Hopefully you can all hear us well. First and foremost, for those of you that actually managed to find West Ballroom as opposed to Westside Ballroom, congratulations. That is by no mean feat. I am happy to have made it here to host this. Otherwise, Guido would be up here on his own.
Yes.
Anyway, without further ado, it is a pleasure to welcome Guido Oelkers, CEO of Sobi. We will sort of come back to that. Just a brief disclaimer before we get started. For important disclosures, please see the Morgan Stanley Research Disclosure website, which is at www.morganstanley.com/researchdisclosures. That is a little bit of a tongue twister, particularly at the end of a long day. Perfect. Great to have you here on the stage, Guido. Again, thank you for persevering through a long and busy day of investor meetings. You have had a great couple of quarters.
From a financial standpoint. What I thought we would start off with is maybe a little bit of a recap on 2026 year-to-date. Obviously, the results you reported on in H1 and sort of how you see the rest of the outlook for the rest of 2026.
We were blessed. Thank you for inviting us to this very exclusive session. Let us say no, but we were blessed by fantastic results. We had a 29% growth in the quarter, Q2. Year-to-date growth is at 20%+. 26% to be honest. We had no other way than to increase guidance for the year, so we are now in the high teens. Also felt, because of the earnings that we saw, that we had to upgrade our earnings forecast and guidance from the mid-to-high 30%. So, it is a very beautiful time for the company. We have very strong underlying growth driven by our launches and our strategic growth products, as well as making progress with our pipeline at scale. So, that basically puts the company in a very fortunate position.
Maybe just coming back to, you had such a remarkable second quarter, and you have obviously upped the guidance, but you also did allude to some tougher comparisons into the second half of 2026. Any sort of more color on that potential headwinds? Is there scope for more, obviously? We will see how the next two quarters go.
No, we think that we have also great second half ahead, but we just wanted to allude to the fact that, for instance, with Gamifant, the comps are getting harder. Gamifant, given, ironically, the virology is affecting part of our secondary HLH business. So it is more skewed towards the second half, so the comps are getting higher on the base effect. Relative growth rates are more challenging to contain that at this rate. That is the reason why we indicated high teens as opposed to into the 20%, but nothing fundamentally wrong. We think that Altuvoct will keep growing at a very accelerated rate. We will accelerate Aspaveli, given the phase of the launch and more countries on stream. And we will also have spectacular continuous growth, we believe, with Gamifant, definitely in absolute terms.
The comps are just getting a little bit harder because we had a spectacular second half last year. We wanted to mention. There is nothing to worry about, nothing fundamentally wrong with the business.
Maybe switching from top line to the margin guidance, which again, was a very positive outcome for the first half of the year. Is the upgraded margin guidance reflective more of a permanent structural effect in the business, temporary effect? How do you see this evolving going forward?
I think it is a function of our top-line growth, and it is a function, obviously, of the way we manage the business. It is also related to the fact, to be honest, that we had to move some of the investments into the NASP launch in the U.S. We had a CRL related to CMC issues, not our Chinese partner, but with our U.S. partners. We understand what needs to be addressed. We have a Type A meeting in October. We are very optimistic that we get this thing approved next year. However, we needed to take into consideration, so you have a little bit less expense. You have a business that is ahead of what was initially expected, and that propels margins.
Perfect. We'll come back to the CRL as a separate topic a little bit later on. But with the core strategic or growth portfolio representing 2/3 of overall group sales, how secure do you feel Sobi is relative to the midterm targets that you've put out for 2027, 2028?
I think we are actually on a very good way. We just looked recently at the stage of our portfolio. So where there's a time when we set out our ambition of SEK 55 billion, so around $5.6 billion-$5.7 billion by 2030, we basically clearly have de-risked our case over the last close to now nine months, or 8.5 months. Because we have more certainty on the growth of Aspaveli. We have more certainty on Tryngolza. So we know now, we have familiarized ourselves with the 700 lipid centers. We have been able to get a couple of projects into motion with the audience. And we have a full organization in place. So we had the first phase III data from pozdeutinurad met the primary endpoint, and I'm impressed by the efficacy of the product and the clean safety profile.
Obviously, we're still waiting for the second phase III. Overall, the company is moving actually where it matters. We have been able to make progress, and we are progressing our IDS activity with the Gamifant. On a whole, quite positive. So if anything, we are right now probably a little bit ahead of our own expectations towards our ambition for SEK 55 billion by 2030.
Good to specify the currency. Okay, let's come back to a couple of the products that you touched upon. Altuvoct has had incredible momentum. What is driving uptake? Are you seeing patients switching, market expansion, some combination of both? Do you expect that current dynamic to continue going forward?
We clustered the launch into three waves. In Wave 1 countries, we launched earlier, foremost Germany, and doing extremely well. In the second wave, we have markets that came now a little later on stream, like France, end of last year, and Italy early this year. So we probably have more of a limited growth potential in Wave 1 countries. We would probably have at most covered 50% of the potential in Wave 2 , and probably in Wave 3 markets, like international markets, at most have covered 30%, if less, of the potential. So there is more to come. I mean, Altuvoct is actually a good example of a combination of an organization that is well-orchestrated, that understands hemophilia very deep. We have many people who spent two decades or more in this indication.
We have two of the previous world leaders in hemophilia in academia working for us full time. So we are doing everything we can in order to drive this indication and stay current. We have a fantastic product that is evidenced by patient feedback, but also KOLs. Improving life, improving protection. I think this propels the story, and it is also evidenced in our more recent research efforts to take the product into synovitis, which is one of the last unmet medical needs in hemophilia, and improving joint protection. First study readout and published soon. We have three more studies on the way.
In those Wave 1 , I suppose is the most developed, Wave 2 , Wave 3 markets. Any sort of insights into the switching versus identifying new patients and what the mix is?
In Wave 1 markets, more than 70% of our patients for Altuvoct are coming from other companies. 30% is a switch from Elocta. When you think about our ambition, more than in Wave 2 countries, it is around 50/50. When you are at an earlier stage, you probably have more Elocta switches than immediately switches from competition. We think that whether it is where we were with Elocta standalone, our Hemophilia A franchise will more than double in the next coming years. We are on a run rate already at over SEK 8 billion for Hemophilia A tech product franchise. We are well on the way to make this franchise, at least Hemophilia A product franchise, blockbuster. Probably the product on a standalone basis, Altuvoct, anyway.
Perfect. You have had another sort of promising launch with Aspaveli.
Yes.
In terms of the European launch in nephrology for C3G, IC-MPGN, any sort of early insights and thoughts around the potential there?
N o, it's a spectacular launch, and we were proud partners of Apellis. Now feel even more proud to be partners of Biogen. So, basically when you think about it, high unmet medical need, super strong data in proteinuria reduction, and removing of stains, and immune complexes, and also stabilization of eGFR at an early stage. In combination, highly differentiated versus the competition. We have launched a new device, the Infuse device, in our markets now synchronized with our launch. Creating also quite a bit of interest to addressing the convenience aspect of the product. I think we set out, we need to be expecting 400 to 500 patients. We are well on track to achieve this, or maybe can do a bit better. So the uptick is very good.
We just need to take into consideration that it takes a little bit of time to bring a patient on. You have to go through a vaccination. In some of the European markets, we have to overcome a bit of a structural topic that the patient was diagnosed in the centers, is now in the community base. You need to make sure that you get the referral back into the centers to provide the product. But, once you get it into continuum, it's going to be good growth. We had the growth that we see on the sales level is not evidencing what actually happened on the patient level because we have a base effect of PNH, and PNH was slightly regressing in Europe and stable in international.
Now we see with the launch also of the device, reversal in international and a stabilization in Europe, so your base is more stable. Then it means you benefit more from the compounding effect. Anyway, the C3G business is the main part of this franchise and becoming extremely relevant in the years to come.
Competitive dynamics in C3G?
Actually we are looking at this. It's always this little David and Goliath game that we are in so many different indications. Here we are ahead of the competition.
Perfect.
In penetration.
Market opportunity, because it's slightly less well-known amongst the larger indication. I just wanted to-
It's not yet commonly agreed upon or understood, but for us, we said at the Capital Market Day, SEK 700 million to SEK 1 billion. Nothing has changed. If anything, we are more confident about this range, and now obviously need to evidence this by real numbers.
Maybe just in terms of the other drivers, Gamifant, indication expansion into MAS and maybe geographic. You talked a little bit about it when you talked about the, obviously, base effect that you will have second half of the year, but any sort of color around progress on that front?
We are in the launch of secondary HLH, MAS- driven with sJIA doing very well with this opening up to secondary HLH, our patient population has expanded. Physicians also see utility of the product in related secondary HLH indications. We are progressing our clinical development, and will announce at the right time a more broader study where they see the utility. Product is doing extremely well. We then saw the opportunity based on a study that we performed with the Hellenic Institute to look at 5,500 patient samples, that there was a subset of patients, 20% in a new archetype or endotype of sepsis disease. That prompted us to conduct a clinical trial in phase IIa.
We have demonstrated in this phase IIa trial, even though the study was not powered for this, but was 75 patients that we could show a mortality benefit of 12%, which is for sepsis, quite remarkable. That prompted us now to go into pivotal. We have agreed on an adaptive design, moving from a phase IIb into a phase III program, and are now putting everything in place. We will also consult with FDA. Initially, we had a more European-driven project with the Emergency Task Force, but given the high unmet medical need, we probably take this a bit broader. Clearly, we will have more development centers, and this will be a very significant undertaking with more than close to, let's say, we'll figure this, but between, let's say, 1,800 to 2,000 patients that we will involve in this study.
It is a very significant stepping stone for the company to enter into an indication that could have a very material impact on the economics of the company going into the future.
If you think about, relative to primary HLH, secondary sepsis, any sense in terms of how this scales the opportunity for Gamifant going forward?
F or us, probably in HLH, Gamifant is given also the fact, we bring it now to Japan and other. We have also submitted for Europe and see where this will go for secondary HLH. So we democratize access to Gamifant in HLH. We think that the HLH function alone, based on what we gave as an indication, is a SEK 500 million-SEK 700 million opportunity. The indication in sepsis is a multi-billion SEK opportunity, even though it's an endotype and a subset. Just looking at the number of patients, provided that we can demonstrate similar efficacy data in a large pivotal trial. Like, we have seen in the phase IIa, it's a very significant opportunity that will propel growth for Sobi.
Maybe moving on to something more from a pipeline standpoint. If we switch to gout.
Yes.
What was the attraction from a Sobi standpoint in terms of entering the category, and as you were looking at the opportunities that are out there, where did you see Sobi being able to move the needle?
I t's not, at first sight, not the most attractive indication. Particularly when you look at disfigured joints. But it is a very material opportunity. We got into gout, we saw the opportunity with NASP. Yes, we talked about it. We had some obstacles that we will overcome. No problem. We work on this. We think this is an opportunity, where not a lot has happened over the last 20 years. So, I think high unmet medical need, still place for new entrants. We thought this was prompting us into NASP. Then we thought, how could we make it a more sustainable franchise that will also allow us to resource this indication competitively, even comparing us with a very large competitor. That prompted us to think about a URAT1 inhibitor.
We then undertook a significant diligence process with a lot of scientists involved, because the URAT1 inhibitors have a bit of a history that not all dreams have come true. But we got comfortable after the diligence process that this is a product that is newly designed, addressing the shortfalls of previous compounds in the class. When you look at the Phase III data, very clean safety profile, supremely high efficacy. We don't want to celebrate. We want to celebrate when we have both phase III data trials read out, and with the secondary endpoints. But it looks like a material opportunity. This is for them, a much larger patient group. We think in the U.S. alone, around 200,000.
Given the fact that we believe the product has capacity not only to address the SUA reduction, but also the material effect on flares and tophi, this will be very relevant. Market research has confirmed this. Hence, we believe that the pricing will be also appropriate and different to the current incumbents.
Then maybe just on pozdeutinurad, mouthful. What are the next kind of milestones in terms of further data, REDUCE 1 timing, regulatory, et cetera?
ACR, in November, will present the complete set of REDUCE 2. Then in January, February, REDUCE 1. The sequence is a little bit the other way around just to
That happens.
Keep it interesting. In February, March, we will have the complete data for the secondary endpoint and then submission end of H1. This is one of our core priorities. We think it is a high unmet medical need. It is not only, and we have now, with the Arthrosi acquisition, one of the leaders in gout in the U.S. on our team, an ex-professor at Duke. He makes sure that this is not. The patients with this indication have been a little bit stigmatized and not taken as seriously. But when you are suffering from it is not necessarily funny. The pain can be excruciating, and the disfigurement is clearly debilitating.
Maybe last question, just around gout and the gout franchise. The NASP CRL. How confident are you on the manufacturing front and update there?
The team that we have is a very competent team. We got a little bit unlucky that our partner had an audit before actually we wanted to clarify our submission, and that was negative. That impacted our data points. We feel that together with the partner and with what we have laid out, we understand what needs to be done. In fact, a lot was done, but we didn't get the credit at the time. I think it's a high probability game to solve. We are preparing launch, and if you want to know what people's strategy are, just look at what they do. We have hired a significant part of the team if not retrenched them. We believe in, we plan for success.
And for another exciting opportunity, Tryngolza, onto FCS. Different area for you. You haven't been in lipidology or.
No.
Before. Again, a similar question around what attracted you to the opportunity, and how are you thinking about the launch, given it is a slight adjacency from where Sobi is today?
I keep myself asking these questions as well, but then I ask Daniel, our Head of PD, and he explains this to me. No, just kidding. We started with FCS. FCS clearly rare disease. We will have this year, let's say between 100, 150 patients, totality in Europe, maximum . We started from our nic thing. We had Waylivra beforehand. Clearly, we feel right to play. All of a sudden comes these spectacular data, in sHTG, three articles in New England Journal of Medicine attached to the indication can't get possibly any better. Very strong reduction of ApoC-III , very strong reduction of triglyceride level. This is how life sometimes goes. You have deliberate and you have emerging strategy. We then said, we know 700 lipid centers, so we know the core of where value is created. This is clearly un-rare.
But the opportunity could be unreal. Very significant because, in theory, you have 1 million patients above 880 in Europe alone. So you're looking at a very significant patient potential. We will not target all of them, it's clear, but we have 300,000 patients in Europe with very severe triglycerides and who are not properly treated. You have moderate patients, another 1/3 . You probably focus on the very severe cases and to a less degree, on the moderate. Still leaves you with a very significant opportunity. This is the advantage when you are working for a mid-cap. You can afford to be agile. What we did in the last nine months or 10 months is building up an organization with people who are not alien to lipids and triglycerides, who have done those launches for big pharma at scale, who have joined the company now.
We have already significant forces now in the field, and we think we have a right to play and a ticket to win.
Those severe and part of the moderate population, do you see them as quite concentrated in a smaller number of centers or you've been able to identify?
To be honest, where we come from, we will start from following a very stringent top-down approach, starting from the territory that we now know with FCS. Then build a referral system into the system. But it is quite clear that over time, this treatment will be democratized. As such, you need to have coverage of other specialties such as endocrinology or cardiology, for argument's sake. It is okay. So it is a step outside. It is not a step away from rare, but it is an opportunity and with a scale that the company cannot ignore and that will be, I believe, has a chance to transform the company one more time.
Last question on Tryngolza, because we are not going to cover everything. We have five minutes left. Competition, plozasiran, I think that is how you pronounce it.
Yeah.
What are your thoughts there? Big enough market?
B ig enough market for two. There is a bit of a competitive spirit left in us. When you look at the odds, we have a very competitive product. If you can afford to look into the placebo-adjusted data for two minutes, then you will find our competitive profile very competitive. We think that the company is very competitive. When you think we are not a platform company, we are coming from the other side of the spectrum. If we cannot make our mark, we have done something fundamentally wrong. So we think that we have a very good case here to make, and we are preparing for success, as we said. We have 1 and a half years in the large indication ahead of them.
Yeah.
The product is well-positioned, and we have demonstrated statistically significant ApoC-III reduction at scale.
As you said, with the experience in FCS, pricing and reimbursement, how do you expect that to-
T hat is always a European question. We have done extensive research in this regard prior, earlier, and have engaged payers. Now you have to This is Europe. There is no guarantee, but we think based on the very strong data and ApoC-III, when you have acute pancreatitis, this is not a trivial event. A friend of mine just had it. Was more than two weeks in hospitalized. It was not so clear for a while whether this was a positive outcome. So it clearly is associated with mortality. So, we think that the product here can make a difference, but that also payers will acknowledge this. Will we achieve U.S. prices? The prices that have been quoted are on a gross basis. On a net basis, we may not be too far off.
Last question, I will sort of tie two topics together. With your time at Sobi, and together with the help of some gentlemen on the bench over there, you have been very prolific, successful on the BD&L side, if you look at some of the upsides that you have just talked about. You have also recently done a partnership with Innate Pharma. What do you think in terms of what else does Sobi need, if anything? What was the basis for Innate Pharma, as you sort of look back and what has been built over the last decade or so?
No, we are looking for, we are constantly screening. Daniel, who sits there, with his team, he screens 400 to 500 companies or products every year. So, that basically is a lot. Innate Pharma came on the screen and we were looking for an adaptive partnership that, when you think about it, we have right now much more opportunity on hand than the size of a company like Sobi typically has.
Why can we do this? We can do this because we are able to leverage this catalyst, our royalty stream, and deploy it, and therefore we can fund it. But it is not like we have endless funding opportunity. We figured with Innate Pharma, we have an opportunity to create a win-win situation for them, fund the next step, and have an option on two indications. First indication is more of a niche indication, but we are not too proud.
Second indication could be a very significant contributor. We seize the opportunity, we create a partnership that is a win-win, and that is always our mantra. Historically, we have used this. I would expect also post my departure that the company remains very inquisitive and very open. That is the foundation of the product. As the platform has become more attractive, I have no doubts that there will be some opportunities arising.
One last question, because we have obviously touched upon it, and we look forward to welcoming you next year in your new capacity. But as you look back at your, and it is not done yet, we still have several months to go, we are well aware. But as you sort of look back at your time at Sobi, what are you most proud of or what stands out for you?
Actually, there are many that will be beyond the time we have left. I think I am proud of the economic achievement. I am proud that we were able to transform diseases. That we were basically moving from a more commercial setup to a really fully integrated company that now endeavors also to do their own development. But I am actually equally proud or excited. Sobi is a company that maybe I had an impact. Sobi is also a company that had a huge impact on me. And initially when I started, I thought patient orientation is more part of our image brochure. I learned it is a fundamental belief that brought me back to, I think, where pharma belongs to, meaning making a difference for patients.
Thank you, Guido.
Thank you, Katie.