Alnylam Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by. Welcome to the El Nilem Pharmaceuticals first quarter 2020 conference call. There will be a question and answer session to follow. Please be advised that this call is being taped at the company's request. I would now like to turn the call over to the company.

Good morning. I'm Christine Lindenboom, Senior Vice President of Investor Relations and Corporate Communications at El Nilem. With me today on the phone are John Merginori, Chief Executive Officer, Barry Green, President, President of R&D, Jeff Poulton, Chief Financial Officer, and Yvonne Greenstreet, Chief Operating 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 on llm.com slash events. During today's call, as outlined in slide two, John will provide some introductory remarks in general context. Barry will provide an update on our commercial and medical affairs progress. Akshay will review recent clinical and pre-clinical updates. will review our financials, and Yvonne will provide a brief summary of upcoming milestones before opening the call for your questions. I'd like to remind you that this call will contain remarks concerning L9M'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. Action results may differ materially from those indicated by these forward-looking statements, as well as various other important factors, including those discussed in our most recent annual report, quarterly report, and 8K current reports on file of the SEC. In addition, any forward-looking statements represent our views only at 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 provide such statements. With that, I'll now turn the call over to John.

Thanks, Christine, and thank you, everyone, for joining us on the call today. I think it goes without saying that the first quarter of 2020 has been unlike any that we have faced as a company, as individuals, or as a society. We find ourselves in an unprecedented situation as the world confronts this ongoing public health crisis with the COVID-19 pandemic. Let me begin by acknowledging the tremendous impact this disease has had on so many people, including our communities, families, friends, and coworkers. And also, let me recognize the heroic efforts of our healthcare workers everywhere during this crisis. I'm also especially proud of the amazing work by our El Nile team in their ongoing efforts to bring medicines to patients around the world, including our work on potential RNAi therapeutics for COVID-19. Together, we are in the fight against this virus. With that, let me start this morning's call with our COVID-19 planning framework. Later, Barry will discuss commercial and supply chain implications of the COVID-19 pandemic, and Akshay will discuss the pandemic's impact on our clinical trials and the steps we're taking to mitigate this. As you know, the COVID-19 pandemic represents a very fluid global crisis that changes almost daily. There is significant uncertainty about how this situation will unfold, but for now, our Alnylam planning framework is based on the following three phases. First, the current pandemic phase, which we believe will likely encompass most of the second quarter. Second, a recovery phase, which we believe will likely encompass most of the third quarter, where we will see a gradual resumption of activities, including at hospitals and clinics and reopening of businesses with precautionary measures. And then, a new normal phase, potentially starting in the fourth quarter, where we hope to see a return toward normalcy. You'll hear us refer to these three phases throughout our presentation this morning. Now, rest assured that El Milam is prepared for times like this. Challenge accepted is part of our RNA. And we are making adjustments as needed across our operations for the benefit of the patients and communities we serve and also for the safety of our employees. Now, in light of the current situation, Despite our strong conviction for El Milo's prospects in 2020 and beyond, we have decided to lower our 2020 guidance for On Patro by 5%. We believe that this is a prudent decision, not because of any underlying lack of confidence in On Patro's growth and long-term prospects, but simply due to the near-term uncertainties that we're all facing. We also intend to moderate our spend this year and are lowering our expense guidance as well. And Jeff will talk about this in just a minute. Now, amid all of this unprecedented public health crisis, El Milo continues to fire on all cylinders, advancing our pipeline and bringing RNAi therapeutics to patients. Oncacho continues to demonstrate steady and continued growth globally with a very strong Q1, which we're very proud of. We're also pleased to have completed our first full quarter as a multi-product global commercial company with Givlari showing impressive performance in the U.S. And then with Lumaceran, we've submitted regulatory filings in the U.S. and Europe with approval anticipated later this year. We also made significant progress across our TTR franchise expansion opportunity, completing enrollment in the Helios A Phase III study of butriceran and continuing enrollment in Apollo B and the Helios B Phase III studies of butriceran and butriceran, respectively. In addition to these achievements across our late-stage pipeline, our early-stage programs continue to advance. For example, we're announcing positive top-line results this morning from our ongoing phase one study of ALN-AGT, an investigational RNAi therapeutic targeting endotensinogen for the treatment of hypertension. We're very excited about the potential of ALN-AGT as hypertension is the number one modifiable risk factor for cardiovascular disease and a safe and effective infrequently dosed therapy could provide much needed innovation in a highly prevalent condition. We are also doing our part to help address the COVID-19 pandemic, and we're proud to be part of an entire industry advancing science and innovation toward this common goal. Our approach includes targeting the RNA genome of SARS-CoV-2, the virus that causes COVID-19. And earlier this week, we announced the selection of a development candidate, ALN-CoV, also referred to as VR2703, with potent and highly cross-reactive activity. and also we announced plans together with our partners at VEER for an accelerated filing of an IND at or around year end 2020. This would break all records from time from program initiation to filing of an IND. Finally, let me finish with the bigger picture for El Milam as we look forward to the rest of the year and beyond. El Milam continues to lead advancement of RNAi therapeutics as a whole new class of medicines, and we're very much on track to achieving and in fact exceeding our L-Nylon 2020 strategic goals that we originally announced in early 2015. Indeed, we believe we're on track to exit 2020 as a multi-product global commercial company with a deep clinical pipeline for future growth and a robust and organic product engine for sustainable innovation. A few weeks ago, we announced the landmark strategic financing collaboration with Blackstone worth up to $2 billion. This deal, one of the largest ever financings in biotech history, provides El Nile with very significant capital that we believe secures our bridge toward achieving a self-sustainable financial profile without the need to access the equity markets ever in the future. With a significantly strengthened cash position along with the multiple drivers for potential top-line revenue growth and disciplined expense management, we are more confident than ever that we can build a top-tier biopharmaceutical company focused on advancing medicines with transformative potential to patients around the world. So with that, I'll now turn the call over to Barry to review our commercial progress and medical affairs activities in more detail. Barry?