MONMOUTH JUNCTION, N.J., Aug. 8, 2011 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today reported results for the second quarter and six-months ended June 30, 2011.
Key Recent Highlights:
- Announced positive results through six cycles of data from the open-label phase 2 study of Arikace (liposomal amikacin for inhalation) in the treatment of cystic fibrosis (CF) patients with Pseudomonas lung infections
- Added to Russell 3000, Russell 2000, Russell Global, and Russell Microcap Indexes
- Clinical hold placed on Arikace phase 3 program by FDA; Insmed to supply currently requested information and data to the Agency by end of August; FDA's response expected within 30 days of receipt of the Company's complete response to the Agency's requests
"We continue to believe Arikace has the potential to be an important treatment option for CF patients and those suffering from non-tuberculous mycobacterial (NTM) lung disease based on the efficacy and safety data generated from our phase 2 clinical trial program," said Timothy Whitten, Insmed's President and CEO. "We believe that we are taking the appropriate steps with FDA to address the findings from the interim results of our long-term rat inhalation carcinogenicity study that led to the clinical hold. Moreover, after reviewing the data, we believe we have a sound scientific rationale for those findings and look forward to working closely with our experts and with FDA to provide the Agency with all relevant information and data required to expedite their review and evaluation. Depending upon the timing and results of FDA's review, we are hopeful that we can resume our phase 3 clinical trial program for Arikace during the fourth quarter of 2011."
Financial Results:
For the second quarter of 2011, Insmed posted a net loss attributable to common stockholders of $10.0 million, or $0.40 per share basic and diluted, compared to a net loss of 0.4 million, or $0.03 per share basic and diluted, for the three months ended June 30, 2010.
Net loss attributable to common stockholders for the six-months ended June 30, 2011 was $26.1 million, or $1.19 per common share basic and diluted, compared to a net loss of $0.3 million, or $0.02 per common share basic and diluted, for the six-months ended June 30, 2010. The net loss attributable to common stockholders in 2011 includes the conversion of the Series B Conditional Convertible Preferred Stock, and a non-cash charge for the beneficial conversion feature of the Series B Preferred Stock in the amount of $9.2 million, which increased the net loss and, in turn, reduced our earnings per common share on a basic and diluted basis by $0.48. The charge represents the $1.00 difference between the conversion price of the preferred stock of $7.10 per share and its carrying value of $6.10 per share. The carrying value of the preferred stock was based on its fair value at issuance, which was estimated using the common stock price reduced for a lack of marketability between the issuance date and the anticipated date of conversion.
