Insmed's Q3 Loss Wider Than Expected, Sales In Line With Estimates

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]