Santhera Pharmaceuticals Holding (SIX Swiss: SANN) Q2 2026 Earnings Call

0:00 Good afternoon and welcome to the Senthera Pharmaceuticals Holdings AG half-year results investor presentation. Throughout this recording meeting, investors will be in listen-only mode. Questions can be submitted at any time by the Q&A tab situated in the right-hand corner of your screen. Just simply type in your question and press send. The company may not be in a position to answer every question received during the meeting itself. However, the company can review all questions submitted and publish responses where it's appropriate to do so. Before we begin I'd like to submit the following poll. I'd now like to hand over to the Thera Pharmaceuticals Holdings team. Good afternoon.

0:32 Good afternoon and welcome to the first half results for the six months ending the 30th of June 2026. Giving the presentation today will be our new CEO Orlando Oliveira, myself Catherine Isted and our Chief Medical Officer Dr Shabir Hasham. Can I please encourage you to type in questions into the Q&A box as we go along and we will answer these at the end of the presentation. As always, we have a disclaimer. Please feel free to read this at your leisure. I now hand over to Orlando to go through the highlights of the first half of the year.

1:14 Thank you very much, Catherine. Good afternoon, everyone. 2026 has been a strong year so far, and we have achieved a lot of success in terms of market access initiatives. I would like to take you through a few of our major achievements during the first six months. The first one, clearly four out of the five major EU markets now are commercially launched. Pricing reimbursement has been secured in Spain and Italy. We continue strong commercial momentum in Germany with volumes up 50% in the first half of 26 versus the first half of 25. and the UK were up 40% in Q226 versus Q126. Our strategic APAC licensing agreements signed with Nexera has been a key achievement as well. This licensing, to remind everyone, is focused on Japan, South Korea, Australia and New Zealand.

2:07 The total deal value is up to $250 million plus royalties, including $30 million in cash and $10 million in equity investment in Santera. We have made continued progress as well across our smaller markets. Swissmedic has approved a GAMRI in Switzerland in January 2026 and pricing and reimbursement was agreed in Luxembourg in August 2026, making this the first Benelux market to secure a reimbursement. We continue our efforts to distribute our drug across the world and we have expanded our distributed markets as footprints by dealing with biomedic and expanding the deal with biomedic in July to include Georgia, Kazakhstan, Belarus, Azerbaijan, and Uzbekistan.

2:55 Genesys, our partner in Central Eastern Europe, has also secured marketing authorization for survey in September, further expanding patient access across that territory. If we could look at long-term data, we've also been able to present at the NDA meeting in March, 2026, data from up to eight years of Vagam retreatment, including baseline results from the ongoing phase four Guardian study. The data has demonstrated comparable long-term effectiveness to standard of care corticosteroids alongside clinically meaningful safety advantages. On the regulatory front, we have also had a CHMP-adopted positive opinion recommending extension of Vagamri in you to patients from two years of age.

3:40 Data from real-world experience in adults was presented at an ICNMD meeting in Florence in 2026, and this data in adult non-ambulatory DMD patients showed stabilization or improvement in upper limb function in this patient population. In terms of executive and board changes, I've been appointed CEO in July, 2026. Marc Klaus has joined us as Chief Commercial Officer in June, 2026. And Dr. Srishti Gupta has been elected to the Santerra Board of Directors in May, 2026. I would like now to show a snapshot of our current situation in Europe, both in our direct markets but also our distributors.

4:26 As said before, we have now commercialized Agamri in four key countries out of the five major markets, Germany, UK, Spain and Italy. Additionally, we've already launched in Austria and Luxembourg. We're focusing now in getting reimbursement in France. The process of reimbursement in France will require a full resubmission of data, so the commercial launch is not expected before 2028. We remain confident in getting reimbursement in this key country, and we're exploring potential routes to accelerate access as we speak. Other mid-sized countries like Nordics, Belgium, Netherlands, Switzerland, Portugal or Ireland are ongoing in terms of market action and pricing discussions. We are focused in achieving pricing that appropriately reflects a government's value and is consistent with established major European markets.

5:18 To not forget our collaboration with Genesis in the CE region. We are now covering with them, or through them, 13 countries. And I have a piece of news to share. We have been able to secure national reimbursement in Poland as of the 1st of October, as of tomorrow. This is definitely a major advance in our role and our goal to really expand the use of a gamut across the world. To remind everyone, Poland is the sixth biggest market in Europe for D&D. Focusing now on the early launch countries in the EU markets. We've seen really fantastic growth in Germany. In the first half of 26, as mentioned before, the volumes were up 50% versus the same period last year. Agamri has now 40% share of steroid using DMD patients. And this comes from newly diagnosed patients, but also switching patients. And we see more and more an increasing number of older DMD patients on Agamri. This is really encouraging and in alignment with our strategy.

6:26 To mention, a new mandatory government imposed pricing discount will be in effect as of Q1 27 and we have accounted for this and this will be compensated by volume increases as of next year. In the United Kingdom, orders have increased by more than 40% in Q226 compared to Q126. This update continued to progress supported by increasing systematic adoption across specialty DMD centers. We have also benefited from updated treatment guidelines and improved access initiatives, including home delivery programs. For Austria, another early launch country, we have now 50% share of steroid usage in DMD patients. Looking then in more detail at distributive markets, as mentioned before, Genesys, our partner in the CE region, and Megafarm in Israel both have delivered strong growth in their regions.

7:25 In September, Genesys has secured marketing authorization in Serbia, which is a key milestone in our expansion in Eastern Europe. Also in July 2026, as mentioned before, we have expanded our agreement with Biomedica to include Central Asia and Caucasus countries. To note, this region has more than 2,000 additional DND patients, which represents a significant growth in terms of our market potential. We thought it would be good to remind everyone the progress that has been achieved since mid last year, which is roughly 12 months. We have expanded significantly our footprint for distributors and partners, covering a very important part of the world from Asia to other countries like Australia and New Zealand. Japan was already mentioned.

8:16 And now our focus is really about going to Latin America, the only remaining key region to be partner. And we expect to have news on this relatively soon. Zooming in in our deal with Nexera, which is definitely a transformative deal for the organization. As mentioned before, the total deal value is up to $215 million, distributed by significant upfronts, milestones, and of course, tiered royalties based on sales. I want to remind everyone that Japan is a very important market with more than 2,000 DMD patients, and where steroids are used in 60 to 70% of those patients. Nexera is a fully commercial company, fully integral commercial company with regulatory commercial and manufacturing activities.

9:03 What is exciting to share, going to the next slide, is that Nexera has publicly announced their intention that beyond DMD, which they are targeting to file in the second half of 2027, they are studying potentially three additional indications which could expand significantly the potential of Vagami as a drug for new diseases, including Fukuyama congenital muscular dystrophy, pediatric nephrotic syndrome and juvenile dermatomyositis. We will be collaborating with them, of course, in this expansion as part of our agreement, and we will be benefiting from loyalty if eventually this indication will become one day commercial. Besides Japan, Nexera is also looking to, of course, expanding their region.

9:52 And one important milestone was the fact that Nexera announced they were on track to submit a marketing authorization application for a gamma in South Korea, following receiving ODD and gift designations from the South Korean regulatory authorities. As you might recall, Catalyst is our partner in the U.S. Catalyst has now been acquired by Angelini Pharma. Agamri has been launched in March 2024. The U.S. is a very, very significant market for us with 11,000 to 13,000 patients potentially with DMD, and the usage of steroids is roughly around 70%. The momentum has continued strong. Catalyst reported a Garmory net product sales of $36.7 million in Q126, up from $22 million in Q125.

10:41 Angeline has completed the acquisition of Catalyst on July 16, 2026, an acquisition of a value of $4.1 billion, expanding their presence in the US with a direct US commercial footprint. In January 26, Catalyst had noted publicly already that 90% of D&D Centers of Excellence were using a gamma ray. And in February 26, Catalyst had communicated expectations of sales for the US between 140 and 150 million. In June 26, Catalyst also reported Phase 1 data suggesting Agamri delivers glucocorticoid and anti-inflammatory activity without significant immunosuppressive effects at approved dosing, supporting its potential evaluation across a broader range of chronic inflammatory rare diseases.

11:28 Another key market for us, China, is progressing well following a commercial launch roughly a year ago. If you recall, this was a non-reimbursement commercial rollout. And so far, close to 1,000 patients have been treated with our drug. We expect Spirogenics, our partner, to continue to do progress in terms of trying to obtain national reimbursement drug listing, which would allow us to cover even more patients in the future. And now I will pass to Shabir, our chief medical officer.

12:00 Thank you, Orlando. We've previously discussed our real-world long-term data, including the Guardian study. But for those attendees who may not be familiar with the importance and the impact of these new data, let me summarize some of the key outcomes, which were announced in March at the MDA Congress this year in the US. We've shown patients treated with Vomolone in a real-world setting for a median of five and up to eight years have durable efficacy equivalent to current corticosteroid standards of care, and I'll go into a little bit more detail momentarily, that they were able to have the same durable efficacy as measured with time to loss of ambulation. Patients maintained a higher dose level over the eight years of about 80% of starting dose, which is in contrast to what we know about current standards of care.

12:53 Children were able to maintain growth at a normal trajectory, and again, in contrast to corticosteroids. 80% fewer vertebral fractures, improvements in overall eye health, and a benefit-risk profile that was consistent with the development program, and therefore no new safety signals. The impressive thing that we saw in the impact of these data, or when they were announced in March, within one or two months, we started to see changes in prescribing behavior, but also uptake across patient segments. And I'm happy to answer questions regarding that at the end of the presentation. Next slide, please. This slide is just an example of the data that was presented. It shows a very impressive reduction in the frequency and severity of vertebral fractures.

13:43 You'll see in the panel that the patients on vermolone had 8.1% of patients had fractures versus 41.9% on deflasocort. We saw an improvement both in terms of the frequency, but also the severity of fractures. Next slide, please. The other thing that we showed, and this was really a turning point for us in terms of data that really shaped the market, we were able to establish with Vermonterone eight years efficacy data. And what you see on the panel on the left is time to loss of ambulation. This is a very important measure. It's a clinically accepted hard outcome measure, but it's also predictive of future disease progression. and what we were definitively able to show was that with Vimolarone, patients had the same durable efficacy as current standards of care.

14:34 On the right hand side, we show height. You'll see in the blue line, it's a Z score, which is basically a measure of age appropriateness. A flat blue line, which shows that trajectory was normal for age. Children on Vimolarone were able to grow normally. Whereas you'll see in the panel on the red line, which is decreasing, children under flaccid core-pregnancy zone were stunted. Now, these are well-known facts. They're very consistent what we see in natural history and registry data. And at the end of eight years, we saw about a 12 centimeter height difference. So boys of the were 12 centimeters taller. These two slides are very important because today the recommendation physicians used to have was that in order to treat children appropriately, they needed to be short. They needed to look much younger than they were.

15:26 And this caused a lot of psychological upset amongst the community, especially the boys. So we are the only corticosteroid to have shown now in several clinical trials that you can maintain normal growth. You can look normal for age whilst remaining efficacious. As we go into the end of 2026 and we're going to 2027, we obviously plan to collect much more data. Our children are getting older, which means that they're in now a more advanced stage of disease. We have the next cut of the long-term data, the Guardian data in quarter two of 27. That's going to be an important inflection point for us. We have a very good safety and efficacy data set for younger children and those who are approaching wheelchair age.

16:17 From 27 onwards, we will be focused on generating data now in children who are older. We will be collecting a broader set of efficacy and safety measures more appropriate to inform physicians about the use of the mRNA in older children. And as an example, we want to highlight data. It's an independent study that was presented at the ICNMD Congress this year in non-ambulant population. The thing to appreciate is as global standards of care are being adhered to and more patients are being treated, the proportion of children who are living longer and becoming adults is increasing. And it's a general acceptance that this is probably underreported at the moment. The exciting thing for us is that a proportion of these patients have either down titrated because of tolerability issues or have discontinued treatment.

17:07 And we are seeing increased interest in patients either switching to vermolorone or restarting treatment. The data that was presented, this independent study, while small, is directionally important for us. Of the patients within one center, and this is data around of 25 patients, one center, eight patients were treated. Eight of eight patients showed stabilization or improvement of muscle function. Now here we're talking about wheelchair bound children who entirely rely on the use of their upper limbs. In those children's function was actually maintained or improved when taking vermolorine. And the exciting fact is that these patients were either half previously treated and switched, but half were actually restarted.

17:55 And of those who had restarted, they actually started either at full dose or slightly below full dose. And in proportion of those who were on lower doses started to increase the dose. Again, this is very important for a segment of the patient population that have no treatment option for them to be able to actually come back to a corticosteroid, not only to preserve upper arm function, but also respiratory and cardiac function, which of course are the leading causes of death. And so it becomes very important for physicians who are looking after these older populations to have a treatment choice. We will continue to collect long-term data in these older boys as we go into 2027.

18:37 Okay, we now move on to the financial highlights for the first six months of the year. We're delighted to say that revenues grew by over 100%, so at 48.3 million. This was due to very strong growth in our GAMRI sales, as well as, of course, recognising the income component of the next year of licensing agreement. Looking at product sales, so that's from our direct markets, but also from the distributors, which are growing, that total amount of product sales grew by 48% over this half over the prior year. And obviously, as we move into the second half of the year, we're excited to add in sales from Italy and Spain.

19:28 Looking at royalties, in terms of royalties and milestones, we received £29.1 million. This was obviously primarily driven by the $30 million cash up front received from Next Thera, as well as the royalty payments that we received from Catalyst and Spirogenics. In terms of revenue from supply of products and services to partners, this was 2.1 million. As I highlighted at the first half of the year, this is a reduction on where we saw last year and this is due to Catalyst now transitioning to direct sourcing. So that is in line with expectations.

20:14 Looking at the global sales of Agamory, so that includes our licensing as well as distribution partners, we exceeded $175 million over four consecutive quarters. And what that meant is that that triggered a $20 million milestone payment to our partner, Reveragen, and this is recognized in cost of sales. I'm pleased to say that we controlled costs well. So actually operating expenses were down 8.4% to 25 million. As a reminder, we're guiding for 50 to 55 for the full year. We're keeping a tight eye on costs.

21:01 The main reason for the reduction on the prior year was a reduction in development costs as we continue to complete some of our post marketing studies that were acquired by regulators. Our operating loss narrowed to 6.6 million for the year from 35.4 million the prior year. And if we look at cash, we had a healthy cash balance of 41.8 million as at the 30th of June, 2026. Going on to the financial guidance for the year. In terms of the 2026, you'll see that this is actually unchanged from the guidance that we gave at the full year results back in May. So to reiterate that, that is full year revenues, we're expecting 80 to 90 million.

21:55 Within that, we're expecting product sales to grow by more than 50%. We're expecting royalty income to increase year on year. However, this will slightly lag the underlying sales from Catalyst. In terms of milestone income, obviously that is going to be primarily driven by the 30 million upfront that we received from Next Thera. I have not included any additional sales milestones in this 2026 guidance. However, we continue to monitor that as the year goes on. In terms of revenues from supply and products and services, as I previously mentioned on the earlier slide, that will be lower than last year.

22:44 However, I will say the second half will be higher than the first half due to extensive product sales to Spirogenics in the third quarter. In terms of operating expenses, again, as I previously mentioned, that remains in the range 50 to 55 million for the full year. In terms of cash outlook, the cash is expected to be broadly stable from 30 September through to the year end. However, we have had some changes that have affected our cash profile as we go into 2027. The first one is a mandatory German price reduction effective of 1st of January 2027. This was unexpected and wasn't in our modelling.

23:31 That combined with some movements of reasonably large inventory purchases into Q1 2027 does mean that we will have a decline in cash during the first half of 2027. However, we will be returning to cash generation in the second half of the year. Importantly, while we have got a change in cash flow profile, we will not require to seek any additional funding. Looking longer term, and you would have seen this guidance before for 2028, we have talked about achieving 150 million euros of sales. This is from direct and distributor markets as well as royalties. As we report in Swiss francs, we actually wanted to move that into Swiss francs.

24:16 So our new guidance going forward, and this is purely just using the exchange rate, will be 140 million Swiss francs. Also, looking further out, we thought it was more helpful to have a guidance for 2030 that encompasses all our areas of revenue. So direct markets, distributor and the royalties. So comparing like for like from 28 to 30, we're targeting 250 million euros of revenues by 2030. I now move on to the expected news flow through the remaining quarter of this year as well as into 2027. We'll be continuing on our discussions in terms of pricing and commercial launches in other mid-sized European countries and we will update you as we progress those.

25:08 As Orlando's already mentioned, we're looking to sign a distribution agreement in South America. That is the last remaining large geography where we don't have a distribution partner. As Shabir's talked about, we will have another cut of our Guardian data that will be coming out during approximately the first quarter of next year. So we look forward to sharing that with you. In terms of indication expansion, we have already highlighted in this presentation the recent update from Nexthera in terms of their guidance of where they are looking to expand Agamri beyond DMD. We are hopeful to be able to provide an update from our partners Angelini, but obviously that is now up to them in terms of how much information they give the market post them acquiring Catalyst in the middle of the year.

26:01 We continue on looking for additional products to in-license in. This is really important for our operational efficiency and Orlando will come back to that shortly. And finally, we note that Nexthera is targeting Japanese regulatory filing in the second half of 27. With that, I'll move back, I'll hand the slides back to Orlando who will discuss the strategic outlook and priorities for this year and next.

26:30 Thank you Catherine. These are indeed exciting times at Sentera and our strategy remains clear and really in four pillars of revenue generation. As mentioned already during the presentation, going direct in Europe remains the cornerstone for us. We want to maximize the opportunity in our currently launched markets and definitely secure reimbursement in France and remaining mid-sized countries. Geographical expansion is important through our current partners, and we continue to focus on that, maximizing the current business that has already lined up, but also securing a lifetime distribution deal, as mentioned before. Acquiring rights to additional synergistic late-stage rare or orphan assets is also a priority for us and continues to be a priority during the coming year. and looking into additional indications through our partners, as already mentioned, Nexera, Angelini will remain a key focus for us as we do see a lot of potential upside and opportunity with our current assets at Gamri.

27:28 And with this, we have now finalized the presentation and are ready to go into question and answers. Thank you. Orlando, thank you very much indeed. And thank you to the team for presenting. Ladies and gentlemen, do please continue to submit your questions just using the Q&A tab situated in the right-hand corner of your screen. Just while the company take a few moments to review those questions submitted, I'd like to remind you the recording of the presentation along with a copy of the slides in the published Q&A can be accessed by your investor dashboard. As you can see guys we've had a number of questions from investors today and thank you for all of those. If I may just ask you just to read out the question where appropriate to do so and I'll pick up from you at the end.

28:07 Okay I think we'll start with the first question here so I'll hand this to Orlando. So what lessons from Germany and the UK are helping you accelerate new launches?

28:20 I love that question. I think, I mean, UK, Germany, but also Austria, as we saw, we have a 50% market share at the moment. I think we've learned that definitely being appropriately staffed, ensuring that we are on message, that we work closely with our key opinion leaders, and ensure that also the benefits of our drug, both on the efficacy and safety side, are well-comprehended will be important. What I think will be different in Italy and Spain, as some of you might know, is that we're talking about a more regional distribution in terms of market access. After guaranteeing national reimbursement, we're now working in secure regional and sometimes hospital by hospital access. And this will be slightly different from a country like Germany. Having said that, we have a very strong chief commercial officer in place. We have very strong general managers in the countries.

29:06 And we see both those processes in Italy and Spain progressing really well. and remain very very confident that we know we will achieve our ambition to have at least the same share than Austria and Germany and UK we have today with those two countries and definitely the fact that we already launched and learned so much with the early launch countries will help us get there okay

29:30 We've now got two financial questions which I'll take, I'll read them out independently. So the first one is, you've previously guided to reaching cash flow breakeven during Q3 26. Given the positive operating cash flow already achieved in the first half of 26, should we view the milestone as effectively achieved? When can we expect breakdowns? Even on a more sustainable underlying basis excluding milestone income, when do you expect the business to become consistently cash generative? So to take that, so in terms of the guidance reaching cash flow breakeven, so we have during the fourth quarter, obviously, our cash, I expect as of now, will remain constant till the end of the year. As I highlighted in the presentation, there have been some One unexpected change in terms of the increased German discounts that has changed our forecasts as well as some movements in inventory and that does impact our Our H1 numbers in terms of our cash position.

30:42 In terms of underlying, so we are in a very good position in an underlying. If you exclude the sales milestones in and out and also exclude financing costs, you can actually we are operationally cash positive. I appreciate that that is sometimes difficult to see. And in terms of when do we expect the business to become consistently cash generative? Well, that does slightly depend on some of the timings of some of these milestones that are received and have to be paid. The timings of those are, I try to guide to them. So, for example, in the second half of this year, I noted that a P&R milestone, so that's a pricing and reimbursement milestone, fell due.

31:30 That is a 20 million milestone milestone. of which in terms of cash payment is around 75% of that is paid in cash. So we do have those fluctuations in the business, but underlying that we are in a good position. Looking at the second question around reaching the 80 to 90 million of revenue guidance, are you expecting any significant milestone payments in H2? or should we assume this is basically the underlying business? This is the underlying business. I actually mentioned that in the guidance. So I have not included any potential sales milestones. We'll wait to see how the US and China progresses in the second half of the year.

32:23 and if that triggers an additional milestone so if there is an additional sales milestone that would be on top of this guidance but we wait to see how they progress in the second half of the year So I think that answers those two questions. There's another one which I think is going to be a question for Orlando and myself. So this is in relation to the Angelini acquisition of Catalyst. And the question is, do you expect continuity in commercial investment and launch execution? is the first part of the question. And are there any provisions in the license that could affect Royalty's milestones or Sunfera's strategic options? Very quickly on the second part, there's no changes.

33:09 So that's quite an easy answer. Orlando, I don't know if you want to comment on the first part.

33:16 No, absolutely. I mean, we know that Angelini saw the catalyst acquisition as a key driver for them in terms of revenue growth, but also in terms of expansion to the US. So not only we would expect a continuation, but I'm sure even maybe an acceleration of the efforts. As we know, the company is really, really focused on making the portfolio of catalyst success. And obviously, Agami is a very, very important component of that portfolio.

33:40 Okay, so this is about reinvestments into the future. So the question, as a GAN regenerates increasing profits, how do you intend to balance reinvesting those profits into further growth? With returning capital to shareholders, could you elaborate on whether you would prioritise investments in additional indications, new rare disease assets or other growth initiatives versus potential shareholder returns such as dividends, share buybacks or special distributions? OK, so I think we've seen from the strategic slide that it's really important for operational efficiency to bring in another asset. You've got to remember that our 50 to 55 million of OPEX can support one or two other assets.

34:31 So bring in a late stage asset. And when we mean late stage, we've said something that has completed OPEX. Thank you very much. In terms of additional indications, again, in line with what we've said previously, we're delighted that our partners are looking to expand indications. And as a reminder, we have an opt-in right on those indications. So, for example, if there is a large indication being developed in one of the countries and we realise that That indication could be available to be commercialised by say 2029, 2030. We can have the discussions at that time of the opt-in rights and the amount that we would pay to opt-in would obviously depend on the amount of time we have left on our patent with our patents running out to 2035.

35:36 This is the best way of us benefiting from that indication expansion because we know how long we've got left effectively on our patent clock when we're paying the financing for that. I think most people would see a specialty pharma company at our stage as not at the stage of developing and paying dividends or share buybacks. I think that is something you would expect, you know, maybe once you're far more mature with a number of products under your belt and that you haven't got other potential areas to invest in. I don't know if Orlando, if you have any...

36:16 I think it's perfect. Yeah, it's perfect.

36:18 Right, I will, next one, question is, can you please update on current market shares in your launch markets, obviously Germany, Austria and UK and comment on Spain and Italy and how you expect them to evolve in H2?

36:36 Great question. So I think, I mean, you guys have seen in the slides, Australia is leading the way with 50% share in DMD patients, Germany with 40%. We do see still potential in these two markets for growth. UK, we're growing. We don't have validated market share tracking as we have in the other two countries that I've just mentioned through IQVIA, but we're growing. We're not at the level yet of Germany, but there's a significant steep growth. I mean, if you look again, are all sales growth from Q2, from Q1. It's pretty inspiring and nothing would be against us getting the same type of market shares we have in Germany and Austria today with the UK. I think for Italy and Spain, it's too early, I mean, to comment on market shares. We got reimbursement over the summer. We're now really working hard on securing regional market access. We see significant sales in both those countries already coming in.

37:24 But it would be way too early for me to talk about market shares. That would not be the right metric, let's say, at this stage for these two countries. Having said that, for the second half of the year, we expect to continue expansion in all these countries. And of course, I mean, Austria at the moment is the benchmark for everyone else, at least. And we have a competitive team here. So I know everyone wants to either match or exceed those shares. And that's what we're striving for.

37:51 So another question here. This is around the mandatory pricing discount in Germany that we have from Q127, which, as I mentioned, was unexpected. It said, could you elaborate on the underlying trigger and how should we think about the magnitude versus the pricing impact experienced in the first half of 26? So yes, this was an unusual move by the German government. So they have done an across-the-board discount on all pharmaceutical companies and all pharmaceutical products. We haven't seen that before, which is why it came as a surprise and we've had to obviously adjust our cash models for that. The order of magnitude is around an 8.5% additional discount that I think that answers both parts of that question.

38:42 Moving on to the next question Regarding the markets where reimbursement discussions are ongoing, can you clarify what is meant by alternative access routes? Are these intended to support patient access until full reimbursement is secured, or are there markets you expect such pathways to remain the primary source to commercialisation on a long-term basis?

39:19 It's a great question. I think, I mean, we'll have to look into country by country situation, but indeed the plan would be here to adopt an early access program in some of these countries, either a cohort program or name patient programs. And this will vary, obviously, by country, the approach. And the idea would be indeed to try to bridge between now and a reimbursed, let's say, drug. More details to follow, but this is what we're looking at in collaboration with the medical team at the moment.

39:50 The next question is around guidance. You mentioned 250 million euros, sorry, 250 million euros Just one. 250 million Swiss francs target. So Swiss francs. Could you give more details regarding the parts of that? So just to be clear, the guidance is 250 million Swiss francs. I wanted to make sure it was actually in the currency that we report in. And hence, that's why we moved the 20... 28 guidance also into Swiss francs as well. We have talked about in the past that and I am now going to switch into euros targeting 150 million euros in our own direct markets so that remains the same otherwise the other components of that are distributor markets which I think people generally underestimate and we've tried to give you a bit more color in this presentation about the potential there and as Orlando said you know we actually Now I have Poland, which is the sixth largest country in Europe as of the 1st of October as well. And then there are the revenues from our royalties, I should say, from our licensing partners, which by 2030 will be not only Catalyst and Spherogenics, but we're also expecting Nextera as well.

41:19 I will say that those royalties, however, are only on DMD. So if by 2030 any of those licensing partners are also selling products, selling a gamary in other indications, that will be additional royalty. So we get royalties on any indication they're in, but those other indications are not factored into the guidance, so that would be upside. The one area that is different from today, we wouldn't expect any revenues from our supply of products and services by 2030. The reason is that Nextera is producing their own product, so is Catalyst, and by then we'd also expect Spherogenics, it's around 2028, to be producing their own products as well.

42:13 Hopefully that helps with that question. The next question, does the unexpected price cut in Germany bear the risk of further pricing pressure in some of your other markets?

42:29 No, that's a good question. I mean, not necessarily because it will not affect the initial listed price that was negotiated. And also to reassure everyone, Germany has anyway one of the highest list prices in Europe, which puts us in a very good space anyway in terms of reference pricing towards other markets.

42:45 and I think actually to add that even with that additional 8.5% reduction, this is significantly above the guidance that we gave of 2,000 euros a bottle. So I think we have to remember that, that the guidance of 150 is based on only 2,000 euros a bottle. So we're well above that. Moving on to the next question. Can you give some indication of the impact Which part of the milestones and royalties on sales are going to financial companies now and which percentage of royalties will go to Sanfera now versus 2030? There's a second part to the question I'll come back to.

43:33 So just as a reminder that as of last year, we have all of our royalties from Catalyst and Spirogenics. are currently going to our royalty partners, that's CBC and Partners Group. We expect to pay that back in the circa 2030 timeframe. However, if there are launches in other indications, which mean that sales are higher, then that potentially could be brought forward. Also, if there is NRDL listing in China which would significantly increase the market size and potential in China that could also potentially bring the time to pay back forward from the 2030 timeframe.

44:28 So that's that question. How many products are planned to in-license in the coming years and how will in-licensing additional products be financed?

44:42 Thank you. No, I mean, definitely we will go step by step. Our goal is first to secure one product. And I think as mentioned before, our desire would be to get a product that is synergistic, ideally commercially ready or very close to be commercial. And I think once we've really achieved that, we'll be thinking and continuing expanding the portfolio, maybe one day adding a pipeline even. But I think we need to be cognizant that this has a cost. So I mean, I'll be very happy if we go step by step in the first asset and then Keep you up to date in further potential developments on the BT side.

45:14 The second component of that is in terms of in licensing additional products. Well, it is quite interesting. It depends on what structure you have. So if you are in licensing, normally the upfront would be in the order of magnitude of about 10% of peak sales. As a reminder, the approximate size of peak sales we're looking at is 50 to 200 million of peak sales. However, that is a licensing deal. We could also look at a distribution deal, which then has the option to convert into a licensing deal. An upfront of a distribution deal is very small. It'll be in the low single digit millions. So it really depends on the type of deal structure that we work with. Also, in terms of financing, I think we have a number of options available. Thank you very much.

46:25 So this one is, I think, for yourself. So now there's a multi-part question here. So I'll start with the first one. In Germany and the 50% volume growth, so this is to talk about the growth, what is the mix of new switchers and older patients? Previously, would you have been majority switching, but perhaps mixed shifting? Yeah.

46:50 No, I think that's a great question. I mean, definitely you're right. The initial part of our business was really coming from switches from the vascular cord and prednisolone. But now we see an evolution indeed with new patients coming in as well. And what is exciting is that older patients are also now being treated with the GAMRI. We don't have precise numbers in terms of share, and I will not try to guess here, but we definitely see that dynamic, which also explains, you're right, the significant volume growth we have assisted to so far. I mean, the commercial team is now very focused in going more granular in their strategy in terms of patient types, patient ages, and so forth, and I think this is paying off. I think number two, we've already responded. Pricing discount, reference pricing.

47:35 It's how we mitigate. So on Germany pricing and the discount that's coming in in January, is there anything you could do to mitigate that and Thank you very much. So it is just slightly different way of how they calculate it rather than the list price reducing. I think otherwise we've commented on, I mean, how we'll mitigate the drop was obviously we have, we were expecting continued sales growth in that territory. And as we saw the data that we've got in older patients in Germany, I'm sure it will be helpful to that.

48:38 The third question that has been answered, what's the breakdown of the 2030 target? Any updates on your progress in seeking new products to license, acquire, to leverage your platform?

48:55 Yeah, no, I mean, the only update I think was already referred, we have a new head of BD that joined us also in June, which has been very, very active in screening and assessing opportunities along with the team. So no concrete update, but just that we're really busy and active in trying to identify the right asset. And of course, we want to do a deal, but it has to be the right asset.

49:16 and then a question around LATAM. What is the potential timing for a partnership in LATAM?

49:23 I think we have communicated before that we would like to do it in 26. My answer will be similar to the one previously. We want to get the right partner. We have great candidates at the moment but we need to make sure the terms are right, that the conditions are right, that the deal is elaborated the right way. So we would hope that this is to come soon but we cannot share a precise timeline at the moment.

49:45 Okay and at the moment this is going to be the final question unless any others come up. I like this question, can you elaborate on how prescription behaviour has changed after the presentation of the Guardian study and how do you expect it to impact your peak sales potential in DMD?

50:03 Cool. No, I think we all love that question. I mean, the short answer, there has been an impact on prescription behavior. Moreover, there's been an impact on reimbursement behavior. I mean, it's fair to say that the long-term guardian data has helped us significantly achieving reimbursement in Italy and Spain. And of course, that has also driven prescription behavior positively in countries that are more established like Germany, Austria, and the UK. But I'll pass the ball quickly to Shabir, which can add a bit more color.

50:29 Thank you, Orlando. So there's a couple of perspectives I'd like to add to this in terms of where the impact is and why. And then you'll understand why we're so excited. When we look at corticosteroids, we know that currently they're used across all segments of patients. And so what we have deliberately done is had an approach to try to generate the most effective data for each segment, addressing the problems for each segment. And there are distinct problems by patient age. The Guardian data basically showed for us what was the most important data set was the durability and efficacy. That was really the door that opened for us that we couldn't previously demonstrate. Physicians have two main problems. They start steroids late. because these kids are very very young they don't want to arrest growth they don't want to cause fractures in a very young child and so of course for us to be able to demonstrate that in the young child you could treat earlier without the fear of stunting growth and a much reduced risk of bone has really helped uptake in new patients especially now that we can show long-term efficacy so they start straight away with the molerone I should add that this year we also got approval in our label to expand the patient population, which is now two years and older as it was four years and older previously.

51:46 So physicians now really have the option to treat younger and that's actually opening the market. These are previously untreated patients. In terms of the older switch segment, which of course is the largest segment and a key focus for us, initially at launch, we were looking at safety switches. So these were children who were having issues, tolerability issues on current standards of switched quite rapidly in the initial uptake phase. But now we're able to show durable efficacy. That hesitancy in switch has gone. We're seeing a lot more physicians aggressively moving to vomulone now because we have demonstrated equivalent efficacy where safety becomes important because now you're treating before the safety problems and the tolerability problems. So there's a philosophy to try to treat now earlier with vomulone to avoid issues. and of course the poster that we presented and the data that we we plan to collect now in 2027 focus very much more on this switch segment and older boy segment with data that is very particular to their stage of disease so we'll be looking at upper limb function we'll be looking at respiratory function Some signals within cardiac function.

52:54 Of course, these are really the important efficacy measures. But we will also be looking at measures that are very important for families and boys. Puberty we will be looking at. We'll be looking at blood pressure, glucose metabolism. So there's a wealth of data that we're coming out The exciting thing for us is we can actually see changes in the market as we announce these data. I get feedback from a lot of the physicians that I speak to that their confidence in Vimarone is improving and their willingness to switch is also increasing earlier. And so that's really a very logical expansion of the market, but also uptake and increasing market share across segments.

53:32 Thanks, Shabir. We've had one last question coming in, just coming back on the in-licensing topic. And it says, is the uncertainty around MFN pricing still impacting your partner discussions? Or are, in particular, US companies more open again to discuss out-licensing assets to the EU?

53:54 No, it's a fair question. And I think it's fair to say, yes, there's still some nervousness by US biotechs to come to Europe because of MFN. Having said that, I mean, what is interesting for us is if you look into rare diseases, essentially pediatric rare diseases, the delta between pricing between US and Europe is normally much lower than other areas. So the risk there is much lower. We also know that innovation that is maybe European focus could be of interest for us. I mean, there's US biotechs that bring innovation, but more and more Chinese biotechs are bringing innovation. This has also been a focus for our BD team to assess assets that could come from other parts of the world beyond the US with the right level of innovation, with the right focus in rare diseases that could be interesting, let's say, for more ex-US markets. And this is something we've been putting some more efforts.

54:43 But we have definitely not given up talking with our US counterparts because people are waiting to see what MFN really plays out. And again, there are areas where MFN has little to no impact, namely pediatric rare diseases.

54:58 That's the last question. Fantastic. Thank you for answering every single question you had through. And there's a fair few of them. So thank you very much indeed for that. Just before redirecting investors to provide you their feedback, which is particularly important to you and the team, Orlando, may I just ask you for a few closing comments, please?

55:14 No, absolutely. Thank you so much for spending this afternoon with us. I mean, I just wanted to say again, the team is very excited about the prospects with the GAMRI. We have achieved a few milestones, but there's still a few more to achieve. And we remain very, very confident that we'll be executing on those during the coming months. We have a great team. We have a great product. And that's all that you need to be successful. So please stay tuned. And thanks for going this ride with us. Fantastic. Thank you very much indeed, Orlando. Could I please ask investors not to close the session to be automatically redirected to provide your feedback in order the management team can better understand your views and expectations.

56:01 This will only take a few moments to complete and is greatly valued by the company. On behalf of the management team of Santera Pharmaceuticals Holdings AG, we'd like to thank you for attending today's presentation. That concludes today's session and good afternoon to you all.