Swedish Orphan Biovitrum AB (publ) Q2 2025 Earnings Call Transcript

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

Question: Gonzalo Artiach Castanon - Danske Markets Equities - Analyst : I have a couple of them. The first one is on your guidance. Does the lack of top line guidance upgrade come only due to questions or uncertainty on Beyfortus' performance in the second half now that there is a competitor around? Or is there anything else that we are missing or being overoptimistic right now and should be more cautious? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JULY 16, 2025 / 12:00PM, SOBIV.ST - Q2 2025 Swedish Orphan Biovitrum AB (publ) Earnings Call And my second question also related to guidance, is on your EBITA margin. I mean, I guess that one of the main reasons for keeping it at mid-30s is due to the base assumption that you guys will receive priority review for SEL-212, which would imply, I would say, high OpEx already in H2 ahead of launch in early 2026. But if you guys do not secure priority review, what will be the impact in your adjusted EBITA margin since the potential approval would come then in mid-2026, if I'm not wrong? Would it make sense to assume you would push SG&A to next year, which would raise your adjusted EBITA margin for 2025 mechanically?

Question: Mattias Haggblom - Handelsbanken Capital Markets - Analyst : Mattias Haggblom, Handelsbanken. I have two, please. So firstly, Roche presented data from a Phase I/II study for its next-generation bispecific [presented] at ISTH. The majority of patients developed antidrug antibodies against the therapy to the extent that their PK data was affected. I was curious if Lydia had any thoughts at this stage of a candidate with such a profile and what to look for in the future programs? And then secondly, with regards to Vonjo, I can't recall we spoke about the confirmatory PACIFICA trial for a long period of time, ClinicalTrials.gov listed it as a reading out late '26. I'm not sure that's up to date. How is the trial enrolling? What are the time lines? Have you activated more sites than originally planned? It's not listed as a pipeline event on the news flow slide. So I guess it's later than '26. That's it.

Question: Mattias Haggblom - Handelsbanken Capital Markets - Analyst : Yes. Sorry for being confusing here. So Roche bispecific next-generation 007 a majority of patients developed ADAs. I was just curious to hear how you thought about that to the extent that PK was affected on the therapy.

Question: Mattias Haggblom - Handelsbanken Capital Markets - Analyst : And then PACIFICA, any update on time lines when we should expect data from this confirmatory trial for Vonjo?

Question: Christopher Uhde - Seb Enskilda (London) - Analyst : Two, if I may. Altuvoct, the first and then the reorganization, the second. So Altuvoct continues to impress, of course. How much of the sequential growth is Germany, Switzerland and how much the other countries? Or put another way, how do the initial launch trajectories in other markets, especially Spain, compared to that of Germany? And my second question is, so the market seems to be interpreting the reorganization and maybe in combination with the Apellis renegotiation pretty negatively as if you're, I don't know, looking for ways to squeeze more margin for something you hadn't previously planned. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JULY 16, 2025 / 12:00PM, SOBIV.ST - Q2 2025 Swedish Orphan Biovitrum AB (publ) Earnings Call Could you expand on the reasons for the reorganization and negotiation, particularly what you might use any added margin headroom for, if anything? And perhaps given that you've got three launches, to what extent has your thinking and expectations changed around those launch costs over time?

Question: Alistair Campbell - RBC Capital Markets Inc - Analyst : I've got two, please, if possible. Just first of all, I wonder, Henrik, if you could give us a bit of thinking about medium-term R&D expenditures (technical difficulty) stepped up quite a bit in the last couple of years, partly after the CTI deal. But what should I be thinking about absolute R&D expenditure maybe for the next sort of two, three period? Is there much more to come in terms of an uplift there? And then secondly, Guido, I'm sure your business development teams are as busy as ever. I just wonder if what you've experienced with CTI, are there any learnings from that acquisition from the process there that you've taken forward to inform BD activity and your thoughts on future deals?

Question: Viktor Sundberg - Nordea Markets - Analyst : I also have another Vonjo question just on the same topic, you mentioned some of the unforeseen events here for Vonjo that we're now seeing in the numbers. So I don't know if you can answer this, but just wondering what risks should we have in our model for any kind of impairment on CTI? I mean if it keeps underperforming in H2, we could see negative growth on this asset on a year-over-year basis, which I guess was not part of your forecast when you acquired the asset. So just wondering how we should view that risk of any kind of trigger event for any impairment? And then also a second one, perhaps on VEXAS syndrome also. Even if prevalence numbers are out there, I guess, very few receive actual treatment today. So do you have any data on how many patients are confirmed by UBA1 gene testing and have a confirmed VEXAS diagnosis? And how much work do you expect you need to kind of create awareness of this product and have doctors start testing for UBA1 gene to formally diagnose patients?

Question: Christopher Uhde - Seb Enskilda (London) - Analyst : I'll keep it very short. Could you just tell us what the bar for success is in your view for Gamifant in IDS for the Phase II?

Question: Christopher Uhde - Seb Enskilda (London) - Analyst : Yes, sorry, that's actually not what I meant. I meant more in terms of what would you be looking to see in terms of driving a go/no-go decision on Phase III? Sorry about that.