Blueprint Medicines Corporation (NASDAQ:BPMC) Q4 2022 Earnings Call Transcript

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And maybe just to close out on kind of the breadth and depth questions that are coming up, we see opportunity in both places, right? So if I think about advanced SM, we are continuing to deepen usage at existing prescribers, what the dynamics that you see is often that they will get comfortable treating a patient and then they will start to identify additional potential candidates. And so we definitely see room to deepen. But breast continues to be really important in a rare disease market like this. And so we’re really pleased to see the number of new accounts that we added in Q4 and expect to see that continue through the year.

Becker Hewes: Yes. And this is Becker. And so with respect to the process with the FDA, just a little bit of background about how this generally happens. So the initial call that we had with them started the process and the way it will end will be with written notification that the partial hold has been ended or been lifted. And we’ve been working very closely with the FDA. We’re rapidly modifying the informed consent and the protocol and the IB. And so far, it’s been going extremely smoothly. This is a collaborative action or interaction with the FDA, and we’ve had alignment along the way. So this is really about informing people and making sure that the right grading system is in the protocol and any adjustments are very clear. So there’s been really quite a bit of alignment.

Christy Rossi: And just so that collaborative nature of the conversations have been really – have been very constructive. We are working to submit the documents. Of course, we’re not in control of the FDA time line on the other side. But I think that collaboration and kind of joint sense of getting the study back on track gives us a lot of confidence that will result this in a short time frame.

Unidentified Analyst: Thank you.

Operator: Our next question comes from Michael Schmidt from Guggenheim Securities. Your line is now open.

Unidentified Analyst: Hey, good morning. This is Paul on for Michael. Thanks for taking our question. Just one from us on the CDK2. Maybe you could help set some expectations for that initial clinical readout this year, specifically on the pharmacodynamic markers of activity, anything that you should highlight that we should expect such as a reduction in passive Rb or cyclin E protein, that would be really helpful. Thank you.

Kate Haviland: Becker, will you take that?

Becker Hewes: Yes. So just as we said earlier, our guidance has been for dose escalation data midyear and then an early look at the combination, we are able to start the combination before we reach a recommended Phase II dose. And so we look forward to presenting that, including safety and biomarker data midyear this year. With respect to biomarkers, we have a number of them. They are circulating biomarkers, they’re tumor biomarkers. And so what we’ll be presenting is an emerging holistic look at the activity and selectivity of BLU-222 in these multiply relapsed Phase I patients.

Unidentified Analyst: Thank you.

Operator: Our next question comes from Michael Ulz from Morgan Stanley. Please go ahead.

Michael Ulz: Thanks and good morning. Maybe I can just ask another question on the ISM opportunity and how you’re thinking about the early trajectory here. I know in your prepared remarks, you commented you’re not anticipating a bolus here. But I’m just curious what impact could presentation of the data at Quad AI next week have on those views. Could it drive additional interest? And could it potentially change your view on the early trajectory? Thanks.

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