diaDexus, Inc. (OTCQB: DDXS), a company developing and commercializing proprietary cardiovascular diagnostic products, today announced financial results for the fourth quarter and full year ended December 31, 2013.
“In 2013, we successfully delivered another year of double-digit sales growth by expanding our partnered sales effort with cardiovascular specialty laboratories and focusing on physician educational events,” said Brian Ward, Ph.D., diaDexus’ president and chief executive officer. “On the new product front, we have made progress toward obtaining U.S. Food and Drug Administration (FDA) clearance for our PLAC® Test for Lp-PLA
Activity by starting clinical sample testing in support of this submission. We have also made progress on expanding our pipeline of cardiovascular markers. As announced today, we have gained exclusive U.S. rights to three independent biomarkers to aid in risk prediction and prognosis for heart failure with a goal of continuing to help address the diagnostic needs of primary care physicians.”
Upcoming 2014 Milestones
- Achieved full year 2013 revenue of $24.9 million, a 20 percent increase compared with the prior year.
- Gross margins for the full year 2013 were 71 percent compared with 70 percent for the prior year.
- Obtained broader reimbursement coverage of our PLAC Test ELISA Kit in the Texas and Mid-Atlantic Medicare regions.
- Advanced the clinical program to support a potential 510(k) submission of the PLAC Test for Lp-PLA 2 Activity.
- Expanded loan facility to $10 million in October 2013, planning for long-term growth focused on potential PLAC Test for Lp-PLA 2 Activity launch, pipeline development and product expansion.
- Highlighted a 6,500 patient Long-term Intervention with Pravastatin in Ischemic Disease (LIPID) sub-study publication in the Journal of the American Heart Association, which presented evidence that supports the elevation of Lp-PLA 2 activity from a predictive bio-marker to a risk-factor.
- Sponsored over 310 physician educational roundtables in support of the PLAC Test.
- Drive revenue growth in the second half of the year by expanding sales reach to new geographies across the U.S. and increasing marketing programs in strategic regions with our partners.
- Announce results from the PLAC Test for Lp-PLA 2 Activity cohort analysis and, if positive, submit a 510(k) application to the FDA by mid-year 2014.
- Continue to expand cardiovascular focused pipeline.
Total revenues for the fourth quarter 2013 were $6.7 million, a 24 percent increase from the $5.4 million reported in the fourth quarter of 2012. Total operating expenses for the fourth quarter 2013 were $6.7 million, compared with $5.7 million for the fourth quarter of 2012. The increase in operating expenses resulted primarily from costs related to developing our pipeline and pre-analytical work for the PLAC Test for Lp-PLA
Activity clinical sample study, higher product costs consistent with sales growth, and costs related to expansion of our sales and marketing programs. The Company's net loss for the fourth quarter 2013 narrowed to $0.2 million, or $(0.00) per share, from a net loss of $0.4 million, or $(0.01) per share, in the fourth quarter of 2012.
Total revenues for the full year 2013 were $24.9 million, a 20 percent increase over $20.8 million reported for the full year 2012, reflecting increased demand for the PLAC Test. Total operating expenses for the full year 2013 were $26.9 million compared with $23.2 million for the full year 2012. The drivers for the increase in total operating expenses for the full year 2013 were similar to those described for the fourth quarter of the year. The Company’s net loss for the full year 2013 narrowed to $2.2 million, or $(0.04) per share, from a net loss of $2.8 million, or $(0.05) per share, in the full year 2012. Cash and cash equivalents and investments at December 31, 2013 were $16.8 million compared with $12.2 million on September 30, 2013 and $13.6 million at December 31, 2012.