Swedish Orphan Biovitrum AB (publ) Capital Markets Day Transcript

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

Question: Christopher Winston Uhde - SEB, Research Division - Analyst : So I have a number of questions. I think I'll start with Gamifant, if you don't mind digging into some detail right away. So on GVHD, can you -- so explain a bit more why you talked about going for patients resistant to standard of care, which I can only presume is ruxolitinib. The reason I ask is because, I guess, they use the same downstream mediator or they target in downstream mediator effectively JAK1, 2, right? That's my first question.

Question: Christopher Winston Uhde - SEB, Research Division - Analyst : Okay. And that leads me to my second question on Gamifant. So can you comment a little bit on the biomarker impact as well as the potential impact, let's say, on study design, particularly endpoints in indications for Gamifant in general, not just for this. But also then on -- to what kind of data do you have at present in terms of how it would affect the addressable market, if there would be a label based, let's say, purely on biomarker expression for at least everything but primary HLH.

Question: Christopher Winston Uhde - SEB, Research Division - Analyst : Exactly.

Question: Christopher Winston Uhde - SEB, Research Division - Analyst : Well, I'm also wondering about the RHLH and infectious HLH.

Question: Christopher Winston Uhde - SEB, Research Division - Analyst : Okay. And then when it comes to SEL-212, I have basically 2 questions there. The first, you talked about potentially building on the program data, on the existing program for more trials to build out the data. And I just wondered if you could give any kind of sort of time scale on that? I mean, REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 10, 2020 / 12:00PM, SOBIV.ST - Swedish Orphan Biovitrum AB (publ) Capital Markets Day are we talking about trials that could potentially read out ahead of launch already? Or is this more of a long-term aspiration? That's the first part of it, yes.

Question: Christopher Winston Uhde - SEB, Research Division - Analyst : Terrific. And then the second SEL-121 question that I have is -- so when it comes to at least with European commercial opportunity, I guess, the orphan designation works differently in Europe than in the U.S. And so 1 sort of argument to why it will be more challenging in Europe would then be -- while you won't be able to salami slice down to chronic refractory gout or tophaceous gout in the same way you could in the U.S., which has been why Horizon didn't go there. So could you perhaps comment on well, why you might expect to get an orphan designation? What particular aspects there are that you can leverage to do that? Or if you don't plan to go for orphan or whether either 1 is a possibility.

Question: Christopher Winston Uhde - SEB, Research Division - Analyst : No, no, that's very understandable. And my last question then would be, can you comment on what it would take coming back to Gamifant to -- well, for the Nacho guidelines to become the way that yes, that payers see reimbursement in the U.S.?