This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
7/16/2026
Please note, anyone who wishes to ask a question during the conference may press star and 1 on the touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to use only hands as well as connect questions. Please hold the line. The conference will begin shortly. Thank you. Please note, anyone who wishes to ask a question during the conference may press star and 1 on their touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to choose only hands as well as in a question. Please hold the line. The conference will begin shortly. Thank you. Orphan Biovitrum AB Please note, anyone who wishes to ask a question during the conference may press star and 1 on the touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to use only hands as well as connect questions. Please hold the line. The conference will begin shortly. Thank you. Please note, anyone who wishes to ask a question during the conference may press star and 1 on their touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to choose only hands as well as any questions. Please hold the line. The conference will begin shortly. Thank you. Orphan Biovitrum AB Please note, anyone who wishes to ask a question during the conference may press star and 1 on the touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to use only hands as well as connect questions. Please hold the line. The conference will begin shortly. Thank you. Please note, anyone who wishes to ask a question during the conference may press star and 1 on their touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to use only hands as well as in a question. Please hold the line. The conference will begin shortly. Thank you. Orphan Biovitrum AB Please note, anyone who wishes to ask a question during the conference may press star and 1 on the touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to use only hands as well as connect questions. Please hold the line. The conference will begin shortly. Thank you. Please note, anyone who wishes to ask a question during the conference may press star and 1 on their touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to use only hands as well as in a question. Please hold the line. The conference will begin shortly. Thank you.
Ladies and gentlemen, welcome to the SOBI Q2 Results 2026 Conference Call and Live Webcast. I am Valentina, the Chorus Call Operator. I would like to remind you that all participants will be in listen-only mode and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Guido Oerker, CEO. Please go ahead.
Yeah, thank you. Hello, everyone. This is Guido Oerker, CEO of Sobi. We are delighted to welcome you to the second quarter and half year of 2026 conference call for investors and analysts. Our presentation was posted on Sobi.com earlier today. Please turn to slide number two. We would like to remind you of the usual provisions on statements about expectations and projections of future events. Unless stated otherwise, we are making comments that mostly relate to the second quarter at constant currency exchange rates and a million Swedish krona. Please turn to the next slide. Today, we plan to cover the key aspects of our Q2 report. I'm joined by Henrik Stenqvist, our CFO, and Lydia Barth-Franzsch, head of R&D and chief medical officer. We plan to review this presentation first and have Q&A until around 3 p.m. today, Central Eastern European time. For those on the phone, please join the queue for questions by pressing star 1. If joining on HD Audio, please use a virtual keypad and press star. We propose that you ask only one, maximum two questions at a time. Please turn to slide number four. It's about the key takeaways for Q2. Let me start with the key messages from what has been a very strong quarter for Solvi. In Q2, we delivered revenue growth of 29%, at constant exchange rates alongside adjusted EBITDA margin of 35%, which clearly demonstrates both the strength of our portfolio and the quality of our execution. This performance was broad-based, driven by our strategic portfolio, supported across all regions, which again highlights the resilience and scalability of our business model. We are pleased with the progress with our latest new newest launches such as ASPA Valley in Europe, and at the same time, we delivered positive data from the REDUCE-2 trial for POTS to itinerate. We continue to make tangible progress across the entire pipeline. We are advancing gamifant and interferon gamma-driven sepsis with EMBRACE-2, expected to initiate it in the second half of this year. Additionally, while we received a complete response letter from NASP related to manufacturing, the path to submission is clear and we are taking the necessary steps to address the concerns of the agency. Importantly, based on the strong first half performance, We are increasing our full-year outlook, which reflects both the momentum of what we are seeing today and our confidence in continued delivery. So overall, the message for the quarter is very clear. We are delivering strong growth, making consistent progress in the pipeline, and building further confidence in our trajectory. Please turn to the next slide. Let's take a closer look at the Q2 performance. Growth was very well diversified across regions and segments. We delivered total net sales of just under 7.8 billion SEC in the quarter, corresponding to growth of 29% at constant exchange rates. which is particularly important here is the quality of that growth. It is driven primarily across our strategic portfolio which accounts around two-thirds of our group sales in Q2 and continues to grow significantly faster than the rest in the rest of the year. From our geographic perspective, the growth was very well diversified across all regions north, America delivered growth of 33%, international markets grew by 45%, and Europe contributed 23%. At the product level, we continue to see strong contributions from Dopdelet, Altuwacht, and Gamifund, whilst newer launches such as Asper Valley are building momentum and expanding their contribution. Taken together, this is a gross profile that is diversified, sustainable, and increasingly driven by high-value innovative medicine. Please turn to the next slide. Let me now turn to our pipeline and development progress. We continue to execute against a focused and disciplined development strategy, which with multiple programs advancing in parallel and delivering important During the quarter, we announced positive plotline results of REDUCE-2 with poitinorad, which demonstrated meaningful urate reduction alongside its favorable efficacy and tolerability profile. At the same time, we are progressing Gamifront in interferon gamma-driven sepsis, where we are aligning closely with regulatory authorities and preparing to initiate the EMBRACE-2 study in the second half of the year. Across the broader portfolio, we continue to see steady progress in regulatory filings, lifecycle management, and new indication development, which together underpin a strong and balanced pipeline. Overall, this pipeline represents a diversified set of launches throughout 2028, supporting our ambition to reach approximately 55 billion SEC in revenues by 2030. Let's look at a few products in more detail. Altovoct, next slide, please. Altovoct continues to perform extremely strongly and is establishing itself as a best-in-class product in Haemophilia A prophylaxis. In Q2, Altowalk delivered very strong growth with sales increasingly significantly on a year-to-year basis, supported by both new patient uptake and continued geographic expansion. We have now launched in 30 markets, including key European markets. We are progressing a three-wave launch strategy, allowing us to increasingly expand our share of the total market potential in the segment. During the quarter, our combined Haemophilia A sales grew by 41% at constant exchange rate. This performance reflects the strong clinical profile of Altowogt and the disciplined launch execution. Please turn to the next slide. The launch strategy in nephrology is progressing well across markets, and we are seeing incongruently early momentum supported by an expanding evidence base. During the quarter, we continued to expand access, including approval in the UK, and we are seeing increasing uptake in markets where reimbursement is already in place. National reimbursement is now in place in Spain or by coming towards the end of Q2. We have introduced the ENFUSE on-body delivery system with the first patient now dosed and very positive initial feedback which reinforces the differentiation of the product. Importantly, the new term outlook, long-term outlook and real-world data continue to support the clinical profile in line with a strong pivotal variant data. We are well on track to reach our 2026 target of four to 500 patients in nephrology, which underpins our confidence in the long-term potential of this franchise. Please turn to the next slide. So Dr. Lett continues to deliver consistent performance and is now firmly established as a leading global franchise. Growth is being diversified and is built on a differentiated product portfolio, including strong efficacy, pure dietary restriction, combined with an excellent execution. We are also continuing to expand internationally with the recent launches across Asia, Latin America, and other regions contributing to an increasing ex-US contribution over time. Overall, this remains a highly attractive asset with continued strong growth performance and a growing significant potential in international regions. Let's turn to the next slide. and speak about Gamifan in HLH and MAS. The US launch in MAS continues to perform well, with strong momentum driven by increasing physician awareness and new patient demand. Growth is also being supported by the expansion in international markets following the FDA label. In parallel, we have now completed filing in both Europe and Japan with a regulatory decision expected in Japan in H2, providing additional future growth opportunities for the product. Let's move to the next slide. Regarding gamifant in interferon-driven sepsis, this represents a significant opportunity both medically and strategically and we are making good progress in defining the development pathway. We had our first meeting with the Emergency Task Force on the design of the IDS program and based on the feedback, we are pursuing a large registrational Phase IIb III study in Europe through the EMBRACE II study, which we expect to initiate in the second half of this year. This study will be conducted in collaboration with the Hellenic Institute for the Study of Sepsis. Based on the data, we will then decide on the regulatory pathway. This provides a clear fast-to-market approach in the area of significant unmet medical need. While there's a lot of work still to be done, we believe that this represents a very meaningful opportunity to address in a high unmet medical need and further strengthens our pipeline. Let's move to the next slide. Turning to our gout franchise. We are building a leadership position across multiple segments in the gout market. For NASP, we received a complete response letter in June related to manufacturing. Not the outcome we obviously would have wished for. However, it is important to note that this is not related to clinical safety or efficacy concerns, and we have a clear plan to resubmit within the next 6 to 12 months. For POTS degenerate, the positive reduce-to data represent a significant milestone demonstrating strong efficacy and a favorable safety profile. We are pleased with the data that we have seen so far. We are on track for further data readouts and plan to progress towards filing in 2027. Together, these assets provide the foundation for meaningful and variable franchise with significant long-term potential. Slide number 13, please. Let me now turn to guidance. Based on our strong performance in the first half of the year, we are increasing our full-year outlook. We delivered outstanding first-half growth of 26% at constant exchange rate alongside strong margin development. At the same time, we have made significant progress across our pipeline. while continuing to execute on multiple key launches. Taken together, this gives us increasing confidence in our ability to deliver both growth and profitability for the full year. Now, I'd like to hand over to Luria.
You're reading a preview of the SOBI.ST Q2 2026 earnings call.
Free account.
