2021 Annual Report
A letter from Will Lewis
To Our Shareholders:
I am proud to report on a tremendously productive year for Insmed, as we continue to build what we believe is one of the few companies in our industry with the potential of producing multi-billion dollars of revenue by the end of this decade.
As we begin 2022, we are a very different company than we were just a few years ago when we launched our first commercial therapy in the U.S. We had an ambitious vision to become a globally recognized leading biotech company, and a long way to go to accomplish that goal. Yet here we sit today, with commercial operations in three territories around the globe, seven ongoing clinical trials, and a highly innovative research engine working to identify the next wave of product candidates to potentially transform patients’ lives.
The past few years have not been easy in the world around us. It often seems that we emerge from one challenge only to be faced with the next, and the ripple effect is enormous—right down to the individual employee level. The stressors are real, and we need to manage through them with a level of compassion and empathy that perhaps wasn’t always present in the workplace. As the outside world changes, within Insmed, I believe we are poised to weather the storm of these turbulent times.
Throughout our transformation and the challenges around us, one thing has stood out to me—the importance and strength of the Insmed culture. We ended 2021 with more than 600 employees around the world, nearly half of whom have joined since the pandemic began. In a different company, this rapid pace of growth could have led to disengagement. Instead, we have never felt more centered around our mission, our vision, and our values. We have embraced a flexible approach to where and how we work that will persist beyond the pandemic, and we have fostered an environment where we can bring our best selves to work on behalf of the patients we have the privilege to serve. Executed well, this creates a sustainable and attractive business model serving both shareholders and society.
We have built something truly special at Insmed, and perhaps it’s no surprise, then, that we were named the No. 1 biopharmaceutical company to work for by Science magazine, vaulting past many long-tenured companies on the list. I am grateful to every team member whose contributions led to this meaningful recognition—and especially our world-class leadership team, which has capably navigated the commercial, clinical, and regulatory pathways that will drive our company forward. Our goals are ambitious, but we have been deliberate in our pursuit, and we have a track record of accomplishing what we set out to do.
Some of the standout achievements for Insmed in 2021 include the approval and launch of ARIKAYCE in Japan; strong enrollment in our frontline clinical trial program for amikacin liposome inhalation suspension as well as in our Phase 3 study of brensocatib in bronchiectasis; advancement of brensocatib into Phase 2 development for patients with cystic fibrosis (CF); and positive Phase 1 data for treprostinil palmitil inhalation powder (TPIP), which supported its advancement into three Phase 2 studies that are now underway. Lastly, we significantly enhanced our translational medicine capabilities with the addition of new technologies and highly accomplished team members.
This early-stage research platform—what I refer to as our “fourth pillar”—is the underpinning of the future of Insmed. In nearly a decade as CEO, I’ve been asked many times, “what’s next?” “What’s the next candidate, the next region, the next business development deal?” Today, I believe we have the engine that can answer “what’s next” for many years to come.
As I reflect on our accomplishments in 2021 in the face of enormous challenges, I feel a sense of confidence and pride that we can do our important work—that we can serve patients and be a source of hope and continuity for them—no matter what circumstances surround us. In difficult times, we redouble our commitment to decency and to humanity.
We begin 2022 from a position of strength and with a growing sense of excitement. I am grateful to you, our shareholders, for being part of this journey. As always, I’d like to thank our Board of Directors, our employees, the healthcare professionals we serve, and, above all, our patients. We appreciate the trust you place in us, and we take enormous pride in our responsibility to you.
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 Smith, J.D.
General Counsel, Senior Vice President
- Eugene J. Sullivan, M.D.
Chief Product Strategy Officer
Board of Directors
- William H. Lewis, J.D., M.B.A.
Chair and Chief Executive Officer,
Chair of the Board, BioNJ
- 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,
- Steinar J. Engelsen, M.D.1,4 *
Former Acting Chief Executive Officer, Centaur Pharmaceuticals, Inc.
- 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: Nomination & Governance; 3: Compensation; 4: Science & Technology
*Steinar J. Engelsen, who is currently serving as a Class I director, will not stand for re-election at the Annual Meeting.
700 US Highway 202/206
Bridgewater, NJ 08807-1704
Tel: (908) 977-9900
The common stock of Insmed Incorporated is listed on the Nasdaq Global Select Market under the symbol INSM.
Transfer Agent & Registrar
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P.O. Box 1342
Brentwood, NY 11717
Tel: (866) 321-8022
Ernst & Young LLP
99 Wood Avenue South
Iselin, NJ 08830-9961
Associate Director, Investor Relations
Tel: (718) 594-5332
Annual Shareholder Meeting
To be held on May 11, 2022,
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, 2021 by going to investor.insmed.com or by sending a written request to Mr. Michael 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, 2021, 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.