Insmed Incorporated

Thank you for standing by and welcome to the INSMED second quarter 2026 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'd like to ask a question during this time, simply press star followed by the number one in your telephone keypad. If you would like to withdraw your question, again, press star one. Thank you. I'd now like to turn the call over to Bryan Dunn, head of investor relations. You may begin.

Thank you, Rob. And good day, everyone. Welcome to INSMED's second quarter 2026 earnings conference call. Before we get started, please note that today's call will include forward-looking statements. 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 most recent filings with the Securities and Exchange Commission for a full description of these risk factors. 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 from Inns Med's quarterly performance and financial position by Will Lewis, Chair and Chief Executive Officer, and Sara Bonstein, Chief Financial Officer, respectively. After their remarks, we will welcome Martina Flammer, Chief Medical Officer, for the Q&A session. I will now turn the call over to Will.

Good morning. I want to start off today's call by framing what I believe are our two key accomplishments this quarter, operational excellence and positioning for our future. Across our commercial, clinical and research efforts, we've demonstrated exceptional operating performance. This has laid the groundwork for Innsmed's potential evolution into a reliably consistent revenue and earnings growth story over the next decade and beyond. Let me briefly summarize what I mean. Brinsupri's launch continues at a truly historic pace, delivering another quarter of performance that more than doubled the results of the best specialty respiratory launches our industry has ever seen at this stage. With the potential to expand its reach with improved diagnosis of appropriate patients and a projected approval in Japan later this year, we believe the Brinsuper story is just getting started. Aircase continues to perform well in its eighth year of launch, growing globally by high single digits this quarter compared to the second quarter of last year. Beyond the current opportunity, there is also potential to expand the label to include all patients with MAC lung disease in the U.S. and Japan next year. From a commercial readiness perspective, we are on track to serve a broader base of appropriate patients while providing education for physicians as we enable them to use Ericase earlier in the treatment paradigm for MAC lung disease. TPIP is emerging as a potentially differentiated asset across four large indications, PHILD, PAH, PPF, and IPF. We believe the data from our ongoing open-label extension study of TPIP in patients with PAH shared last month are further evidence of the strength of TPIP's profile, which we believe has the potential to be the prostanoid of choice. In addition to the progress Our top three assets are making. We are also positioning the company for continued success in the future. We are steadily progressing a broad and diversified early stage pipeline consisting of multiple potential blockbuster treatments for a wide range of serious diseases. The FDA recently cleared the IND for INS1033, the first of several next generation DPP-1 inhibitors advancing within our pipeline. to proceed into the clinic. The first planned indication for INS1033 will be in patients with rheumatoid arthritis for which we have promising preclinical data. We anticipate following that with additional clinical programs in ulcerative colitis and COPD for which there is also supportive preclinical data. These indications highlight the potential relevance of DPP-1 inhibition beyond bronchiectasis and other large neutrophil-mediated inflammatory diseases. We also added new talent to our leadership team with the hiring of Samuel A. Butera as our Senior Vice President and General Manager of our Global Respiratory Therapeutic Area. Samuel A. brings with him a wealth of commercial experience in U.S. and international markets, having led multiple global launches at Johnson & Johnson and Novartis throughout his career. We view his hiring as a huge win for Insumid and an equally large endorsement of Insmed's future. Finally, it is important to mention that we are making all these strides while maintaining our financial strength. We continue to believe we are sufficiently resourced to fund our business through cash flow positivity next year without raising additional capital. With Brinsupri's remarkable performance through nearly one full year of launch and the latest results from our ongoing open label study of TPIP and PAH, Our confidence in the future potential of these assets has grown. As a result, we are raising our peak sales estimates for both assets. For Brinsupri, we now estimate global peak sales of greater than $7 billion, up from our previous projection of greater than $5 billion. This updated estimate reflects expected growth of the current addressable market, driven by earlier and more consistent diagnosis due to increased awareness among physicians and patients. Importantly, this peak sales projection does not include contributions from the potentially meaningful opportunity to identify additional bronchiectasis patients from the comorbid COPD and asthma populations, which would represent upside to this outlook. For TPIP, we believe the peak sales opportunity is greater than $6 billion, up from our previous peak sales projection of greater than $2 billion, which was provided prior to seeing the strength of our phase two readouts in PHILD and PAH and before we chose to pursue PPF and IPF. This assumes clinical and regulatory success in all four indications and the TPIP's profile continues to distinguish itself as meaningfully differentiated versus other prostanoids with comparable efficacy to Sotatercept. while maintaining a favorable tolerability profile, which allows for higher dosing. Along with the reiterated peak sales estimate of greater than $1 billion for EraCase, the combined peak sales estimates for our three lead assets now exceeds $14 billion U.S. dollars, up 75% from the greater than $8 billion peak sales estimate we previously provided for these three products. Let's now move to a deeper discussion of Brinsupri's ongoing launch. In its third full quarter of launch, Brinsupri produced $309.2 million in revenue. We believe Brinsupri is on its way to becoming the most successful launch in the history of specialty respiratory medicine and has the potential to become one of the top 20 medicine launches of all time in any category. This outstanding performance gives us confidence to increase our full year 2026 Brinsupri revenue guidance to between 1.25 and 1.4 billion from our previous guidance of greater than 1 billion. This quarter's impressive results demonstrate the remarkable momentum of Bransupri's launch and reinforce our confidence in its future. All detailed metrics we monitor, including payer access, patient compliance and continuation rates, continue to track ahead of our expectations. Bransupri added approximately 7,000 new patients in the second quarter. exceeding our previous expectation of approximately 6,300 new patient starts. This result demonstrates the robust ongoing demand for the treatment. We now expect approximately 7,000 new patient starts per quarter for the remaining quarters in 2026, which is reflected in our updated revenue guidance. Strong new patient demand was driven by an acceleration in new prescribers and a deepening of prescribing. As of the end of June, We had more than 6,300 cumulative prescribers, which was the increase of approximately 1,300 writers compared to the end of March. We are also making good progress on depth of prescribing. Approximately 30% of Brunsupre's writers have prescribed it for at least five of their patients, up from around 20% at the end of March. However, there is still significant opportunity here. Many doctors, including some who treat large numbers of patients with bronchiectasis, are still trialing the medicine and have considerable capacity to write for more patients if their experience is positive. This quarter, the European Multi-Center Bronchiectasis Audit and Research Collaboration, or MBARC, announced its intention to collaborate with us to evaluate Brenzocatib's 25 milligram dose in a three-year open-label study of up to 3,000 patients with bronchiectasis in six European countries. Embark's intention with this study is to shed light on two important questions. First, whether long-term use of Brenzocatib has the potential to modify the course of the disease. And second, whether earlier upstream use of Brenzocatib is effective in further slowing disease progression. We look forward to collaborating with Embark to address these important questions. We also have ongoing plans to support additional long-term data generation through phase four and real-world evidence trials in the U.S. to further solidify our position as the leader in bronchiectasis and DPP-1 inhibition and to show the long-term benefits of Brinsupre. Beyond what we have just discussed, we see a significant opportunity to expand the diagnosed bronchiectasis population by improving diagnosis among patients with comorbid COPD or asthma. This effort to identify patients with comorbid bronchiectasis is being resourced like its own separate launch and is expected to yield increased diagnosis over the next several years. Some of our initial efforts around improving diagnosis, including our support behind an ATS-led initiative to analyze electronic health records across seven large academic medical systems, the Suspect BE Celebrity Campaign with Ty Pennington, and hosting the inaugural Bronchiectasis and COPD Stakeholder Summit at the World Bronchiectasis Conference, just to name a few. And we are just getting started with other initiatives currently being piloted, which could advance our efforts to support earlier and more accurate diagnosis of appropriate patients. We will track a variety of indicators to look for signals of progress, including monitoring claims data for increased diagnosis rates and high resolution CT scans. Given the time it takes for this information to become available, and the fact that they are trailing indicators, we will have insights from these data in approximately the middle of next year. We look forward to sharing updates as these initiatives progress. We are convinced that the best of this story is yet to come as more patients receive a proper diagnosis and gain access to appropriate treatment. Now let me provide an update on error case. In addition to continued sales growth, we are making progress toward a potential expansion from refractory MAC into all MAC lung disease. Backed by robust clinical evidence and an experienced commercial organization, we believe EraCase is well positioned to make the transition to this larger opportunity in the US and Japan. We recently submitted the supplemental new drug application to the FDA for EraCase in newly diagnosed patients with MAC lung disease, and we intend to submit an application to Japanese regulators in the second half of this year in support of potential launches in 2027. This sets the stage for a particularly dynamic time for our Japan team, who could be simultaneously launching both the expanded error case indication and Brinsupri in bronchiectasis. These products have clear synergies in terms of their call points, which we expect to benefit both launches. Given the impressive results we have seen from that team as they have executed on error cases current indication, we are excited to see the positive impact they can have on patients once presented with this expanded opportunity. We look forward to sharing additional updates on error cases progress as the regulatory process continues. Let's turn to TPIP. Last month, we announced positive 12-month data from our ongoing open-label extension study of TPIP in patients with PAH. To contextualize how unique and impressive those results were, let's begin with a recap of the randomized Phase IIb trial that preceded it. On a placebo-adjusted basis, T P I P demonstrated a 35% reduction in PBR, a 35.5 meter improvement in six minute walk distance and a 60% reduction in NT pro BNP at the end of 16 weeks of treatment. Recall each of these efficacy metrics was measured at trough or approximately 20 hours after the previous dose was administered. The magnitude of these benefits support our belief that T P I P has the potential to become the clear prostanoid of choice. This study also showed good tolerability with a low 10% dropout rate and 95% of completers choosing to continue in the OLE study. Let's move now to the results of the OLE study. At 12 months, patients who remained on TPIP maintained or improved across all efficacy measures. Moreover, patients who had been on placebo in the lead-in study and switched to taking TPIP in the OLE not only improved, but fully caught up to the continued TPIP group. This trend is something rarely observed in other open-label extension studies in PAH patients. At month 12, compared to the baseline of the lead-in study, patients in the OLE experienced an approximately 55-meter improvement in six-minute walk distance and an approximately 60% reduction in NT-proBNP. like the phase two B study, these endpoints were measured at trough. Additionally, about 80% of patients achieved functional class one or two with over 25% of all patients achieving functional class one, meaning these patients no longer have symptoms of PAH. We also looked at Reveal Light 2.0 scores, which are a validated measure of the risk of morbidity and mortality in patients with PAH. Impressively, the average reveal risk status for all OLE patients improved by two categories from intermediate risk to refined low risk status. This improvement in score is associated with moving from a five to 10% risk of mortality in the next year to less than 5% risk of mortality in the next three years, along with meaningful improvements in the risk of clinical worsening. Remarkably, 65% of all patients achieved refined low risk status by month 12. Together, these efficacy benefits far exceeded anything we have seen from other inhaled prostanoids in PAH and were comparable to Sotatercept. On safety, we identified no new safety signals despite longer duration of use and higher doses in the OLE. Notably, we also saw a low 15% rate of treatment emergent cough which was predominantly mild and only one discontinuation due to cough over the first 12 months of the study. In addition, we saw a high continuation rate with 91% of patients remaining on treatment at the 12-month point. Overall, these results add to our confidence in TPIP's potential to be the next major advancement in the treatment of PAH. Our comprehensive phase three development program is progressing well with both our PHILD and PAH studies actively enrolling patients. In the past, we have seen a boost in enrollment after sharing positive data updates from the program. We hope that the strength of the OLE data will once again bolster interest in our trials. We're also pleased to report the first data monitoring committee meeting for the Palm ILD study recently occurred, resulting in a positive recommendation for the study to continue unmodified. Additional Phase III studies in PPF and IPF to additional large indications remain on track to initiate in the second half of 2026 and the first half of 2027, respectively. In the Phase III studies, patients begin with an initial titration phase to a target dose of 640 micrograms once daily. Upon completing titration, investigators may further escalate the dose to a maximum of 1280 micrograms once daily when clinically appropriate. The decision to escalate is based on individualized clinical judgment, taking into account the patient's treatment tolerability and clinical status, including evidence of disease progression or the potential for additional therapeutic benefit. We believe TPIP's broad dosing range could provide physicians with the flexibility to optimize the balance between efficacy and tolerability while also allowing treatment strength to be adjusted as a patient's clinical needs change. The flexibility to quickly and safely dose to much higher levels than other inhaled trypanosomal products could represent a meaningful differentiator within the class and resembles the individualized dosing approach physicians already use with parenteral therapy since patients respond differently across trypanosomal dose levels and their dose requirements may increase over time. The ability to continue to dose higher could also expand the duration of time patients spend on inhaled therapy, delaying the need for patients to switch to parenteral options. As I look across our portfolio at Brinsupri's historic launch trajectory, EraCase's steady contributions, and TPIP's potential to be the prosonoid of choice in our earlier stage programs, which are steadily producing encouraging data, I am energized by what the future can hold for Insmed. I believe we are only just scratching the surface of the positive impact this company can have on patients in need. With that, I'll turn the call over to Sara, who will walk you through the financial details of the quarter.