Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) Q4 2022 Earnings Call Transcript

Pushkal Garg: Yes, thank you. Look, in terms of the impact if we’re asked to supply additional data, I really can’t speculate. Certainly we will provide whatever data the agency requires to facilitate their review. And we look forward to sharing that data in the course of questions that come from the agency and at the advisory committee. The FDA has declared a PDUFA date of October 8, and I know they’ll be striving to achieve that, and we’ll update if there’s any changes to that based on their requests. In terms of the data, look, we look forward to seeing the results. I think it’s scheduled for the middle of the year, but I don’t think that really changes anything for us in the context of the APOLLO-B sNDA. That study is completed and under review and so we’ll certainly be looking for those results, but — and watching them, but there’s, I don’t see any really particular impact on the APOLLO-B sNDA.

Yvonne Greenstreet: Yes, so informative for the field, yes. But of no real kind of consequence to our specific programs, correct, yes. Next question?

Operator: One moment for the next question and your next question comes from the line of with Morgan Stanley. Your line is now open.

Unidentified Analyst: Good morning and thanks for taking the question. May be just a quick one on AMVUTTRA in polyneuropathy. I noticed you got a J-Code in early January. Just curious what impact you think that could have on the trajectory of the launch and is it potential we could see an inflection there? Thanks.

Yvonne Greenstreet: Yes, that’s a nice short question for Tolga, implications of the, our receipts of the J-Code.

Tolga Tanguler: Right. Hi Mike. Thanks for the question. We’re very pleased with the fact that the J-Code we received the J-Code as a, on the due date. Prior to the J-Code we already had a generic J-Code that allowed us to be able to have access to provide the right access to our patients in the U.S. Therefore, we wouldn’t necessarily be expecting any significant change. Now in terms of the outtake is already itself has been, as Yvonne put it, has been a game changer. We have doubled the number of start forms that we would normally receive in a steady state of ONPATTRO. Therefore, we’re very pleased with the accelerated growth that our parity pricing at launch, as well as our good value based access strategies that we were able to establish prior to the launch, that’s really allowing us to have a smooth sailing in terms of the access front, and the growth is really coming from thanks to the profile of the product as well as our efforts in expanding the prescriber base for the polyneuropathy across the U.S. as well as now in Japan and Germany.

Unidentified Analyst: Got it. Thank you.

Yvonne Greenstreet: Thanks, Tolga. Next question, please?

Operator: One moment for the next question and your next question comes from the line of Myles Minter with William Blair. Your line is now open.

Myles Minter: Hi, thanks for taking the question. Just on the HELIOS extension and the 50 mg biannual dosing, did the five patients that passed away in that arm all achieve the 80% TTR knockdown, or did they not? And did they all die from cardiomyopathy? There just again seems to be an imbalance between mortality on the 25 mg every quarter and the 50 mg biannual. And we know that the 25 mg quarterly is efficacious. So just clarifying that would be helpful.

Tolga Tanguler: