Insmed Q1 2024 Financial Results and Business Update

Insmed Incorporated, a global biopharmaceutical company, announced its first-quarter 2024 financial results and provided a business update. Notably, the company reported significant achievements and steady progress in its key therapeutic pillars, including ARIKAYCE, brensocatib, and TPIP.

For the first quarter of 2024, Insmed reported a total revenue of $75.5 million, reflecting a 16% growth compared to the same period in 2023. The revenue growth was driven by the sales of ARIKAYCE, which saw increased year-over-year sales in the United States, Japan, and Europe. Specifically, ARIKAYCE net sales were $56.3 million in the U.S., $14.9 million in Japan, and $4.3 million in Europe and other regions. Insmed also reiterated its 2024 full-year revenue guidance for ARIKAYCE, projecting global revenues between $340 million and $360 million.

In their update, Insmed highlighted the positive outcomes from the Phase 2 PH-ILD study of TPIP (treprostinil palmitil inhalation powder), where 79.3% of patients reached the maximum dose of 640 µg by Week 5. The study also demonstrated a significant reduction in clinical worsening events among TPIP-treated patients compared to the placebo group. Encouraging results were also reported from the Phase 2 PAH study of TPIP, with the combined active treatment and placebo groups showing a mean reduction in pulmonary vascular resistance (PVR) of 19.9% and an improvement in the 6-minute walk distance of 43 meters.

Insmed's Phase 3 ASPEN trial of brensocatib in patients with non-cystic fibrosis bronchiectasis (NCFBE) is on track, with topline data expected in the latter part of the second quarter of 2024. All adult patients in the ASPEN trial have completed their 52-week visit, and the company is preparing for a potential U.S. launch in mid-2025, with subsequent launches in Europe and Japan in the first half of 2026. Additionally, brensocatib received an Innovation Passport designation in the United Kingdom, which aims to accelerate its market access.

The company's robust pipeline includes multiple ongoing studies and early-stage research programs. Insmed continues to advance its clinical programs for ARIKAYCE, brensocatib, and TPIP, anticipating several key milestones and data readouts in the coming years. The Phase 2b BiRCh trial of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) is ongoing, and a Phase 2 study in patients with hidradenitis suppurativa (HS) is expected to commence in the second half of 2024, contingent on positive ASPEN results.

Financially, Insmed's cost of product revenues for the first quarter of 2024 was $17.5 million, reflecting increased sales volumes of ARIKAYCE. Research and development expenses totaled $121.1 million, while selling, general, and administrative expenses were $93.1 million. The company reported a net loss of $157.1 million for the quarter, slightly lower than the $159.8 million net loss reported for the same period in 2023. As of March 31, 2024, Insmed had cash and cash equivalents totaling $595.7 million.

Looking ahead, Insmed plans to continue investing in the commercialization and global expansion of ARIKAYCE, as well as the advancement of its clinical programs for brensocatib and TPIP. The company's early-stage research efforts include over 30 pre-clinical programs, with a commitment to allocating less than 20% of overall expenditures to these initiatives.

Insmed's CEO, Will Lewis, emphasized the importance of the data readouts and the company's strategic focus on transforming the lives of patients with serious and rare diseases. The company's commitment to innovation and patient care remains evident as it progresses its pipeline and prepares for upcoming regulatory and commercial milestones.