10/30/2025

speaker
Operator
Conference Call Operator

Ladies and gentlemen, and welcome to the Alnylam Pharmaceuticals 3Q 2025 Earnings Conference Call. At this time, all lines are in the listen-only mode. Following the presentation, we will conduct a question and answer session. And if at any time during this call you require immediate assistance, please press star zero for the operator. Also note that this call is being recorded on Thursday, October 30th, 2025. And I would like to turn the conference over to management.

speaker
Christina Kinch
Chief Corporate Communications Officer

Please go ahead. Good morning, I'm Christina Kinch, Chief Corporate Communications Officer at Alnylam. With me today are Yvonne Greenstreet, Chief Executive Officer, Tolga Tangular, Chief Commercial Officer, Krish Kulgar, Chief Research and Development Officer, and Jeff Fulton, Chief Financial Officer. For those of you participating via conference call, the accompanying slides can be accessed by going to the events section of the investors page of our website, investors.alnylam.com slash events. During today's call, as outlined in slide two, Yvonne will offer some introductory remarks and provide general context. Tola will provide an update on our global commercial progress. Pushka will review pipeline updates and clinical progress, and Jeff will review our financials and guidance, followed by a summary of upcoming milestones before we open the call to your questions. I would like to remind you that this call will contain remarks concerning L&M's future expectations, plans, and prospects, which constitute forward-looking statements for the purpose of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our most recent periodic report on file with SEC. In addition, any forward-looking statements represent our views only as the date of this recording. It should not be relied upon as representing our views as any subsequent date. We specifically disclaim any obligation to update such statements. With that, I'll turn the call over to Yvonne.

speaker
Yvonne Greenstreet
Chief Executive Officer

Yvonne? Thanks, Christine, and thank you, everyone, for joining the call today. Our Nilem's Q3 results announced this morning demonstrate the exceptional progress we are making across all aspects of the business. As we continue to evolve into a top-tier biotech company, our focus remains on these three core pillars that we believe will drive sustainable growth and value creation for years to come. The first is TTR leadership. The Ambutra cardiomyopathy launch delivered another strong quarter. It's still early, but we're very encouraged by the progress and dedicated to establishing long-term leadership in TTR. Next is growth through innovation, focused on the potential multi-billion dollar opportunities within our pipeline and an R&D engine positioned to deliver sustainable innovation and value creation for many years to come. The third element is strong financial performance with robust top-line growth and disciplined capital allocation providing us with the opportunity to sustain profitability going forward. And of course, all of this is underpinned by a best-in-class team and our award-winning culture. The quarterly results announced this morning represent strong execution on each of these fronts. Our commercial performance was driven by TTR franchise revenues of $724 million, or 135% year-over-year growth, with growth largely attributable to the Ambuter CM launch in the US, where we achieved total TTR revenues of $543 million, representing 194% year-over-year growth. As Tolga will describe, the broad and balanced uptake in the second full quarter of launch drove an approximate doubling of TTR cardiomyopathy revenue compared to the prior quarter. In addition to these commercial results, we continue to advance our leading pipeline of RNAi therapeutics. Two new Phase III trials are getting underway. The ZENUS Phase III Cardiovascular Outcomes Trial of Zalbiceran in Hypertension has initiated, and the TRITON-PN study of Nucreceran in HATTR-PN will be initiating shortly to complement the Triton CM study that was initiated last quarter. We're also excited by earlier stage pipeline advancements in bleeding and neurologic disorders. And with regard to financial performance, our third quarter results show continued growth with $851 million in total net product revenues up 103% year-over-year. As a result, we've again increased our total net product revenue guidance for 2025 from a range of $2.65 billion to $2.8 billion to a revised range of $2.95 billion to $3.05 billion, representing an increase of $275 million, or 10%, at the midpoint, underscoring our confidence in the Anvutra ATTRCM launch and our other commercial products for the remainder of the year. Now, with our Arnhartland piece of this by 2025 era concluding soon, we're thrilled by this incredible execution over the past five years, reflecting tremendous progress on these ambitious goals. This is indeed a strong foundation on which to build our next phase of significant growth, and we look forward to harnessing this momentum. With that, let me now turn the call over to Tolga for a review of our commercial performance.

Disclaimer

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