February 23, 2023 The forward-looking statements in this presentation are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors ...

Product Approvals and Development - ARIKAYCE received accelerated approval in the US in September 2018 for the treatment of refractory MAC lung disease, with subsequent approvals in Europe (October 2020) and Japan (March 2021) for similar indications [19][24][32]. - The company anticipates sharing topline efficacy and safety data from the ARISE trial in Q3 2023 and completing enrollment in the ENCORE trial by the end of 2023 [20][30]. - Brensocatib is in Phase 3 development for bronchiectasis and CF, with plans to advance CRSsNP into Phase 2 development in mid-2023 [20][21]. - The FDA granted ARIKAYCE a total of 12 years of exclusivity due to its orphan drug and Qualified Infectious Disease Product (QIDP) designations [25]. - The CONVERT study showed that 63.1% of patients on ARIKAYCE plus guideline-based therapy maintained durable culture conversion for three months off therapy compared to 0% on guideline-based therapy alone (p<0.0002) [34]. - The ARISE trial completed enrollment in Q4 2022, with a blinded treatment discontinuation rate of 15% reported in January 2023, and topline efficacy and safety data expected in Q3 2023 [37]. - The ENCORE trial is currently enrolling approximately 250 patients, with completion of enrollment anticipated by the end of 2023 [38]. - The estimated number of patients diagnosed with NTM lung disease in the US is between 95,000 and 115,000, with 12,000 to 17,000 patients refractory to treatment [42]. - The potential addressable market for bronchiectasis is estimated at 450,000 patients in the US, 400,000 in the European 5, and 150,000 in Japan [57]. - Brensocatib demonstrated a 42% reduction in the risk of exacerbation for the 10 mg group and a 38% reduction for the 25 mg group compared to placebo in the WILLOW study [51]. - The FDA granted breakthrough therapy designation for brensocatib for treating adult patients with non-cystic fibrosis bronchiectasis, expediting its development [47]. - The ASPEN trial for brensocatib is expected to enroll approximately 1,620 patients across 480 sites in 40 countries, with topline data anticipated in Q2 2024 [45]. Research and Development Initiatives - The company is actively evaluating in-licensing and acquisition opportunities for a broad range of rare diseases to complement its internal R&D efforts [22]. - The company plans to share interim data from the PH-ILD study in the second half of 2023 and topline results in the first half of 2024 [25]. - The company plans to explore brensocatib's potential in additional neutrophil-mediated diseases, including CRSsNP, with Phase 2 development anticipated in mid-2023 [55]. - Two ongoing Phase 2 studies for TPIP are assessing safety in PH-ILD and efficacy in PAH, with topline results from the PH-ILD study expected in the first half of 2024 [61][62]. - The company acquired a proprietary protein deimmunization platform and two preclinical stage companies in 2021 to enhance its gene therapy capabilities [63]. - The first IND filing is anticipated in the first half of 2023, with preclinical data expected in musculoskeletal and CNS indications [65]. Commercialization and Market Strategy - The company is advancing commercial readiness activities in 2023 in preparation for the potential launch of brensocatib [21]. - The company is working to ensure an uninterrupted supply of ARIKAYCE in Germany while negotiating pricing agreements with local health authorities [31]. - The company plans to rely on third-party manufacturers for the commercial supply of product candidates, with an estimated investment of approximately $99 million to increase ARIKAYCE production capacity [68]. - The company has invested significant resources in the commercialization of ARIKAYCE, which may exceed those required for more established technologies [217]. - The company may seek partnerships for marketing and distribution of ARIKAYCE, which could limit control over commercialization efforts [215]. Financial and Market Position - The company has a history of operating losses and expects to incur losses for the foreseeable future, impacting its financial condition [213]. - The company may need to raise additional funds to continue operations, facing uncertainties regarding capital access [213]. - The market price of the company's stock has been highly volatile, which could lead to shareholder litigation [213]. Regulatory Environment and Exclusivity - The FDA has 60 days to determine if an NDA or BLA is accepted for filing, with a goal to complete 90% of standard applications within 10 months [118]. - The FDA may require substantial post-approval testing, known as Phase 4 studies, to gather additional information on the drug's effects and side effects [121]. - The FDA's accelerated approval program allows for drugs to be approved based on surrogate endpoints, potentially reducing time to market [122]. - Fast track designation can expedite development and review for drugs intended to treat serious conditions with unmet medical needs [126]. - Breakthrough therapy designation provides intensive guidance on drug development and expedited review, with a response required from the FDA within 60 days [128]. - Drugs designated as Qualified Infectious Disease Products (QIDPs) may receive priority review and fast track designation, with ARIKAYCE being a notable example [129]. - Non-patent exclusivity for new chemical entities (NCEs) lasts for five years, preventing the FDA from accepting abbreviated NDAs during this period [134]. - A three-year non-patent exclusivity is granted for drugs with new clinical investigations essential for approval, covering only the new conditions of use [135]. - QIDP designation can extend non-patent exclusivities by five years, potentially allowing for a combined 12 years of exclusivity for drugs like ARIKAYCE [137]. - Reference product exclusivity prevents the FDA from accepting a BLA for a proposed biosimilar product for 4 years and from approving it for 12 years after the reference product's first licensure [138]. Workforce and Corporate Governance - As of December 31, 2022, the company had a total of 736 full-time employees, with 579 in the US, 85 in Europe, and 72 in Japan [194]. - The company anticipates increasing its headcount in 2023 [194]. - Women represent 38% of the executive team, 28% of the leadership team, 33% of the board of directors, and 51% of the overall workforce [199]. - The company has a compensation program designed to attract and retain talent, with total compensation generally positioned within a competitive range of the peer market median [196]. - The company is committed to equitable pay and conducts annual internal equity reviews to ensure a fair compensation system [199]. - The company has a cross-functional group focused on Environmental, Social, and Governance (ESG) considerations and strategy [200]. - The company supports several green measures and community service programs to improve sustainability efforts [201]. - The company has implemented flexible work arrangements for employees to manage business and personal responsibilities during COVID-19 [202]. - The company is dedicated to promoting patient advocacy and safety as part of its corporate governance [201]. - The company aims to ensure diverse succession plans in its workforce and board of directors [199]. Competitive Landscape - The company faces competition from various sectors, including established pharmaceutical and biotechnology firms, which may have more advanced products [97]. - There are currently no approved inhaled therapies for refractory NTM lung infections in North America, Europe, or Japan, positioning ARIKAYCE uniquely in the market [99]. - The company expects competition in gene therapy and protein engineering to intensify, impacting its market position if approved products are developed by competitors [100]. Intellectual Property and Licensing - The company holds over 450 patents related to its products, including 12 issued US patents for ARIKAYCE, with coverage expected through May 15, 2035 [70][75]. - The company has licensed multiple patents related to brensocatib, with the earliest expiring in March 2035 [79]. - TPIP is protected by several US patents expiring in October 2034, covering its use in treating pulmonary hypertension [80]. - The company has filed applications to register trademarks for INSMED and ARIKAYCE, with some registrations already granted [83]. - The licensing agreement with PARI includes rights to use the optimized Lamira Nebulizer System for ARIKAYCE, which is approved in the US, EU, and Japan [85]. - Milestone payments to PARI totaled €3.0 million upon FDA and EMA approvals of ARIKAYCE, with ongoing royalty payments in the mid-single digits on global net sales [87]. - The agreement with Resilience mandates a minimum payment of $6 million annually for ARIKAYCE production, with an initial term of five years starting in October 2018 [91]. - The investment to increase long-term production capacity with Patheon is estimated at approximately $99 million, with agreements remaining in effect for successive renewal terms [92]. - Cystic Fibrosis Foundation Therapeutics, Inc. funding agreements resulted in milestone payments owed totaling $13.4 million through 2025, with $4.9 million paid as of December 31, 2022 [93]. - The AZ License Agreement with AstraZeneca includes an upfront payment of $30 million and potential milestone payments up to $72.5 million for clinical development [96]. Regulatory Designations and Orphan Drug Status - ARIKAYCE has received orphan drug designation for treating NTM infections and bronchiectasis, qualifying the company for various development incentives [102]. - The European Commission granted orphan drug designation for ARIKAYCE for the treatment of NTM lung disease, promoting its development for conditions affecting fewer than 5 in 10,000 people in the EU [105]. - Orphan exclusivity lasts for 10 years, extendable by 2 years if a pediatric investigation plan is implemented, but can be reduced to 6 years if the product is sufficiently profitable [106]. - Orphan drug designation provides opportunities for fee reductions and exemptions for small and medium enterprises, as well as potential national benefits from EU member states [107]. - In Japan, ARIKAYCE did not qualify for orphan drug designation due to the estimated number of NTM patients exceeding 50,000 [110].

placebo -14.7% 95.6% 2.5% patients with insmed The forward-looking statements in this presentation are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, un ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 000-30739 INSMED INCORPORATED (Exact name of registrant as specified in its charter) Virginia 54-1972729 (State or other jurisdi ...

Insmed Incorporated (NASDAQ:INSM) Q2 2022 Earnings Conference Call August 4, 2022 8:30 AM ET Company Participants Eleanor Barisser - Investor Relations Will Lewis - Chair & Chief Executive Officer Sara Bonstein - Chief Financial Officer Conference Call Participants Jeff Hung - Morgan Stanley Andrea Tan - Goldman Sachs Judah Frommer - Credit Suisse Joori Park - SVB Securities Stephen Willey - Stifel Jennifer Kim - Cantor Fitzgerald Operator Good morning. My name is Dennis, and I will be your conference oper ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) Virginia 54-1972729 (State or other jurisdiction of incorporation or organization) (I.R.S. employer identification no.) For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transit ...

Insmed Inc. (NASDAQ:INSM) Q1 2022 Results Conference Call May 5, 2022 8:30 AM ET Company Participants Eleanor Barisser - IR Will Lewis - Chairman, CEO Sara Bonstein - CFO Conference Call Participants Andrea Tan - Goldman Sachs Anita Dushyanth - Berenberg Jeff Hung - Morgan Stanley Jennifer Kim - Cantor Fitzgerald Jessica Fye - JPMorgan Joseph Schwartz - SVB Securities Judah Frommer - Credit Suisse Ritu Baral - Cowen Stephen Willey - Stifel Operator Hello, everyone, and welcome to the Insmed First Quarter 2 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 000-30739 INSMED INCORPORATED (Exact name of registrant as specified in its charter) Virginia 54-1972729 (State or other jurisdictio ...

Insmed Incorporated (NASDAQ:INSM) Q4 2021 Earnings Conference Call February 17, 2022 8:00 AM ET Company Participants Will Lewis - Chairman and Chief Executive Officer Eleanor Barisser - Associate Director, Investor Relations Martina Flammer - Chief Medical Officer Roger Adsett - Chief Operating Officer Sara Bonstein - Chief Financial Officer Conference Call Participants Jessica Fye - JP Morgan Melina Santoro - Morgan Stanley Ritu Baral - Cowen Judah Frommer - Credit Suisse Joori Park - SVB Leerink Stephen W ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to 54-1972729 (I.R.S. employer identification no.) Commission File Number 0-30739 INSMED INCORPORATED (Exact name of registrant as specified in its ...