Promising Therapies Inspired by Urgent Unmet Patient Needs 2 Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "est ...

Insmed Incorporated (NASDAQ:INSM) Q3 2020 Earnings Conference Call October 29, 2020 8:30 AM ET Company Participants Sara Bonstein - Chief Financial Officer Will Lewis - Chair & Chief Executive Officer Martina Flammer - Chief Medical Officer Roger Adsett - Chief Operating Officer Kevin Mange - Head of Clinical Development Conference Call Participants Ritu Baral - Cowen Martin Auster - Credit Suisse Stephen Willey - Stifel Connor Meehan - Morgan Stanley John McNeil - Goldman Sachs Joseph Schwartz - SVB Leerin ...

Financial Performance - Total revenues for the three months ended September 30, 2020, were $43.643 million, an increase of 12.5% compared to $38.885 million for the same period in 2019[12]. - Gross profit for the nine months ended September 30, 2020, was $93.988 million, up from $75.253 million in the same period of 2019, reflecting a year-over-year increase of 24.5%[12]. - The net loss for the three months ended September 30, 2020, was $63.659 million, compared to a net loss of $60.682 million for the same period in 2019, indicating a 4.9% increase in losses[12]. - The total comprehensive loss for the three months ended September 30, 2020, was $63.447 million, compared to $60.683 million for the same period in 2019, indicating an increase of 4.6%[12]. - The company reported a net loss of $191.9 million for the nine months ended September 30, 2020, compared to a net loss of $201.3 million for the same period in 2019, representing a 4.5% improvement[24]. Cash and Assets - Cash and cash equivalents as of September 30, 2020, were $588.753 million, an increase from $487.429 million as of December 31, 2019, reflecting a growth of 20.7%[10]. - Total assets increased to $840.715 million as of September 30, 2020, from $742.299 million as of December 31, 2019, marking an increase of 13.2%[10]. - Shareholders' equity increased to $357.061 million as of September 30, 2020, compared to $261.674 million as of December 31, 2019, representing a significant increase of 36.4%[10]. - As of September 30, 2020, the company's inventory balance was $43.5 million, an increase from $28.3 million as of December 31, 2019[58]. Research and Development - Research and development expenses for the three months ended September 30, 2020, were $41.411 million, compared to $34.340 million in the same period of 2019, representing an increase of 20.5%[12]. - The company expects R&D expenses to increase with the initiation of the Phase 3 ASPEN trial of brensocatib and a confirmatory clinical trial of ARIKAYCE[149]. - The company incurred stock-based compensation expense of $27.4 million for the nine months ended September 30, 2020, compared to $21.1 million in the same period of 2019, reflecting a 30% increase[24]. Product and Revenue Sources - The company's product revenues primarily consist of sales of ARIKAYCE in the US, with revenue recognition based on the completion of five specific steps outlined in ASC 606[39]. - Net product revenues from the US increased by $4.2 million, or 11.2%, to $42.0 million compared to $37.8 million in the same quarter of 2019[146]. - Revenues from EAP sales of ARIKAYCE increased by $0.5 million, or 48.3%, to $1.6 million compared to $1.0 million in the same quarter of 2019[146]. Liabilities and Expenses - Total liabilities as of September 30, 2020, were $483.654 million, slightly up from $480.625 million as of December 31, 2019[10]. - SG&A expenses decreased to $46.6 million during the quarter ended September 30, 2020, down $6.8 million or 12.7% from $53.3 million in the same period in 2019[152]. - Interest expense for the quarter was $7.2 million, an increase of $0.3 million from $6.8 million in the same period in 2019[154]. Future Outlook and Plans - The company expects substantial future cash requirements and may need to raise additional capital to fund operations, including commercialization of ARIKAYCE and clinical trials for brensocatib and TPIP[25]. - The company plans to support the commercialization of ARIKAYCE in the US and expand into the European Union and Japan[168]. - The company is evaluating in-licensing and acquisition opportunities for a broad range of rare diseases to complement its internal research and development efforts[105]. Impact of COVID-19 - The company is closely monitoring the impact of the COVID-19 pandemic on its business, although it did not materially affect financial results for the nine months ended September 30, 2020[26]. - The COVID-19 pandemic has negatively impacted the company's operations, including access to prescribers and the ability to conduct clinical trials[186]. - The company modified its business practices in March 2020 to allow employees to work remotely, which may continue to impact business operations[187]. Clinical Trials and Approvals - The company’s clinical-stage pipeline includes brensocatib and TPIP, targeting bronchiectasis and pulmonary arterial hypertension, respectively[20]. - The Phase 3 CONVERT study demonstrated that adding ARIKAYCE to guideline-based therapy resulted in sustained culture conversion through the end of treatment and durable culture conversion three months post-treatment compared to guideline-based therapy alone[112]. - The company plans to initiate the ENCORE trial and the ARISE trial by the end of 2020 to assess the clinical benefit of ARIKAYCE in patients with MAC lung disease[114].

Financial Data and Key Metrics Changes - The company reported total net revenue for Q2 2020 of $42.5 million, representing a 42% increase year-over-year [17] - Gross margin for the quarter was approximately 77%, with a gross-to-net ratio of about 13% [17] - Adjusted operating expenses were $73.7 million, slightly down from $74.4 million in Q2 2019, indicating a focus on cash discipline [19] - The company ended the quarter with a strong cash position of $641.9 million, bolstered by recent financing [20] Business Line Data and Key Metrics Changes - ARIKAYCE sales showed strong sequential growth despite COVID-19, contributing significantly to the overall revenue increase [16][39] - The company is preparing for a confirmatory study to evaluate ARIKAYCE as a new standard of care in front-line treatment settings [9] Market Data and Key Metrics Changes - The company anticipates approval for ARIKAYCE in Europe by the end of September 2020, expanding its commercial territory [8] - The company is also making progress in Japan, with a New Drug Application submitted for ARIKAYCE [51] Company Strategy and Development Direction - The company is focused on advancing its pipeline, including brensocatib for bronchiectasis and treprostinil palmitil for pulmonary arterial hypertension [15][35] - The management emphasized the potential synergies between its pipeline programs, particularly between NTM and bronchiectasis [61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to adapt to the challenges posed by COVID-19 and highlighted the importance of maintaining patient care [41][63] - The management noted that the index of suspicion for NTM among healthcare professionals has increased, which could lead to more patient referrals as COVID-19 cases decline [112] Other Important Information - The company is preparing for a virtual Research and Development Day on September 30, where more details about its programs will be shared [12][125] - The company has maintained satisfactory inventory levels for ARIKAYCE and has observed no supply chain disruptions [60] Q&A Session Summary Question: Update on pricing strategy for Europe - The company plans to set a price in free pricing markets like Germany and the UK, with a narrow pricing band anticipated [69][70] Question: Expectations for treprostinil palmitil's tolerability profile - The management expects improved safety and tolerability with the dry powder formulation compared to previous nebulized versions [73] Question: Impact of COVID-19 on patient backlog and physician interactions - The management noted that new patient starts are increasing month-over-month, reflecting a return to normalcy, but challenges remain due to COVID-19 spikes [80][83] Question: Geographic distribution of new patient adds during the pandemic - The management acknowledged significant variability across regions, with some areas seeing a rebound in patient engagement as COVID-19 cases decline [90][91] Question: Market size and launch pace in Europe - The management indicated that the initial uptake in Europe may be slower than in the U.S. due to the center of excellence model, but long-term opportunities remain robust [100][101]

(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q 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 jurisdiction ...

Insmed Incorporated (NASDAQ:INSM) Q1 2020 Results Conference Call April 30, 2020 8:30 AM ET Company Participants Sara Bonstein - CFO Will Lewis - Chairman and CEO Roger Adsett - COO Dr. Martina Flammer - Chief Medical Officer Conference Call Participants Connor Meehan - Morgan Stanley Adam Walsh - Stifel Martin Auster - Credit Suisse Ritu Baral - Cowen Joe Schwartz - SVB Leerink Liisa Bayko - JMP Graig Suvannavejh - Goldman Sachs Josh Schimmer - Evercore ISI Operator Good day, and welcome to the Insmed Firs ...

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, 2020 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 ...

| --- | --- | --- | --- | --- | |----------------------------------------------------------------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | 2019 Financial Results and Corporate Update February 25, 2020 | | | | | | | | | | | Not for promotional use Forward-Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of ...

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, 2019 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 0-30739 INSMED INCORPORATED (Exact name of registrant as specified in its charter) Virginia (State or other jurisdiction ...

Financial Data and Key Metrics Changes - Insmed reported total revenue of $39 million for Q3 2019, with a revenue guidance increase to a range of $133 million to $138 million for the full year [5][29] - The net loss for Q3 2019 was $60.7 million, or $0.68 per share, compared to a net loss of $87.7 million, or $1.14 per share, for Q3 2018 [24][25] - Gross margin for the quarter was 83%, consistent with Q2 2019 [25] Business Line Data and Key Metrics Changes - Global net sales of ARIKAYCE for Q3 2019 were $38.9 million, with $37.8 million from the US and $1.1 million from name patient programs in France and Germany [16][24] - Over 600 new patients initiated therapy during Q3 2019, reflecting strong demand and unmet treatment needs for refractory MAC lung disease patients [17][71] Market Data and Key Metrics Changes - Approximately 85% of patients who started therapy in the first six months remained on the drug by the end of Q3 2019 [19][36] - The company is optimistic about the potential for ARIKAYCE in the EU and Japan, with regulatory filings expected in 2020 [7][8] Company Strategy and Development Direction - Insmed is focused on expanding the label for ARIKAYCE to treat more patients with MAC lung disease and plans to initiate a study in a frontline setting next year [8][9] - The company is also advancing its pipeline, with the WILLOW study of INS1007 expected to yield top-line data in Q1 2020 [9][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the long-term growth potential of ARIKAYCE, citing positive feedback from physicians and encouraging trends in patient starts and duration of use [5][6] - The company is managing operating expenses carefully, expecting cash-based operating expenses to be flat to down in the second half of 2019 [14][27] Other Important Information - Insmed appointed Dr. Martina Flammer as the new Chief Medical Officer, bringing over 17 years of experience [12] - The company is evaluating external programs that may create value through addressing unmet medical needs [14] Q&A Session Summary Question: Can you expand on the metrics driving the lower discontinuation rate and duration of therapy? - Management noted that significant efforts in educating physicians and patients about therapy expectations have contributed to improved discontinuation rates and strong persistence in therapy [35][36] Question: What is the strategy for the PRO in the frontline trial? - The PRO will be derived from existing questionnaires, and validation may occur independently or in parallel with the Phase 3 study [50][52] Question: What are the expected improvements in rates of exacerbations in the WILLOW study? - Management expects to see an impact on the rate of pulmonary exacerbations and a correlation with neutrophil serine protease reductions [90][91] Question: What is the timing for the next trials for ARIKAYCE? - The timeline for the frontline study is uncertain and will depend on discussions with the FDA, but both frontline and M abscessus studies are being prepared [75][78] Question: How should milestone payments be viewed going forward? - Future milestone payments related to ARIKAYCE are not expected to be material, as they tend to be lumpy [80]