Insmed Incorporated (NASDAQ:INSM) has reported its fourth-quarter and full-year 2023 financial results and provided a business update. The company ended 2023 with $780 million in cash, cash equivalents, and marketable securities, providing a runway beyond the expected Aspen trial readout. The company's total revenue for the full year 2023 was $305.2 million, reflecting 24% year-over-year growth.
Will Lewis, Chair and Chief Executive Officer of Insmed, commented on the company's performance, stating, "Insmed continued to deliver strong performance in 2023, demonstrating commercial success evidenced by Arikayce revenues that exceeded the upper end of our 2023 sales guidance range."
Lewis also expressed optimism about the company's upcoming data readouts, saying, "This series of meaningful data readouts from our mid- to late-stage pipeline is expected to continue uninterrupted in the months ahead, with topline results from the PH-ILD and Aspen trials expected in quick succession in the second quarter. We believe these near-term data readouts have the potential to fundamentally change the trajectory for our company and the patients we serve."
Regarding specific product highlights, Arikayce global revenue grew 24% in 2023 compared to 2022, with encouraging feedback from the U.S. Food and Drug Administration (FDA) on the patient-reported outcome data produced in the Phase 3 Arise study. The company expects to meet with the FDA in the coming months to gain additional insights and guidance.
The company also provided details on its other pillar programs, including the Phase 3 Aspen study of Brensocatib and the Phase 2 study of TPIP in patients with PH-ILD. Insmed continues to anticipate topline data from the Aspen study in the latter part of the second quarter of 2024.
In terms of financial results, total revenue for the full-year 2023 was comprised of Arikayce net sales of $224.2 million in the U.S., $65.7 million in Japan, and $15.3 million in Europe and the rest of the world. The company reported a net loss of $186.1 million, or $1.28 per share, for the fourth quarter of 2023, compared to a net loss of $160.1 million, or $1.21 per share, for the fourth quarter of 2022.
Looking ahead, Insmed is reiterating its sales guidance for full-year 2024 global Arikayce revenues in the range of $340 million to $360 million, representing 15% year-over-year growth at the midpoint compared to 2023. The company plans to continue to invest in commercialization and expansion of Arikayce globally, advancement of Brensocatib, and the development of its early-stage research programs.
The company's full 8-K submission is available here.
