The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Christopher Winston Uhde - SEB, Research Division - Analyst
: Congrats on a solid quarter despite difficult circumstances. So the first question, the EU ITP timeline is still 2021, but why the delayed launch in CLD
in the EU? Because I think at the deal announcement, it was originally 2019. That's the first question. Then can you provide some detail on your
expansion into Asia? I mean, particularly what products are sold directly by you there now? And what are your plans for the future with your current
stable of products? Or what's the orders in the pipeline?
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JULY 16, 2020 / 11:00AM, SOBIV.ST - Q2 2020 Swedish Orphan Biovitrum AB (publ) Earnings Call
Question: Christopher Winston Uhde - SEB, Research Division - Analyst
: Okay. And then a couple questions on Haemophilia and SEL-212. So Haemophilia in the wake of the U.K. tender agreement, will there be any
temporary negative impact from lower pricing? And if so, when should we expect it? And then as far as Haemophilia factor consumption is concerned,
how much of the effect Q-on -- year-on-year was the result of lower activity on the part of patients and how much is from fewer surgical procedures,
if you know? And then for SEL-212, are there any obvious antitrust -- potential antitrust issues that I'm missing? Or do you expect this to be
straightforward from an antitrust perspective, at least? And then lastly, there -- is there a scenario in which SEL-212 could get accelerated approval
on the basis of COMPARE?
Question: Christopher Winston Uhde - SEB, Research Division - Analyst
: Yes. Great. And then the last one was about whether you could get accelerated approval for it on the basis of the COMPARE trial?
Question: Christopher Winston Uhde - SEB, Research Division - Analyst
: I just wanted -- had a couple of quick follow-ups. So I guess, the manufacturing revenue, 2 consecutive quarters of quite high performance. Should
we be expecting that to drop back down or is this the new normal? And the last question I have was this type 2 variation submission. Is this -- I
mean, I'm a bit confused as I think that was basically like a reformulation. Is this an [SFDA] or -- type of thing equivalent for Europe or I mean, why
bring it up if there are no new safety findings?
Question: Christopher Winston Uhde - SEB, Research Division - Analyst
: Sorry?
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JULY 16, 2020 / 11:00AM, SOBIV.ST - Q2 2020 Swedish Orphan Biovitrum AB (publ) Earnings Call
Question: Christopher Winston Uhde - SEB, Research Division - Analyst
: It was the Kineret for -- or is it -- it was one referred to in the report, yes, for the Sobi.Anakin-302 [instills].
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