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It's been a big week for Pharmacyclics (UNKNOWN: PCYC.DL ) . On Tuesday, the small biotech announced that the Food and Drug Administration had granted Breakthrough Therapy Designation to ibrutinib for the treatment of relapsed or refractory mantle cell lymphoma, or MCL, and for the treatment of Waldenstrom's macroglobulinemia. The company also released quarterly results after the market closed on Thursday. Here are the highlights from those results.
Pharmacyclics reported net income for the quarter ending Dec. 31, 2012 of $41.9 million, or $0.56 per diluted share. This figure was lower than the $0.78 per diluted share from the same quarter in 2011 but beat average analyst expectations of $0.31 per share. On a non-GAAP basis, the company said that earnings per share for the quarter was $0.62 per diluted share compared with $0.82 per diluted share in the prior year.
Revenue for the quarter came in at $58 million -- less than the $77.9 million reported in the same quarter of 2011. Pharmacyclics' major partner on ibrutinib, Johnson & Johnson's (NYSE: JNJ ) Janssen unit, contributed $50 million of that revenue total. Another $5 million came from Novo Nordisk A/S (NYSE: NVO ) . The larger pharmaceutical company bought the rights for Pharmacyclics' small molecule Factor VIIa inhibitor, PCI-27483 for use outside of oncology.
All of the key numbers were down from the same quarter in 2011 because fewer milestone payments were received and expenses were higher. That's not necessarily bad news at this stage in the game for Pharmacyclics, though. Milestone payments can be lumpy, coming at irregular intervals. And the higher expenses are a direct result of moving things along more quickly with clinical studies and research and development.
The future for Pharmacyclics, for now at least, is all about ibrutinib. A grand total of 27 different clinical trials are registered for the drug with the National Institute of Health. Gaining Breakthrough Designation from the FDA is a big deal, allowing the company a faster path to ultimate approval and commercialization of the drug.
Pharmacyclics is also in the nice position of not having to worry too much about cash, a problem many small biotechs face. It has a stockpile of more than $317 million in cash and equivalents. Even better, Janssen funds much of the development for ibrutinib. Pharmacyclics projects that it will finish this year with more than $225 million in cash despite increasing expenses.
Five phase 3 trials are under way for ibrutinib. None of these will finish in 2013, but this will be an important year for Pharmacyclics. Shares are up over 30% year to date, including a nice 4% bump in trading on Friday after the earnings announcement. This was a big week for the company. I expect there will be plenty more big weeks ahead.
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