Even then, our vision was to use the success of what we believed would be our first product to build the credibility to pursue and launch multiple subsequent products using that same infrastructure. We also envisioned building a robust research capability to advance urgently needed medicines that would represent the future of Insmed.

As I sit here today, I couldn’t be prouder of what our team has accomplished. We have successfully launched ARIKAYCE^® (amikacin liposome inhalation suspension) for the treatment of patients with refractory Mycobacterium avium complex (MAC) lung disease in the U.S., Europe, and Japan, building our own commercial infrastructure in each of these regions and achieving double-digit growth year over year, despite a global pandemic. We have put into place the subsequent development programs, now in late stage, which we believe will catapult us into the small category of companies that have multiple first- or best-in-class commercial programs available in key markets around the world. And we have already assembled multiple research platforms and technologies to build a foundation for the future. Most importantly, we have attracted the best global talent to build the next great biotechnology company. With all of these pieces in place, I believe this is the year Insmed will undergo a transformation the likes of which is rarely seen in our industry. It has been a long but deliberate road to get to this point, but we are here, and we are ready.

With positive topline data from the Phase 3 ARISE trial of ARIKAYCE in patients with newly diagnosed or recurrent MAC lung disease released last September, we are incredibly excited for upcoming data from the next two pillars of our company: topline data from our Phase 2 study of TPIP in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), expected in the first half of the second quarter of this year, and topline data from our Phase 3 ASPEN trial of brensocatib in patients with bronchiectasis, expected in the latter part of the second quarter. Both represent first- or best-in-class programs for life-threatening and debilitating diseases.

We are eager, first and foremost, for what these readouts may mean for patients. But we also anticipate that this rapid succession of ARISE, TPIP, and ASPEN data will herald a new era for Insmed, as we prepare to serve these patient populations around the world. Importantly, behind these three pillars, we are meaningfully advancing our fourth pillar programs, now numbering more than 30, so that in the next two years or so we hope to begin to introduce these potential therapies into the clinic in order to assess their safety and effectiveness in the severe and devastating diseases we seek to address.

I often say that the best companies are built in the worst of times, and we’ve seen proof of that in the past few years at Insmed. We continue to operate in one of the most challenging macroeconomic and geopolitical environments our industry has ever seen. This is not an easy time to be in our business and, unfortunately, we have witnessed many peers undergo program cuts and layoffs amid capital constraints. Yet despite the storms around us, Insmed has continued to deliver critical business objectives as we strive to attain our vision.

As we look at our own progress and question how and what we could have done better, I conclude that our greatest enemy is time. Our industry today requires too much time to get medicine from candidate to approved product in patients’ hands. And extra time means extra cost as the infrastructure of any company needs to be supported during the gestation of these therapies. Reducing timelines will bring down cost and deliver medicines sooner, a critical need for diseases where every day counts. As I reflect on how we can accelerate timelines without compromising quality and safety, we are inevitably drawn to the use of AI across our enterprise to enable productivity. This is why in late 2023 we launched a collaboration with Google Cloud to harness the potential of generative AI to reduce the time and cost associated with bringing life-changing therapies to patients with serious and rare conditions. While our work is in its early stages, we are advancing these efforts in earnest in the areas of drug discovery, drug development, drug commercialization, and enabling functions.

Beyond what Insmed has accomplished from a business perspective, I am proud that we have continued to operate as an intentional community—one in which people live our values, keep patients at the forefront of decisions, question the status quo, and strive to act as an example to others. In 2023, for the second year in a row, we held our annual Global Day of Good, where more than 700 Insmed employees volunteered simultaneously in communities around the world, focused on the most pressing local needs related to health, education, and human services.

This is but one example of our greatest strength at Insmed: our culture. We hear time and again from our employees that they are deeply passionate about our mission, that they believe in our future and our ability to get there, and that they feel empowered to do their best work for patients. I am enormously proud to be part of this team—now nearly 1,000 people strong—and I have never been more confident in our ability to achieve the ambitious goals we have set for ourselves.

If we are successful in the path we have laid out for the next few years, including achieving label expansion for ARIKAYCE and regulatory approvals for brensocatib and TPIP, we believe these therapies collectively represent more than $8 billion in peak sales potential—a staggering opportunity for any company, but especially one our size. These revenues, the result of meaningful impact on the lives of patients around the world, will more than support the costs associated with the development of the breakthrough medicines being studied in our fourth pillar. Looking a bit around the corner, we believe Insmed has the potential to become a company with multiple significant commercial programs that have a positive impact on patients, fueled by our fourth pillar providing a steady stream of potentially life-transforming therapeutic candidates. This is our enduring vision.

I am grateful to our shareholders, who have believed in Insmed and the future we aim to achieve. Thank you for being part of the journey with us. Thank you, as well, to our Board of Directors, our wildly talented employees, and the healthcare professionals and researchers we work with and serve. My greatest thanks, always, goes to our patients and their families for the trust you place in us. In this critically important year where we seek to fundamentally change the trajectory of our company, there is no greater motivation than the opportunity to deliver treatments where there are none today.

Will Lewis

Chair & Chief Executive Officer