BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on developing orphan treatments for rare pulmonary diseases, today reported financial results for the quarter ended March 31, 2015.
First quarter and recent highlights include:
• Validation of the company's Marketing Authorization Application (MAA) for ARIKAYCE™ by the European Medicines Agency (EMA).
• Advancement of the company's phase 3 global 212 study of patients with treatment-resistant nontuberculous mycobacteria (NTM), lung infections with the opening of multiple clinical trial sites.
• Acceptance of six abstracts for poster presentation at the American Thoracic Society (ATS) 2015 International Conference taking place in Denver from May 15 - 20.
• Additions to the senior leadership team including the appointments of Eugene Sullivan, MD, chief medical and scientific officer and Don Nociolo, vice president of technical operations.
• Completion of a public offering of 11.5 million shares of common stock that generated net proceeds of approximately $223 million.
"2015 is a year of key deliverables for Insmed and we remain on track to deliver our five stated corporate objectives, which include the advancement of ARIKAYCE and the development of INS1009," said Will Lewis, president and chief executive officer of Insmed. "Our global registration program for ARIKAYCE is making important progress with an increasing number of sites actively recruiting patients in the 212 study. We are also advancing our newest program, INS1009, an inhaled prodrug formulation of treprostinil for pulmonary arterial hypertension, and we look forward to providing additional updates on this promising clinical candidate as the year progresses."
First Quarter 2015 Financial Results
For the first quarter of 2015, Insmed posted a net loss of $27.4 million, or ($0.55) per share, compared with a net loss of $14.3 million, or ($0.36) per share, for the first quarter of 2014. The company's financial results for the first quarter of 2014 were positively impacted by a $4.4 million income tax benefit that resulted from the sale of a portion of its New Jersey Net Operating Losses under New Jersey's Technology Business Tax Certificate Transfer Program.
Research and development expenses were $17.2 million for the first quarter of 2015 as compared with $11.4 million in the first quarter of 2014. The increase in research and development expenses was primarily due to the advancement of the company's clinical development program for ARIKAYCE, the build-out of additional third-party manufacturing capacity, and an increase in internal expenses.
General and administrative expenses for the first quarter of 2015 were $9.5 million as compared with $6.7 million in the first quarter of 2014. The increase in general and administrative expenses was primarily related to an increase in personnel-related expenses, which included a $1.5 million increase in non-cash stock-based compensation expense related to performance-based stock options that vested upon EMA's validation of the ARIKAYCE MAA, as well as pre-commercial activities related to Europe.