Insmed Incorporated

Good day and thank you for standing by. At this time, I would like to welcome everyone to the INSMED fourth quarter and full year 2020 financial results 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. If you would like to ask a question during that time, simply press star, then the number one on your telephone keypad. If you would like to withdraw your question, press the pound key. Thank you. It is now my pleasure to turn the conference over to Eleanor Barrister, Associate Director, Investor Relations. Please go ahead.

Thank you, Lee. Good morning and welcome to today's conference call to discuss our fourth quarter and full year financial results for 2020 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. Our 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 Securities and Exchange Commission, 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. The information on today's call is not intended for promotional purposes and 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, Roger Adset, Chief Operating Officer, and Sarah Bonsking, Chief Financial Officer. Additionally, Dr. Eugene Sullivan, Chief Product Strategy Officer, will be available during the 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, Eleanor. 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 on what was the most transformational year in our company's history. As Insomed enters a new phase of growth in 2021, we are carrying forward the strong momentum of a successful 2020 marked by significant accomplishments across our business. Over the past 12 months, we have matured from a single product company to a global organization advancing three substantial programs. These programs are TPIP, rensocatib, and Aracase, and each is positioned to become potentially a cornerstone of therapy in their disease areas. With that in mind, let me dive into some of the key highlights for the fourth quarter and full year 2020. I'll start with proprosenil palmitoyl inhalation powder, or TPIP. We were very excited to provide an update on this program just last week when we announced top-line data from our Phase I study in Healthy Volunteers. The results demonstrated the potential for TPIP as a once-daily treatment, which may be able to unlock the full potential of the prostanoid class of therapy for pulmonary hypertension and related diseases. The detailed review is available on our website. Our second program is Brenzocaptive, which represents a new way to harness the DPP-1 pathway for treating neutrophil-mediated diseases. In the middle of last year, we were excited to announce that the FDA had granted breakthrough therapy designation to Brenzocativ for the treatment of noncystic fibrosis bronchiectasis, or NCFBE. We were also pleased to report the EMA's decision to grant Brenzocativ prime designation for the treatment of NCFBE. This was followed shortly thereafter by the initiation of our Phase III Aspen trial, which is now well underway. Additional information about Brenzocatib's mechanism of action will soon be available from an investigator-initiated study of Brenzocatib in patients with COVID-19. We anticipate that the principal investigator will obtain and share data about our drug from this study early in the second quarter. In addition to the Aspen study, we will be advancing clinical development of rencocaptive and cystic fibrosis. We anticipate initiating our Phase II PK-PD multiple dose study to explore the appropriate rencocaptive dosing for cystic fibrosis patients by mid-2021. Beyond bronchiectasis and cystic fibrosis, we are continuing to explore other potential disease areas where rencocaptive may have a therapeutic effect. As an example, a recent paper was published in a cancer research journal, Cancer Cell. In this article, researchers who used our drug, Brenzocatib, documented how it prevented lung metastases in an animal model of breast cancer. As you may recall from our R&D day last September, we've begun our own exploration of the potential role of Brenzocatib in oncology, among other potential diseases. This paper provides one example of Brenzacatib's ability to demonstrate the potential for a positive impact across a variety of disease models. We look forward to keeping you updated on further advancements we expect to make across our Brenzacatib program. Let's now turn to EraCase, where our franchise continues to advance around the world, despite the headwinds from the impact of the ongoing pandemic. We are all looking forward to the day when the COVID-19 pandemic subsides. In the meantime, our global expansion plans have continued to progress as expected, with European approval and the subsequent launch of ARICASE in Germany and the Netherlands now underway. We also remain on track for commercial launch in Japan by mid-year if ARICASE is approved in Japan. Finally, in late 2020, we were pleased to initiate our frontline clinical trial program for EraCase, which is intended to support full approval of EraCase in the U.S. and potential expansion into the larger frontline opportunity in MAC lung disease in the U.S., Europe, and Japan. We believe this program offers the potential to establish EraCase as the standard of care for the frontline treatment of MTM. As we now turn our focus to 2021, we believe InSmed is well-resourced with an industry-leading team and a strong capital position to execute on our goals of bringing potentially life-altering treatments to patients in need. With that background, let me now turn the call over to Sarah to run through our financial results. Sarah?