Attention Turns to Afrezza as MannKind's Loss Widens in Q3

Clinical-stage biotechnology company MannKind (NASDAQ: MNKD  ) left investors hanging after reporting its third-quarter earnings results before the opening bell this morning, but leaving out any talk of potential blockbuster inhaled insulin product Afrezza.

For the quarter, MannKind recorded no revenue as it's still in the clinical research stages of its existence, while its total operating expenses rose 26.2% to $44.8 million from the year-ago period and 7.7% sequentially from the second quarter.

Research and development costs, which are the bulk of MannKind's expenses, rose by 7.1% to $27.3 million, while general and administrative expenses exploded higher by 73.3% primarily due to higher non-cash stock compensation expenses during the quarter. Net loss for the quarter ballooned 18.7% to $50.8 million from $42.8 million in the year prior, however, due to a higher number of shares outstanding, losses shrank to just $0.17 per share from the $0.22 in EPS losses reported last year at this time. The $0.17 loss in EPS was still $0.01 worse than the Street had expected.

Being a clinical-stage company, having a reasonable amount of cash on hand to fund ongoing research is also crucial. MannKind ended the quarter with $93.8 million in cash and cash equivalents, up notably from the $28.5 million it reported at the end of the second quarter.

What was missing in MannKind's press release was any substantive update on its lead inhaled diabetes product, Afrezza. This was notably disappointing to investors considering that the company announced last Wednesday that the Food and Drug Administration had acknowledged the resubmission of its new drug application for Afrezza, which had been rejected via a complete response letter in January 2011. Moving forward, all eyes remain on Afrezza's PDUFA date of April 15, 2014, and the FDA's advisory panel meeting some weeks before that decision date. 

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  • Report this Comment On November 04, 2013, at 12:57 PM, Skiidog wrote:

    Wow Sean, now that was an article that needed to be written. Maybe you should hold off on your articles until there is something to write about. Listen to the conference call and the comments that will be given and then you can write an article that has some substance. Until then, please stop wasting your time and mine, writing an article like this.

  • Report this Comment On November 04, 2013, at 1:28 PM, sanityrules wrote:

    LOL. was thinking the same thing. Got to love this line 'MNKD left investors hanging'....

    Who doesn't get it that at this stage, MNKD doesn't really have alot to say about Alfrezza that hasn't been said, dissected/parsed, you name it.

    But hey, MNKD left us 'hanging' dang nab it... (smile)

  • Report this Comment On November 04, 2013, at 3:27 PM, JPG101 wrote:

    You state: Moving forward, all eyes remain on Afrezza's PDUFA date of April 15, 2014, and the FDA's advisory panel meeting some weeks before that decision date.

    Advisory panel meeting

    Where did that come from?

    Where did you get this information?

  • Report this Comment On November 04, 2013, at 11:02 PM, bamobrien wrote:

    He made it up. There is no advisory panel meeting set up at this time- it was specifically addressed in the conference call.

    What was the point of this article?

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