MannKind Corporation’s second quarter 2011 adjusted net loss of $0.33 per share was wider than the Zacks Consensus Estimate of a loss of $0.29. The wider-than-expected loss was attributable to the higher research and development (R&D) expenses incurred during the reported quarter. The company posted a loss of $0.37 in the year-ago quarter.
MannKind did not report any revenues in the second quarter of 2011. The company generated revenues of $0.09 million in the comparable quarter of 2010.
R&D spend in the reported quarter increased 16% to $30.3 million. The increase was attributable to the expenses incurred towards the settlement of the dispute with Merck’s (MRK) subsidiary Organon in February 2011, following the termination of the insulin supply deal.
MannKind canceled the insulin supply deal following the receipt of the second complete response letter from the US Food and Drug Administration in January for the company’s inhaled insulin candidate Afrezza. The candidate is developed for the treatment of type I and type II diabetes.
Per the agreement, reached in June 2011, MannKind agreed to pay Organon $16 million in two installments after receiving certain quantities of the recombinant human insulin. The first installment was paid in the reported quarter.
We remind investors that the first CRL was issued in March 2010. The agency accepted the company’s resubmitted new drug application in July 2010. The second CRL was issued in January this year.
While issuing the latest CRL, the FDA asked the company to conduct two phase III trials with Afrezza. One trial is earmarked for patients with type I diabetes and the other for type II diabetes patients.
MannKind met with the FDA on May 4, 2011, regarding the contents of the CRL. Management stated the protocols of the studies were being finalized. During the second quarter, general and administrative (G&A) expenses declined 20.5% to $8.9 million.
We believe that the earnings report is a non-event for the company as investor focus will be on the fate of Afrezza going forward.
We have a Neutral stance on MannKind in the long-run. The uncertainty regarding Afrezza’s approval is the main reason behind the near-term pressure reflected by the Zacks #4 Rank (Sell rating) carried by MannKind in the short-run.