Swedish Orphan Biovitrum AB

The conference will not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Guido Oelkers, CEO. Please go ahead, sir.

Yeah, thank you so much and welcome everybody. And with this having said, you know, let's go straight to the first slide. It's really a pleasure to welcome you today to our Q1 report. And today, I'm, you know, forward-looking the statement as per usual. Today I'm joined by Henrik Sennquist, our chief financial officer, and Julia, our head of R&D and CMO. And in the Q&A session, we will have also Armin Greininger, our senior scientific advisor. Please go to the next slide. Good. I mean, you have seen the results this morning. I mean, the results were excellent from our perspective. It's plus 20% versus previous year. I think this weighs even more when you consider that we had to make up for 880 million roughly of sales that we lost with synergies. So we're quite happy with the results from the offset. But due to this erosion of synergies, and it was not made up obviously fully by Fortis revenues, we had also a lower EBITDA margin. We will talk about this. So this previous year, when you think about, you know, our strategic portfolio, the strategic portfolio grew at 177%. This is our launch medicines and our new royalties that we received for our bisphortis and for our tubio. This is quite significant, and this is making up for around 140% of our growth despite the fact that we had a pretty good quarter with our hemophilia franchise as well. So, you know, and when you see the slide and all the growth rates here, I mean, it's very substantial for Dr. Lett. Come in front and it's nice to see materiality with Astavelli and Netavelli this quarter. We will talk about Wonju a little bit because I'm sure this is on everybody's mind as well, you know, where we had more of a stable comparison versus previous quarter. and there's more to say to this. And with regard to key milestones that we achieved, I think it's very nice to see that we've got fast-track designation for SEL212, and this increases our confidence around the product. We have positive Phase III data for Doctellate, and we had a positive CHMP opinion for first-line treatment of Aspavelli and Alpavelli. which is also helpful to be more competitive in your future competitive entries. Outlook remains unchanged simply because it's early in the year and we have to make up also, for instance, for one or the other topic and foremost here that we will have no closing sales in Q2. Let's move to the next slide. So when you basically look at the areas of business growth, as you can see, you know, the hematology being the course leader with 46%, hemophilia sales very positive, you know, positively influenced by some of the international business where we want some tenders, but also still strong growth in the more established markets. It makes us quite confident that we retain competitiveness in hemophilia, but overall hematology is the growth leader. Immunology impacted by the synergist development and specialty care in line with what we expected because this business is something that we manage for cash and earnings to support the growth in our core areas. When you look at the regions, Europe is growing very strongly with 15% based on the strategic growth portfolio but also supported by the growth in Australia. And the North American business is impacted by the erosion of still nitrogen. We are not adding here the royalties in the North American number If you would ask it to the yin and the yang, then this business would have done still very well. International being our goals leader and becoming material, so our strategy to diversify in countries beyond North America and Europe is starting to pay dividends. Next slide. spend a bit of time here to break out the strategic portfolio, which is really our work with company products plus the products that we have recently launched on this early stage of commercialization. And as you can see, these are pretty significant growth rates, and I think we talked about it, and if you exclude the frozen business for Doctella, 59% at this point in time, makes us very confident that we have also more goals for this product. Let's go to the next slide. And here it's broken up. So, you know, what you can see is really that the product portfolio that is relatively early is growing in significance and is now also this quarter 35%. And if anything, that part will grow, while the foundation portfolio is also healthily growing, and this foundation portfolio does not include all the seed images, which is in the legacy portfolio. But the health figures of the company is strengthened over time. We pay quite a bit of attention to this, that we have a healthy portfolio of tomorrow's breadwinners and today's cash contributors. Next slide. This shows you that, you know, we are far not yet done, but there's still a lot of growth. I think, you know, once we have submitted the SEL 2.2, we will talk a little bit more about the opportunity and product respect in regard to this new material. You know, I was very, obviously, waiting for the nephrology indication to Google, sorry, for the page 3 database. And, you know, we believe that this is a material opportunity. And then, obviously, F&S Octocop Alpha, Antiportus. But we are also this top talent, you know, outside of the four regions. A lot of growth is still to come. And, yeah, we just launched in Japan. And, you know, great strides. There's still a lot of opportunity ahead of us in suicide fidelity. 540 is also an important gross driver. And just, you know, when you think about the R3 franchise as such, I mean, when you look at it, because you have to look at it really not as a calendar year, but, you know, as a season. And the last, you know, for the season, which basically started in October last year to March, it's a three-year than roughly SEC region. I understand that you have difficulties to hear me. Is this correct? Can you hear me better now? And, you know, when you think about the season, so it's a 3 billion SEC season, started a bit late, so not a season as we are used to, but by no means, let's say, a reason for us to be less confident about RSV. Yeah, so maybe we move to the next slide. And, you know, here you can see the hematology franchise, how it's growing. It's an example of Doctelid. I think we talked about it. Next slide. Aspavelli and Pavelli, I'm quite happy with the acceleration of growth that we have seen in Q1. And, you know, we are now launching in more countries, Japan and Stream, you know, and becoming... sizable and more countries to come. We announced a joint venture in Korea and you would expect quite a bit from there until we have Latin America emerging. So there's still a lot of new markets for us and then obviously the nephrology indication. So we stay quite positive about this franchise despite the fact that it will get more crowded. Next slide. And Wonder Launch, I think one needs to add a couple of points. When you look at it, it has been nearly perfectly flat from Q3 to Q1 this year. And I think it's fair to say it took us some time to restructure the team and to bring these two organizations together, understand what needed to be done in terms of messaging, and strategy and basically, you know, and we were impacted as we outlined in our report by the Part D, meaning also unpaid patients at the crossover from last year to this year. And, you know, so it took us some time. What we have seen, and this is, I think, the best yardstick, And this is that A, we have got very positive feedback from market research where physicians believe in the utility of the product. We have obviously very strong data. Lydia will show you some of them later. And so there's a strong preference share for Vonjo, but it needs some time until we make sure that this messaging is getting understood. We have seen some positive signals during the second half of the quarter. And what we see is, you know, this is what we announced because we wanted to give you a fair appraisal where we are and where we are not. And this is the 29% growth of March versus the average of January and February. And so we are confident about this product. It is not growing, you know, at the pace we want at this point of time, I mean, needless to say. but to the feedback that we get now and the indicators make us believe that we have, that we're on the right path and that's what we said also in our report. Next slide. Yeah, strong demand in hemophilia. I think, you know, is this a reason to change our perspective on the franchise? We think this is a stable, growing business, you know, and obviously we get a positive We got a part of this uplift for the reasons that I mentioned. This is an important franchise, and we can't wait to add FNS Octocock Alpha to this franchise. Next slide. This is the RSV season, and as you can see, when you look at this on a seasonal basis, which is not so obvious when you just look at the Q1 data, Yeah, the season was not the best season as we reported last year. Started a bit late. And, you know, Bay Fortis obviously being a formidable product and there is an asymmetry between the value of a Bay Fortis patient obviously and synergies. Therefore, it's a little bit difficult to predict this at times. But, you know, we stay very positive about this franchise overall and think that they're that when you look at it even on a calendar year basis, that there's a positive outlook, and clearly there's a positive outlook once the new market dynamics have been established, and we believe in the future of Bay Fortis. And don't forget that over time, our royalty percentage is also increasing, so we should get it. a dual benefit from the increase of adoption, but also from the increase of our participation in the earnings stream. Next slide. Tami Fund's strategy is working out. We're very happy with the Q1, which is in line with previous quarters. But overall, it's obviously a massive change versus the Q1 that we had last year. And we believe in the future of this product. Secondary HLH submission coming, new data coming for Gummy Fund. And hence, we are quite bullish about this product, even though it's sometimes quite difficult to predict given the small number of patients and the relatively high value per patient. And Kineret, very gratifying to see this now. They see evolution for the product and making good strides. And after we had to wash out of the COVID business, the product is now following a more normal pathway. Next slide. I think now it's time to hand over to Hendrik, who will update you on the financials.

Thank you, Guido, and hello, everyone. So if we go to the next slide, please, and the key financials for the first quarter in 2024. So as we heard, Q1 was a very strong growth quarter with a solid business performance, revenue growth of 20% at CER, and an adjusted EBITDA of 37%. If we look at the bars to the left, we see the consistent trend in hematology, reflecting the 46% growth in Q1 through strong double-digit growth for both Nocta and Alperix, Dr. Letzesta Valley, and the additional Wonjo, and the last revenue from the discontinued manufacturing of Refacto. In immunology, which was down 11% versus Q1-23, we saw Gamifant deliver 100% growth over Q1 last year, representing the fourth consecutive quarter with sales in excess of 400 million SEC. So the decline in immunology is explained by the new situation in RSV with the launch of Bay Fortis and an earlier peak of the RSV season. Stimulus declined by 63%, and this was only partly compensated by royalty revenues from Bay Fortis in the quarter. But as the new dynamics settled in this market, we have a very positive view on the franchise, even if seasonal patterns of Bay Fortress royalties could differ from those we have had for synergies. And as you saw in the Q1 report, in order to adapt to a lower demand of synergies in the quarter, we took the unfortunate but necessary decision to reduce the synergies commercial organization by approximately 70%. So over to the table on the right, revenues reached almost 6.3 billion, and this was the 20% at constant currencies. The lower adjusted gross margin in the quarter of 76% versus 80% in Q1-23 was from the impact of lower RSV sales in the same period last year, including some inventory adjustments, as well as other country and product mix effects. The adjusted EBITDA margin reached 37%, below last year of 40%, of course impacted by the lower gross margin that I just mentioned. Focusing now on the operating expenses in the quarter, we saw a growth of 17% at CER versus the same period in 2023. FT&A, excluding non-recurring costs, increased by 13%, mainly related to VONJO, which was not there in Q123, but also accelerated activities for launch products. R&D expenses, excluding non-recurring costs, increased by 24% at CER, mainly also due to the addition of VONJO, but also the filing activities for SAL212. The non-recurring costs or items affecting comparability amounted to $155 million in quarter. This resulted from cost related to the integration of CTI of 42 million as well as the restructuring of the synergies commercial organization which I just mentioned amounting to 85 million. Moving forward we don't expect any material additional non-recurring costs from the acquisition of CTI except for the adjustment to COGS related to the fair value of the acquired inventory. And for details on these non-recurring items in the quarter, please see page 3 in the Q1 report. The operating cash flow in the quarter was 2.3 billion, 14% higher than the same quarter last year, reflecting an improved working capital. And as a result, the net debt at the end of the quarter was 18 billion, a reduction from 19 billion at the end of Q4. corresponding to a net debt to EBITDA ratio of about 2.3 and reflecting our consistent cash flow generation. If we go to the next slide, please. Add a look at the financial outlook for the full year. As usual for revenue growth at constant exchange rates and adjusted EBITDA margin. So we confirm the guidance for the full year, meaning that revenue is anticipated to grow by high single-digit percentage at CER, and the adjusted EBITDA margin is anticipated at the mid-30s percentage of revenue. We expect the main drivers of growth in 2024 to be the same as we discussed in connection with giving this guidance the first time, at the time of the Q4 report, and those were the uptake of Bonjo, including, of course, the full year impact, the launch product Stop to Let, Aspa Valley, and Gamifunds, and the royalties for May 40s. In reflecting over the high single-digit full-year revenue forecast versus the 20% growth that we've seen in Q1, we should remember that we are early in the year and that there are a few factors that can be expected to be different for the rest of 2024 compared to Q1. First, hemophilia product sales. In the quarter, we had Sales of close to 2 billion, growth of about 15% at CER. This was driven in part by facing of international orders. And due to the facing of these orders, although we expect to maintain very strong position, we do not expect the same growth rates for the rest of the year. Second, as we heard, there was a 0.6 billion sales of Dobson to China in Q2-23. And as you probably know, we don't expect any further sales of Dobson to China at this stage. We still expect material growth in our ex-China Dobson sales for the rest of the year. But the growth rates will be impacted by the China sales from Q2-23. And third, Gamifan saw a significant step up in sales in Q2-23 to more than 400 million SEC, which we have now maintained the last four quarters. And with the comp starting in Q2, it will be more difficult to show significant growth in percentage terms compared to the situation in Q1. And finally, we had the final refacto manufacturing revenue of $375 million in Q1, and there will be no more sales of refactos moving forward. So with the outlook covered, I will now hand over to Lydia. Thank you.