Insmed, Inc. 2026 Q2 Earnings Call

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 Insmed'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 2 key accomplishments this quarter, operational excellence and positioning for our future. 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 BRINSUPRI story is just getting started.

ARIKAYCE continues to perform well in its 8th 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 ARIKAYCE earlier in the treatment paradigm for MAC lung disease. TPIP is emerging as a potentially differentiated asset across four large indications: PH-ILD, 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 prostacyclin 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 DPP1 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 DPP1 inhibition beyond bronchiectasis in other large neutrophil-mediated inflammatory diseases.

It is important to mention that we are making all these strides while maintaining our financial strength. We also added new talent to our leadership team with the hiring of Samuele Butera as our Senior Vice President and General Manager of our Global Respiratory Therapeutic Area. Samuele 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 Insmed and an equally large endorsement of Insmed's future. 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 in PAH, our confidence in the future potential of these assets has grown.

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 II readouts in PH-ILD and PAH, and before we chose to pursue PPF and IPF.

This assumes clinical and regulatory success in all four indications, and that 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 ARIKAYCE, the combined peak sales estimates for our three lead assets now exceeds $14 billion, 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 billion and $1.4 billion from our previous guidance of greater than $1 billion. This quarter's impressive results demonstrate the remarkable momentum of BRINSUPRI'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. BRINSUPRI 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 an 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 BRINSUPRI'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 Multicentre Bronchiectasis Audit and Research Collaboration, or EMBARC, announced its intention to collaborate with us to evaluate brensocatib's 25 mg dose in a three-year open label study of up to 3,000 patients with bronchiectasis in six European countries. EMBARC's intention with this study is to shed light on two important questions. First, whether long-term use of brensocatib has the potential to modify the course of the disease. Second, whether earlier upstream use of brensocatib is effective in further slowing disease progression. We look forward to collaborating with EMBARC to address these important questions. We also have ongoing plans to support additional long-term data generation through phase IV and real-world evidence trials in the U.S. to further solidify our position as the leader in bronchiectasis and DPP1 inhibition, and to show the long-term benefits of BRINSUPRI.

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. 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.