at a time.
A letter from Will Lewis
To Our Shareholders:
I am proud to reflect on a year of tremendous execution in 2022, as we laid the groundwork for what I believe will be the total transformation of Insmed. Today we stand at a major inflection point, with substantial cash on hand, a strong commercial engine, and four distinct development programs that have the potential to accelerate Insmed to the next level through their positive impact on patients’ lives: ARIKAYCE® (amikacin liposome inhalation suspension), brensocatib, treprostinil palmitil inhalation powder (TPIP), and our fourth pillar, early-stage research. We take great pride in what we have built, but we are even more excited for where we will be in the very near future.
We are operating in some of the most turbulent times in recent memory. Macroeconomic and geopolitical pressures are the worst they have been in decades. Insmed cannot control these forces, but we can anticipate them and prepare for them. This is exactly what we have done. Completing a large financing of mostly non-permanent capital last fall has enabled us to operate in a fairly insulated fashion, progressing our goal of creating the next great biotechnology company by amassing programs, human talent, and financial capital. The best companies are built in the most challenging times. We must hold fast and focus on the execution of the many programs we possess—each of which, we believe, will become a meaningful first-in-class or best-in-class therapy addressing a clear unmet medical need.
As we consider the broader biotech landscape, the industry is facing a reckoning where not all companies will prosper, either due to lack of financial resources or lack of clinical programs at a stage that will drive value during their window of existing financial resources. We have positioned ourselves to transit these turbulent times and are pushing forward aggressively to build upon our successes. We are very deliberately adding while others are cutting, and we keep a close eye out for additional programs to augment the opportunity we see across our four pillars and beyond. From an accountability standpoint, we believe a substantial increase in the realization of our shareholder value will be clear by the time of our 2024 Annual Shareholder Meeting, reflecting new clinical data from each of our four pillars that will clarify their intrinsic value.
The means to build the next great sustainable biotechnology company are already within our grasp. With near-term readouts for ARIKAYCE and brensocatib potentially unlocking the commercial value of these assets, we believe the Company will be on the path toward profitability, leveraging potential revenues from our late-stage pillars to fund the earlier ones. To answer the question of how we will accomplish this given the different development stages, technologies, and patient populations we are pursuing, we have developed an operational design that is flexible and scalable. A global leader is responsible for the overall success of each program, and our central support functions act as a distinct entity within the company, responsive to the different operating tempos of each pillar. The ability of the central functions to treat each pillar like a ‘customer’ allows seemingly disparate programs to progress in harmony. The common denominator of each pillar—regardless of modality or life stage—is its potential to deliver a life-transforming impact to patients with some of the most urgent unmet needs.
As we reflect on the key ingredients that will enable us to achieve this vision, our culture is undoubtedly the most important. We believe that the best performers are unleashed, not managed. We find great talent and give people the latitude to deliver what they are capable of, while challenging each other to do the same. I often describe the culture we’ve built at Insmed as intentional and bottom-up. Our values and ways of working are crafted by our people, and we all share a singular focus on the needs of patients and their families. That is why people choose to work—and stay—at Insmed.
I’ve had many recent opportunities to see this culture on display, including during our inaugural Global Day of Good, when more than 500 employees came together to volunteer simultaneously in communities around the world. And it was no surprise to me that in 2022, Insmed was named Science magazine’s No. 1 Top Employer for the second year in a row—an achievement only previously earned by Regeneron and Genentech.
This same culture enabled us to deliver critical business achievements in 2022 and early 2023, including:
- 30 percent global revenue growth for ARIKAYCE in 2022 over the prior year;
- enrollment completion in the ARISE study of ARIKAYCE in the frontline setting;
- enrollment completion of adult patients with bronchiectasis in the pivotal ASPEN trial of brensocatib;
- compelling Phase 2 pharmacokinetic/pharmacodynamic (PK/PD) data for brensocatib in patients with cystic fibrosis (CF);
- continued advancement of our Phase 2 studies of TPIP;
- and strategic financings that resulted in aggregate gross proceeds of $775 million, allowing us to end the year with approximately $1.15 billion in cash.
We also pulled back the curtain on our fourth pillar and highlighted some of the cutting-edge early-stage research taking place in San Diego, New Hampshire, and New Jersey. These efforts encompass a wide range of technologies, including gene therapy, protein engineering, and protein manufacturing, and are driven by industry-leading scientists. Even as we take on newer modalities, we believe these programs fit squarely into our company ethos of addressing the most significant unmet patient needs in transformational ways. We further believe our differentiated approach has the potential to deliver safer and more effective gene therapies for monogenic diseases in less time and for lower cost—further positioning us to navigate impending economic pressures. As we have done historically, we will continue to dedicate more than 80 percent of 2023 expenditures to our mid- to late-stage and commercial programs, and we are excited about the potential that our early-stage research holds for the future.
We have a rallying cry at Insmed that you’ll see reflected in these pages: “Count Us In.” It summarizes our unique culture and steadfast commitment to patients, and I believe we walk the talk of patient advocacy in a sincere way as we operate across the biotechnology ecosystem. It is true, few companies are taking on as much as we are. But we are in this to build a great company, not clear a single milestone, and our focus remains on this now-visible destination.
As always, I am grateful to you, our shareholders, for believing in our vision. This will be the year you truly begin to see it take shape and I thank you for your support throughout this journey. Thank you, also, to our Board of Directors, our dedicated employees, and the healthcare professionals and investigators we work with. Above all, thank you to the patients who are our true North Star. When it comes to serving you and your families, you can count us in.
Chair & CEO
- William H. Lewis, J.D., M.B.A.
Chair and Chief Executive Officer
- Roger Adsett, M.B.A.
Chief Operating Officer
- Sara M. Bonstein, M.B.A.
Chief Financial Officer
- Martina Flammer, M.D., M.B.A.
Chief Medical Officer
- S. Nicole Schaeffer, M.B.A.
Chief People Strategy Officer
- Michael A. Smith, J.D.
General Counsel, Senior Vice President
- Eugene J. Sullivan, M.D.
Chief Product Strategy Officer
- Drayton Wise, M.B.A.
Chief Commercial Officer
Board of Directors
- William H. Lewis, J.D., M.B.A.
Chair and Chief Executive Officer,
Chair of the Board, Adrestia Therapeutics
- David R. Brennan3
Lead Independent Director,
Former Chief Executive Officer, AstraZeneca PLC
- Alfred F. Altomari1,3
Chairman and Chief Executive Officer, Agile Therapeutics, Inc.
- Elizabeth McKee Anderson2
Former Worldwide Vice President, Global Strategic Marketing and Market Access, Infectious Diseases and Vaccines, Janssen Pharmaceuticals, Inc.
- Clarissa Desjardins, Ph.D.4
Founder and Chief Executive Officer,
- Leo Lee3,4
President, Japan, Novartis Pharma
- David W.J. McGirr1
Former Chief Financial Officer, Cubist Pharmaceuticals, Inc. (acquired by Merck & Co., Inc.)
- Carol A. Schafer1,2
Managing Partner, Hyphen Advisors, LLC
- Melvin Sharoky, M.D.2,4
Former President and Chief Executive Officer, Somerset Pharmaceuticals, Inc.
Committee Legend (chairpersons in green)
1: Audit; 2: Nominations & Governance; 3: Compensation; 4: Science & Technology
700 US Highway 202/206
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Tel: (908) 977-9900
The common stock of Insmed Incorporated is listed on the Nasdaq Global Select Market under the symbol INSM.
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Annual Shareholder Meeting
To be held on Thursday, May 11, 2023 at 9:00 a.m. ET
Shareholders may receive without charge a copy of our Annual Report on Form 10-K for the year ended December 31, 2022 by going to investor.insmed.com or by sending a written request to Mr. Michael A. Smith, Corporate Secretary, Insmed Incorporated, 700 US Highway 202/206, Bridgewater, New Jersey, 08807, (908) 977-9900. In connection with any such request, we will provide a list of exhibits to the Annual Report on Form 10-K for the year ended December 31, 2022, and will provide copies of any such exhibit upon the payment of a reasonable fee.
Various statements in this annual report are “forward-looking statements,” as that term is defined in the Private Securities Litigation Reform Act of 1995. Words herein such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “intends,” “potential,” “continues,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) identify forward-looking statements. Forward-looking statements are based on our current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause our actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. For additional information, see Item 1A – Risk Factors of the Form 10-K included in this Annual Report. We undertake no obligation to update or revise publicly any forward-looking statements.