SANTHERA PHARMACEUTICALS HOLDING AG (CHF.IMC) — HY 2025 Results

0:02 Good afternoon, ladies and gentlemen, and welcome to the SANTHERA PHARMACEUTICALS HALF YEAR RESULTS INVESTOR PRESENTATION. Questions are encouraged. They can be submitted at any time via the Q and A tab that's just situated on the right hand corner of your screen. Please just simply type in your questions and press send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company can review all questions submitted today and will provide shared responses where it's appropriate to do so. Before we begin, we would just like to submit the following poll. If you could give that your kind attention, I'm sure the company would be most grateful. And I would now like to hand you over to the team from SANTHERA PHARMACEUTICALS, Catherine Shabir. Good afternoon. Good afternoon, everyone, and welcome again to the interim results for the six months ending the 06/30/2025.

0:51 Giving the presentation today is myself, Katherine Issaid, the CFO, as well as our chief medical officer, doctor Shabir Hassan. Unfortunately, our CEO, Dario Eklund, cannot be with us today as

1:06 he's actually had a recent operation on his shoulder, but he will be back with us shortly. As was said in the introduction, there will be an opportunity to ask questions at the end of the presentation, so please add these into the box as we go along. To start with, as always, we have disclaimer. Please feel free to read this at your leisure. While I appreciate this is a results call, we thought it's worthwhile spending a bit of time going through who SANTHERA is and what we do and also a reminder about the DMD market. So I will start off with this small snapshot of the company. So we are a Swiss listed company listed on six with our global headquarters in Basel with about a 110 employees in total about a 150 including contractors.

2:04 We have a product called a GAMRI. This is a differentiated product in the Duchenne muscular dystrophy market and it is unique because it is dissociative corticosteroid and we'll come into that in more details later.

2:20 A GAMRI is being rolled out worldwide and we have approvals across The US, Europe, UK, China and Hong Kong. And our own commercialization in Western Europe is going well with launches in Germany, Austria and The UK. We've also had a good launch in The US from our partner, CATALYST. In terms of financing, as we announced this morning, we have a new financing for CHF 20,000,000. This means that we have a runway through to cash flow breakeven by the mid twenty twenty six. And our cash at the end of June twenty twenty five was GBP 18,400,000. I'll now hand over to Shabir to go through a bit more details about the DMD market.

3:09 Thank you, Catherine. Just for those of you who may not be familiar with Duchenne muscular dystrophy, I'm just going to give you a very brief overview and then go into a little bit more detail about the value proposition and why we have such confidence with Vimolero. Duchenne is a lifelong neuromuscular disorder characterized by progressive loss of muscle strength and function. These are the main characteristic features. The thing to understand about it is that currently there is no cure. It's such a large gene with so many mutations that current technologies just will not, afford a cure. At best, you could try to moderate the disease to be a little bit milder, and that's really the aim of most of the therapies coming to market. Age of onset is very young, three to five years of age. Children often start to present symptoms of of weakness and inability to walk and run and keep up with their peers.

4:00 And what this means is that they actually present very early to physicians and to the health care system. Unfortunately, life expectancy is only limited to the mid twenty to thirty years of age. You get a progressive weakness with loss of ambulation, no ability to run, walk. You end up in a wheelchair. You get weakening of the upper limbs. But really what's more important to understand is as the disease continues, you get weakness of the heart and lung muscles leading to cardiac or respiratory failure, which is the predominant cause of death. Current therapies. Today, let me talk a little bit about corticosteroids. Corticosteroids have been and will remain the cornerstone of treatment with Duchenne muscular dystrophy. They have twenty years of experience and data behind them, a robust dataset, perhaps the most robust dataset of all therapies at market in the moment.

4:56 They have been shown to delay progression of disease at all stages, so the ability to run, walk, they delay the time to getting into a wheelchair, they delay the loss of ability to use the upper limb, hands, fingers, fine motor skills, but they also now show an impact in terms of a delay to cardiac function decline and respiratory function decline. So they have shown robustly this ability to slow down the disease progression at all stages, and that's why it's absolutely crucial to try to encourage patients to stay on drug as long as possible. However, corticosteroids do have limitations. We know that they are relatively toxic. We know from experience across all diseases, all therapy areas where they're used, that these can be limiting in terms of the ability to maintain a high dose and to be able to stay on drug.

5:44 The challenge with you're diagnosed at the age of three to five, but you're often started treatment about seven to eight years, and this is because of the toxicity. When you give steroids to children at such a young age, you're impacting really important periods of growth and bone formation and behaviour. Children aren't able to stay on therapeutic doses for long enough, often having to down titrate within about two to three, four years of treatment, and then having to stop very soon before you start to see the benefit on the cardiac and respiratory function, which are the really important ones to try to moderate. And of course, they stop very quickly. This is a graph depicting what I think is a very nice way to show the key challenge in terms of how physicians try to keep patients on steroid treatment.

6:33 If you are to stay on maximum therapeutic dose, over time the toxicity accumulates. When you start steroids, early you see behavioral change in weight gain, which is common to all steroids. As you stay on drug beyond two to three years two to three years, you start to see an impact on growth, vertebral fractures, long bone fractures, ophthalmological conditions, eye conditions, and then eventually hypertension and insulin and diabetes. And so really, with the pivotal data that we had some years ago, we were only able to demonstrate the benefits in the short term, the behavior and weight gain. We showed some data showing that we didn't impair growth. But now, of course, the focus is on the longer term data.

7:18 A GEMRI, just in summary, is a dissociative corticosteroid. It's the first dissociative corticosteroid to be approved. We've demonstrated that we have the anti inflammatory effects associated with corticosteroid treatment. In the short term data we were able to show that we don't impede growth, that we don't have a negative effect in terms of bone health, and that's both bone biomarkers, but some early data on bone density. We showed a benefit in behavior. Now, of course, we're focusing on the longer term data. We've got children who've been on treatment five to seven years, and we're currently analyzing these data and hope to make an announcement somewhere in quarter four about the longer term effects and some of the more deleterious side effects. But in essence, because this treatment is tolerated better and the side effect profile doesn't really impact children of a very young age, and this is growth, osteoporosis and bone fractures, We see a gamma ray being adopted earlier in terms of the treatment algorithm.

8:17 We see patients are maintaining a higher dose for longer, and some of that evidence will be coming out with the data announced in quarter four. And of course, we see patients are able to maintain for longer than when we compare them to natural history. What makes DMD very attractive, of course, is it's one of the larger of the rare diseases. There are around three hundred individuals affected globally. Of those in North America and Europe, ninety percent are diagnosed because the symptoms are very obvious and and parents report readily to health care systems. The steroid utilization varies, and that's an opportunity for us to, of course, expand segments where current usage may not be as much. North America and some countries in Europe have a very good standard of care, but there are opportunities in some other European countries where steroid use could be improved.

9:07 Patients and parents, of course, are often treated within specialized treatment centers,

9:13 and that's an advantage for a rare disease but also a small company to be efficient, to be able to commercialize this product. And, of course, physicians have been using this drug for decades. They're very familiar with it. There's nothing very different about vimolorone that it can't be adopted immediately into corticosteroid guidelines. In fact, we are now seeing guidelines clearly adopting a position for vimolorone, which is encouraging, and we'll continue to work with the community to educate them on that. With that, Catherine, I hand back to you. Thank you, Shabir. So I also just want to go through the market opportunity for a GammaRay. I think in this slide, it shows it very clearly in terms of our expectations of a total market size of an excess of $600,000,000 If we break that down, the first box highlights our percentage of that market. So we all have potentially this 13,000 patients, DMD patients and we expect that market to be in excess of €150,000,000 As a reminder, these are all our own sales.

10:16 So this is 100% of net sales that we report on our financial statements. Moving on to Catalyst, in that market, we're expecting in excess of $350,000,000 market size, obviously Catalyst is doing very well. And in China, we have Spiragenyx and the market size there we expect in excess of a $100,000,000. For both Catalyst and Spirigenics, the way we get paid is through upfront payments on signing those agreements, as well as milestone payments as we reach certain milestones as well as royalty income. Moving to the next bucket of revenues, this is for what we call the rest of the world. So this is our distributor market.

11:03 And here we have the likes of Genesis and also the new agreements that we have signed over the course of the summer. For the rest of the world sales, we have a what we call a sort of a distribution agreement of which we book about 60% of net sales. So now moving on to the results itself. So these are the operational highlights. So I start with Germany and Austria. We see there a very strong growth. We're pleased to announce that approximately forty percent of steroid using DMD patients in Germany and Austria are now treated with a GammaRy. Obviously the last time we spoke about this, this was thirty percent.

11:49 Also, if we look at Austria in its own right, it's the first country to have in excess of 50% market share. I think this really shows what a difference a GammaRee can make to DMD patients in these markets. Moving on to other EU markets, we are very pleased to announce that we have the launch in The UK in the second quarter of this year and we're seeing growing demand. We've just started a home delivery program that was commenced only last month. The idea here to be able to streamline access and reduce admin burden in the NHS, which is causing issues within the NHS. We are already seeing a strong uptake of that and we expect that to be reflected in sales as we go through the rest of the year.

12:39 Other launches across Europe are expected in Q4 and into 2026 and we'll talk about that on the following slide. Going to The US, our partner, CATALYST continues to perform very well. Their reported h one twenty twenty five sales were 49,400,000 US dollars. As a reminder, they've guided for the full year of a 100 to a $110,000,000. So you can see they're all they are very much on track to meet their guidance. What is important here for us is that when they have in a calendar year greater than a $100,000,000, this will trigger a $12,500,000 milestone payments to SANTHERA.

13:27 At the current rate, we are expecting that to be triggered during 2025. But I will note that in terms of cash flow that will be received in early twenty twenty six. Moving on to Spiragenyx, again, really positive movement. Previously, they had an early access program ongoing in during 2025. But as of September, they've now commenced their non reimbursed commercial rollout. So what we mean by this is this is the private payer market in China. We're delighted that in excess of two fifty patients have already started taking a GammaRee in China. And if you think about that, that is actually around about 50% of the size of Germany and Austria combined.

14:16 Due to the increased demands for products in China both in 2025 and 2026, We are having to increase inventory and that is part of the reason for our raise today. If we look at other rollouts in other territories, the summer has been incredibly busy for the team. We we signed agreements in three different areas for five Gulf Cooperation Council countries as well as India and Turkey. The team remains actively engaged with other geographical expansion partners and we look forward to announcing those during the rest of the year and into next year.

15:02 Additionally, there has been changes at the exec and board level. I joined SANTHERA as CFO in February of this year and we're delighted that doctor Melanie Rowley joined SANTHERA board in May at the AGM. So going into a bit more detail around Germany and Austria. As I mentioned, in Germany and Austria, approximately forty percent of patients or steroid using DMD patients have now been treated with a gamma ray. We'd previously talked about the fact that this was with newly diagnosed patients aged four and five years old, as well as switches in the six to 12 range. What we're now seeing is an increasing number of older DMD patients either start or restart corticosteroids with a gamma ray. So this is really growing the market.

15:59 We now have between four fifty and 500 patients that have started on a gamma ray and delighted to see that growth. As I've already mentioned, Austria is the first country to have an excess of fifty percent of steroid using DMD patients now on a gamma ray. And we look to hopefully replicate this across other countries as we roll out. The reason why we're particularly pleased with Germany and Austria is that there is no there was no clinical trial sites or experience in either of these countries. So I think it really shows the benefit that the product is having to patients. I think any company seeing a 40% market share within about eighteen months of launch would be pleased.

16:47 We've talked about previously about the price. We have a good price of just over €3,600 and Germany as you'd imagine is a reference country for many other markets.

17:05 If I now go through to the rest of Europe, we've obviously discussed the top two lines on this chart in terms of Germany and Austria. In The UK, I mentioned that previously that we had the launch in q two and we're now moving ahead with our delivery service, which I think is really helping to boost sales there. We look forward to the second half of the year as that continues to grow. Moving on to other countries in Spain, we have a October CIMP meeting. Assuming that is positive, we'll then expect a rollout to commence across the regions and the hospital formularies to begin late q four. For The Nordics, we have the team fully in place. Obviously, with the different countries, we have different dates for commencement of sales. We're expecting those in q four and then following through into q one.

18:05 Finally, I'll mention Italy, we're expecting there a approval as of late Q1 having decided that we will add the Guardian data to the reimbursement dossier for Italy. If there's other questions around other markets, then please feel free to ask us in the q and a. So to move to The US, as I highlighted, the GAMRI grew to just under $50,000,000 worth of sales in the first half and that Catalyst has maintained their guidance of total sales of a 100 to a 110,000,000 for the for the full year.

18:53 And then moving on to China with the early access program that started in June 2024, we're delighted with their commercial rollout. This is in the non reimbursed market that started only literally a few weeks ago. I mentioned this briefly earlier, but I think it is very impressive to see that they already have more than two fifty DMD patients treated to date. And I think this shows the size of the market even in the non reimbursed market in what is effectively a very short period of time. Over the last few months, we've seen increasing demand not for product that we need to manufacture not only for 2025, but 2026.

19:40 And hence, SANTHERA has needed to bring forward our inventory plans to service not only this market, but also The US.

19:52 So so now moving to the financial highlights for the year. So total revenues were 24,000,000. This was a 70% growth on the prior year and driven by strong product sales in our launch markets as well as strong royalties and product supply revenues. If we look at product revenues in their own right, that was CHF 11,600,000. And we have seen an increase there of 7076%. This is obviously primarily driven by Germany and Austria, but also with the first contributions from The UK post the launch in April 2025. If we combine the total sales from our US and Chinese partners, so this is relating to royalties, milestones, and product supply.

20:44 Our total revenues from part those two partners was 12,400,000. Again, a very big increase over the the 7,600,000 that we saw in the in the prior year. And we're expecting that to continue to grow strongly as we go into the second half of the year. Global sales. So this is from all of our partners and our own sales. At the end of q two was in excess of a $100,000,000. I think this is a great achievements that over four quarters this has been achieved. This was achieved ahead of our expectations, again, showing the strength of sales from ours and our partners markets. The one thing that comes with success is the fact that we have actually now triggered a 20,000,000 milestone payment to the originator, Rverigen and this is seen in the cost of sales line.

21:40 Moving on to operating expenses. It is very important to me as the CFO that we manage these and keep the costs in control. Operating expenses were 27,300,000 for the first half of the year. If we exclude share based payments that reduces it down to CHF 25,000,000. And if you remember previously, my guidance for the full year was CHF 50,000,000 to 55,000,000. So you can see we are very much on track to keep our costs in control despite the fact that we are seeing some very good revenue growth. Our operating loss was CHF 35,400,000. If you exclude the milestone of CHF 25,000,000 that I mentioned earlier, it was very similar to last year. Although actually in fact that the loss was slightly reduced.

22:31 As we'll talk about in a minute, we had a financing that was announced this morning where we secured 20,000,000 Swiss francs. This was a combination of a royalty agreement for $13,000,000 and a 10,000,000 convertible bond. As I said, we'll come on to that more over the next slides. And finally, cash and cash equivalents at the June 30 was 18,400,000.

23:01 So to go into the financing in more more detail and I think, know, what is the key thing here is really as a reminder of why we've done this. This is for additional growth capital. The key reason for this is we've seen increased product demand from our partners, especially Catalyst and Spirigenics over 2025 and also into 2026. It is really important to us that we're able to service the product that they need to be able to continue on their strong sales and launches. We obviously saw the strong launch of catalyst or the strong sales of catalyst in the first half and we've already seen the success that Spiragenyx has had in their non reimbursed commercial launch.

23:48 This demand from our partners has meant that we have actually brought forward our inventory plans, hence the requirement for additional working capital. It is very important as I said that we help support the acceleration of these global launches. So going into the details, for Highbridge and CBC or RBridge, these are our existing financing partners and we have extended our agreements with both of them. So for hybrid, we have an additional 10,000,000 Swiss francs convertible bond. This is added to the existing 7,000,000 convertible bonds that is exchanging at parity. The price of this bond will be priced at a 10% premium to the closing price as of today and it will have a three year maturity.

24:39 We've also issued approximately 110,000 shares to Highbridge. This is in consideration for increased flexibility in relation to their CHF 35,000,000 term loan that we signed last year. In relation to our royalty monetization agreement with Arbridge, you may previously remember that we had an agreement with them for 75% of the net royalties. And last year, we received $30,000,000 with a potential to receive up to 8,000,000 more for these royalties. We've now extended that to the remaining 25% of net royalties and have received 13,000,000 US dollars for that.

25:30 On terms, will say that are slightly better than we did last year. To note on this these both of these agreements, these agreements are capped and the full royalty stream will return to SANTHERA at once the cap has been met. And also SANTHERA returns certain rights to buy back royalty stream.

25:52 I'll also remind you that the milestones that we received from CATALYST and SPHEROGENX are excluded from this agreement and will continue to be fully received by SANTHERA. I now move on to the financial guidance. I'm delighted to say that we've been able to increase our revenue guidance for this year. You may remember previously that we talked about full year revenues in excess of CHF 65,000,000 to CHF 70,000,000.

26:23 That was our previous guidance. We've now said that we can we're expecting in excess of that level for the full year 2025. For 2028, we maintain our guidance of EUR 150,000,000. This is for revenues from direct and partner markets, including our royalty income from North America and China. It does exclude any milestone payments received from partners.

26:51 Looking to our twenty twenty, two thousand and thirty guidance, again, we maintain that guidance that in direct markets, so that is our own markets, we expect in excess of a €150,000,000 of sales in 2030. And finally, I think it's very important to reiterate our guidance on operating expenses that on a on 2025 and on a going forward constant portfolio basis, we expect this in the range of CHF 50,000,000 to CHF 55,000,000 excluding non cash share compensation.

27:31 Moving on to strategy. And for those of you at the Capital Markets Day, you would have seen this before, but I think it's helpful to reiterate our strategy over the coming years. Obviously, the key focus for this year and into next year is that continued rollout across Europe. And we're working hard to increase the number of geographies where a gamma ray is available for DMD patients. We'll also increase our expansion geographically beyond Europe through distribution partners and continue to work to sign up more distribution partners. The next stage of development is really around how do we maximize our infrastructure that we have here.

28:19 I call it operational efficiency. We have a head office here in in Pratten in in Switzerland and we are servicing one product. It makes complete sense to add in a second product in the rare or orphan disease space. That way with very minimal incremental costs, we can really leverage the marketing and sales team as well as the the in house infrastructure that we have here. Looking to additional indications, our partners are working on additional indications. We've said that we won't currently be funding any new indications. However, as our partners progress, we have opt in rights and we'll be discussing with them at that time, obviously assuming positive data if we will look to opt in.

29:14 And finally, just to go back to a summary of the company. We have a differentiated product in a GammaRy with worldwide rights. I hope you can see today we have a clear growth strategy and we had strong growth in the first half of the year. We've got a strong and growing partner network, again, as evidenced by our new distribution agreements as well as progress with our licensing partners. It's important that, you know, we remain nimble.

29:47 And with this this being a being able to be nimble, we're able to move and react to opportunities. And hopefully, we'll be able to announce something during 2026 in terms of additional products that we'd look to license in. And finally to note, we are funded to cash flow breakeven. With that, I'd like to move to the to the the q and a. So just ahead of that if I can maybe remind you if there's any more questions if you could please please ask them in the chat.

30:28 Right. I will start here. I'm gonna read them out and then between myself and and Shabir will answer answer them. Just a moment. On there. Right. So the first question is how is the rollout of a GAMRI in Europe and West rest of the world progressing, including pricing, reimbursement, and hiring of staff?

30:57 Do you see Germany, UK pricing and reimbursement support decisions in other countries? So I think the first part of that question in terms of rollouts across Europe and the rest of the world, I think that's very clear. You know, we are seeing very good growth, in our own markets as well as partner markets. We've maintained a good pricing as well. You saw the pricing in in Germany. And in terms of reimbursement, we're moving ahead in terms of new markets to get the right price, for our for our GammaRay as we roll that out in the remaining countries in Europe. In terms of hiring of staff, we have had no problem hiring staff. In the end, I think if you have a good product when people can really see that you have something that is differentiated, people want to work for you as a company.

31:49 And obviously, we are hiring people as we increase our commercial presence. The second part of that question asking about German and UK pricing reimbursement, does that support other countries? Well, in terms of the German pricing, absolutely, many countries use that as a reference pricing. In The UK, it's more around NICE approval. As a reminder and as as a as a as a native Brit to actually get NICE approval and recommendation is incredibly difficult. So that is,

32:26 very positive that we have that. So the combination of the German pricing, and the NICE recommendation absolutely is positive in terms of decisions, in other countries. So moving on to the second question. What is the reason for your full year 2025 revenue, expecting to exceed the previous guidance range? Well, I think you can see obviously we got good growth in our own direct markets. China has only just started to be launched in in September. So obviously good growth there as well as the annualization impact of The US.

33:14 So across all of those areas, we actually expect h two to be far stronger than h one. In addition, as I as as I mentioned earlier in the presentation,

33:26 assuming that catalyst does reach that 100,000,000 sales milestone by the end of the year, we would have an extra 12,500,000 of sales milestone that would be recognized in 2025. I hope that answers the question. Moving on to the third question. Are there are the terms of the new Arbridge royalty monetization agreement of $30,000,000 at similar terms as the early agreement or better. Now we've never given exact details on this. However, I will say that we have agreed better terms not only on the cap, but also on the the coupon rate.

34:11 We had long discussions around this, but I think considering the strength in both those markets and the reduction in risk, it was only right that we should have a lower cap and a lower coupon rate. So I'm pleased to say that that was negotiated into that discussion. Moving on to the next question. This is probably one more for Shabir. It says, although it is still early days, do you see evidence for gamma ray to allow patients to stay on time on dose and on treatment addressing the limitations of standard corticosteroids? The answer to that, Kathleen, is is yes. We're seeing evidence, and and this is something you pointed out to when we discussed Germany, that the drug is being used across all segments in terms of age.

35:02 So, specifically, we're seeing new starters grow and tolerate treatment well. We're seeing patients now who are on other corticosteroids switching to a gamma ray and those who are either discontinuating or down titrating also adopting a gamma ray. We've been following patients up, and we'll we'll be announcing data from our long term follow-up study in quarter four, but we are seeing a majority of patients tolerating drug at a higher dose for longer than we see in terms of natural history. Thank you, Shabir. So the next question is regarding China. It said, when do you expect first sales in China? Does this trigger a milestone payment from Spiragenyx?

35:48 And what has increased the forecasted demand in China for '25 and '26? So absolutely, we had actually sales in in the first half of the year. We have EAP sales. In addition, we now have sales in the second half of the year in relation to their commercial non reimbursed rollout. We have, obviously, the royalty component of their sales, but also importantly, we have the the product sales as in bottle sales that go to China as well. So we have a a double impact of the the benefit from a strong Chinese market. The Chinese market, think we've already seen as I mentioned with an excess of two fifty patients already on a GammaRay, they have only just launched.

36:37 That's already half the size of Germany and Austria in such a short period of time. I think that really shows the potential of the product in China, and our partner is very confident about forecasts. And we have binding forecasts with them out a number of months, and those have increased. And that is a a key reason for the increased need for inventory to provide to the Chinese market. Moving on to the next question. This is another one for Shabir. On positive POC trial results for GammaRy in in Becker's, how long would it take to gain market approval for this indication, and how significant is the market potential? I don't know how much you can say, but that's the the question's been asked. Thank you for the question.

37:29 It's a little too early to say. We haven't seen the data yet. I'm awaiting that imminently. I think depending on what we see in the data, there were some thoughts in terms of regulatory strategy, whether it would be an accelerated submission or not. So that depends really on on the data. BEKAUS is obviously an attractive market. It's the same call point or touch point. It's the same physicians that treat Duchenne and the neuromuscular centers for those who are at different age ranges, and the market size is somewhat similar. I can't make any comments really until I see the data, and then then, of course, we'll we'll provide our view. Okay. Moving on to the next question. That is how is the mark manufacturing expansion progressing?

38:19 We're actually put this slide deck up onto our website and one of the slides in the appendix actually talks about manufacturing capacity expansion. We are delighted to say that our second site is running ahead of, I think, the previous guidance that we gave, and we are now expecting that to be able to deliver first supplies of product in the fourth quarter of this year. It's important to us because this does bring down our cost of goods, and, also, it gives that certainty of supply. When you are single sourced, there is obviously always a higher risk level. So to be dual sourced, I think, is very important. But, also, because of the size of the manufacturing site and the size of the batches, this also increases our our or improves our cost of goods. So delighted to say that that is progressing well.

39:21 The next question I think I've covered off, it's it's another question asking about total revenues for 2025 exceeding previous guidance. Can you give a bit more detail on how you expect this from different sources? I think I ran through that earlier in terms of the increased direct markets, obviously, the the positive impact that we would expect from from the milestone, but additionally, strong royalty income as well as product direct product sales to The to The US and to to China. Going to the next question.

40:08 You said you have announced quite a few additional distribution agreements, Turkey, Gulf countries, India. Maybe could you maybe comment high level on the financing terms and the market potential you see in these respective markets? And then maybe also could you share what you consider to be remaining key markets to partner and where you stand on these discussions? So in terms of the high level, in terms of the financials, and I think this is quite an important point because there there has been some, I think, some misunderstanding on this front. We book approximately 60% of the the net sales from these countries. So those are booked to our top line, and that is the commercial agreements that we have. So some are a fraction more, some are a fraction less.

41:08 Sometimes we get a small upfront payment as we had over the summer. So those are the the the financial terms. I think if you look at any individual country, the the incremental benefit to the top line is not going to be, you know, the same as one of the major European countries. But if you continue adding all of those up, then those are very meaningful. We certainly are looking to expand to other countries. And, actually in the the appendix to the slides that will be available later, we list some of the other countries that we are looking at. This includes the likes of, looking into Latin America, Russia, Australia, New Zealand, as well as South Korea.

42:00 So if you're looking at key countries that we're looking at as the next phase, those are they're high highlighted in the in the appendix to the to the deck. I think that's I think that's the main that answers that question. The next one, can you please compare The UK launch to the launch in Germany and Austria where you achieved 30% market share in the year one of launch. Are you seeing any reasons why your market share in UK or other key markets should be different? We've obviously had the summer months over The UK. We also have we we have needed to get in place the the the delivery program to actually help with logistics.

42:52 We are seeing good sales in The U in The UK, and they continue to grow strongly. Even in September, we've actually got some very strong growth there, particularly since the start of the the delivery agreements being started to be rolled out. At present, we won't discuss market share, but we said we are pleased with how that launch is going. Let me just go to see if there's any those are the some of the questions that have come in. Let me have a look to see if I can see if there's any more here. There is. Yep. So other questions.

43:41 When you secured the financing agreement in August last year, you expected it to extend the cash runway to anticipated cash flow breakeven. Now today, you secured an extra CHF 20,000,000 in new capital. Could you help us understand what has changed the underlying conditions to make this additional capital necessary beyond the increased inventory needs related to this? And when do you expect local manufacturing supply to be up and running in The US and China? So two two very different questions. So let's answer the the first one to start with. So certainly, last year, we hadn't expected the large increase in inventory. This is a major factor particularly in China. From the time frame when we actually have to put our first, I was gonna say, binding forecast in to when it's actually made is about sixteen months.

44:38 So it is a long period of time. We do have to and it takes quite a while to actually produce the product as well. So we do have to carry higher levels of inventory. I think it's important that we have flexibility to be able to help our partners and really help with with their growth as they continue to expand a GAMRI sales. In terms of US and China, The US is progressing ahead with manufacturing, and this happened before any of the the Trump's discussions. However, that won't be online and producing product into some point, into probably the second half of next year.

45:25 That's probably more of a a question for Catalyst to to firm up the exact timings. For China, that will still be a number of years away, in terms of them, being able to manufacture themselves. Although I know that's very key to them because that helps extend their patent life. Another question. This is probably more for Shabir. Can you elaborate further on the Guardian study? What kind of endpoints will you report? And if positive, how do you expect it will impact uptake in existing markets and help to help in reimbursement pricing discussions with regulators?

46:11 Thank you. So let me just remind you of what the Guardian study is. As you'll know, we've had children who've been on various programs, various studies in the development program, phase two a, phase two b studies. Those children then went into expanded access programs, and what we've done is for a subset of these patients, we've actually rolled them into a formal long term extension study, the Guardian study. So we have 40 to 41 children anticipated in the study. They've been on drug five to seven years. I think this is a very important study. If you remember, being on on a steroid at high dose, the toxicity accumulates. So what we've been able to show so far has really been based on short term outcomes from the pivotal study.

46:58 The GUARDIAN study will will be the first time we see what I believe is the true value of familarone. We have two objectives. One is to show that we maintain efficacy and that vimolorone is comparable to standard of care corticosteroids in terms of outcomes. We wanna show that children remain mobile for longer. There's a delay in loss of ambulation. And secondly, we really want to start to differentiate on important safety outcome measures. So rather than looking at just bone biomarkers, we'll be looking at, actual bone fractures, hard clinical outcome measures. We have a measure of eye health, ophthalmological assessments of cataracts and glaucoma. We're looking at bone age. We're looking at, delay in puberty, which is common, with corticosteroids, especially with boys who are now in the Guardian study coming up to the age of about 11 to 12 entering into puberty, and of course we're looking generally across a number of safety outcome measures.

47:56 These data are very important. Physicians are currently using a gamma ray in all segments of ages as experience accumulates, but predominantly in the younger age group. With these data, I believe it will give physicians the confidence to switch away from current standard of care corticosteroids. Having confidence that the efficacy has been maintained for five to seven years would be very important in that switch decision. And so I believe it will have a very positive impact. Of course, in terms of safety differentiation, if we can show hard clinical outcome measures in addition to consistency across several earlier studies in in both biomarkers and X rays, again, it gives confidence to the market that the safety differentiation really is a key value driver of the monorone.

48:43 In terms of reimbursement pricing discussions where we are able to use these, of course, I think it will have a a positive outcome, and I look forward to to the data being announced very soon. Okay. Thank you, Shabir. I'm gonna answer one of the questions. Now there's there's several that are along this themed around how to explain the weak share price performance and commenting that that we're not looking after the interest of shareholders. I think the most important thing is to have growth in this company. We need to support not only our markets, but also our markets of our partners. So if that needs us to increase our inventory levels to help do that, then I think that's important for the long term growth because in the end, we want to see more sales of a grammarie around the world.

49:34 In terms of share price performance, I mean, I tend to not look at it day to day. You need to look over at the longer term. If I go back to this time last year, the share price has increased 35%. I think most people would be very happy with that, and I appreciate today that there has been a dip in the share price. I am hoping that after this call, people will have a better understanding of our excitement for the rest of 2025 and into 2026 and why we're increasing our sales guidance on the back of that confidence. So I hope that sort of answers the question. We are looking at the long term. We don't look at day to day movements, and we've had some very good growth over the last year, and that's what we'd look to have over the coming twelve months too.

50:26 Another question is why do you not see an increase in sales in from 2028 to 2030? I'm actually just gonna go back to that slide if it's gonna allow me to. It's actually two definite different definitions. So what we say for 2028 is basically all revenues excluding milestone payments. So milestones, you know, they can be lumpy. They could fall one side of a year or the other side of the year. If you think of the remaining part of that sales, so that's our own sales or partner market sales or royalty income, this is the underlying revenues for the company. And we're saying that they will reach a 150,000,000 by 2028.

51:16 By the time we get to 2030, what we said is we're just gonna take only our portion. So that is just purely those European sales, our direct market sales in Europe. So if you remember back to the earlier slide when we talked about we expect the European market to be in excess of a €150,000,000 by 2030, that is that that figure there. So by twenty twenty thirty, we'll have not only, a €150,000,000 of of sales, we'll then have the royalty streams in relation to our, our Chinese and, US partners, which obviously by which stage could be very, very sizable, in addition to our distribution partners. And as you can see, we've been rolling those out as well.

52:02 So by twenty twenty thirty, yes, we would expect sales far far in excess of a €150,000,000 euros if you're looking at all sources of revenue streams. And I think we're nearly on to the the final question here now. So there is question saying, how much do you believe the market for a gamma ray will grow as DMD patients who have stopped taking other products return to take a gamma ray. So I think it's probably more one fifth for you, Shabir. Yeah. So let let's talk about unmet need first because that'll give you an idea both of the of the the urgency, but also of the of the opportunity.

52:47 So those who tend to stop treatment, corticosteroids or others, tend to be in the older age segments. Now remember, there are very few options for children who are in the older age segments. You'll know from the the gene therapy stories and elevitis that it's unlikely that gene therapy will be a suitable treatment for those who are older, which remains then the only option you have are corticosteroids and potentially juvenostat in the marketplace. So a lot of adult neuromuscular physicians that I speak to are quite frankly absolutely desperate. They have nothing really to treat older kids, whether they've stopped other treatments or wish to restart corticosteroids.

53:35 Remember, the leading cause of death in Duchenne isn't going into a wheelchair, isn't having weak arms or legs. It's the cardiorespiratory failure that kills you and prematurely kills you. Now steroids have been shown to actually also delay time to onset of cardiac and respiratory failure, so they are a very important treatment option with the evidence base already established. And I'm hearing very positive sentiments from adult neurologists for people who want to come back to corticosteroids that a gamma ray is a very valuable and suitable option. It's really based on an unmet need where we believe the drive and growth opportunity will be. Thank you, Shabir. With that, I will hand back to the operator. Perfect, Catherine. Shabir, if I may just jump back in there. Thank you very much indeed for your presentation, for being so generous of your time and addressing all of those questions that came in this afternoon. And of course, if there are any further questions that come through, we'll make these available to you immediately after the presentation has ended. But, Catherine, perhaps before really now just looking to redirect those on the call to provide you with their feedback, which I know is particularly important to yourself and to the company. If I could please just ask you for a few closing comments just to wrap up with, that'd be great.

54:47 Thank you. First, I want to say thank you again for your time today to hear about SANTHERA and our results over the first half of twenty twenty five. I hope you can see here, you know, the impact that we're having from having a differentiated product in the DMD market. I hope it's clear. You can see about our growth strategy and how we are executing on that. And also how with our strong partners, we're continuing to grow a gamma ray sales globally. So with that, I'd like to thank all my colleagues, for their efforts over the last six months, and, thank you again for your time and listening today. Perfect, Catherine. That's great. And thank you once again for updating investors this afternoon. Could I please ask investors not to close this session as you will now be automatically redirected for the opportunity to provide your feedback in order the management team can better understand your views and expectations.

55:47 This will only take a few moments to complete, but I'm sure it'll be greatly valued by the company. On behalf of the management team of SANTHERA PHARMACEUTICALS, we would like to thank you for attending today's presentation. That now concludes today's session. So good afternoon to you all.