OREANDA-NEWS. MDxHealth SA today announced its financial results for the second quarter and first half year ended June 30, 2016.

Q2 Financial Highlights

  • Q2 total revenues increased 63% to $6.3 million (Q2 2015: $3.9 million)
  • ConfirmMDx®  revenues up 79% to $5.6 million (Q2 2015: $3.1 million)
  • Q2 net loss of $4.2 million (Q2 2015: $3.0 million)
  • Basic and diluted net loss per share of $0.09

 H1 Financial Highlights

  • H1 2016 total revenues increased 65% to $13 million (H1 2015: $7.9 million)
  • ConfirmMDx revenues up 56% to $10.8 million (H1 2015: $6.9 million)
  • H1 net loss of $7.6 million (H1 2015: $5.5 million)
  • Basic and diluted net loss per share of $0.17
  • Cash and cash equivalents at June 30, 2016 of $20.1 million

"Inclusion of our ConfirmMDx test in the US National Comprehensive Cancer Network  (NCCN) Clinical Guidelines in Q1 enabled us to effectively execute on key growth drivers, supporting further clinical adoption, facilitating contract negotiations with new payors and resulting in a sharp increase in revenues," commented Dr. Jan Groen, CEO of MDxHealth. "In the first half of 2016, we negotiated ten new or expanded payor agreements for ConfirmMDx, and as of today more than 57% of the male population considered at risk of prostate cancer in the US is covered. To date over 3,000 urologists have ordered ConfirmMDx in a clinical setting on more than 45,000 men at risk for prostate cancer.

"The successful launch of SelectMDx® in the US and the publication of pivotal SelectMDx validation study results in the leading journal European Urology during H1 led to six new payor agreements for the test and growing clinical adoption by the urology community," continued Dr. Groen. "Since the introduction of SelectMDx, more than 1,000 people have already been tested."   

H1 Business Highlights

  • ConfirmMDx for Prostate Cancer
    • ConfirmMDx included in the US 2016 National Comprehensive Cancer Network (NCCN) Guidelines for Prostate Cancer Early Detection
    • Clinical validation of ConfirmMDx Risk Profile for aggressive prostate cancer published in The Prostate
    • New and expanded payor agreements signed for commercial and Medicare Advantage plans for coverage of ConfirmMDx with Gilsbar 360, USA MCO, Fortified Provider Network, Vanderbilt, JVHL, Blue Cross Blue Shield of Alaska, Fallon Community Health Plan, Three Rivers, Prime Health Services and Equian
  • SelectMDx for Prostate Cancer
    • Global commercial team appointed to drive adoption of SelectMDx internationally
    • SelectMDx launched in the US in Q1 2016
    • Multicenter, prospective clinical validation study for SelectMDx published in European Urology
    • Established coverage agreements for coverage of SelectMDx with US payors, including MultiPlan, Interwest Health, Midland's Choice, Intergroup Network Services, Fortified Provider Network, and Equian
  • Other business
    • Analytical Validation Study on AssureMDx for Bladder Cancer Published in The Journal of Urology
    • Worldwide, non-exclusive license granted to QIAGEN on MSP technology for use in cervical cancer

Post Q2 Events

In August MDxHealth announced that it had received a positive medical coverage policy decision for ConfirmMDx® for Prostate Cancer test by Cigna, one of the top five largest health insurers in the US. Cigna's positive policy on ConfirmMDx will provide access to their 15 million global medical members.

In July, MDxHealth signed a collaboration agreement with Cerba HealthCare Belgium to commercialize SelectMDx in France, Belgium and Luxembourg. Cerba is a leading healthcare provider specializing in the delivery of advanced diagnostic assays through its 5,000 customers worldwide, serving 15,000 patients per day.

MDxHealth is also pleased to announce that the Board of Directors elected Shaffar LLC, represented by Mr. Mark Shaffar, as its Chairman. Mr. Shaffar, a former Abbott Diagnostics executive who joined MDxHealth's Board of Directors in June 2016, has nearly 40 years of experience in the biotechnology sector, having held numerous positions at Abbott Laboratories, including divisional vice-president of acquisition and licensing for 12 years, director of technology acquisition and licensing for seven years, and manager of licensing and acquisitions for five years. He holds a Master of Management with a major in management policy, finance, from the Northwestern University Kellogg Graduate School of Management, and a Bachelor of Science degree in biochemistry from the University of Wisconsin-Madison. Mr. Shaffar also serves, through Shaffar LLC, as an independent director on the boards of Biocartis Group NV and MyCartis NV.

"On behalf of the Company and our shareholders, we would like to welcome Mark to our Board as Chairman, and thank Edward Erickson (acting through Greenlands Consulting LLC), who retired as Director as well as Chairman of the Board on June 30, 2016, for his leadership, diligence, and hard work for the Company over the last six years," Dr. Jan Groen said.  

Revenue and Income

Total company revenues for the first six months ended June 30, 2016, increased 65% to $12.9 million, compared to total revenues of $7.9 million for the prior year. ConfirmMDx for Prostate Cancer accounted for 83% of the Company's revenue in H1 2016, compared to 88% in H1 2015. Total revenues for Q2 2016 increased to $6.3 million compared to $3.9 million during the same period in 2015. Revenue from ConfirmMDx represented 88% of total Q2 revenues compared to 81% in the same quarter last year. The growth in Q2 2016 revenues compared to the prior period was principally driven by increased sales of ConfirmMDx as well as royalty and milestone payments from Exact Sciences. The SelectMDx for Prostate Cancer assay, still in the early stages of commercialization, contributed less than 1% of total revenue.

The Company's net loss for the first six months ended June 30, 2016, was $7.6 million, or ($0.17) a share, compared to a loss of $5.5 million loss, or ($0.12) a share, for the prior year.  The $2.1 million increase in net loss compared to the same period last year is due to the anticipated initial losses of the newly acquired Dutch entity NovioGendix, laboratory investments related to the new SelectMDx for Prostate Cancer assay, and non-recurring corporate development spending in the first half.

Cash Position

The Company's cash and cash equivalents were $20.1 million on June 30, 2016, compared to $40.4 million on June 30, 2015. Collections from ConfirmMDx reimbursements were $8.2 million in 2016 vs. $5.3 million in the first half of 2015. Average net cash burn in the first six months of 2016 was approximately $1.9 million per month.

Q3 and FY2016 Outlook

The Company maintains its guidance for the full year ending December 31, 2016, and expects continued revenue growth predominantly from product and service revenue in the US and international markets, driven by the inclusion of the ConfirmMDx test in the NCCN guidelines in the US, additional coverage agreements with major payors, for both ConfirmMDx and SelectMDx, and growing adoption of MDxHealth products among the urology community. The continued infrastructure investments over the last twelve months, particularly in the sales force, managed care, and billing and collections are expected to further improve volume, collections, EBITDA and revenue recognition in the second half.

2016 guidance:

  • Revenue growth between 30% to 50%
  • Improved EBITDA compared to 2015
  • Publication of US SelectMDx validation data
  • Launch of AssureMDx on the US market in H2

Reporting Calendar

  • Q3 results; November 3, 2016
  • Top-line 2016 results: January 9, 2017

MDxHealth is a multinational healthcare company that provides actionable epigenetic information to personalize the diagnosis and treatment of cancer. The company's tests are based on proprietary gene methylation (epigenetic) technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy.