On May 05, 2016 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, reported financial results for the quarter ended March 31, 2016 (Press release, Insmed, MAY 5, 2016, View Source [SID:1234512005]).
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Business Update
Global Phase 3 CONVERT study advancing. Patient enrollment continues to proceed on track in the company’s global phase 3 study of ARIKAYCE (liposomal amikacin for inhalation or LAI) in nontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC) (CONVERT or INS-212 study). The CONVERT study is taking place in 16 countries and at more than 130 sites. The company continues to expect to achieve its enrollment objective in the second half of 2016.
EMA regulatory review of ARIKAYCE progressing. The company remains on track with previous guidance, having submitted its responses to the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) 180-day list of outstanding issues related to the company’s Marketing Authorization Application (MAA) for ARIKAYCE. Insmed expects to participate in an oral explanation meeting in the second quarter of 2016 and the CHMP to render an opinion on its MAA around the middle of 2016.
Data accepted for presentation at ATS 2016. Three ARIKAYCE-related abstracts and one treprostinil prodrug abstract have been accepted for presentation at the American Thoracic Society (ATS) 2016 International Conference taking place May 13-18 in San Francisco. The ATS presentations include (i) one-year follow-up data from the phase 2 112 study, (ii) lung distribution and retention data from a scintigraphy study in patients with NTM lung disease, (iii) a preclinical study of ARIKAYCE, and (iv) a preclinical study of a variety of treprostinil prodrugs.
Phase 1 clinical study of INS1009 submitted for presentation. Insmed has completed a phase 1 study of INS1009 and submitted the results for presentation at a future medical meeting. This first-in-human study of INS1009 was designed to determine the maximum-tolerated dose of a single dose of INS1009 and to characterize the pharmacokinetic profile of free treprostinil and INS1009 in healthy volunteers. INS1009 is one of the company’s nebulized treprostinil prodrugs, which may offer a differentiated product profile with therapeutic potential in rare pulmonary disorders such as pulmonary arterial hypertension (PAH), idiopathic pulmonary fibrosis (IPF), sarcoidosis, and severe refractory asthma.
Canadian patent strengthens global patent portfolio. The Canadian Intellectual Property Office issued patent no. 2,838,111, which covers pharmaceutical formulations that include mixtures of liposomal quinolone antibiotics, together with free, unencapsulated quinolone antibiotics, such as ciprofloxacin. The patent also covers the use of such formulations for the treatment of various pulmonary disorders, for example, in bronchiectasis patients. The Canadian patent complements ARIKAYCE’s global intellectual property estate. Counterpart patent applications to this Canadian patent are pending in other countries.
"2016 is off to a solid start with all of our clinical, regulatory, and commercial-readiness activities remaining on track with our previously stated timelines," said Will Lewis, president and chief executive officer of Insmed. "Our top corporate priority is our global phase 3 CONVERT study and we look forward to achieving our patient enrollment objective later this year. In parallel with our clinical activities, our team is advancing the regulatory process for ARIKAYCE in Europe. For INS1009, we completed the phase 1 study and submitted the results for presentation at an international respiratory congress in the third quarter. Lastly, our talented team of scientists remain focused on advancing a number of preclinical programs and identifying our next candidates for clinical development."
First Quarter Financial Results
For the first quarter of 2016, Insmed posted a net loss of $33.5 million, or $0.54 per share, compared with a net loss of $27.4 million, or $0.55 per share, for the first quarter of 2015.
Research and development expenses were $20.5 million for the first quarter of 2016, compared with $17.2 million for the first quarter of 2015. The increase was primarily due to the advancement of the company’s global phase 3 CONVERT study of ARIKAYCE in NTM lung disease.
General and administrative expenses for the first quarter of 2016 were $12.5 million, compared with $9.5 million for the first quarter of 2015. The increase was primarily related to pre-commercial activities in Europe, namely the buildout of the company’s infrastructure and NTM disease awareness activities, as well as an increase in headcount and related expenses.
Balance Sheet Highlights and Cash Guidance
As of March 31, 2016, Insmed had cash and cash equivalents of $253 million. Excluding depreciation and stock-based compensation expense, the company’s cash operating expenses for the quarter ended March 31, 2016 were $28 million. Insmed ended the first quarter of 2016 with $25 million in debt and working capital of $233 million.
The company is investing in the following activities in 2016: (i) clinical development of ARIKAYCE, (ii) regulatory and pre-commercial initiatives for ARIKAYCE, and (iii) preclinical and clinical activities for its earlier-stage pipeline. Insmed continues to expect its cash-based operating expenses for the first half of 2016 to be in the range of $58 to $68 million.