Insmed Inc. reported a net loss of $913.7 million for the year ended December 31, 2024, compared to a net loss of $749.6 million in 2023. Net product revenues, primarily from ARIKAYCE sales, increased by 19.2% to $363.7 million in 2024 from $305.2 million in 2023. This increase was driven by growth across all geographic regions: the US saw a 13.7% increase, Japan a 33.4% increase, and Europe and the rest of the world a 38.8% increase. However, the cost of product revenues also rose by 30.8% to $85.7 million, reflecting the increased sales volume.
Research and development (R&D) expenses increased by 4.8% to $598.4 million in 2024, primarily due to higher compensation and benefits, stock-based compensation, and manufacturing expenses. This increase was partially offset by a decrease in external expenses related to non-cash asset acquisitions. Selling, general, and administrative (SG&A) expenses saw a more substantial increase of 33.9% to $461.1 million, again largely attributed to higher compensation and benefits, stock-based compensation, and professional fees. The change in fair value of deferred and contingent consideration liabilities increased by $63 million compared to the prior year, primarily due to an increase in the company's share price.
Significant developments during the year included the completion of enrollment in the ENCORE trial for ARIKAYCE in the fourth quarter of 2024, with 425 patients enrolled. The company also initiated a Phase 2b study of brensocatib in patients with hidradenitis suppurativa (HS) in the fourth quarter of 2024 and received FDA clearance for an Investigational New Drug (IND) application for INS1201, a gene therapy for Duchenne muscular dystrophy (DMD), also in the fourth quarter of 2024. The company also completed several acquisitions, including Adrestia Therapeutics Ltd. in June 2023 and Vertuis Bio, Inc. in January 2023.
The company's manufacturing strategy relies heavily on third-party contract manufacturing organizations (CMOs). Agreements were made with Patheon Inc. in January 2024 and Esteve Química, S.A. in September 2024 for the manufacture and supply of brensocatib. The company anticipates initiating a Phase 3 registration program for TPIP in pulmonary hypertension-interstitial lung disease (PH-ILD) in the second half of 2025 and expects topline results from its Phase 2b study of TPIP in pulmonary arterial hypertension (PAH) in mid-2025. The company also anticipates initiating a clinical trial for INS1201 in the first half of 2025.
Insmed's outlook is contingent upon the successful commercialization of ARIKAYCE, the approval and commercialization of brensocatib and TPIP, and the advancement of its pre-clinical programs. The company acknowledges significant risks related to regulatory approvals, market acceptance, manufacturing, and financial resources. The company expects to continue incurring operating losses for the foreseeable future and may need to raise additional capital to fund its operations. As of December 31, 2024, the company had 1,271 full-time employees, with 1,007 in the US, 153 in Europe, and 111 in Japan. The company anticipates increasing its headcount in 2025.
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