On Apr. 2, MannKind Corp. (NASDAQ:MNKD) stock volume and share value shot through the roof on news that a FDA panel granted market approval for the biotech company's inhalable insulin.
The FDA is not bound by the Advisory Committee's recommendation but will consider its guidance in reviewing the New Drug Application (NDA) that was submitted for Afrezza. The Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review of Afrezza is Apr. 15, 2014.
Let the Surge Begin
MNKD share value surged 74%, on stock volume of 97,357,184 shares, which is 11 times its three-month average volume of 8,715,924 shares.
The tremendous uptick in volume and share value came on the heels of the Valencia, Calif.-based company's Apr. 1 announcement that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 13 to 1 to recommend that Afrezza, its inhalable insulin, be granted marketing approval by the FDA to improve glycemic control in adults with type 1 diabetes.
The FDA panel also voted 14 to 0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with type 2 diabetes. If Afrezza receives final FDA approved, it will be the first ultra-rapid-acting mealtime insulin therapy available in the United States.
Recap of the Valencia, Calf.-based Pharmaceutical Company's 2013 Financial Results
For the fourth quarter of 2013, total operating expenses were $46.6 million, compared to $33.5 million for the fourth quarter of 2012, an increase of $13.1 million.
Research and development expenses were $29.0 million for the fourth quarter of 2013, compared to $25.3 million for the corresponding quarter in 2012, due to an increase in non-cash stock compensation expense of $4.3 million that was offset by a decrease in clinical trial related expenses of $1.3 million.
General and administrative expenses increased by $9.4 million to $17.6 million for the fourth quarter of 2013, compared to $8.2 million in the fourth quarter of 2012. The increase in G&A expenses was due to an increase in non-cash stock compensation expense of $6.0 million and increased professional legal and financing fees of $2.2 million as compared to the corresponding quarter of the prior year.
For fiscal year 2013, operating expenses totaled $169.4 million, compared to $147.0 million for fiscal year 2012. Total R&D expenses for fiscal year 2013 increased by $8.2 million, or 8.1%, to $109.7 million for fiscal year 2013 as compared to $101.5 million for fiscal year 2012, due to an increase in non-cash stock compensation expense of $14.2 million that was offset by a decrease in clinical trial related expense in 2013.
G&A expenses increased by $14.2 million, or 31.2%, to $59.7 million for fiscal year 2013 as compared to $45.5 million in fiscal year 2012, due to increased non-cash stock compensation expense of $17.7 million and increased professional legal and financing fees of $2.3 million in 2013 that was offset by the $6.5 million litigation settlement accrual recorded in 2012.
The net loss applicable to common stockholders for fiscal year 2013 was $(191.5) million, or $(0.64) per share based on 299.6 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $(169.4) million, or $(0.94) per share based on 180.9 million weighted average shares outstanding for fiscal year 2012. The number of common shares outstanding at December 31, 2013 was 369,391,972.
Cash and cash equivalents were $70.8 million at December 31, 2013 and $61.8 million at December 31, 2012. Currently, there is $30.1 million of available borrowings under the amended loan arrangement with The Mann Group.
Of the 5 analyst firms covering MNKD, 1 rates it a "strong buy," 3 a "hold" and 1 an "underperform."
On Apr. 2, MNKD's share price closed at $6.99, up $2.97, or 74%, from the previous day’s close of $4.02 cents a share.
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FDA Approves Avanir Pharmaceuticals Inc. Application for New Drug Device
In other news, Avanir Pharmaceuticals Inc.(NASDAQ:AVNR) on Mar. 26 announced that the FDA has accepted the company's New Drug Application of AVP-825, its innovative Breath Powered(TM) investigational drug-device combination product for the acute treatment of migraine headaches.
This latest announcement from the San Diego-based pharmaceutical company comes on the heels of the reporting of its quarterly results for the period ending Dec. 31, 2013.
Highlight of Quarterly Report
The company reported ($0.07) earnings per share (EPS) for the quarter, missing the consensus estimate of 43 cents by 50 cents.
Nonetheless, it had revenue of $26.70 million for the quarter, compared to the consensus estimate of $24.84 million. During the same quarter in the previous year, the company posted ($0.09) earnings per share. Avanir's revenue for the quarter was up 61.8% on a year-over-year basis. Analysts forecast that Avanir will post $-0.29 EPS for the current fiscal year.
On Apr.2, AVNR's share price closed at $3.79 up 1 cent from the share price of $3.78 the previous day, on below average volume of 764,814 shares.
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