NEW YORK – Molecular diagnostics company MDxHealth reported on Wednesday that its fiscal year 2020 revenues rose 57 percent year over year, on a reported basis.
For the year ended Dec. 31, 2020, the company said total revenues rose to $18.5 million from $11.8 million a year earlier. Revenues for 2020 were affected by a one-time adjustment of $10.1 million following a significant change of estimates primarily related to management's decision to reduce the length of time it carries accounts receivable from 24 months to 12 months. Excluding this one-time adjustment, 2019 revenues would have been $21.9 million on a pro-forma basis, indicating a 16 percent year-over-year decrease to 2020 revenue levels.
Product revenues rose 58 percent to $18.1 million in FY 2020 from $11.4 million in 2019. On a pro-forma basis, product revenues fell 16 percent in 2020 from $21.5 million in 2019. Revenues from royalties, patents, and other income rose 16 percent in 2020 to $396,000 from $342,000 in 2019.
For Q4, global billable test volume for the company's SelectMDx prostate cancer test fell 29 percent to 3,472 from 4,898 in Q4 2019 and test volume for ConfirmMDx fell 28 percent to 3,704 from 5,158. For the year, SelectMDx global billable test volume fell 39 percent to 13,201 from 21,669 in 2019, and test volume for ConfirmMDx fell 18 percent to 14,945 from 18,195.
"While 2020 has indeed presented challenges due to the COVID-19 pandemic and the impact on the market, we have made significant progress based on our commitment to execute on our stated goals of advancing our turnaround of every operating discipline within the business," MDxHealth CEO Michael McGarrity said in a statement.
He highlighted the $14 million infusion the company received in 2020 from funds managed by MVM Partners, followed by $30 million it raised in a funding round in January; SelectMDx's inclusion in the 2020 National Comprehensive Cancer Network Guidelines for Prostate Cancer Early Detection; and said that Q4 had MDxHealth's second consecutive sequential increase in billable volume for both ConfirmMDx and SelectMDx.
"We believe these results represent clear validation that the fundamental growth drivers and value that were communicated prior to the pandemic have been instilled in our organization," McGarrity added. "Furthermore, the redesigned approach of our salesforce to remain highly engaged and utilize our advanced digital marketing strategy with the urology community will become evident as the pandemic lifts and patient flow returns."
Cash collections from ConfirmMDx and SelectMDx amounted to $21.0 million, a decrease of 12 percent compared to 2019, despite larger decreases in billable volume due to COVID-19, the company said.
The firm's net loss for the year narrowed to $28.7 million, or $.34 per share, from $43.1 million, or $.69 per share, in 2019. On a pro-forma basis, MDxHealth had reported a loss of $33.0 million, or $.53 per share, for the year in 2019.
At the end of December, MDxHealth, which has offices in Belgium and Irvine, California, had cash and cash equivalents of $16.0 million.
McGarrity noted that the company is also developing active surveillance tests for prostate cancer called AS-MDx and MonitorMDx tests. "These two menu additions would provide clinically actionable results for clinicians evaluating patients for active surveillance," he said. "We believe these initiatives, coupled with our current menu, will allow MDxHealth to be the only company in the space that affords clinicians a menu of advanced tests to take a patient from positive PSA screen all the way through the diagnostic pathway continuum of care with clinical confidence."