What: Shares of IGI Laboratories (TLGT), a specialty generic pharmaceutical company, soared more than 22% higher this morning after the company reported second quarter earnings last night.
So what: Revenue for the quarter jumped 37% year-over-year to $8.9 million, slightly ahead of the $8.89 million that analysts were expecting. On a GAAP basis, net loss for the quarter was -$0.04 per share, which was well ahead of the -$0.08 loss that analysts were expecting.
The company reaffirmed revenue guidance for the full year to land between $35 and $40 million and also expects that gross margins will improve with each passing quarter. This should allow the company to approach a break-even operating margin by the fourth quarter.
In addition, the company is planning to submit up to 20 abbreviated new drug applications, or ANDAs, to the FDA by the end of the year. An ANDA is an application for a generic drug approval for an existing licensed medication or drug.
Now what: IGI was able to submit 6 new ANDA submissions to the FDA for approval during the quarter, bringing their total to 28 ANDAs currently pending approval. Combined, the company estimates that these 28 generic drugs represent a $1.2 billion market opportunity, which is a huge increase from the $702 million opportunity that the company was previously targeting from their ANDA submissions just last quarter.
Although ANDAs can take a long time to get through the FDA, I think investors were right to cheer the news today, as a $1.2 billion market opportunity is simply massive for a company that is estimating full year revenue of just $35 to $40 million.
With more than $150 million in cash on the balance sheet, the company appears to have plenty of capital to fund its research and development efforts needed to complete the additional ANDA filings. If IGI can manage to reach a break-even operating margin by the end of the year, it should put the company on solid financial footing, which could make the stock a very interesting investment opportunity, even after today's huge move.