Insmed Incorporated

Hello everyone and welcome to the INSMID first quarter 2022 financial results call. My name is Daisy and I'll be coordinating today's call. You will have the opportunity to ask a question at the end of the presentation. If you would like to register a question, please press star followed by one on your telephone keypad. Please kindly only ask two questions, after which you may rejoin the queue. I will now hand the call over to your host. Eleanor Barrister, investor relations are intimate to begin. So Eleanor, please go ahead.

Thank you, Daisy. Good morning and welcome to today's conference call to discuss our first quarter financial results for 2022 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 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 it 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, and Sarah Bonstein, Chief Financial Officer. INSMED's business is currently segmented into four pillars, AeroCase, RenssoCative, TPIP, and Translational Medicine. We will keep our prepared remarks brief on today's call, focusing on the key activities and milestones within each of these four pillars. followed by a financial overview. 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, and good morning, everyone. INSEMED had a strong start to 2022, marked by continued execution across our four pillars. All of our prior guidance remains intact, and we are executing effectively across our global operations. This is evidenced by strong first quarter revenue growth of 32% year over year during what is typically our most challenging quarter, giving us continued confidence in our anticipated growth of at least 30% this year. Let's start with our first pillar, EraCase, our marketed product for the treatment of refractory NTM lung disease. EraCase is also being explored in a frontline clinical trial program consisting of the ARISE and the ENCORE trials which we believe will support full FDA and select international approvals of ERICase for newly diagnosed NTM patients. Enrollment in the ARISE study remains on track, and we still anticipate reaching full enrollment this year with top-line data to follow in the first half of next year. In line with prior guidance, we anticipate OnCore will be fully enrolled in 2023. I'm also pleased to share that the first meeting of the Data Safety Monitoring Board, or DSMB, was held in March and that the DSMB recommended the ARISE and ENCORE trials continue as planned. Our second pillar is brenzocatin, a reversible DPP-1 inhibitor targeting the release of neutrophil serine proteases in a range of neutrophil-mediated diseases. This mechanism of action would be a novel approach in the anti-inflammatory class of therapies. We are currently pursuing four separate indications within the brenzocatin pillar. First, in bronchiectasis, we continue to anticipate completing enrollment in early 2023 for the Phase III Aspen study. The second meeting of the DSMB for this trial was held in March, and it was again recommended that the Aspen trial continue as planned. When we look to the market size in bronchiectasis, we see that it is a very substantial opportunity. At the time of potential launch, we will be targeting a patient population that aligns with the patient population we are studying in Aspen. Further, our commercial preparations for Brenzocativ dovetail off the infrastructure we have already built for Ericase. For our cystic fibrosis program, the Phase II PKPD study continues to progress as planned, and we look forward to sharing top-line data later this year or early 2023. In line with our strategy of building an anti-inflammatory portfolio, harnessing the DPP-1 inhibition pathway, we recently announced that we are advancing development of Brenzocativ into two additional indications, which we believe represent substantial potential market opportunities. The first is chronic rhinosinusitis without nasal polyps, or CRS. As a reminder, CRS without nasal polyps, which we are targeting, generally involves more neutrophil recruitment in the inflammatory process versus CRS with nasal polyps. Currently, there are no approved treatments for the approximately 26 million patients with CRS without polyps in the US. We will be targeting patients with severe disease, characterized by eligibility for endoscopic sinus surgery. Each year in the US, approximately 155,000 patients undergo surgery for CRS without nasal polyps. Of those, approximately 15% or 23,000 patients require revision or repeat surgery. The second indication is hydroadenitis suprativa, or HS, for which the only approved therapy is Humira. We believe a well-tolerated, once-a-day oral therapy, such as Brenzocatib, would be a welcome addition to the treatment armamentarium. We anticipate that success in these four indications, bronchiectasis, cystic fibrosis, CRS without nasal polyps, and HS, could position brenzocatib as a leading anti-inflammatory therapy for neutrophil-driven diseases. Our third pillar, TPIP, a dry powder formulation of tryprosinopalmitil for the treatment of pulmonary hypertension, is in three parallel Phase II trials. The Phase IIa trial evaluating TPIP for the treatment of PAH is currently underway. We plan to share preliminary data from a small number of patients over the course of this year. As a reminder, this study is not gating to the other phase two trials for TPIP. These are the phase two B trial in PAH and the phase two trial in PHILD, both of which are currently active in recruiting patients. We look forward to providing updates for these three trials throughout the year. Finally, our fourth pillar, translational medicine, which encompasses a wide range of innovative technologies and modalities, including gene therapy, gene editing, protein de-immunization, and manufacturing capabilities. From this platform, we plan to file at least one IND per year. Preclinical work in our two most advanced indications continues to look very encouraging. Upon completion of these studies, we will look to provide a comprehensive update of our translational medicine work and its anticipated next steps. Turning to the upcoming American Thoracic Society Conference, or ATS, taking place later this month. We will have a number of presentations across three of our pillars at ATS, and I'd like to highlight two of those for you now. The first of these is a retrospective cohort study of error case patients demonstrating reduction in hospitalizations after initiating error case treatment. Another noteworthy presentation provides a post hoc analysis of the phase two willow study, assessing the number needed to treat and the number needed to harm indicating a favorable benefit-risk profile for brenzocathib in non-cystic fibrosis bronchiectasis. In closing, INSMED is in a period of execution in our late-stage pipeline alongside our commercial franchise. Broadly, we are keenly aware that these are the most challenging biotech market conditions seen in our lifetime, which we anticipate will persist throughout the year. However, Incivet is in the enviable position of having the resources to see through the current market conditions and beyond. We are a revenue-generating company that benefits from a rich, late-stage pipeline and a strong cash position to support further development. With that, let me now turn the call over to Sarah.