Insmed Incorporated

Thank you for standing by. My name is John, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Incident Second Quarter 2024 Financial Results Call. All lights have been placed in 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, please 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, John. Good day, everyone, and welcome to today's conference call to discuss Inns Med's second 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 Lewis for prepared remarks.

Will Lewis Thank you, Brian, and welcome, everyone. The second quarter of 2024 will go down and intimate history as the start of an important new era as a mid cap biotechnology company. During this quarter, we not only saw the continued growth of Eric case and refractory MAC lung disease, but also positive phase two data for tp IP and pH ld. And, of course, most significantly, the successful results of the landmark Aspen study, we are grateful to be able to mark and celebrate this moment with patients physicians and investors. It is a time that reminds us why it is so rewarding to work in the field of biotechnology. Today, I intend to focus on a number of exciting catalysts across all of our pillars. However, we are keenly aware that nothing is more important for our near and medium-term success than flawlessly executing the launch of Brenzocatab and Bronchiectasis. If we can get that right, we believe it holds the potential to transform this company once again, which is why executing on that opportunity will continue to be such a focus for us. So let me start there with an update on Brenzocatib. The World Bronchiectasis Conference held in Dundee, Scotland in July was nothing short of a celebration of the positive results from the Aspen study. We've been touched and honored by the enthusiastic and often emotional responses we've heard from patients and the physicians who treat them to Aspen's overwhelmingly positive results. Brenzocatib's demonstrated ability not only to reduce the rate of pulmonary exacerbations, but also to preserve lung function and improve how patients feel all while displaying a safety profile that was comparable to placebo is something that we believe has the potential to be life-changing for patients living with bronchiectasis. We look forward to releasing additional data, including pre-specified subpopulation data from the Aspen trial at the chest conference in October in Boston. I want to reiterate that these subgroups have shown good consistency with the overall results of the study. So there should not be any negative surprises when these data are presented. We are immensely proud to be a part of this type of breakthrough for patients, and if approved, we look forward to getting Brenzocatib into the hands of those who need it as quickly as possible. We continue to prepare for the expected US filing of Brenzocatib in bronchiectasis in the fourth quarter of this year, and our progress toward that goal remains on or even slightly ahead of schedule. Importantly, all of the necessary clinical and preclinical data required for the filing have already been completed, so there are no large gating factors left in front of us. As you know, the Aspen trial represents an enormous data set, and we are focused on thoroughly documenting those results for the filing, including making the final determination on whether we will file one or both doses for approval. We continue to anticipate a launch in the US in the middle of next year. Our commercial team has also been diligently preparing for that expected launch, Nearly all of the additional 120 sales reps we intend to add to the US sales force have already accepted offers and these were chosen from a pool of more than 7,000 resumes. We expect to have all 120 new sales reps trained and in the field by October of this year. This timeline for deployment of sales reps follows a similar pattern as the error case launch. We put those reps into the field six months ahead of the approval and we believe that proactive approach contributed to error case ranking in the top 10 of non-oncology rare disease launches. For Brenzocatib, we intend to have reps in the field even earlier where they will work on disease state awareness and education while also detailing error case to physicians in the hopes of helping more patients who could benefit from that treatment. In addition, we have made great progress with both national and regional payers on disease state education and have engaged close to 90% of US patient lives via payer discussions already. Payers have been receptive to learning about the disease and the permanent damage caused by bronchiectasis exacerbations. Our medical team is already sharing the Aspen data reactively upon request, and more detailed pre-approval discussions will follow our NDA filing next quarter. Finally, it is important to note in the context of our anticipated launch next year that we are in a very good position from a supply perspective, with ample API inventory already in hand. In fact, by the end of this year, we expect to have converted enough of that API into tablet form to meet our current anticipated demand for Brenzocatab in the U.S. through at least the first year of its launch. As a matter of policy, we always look to prioritize continuity of supply for our patients. It was that principle that allowed us to maintain a steady supply of error case even during a global respiratory pandemic by establishing robust supply chains and a sufficient safety stock of inventory. Even though Brenzocatab is easier to make in large quantities and on shorter notice compared to Aracase, we intend to build meaningful inventory and establish backup supply chains, and that work is well underway. Moving beyond bronchiectasis, we continue to be encouraged by the progress of our ongoing phase two study in CRS without nasal polyps, which we expect to read out in the second half of 2025. We continue to see improvements in average symptom scores in the blinded data from that study. which appear to correspond with the time when NSP reduction from DPP-1 inhibition should be occurring. We acknowledge that the data is blinded and still early, but we find it encouraging nonetheless. We are excited to be moving forward with our previously stated plans to kick off a Phase II study of Brenzocatib and Hydradenitis suprativa, now that the Aspen study has demonstrated the potential of the DPP-1 mechanism. We remain on track to have the first active U.S. sites open before the end of the year with the first patients being screened shortly thereafter. Finally, I want to comment briefly on the work we are doing to develop next generation DPP-1 inhibitors in an effort to maintain our leadership in this important new class of medicines. This work is not new, having begun shortly after the Phase II willow results first read out. In fact, we have already synthesized and screened over 850 novel DPP-1 inhibitors and have filed over 10 unique patent applications that disclose and claim these compounds. We are now advancing the first candidate from this group into IND-enabling studies, and we expect one to two more to follow closely thereafter. Based on the strength of the efficacy and safety data from Aspen in patients with bronchiectasis, we are evaluating if there may be other indications we want to explore using DPP-1 inhibition. This can include other indications with significant neutrophil involvement and where patients continue to face significant unmet needs despite current treatments such as rheumatoid arthritis, lupus nephritis, and other inflammatory conditions. Keep in mind that we could develop these molecules for these new indications ourselves, or we could choose to sell or partner them with others who already have a presence in those markets. Either way, these follow-on compounds are expected to keep us at the forefront of this exciting new drug class. Now let me turn to Eric Case. I am pleased to report that EraCase continues to perform well commercially, delivering 17% growth this quarter compared to the second quarter last year. Much of that success is directly related to the strong execution of our commercial teams across the world. Keep in mind that these same teams will be the ones to launch Brenzocatib, assuming regulatory approvals are achieved. In addition to commercial execution, we have also made progress on EraCase's clinical development this quarter. As previously indicated, we met in June with the Division of the FDA responsible for patient-reported outcome measures. That meeting resulted in us successfully aligning with the FDA on the primary endpoint for the OnCore study that can support label expansion to include all MAC lung patients and full approval for the current refractory indication if the data are positive. Now that we have this clarity from the FDA, we have reevaluated OnCore's enrollment target with the goal of ensuring we give the study the best chance of success in achieving its objectives. using appropriately conservative powering assumptions. Based on that evaluation, we have updated OnCourse target enrollment to 400 patients with targets powering of more than 90% for the primary endpoint. Importantly, recruitment for the trial has been proceeding very well throughout 2024 following the ARISE study results. As a result, we expect to be in a position to stop screening new patients later in the third quarter and would then expect the top line results for encore to read out in the first quarter of 2026. As we have commented before, we can now approach the FDA about the possibility of an accelerated filing under subpart H. We expect to have that answer by the end of this year. As a reminder, our expectation continues to be that the encore data will be required for all global regulatory filings to potentially expand the label for error case to include all patients with MAC lung disease. We will update you as we learn more from our interactions with the FDA. Let me also provide a quick update on our TPIP development program. Enrollment in our phase two PAH study has also accelerated recently, likely resulting from the strong phase two trial readout in PHILD in May. We now have more than 75% of the enrollment completed in our PAH trial, which keeps us on track for an expected readout in the second half of 2025. We are consistently monitoring the results of the study on a blinded basis, which continue to show impressive reductions in pulmonary vascular resistance for many of the patients in the study. These improvements in PVR would not normally be expected for patients who have not had a change in their therapy. All of this adds to our excitement for the upcoming readout of the trial and for the potentially compelling profile that began to emerge with the recent PHILD topline results. If I can summarize today's update, it is this. INSEMED is preparing diligently for the expected launch of Brenzocatab and Bronchiectasis next year, including regulatory filings, commercial readiness, payer discussions, and inventory planning, all of which is progressing on or ahead of schedule. This launch represents the type of opportunity that only comes along once in a career, if you're lucky. We all recognize the enormity of what lies ahead and how important it is for us to get it right for our patients, investors, and other stakeholders. While we acknowledge the critical importance of the successful launch of Brenzocatib, I also want to recognize the remarkable progress we are making in parallel across every other area of clinical development and research and the exciting opportunities that this work has the potential to unlock. Shortly after we launch Brenzocatib, we anticipate additional clinical readouts that could represent sizable growth opportunities in their own right, such as phase two readouts for Brenzocatib and CRS without nasal polyps and TPIP and PAH followed by the phase three readout of error case in newly diagnosed MAC lung infection. We look forward to continuing to execute on behalf of patients and our stakeholders as we enter the unique period of potential growth that lies ahead of us. Now I will turn the call over to Sarah to walk through the financials for the quarter.