IRVINE, Calif. & LIEGE, Belgium--()--Regulatory News:
“In the first half of 2012, we accomplished many milestones to support the commercialization of our ConfirmMDx™ product for prostate cancer in the U.S. market”
MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, announced today its 2012 first half results.
In the first half of 2012, MDxHealth made significant progress in both its ClinicalMDx and PharmacoMDx businesses.
In H1 2012, MDxHealth presented positive clinical trial data on the ConfirmMDx™ for Prostate Cancer at the American Urology Association (AUA) annual meeting, signed a co-marketing agreement for this test with PLUS Diagnostics, built out its own sales and marketing organization and launched the ConfirmMDx test in May. In the same period, MDxHealth licensing partner Predictive Biosciences launched its CertNDx™ bladder cancer test. The company also signed a worldwide development and commercialization agreement for the company's PredictMDx™ test as a companion diagnostic to Merck KGaA’s drug candidate cilengitide, a treatment for glioblastoma currently in Phase III clinical trials.
The company received its CLIA (Clinical Laboratory Improvement Amendments) accreditation, CAP (College of American Pathologists) certification, and licenses from California, Maryland and Florida for its reference laboratory in Irvine, CA. Additionally, the company received the Frost & Sullivan European award for technology leadership in oncology molecular diagnostics.
"In the first half of 2012, we accomplished many milestones to support the commercialization of our ConfirmMDx™ product for prostate cancer in the U.S. market” said Dr. Jan Groen, CEO of MDxHealth. Commenting further, he went on to say, “To date, the test has been well received by urologists and sales are on track with our forecast. We saw double-digit growth of revenue in both our ClinicalMDx and PharmacoMDx businesses compared to the first half of 2011, and we expect full-year 2012 revenues to exceed 2011 levels as second half revenues continue to increase”.
Key non-audited financials, as of June 30, 2012
Amounts as at and for the six months ended
|Euro thousands||June 30, 2012||June 30, 2011|
|EBIT Operating Income (Loss)||(4,260)||(3,851)|
|Net Profit (Loss)||(4,259)||(3,813)|
|Cash and cash equivalents||6,551*||14,646|
*does not include gross proceeds of €10 million from the private placement on July 4, 2012
Commercial revenues in H1 2012 increased by 78% to €1.5 million over the comparable period in 2011. Revenues are derived from both our PharmacoMDx business and our ClinicalMDx business. PharmacoMDx revenues grew 54% to €908K while ClinicalMDx revenues grew 122% to €413K. Income from government grants and other sources declined by 5% as the company continues to focus on growing its commercial revenue sources. However, due to the strong overall commercial revenue growth achieved by the company, total revenue grew by 43% to €2.0 million in H1 2012.
The company’s operating loss (EBIT) increased by 11%, and the net loss increased by 12% in H1 2012 due to the anticipated cost increases associated with the scale up of U.S. sales and marketing and CLIA reference laboratory operating expenses. This was partially offset by cost reductions implemented in the previous year that benefited Q1 2012 spending levels.
MDxHealth ended the first half of 2012 with cash and cash equivalents of €6.6 million compared to €14.6 on June 30, 2011, €787K lower than the same period last year after adjusting for the April 2011 capital increase. The higher cash utilization is attributed to the scale up of U.S. sales and marketing and CLIA laboratory operating costs. Consistent with our commercialization plan, cash used in operations for the 6 months ended June 30, 2012 increased by 11% as compared to a year earlier, again due to the U.S. commercial expansion.
For 2012, the company expects overall revenues to exceed 2011 levels as second half revenues continue to increase. The PharmacoMDx business is expected to continue to have strong performance as projects with Merck KGaA, GSK, and other partners continue. Revenues from the ClinicalMDx business are expected to be bolstered by revenues from the ConfirmMDx for Prostate cancer test in the second half of 2012 as the company continues to focus on building its commercial revenue, while revenues from grants is expected to decline compared to 2011.
Total operating costs in the second half are expected to increase due to higher sales and marketing and other operating activities to expand the sales of ConfirmMDx. As testing volumes increase, variable laboratory costs will increase proportionally along with some administrative costs related to billing and collection activities. Reimbursement support and information technology costs are also expected to increase in the second half. As a result, EBIT is expected to be at planned levels, but will be lower than 2011.
On July 4, 2012, MDxHealth listed 6,891,113 new shares on the Brussels NYSE Euronext exchange resulting from successfully raising €10 million in gross proceeds through a private placement with investors in various countries. The average subscription price was €1.45. Biovest Comm. VA, an existing investor, purchased 1,996,008 of the new shares at €1.50, while the remaining 4,895,105 shares were purchased by other existing and new shareholders at €1.43. ING Belgium NV/SA was the global coordinator, and both ING Belgium NV/SA and Petercam jointly performed the role of book runners.
The funds from the private placement along with the existing cash reserves allows for the continued scale up of U.S. sales and marketing efforts for the company’s ClinicalMDx business and the expansion of operations of the U.S. CLIA reference laboratory.
In Q3 2012, the company recognized its first revenues from sales of the ConfirmMDx for Prostate Cancer test. Although the company initiated billing to third party payors for tests performed in Q2 2012, the process to setup accounts and establish reimbursement rates with payors typically takes months.
In March, Prof. Dr. Wim van Criekinge became MDxhealth’s Chief Scientific Officer. In this role, Prof van Criekinge is guiding the future of MDxHealth’s epigenetic product development strategy and scientific projects and providing scientific support for both our ClinicalMDx and PharmacoMDx businesses. In March, Mr. Francis Ota was appointed as Vice President of Finance. He is based at the company’s U.S. headquarters in Irvine, CA. Mr. Ota brings valuable CLIA reference laboratory and medical device experience to MDxHealth, having served as a senior finance executive with a number of leading healthcare companies in the U.S.
Statutory Auditor's Limited Review Report
We have reviewed the accompanying interim consolidated statement of financial position of MDxHealth SA as of 30 June 2012 and the related interim consolidated statements of comprehensive income, cash flows and changes in equity for the six-month period then ended, as well as the explanatory notes. The Board of Directors is responsible for the preparation and presentation of this consolidated interim financial information in accordance with IAS 34 “Interim Financial Reporting”, as adopted by the European Union. Our responsibility is to express a conclusion on this consolidated interim financial information based on our review.
We conducted our review in accordance with International Standard on Review Engagements 2410, “Review of Interim Financial Information Performed by the Independent Auditor of the Entity”. A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Based on our review, nothing has come to our attention that causes us to believe that the accompanying consolidated interim financial information is not prepared, in all material respects, in accordance with IAS 34 “Interim Financial Reporting”, as adopted by the European Union.
Zaventem, August 30, 2012
|BDO Bedrijfsrevisoren Burg. Ven. CBVA / BDO Réviseurs d’Entreprises Soc. Civ. SCRL|
|Represented by Bert Kegels|
Complete Financial Statements:
To download the 2012 interim report, go to: http://www.mdxhealth.com/investors/financials
MDxHealth is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. By applying patented DNA methylation platform and biomarkers, MDxHealth helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information. For more information visit http://www.mdxhealth.com.
This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation.