Insmed Incorporated

Thank you for standing by. My name is Jeannie and I will be your conference operator today. At this time, I would like to welcome everyone to the INSMED third quarter 2024 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 followed by the number one on your telephone keypad. If you would like to withdraw your question, press star when again. We do ask at this time to limit yourself to two questions and to re-queue if you would like any follow-ups. Thank you. I would now like to turn the conference over to Brian Dunn, Head of Investor Relations. You may begin.

Thank you, Jeannie. Good day, everyone, and welcome to today's conference call to discuss Innsmouth's third quarter 2024 financial results and provide a business update. I am joined today by Will Lewis, Chair and Chief Executive Officer, and Sarah Bonstein, Chief Financial Officer. who will each provide prepared remarks, after which they will be joined by Martina Flammer, Chief Medical Officer, for the Q&A session. 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. The information we will discuss on today's call is meant 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 for prepared remarks.

Thank you, Brian, and welcome, everyone. The announcement of the positive Aspen data earlier this year marked the start of a new era for Insmed, one that will be defined by our ability to execute on the many opportunities we have in front of us. Our performance this quarter demonstrated the level of execution, that level of execution sets us up for this exciting new chapter of Insumid's story. The opportunities before us are significant, not only in terms of their potential impact on patients and our company, but also in terms of their sheer quantity. I'm proud to say that our team across the organization have continued to show a remarkable ability to deliver simultaneously on all of them. For example, in the third quarter, our commercial team once again delivered double-digit year-over-year sales growth for EraCase across all of our regions. At the same time, the U.S. team was also working to build out its infrastructure by nearly tripling its sales force in preparation for the expected launch of Brenzocatib in the middle of 2025. Similarly, our clinical development team remains on track to file the NDA for Brenzocatib in the U.S. this quarter, while at the same time they have been driving increased enrollment rates across our ongoing clinical trials and working to present and publish data from the Aspen trial. Today I intend to highlight the progress we have made across multiple ongoing initiatives at InnsMed and why this progress should add to confidence in our ability to execute on the tremendous opportunities ahead. Let's begin with Brent Sokata. Earlier this month at the American College of Chest Physicians annual meeting in Boston, we presented subpopulation data from 19 pre-specified categories from the Aspen trial based on baseline patient demographics, comorbidities, and disease severity measures. Within those 19 categories existed dozens of subgroups, which emphasizes how robust and comprehensive this data presentation was. In a population that is known to be very heterogeneous, it was remarkable how broadly beneficial treatment with Brenzocatib was observed to be across these various subgroupings, which is similar to what we had observed in the Phase II willow trial. We continue to expect to file the NDA for Brenzocatib in the fourth quarter of this year. Presuming that filing is accepted, we would expect to announce the acceptance, along with the expected timelines for a decision by the FDA in the first quarter of 2025. Moving to our US commercial launch preparations, I'm pleased to report that all 120 new US-based sales reps have been trained and are currently deployed in the field, bringing our total sales reps to 184. These additional sales territories have been constructed based on claims data showing us where the diagnosed patients are being treated. Our intention is to have broad sales representation from day one, not just in the academic centers and centers of excellence, but also in the community pulmonologist offices where many of these patients receive care. In fact, the U.S. sales force is intentionally sized to enable Insomed to call on every pulmonologist in the United States. We believe that these early investments will position Brenzocatib for a strong, successful launch in bronchiectasis pending FDA approval. Let me also provide an update on the two additional indications we are currently pursuing with Brenzocatib. Chronic rhinosinusitis without nasal polyps and hydradenitis supertiva. The phase two Birch study in CRS without nasal polyps has been rapidly bringing new sites online in Europe and in the US and is now more than 40% enrolled. with many more patients currently in screening. We continue to anticipate top line results by the end of 2025. Our phase two HS study is also steadily progressing on schedule toward its first site being opened before the end of this year. The study, which will be called CEEDAR, is expected to enroll approximately 204 subjects randomized one to one to one to receive Brenzocatib 10 milligrams, Brenzocatib 40 milligrams, or matching placebo once per day. The primary endpoint in the study will be percent change from baseline in total abscess and inflammatory nodule count measured at week 16. The study is then expected to continue until week 52 with those randomized to the Brenzocatab arms continuing to receive that same dose. Those who are randomized to the placebo arm would join one of the Brenzocatab arms at week 16 based on randomization, which would also have occurred at baseline on a blinded basis. As we have signaled in the past, the study will include an interim futility analysis conducted by an independent data monitoring board, which will examine data from approximately half of the patient population once they reach week 16. This will allow us to stop the study early if the data does not look promising. If the recommendation from that interim analysis is to continue the study, we will remain blinded to the data that is reviewed by the monitoring board. There is no interim efficacy analysis built into the trial design, so there is no potential for early stoppage due to overwhelming efficacy. If the study continues to completion, we would read out the top line results after all patients reach week 16. We expect more details for this trial to become available on clinicaltrials.gov before the end of this year, and we look forward to providing updates as the trial progresses. Now turning to Error Case, which posted its seventh consecutive quarter of double-digit year-over-year revenue growth in the third quarter of 2024. We have become accustomed to seeing this level of growth from error case, but when you remember that error case is now in its seventh year post launch, it makes the achievement all the more unique and impressive. In addition to strong commercial execution, we are also making great strides clinically. Last quarter, we stated our intention to stop screening new patients for the phase three encore study by the end of the third quarter. Thanks to very strong recruitment, we were able to close the screening of new patients a little ahead of that schedule. While we won't know the exact enrollment number until all patients have finished the six to eight week screening process, I'm pleased to report that we have already randomized more patients than the trials target enrollment of 400 participants. Importantly, this level of enrollment will mean that the study is powered at well over 90% for both the patient reported outcome primary endpoint for US regulators, as well as for the durable culture conversion primary endpoint for the Japanese health authorities. We plan to meet with the FDA this quarter to discuss the possibility of an accelerated filing under subpart H using the successful phase three ARISE trial data. As we have previously mentioned, we feel the most likely pathway to a potential label expansion for error case will require the full data set from the ongoing OnCore trial, which remains on schedule to read out in the first quarter of 2026. Finally, let me provide an update on TPIP. Last quarter, I was excited to report that enrollment in our Phase II study of patients with PAH had accelerated and that we had passed 75% of the target enrollment as of that date. Today, I'm equally pleased to share that this momentum has continued. As of last week, we had enrolled more than 90% of the target for this trial, keeping us firmly on track to report the top line results in the second half of 2025. In PHILD, we expect to present the full results from our Phase II study, which had a top line readout in May of this year, in early 2025 at the Pulmonary Vascular Research Institute's 2025 Annual World Congress in Rio de Janeiro. We look forward to sharing those details then. We're also working to optimize the manufacturing of TPIP so that higher doses can be delivered using the same quantity of dry powder as lower doses. This improved delivery, which would allow patients to take doses up to 640 micrograms in a single capsule, is how we expect TPIP to be offered in the commercial setting presuming clinical and regulatory success. We're doing this work now so that our phase three program can be conducted using that same commercial-ready product, which would be required for a potential future NDA filing. We remain on track to kick off that phase three program for TPIP and patients with PHILD using these optimized doses in the second half of 2025. In summary, I couldn't be more pleased with where we are as an organization. I am proud of how we have been able to maintain and strengthen Intmed's culture during an unprecedented period of growth for the company. Last week, we announced that we were ranked as the number one employer in science's annual top survey of survey of top employers for the fourth consecutive year. The only other company in the history of this survey to have earned this honor at least four years in a row was Genentech. This external recognition validates what I see every day. which is that even as we transform as an organization, we remain grounded in our core values. The consistent progress that I have seen to date across the company, both operationally and culturally, only adds to my confidence in the future of Insumet. For most companies in our field, any one of the opportunities in our late-stage pipeline, from the potential error case label expansion to the potential launch of a product representing a promising new mechanism of action, like Brent Socadeb, to the chance to develop a potentially paradigm-shifting medicine like TPIP would represent the single most exciting opportunity at the organization. At InciMed, we not only find ourselves in the rare position to execute on all three of these programs at once, but I'm also proud to say that we are three for three so far, with each program having already demonstrated meaningful clinical success. We take the responsibility to deliver these therapies to patients very seriously, and we are committed to following through on these promises. I'll now turn it over to Sarah, who will walk us through this quarter's financial results.