About Insmed

Insmed Incorporated operates as a global biopharmaceutical company. The company’s first commercial product, ARIKAYCE, is approved in the U.S. as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590mg (amikacin sulfate inhalation drug product). ARIKAYCE received accelerated approval in the U.S. in 2018 for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options in a refractory setting. In 2020, the European Commission (EC) approved ARIKAYCE for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by MAC in adults with limited treatment options who do not have cystic fibrosis (CF). In March 2021, Japan's Ministry of Health, Labour and Welfare (MHLW) approved ARIKAYCE for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. NTM lung disease caused by MAC (which the company refers to as MAC lung disease) is a rare and often chronic infection that can cause irreversible lung damage and can be fatal. The company’s pipeline includes clinical-stage programs, brensocatib and TPIP, as well as other early-stage research programs. Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), which the company is developing for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases, including chronic rhinosinusitis without nasal polyps (CRSsNP). TPIP is an inhaled formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH). The company’s early-stage research programs encompass a wide range of technologies and modalities, including gene therapy, artificial intelligence-driven protein engineering, protein manufacturing, RNA-end joining, and synthetic rescue. The company announced positive topline results from the ARISE trial in the third quarter of 2023. Based on these results, the company has proposed to the FDA that the change of the respiratory score derived from the Quality of Life – Bronchiectasis (QOL-B) respiratory domain PRO be the primary endpoint for the ENCORE study, the second trial in its post-marketing confirmatory clinical trial program for ARIKAYCE. In December 2023, the company received written feedback from the FDA on the PRO data produced in the ARISE study. In 2023, the company completed enrollment of the Phase 3 ASPEN trial in adult patients with bronchiectasis, and it anticipates sharing topline data in the latter half of the second quarter of 2024. The company plans to explore the potential of brensocatib in additional neutrophil-mediated diseases. The company has initiated the Phase 2b BiRCh trial of brensocatib in patients with CRSsNP. The company is advancing commercial readiness activities in preparation for a launch of brensocatib for patients with bronchiectasis, if approved. If successful, it anticipates a launch in the U.S. in mid-2025, followed by launches in Europe and Japan in the first half of 2026. The company expects to initiate a Phase 2 study of brensocatib in patients with hidradenitis suppurativa (HS) in the second half of 2024. In November 2023, the company completed enrollment in the Phase 2 PH-ILD study, with 39 patients enrolled. Topline data from the study are anticipated in the second quarter of 2024. Enrollment in the Phase 2 study of TPIP in PAH remains ongoing. The company anticipates enrolling 99 patients in the study, 45 of whom had been enrolled by year-end 2023, with topline results expected in 2025. The company continues to progress its early-stage research programs across a wide range of technologies and modalities, including gene therapy, artificial intelligence-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue. To complement its internal research and development, the company is also actively evaluate in-licensing and acquisition opportunities for products, product candidates and technologies, including those that address serious and rare diseases with significant unmet need. Strategy The company’s strategy focuses on the needs of patients with serious and rare diseases. The company’s first product, ARIKAYCE, is approved in the U.S. as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590mg (amikacin sulfate inhalation drug product). The company’s product candidates are brensocatib, its Phase 3 product candidate which the company is developing for patients with bronchiectasis and other neutrophil-mediated diseases, and TPIP, its Phase 2 product candidate that may offer a differentiated product profile for patients with PH-ILD and PAH. The company is also advancing its early-stage research programs encompassing a wide range of technologies and modalities, including gene therapy, artificial intelligence-driven protein engineering, protein manufacturing, RNA-end joining, and synthetic rescue. The key elements of the company’s strategy are to continue to provide ARIKAYCE to appropriate patients and expand its reliable revenue stream; produce topline clinical data readouts in the near and long term; advance commercial readiness activities to serve significantly more patients with serious and rare diseases; and control spending, prudently deploying capital to support the best return-generating opportunities. ARIKAYCE for Patients with MAC Lung Disease ARIKAYCE is the company’s first approved product. ARIKAYCE received accelerated approval in the U.S. in September 2018 for the treatment of refractory MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. In October 2020, ARIKAYCE received approval in Europe for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF. In March 2021, ARIKAYCE received approval in Japan for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. MAC lung disease is a rare and often chronic infection that can cause irreversible lung damage and can be fatal. Amikacin solution for parenteral administration is an established drug that has activity against a variety of NTM; however, its use is limited by the need to administer it intravenously and by toxicity to hearing, balance, and kidney function. ARIKAYCE's ability to deliver high levels of amikacin directly to the lung and sites of MAC infection via the use of the company’s Pulmovance technology distinguishes it from intravenous amikacin. ARIKAYCE is administered once-daily using Lamira, an inhalation device developed and manufactured by PARI. Lamira is a portable nebulizer that enables aerosolization of liquid medications via a vibrating, perforated membrane, and was designed specifically for ARIKAYCE delivery. ARIKAYCE also has been included in the international treatment guidelines for NTM lung disease. The evidence-based guidelines, issued by the American Thoracic Society (ATS), European Respiratory Society (ERS), European Society of Clinical Microbiology and Infectious Diseases (ESCMID), and Infectious Diseases Society of America (IDSA), strongly recommend the use of ARIKAYCE for MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options who have failed to convert to a negative sputum culture after at least six months of treatment. In October 2020, the FDA approved a supplemental new drug application for ARIKAYCE, adding important efficacy data regarding the durability and sustainability of culture conversion to the ARIKAYCE label. The data, which are from the Phase 3 CONVERT study of ARIKAYCE, demonstrate that the addition of ARIKAYCE to guideline-based therapy (GBT) was associated with sustained culture conversion through the end of treatment, as well as durable culture conversion three months post-treatment compared with GBT alone. In March 2018, the company submitted a new drug application (NDA) for ARIKAYCE to the FDA to request accelerated approval. As a condition of accelerated approval, the company must conduct a post-marketing confirmatory clinical trial. In December 2020, the company commenced the post-marketing confirmatory clinical trial program for ARIKAYCE in patients with MAC lung disease consisting of the ARISE trial, an interventional study designed to validate cross-sectional and longitudinal characteristics of a PRO tool in MAC lung disease, and the ENCORE trial, designed to establish the clinical benefits and evaluate the safety of ARIKAYCE in patients with newly diagnosed or recurrent MAC lung infection who have not started antibiotics using the PRO tool validated in the ARISE trial. In September 2023, the company announced positive topline results from the ARISE trial. The company reached its original target enrollment of 250 patients in the ENCORE trial in patients with newly diagnosed or recurrent nontuberculous mycobacterial lung infection caused by MAC who had not started antibiotics. Enrollment in the study remains ongoing. The company received written feedback from the FDA on the patient-reported outcome data produced in the Phase 3 ARISE study in December 2023. In 2020, the EC granted marketing authorization for ARIKAYCE for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF. ARIKAYCE can be prescribed for patients across the European Union (EU) countries as well as in the U.K. ARIKAYCE is reimbursed nationally in France, Belgium, the Netherlands, the U.K. and Ireland. The company has worked with the German National Association of Statutory Health Insurance Funds (GKV-SV) towards an agreement on the price of ARIKAYCE that would allow it to better serve the needs of patients in Germany; however, since the company has been unable to reach an agreement, patient supply of ARIKAYCE in Germany was enabled by import from other EU countries in September 2022. The company is working to ensure an uninterrupted supply of ARIKAYCE for patients in Germany and to provide physicians and pharmacists the information they need to obtain ARIKAYCE for their patients through the importation pathway. In January 2023, the company agreed upon reimbursement terms with the French authorities. In July 2021, the company launched ARIKAYCE in Japan. The company is exploring and supporting research and lifecycle management programs for ARIKAYCE beyond treatment of refractory MAC lung disease as part of a combination antibacterial regimen for adult patients who have limited or no treatment options. The company will continue to advance the post-marketing confirmatory MAC lung disease clinical trial program for ARIKAYCE, through the ARISE and ENCORE trials, which are intended to fulfill the FDA's post-marketing requirement to allow for the full approval of ARIKAYCE in the U.S., as well as to support the use of ARIKAYCE as a treatment for patients with MAC lung disease. In 2020, the EC approved ARIKAYCE for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF. The CONVERT study included a comprehensive pharmacokinetic sub-study in Japanese subjects in lieu of a separate local pharmacokinetic study in Japan, as agreed with the PMDA. In March 2021, Japan's MHLW approved ARIKAYCE for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. Brensocatib is a small molecule, oral, reversible inhibitor of DPP1, which the company licensed from AstraZeneca in October 2016. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs) in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. Neutrophils contain the NSPs (including neutrophil elastase, proteinase 3, and cathepsin G) that have been implicated in a variety of inflammatory diseases. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs. In March 2020, AstraZeneca exercised its first option pursuant to the company’s October 2016 license agreement under which AstraZeneca can advance clinical development of brensocatib in the indications of chronic obstructive pulmonary disease (COPD) or asthma. Under the terms of the agreement, upon exercise of this option, AstraZeneca is solely responsible for all aspects of the development of brensocatib up to and including Phase 2b clinical trials in COPD or asthma. The agreement also includes a second and final option which, if exercised, would permit AstraZeneca to further develop brensocatib beyond Phase 2b clinical trials upon reaching agreement on commercial terms satisfactory to each party for the further development and commercialization of brensocatib in COPD or asthma. The company retains full development and commercialization rights for brensocatib in all other indications and geographies. In 2020, the FDA granted breakthrough therapy designation for brensocatib for the treatment of adult patients with non-cystic fibrosis bronchiectasis (NCFBE) for reducing exacerbations. The FDA's breakthrough therapy designation is designed to expedite the development and review of therapies that are intended to treat serious or life-threatening diseases and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy. In October 2021, the EMA’s Paediatric Committee approved the brensocatib Pediatric Investigational Plan for the treatment of patients with NCFBE. Subsequently, the ASPEN trial will include 41 adolescent patients between ages 12 to 17, which will fulfill the pediatric study requirements to support marketing applications in this patient population in the U.S., Europe and Japan. In January 2023, the company reported topline data from the Phase 2, multiple-dose, pharmacokinetic/pharmacodynamic study of brensocatib in patients with CF. This Phase 2 study included both patients who were on background CFTR modulator drugs and patients who were not on CFTR modulator drugs. The study duration was approximately one month and dosed CF patients to placebo, 10 mg, 25 mg, and 40 mg of brensocatib. A clear dose-dependent and exposure-dependent inhibition of blood NSPs was observed in patients treated with brensocatib across all doses in this study, consistent with the mechanism of action of brensocatib. Safety and tolerability were consistent with what was observed during the Phase 2 WILLOW study, with no significant drug-related findings. The company concluded that an additional cohort evaluating a 65 mg dose of brensocatib is not needed in this patient population. Upon the availability of the ASPEN study results, it will evaluate potential future developments in CF patients. In February 2021, the company announced topline results from the Phase 1 study of TPIP in healthy volunteers. The company is advancing the development of TPIP with two ongoing Phase 2 studies. The first study is designed to assess the safety and tolerability of TPIP in patients with PH-ILD over a 16-week treatment period using an up-titration, once-daily dosing schedule. The second study is designed to investigate the effect of TPIP in patients with PAH on changes in PVR and six-minute walk distance over a 16-week treatment period and will also employ an up-titration, once-daily dosing schedule. A third study, which was a Phase 2a study designed to study the immediate impact of a single dose of TPIP in PAH patients over a 24-hour period was discontinued primarily due to hospital and intensive care unit restrictions during the COVID-19 pandemic that The company will continue to advance its Phase 2 development work in both PH-ILD and PAH. The company expects topline results from the PH-ILD study to be shared in the second quarter of 2024. The company’s early-stage research efforts are comprised of its preclinical programs, advanced through internal research and development and augmented through business development activities. In 2021, the company acquired a proprietary protein deimmunization platform, called Deimmunized by Design, focused on the reengineering of therapeutic proteins to evade immune recognition and reaction. In 2021, the company acquired Motus Biosciences, Inc. (Motus) and AlgaeneX, Inc. (AlgaeneX), preclinical stage companies engaged in the research, development and manufacturing of gene therapies for rare genetic disorders. In January 2023, the company acquired Vertuis Bio, Inc. (Vertuis), a privately held, preclinical stage company engaged in the research and development of gene therapies for rare genetic disorders. In June 2023, the company acquired Adrestia Therapeutics Ltd. (Adrestia), a privately held, preclinical stage company using precision genetic models to search for therapeutic targets, precision diagnostics, novel drug compounds and new applications for existing drugs. The company continues to progress its early-stage research programs across a wide range of technologies and modalities, including gene therapy, artificial intelligence-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue. Manufacturing In October 2017, the company entered into certain agreements with Patheon UK Limited (Patheon), a wholly-owned subsidiary of Thermo Fisher Scientific, Inc. (Thermo Fisher), related to increasing its long-term production capacity for ARIKAYCE commercial inventory. The agreements provide for Patheon to manufacture and supply ARIKAYCE for its long-term anticipated commercial needs. Under these agreements, the company is required to deliver to Patheon the required raw materials, including active pharmaceutical ingredients, and certain fixed assets needed to manufacture ARIKAYCE. Intellectual Property The company owns or licenses rights to more than 900 issued patents and pending patent applications in the U.S. and in foreign countries, including more than 300 issued patents and pending patent applications related to ARIKAYCE. The company’s success depends in large part on its ability to maintain proprietary protection surrounding its product candidates, technology and know-how; to operate without infringing the proprietary rights of others; and to prevent others from infringing its proprietary rights. The company actively seeks patent protection by filing patent applications, including on inventions that are important to the development of its business in the U.S., Europe, Japan, Canada, and selected other foreign markets that it considers key for its product candidates. These international markets generally include Australia, China, India, Israel and Mexico. The company’s patent strategy includes obtaining patent protection, where possible, on compositions of matter, methods of manufacture, methods of use, dosing and administration regimens and formulations. ARIKAYCE Patents Of the patents and applications related to ARIKAYCE, there are 12 issued US patents that cover the ARIKAYCE composition and its use in treating NTM that are listed in the FDA Orange Book. These patents and their expiration dates are as follows: US Patent No. 7,718,189 (expires June 6, 2025) US Patent No. 8,226,975 (expires August 15, 2028) US Patent No. 8,632,804 (expires December 5, 2026) US Patent No. 8,802,137 (expires April 8, 2024) US Patent No. 8,679,532 (expires December 5, 2026) US Patent No. 8,642,075 (expires December 5, 2026) US Patent No. 9,566,234 (expires January 18, 2034) US Patent No. 9,827,317 (expires April 8, 2024) US Patent No. 9,895,385 (expires May 15, 2035) US Patent No. 10,251,900 (expires May 15, 2035) US Patent No. 10,751,355 (expires May 15, 2035) US Patent No. 11,446,318 (expires May 15, 2035) In addition, the company owns five pending US patent applications that cover the ARIKAYCE composition and/or its use in treating NTM, including MAC infections. One or more of the patent applications, if issued as patents in their current form, may be eligible for listing in the FDA Orange Book for ARIKAYCE. The company also owns a pending US application that covers methods for making ARIKAYCE. The company anticipates that in the U.S., it will have patent coverage for ARIKAYCE and its use in treating NTM lung disease, including NTM lung disease caused by MAC, through May 15, 2035. Ten patents have been granted by the European Patent Office (EPO) (European Patent Nos. 1581236, 1909759, 1962805, 2823820, 2852391, 3067046, 3142643, 3427742, 3466432 and 3766501) that relate to ARIKAYCE and its use in treating NTM, including MAC infections. In addition, the company has additional patent applications pending before the EPO that relate to ARIKAYCE and its use in treating NTM lung disease. European Patent No. 1909759 (the ’759 patent), owned by the company, was previously opposed by Generics (UK) Ltd. A hearing was held on October 19, 2015, during which the company submitted amended claims. The European Patent Office Opposition Division (EPOOD) maintained the patent as amended and Generics (UK) Ltd appealed the decision. The EPO Technical Board of Appeals heard arguments related to the appeal on January 8, 2019 and the product claims of the patent were held invalid. The method of manufacture claims was remitted to the EPOOD for further consideration, and the EPO has since maintained the validity of these claims. European Patent Nos. 1962805 and 3067046, both of which expire approximately five months after the ‘759 patent (December 5, 2026 vs. July 19, 2026), also include claims related to ARIKAYCE and its use in treating NTM lung disease. European Patent No. 2852391 expires May 21, 2033 and includes claims related ARIKAYCE together with a vibrating mesh nebulizer having certain properties. European Patent Nos. 3142643, 3466432 and 3766501 each expires May 15, 2035 and include claims related to ARIKAYCE and its use for treating MAC lung infections. More than 60 patents have also been issued in other major foreign markets, e.g., Japan, China, Korea, Australia, and India, that relate to ARIKAYCE and/or methods of using ARIKAYCE for treating various pulmonary disorders, including NTM lung disease. More than 30 foreign patent applications are pending that relate to the ARIKAYCE composition and/or its use in treating various pulmonary disorders, including NTM lung disease. Through its agreements with PARI, the company has license rights to US and foreign patents and applications that cover the Lamira medical device through January 18, 2034. The company has entered into a commercial supply agreement with PARI and it also has rights to use the nebulizers in expanded access programs and clinical trials. Brensocatib Patents Through its agreement with AstraZeneca, the company has licensed US Patent Nos. 9,522,894, 9,815,805, 10,287,258, 10,669,245, 11,655,221, 11,655,222, 11,655,223, 11,655,224, 11,673,871, 11,773,069, and 11,814,359, which have claims related to brensocatib and methods for using brensocatib in certain treatment methods, including the treatment of obstructive diseases of the airway such as bronchiectasis. US Patent No. 9,522,894 expires March 12, 2035 while the remaining US patents expire January 21, 2035 (not taking into account any potential patent term extension). Counterpart patents have issued in Australia, Canada, Europe, China, Japan, South Korea, India, Israel, and Mexico and expire January 21, 2035, not accounting for any potential patent term extension. In addition, patent applications related to brensocatib are pending in the US and throughout the world, including in Europe, China, and Japan. TPIP Patents The company owns US Patent Nos. 9,255,064, 9,469,600, 10,010,518, 10,526,274, 10,995,055 and 11,795,135, each expiring October 24, 2034 (not taking into account any potential patent term extensions or adjustments), each with claims covering treprostinil palmitil, the treprostinil prodrug component of TPIP, compositions comprising the same, and/or its use. US Patent No. 9,255,064 has claims reciting hexadecyl-treprostinil, and other treprostinil prodrugs. US Patent No. 9,469,600 has claims related to TPIP and other treprostinil prodrug formulations. US Patent No. 10,010,518 has claims directed to methods of treating pulmonary hypertension, including PAH, using compositions related to TPIP, such as treprostinil prodrug formulations. US Patent No. 10,526,274 has claims directed to methods for treating pulmonary fibrosis with treprostinil palmitil. US Patent No. 10,995,055 has claims directed to compositions comprising treprostinil palmitil in the form of a dry powder, and methods for treating pulmonary hypertension with the same. US Patent No. 11,795,135 has claims directed to methods for treating PH-ILD, with treprostinil palmitil. Counterpart patent applications to these US Patents have issued in Europe, Japan and other foreign jurisdictions. Counterpart patent applications to these US Patents are also pending in select jurisdictions, including the U.S., Europe and Japan. The company owns pending patent applications that relate to methods for using treprostinil prodrugs and formulations comprising the same, including TPIP in treating patients with PAH and other diseases, as well as methods for manufacturing such treprostinil prodrugs and formulations. Should the patent applications related to TPIP formulations and methods of using TPIP in pulmonary hypertension treatment methods issue, these patents would expire in October 2041. Trademarks In addition to its patents and trade secrets, the company has filed applications to register certain trademarks in the U.S. and/or abroad, including INSMED and ARIKAYCE. The company has two registrations for the INSMED mark and one registration for the ARIKAYCE mark from the US Patent and Trademark Office (USPTO). The company has also received notices of allowance or registrations in a number of countries abroad for the INSMED and ARIKAYCE marks, among others. The EMA has authorized the use of the name ARIKAYCE liposomal, and the FDA has approved its use of the name ARIKAYCE, as the trade name for amikacin liposome inhalation suspension. License and Other Agreements ARIKAYCE-related Agreements The company relies and will continues to rely, on agreements with a number of third parties in connection with the development and manufacture of ARIKAYCE. PARI The company has a licensing agreement with PARI for use of the optimized Lamira Nebulizer System for delivery of ARIKAYCE in treating patients with NTM lung infections, CF and bronchiectasis. Under the licensing agreement, the company has rights under several US and foreign issued patents and patent applications involving improvements to the optimized Lamira Nebulizer System, to exploit the system with ARIKAYCE for the treatment of such indications, but it cannot manufacture the nebulizers except as permitted under its Commercialization Agreement with PARI. Lamira has been approved for use in the U.S. (in combination with ARIKAYCE) and EU and is authorized for use in Japan. The company has rights to use the nebulizers in expanded access programs and clinical trials. Lamira must receive regulatory approval before it can market ARIKAYCE outside the U.S., EU and Japan, and it is labeled as investigational for use in the company’s clinical trials outside of these regions. The company has certain obligations under this licensing agreement in relation to specified licensed indications. With respect to NTM, the company meets all obligations to achieve certain commercial, developmental and regulatory milestones by the required deadlines. With respect to bronchiectasis, the company has an obligation to use commercially reasonable efforts to initiate a Phase 3 trial for bronchiectasis by a set deadline. With respect to CF, the company is obligated to use commercially reasonable efforts to develop, obtain regulatory and reimbursement approval, market and sell ARIKAYCE in two or more major European countries, as well as to achieve certain milestones specified in the licensing agreement. Termination of the licensing agreement or loss of exclusive rights may occur if it fail to meet its obligations, including payment of royalties to PARI. Resilience In February 2014, the company entered into a contract manufacturing agreement with Therapure Biopharma Inc., which has been assumed by Resilience, for the manufacture of ARIKAYCE, on a non-exclusive basis, at a 200 kg scale. Patheon (a wholly-owned subsidiary of Thermo Fisher) and related agreements In 2017, the company entered into certain agreements with Patheon related to the increase of its long-term production capacity for ARIKAYCE. The agreements provide for Patheon to manufacture and supply ARIKAYCE for the company’s anticipated commercial needs. Under these agreements, the company is required to deliver to Patheon the required raw materials, including active pharmaceutical ingredients, and certain fixed assets needed to manufacture ARIKAYCE. Patheon's supply obligations will commence once certain technology transfer and construction services are completed. PPD Development, L.P. (a wholly-owned subsidiary of Thermo Fisher) In 2020, the company entered into a master services agreement with PPD Development, L.P. (PPD) pursuant to which it retained PPD to perform clinical development services in connection with certain of its clinical research programs. AstraZeneca In 2016, the company entered into a license agreement with AstraZeneca (the AZ License Agreement), pursuant to which AstraZeneca granted it exclusive global rights for the purpose of developing and commercializing AZD7986 (renamed brensocatib). Research and Development (R&D) The company’s R&D expenses were $571.0 million during the year ended December 31, 2023. History Insmed Incorporated was founded in 1988. The company was incorporated in the Commonwealth of Virginia in 1999.