Insmed Incorporated (INSM) announced that the FDA has accepted its new drug application (“NDA”) seeking approval of its reversible inhibitor of dipeptidyl peptidase 1 (DPP1), brensocatib, for treating patients with non-cystic fibrosis bronchiectasis.With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Aug. 12, 2025.If approved, brensocatib will become the first and only approved treatment for bronchiectasis, a chronic lung disease with no approved treatments ...

—Brensocatib Would be the First and Only Available Treatment for Bronchiectasis and First DPP1 Inhibitor, if Approved—BRIDGEWATER, N.J., Feb. 6, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for brensocatib for patients ...

--ARIKAYCE® (amikacin liposome inhalation suspension) Exceeds the Upper End of Guidance Range for Full-Year 2024 with Unaudited Global Revenues of Approximately $363.7 Million----2025 Global ARIKAYCE Revenues Expected to be Between $405 Million and $425 Million, Reflecting Continued Double-Digit Growth Compared to 2024----NDA for Brensocatib in Bronchiectasis Submitted to FDA in December 2024, Narrowing the Timing for Expected U.S. Launch to the Third Quarter of 2025, Pending Approval Under Priority Review- ...

BRIDGEWATER, N.J., Dec. 2, 2024 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that management will present at the following investor conferences: Evercore ISI HealthCONx Conference in Coral Gables, Florida, on Wednesday, December 4, 2024, at 11:15 a.m. ET. Nasdaq 51st Investor Conference held in association with Morgan Stanle ...

Company Overview - Insmed Incorporated is a global biopharmaceutical company focused on delivering first- and best-in-class therapies for patients with serious diseases [4][5] - The company is advancing a diverse portfolio of approved and investigational medicines, particularly in pulmonary and inflammatory conditions [4] - Insmed is recognized as one of the best employers in the biopharmaceutical industry, having been named the No. 1 Science Top Employer for four consecutive years [5] Upcoming Investor Conferences - Insmed will present at the Guggenheim's Inaugural Healthcare Innovation Conference in Boston on November 11, 2024, at 1:00 p.m. ET [1] - The company will also participate in the UBS Global Healthcare Conference in California on November 12, 2024, at 11:45 a.m. PT / 2:45 p.m. ET [2] - Additional presentations include the Wolfe Research Healthcare Conference in New York on November 20, 2024, at 8:00 a.m. ET and the Jefferies London Healthcare Conference on November 21, 2024, at 8:30 a.m. GT / 3:30 a.m. ET [2] Webcast Information - The events will be webcast live and accessible via the investor relations section of Insmed's website [3] - Webcasts will be archived for 30 days following the live events [3]

Core Insights - Insmed reported a third-quarter 2024 loss of $1.27 per share, which was wider than the Zacks Consensus Estimate of a loss of $1.19, and compared to a loss of $1.11 per share in the same quarter last year [1] - Total revenues for the quarter were $93.4 million, reflecting an 18% year-over-year increase, and were in line with the Zacks Consensus Estimate [1] - The company's shares declined over 4% following the earnings miss [1] Revenue Generation - All revenues in the reported quarter were generated from Arikayce, the company's only marketed drug, which treats refractory mycobacterium avium complex (MAC) lung disease [4] - Arikayce sales increased by 13% to $66.9 million in the United States, 31% to $21.0 million in Japan, and 45% to $5.6 million in Europe and the rest of the world [5] Expenses - Research and development (R&D) expenses rose 38% year over year to $150.8 million, while selling, general and administrative (SG&A) expenses increased by 31% to $118.9 million [6] Cash Position - As of September 30, 2024, Insmed had cash, cash equivalents, and marketable securities of approximately $1.5 billion, up from $1.2 billion as of June 30, 2024, due to net proceeds of $371 million from the company's equity program [7] Guidance - Management maintained its sales guidance for Arikayce for the full year, expecting product sales to be between $340 million and $360 million, indicating a 15% year-over-year growth at the midpoint [8] Pipeline Updates - Insmed plans to meet with the FDA to discuss the potential for accelerated approval to expand Arikayce's label for all patients with MAC lung infection [9] - The total addressable market (TAM) for refractory MAC is estimated at around 30,000 patients, which could increase to approximately 275,000 patients if Arikayce is approved for newly infected patients [10] - Insmed is on track to submit a regulatory filing for brensocatib in bronchiectasis by the end of the year, with a potential commercial launch in mid-2025 [11] - The company is also evaluating brensocatib in chronic rhinosinusitis and plans to initiate a mid-stage study for HS indication before the end of 2024 [12] - Top-line data from a mid-stage study of TPIP in pulmonary arterial hypertension is expected in the second half of 2025 [13]

Core Insights - Insmed reported $93.43 million in revenue for Q3 2024, marking an 18.2% year-over-year increase, with an EPS of -$1.27 compared to -$1.10 a year ago [1] - The revenue exceeded the Zacks Consensus Estimate of $93.31 million by 0.12%, while the EPS fell short of the consensus estimate of -$1.19 by 6.72% [1] Revenue Breakdown - Revenue from Japan was $20.98 million, below the estimated $24.10 million, but showed a year-over-year increase of 30.9% [3] - Revenue from Europe and the rest of the world reached $5.57 million, slightly above the $5.45 million estimate, reflecting a 45.3% year-over-year growth [3] - U.S. revenue was $66.87 million, surpassing the average estimate of $64.70 million, with a year-over-year increase of 13% [3] Stock Performance - Insmed's shares have declined by 3.7% over the past month, contrasting with a 1% increase in the Zacks S&P 500 composite [4] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [4]

Insmed (INSM) came out with a quarterly loss of $1.27 per share versus the Zacks Consensus Estimate of a loss of $1.19. This compares to loss of $1.10 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -6.72%. A quarter ago, it was expected that this biopharmaceutical developing inhaled treatments for patients battling rare lung diseases would post a loss of $1.22 per share when it actually produced a loss of $1.94, delivering a ...

Exhibit 99.1 1 Insmed Reports Third-Quarter 2024 Financial Results and Provides Business Update —ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of $93.4 Million for the Third Quarter of 2024, Reflecting 18% Growth Over the Third Quarter of 2023— —NDA Submission for Brensocatib in Bronchiectasis Remains on Track for the Fourth Quarter of 2024 with Potential U.S. Launch Still Expected in Mid-2025— —Expanded U.S. Sales Force is Now Fully Deployed; Focusing on Bronchiectasis Disease-State Awa ...

—ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of $93.4 Million for the Third Quarter of 2024, Reflecting 18% Growth Over the Third Quarter of 2023——NDA Submission for Brensocatib in Bronchiectasis Remains on Track for the Fourth Quarter of 2024 with Potential U.S. Launch Still Expected in Mid-2025——Expanded U.S. Sales Force is Now Fully Deployed; Focusing on Bronchiectasis Disease-State Awareness and Supporting the Growth of ARIKAYCE Prior to the Anticipated Launch of Brensocatib——Ends ...