Insmed Incorporated

Thank you for standing by. My name is Tiffany and I will be your conference operator today. At this time, I would like to welcome everyone to the InSmith second quarter 2025 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 that time, Simply press star, then the number one on your telephone keypad. I would now like to turn the call over to Brian Dunn, Head of Investor Relations. Brian, please go ahead.

Thank you, Tiffany. Good day, everyone, and welcome to today's conference call in which we will discuss Innsmed's second quarter 2025 financial results and provide an update on our business. 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 projections discussed. Please refer to our filings with the Securities and Exchange Commission for more information. 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. Today's call will feature prepared comments by Will Lewis, Chair and Chief Executive Officer, Roger Adset, Chief Operating Officer, and Sarah Bonstein, Chief Financial Officer. After their comments, they will be joined by Martina Flammer, Chief Medical Officer, for the Q&A session. I will now turn the call over to Will.

Thank you, Brian, and welcome, everyone. As I reflect on the first half of 2025, I am enormously pleased with where InsMed stands as a company and the potential impact we can have on the lives of the patients we serve. InsMed is now three for three. All three of our late stage assets, EraCase, RensoCatab, and TPIP appear to be clear winners with positive phase two or phase three clinical data having been produced by each, which is an extraordinary achievement for any company in this industry. These successes have been made possible by the work we've put in over the last 18 months across every aspect of our business, including commercial execution, pre-commercial launch readiness, regulatory interactions, clinical development activities, early stage research, and enabling functions. I could not be prouder of our teams of dedicated colleagues at Insmed. As a result of this impressive operational performance and our solid financial position flowing both from the performance of our case and our recent capital raise, we feel Insmed is in an incredible position of strength. I want to emphasize that this is just the beginning. The next 12 months for Insmed are shaping up to be extraordinarily impactful. We expect a steady cadence of meaningful events, both commercially and clinically, that have the potential to significantly expand the company's impact on patients and establish Insmed's next wave of products and indications that will drive future growth. If successful, these catalysts could enable us to address more than 2 million patients with serious diseases across multiple products and indications in the coming years. To summarize the progress INSMED has made and highlight what still lies ahead, I'd like to divide our discussion into two sections, our late-stage portfolio and our early-stage portfolio. Our late-stage portfolio is made up of EraCase, BrensoCATIB, and TPIP. EraCase continues to perform in its current indication, demonstrating consistent year-over-year growth in its seventh year of launch. We believe we are on track to achieve our full-year 2025 sales guidance, driven by continued growth in the U.S., Europe, and Japan. Our performance to date has been particularly impressive given that our U.S. sales team has been simultaneously conducting disease state education on bronchiectasis. In the first half of 2026, we anticipate the clinical readout of the Phase III OnCore study in patients with newly diagnosed or recurrent MAC lung disease who have not started antibiotics. If OnCore is successful, as Arise was, approximately 225,000 additional patients could gain access to Ericase, driving another leg of growth for the franchise. Moving now to Brenzocatib, we are days away from potentially launching the first indication for Brenzocatib in the U.S., representing one of the most anticipated launches in our industry this year. Launches for Brenzocatib and noncystic fibrosis bronchiectasis in Europe, the U.K., and Japan are expected in 2026. We also expect top-line data from our Birch study of Brenzocatib in patients with CRS without nasal polyps by the end of 2025, and the interim futility analysis for our CDER study of brenzocatab in patients with hydradenitis suprativa in the first quarter of 2026. As we've indicated before, if successful, these studies could unlock a massive opportunity for brenzocatab to potentially serve other large patient populations with very few treatment options. Lastly, TPIP. We have now produced positive results for TPIP in two phase two studies. We anticipate entering phase three for PHILD in 2025 and for PAH in early 2026. We believe TPIP has the potential to become the progenitor of choice for the treatment of PAH and PHILD pending positive results in these phase three programs. Turning now to our early stage portfolio. This portfolio is made up of our gene therapy operation in San Diego, our de-immunized therapeutic protein operation in New Hampshire, our synthetic rescue research efforts in Cambridge, England, and our research work happening in our original labs based in New Jersey. Across all four of these operations, we have more than 30 preclinical programs in active development. We've historically highlighted that our preclinical research efforts are expected to stay below 20% of our overall spend with a goal of producing one to two new INDs a year on average. To that end, the last several years have produced significant progress. Our San Diego research site, which was acquired four years ago, has published encouraging preclinical data in DMD, ALS, and Stargardt disease, with the latter representing the first application of our proprietary RNA end-joining technology. This research site recently initiated its first phase one study in patients with DMD with additional IMDs expected in the coming years. Our New Hampshire research site, which has been part of InnsMed since early 2021, has produced exciting progress as well with its AI-based protein de-immunization platform, demonstrating promising results in preclinical models, setting up the possibility for de-immunized proteins to potentially address a variety of conditions, initially looking at uricase and IgG protease. Our Cambridge, England site, which we acquired in 2023, continues to make steady progress on identifying targets for its synthetic rescue platform, to potentially be employed against some of the world's most difficult-to-treat diseases, such as ataxia telangiectasia. More recently, they have also advanced a potential treatment in ALS using a different approach from the SOD1 gene therapy being developed by our San Diego team. Finally, our original New Jersey-based research site continues to be a hub of innovation for InSmed. Not only were ARICase and TPIP produced from these labs, but they have also screened approximately 850 potential next generation DPP-1 inhibitors and are currently conducting pre-IND work for the first of these molecules that we hope will enter the clinic next year. Consistent with IntuMed's core values, a spirit of collaboration and mutual support exists between these sites. They are overseen by a research council, which is comprised of two representatives from each location. The council and select members from each of these research sites gather in person twice each year to provide progress updates, offer input, and explore ways to collaborate to potentially accelerate the development process. While there's a lot going on in our early research engine, we will only provide regular updates on the programs that have cleared the IND hurdle. In general, we continue to see meaningful progress across each of our early stage research platforms and are excited for what is to come. As one example of the progress being made, last month our first patient with DMD was dosed with INS1201, our investigational intrathecally delivered gene therapy as part of our phase one ASCEND study. Moreover, we anticipate multiple INDs coming from our early stage research engine over the next year, including our gene therapies for ALS and Stargardt disease, as well as our next generation of DPP-1 inhibitors. In addition to the advancement of our internal research efforts, targeted business development remains a priority. As always, we will aim to advance the best opportunities that are aligned with our strategy of bringing first and best-in-class therapies to patients facing serious diseases. With this architecture in mind, it is my hope that you can appreciate INSmed's significant progress while visualizing the exciting future ahead for both our late-stage and early-stage portfolios. Let's now take a few moments to walk through some updates from our late-stage programs, starting with Brensocadab. The U.S. launch of brenzocatab and bronchiectasis is arguably the most important catalyst for us to get right in the near term. I'm pleased to report that we have submitted our agreement to the FDA about our label, and from our perspective, we remain on track for a decision on or before the PDUFA target action date next week. Given how close we are to launch, I've asked Roger, our Chief Operating Officer and former Chief Commercial Officer, to share some of his own thoughts on how our launch preparations compare to those he has seen throughout his distinguished career. Let me now turn it over to Roger.