Roche Holding AG reported a 6% growth in group sales for the first quarter of 2025, driven by an 8% increase in pharmaceutical sales. However, the company’s diagnostics sales remained flat, primarily due to healthcare pricing reforms in China. The Swiss pharmaceutical giant maintains its full-year guidance, anticipating mid-single-digit sales growth despite a projected 5% negative impact from currency fluctuations. Roche’s stock, currently trading at $55.30, remained stable, reflecting a cautious investor sentiment amid mixed market conditions. According to InvestingPro analysis, the stock appears undervalued based on its Fair Value model, suggesting potential upside for investors.
Key Takeaways
- Roche’s Q1 2025 group sales increased by 6%, with pharma sales up by 8%.
- Diagnostics sales were flat due to pricing reforms in China.
- Currency fluctuations are expected to impact full-year sales by -5 percentage points.
- Roche plans to invest $50 billion in US R&D and manufacturing by the end of the decade.
- Roche confirmed its 2025 guidance, expecting mid-single-digit sales growth.
Company Performance
Roche’s overall performance in Q1 2025 showed resilience, with a notable 6% increase in group sales. The pharmaceutical division, a significant revenue driver, experienced an 8% growth, highlighting strong demand for its products. In contrast, the diagnostics division faced challenges from healthcare pricing reforms in China, resulting in flat sales. Despite these hurdles, Roche’s constant currency sales growth was 6.4%.
Financial Highlights
- Group sales: 6% growth year-over-year
- Pharmaceutical sales: 8% growth
- Diagnostics sales: Flat
- Constant currency sales growth: 6.4%
- Currency impact on full-year sales: -5 percentage points
Outlook & Guidance
Roche reaffirmed its 2025 guidance, anticipating mid-single-digit sales growth and high-single-digit growth in core EPS. The company also plans to increase dividends. Roche expects significant developments in its pharmaceutical and diagnostics segments, with multiple Phase III readouts anticipated. The company’s strong financial position is evidenced by its healthy current ratio of 4.0 and low debt-to-equity ratio of 0.02, according to InvestingPro data. For deeper insights into Roche’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, which provides detailed analysis of key metrics and growth drivers.
Executive Commentary
CEO Thomas Schinnicker expressed confidence in the company’s strategy, stating, "We will deliver." He emphasized the disciplined and swift implementation of Roche’s strategic initiatives. Theresa, an executive, highlighted the competitive edge of Roche’s BTK inhibitor, saying, "We believe we have a better BTK."
Risks and Challenges
- Currency fluctuations could negatively impact sales by 5 percentage points.
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- Healthcare pricing reforms in China may continue to affect diagnostics sales.
- Competitive pressures in the pharmaceutical market could impact market share.
- Supply chain disruptions could affect production and distribution.
- Regulatory changes in key markets may pose compliance challenges.
Q&A
During the earnings call, analysts inquired about Roche’s strategies for mitigating US tariffs and the dynamics of the Vobismo market. The company also detailed its plans for next-generation hemophilia treatment (NXT007) and its obesity drug development strategy.
Full transcript - Roche Holding AG Participation (ROG) Q1 2025:
Call Moderator: On listen only mode during the call. After the presentation, there will be a question and answer session. You’re invited to send in questions for this throughout the entire session using the q and a functionality of Zoom. In addition to that, you may also raise your virtual hand to address your questions verbally. For participants joining via phone, to raise your hand, your star nine on your phone’s dial pad.
One last remark, if you’d like to follow the presented slides on your end as well, please feel free to go to wolf.com/investors to download the presentation. At this time, it’s my pleasure to introduce you to Thomas Schinnicker, CEO of Wolfe Group. Mr. Schinnicker, the stage is yours.
Thomas Schinnicker, CEO, Wolfe Group: Thank you very much, and I’m happy to share our Q1 twenty twenty two twenty twenty five sales with you today. Now let’s look at our performance. We had really a good start in 2025 with group sales growing 6%, and this was driven by pharma with, again, very strong sales growth of 8%. So you can see that we continue our very strong momentum in on the pharma side. Diagnostics was flat, and this was due to health care pricing reforms in China.
Matt will cover that. Again, this did not only impact us, it impacted the entire industry. And this is something that we had flagged also at the full year results presentation in January. The LOE impact was also in line with guidance. So now let’s look at the key milestones in Q1.
On the pharma regulatory side, we had EU approval of COLONVI plus GEMOX in second line DLBCL. And this is based on the very strong Phase III STARGLOAD data, and it’s the first and only bispecific with an EU approval in second line DLBCL. We also had The US approval of SUSVEMO in DME, so the second indication, and DNKs in acute ischemic stroke. We have the filing in The US and in The EU for KOSAIVA in lupus nephritis, and this is based on the positive phase three Regency data, which was presented at WCN and is also published in the New England Journal of Medicine. And we had the filing in The EU for Lunsumio in third line follicular lymphoma.
We’ve had a number of positive Phase III readouts. Let me highlight the SANMO Phase III readouts from Lenoxumio and POLYVIE in second line, DLBCL. And we are now excited to move now our second bispecific into a chemo free combination with POLYVIE into early line of treatment of DLBCL. More information on the positive outcome will be shared later in this year at a medical conference. We’ve also taken a number of Phase III decisions.
As we mentioned at the full year call, we said there are potentially seven enemies that could move into Phase three, which would be a record in terms of how many enemies we move into late stage. And these are all based on the bar criteria. In Q1, we did make two decisions to move two of them into the last stage of development into Phase III based on the latest data. Trantinumab being one of them in Alzheimer’s disease, The positive data was shared at ADPD, and Phase III is expected to start later this year. And the second one is NXT-seven in hemophilia A, and the Phase II data for this will be presented later in this year.
We also had a very exciting business development deal, this collaboration with Zealand Pharma on petrolintide, the leading long acting Amylin. And there will be more on this in a couple we’re also progress on And a of business. Business. And of specifically here on SDI, and we continue to place more of these systems in the market. Also, very excitingly, we had the unveiling of a novel SBX sequencing technology, so sequencing by expansion.
And I will also provide a little bit more context as well as Matt will provide more context. And we shared real world and life experience of customers here at the AGBT. We have significant news flow upcoming in 2025 for both pharma and diagnostics, and Therese and Matt will go into more granularity here. Clearly, there are a number of phase three readouts coming, including multiple enemies that could lead to launches, next year across oncology with Gerodestrant, neurology with fendiprutinib, immunology, astigolumab, and ophthalmology with vermicubarts. Equally, we still have a number of phase three enabling readouts coming, which could enable us to move another five molecules into Phase III, again keeping to the bar criteria.
Diagnostics is looking forward to several key launches still in 2025, including the Alexis pTau-one hundred eighty one and the high sensitive Troponin T next generation assays. Now let’s move on and let’s take a closer look. We’ve had strong sales of 8% on the pharma side, so continuously very strong momentum. Diagnostics is flat, and I already mentioned that this was driven by health care pricing reforms in China, not only impacting us, but the entire industry. Now I used to have a favorite slide, and I have a new favorite slide, which is this one, which really shows that over the last four quarters, we’ve had a significant growth of 8% across in our entire business.
But if you go back until ’23, we really had an underlying growth of 8% consistently. So we have consistently performed very strongly over the last two years and one quarter. And this is a strong pickup in our growth versus the twenty two twenty twenty two time frame. Now let me go to the key growth drivers. And I will start at the right top.
Perjeta, FESCO conversion is now at 47%. Both of our on the hemophilia side or hematology side, both of our CD20, CD3 bispecifics are advancing now into second line DLBCL, and this is increasingly increasing our opportunity significantly. Column V, GemOx receiving EU approval and the positive Phase three results from SunMo. NXT Series seven moving into Phase three, as already mentioned. On the neurology side, very importantly, Sunnova received the permanent J code granted on first of April, so we should definitely see a pickup here.
As mentioned before, we do believe that the subcutaneous version of OCREVUS will add 2,000,000,000 incremental sales. And right now, the consensus is at about 8,500,000,000.0. We feel very comfortable with that consensus. And the 2,000,000,000 incremental will, obviously, be there will be more sales for the subcutaneous version, but there will be also be some switches. Everesty receiving U.
S. Approval for tablet formulation, Engsola still doing extremely well with now more than fifty thousand patients on treatment. But Biasmal keeps expanding market share in all approved indications, and Theresa will talk about that as well. And she will also talk about the market contraction in the branded segment because of less funding for co pay assistance foundations. But we keep seeing very strong momentum, as you can see here, with 17 or I think Verbeismann’s eighteen percent growth, and we do believe that we can continue this kind of momentum going forward.
Diagnostics, I’ve already mentioned as well. Now the young portfolio continues to drive growth in the near to midterm. If you look at the right hand side, now the young portfolio accounts for 59% of our sales, up from 55% the year earlier. We have four pivotal NME readouts for new NMEs. As I mentioned also before, asigolumab in COPD, vimekibart in UME, tiradestrand in breast cancer, and phenobrutinib in multiple sclerosis.
And we do believe that this new portfolio will continue to drive growth at least until 2028, and we know that Diagnostics will continue to contribute positively in terms of growth, especially with the new products, and all positive readouts that we should expect over the next years will then add to this growth. We don’t have a cliff situation. And with that, we’re at a more favorable starting position than many of our peers. Now let me just highlight a couple of things on the recent announcement that we’ve made of our investment in The US. We have a strong legacy of partnership with a 30 countries around the world.
We basically have the full value chain present in most of our key markets, such as The US, in Europe with Germany, Switzerland, Japan, and China. It’s always been our strategy to build out a fully value chain in each of these markets to be present where the patients are. And key part of this legacy of investment is also our research and development and manufacturing footprint in The United States. Now Tuesday’s announcement to invest further 50,000,000,000 into r and d and PP and E in The US until the end of the decade. Let me put that into a bit of context.
This would be almost a doubling of our investment in The US over the next five years compared to the previous ten years where we invested 67,000,000,000 in R and D and PP and E. Let me also say this does not mean that we change what we’ve said before in terms of CapEx availability between €3,000,000,000 to €4,000,000,000 annually. This is already included in any of these comments that we’ve made in the past. It also doesn’t change what we have said in the past in terms of R and D spending. You can expect R and D to be flat this year and that we keep very disciplined when it comes to our spending.
Currently, we have 13 manufacturing and 15 R and D sites in The U. S. Across pharma and diagnostics, and we are planning to add two new sites. First is this announcement of investments, including the construction of a new R and D site in Boston. We’ve discussed this as a team that we have a very strong presence in on the West Coast in terms of r and d, but we didn’t have a presence on the East Coast.
And so we strategically said we wanted to tap in into the ecosystem in the Boston area, which is, I would say, next to San Diego and San Francisco, the third key ecosystem that we wanna be present in. And that’s why we’ve committed to make an investment here and also in collaboration with Harvard. And then there is also one many new manufacturing site that we will establish in The US where we’ve been in negotiations with different states in The US. We have not named the location yet, but we’ll do that soon. And this is basically also for the manufacturing of peptides, so the incretins and also the amylin.
And so both of our new sites will have a strong focus on CVRM. Let me also highlight that we are probably in a much better position than most other companies in terms of our manufacturing capacity that already exists in The United States. Our drug substance capacity utilization is at 50%, which truly gives us a lot of flexibility to adjust our manufacturing volumes. And this is due to the fact that, and you can see it on the right hand side, that we’ve driven a fivefold productivity increase in terms of yields from our cell lines. So what that enabled us to do is actually some of our medicines that we already produced in The US, we could increase the manufacturing in The US basically overnight of these medicines.
And the only remaining medicine that we have to tackle when it comes to tariffs is one that’s currently not being produced or, yeah, produced in The US, and we already started the tech transfer of this medicine a number of weeks ago. Let me also highlight that we when we acquired Genentech, not only did we keep manufacturing there, so we didn’t move to Ireland, for example, we also kept our IP there. And with that, we’ve been a significant taxpayer in The US. Again, so I would just highlight here, we’re probably in a better position than many others. Taken together, I do believe this sets us a stage for next area era of growth and innovation for us as a company to benefit patients in The U.
S. And abroad. But it also just want to reiterate, we’ll also continue to invest in countries like China, where we’re also expanding our manufacturing footprint. Now let’s move to the outlook, and I wanna highlight two areas. One is Roche sequencing, and the other one is our efforts around CDRM.
And I know both Matt and Theresa will go into more details on this. At AGBT, we unveiled our novel sequencing solution, which combines our highest throughput sensor module that we developed over the last years. And now comes the secret sauce. That’s the SPX chemistry, the sequencing by expansion chemistry, which actually expands the DNA 50 times so that you get a better signal to noise ratio. With that, you increase the accuracy significantly, and you increase the speed and throughput because you don’t actually need to slow down this molecule as it goes through the pore.
It goes through very quick, and you get a very clear and clean signal. With that, we have a very high accuracy, which is fit for clinical applications. We are extremely fast, and we have a lot of throughput. And and what also is unique is the flexibility. Because with technologies that are used today, you have to run a full plate to benefit get the benefit of the price and cost.
You don’t have to do that with this technology. So we do believe that we are in a pretty good position here as well. Let me talk about our commitment to become a leader in CVRM. In e pharma, we now have a broad portfolio of differentiated assets that address address unmet needs in obesity, diabetes, and a number of adjacent indications. Let me just highlight there are probably more than two hundred comorbidities that are linked to obesity.
The GLP-one GIP from the Comet acquisition. And also in Q1, we announced a collaboration with Zealand Pharma to develop Petrolinthite, a long acting amylin analog, and I know Theresa will go into that detail. Also, in q one, we announced our plan to build a Boston Innovation Center in partnership with Harvard, and this will be focused on CVRM drug discovery and development. On the diagnostic side, again, let me highlight this. We are the global leader in this space.
We know all of the key opinion leaders. We have the leading portfolio of cardiac and metabolic markers. We develop holistic solutions for the management of the diabetes and cardiac indications, and this includes CGM that offers unique smart algorithms and easy one step application. But I know that both Matt and Theresa will cover more here. Let me just highlight here on the 2025 pipeline for pharma, the positive news flow and also the negative news flow.
In green, you see the positive and in red, the negative. On the negative side, let me just highlight Skyscraper seven in ESCC, which missed its primary endpoint. But let me also highlight that when Sky six failed middle of last year, we stopped all of the pherogonma studies that were still in progress and could be stopped, as we mentioned at the time in this investor call, and we only let the ones run where it was not appropriate to stop these trials anymore. On OCREVUS high dose, which missed its primary endpoint, again, I just want to say we’re comfortable with the OCREVUS consensus where it is right now, which includes the 2,000,000,000 incremental sales, which are driven in the combination of SUBCAT and IV. And let me also say that we don’t see a cliff situation also for OCREVOS beyond the end of the decade because of OCREVOS SUBCAT and OCREVOS high concentration, which you see in green here as well.
On the positive side, again, I just wanna mention trastuzumab and NXT007 moving into phase three, COLONVI with the EU approval, Lonsumio with a positive phase three readout in second line DLBCL, obesity for GIM three to nine, where we are starting a phase two combination with incretins, and atopic dermatitis and MATCH, two new indications for atemcaport, DMD for Enspring, and the high concentration OCORUS that I mentioned. Let me just close by saying that we confirm the 2025 guidance. As you can see on this slide, sales growing mid single digit, core EPS growing high single digit and dividends to further increase. With that, thank you very much, and I hand over to Alain to take us through the finance slides.
Alain, CFO, Wolfe Group: Yes. Thanks, Thomas. As everybody knows, a sales call today. I hope everybody’s well. So my my contribution will be brief today.
Yeah. Let me jump into the sales. And what you see here, the reported sales in in Swiss francs quarter 1 2 thousand 20 4 compared to quarter one two thousand and twenty five. So in total, a 7% increase. Let me start with the highlighted 6% in constant currencies.
And you see we have different factors here. I think one one element is really here on on the diagnostic side. You see the China health care pricing reform that Thomas has mentioned already, yeah, which which was a reduction, yeah, for sales on diagnostics. On the other hand, excluding China, as they’ve grown by by roughly 5%, which I think is quite an achievement. So Matt will dive into this.
And you see on the pharma side, I think, really good underlying growth. Then as expected, the loss of exclusivity impact with a certain erosion in Q1. As you know, we expect more erosion for Alktemra in the quarters to come. So still, we stick to our expectations that we’re going to lose 1,200,000,000 in that segment over the year. You see currency is a positive in q one, you know, translating into Swiss francs.
So get to to get to the plus 7%, and I will dig into that. But let me say, enjoy the moment. When you look really then at the exchange rate impact, yeah, on the sales growth, yeah, and that is the 6% on the left hand side in constant rates that you know already. It’s now 6.4%, yeah, as we added the decimal. And you see on the right hand side, in Swiss francs, a 7.2% growth.
And then you see with the currency fluctuations in between, and you see a major contributor to the performance has been the US dollar, which has strengthened in that period. We all know what happened in April, yeah, and I will talk about that in the next slide, and here it is. Because as you know, what we do is we keep all the currencies stable at the end of Q1 and then basically project them until the certain quarters, but also until the end of the year and then measure the impact and announce that here. But let me see, let’s say, one thing. After March, as mentioned, I think we have seen a major volatility and a major weakening, yeah, of the US dollar, I will get to that.
When you really look at full year 02/2025 impact, yeah, as of April 23, so really recently, and you assume all these currency rates remain stable until the end of twenty twenty five, we will have a currency impact at full year on group sales of minus five percentage points. So quite significant, but as said, we’re also not alone. I think other companies will be affected by this as well. I know it is of interest what that means for core operating profit and for core EPS, so let me give you these projections, which are certainly highly speculative and very unlikely, yeah, that they will really realize. But for core operating profit full year, it would mean a minus seven percentage points, and on core EPS, an impact of minus eight percentage points.
So that’s quite significant. As I’ve said, you see Q1 enjoy the moment, I think, for the next quarters to come. I think if the currencies stay where they are basically today, I think we will see much worsened picture. Good. I think Thomas said everything about the guidance.
I don’t wanna just reiterate here that we confirm the guidance for 02/2025. And with that, happy to move over to
Thomas Schinnicker, CEO, Wolfe Group: to Peter.
Theresa, Executive, Wolfe Group: Great. Thank you, Alan. In q one, pharma delivered 11,900,000,000.0 Swiss francs in sales with an 8% growth at constant exchange rates. You see The US, Europe, and international all delivered strong growth with 6%, five %, and 18% respectively, and Japan is now returning to growth with a 3% up 3% in Q1. Overall, pharma volumes were up by 13% in Q1.
So let’s kick things off with a look at the sales growth across the pharma portfolio. Please note that all absolute values and year over year growth rates are presented in Swiss francs at constant exchange rates. As Thomas mentioned, our young portfolio continues to deliver strong growth led by the key brands, Fezbo I’m sorry, Fezgo, Vabismo, Hemlibra, Pellivri, Ocrevus. Together, these added 700,000,000 of new sales at constant exchange rates in q one. For the first time, Fezgo is our number one growth driver, and that’s strike that’s thanks to the very strong performance in our international region.
So now let’s take a closer look at our key therapeutic areas starting with oncology. Oncology sales increased by 2% to 3,900,000,000.0 Swiss francs in q one. This growth was primarily driven by the HER2 franchise. FESGO continues to impress with incredibly strong 52% growth in q one. The global conversion rate continues to climb.
We’re now at 47% across our 58 launched countries with the growth in China accelerating noticeably following the NRDL listing earlier this year. Perjeta conversion to FeSGO is ongoing, and we are looking forward to sharing the final affinity analysis, which is that eleven year follow-up at an upcoming conference this year. Kadcyla continues to deliver good growth driven by uptake in the adjuvant setting. Switching gears over to Tecentriq. Sales in the first quarter remained stable.
And as we mentioned at full year, we believe Tecentriq is close to peak with limited to no growth going forward. U. S. Launch of Itovi is continuing as planned, and we are expecting EU approval later this year. Looking ahead through the end of twenty twenty five, we have two highly anticipated Phase III readouts for gerodestrant with EVERA and PERSOVERA expected in the second half.
And additionally, we are looking forward to initiating our phase three trial of divaracib, our KRAS inhibitor on top of standard of care in first line non small cell. So now let’s move on to hematology. Hematology growth remains strong, starting the year with 14% growth, CHF 2,100,000,000.0 in sales. Hemlibra showed strong growth momentum across all patient segments. As expected, The U.
S. Q1 year over year sales were flat, and that follows the very strong growth we saw in q four. We had 20% growth in q four in The US, and that was impacted by a buying pattern from one of our largest distributors. So we sort of expected this and signaled it as we head into as as we signaled it at full year. Ex US, however, we saw very strong growth in q one with the international markets growing 72% and the EU markets growing 7%, and basically all countries contributed across those regions.
For a full year, we are confirming the ambition of mid single digit global sales growth for HEMLIBRA. There is also some exciting news on our next generation bispecific in hemophilia, NEXT007, which I will cover in the coming slide. But for now, let’s move on to our malignant hematology portfolio. Polivy first line DLBCL continues to drive strong growth, and we’ve reached yet another milestone with more than fifty thousand patients treated globally. US First Line DLBCL patient share continues to climb.
We’re now at thirty one percent, and we are looking forward to presenting the updated phase three PELARGO data in relapsing remitting DLBCL at an upcoming medical conference at Midyear. COLUMBI and Lonsumio are CD20CD3 bispecifics. Launch performance is on track for both in their lead indications, third line plus DLBCL for COLUMBI and third line plus follicular for Lonsumio. We expect to achieve the combined peak sales potential of severed hundred million Swiss francs in those initial indications, which are relatively small. I do want to highlight that both of these bispecifics are making good progress to move into earlier lines of treatment and therefore bigger marks markets, specifically those first moves into second line DLBCL.
As Thomas mentioned, Colombia recently achieved EU approval based on StarGlow, which demonstrated an OS benefit a hazard ratio of point five nine, making it the first and only bispecific in the EU approved in second line DLBCL. And in The US, we are still expecting FDA approval around midyear. As mentioned before, we’re also excited about the positive phase three SUNMO data for Lonsumio and Polivy in second line plus DLBCL, which offers patients another chemo free treatment option, and we are looking forward to sharing that full data set with you in the near future. Staying with Lonsumio, there is quite the rich outlook in 2025 for hematology. We have The US PDUFA, as Thomas mentioned, the subcutaneous portion the subcutaneous formulation of Lunsumio in third line follicular, and that is set for September 22.
We are also expecting the phase three CELESTIMA readout in second line follicular later this year as well. And then additionally, we are expecting phase three readouts for VENCLEXTA in first line MDS and PSKY and aHUS. So now as promised, let’s take a look at NEXT seven. Certainly, the key news here is that we are moving NEXT seven into phase III trials. This is the next generation Factor VIII bispecific monoclonal antibody that we have in development with Chugai.
Preclinical results indicate that it has the potential to achieve zero treated bleeds for hemophilia A patients without the need for additional Factor VIII treatment. We’ve mentioned before that NEXT007 is 30 times more potent than Hemlibra, and we believe that this really could be a game changer for hemophilia patients. The aforementioned so we are moving in to phase threes. We are launching three phase three trials this year, including one head to head with HEMLIBRA. I think this gives you a very good sense of our excitement for NEXT seven, and quite frankly, it really only makes sense to be including HEMLIBRA, which is the standard of care, as the comparator for any new trials in hemophilia A.
All of these trials are expected to initiate in 2026, and we are also exploring device options. Phase two data for next double o seven will be shared in an upcoming medical congress and as covered as part of the IR event on June 23. So up next, let’s head over to our neurology our neurology franchise. Neurology continues to deliver strong growth of 10% at constant exchange rates, achieving 2,400,000,000.0 Swiss francs in sales. Ocrevus momentum remains strong at 6% globally.
A lot has happened with Ocrevus in q one, so let’s delve a little bit deeper into the q one news flow. So as you know, the permanent j code for Ocrevus de novo, our q formulation, was granted on April 1 in The US. We believe that this will lead to an acceleration of US uptake, particularly in the second half of the year. The early market response has been very positive, and we know that some practices were not only actively waiting for the permanent J code, but we’re also deciding against adding additional infusion shares in favor of starting on or switching patients over to Ocrevus de novo. Importantly, based on internal patient claims data, we see that about fifty percent of Xenovo patient starts are naive to Ocrevus.
So that continues to give us confidence that this new formulation will open up new patient new patient populations to Ocrevus and not simply cannibalize existing share. Of course, in q one, we also shared the negative OCREVUS high dose readout in RMS. And while disappointing, think it is important to remember why we ran this trial. And the purpose of the high dose trial was really to understand if patients would experience greater efficacy with a higher dose of OCREVUS. And while this trial didn’t meet its primary endpoint, the results clearly support OCREVUS standard dose as the optimal dose to slow disability progression, and this is actually great news for patients.
So now that we have the answer to what is the optimal dose of Ocrevus, we are quickly moving forward with the development of a novel subcutaneous formulation that has a higher protein concentration, which will significantly reduce injection volume, which allows us to move into a more convenient on body device with the goal of bringing Ocrevus closer to home. So more on this exciting development will be shared at a later stage, but we are moving with urgency into this next phase of the life cycle for OCREVUS. In the meantime, OCREVUS franchise modeling remains largely unchanged. We predict the franchise to peak at the end of the the end of the decade and do not expect, as Thomas mentioned, an abrupt an abrupt cliff situation due to Ocrevus subcut providing some level of protection to the franchise. For 2025, we continue to expect high single digit global sales growth, and we continue to be comfortable with the Ocrevus consensus peak sales of 8,500,000,000.0, including the 2,000,000,000 Swiss franc incremental sales opportunity for Ocrevus Subcut.
Moving on to Evrysdi. Evrysdi continues to deliver strong growth, and we expect the full year growth rate to be at roughly the same level as the 18% that we achieved in q one. The tablet formulation received its US approval in February, which offers patients a simplified storage option eliminating the need for cold chain and easing administration. EU approval is expected before midyear for the tablet. The early launch momentum for Elevitis and DMD continues to be strong in ex US and ex EU countries with 43,000,000 in sales in q one.
We were profoundly saddened that a young man with Duchenne’s passed away following treatment with LOVDs having suffered acute liver failure. Following this event, ongoing studies were put on temporary clinical hold by EU regulators. And as always, Roche and Sarapta are focused on doing what is most important for patients, and patient safety is always our paramount concern. Based on the totality of data, however, we do remain confident in the efficacy and safety profile of LAVDs, and we are not changing forecast guidance at this time, and we will work with EU regulators to minimize any potential delays to the program. Tarantinimab in Alzheimer’s, we presented the more mature phase onetwo dataset at ADPD, and more on that on the next slide.
But importantly, we have made the decision to move Tronte into phase three and look forward to initiating that trial later this year. On the outlook for neuro, we expect a steady news flow through the end of the year. The phase three readouts for fenobrutinib in RMS and PPMS are expected at the end of the year, and there are phase two two phase two readouts for GIM-three twenty nine expected in 2025, ’1 in combination with Evrysdin SMA, and one is monotherapy in FSHD. But before we leave neuro, let’s take a closer look at the two molecules we highlighted at the recent ADPD conference, Tronte and prasinezumab. Starting with Tronte, as we mentioned, we presented updated data from our phase one two brain shuttle trial of Tronte in Alzheimer’s, and you can see that that rapid and deep amyloid clearance continued to be achieved at different doses.
Importantly, eighty one percent of patients on the three point six mg per kg dose achieved amyloid PET negativity within just twenty eight At the same time, in the safety and tolerability profile remained very favorable, ARIA E and ARIA H rates were below 5% across the 114 patients treated in Parts one and two. Based on these very positive results, we’ve decided to move Tronte forward into phase three with the trial start planned for later this year, and we would expect final readout of that phase three trial in 2028. So now let’s briefly move on to Parkinson’s. At ADP, we presented the phase two b Padova data. Despite missing the primary endpoint, the results show a delay of confirmed motor progression in PD, especially in L DOPA treated patients.
We are waiting for additional data from the ongoing label extension, and with the benefit of that additional data and an in close alignment with regulators, next steps for prozi will be decided around mid year. Just to remind everyone, we continue to see prozi as opportunity. So now let’s continue on to immunology. Our immunology franchise achieved 1,600,000,000.0 Swiss francs in sales and grew 8% at constant exchange rates. This growth was primarily driven by Xolair and its strong launch trajectory in food allergy.
Xolair’s benefit in food allergy was further confirmed by positive updated data from Outmatch, which showed that Xolair is more effective and has fewer side effects than oral immunotherapy for treating food allergy. For the full year, we expect growth in the mid teens for Xolair. And as a reminder, we don’t expect any biosimilar launches in 2025. Actemra
: saw a
Theresa, Executive, Wolfe Group: minor decline of 1% due to biosimilar impact. US biosimilar launches continue to be slower than we expected while EU biosimilar penetration is increasing as planned. And we anticipate that the overall biosimilar impact will accelerate in the second half of this year. And as Alan mentioned, we are confirming that that 1.2 biosimilar impact for the full year across the portfolio. More on Gazyva on the next slide, but let me just mention here that the positive Regency results were recently published in the NEGEM.
Our TL1A program had quite the busy start to the year. First and foremost, we have finally received our INN just last week, and so we are now officially known as afibcabart. We also started trials in three indications, all of them achieving FPI in q one. Phase three in Crohn’s disease, a phase two in atopic dermatitis, and a phase one in NASH. Further indications are currently being evaluated.
Afimke is one of our internal fast track molecules where we work across all levels of the organization to ensure development at speed. And this is a direct outcome of our R and D excellence work, and Afimchi is one of the programs where you can really see the impact of that. Considering the outlook for the rest of the year in immunology, we have phase three trials for GAZYVA in SLE and astagolumab in COPD expected to read out. And for ASD, as a reminder, we continue to see this as a high risk, high reward opportunity. Now let’s take a closer look at GAZYVA in lupus.
We shared the positive Regency results at the WCN conference in February. GAZYVA demonstrated a superiority over the standard of care with a clear benefit in complete renal response. Safety was in line with the very well characterized profile of Gazyva with no new safety signals, and The US PDUFA has been set for October, and EU filing has been completed. Phase three readouts for additional indications are expected in 2025, Allegory and SLE, and INSURE and INS. And then obviously, the MN trial is ongoing.
Moving on to ophthalmology. Ophthalmology grew by 17% in q one achieving 1,100,000,000.0 Swiss francs in sales, but Bismaro is now the most prescribed treatment in AMD in The US. Market shares in The US continue to expand with AMD now at 33%, that’s up 3%, DME up two percent, and RVO up 3%. This is also true for ex US launch countries where we continue to see market share increases across all indications. Additionally, the share of treatment naive patients starting Vovismo in The US is now approaching sixty percent, and I think this further confirms Vovismo’s positioning as a first line treatment.
As Thomas mentioned, at the same time US sales were impacted by of The US branded market, and this is primarily caused by funding shortfalls from the co pay assistance foundations. This dynamic in The US is likely to persist and the overall impact of that constriction will look will likely take several quarters to wash out. Outside The US, we see very strong uptake. EU conversion to the recently launched PFS is rapidly increasing. It’s already at greater than 70% in all the markets where it’s available, and the China launch accelerated markedly after achieving NRDL listing in January for all three indications.
Taken altogether, we still expect roughly 20% sales growth globally for Vovismo this year, but we do have to caveat that there is a difficult to predict development or it is sort of difficult to predict how The US branded market will develop in the coming months. Some good news for SESVEMO, US approval in DME was achieved and EU filing for AMD is expected later this year. And similarly, we expect data for our IL-six, the Mickey Bart in UME later in 2025. Wrapping up our tour of the therapeutic areas with a quick look into our CVRM franchise. Like Thomas, I am very excited about our recently announced collaboration with Zealand to partner on petrolintide in obesity.
Together with Zealand, we believe that monotherapy petrolintide has the potential to become a foundational therapy in weight management with improved tolerability and a mode of action differentiated from GLP-1s as amylins work by increasing that feeling of satiation while GLPs work by reducing hunger. Petrolintide’s favorable physiochemical properties will allow for easier co formulation and co administration with other peptides. So thus, in addition to just exploring as a monotherapy, we are also exploring different combination opportunities starting with a fixed dose combination of petrolintide and CT388. Our belief in the best of in the best of class potential is also based on the strong phase one results shown here. Placebo adjusted weight loss of up to 6.9% was achieved at sixteen weeks, and at the same time safety and tolerability were quite favorable with the vast majority of treatment emergent adverse events reported as mild.
A phase two in obesity without type two diabetes is currently ongoing. Now The Zealand collaboration very nicely complements our existing obesity and diabetes portfolio, and we see great potential for monotherapies and combinations to address the various unmet needs in obesity, diabetes, and the co linked the linked comorbidities. And we’re making very good progress with multiple molecules expected to advance in 2025. It is quite a list. The interim data for CT388 in obesity will become available this year and will inform our phase three go decision in the second half.
I did want to reiterate what we shared at half year that we only plan to share the final phase two results for this study, which are expected in early twenty twenty six. We will, however, announce a phase three decision once it is taken. Data for CT eight sixty eight phase two in type one diabetes with overweight and obesity is also expected this year. Our phase two trial for CT nine ninety six, our oral, will also begin this year, as will our phase one for CT one seven three or PYY in obesity, and the phase two trial for GIMP three two nine plus a GLP one in obesity. For 2026, we, as I mentioned, we expect the CT three eight eight plus petrolintide phase two study to be initiated.
As Thomas mentioned earlier, Roche is committed to becoming a leader in CVRM, and the scope and speed at which we are just expanding and developing our portfolio, I think really underscore this. And so to close my section, let’s look at the key news flow side. So we’ve added quite a number of check marks since we last showed you this slide at the full year presentation. I won’t go through them in detail since we covered most already. So just a quick run through.
Columbia received EU approval in second line DLBCL. Gazyva completed US and EU filing in lupus nephritis. CisVemo achieved US approval in DME. Lonsumia with positive phase three results in second line DLBCL. NEXT double o seven in hemophilia A and trunnionemab and Alzheimer’s are both moving into phase three.
And as Thomas mentioned, TNKs TNKs achieved US approval in acute ischemic stroke. Of course, we also had to add a Red Cross for the OCREVOSE high dose study in RMS with the GAVAT trial in PPMS still ongoing, but, of course, our hopes for a positive trial in that indication are diminished somewhat with the result that we saw with Muset. So now that is all for me, and I have the pleasure of passing it over to Matt to cover diagnostics.
Matt, Executive, Wolfe Group: Thanks very much, Theresa. So, good morning, good afternoon, everyone. It’s my pleasure to present the q one twenty twenty five diagnostics division sales results. So as you heard already from from Alan and Thomas, with sales of 3,500,000,000.0 Swiss francs, the diagnostics division sales were stable versus q one twenty twenty four. And this was really driven by the health care pricing reforms and volume based procurement in China.
As as Alan mentioned, excluding China, the growth of the business was plus 5%. So let me walk you through that on a customer area level. So sales in our core lab decreased at minus one. Now this is really impacted by the reimbursement reductions in the VBP in China. This resulted in a decrease of immunodiagnostics by 3%, which was partially offset by 4% growth of our clinical chemistry business.
Excluding China, Core Lab grew at 8%. Now sales in our molecular lab increased at plus 2%, and this is due to strong growth in our blood screening segment at plus 6%, but this was offset by a minus 5% in our infectious disease business. Now this infectious disease decline was driven by a decrease in our HIV business in Africa. This is a result of the USAID funding pause for testing. Now excluding this effect, Molecular Lab grew at plus 6%, and we are optimistic that the USAID pause will end and that this business will resume.
We will keep you updated in the coming quarters. Now sales in our near patient care business decreased at minus 5%. Now this is mainly driven by the decline of our blood glucose monitoring business at minus seven due to the market shift to continuous glucose monitoring. And this was partially offset by a healthy plus 6% growth of our molecular point of care Liat business. We’ll talk about the STI approval for CTNG later.
And I would note that we are are confident that our CGM solution and COBOS Lumira will drive growth of our near patient care business in the future. As I’ve said at the the full year, we don’t expect material contribution from CGM in 2025, but our manufacturing scale up is going as planned, and our launches are going as planned and look forward to updating you on that in future in future calls. So now switching to the regional view, I’ll take you through the the business performance by geography. In North America, we saw strong growth of plus 7%. In EMEA, the business grew at plus 4%.
In LatAm, we saw strong growth at plus 11%. And in APAC, we saw a decline of minus 15%. And as previously mentioned, sales growth in q one was impacted by the health care pricing reform and VBP in China. As a result of this, the sales in China declined by 23%. Now we expect this effect to continue over the course of 2025.
And since this is primarily due to the price decrease, there’s obviously a corresponding impact on the profitability of this business. I would call out that we’re implementing operational excellence and cost discipline measures to offset this. And I would also call out that we had a strong quarter in terms of instrument placements in China and that China is still a critical market for us, and we remain the market leader. And our ambition, again, for the division for this year is to grow by low to mid single digits. And now I’d like to talk, you know, to the engine of our our growth for the future is really our instrument placements.
And and here in the full year of 2024, we saw strong growth across all of our customer areas versus 2023. And let me point out a few areas of of growth by customer area. So in the core lab, those are our COBOS pro, which is our high throughput serum work area, and our COBOS pure, which is our mid throughput serum work area. Placements grew by 65%. In our molecular lab, placements of our fully automated COBOS 5,800, 60 eight hundred, and 8,800 systems for low to high throughput testing in molecular diagnostics grew at plus 22%.
And I would call out here that we’ve seen continuous growth of these platforms even through the pandemic into the endemic phase, which really shows that they are the standard for automated molecular diagnostics testing in the clinical laboratory. Moving to pathology lab, we saw placements of our benchmark Ultra and Ultra Plus have combined growth of plus 10%. In digital pathology, our d p two hundred and d p six hundred grew by 36%, and I would call it we got the primary diagnosis claims for these last year, which is gonna accelerate our position in digital pathology. And our primary staining business, the h e six hundred placements grew at plus 4%. Now in near patient care, placements of our COBOS Liet, our lab equivalent PCR solution, grew at plus 7%, and I look forward to updating you in the future on some of the growth of our newer platforms in in the next year.
But lastly, we also saw strong growth of preanalytics and connectivity by 12% and our Navify lab operations with good growth of plus 16%. So now I’d like to come to some of those new launches that you heard Thomas mention and start with our Cobalt’s max spec mass spec solution, which got a CE mark at the end of twenty twenty four. So with this launch, we plan to establish and shape the IVD market for automated, simplified, end to end mass spectrometry testing. This will drive market expansion and a transition from a segment dominated by lab developed tests to one with mass spec as a part of the routine core laboratory environment. I’m pleased to report that we’ve had significant progress since launch with a number of placements throughout Europe.
We also achieved c launch for our our system and steroid assays on track and vitamin D assays in February 2025. And we delivered some of the key installations already this year, and I’m pleased to to share that the initial sites reported a very fast installation time and positive system performance in terms of uptime and serviceability. I recall that we are on track to launch approximately 40 assays in the first wave throughout 2025, which will cover the vast majority of routine testing for mass spec, and a second wave will come in the following years. So now going back to some of that innovation that you you heard Thomas mention about our sequencing solution, which is the really exciting unveiling we had at the AGBT conference. And what really makes this solution so exciting is, as you heard, the marriage of the Genia technology with the Stratos SBX technology.
And the Genia technology is a nanopore technology, which is complementary metal oxide semiconductor. It allows for extremely high resolution nanopore signal to noise ratio. And you combine that with the Stratos SBX technology, which is a surrogate polymer encoding what’s called an expander. As you saw from Thomas’ slide, it’s 50 times larger than a native nucleotide and also enables really high signal to noise ratio. Combining these together, you’re gonna get high throughput, high unprecedented throughput, high accuracy, and high flexibility, which you don’t have in standard next generation sequencing.
And so the NGS market, which is valued at 6,400,000,000.0 US dollars, is projected to grow at around 9% per year over the next three years. And the clinical segment will experience strong double digit growth driven by applications like therapy selection and minimal residual minimal residual disease monitoring in oncology. Our Roche XBX technology has the potential to really be transformational, and you see here on the slide some of the data presented at AGBT from the Broad Institute. Now here, the Broad Institute demonstrated the high speed potential of the technology, completing the entire sequencing workflow from library preparation through a whole genome sequence analysis with variant calling in under seven hours with the SVX fast workflow. And I would call out, as you heard from the founder of Stratos Genomics, Mark Kakoras, on at the AGBT webinar, that this was not even an optimized protocol, and we’re hopeful that we can even improve this in the future.
I would emphasize that this data showed a level of accuracy that could lend itself well to clinical applications as demonstrated by the strong Q and F1 scores. This workflow could be practice changing in clinical environments where a fast genome is important for decision making such as the NICU. And and third, as you heard me say before, this sequencing chemistry enables batch flexibility and makes it cost effective to run small batches. We deck we demonstrated flexibility in read length with one workflow operating the classic short read range and the other having the potential for longer reads to improve coverage. The unveiling of our XPEX technology showcases our commitment and the capability to deliver innovations that could transform the sequencing field.
So now moving to our near patient care business, I’d like to speak about our Liat CT and G for which we received FDA clearance with CLIA waiver in January of twenty twenty five. So the molecular STI market is valued at about 1,000,000,000 in 2023. There’s over two million STI infections for chlamydia and gonorrhea in the in The United States and affects over two hundred million people yearly worldwide. With the COBOS lead at CT and G, we offer the first FDA cleared, CLIA waived molecular diagnostics point of care solution for CT and G and expand Roche’s menu of lab equivalent PCR solutions for rapid and accurate diagnosis at the point of care. With this launch, we can leverage our installed base of over 13,500 LiDAR analyzers to drive access to our point of care molecular menu.
And so now, following with Teresa, I’ll I’ll provide a a report on our key launches for the diagnostics division. So the 14 launches shown here, we achieved two in q one, the Lee S e t and g, as I just covered, and our chest pain algorithm, which will, it helps triage in the emergency room for suspected myocardial infarction. We are making good progress towards the other launches, which are on track, and I look forward to providing further updates in the future. Last but not least, I’m also pleased to invite you to our Diagnostics Day on May 27, a hybrid event in London and also online. Here, we have a prepared and exciting agenda, and we’ll further discuss our forthcoming row sequencing solution as well as our pipeline and portfolio highlights across our customer areas.
And with that, I will pass it over to Bruno, and thank you very much for your attention.
Bruno, Moderator, Wolfe Group: Yeah. Thanks, Matt. And just quickly to summarize here, Matt already mentioned the next upcoming IR event will be the live diagnostics event in London again. And then as mentioned already by Theresa, in June, on June 23, we will have a hematology update, basically covering all the data for malignant and nonmalignant hematology, which are presented at the summer conferences, so including ASCO, EHA, ICML and then also ISTH. That’s the first time when we will show the clinical data for seven, which were the basis of the decision taken now to move the molecule into Phase III.
And with that, I think we are ready to open the Q and A session. The first one in the row is Sachin Jain from Bank of America. Sachin, please.
Speaker 7: There. Can you hear me?
Bruno, Moderator, Wolfe Group: Yes, we can hear you.
Speaker 7: All right. Thanks. Two questions, please. So first, I’m going to kick off with vivisma, if I may. So Theresa, can you just comment to how you see U.
S. Sequential growth from here? Should we expect continued sequential decline through the year, given comments for several quarters to wash out? And if that’s the case, to get to the 20% global growth that you’re sort of roughly guiding to, is the bulk of that coming from ex U. S.
Where we have lower visibility? And then the second is a big picture one you’d expect, Thomas, on sort of U. S. Policy. You commented on the wise tariffs you thought were absorbable.
What assumptions within that have you made given the wide variety of scenarios? And then on your US manufacturing R and D commitments, you and others have made commitment for US in recent months. Is there an expectation that this commitment from the industry can reduce or influence tariff proposals from the administration? Or just sort of what’s the big picture intent? Thank you.
Thomas Schinnicker, CEO, Wolfe Group: You can go ahead with Sure.
Theresa, Executive, Wolfe Group: So starting with the BIZMO. So, basically, the dynamic that’s happening in The US, we all know that within The US retinal space, there is has always been a very large sort of unbranded market dominated by Avastin. Over the course of the last couple of years, what we’ve seen is a decline in that portion of the market and more patients funneling into the branded therapies. With the early closure of the co pay assistance fund or the CAF, we are now seeing the unbranded market and in particular the Avastin share continue to grow while the branded market constricts. Within that branded market, however, the Bisimo is growing in every indication that we have, and so we will continue to see growth in The US.
It may just be at a lower rate since the overall branded market has shrunk, if that makes sense. So but we will definitely continue to see our share of that branded market continue to grow. We do also anticipate significant growth outside The US as new countries come online and as the prefilled syringe continues to enter into new markets. So overall, we think it is a story of growth everywhere in the world, and that dynamic in The US will likely just take a little time to wash out.
Thomas Schinnicker, CEO, Wolfe Group: Good. Yeah. Sachin, thanks for that excellent question. What I can say is that we’ve looked at a very wide range of different scenarios, and I think we cannot go through all of the scenarios today, although I’m sure that everyone would like to. But we’ve put in mitigation measures to mitigate against these different scenarios.
What I can say already is if we look at the first half of of the year and also in q two, we will not see much of an effect from the tariffs. One reason is that we’ve shifted inventories, and that should mitigate a significant impact already this year. And the other part is we already started to increase manufacturing of a number of medicines in The United States. So we are very actively working on mitigating all of these topics. And, you know, we also, in our budget, are making sure that we can absorb potential tariffs throughout the year.
We’re really working hard on all of those different topics. Regarding our engagement with the US government, I can just say that we are in exchange with the US government. We are in exchange with the US government through the industry association and but also with other governments like the EU and certain EU member states. And I don’t wanna disclose all of those conversations at this stage, but I can just tell you that we’re on the case.
Bruno, Moderator, Wolfe Group: Okay. Then we move on. Next questions would come from Matthew Weston, UBS.
Speaker 8: Thank you, Bruno. Can you hear me?
Bruno, Moderator, Wolfe Group: Yes, we can hear you.
Speaker 8: It’s just one question from me, please, and it’s for Theresa. It’s a follow-up to Sachin on Verbisimo. So you made clear the success that Verbisimo has as the market leader in AMD in The US. But you I just wanna dig into this charitable foundation issue. So the previous Optum market leader was a leading donor in the charitable access foundation market.
Now that you’re a leader, shouldn’t we expect that Roche steps up its contributions to the charitable foundations? And if not, why not Theresa? Is it potentially linked to the DOJ’s continued investigation into charitable donations? Or it seems that after the recent court win and appeal win, that looks like it’s broadly resolved.
Theresa, Executive, Wolfe Group: So, Matt, as as I’m sure you can appreciate, all charitable foundation giving is done through our foundation, which is completely separate, and it would be inappropriate for me to comment on how they how they do their giving. So unfortunately, I I really can’t answer your question.
Bruno, Moderator, Wolfe Group: Mhmm.
Speaker 8: Okay. Understood. Can I just quickly follow-up? Your answer to Sachin’s question suggested that you felt that the calf market was just winding down. But can I just check that there’s no structural reason why we should assume that CAF from everybody’s donations should wind down?
It’s simply that at the moment, the charitable foundations are short of money.
Theresa, Executive, Wolfe Group: At at the moment, the charitable foundations seem to be without money.
Thomas Schinnicker, CEO, Wolfe Group: Thank you. Just to say that, I mean, that will be just a rebasing of the market, and it just will take a couple of quarters to to wash out.
Speaker 8: Okay. Thank you.
Thomas Schinnicker, CEO, Wolfe Group: But overall, I mean, the growth rates you saw in q one with 18% is roundabout what we expect for the full year. Understood.
Speaker 8: Many thanks for the detail.
Bruno, Moderator, Wolfe Group: Okay. Then let’s move on. Next one is Emily Field from Barclays.
: Hi. Thanks for taking my question. Maybe one on MXT-seven. What dosing intervals will you be targeting in the Phase III studies? And then for the comparator study versus Factor VIII, will you be using a long acting Factor VIII as one of the as the comparator?
And then going back to obesity on CT-nine ninety six, was wondering if you could make any comments on the back of the high level orfaglobron data that we saw last week. You know, you’re able to comment on any structural differences between the two molecules and if that is sort of the framing of targeting what you think you could achieve with CT-nine ninety six in a pivotal study? Thank you.
Theresa, Executive, Wolfe Group: Great. So with regards to the NXS007 trial design, both in terms of dosing and in terms of which factor we would use, those are both great questions, which when we have the phase three trial design, will be able to answer for you. But right now, it would be it would be premature. In regards to your question around the the Lilly molecule and our our CT nine nine six, that structure has not yet been disclosed. And I think as we’ve sort of repeatedly said, reducing everything down to just structure sometimes is a little bit overly simplistic.
One molecule or one atom here and there can really, really make a big difference. And so I think we are very confident in the data that we’ve seen thus far with with our with with our oral molecule, and we are looking forward to advancing it in other trials. And we’ve all at this point, we’ve seen just phase one data, just to be clear.
Bruno, Moderator, Wolfe Group: Emily, did this answer your questions?
: Yes. Thank you.
Bruno, Moderator, Wolfe Group: Mhmm. Okay. Next questions come from Justin Smith from Bernstein.
Speaker 9: Yeah. Thanks very much. Just one from me. Sorry if I’m being slow. On Vobismo, are you basically saying that the global area under the curve of the drug is the same, or it’s just gonna come down?
Theresa, Executive, Wolfe Group: So the overall size of The U so if you think about The US market as a as a pie, the size of the pie will likely remain the same. The amount of that pie that goes to the unbranded options is likely to get a bit bigger. So the slice that’s left for the branded market, we would expect Vobizmo to continue to take share. And so I I I just wanna continue to underline, we do believe that the Baizmo will continue to grow. And as Thomas mentioned, the same level of growth that we saw in in q one is the level of growth that we are we’re hopeful to see throughout the rest of the year.
Thomas Schinnicker, CEO, Wolfe Group: And, again, this is just a base now a base effect for a couple of quarters, and then it will wash out, and we will see continued growth like we’ve seen now in first quarter. We’ll continue to see growth going on in the buys.
Speaker 9: Thank you. So just very quickly. So so I get that. And then so in terms of ability of ex US to pick up any slack, does that help as well? Or
Theresa, Executive, Wolfe Group: I mean, remember ex US, we still have a number of markets that aren’t yet approved or reimbursed, and we’re still in the midst of launching the prefilled syringe ex US. So there is actually a tremendous amount of opportunity that remains. And we’re still in very early days in very big markets like China, which just launched in January with NRDL coverage for all three indications. So there is still a tremendous amount of room for Vibismo.
Thomas Schinnicker, CEO, Wolfe Group: There’s a significant amount of growth left in Vobismo.
Theresa, Executive, Wolfe Group: Exactly.
Bruno, Moderator, Wolfe Group: Thank you. Okay. Next questions go to James Quickley from Goldman Sachs.
Thomas Schinnicker, CEO, Wolfe Group0: Great. Thanks for taking my questions. I’ve got two on some of upcoming news flow for second half of this year. So firstly, on gerodestrant. Again, know this isn’t necessarily the best indicator, but primary completion dates listed on clinicaltrials.gov for Persevera and Evera have now slipped into 2026.
So and you’ve already confirmed 25 readouts, but is there any risk of slipping into 2026? And also similarly on the SERD space, we’ve seen some data from AstroLily and Pfizer. So just wondering what your take is on this, particularly with continued success in the ESL1 mutation population? And then what are your thoughts on the commercial opportunity? And secondly, on phenobrutinib.
We spoke to some KOLs recently that suggested that in terms of Aubagio’s apparent overperformance in recent Phase III trials relative to the original Phase III program, patient population was the biggest change there. So from what you’ve seen, is there anything sort of different or novel for your trials versus what we’ve seen for the other two competitor trials in their populations? And when you’re planning the studies, to what extent did you assume an uplift in efficacy for Aubagio? Thank you.
Theresa, Executive, Wolfe Group: And I’m sorry, James, could you repeat the first part of your second question? I didn’t catch it.
Thomas Schinnicker, CEO, Wolfe Group0: So first part, second question, too. We spoke to some KOLs recently who said that in terms of Aubagio’s apparent overperformance in the current Phase three trial to your competitors versus its own Phase three program, the key change there was patient population. So is there anything different in your patient population versus what we’ve seen for tobrutinib and or uvabrutinib?
Theresa, Executive, Wolfe Group: So I’m still not sure I totally understand what your question your second question is. The first one’s fairly easy. These are event the gastrointestinal trials are event driven trials. It is possible that we may see slippage just because they are event driven. And as soon as we have concrete information, we will certainly share that.
And, you know, we continue to believe that our SERD is materially differentiated from a structural standpoint from the other SERDs out there, and so while I think the additional data from other trials is certainly informative, it’s not definitive. And I think that would probably be be the way that we would look at it. So you’re talking about fenobrutinib. Okay. Got it.
It it so the question the second question was fenobrutinib, and did we see anything different in our phase III patient population?
Thomas Schinnicker, CEO, Wolfe Group0: Yes. So infinabrutinib, Aubagio has done better than people thought, right? So that seems to be the reason as to why tolobrutinib and evobrutinib didn’t weren’t successful. And KOLs, we spoke to said that’s because of the patient population. So have you adjusted for that patient population in your trial?
What were you expecting in terms of the Aubagio efficacy when you originally planned the trials and as well?
Theresa, Executive, Wolfe Group: Got it. So I would say that based on the phase two data that we have seen from phenobrutinib, based on the fact that it is a materially different BTK from the other BTK’s that are out there, it’s non covalent. It’s more potent. We we believe preclinically that it’s more potent, that it’s more selective. We we’ve seen very strong phase two data with federbrutinib, you know, virtually, you know, we are quite confident that we have a molecule that is very different from the other molecules that are out there.
So from a patient population, I’m not entirely sure that there’s anything materially different in the patient populations that we’re looking at, but I think we do believe that we just frankly have a better a better BTK, and one that we were able to bring forward into phase threes at what we believe to be the most appropriate dose. And I think that’s the other thing that has potentially impacted some other trials is they just weren’t able to get to the level of dosing that they needed. We we believe we’ve gotten to the level of dose that we need. But obviously, you know, the trial is still ongoing, so we haven’t been able to formally look at the baseline characteristics for all the patient populations. But, you know, there wasn’t anything in how we structured the trials that we think would be materially different.
Thomas Schinnicker, CEO, Wolfe Group0: Got it. Thank you.
Bruno, Moderator, Wolfe Group: Yeah. Maybe, James, I can quickly add here. Your first question was this referring to gibidescent timelines?
Thomas Schinnicker, CEO, Wolfe Group0: Yes. On clinical trials.
Bruno, Moderator, Wolfe Group: So there’s no change there. To confirm, they both will read out in 2025 with Evira expected to come in before Pesavira, and you would have these we expect these data still to come in from midyear towards second half, one after the other. And the other question on the Orbaccio performance, I think, you know, this was widely debated, I think, once the competitor data were out and several KOLs communicate communicated on it. I think due to the changes in the treatment paradigm in the meantime, you can expect these effects, But it’s not that we would have known the extent upfront and would have, you know, fundamentally differently designed our studies or selected the patients.
Thomas Schinnicker, CEO, Wolfe Group0: Great. Thank you.
Thomas Schinnicker, CEO, Wolfe Group: I think dose is a very important point in terms of the ability to go to higher dose.
Bruno, Moderator, Wolfe Group: Yep. Okay. Then we move on, and the next one is Carrie Holford from Berenberg. Carrie?
Thomas Schinnicker, CEO, Wolfe Group1: Thank you, Bruno. A couple of questions for me on obesity, please. So CT three eighty eight, in the context of what is now your interest in a triple approach with Zealand’s Amylin, can I ask do you still remain committed to pursuing the dual agonist alone? So can we anticipate a phase restart for three eighty eight next year? And then secondly, in the context of your incremental U.
S. Investment, I wonder if you would be willing to tell us approximately how much of the €50,000,000,000 will be allocated to obesity. And can you confirm whether you ultimately plan to manufacture 100% of the Roche obesity assets in house or indeed whether you do intend to use CMOs for API and fillfinish? Thank you.
Theresa, Executive, Wolfe Group: So with CT three eight eight, we certainly do remain committed, and that phase three will actually start most likely this year. The we are anticipating the phase three go decision for the CT three eight eight phase three this year. Thomas, do you wanna take the
Thomas Schinnicker, CEO, Wolfe Group: Yeah. Just wanted to say around the 50,000,000,000, r and d investment. So around, 80% of that is or close to 80% is actually, r and d investment, in The United States. The remainder is a CapEx investment, and this includes all the different sites investments that we highlighted in the press release.
Thomas Schinnicker, CEO, Wolfe Group1: And then your plans with manufacturing of obesity assets going forwards
Theresa, Executive, Wolfe Group: in house?
Thomas Schinnicker, CEO, Wolfe Group: So in the transition, as we are working in in the different phases through development, we will also work with CMOs, but it gives us enough time to build up, our manufacturing plants, which we will announce, very soon. And let me just highlight again what I said during my presentation just to be clear and not, yeah, to to be to be very sure that everyone gets this message. This investment that we’re making in The United States is included in all of the messages we have made in the past in terms of our annual spend on CapEx. So there is no change of any of the messages that we’ve made in the past. We believe we have enough space in our CapEx because we’ve, put a lot into manufacturing over the last decades, in our network.
So we have enough space in our CapEx to make those investments. And, the same goes for r and d. When we talk about r and d investments, flat this year and very disciplined in the future years.
Thomas Schinnicker, CEO, Wolfe Group1: Got it. Thank you very much.
Bruno, Moderator, Wolfe Group: Okay. Then we have next in the row, Sarita Capilla from Morgan Stanley. Sarita?
Thomas Schinnicker, CEO, Wolfe Group2: Thanks for taking my question. So just on the Zealand Amylin, how are you viewing the upcoming competition from Lilly’s Amylin where we get data in phase phase two data, sorry, in q three? And then also be interested to get your thoughts on the gibra molecule and if you or why you passed on it given 8% weight loss posted at at week six and a much smaller upfront contribution from AbbVie? And then just a follow-up question on double o seven, please. If the phase threes are initiating in ’26, how soon can we expect it to be on market?
So are you targeting before the Hemlibra patent expiry in 2030? And do you expect NXT to expand on the current Hemlibra peak sales opportunity where I believe consensus is touching 5,000,000,000? Thank you.
Bruno, Moderator, Wolfe Group: So
Theresa, Executive, Wolfe Group: start from the back and move up. So double o seven phase three is, I think, when we have the announcement on the phase three trial designs and starts, we’ll be able to tell you when we expect those trials will read out. We are obviously, as we would with any molecule that we believe has this kind of transformative potential, we will be moving as quickly as possible to bring this to patients. And so it would be premature to comment at this point exactly when it will come into market and what our what our plans would be, but we do believe that this could potentially expand the number of patients that are on prophylactic treatment just just based on what we believe it it may be able to do from a clinical standpoint. From the The Zealand perspective, I mean, certainly, we would expect the amylin space as every space in this market is to be competitive.
That having been said, we think that the data that we’ve seen from the Zealand molecule is has the potential to be best in class and certainly to be first into the market. And we don’t yet have data from from the the follow on compounds, and so I think we’re we’re extremely excited about the opportunity in front of us. And, again, this is going to be a competitive space, but we feel like this molecule is well positioned to compete. I don’t know. Thomas, do you wanna take the
Thomas Schinnicker, CEO, Wolfe Group: Yeah. Just, I would like to just add that when we screened the market for potential partnering opportunities, we obviously looked at all partnering opportunities, and we saw this one as the best and first choice for us in terms of partnership because of it showing the best data versus the other available potential ambulance that we’re we could partner with.
Theresa, Executive, Wolfe Group: Yeah. The combinability too here is
Thomas Schinnicker, CEO, Wolfe Group: really and safety. Exactly.
Bruno, Moderator, Wolfe Group: And, Sarita, let me, also here quickly add, the patent expiry for Hemlibra is actually not scheduled for 2030, but it’s beyond 2030. That’s the guidance we have previously given. Mhmm.
Thomas Schinnicker, CEO, Wolfe Group2: Okay. Thank you.
Bruno, Moderator, Wolfe Group: Yep. Okay. Then we move on and to Simon Baker from Redburn.
Thomas Schinnicker, CEO, Wolfe Group3: Thank you, Bruno. Good afternoon, everyone. Two questions, if I may, please. Just going back to for Bizmo. Your comment, Theresa, about being comfortable with sales expectations in light of larger slice of smaller pie would imply that you have reduced expectations for the competition in that category.
Is that indeed the case that you’d you simply see that Baizmo market share is likely to be higher than previously thought? And then secondly, for for you, Thomas, going back to the question on CapEx. You you indicated that the the total level of CapEx is the same. The total level of OpEx is the same. The amount being spent in The US is higher than before.
I’m assuming that wasn’t in the budget. So, definitionally, you’ll end up with a happy US Government because more money is being spent in The US. Therefore, there will be less money spent ex US. I I just wonder, am I thinking about that the right way? And where is that where is less money going to be spent going forward?
And are there any political implications for doing that? Thanks so much.
Thomas Schinnicker, CEO, Wolfe Group: Should we should I take the first the the last question first? So if you look, for example, at, our manufacturing network, we’ve completely modernized our manufacturing network over the last, decade. If you look at our r and d, network, for example, in Switzerland, if you’ve been here recently, it’s completely modernized. So, a lot of the investments that we had in other areas, we can now also redirect. And it was very clear if we want to enter the peptides manufacturing with incretin and amylin, we also have to build manufacturing.
So this was part of our budgets when we made the acquisition. The same goes for CGM. In terms of CGM manufacturing, that was also part of our business plan. So these are all investments, that, we’ve made, and we’ve decided to make those investments in The US also because it’s the biggest market in terms of obesity medicines, but also in terms of CGM. So I think it’s just a a very logical step in terms of the investments that we that we wanted to make.
Theresa, Executive, Wolfe Group: And, you know, the simple answer to your question is I I would just reiterate what I’ve been saying now for for a number of years, which is I do believe that Vobismo is the new standard of care in retinal disease. We are steadily increasing our market share in every indication. We continue to grow our first line share. The prefilled syringe is has extremely high adoption in The US, is growing in adoption in those markets where it’s launched. This is the drug on the market to beat, and so I I just fundamentally do believe that we will be taking share from others in those branded in in that branded space.
Bruno, Moderator, Wolfe Group: Right. Thanks so much. Mhmm. Okay. Then we have Richard Fossa from JPMorgan.
Richard?
Thomas Schinnicker, CEO, Wolfe Group4: Thanks, Bruno. A couple of questions, please. Firstly, on Perjeta and FSCO. I wondered if you could give us an idea of the share of the two products between metastatic and adjuvant and whether the switching of FEZCO is greater in adjuvant or in metastatic or very similar? And secondly, on Perjeta as well, biosimilars were highlighted in the annual report as coming in ’twenty six.
Could you give a bit more color on the timing and whether we could anticipate that being pushed out? Xolair was. I’m just trying to ascertain that. And then finally, one question on September ’6. We saw danaglipron from Pfizer having liver enzymes and being discontinued.
Could you just talk about how you’re thinking about that and with in relation to nine nine six? Thanks.
Theresa, Executive, Wolfe Group: Sure. So for your first question, I don’t believe that we’ve broken down Perjeta penetration by line of therapy, so I I don’t have that information. In terms of biosimilars, we expect that the biosimilar exposure for Perjeta is gonna be relatively limited. Right now, we only see one that has the opportunity to come in at around the time that that it would be eligible to do so. So, you know, we we don’t think that they’re likely to enter the market until sort of the end of twenty twenty seven or later.
So right now, it’s not a threat that we’re we’re super worried about for Perjeta, but we’ll obviously continue to keep an eye on it and and keep you informed. In terms of September, you know, obviously, our number one concern with any new molecule is patient safety. And so we are with all of our molecules, we pay very, very close attention to the potential risks, and and liver risk is certainly one of them. Right now, there isn’t anything that’s necessarily giving us undue pause here, but it is clearly something that that we will continue to monitor as we would with any of our molecules.
Thomas Schinnicker, CEO, Wolfe Group: Yeah. And let me just let me just add that there’s no biosimilar expected in the midterm for FASCO. Very important.
Theresa, Executive, Wolfe Group: Yes. That is true.
Bruno, Moderator, Wolfe Group: Yep. And maybe here to add one thing, Richard, I think in terms of the split you asked about adjuvant versus metastatic, the only number we once mentioned is it’s a roughly sixty forty split over the entire franchise, but we have not specified, you know, whether there is a big deviation now between Perjeta or FESCO in in the early versus late setting.
Thomas Schinnicker, CEO, Wolfe Group4: Splendid. Thanks all. Very kind.
Thomas Schinnicker, CEO, Wolfe Group: Thank you.
Bruno, Moderator, Wolfe Group: Okay. Then next one in a row is Peter Fiddult. Peter?
Thomas Schinnicker, CEO, Wolfe Group5: Yeah. Thanks for your help. Pete Beadult, BNP Paribas. Two questions for Theresa, please. Theresa, I’m gonna be sort of positive on one and perhaps a little bit negative and cynic on the other.
Forgive me. But look. Starting a lot on a positive note. Just on fenebrutinib, the conventional wisdom out there is that the trial won’t work because you’ve seen two competitors. Now we’ve had hypothesis already put on the call as to why that may be, but the one that we get from KOLs is that, you know, basically, the t one g d lesion reduction was just, you know, that efficacy weighing for your competitors.
So can you remind me sorry to be gnarly. Can you just comment whether the suppression you’ve seen with fenebrutinib is sustained beyond the early cuts of data, and just whether you’re cautiously optimistic or optimistically cautious about beating in PPMS. So that’s the sort of positive spin question. And then just being a little bit cynical on double o seven. In your prepared mark, you talked about, you know, 30 times more potency.
That sounds very much like the Novo pitch on Hemlibra. And to be fair, you you gotta, you know, admit you’ve been talking down the advantages of Mimo versus Hemlibra over the last few years with those sort of arguments. So just wanna better understand where double o seven differentiation is coming from. Is it just that, or are there other things that you didn’t mention in your prepared remarks? Thanks.
Theresa, Executive, Wolfe Group: Yeah. No. I think so let’s start with double o seven. I mean, I think fundamentally double o seven, yes, we believe that it is more potent, but it also has the recycling and sweeping technology built into it. And so, I mean, it is just fundamentally a next generation molecule.
I I don’t know how much we’ve actually disclosed on on the actual composition of that molecule. Bruno, maybe you can remind me. But it it is just fundamentally a different molecule from Hemlibra. So this isn’t just, I think, a little bit better than. I think this is a different than.
Bruno, Moderator, Wolfe Group: Right. I think, Peter, what you should read into the announcement is also if you we made the comment, you know, that we would benchmark versus Hemlibra. So I think this was missing in with competitor studies, and I think that’s the ultimate test to really see whether we can establish a new standard of care.
Theresa, Executive, Wolfe Group: Absolutely. I mean, I think we’ve we’ve been very clear that we believe that Hemlibra is the gold standard for treatment in hemophilia, and we are putting our money as we always do where our mouth is in these trials and running our next generation up against the current standard of care, and we love nothing more than beating ourselves. So we’re we’re excited for that possibility.
Call Moderator: I think,
Bruno, Moderator, Wolfe Group: yeah, that’s something we can discuss in more detail at the June 23 meeting. And
Theresa, Executive, Wolfe Group: then in terms of in terms of phenobrutinib, mean, again, just to reiterate, I think we just fundamentally believe that we have a different molecule than the other BTK’s that are out there. It is it is a it is a different composition. It’s a different structure. It’s more potent. It’s more selective.
It’s noncovalent. And we have, I think, more phase two data than most of our other competitors have had. And I’m just referencing here, we have longer term forty eight week open label extension data that, you know, really shows that we’re able to to suppress disease activity. So the open label extensions here will go out to ninety six weeks. We’ll get that later this year.
And so I think we we do believe that we have something different on our hands, and the phase two data is playing that out. And, again, when we get that ninety six week open label extension data, hopefully, that will be another piece of the puzzle. But, you know, I Thank you. This is really one area where I don’t think you can compare our molecule to someone else’s molecule because they just are different.
Thomas Schinnicker, CEO, Wolfe Group5: And and and, Theresa, just I know I asked three parts. Just PPMS. I mean, are you cautiously optimistic or optimistically cautious you could be a grievous?
Theresa, Executive, Wolfe Group: I think I’m cautiously optimistic, and Ocrevus really is the standard of care for these patients. So if if it beats Ocrevus, I think we really know we have something. And that having been said, orals comprise 30% of the MS market. And so, you know, there is a very good spot for phenobrutinib even if we don’t see superior superiority to Oprivus, understanding it’s a slightly different population.
Thomas Schinnicker, CEO, Wolfe Group5: Thanks.
Bruno, Moderator, Wolfe Group: Okay. Then we move on. David Evans from Kepler. David.
Thomas Schinnicker, CEO, Wolfe Group6: Thanks very much, Bruno. So, yes, two two questions, please. One on Petrolinside and one on Brain Shuttle. So on Petrolinside, in your in your slides, you referred to looking for high quality weight loss. I was just wondering how convinced or confident are you that Amylin could be differentiated on less muscle loss and more fat loss.
How how much of the rationale was that for you going into Amylin? And then is that in in practical terms how Amlan you think can really differentiate? And then and then on brain shuttle, well, we’ve seen amazing proof of concept data from trontinumab so so far. But where are you on on your on your brain shuttle c d 20 in MS? Might we see data on that any anytime soon?
And are there any other brain shuttle projects in the way that we should know about? Thanks.
Theresa, Executive, Wolfe Group: Yep. So as you mentioned, we do have the brain shuttle anti CD 20 in very early very early r and d. I don’t believe we’ve disclosed when that first dataset will will come out, but it it’s likely not to be for some time. That’s that’s relatively early stage. And we are certainly looking at the brain’s shuttle technology in other diseases where we believe crossing blood brain barrier is going to make sense to do so.
So clearly a technology that has really proven itself in AD, and we will be bringing forward other other op opportunities to look at that in other diseases. In terms of parenteralintide, you know, the amylin class does work fundamentally differently, obviously, than than the incretins do. And so it is, I think, very likely that we could see a different kind of weight loss with patients on these drugs. And clearly, data are early days, but the clinical hypothesis is solid. And so I think we’re very hopeful that this could be a fundamentally different kind of weight loss than what you saw with GLP, GLP ones.
Thomas Schinnicker, CEO, Wolfe Group6: Thanks very much.
Bruno, Moderator, Wolfe Group: David, did this answer your questions or any follow on?
Thomas Schinnicker, CEO, Wolfe Group6: Yep. Perfect. Yeah. Thanks very much.
Bruno, Moderator, Wolfe Group: Okay. I think with that, we are at the end of today’s call. I will hand back to Thomas for a final remark. Thomas, please.
Thomas Schinnicker, CEO, Wolfe Group: Yes. Thank you very much, Bruno, and thank you very much to this team. I really appreciate everything that you’re doing every day. And to all of you, also, you very much for your interest. I can just say we are implementing our strategy that we have rolled out last year with a lot of discipline and also with a lot of speed, taking out costs out of the system where possible and shifting it into new areas, staying very cost disciplined.
We are focusing on our pipeline, and we’re also focusing on commercial execution. And I can only say we will deliver.
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