker from Redburn.

Interrent patient phase III and then for the other studies.

I alluded to the fact that we will take a portfolio view on asthma with a number of assets and figure out what we take for divestment.

Operator: Yes. Next question from Simon Baker from Redburn. Simon?

Simon Thank you for taking my questions. Two please firstly on the peaks and troughs. So you said that the.

[Company Representative] (Sanofi): Thank you for taking my questions. Two, please. Firstly, on Dupixent front, you said that the gross margin benefit from manufacturing improvements is now fully being captured. I just wonder if you could give us some idea of the magnitude of the gross margin improvement this quarter, which is down to Dupixent manufacturing. Then a question on indication opportunities.

Simon Baker: Thank you for taking my questions. Two, please. Firstly, on Dupixent front, you said that the gross margin benefit from manufacturing improvements is now fully being captured. I just wonder if you could give us some idea of the magnitude of the gross margin improvement this quarter, which is down to Dupixent manufacturing. Then a question on indication opportunities.

And the <unk>, we've just had access to the results.

The gross margin benefit from manufacturing improvements is now.

I've outlined the importance of ACR, <unk> and <unk> and the fact that clinically meaningful and we'll figure out as we've always said we've been consistent in our view that we'll figure out exactly the role the bottleneck in.

Fully being captured I, just wondering if you could give us some idea of the magnitude of the gross margin improvement this quarter, which is down too.

In mono and combination therapy, spin, alright, and small molecules and Thomas.

Depiction in fracturing.

And then a question on <unk>.

Indication opportunities.

I think human thank you share with your great questions.

You mentioned.

I think we've seen it with many of our.

Bush net increase disease.

Simon Baker: Houman, you mentioned risdiplam in Graves' disease. That's potentially not a particularly rare condition. I just want to get your thoughts on the potential you see there. And also the other one, in light of Moderna's failure this week is CMV vaccination. I know you've been in this space in the 1990s. Just wonder what your level of appetite was for it now. Thanks so much.

Competitors, nothing hits and misses in immunology over the last months.

Potentially not particularly wet condition. So I just wanted to get more thoughts on the potential you see there and also the other one.

These extra levels of thinking actually was doing in center in good stead.

Because you really do pick the right patient populations.

In light of Magennis high this week.

Paul Hudson: This innovative medicine provides a new option for patients with immune thrombocytopenia that extends beyond their platelet count needs to addressing quality of life burdens. We're seeing good uptake across our portfolio of new medicines and vaccines. Beyfortus, which achieved blockbuster status last year in its first full year of sales, continues its expansion into new geographies. ALTUVIIIO is on track to reach blockbuster status this year, and Avakit will become our next blockbuster in 2026. Dupixent has reached a new milestone this quarter, exceeding €4 billion in quarterly sales for the first time. More than eight years after its initial launch in atopic dermatitis, we saw an increase of over 30% in the number of patients during the last 12 months. In the U.S. we surpassed the €3 billion quarterly sales mark, maintaining leadership in both new and total prescriptions across established indications.

Vaccination. Thank you you've been in this space in the nineties.

Tom I think is wise for US next question next question from Simon Baker from Redburn.

Just wondering what your level of appetite more swing so much.

Alright, Thank you Simon pencil and Simon.

Simon Thank you for taking my questions. Two please firstly on depicts some front. So you said that the.

[Company Representative] (Sanofi): All right. Thank you, Simon. Francois?

Paul Hudson: All right. Thank you, Simon. Francois?

The gross margin contribution from the screen manufacturing was actually very neatly into three itself. I mean this is we just took the opportunity to mention that we have completed the full implementation of this new technique, which has probably done a quite a few of those maturities, but it did not have significant impact in Q3 percent I think you're looking at it.

Francois: Yes, Simon. on Dupixent, the gross margin contribution from the C3 manufacturing was actually very limited in Q3 itself. I mean, we just took the opportunity to mention that we have completed the full implementation of this new technique, which has spread over a couple of years, actually. but it did not have a significant impact in Q3, per se. I take the opportunity to mention that our gross margin increased globally for the company by 2.5 percentage points in Q3 and by 1.8 percentage points in H1. Most of the factors are still contributing to it, are still relevant for the future to a certain extent. One of them is volume growth. Our volume grew by 12% since the beginning of the year. We expect to continue at high level.

François-Xavier Roger: Yes, Simon. on Dupixent, the gross margin contribution from the C3 manufacturing was actually very limited in Q3 itself. I mean, we just took the opportunity to mention that we have completed the full implementation of this new technique, which has spread over a couple of years, actually. but it did not have a significant impact in Q3, per se. I take the opportunity to mention that our gross margin increased globally for the company by 2.5 percentage points in Q3 and by 1.8 percentage points in H1. Most of the factors are still contributing to it, are still relevant for the future to a certain extent. One of them is volume growth. Our volume grew by 12% since the beginning of the year. We expect to continue at high level.

The gross margin benefit from manufacturing improvements is now.

Fully being captured I, just wondering if you could give us some idea of the magnitude of gross margin improvement.

And which is down too.

<unk> manufacturing.

And then a question on <unk>.

You mentioned that.

Indication opportunities.

Margin increased nominally from the company by two five percentage points in Q3 and by one eight percentage points in each one.

You mentioned.

Those boots knit and graves disease.

Box potentially not a particularly rare condition. So I just wanted to get your thoughts on on the potential you see there and also the other one in light of medallion is highly this week is CMV vaccination I know you've been in this space in the nineties.

Or would affect us.

Contributing to wheat are still relevant for the future to certain extent one of them is volume growth our volume grew by 12% since the beginning of the year, we expect to continue.

High level.

We used to be benefiting from a positive product mix, including each quarter Iraqi should give ITG is much more significant.

Paul Hudson: Our launches in the recently approved indications COPD, CSU, and BP are progressing as planned. Outside the U.S., sales grew 21%, exceeding €1 billion in the quarter. We continue our efforts to make Dupixent available to more patients, helped by the positive CHMP recommendation for CSU in the EU and regulatory submission for CSU in children in the U.S. and EU. Turning to our vaccine business, Q3 sales were €3.4 billion. This performance compares to a high base in the previous year and reflects the competitive price pressure as well as the lower flu immunization rate in the U.S. A new highlight among our respiratory vaccines is the early start of Nuvaxovid, the only non-mRNA COVID-19 vaccine available in the U.S., and from our collaboration with Novavax, the shipments of Nuvaxovid were delivered in the U.S. in September.

What your level of appetite most right now thanks, so much.

Francois: We are obviously benefiting from positive product mix, including this quarter, Ayvakit. Sure, Ayvakit is much more significant than the new manufacturing technique for Dupixent. We are also obviously benefiting from the industrial restructuring that we did over the last couple of years. Plus there were some one-offs this quarter, last year on this year, which did create a little bit of positive impact as well. If we look at it underlying, because we were at a high range, once again with 2.5 percentage points of increase in Q3. If we exclude the one-offs and some of the items that will not necessarily replicate each and every single quarter, like Ayvakit, for example, you can consider that the underlying gross margin increase that we have experienced since the beginning of the year is around 1 percentage point.

François-Xavier Roger: We are obviously benefiting from positive product mix, including this quarter, Ayvakit. Sure, Ayvakit is much more significant than the new manufacturing technique for Dupixent. We are also obviously benefiting from the industrial restructuring that we did over the last couple of years. Plus there were some one-offs this quarter, last year on this year, which did create a little bit of positive impact as well. If we look at it underlying, because we were at a high range, once again with 2.5 percentage points of increase in Q3. If we exclude the one-offs and some of the items that will not necessarily replicate each and every single quarter, like Ayvakit, for example, you can consider that the underlying gross margin increase that we have experienced since the beginning of the year is around 1 percentage point.

Alright, Thank you Simon a pencil.

Then.

<unk> the gross margin contribution from these three manufacturing was actually very limited in Q3 itself. I mean this is we just took the opportunity to mention that we have completed the full implementation of this new technique, which is spread over a couple of females actually so but he did not have a cheeky began back in Q3 personally I think the opportunity.

New manufacturing techniques for <unk>. We are also obviously benefiting from the industrial restructuring that we did over the last couple of years.

Plus there were some one offs this quarter last year on this year, which lead free.

Created a little bit of positive impact as well if we look at it underlying because we are too high range. Once again with two 5% percentage points of increase in Q3, if we exclude the one offs on some of the items that would not necessarily replicate each and every single quarter like if I keep for example, you can consider.

Did you mention that gross margin increase globally for the company by two five percentage points in Q3 and by.

One eight percentage points in each one but most of the factors are still contributing to eat still relevant for the future to certain extent one of them is as volume grows our volume grew by 12% since the beginning of the year, we expect to continue.

The underlying gross margin increase that we have experienced since the beginning of the year is around one percentage point.

I live on.

So it is obviously before any impact if you want to use that for the future that does not include any potential impact from tariffs.

Obviously benefiting from a positive product mix, including as each quarter should give ITG is much more significant.

Francois: It is obviously before any impact, if you want to use that for the future, that does not include any potential impact coming from tariffs.

François-Xavier Roger: It is obviously before any impact, if you want to use that for the future, that does not include any potential impact coming from tariffs.

Paul Hudson: In RSV, Beyfortus continues its impressive expansion of 20% this quarter and is now available in 40 countries. As you may have seen in our press release this morning, we decided to discontinue our RSV toddler program. While the safety profile was acceptable, the predetermined criteria for efficacy was not met in the planned futility analysis. The PPH and booster franchise remains an important contributor to our vaccine business, with the performance in Q3 reflecting phasing in the first half of the year. Sanofi has a proud legacy in flu vaccines and we remain committed to bringing innovation to strengthen our leadership in flu and to provide better protection for patients. Our Fluzone High-Dose study published in The Lancet last week demonstrated that our high-dose flu vaccine, Fluzone High-Dose, provided superior protection versus standard-dose vaccine on the sometimes devastating consequences of flu.

Then the.

Doug.

New manufacturing technique for <unk>. We are also obviously benefiting from the industrial restructuring that we did over the last couple of years.

Okay Human graves and then Thomas.

[Company Representative] (Sanofi): You don't? Okay. Houman, Graves, and then Thomas, CMV.

Paul Hudson: You don't? Okay. Houman, Graves, and then Thomas, CMV.

Alright, thanks for that insightful question, you'll know races, well established auto antibody related disorder.

Houman Ashrafian: Okay. Sorry. Thanks for that insightful question. You'll know Graves' is a well-established autoantibody-related disorder. The classic long-acting thyroid stimulating antibodies, DTH-TSHR antibodies are important. 1, it's a canonical autoimmune disorder. 2, we know from an investigator-initiated study that B-cell suppression is a successful therapy, particularly for the ophthalmopathy. Thirdly, with our unique reversible covalent molecule in rilzabrutinib, that has already shown significant promise in multiple disorders, including wAIHA, IgG4-related disease, and ITP. I think that Graves' is a promising opportunity, and we look forward to taking the molecule forward. You are completely correct that it's not a rare disorder of that sort, per se. It's not super rare. Therefore, I think it's a potential opportunity, particularly the ophthalmopathy.

Plus there were some one offs this quarter last year on this year, which did.

<unk>.

Caustic long acting <unk> antibodies vacation DSA charging orders are important.

Little bit of positive impact as well if we look at it underlying because we are too high range. Once again with two 5% percentage points of increase in Q3, if we exclude the one offs on some of the items that we would not necessarily replicate each and every single quarter like if I keep for example, you can consider.

So while it's economical.

Any sort of number two we know private investigator initiated studies that b cell suppression.

Successful therapy, particularly to the orthodoxy and thirdly with our unique.

The underlying gross margin increase that we have experienced since the beginning of the year is around one percentage point.

Covalent reversible molecule relative Bruton, Ed and it's already showing significant promise and multiple disorders, including where IGT for disease, and ICP I think that grades.

It is obviously before any impact if you want to use that for the future that does not include any potential impact coming from tariffs.

As a promising opportunity and we look forward to taking the molecule forward.

You are completely correct that it's not raw disorder of that salt precise doses <unk> and <unk>.

Yeah.

Paul Hudson: Data showed an 8.8% reduction in pneumonia or flu hospitalizations and an important 32% reduction in laboratory-confirmed flu hospitalizations versus standard-dose vaccines, and we're expanding access to this beneficial protection with positive phase 3 data that support a label update extending the age down to 50 years for Fluzone High-Dose. Looking ahead, we're advancing our flu pandemic preparedness for two programs while improving vaccination convenience with positive data on flu Covid combination vaccines. These achievements underscore our commitment to delivering enhanced protection against respiratory viruses to more people worldwide. In addition to our unwavering commitment to innovation and respiratory viruses, we're also steadfast in our commitment to improve patients' access to healthcare. Our Global Health Unit has reached a remarkable milestone. A million patients treated for non-communicable diseases across more than 40 low and middle income countries since 2021, putting us on track to reach 2 million patients by 2030.

Okay Human graves and then Thomas here.

And therefore, I think it's a potential uptick opportunity, particularly dealt sloppy commodity Thomas.

Alright, Thanks for that insightful question, you'll know grapes is well established auto antibody related disorder.

<unk>, let's just say the newsy.

The classic long acting thyroid stimulating antibodies vacation TSA HR antibodies are important.

[Company Representative] (Sanofi): Thank you. Thomas, CMV.

Paul Hudson: Thank you. Thomas, CMV.

Francois: CMV, I'll be short. Not much to say. The news is very recent, as you know very well, Simon. I will not comment. I need to see the full data set. The only thing I can refer to is indeed, you know that, quite a while ago, a few decades ago, we had worked on this antigen. It's a difficult target. While we had reached some, I would say interim efficacy, our assumption at that time was that it would not be sufficient to reach a protection level, and that's why we had interrupted this program quite a while ago. Sadly, overall, because the field of CMV vaccination is an important field, and we would welcome a vaccine against this devastating disease.

Thomas Triomphe: CMV, I'll be short. Not much to say. The news is very recent, as you know very well, Simon. I will not comment. I need to see the full data set. The only thing I can refer to is indeed, you know that, quite a while ago, a few decades ago, we had worked on this antigen. It's a difficult target. While we had reached some, I would say interim efficacy, our assumption at that time was that it would not be sufficient to reach a protection level, and that's why we had interrupted this program quite a while ago. Sadly, overall, because the field of CMV vaccination is an important field, and we would welcome a vaccine against this devastating disease.

Nobody would assignments.

So we're not committing to me to see that.

So number one it's economical autoimmune disorder and number two we know from investigator initiated studies that b cell suppression is successful therapy, particularly for the uptake.

The only thing I can.

Liza two is Indonesia.

Quite a way to grow a few decades ago Windward condition, Tien tsin, it's a difficult target, but we had to reach some that we see in denim efficacy.

And thirdly with our unique.

Our assumption at the time, whether it even be sufficient.

Covalent reversible molecule in real scrutiny that is already showing significant promise and multiple disorders, including weihai GG four disease and ICP I think the graves.

Reach of protection Levered, and that's quite ready 30. This program by the way to go.

Certainly.

Because the <unk> initiatives and the button season.

As a promising opportunity and we look forward to taking the molecule forward and you are completely correct that it's not a rare disorder of that store per se, it's not super App and.

Would welcome a vaccine against these divested entities.

Okay. Thank you. The next question. Please next question from Richard <unk> from Jpmorgan. Please go ahead.

[Company Representative] (Sanofi): Okay. Thank you. Next question, please.

Paul Hudson: Okay. Thank you. Next question, please.

Simon Baker: Next question from Richard Vosser from J.P. Morgan. Richard.

Operator: Next question from Richard Vosser from J.P. Morgan. Richard.

Yeah.

Alright, Thanks for taking my question a question on <unk>, and then just giving us a little bit more on the development around COPD and the Oh, sorry, the gross to net.

And therefore, I think it's a potential uptick opportunity, particularly the ophthalmology come up thank you.

Richard Vosser: Hi. Thanks for taking my question. Question on Dupixent and just giving us a little bit more on the development around COPD and also the gross to net, how that developed in the quarter and how we should think about that in 2026, but also how the COPD launch is going seems to be developing a little bit better this quarter. Second question, just on the Inhibrx data, just your to file, I think you need some of the more long-term safety data that you called out from the open-label extension. Just wondering what, if anything, is being looked at in terms of that safety data from the regulators. Is there anything of interest that they want to see or rule out? Thanks very much.

Thomas <unk> to be short and administer to say the news is really the reason is as you know there was semen.

Paul Hudson: We trained over 27,000 healthcare workers and reached 4 million people through our partnership programs during this same period. We're not stopping there. In the U.S. we're expanding our Insulins Value Savings Program to ensure every American has access to our insulins. At just $35 per month, this initiative builds on Sanofi's long-standing efforts to provide patients access to a reliable and affordable supply of critical medicines. Thank you and I will now hand over to François-Xavier Roger, our CFO, for more details on the financials.

How that developed in the course of how we should think about that in in 'twenty six but also how the COPD launches going seems to be developing a little bit better this quarter.

So we're not committing to me to see the full dataset the only thing I can leave.

Two is indeed.

Quite a way to grow a few decades ago. We'd worked on this antigen is a difficult target what we had to reach some of the north sea.

Then second question just on the.

The handbrake stater.

E E. Yeah to fall I think you need some of the more long term safety data that you called out from the open label extension just wondering what if anything is being looked at in terms of that safety data from the regulators is there anything of interest that they want a sale rollout thanks very much.

In the same efficacy.

Our assumption at the time was that he would not be sufficient to reach a production level and thats quite ready Dirty This program by the way to go.

Suddenly the world because the fee does seem to have X. Initially didnt button season, we would welcome a vaccine against these divested entities.

Okay Brian.

François-Xavier Roger: Thank you Paul and hello to everyone. In Q3, our net SAMs grew by 7% at constant exchange rates. This growth was primarily driven by pharma and more specifically by immunology and recent launches. Our new launch is demonstrating a strong momentum with 41% sales growth, while Dupixent sales grew by 26% this quarter. Vaccine sales were down primarily due to flu as expected, the decrease resulted from a combination of competitive price pressure, mainly in Germany, and lower vaccination rates. At published rates, net Group sales increased by 2%, impacted by a negative foreign exchange effect. These solid results highlight our ability to drive growth against headwinds. Our business gross margin increased by 2.3 percentage points this quarter with a continued improvement in product mix enhanced by productivity gains.

Yes, Richard Thank you so much for the question and first and foremost I think you did.

Okay. Thank you and next question. Please next question from Richard Vasa from Jpmorgan.

[Company Representative] (Sanofi): Okay. Brian, Dupixent.

Paul Hudson: Okay. Brian, Dupixent.

[Company Representative] (Sanofi): Yeah, Richard, thank you so much for the question. First and foremost, I think the really strong overall growth that you've seen is really coming from all different sources of growth. If you think about it, first, our foundational indications, we continue to grow biopenetration in things like asthma, atopic dermatitis, EOE, nasal polyps. Also we've moved into about a year ago, we launched in COPD, and we've really seen a strong success actually in COPD, one of our fastest sections, our fastest respiratory indication as far as growth rate goes. That plus CSU, plus BP, you can see now eight indications deep into the US, our sources of growth are coming from everywhere, and of course, launching around the world. It also is has actually created this really strong momentum.

Brian Foard: Yeah, Richard, thank you so much for the question. First and foremost, I think the really strong overall growth that you've seen is really coming from all different sources of growth. If you think about it, first, our foundational indications, we continue to grow biopenetration in things like asthma, atopic dermatitis, EOE, nasal polyps. Also we've moved into about a year ago, we launched in COPD, and we've really seen a strong success actually in COPD, one of our fastest sections, our fastest respiratory indication as far as growth rate goes. That plus CSU, plus BP, you can see now eight indications deep into the US, our sources of growth are coming from everywhere, and of course, launching around the world. It also is has actually created this really strong momentum.

Really strong overall growth that you've seen is really coming from all different sources of growth. If you think about it first our foundation of indications, we continue to grow bio penetration and things like asthma atopic dermatitis AOE nasal polyps, but also we've moved into about a year ago, we launched in COPD and we've really seen a strong success actually in COPD one of our fastest tax it's our fastest respiratory.

Kent.

Hi, Thanks for taking my question a question on topics and then just answered a bit more on the development around COPD.

And the.

Gross to net.

How that develops and of course now think about that in 'twenty six but.

Indications as far as growth rate goes so that plus CSU plus BP you can see now eight indications deep into the U S. Our sources of growth are coming from everywhere and of course launching around the world. It also is it's actually created this really strong momentum we've seen a 26% growth this quarter and reaching over $4 billion sales as it relates to gross to net obviously that's <unk>.

How does the NPD launches guide seems to be at.

Divesting a little bit about this quarter and then second question just on the Handbrake Stater just E E.

I just thought I think you need some of the more long term safety data that you've called out from the open label extension just wondering what if anything is being looked at in terms of that safety data from the regulators is there anything of interest that they want to see a rollout thanks very much.

[Company Representative] (Sanofi): We've seen a 26% growth this quarter and reaching over EUR 4 billion sales. As it relates to gross to net, obviously, that's captured in there in reference to our sales growth. This is something that we've monitored for a long time. Actually, we see that as we go into additional sources, if you will, or different payer groups, we obviously will provide discounts to get into different access for different patient populations. Again, this is something we've known for a long time, and it's captured in our long-term guidance for Dupixent.

Brian Foard: We've seen a 26% growth this quarter and reaching over EUR 4 billion sales. As it relates to gross to net, obviously, that's captured in there in reference to our sales growth. This is something that we've monitored for a long time. Actually, we see that as we go into additional sources, if you will, or different payer groups, we obviously will provide discounts to get into different access for different patient populations. Again, this is something we've known for a long time, and it's captured in our long-term guidance for Dupixent.

<unk> and Theyre in reference to our sales growth. This is something that we monitor for a long time actually we see that as we go into additional.

Okay, Brian deeper Richard Thank you so much for the question and first and foremost I think the really strong overall growth that you've seen is really coming from all different sources of growth. If you think about it first our foundation of indications, we continue to grow bio penetration and things like asthma atopic dermatitis <unk> nasal polyps, but also we've moved into about a year ago.

Sources, if you will or a different.

François-Xavier Roger: We now capture the full benefit of Dupixent improved manufacturing process as well as a contribution from Blueprint Medicines since the Blueprint closing in mid July. As we move into 2026, the gross margin profile will return to its fundamental growth as the step up from Dupixent C3 manufacturing transition is now complete. Operating expenses grew by 6% excluding the impact of the Blueprint acquisition. Operating expenses grew by low single digit, highlighting our cost discipline. R&D expenses increased by 5% broadly reflecting the underlying activity level. We continue to invest in sales and marketing to support our launches and G&A costs were slightly down in line with our objective to keep them broadly stable going forward. Other operating income and expenses are moving up primarily due to the increased share of profits paid to Regeneron as Dupixent continues its strong growth trajectory.

Payer groups, we obviously will provide discounts to get into different access for different patient populations, but again, it's something we've known for a long time. It is captured in our long term guidance for to make sense.

Okay human in.

And the bricks.

Sure.

[Company Representative] (Sanofi): Okay, Houman in the Inhibrx.

Paul Hudson: Okay, Houman in the Inhibrx.

Excited to have done this acquisition.

Houman Ashrafian: Excited to have done this acquisition, an example of our disciplined capital allocation policy. It's exciting that the preliminary data has proved so promising, superior both at Q3 and Q4 to some of the standards of care. You're correct that we're interested in the long-term extension study, which is open label for the safety data. There is no. Remember, this is a fusion protein, like an antibody. There's no specific side effects we are looking for. You'll have noted from the press release that the safety and tolerability were in line with that which was expected.

Just in COPD, and we've really seen a strong success actually in COPD, one of our fastest exits our fastest respiratory indications as far as growth rate goes so that plus CSU plus BP you can see now eight indications deep into the U S. Our sources of growth are coming from everywhere and of course launching around the world. It also is.

An example of our disciplined capital allocation policy.

And it's exciting to.

Preliminary data as crude so promising superior both Q3 and Q4.

Some of the standards of care.

You're correct.

We're.

Actually created this really strong momentum we've seen a 26% growth this quarter and reaching over 4 billion sales as it relates to gross to net obviously that's captured in there in reference to our sales growth. This is something that we've monitored for a long time actually we see that as we go into additional.

Interested in the long term.

Attention study, which is open label for the safety data.

There is a specific.

But this is a fusion protein like an antibody that's nice specific side effects. We are looking for but you will have noted in the press release.

Sources, if you will or a different.

Safety and Tolerability were in line with that which was excellent.

Payer groups, we obviously will provide discounts to get into different access for different patient populations, but again. This is something we've known for a long time and it's captured in our long term guidance pretty vixen.

Okay. Thank you next question please.

And for making Michigan from Jefferies Micah.

[Company Representative] (Sanofi): Okay, thank you. Next question, please.

Paul Hudson: Okay, thank you. Next question, please.

Operator: The next question from Michael Leuchten from Jefferies. Michael?

Thank you very much two questions for formula.

François-Xavier Roger: Business EPS reached €2.91, a robust growth of €0.19 and 13% compared to Q3 2020. This strong performance reflects our compelling sales growth and increasing gross margin combined with cost discipline. Looking at our year to date progress, we are maintaining strong earnings momentum with 9% sales growth and business EPS growing faster at 12%. It fully supports our guidance for the full year and demonstrates our ability to deliver profitable growth consistently. Based on our year to date performance, we reiterate our full year guidance of high single digit sales growth and low double digits business EPS growth at constant exchange rates. We have now completed the acquisitions of Drains, BIOS, Dr. Vigil Neuroscience and Blueprint Medicines and their associated costs are fully factored in our guidance.

Okay human he bricks.

One just wondering if I could probably a little bit more on the seasonality comment on gross margin you said.

Michael Leuchten: Thank you very much. 2 questions for Francois, please. One, I just wondered if I could probably a little bit more on the seasonality comment on gross margin. You said the Dupixent process is now tucked in and you return to normal patterns. Just wonder what you meant by that. If most of the driver of the gross margin increase in Q3 still hold, just wondering why you opted not to offer an increase to guidance for this year. Thank you.

<unk>.

Excited to have done this acquisition.

An example of our disciplined capital allocation policy.

To pick some proceeds not tucked in and you return to normal patterns, just wonder what you meant by that.

And it's exciting.

The preliminary data has proved so promising superior both Q3 and Q4 to some of the standards of care.

And then if if most of the driver of the gross margin increases Q3 still.

Still a whole just wondering why you opted not to offer an increase to the guidance for this year. Thank you.

You're correct.

Yeah.

Interested in the long term.

Thank you Francois.

So as I said, the two five percentage point of increase that we had the number of smoking in Q3 is probably not necessarily a good proxy for 2026, but we believe that we have some factor that we stay there lack of volume rules like for example, given the product mix issues are structural but we didn't get an answer.

Extension study, which is open label for the safety data.

[Company Representative] (Sanofi): Okay, thank you. Francois?

Paul Hudson: Okay, thank you. Francois?

Francois: Mike, as I said, the 2.5 percentage point of increase that we had in our gross margin in Q3 is probably not necessarily good for C for 2026. We believe that we have some factor that will stay there, like our volume growth, like, for example, even the product mix. These issues are structural, but we won't get another increase next year of 2.5 percentage point in gross margin. It will be probably closer maybe to what I said underlying maybe 1 percentage points benefiting from volume and product mix. The other thing, in terms of guidance, I'm glad you asked the question. We do confirm our full-year guidance, which is high single-digit sales growth. Today, after nine months, we are at 8.8% year-to-date.

François-Xavier Roger: Mike, as I said, the 2.5 percentage point of increase that we had in our gross margin in Q3 is probably not necessarily good for C for 2026. We believe that we have some factor that will stay there, like our volume growth, like, for example, even the product mix. These issues are structural, but we won't get another increase next year of 2.5 percentage point in gross margin. It will be probably closer maybe to what I said underlying maybe 1 percentage points benefiting from volume and product mix. The other thing, in terms of guidance, I'm glad you asked the question. We do confirm our full-year guidance, which is high single-digit sales growth. Today, after nine months, we are at 8.8% year-to-date.

There is no specific if you remember this is a fusion protein like an antibody. There is no specific side effects. We are looking for but you will have noted from the press release that the safety and Tolerability were in line with that which was expected.

Okay. Thank you next question. Please next question from Mike in Michigan from Jefferies Micah.

Increase next year of two five percentage points in gross margin will be probably closer maybe to what I said underlying maybe one percentage points benefiting from volume and product mix. The other thing in terms of the guidance I'm glad you're asking a question. So we do confirm of items, which is high single digit growth sales growth to date.

Thank you very much two questions for follow up. Please one just wondering if I could probably a little bit more on the seasonality comment on gross margin you said.

François-Xavier Roger: While we typically provide full year guidance at the beginning of each year, we can share a few business trends for next year which you may find useful for modeling purposes. R&D next year is expected to increase moderately. We will continue investing in sales and marketing to support our product launches as well as our strong sales momentum. At the same time, we will remain disciplined on G&A cost with the objective to keep them broadly stable. We expect to achieve around €0.5 billion of capital gains from divestments, similar to what we anticipate for 2025. Regarding Amputra royalties, based on the latest Evaluate Pharma sell-side consensus, the implied royalties are now expected around €700 million for next year. You will find a slide with the updated Amputra royalty considerations reflecting current external consensus in the appendices of this presentation.

The <unk> process is not tucked in and you return to normal patterns, just wonder what you meant by that.

And then if if most of the driver of the gross margin increase in Q3 still a whole just wondering why you opted not to ask for an increase to the guidance for this year. Thank you. Okay. Thank you Francois.

After nine months at eight 8% year to date, so do expect some increase from where we are in.

Francois: Do expect some increase from where we are at the end of September. Business EPS growth is low double digits, even excluding the benefit of share buyback. We are excluding share buyback at 9.9%. Do expect there as well for the full year that we will go up from where we are as at the end of September. Just to clarify as well, our full year guidance assumes basically that Q4 will be the best quarter in sales, UI, and EPS growth this year. We will do better than we have done in any other quarter. Q3 was anyway a bit softer because of the comps, as we said earlier. There is just one thing. I want to take the opportunity to mention one thing.

François-Xavier Roger: Do expect some increase from where we are at the end of September. Business EPS growth is low double digits, even excluding the benefit of share buyback. We are excluding share buyback at 9.9%. Do expect there as well for the full year that we will go up from where we are as at the end of September. Just to clarify as well, our full year guidance assumes basically that Q4 will be the best quarter in sales, UI, and EPS growth this year. We will do better than we have done in any other quarter. Q3 was anyway a bit softer because of the comps, as we said earlier. There is just one thing. I want to take the opportunity to mention one thing.

At the end of September.

Business EPS rules.

Low double digits, even excluding the benefit of share buyback, we are excluding Shanghai back at nine 9%. So we expect there as well for the full year that we would go up from where we are as at the end of September.

So as I said, the two five percentage point of increase that we had in our gross margin in Q3 is probably not necessarily good proxy for 2026, but we believe that we have some factor that we stay there lack of volume growth like for example.

So just to kind of it's funny as one off we do on guidance assumes basically that Q4 will be the best quarter in Sam's UI on EPS growth. This year, we will do better than we have done.

Product mix issues are structural but we won't get another increase next year of two five percentage points in gross margin. So it will be probably closer maybe to what I said underlying maybe one percentage points benefiting from volume and product mix. The other thing in terms of the guidance I'm glad you're asking a question. So we do confirm our full year guidance.

Good quarter.

Q3 was a bit softer because of the comps as we said earlier. There is just one thing I want to take the opportunity to mention one thing with maybe what the street does not what is his teammates is a profit sharing with Richard around them that includes by the way boutiques.

François-Xavier Roger: Another indicator for 2026 is a reduction of approximately €300 million reimbursement from Regeneron for the R&D balance. Both items, Amputra gains and reduced Regeneron R&D reimbursement, will offset each other next year. We continue to execute our capital allocation policy and we remain disciplined and balanced across four priorities: investing in organic growth drivers, pursuing selective bolt-on acquisitions, maintaining our policy of progressive dividends, and executing opportunistic share buybacks based on our projected trajectory for 2026 and beyond. We remain confident in our ability to sustain our profitable growth momentum for the next few years. I now hand over to Houman to provide an update on the progress of our innovative pipeline.

She is a high single digit growth sales growth to the nine months, we are at eight 8% year to date. So do expect some increase from where we are in.

Francois: Maybe what the street does not always estimate is the profit sharing with Regeneron. That includes, by the way, both Dupixent and Kevzara. Because there is probably an understanding that it grows in line with sales of Dupixent. It doesn't. Let me just give you some further color. For example, if we look at Dupixent sales in H1, they grew by 21% and the Regeneron profit sharing grew by 32%, so 11 percentage points faster. If I do the same analysis for Q3, Dupixent sales grew by 26%, which is remarkable, and the profit sharing with Regeneron grew by 37%, so another 11 points higher than sales. Once again, it is a profit sharing. It's not linked necessarily fully to sales.

François-Xavier Roger: Maybe what the street does not always estimate is the profit sharing with Regeneron. That includes, by the way, both Dupixent and Kevzara. Because there is probably an understanding that it grows in line with sales of Dupixent. It doesn't. Let me just give you some further color. For example, if we look at Dupixent sales in H1, they grew by 21% and the Regeneron profit sharing grew by 32%, so 11 percentage points faster. If I do the same analysis for Q3, Dupixent sales grew by 26%, which is remarkable, and the profit sharing with Regeneron grew by 37%, so another 11 points higher than sales. Once again, it is a profit sharing. It's not linked necessarily fully to sales. There is about 10 to 11 points of growth in terms of difference between the two concepts.

Uh huh.

Because there is probably an understanding that.

So at the end of September.

Rose in line with Samsung <unk> doesn't.

Business EPS rules is low double digits, even excluding the benefit of share buyback, we are excluding share buyback at nine 9%. So do you expect there as well for the full year that we would go up from where we are as at the end of September. So just to clarify you guys went on our full year guidance assumes basically.

If you sum those up.

For example, we looked at do pick some sandwich in etch one that grew by 21% on the original featuring grew by 32%. So 11 percentage points faster if I do some seminar at least for Q sweep you pick some census grew by 26%, which is remarkable and regional profit the profit share.

Q4 will be the best quarter in Sam's.

And with Regeneron grew by 37% so announcer 11 points.

On EPS growth. This year, we will do better than we have done.

Sales once again it is a profit sharing is not linked necessarily fully to Samsung about 10 to 11 points.

Of the quarter.

Q3 was a bit softer because of the pumps as we said earlier. There is just one thing I want to take the opportunity to mention one thing with maybe what the street does not always estimates is a profit sharing with regeneron that includes by the way both duplex and.

Our growth in terms of difference between the concept.

Francois: There is about 10 to 11 points of growth in terms of difference between the two concepts.

Houman Ashrafian: Thank you, François-Xavier. I'm pleased to share our Q3 pipeline achievements with progress in many programs. We received regulatory approvals for WAYLIVRA in the United States in ITP and Tzeald in China. Further, we received regulatory submission acceptances for Dupixent CSU in children in the U.S. and in the EU. The FDA nominated Tzeald to the new Commissioner's National Priority Voucher Program to speed up the review. WAYLIVRA ATP was submitted in Japan and Sarclisa subcutaneous was accepted globally in myeloma. Our phase 3 programs have delivered successful readouts with amlotilumab meeting the primary endpoint in the phase 3 study in atopic dermatitis dose 1 and Fluzone High-Dose in people 50 years and above. We also commenced dosing first patients in the U.K. Three studies, one of the two studies for lensacamig in COPD and WAYLIVRA in sickle cell disease and warm autoimmune hemolytic anemia.

Q next question. Please next question comes from.

[Company Representative] (Sanofi): Thank you. Next question, please.

Paul Hudson: Thank you. Next question, please.

It is from Berstein.

Operator: Yes. Next question from Florent Cespedes from Bernstein.

Good afternoon.

Kids are.

Because there is probably an understanding that it grows in line with sales of <unk> doesn't.

Yeah.

Florent Cespedes: Good afternoon.

Yes. Thank you very much what taking my question.

[Company Representative] (Sanofi): Yeah.

Paul Hudson: Yeah.

Florent Cespedes: Good afternoon. Can you hear me?

[Company Representative] (Sanofi): Yeah.

Paul Hudson: Yeah.

From the team.

Florent Cespedes: Yeah. Thank you very much for taking my question. Florent Cespedes from Bernstein. Two quick questions, please. First on M&A, with the massive success of Dupixent, and with the mix you saw on pipeline, maybe could be more aggressive in terms of products acquisitions, and maybe kind of a Blueprint-like transactions, is something that we should see in the future. Maybe a second quick question for Thomas on vaccines. If you share with us, how do you see the trend that have been flu with the vaccine fatigue that we observe across the world. Some color on this would be great. Thank you.

If you sum those up.

For example, if we look at do pick some sales in each one they grew by 21% on the original profit sharing grew by 32%. So 11 percentage points faster if I do the same analyses for Q3 depicts some census grew by 26%, which is remarkable and regional profit the profit.

Two quick questions. Please.

First.

It was a massive success.

The peak sent.

And wisdom.

I think maybe to be more aggressive in terms of our perks acquisition.

And may be.

Kind of a blueprint like transactions.

And as we shall see.

Touring with Regeneron grew by 37% so another 11 points higher than sales. So once again it is a profit sharing is not.

In the near future and maybe a second quick question for Thomas on vaccines.

With us housing.

The trend that <unk> been through.

The linked necessarily fully two sounded about 10 to 11 points.

With the vaccines fatigue that we observed across the world.

Growth in terms of difference between the concept.

Sort of some color on this would be great. Thank you.

Maybe I didn't quite catch perfectly the first question, but it was regarding M&A.

Thank you next question. Please next question comes from.

[Company Representative] (Sanofi): Maybe I didn't quite catch perfectly the first question, but it was regarding M&A and should we be doing more and more blueprint, I guess, is what I think I heard. Francois, do you want to comment?

Paul Hudson: Maybe I didn't quite catch perfectly the first question, but it was regarding M&A and should we be doing more and more blueprint, I guess, is what I think I heard. Francois, do you want to comment?

From Bernstein.

Houman Ashrafian: Finally, WAYLIVRA is emerging as a multi-immune modulation platform in rare diseases with an approval in the U.S. and a positive recommendation in the EU for ITP. Multiple designations across new indications, further strengthening our rare disease portfolio. Please turn to the next slide. Moving to dermatology, amlotilumab met all primary and secondary key endpoints in the first phase 3 study in AD. Data demonstrated clinically meaningful improvement in several measures of skin clearance. As an example, looking at the VIGA measure, the efficacy progressively increased and showed no plateau at 24 weeks. Further, amlotilumab offers patient-friendly quarterly dosing. There were no new safety concerns identified in this study. Oceana AD is a comprehensive program including five phase 3 studies in adult and adolescent biologic-experienced patients and across different geographies. We anticipate full data to report out throughout 2026.

Good afternoon.

Should we be doing more and more blueprint like is what I think.

Good afternoon can you hear me, yes, yes.

So do you want to just a few wells may be completed.

Thank you very much what taking my question.

From Barrington.

We do about being aggressive about funding the relevant acquisitions, we have space in our balance sheet, we said that we want to retain our double a rating.

Francois: Just a few words, maybe Paul can complete it. It's not really about being aggressive, it's about finding the relevant acquisitions. We have space in our balance sheet. We said that we want to retain our AA rating. In order to get there, we could afford, once again, this is not necessarily what we want to do, but we could afford investing in M&A currently something like EUR 14, 15 billion and still retain our AA rating. Anyway, what we are looking for is to meet three criteria, basically. Strategic fit, which is around our four therapeutic areas and possibly white spaces as well. Second, scientific differentiation and relevance and first in class, best in class. Third, financial return as well without any certainty. It's less a matter of amount or aggressiveness.

François-Xavier Roger: Just a few words, maybe Paul can complete it. It's not really about being aggressive, it's about finding the relevant acquisitions. We have space in our balance sheet. We said that we want to retain our AA rating. In order to get there, we could afford, once again, this is not necessarily what we want to do, but we could afford investing in M&A currently something like EUR 14, 15 billion and still retain our AA rating. Anyway, what we are looking for is to meet three criteria, basically. Strategic fit, which is around our four therapeutic areas and possibly white spaces as well. Second, scientific differentiation and relevance and first in class, best in class. Third, financial return as well without any certainty. It's less a matter of amount or aggressiveness. It's more about finding the right targets at the right time, at the right price

Two quick questions. Please.

First on M&A.

Is the message.

Depicts scent.

And wisdom.

So to get there we could unfold once again this is not necessarily what we want to do.

I think maybe to be more aggressive in terms of acquisitions.

Investing in BD and M&A currently something like 14, 15 billion euros on steel and retain our deleveraging and you might what we're looking for is to meet <unk> criteria, basically spreadsheet, which is around the four therapeutic areas, possibly widespread seasons wellness against scientific.

And may be.

Kind of a blueprint like transactions.

Let's see.

In the future and maybe a second quick question for Thomas on vaccines that you share with US how you see the trend that <unk> been through with the vaccines fatigue that we observed across the world.

Differentiation and relevance under the first in class best in class unsettled financial return as well without any certainty. So it's less a matter of Mount or aggressiveness, it's more about finding the right targets at the right time at the right place.

So some color on this would be great. Thank you.

Maybe I didn't quite catch perfectly the first question, but it was regarding M&A.

Should we be doing more and more blueprint like is what I think.

Francois: It's more about finding the right targets at the right time, at the right price.

So do you want to.

A few wells, maybe Burlington completed.

Yes, yes.

Houman Ashrafian: Brivecameg, our TNF alpha and OX40 ligand nanobody, achieved its primary objective in a phase 2a study in HS. We observed clinically meaningful improvements in both primary and secondary endpoints in biologic-naive patients at age 16. Brivecameg was well tolerated. Data were presented at EADV in Paris in September where I also had the pleasure to meet many of you at our IR Roundtable. Our phase 2b study is now starting its recruitment. Please turn to the next slide. Moving to respiratory, amlotilumab has shown an intriguing efficacy in its phase 2 study in asthma, a difficult-to-treat subgroup. While the primary endpoint of annualized asthma exacerbation rate reduction at week 48 did not reach statistical significance at the highest dose, notable improvements were observed in T second.

It's not really about being aggressive about funding the relevant acquisitions and we have space in our balance sheet and said that we want to retain the portfolio, we're seeing in order to get them kudos once again.

Greg we've been really disciplined approach when he came in.

[Company Representative] (Sanofi): Yeah. Yeah. I think that's great. We've been really disciplined. You know, Francois, when he came in, actually went back and looked at all of our acquisitions and agreements to decide whether we allocated capital to his standard. I was somewhat relieved to find out that he did. There is a huge amount of discipline. There is a huge amount of discipline, and I think, you know, you've just heard, you know, how Aimovig's done in Q3. We're very good at it, but we have to be a little bit choosy about what we do. I think that's very reasonable. Okay, Thomas, vaccines.

Paul Hudson: Yeah. Yeah. I think that's great. We've been really disciplined. You know, Francois, when he came in, actually went back and looked at all of our acquisitions and agreements to decide whether we allocated capital to his standard. I was somewhat relieved to find out that he did. There is a huge amount of discipline. There is a huge amount of discipline, and I think, you know, you've just heard, you know, how Aimovig's done in Q3. We're very good at it, but we have to be a little bit choosy about what we do. I think that's very reasonable. Okay, Thomas, vaccines.

We went back and looked at all of them.

Acquisitions and agreements to decide whether we allocated capital to his standard.

Starting with <unk>.

That was somewhat relieved to find out that there is a huge amount of discipline. There was a huge of a disciplined and I think you just said.

Testing in BD and M&A.

Something like 40 to 50 million euros still retain a lot of our rating.

Ed.

Ava gets done in Q3, so we're really.

What they're looking for.

Fleet strategy.

Very good at it but we have to be little bit choosy about what we do okay thats very reasonable.

<unk>.

False or a particular, Arizona was widespread as wellness against scientifically.

Hum.

<unk>.

This differentiation relevance.

Thanks, Rob.

And then through a couple of points first of all it's early on with <unk>, but indeed as you didn't mind with your question I think it's here with the first few weeks that we observe.

That's best in class financial returns as well without any certainty so it's less.

[Company Representative] (Sanofi): Thanks, Laurent, for the question on flu. A couple of points. First of all, it's early. We're still in October, but indeed, as you had in mind with your question, I think it's fair with the first two weeks that we observe, a little bit vaccination rate on the soft side when it comes to flu vaccination, particularly in the US. We see a softer this year to date. A couple of points, though, I'd like to highlight when it comes to the 2025 performance that you see in this quarter. First of all, we highlighted it before, but I just want to be clear. It's linked to two elements. In Germany, there is a price effect. There is a significant price effect due to the change of recommendation.

Thomas Triomphe: Thanks, Laurent, for the question on flu. A couple of points. First of all, it's early. We're still in October, but indeed, as you had in mind with your question, I think it's fair with the first two weeks that we observe, a little bit vaccination rate on the soft side when it comes to flu vaccination, particularly in the US. We see a softer this year to date. A couple of points, though, I'd like to highlight when it comes to the 2025 performance that you see in this quarter. First of all, we highlighted it before, but I just want to be clear. It's linked to two elements. In Germany, there is a price effect. There is a significant price effect due to the change of recommendation.

Mount richness, it's more about finding the right.

A little bit vaccination rate on the sub side when it comes to food recognition.

Our targets at the right time at the right place.

Houman Ashrafian: The heterogeneous inflammation subgroup of patients with high blood eosinophils greater than 300 cells per microliter and elevated neutrophil at greater than 4,000 cells per microliter showed the greatest benefit. Treatment was well tolerated with no new safety concerns. We're still analyzing study data including biomarkers. Next steps will be subject to prioritizations within our overall respiratory portfolio. We're pleased by the recent ethnoliprin alpha data which showed superiority to the standard of care in phase 2 study for alpha 1 antitrypsin deficiency emphysema. The recombinant protein has a longer half-life and can provide higher AAT serum levels with less frequent dosing of either once every three or four weekly. A phase 2 open-label study is currently ongoing which will add to the safety data.

Yes, yes.

In the U S that we see.

We've been really disciplined when.

It's up to date, a couple of points, though I'd like to highlight when it comes to the 2025 minutes that you've seen this quarter.

He came in I actually went back and looked at all of them.

<unk> and agreements.

We allocated capital to us.

We had a lagging before but I just want to begin it it seemed to two elements in Germany. There is a price effect without agencies, you can pipe exceed two to change our recommendation.

Sure.

That was somewhat relieved to find out that there is a huge amount of discipline. There was a huge amount of discipline and I think you've just heard.

Ed.

And in the U S. It's more what you're mentioning.

Ho Ava gets done in Q3, so we're really.

The <unk>, but in both cases in the 2025.

[Company Representative] (Sanofi): In the US, it's more what you're mentioning, the soft OX40. But in both cases, in this 2025 environment, we are keeping a very strong market share performance. It's overall for Sanofi flu vaccines, but in particular, even for differentiated vaccines. Beyond the performance in terms of market share, what I'd like to highlight also this quarter in terms of flu is the progress we're also making on an R&D perspective. You see that we have a positive Phase III in flu and high-dose influenza 50-plus extension. So with the great performance you've seen with the FLUNITY trial, and the fantastic 32% improvement compared to standard dose and flu specialization, if we can extend that to people above 50 years of age, that will be fantastic.

Thomas Triomphe: In the US, it's more what you're mentioning, the soft OX40. But in both cases, in this 2025 environment, we are keeping a very strong market share performance. It's overall for Sanofi flu vaccines, but in particular, even for differentiated vaccines. Beyond the performance in terms of market share, what I'd like to highlight also this quarter in terms of flu is the progress we're also making on an R&D perspective. You see that we have a positive Phase III in flu and high-dose influenza 50-plus extension. So with the great performance you've seen with the FLUNITY trial, and the fantastic 32% improvement compared to standard dose and flu specialization, if we can extend that to people above 50 years of age, that will be fantastic.

Very good at it but we have to be little bit choosy about what we do okay thats very reasonable.

We are keeping a very strong market share performance.

<unk> tomo vaccines.

Our authentic vaccines, but in particular events are differentiated from <unk> and beyond.

Thanks.

So the question on flu a couple of points first of all.

It's early on with <unk>, but indeed as you are.

The government in terms of market share with electronic also this quarter in terms of fluke is the political and snowmaking on the 19th best to keep you see that we have a positive phase III infusion idose it with 50 for this extension.

I didn't mind with your question I think it's fair with the first few weeks that we observe.

Houman Ashrafian: We will now engage in discussions with legacy regulatory agencies to see if we can move ahead based on the data we have supported by the upcoming safety studies. Please turn to the next slide. Lead 212 dotamate, our radioligand, showed intriguing overall response rates in patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors, otherwise known as the GEP-NETs, a group of difficult to treat rare endocrinological cancers, and peptide receptor radionuclide therapy naive patients. The overall response rate was 57.1% and in PRRT exposed patients the overall response was 19.2%. Both measures were based on blinded independent central review. We observed a manageable safety profile that was similar across both cohorts.

Little bit vaccination rate on the sub side when it comes to food recognition.

In the U S. So we see this year to date, a couple of points, though I'd like to highlight when it comes to the 2025 specimens that you've seen this quarter.

Great.

With the affinity trial.

And the synthetic 32% improvement compared to standardize on <unk>, but in addition.

First is what we had before but I just want to be candidates. It is linked to two elements.

Can they extend that <unk> deal I think Toby phonetic.

Germany is a price effect, we have a significant price exceeds two to change your recommendation.

To be associated with the points, we've made an anemic flu with I think with our best in class H five additional.

[Company Representative] (Sanofi): To be associated also with the progress we've made on pandemic flu with, I think, with our best-in-class H5 cell potential results, and the move and progress we're making on flu-combined combination. Flu remains important for us. We're moving forward full steam commercially and R&D wise.

Thomas Triomphe: To be associated also with the progress we've made on pandemic flu with, I think, with our best-in-class H5 cell potential results, and the move and progress we're making on flu-combined combination. Flu remains important for us. We're moving forward full steam commercially and R&D wise.

Additional reserve.

And in the U S. It's more what youll mentioning I E. The southern <unk>, but in both cases in the 2025 environment.

Move in progress when would you think would be needed competition. So blue remains important part when.

We're moving forward with steam commercially anyway.

Keeping a very strong market share performance.

Okay. Thank you next question. Please next question is from David Risinger from Leerink David.

Hello, <unk> vaccines, but in particular, even for differentiated from next year and beyond.

[Company Representative] (Sanofi): Okay. Thank you. Next question, please.

Paul Hudson: Okay. Thank you. Next question, please.

Operator: Yes. Next question from David Risinger from Leerink. David?

Yes, thanks, very much so congratulations on the positive and bricks elevate results. This week could you provide some more color on how you would characterize for AA <unk>, both the normal range in the trough levels and then regarding net price prospects for U S depicts and in 2026.

The government in terms of market share with <unk> also this quarter in terms of flu is the policy. We will have snowmaking on the 90 perspective, you see that we have a positive phase III influences in Idaho.

David Risinger: Yes. Thanks very much. Congratulations on the positive ENHANCE ElevAATe results this week. Could you provide some more color on how you would characterize for AATD both the normal range and the trough levels? Regarding net price prospects for US Dupixent in 2026, since your contracting is likely largely complete at this time of the year, how would you characterize the expected net change in pricing in 2026 versus the net change in pricing in 2025? Thanks very much.

Houman Ashrafian: In immunology, our oral TNF balunetanofib didn't meet the predefined primary endpoint of ACR20 but showed clinically meaningful efficacy in the phase 2 study in uncontrolled advanced treatment naive rheumatoid arthritis patients on background methotrexate across endpoints requiring a deeper disease control including ACR50 and ACR70. This oral treatment has the potential to be used as a combination backbone therapy with internal and external oral medicines, the next step currently being evaluated. Finally, we are close to initiate two replicate phase 3 studies for Duvaticuc in both Crohn's disease and colitis. This treatment offers patient-friendly subcutaneous dosing with a potential competitive safety and efficacy by selectively targeting the DC3 receptor. This follows the positive phase 2 data that read out last year and were presented at the ECHO meeting this year. Next slide please. As a conclusion, let me share a status of our key mid and late-stage development projects.

50, plus extension so we the great for someone that you've seen with the affinity trial.

Since you're contracting is likely largely complete at this time of the year, how would you characterize the expected net change in pricing in 2006 versus the net change in pricing in 2025, thanks very much.

<unk>, 32% improvement compared to stand others on hospitalization.

If we can extend that to <unk> 50 years that'll be fantastic to be associated with the progress. We've made on anemic flu with I think with our best in class H five silver petition reserves and to move in and progress we're making on through COVID-19 cognition. So flu remains important.

Okay. Thank you.

Ebix ACD.

[Company Representative] (Sanofi): Okay. Thank you. Enbrel's AATD.

Paul Hudson: Okay. Thank you. Enbrel's AATD.

Yes.

Without running into any market issues, you'll remember that the definition of and Alpha one antitrypsin levels is ready to do their own crystal Anemogram.

Moving from what was deemed commercially in R&D wise.

Houman Ashrafian: Yeah. Without running into any ADA issues, you'll remember the definition of alpha-1 antitrypsin levels is related to the wrong crystal nomogram. I'll speak in broad terms. Standard of care, by and large, doesn't get into the normal range for alpha-1 antitrypsin levels. Our Q3 and Q4 molecules provide very commendable alpha-1 antitrypsin nomogram levels both for trough and mean days.

Okay. Thank you next question. Please yes next question is from David Risinger from hearing Steven.

I'll speak in broad terms.

Yes, thanks, very much so congratulations on the positive and hemp bricks elevate results. This week could you provide some more color on how you would characterize for TD, both the normal range in the trough levels.

Was that a cat by and large doesn't get into the <unk>.

Normal range for Alpha one antitrypsin level, our Q3 and Q4 molecules provide very commendable very commendable.

And then regarding net price prospects for U S depicts and in 2026 since you're contracting is likely largely complete at this time of the year. How would you characterize the expected net change in pricing in 2006 versus the net change in pricing in 2025.

F. One antitrypsin name came up with both the Croft and the index.

Houman Ashrafian: Our immunology pipeline includes medicines with available data such as sanlatilimab's phase 3 program in atopic dermatitis with further potential lifecycle management, second mig in phase 2 in different asthma patient subgroups and potential lifecycle management such as COPD as well as bravecamag in HS and others in this stage development, some of which I covered earlier like alimetamset and Diveticum on the topekmab. I can share that a decision to move forward in COPD will be made subject to regulatory discussions and in collaboration with our valued partner Regeneron. In rare diseases, WAYLIVRA is now approved for ITP in the U.S. with potential for multiple new indications. Bengalisat is currently in phase 3 for Fabry disease and Gaucher disease type 3 and lastly efdoliprin alpha successful in phase 2 for HIF1 antitrypsin deficiency with encouraging update just the other day.

Thank you Brian.

<unk> been trying to get at.

[Company Representative] (Sanofi): Thank you. Brian, I think a clever question from David trying to get at the rebates likely for 26 over 25, but I'll let you answer.

Paul Hudson: Thank you. Brian, I think a clever question from David trying to get at the rebates likely for 26 over 25, but I'll let you answer.

Rebates slightly for 2000 and 625.

Yes, I think that's a great question, David Thank you so much for asking it.

[Company Representative] (Sanofi): Yeah. I think that's a great question, David. Thank you so much for asking it. As you know, we don't typically give guidance on the net price year-over-year. One thing I will say is you can see we've been incredibly disciplined over the years. We're now 8 years into the launch of this asset, and it's been captured in our long-term guidance, how we believe the net price will develop over time.

Brian Foard: Yeah. I think that's a great question, David. Thank you so much for asking it. As you know, we don't typically give guidance on the net price year-over-year. One thing I will say is you can see we've been incredibly disciplined over the years. We're now 8 years into the launch of this asset, and it's been captured in our long-term guidance, how we believe the net price will develop over time.

We don't typically give guidance on the net price a year over year, but one thing I will say as you can see we've been incredibly disciplined over the years. We're now eight years into the launch of this asset and its been captured in our long term guidance. How we believe the net price will develop over time.

Thanks very much.

Okay. Thank you.

And Ebix HED, yes.

Without running into any issues, you'll remember that the definition of and alpha one antitrypsin levels just related to the wrong Crystal nomogram.

Next question because yes next question from Savi <unk> from Morgan Stanley.

[Company Representative] (Sanofi): Thank you. Next question, please.

Paul Hudson: Thank you. Next question, please.

I'll speak in broad terms.

Operator: Yes. Next question from Sarita Kapila from Morgan Stanley.

Hi, Thanks for taking my questions just on and listen to that how should we think about the upcoming readouts is that.

Added a cat by and large doesn't get into the normal range for Alpha one antitrypsin levels are Q3, and Q4 molecules provide very commendable very commendable.

Sarita Kapila: Hey. Thanks for taking my questions. Just on atlurtilimab, how should we think about the upcoming readouts? Is there potential for the placebo arm in the COAST 2 trial to behave more normally, or should we think about it as a pure sister trial to COAST 1? Just on ESTUARY, beyond the no plateau in efficacy that we saw in COAST 1, what's underpinning the confidence that the long-term efficacy can improve with time? Thanks.

So for the placebo arm and the <unk> two trial.

Well normally or should we think about it at the appeal sister trial to kind of just one and then just I'll ask Gerry beyond <unk> in efficacy that we saw in <unk> underpinning our confidence that the long that efficacy can improve with time.

<unk>.

F. One antitrypsin pneumogram level, it's both a trough I mean this.

Houman Ashrafian: Sarclisa is well underway with a subcutaneous formulation already approved across different lines and combination regimens in multiple regions and led 212 dotamate in GEP-NET with data this week at ESM in Neurology. Tolebrutinib is in review for SPMS with a revised PDUFA date of December 28 and in phase 3 for primary progressive multiple sclerosis with a readout before the end of the year. Fraxalumab is in phase 3 for relapsing remitting multiple sclerosis and SPMS too and lastly rilly pribar in 2 phase 3 studies chronic inflammatory demyelinating polyneuropathy. Finally, in vaccines we have multiple phase 3 programs underway such as rabies V21, yellow fever vaccine, and broad opportunities in flu, flu Covid combinations, and pandemic flu right behind as Paul Hudson covered earlier in his slides. Next slide please.

Thank you.

Ryan.

Have a question from David trying to get at.

Our rebate slightly to $26 25.

Great questions Okay.

Yes, I think it's a great question, David Thank you so much for asking it.

I'll, even while its Tom Thanks for the question first.

[Company Representative] (Sanofi): Great questions. Okay, Houman.

Paul Hudson: Great questions. Okay, Houman.

First of all kinds to precise.

Houman Ashrafian: Okay. I'll take them one at a time. Thank you for the question. Firstly, on COAST 2, it's a precise replicate sister study. There are some subtle differences in regional recruitment and execution, but essentially, it's a replicate study. We anticipate and hope that we will get a replicate of COAST 1. As you'll remember also, you said correctly on ESTUARY, it's a slightly more nuanced study than has perhaps been observed, as well as being able to tell us about durability ultimately in a randomized way. It will also give us a sense of dose variation that we will do. You'll remember there are multiple dose switching arms.

As you know, we don't typically give guidance on the net price that year over year, but one thing I will say as you can see we've been incredibly disciplined over the years. We're now eight years into the launch of this asset and its been captured in our long term guidance. How we believe the net price will develop over time.

Precise replica assisted study there are some subtle differences in regional recruitment and execution, but essentially its rapid study.

And we anticipate and hope that we will get replicated.

Thank you next question. Please yes next question from Savi <unk> from Morgan Stanley.

Just one.

Uh huh.

As you will remember also you said correctly necessary, it's a slot.

Hi, Thanks for taking my questions just on amplitude of that how should we think about the upcoming readouts is that.

Lately more nuance study then.

Has perhaps been observed as well as being able to tell us about durability ultimately in a randomized way.

If you will for the placebo arm and the <unk> two trial to behave more normally or should we think about it as appeal sister trial to coast. One and then just on <unk> beyond the <unk> and efficacy that we saw in <unk>.

We'll also give us a sense of dose variation that we will do if you remember there are multiple day switching arms. So punch line last year, which we look at.

Houman Ashrafian: On my last slide I plan to cover my usual news flow of news for a slide for the remaining three months of the year and all of 2026. The last significant items for 2025 are U.S. decisions on tolebrutinib and SPMS and phase 3 readouts in PPMS and multiple regulatory decisions. Next year we expect the remaining phase 3 readout amlotilumab in atopic dermatitis in rare diseases. We also expect Bengalostat Phase 3 readouts in two indications. In all cases, if positive, regulatory submissions will follow later in the year. In addition, we anticipate multiple regulatory submissions based on data we've already received this year, as well as regulatory decisions for medicines and vaccines under review.

Squad, what's underpinning the confidence that the long term efficacy can improve with time.

Out next year.

Houman Ashrafian: Punchline on ESTUARY, which we'll get throughout next year, is not only will it tell you about durability, but it'll tell you about the relationship between dose and durability. Those are going to be critical, in terms of our understanding and positioning atlurtilimab. Thanks.

And when you talked about your ability, but I will tell you about the relationship between days in Germany, and there is going to be critical.

Great questions Okay.

I'll take them one at a time. Thank you for the question first.

In terms of our understanding of the positioning of Amazon.

Okay too precise.

Precise replicates just to study there are some subtle differences in regional recruitment and execution, but essentially its replicate study.

Thank you chairman.

[Company Representative] (Sanofi): Okay. Thank you very much, Houman. Yeah, we'll see. We'll get the data. We'll see how competitive we are. I think from a commercial perspective, we're very enthusiastic, but we'll let the data read out. Okay. Next question, please.

Paul Hudson: Okay. Thank you very much, Houman. Yeah, we'll see. We'll get the data. We'll see how competitive we are. I think from a commercial perspective, we're very enthusiastic, but we'll let the data read out. Okay. Next question, please.

We will see we'll get the data, we'll see our competitors.

From a commercial perspective.

And we anticipate and hope that we will get replicate.

Very enthusiastic.

We'll let the data read out okay.

Just one.

Okay. Next question next question from Keith cannot from TD Cohen.

Uh huh.

As you will remember also you said correctly I'm not sure. It's a slightly more nuanced study then.

Operator: Next question from Steve Scala from TD Cowen. Steve?

Thank you so much two questions yesterday rush said they were taking patients back from <unk>. What is the nature of the patient that is being taken back and what does this mean for <unk> long term growth outlook and the second question is based on the subgroup data presented at Ash actress.

Steve Scala: Thank you so much. Two questions. Yesterday, Roche said they were taking patients back from ALTUVIIIO. What is the nature of the patient that is being taken back? What does this mean for ALTUVIIIO's long-term growth outlook? The second question is, based on the subgroup data presented at ECTRIMS and the language in today's press release, it seems that any tolebrutinib SPMS approval will be in subgroups. What subgroups are likely to be in the final label, and what portion of the overall SPMS market will this represent? Thank you.

Houman Ashrafian: Before I close, my sincere thanks to all colleagues in Sanofi R&D who share my commitment to improve science at Sanofi and help advance our pipeline further, new initiatives in research all the way to regulatory approval. With this, I hand back to Paul.

Has perhaps been observed as well as being able to tell us about durability ultimately randomized way. It will also give us a sense of dose variations. We will do if you remember there are multiple day switching arms, so punchline on ESG, which we'll look at throughout next year.

And the language in today's press release, it seems that any told Ibrutinib spm's approval will be in subgroups.

Paul Hudson: Okay, thank you, Houman. We'll now open the call to your questions. As a reminder, we would ask you to limit your questions to one or two each. You'll be notified when your line is open to ask your question. At that time, please make sure you unmute your microphone or option two, submit your question by clicking the Q and A icon at the bottom of the screen. Your question will be read by our panelists. Now we will take the first question. Please go ahead.

Peter Verdult: The language in today's press release, it seems that any tolebrutinib SPMS approval will be in subgroups. What subgroups are likely to be in the final label, and what portion of the overall SPMS market will this represent? Thank you.

Not anybody tell me about your ability, but I will tell you about the relationship between tax in Germany, and things are going to be critical.

Subgroups are likely to be in the final label and what portion of the overall S. P. M. S market will this represent thank you.

In terms of our understanding of the positioning of Hamilton. Thanks.

Okay. Thank you very much chairman.

We'll see we'll get the data we'll see our competitors we are looking from a commercial perspective.

With that last question, but a tough for those suezmax yesterday, just to be clear I'm going to give you two facts.

[Company Representative] (Sanofi): Well, Houman, why don't you deal with that last question 'cause we better clap for that as soon as possible.

Paul Hudson: Well, Houman, why don't you deal with that last question 'cause we better clap for that as soon as possible.

Very enthusiastic.

We'll let the data readout.

Houman Ashrafian: Yeah, just to be clear, I'm gonna give you two facts. The SPMS population is about 170,000, and the PPMS population 120,000. At no point have we entertained the notion of doing subgroups. The regulatory discussions are ongoing. We don't anticipate any further insight during the regulatory discussions.

That population is about a 170000.

Operator: Yes, first question from Sachin Jain from Beaufort.

Okay. Next question. Please next question from Steve <unk> from TD Cohen.

120000 at that point have we entertain the notion of good.

Houman Ashrafian: Hi there. Thanks for my questions.

Paul Hudson: I wonder if you.

Houman Ashrafian: Just update us on the Tolly SPMS regulatory debates and confidence resolving any questions the FDA has had with that delayed PDUFA.

In some quarters.

Regulatory discussions are ongoing and we get to participate in any further insight during this regulatory decisions.

Paul Hudson: The second one, just to make sure there's no confusion in the market. Given the debates at Q2, can we.

<unk>.

Brian.

Houman Ashrafian: Assume that your wording of profitable growth.

[Company Representative] (Sanofi): Thank you. Brian.

Paul Hudson: Thank you. Brian.

<unk>.

Paul Hudson: For 2026, means EBIT and EPS ahead of sales?

Thanks, Steve so much for the question. So couple of things I will tell you saw another really strong quarter.

And the language in today's press release, it seems that any told a brit to nib spm's approval will be in subgroups.

[Company Representative] (Sanofi): Yeah.

Brian Foard: Yeah.

[Company Representative] (Sanofi): ALTUVIIIO. Sorry.

Paul Hudson: ALTUVIIIO. Sorry.

Houman Ashrafian: Thank you.

Paul Hudson: Okay, thank you. Do you want to provide some clarity on the regulatory piece on SPMs? Tolibrutinib?

[Company Representative] (Sanofi): Thanks, Steve, so much for the question. A couple of things. ALTUVIIIO saw another really strong quarter. It's becoming very clear to us this is the number one switched asset. It's being switched to. We are the number one asset that's being switched to in the hemophilia marketplace, in hemophilia A. We're still seeing, as we have shared before in the past, we've seen about two-thirds of our switches coming from competitors. Of that, still 10% is coming from Hemlibra. I can't really comment on what Ro shared, but what we are still seeing is 10% is coming directly from Hemlibra, and we are the number one asset that is being switched to.

Brian Foard: Thanks, Steve, so much for the question. A couple of things. ALTUVIIIO saw another really strong quarter. It's becoming very clear to us this is the number one switched asset. It's being switched to. We are the number one asset that's being switched to in the hemophilia marketplace, in hemophilia A. We're still seeing, as we have shared before in the past, we've seen about two-thirds of our switches coming from competitors. Of that, still 10% is coming from Hemlibra. I can't really comment on what Ro shared, but what we are still seeing is 10% is coming directly from Hemlibra, and we are the number one asset that is being switched to.

It's becoming very clear to us. This is the number one switched assets. So it's being switched to we are the number one asset is being switched to the hemophilia marketplace in hemophilia, a we're still seeing as we've shared before in the past we've seen about two thirds of our switches coming from competitors of that still 10% is coming from him Libre. So I can't really comment on what ROE shared.

Subgroups are likely to be in the final label and what portion of the overall S. Pms market will this represent thank you.

Houman Ashrafian: Yeah, thanks for the question. Pretty straightforward. As we reported earlier in the year, the FDA requested an extension. We've submitted data sets with the FDA, continue conversations, and look forward to December 28th.

Uh huh.

With that last question, but on top of that as soon as Paul Yes, So just to be clear I'm going to give you two facts.

But what we are still seeing 10% is coming directly from him Libra and we are the number one asset that is being switched to know.

That population is about.

Paul Hudson: Thank you. François, yes, on profitable growth, I.

170000.

François-Xavier Roger: Confirmed that the idea is to have, as we go down through the P&L, all items growing faster than at the upper end of the P&L, which means basically gross margin growing faster than sales growth, EBIT growing faster than gross margin, and EPS growing faster than EBIT. We have achieved that each and every single quarter this year. We'll do it in 2025. We expect to get there in 2026. We are working in the same way to deliver the same objective for the following years as well.

International plus 120000 at no point have we entertain the notion of <unk>.

Now about a third of our business is still coming from a locked in but you can see our overall, that's starting to stabilize our overall he MA business is actually growing quite significantly. So again, we're very pleased with the performance and remain committed to delivering our next blockbuster this year without tibia.

Sub groups.

[Company Representative] (Sanofi): Now about a third of the business is still coming from Eloctate. You can see that's starting to stabilize, and our overall hema business is actually growing quite significantly. Again, we're very pleased with the performance and remain committed to delivering our next blockbuster this year with Altuviiyo.

Brian Foard: Now about a third of the business is still coming from Eloctate. You can see that's starting to stabilize, and our overall hema business is actually growing quite significantly. Again, we're very pleased with the performance and remain committed to delivering our next blockbuster this year with Altuviiyo.

<unk>.

Regulatory discussions are ongoing we don't participate in any further.

During this regulatory decisions.

Hugh.

Great. Thank you and our next question Luiz.

Brian.

Yes.

Okay.

[Company Representative] (Sanofi): Great. Thank you. Next question, please.

Paul Hudson: Great. Thank you. Next question, please.

I'm, sorry from James Skidmore from Goldman Sachs.

Thanks, Steve so much for the question. So a couple of things I will tell you saw another really strong quarter.

Operator: Next question, sorry, from James Quigley from Goldman Sachs. James.

I heard I think.

Paul Hudson: That's very clear. Thank you, Councillor. Next question.

Alright, Thanks for taking my question.

It's becoming very clear to us. This is the number one switched assets. So it's being switched to we are the number one asset that being switched to the hemophilia marketplace in hemophilia, a we're still seeing as we've shared before in the past seen about two thirds of our switches coming from competitors that still 10% is coming from heavily so I can't really comment on what ROE shared.

Operator: Next question is from Luisa Hector from Berenberg. Thank you. Perhaps I could ask the obligatory U.S. policy question. Do you have any updates on your conversations with the U.S. administration? Is it more complex for you with shared assets like Dupixent? Should we be concerned about a degree of silence right now, or is it simply that there is more of a bottleneck in terms of a long queue to speak with the administration, maybe Trump's busy agenda? Any color on that sort of ability to communicate. I'll stop there. Thank you.

James Quigley: Hello. Thank you. Sorry. Thank you for taking my questions. I've got a follow-up question for Francois on the Dupixent or on the antibody pay away. I think backing out how the BOI margin seems to have been developing for Dupixent, it looks like last year it was in the region of sort of 62%. This year, Q3 looks like it reached 72%. Again, we're working backwards, maybe there's like a 92%, 93% gross margin. First of all, is that the right ballpark in terms of what we should be thinking about when calculating the pay away? As you mentioned, it seems not necessarily be fully reflected in consensus.

A follow up question for <unk> on the on the Jupiter.

Absolutely pay away so backing out how the how the DIY margin seems to have been developing for 40 pixels.

Like last year. It was in the original sort of 62% this quarter looks like it reached 73% against working backwards, maybe there's like a 90, 293% gross margin. So first of all we've got the right ballpark in terms of what we should be thinking about when calculating me.

But what we are still seeing a 10% <unk>.

Record from him Libra, and we are the number one asset that is being switched to <unk>.

About a third of our business is still coming from a Lockheed but you can see our overall, that's starting to stabilize and our overall he may business is actually growing quite significantly. So again, we're very pleased with the performance and remain committed to delivering next blockbuster this year ought to be.

As you mentioned it seems not necessarily be fully reflected in consensus and going from a 72% operating margin going forward, how should we be thinking about operating leverage obviously going from last year to this year.

James Quigley: Going from a 72% operating margin going forward, how should we think about operating leverage, obviously, going from last year to this year? It looks like there was a big step up. You mentioned the increase in percentage points growth for the pay away relative to Dupixent. Where could the margin go and how should we think about that going forward? Maybe more so, at what point could the margin peak? Secondly, maybe one for Brian as well. A follow-up on Altuviiyo. You mentioned about taking share from other factor VIII therapies. Where are you now in terms of the factor VIII market? From a market penetration, market share perspective, where do you think you're going to end up?

Thomas Triomphe: Thank you.

There was a big step up you mentioned.

Great. Thank you and next question.

Paul Hudson: I think our answer is pretty straightforward, which is we've had ongoing dialogue with the U.S. government and indeed multiple governments since before we received the letter back at the end of July, I think it was. We focus on making sure that people understand the value we can bring, and those conversations have continued throughout this whole process. Probably common on bottlenecks or other implications, but I think that's probably as much as we can say at this point. Okay, thank you, Luisa. Next question please.

Increase in percentage points growth for the highway relative to fix and so.

Richard Sorry from James Quigley from Goldman Sachs.

Tim.

Where could the margins go and how should we think about that going forward or what might be mostly where at what point could the margin.

All right.

Alright, Thank you for taking my questions.

I've got a follow up question for Francois on the on the Jupiter on the absolutely pay away. So I think backing out how the how the DIY margin seems to have been developing for it depicts and so it looks like last year. It was in the region of 62%.

And secondly, maybe one for Brian as a follow up on what ought to be.

You mentioned about taking taking share from around the fact, the right therapies.

Where are you now in terms of the fact the rate market.

Third quarter looks like it reached 73% against working backwards, maybe there's like a 90, 293% gross margin. So first of all we've got the right ballpark in terms of what we should be thinking about when calculating me.

Our market penetration and market share perspective.

Where do you think youre going to end up and.

If that's below 100% given a data why would that be the case.

James Quigley: If that's below 100%, given the data, why would that be the case?

Pay away as you mentioned it seems not necessarily to be fully reflected in consensus and going from a 72% operating margin going forward, how should we be thinking about operating leverage obviously going from last year to this year.

Operator: Next question. Shirley Shin from Barclays. Shirley, hi, can you guys hear me?

Okay, well some highly specific questions. Just thank you I think from cellular skip abroad.

[Company Representative] (Sanofi): Okay. Well, some highly specific questions, James. Thank you. I think, Francois, you're gonna skip aboard, come up to that.

Paul Hudson: Okay. Well, some highly specific questions, James. Thank you. I think, Francois, you're gonna skip aboard, come up to that.

James I would like to help you, but don't disclose the margin by products. So we don't do it for BP.

Houman Ashrafian: Yeah, hi.

Operator: Thank you so much for taking my question. I have a question on Beyfortus. As you guys said, the Q3 orders have been impacted by inventory carryover from last season. Could you please give us a sense of how Q4 ordering trends are tracking so far? Are we still expecting a Q3 Q4 equal split? Also, given the competition that is ongoing, how do we see the class roadmap competition is going to impact the Q4 number given we know that Merck actually entered the market late in Q3 and also we saw very strong growth in ex U.S. market.

Francois: James, I would like to help you, but we don't disclose the margins by products. We don't do it for Dupixent or for any of our products. Unfortunately, I cannot provide you any information on that. Obviously, the margin has been improving for Dupixent over time, given that we are benefiting, obviously, from scale and efficiency, as I said earlier. Our margin has continued to increase.

François-Xavier Roger: James, I would like to help you, but we don't disclose the margins by products. We don't do it for Dupixent or for any of our products. Unfortunately, I cannot provide you any information on that. Obviously, the margin has been improving for Dupixent over time, given that we are benefiting, obviously, from scale and efficiency, as I said earlier. Our margin has continued to increase.

Sorry, there was a big step up you mentioned.

Many of our products. So unfortunately I cannot provide you any information on that obviously the margin has been improving for <unk> over time, given that we are benefiting obviously from scalar decisions.

The increase in percentage points growth for the pay away relative to tissue picks and so well.

Where could the margin go and how should we think about that going forward or what might be most of the work of at what point could the margin.

<unk> seen as I said there'll be a small London has continued.

Peak.

And then secondly, maybe one for Brian as a follow up on what our T V.

Okay. Thank you.

Similarly, how specific you want to be among the case I think we'll get incredibly specific on that I mean, what are you seeing the he may marketplaces that you got to factor marketplace, which is again as we said where we continue to take the most business from is the factor marketplace. Again. This is a fact that therapy that obviously comes with increased efficacy. We are taking from some from the non factors as I mentioned before 10% come.

[Company Representative] (Sanofi): Okay. Thank you. Brian, maybe similarly, I don't know how specific you want to be on margin.

Paul Hudson: Okay. Thank you. Brian, maybe similarly, I don't know how specific you want to be on margin.

You mentioned about taking taken taking share from some other factor right therapies.

[Company Representative] (Sanofi): Yeah. James, we won't get incredibly specific on that. I mean, what you see in the hema marketplace is that you've got the factor marketplace, which is again, as we said, where we continue to take the most business from is the factor marketplace. Again, this is a factor therapy that obviously comes with increased efficacy. We are taking some from the non-factors, as I mentioned before, 10% coming from HEMLIBRA. We don't know. We haven't shared exactly where that might end at the end of the day. Again, as we said, we're the number one asset that is being switched to. The progress continues, and we'll continue to keep you updated as it develops.

Brian Foard: Yeah. James, we won't get incredibly specific on that. I mean, what you see in the hema marketplace is that you've got the factor marketplace, which is again, as we said, where we continue to take the most business from is the factor marketplace. Again, this is a factor therapy that obviously comes with increased efficacy. We are taking some from the non-factors, as I mentioned before, 10% coming from HEMLIBRA. We don't know. We haven't shared exactly where that might end at the end of the day. Again, as we said, we're the number one asset that is being switched to. The progress continues, and we'll continue to keep you updated as it develops.

Where are you now in terms of the fact, the REIT market.

From a market penetration and market share perspective.

Where do you think youre going to end up and.

If that's below 100% given the data why would that be the case.

Paul Hudson: And.

Operator: What do you see the opportunities there? What is your overall perspective for Beyfortus in 2026? Thank you.

Lever, but we don't know we haven't shared exactly where that might end at the end of the day, but again as we said we're the number one asset that is being switched to sort of progress continues and we will continue to keep you updated as it develops.

Okay, well some highly specific questions Jim Thank you.

Thank you skip abroad.

James I would like to <unk>, but we don't disclose the margin by products and so we don't do it for BP.

Paul Hudson: Okay, so the poll questions, Thomas Larsen, are for you.

Okay. Thank you.

Houman Ashrafian: Rich question.

And then the last question I think yes last question from Peter <unk> from BNP.

Thomas Triomphe: Thank you very much, Julie. Maybe a couple of points to address these different elements. Thanks for giving an eye to the best artist performance in Q3 as you did a few points of highlight. First of all, overall for Beyfortus, you saw that we increased our performance versus last year and we have done that notably by extending the penetration to about 40 countries. Now in your question, there were some geographic elements to it on the U.S. part. Yes, absolutely, you're correct on what's going on in the U.S. and yes we do confirm the guidance that we have provided at the last quarter at Q4. We expect it to be roughly in the same order of maximum but Q3 for Beyfortus overall for global performance.

Many of our products. So unfortunately I cannot point you any information on that obviously as our margin has been improving for the peak zones over time, given that I mean, we have been.

[Company Representative] (Sanofi): Okay. Thank you. The last question, I think.

Paul Hudson: Okay. Thank you. The last question, I think.

Operator: Yes. Last question from Peter Verdult from BNP. Peter.

Peter.

Yes, hi, there.

<unk>, obviously from scale.

BNP.

Kevin on the loss of the cold weather.

Peter Verdult: Yeah. Hi there. Peter here from BNP. Given I'm the last on the call again, maybe I can pepper Houman with a few quick pipeline questions. Just on if I can pick your mind, Houman. Is it simply the case, the go-forward strategy that you repeat the ARIFy trial, or will you solely be looking at the former smokers only? On SDO, data looks great. You need to gather safe data. Just on the regulatory pathway, if I recall a few years ago, FDA was making some noise about wanting to see your respiratory functional endpoints, as well as the biomicro analysis. Is there any of that gonna be required for SDO? Lastly, on TOLI, SPMS opportunity is huge.

Peter Verdult [Managing Director: Yeah. Hi there. Peter here from BNP. Given I'm the last on the call again, maybe I can pepper Houman with a few quick pipeline questions. Just on if I can pick your mind, Houman. Is it simply the case, the go-forward strategy that you repeat the ARIFy trial, or will you solely be looking at the former smokers only? On SDO, data looks great. You need to gather safe data. Just on the regulatory pathway, if I recall a few years ago, FDA was making some noise about wanting to see your respiratory functional endpoints, as well as the biomicro analysis. Is there any of that gonna be required for SDO? Lastly, on TOLI, SPMS opportunity is huge.

Efficiencies as I said earlier 100 us continue please.

Okay.

With a few quick questions.

Okay. Thank you and prime maybe similarly, I don't know how specific you want to be amongst the case I think we'll get incredibly specific on that I mean, what are you seeing the hema marketplaces that you've got the factor marketplace, which is again as we said where we continue to take the most business from is the factor marketplace. Again. This is a fact that therapy that obviously comes with increased efficacy we are taking from.

Questions just came out human is it simply face the go forward strategy.

<unk> trial or are you solely be looking at the full smokers.

And also data looks great.

<unk>.

You need to calibrate states it but just on the regulatory pathway.

A few years ago, the FDA was making some noise about wanting to see yeah respiratory functional endpoints.

Some from the non factors as I mentioned before 10% coming from EM lever, but we don't know we haven't shared exactly where that might end at the end of the day, but again as we said we're the number one asset that is being switched to sort of progress continues and we will continue to keep you updated as it develops okay. Thank you and then the last question I think yes last question.

As well as the biomarker analysis is there is there any of that going to be required for <unk>.

And also you're totally.

Estimates.

Thomas Triomphe: The second point, I think you wanted to mention a couple of points on the environment and the competition without talking about the competition specifically because we don't do that. Maybe I can say a few words on the fact that actually if you look at last year 2024, first year of full supply and Beyfortus was a blockbuster. You remember that if you look at the U.S. performance the total I would.

The change is huge.

How concerned should we be about totally getting onerous labour requiring weekly liver molecule how much of an issue would that be in your mind commercially.

Peter Verdult: How concerned or not should we be about TOLI getting an onerous label requiring weekly liver monitoring? How much of an issue would that be in your mind commercially? Thank you.

Because I don't from BNP.

Peter Verdult [Managing Director: How concerned or not should we be about TOLI getting an onerous label requiring weekly liver monitoring? How much of an issue would that be in your mind commercially? Thank you.

Peter.

Yes, hi, there.

Okay. Thank you last but not least.

BNP.

Given on the loss on the cold again.

[Company Representative] (Sanofi): Okay, Peter, thank you. Last but not least. Okay, Houman.

Paul Hudson: Okay, Peter, thank you. Last but not least. Okay, Houman.

Okay human.

With a few quick.

It's saying you next week.

Heartland questions just pick them up.

To start our second let's let's get into it I will say three broadly speaking.

Houman Ashrafian: We look forward to seeing you next week, firstly, to start. Second, let's get into it. R 33, broadly speaking, we anticipate that we will have to do some form of replicatory trial. The details of exactly what we do have been guided by both internal and external datasets. We've looked broadly, trying to understand why ARIFy 1 and 2 differed. The exact construction of those trials will be dependent on the discussions with our beloved partner, Regeneron, but also with the regulator. Look forward to more on that soon. On ESTO, or as we call it internally, DORA, just to be clear, you're right that FDA and EMA have different perspectives.

Is it simply a case of the go forward strategy that you repeat the Aerify trial or will you solely by looking at the full of smokers.

Houman Ashrafian: Say coverage rate of all babies in.

Thomas Triomphe: The U.S. was around 55%. For all RSV solutions available, roughly 55% of babies were getting some form of RSV protection. We really focused in 2025 and I think we will be focused in 2026 to increasing that vaccination coverage rate. We expect 2025 to land around 70% vaccination COVID rate in the U.S. and therefore we're welcoming all efforts from everywhere to make sure that we increase the importance of awareness. What we are seeing in the signals in the U.S. is that Beyfortus is the favorite product, the favorite prescription from U.S. prescribers simply due to the fact that it's highly differentiated with an extended half-life of 71 days. It makes it by far the longest acting molecular antibodies for the prevention of RSV. It has an incredible real world evidence behind it. That's very important moving forward.

We anticipate that we will have to be some form of regulatory trial. The details of exactly what we do have been guided by banks internal and external datasets. We've looked broadly trying to understand why our five to one and two different and the exact construction of these trials will be dependent on the discussions with all the love.

And also data looks great.

You need to gather safety data, but just on the regulatory pathway.

Recall, a few years ago, the FDA was making some noise about wanting to see respiratory functional endpoints.

Well as the biomarker analysis is there.

It.

Is there any of that going to be required.

Our partner Regeneron, but also recognizing.

And then lastly, I'll totally Sps.

So look forward more on that soon.

Opportunity huge but how concerned should we be about totally getting onerous labral requiring weekly liver monitoring how much of an issue would that be in your mind commercially.

Or as we call it internally Dora.

Just just to be clear youre right that the FDA.

Yes, definitely I mean, you might have different objectives.

Okay. Thank you last but not least.

You will remember that.

Current standard of care.

Houman Ashrafian: You'll remember that current standard of care gauges to a target of 11 microliter, which is about 50% below the limit of normal of the range. Many patients drop below, way below that, 3 to 5-day. The first point I would make is we will disclose the data at a conference, but the Q3 and Q4 W dosing that we have is substantially better than that. We will have a conversation with the regulator as to, hey, their intrigue related to those levels, but also what other additional endpoints we'll need pursuant to both natural history data and our open label extension safety data. On your third point, on tolebrutinib SPMS, we're in late-stage discussions. As I said, the PDUFA is 28 December.

Okay human.

Cases to a target.

We look forward seeing you next week firstly to start a second let's let's get into it I will say three broadly speaking.

11 micro molar.

Which is about 50% of the lower limit of normal of the range.

And then.

We anticipate that we will have to be some form of regulatory trial. The details of exactly what we do.

Many patients struggle is way below that.

Paul Hudson: Okay, thank you. Next question, please.

Three to five days.

Operator: Yes, next question. Matthew Whiston from UBS. Matthew.

The first point I would make is we will decide the data at a conference, but the Q3 and Q4 W dosing that.

Have been guided by both internal and external datasets, we've looked broadly trying to understand why our five one and two different and the exact construction of these trials will be dependent on the discussions with all the love it.

Houman Ashrafian: Thank you. Two questions please. François-Xavier Roger, I'm going to buck the trend. Most people ask 2026 guidance questions. I'm going to ask a 2027 guidance question. Slide 29 flags the Regeneron R&D reimbursement stepping down. It's something that's been familiar I think for many people for a while, but maybe not fully reflected in consensus. The step down is actually much greater in 2027 than in 2026. Your slide implies about a half a billion EBIT gap in 2027. I'm just trying to understand are there any additional levers within manufacturing, gross margin, or the business that could help mitigate that or is that something that we've just got to get prepared for even though it's a year and a half away. One for Houman Ashrafian. You set out your enthusiasm for amlotilumab.

We have a substantially better than that so we will have a conversation with the regulator.

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Yes.

Yeah.

Partner Regeneron, but also recognizing that.

Intrigued related too.

<unk> levels, but I will say one other additional endpoints will need.

So look for more on that soon.

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Natural history data and.

As we call it internally Dora.

Oklahoma extension safety data and on your third point.

Just just to be clear youre right that the FDA.

Totally Sps.

First FDA and EMA have different perspectives.

We are in late stage.

You'll remember that.

Discussions as I said that produces 28 December.

Current status.

And while we anticipate it will need some sort of ramp with Tony.

Cases to a target of.

Houman Ashrafian: While we anticipate there will be some sort of rounds, with tolebrutinib, there's been no further disclosable comment on the intensity of blood pools.

Micro molar.

Which is about 50% of the lower limit of normal of the range.

There are no further.

Disposable comment on the.

And then Ah 90.

And many patients struggle is way below that.

Intensity.

Three to five day.

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The first point I would make is we will disclose the data or the conference, but the Q3 and Q4 W. Dosing that we have.

Okay.

And the last point stratosphere.

Houman Ashrafian: Lilly has just reported the findings from the Phase 3 ADjoin extension study for Eblas which looked at Q8 week dosing and showed very limited erosion in efficacy. I'd be very interested if you think that limits the differentiation for amlotilumab where you were aiming for your 12 week to be differentiated.

[Company Representative] (Sanofi): I think maybe on that last point, it's fair to say, isn't it, that we learned a lot actually between RFI 1 and RFI 2. I think you touched on that a little ago. I feel like even better informed. On tolebrutinib, that first 90 days, what we did in the clinical trial program and what we're doing in real life, seems to be very practical and responsible. I think we're confident we have the right approach. Of course, it's the regulator that will decide what that looks like. Well, okay. Thank you, Peter. Thank you all. Our growth momentum continued in Q3. After 3 quarters of sales and earnings progress, we reiterated our 2025 guidance. Our pipeline delivered important milestones this quarter, as outlined earlier.

Paul Hudson: I think maybe on that last point, it's fair to say, isn't it, that we learned a lot actually between RFI 1 and RFI 2. I think you touched on that a little ago. I feel like even better informed. On tolebrutinib, that first 90 days, what we did in the clinical trial program and what we're doing in real life, seems to be very practical and responsible. I think we're confident we have the right approach. Of course, it's the regulator that will decide what that looks like.

With that I'll actually between that if I wanted to add if I took an interest in that.

Have a substantially better than that so we will have a conversation with the regulator as to a.

Sure.

So I feel even better unfold.

Holly.

That the.

The first 90 days, what we did in the clinical trial program and what we're doing in real life.

Intrigue related too.

Those levels, but I will say one other additional endpoints will need pursuance debate natural history data and our.

Seems to be.

Thomas Triomphe: Thank you.

Private school and responsible.

Paul Hudson: Okay, thank you, William. François-Xavier Roger, you want to catch that? Maybe Brian Foard and Hooman Ashrafian, depending.

Open label extension safety data and on your third point.

So I think.

I think we're confident we have the right approach ecosystem regulated that we'll decide what that looks like well. Okay. Thank you Peter Thank you all.

François-Xavier Roger: Yes, Matthieu, I think that this is a good question for 2027.

Totally Sps.

Thomas Triomphe: Indeed.

François-Xavier Roger: Which is what I presented in the last call at the end of July, the fact that in 2026 we will lose about $300 million of R&D reimbursement from registered amount. As I said a few minutes ago, it will be entirely offset by the additional royalties that we will receive from abu trap in 2027. Indeed, we will have a much more significant amount of R&D reimbursement in terms of big freeze because we will lose $800 million from one year to the other. This will not be fully offset in 2027 by the additional royalties, which will be around $300 million, which is one of my appendices in this presentation as well. We have a gap indeed of about half a billion. Will we be able to cover it with other exceptional items or let's say non-recurring items? The answer is no.

We're in late stage.

Discussions as I said that produces 28 December.

Paul Hudson: Well, okay. Thank you, Peter. Thank you all. Our growth momentum continued in Q3. After 3 quarters of sales and earnings progress, we reiterated our 2025 guidance. Our pipeline delivered important milestones this quarter, as outlined earlier.

Our growth momentum continued in Q3 after three quarters themselves earnings progress, we reiterated our 2020 guidance of pipeline to deliver important milestones this quarter as outlined earlier.

And while we anticipate that we'll need some sort of rins.

Tony.

They can go further.

<unk> will comment on the.

Only as we're looking forward to 2026, we are confident in our ability to pursue our current trajectory of profitable growth.

Yeah.

Intensity.

[Company Representative] (Sanofi): Finally, as we're looking forward to 2026, we are confident in our ability to pursue our current trajectory of profitable growth. With this, I wish everyone a good autumn, and we'll now close the call. Thank you.

Paul Hudson: Finally, as we're looking forward to 2026, we are confident in our ability to pursue our current trajectory of profitable growth. With this, I wish everyone a good autumn, and we'll now close the call. Thank you.

Gross.

Maybe just on that last point stratosphere.

I wish everyone a good awesome.

With a lot actually between there probably wasn't a part two of the interest in the show.

Ill close the call. Thank you.

Joe.

If you like even bedroom fold in on coli.

The first 90 days, what we did in the clinical trial program and what we're doing in real life.

Seems to be a very private school, a responsible and so I think.

François-Xavier Roger: That being said, we will continue growing at a reasonable pace as well. I said it last time that if there was one year where we weren't sure about increasing our profitability and deliver this profitable growth, it would be 2027 for that same reason. That being said, I repeat what I said last quarter, which is we expect our BOI to increase in absolute value in 2027 in spite of this impact. We will be able in absolute value to cover the gap, the $500 million gap. Most probably I believe that we may be in position, still early to say, to even increase our profitability in terms of by 2027 as well. I say we may be still very early. We have not even completed our 2026 budget. I want to be careful.

I think we're confident we have the right approach for closest for regulated that will decide.

What that looks like.

Okay.

Thank you Peter Thank you all.

Our growth momentum continued in Q3 after three quarters of sales earnings progress, we reiterated our 2025 guidance.

Pipeline delivered important milestones this quarter as outlined earlier and finally as we're looking forward to 2026, we are confident of our ability to pursue our current trajectory of profitable growth.

I wish everyone a good awesome will now close the call. Thank you.

François-Xavier Roger: Directionally there is probably a possibility largely as a consequence of the gross leverage that we will get from superior growth.

Paul Hudson: Okay, thank you. Maybe Brian Foard first and then Hooman Ashrafian.

Houman Ashrafian: Yeah, I think for.

Brian Foard: Great question. Thank you very much. I think as you look at the marketplace, we've always said this is a marketplace that's going to continue to grow. The biopenetration rate is extremely low, just over 14%. More assets coming into the marketplace will only help the marketplace grow as you can see from our growth today. Dupixent, a product that's already on the marketplace, is benefiting from other therapies coming in the marketplace. That said, one thing that we've said consistently for a very long time, these IL13s are incomplete therapies and we've seen them on the market now. Actually, if you look at Lebry, that's been on the market for nearly a year now as single digit share. We're seeing while it's helping grow the marketplace, it's really not taking very much share from Dupixent. Dupixent, we believe, still has a very.

Houman Ashrafian: Strong profile in each of these still.

Brian Foard: These dosing ranges are either two weeks or, at the best, four weeks is what we're seeing right now. We think that there's a lot of room for a much more durable dose in the marketplace, assuming we finish the regulatory trials and get it to the marketplace for NEMA or, excuse me, for Pneuma.

Houman Ashrafian: No, just Matt, to answer the question as well as the Biopen comment, which is important. This is a totally novel mechanism, an apical node in the immune response with not only durability but multiple differentiating factors. We remain, based on the data, actually the case one study, encouraged by the potential for amlotilumab.

Paul Hudson: Great, thank you. Next question.

Operator: Yes, next question from Seamus Fernandez from Guggenheim.

Brian Foard: Thanks very much.

François-Xavier Roger: have just a couple of quick questions.

Brian Foard: Can you just update us on RILLA approved art and just kind of timing dynamics around that? It's unclear if that's still on track for second half 2026 readout in CIDP. I just wanted to clarify that, and then more broadly, just hoping to get a better understanding of when we're going to learn more about the programs that have had kind of unfortunate outcomes and where a number of programs are under review, including the oral TNF, including itapekamab. It just seems like there's a lot of secondary analysis exploration going on and holding on to assets as part of the pipeline. I'm just trying to get a better understanding of when we're going to know the advancement or elimination of some of those assets that haven't quite lived up to at least investor expectations.

Paul Hudson: Thanks. Okay, Hooman, thanks Seamus.

Houman Ashrafian: I'll try and be succinct on this one. On really Proof Arts, we've updated the timelines at this Q3, and the reality is that the outcome for the two phase 3 studies for CIDP are just grouping over the year. This is purely a patient recruitment phenomenon, and we look forward to seeing the results of those studies that you'll remember. The phase 2 studies were extremely encouraging. On your second point about when you'll see the data and when we make decisions, obviously those data sets will all be presented at the relevant scientific congresses. I've already announced today that we will go forward, subject to regulatory approval, with our partners in at the pecumab. There's no tardiness there. Obviously, we have to take a regulatory opinion before we move forward into replication phase 3.

Houman Ashrafian: For the other studies, I've already alluded to the fact that we will take a portfolio view on asthma with a number of our assets and figure out what we take forward in asthma and on balance, the 10 fiber. We just had access to the results. I've outlined the importance of ACR 50 and 70 and the fact they're clinically meaningful. We'll figure out, as we've always said, we've been consistent in our view that we'll figure out exactly the role of Balina in mono and combination therapies, both with our own molecules and partners. Thank you.

Paul Hudson: Thank you, Sherry, great questions. We've seen it with many of our competitors having hits and misses in immunology over the last months that these extra levels of thinking actually are worth doing and standing in good step because you really do pick the right patient population. Taking time I think is wise for us.

Operator: Next question from Simon Baker from Redburn.

Houman Ashrafian: Simon, thank you for taking questions too.

Paul Hudson: Please.

Houman Ashrafian: Firstly, on Dupixent. You said that the gross margin benefit from manufacturing improvements is now fully being captured. I just wonder if you can give us some idea of the magnitude of the gross margin improvement this quarter, which is down to Dupixent manufacturing. A question on indication opportunities. Hooman, you mentioned Rilzabutinib in Graves disease. That's potentially not a particularly rare condition. I just want to get your thoughts on the potential you see there. Also, the other one in light of Moderna's failure this week is CMV vaccination. I know you've been in this space in the 1990s. I just wonder what your level of appetite was for it now. Thanks so much.

Paul Hudson: All right, thank you, Simon.

François-Xavier Roger: Yes, Simon, on Dupixent. The gross margin contribution from the C3 manufacturing was actually very limited in Q3 itself. This is, we just took the opportunity to mention that we have completed the full implementation of this new technique, which has spread over a couple of years actually, but it did not have a significant impact in Q3 per se. I take the opportunity to mention that our gross margin increased globally for the company by 2.5% in Q3 and by 1.8% in H1. Most of the factors still contributing to it are still relevant for the future to a certain extent. One of them is volume growth. Our volume grew by 12% since the beginning of the year. We expect to continue at a high level. We are obviously benefiting from a positive product mix including this quarter. Evakit.

François-Xavier Roger: Evakit is much more significant than the new manufacturing technique for Dupixent. We are also basically benefiting from the industrial restructuring that we did over the last couple of years. Plus there were some one-offs this quarter last year and this year which did create a little bit of positive impact as well. If we look at it underlying, because we were at the high range once again with 2.5% of increase in Q3. If we exclude the one-offs on some of the items that will not necessarily replicate each and every single quarter like Evakit, for example, you can consider that the underlying gross margin increase that we have experienced since the beginning of the year is around 1%. It is obviously before any impact. If you want to use that for the future, that does not include any potential impact coming from tariffs.

Paul Hudson: Okay, Houman Ashrafian and then Thomas Gusladen.

Houman Ashrafian: Okay, thanks for that insightful question. As you'll know, Graves is a well-established autoantibody-related disorder. The classic long-acting thyroid-stimulating antibodies, the TSHR antibodies, are important. Number one, it's a canonical autoimmune disorder. Number two, we know from an investigator-initiated study that B cell suppression is successful therapy, particularly for the ophthalmopathy. Thirdly, with our unique covalent reversible molecule in rilzobrutinib that has already shown significant promise in multiple disorders including IgG4 disease and ITP, I think that Graves is a promising opportunity and we look forward to taking the molecule forward. You are completely correct that it's not a rare disorder of that sort per se. It's not super rare and therefore I think it's a potential opportunity, particularly the ophthalmopathy. Come on.

Paul Hudson: Thank you, Thomas.

Thomas Triomphe: CMV will be short. Not much to say. The news is very recent as you know very well, Simon. I would not comment on me to see the full data set. The only thing I can refer to is indeed, you know that quite a while ago, a few decades ago we had worked on this antigen. It's a difficult target. While we had reached some, I would say, interim efficacy, our assumption at that time was that it would not be sufficient to reach a protection level. That's why we had interrupted this program quite a while ago, sadly overall, because the field of CMV vaccination is an important field and we would welcome a vaccine against this devastating disease.

Paul Hudson: Okay, thank you. Next question, please.

Operator: Next question from Richard Vosser from J.P. Morgan.

Paul Hudson: Richard, hi.

Houman Ashrafian: Thanks for taking my question on Dupixent and just giving us a little bit more on the development around COPD and also the gross to net, how that developed in the quarter and how we should think about that in 2026. Also, how the COPD launch is going seems to be developing a little bit better this quarter. My second question is just on the inhibrix data. I think you need some of the more long-term safety data that you called out from the open-label extension. Just wondering what, if anything, is being looked at in terms of that safety data from the regulators. Is there anything of interest that they want to see or rule out?

Paul Hudson: Thanks very much. Okay, Brian, do you think.

Houman Ashrafian: One of our fastest, actually it's our.

Brian Foard: Fastest respiratory indication as far as growth rate goes. That plus CSU plus BP, you can see now eight indications deep into the U.S., our sources of growth are coming from everywhere, and of course launching around the world. It also has actually created this really strong momentum we've seen with 26% growth this quarter and reaching over $4 billion sales as it relates to gross net. Obviously, that's captured in there in reference to our sales growth. This is something that we've monitored for a long time. We see that as we go into additional sources, if you will, or different payer groups, we obviously will provide discounts to get into different access for different patient populations. Again, this is something we've known for a long time, and it's captured in our long-term guidance for Dupixent.

Thomas Triomphe: Okay.

Paul Hudson: Houman and Hooman Ashrafian.

Houman Ashrafian: Yeah, I'm excited to have done this acquisition. An example of our disciplined capital allocation policy, and it's exciting that the preliminary data has proved so promising, superior both at Q3 and Q4 to some of the standards of care. You're correct that we're interested in the long term extension study, which is open label for the safety data. There is no specific, remember this is a fusion protein like an antibody. There's no specific side effects we are looking for. You'll have noted from the press release that the safety and tolerability were in line with that which was expected.

Paul Hudson: Okay, thank you. Next question, please.

Operator: Next question for Michael Lushton from Jefferies.

Houman Ashrafian: Michael, thank you very much.

François-Xavier Roger: Two questions for François-Xavier Roger please.

Houman Ashrafian: One, I just wondered if I could produce a little bit more on the seasonality comment on gross margin. You said the Dupixent process is now tucked in and you return to normal patterns. Just wonder what you meant by that. If most of the drivers of gross margin increase in Q3 still hold, just wondering why you opted not to offer an increase to guidance for this year.

Paul Hudson: Thank you. Okay, thank you François-Xavier.

François-Xavier Roger: Michael, as I said, the 2.5% point of increase that we had in our gross margin in Q3 is probably not necessarily good. Proceed for 2026. We believe that we have some factors that will stay there like our volume growth, like for example even the product mix. These issues are structural, but we won't get another increase next year of 2.5% points in gross margin. It will be probably closer maybe to what I said underlying, maybe 1% point benefiting from volume and product mix. The other thing in terms of guidance, I'm glad you asked the question. We do confirm our full year guidance, which is high single digit growth, sales growth. Today after nine months we are at 8.8% year to date. Expect some increase from where we are at the end of September.

François-Xavier Roger: Business EPS growth is low double digit, even excluding the benefit of share buyback. We are excluding share buyback at 9.9%. Expect there as well for the full year that we will go up from where we are as at the end of September. Just to clarify as well, our full year guidance assumes basically that Q4 will be the best quarter in sales, BOI, and EPS growth this year. We will do better than we have done in any other quarter. Q3 was anyway a bit softer because of the comps, as we said earlier. There is just one thing I want to take the opportunity to mention. Maybe what the street does not always estimate is the profit sharing with Regeneron. That includes, by the way, both Dupixent and Kev Zahra, because there is probably an understanding that it grows in line with sales of Dupixent. It doesn't.

François-Xavier Roger: Let me just give you some further color. For example, if we look at Dupixent sales in H1, they grew by 21% and the Regeneron profit sharing grew by 32%, so 11% points faster. If I do the same analysis for Q3, Dupixent sales grew by 26%, which is remarkable, and Regeneron profit, the profit sharing with Regeneron, grew by 37%, so another 11% points higher than sales. Once again, it is a profit sharing. It's not linked necessarily fully to sales, and there is about 10% to 11% points of growth in terms of difference.

Houman Ashrafian: Between the two concepts.

Paul Hudson: Thank you. Next question, please.

Operator: Next question from Florent Cespedes from Bernstein.

Houman Ashrafian: Good afternoon.

Paul Hudson: Good afternoon.

Houman Ashrafian: Can you hear me?

Paul Hudson: Yep.

Houman Ashrafian: Yeah. Thank you very much for taking my questions from Bernstein. Two quick questions, please. First, on M&A, with the massive success of Dupixent and with the mixed-use flow pipeline, maybe could be more aggressive in terms of product acquisitions.

François-Xavier Roger: Maybe kind of Blueprint Medicines-like transactions is.

Houman Ashrafian: Something that we should see in the future.

François-Xavier Roger: Maybe a second quick question for Thomas on vaccines.

Paul Hudson: Can you share with us how you do.

Houman Ashrafian: You see the trend that have been flu with the vaccine fatigue that we.

Paul Hudson: Observe across the world?

François-Xavier Roger: Additional color on this would be great.

Houman Ashrafian: Thank you.

Paul Hudson: Maybe I didn't quite catch perfectly the first question, but it was regarding M&A and should we be doing more and more Blueprint Medicines-like is what I think I heard. François-Xavier Roger, do you want to.

François-Xavier Roger: Just a few words. Maybe you can complete it. It's not really about being aggressive. It's about finding the relevant acquisitions. We have space in our balance sheet. We said that we want to retain our AA rating in order to get there. We could afford. Once again, this is not necessarily what we want to do, but we could afford investing in M&A currently something like €14 billion, €15 billion and still retain our AA rating. Anyway, what we are looking for is to meet three criteria. Basically, strategic fit, which is around our four therapeutic areas and possibly white spaces as well. Second, scientific differentiation and relevance, and first in class, best in class. Third, financial return as well, without any certainty. It's less a matter of amount or aggressiveness. It's more about finding the right targets at the right time at the right price.

Paul Hudson: Yeah, I think that's great. We've been really disciplined. François-Xavier Roger, when he came in, actually went back and looked at all of our acquisitions and agreements to decide whether we allocated capital to his standard, and I was somewhat relieved to find out that he did. There is a huge amount of discipline, and I think you've just heard how ALTUVIIIO has done in Q3, so we're really very good at it. We have to be a little bit choosy about what we do. I think that's very reasonable. Okay, Tom, vaccines.

Thomas Triomphe: Thanks for the question on flu. A couple of points. First of all, it's earlier, we're still in October, but indeed as you had in mind with your question, I think it's fair with the first few weeks that we observe a little bit vaccination rate on the soft side when it comes to flu vaccination, particularly in the U.S., so we see a soft this year. A couple of points though I'd like to highlight when it comes to the 2025 performance that you see in this quarter. First of all, we had highlighted it before but I just want to be clear. It's linked to two elements. In Germany, there is a price effect where there is a significant price exceed due to change of recommendation and in the U.S. it's more what you're mentioning that is the soft VCR.

Thomas Triomphe: In both cases in this 2025 environment we are keeping a very strong market share performance overall for Sanofi flu vaccines, in particular even for different shape vaccines. Beyond the performance in terms of market share, what I'd like to highlight also this quarter in terms of flu is the progress we're also making on the mRNA perspective. You see that we have a positive phase 3 influenza high dose Fluzone High-Dose 50 plus extension. With the great performance you see with the fluidity trial and a fantastic 32% improvement compared to standard dose and flu specialization. If we can extend that to people above 50 years of age that would be fantastic. To be associated also with the progress we've made on pandemic flu with, I think, with our best in class H5 soil protection results and the move and progress we're making on flucoinezine combination.

Thomas Triomphe: Flu remains important for us. We're moving forward full steam commercially and rmby.

Paul Hudson: Okay, thank you. Next question, please.

Operator: Yes, next question from David Riesinger from UBS. David.

Brian Foard: Yes, thanks very much.

Houman Ashrafian: Congratulations on the positive and hemophilia A metrics.

Brian Foard: Elevate results this week. Could you provide some more color on?

Houman Ashrafian: How you would characterize for AATD both.

Brian Foard: The normal range and the trough levels. Regarding net price prospects for U.S. Dupixent in 2026, since your contracting.

Houman Ashrafian: Is likely largely complete at this time of the year, how would you characterize the expected net change in pricing in 2026 versus the net change in pricing in 2025?

Brian Foard: Thanks very much.

Paul Hudson: Okay, thank you.

Brian Foard: Yeah.

Houman Ashrafian: Without running into any issues, you'll remember that the definition of alpha 1 antitrypsin levels is related to the wrong crystal nomogram. I'll speak in broad terms. Standard of care by and large doesn't get into the normal range for alpha 1 antitrypsin levels. Our Q3 and Q4 molecules provide very commendable alpha 1 antitrypsin nomogram levels, both for trough and meanders.

Paul Hudson: Thank you. Brian, I think a clever question from David trying to get at the rebates likely for 2026 over 2025.

Houman Ashrafian: I'll let you answer.

Brian Foard: Yeah, I think it's a great question, David. Thank you so much for asking it. As you know, we don't typically give guidance on the net price year over year. One thing I will say, as you can see, we've been incredibly disciplined over the years. We're now eight years into the launch of this asset, and it's been captured in our long-term guidance how we believe the net price will develop over time.

Houman Ashrafian: Thank you.

Paul Hudson: Next question, please.

Operator: Yes, next question from Sarita Kapila from Morgan Stanley. Hey, thanks for taking my questions. Just on amlotilumab, how should we think about the upcoming readouts? Is there potential for the placebo arm in the COAST 2 trial to behave more normally, or should we think about it as a pure sister trial to COAST 1? Then just on Estuary, beyond the no plateau in efficacy that we saw, what's underpinning the confidence that the long-term efficacy can improve with time? Thanks.

Paul Hudson: Great questions. Okay, Numa.

Houman Ashrafian: Okay, so I'll do them one at a time. Thank you for the question. Firstly, on Coast 2, it's a precise replica sister study. There are some subtle differences in regional recruitment and execution, but essentially it's a replicate study and we anticipate and hope that we will get replicate Coast 1. As you'll remember, also you said correctly, on Estuary, it's a slightly more nuanced study than has perhaps been observed. As well as being able to tell us about durability ultimately in a randomized way, it will also give us a sense of dose variation that we will do. You'll remember there are multiple day switching arms. The punchline on Estuary, which we'll get throughout next year, is not only will it tell you about durability, but it'll tell you about the relationship between days and durability.

Houman Ashrafian: Those are going to be critical in terms of our understanding of positioning around the timbre.

Paul Hudson: Thanks. Thank you very much. Houman. We'll see, we'll get the data, we'll see how competitive we are. I think from a commercial perspective we're very enthusiastic, but we'll let the data read out. Okay, next question please.

Operator: Next question from Steve Scala from TD Cowen.

Houman Ashrafian: Steve, thank you so much. Two questions. Yesterday Roche said they were taking patients back from ALTUVIIIO. What is the nature of the patient that is being taken back, and what does this mean for ALTUVIIIO's long-term growth outlook? The second question is based on the subgroup data presented at ECTRIMS and the language in today's press release, it seems that any tolebrutinib SPMS approval will be in subgroups. What subgroups are likely to be in the final label, and what portion of the overall SPMS market will this represent? Thank you.

Paul Hudson: I think we might deal with that last question because we better clarify that as soon as possible. Yeah.

Houman Ashrafian: To be clear, I'm going to give you two facts. The SPMS population is about 170,000 and the CBMS population is 120,000. At no point have we entertained the notion of doing subgroups. The regulatory discussions are ongoing. We don't participate in any further insight during the regulatory discussions.

Paul Hudson: Thank you, Brian. ALTUVIIIO.

Brian Foard: Thanks, Steve, so much for the question. A couple things. ALTUVIIIO saw another really strong quarter. It's becoming very clear to us this is the number one switched asset.

Houman Ashrafian: It's being switched to.

Brian Foard: We are the number one asset that's being switched to in the Hemophilia marketplace. In Hemophilia A we're still seeing, as we have shared before in the past, about 2/3 of our switches coming from competitors. Of that, still 10% is coming from Hemlibra. I can't really comment on what.

Houman Ashrafian: Roche shared what we are still.

Brian Foard: Seeing is 10% is coming directly from WAYLIVRA and we are the number one.

Houman Ashrafian: Asset that is being switched to.

Brian Foard: Now, about a third of the business is still coming from Lantus, but you can see overall that's starting to stabilize, and our overall hemade business is actually growing quite significantly. We're very pleased with the performance and remain committed to delivering our.

Houman Ashrafian: Next blockbuster this year with ALTUVIIIO. Great, thank you.

Paul Hudson: Next question.

Operator: Lou, question. Sorry from James Quigley from Goldman Sachs.

[Analyst]: Hello. Thank you. Thank you for taking my questions. I've got a follow up question for François-Xavier Roger on the Dupixent or on the antibody payaway. I think backing out how the BOI margin seems to have been developing for Dupixent, it looks like last year it was in the region of sort of 62%. This year, third quarter looks like it reached 72% again. We're working backwards maybe as like a 92% or 93% gross margin. First of all, is that the right ballpark in terms of what we should be thinking about when calculating the payaway? As you mentioned, it seems not necessarily fully reflected in consensus. Going from a 72% operating margin going forward, how should we think about operating leverage, obviously going from last year to this.

Paul Hudson: Year looks like there was a big step up.

[Analyst]: You mentioned the increase in percentage points growth for the payway relative to Dupixent. Where could the margin go, and how should we think about that going forward? At what point could the margin peak? Secondly, maybe one for Brian Foard as well. Follow up on ALTUVIIIO, you mentioned about taking share from other Factor VIII therapies. Where are you now in terms of the Factor VIII market? From a market penetration, market share perspective, where do you think you're going to end up? If that's below 100% given the data, why would that be the case?

Paul Hudson: Okay, some highly specific questions, James, thank you. I think François-Xavier Roger is going to scale up a little to that.

François-Xavier Roger: James, I would like to help you but we don't disclose the margin by products, and we don't do it for Dupixent or for any of our products. Unfortunately, I cannot provide you any information on that. Obviously, the margin has been improving for Dupixent over time given that we are benefiting from scale efficiency as I said earlier. Margin has continued to increase.

Paul Hudson: Okay, thank you. Maybe similarly, I don't know how specific you want to be on margin.

François-Xavier Roger: Get incredibly specific on that.

Brian Foard: I mean what you see in the hemophilia A marketplace is that you've got the factor marketplace, which is again, as we said, where we continue to take the most business from is the factor marketplace. Again, this is a factor therapy that obviously comes with increased efficacy. We are taking some from the non-factors, as I mentioned before, 10% coming from Hemlibra, but we don't know, we haven't shared exactly where that might end at the end of the day. As we said, we're the number one asset that is being switched to. The progress continues and we'll continue.

Paul Hudson: To keep you updated as it develops. Thank you. The last question, I think.

Operator: Yes, last question from Peter Verdult from BNP.

Paul Hudson: Peter, yeah, hi there, Pete here from BMP. Given I'm the last on the call again, maybe I'm going to pepper Hooman with a few quick pipeline questions. Just on isipicumab, Hooman, is it simply a case the go forward strategy that you repeat the RFI trial, or will you solely be looking at the former smokers only, and on EFDO data looks great. You need to gather phase data, but.

Houman Ashrafian: Just on the regulated pathway.

Paul Hudson: If I recall a few years ago, FDA was making some noise about wanting to see respiratory functional endpoints as well as the biomarker analysis. Is there any of that going to be required for efo? Lastly, on Tolly SPMS opportunity, huge. How concerned or not should we be about Tolly getting an onerous label requiring weekly liver monitoring? How much of an issue would that be in your mind commercially?

Houman Ashrafian: Thank you.

Paul Hudson: Okay, thank you. Last but not least.

Houman Ashrafian: Okay, we look forward to seeing you next week. Firstly, to start second, let's get into it. I'll say three. Broadly speaking, we anticipate that we will have to do some form of replicatory trial. The details of exactly what we do have been guided by both internal and external data sets. We've looked broadly to try and understand where RFI 1 and 2 differed, and the exact construction of those trials will be dependent on the discussions with our beloved partner Regeneron, but also the regulator. Look forward to more on that soon. On EFTO, or as we call it internally, Dora, just to be clear, you're right that the FDA, first FDA NEMA, had different perspectives.

Houman Ashrafian: You'll remember that current standard of care gauges to a target of 11 micromolar, which is about 50% the lower limit of normal of the range, and then many patients drop way below that three to five days. The first point I would make is we will disclose the data at a conference, but the Q3 and Q4W dosing that we have is substantially better than that. We will have a conversation with a regulator as to their intrigue related to those levels, but also what other additional endpoints we'll need pursuant to both natural history data and our open label extension safety data. On your third point on trolley SBMs, we're in late-stage discussions, as I said, at the due fees 28th of December. While we anticipate that we'll need some sort of rounds with Tolly, there's been no further disclosable comment on the intensity of blood draws.

Paul Hudson: Maybe it's on the last point here, and it's fair to say, isn't it, that we learned a lot actually between RFI1 and RFI2. I think you touched on that. If you're even better informed and on polly, that first 90 days, what we did in the clinical trial program and what we're doing in real life seems to be very practical and responsible. I think we're confident we have the right approach. Of course, it's the regulator that will decide what that looks like. Thank you, Peter. Thank you all.

François-Xavier Roger: Our growth momentum continued in Q3.

Paul Hudson: After 3/4 of sales and earnings progress, we reiterated our 2025 guidance. Our pipeline delivered important milestones in this quarter as outlined earlier. Finally, as we're looking forward to 2026, we are confident in our ability to pursue our current trajectory of profitable growth. With this, I wish everyone a good autumn and will now close the call. Thank you.

Q3 2025 Sanofi SA Earnings Call

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