Celldex Therapeutics Inc. Q4 Earnings Overshadowed by FDA News

Celldex reports fourth-quarter earnings -- but the big story is an FDA decision on rindopepimut.

Keith Speights
Keith Speights
Feb 24, 2015 at 11:38AM
Health Care

Celldex Therapeutics (NASDAQ:CLDX) reported its fourth-quarter earnings results before the market opened on Tuesday. But hardly anyone really cared.

Plenty of people care about how Celldex is doing, as evidenced by the stock's 16% jump on Monday. However, one catalyst overshadowed the biotech's financial results and drove the big gain: the Food and Drug Administration breakthrough designation for Celldex's lead drug.

Source: Celldex Therapeutics.

First, about those results
No one expected the financial results from fourth quarter to be impressive, since Celldex remains a clinical-stage development drug company. The consensus analysts' estimate was for a net loss for the quarter of $0.35 per share. Celldex narrowly missed that estimate with a net loss of $31.8 million, or $0.36 per share. 

The fourth-quarter loss was larger than the $0.27 per share loss reported in the same period of 2013. Higher expenses, particularly related to research and development, made the difference. Celldex reported R&D expenses of $27 million in the fourth quarter of 2014, compared to $17.8 million in the same quarter of 2013.

While Celldex doesn't yet have an approved product of its own on the market, the company does generate some revenue through collaborations. Celldex announced revenue of $1.5 million in the fourth quarter, up from $0.6 million in the prior-year period. 

For full-year 2014, Celldex recorded revenue of $3.6 million, compared to $4.1 million in 2013. The drop stemmed primarily from the loss of royalties from GlaxoSmithKline due to Rotarix losing patent protection. The biotech also reported a net loss of $118.1 million, or $1.32 per share, for the year.

The big story
These financial results, though, were akin to a flute solo being played while cymbals are crashing. You don't pay much attention to the flute.

The big news was the announcement on Monday that the FDA had granted breakthrough therapy designation for Rintega (rindopepimut) for the treatment of adult patients with EGFRvIII-positive glioblastoma. This designation was based on supporting clinical data from a phase 2 study.

The FDA decision is not too surprising. Glioblastoma is the most aggressive type of brain cancer. Only three new drugs have been approved for glioblastoma in the last two decades.

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Celldex is now conducting a phase 3 study of Rintega. Enrollment was completed in December, and the company expects interim results in mid-2015. 

Looking ahead
Perhaps the most important financial figure from Celldex's earnings announcement related to cash. The company reported $201 million in cash, cash equivalents, and marketable securities as of the end of 2014. Celldex said that is enough to fund operations through 2016, although that outlook could change thanks to results from the late-stage Rintega study.

Even with the nice bump on Monday, Celldex has a long way to go to recapture its stock's highs from a year ago. However, positive results later this year from the phase 3 study of Rintega could make that goal attainable.