Alnylam Pharmaceuticals, Inc.

Thank you for standing by. My name is Prilla, and I will be your conference operator today. At this time, I would like to welcome everyone to the El Milo Pharmaceuticals Q2 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. And if you would like to ask a question during this time, simply press the star, followed by the number one on your telephone keypad. If you would like to withdraw your question, please press the star one again. Thank you. I would now like to turn the conference over to the company. You may begin.

Good morning. I'm Josh Brodsky, Vice President of Investor Relations at Elm Island. With me today are Yvonne Greenstreet, Chief Executive Officer, Jeff Poulton, Chief Financial Officer, Tolga Tanguler, Chief Commercial Officer, and Pushkal Garg, Chief Research and Development 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 on slide two, Yvonne will offer introductory remarks and provide some general context. Jeff will review our financials and guidance. Tolga will provide an update on our global commercial progress. And Pushkal will discuss our TTR franchise, our confidence in Triton CM, and upcoming pipeline milestones. before we open the call for your questions. I would like to remind you that this call will contain remarks concerning LLM's future expectations, plans, and prospects, which constitute forward-looking statements for the purposes of the safe harbor provision. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important risks and uncertainties, including those discussed under the heading risk factors in our most recent periodic report available on our website and on file with the SEC. We disclaim any obligations to update such statements. And with that, I'll now turn the call over to Yvonne. Yvonne?

Thanks, Josh, and thank you, everyone, for joining the call today. During the second quarter, we demonstrated strong performance across all aspects of the business. Notably, it marked the first time Amvutra revenues exceeded $1 billion in a single quarter, representing an annual run rate of more than $4 billion, just 15 months into the ATTR cardiomyopathy launch, a testament to both the commercial opportunity and our Nynum's execution. As we reflect on the launch, several insights reinforce our confidence in the durability of Amvuta growth over the years ahead. First, this has been an impressive launch by industry benchmarks when looking across market share, access, and revenue generation. Second, the fundamentals of our TTR business are strong, and they include Amvutra's compelling clinical profile and label, the strong access that we established at launch, which continues to improve, and our robust and expanding provider network. Third, patient demand for Amvutra continues to grow robustly, particularly in the first line setting, which has been our focus as we aspire to market leadership. given Ambutra's clinical differentiation and desirability as a foundational therapy for newly diagnosed patients. Tolga will discuss how we are now further investing in broadening our Ambutra prescriber base and supporting overall category growth, the latter of which has been accelerating. Finally, our geographic expansion strategy continues to gain momentum. And today, we're pleased to announce our collaboration with B1 through which they will have exclusive commercialization and distribution rights for Ambutra in Mainline China and Macau, subject to Ambutra receiving marketing authorization. Together with B1, we aim to help advance awareness and support diagnosis of ATTR amyloidosis, and if approved, bring the strength of TTR silencing with Ambutra to patients in these underserved regions. As Jeff will describe shortly, We are lowering our 2026 revenue guidance today to reflect a better understanding with hindsight of the first few quarters of our US launch. Specifically, that early second line demand growth in 2025 benefited significantly from pent up demand for a new therapy that has since normalized. With that learning and our strong 2026 second quarter performance, our confidence in Amvutra's growth trajectory has never been stronger. First-line new patient starts are now responsible for about 80% of category growth in this accelerating market, and we believe we're making great progress in establishing Amputra as a foundational therapy. I will now turn to recent developments in the competitive landscape, specifically the negative outcome of the CardioTransform study of Eplon-Tersen. We recognize investor interest in understanding any potential implications of that study's failure for our probability of success in Triton-CM, our Phase III cardiovascular outcomes trial of NucreSRAM. Let me be clear. This outcome does not alter our conviction in the Triton-CM study. And as Pushkal will share in greater detail, our strong confidence is grounded in the established clinical evidence for RNAi therapeutics in TTR and the track record of our clinical organization. At the same time, we have a variety of options at our disposal to potentially adapt the study and position it for optimal success. We will carefully review the full Eplon-Thurston data set when it becomes available and adapt our study plan if appropriate. We have successfully navigated complex TTR development before and believe we are exceptionally well positioned to do so again with Niflisaran. Additionally in the quarter, We are pleased to announce a series of strategic AI collaborations across the enterprise, including with Inceptive to expand the next frontier in the discovery of RNAi therapeutics, and a collaboration we're pleased to announce today with a large healthcare system in California aimed at supporting early identification of ATTR cardiomyopathy in routine care. This builds on our previously announced partnerships with Viz.AI and Komodo Health. Altogether, This cohesive AI strategy, from discovery and evidence generation to disease identification, clinical practice, and commercial execution, reflects our long-term conviction that AI will fundamentally reshape how medicines are discovered, developed, and ultimately delivered to patients. Finally, we also continue to progress our deep pipeline of investigational medicines, initiating a Phase II trial of ALN6400 in von Wiedebrand's disease, and a phase two trial of Mivalceran in Down syndrome associated Alzheimer's disease. And we look forward to a series of clinical data readouts in the back half of this year, including presentation of initial phase one results of ALN-HTTO2 in patients with Huntington's disease at EHDN in October. All of this progress builds our momentum towards accelerating innovation and scaling our impact as we look to deliver on our five-year vision are now in 2030. And our strategy is anchored around three pillars. The first pillar is to establish global leadership in TTR while continuing to build a doable franchise. The momentum we have built in ATTR cardiomyopathy to date, along with recent developments in the competitive landscape, including the CardioTransform Phase 3 top-line results and the delay in expected U.S. generic entry for tefamidus until mid-2031, further reinforce The second pillar is growing through sustainable innovation, where we aim to deliver therapies that not only slow the progression of disease, but prevent, halt, or reverse it. And the third pillar is scaling with discipline and agility to enable durable, profitable growth. Al-Nalam 2030 represents our commitment becoming the leading science-driven, fully integrated global biopharmaceutical company and to maximize the full potential of RNAi therapeutics for patients. With that, let me now turn the call over to Jeff for a review of our second quarter financial results and 2026 guidance.