Insmed(INSM) - 2025 Q4 - Annual Results

Financial Performance - Insmed reported total revenues of $606.4 million for the full year 2025, with BRINSUPRI revenues of $172.7 million and ARIKAYCE revenues of $433.8 million, reflecting a 19% annual growth for ARIKAYCE[1]. - The company expects full-year 2026 BRINSUPRI revenues to be at least $1 billion and maintains ARIKAYCE revenue guidance of $450 million to $470 million[1]. - ARIKAYCE global revenue grew 19% in 2025 compared to 2024, exceeding the upper end of the 2025 guidance of $420 million to $430 million[7]. - Product revenues for the three months ended December 31, 2025, were $263.843 million, a significant increase from $104.442 million in the same period of 2024, representing a growth of 152%[21]. - Total operating expenses for the twelve months ended December 31, 2025, were $1.853 billion, up from $1.242 billion in 2024, reflecting an increase of 49.1%[21]. - The net loss for the three months ended December 31, 2025, was $328.485 million, compared to a net loss of $235.548 million for the same period in 2024, indicating a 39.3% increase in losses[21]. - The company reported a net loss of $328.5 million, or $1.54 per share, for the fourth quarter of 2025, compared to a net loss of $235.5 million, or $1.32 per share, for the same period in 2024[16]. - Cash and cash equivalents as of December 31, 2025, were $510.445 million, down from $555.030 million as of December 31, 2024, a decrease of 8%[23]. - Total assets increased to $2.265 billion as of December 31, 2025, from $2.025 billion in 2024, marking an increase of 11.8%[23]. - The total liabilities decreased to $1.526 billion as of December 31, 2025, from $1.740 billion in 2024, a reduction of 12.3%[23]. Research and Development - Research and development expenses for the full year 2025 were $771.1 million, up from $598.4 million in 2024, primarily due to increased compensation and the acquisition of INS1148[16]. - Research and development expenses for the twelve months ended December 31, 2025, were $771.093 million, up from $598.367 million in 2024, an increase of 28.9%[21]. - Insmed plans to advance Phase 3 studies for TPIP in patients with pulmonary arterial hypertension (PAH) and interstitial lung disease (ILD) in 2026[19]. - The company anticipates submitting an average of one to two INDs per year from its pre-clinical research programs[19]. - Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS) and expects to report topline data in the second quarter of 2026[9]. - Insmed's early-stage programs include technologies such as gene therapy and AI-driven protein engineering[59]. Product Portfolio and Market Focus - The company is focused on expanding its product portfolio with innovative therapies such as ARIKAYCE and BRINSUPRI, which are already approved for specific indications[24][26]. - ARIKAYCE is indicated for adults with limited or no alternative treatment options for Mycobacterium avium complex (MAC) lung disease, requiring a minimum of 6 consecutive months of multidrug therapy[45]. - The company has developed several investigational products, including INS1201 and INS1202, targeting significant unmet medical needs in respiratory and neurological diseases[30][31]. - Insmed is advancing a diverse portfolio of approved and investigational medicines, focusing on pulmonary and inflammatory conditions[59]. Adverse Reactions and Safety - The most common adverse reactions in patients using ARIKAYCE included dysphonia (47%), cough (39%), and bronchospasm (29%), with significant differences compared to the background regimen alone[42]. - In the ASPEN trial, the incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9% for placebo and BRINSUPRI 10 mg and 25 mg, respectively[53]. - The incidence of skin cancers in patients treated with BRINSUPRI was 0.5% and 1.9% for 10 mg and 25 mg doses, compared to 1.1% in placebo-treated patients[54]. - The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease[46]. Company Recognition and Forward-Looking Statements - The company has been recognized as one of the best employers in the biopharmaceutical industry, including five consecutive years as the No. 1 Science Top Employer[60]. - Forward-looking statements indicate potential risks, including failure to successfully commercialize ARIKAYCE and BRINSUPRI in key markets[61]. - The company cautions that actual results may differ materially from forward-looking statements due to various risks and uncertainties[63].