...My name is Ludvig Svensson, and I'm an equity analyst here at the bank. With me today, I have Klaus Sindahl, who is IR at Hansa Biopharma. Welcome, Claus.
Good morning. Nice to be here.
Yeah, thank you for being here, so you released your Q1 report this morning. Could you please start with going through some of the progress that you have made during the quarter?
Absolutely, I would be happy to. Yeah, so this morning, we released our Q1 report, highlighting good progress on our commercial launch activities and market access in Europe. As you may be aware, we have recently secured Spain, which will complete market access in the five largest markets in Europe, representing 2/3 of all kidney transplantations and 12 markets in total. So we have good progress on that side. We expect, however, not to see effect from Italy, Spain, and the UK towards the second half of the year, because it takes typically six to nine months to implement new guidelines and local protocols to these markets, as well as the clinics obviously needs to be clinical ready to take on patients.
So, so good progress on the market access side. We have also highlighted in our report that we have expanded our commercialization partnership with Medison Pharma to also cover the Baltics. Fifteen months ago, we announced the collaboration for the first time, covering Israel and select Eastern European markets. So, that's great that we can expand access to new markets. On the performance, the first quarter came in with revenue of SEK 24 million , whereof SEK 14 million from product sales. We have always said that sales will fluctuate a bit between quarters, so sometimes a bit lower, sometimes a bit higher.
It's fairly unpredictable at this stage, given that we only have conditional approval, and we need to establish a foundation at the clinics where we start to see positive experience, repeat business, et cetera, but we're actually seeing now repeat business at select clinics, and also, we have reasons to believe that sales will pick up significantly in the second half of the year, as the Eurotransplant allocation system will undergo some changes this summer, allowing for more organs to be allocated to highly sensitized patients, so patients who previously were incompatible will now have access to more organs through the allocation systems, and then in the second half, we should also see those countries I mentioned before kick in more materially in terms of sales.
I have to highlight, however, that we are still running the post-approval study, which whether we like it or not, will have an impact on the commercial sales as we are running this post-approval study in parallel with the commercial launch in 50 patients. 50 patients who potentially could have been commercial, but this will actually help us to generate valuable experience in the clinics, which then afterwards can be converted into commercial sales. So we are actually very happy with this study also. If we look at the pipeline, we have communicated that we are very close to completing enrollment in the US ConfIdeS study. This is the pivotal phase 3 study leading us into the US. We have 62 out of 64 patients enrolled.
What is critical here to understand is that patients will not be randomized until they have actually been offered an organ. So this process will take a few months on top of enrollment. So we expect a randomization to be complete towards the end of this year. Then there will be a 12 month follow-up before we potentially can file a BLA, as we have communicated. Then we have also communicated end of the first quarter that we have completed the enrollment in GBS. This is the second indication we have in the autoimmune space with an addressable patient population of you know thousands of patients because it's less rare than the Anti-GBM indication we've talked about previously.
So we expect high-level data from GBS to come out in the second half of the year, and then we will have a comparative outcome analysis versus a historical cohort from the IGOS database in Rotterdam, and that's expected to be announced in the next year in twenty-four, where we would compare efficacy. This is what to look out for. And then finally, we have also communicate that we have started a new clinical study with our second-generation enzymes. So the lead molecule is HNSA-5487, and this is where we are investigating potential repeat dosing, which will open up a new space for our antibody cleaving enzyme technology, because we potentially can deal with these relapsing diseases, dealing with these flares.
We have commenced a clinical study in healthy subjects or volunteers initially, and expect that to probably be complete within a year or so, and then we would pursue an indication after we have received the data. So that's a wrap-up of what we have communicated in the report.
Okay, great. So you touched on it, but, you expect the sales to pick up, the second half of this year, if I understood you correctly?
Yeah, that's correct. As it is with the new transformative therapies, it takes time. I mean, and also in this case, I mean, it's a completely paradigm shift within transplantation, so we need to ensure that the first clinics, you know, see positive outcome before they will start to treat the next patients. We will also see that sales will be dependent on market access. As I mentioned before, we have secured market access now in all of the five major markets, but local protocols and procedures and guidelines needs to be implemented before we will start to see sales pick up in those markets, and that's expected in the second half of the year.
And then there, there's also this change to the Eurotransplant system, which will support sales in this second half, as it's expected to be implemented during the summer. So all of that should be beneficial for our sales in the second half of the year.
Mm-hmm. Perfect, Claus. Thank you for this wrap-up.