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 2 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.”
- 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.
Upcoming 2014 Milestones
- 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.