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Operator: Dear ladies and gentlemen, welcome to the Merck Investor and Analyst Conference Call on Third Quarter 2025. [Operator Instructions] Please note that at our customers' request, this conference will be recorded. I'm now handing over to Florian Schraeder, Head of Investor Relations, who will lead you through this conference. Please go ahead, sir.
Florian Schraeder: Thank you so much, Smart Sarah, and a sincere welcome to everyone joining the Merck Q3 '25 Results Call. I'm Florian Schraeder, the Head of Investor Relations at Merck. I'm delighted to be here today with Belén Garijo, our Group CEO; and Helene von Roeder, our Group CFO. During the Q&A part of this call, we will also be joined by Kai Beckmann, CEO of Electronics and Deputy Chair of the Executive Board; Jean Charles Wirth, CEO of Life Science; and Danny Bar-Zohar, CEO of Healthcare. In the first few minutes, we will walk you through the key slides of our presentation. After that, we will be happy to take your questions. Now I will turn it over to Belen to get started.
Belén Garijo López: Thank you, Florian. Good afternoon, and welcome, everybody, to our Q3 earnings call. I am now on Slide #5, starting with the highlights of this quarter. So as you have seen during the morning in Q3, we delivered solid organic growth across all 3 sectors. Organically, the group revenues increased by 5.2% and EBITDA pre went up by 8.8%. Life Science delivered the strongest organic sales growth at 6%, followed by our Healthcare and Electronics businesses, which both delivered solid organic growth of 5%. One key highlight of the quarter is the continuation of the strong performance of our Process Solutions business, which showed organic growth above 10% for the third consecutive quarter despite rising comparables. We saw a very strong order growth year-over-year and a book-to-bill ratio that is still comfortably above 1. In Science & Lab Solutions, we returned to organic growth, and that despite continued near-term headwinds. In Healthcare, organic growth was largely driven by the CM&E franchise, up 7% and solid N&I performance of 6%, driven by Mavenclad which reached double-digit growth in this quarter. Oncology showed moderate organic growth despite heavy competitive headwinds for Bavencio and rising competition for Erbitux in China from noncomparable biologics. Following the closing of the SpringWorks acquisition on July 1, this is the first quarter in which we are consolidating our rare disease franchise, which has contributed 4% portfolio growth for Healthcare and has performed well in line with our expectations. Moving into Electronics, we saw organic growth of 5%, driven by our semi-material business, and in this context, please note that Q3 includes 1 final month of Surface Solutions since we have now successfully divested as of July 31. Regarding full year 2025, we are now confirming and narrowing our absolute guidance ranges for net sales, EBITDA pre and EPS pre. We are maintaining the midpoints for net sales and EBITDA pre, while slightly increasing the midpoint for EPS pre. So turning to Slide 6 for an overview of our performance by business sector. Once again, organic sales growth in the third quarter was plus 5.2% and Life Science was the largest contributor with organic sales growth of almost 6%, driven once again by the stellar performance of Process Solutions. Healthcare grew 4.6% organically, driven by strong growth of our CM&E franchise alongside contribution from Mavenclad and Fertility, which has returned to growth, supported by Pergoveris. Electronics also showed the solid organic sales growth with Semi Materials up high single digits, while DS&S was down in the low teens range as was expected. Regarding our earnings, EBITDA pre amounted to EUR 1.69 billion, up plus 8.8% organically versus the same quarter of last year. The currencies had a negative effect across all sectors, while the portfolio effect was slightly positive driven by the contribution of SpringWorks. As flagged in our Q2 earnings call, EBITDA pre in Q3 was supported by the sale of a priority review voucher resulting in a gain of plus EUR 60 million in health care and legislative changes in South America, adding another EUR 59 million of income in [ CO ]. Our underlying EBITDA pre margin, excluding these 2 effects, was stable at around 29%, fully aligned with our expectation for the full year. And with this, let me hand it over to Helene for a more detailed review of our financials.
Helene von Roeder: Thank you very much, Belen, and also a warm welcome from my side. And with that, I'm now on Slide 8, and we'll start with an overview of our key figures in the third quarter. Net sales increased by 1% to EUR 5.318 billion. Organic growth of EUR 273 million and a portfolio effect of EUR 34 million were largely offset by FX headwinds of minus EUR 256 million. EBITDA pre was up by 3.1% to EUR 1.669 billion with a margin of 31.4%, and that is up 70 basis points year-on-year. The group margin benefited from the sale of a priority review voucher and legislative changes in Latin America, which together contributed EUR 119 million supporting the margin by 220 basis points. EPS pre increased slightly by 0.9% to EUR 2.32 per share. The gains resulting from the aforementioned priority review voucher and legislative changes have supported EPS pre growth and overcompensate the higher interest related to the SpringWorks acquisition. Our operating cash flow increased moderately by 4.1% to EUR 1.518 billion. Net financial debt rose 29.8% to EUR 9.228 billion (sic) [ minus EUR 9.228 billion ], primarily reflecting financing for the SpringWorks acquisition via a U.S. dollar bond issuance. Our return to the U.S. dollar bond market after 10 years was highly successful and further diversified our fixed income investor base. We were over 4x oversubscribed and that enabled us around 25 basis points of pricing tension underlining the strong confidence from fixed income investors. Let me also briefly comment on our reported results. And with that, I'm now on Slide 9. EBIT was up by 11.3% year-on-year. The financial results declined significantly from minus EUR 54 million to minus EUR 99 million, and that is primarily due to higher interest costs from the U.S. dollar bond related to the SpringWorks acquisition. The year-to-date effective tax rate was 21.2%, and that is within our guidance range and reflects normal quarterly fluctuations throughout the year. Turning to EPS. Reported EPS was EUR 2.07, which is up 11.3% year-on-year and is on par with our EBIT growth. With that, let's move to the business sector review, and I'm beginning with Life Science on Slide 10. Life Science grew organically by plus 5.9% in Q3. Growth accelerated versus prior quarters with Process Solutions maintaining its momentum and Science & Lab Solutions returning to growth. As projected, Process Solutions continued its strong momentum with organic sales up by 10.3%. That is the third consecutive quarter of low teens growth despite increasing comps. Order intake remained strong in Q3 and the book-to-bill ratio stayed comfortably above 1. To further strengthen our Process Solutions downstream offering, we announced on October 15, the acquisition of JSR's Chromatography business. This adds advanced protein A chromatography capabilities, enhancing our ability to offer more efficient, scalable protein purification solutions that support accelerated biopharmaceutical production. Turning to Science & Lab Solutions. Sales grew by 2.5% organically despite continued headwinds from U.S. policy changes weighing on academic and government lab spending and still challenging market conditions in China. While the U.S. government shutdown had no impact in Q3, we do expect some effects to materialize in Q4. Life Science Services reported organic sales growth of 5.2% against the low comp, driven by our CDMO business, and that is notably bioconjugation for ADCs. As noted at our recent Capital Markets Day, Life Science intends to gradually increase R&D investment towards roughly 5% of sales over the midterm. And the R&D increase in Q3 is absolutely in line with this goal. EBITDA pre increased by 6.1% organically, with the margin up by 20 basis points year-over-year, reflecting operational leverage. I'm now on Slide 11 with an overview of the Healthcare business sector's performance. Healthcare delivered solid organic sales growth of 4.6% in Q3, about 1% of the growth resulted from a pull-in from Q4. For the first time this year, we consolidated our rare disease franchise contributing a plus 4 percentage point portfolio effect well in line with expectations. CM&E was once again the largest contributor of Healthcare's organic growth, delivering 7% organic growth with all therapeutic areas contributing. Fertility sales were up 2% organically, mainly driven by very strong growth of Pergoveris, up 37%. Meanwhile, we announced on October 15, a voluntary agreement with the U.S. government to accelerate the U.S. review time lines for Pergoveris and access to our IVF therapies via trumprx.gov. Our oncology franchise delivered 3% organic sales growth as Erbitux sales rose by 10.3%. Erbitux' performance was driven by strong growth in Latin America and Europe, more than offsetting tougher competition for noncomparable biologics in China where sales declined in the low teens. Our N&I business grew by 5.6% organically in Q3. Mavenclad delivered stellar organic growth of 20.4% supported by continued strong commercial execution. I want to briefly comment on the recent decision by the Court of Appeals for the Federal Circuit, which has affirmed the conclusion by the U.S. Patent Office that our 2 Mavenclad dosing regimen patents are invalid. We are disappointed by the ruling and intend to file a petition for rehearing or rehearing en banc. Belen will comment on implications later. Regarding our pipeline, longer-term results from Part 2 of the Phase III pimicotinib study were presented at ESMO, showing increasing ORR over time and ongoing improvements in key secondary endpoints. We intend to launch pimicotinib in 2026 in TGCT. On R&D spend, as mentioned in our Q2 earnings call and the Capital Markets Day, we are increasing our R&D ratio in H2. The key drivers are project ramp-up costs and a small effect from the SpringWorks acquisition. Our Q3 ratio of 20.9% is in line with our midterm ambition of around 20%. Overall, EBITDA pre amounted to EUR 818 million in Q3, which represents a margin of 37%. Please keep in mind that this includes the EUR 60 million gain from a sale of a priority review voucher and only a modest dilution from SpringWorks. Furthermore, please note that the margin in Healthcare tends to be lower in Q4 due to seasonality. Let us move to electronics on Slide 12. Organically, sales increased by 4.8% in Q3. Semiconductor Solutions sales were up in the high single-digit percentages organically overcompensating lower DS&S sales. In Semi Materials, AI and advanced nodes continue to drive growth. In addition, we see demand from mature nodes in Asia, where we have been able to gain market share with new qualifications. On business, the quarter was in line with our expectations. As we communicated in Q2, we expect a very muted year 2025. Considering the usual back-end loaded seasonality of DS&S, we're calling out Q4 '25 as the bottom. We're more constructive on the outlook for 3D NAND driven by [ eSSDs ]. This is consistent with the view Kai and his team shared at the Capital Market Day '25. Our Optronics business achieved moderate organic growth of 2.9%. Resilience in our offerings for liquid crystal and OLED drove organic growth complemented by a strong portfolio contribution from UnitySC. The EBITDA pre margin went up by 150 basis points year-on-year to 27%, mainly driven by the accretion from the divestment of Surface Solutions. We see gradual improvement of Electronics margins from here onwards. Before handing back to Belen, let me also briefly comment on our balance sheet and cash flow statement. Now as you can see on Slide 13, our balance sheet decreased by EUR 700 million compared with the end of December '24. Taking a closer look on the asset side. Cash and cash equivalents increased quarter-over-quarter, reflecting the U.S. dollar bond issuance and receipt of proceeds from the divestment of Surface Solutions. Inventories were stable, while receivables rose by EUR 300 million, following a quarter of strong focus on cash collection efforts. Intangible assets increased slightly by EUR 100 million due to goodwill created by the SpringWorks acquisition, partially offset by negative FX. Property, plant and equipment decreased slightly by EUR 200 million, which is mainly due to FX translational differences. And lastly, other assets were down by EUR 700 million, mainly due to the divestment of Surface Solutions and revaluation effects. On the liability side, financial debt increased by EUR 1.8 billion with the issuance of the U.S. dollar bonds. Pension provisions were slightly down, driven by actuarial gains. Payables decreased by EUR 100 million as we saw declines in current payables across all 3 sectors. And net equity decreased by EUR 1 billion as the increase in retained earnings was more than offset by FX differences, primarily reflecting a weakening U.S. dollar. In summary, our equity ratio declined from 58% at the end of December '24 to 57% at the end of Q3. Turning to cash flow on Slide 14. Operating cash flow increased to EUR 1.518 billion in Q3 '25, up from EUR 1.456 billion (sic) [ EUR 1.458 billion ] in Q3 of last year. Profit after tax rose driven primarily by the gain of the sale of a priority review voucher and changes in local legislation in Latin America. The EUR 166 million year-over-year delta in other assets and liabilities reflect variable compensation and tax adjustment. Other operating activities decreased by EUR 181 million year-over-year in Q3 '25, largely due to the neutralization of gains from the PRV voucher and the Surface Solutions divestment. Net cash used in investing activity reflects the SpringWorks acquisitions and the Surface Solutions divestment. CapEx on PPE was EUR 63 million lower, in line with the updated full year guidance of EUR 1.5 billion to EUR 1.7 billion, down from previously EUR 1.6 billion to EUR 1.8 billion. The change in financing cash flow is explained by the proceeds from the U.S. dollar bond issuance. Lastly, consistent with my comments at the Capital Markets Day, within CDMO, we are actively reviewing our mRNA and viral vector activities with potential financial implications in the next quarters. And with that, let me hand back to Belen for the outlook.
Belén Garijo López: Thank you very much, Helene. Let's now move into taking a closer look at our full year guidance on Slide 16 before we open for Q&A. As you may have seen in the press release, we have sharpened our group sales guidance to a range of EUR 20.8 million to EUR 21.4 billion with an unchanged midpoint at EUR 21.1 billion. FX remains a strong headwind and has been refined to minus 5% to minus 3% from the earlier minus 5% to minus 2%. Our organic net sales growth guidance is now set at around 3%, staying within the previously communicated range. Turning to EBITDA pre, we have also kept the midpoint at EUR 6.1 billion and narrowed the absolute range to between EUR 6 billion and EUR 6.2 billion. Organic sales growth has been narrowed from previously plus 4% to plus 8% to now plus 5% to plus 7%. For EBITDA pre, we anticipate an FX between minus 6% and minus 4%, adjusted from the previous minus 6% to minus 3% and we have raised the midpoint of our EPS pre guidance by EUR 0.05, now guiding a range of EUR 8.20 to EUR 8.60. For some additional color, let's take a look at Slide 17. Consistent with our group-wide approach, we are narrowing our organic sales growth guidance to plus 4% to plus 5%, while reaffirming the midpoint at 4.5% for the full year. We're also maintaining the midpoint at 5% for EBITDA pre and narrowed the guidance to a corridor of plus 4% to plus 6%. In Healthcare, we anticipate organic sales growth of around 3% at the lower end of our previously communicated guidance range of plus 3% to plus 5%. This reflects the underlying year-to-date trends and some uncertainty for Q4 related to the recent Mavenclad news Helene referred to earlier. For organic EBITDA pre, the guidance has been updated to plus 9% to plus 11%, consistent with the adjustment to sales and within the corridor communicated in August. As portfolio effect, we now expect the SpringWorks to contribute EUR 180 million in sales, up from EUR 170 million previously guided and EBITDA pre of between 0 and minus EUR 20 million, which is significantly better than the prior minus EUR 70 million to minus EUR 90 million communicated before. For Electronics, we forecast organic sales development between minus 3% to minus 1%, tightened from the prior range of minus 5% to minus 1%. Organic EBITDA pre for electronics is now expected to be between minus 11% to minus 7%, compared to the earlier guidance of minus 15% to minus 7%. Now turning to 2026 in which, I am sure, you are expecting a bit more transparency. We recently provided you at our Capital Markets Day with an early indication of group sales and margin for 2026. You may now be wondering about the potential impact of the recent Mavenclad news regarding the upcoming loss of exclusivity in the U.S. To no surprise, this will impact the 2026 sales and earnings projections for Healthcare. To what extent it's going to be influenced by the phasing of U.S. generic launches and our ability to drive volume also outside of the U.S. and Danny can provide further information later during Q&A. Hence, we will closely monitor the developments in these respects means U.S. generic launches, an update due in Q4 with the full year guidance. In any case, you should assume for your modeling that Healthcare margins should remain north of 30%. Coming to the group, first of all, we see our early 2026 indication for the group during the Capital Markets Day for sales within the range we provided, trending to the lower end. When it comes to group margins, you can ensure that we stay laser focused to mitigate the potential impact of the Mavenclad erosion in the U.S. While acknowledging state cost mitigation measures, you could assume for 2026 a margin of around 28%. As mentioned, more to come at Q4 earnings when we will provide a full year guidance to all of you. And with that, Florian, over to you to lead us through the Q&A session for today.
Florian Schraeder: Thank you, Belen and Helene, for leading us through the slides. Actually, there's one small amendment to what we have set and is on group level, the organic EBITDA growth, which has been narrowed from previously quarter 8 to now 5% to 7%, not the organic sales growth. With that, Sarah, I'm very happy to hand over to you to manage the Q&A part of the call.
Operator: [Operator Instructions] Your first question today is from Matthew Weston from UBS.
Matthew Weston: Two questions, if I can, please, both on pharma and on the guidance for 2025. Belen, you called out the SpringWorks change in guidance where we've seen a very sharp turnaround in profitability of what you expect from inorganic this year. I'd love to understand what's changed in your assessment of SpringWorks? Have you reduced costs? Have you had more revenue leverage? Because it looks like a very dramatic change in assumption. And then the second question is around the offset to that within guidance, which is a downgrade to the organic Healthcare growth. I'd love to understand if that's also associated with an assumption of Mavenclad U.S. generics entering on the 22nd of November, as you previously flagged in the release around the patent board decision? Or is it another part of the business which is performing less well?
Belén Garijo López: Thank you, Matthew. Let me invite Danny to address the 2 questions for Healthcare.
Danny Bar-Zohar: Thanks, Belen. Hello Matthew, thank you for the questions. So I'll address first the SpringWorks question around the margins for Q3. So it is rather technical. We have taken a conservative approach when we provided the first guidance. As you remember, the first guidance was provided several weeks only after closing. So we took a rather conservative approach for that in terms of cost. Now moving forward, as you could see, we have upgraded the guidance on the portfolio from EUR 170 million to EUR 180 million. So there is a gain there. And so we do expect sequential sales growth in Q4 for the SpringWorks Therapeutics compounds. We do expect an EBITDA pre loss in Q4, which will be a bit above Q3 due to the phasing of investments. But overall, you're absolutely right, most of the assumptions were conservative when it comes to the cost of SpringWorks marketing and sales and a little bit on R&D. When it comes to the EBITDA pre at the group level -- sorry, at the Healthcare level. So what did we communicate? We communicated an update to the top line of around 3% growth, instead of of the 3% to 5%. What are the drivers for that? First and foremost, as Belen said, when we look at the 9 months year-to-date, we see the trends on Erbitux. We see the trends on Gonal-f on Bavencio. Only this would bring us to the, I would say, the lower half of the previous guidance. Add to that, that in Q3 for Healthcare, the 4.6% growth is approximately 1% overstated. There is a pull-in from Q4. That's the second component. And then goes to the last one, which is the uncertainty regarding the effect of Mavenclad in Q4, and I'm sure that we will get questions around that later. So the guidance for the EBITDA for Healthcare, we upgraded it slightly and what it reflects are actually the downside on the updated sales, the 3% -- around 3% instead of 3.5%, the updated headwinds on FX. And on the upside, the pull-up of the portfolio effect when it comes to the SpringWorks. I hope that it gives you the bigger picture.
Matthew Weston: Danny, perfect. If I could add one very quick follow-up. Can you tell us where the 1 percentage point to pull-in from 4Q was in terms of the product breakdown? Which drug should we look at?
Danny Bar-Zohar: Yes. Thank you. That's a good one. In terms of regions, it was mainly in Middle East, Africa due to the tensions in the Middle East or the fluctuating tensions in the Middle East they -- there was a tendency to play safe and to stock a little bit ahead of time. So we are talking about mainly the CM&E and a little bit of Erbitux.
Operator: The next question is from Richard Vosser, JPMorgan.
Richard Vosser: One follow-up just on Mavenclad. Danny, I think Belen was saying, you would give some more color maybe about Mavenclad and the assumptions for '26 in terms of the growth, the generics coming in, et cetera, into the U.S. and growth ex U.S. Maybe you could give us some of that color, that would be great. And then secondly, on Electronics. it seems that Surface Solutions, as I think we all know, was a lower-margin business. So that should enhance the margins going forward. But also there's been the widening of growth, a little bit elements beyond maybe in Semi Materials outside of just traditional AI. So perhaps you could talk about the implications for growth -- for the gross margin of that and the margins going forward in the Electronics business.
Danny Bar-Zohar: Okay. Richard, thank you for the Mavenclad question, and I think that, yes, it is appropriate to provide more color. So let's step one step -- let's take one step backwards. This quarter, sales of EUR 304 million, exceptional growth of 20%, and this 20% growth is driven pretty much equally between North America and Europe. Very strong commercial execution. Now when it comes to what's next, how should we think about it? First of all, Europe, which is approximately 1/3 of the revenue should continue growing in 2026. So this one is clear. When it comes to the U.S., we are definitely not in a position to speculate here. Technically, there is one single company with a tentative FDA approval for a generic version of Mavenclad and the earliest possible conversion of it to a full approval is the 22nd of November. Now the FDA guidance states that it generally assesses a request for a conversion from tentative approval to a final approval within 3 months. So we don't have the full clarity on where it is going to land. So the -- when it comes to 2026, so this is a little bit of premature. Why? Because the time of entry of a generic is still unknown. We can think about something about early 2026, and we don't know about other generics. There is no other generic that has an FDA tentative approval, but we know about other generics. It's in the public domain. We have a petition prepared for filing and also generics are generics and the game and the price play is not always expected. So obviously, what we told you at the Capital Markets Day when it comes to the top line, as Belen said, will need to be adapted and when it comes to the [ staged ] cost mitigation that Belen mentioned, so this is a U.S. play only, and it will depend a lot on the timing and on the phasing of who comes after the first generic. When the first generic is there, we can continue playing, and we should continue investing moderately. What's good in the U.S. is that once we see the dynamics, we can act very rapidly, so we will modulate the cost appropriately. Just one sentence to add. With this, repeating what Belen said, all of this negative impact on the top line that we expect for Healthcare in 2025. The costs will be managed and the margins will be managed to be north of 30%.
Kai Beckmann: Second attempt. Richard, I'm taking the Semi question on the margin. Let me provide a bit more color on this one. So we made steady progress on the EBITDA margin in Q3 with 27% now and we've put the exceptional items that you have seen in Q2 '25 behind us. Still we aren't where we want to be in Electronics. The margins should be higher, but the biggest missing piece is the acceleration in volumes and our midterm target to the mid- to high-single-digit organic sales growth. So in Q3, we see support from the first 2 months where Surface is deconsolidated. On an annualized basis, we expect 100 basis points of margin accretion from the Surface Solutions divestment. We also see the continued benefit of operational leverage in Semi Materials and positive mix for materials for applications that serve AI and advanced nodes. And we did get some support from the release of some provisions in Q3 '25 as well. And it's worth remembering that biggest driver of lower margins are the investments we make in capacity for our local-for-local strategy, investments like the new Taiwan site are helping us to mitigate tariff operationally as well as gaining share via new qualifications. What we anticipate is exiting the year with margins in the high 20s with the guidance implying 26% to 27% EBITDA pre margin. So clearly, we have still work to do, but it's a clear sign of focus, Richard.
Operator: We'll now take the next question. And this is from Shyam Kotadia from Goldman Sachs.
Shyam Kotadia: I have one on the SpringWorks assets. So on a quarter-over-quarter basis, it appears Ogsiveo sales were broadly flat. So given your portfolio effect guide for Healthcare assumes EUR 180 million and you achieved EUR 85 million in 3Q, it implies EUR 95 million of sales for 4Q. I imagine the majority of this EUR 10 million uplift in 4Q may come from Gomekli, given its earlier in the launch and the recent growth momentum. So this would again imply Ogsiveo being relatively flat in 4Q. So I just wanted to, therefore, check what's driving this flat quarter-on-quarter revenue assumption for Ogsiveo? And are you anticipating a growth uplift there? That's the first question. And then Second question on SLS. So there was some positive phasing dynamics I saw in the release in the chemistry subdivision. So how much of that supported the low single-digit organic growth this quarter? And given it was a phasing impact, how should we think about 4Q for SLS? And also if you could quantify the potential impact from the government shutdown, that would be great.
Danny Bar-Zohar: So regarding Ogsiveo, I'll give a little bit more color. So in the third quarter, sales came in at EUR 62 million, which is 38% up year-over-year, which is practically the strongest quarter since launch and the drug was launched exactly 2 years ago. So it's not a very fresh launch. We continue to see robust underlying demand with new patient adds and refills and also low discontinuations. Ogsiveo is the standard of care holding more than 70% share of first-line systemic new patient starts. So this is very significant for us. Why are we confident with Ogsiveo? We saw a drop in surgery rate from 70% prior to launch to 50% already 18 months after the launch in the U.S. We see a very high level of satisfaction amongst both patients and prescribers, 90% prescribers have the intent to prescribe again. The drug is in the NCCN guidelines, high level of refills above 90%, real-world data that suggests a very positive feedback from both physicians and patients. Long-term efficacy and safety data we published a couple of weeks ago, that indicates clear increase in response rates over time, sustained improvement in quality of life and a very consistent safety profile. So we are definitely, definitely excited about that. What we need to do is to continue to drive leadership as first-line systemic treatment of choice, continue to grow the systemic treatment market for desmoid tumors through physician and patient education. And then when it comes to the flattening that you suggested, we are changing practice here. And this is the first in disease in this indication, in this severe indication. And in some cases, you need to, I would say, do a lot of education in terms of mobilizing patients. As I indicated on the Capital Markets Day with Ogsiveo, we are moving now. And I guess that SpringWorks has moved into this phase just between signature and closing to the second phase of the launch. This is the phase where the bolus of patients waiting at the center of excellence for the first drug ever are already treated. And now the task on us is to mobilize those patients under, what we call, active surveillance into therapy and increase the number of new patients, increase the funnel. So I'm referring back to two other things that I said when we announced the deal. One, expect volatility. Second, we'll need to deepen penetration in the U.S. The potential of more than 20,000 diagnosed patients in the U.S. only is huge, and the vast majority are sort of stuck with symptoms, but no decision how to treat these, and these are the patients that we need to get. So we have this -- and this is exactly what I meant when I said at the closing depending on our efforts in the U.S. Now specifically, when it comes to Q3, chronic disease, we do see summer seasonality. And if one splits that 2 months, you clearly see the seasonality there. When it comes to Q4, you saw that overall, we topped the SpringWorks guidance a bit. It's for both compounds. We will not provide additional split. But I would not expect the dynamics also that you might have observed between Q3 and Q4 last year, which was, as communicated by SpringWorks, a result of increased stocking in anticipation for a price increase. So we will consciously control this. We will continue to see broadly consecutive growth, and we are super excited with the recent launch in Germany. We launched 3.5, 4 weeks ago, and I spoke with a commercial lead there. And I'm very, very content about the progress of both Ogsiveo and Gomekli. You're absolutely right about Gomekli, fantastic launch as it looks right now in the U.S., EUR 23 million, 73% growth quarter-over-quarter. Both adult and pediatric population, we feel very confident with this product.
Jean Wirth: And Shyam, let me comment on SLS overall. So first of all, talking about Q3. Yes, we returned to positive organic growth in Q3 despite changing environment. When you peel the onion, biomonitoring from a portfolio point of view was a strong driver. Same is true for Chemistry and Lab Water as well. From a region point of view, Europe was the key driver. Now I would like to share also the fact that a few months ago, we launched an initiative around customer focus. What I mean and what we mean by customer focus. We have concentrated on enhancing our supply chain in SLS, particularly regarding inventory management and fill rates in order to improve the customer experience. And yes, we saw a nice and important benefit on chemistry, but this is a onetime effect. Moving forward, we are seeing some kind of sequential stabilization in academia, government and hospital, but the market remains volatile. And I will give you 2 concrete examples. One is China, where we continue to see China as a muted market linked to geopolitical situation, local competition and so forth. And the second key driver I would like to highlight looking forward or going forward is the U.S. government shutdown that caused some kind of uncertainty within the market, especially for academic government hospital customer segments. And we saw, let's say, a slowdown of our order intake per week in U.S. over the last few weeks. Good news is the shutdown should be now behind us, but it's true that it has impacted the first weeks of Q4.
Operator: The next question is from Charles Pitman-King, Barclays.
Charles Pitman: Just a first question please on the kind of thinking about the Fertility business. Just thinking about the kind of [indiscernible] performance in the quarter versus consensus a little bit weaker, but also just thinking a little bit more broadly next year, now that you've signed your MFN agreement with the U.S. administration to improve access to your Fertility business, what sort of dilution should we really be expecting to be reflected in FY '26? Or do you expect that to be offset by volume rises due to the improved access? And just wondering if you can confirm this is expected to eliminate the rest of your portfolio tariff risk as a result of the agreement, just given that happened about a couple of hours after the end of your CMD? And then just a second question. I'm not sure I have missed it earlier, apologize I had to join late. But can you just talk a little bit more -- can you just confirm what the driver of the lower dilution seen from the SpringWorks acquisition was for the third quarter and why you're now only expecting EUR 10 million for the year? Is it just the better-than-expected sales seen for Ogsiveo and Gomekli you were just referencing?
Danny Bar-Zohar: Yes. Thanks. I'll take that. I'll start from the second one because it has the potential to be shorter. So the driver -- the key driver of the lower dilution of SpringWorks in Q3, we moved it from a midpoint of minus 70 to a midpoint of minus 10 is mainly a very conservative approach that we took just a few weeks after we closed the deal in terms of commercial and R&D spend. So we are releasing a little bit of this conservative approach when it comes to spend, some of it will phase to Q4, but overall that's the key reason for this lower dilution. I hope that it helps. So when it comes to Fertility, the third quarter was at EUR 360 million as a franchise, 2% up organically. And we pretty much anticipated that. It's the first quarter this year that returns to growth. The previous 2 ones were flattish to minus low single digit. By region, yes, a double-digit decline in North America due to mainly almost exclusively Gonal-f price erosion as we flagged in the last couple of quarters. And this decline in North America was more than offset by growth across all other regions. First, Europe, then Asia Pacific, Middle East, Latin America. When it comes to the brands, high single-digit decline in Gonal-f and this is driven, as we said, in North America by negative price effects and in the U.S. and in China as it has been the situation in the last 2 quarters. I would call them still temporary market softness in China in a rather competitive environment with local biologics and local hMGs. But these were largely offset by double-digit growth, 36%, 37 almost percent growth of Pergoveris across all regions, and it's a very differentiated profile that this drug offers and all other fertility products grew moderately. So this is what we have in terms of the status quo. Now for 2026, we are anticipating low single-digit growth as near-term headwinds, Gonal-f price erosion and also a little bit of the muted market growth in China will be more than offset by the continued strong growth of Pergoveris. We expect the launch of Pergoveris in China in the first half of 2026, which is very important for us. And as you mentioned, we are working towards a launch of Pergoveris in the U.S. in the second half of 2026 under the Commissioner's National Priority Review Voucher Program. Now this is, I would say, a breaking news immediately after the Capital Markets Day with the private public deal that we have with the White House and we intend to file Pergoveris to the U.S. FDA in the next couple of weeks after the shutdown is over. And we hope to have, I would say, if approved, with a broad label, a significant upside in the U.S. and globally. Now in the midterm, I expect Fertility to grow, as we said at the Capital Markets Day mid-single digits. And the key growth drivers for Fertility are, first of all, a growing market fueled by the increased need for IVF combined with improving access in many areas, Asia Pacific and Europe and also reimbursement and market share gains of Pergoveris and we also intend to launch Pergoveris Pen to replace the vial in several markets. So this is likely to give us an additional boost. There are risks, further penetration by biosimilars, and most of the risks are on Gonal-f in China and in Europe, but we are very confident with this forecast. When it comes to the tariffs. So the second part of this agreement with the White House, the first part was on [ DTC ] for Gonal-f and for Pergoveris. The second part was a letter of intent with the Ministry of Commerce, where the aim actually once we finalize this conversation is to exclude a pharmaceutical product and ingredients from the Section 232 tariffs. So we are in negotiations with a very good intent in order to relief us from the pharmaceutical tariffs moving forward.
Operator: Now I'll take the next question. This is from Peter Verdult, BNP Paribas Exane.
Peter Verdult: Danny, just can we come back to Fertility, just in the context of how much of a medium to long-term underappreciated value driver is the deal that you've done with the U.S. So I heard all the comments you made with respect to the previous question, but could you perhaps be helpful in baseline for us as we exit 2025, the run rate of Pergoveris. And I think most people on the call would think that Fertility might be a sort of mid-single-digit growth franchise. So I don't want you to repeat all the dynamics that you've just said. But I do want to ask, when you think about that government deal and the volume opportunity, and the fact that you're not yet in China and Japan with Pergoveris. Do you, as a management team, think about Fertility as a mid-single-digit growth? Or do you start to think about upside to that. So baseline on Pergoveris and the medium- to long-term outlook for Fertility.
Danny Bar-Zohar: Thank you, Peter, for this question, and I will clarify, you're absolutely right. So what we expect for the full year this year for Fertility is flattish organic sales growth. You saw the effects -- the very muted effects in the first 2 quarters, returning to growth, getting our heads above the water in the next couple of quarters. So this is what you should expect for this year. Now for Gonal-f, I would say expect the pressure. We broadly think that it's going to be stable midterm outlook for Gonal-f. On one hand, we see the drivers that I mentioned before. On the other hand, we'll see the biosimilars, the price pressure and also to some extent, some extent, partial cannibalization by Pergoveris. Now when it comes to the U.S. deal, you need to think about it like this. There are 2 channels where we commercialize Gonal-f. There is the private channel, which is a cash-paying channel, and there is managed care through PBM, okay? The deal with the White House relates to the private one. So this discount or rebate that we are providing around 83% brings, generally speaking, the price to the private channel at the same range that is currently on the public one. So I would continue given that we are still -- we still have contracts with managed care channels, I do expect continued erosion in the next year and then eventually in outer years, not in 2026, we will start seeing, I would say, a stabilization. But this should be largely offset by Pergoveris, which is, in my opinion, and not just in my opinion, key opinion leaders, patients, a huge innovation in each and every market that we have Pergoveris. Both Pergoveris and Gonal-f are doing better. So this makes us very excited about the potential of this drug. And of course, we confirm the mid-single digit for Fertility in general. I don't think that we are at the stage to change it either up or down. We need to see how it [indiscernible].
Operator: And the next question is from Oliver Metzger, ODDO BHF.
Oliver Metzger: So the first one is on Healthcare. It's more about the strategic nature. So the recent news regarding Mavenclad and the loss of exclusivity, how has this, say, earlier happening or changed your view on the MS business as a whole? Second question, in your qualitative comments on SLS, you described some higher demand coming from early biotech. Do you consider this as a sustainable turn to be better? Or would you rate this still as a quarterly volatility.
Danny Bar-Zohar: So regarding Mavenclad loss of exclusivity and the impact on the multiple sclerosis franchise. So as I said before, the loss of exclusivity, yes, it came 10 months, 11 months earlier than expected in the U.S. In Europe, the end of regulatory exclusivity is in August 2027. And after that, we have SPCs per country. So the situation in Europe is well known, and we expect Europe or ex U.S. to continue to grow when it comes to Mavenclad. Now in the U.S., as I said at the beginning and as was mentioned a couple of times, we will need to manage this decline properly, and we have all the plans and all the capabilities to do that and to respond as fast as possible. Now longer term in multiple sclerosis, you know exactly what is the situation of our pipeline when it comes to multiple sclerosis. We don't have additional products in this field. So what we are going to do, and I mentioned that at the Capital Markets Day when it comes to Mavenclad, it just came a little bit earlier. We will manage the Mavenclad decline for cash, which means having a profitable decline. I hope that it gives you more color on that.
Jean Wirth: Jean-Charles speaking. So to answer to your question related to SLS, we confirm that we are seeing some positive green shoots from pharma company impacted Science & Lab Solution moving forward. However, I want to repeat what I said about China. We have seen some quite muted demand in China on short term. Nevertheless, China remains a very important strategic pillar for Life Science in general. And a few weeks ago, in this context, we announced a new go-to-market transformation. We are making good progress. We just nominated 24 hours ago, the new head of of China. And again, it highlights the fact that China for us remains very, very important. And last but not least, I also would like to repeat again that we are seeing some impact coming from the U.S. shutdown on our academic customer in North America.
Operator: We'll now take the next question. And this is from Florent Cespedes, Bernstein.
Florent Cespedes: Two quick ones, please. First on pharma for Danny on the pipeline, could you maybe share with us which are the key milestones that we should anticipate for 2026 in terms of clinical trial readouts? And my second question for Kai. Electronics, DS&S, why do you anticipate stabilization in 2026 for this business?
Danny Bar-Zohar: Florent, thanks. I'll take the first one. Key milestones. First, you should expect initiations, Phase III trial initiations for precemtabart tocentecan, the ADC, in colorectal cancer third line. As I mentioned and also David mentioned at the Capital Markets Day, we are in active discussions when it comes to partnering because of the size of -- potential size of this program also in the second line and the first line. You should expect data release in 2026, initial data release from the pan tumor trial. For that compound, we are testing it in pancreatic, in gastric and in lung cancer in a basket study. So that's for [ Pareto ] you should expect enpatoran entering Phase III trial in lupus rash. We completed the interactions with the regulators, very fruitful interactions. And these are the big ticket items, the myasthenia gravis with cladribine is enrolling patients, the Phase III, and of course, super important. It's not a trial. It's a drug in registration. We are expecting the launch of pimicotinib in China and also in the United States. In China, it's currently under review. In the U.S., it's going to be submitted in the next few days. We had the shutdown thing, but it's going to be released. We are going to also to get into a decision -- data-based decision on the PARP1 selective.
Kai Beckmann: Florent, let me take the DS&S question. So let me take it from where we started in Q2 with our messaging. In Q2 '25, we envisioned a drop of sales of EUR 200 million to EUR 300 million. That was the organic sales downside that we have mentioned in Q2. Now that we are 3 months further, we can confirm that slightly more than EUR 200 million, which was our optimistic case. So that's where we are ranging. So the downside is largely projects and related equipment, and we have seasonality in the large capital equipment and protect business and a lot of revenue here is booked at the year-end. You can see that since we bought Versum, Q4 was often seasonally the highest sales quarter of the year. And as we have seen now EUR 100 million downside in the first 9 months of the year, that means counterseasonal downside now of another EUR 100 million in Q4 '25 to get to the slightly more than EUR 200 million, I just mentioned. So we are calling Q4 '24 now as the bottom for DS&S and that's why when you do the math on the Electronics guidance, expect Q4 '24, it's our lowest sales quarter of the year. And if you take the guidance, midpoint down around 7% organically and around EUR 200 million down considering the divestment of Surface as well. So that's the bridge for Electronics and specifically for DS&S. And looking at our order pipeline and a very low base of projects, we expect stabilization for 2026.
Operator: The last question today is from Simon Baker from Rothschild.
Simon Baker: Two, if I may, please. Firstly, going back to Pergoveris in the U.S. Danny, you said you will be filing in the next couple of weeks now that shutdown has been resolved. Given the 1- to 2-month review period of these national priority vouchers, can you explain what else needs to be done in order to get to a second half rather than the first half launch in the U.S.? And then a question on SpringWorks and just in terms of phasing of the integration costs, it looks like more was taken in Q3 than we were perhaps expecting. So I just wonder if you could give us some idea of the phasing and cadence of SpringWorks related costs on acquisition and integration.
Danny Bar-Zohar: Thanks. So when it comes to Pergoveris, so this, I call it, an exercise with the Commissioner's National Priority Review Voucher is new to us and is also new to the FDA. So on that, we are in -- despite even the shutdown, we are in active discussions with that particular division, and we are preparing the file. So we have what we need to do when it comes to preparation of the file. The file needs to be prepared based on data that was submitted to the EU regulators. As you know, there were no trials in the United States on Pergoveris, and there is work that needs to be done on that regard. And then we need to get this reviewed. It's up to 60 days, it's, I would say, one of the -- it's a leading assumption by the FDA, but we need to see how it goes because still the drug was not tested in the United States. But I also want to make sure that we have the right label for this drug and prepare for this launch. So yes, theoretically, you can see that at the very end of H1 2026, we'll update you as we go because we are relatively early in this process. When it comes to SpringWorks integration, we actually have a positive update on integration and transaction costs, which we now expect at approximately EUR 250 million in total versus the EUR 260 million that we communicated previously, EUR 300 million originally. And in detail, we confirm our assumption for the integration cost of EUR 200 million and have slightly lowered our assumption for the transaction costs to around EUR 50 million, the previous assumption was at EUR 60 million, due to some lower legal costs. I hope that gives more clarity.
Operator: I will now hand the conference back to Florian Schraeder for closing comments.
Florian Schraeder: Thank you, Sarah, and thank you, everyone, for your continued interest in Merck. With this, we closed the Merck Q3 '25 results call, and we look forward to meeting many of you in our upcoming roadshows. Thank you, and goodbye.
Operator: Ladies and gentlemen, thank you for your attendance. This call has been concluded. You may disconnect.