Swedish Orphan Biovitrum AB (publ) NASP and Uncontrolled Gout Call Transcript

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

Question: Gonzalo Artiach Castanon - Danske Markets Equities - Analyst : Gonzalo Artiach from Danske Bank. I have two for Dr. Baraf. The first one, it's on the comparison between KRYSTEXXA and NASP. And we know that from a response rate endpoint perspective, the COMPARE study did not show a statistical difference between the two drugs, but NASP patients showed lowering levels of serum urate maybe faster than KRYSTEXXA. So how would you compare these two options? And the second question also for Dr. Baraf. It seems that on paper, KRYSTEXXA combined with methotrexate, which is already approved that combination has an improved efficacy profile versus monotherapy. But you said that there is some reluctance on the use of this combo in the clinic. So in your practice, what proportion of patients eligible for uricase treatment would you put in the combination therapy and in monotherapy? And what will be your to-go-patient group? Treatment-naive patients for NASP or patients that do not respond properly to this methotrexate combination? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 16, 2025 / 2:30PM, SOBIV.ST - Swedish Orphan Biovitrum AB (publ) NASP and Uncontrolled Gout Call Herbert Baraf - Swedish Orphan Biovitrum AB - Clinical Professor of Medicine, George Washington University Associate Clinical Professor, University of Maryland Let me see if I can retain all the elements of those two questions. In the COMPARE study, to me, what's struck me -- first of all, the comparison was between NASP and pegloticase without methotrexate. And the primary endpoint was patients who achieved superior results in both the three- and the six-month periods. And NASP just missed superiority for the combination result, but at the three-month result was superior. If you look at the time of uric acid suppression in NASP, most of -- there was a superior outcome through probably the fourth month, and then the loss of efficacy of NASP came up to the same level as the loss of efficacy with pegloticase, at least that's how I interpreted it. And it's the difference in the two curves probably would indicate that even if the patient didn't sustain a superior outcome at six months, I think it was numerically superior, that period of time of difference likely led to a significant difference in the amount of urate burden at the end of the treatment period. So my impression is that NASP performed superiorly in that setting. The practical question, who's going to get NASP as a first option and who's going to get pegloticase. I think pegloticase will still take the lion's share for a few reasons. One is that it's been in the marketplace and people are comfortable with it and certainly in the first few years. But the advantages for a four-week versus a two-week are those of convenience. There's a maldistribution of rheumatologists in the United States. And in addition to that, there's an inadequate supply of rheumatologists. And these would be the people who would be administering the drug. So patients who have to travel the distance will find an every four-week option better than an every two-week option. It's conceivable that pegloticase will get an every four-week indication. And then how does it differ? I think the main difference would be -- well, the initial difference would be, is the patient a good candidate for methotrexate? Does the patient drink? Is the patient reliable enough to take their co-therapy, their methotrexate, on a regular basis, and not skip out on doses. NASP gives the doctor 100% control of the treatment end to end where you're relying -- I don't think rheumatologists are at all worried about methotrexate except for the compliance issue and for the occasional patient, not so occasional in the gout population with an alcohol problem or with liver function abnormality. So I think that's how it will sort out. And overall, I suspect that having two drugs in the market -- oh, and the last one is that both drugs are immunogenic. Once immunogenicity is established neither for either drug, the drug is no longer valuable. And although we don't have any data or any knowledge about cross-reactivity, we don't see cross reactivity with other biologics that have similar mechanisms of actions. For example, TNF inhibitors, there's no cross-reactivity of immunogenicity with the monoclonal antibodies used to inhibit TNF. So I think there's clearly a niche for a new entry and a niche for an alternative, a niche for patients going from NASP to pegloticase or pegloticase to NASP that will probably be tested in the marketplace, not necessarily in the clinical trial world. But as a practical consideration, these patients are fairly desperate, and desperate patients require desperate measures. I hope that helps.

Question: Mattias HSggblom - Handelsbanken Capital Markets AB - Analyst : I have two questions for Sobi, I guess. And the first one is the platform ImmTOR has never been manufacturing larger commercial volumes. So can you talk about your confidence in the CMC package? And if you can remind me how and where you intend to manufacture NASP and the status of any FDA audits? And then secondly, in 2020 at the CMD in December, you described the peak sales potential of the project at the time called SEL-212, a SEK3 billion to SEK5 billion; in dollar terms at the time, $350 million to $600 million roughly. Is that still how you feel about the opportunity five years later? Or how would you describe it? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 16, 2025 / 2:30PM, SOBIV.ST - Swedish Orphan Biovitrum AB (publ) NASP and Uncontrolled Gout Call

Question: Michael Leuchten - Jefferies LLC - Analyst : Two questions, please. One for Dr. Baraf. Just going back to phasing of products. Just interested in the data that you showed on eGFR in the active arms versus control are quite compelling. And I suspect whether that's a spot estimate or just looking at the eGFR slope, that's quite a strong argument to use the product earlier than existing alternatives. So just going back to your comment that pegloticase will remain as the first-line option. Why wouldn't the data in and around the existing comorbidities push for early use already? And then I guess related to that, what's the clinical burden of proof now for these comorbidities? Does it require CV outcome trials, or do you think there's enough data to make that case for the comorbidities? And then a question for Guido. Just in terms of market access expenses, how do we think about the phasing of those as we head towards the June 2026 PDUFA?