Hurricane Sandy delayed the release of third-quarter results for pharmaceutical company MannKind (MNKD 0.87%), but now we know the story. MannKind beat expectations by posting a loss of $0.22 per share compared to average analyst estimates of $0.24. That's really not the important stuff, though.
Inquiring minds want to know about three critical challenges facing MannKind. Were answers given to these questions? While the earnings release itself didn't shed much light, the company's management did give some answers in the earnings call. Here are the three questions investors interested in MannKind will want to know about.
How is the cash situation?
Better. That's despite MannKind's cash burn increasing from $24.7 million in the second quarter to $29.9 million in third quarter. Expenses were higher primarily due to clinical trial costs. Management expects costs to continue to rise during the rest of 2012.
Although MannKind officially finished the quarter with $2.1 million in cash and short-term investments, the public offering in October replenished its coffers by $86 million. On top of that, Alfred Mann -- founder, chairman and CEO of MannKind -- will help the company improve its financial situation through a shuffle of sorts.
Mann plans to buy $107.4 million in shares to be paid by reducing the amount of debt that the company owes to him. He will then allow MannKind to borrow the amount again through the existing loan agreement. Adding in the existing amount that the company can borrow, this move provides around $120 million in additional funding when needed.
Management expects that the money raised through the public offering combined with the additional borrowing made available will allow it get through 2013. The company also will be able to raise close to $90 million next October through warrants that were included in the recent public offering.
How are the Afrezza phase 3 studies?
Full steam ahead. MannKind finished its patient recruitment and is ramping up two phase 3 studies. The company expects that the first study will conclude in May, with the second study wrapping up soon afterward.
Plans are under way to move things along as expeditiously as possible. If all goes well, the NDA should be submitted to the Food and Drug Administration in the third quarter of 2013. Mann's phrase to describe where MannKind stands now was "clear path to FDA approval."
Are any partnerships on the horizon?
Maybe. President and COO Hakan Edstrom stated that several "newcomer" companies expressed interest in potential partnerships after the FDA added the second phase 3 study of Afrezza for early-stage type 2 diabetes. Edstrom commented that discussions with different companies are at varying stages. He indicated that more serious negotiations probably wouldn't kick into gear until early to mid-2013.
Foolish take
MannKind's recent public offering did cause a problem with share dilution, but it really didn't have much of a choice. The company can now at least make it through completion of phase 3 studies for Afrezza and should be in decent shape to go beyond that point.
The company seems to have its act together on the phase 3 studies. If the CEO's confidence made the difference, MannKind would breeze through the studies. Mann is quite possibly the best cheerleader for his company out of any CEO out there. And he certainly puts his money where his mouth is.
I'm not sure how much hope to put in the partnership talks at this point. Who are the "newcomers" referred to by Edstrom? My guess is that the prime partner candidates likely include Abbott Labs (ABT 0.41%), GlaxoSmithKline (GSK 0.11%), Johnson & Johnson (JNJ +0.51%), Eli Lilly (LLY 2.12%), Novo Nordisk (NVO 1.07%) and Sanofi (SNY +0.34%). All have diabetes products at some stage of development and plenty of cash. However, which of these (if any) were in past discussions, and which (again, if any) are currently talking with MannKind remains a mystery.
The bottom line as I see it is that MannKind is probably in as good of a position as it can be, considering what it's been through to get to this point. If you're willing to take on some risk, this could be a good time to look at this stock. More good answers are hopefully on the way.
