If you like what you have just read and want to receive at least 4 exclusive stock tips every week focused on Pharma, Biotech and Healthcare, then join me at my marketplace channel, Haggerston BioHealth . Invest alongside the model portfolio or simply access the investment bank-grade financial models and research. I hope to see you there.Insmed Incorporated ( INSM ) is a Bridgewater, New Jersey based, commercial stage biotech. It markets and sells Arikayce — amikacin liposome inhalation suspension — in the ...

Core Viewpoint - Insmed Incorporated has received FDA acceptance for its new drug application for brensocatib, a reversible inhibitor of dipeptidyl peptidase 1 (DPP1), aimed at treating non-cystic fibrosis bronchiectasis, with a decision expected by August 12, 2025 [1][2]. Company Developments - If approved, brensocatib will be the first and only treatment for bronchiectasis, a chronic lung disease currently lacking approved therapies, and the first DPP1 inhibitor for neutrophil-mediated diseases [2]. - Insmed plans to launch brensocatib in the U.S. in Q3 2025, following the expected approval [2]. - The NDA is based on data from the phase III ASPEN study, which demonstrated significant reductions in pulmonary exacerbations with both 10mg and 25mg doses of brensocatib compared to placebo [3][4]. Clinical Study Insights - The ASPEN study met its primary endpoint, showing both doses of brensocatib achieved statistically significant reductions in the annualized rate of pulmonary exacerbations [4]. - Secondary endpoints were also met, including prolonged time to first pulmonary exacerbation and increased odds of remaining exacerbation-free over a 52-week treatment period [4]. Future Plans - Insmed intends to submit regulatory filings for brensocatib in the UK, EU, and Japan in 2025, with a potential launch in 2026 for these territories [5]. - Additionally, brensocatib is being evaluated in the phase IIb BiRCh study for chronic rhinosinusitis without nasal polyps, with top-line data expected by the end of 2025 [6]. Market Performance - Over the past year, Insmed's shares have increased by 182.7%, contrasting with a 6.5% decline in the industry [3].

Core Viewpoint - Insmed Incorporated's brensocatib has received FDA acceptance for New Drug Application (NDA) for treating non-cystic fibrosis bronchiectasis, potentially becoming the first approved treatment for this condition and the first DPP1 inhibitor if approved [1][2] Group 1: FDA Review and Approval Process - The FDA has granted Priority Review to the NDA with a target action date of August 12, 2025, under the Prescription Drug User Fee Act (PDUFA) [1] - The FDA has previously granted brensocatib Breakthrough Therapy Designation, indicating its potential for significant improvement in treating serious conditions [4] Group 2: Clinical Study Results - The NDA is based on the Phase 3 ASPEN study, which demonstrated statistical and clinical significance in reducing the annualized rate of pulmonary exacerbations over a 52-week treatment period [2][6] - Both dosage strengths of brensocatib met several prespecified exacerbation-related secondary endpoints, including prolonging time to first exacerbation and increasing odds of remaining exacerbation-free [2] Group 3: Patient Population and Market Potential - Approximately 500,000 patients in the U.S., 600,000 in the EU5, and 150,000 in Japan are diagnosed with bronchiectasis, with no approved therapies currently available in these regions [7][8] - Insmed plans to file regulatory submissions for brensocatib in the EU, UK, and Japan in 2025, with commercial launches anticipated in 2026, pending approval [5] Group 4: Safety and Tolerability - Brensocatib was well-tolerated in the study, with treatment-emergent adverse events occurring in at least 5.0% of patients, including COVID-19 (15.8% for 10 mg, 20.9% for 25 mg), nasopharyngitis (7.7% for 10 mg), cough (7.0% for 10 mg), and headache (6.7% for 10 mg) [3]

--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 ...