Insmed Incorporated

Thank you for standing by. My name is Dee, and I will be your conference operator today. At this time, I would like to welcome everyone to the INSMID First Quarter 2024 Financial Results 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 followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Brian Dunn, Head of Investor Relations. Please go ahead.

Thank you, Dee. Good day, everyone, and welcome to today's conference call to discuss INSMED's first quarter 2024 financial results and provide a business update. I am joined today by Will Lewis, Chair and Chief Executive Officer, Jean Sullivan, Chief Product Strategy Officer, and Sarah Bonstein, Chief Financial Officer, who will each provide prepared remarks before we open it up for your questions. Before we start, please note that today's call will include forward-looking statements based on our current expectations. These statements represent our judgment as of today and inherently involve risks and uncertainties that may cause actual results to differ materially from the results discussed. Please refer to our filings with the Securities and Exchange Commission for more information concerning the risk factors that could affect the company. Also note that our call today will include blinded observations from our ongoing phase two study of TPIP and pulmonary arterial hypertension. These observations may not be representative of results once the study is completed and all data is collected and analyzed. As a result, any future interim data readouts and the final data from this study may be materially different than the observations described today. Finally, the information on today's call is for the benefit of the investment community. It is not intended for promotional purposes, and it is not sufficient for prescribing decisions. I will now turn the call over to Will Lewis for prepared remarks.

Thank you, Brian. Welcome, everyone. Today, we intend to review the progress from three of the company's main programs, Error Case, TPIP, and BrenzoCADD. Let's begin with TPIP. The first of this quarter's two important data readouts came this morning with the announcement of the top line results from our phase two study examining TPIP in patients with pulmonary hypertension associated with interstitial lung disease, as well as an update of blinded data from our ongoing phase two study in pulmonary arterial hypertension. In a moment, Gene Sullivan will review these data in greater detail. But let me just say that we couldn't be more pleased with the progress and the clinical results that continue to come from this exciting program. Turning to Brents Ocada, the highly anticipated top line release of the phase three Aspen trial remains on track to read out in the second half of this quarter. Let me take one additional moment to touch on the detailed events and timelines relating to Brents Ocada. At the end of March, all adult patients in Aspen had completed their 52 week visit, which is the point at which the primary and secondary efficacy endpoints are measured in the trial. As a result, we remain confident that the readout will come during the 45-day window from mid-May to the end of June that we have outlined previously. We look forward to sharing the top line results, which will include the pre-specified primary and secondary endpoints, as well as safety data across treatment arms once the work to clean, compile, lock, and analyze the data is completed. In regard to error case, we were pleased that error case delivered double-digit year-over-year growth across all three of our geographic regions and 16% growth overall compared to the first quarter of 2023. We delivered this result despite minor headwinds that occurred in the quarter, which Sarah will walk you through in her remarks. Notwithstanding those isolated events, our performance this quarter keeps us on track to deliver on our previously announced revenue guidance for the year. Turning now to the potential expansion of error case to all MAC-NTM patients, I'm pleased to report that our presentation of the full ARISE results has been selected for a plenary session at the upcoming ATS conference in San Diego later this month, which speaks to the significance of that study and the excitement for it within the medical community. I'm also pleased to report that the Data Monitoring Committee for the ongoing ENCORE trial held their fourth meeting in April, which resulted in a recommendation to continue the study unchanged. As a reminder, there are no interim efficacy analyses built into the OnCore study, so this represents a best-case outcome from that meeting. With regard to securing agreement on the PRO, we are now scheduled to meet with the team of patient-reported outcome experts at the FDA in late June, after which we will settle on the final statistical plan for OnCore. We intend to provide you with additional updates once that work is complete. Finally, I want to take a moment to note the changing approach within the medical community to the treatment of NTM and bronchiectasis and the clear synergies that are being recognized by patient advocacy groups and physicians as they contemplate how to bring forward the best possible care to patients with these two diseases. This quarter, we signed on to be the founding sponsor of the COPD Foundation's new care center network for patients with bronchiectasis and NTM. Through this initiative, the COP Foundation aims to create 150 multidisciplinary centers of excellence across the U.S. This will establish consistent standards of care coming from expert-led academic centers and share them with the broader community in an effort to bring more comprehensive care to patients with NTM and bronchiectasis as they strive to meet treatment goals. This effort recognizes the clear synergy that can be achieved by physicians treating NTM and bronchiectasis and we will be structuring our medical support efforts to augment this new approach to patient care across the United States. We consider it an honor to be supporting this important work on behalf of patients. Now, let me turn the call over to Gene to talk about the big news of the day, the results from our TPIP program.