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MDxHealth Q4 Revenues Rise 68 Percent

NEW YORK (GenomeWeb) – MDxHealth reported today that its fourth quarter revenues rose 68 percent percent year over year, driven largely by higher sales of its ConfirmMDx prostate cancer test.

For the three months ended Dec. 31, 2015, MDxHealth reported revenues of $5.7 million compared to $3.4 million in Q4 2014.

Sales of the ConfirmMDx test represented 86 percent of the quarter's total revenues compared to 70 percent of revenues in Q4 2014. The increase was also due in part to royalty and milestone payments from Exact Sciences.

The company's Q4 net loss widened to $4.1 million, or $.09 per share, from $3.0 million, or $.08 per share, in Q4 2014. MDxHealth attributed the increased loss to costs associated with its acquisition of NovioGendix in the Netherlands, continued investment in commercialization efforts in the US, and changing revenue recognition policies for ConfirmMDx sales.  

The company also reported that operating expenses in Q4 2015 rose to $9.8 million from $7.1 million in Q4 2014, and attributed the increase to spending on R&D, continued costs related to a clinical utility study for ConfirmMDx, and additions to staff in sales, managed care, information technology, and medical affairs.  

For full-year 2015, MDxHealth reported total revenues rose 50 percent to $17.6 million from $11.7 million in 2014. Sales of the ConfirmMDx test rose 62 percent to $15.2 million in FY 2015 from $9.4 million in 2014. Overall, sales of the test accounted for 86 percent of the company's yearly revenue compared to 80 percent in 2014. ConfirmMDx case volume also increased, exceeding 15,000 patients for the year compared to 12,300 in 2014.

The company further said it signed 19 contracts for ConfirmMDx with commercial or Medicare Advantage payer organizations, such as Aetna, Vanderbilt University, Tufts, and various states' Blue Cross Blue Shields, in order to gain broader reimbursement for the test.

"The strategic investments we made in our sales force and managed care teams in the second half of 2015 were effective as evidenced by the sharp increase in revenue," said MDxHealth CEO Jan Groen in a statement. "During the year we substantially expanded adoption of ConfirmMDx within the US urology community. … We expect to carry this positive momentum into 2016."

The firm's net loss for the year narrowed to $14.5 million, or $0.32 per share, from $15.3 million, or $.40 per share, the year before.

The company's SG&A expenses rose to $22.4 million from $18.3 million in 2014. R&D expenses rose to $3.3 million from $2.4 million in the year-ago period.

MDxHealth ended the year with cash and cash equivalents of $31.7 million. 

For 2016, the company said it expects to see continued growth in revenue driven largely by increased adoption of ConfirmMDx and the introduction of a new liquid biopsy prostate cancer test, SelectMDx, in the US and Europe. Overall, the firm expects revenue growth of 30 percent to 50 percent for the full year. It also plans to publish its validation study for SelectMDx, launch the test in the US in the first half of the year, and launch a liquid biopsy test for bladder cancer called AssureMDx in the second half of the year.

"In the coming year, an important strategic focus for the company will be expanding our product pipeline and test indications to address further unmet medical needs for cancer patients," Groen added.