MannKind: Year in Review

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As 2012 draws to a close, we're looking back at some of the most compelling stories of the year. Some companies experienced amazing success while others failed miserably. A few, though, are intriguing simply because of sheer steadfastness and perseverance. That's MannKind's (NASDAQ: MNKD  ) story. Let's look at the past year for this plucky pharmaceutical company. 

Staying alive
The most important achievement for MannKind in 2012 was that it stayed alive. At two times during the year, the company's cash approached the bottom of the barrel. MannKind avoided catastrophe both times.

By late January, MannKind's shares were up nearly 35%. However, that surge didn't last long. On Jan. 31, the company announced a public offering of shares and warrants. The stock collapsed, even though no one should have been surprised by the news. MannKind warned in 2011 that it could only fund operations through the first quarter of 2012.

While this offering raised more than $86 million in gross proceeds, by October MannKind was in trouble yet again. The company announced another public offering. This second offering of the 2012 netted another $86 million, keeping the ship afloat for a while longer. 

Founder and CEO Alfred Mann also helped considerably. Mann twice bought additional shares in the company by reducing MannKind's debt to him. These moves allowed the company to borrow more.

Clearing the bench
Some might think that MannKind focuses only on diabetes. That view isn't entirely accurate, though. The company also includes a couple of cancer drugs in its pipeline. However, those programs were benched because of financial constraints.

2012 saw something of a clearing of the bench. In April, MannKind announced a deal with Tolero Pharmaceuticals to license its BTK (Bruton's tyrosine kinase) program. My colleague Brian Orelli aptly referred to this as "MannKind rents out a drug program," since the arrangement allows the company to repurchase the program within 60 days after the completion of the first phase 1 study.

In November, MannKind signed another deal with Colby Pharmaceutical. Colby licensed the company's MKC1106 active immunotherapy programs. However, this time MannKind didn't retain an option to buy the programs back.

Both agreements still appear to be good moves for MannKind. The company couldn't afford to keep the programs going. Even though neither brought in huge amounts of cash immediately, any extra money coming through the doors is always helpful.

All about Afrezza
A year later, it's still really all about Afrezza for MannKind. The company has been on a roller-coaster ride for years with the inhalable insulin drug, but it's still hanging in there.

The biggest news about Afrezza during 2012 was the completion of enrollment for two phase 3 studies in October. CEO Mann correctly noted at the time that this step was quite significant because enrollment is "often the lengthiest" part of the process.

Another lesser development that could ultimately become a big story relates to a comment from MannKind's President and COO Hakan Edstrom that several "newcomer" companies are now interested in potential partnerships with Afrezza. He stated that the motivation for this newly found interest stems from the FDA's decision to add the second phase 3 study for early stage type 2 diabetes.

The year ahead
2013 looks to be pivotal for MannKind. The company expects to have results from the phase 3 studies in the summer and plans to resubmit an NDA for Afrezza in the third quarter.

Positive news could help MannKind land a partnership deal with a major player. Fellow Fool Max Macaluso has pegged Pfizer (NYSE: PFE  ) as a good fit.  There are plenty of other possibilities, though, including Abbott's (NYSE: ABT  ) upcoming AbbVie spin-off, Lilly (NYSE: LLY  ) , and Johnson & Johnson (NYSE: JNJ  ) .

Regardless of what happens, MannKind seems likely to still be fighting a year from now. My guess is that the company's story will still be compelling. Nearly everybody likes to root for an underdog.

Still down around 90% from its highs less than a decade ago, there's been no giant leap for MannKind shareholders. The debate rages over whether the company's revolutionary inhalable insulin, slated to go in front of the FDA next year, will be a complete flop or a massive blockbuster success. In this brand new premium report on MannKind, we outline every key topic investors have to know with this risky stock. It also comes with a full year of analyst updates to keep you covered as key news develops, so don't miss out -- simply click here now to claim your copy today.

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