ImmunoGen, Inc. (NASDAQ:IMGN) Q3 2023 Earnings Call Transcript

Michael Vasconcelles: I’ll just briefly respond to the second question, and I think Mark or Isabel may tackle your question about Europe. So this is a cohort expansion of a Phase I study. And so it’s essentially — think about it as sort of fully enrolling that cohort and having the sufficient data to be able to share that in totality. It’s nothing really more complicated than that and if patients remain in the cohort, it’s just prudent to — on therapies it’s prudent to wait for that to mature and we look forward to sharing those data next year.

Mark Enyedy: Great. And so in terms of Europe, I’ll start and then ask Isabel to comment further. But we were very pleased last week that the EMA had validated our marketing authorization application. And we think that sets us up very nicely for an approval late next year. In terms of the launch events, we’re on the ground already in Europe with established headquarters in Switzerland and a small stack to support the key functions around market access, regulatory and the like and are starting to build a team to support initial sales in Germany, and then there’ll be subsequent countries added on as we go forward. And then I’ll let Isabel talk a little bit about the market. And overall, the comment here is that we can address this market with a modest incremental investment for the business. But maybe just talk a little bit about the dynamics there.

Isabel Kalofonos: Yes, Mark, thank you. Well, as we have shared previously, the market in Europe is highly concentrated, and really the majority of the 65 centers account for about 80% of the patients there. So as Mark alluded to, with a small investment, we are able to reach these customers. We also have started already our engagement. And as you show, we presented at ASCO and ESMO, and we have very strong relationships with KOLs in Europe that are really excited to have this therapy available to them in a of course, our very much supporting our efforts in this. In addition to that, we are going up our team in in Germany, in all countries, and we are very excited to start our market research, our preparations to basically replicate the success of the launch that we have seen in the U.S.

Michael Vasconcelles: And 1 other point to add to that, which is Kelly, our physician base there has tremendous experience with the drug already. So when we look at MIRASOL, we look at SORAYA. More than 70% of the patients were enrolled outside of the United States, and the vast majority of those were enrolled in Europe. And so this is a group of physicians that has already significant experience with the drug. So we’re excited about our prospects there.

Operator: And our next question coming from the line of Asthika Goonewardene from Truist.

Asthika Goonewardene: First off, congrats on another robust quarter for especially coming in line with the aggressive buy side expectation. That’s good to see. I understand that you can’t be too specific on off-label use here, but can you at least give us some sort of a bit of color here on what off-label population is the largest in what you’re seeing so far? And what is growing the most rapidly. I think that could just be a little helpful here for us as we’re tweaking our models here. And then on PICCOLO, good to hear about what the ORR is trending at, but what about duration of response? As you’ve given us what the statistical are, can you tell us what you need to beat for DOR? And I’ll also add in previous calls, I think Anna and some of you guys have mentioned that suggested that this could be also an area where PICCOLO could look good.

So I just want to see if you feel confident about that as well now that you’re seeing more of the data in-house? And then lastly, do you need to publicly present PICCOLO in order to discuss it with the NCCN? Or can you share that with the NCCN ahead of a public presentation?