SOUTH SAN FRANCISCO, Calif., Nov. 9, 2011 /PRNewswire/ -- diaDexus, Inc. (OTC Bulletin Board: DDXS), a diagnostics company focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease, today announced financial results for the third quarter of 2011.
Total revenues for the quarter ended September 30, 2011 were $4.4 million, representing 38% growth over total revenues of $3.2 million for the third quarter of 2010. Total operating costs and expenses for the quarter were $6.3 million as compared to $6.0 million for the 2010 third quarter, with the increase in expenses primarily related to current severance obligations and increased product costs due to product volume increases. Net cash used in operating activities for the third quarter of 2011 was $1.7 million versus $2.1 million for the same period the year prior, up from $1.4 million in the second quarter of 2011.
As of September 30, 2011, diaDexus had cash, cash equivalents, and investments of $19.8 million, compared to $16.8 million at June 30, 2011. This includes $5.0 million in borrowings under a secured loan made by to diaDexus by Comerica Bank in September 2011.
diaDexus also said today that, following discussions with the FDA, it elected to withdraw the 510(k) application filed in June for its new automated Lp-PLA2 activity assay. The company indicated it was planning to develop a new submission. It has identified completed clinical trials from which blood samples of patient cohorts may be obtained and then tested to demonstrate the effectiveness of the new automated Lp-PLA2 activity assay. diaDexus is in discussions with the FDA on the appropriateness of utilizing these trials.
Commenting on the financial results, Chief Executive Officer Brian E. Ward, Ph.D. stated, "Our third quarter results reflect continued strong sales of our PLAC ELISA test and mark our fifth consecutive quarter of revenue growth. We are projecting continued growth this year and adjusting guidance upward to $15 16 million in total revenues for the full year. Looking forward, we expect to introduce the Lp-PLA2 activity assay in Europe in the first half of next year. We do not expect the announced 510(k) withdrawal to impact the EU launch or our 2012 revenues."
Guidance
diaDexus said that it expects 2011 total revenue to be $15 - 16 million.
The company also said it is maintaining its guidance for 2011 net cash used in operating activities at $10 - 12 million. This projection takes into account costs associated with the consolidation of operations into one leased building, current severance obligations and equipment purchases associated with anticipated commercialization of the Lp-PLA2 activity assay in Europe in the first half of 2012.
diaDexus said that it believes it will have sufficient cash through at least the end of 2012, based on its current operating plan. Future financing needs will depend on the company's ability to increase the rate of adoption of the company's products by physicians and laboratories and progress in achieving additional positive coverage decisions from insurers for the PLAC Test.
Webcast
diaDexus said it is hosting a webcast on Wednesday, November 9 at 1:30 PM PST (4:30 PM EST) to discuss the 2011 third quarter financial results. The webcast may be accessed via the company's website at www.diadexus.com/webcast.
About diaDexus, Inc.
diaDexus, Inc., based in South San Francisco, California, is focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease. The company's PLAC ELISA Test for Lp-PLA2 is the only blood test cleared by the FDA to aid in assessing risk for both coronary heart disease and ischemic stroke associated with atherosclerosis. For more information, please visit the company's website at www.diaDexus.com.
