Insmed, Inc. 2026 Q3 Earnings Call

Good morning. Today's updates are intended to illustrate three overarching ideas. The first is that Insmed has evolved into a diversified biotechnology company that we believe can generate significant revenue and earnings with substantial growth over the next 10 years and beyond. In addition to exceeding $1 billion in total company revenue year to date, I am pleased to announce that BRINSUPRI has already achieved blockbuster status, having generated more than $1 billion in revenue in its first four full quarters of launch. We believe we have only scratched the surface of the potential addressable patients who may benefit from this first-ever approved foundational medicine in bronchiectasis. While we have treated tens of thousands of patients in the first year, there remain hundreds of thousands of patients already diagnosed and waiting, with potentially millions more who may benefit.

We have literally only just begun to see the benefit BRINSUPRI will bring to patients, and this has been achieved while continuing to deliver for patients with NTM with ARIKAYCE. As a result of this performance, we are raising our full year 2026 guidance for both products. I am very proud of the work we have done, but there is always more we can improve upon. I continue to believe the growth road ahead for our medicines is very substantial. Looking ahead, we have forecasted our three lead respiratory assets to collectively grow at a compound annual growth rate of more than 20% over the next 10 plus years. In doing so, we expect our three lead respiratory assets to collectively exceed $14 billion in estimated peak sales, with room for potential upside.

BRINSUPRI's peak sales estimate of more than $7 billion does not include the COPD and asthma comorbid patient populations, which we estimate number in the low single-digit millions of additional patients. We believe the future impact of BRINSUPRI on these additional patients, who are on max dose treatments for their conditions but are still suffering damage from exacerbations, could be significant. The consequent revenue generation from success in treating these patients could represent potentially as much as, or even more than, the current $7 billion peak sales estimate. In a moment, I will speak to the initiatives we are deploying to tackle this important opportunity. TPIP is also expected to be a massive product, potentially hitting the market by the end of this decade with a peak sales estimate of more than $6 billion from four separate indications.

Thus far, TPIP has distinguished itself within the prostanoid class with superior improvement in 6-minute walk distance and PVR reduction, among other efficacy measures, as well as better safety and convenience with its clearly differentiated profile. We believe TPIP, a once-daily inhaled treprostinil prodrug, has the potential to unlock previously unknown clinical, safety, and convenience benefits through a validated mechanism of action. I want to be very clear that we remain fully prepared for any and all challenges brought by companies who try to stand in the way of patients potentially gaining access to this innovative therapy. Finally, we believe ARIKAYCE, with an expanded label possible next year, has the potential to achieve more than $1 billion in peak sales, with launch preparation in the U.S. and Japan well underway, assuming approvals in both territories.

We believe that having a diversified portfolio of respiratory assets, each of which we believe have the potential to be a blockbuster, will enable us to deliver among the best revenue growth and ultimately earnings growth and place Insmed at or near the forefront of commercial-stage biopharma companies for the foreseeable future. The second idea is that Insmed continues to demonstrate operational excellence. We measure operational excellence by our ability to deliver strong revenue performance while scaling commercial, clinical, and technical capabilities designed to meet our future. Today, operational excellence is seen in the continued advancement of our four phase III TPIP trials in PHILD, PAH, PPF, and IPF. It will continue to be demonstrated through the anticipated initiation of multiple phase II programs over the next several years.

Pending positive data from the phase I healthy volunteer study of INS1033, we expect to initiate a phase II study in rheumatoid arthritis in 2027, followed by ulcerative colitis and COPD. Also in 2027, we plan to begin a phase II study of INS1148 in IPF, with plans to evaluate it in PPF and other inflammatory and fibrotic diseases thereafter. The third idea is that our research engine continues to advance therapies that we believe have the potential to be first or best in class. In 2027, we expect to share data from our phase I gene therapy programs in DMD and ALS. We are also reiterating our guidance to submit one to two INDs per year through the end of the decade.

While there are many more programs under evaluation, we currently have line of sight to nine research programs from across our four research centers, all of which we believe could be first or best-in-class medicines. These programs have the potential to enter the clinic between now and 2029, and we believe several could qualify for accelerated approval. Beyond our internal pipeline, we continue to have an active business development effort in search of medicines like BRINSUPRI. They are very hard to find, but we believe they are out there. The takeaway should be that our combination of sustained commercial growth, operational excellence, and differentiated scientific innovation has the potential to set Insmed apart from its peers and position it at the forefront of high-performing biotechnology companies. Now let's take a closer look at BRINSUPRI. BRINSUPRI produced $400.1 million in revenue in the third quarter of 2026.

This represents 29% sequential growth versus the prior quarter. On slide seven, you can see that BRINSUPRI revenues continue to far exceed those of other strong respiratory launches, including blockbusters like DUPIXENT, TEZSPIRE, FASENRA, and WINREVAIR, on a launch-aligned quarterly revenue basis. On August 12th, we celebrated BRINSUPRI's one-year anniversary of FDA approval and U.S. launch. With more than one year of commercial launch behind us, I am pleased to report that we remain excited by our performance relative to key internal launch benchmarks, and we continue to be comfortable with the historic direction we have provided on metrics like new patient starts, which we believe has the potential to expand as we move through 2027. As previously communicated, now that we are past the first full year of launch, we no longer plan to provide specific updates to each individual launch metric.

We are extremely happy with our performance, and we are seeing particular strength in payer approval rates, reauthorization rates, persistency, and dispenses, and continued positive feedback from patients that say they feel better on BRINSUPRI. Across the board, we are happy with where we are and where we are going. We remain focused on continuously refining our commercial strategy and optimizing resource allocation to maximize the launch's potential. For example, we continue to sharpen our physician engagement strategy, prioritizing top-tier prescribers where we see the greatest potential for increased depth. We also look forward to launching our first branded TV campaign, which will complement our existing collection of unbranded campaigns and hopefully help patients with bronchiectasis understand that an approved once-daily oral treatment option may be right for them.

We have determined that this type of commercial outreach usually has a very high return on investment, and we are excited for its launch next month. Given BRINSUPRI's consistent outperformance to date, we are raising our full-year 2026 revenue guidance range to $1.35 billion-$1.4 billion, which represents an increase to the low end of our previous guidance range by $100 million. Turning now to Japan. Last week, we officially launched BRINSUPRI 25-milligram tablets in Japan. BRINSUPRI is the first and only approved medicine for patients with bronchiectasis in Japan. Recall, Japan is home to approximately 150,000 patients currently diagnosed with bronchiectasis. In our phase III ASPEN study, Japanese patients demonstrated a substantially greater reduction in exacerbations, with a 68% reduction in annualized exacerbation rate compared to approximately 20% in the global study.

In addition, Japanese patients demonstrated more than twice the improvement in lung function observed in the global study, as measured by a change in FEV1 and FVC. While the biological reasons for this differentiation are not known, the difference is dramatic and underscores the potential of BRINSUPRI to make a profound difference in the lives of Japanese patients with bronchiectasis. As a result of this positive clinical impact on Japanese patients, we are also pleased to have secured very favorable pricing for BRINSUPRI in Japan. We expect Japan to be the main driver of any ex-U.S. BRINSUPRI sales. As a reminder, precedent from other specialty medicines launched in the U.S., Europe, and Japan suggest that collectively, ex-U.S. markets typically represent approximately 10%-15% of global peak sales.

We are energized by the opportunity to serve Japanese patients, and we celebrate the hard work of our Japanese colleagues for reaching this important milestone while continuing to deliver strong ARIKAYCE performance over the last several years. Turning now to our efforts to generate real-world evidence for BRINSUPRI. Our medical and clinical teams have been hard at work building a robust body of long-term evidence to support BRINSUPRI. In August, the Bronchiectasis and NTM Association announced our collaboration on the first in-disease observational study evaluating the real-world effectiveness of 10 and 25 milligrams of brensocatib. The Brensocatib Effectiveness, Safety, and Tolerability in Bronchiectasis, or BEST-BE study, is designed to measure the incidence and frequency of pulmonary exacerbations in patients with non-cystic fibrosis bronchiectasis over a two-year period. The study will also track changes in patients' quality of life and the incidence and frequency of adverse events.