Sanofi – Q1 2025 Earnings Call

Summary

Highlights

• Sanofi achieves a 9.7% sales increase in Q1 2025 driven mainly by Dupixent and Bayforis 🚀.
• A focus on sustainability highlights Sanofi's commitment to healthier outcomes and environmental responsibility 🌍.
• A significant strategic move towards a €5 billion share buyback is underway 📊.
• Sanofi's innovative pipeline shows promise with developments in key areas like COPD and vaccines 💉.
• Expectations for continued growth in respiratory and vaccine segments as the company aligns its industrial footprint strategically 🏭.

Key Takeaways

• Sanofi records a solid 9.7% growth in Q1 2025, with a strong focus on Dupixent and Bayforis in vaccines 💪.
• The company highlights its commitment to sustainability, linking health outcomes with environmental and social responsibilities 🌿.
• Sanofi plans a significant €5 billion share buyback to boost shareholder value 📈.
• The pipeline is expanding with promising developments in COPD and vaccines to drive future growth 🚀.
• Management aims for strategic investments in R&D and talent to fuel organic growth 📚.

Overview

Chapters

• 00:00 - 01:30: Introduction and forward-looking statements The introduction begins with Thomas Glen from the Zenovi Investor Relations team welcoming participants to the Q1 2025 conference call aimed at investors and analysts. Participants are directed to the presentation slides available on the company's website. The initial focus is on the forward-looking statements, where a standard disclaimer is provided, reminding attendees that such statements involve significant risks and uncertainties, which could lead actual results to differ from expectations.
• 01:30 - 03:00: Q1 2025 performance highlights and strategic focus The chapter focuses on the Q1 2025 financial performance and strategic emphasis of the company. It addresses the importance of reviewing the disclaimer in their slide presentation and refers to the newly filed form 20F with the US SEC along with the France registration document to describe risk factors. The financials are reported under a new scope that excludes the Opela consumer health business. Additionally, it highlights their use of constant exchange rates and other non-IFRS measures, with all numbers presented in millions.
• 03:00 - 05:00: Sales growth and product launches The chapter titled 'Sales growth and product launches' covers financial and operational information related to Q1 2025. The presentation is brief, due to the busy reporting season, with a goal of keeping the call under one hour. Key figures such as Brian Olivier Thomas, Roy, and Brendan are present to address questions related to global business, legal matters, and manufacturing supply. The chapter likely delves into details on sales performance and any recent or upcoming product launches.
• 05:00 - 06:30: Vaccine business and pipeline The chapter discusses the recent performance and strategic focus of a business in the vaccine sector. There was a 9.7% sales growth in the first quarter of 2025, thanks to innovations and new product launches, specifically mentioning 'dupixent' and 'bay fordis' in their vaccines portfolio. The chapter likely includes details on recent business strategies and further insights on their new product developments.
• 06:30 - 08:00: Sustainability strategy and its impact In the first quarter, product launches generated 1.1 billion euros, accounting for 11% of total sales. This success was driven by strategic phasing and geographical expansion. Altuvio, benefiting from patient switches, is poised to become a blockbuster. Notably, Qitlia received FDA approval for hemophilia on March 28th with early prescriptions noted, marking it as the first of three potential product launches this year.
• 08:00 - 10:00: CFO's financial update and Opella transaction In Q2, Dupixon demonstrated robust growth, with a 20% increase in Q1 sales owing to widespread demand, reaching €3.5 billion. Specifically in the US, sales grew by 18% to €2.5 billion. Dupixon now leads in total prescription share across all its approved indications. The usual Q1 impact was noted in the US, where resetting of insurance deductibles had an effect on the sales figures.
• 10:00 - 13:00: Innovative pipeline updates Sanofi's Dupixon sales have exceeded €1 billion outside the US, with significant contributions from Japan, China, and Germany.
• 13:00 - 16:30: R&D strategy and new studies The chapter discusses the expansion of leadership in type 2 inflammatory diseases, with a focus on unmet needs in patients with uncontrolled COPD. It highlights the approval and launch of Dupixon in several countries, including major markets such as the US, Germany, China, and Japan. The approval and recognition by payers ensure better access for patients, underlining the importance and recognition of this biologic medicine in treating COPD.
• 16:30 - 27:00: Q&A session The chapter titled "Q&A session" discusses the strategic initiatives for improving the adoption of a product named Dupixon. The two main objectives highlighted are educating pulmonologists about the benefits of Dupixon and increasing patient awareness through a DTC campaign launched in the US. Additionally, the chapter mentions the robust performance of a vaccine business, which achieved double-digit growth in Q1 due to favorable factors and new country launches, especially in the US.

Sanofi – Q1 2025 Earnings Call Transcription

• 00:00 - 00:30 Hello everyone. This is Thomas Glen from the Zenovi IR team. Welcome to the Q1 2025 conference call for investors and analysts. As usual, you can find the slides on senua.com. Please turn to slide number three, please. Here we have the usual forward-looking statements. We would like to remind you that information presented in this call contains forward-looking statements which are subject to substantial risk and uncertainties that may cause active results to differ
• 00:30 - 01:00 materially. We encourage you to read the disclaimer in our slide presentation. In addition, we refer to our new form 20F on file with the US SEC and our France registration document for description of these risk factors. As last quarter, financials reported are under the new reporting scope that excludes the Opela consumer health business. As usual, we will be making comments on our performance using constant exchange rates and other non if measures. Numbers used are in millions
• 01:00 - 01:30 of euros and for Q1 2025 unless stated otherwise. Now, please turn to slide number four. First, we have a presentation, then we'll take your questions. We have kept the presentation as short as in the past as other companies report today and we aim at keeping the call to maximum one hour. For Q&A, we have Brian Olivier Thomas to cover our global businesses as well as Roy, our general council and Brendan, head of manufacturing and supply. With the Q&A, you have two
• 01:30 - 02:00 options in Zoom. Raise your hand or submit your question using the Q&A function. With this, I'll hand you over to Paul. Well, thank you, Thomas. Nicely done. And hello everyone on the call. We had a strong start to 2025 with a 9.7% sales growth in the first quarter. Our strategic focus on innovation continues to deliver driven by farmer launches dupixent and bay fordis in our vaccines portfolio. Let me highlight our performance of new launches on slide
• 02:00 - 02:30 six. In Q1, our launches generated 1.1 billion euros in sales contributing 11% of the total. This performance was driven by an element of bay foris phasing and expansion in Europe and rest of world. Altuvio benefited from continued patient switches and has the potential to become our next blockbuster this year. Of note, on March the 28th, we obtained FDA approval for Qitlia in hemophilia, one of three potential launches this year with initial prescriptions already recorded in early
• 02:30 - 03:00 Q2. Moving to slide seven, Dupixon. The epixen delivered strong growth of 20% in Q1 driven by broad-based demand and reached €3.5 billion euros of sales. In the US, sales were 2.5 billion euros in the quarter, up 18%. Depixen now also leads total prescription share across all approved indications. As usual, in the first quarter, US sales reflected the impact from the annual reset of insurance deductibles driving higher
• 03:00 - 03:30 utilization of copay assistance. Outside the US, Dupixon sales exceeded€1 billion euros for the first time supported by the contribution from Japan, China and Germany. Looking at the remainder of the year, we will continue to drive Dupixon's growth across our markets and in all approved indications. As a reminder, bio penetration still remains quite low. We are excited about the US approval for CSU last week and the upcoming regulatory decision in the US for bulismpigoid.
• 03:30 - 04:00 These additional indications continue to expand our leadership across type 2 inflammatory diseases. On slide eight, let me briefly remind you of the higher met need among people with uncontrolled COPD, many of whom have resigned themselves to their condition. Dupixon is the first biologic medicine approved in this disease. We have already launched COPD in eight countries including the US, Germany, China, and Japan. Lupixon's value is being recognized by payers in key countries, ensuring access for all patients. To
• 04:00 - 04:30 improve adoption, we focus on two main objectives. First, we continue to educate pulmonologists about Dupixon's benefits, the role of type 2 inflammation and the urgency to treat patients. Second, to drive patient awareness. In April, we just launched our DTC campaign in the US. Moving to slide nine, our vaccine business delivered double-digit growth in Q1. This performance was driven by favorable paid forest phasing and new country launches. In the US, we are focused on
• 04:30 - 05:00 improving the immunization rate to ensure infants born in late season are also immunized and protected. Turning to flu, our manufacturing is progressing as planned following the WHO and FDA strain selection. As the world leader in flu vaccines, we continue to focus on improving the vaccination rate by increasing awareness of the benefits of our differentiated flu vaccines. On our vaccines pipeline, we continue to push the boundaries of innovation, pioneering the development of a vaccine candidate for the
• 05:00 - 05:30 prevention of chlamydia. In March, the US FDA granted fasttrack uh designation in recognition of our commitment to improving public health and addressing high unmet medical needs. On slide 10, I'd like to introduce introduce you to our updated sustainability strategy focused on aligning health outcomes with environmental and social responsibility, environmental challenges, and human health. An estimated 3.6 people uh 3.6 billion people are living in climate sensitive areas with 6 million deaths
• 05:30 - 06:00 reported annually from air pollution alone. That makes it clear people's health and environment are deeply linked. The new air strategy focus our uh focuses our efforts on three strategic imperatives. Access to healthare, environmental impact and the resilience of healthare systems. With over 70 uh 70% of our portfolio and more than 75% of our pipeline involved in climate related diseases, has a key role to play and through air we are furthering SEO's commitment to global
• 06:00 - 06:30 health by working to break the cycle of environmental decline and declining public health. Thank you. I'll now hand over to Francois our CFO for more details on the financials. Thank you Paul and hello to everyone. As highlighted by Paul earlier, net increased by 9.7% at constant exchange rates to 9.9 billion euros. This growth was primarily driven by our by Dupixon by our new product launches and by favorable phasing in vaccines. Gross
• 06:30 - 07:00 margin improved significantly to 78% up 2.3 percentage point from the previous year driven primarily by an improved product mix and by efficiencies. Our Q1 effective tax rate was 22.3% linked to a one-off item this quarter. We maintain our full year indication of a broadly stable effective tax rate versus 2024 which means around 20% for this current year. Business EPS was 1.79 euro up
• 07:00 - 07:30 15.7% reflecting our strong sales performance, our improved gross margin and our operating leverage. This Q1 growth confirms our expected strong EPS rebound in 2025. Moving to Opella, we expect to close a transaction in the coming day in the coming days. Sanophi will receive about 10 billion euros while retaining a significant stake in Opella to support the company in its journey to independence and to participate in its
• 07:30 - 08:00 future value creation. The expected proceeds from this sale will be reallocated in accordance with our capital allocation policy presented on the right hand side of this slide. First, our primary focus is to invest in our business to drive organic growth, which means investing in R&D in sales and marketing, industrial assets, AI and talents, just to name a few. Second, we continue to explore external growth opportunities through Bolton
• 08:00 - 08:30 acquisitions. In March, for example, we we agreed to acquire DR0201 from Den Bio. These promising molecules strengthen our our early pipeline in imunology. Third, we maintain our progressive dividend policy and 2025 will mark our 30th consecutive year of dividend increase. Fourth, regarding value enhancing share repurchases, we are executing our 5 billion euro share by program in
• 08:30 - 09:00 2025 with 76% already completed as of yesterday. We have repurchased 37.7 million shares at an average price of 1.5 euro all for the purpose of consolidation. This underscores our commitment to delivering long-term shareholder value and partially mitig mitigating the dilution from the OPEA transaction. Looking ahead to the balance of 2025, I would like to remind you of some anticipated key business dynamics which
• 09:00 - 09:30 may be helpful for modeling purposes. For Q2, please note that Lantus US started to increase materially in Q2 2024 due to the unavailability of a competitor's product representing a higher base of comparison for the next few quarters. Despite this higher baseline, we expect stable sales for Lentus in 2025 as we continue to capitalize on favorable market dynamics
• 09:30 - 10:00 and competitive opportunities. In R&D, we remind you that we received in Q2 2024 a one-off payment from SOI of about 200 million euros for the development of Altuvote at the time of approval in Europe. For the full year 2025, foreign exchange impact is moving against us and it is now estimated to be around minus 1.5% on sales and around minus 2% on EPS. All other business dynamics remain unchanged
• 10:00 - 10:30 compared to what we communicated at the beginning of the year. I now hand over to um to provide an update on the progress of our innovative pipeline. Thank you, Francois. During the first quarter, we obtained six approvals, including kafitleia, the first anti-throbin lowering prophylaxis therapy for patients with hemophilia A or B, regardless of inhibitors, and additional approvals for depiction in COPD in Japan and CSU in the US and sarlesia cross different lines in
• 10:30 - 11:00 several countries. Moreover, as Paul has already alluded to, Depixant was granted priority review in bulis penguid with a pedufa date of June 20th. This was followed by regulatory acceptance of tool prudnip which is now set for a pedufa date of September 28th complemented by two recent New England journal paper publications. As Francois said last month, we announced the acquisition of DR0201 from DEMIO, a potential
• 11:00 - 11:30 first-in-class CD20 directed bicep specific antibbody targeting and enga engaging myoid cells with a potentially favorable and superior safety profile compared to T- cell engages which may carry a risk of cytoine release syndrome and other imunological risk. DR201 has the potential to induce deep B cell depletion via fagocytosis enabling sustained treatment free remission in autoimmune diseases such as lupus and where significant unmet medical need
• 11:30 - 12:00 remains. Next slide please. Last week we shared advances from our mid and late stage respiratory pipeline for amlletamab luncamig andcamab across several indications. The clinical evidence supporting the Ox 40 liand inhibition across three major diseases namely asthma, HS and AD is compelling. Furthermore, the efficacy of our medicines targeting this pathway with different modalities is supported by the following data.
• 12:00 - 12:30 Preliminary efficacy results show that the treatment with amlletamab led to clinically meaningful and durable efficacy on exacerbations lung function and symptoms in patients with moderate to severe asthma including in but not limited to those with heterogous inflammation. This limited phase 2 forearm dose finding study did not reach statistical significance the primary endpoint of reductions in exacerbations at the highest dose level in the ITT population. As a result, all the
• 12:30 - 13:00 endpoints are highly biologically plausible but exploratory. In certain groups, including the subgroup of patients with high xenophils and elevated neutrfils, amlletamab showed a robust reduction of more than 70% in the annualized rate of severe exacerbations of asthma. Amlatillamab was generally well tolerated with no new safety concerns. We and members of some of the Kol community uh uh feel that they are very excited by this result with a
• 13:00 - 13:30 relevant statistical caveat that I've already mentioned amatilab appears to have a differentiated efficacy profile in selected asthma patients potentially representing a breakthrough for this underserved population if this result is confirmed in future phase three studies we are in uh for which we are in the midst of designing as our early R&D pipeline continues to develop pleasingly. I'd like to take this opportunity to shine a light on our versatile nanobbody platform. Not only has this produced the potentially best-in-class in asthma
• 13:30 - 14:00 drug, Luncamig, but now is continued to deliver with Brecamig our anti-tenf antiox 40 by specific NHS. Bravcim achieved its primary objective with clinically meaningful improvements of both high score 50 the primary endpoint and other endpoints in patients with moderate to severe HS that are naive to biologics. I'm delighted to observe that the treatment benefit has a competitive efficacy profile when compared to currently approved and emerging
• 14:00 - 14:30 medicines in HS with a safety profile in line with expectations and no new safety concerns identified. These results show the potential to increase efficacy by targeting ox 40 lian on top of the conventional anti-NF treatment in HS through this dual targeting mechanism is effective. We have therefore decided to prioritize precamig for further development in HS. Finally, amllet recruitment is progressing ahead of plans in attopic dermatitis for the phase three studies. The Oceanana program is anticipated to
• 14:30 - 15:00 read out in its entirety in 2026 and will provide the foundation for future regulatory submissions. As a result of the accelerated recruitment, the initial results from coast one and shore studies might emerge earlier than anticipated. Turn turning to Balanotunafhib preliminary results preliminary safety results show that the treatment was generally well tolerated across multiple doses with no new safety concerns being identified. Most significantly this
• 15:00 - 15:30 study confirmed its differentiated safety profile. While the primary endpoint of PZY 75 compared to placebo amongst the highest treatment dose evaluated in patients with naive to biologics moderate to severe plaque psoriasis did not meet the statistical significance due to the nature of this limited phase 2 study. Lower doses across naive and experienced patients showed clinically relevant pie 75 responses which are comparable to other medicines previously assessed in psoriasis. Our additional phase two in
• 15:30 - 16:00 RA is anticipated to read out later in the latter part of this year. If successful, we will combine our oral TNFR1 signaling inhibitor and innovative standard of care therapies with a view to increasing the efficacy ceiling. As we've always considered one potential application of this molecule in combinations, including fixed dose combinations, we are assessing combination options with internal assets. In addition, we're at various stages of discussion with major farmer and biotech partners to generate novel
• 16:00 - 16:30 combinations for multiple immune mediated diseases. For example, with Eli Lillian company, we're exploring the potential to combine increins with sanify immunology pipeline medicines such as balotunaf. The updates on the progress of our pipeline today support our ongoing commit commitment to bringing innovative medicines to all patients. It is acknowledged that the study design and previous strategy were not optimized in all cases. However, the incorporation
• 16:30 - 17:00 of this knowledge to enhance productivity is underway. Furthermore, the progress of new studies exploring lens for potentially broader use in high-risisk asthma, COPD and attopic dermatitis and a topekab in CRS with and without nasal polyp continue to reinforce our pipeline. The FDA's recent approval of citilia prophylaxis for patients with hemophilia A and B irrespective of inhibitors underpins a significant milestone for this community of patients with a unique
• 17:00 - 17:30 mechanism of action. Defitly is a small interfering ribou nucleic acid therapy that targets anti-throbin requiring only six small volume subcutaneous injections per year. This approval is expected to contribute to a redefinition of the standard of care with a reduced treatment burden resulting from optimized dosing complementing by complemented by AT levels monitored by Zemen's companion diagnostic available at no cost with Sanathy Labcort's
• 17:30 - 18:00 support program. A regulatory decision in China is anticipated by the end of the year with submissions in the EU and Japan expected next year once pediatric data are available. I'd like to conclude with my usual news flow slide for 2025 and for next year. We plan 11 phase three readouts, 15 regulatory submissions and 14 regulatory decisions in multiple jurisdictions increasingly capturing the improving value of our pipeline. I would mostly highlight two upcoming phase three
• 18:00 - 18:30 results for this year that will be significant to Brutnib in PPPMS and itemab in COPD with a sum with the aim of launching next year depending on the data. Next year I'm looking forward to seeing the results of the phase three data for improve art for subcutaneous C1 as pathway inhibitor. Our objective is to improve the journey of CIDP patients with really improve art as a potential treatment option for those who are inadequately responding or a failed standard of care therapies. We very much
• 18:30 - 19:00 look forward to updating you on this progress. As I frequently emphasize, we adopt a humble stance in the face of disease, acknowledging that not all of our efforts will be successful. It is nevertheless anticipated the synergy of skilled science focused teams in conjunction with our augmented exposure to cutting edge digital technologies will facilitate the advancement of this unique pipeline within our core therapeutic areas with the objective of benefiting patients. I would like to
• 19:00 - 19:30 thank all of my brilliant R&D team members and colleagues across the company for the positive progress made this year. We're chasing the miracles of science to improve people's lives. With this, I hand back to Paul for Q&A. Okay. Thank you. 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 questions. At that time, please make sure you unmute your microphone or option two, submit your question by clicking the Q&A icon
• 19:30 - 20:00 at the bottom of the screen. Your question will be read by our panelists. Now, we'll take the first question. Please go ahead. Yes. First question is from Emily Field from Barclays. Emily. Okay. Should we take the next question? Try and come out to Emily if she uh if we can. Okay. So, next question is from Richard Voser from JP Morgan.
• 20:00 - 20:30 This is going to be a quick afternoon. It certainly is. I'll be very quick as well. I think I've got it to work hopefully. Um so a couple of questions please. Firstly maybe one just on the amatellab asthma data. Um uh obviously efficacy in these type two type two low patients. Um just thinking more deeply how how you think that efficacy compares to to dupy and and really how you think
• 20:30 - 21:00 that will read to the efficacy in AD relative to to depixent from from what you can see and then a second question just on this novel combination which I think I heard was with incretins uh and your oral antiF just thinking through that combination are we should we be thinking about um that in uh HS s um obviously there's a disease overlap with obesity there um uh struggling to think beyond that in terms of the the the
• 21:00 - 21:30 combinability. So just just thoughts on what how we should think about that that combination um uh that you're thinking there. Thanks very much. Thanks. Thanks Richard. Three little sneaky questions uh dropped in there and I'll address all three very quickly. Firstly on Amly and asthma, let me start by saying that uh as we said at the top of this call, we remain hugely committed to Dupixent uh with our partner Regeneron and we will continue driving that in pulmonology
• 21:30 - 22:00 both in asthma uh in CRS with MP etc. and of course in COVID. So I I you know I I I absolutely would not take a comparison between Amily and Chipilamab. Let me answer your question though promptly. Um we're very excited by the results we've seen with AML and asthma. We've been very clear and cautious that it missed its primary endpoint. But I have to say from where I'm sitting and when you see the data I feel that in multiple subgroups we have really very compelling data which has uh driven our
• 22:00 - 22:30 commitment to going straight to phase three um in uh subgroups with substantial unmet medical need. you talked about the higher group and indeed the heterogenous inflammation group and in those populations um amlletamab has a distinct place uh for the treatment of patients both because of the efficacy in those groups but also it's Q12 dosing. Um so I hope that answers your first question. Um the the the second question was uh related to uh balent um and
• 22:30 - 23:00 combination therapies. As I said very clearly actually we said this early on there would be a small number of indications in which we would go with monotherapy but uh we always plan to combine this in uh combination indeed even in rheumatoid arthritis today antitenos combined with methtoresate which is synthetic demart. Um so our strategy is indeed uh to uh go into combination therapies including fixed dose combinations. We are in discussions
• 23:00 - 23:30 with multiple um uh big pharma and uh biotech companies for the appropriate rational conversations and of course with our internal pipeline and your direct question about increins actually there is a substantial body of literature across multiple inflammatory disorders and we could list them but I won't do that here um uh where metabolic contributions to disease are extremely substantial uh you'll appre appreciate
• 23:30 - 24:00 that for the sake of uh uh disclosures we won't go into those disorders now but you'll you'll you'll also appreciate we're explor exploring multiple opportunities. Thank you uh thank you Hman. Thank you uh Richard. Okay, next question please. Yes, next question is from Louisa Ector from Berber. Louisa, thank you. Sorry, had to find my unmute button. Um thanks for the call. My question is still on um amlletab and
• 24:00 - 24:30 asthma but maybe to go a little bit more broadly because you have other assets uh in development for asthma. So how do you see sort of more broadly a respiratory franchise um developing within your pipeline leng etc. And then perhaps I could just check on on Dupixent again respiratory so a little bit more color on that COPD launch reimbursement status of COPD and how you we should think about that phasing through 2025. Thank
• 24:30 - 25:00 you. Thanks L. So I'll take the first part just to set up and then hand you for the second part which was you know we've said all along that we wanted for multiple different mechanisms addressing different parts of the patient journey. Um it's clear that biologic penetration even after all these years is still in the high teens in um in asthma and of course we'll get to COPD and so we need to have different offerings that you mentioned Lakim. I think we showed data
• 25:00 - 25:30 back in 23 at ATS on the pheno drop which was uh radically different and you can see us starting to shape up how the market could look with high efficacy approaches for those that needed more uh longer interval for those that want less needle burden and then of course uh safety and other elements of efficacy. We think we're very well positioned given the low penetration and the very different offerings for each patient. It's I think quite a novel approach that
• 25:30 - 26:00 we've taken and we've done this in multiple diseases. I think it's going to play out quite successfully for us. Human, anything to add in on the second part of the question? Yeah, and I'm going to hand over to Brian for the launch piece. Um uh just just very clearly what Paul said. Remember in lensig we have uh multiple respiratory populations um uh including high-risisk asthma and patients with severe asthma and we really really Louise as you know with a combination of credentialed target CSRP 13 uh shooting for uh
• 26:00 - 26:30 breaking the efficacy ceiling it's pretty straightforward the the TPP for that is really very straightforward I won't repeat the other things that Paul said because I think we our commitment from the very beginning was to take franchise areas to take whole areas and to provide patients in those areas um with the very best treatment we could do and and to to really begin to tease out substrata and that's what we've done. Brian,
• 26:30 - 27:00 uh thank you so much for the question and I love that we keep getting asked the questions on COPD. This is a really important disease state that's very heterogeneous like like asthma is as a matter of fact that we're just articulating and we've got a couple of shots on goal I think here from a COPD standpoint. But let me first start off with Dupixent. You know, we anticipated always that it would continue to gain momentum. We launched it at the end of last year. We saw really good progress at the end of last year, but it's gain gaining momentum even as we started into this year when we still see the inflection point will be in 2025. Um actually, we've seen early data suggest that we have a record setting pace so
• 27:00 - 27:30 far as it relates to Medicare and Medicaid coverage or Medicare and commercial coverage. About 90% Medicare coverage and at this point 88% commercial lives are covered. So that's really record setting for the indications that we've had. Additionally, as you look at indicica or initiations, we're seeing it's our most rapid respiratory initiation launch so far again, but these are initiations. They need to turn into NVRXs and need to turn into TRXs and that's what we're out there doing now. So we feel that this is continuing to strengthen our position in the pulmonologist offices having it's
• 27:30 - 28:00 having a nice play as well with asthma. But again, as we said before, Luis, we expect 2025 to be the inflection year for COPD and for it to continue to be a part of many indications now. Our seventh indication recently approved in CSU, but a part of the overall growth that we anticipate will drive double digit CAGER growth from 23 to 30 generating roughly 20 22 billion or so by 2030 time frame. Okay, thank you. Next question. Yes, let's try uh again Emily Field please.
• 28:00 - 28:30 Hi, thanks and sorry for the uh mix up before. Um anyways, okay. So um on beforis um I was just wondering if you could help us kind of understand um the or quantify the phasing impact. Um you know was there any incentivizing for stocking ahead of a potential competitor launch and then you know in the slides you also mentioned that you're focusing on increasing the next season immunization rate. you know, particularly in the US, what was the penetration of Bay Fortress over last season and how far do you see yourselves being able to take that up this year?
• 28:30 - 29:00 Um, and then, um, a question on Brebeck. Um, I was just wondering if you could give us a little more color on the synergistic component of the MOA given that, you know, we know the TNFs, um, uh, alone look inferior to the IL7s and then the Ox 40 Lam uron monotherapy didn't succeed. So I was just sort of curious why you think that um the accommodation there will look better than each on its own. Thank you. Okay, Tom. Yes, thank you Emily. Happy to to provide a bit of color there. So
• 29:00 - 29:30 just to get started, I want to reassure you or anybody that no, there is no incentive. There was no incentives during the season to to stock up beert ahead of any competitive entry. Absolutely not. No, the the the color is more specifically indeed as you as you were pointed out on the US market. I'll give you a couple of numbers I think that that can help. uh if you look at the overall RSV uh prevention uh vaccination coverage rate during the
• 29:30 - 30:00 2024 2025 season so let's say the month of October to February March roughly in the US there's a vaccination coverage rate which is around 55 to 60% all product included of course the lion share of that was before which is great and therefore it means that we have more to go because above 60% you know that we expect big VCR to be close to the traditional vaccination coverage rate for infants. So there's room to go and
• 30:00 - 30:30 that's why we we're saying that we have job to do. We need to work on increasing the immunization rate in 25 and 26 to go and needs to be because all babies need to be protected against against RSV. And to give you a bit of color exactly on what we're going to do, I think the qualitative part is important. When we look at the immunization over the past winter, what we saw is that the F community gathered and did a great job at doing preventive measures early on. So let's say in the month of October,
• 30:30 - 31:00 November where the right interventions were in place but it got a little bit fading out when you look at the month of January, February and March. And I think that shows that people have not yet fully understood that it's a full season protection that babies are at risk when they are born in January, March and February, February and March. And that's the job we're going to do this season and the next season. So that's why we're focusing on this room to grow there. As for Bertus for the full year, we've told you last year that our intention is to
• 31:00 - 31:30 grow 2025 sales of Bertus versus 2024. We're still on that trajectory and we're focusing on protecting as many babies as possible moving forward. Okay, thank you. Uh, do you want to make a comment on Rebecca? Um, thank you for the question on brek. Um, uh, I'll structure the answer briefly in three parts. Uh one is um you know this is a demonstration of our continuing commitment to internal research at Sanfi. Um um I'm reflective
• 31:30 - 32:00 in the comments people have historically made about research and development at Sanfi and it's a source of particular pride for me to bring in innovation from the outside but especially do work internally and these by specifics are beginning to demonstrate the muscle we have in research as well as development and salvage. Point two is you asked the question why would there be uh combination value in those two targets. Remember of course the ox 40 liand is a member of the TNF super family as is TNF. Then the we specifically designed
• 32:00 - 32:30 the exploratory uh studies uh to be able to see whether uh oxy lian alone or in combination with TNF would make a difference posing the question that you asked in exactly the same way. Um and I'm I'm really delighted to be able to provide you know albeit early with all the caveats that go with early studies and patients particularly biologic naive patients that that combination works. The reason it probably works is that TNF
• 32:30 - 33:00 itself induces um oxford liand on cells oxford lian licenses multiple cells particularly T- cells by by dendritic cells. So, I really do feel that we the double punch um has a precedented biology for synergy. Um and you know, I I've got to say it the the fact that it um really uh is competitive with best-in-class molecules out there for HS gives me uh
• 33:00 - 33:30 great aspiration as we move forward with these studies. And may maybe I could add I mean I think human touched on it in terms of this cool work we're doing with bicep specifics and things. Let's not forget I mentioned ATS earlier from 23 is 13 and TSLP phenotrop was in excess of the individual model components. Let's also remember I think and bra you correct me for 13 didn't work in on its own. So it's a red herring to think that because you get good or mixed data on one you don't get a synergistic effect.
• 33:30 - 34:00 And there is very definitely something in targeting two pathways that 1 plus 1 equals 3. It's the next sort of exploratory exploratory battleground for us. I think we're excited about what we've seen. Next question please. Yes. Next question is from Sheimus Fernandez from Gugenheim. Shimus. Okay. Um, so yes, Sheamus.
• 34:00 - 34:30 Hi, this is Colleen on for Sheamus. Thanks for taking our question. Um, is there anything you can share to help us un to help us get a sense of your level of tariff exposure um to transfer pricing and on Dupixent um and any strategy and steps you're considering that may limit this exposure. Thanks. Okay, thank you very much. Uh, Franis over the air. Yes, at this stage we have no specifics to share regarding US tariffs. That said, we have run through
• 34:30 - 35:00 all scenarios and we will communicate any development if need be when the time is right. Um, I would really like to help you, but it's difficult to comment on the occurrence of possible future events that are still unknown or speculative at this stage. So, there is no certainty beyond what has been announced and has been announced so far has been fully included in our confirmed guidance for the full year 2025. Not to go beyond that would be a little bit complicated because we don't know which country would they apply to, which
• 35:00 - 35:30 products would they would be impacted, which rate would be applied, when would it start. So it's extremely difficult for us to comment on a certain number of scenarios. But just be aware of the fact that we are ready and we have fully if anything else happen and we have fully factored whatever has been officially confirmed and announced so far. Thank you very much. Next question please. Yes. Next question is from Ben Jackson from Jeff. Ben, hi. Yeah, thank you. Um, just two quick
• 35:30 - 36:00 ones for me today. First, just a little bit more on the uh Ox 40L TNF approach. With the results that you've seen in HS, does this bridge any kind of confidence that there are additional indications that this combination could be useful for? And does that change the relative positioning that you're thinking about with regards to the broader portfolio? Obviously, we've just mentioned the the Oct 4L standalone there and potentially seeing a synergistic effect, but does has this changed how you view uh any
• 36:00 - 36:30 other assets in your portfolio? Uh and then secondly, just on the TFR1 as well, uh with regards to the psoriasis readout, has the data that you've seen changed any expectations for the rheumatoid arthritis readout coming up? And then with regards to the combo strategy, I appreciate that you've uh quant well said that um the monotherapy was only a small part of the actual opportunity that you were seeing in the first place, but perhaps could you provide a little bit more color around that uh and what you see the biggest um
• 36:30 - 37:00 potential there is for uh Thank you. Okay. Uh thanks Ben Hman. Um let me start with Breken. Um you're entirely right that the the combination of um oxygenf is super interesting. Uh what what I won't talk about today is the uh the molecular data we got out of those studies that the molecular data from those studies give us a number of
• 37:00 - 37:30 increased leads in what we do. I think it's an unspoken part of being uh an emerging uh iminology powerhouse that we have enough internal network strength that we observe from experime experiments that we do and it guides us as to where we can drive these molecules uh through life cycle management. Short answer to your question is yes. Uh asymmetric contrarian insights that emerge from our own data allow us to develop further as a iminology powerhouse. And then to your two direct
• 37:30 - 38:00 questions on uh TNF small molecule uh TNFR1 small signaling inhibitor um the answer to your question is uh we always knew that psoriasis uh uh was a pathfinder indication. What I mean by that is allowed us to identify the differentiated safety profile tick. It allowed us to um uh establish dosing very straightforwardly tick uh and it and it allowed us to really understand where we would go with in combination therapy. There are a number of disorders
• 38:00 - 38:30 you'll appreciate disorders like uh um RA and anklosium spondilitis that are very TNF responsive and we may well end up there in monotherapy and then there are variety of conditions that naturally lend themselves to combination therapy um I won't disclose those now but the biology of those is well well precedented yeah uh thanks I mean it's it's exciting actually in terms of the opportunities it's wide space for us it really was HS so I think very interested to see what the the 1
• 38:30 - 39:00 plus 1 equals 3 is. Uh I personally haven't been involved with TNF for most of my career. The safety piece in the psoriasis study was the piece we were looking out for first followed by efficacy and said that was never our target. But the combinations with TNF as backbone, you know, the it's interesting the number of conversations we're having externally, there's a great level of interest in raising the efficacy of other adjacent orals to make sure that we can break new efficacy standards for different diseases and that's that was sort of always the goal and that's now
• 39:00 - 39:30 playing out a little bit like that. So, of course, lots of work to do to get there, but um I think we're feeling pretty positive. Okay, next question, please. Yes. Next one is from Peter Vul from BNP Exam. Peter. Hello. Hello. Hi Pete. Hello. Hi there. How you doing? It's Pete here from uh BMPX. Just two questions. I'm surprised this one hasn't been asked yet already. Paul, the letter you and Vance
• 39:30 - 40:00 penned in the FT uh does make valid and fair points, but we know governments have big commitments to defense spending increases and not unlimited budget. So the simple question from me is have you had any recent interactions with European politicians that give you hope or should we remain cynical about their appetite to better reward innovation in Europe and then Hman sorry just to sort of labor the point um I know you can't talk about the data but HS is a big focus for everyone you know why so when
• 40:00 - 40:30 you are when you are expressing excitement for for brek when we finally see that phase 2 data we're all going to do cross trial comparisons to the IL7 So just want to be clear. Are you saying that you feel the data is competitive to the data sets we've seen from the IS17A and ANFS? Thank you. Well, let you go first and then I'll mention the letter to the FT. Yeah. So, uh, so you you you may know I was, um, at a cameo role, maybe a bit more of it
• 40:30 - 41:00 than a cameo role in, uh, the early days of Bimzellic when I was at UCB. Um, uh, and have an intimate, uh, knowledge of that molecule in multiple indications. Um suffice it to say that um uh Brebecameig in my mind uh albeit early with all the caveats that um you make about small early exploratory studies uh is certainly competitive in relation to me Alex and I'm excited to see how it goes forward
• 41:00 - 41:30 in phase phase 2B and three and due course. Okay. Thank you. And as to the letter Pete, you know, we've been, I think, very poised, you know, given uh China, US, Europe, and the state of things in terms of our expectations. I I think for a long time, even before the conversations um over the last weeks with the change administration in the US, there's been um a longtime campaign to really help Europe understand the value um of medicines and investing in
• 41:30 - 42:00 them and uh the quality of jobs and the impact. Very few people fully appreciate that the number one exporter from the EU is in fact pharmaceuticals at 300 billion plus. They've been public about that. that's been uh well documented and I think we have had conversations uh with the uh presidency of the EU over the last um over the last weeks just to try and remind everybody of the role that Europe can play in uh the global
• 42:00 - 42:30 pharmaceutical uh industry and that this is a good moment to express some uh commitments to them. Of course, these things have to be said. They don't always materialize in changes in stances. But I think it has to be no regrets from us to try and make sure people understand what we bring to patients, why we do it, what it means for countries and for Europe in particular and be very composed with where Europe sits between the US and China. Um, you know, it's delicate as you would imagine. So, okay, next
• 42:30 - 43:00 question. Yes. Next question from Joe Walton from UBS. Thank you. Um I've got one I guess slightly philosophical question about R&D and then uh one about situation in the US. So uh the the philosophical one is uh we've seen a couple of what look like failed results or at least not particularly good results which have been uh blamed on very small sizes of of studies. So uh we can't get to increase
• 43:00 - 43:30 our probabilities of success until perhaps the the studies are are bigger. Are there any other of your phase 2 studies that are coming out that we may also find just perhaps a little bit too small to give us the answer that we want? And I'm thinking you the ox 40 like the data wasn't statistically significant. You're very you're very um convinced it's going to be competitive with BIMs for example in HS but we can't see that data yet. and the oral TNF that
• 43:30 - 44:00 also seems to be too small a study to be really very clear about it. Could you perhaps tell us whether you think there is still a decent chance of an oral only indication for something like RA or whether this is really going to always now be uh perceived as a combination product and my second question um is just in the US and Paul I'm asking you this is your role in farmer more than from a sanify perspective but uh if you do get the opportunity to uh renegotiate
• 44:00 - 44:30 uh the IRA and go from 9 to 13 years for everything which everybody thinks is appears to be what Trump is encouraging Congress to do. Do you think there will be a significant payway that you will have to give in exchange for that? Because clearly the CBO would say, well that's going to cost us much more money. So should we see that still as a net benefit for the industry? Many thanks. Okay, thanks Joe. One of the fastest to connect. Thank you for uh Hman. Yeah. So
• 44:30 - 45:00 Joe, thank you for the philosophical question. Let me be um very direct. Um I've been very reflective about the comments we've received after disclosure of our results. Um uh in an effort to demonstrate uh an abundance of caution, in an effort to be extremely statistically rigorous, I think we may have not conveyed the clarity of the message about the value and success of these trials. And I'm just going to say these very directly um and you will see
• 45:00 - 45:30 the data but with the amly asthma data we've been very clear that we missed a primary endpoint but I've been abundantly clear that there is no equivocation in my mind that this is a drug it will go through phase three and with a reasonable wind behind us as with all phase 3es I have significant confidence that it'll be successful. So this isn't a function of a small trial that there are always in new exploratory dose finding studies a bit of
• 45:30 - 46:00 statistical wobble but my confidence in amalasma is unequivocal. Secondly in brekamig the study did not miss its primary endpoint. We've I we went to some pains to craft the language about not missing its primary endpoint. Just to be super clear, the study's uh statistical approach was a basian approach which we didn't invent actually. It's a basian approach that uh is very similar to the first in human for Bimzel published by Sophie Glatt as
• 46:00 - 46:30 the first author and my old friend Steve Shaw as the final author. I was there when that study was delivered. It's a very straightforward and I won't explain it here. Basian study. The credibility intervals on that molecule did not pass the null point. Um I I won't talk about the exact numbers but the level of confidence by which we know this is better than placebo albeit in a super early study is not just compelling. It's not highly compelling. It's exquisitly highly compelling. Right? So we didn't
• 46:30 - 47:00 miss the primary endpoint but we've been really very diligent about not making claims that we might be criticized for latent. And then the final question was on this small molecule TF FR1 signaling inhibitor. um uh we have to be humble in the face of disease. We tried this molecule um in a disease that isn't exquisitly antitrf responsive. We did it because you can judge uh pazes on the skin very quickly. We needed to make sure the molecule was safe. We needed to make sure, as Paul has said, had a differentiated safety profile, but we also needed to make sure that we could
• 47:00 - 47:30 um judge the dose appropriately. And skin's a very good way to assess dose response. Um I I think that a disorder like rheumatoid arthritis that is more exquisitly TNF responsive uh may show a greater relative efficacy profile. But we said from the very beginning that as well as treatment in rheumatoid arthritis and other TNF responsive disorders, we would go into combination therapy. And I feel that the conversations with multiple large pharma
• 47:30 - 48:00 partners who have significant provenence in the space um is unequivocal in my mind validation of the value of this as a combination therapy for those kind of disorders. So philosophically I think we're in good shape. Yeah. Thanks. You know it's uh it's a it's a good question because you mentioned you know could we have had uh bigger populations. I think you touched on I don't want to repeat myself or repeat what you said too much but it was about safety at least in showing some efficacy in psoriasis
• 48:00 - 48:30 before we go and put RA I think you know back to the monotherapy question it would be great to deliver a uh a primary input in RA in later in the year um but but we'll wait and see um because the safety meant that we're combinable and that was always the subtext I thought we'd been quite explicit but but we will see there was efficacy you know we've been I've been in psoriasis a very long time the efficacy bar has already been set there there was really no way to
• 48:30 - 49:00 overachieve that but our alternative was to do really start with the RA study and that would have taken too long so so I think uh uh perhaps we took some risk in terms of not delivering you know uh the primary endpoint in psoriasis but I think we sort of understood that to be clear we're pretty much at the end of the phase 2's is now in immunology. So in answer to the first part of your question, are we really um what else might we see or even miss on? I don't really think that's a a question uh at
• 49:00 - 49:30 this point. Um as for the the farmer uh piece, um you know, and I think France answered it very eloquently, you know, we there's really scanned detail in terms of the numbers to be able to make any type of predictions. However, the executive order from last week was reasonably explicit in its intensity. It stepped back a little bit from most favored nation, stepped forward a little bit into what it means for patients and what it could mean for out of pocket and
• 49:30 - 50:00 importantly brought in 340B and PBMs into that narrative. So um I would imagine there'll be a pay for because you know clearly if you move them from 9 to 13 there would be and we'd be uh delighted as an industry because I think some small molecule innovation was lost in that mistake first time round. Um uh I think uh it looks to me at least from the executive order and subsequent conversations that it it may be a shared responsibility in how we get there to do
• 50:00 - 50:30 that. I would hope that's the case. Again, with the administration, we take nothing for granted. We read the executive order. We'll reflect on it. We'll see what it means in practical application. Uh, next question. Yes. Next question from Grai from Vox. Hi. Uh, hey, can you hear me? Yeah. Yeah. Great. Um, so just wanted to go back to the question on tariffs. Um, and just sort of push Franc Zavia a little
• 50:30 - 51:00 bit on on that. So uh you know based on the administration comments the you know they have talked about 25% farmer tariffs it's obviously going to section 232 um and there's a lot of discussion around whether that goes on to transfer prices into the US. So perhaps you could just help us by if that's the most likely scenario, what sort of impact could that have on Santa Fe, a 25% tariff on transfer prices into the US. Um how easily could you mitigate that either with prices at one end uh or with
• 51:00 - 51:30 just lowering transfer prices and and would that is material impact on SanFi tax rate? Um and and also perhaps on depicting just help us understand where the US supply is coming from. Is it all regener on Ireland and US plants or is there a Sani impact from Santa's European um plants as well? Um and then just following up on the Rebecca question around being competitive um when you say competitive with the existing assets do you mean it's sort of same ballpark or are you looking for
• 51:30 - 52:00 something here that is better than what's there already? Thank you. Okay, thank you. I mean France show what you uh are able to. No, no, no. I I wish I could help you Ram but uh once again I mean I don't want to stop discussing about various scenarios because it's very speculative by nature once again we have we are aware of some of the tariffs that are impacting for example trade between the US and and China for example which we have factored in fully in our confirmed guidance for for the full year 2025 after that I don't want to enter
• 52:00 - 52:30 into scenario you are talking about 25% because we could run scenarios at 5% 10 whatever it is on which product does it apply to which country from which country very very difficult to comment on what is once again relatively speculative uh as of now. Let me just help you a bit though on our industrial footprint in the US. So regarding our presence on production footprint in the US, Sanopi has been even prior to these discussions about tariff actively increasing its share of manufacturing in
• 52:30 - 53:00 the US and specifically biologics drug substance. So we continue to assess our future capacity requirements and we are considering additional measures potentially including investment in the US aligning our industrial footprint to the needs of our pipeline and to our expected future growth. Uh so just as we did of for example our modulus investment in Europe and in Asia as we do as well the modernization of our Frankfort insulin site we are always exploring opportunities to expand our
• 53:00 - 53:30 industrial footprint including in the US to meet both our production needs and the needs of our patients. Thank you Hman. Uh thanks for the question. Um uh Graeme, I think, um I just let's just very briefly start with the caveats, which is as I said to Joe, we exercise an abundance of caution. Uh we don't over interpret our small studies. We convey the messages very clearly to the outside world because I believe we've we've attained a level of credibility in R&B
• 53:30 - 54:00 that we need to uh enviously protect. Uh with that said um uh and the caveat that we used a precedented statistical approach that in fact bismab used um uh I think that uh this molecule has a chance to fall somewhere between the two bookends that you provided um and we will find out when we run it in a broader group of patients. I still think by the way that a it's competitive and
• 54:00 - 54:30 the unmet medical need as we found with psoriasis with this extremely severe skin disorder will continue to progress and emerge and that's what we're hearing from all the conferences of okay thank you next question please. Next question is from Florence Pedes from Bernstein. Okay. Uh we should perhaps move on. No. Okay. Uh next question is from James
• 54:30 - 55:00 Quigley from Gunman Sachs. Okay. We seem to have some type of delay. You may have got me. Uh James, we got you. Excellent. Thanks for taking my questions. I got two please. So first uh on ammo and asma apologies if I may have missed that but you've highlighted your confidence in moving to phase three uh given the potential benefits demonstrated but would you be able to share if you're planning to move into phase three with the broad population or a selected population or multiple phase
• 55:00 - 55:30 3es across different populations. It would be good to get your thoughts there and and how quickly do you expect to move um here and and what could be the next steps in terms of starting the phase three. And secondly, on the gross margin, uh the impact was pretty strong uh this quarter with COGS declining slightly year on year versus the increase in revenue. So could you give us a little bit more color over the drivers of the gross margin? Uh to what extent is this partly driven by some of the benefits from the new depiction manufacturing process? Uh and how would you expect the gross margin to progress through the rest of 25 and into 26?
• 55:30 - 56:00 Thank you. Thank James. Uh human. So um thanks for the question uh James. The the first point is that we you know it's important to say we've just got this data. Um we've recently received the data are in deep consultations with significant KS in this space who by the way thus far seem excited by the data. We'll continue that work to define the phase three protocol fully. Um we need to make sure the community is with us. But the short answer to your question is that we have unequivocally identified in
• 56:00 - 56:30 our phase 2 uh uh population with high unmet medical need and we will ensure that that population is over represented in any phase three study we do. Well, maybe I'll add a little bit to that because uh of course we have the benefit of seeing the data. We would never want to put at risk any publications or anything like that. But uh the population I think humans alluding to is a significant percentage of the biologic eligibles just to be clear. So that's very very important for us. Um and I
• 56:30 - 57:00 think people need to realize that um you know when we originally went to take on the ox 40 lan it was targeted at AD originally. That's was the original acquisition. Our base case in AD not that anybody's asked is that we meet the primary endpoint. That is where we would like to be. Um and that's our base case. Of course, the science will tell us whether we are right or not. Um uh asthma, the data in asthma is actually very encouraging in terms of safety and
• 57:00 - 57:30 efficacy. So, we'll wait and see. You know, these you turn these cards over, but um I think we feel very positive. Gross margin. Yes, gross margin, James. Um if we look at it, 5 years ago, we were significantly behind our peers in terms of gross margin, almost 5 percentage points. Today we are almost at par with our peers in terms of average gross margin. You saw a significant increase in Q1, two percentage points from last year. About a third of it is linked to inventory revaluation. That happens traditionally up or down, but in that case it's up in
• 57:30 - 58:00 Q1. But beyond that, you have twoird of it is linked to essentially product mix and efficiencies. As you know, we have significantly worked in order to improve the efficiency of our industrial footprint over the last couple of years. Um and we are starting to get the benefits now and the product mix is happening across the board. It's not only Dupixent you were mentioning the new Dupixon process. It is one factor among others. By the way, this one has been spread over a few years. So it's not specific to Q1 and it started
• 58:00 - 58:30 already two years ago and it's not completed yet. So it's over a relative long period. Going forward do expect to see some further increase in gross margin. not necessarily significant for the remainder of 2025 but over the next couple of years we will continue to see our gross margin improve. Okay, thank you. Next question. Okay, let's try again with Florence Pedes from Burkin. Good afternoon. Flores Pedes from Bin. Can you hear me? Yes, we got you. Good.
• 58:30 - 59:00 Thank you very much. Apologize for for that. So, two quick questions please. Uh first, I would like to come back on Emily Teleimab. Uh could you maybe give a little bit more uh color on the percentage of the population with severe asthma that would should respond the most to to the product? You highlighted the asenfield or neutrofil. What percentage of severe asthma population these people represent? And my second question is on uh medical part D redesign. um it was supposed to impact
• 59:00 - 59:30 uh most likely the uh more heavily the first quarter and then the impact should ease during the course of the year. Could you maybe elaborate a bit and give some color on the impact from this measure on your accounts? Thank you. Thank you. In the interest of time, I'll just quickly answer the the uh subpopul question. We we've not shared and we're not um trying to help calibrate that at the moment. We'll get into the phase three and we can get into more detail on
• 59:30 - 60:00 that. Brian, part D. Yeah, Medicare Part D. Remember, there's two pieces to this. Um, first piece, actually, I'll cover Dupix in a little bit more specifically. Just to remind you, most of our business, more than 70% of our business is still on the commercial side. About 30% of it is on the government based side. A percentage of that is actually Medicare quite specifically. And then there's two pieces as it relates to the Medicare Part D redesign. One is obviously the covering the the gap there. And that is we've seen a slight impact of that obviously as we anticipated and that was part of our plans. Actually, we originally knew this
• 60:00 - 60:30 for quite some time. But the other part that actually is interesting to us is the cap of 2,000 out of pocket. And while we haven't seen an inflection of that yet, there are some early signs that actually there might be more patients up for grabs now with the fact that they have no more than 2,000 out-of- pocket expense. So, we'll see how that progresses in in 2025. Uh but so far we think that there'll be some some positives and some offset of that actually for the Medicare Part D redesign. Okay. Thank you. Uh next question. Yes. Next question is from Sarita Capila from Morgan Stanley.
• 60:30 - 61:00 Hello. Can you hear me? Yeah, we got you. Hi. Hi. Thank you for taking my questions. Just a quick one on your US flu vaccine dynamics. I think you called out softer demand and intensifying pricing pressure. So is this baked into your guidance for this year and consensus is factoring 3% sales growth for flu this year. Should we be thinking about 25 as another year of potentially low singledigit declines? And then taking a step back on AD, you have
• 61:00 - 61:30 multiple modalities. Ox 40 are also by specifics with linamig. Some of your peers FISA and J&J are pursuing tri specifics. So it'd be interesting to get your thoughts here. Is this something you also plan to do? And any thoughts on uh tri specifics and ad sorry would be interesting. Thank you. Okay. Uh Tom. Yes. Thank you. on US flu a bit too early to be definitive there because we are still in pre-booking period right now for flu in the US uh but we wanted to highlight
• 61:30 - 62:00 what we observe in this process uh you remember that last year during the flu season we observed in the US a soft vaccination coverage rate roughly minus 5% for the US population last year and uh that turns out to to generate some price competition as we observe it today in the us for the during the pre-bookings a bit too early. Usually I give more color at the Q earnings after the pre-booking season. So so stay tuned for the next part. Thank you. Uh Hman uh
• 62:00 - 62:30 tri specifics. Yeah, I'll be we're at close to time so I'll be super brief. Um ju just to say obviously we are well aware of tri specifics. Our antibody platform allows us to generate try or quadra specifics uh etc. It's an area we've looked at. Uh just a point of caution um it's very hard to calibrate the geometric interactions between each of the heads and we don't expect repeated incremental additional value. we're adding additional um biology but
• 62:30 - 63:00 the short answer to your question is yes of course we've thought about um tri specifics and I should say when you talk about attopic dermatitis I just want to remind everybody that it's a massively biologically underpenetrated marketplace and there is substantial room uh for new molecules in that space we remain committed digent yeah and just before I move to the last question I think this is we said this at the end of I think it was 23 at R&D day I think it's still not fully appreciated did that multiple mechanisms in diseases drive up um
• 63:00 - 63:30 biologic penetration. I think we're still at low double digit or high single digit 14 in AD. So 86% of the patients that are biologic eligible don't get a biologic in AD. So we know that RA is closer to 50% at this point that between then and there there is so much opportunity and it's new entrance different approaches. I I think I think this coexisting of different mechanisms is completely uh under represented in forecasting. Still we see people
• 63:30 - 64:00 thinking it's winners and losers. A good example would be the enthusiasm we have and human said it up top for amnotelmab and dupixent to both grow you know very well all the way to the end of patent by taking up new patients and coexist with different uh approaches and over time you know people's confidence in this approach will play out but for us having seen a little bit more data than the rest of you we're very confident in how that manifests okay last question yes last question from Simon Baker from
• 64:00 - 64:30 Redburn Thank you for taking my my question at the end. Uh most of them have been picked off so I could be I can be pretty quick. Firstly, just going back to Bravecime. Um you gave us the uh P value and I just wonder given it's a basian study if you could give us the posterior probability uh in that study and then moving back to the oral TNF. Um and thinking about the internal uh combination uh candidates, the Iraq 4 degrader springs to mind. Are there any others that we should be thinking about that you may well combine the oral TNF
• 64:30 - 65:00 with? Thanks so much. Okay. Well, we'll finish on uh on this. Over to you. Repeat your second question briefly for me. The combinations are the oral combinations internal and external. Oh yeah. Okay. Yeah. Thank you. Um okay. So, so Simon, thank you for asking the excellent basian question. Uh I can't give you the posterior probability. post theory probability nor did I give you the probability unless I was hallucinating. Um
• 65:00 - 65:30 uh apparently the probability was in the footnote which is great. So so no I I can't you are hallucinating. I am hallucinating. I can't give you the posterior probability but actually um based on the data in the public domain in HS you could work it out. Um um that's a little test for you and the answer for you but but you you'll appreciate um that based on the data in the footnote it's compelling um and then uh and then the answer to the combos is there are multiple rational
• 65:30 - 66:00 combinations. I it would be unwise of me to disclose um and prior art myself in this discussion. Uh, but I think that the um uh the the natural combinations with a TNF are uh super clear to people in the in the art and um and we will pursue any of them. Yeah, maybe just to finish on that note that they're sort of obvious I guess based on whether you're trying to break new efficacy goals could be an IBD, could be an RA, could be in different order to treat diseases. You
• 66:00 - 66:30 know, you I think the the open question we asked ourselves some time ago was where is TNF um uh approved and indicated where was it overtaken on injectables by other um more selective approaches? And then if you're going into orals, what does that tell you about the combinations that would be ideal? Because either are likely to not make it on efficacy on their own, but together they would. And that's the magic. So, we'll get into that over the coming months and hopefully have some
• 66:30 - 67:00 things to share and we'll do that as we go. But otherwise, um, thank you all, uh, for the call. Appreciated and, uh, we'll look forward to catching you.