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Insmed(INSM) - 2019 Q4 - Earnings Call Presentation
2020-02-25 15:31
| --- | --- | --- | --- | --- | |----------------------------------------------------------------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | 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 ...
Insmed(INSM) - 2019 Q4 - Annual Report
2020-02-25 12:30
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 ...
Insmed(INSM) - 2019 Q3 - Earnings Call Transcript
2019-10-30 18:53
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]
Insmed(INSM) - 2019 Q3 - Quarterly Report
2019-10-30 11:31
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, 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 000-30739 INSMED INCORPORATED (Exact name of registrant as specified in its charter) Virginia 54-1972729 (Address of principal e ...
Insmed (INSM) Investor Presentation - Slideshow
2019-09-16 16:56
Investor Presentation September 2019 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 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(INSM) - 2019 Q2 - Earnings Call Transcript
2019-08-03 00:13
Insmed, Inc. (NASDAQ:INSM) Q2 2019 Results Conference Call August 1, 2019 8:30 AM ET Company Participants Blaine Davis - Head of Investor Relations Will Lewis - Chairman and Chief Executive Officer Roger Adsett - Chief Commercial Officer John Goll - Chief Accounting Officer Conference Call Participants Martin Auster - Credit Suisse Matthew Harrison - Morgan Stanley Adam Walsh - Stifel Financial Corp Joseph Schwartz - SVB Leerink Josh Schimmer - Evercore ISI Liisa Bayko - JMP Securities Operator Good day, la ...
Insmed(INSM) - 2019 Q2 - Quarterly Report
2019-08-01 11:33
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 June 30, 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 000-30739 INSMED INCORPORATED (Exact name of registrant as specified in its charter) Virginia 54-1972729 (State or other jurisdiction ...
Insmed(INSM) - 2019 Q1 - Earnings Call Transcript
2019-05-07 17:31
Insmed, Inc. (NASDAQ:INSM) Q1 2019 Earnings Conference Call May 7, 2019 8:30 AM ET Company Participants Blaine Davis - VP & Head of IR William Lewis - President, CEO & Chairman Roger Adsett - Chief Commercial Officer Paolo Tombesi - CFO Conference Call Participants Martin Auster - Crédit Suisse Ritu Baral - Cowen and Company Dewey Steadman - Canaccord Genuity Joseph Schwartz - SVB Leerink Adam Walsh - Stifel, Nicolaus & Company Operator Good day Ladies and gentlemen, and welcome to Insmed Conference Call to ...
Insmed(INSM) - 2019 Q1 - Quarterly Report
2019-05-07 11:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Virginia 54-1972729 (State or other jurisdiction of incorporation or organization) (I.R.S. employer identification no.) (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 OR o 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 IN ...
Insmed(INSM) - 2018 Q4 - Annual Report
2019-02-22 12:30
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ý ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR o 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 jurisdictio ...