MannKind Corporation (Nasdaq:MNKD) today reported financial results for the first quarter ended March 31, 2010.
“The most significant event of the first quarter was clearly the FDA's response to our NDA for AFREZZA”
For the first quarter of 2010 total operating expenses were $40.6 million, compared to $57.8 million for the first quarter of 2009. Research and development (R&D) expenses were $30.5 million for the first quarter of 2010 compared to $42.9 million for the same quarter in 2009, a decrease of $12.4 million. This 29% decrease in R&D expense was primarily due to reduced costs associated with the clinical development of AFREZZA™ after the submission of its NDA in March 2009. General and administrative (G&A) expenses decreased by $4.8 million to $10.1 million for the first quarter of 2010 compared to $14.9 million in the first quarter of 2009. This 32% decrease in G&A expense was mainly due to decreased salary related costs resulting from the April 2009 reduction in force and the non-recurrence of costs related to the negotiation of the transaction with Pfizer, which occurred during the first quarter of 2009.
The net loss applicable to common stockholders for the first quarter of 2010 was $44.7 million, or $0.40 per share based on 113.1 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $59.4 million, or $0.58 per share based on 102.0 million weighted average shares outstanding for the first quarter of 2009. The number of common shares outstanding at March 31, 2010 was 113,449,327.
Cash, cash equivalents and marketable securities were $31.5 million at March 31, 2010 and $32.5 million at December 31, 2009. Currently, the Company has $145.0 million of available borrowings under the loan agreement with an entity controlled by the Company's principal stockholder.
"The most significant event of the first quarter was clearly the FDA's response to our NDA for AFREZZA," said Alfred Mann, Chairman and Chief Executive Officer. "Since that time, we have been preparing for an upcoming meeting with the agency and readying a submission that is intended to address the FDA's questions about AFREZZA. We also completed Study 117, an efficacy study in patients with type 1 diabetes, and are pleased to report that AFREZZA met the primary endpoint of non-inferiority in HbA1C levels compared to standard insulin therapy. This is a very busy time for MannKind Corporation."
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