Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) Q3 2023 Earnings Call Transcript

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Pushkal Garg: Yes, Maury, I think I’m going to probably restate what we’ve talked about previously, which is it’s our teams are looking obviously at data in the study. We’re looking at external data sets, et cetera. And as is normal in the industry, has been normal practice here at Alnylam, there are tweaks that can be made. In past instances, we’ve looked and changed from parametric to non-parametric statistical tests, et cetera. We’ve added subgroups, et cetera. So there are things that can be done, that can help either in the primary analysis or the overall data set that are being done in terms of may be, it terms of prespecified analyses or methodologies that are applied. It’s I’m not going to speculate or hypothesize about what’s going to be aligned with agencies or not, so I think but if there’s material information there, we’ll certainly share that with you in due course.

Christine Lindenboom: Thank you. Next question?

Operator: Our next question, give us one moment. Gena Wang of Barclays. Your line is now open.

Gena Wang: Thank you. Maybe just follow Maury’s question. So are you planning to add, say, adding additional follow up time, flexibility regarding because right now when I look at your slides, it’s still saying the last patient follow up reach month 30 and do you have a flexibility and a willingness or plan to extend to 36-months? And then another very quick question regarding tafamidis, I just wanted to make sure I heard it correctly. Pushkal, I think you mentioned 50% of patient on baseline tafamidis. Was that correct or was it close to 50%? And also regarding the tafamidis dropping, is BridgeBio 14% is a good benchmark for HELIOS-B?

Pushkal Garg: Yes. Thanks, Gena. Maybe a couple of points, just to clarify. So look, in terms of the study design, the study design has variable follow up of 30 to 36 months and so we will be following the majority of the patients out to the 36 months because of the way that enrollment occurred. But there is variable follow up in the context of the study. During the blinded portion of the study, in terms of baseline tafamidis, we had an operational target of 50%. But as we’ve stated previously, we came in under that number. And then with regard to drop-ins, what we’ve said is that the drop in rate remains below the assumptions that we had when we designed the study. So, again, all of these offer tailwinds in terms of what we believe in the overall powering of the study. So hopefully that helps.

Gena Wang: Thank you.

Christine Lindenboom: Great. Any other questions?

Operator: Yes, our next question. Give me one moment. Our next question comes from Mike Ulz of Morgan Stanley. Your line is now open.

Mike Ulz: Good morning and thanks for taking the question. Maybe just another follow up on HELIOS-B. When you share the data early next year, can you give us a sense of what level of detail and data that you will include in the top line results. For example, will we see the tafamidis combo subgroup analysis? Thanks.

Pushkal Garg: Yes, thanks for the question, Mike. Look, I think, as it’s our norm during top line results, we will present the pre specified hierarchical endpoints along with P values, along with an update on safety and then with subsequent data presented at a scientific congress.

Christine Lindenboom: Great. Next question?

Operator: This concludes the question-and-answer session. I’d like to now turn it back to the company for closing remarks.

Yvonne Greenstreet: Great. Thank you everyone, for joining us on this call. We’re very pleased with our progress in the third quarter of 2023 across the business and look forward to sharing more progress with you in the coming months as we deliver on our goals. Thank you very much and have a good day.

Operator: Thank you for your participation on today’s conference. This does conclude the program. You may now disconnect.

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