Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB) Q2 2023 Earnings Call Transcript

Thomas Gad: Yeah. Thanks. I mean, I can, high level and then, Vignesh, maybe you can follow-up. So, I think the market is currently looking at introducing GD2 antibody upfront and at the same time, discussing the need for bone marrow transplant. So I think maybe the whole GD2 market is swearing towards induction. And I will let Vignesh talk a little bit about more of the trial design and how it positions versus, the traditional front line.

Vignesh Rajah: Yes. I mean, the clinical landscape is definitely moving towards looking at the combination of chemo immunotherapy, both at the induction as well as a consolidation state, partly to maximize the efficacy or the response seen at the end of induction, which is as I alluded to earlier, this has been correlated with a positive survival outcomes or improved survival outcomes. And in the consolidation setting, there is increasing awareness and consensus that potentially combination of anti-GD2 plus current standard treatment of chemotherapy may be as good as or equivalent to stem cell transplant. So these are discussions still very early at this stage, but I think the scientific community is now looking to see how that landscape of anti-GD2 entering into both induction and consolidation setting in order to improve the safety profile and the safety outcomes of patient is definitely there.

And as far as naxitamab specifically concerned, we are definitely prioritizing the development of naxitamab as a randomized study, looking at how the combination of naxitamab plus standard induction chemo compares to just standard induction chemo. This seems to be the way forward now, and the aim is, of course, to maximize a complete response rate. A recent COG study report confirmed as a publication, which showed how combination of — well, not a combination, but at least maximizing treatments in these setting led to superior event-free survival based on looking at QE scores before and after. And they go on to conclude that further improvements in survival outcome will depend on improved induction therapy regimens with the agents like anti-GD2 antibody.

So the landscape is definitely evolving in that direction. And yes, I can’t say anything more specific than that because trial discussion is still ongoing with the COG and the BCC.

Bill Maughan: Understood. And as a quick follow-up, so, looking at the Brazil launch, from having seen other drugs that are reimbursed in Brazil, sometimes, just given the government pay dynamics, the ordering and revenue can be very choppy. Is that what you expect out of DANYELZA in Brazil? Or do you expect more of a curve where volume and demand matches revenue?

Thomas Gad: Yeah. No, we expect, pending, successful negotiations with c-Met on pricing. We do not expect any choppy reimbursement. And — but it’s still ongoing.

Bill Maughan: Okay, great. Thanks.

Operator: Our next question comes from the line of Tessa Romero with JP Morgan. Please proceed with your question.

Tessa Romero: Good morning, guys. Thanks so much for taking our question. In terms of the ex — the US, ex US split here to reach your $80 million to $85 million guidance, what is your current expectation as to how this will split out? Do you still think it should be kind of in the mid-70s in the US here? And then another launch follow-up for us. To be clear, July Symphony was down 47% month-over-month Are you suggesting that you think this will pick back up in August? And even last summer, we didn’t see any seasonality in DANYELZA based on the Symphony data that is available to us. Thanks so much.

Thomas Gad: I guess I’ll take the first one. Yeah, I do think, we are comfortable in seeing mid-70s in US and then the remainder from ex US sales. I don’t know, Bo, Sue, if those who you want to comment on the Symphony.