Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Q3 2023 Earnings Call Transcript

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Raul Rodriguez: Yes, just smaller, but I think the percentage of IDH positive is a bit higher than in AML. So — but it’s still a smaller population on the whole.

Unidentified Analyst: Great. Okay. Thank you, very much.

Raul Rodriguez: Thank you, Rick

Operator: Next question is from the line of Yigal Nochomovitz with Citi. Please proceed with your question.

Q – Unidentified Analyst: Hi, team. This is Carly [ph] on for Yigal. Thanks for taking our question. We had a few follow-ups on REZLIDHIA. First, wondering if you can comment on the contribution from new versus existing patients during the third quarter and approximately what percent share of the market you believe you have within the incident patient population? And then second, of the different label expansion opportunities that you outlined, just curious if there’s one that you would maybe highlight as the highest priority and when we might get more details on your future plans there? Thank you.

Raul Rodriguez: Dave, do you want to comment on REZLIDHIA contribution, new versus established patients and share of incident population?

Dave Santos: Yes. So if you’re looking at our total bottle shift in Q3. Obviously, the majority of those were carryover from previous. I’d have to — let me say here. It’s probably generally, maybe two-thirds to three quarters carryover and about a quarter to one-third is new. And again, that always depends on when you get those new patients. We got our new patients, a lot of them, as I said, in September. So that’s why I think that number is like the — or is the way it is. So I hope that makes sense but the majority this quarter was carryover. And again, a lot of that is because our new patients really — because it is kind of lumpy, showed up in September. Coming on your second question in terms of share of those, if you do this, you’re talking about maybe 250 patients a quarter, you heard from our first quarter on launch, we were around 30 patients. So we think we’re probably in that double-digit share of incident new patients.

Raul Rodriguez: And on the label expansion priority, all three of those that I mentioned, and there are others, in fact, in other segments of AML, in Glioma and MDS are attractive and different one to the other. AML, we know the product works and has shown a benefit in the relapsed or refractory setting. Obviously, other opportunities within that patient’s maintenance in first-line are things that we’re thinking about. In addition, Glioma is a sizable, sizable opportunity, and just so poorly, poorly treated today. That is a very exciting opportunity, a larger opportunity perhaps. And MDS, while smaller, as we mentioned just a minute ago, an area with significant medical need as well, both in low-risk and high-risk MDS. So there really is a highly varied array of different opportunities for olutasidenib.

And clearly, we are going to focus on a subset of those and do so in a focused, efficient cost-wise manner, perhaps in some cases, with academic and government partners.

Unidentified Analyst: Okay. Great. That’s helpful. Thank you very much.

Operator: Thank you. The next question is from the line of Joe Pantginis with H.C. Wainwright. Please proceed with your question.

Joe Pantginis: Hey, everybody. Good afternoon. Thanks for taking the questions. So I was curious, first, I wanted to go back to TAVALISSE patient populations? And I guess I’ll ask the question, but I don’t know if you have this level of granularity in the data you collect. So in the second line or moving to second-line patients, do you have data that show, for example, patients that are — that you’re replacing TPOs or say you’re prescribing TAVALISSE in lieu of TPOs. Do you have that level of granularity that or say RITUXAN?

Ray Furey: Dave.

Dave Santos: Well, just to be clear, where our data comes from is rock. We actually — because we have those histories, we know what line of therapy that is. So we don’t — but we don’t have is kind of what they would have intended to use. So we’re mixing two kind of different things there. The data that we are sharing in terms of 30% of those patients that are going through rock, our second line but we don’t know what they would have used had they not chosen TAVALISSE. Does that make sense?

Joe Pantginis: Yes. It does.

Dave Santos: So from our ATU, I think those clinicians who do use it second line, those are clinicians who’ve had experience with TAVALISSE like how TAVALISSE works and they just — they tend to move it up because it’s very predictable. So that’s probably the best way I can say it. I don’t want to jump to any conclusions about where our second line business is coming from in terms of what product they would have chosen.

Joe Pantginis: No, that’s completely fair. I appreciate that. And then with regard to REZLIDHIA, obviously, the launch continues to be impressive. And I guess I wanted to touch upon any potential real-world safety signals, for example, with regard to differentiation syndrome since it is one of the warnings on the label. Is there anything to discuss there and the fact that physicians are becoming much more adept at handling that?

Dave Santos: No, I wouldn’t say we have anything that indicates. Look, this is a class effect. It’s a black box warning across the class, both with FLT3 inhibitors as well as IDH1 inhibitors 90H2. So, it’s a class effect in that. We have not heard anything or have reason to believe that our differentiation syndrome would be a differentiator for REZLIDHIA. That said, we do believe that it is a different toxicity profile and we do believe that the lack of any reference to needing to do cardiac monitoring in our label is a differentiator for certain patients who might have cardiac comorbidities. So, that continues to be something that we will look into and potentially, hopefully, in the future with real-world evidence helping to show that.

Joe Pantginis: Great. Appreciate the color. Thank you very much.

Operator: Thank you. There are no further questions at this time. And I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments.

Raul Rodriguez: Thank you. This quarter was a really very good one. We grew our products very nicely and we’re happy with that. We made progress on our financial goals as well. So, we’re very pleased where we are. So with that, I’d like to close by thanking every one of you for your continued interest and support of Rigel. And as always, I’d like to thank our employees for their commitment to improving the lives of patients. They work hard every single day. And with that, I look forward to updating you on future calls. Have a great day.

Operator: This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.

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