Swedish Orphan Biovitrum AB

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

Yeah, thank you. Hello, everybody. This is Guido Oelkers, CEO of SOBI. We are delighted to welcome you to the second quarter 2025 conference call for investors and analysts. We posted this presentation to SOBI.com earlier. forward-looking statement as per usual. Please take note of this. And with this, let's go right into the next slide. Today, we plan to cover key aspects of our Q2 report. I'm joined by Henrik Stenqvist, our CFO, and Lydia Abarth-Franch, head of R&D and chief medical officer. We plan to review the presentation first and then have a Q&A until around 3 p.m. CET. For those on the phone, please join the queue. And for questions, as mentioned, please press star one. And we ask you to only ask, really request only to ask one, maximum two questions at a time. Let's go to slide number four. You know, the second quarter, when you elevate yourself, was really for us about, you know, strong economics, drive important pipeline milestones, and create economic preconditions to support our future growth ambitions. So with regard to the first subject, strong economics, we delivered 6.2 billion revenues representing a 22% growth at constant currency and our adjusted EBITDA was at around 34%. I think it's important to note that our strategic growth portfolio or portfolio is accounting now for 55% of total revenues and grew impressively 65%. And this supports, you know, our quest of transforming Sobi into the next phase. And the growth was driven by Altuvox, Dr. Lead, Asper Valley and Gamifund. Wonjo had a slower quarter and showed a 4% decline. We'll talk more about it because it's primarily driven by the gross-to-net effect. On the R&D milestone side, we were able to show an approval of Gummy Fund in HLH, MAS, and SILS disease by FDA, marking a significant expansion of our potential market. We were able to complete the filing for NASP with the FDA in an uncontrolled gout. And we were also able to present very strong 52-week data for Asper Valley in the two nephrology indications. As regards to economic preconditions, to support our launches and our ongoing R&D projects primarily, we were able to sign a royalty agreement that we will talk more about with Appellis. And we were taking out costs in the organization in a very selective way, and Henrik will talk more about this. On guidance, we have obviously a strong momentum, and we are very confident about our business also growing this into the future. But at this moment of time, we feel it's prudent, let's say, to confirm the guidance that we set out earlier and not going ahead of ourselves. So let's turn to slide number five. Let's look at the overall performance in more detail. We saw SOBE's continued performance in Haemophilia with strong 27% growth and the combined Haemophilia franchise growing at 24%, portraying a robust growth of Althovox in Haemophilia A. Immunology has grown at 11% by strong performance of Gramifan and Kineret, And geographically, Europe's growth of 21% has been propelled primarily by Altovocht and Doctolet during the second quarter. North America and international have been contributing growth of 16% and 44% respectively. And the growth of North America is primarily driven by Doctolet and Camifant. Let's move to the next slide. Focusing a bit more across the portfolio in the second quarter, we have seen good growth momentum and strong progress for Altovox launch within the Haemophilia A franchise. We have demonstrated growth of 32%. And we believe that this is really just the beginning for Altovox, because the growth in the first, let's say, two quarters was really primarily driven by three markets. and we have now 17 markets on stream, but most of these markets are at a very early stage, so the best is still to come. Dr. Lett showed continuous strong demand across all regions, including the US, with 43% growth in 2024. This highlights the continuous confidence in the product's efficacy and in expanding reach. For Aspaveli, we are pleased to see continued growth in the number of patients across markets, even though we are facing competitive pressure in the P&H space by Orwells. We are seeing more pressure in Europe than in international markets, but believe that we can continue driving growth with this important product for us. Wonjo experienced a 4% decline, whilst demand was increasing significantly versus Q2 last year. The decline is attributed to gross to net adjustments, which we are closely monitoring. Camifund and Kineret continue to show good demand in the US. Camifund delivered an exceptional performance in Q2 with 33% growth driven by robust demand. Overall, these results underscore the strength of our portfolio and our ability to navigate in competitive markets effectively. Please turn to slide number seven. So let's turn our attention to the continued success of Altevocht. In the second quarter, hemophilia as reported of Altevocht and Elocta grew impressively 32%. This growth is a testament to the strength of our portfolio and the successful launch of Altevocht. Focusing on Altovox specifically, the product achieved sales of 627 million SEC in Q2, reflecting a strong growth momentum. Launches are progressing well across Europe and the Middle East. And as mentioned, we have now 17 countries on stream, while the growth of the actual sales are really primarily driven at this juncture by Germany, Switzerland, and Spain. And we are also excited to announce a full launch in the UK this July, which we anticipate will further drive adoption. Overall, the launch of AltaWorks is progressing exceptionally well, and we remain focused on expanding access and delivering meaningful benefits to patients in our territories, and look forward to continuing to add launch countries in the second half of this year. Please turn to slide number eight, Aspar Valley. Let's now review the latest updates on Aspar Valley. Starting with P&H, we continue to see strong year-on-year growth across markets, driven by increasing adoption of therapy. However, we are also navigating growing competitive pressure in Europe. Moving to nephrology, we are excited about the progress in this area. In the EU, we anticipate a CHMP opinion by the end of 2025, which will be a key milestone for our portfolio. Our confidence in the product is bolstered by the 52-week VALIANT data, which were presented at ERA 2025. These results reinforce the product's best-in-class profile, positioning it as a leading option for patients in this space. Lilia will cover the results in more detail in her presentation. Additionally, we have made a significant update to our royalty agreement with Appellus. Under this new agreement, we have achieved a 90% reduction in ex-US royalty obligations until defined caps are reached. After these caps are achieved, the royalties will revert to original license agreement. This agreement involved an upfront payment of 275 million in cash, with an additional 25 million contingent upon EMA approval in nephrology. We will offset the upfront by having lower royalties both from cash flow perspective on our P&L moving forward. This deal reaffirms our commitment to our ongoing partnership with Appellus and our belief in the product's potential to deliver significant benefits to patients and to SUBI's long-term growth. Let's turn to Wonjo, where we continue to see a positive momentum despite external challenges. Demand for Wonjo increased quarter on quarter, reflecting its growing adoption. However, this growth was outweighed by continued impact of healthcare reforms, primarily to mention here the reform in Medicare and the 340B scheme. In patients with below 50,000 platelets, Wonjo has achieved a significant market share underscoring its strong position in this patient population. Looking ahead, our strategic focus for Wonjo is firmly focused on a number of elements. First, we want to continue to grow in the below 50,000 platelet population whilst expanding into the 50 to 100,000 platelet population in alignment with the NCCN guideline. Second, we are committed to generating additional data to support potential label expansion and to complete the pacifica trial which is critical for achieving full approval status and broadly internationalizing the product third we plan to leverage the pacifica data as mentioned to drop to broaden the product on a global scale and finally we are exploring new indications and in this context we need to mention the pax study where we start to enroll. These initiatives reflect our commitment to maximizing Wanzhou's long-term potential and delivering meaningful benefits to patients across a range of indications. Let's turn to slide number 10, Gummy Fund. I'm thrilled to share a significant milestone for Gummy Fund and the patients we serve. The FDA approved Gummy Fund as the first ever treatment for adults and children with macrophage activation syndrome in stills disease. This approval addresses a critical unmet medical need, where we have demonstrated compelling results. 54% of patients achieved a complete response, highlighting the therapy's effectiveness in resolving MAS symptoms at week eight, and 82% of patients achieved clinical MAS remission. This approval not only validates the strength of our clinical data, but also reinforces Gamifran's potential to transform the lives of patients with HLH and MERS-instilled disease. We look forward to further unlocking the unique anti-interferon gamma mechanism of this molecule in the future. Let's turn to slide number 12. You have seen in the first quarter that we have now made tremendous progress in our key building blocks with the approval of Gummy Fund and completing the filing in the U.S. with NASP. We continue to focus on two launches in the future now on three launches including Gummy Fund and secondary HLH. ASPA Valley is on track and a CHMP opinion is expected by end of year. And four innovative development programs are on track with first patient in achieved for the PECSIS-30 in Vexus during this quarter. These initiatives reflect our commitment to drive innovation, expand our portfolio, and to deliver transformative treatments and therapies to patients worldwide. With these investments, we are well poised to achieve sustained growth and make a meaningful impact in the years ahead. Let's turn to slide number 12, and now I'd like to hand over to Henrik, our CFO.

Thank you, Guido, and hello, everyone. So please turn to slide 13, and we will take a look at some key financial metrics for the quarter. So in Q2, our revenues of 6.2 billion corresponded to a revenue growth of 22% at constant currencies with growth across the portfolio. Growth has been driven by a hemophilia franchise, including a continued strong launch of Altobox, as well as Topselet and Gamifund. In addition to strong revenue growth, we delivered an improved Q2 adjusted EBITDA margin of 34% compared to 28% last year. So if we look at the bar chart on the left with revenues by quarter and business area, we see the solid growth in hematology of 27% in the quarter at CER, including our hemophilia A products, Eloxta and Altubox, increasing by 32% at CER. And we continue to see strong momentum for out-of-the-box in the markets where we have launched to date. In addition, we've continued strong growth in top-to-net of 43% at CER due to growth, both in the U.S. and ex-U.S., as well as with Asper Valley, driven in large part by our international region. Bonjo demand decreased quarter-on-quarter, but was negatively impacted by gross-to-net adjustments, mainly related to Medicare redesign requirements. Immunology grew at 11% in the quarter due to double-digit growth in Kindred and our highest quarter of sales to date in Gamifant. And sales in our international region was another positive for Gamifant. And as a reminder, Bay Fortis sales and the royalties we receive from Sanofi are seasonal in the second half of the year. Referring back to the table on the right and the adjusted gross margin of 77% in the quarter, a slight improvement from Q2 last year. Gross margin was positively impacted by products and country mix effects, offset by products return in synergies. And looking at the operating expenses for the quarter, we observed a 7% growth at CER compared to the same period in 2024. SG&A, excluding non-recurring items and amortization, increased by 14% at CER in the quarter, driven by launch and pre-launch costs for Altevocht, Asper Valley in nephrology, and NASP. And this was partially offset by lower costs for synergies and Elocta. R&D expenses declined by 8% at CER, excluding non-recurring items, mainly due to NASP programs that are now complete. And this was partially offset by post-approval development costs for Altevoxt and development costs for Gamifund and Bonjo. We're also investing in the four innovative programs for Bonjo in Vexus and CMML, Altevoxt in Sinobitis, and Gamifund in IDS. Operating cash flow for the quarter was 1.4 billion. The decrease from last year is mainly due to the seasonal shift of RSV revenues to the second half of the year, partially offset by higher operating profit and lower interest payments. Net debt continues to go down, ending the quarter at $11.4 billion, corresponding to a net debt to EBITDA ratio of 1.1 times. Please turn to slide 14. And I would like to take a moment to address the restructuring charges of 208 million recorded this quarter. And you will find additional details on page three of our report. And this was a proactive and strategic decision aimed at positioning our organization for long-term success. As Guido mentioned earlier, we are in a phase with two major launches, three key filings, and four high-priority development programs. These initiatives require focused investments and organizational agility. We see it as a reallocation of resources, prioritizing areas that will drive innovation and deliver the greatest impact. While these decisions are never easy, they are necessary to ensure responsiveness and focus on the right key priorities going forward. Next slide, please. And we will now discuss the financial outlook for the full year 2025. As usual, this outlook is based on revenue growth at constant exchange rates and adjusted EBITDA margin. For the full year 2025, our outlook is unchanged. We anticipate revenue to grow by a high single-digit percentage at CER and an adjusted EBITDA margin in the mid-30s percentage of revenue. The key considerations for our outlook have not changed since Q1. To start, the royalties we received from Sanofi for Bay Fortis sales remain the largest uncertainty, both for revenue and beta margin guidance. While our view on Bay Fortis is clearly positive, we do not control the outcome. And there are unknowns related to new competition in this space, as well as other factors within the U.S. healthcare landscape. However, we are continuing to see strong patient uptick in out-of-box markets where we have launched, with more major markets launching in the second half of the year. We also expect continued progress with our current commercial portfolio. In regards to our EBITDA margin guidance, we will increase investments in our pre-launch assets, specifically NASP and S&LE in nephrology in the second half of the year. In R&D, we have the four priority development projects. On a final note, these are uncertain times for forecasting with everything that is going on in the world and in our industry, and many of these topics are still unknown and speculative, making them difficult to quantify and comment on. Having said that, and as evidenced by our Q2 report, we have very strong momentum in our business going into the second half of 2025. And I will now hand over to Lydia. Thank you.