Insmed Incorporated

Good morning, my name is Dennis, and I will be your conference operator today. At this time, I would like to welcome everyone to the NSMED second quarter 2022 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 this time, simply press star, then the number one on your telephone keypad. To withdraw your question, press star one again. I would now like to turn the conference over to Eleanor Barriser, Investor Relations. Please go ahead.

Thank you, Dennis. Good morning and welcome to today's conference call to discuss our second 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 action. 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. 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. INSMED finished the second quarter of 2022 in a stronger position than ever before as we continue to execute effectively across the four pillars of our business. Our global commercial operations are advancing, evidenced by the tremendous second quarter sales of Ericase. The second quarter marked our highest active number of patients on therapy since launch. Building on this success, we are advancing a robust pipeline that we expect will deliver transformative improvements to patients' lives and create significant shareholder value. On the clinical development side, our ability to attract patients into our clinical trials has been strong. and all of our clinical programs are continuing to track in line with our expectations. Let me briefly touch on the progress we have made across our business. Starting with the first pillar, EraCase, our marketed product for the treatment of refractory MAC lung disease. On a global level, we are extremely excited to see an increase in demand for our product in the first half of the year in all three markets we serve. As a result of this strong demand, we are reiterating our anticipated revenue growth of at least 30% in 2022. We are particularly excited about this performance in light of the significant foreign exchange headwinds we have experienced. Let me touch upon our recent progress in each market. In the U.S., the second quarter marked the most successful quarter we've seen since Aircase launched. During the quarter, we saw higher demand, which we attribute to new patient starts and favorable duration of use and continuation rates, in addition to an increase in patients going back to in-person visits with their physicians. We also saw an increase in retreatments, which we believe may be a key driver to future growth. In Japan, we saw an exceptionally strong revenue performance in the second quarter, driven by strong continuation rate and underlying demand. Now, one year into the launch in Japan, we remain extremely excited about the opportunity and importance of this market to the overall Aircase franchise. Finally, in Europe, we are approaching finalization of pricing decisions in England, Italy, and France. We look forward to updating you on this progress in the coming quarters. Recall that the global market for refractory MAC is sizable, with an estimated addressable population of 12,000 to 17,000 patients in the U.S., 15,000 to 18,000 patients in Japan, and approximately 1,400 patients in Europe. As you know, error cases are also being explored in a frontline clinical trial program, we believe will support full FDA and select international approvals of error case for newly diagnosed NTM patients. As a reminder, the frontline program consists of the ARISE and ENCORE trials. The pace of enrollment has been strong, and we plan to complete screening in ARISE before the end of this month, allowing all future recruitment efforts to focus on the ENCORE trials. We reiterate our guidance that ARISE will be fully enrolled by the end of this year, and we remain on track to share a range of data from the ARISE trial over the course of 2023. The expansion into the frontline setting would open the door to a much larger opportunity in our two largest markets, the U.S. and Japan. We estimate there are approximately 95,000 to 115,000 diagnosed NTM patients in the U.S., and 125,000 to 145,000 diagnosed NTM patients in Japan. Pending approval, we anticipate that the frontline indication could represent a multi-fold increase to the size of the refractory market alone. Our second pillar is brenzocatin, a small molecule oral once-a-day reversible inhibitor of EPP1 that we are using to treat a range of neutrophil-mediated diseases, which involve the release of active neutrophil serine proteases, or NSPs. We believe that by inhibiting the activation of NSPs, Brenzocatib could be a key component in interrupting the inflammatory process, potentially impacting a range of inflammatory conditions. In this way, we see a clear pathway for Brenzocatib to become a novel addition to the anti-inflammatory class of therapies. We are currently pursuing four separate indications with Brenzocatib and will continue to evaluate additional disease areas. The first of these is bronchiectasis. Our phase three Aspen trial is on track to complete enrollment in the first quarter of 2023. Our confidence in our timelines has grown, and as a result, we have turned our internal attention and resources to commercial readiness. As part of this process, we have generated a more specific estimate of the addressable patient population at the time of potential launch of Brenzoketin. We currently forecast approximately one million addressable patients at launch, an enormous market opportunity for an indication with no approved therapies. An approval in this indication would represent a major advancement for patients in specialized respiratory medicine. I'm also pleased to announce that for our second indication, cystic fibrosis, we have completed enrollment of the CFTR modulator arm of the Phase II PK-PD study, and we anticipate having top line data later this year. For our newly announced indications, We anticipate moving brentzocatib into clinical development for chronic rhinosinusitis without nasal polyps, or CRS, by the middle of 2023, followed thereafter by hydradenitis suprativa, or HS. Taking a step back, there are 26 million patients with CRS without nasal polyps in the U.S. alone, with no approved therapies to treat CRS without nasal polyps. this presents another extremely attractive market opportunity for Brenzocatic. Our initial focus will be on the most severe patients, where we believe on an annual basis we can target several hundred thousand patients globally. With HS, we plan to target the moderate to severe patient population, which represents approximately 100,000 patients in the U.S. Currently, there is one approved product on the market for HS, Humira. and injectable biologic with significant side effect considerations. As a once-a-day pill, Forensicatib could be an important therapy for patients. Turning our attention to our third pillar, TPIP, which is a dry powder formulation of proprosenol palmitoyl for the treatment of pulmonary hypertension. Our Phase II trial in PHILD and Phase IIB trial in PAH are currently underway, and sites are continuing to open in line with expectations. Once we have clarity on enrollment rates for each trial, we expect to share specific timing for top line data. At a high level, we currently anticipate having data in PHILD first, which could be as early as before the end of next year, followed thereafter by data in PAH. For an update on the PAH Phase IIa study, this study has a novel design, which in a practical setting proves extremely difficult to recruit. Nonetheless, we did manage to recruit and successfully treat one patient in this challenging study setting. While data from a single patient is not predictive, we are encouraged by a trend in improvement in various cardiac measures during the 24-hour period. Importantly, the patient also completed the 16-week extension period and was successfully titrated to a dose of 320 micrograms. We did not observe any safety concerns with TPIP. Finally, our fourth pillar is translational medicine. encompassing the important work emerging from our research department. We are making progress in a range of disease areas, harnessing gene therapy, protein engineering, and novel manufacturing, all of which work together as a platform of capabilities that we anticipate will yield one to two INDs per year for the next several years. We expect to host a comprehensive commercial and research day, at which time we will provide an in-depth look across our four pillars including details on addressable markets, additional indications, promising technologies, and anticipated data timelines. As you can appreciate, we have made significant progress and performed very well across our four pillars, building on our strong start to 2022. We continue to execute effectively across our operations, and underpinning the work supporting our four pillars is a disciplined approach to cash management. Let me now turn the call over to Sarah for further comments about our financial profile during the second quarter.