Insmed Incorporated

Good morning. My name is James and I will be your conference operator today. At this time, I would like to welcome everyone to the Innsmed third quarter fiscal results conference call. All lines have been placed on mute to prevent any background noise. And after the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you'd like to withdraw your question, press the pound key. Thank you. I'd now like to turn the call over to Sarah Bondstein. You may begin.

Thank you. Good morning and welcome to today's conference call to discuss our third quarter 2020 financial results and provide a business update. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations. Such statements represent our judgment as of today and may involve risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements. Please refer to our filings with the SEC, which are available through the SEC's website at www.sec.gov or from our website for information concerning the risk factors that could affect the company. Additionally, the information on today's call is not intended for promotional purposes and is not sufficient for prescribing decisions. Joining me on today's call are members of the InSmed Executive Management Team, including Will Lewis, Chair and Chief Executive Officer, Dr. Martina Flammer, Chief Medical Officer, and Roger Atset, Chief Operating Officer. Dr. Eugene Sullivan, Chief Product Strategy Officer, and Dr. Kevin Mange, Head of Clinical Development, will be available during our Q&A portion of today's call. Let me now turn the call over to Will Lewis for prepared remarks. Upon completion of those remarks, we will open the call up for your questions.

Thank you, Sarah. Good morning, everyone, and thank you for joining us. We hope you and your families continue to remain safe and healthy. On behalf of Insomed, I am pleased to report a very productive third quarter. The primary drivers of potential value in the near to medium term are all on track. Starting with our Phase III Aspen study of bruncicative in non-cystic fibrosis bronchiectasis, we are very pleased with the progress we are making. From a site initiation perspective, we have already secured Health Authority approval in the United States and expect approval in three additional fast-track countries before the end of the year. We are on track to start enrolling our first patients before the end of this year. We are also working to expand site openings globally and have set ambitious goals in this regard for the first quarter of 2021. Our error case frontline clinical trial program is also on track with trial sites for both the arise and encore studies already in the process of opening in the United States with additional international sites soon to follow. Across the board, our clinical development teams are executing these trials swiftly and effectively. This is promising news for both the MAC frontline and non-cystic fibrosis bronchiectasis patient populations, neither of whom have approved treatments available for their respective conditions today. We take our role as the sponsor of these clinical trials very seriously. We are bringing all resources to bear to enroll the trials rapidly without sacrificing the focus on quality to potentially bring forth these first in disease medications. Our third program, proprostenol palmitoyl inhalation powder, or TPIP, continues to advance. In our phase one study, four dosing strengths have already been completed, with data currently being examined. Assuming these data are positive, we look forward to advancing this program into phase 2a as planned in early 2021. On the commercial front, the EraCase franchise continues to perform in the face of pressures brought on by the pandemic. If we take a step back and look at our overall performance, we continue to advance the major catalysts that we believe will drive future growth. These include the physician's propensity to prescribe, the strong recommendation for use in the guidelines, the availability of a peer-reviewed paper discussing how to manage adverse events and get the most use from the medicine, and most recently, the approval of an SNDA that highlights the long-term durability of the culture conversion seen with our drug. I continue to be impressed with our commercial team's ability to make the most of a very challenging situation, and I look forward to further growth in coming quarters, including from our international expansions. On the international front, I am pleased to report that we recently achieved a significant milestone with the marketing authorization for EraCase in the European Union. We plan to launch EraCase first in Germany, with the United Kingdom and other EU markets to follow. This is a significant accomplishment as we look to make EraCase available globally and an important step as we advance toward approval in Japan. As we expand in refractory NTM around the world and advance into the frontline setting in both the U.S. and internationally, we are well on our way toward establishing ARICase as the standard of care for the treatment of NTM. As many of you know, we discussed each of our three programs in greater detail during our R&D day last month. For those of you who missed our event, I encourage you to access the presentation available on our website for a detailed update on the impressive lineup of clinical development and ongoing commercialization opportunities. As we look toward the end of 2020 and turn our focus to 2021, we believe we are well-positioned to accelerate commercial and pipeline opportunities within NCMEC. I could not be prouder of the INSEMED team for their efforts and their continued commitment to serving patients. With that context, let me now turn the call over to Sarah to run through this quarter's financial results. Sarah?