Ionis Pharmaceuticals Inc To Discuss TRYNGOLZA(olezarsen) FDA approval Call Summary

The following is excerpted from the question-and-answer section of the transcript.

Question: Gary Nachman - Raymond James - Analyst : Alright, great. Congrats on the approval and what seems to be a good label. So a few questions. First, the indication seems broad across FCS, as you said. So, doesn't specify genetically or clinically confirmed diagnosis. So how much does that help in targeting FCS patients? Just give us a little more on where the diagnosis rates are now. And what will you do to try and improve those? So, that's first. And then regarding the mention of the reduction in the acute pancreatitis in the label, what portion of the 3,000 patients with FCS could be at risk for acute pancreatitis? So just how important is that angle for this drug? And maybe comment how costly it is in terms of the hospitalization relative to the pricing that you mentioned?

Question: Yanan Zhu - Wells Fargo Securities, LLC - Analyst : Great. Thanks for taking our questions and congrats on the approval. Maybe a question on the label, the label looks very, very clean. But I do wonder if you can comment on there is a section about lab -- lab numbers. There was mentioning of a platelet, LDL, and the information provided there. Could you comment on if there's anything of note? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 19, 2024 / 11:45PM, IONS.OQ - Ionis Pharmaceuticals Inc To Discuss TRYNGOLZA(olezarsen) FDA approval Call Also, if you don't mind, can you comment on the competitive dynamics given that Arrowhead has submitted its BLA also. So going forward how do you see the launch and how does the approval of the Arrowhead product potentially impact the patient you have already put on commercial treatment or affecting -- discovering new patients? Thank you.

Question: David Lebowitz - Citigroup Inc. - Analyst : From a payer perspective, while genotypic or genetic diagnosis of a patient would be a clear cut, how are they looking at the scoring methodology for clinical diagnosis with respect to reimbursing for those patients?

Question: Mani Foroohar - Leerink Partners - Analyst : Congrats on the approval and the clean label. I was hoping to dig in a little bit on how to think about launch dynamics in a little bit more of a quantitative way. Can you give us a sense either approximately or precisely, if you can disclose that, the size of the population of patients in the EAP part of the ongoing clinical population, time horizon over which you would expect them to transition on the commercial drug. And to what extent that's influenced by payer mix, et cetera? And if this varies by geography, that would be great to know as well.

Question: Yale Jen - Laidlaw & Company - Analyst : Also add my congrats on the approval. Just two quick ones. The first one is that although we all talk about the US right now, what's the current thoughts of steps for the European strategy? And then I have a follow-up.

Question: Yale Jen - Laidlaw & Company - Analyst : Okay. Great. Maybe a follow-up here is that it's a very impressive in terms of almost 60% reduction in triglyceride in 12 months. Just curious in the real-world going forward, is there an absolute level of TG that the patient could, for example, have a treatment holiday or they should continue their treatment 12-month a year or continuously.

Question: Andy Chen - Wolfe Research, LLC - Analyst : And congrats on the approval. So we know your price for FCS, just trying to be future looking here. Is there some creative way where you can keep your pricing high for FCS, while in the future, lowering the price only conditionally for high trig, in order to preserve the value of the FCS market. So we're suggesting indication-based contracting. We know it's tough, but it's certainly possible and a good idea. So curious about your thoughts on the feasibility of this.