MONMOUTH JUNCTION, NJ -- (Marketwire) -- 03/18/13 -- Insmed Incorporated (NASDAQ: INSM), a biopharmaceutical company focused on developing and commercializing inhaled therapies for patients battling serious lung diseases that are often life-threatening, reported financial results for the three and twelve months ended December 31, 2012.
Highlights of the fourth quarter and recent weeks include:
•Completed enrollment of the Phase 3 study of ARIKACE®, or liposomal amikacin for inhalation, in patients with cystic fibrosis (CF) who have Pseudomonas aeruginosa lung infections and remain on schedule to report top-line results in mid-2013 •Concluded the nine-month dosing phase of a dog inhalation toxicity study of ARIKACE and submitted an unaudited interim report to the US Food and Drug Administration (FDA) stating that the macrophage response was similar to that seen in our previous three-month dosing study in dogs and that there was no evidence of neoplasia, squamous metaplasia or proliferative changes •Strengthened the cash position by drawing down the remaining $10 million under a loan and security agreement entered into in June 2012 •Recruited Matt Pauls as Chief Commercial Officer. Mr. Pauls, who will join the Company on April 1, 2013, brings to Insmed more than 20 years of experience in the pharmaceutical industry, including senior-level leadership roles in global marketing, sales, reimbursement, new product launches and commercial operations at leading pharmaceutical companies including Shire Pharmaceuticals, Bristol-Myers Squibb and Johnson and Johnson
"During the past six months, we laid the foundation for Insmed's transition to a commercial enterprise," noted Will Lewis, President and Chief Executive Officer of Insmed. "Our focus for 2013 will be to advance our regulatory filings with the data readouts from our two lead clinical trials, expand our leadership team, build out our supply chain and advance our commercial strategy to bring our inhaled therapies to patients suffering with serious lung diseases in these orphan indications."
Fourth Quarter Financial Results
For the fourth quarter of 2012 Insmed posted a net loss attributable to common stockholders of $15.5 million, or $0.49 per share, compared with a net loss of $8.2 million, or $0.33 per share, for the fourth quarter of 2011.
Research and development expense for the fourth quarter of 2012 increased to $12.2 million from $6.8 million for the fourth quarter of 2011. The increase was due to the active clinical development programs for ARIKACE in CF patients with Pseudomonas lung infections and in NTM patients during the fourth quarter of 2012.
General and administrative expense for the fourth quarter of 2012 was $3.6 million, compared with $3.5 million in the fourth quarter of 2011. The fourth quarter 2012 expenses included $1.0 million of severance expenses related to the departure of certain executives and employees. The fourth quarter 2011 expenses included $1.2 million in charges related to the discontinued use of the Company's Richmond, Virginia facility.
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