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7/28/2022
Hello, thank you for standing by and welcome to the Alnylam Pharmaceutical Second Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. Please be advised that today's conference may be recorded. I would now like to hand the conference over to the company. Please go ahead.
Good morning. I'm Christine Lindenboom, Senior Vice President of Investor Relations and Corporate Communications at Alnylam. With me today on the phone are Yvonne Greenstreet, Chief Executive Officer, Tolga Tangular, Chief Commercial Officer, Akshay Vaidyanand, President, and Jeff Poulton, 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. During today's call, as outlined in slide two, Avon will offer introductory remarks and provide some general context. Tolga will provide an update on our global commercial progress. Akshay will review recent clinical and preclinical updates, and Jeff will review our financials and guidance, followed by a summary of upcoming milestones before we open the call for your questions. Please note we are in a quiet period with regard to the upcoming Apollo B results and therefore will not be addressing any questions on that matter. I would like to remind you that this call will contain remarks concerning Allen Island'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 quarterly report on file with the SEC. In addition, any forward-looking statements represent our views only as to the date of this recording and should not be relied upon as representing our views 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. We're very pleased with our second quarter results and the progress we've made towards our near and long-term goals. we achieved 14% product sales growth compared with the first quarter as we continue to drive a steady increase in patients on therapy across our portfolio of marketed products, including Onpatro, Iblari, and Oxlumen. And we're excited to have expanded that portfolio with a recent U.S. approval and positive HMP opinion for Ambutra for HATTR amyloidosis patients with polyneuropathy. and we're looking forward to executing on Ambuta's launch and the potential for further global expansion. Five RNAi Therapeutics from our organic platform approved in under four years is truly remarkable. In addition to our growing commercial portfolio, we continue to make great strides with our RNAi Therapeutic pipeline programs. This includes our progress in establishing our TTR franchise, where we are tracking towards plan and are on the cusp of seeing results from the Apollo B phase three study of the TTRAN in patients with ATTR amyloidosis with cardiomyopathy. We've announced today that we expect to share top line data within the next three weeks with full data to be released thereafter at the medical congress. In addition to these highly anticipated results, We also continue to make exciting progress across numerous other progress within our pipeline. We have and continue to innovate upon what we believe to be one of the most productive, organic and self-sustainable platforms in biotech, which has the potential to deliver meaningful value creating therapies for rare and prevalent diseases in the years to come. To that end, There are many recent and upcoming milestones that underscore the breadth and scope of our pipeline. For Semdesiran, we reported positive top-line Phase II results in patients with IgA nephropathy, a kidney disease with significant unmet medical needs. We're now working with Regeneron to finalize Phase III plans and potentially initiate a program by the end of this year. We were also excited to see positive data presented by Sanfi from the Phase III ATLAS PPX study of Fetuceran in patients with hemophilia, which met its primary endpoint and demonstrated that Fetuceran prophylaxis significantly reduced bleeding episodes compared to prior factor or bypassing agent prophylaxis. Looking through to the end of this year, we expect to have updates across our pipeline, including the potential for top-line results from early studies of ALN HSD in NASH, ALN XCH in gout, and ALN APP in early-onset Alzheimer's disease, our first CNS endeavor. Taken together, this all highlights our focus on these three key drivers for our Nylund growth over the next several years. First is the potential near-term expansion of our TTR franchise opportunity, where we aim to become a global leader in delivering impactful and highly differentiated medicine to patients. The second key growth driver is our expansion beyond rare diseases into prevalent diseases. And the third growth driver for the company comes from our sustainable innovation engine, comprised of new platform enhancements, opportunities with extra-hepatic delivery, and our ability to find new genetically validated targets which can drive further pipeline expansion to 2025 and beyond. We believe all of those positions as well to deliver on our NILAM piece of fifth by 25 goals, making our NILA a top biotech company, developing and commercializing transformative medicines for rare and common diseases for patients around the world, 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?
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