Alnylam Pharmaceuticals, Inc.

Good day, and thank you for standing by. Welcome to the iNILAM Pharmaceuticals Q3 2023 Earnings Conference Call. At this time, participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference call over to the company.

Good morning, I'm Christine Lindenboom, Senior Vice President of Investor Relations and Corporate Communications at Alnylam. With me today are Yvonne Greenstreet, Chief Executive Officer, Toga Tangular, Chief Commercial Officer, Sushkal Garg, Chief Medical 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 introductory remarks and provide general context. Silva will provide an update on our global commercial progress. Pushkel 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'd like to remind you that today's call will contain remarks concerning L9LM's future expectations, plans, and prospects. which constitute forward-looking statements for the purposes 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 the SEC. In addition, any forward-looking statements represent our views only of the date of this recording and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements. With that, I'd like to turn the call over to Yvonne. Yvonne?

Thanks, Christine, and thank you, everyone, for joining the call today. In the third quarter of 2023, we continue to make great progress across our business while also experiencing a disappointment. As we announced last month, the U.S. Food and Drug Administration declined to approve the supplemental new drug application for Patisram, an investigational RNAi therapeutic that was in development for the treatment of the cardiomyopathy of ATTR amyloidosis. As we have conveyed, we are extremely disappointed with this outcome, particularly with regard to the needs of patients, many of whom spoke at the advisory committee meeting in September. We have been steadfastly committed to this underserved for over a decade and remain confident in our long-term strategy to building a leading TTR franchise with the Tresuran and the Helios B study serving as a very important next step in this journey. We look forward to sharing those top line results which remain on track for early 2024. As we continue to progress our plans in ATTR cardiomyopathy, our commercial strength in the third quarter was driven by the ongoing successful launch of Ambutra in patients with hereditary ATTR amyloidosis with polyneuropathy. This contributed to a 35% year-over-year growth in total net product revenues compared to the third quarter of 2022. We also delivered important clinical updates from key pipeline programs in the third quarter. In September, we announced positive top-line results in the CARDIA-1 Phase II dose-ranging study of Zalbiceram, which demonstrated greater than 15 millimeters of mercury reduction of systolic blood pressure at three months of treatment compared to placebo, as well as an encouraging safety and tolerability profile in adult patients with mild to moderate hypertension. Additionally, the results also reflected sustained reductions in systolic blood pressure at six months, supporting the potential for quarterly or biannual dosing. We also shared updated positive interim results from the phase one study of ALN-APP in patients with early onset Alzheimer's disease, which showed rapid and robust target engagement with sustained effects out to 10 months with a single dose and an encouraging clinical safety and tolerability profile. Additionally, we presented data from the Apollo B study of Patisran at HFSA, showing that the effects of the treatment on six-minute walk tests and KCCQ were maintained through 24 months of treatment. This type of relative stabilization in what is otherwise a steadily progressive disease is very encouraging and further bolsters our confidence in HDSB. We're thrilled to have had these results published in the New England Journal of Medicine just a few weeks ago, which is accompanied by a favorable editorial highlighting the step forward represented by RNAi Therapeutics in this disease. Lastly, we're excited to have achieved the third place ranking in Science Magazine's Top Employer Survey for 2023. This marks the fifth year that Arnylam was featured as one of the top three companies in their annual survey of industry professionals. We are poised to deliver a couple more pipeline updates by the end of the year, including top line phase one results for ALN-TTR-SCO4, as well as ALN-KHK, our investigational RNAi therapeutic for type 2 diabetes. And I encourage you all to save the date and tune in to our annual R&D day, which will be held virtually on December the 13th, where we will discuss all of the exciting progress across our pipeline and platform. We believe all of this puts us on track with our nylon piece of fifth by 25 gold, making our item a top-tier biotech, developing and commercializing transformative medicines for patients around the world with rare diseases and beyond, driven by a high-yielding pipeline of first and all best-in-class product candidates from our organic product engine, all while delivering exceptional financial results. With that, let me now turn the call over to Tolga for a review of our commercial performance. Tolga?