Swedish Orphan Biovitrum AB (publ) Q4 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Mattias Haggblom - Handelsbanken Capital Markets - Analyst : Thank you so much, (inaudible) and two questions, please. So Beyfortus royalties made up a third of your 2024 EBITA in light of a potential competitive launch by Merck ahead of the '25, '26 RSV season and the 100% margin contribution a royalty stream provides. I was curious how you incorporated that potential competitive launch into your 2025 guide. Does guidance include at Merck launches and grab a fair share of the US market season one? And as a consequence, Beyfortus royalties have now peaked in contrast to what consensus models or what is baked into your guidance? Secondly, investors appear to expect that Sobi will host a CMD later this year and perhaps provide 2030 revenue targets. Is that fair assumptions? Or are you more likely to do selective deep dives on select assets rather than host a full-blown CMD? Thanks so much.

Question: Mattias Haggblom - Handelsbanken Capital Markets - Analyst : A quick follow up if I could. Some of it said they expect to grow global sales of Beyfortus, but they refused to comment on, US sales since you only have exposure to the US portion, any insight to how you expect that market to progress in '25.

Question: Mattias Haggblom - Handelsbanken Capital Markets - Analyst : Thanks so much. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 05, 2025 / 1:30PM, SOBIV.ST - Q4 2024 Swedish Orphan Biovitrum AB (publ) Earnings Call

Question: Brian Balchin - Jefferies LLC - Analyst : Hey, yeah, thanks. Just the one question on margins. So clearly 2025 margin guided mid-30s, factors in the build out of Aspaveli in nephrology and NASP in CRG but then you look at the 2026 consensus, margins are stepping up to 40%. So Guido, it would be great to just get your thoughts on that step up into next year, just how we should be thinking about margins going forward? Thank you.

Question: Brian Balchin - Jefferies LLC - Analyst : Love it, thank you.

Question: Harry Gillis - Berenberg - Analyst : Thanks for taking the questions. I have a couple on Haemophilia A please. So given the strong Altuvoct launch in Germany, just wondering how you're thinking about your target market share. You've given the 30% to 40% range, but should we now sort of consider that your aiming for the higher end of that range and perhaps it's 35% now a reasonable floor. And then I know you've talked about considering Altuvoct and Elocta as a single Haemophilia A franchise. So just wondering, do you think you can grow this franchise as a whole by double digits consistently over the next few years? Thank you.

Question: Christopher Uhde - SEB Equities - Analyst : Yeah, I thank you for taking my questions. Two, please. First, just coming back to that 2026 margin, and I mean, noting that some of the R&D investments are obviously going to take a little time to kick off. I guess, a few trials yet to be put in. How -- I mean, is there some indication you can give on sort of a long-term floor for R&D? And also as it relates to the margin going forward, you've been on pause for a little while for BD and M&A. Is that a factor when you are guiding on the margins? Or do you tend to exclude that? And then my -- so my second question then is on Altuvoct, can you give us a sense of the demand in markets you've entered outside Germany and what proportion of switches are nonfactor therapies versus what are non-Elocta factor VIII switches? Thank you.

Question: Christopher Uhde - SEB Equities - Analyst : Thanks very much.

Question: Erik Hultgard - Carnegie Investment Bank AB - Analyst : Yes, hi. Two questions, if I may. First, on Vonjo, could you give us an update on the IP status for Vonjo and the patent extension application, if I remember it correctly, the application was pending the time of the acquisition and was expected to be approved in 2024. So I may have missed it, but I haven't seen an update on the matter. And then secondly, on Vonjo as well and the PAXIS study, is that -- do you think registrational given the unmet medical need? Or should we sort of think that additional Phase 3 studies will be required as well? And then maybe the opportunity within this indication compared to MS, if you could categorize that, that would be helpful. Thank you.

Question: Erik Hultgard - Carnegie Investment Bank AB - Analyst : (multiple speakers)

Question: Gonzalo Artiach Castanon - Danske Markets Sweden - Analyst : Hi, Gonzalo Artiach from Danske Bank. Two questions. First one is on Aspaveli. Apellis mentioned recently that they will aim to initiate two new Phase 3 studies in renal diseases in FSGS and DGF. So I was wondering what is your plan here? Do you have any intention to join on that given the strong data you saw in VALIANT or yeah, I haven't heard anything from that from you guys. And the second question is on SEL-212. Based on the interactions you have had with clinicians, what is the feedback you get for a potential launch, yeah, this year, beginning of 2026. Is it, I mean, because based on the way you have phrased it, it seems that you are more cautious in terms of that launch. So where do you see the initial patient indication? Is it in methotrexate intolerance or resistant patients or are you planning to compete straight with KRYSTEXXA and KRYSTEXXA with methotrexate? Thank you.

Question: Shelly Chen - Barclays Investment - Analyst : Hi, thank you for taking my question. I have one on Aspaveli. So we saw a slowdown of growth this quarter, and you mentioned about permutation in PNH. Just want to -- can you please talk about your observation so far Aspaveli competing with these recently approved drugs? And would you expect them to take a big role in -- towards the first-line treatment? And also what your view on the sales growth for 2025? Where we see some initial uptake from C3G and IC-MPGN towards the very end of this year? Thank you.

Question: Viktor Sundberg - Nordea Markets - Analyst : Yes, hi, thank you for taking my questions. So one question on Gamifant. Before, there have been some uncertainty if the pool data from the open-label and EMERALD trials, you have submitted to the FDA for getting it approved in secondary HLH is enough for the agency to make a decision on this indication. I guess now with more interactions, have you got more confidence that the data you have at hand is enough for the FDA to take a decision on this? And then just secondly, I think a lot of the investor debate this morning was about your outlook on EBITA margin in the mid-30s, with consensus being a bit higher here in 2025, especially as the guidance for '24 set in the beginning of last year was a good indicator of the actual outcome last year, even if you have beaten your usual guidance quite often historically. But I just wanted to understand a bit more of a kind of moving parts you expect for EBITA guidance this year, what could get you in the high end of margin or even surpassing in 2025? Thanks.

Question: Alistair Campbell - RBC Capital Markets - Analyst : Hi there, thanks for filling me in. To be honest, You have covered most of my questions, but if I could just have a follow-up on Vonjo and the PAXIS trial. VEXAS is a disease area, I'm frankly not very familiar with. But just to get a sense, as you launch that study given the biology of the disease, is that somewhere where you feel quite a high degree of confidence? Or is this more of a sort of -- well, it might work, let's give a chance? I just want to get a sense of your confidence levels as you head into that trial. And then maybe just coming back to balance sheet Guido, you obviously talked a lot about there's a lot going on internally. But with the balance sheet strengthening, do you think you would be looking at new deals and new opportunities going to this year? Or do you think focus will be very much internal?

Question: Yifeng Liu - HSBC Bank Plc - Analyst : Right, thanks for taking my question. Just one on Vonjo, specifically on CMML and you just talked about it. Could you give you a bit more color on the development time lines and when you're sort of planning to launch clinical trials and whether that's the trial has a registrational potential, how should we think of that in 2025 and 2026? Thanks.