MDxHealth Reports Q3-2022 Results
IRVINE, CA, and HERSTAL, BELGIUM – October 27, 2022 – MDxHealth SA (NASDAQ/Euronext: MDXH), a commercial-stage precision diagnostics company, today announced its financial results for the third quarter ended September 30, 2022.
Michael K. McGarrity, CEO of mdxhealth, commented: “We are pleased to report continued strong operating results for the third quarter 2022. Our focus on operating discipline and commercial execution and continued implementation of our growth strategy is building the foundation for sustained growth for mdxhealth as the leading provider of personalized diagnostic solutions focused exclusively into urology.”
Highlights for the third quarter ended September 30, 2022
Q3-2022 revenue of $11.2 million, representing an increase of 103% over Q3-2021; excluding revenues from the recently acquired Oncotype DX Genomic Prostate Score (GPS) test, Q3-2022 revenue increased 42% over Q3-2021, reflecting continued execution by our sales team, expanded coverage of our menu and efficient revenue cycle management
Closed our acquisition of the Oncotype DX GPS business from Exact Sciences on August 2, 2022
Continued commercial uptake of our Urinary Tract Infection (UTI) test, newly branded as Resolve mdx
Q3-2022 Confirm mdx billable test volume increased 14% to 4,272 versus 3,748 for the same period last year
The Company’s guidance for 2022 revenue remains unchanged at $40-42 million
Cash and cash equivalents of $27.4 million as of September 30, 2022
Summary of Billable Test Volume by Product
Product
Three months ended September 30,
2022 2021 % Change
Confirm mdx 4,272 3,748 14%
Select mdx 3,004 3,218 (7%)
Product
Nine months ended September 30,
2022 2021 % Change
Confirm mdx 12,681 11,726 8%
Select mdx 9,558 10,269 (7%)
Financial review for the three and nine months ended September 30, 2022
USD in ‘000 (except per share data)
Unaudited
Three months ended September 30 Nine months ended September 30
2022 2021 % Change 2022 2021 % Change
Services 11,136 5,482 103% 24,111 15,944 51%
Licenses and royalties 18 13 38% 52 282 (82%)
Total Revenue 11,154 5,495 103% 24,163 16,226 49%
Cost of goods (4,931) (2,933) 68% (12,168) (8,449) 44%
Gross Profit 6,223 2,562 143% 11,995 7,777 54%
Operating expenses (14,364) (9,713) 48% (37,159) (27,371) 36%
Operating loss (8,141) (7,151) 14% (25,164) (19,594) 28%
Net loss (8,613) (7,621) 13% (26,717) (20,920) 28%
Basic and diluted loss per share (0.05) (0.06) (6%) (0.17) (0.18) (6%)
Total revenue for the three months ended September 30, 2022, was $11.2 million, an increase of 103% as compared to total revenue of $5.5 million for the three months ended September 30, 2021. Excluding the Oncotype DX GPS revenues, total revenues for the quarter were $7.8 million, an increase of 42% compared to the third quarter of 2021.
For the nine months ended September 30, 2022, total revenue was $24.2 million, an increase of 49% as compared to total revenue of $16.2 million for the nine months ended September 30, 2021. Excluding the Oncotype DX GPS revenues, total revenues were $20.8 million, an increase of 28% compared to the first nine months of 2021.
Gross profit for the three months ended September 30, 2022, was $6.2 million, an increase of 143% as compared to $2.6 million for the three months ended September 30, 2021. Gross margins were 55.8% for Q3-2022 as compared to 46.6% for Q3-2021, an improvement of 917 basis points attributed to contribution from Resolve mdx and the addition of initial Oncotype DX GPS revenues.
For the nine months ended September 30, 2022, gross profit was $12.0 million, an increase of 54% as compared to $7.8 million for the first nine months of 2021. Gross margins were 49.6% for the first nine months of 2022 as compared to 47.9% for the first nine months of 2021.
Operating expenses for the three months ended September 30, 2022, were $14.4 million, up 48% from $9.7 million for the three months ended September 30, 2021, primarily driven by acquisition-related expenses as well as additional field sales personnel associated with the Oncotype DX GPS business.
For the nine months ended September 30, 2022, operating expenses were $37.2 million, up 36% from $27.4 million for the nine months ended September 30, 2021, primarily due to additional public company expenses as a result of the dual listing as well as expenses related to the acquisition of the Oncotype DX GPS business in August 2022.
Operating loss and net loss for the three months ended September 30, 2022, were $8.1 million and $8.6 million, respectively, compared to $7.1 million and $7.6 million, respectively, for the three months ended September 30, 2021.
For the nine months ended September 30, 2022, operating loss and net loss were $25.2 million and $26.7 million, respectively, compared to $19.6 million and $20.9 million, respectively, for the nine months ended September 30, 2021.
Cash and cash equivalents as of September 30, 2022, were $27.4 million.
Mr. McGarrity concluded, “Today’s results reflect our previously communicated view that mdxhealth is fast becoming a leading precision diagnostics company that can deliver sustainable growth. We anticipate coverage for our Select mdx test, coupled with the addition of our UTI and GPS test revenue, will further support gross margin accretion. While we are still at the beginning stages of our integration plan for the Oncotype DX GPS business, our field sales organization is now fully restructured and in place to support our growth, and we look forward to providing a view forward of 2023 as we enter the new year.”