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MDxHealth SA

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Market Data: Yahoo Finance, Bloomberg

Report Link: Updated Research Report (Dated 03/05/2018)

Symbol: MXDHF
Analyst: Howard Halpern
Taglich Rating: Speculative Buy
Price Target: $5.00
Time Horizon: 12 Months
Rating Established: May 5, 2016
Price When Established: $4.03
Most Recent Report: March 5, 2018
Price When Issued: $4.35

What's New

MDxHealth Announces 1Q18 Results

On April 24, 2018, MDxHealth reported 1Q18 results.

The company reported revenue increased 50% to $9.7 million versus $6.5 million in the same period last year. Net loss for the period was $6.7 million versus a loss of $5.8 million or ($0.17) per share.

Revenue growth was driven by a 55% increase in global test volume to 9,300, up from 6,000 in 1Q17.

On March 31, 2018, the company had cash of $51.3 million due to a $44 million equity raise through the issuance of nearly 10 million common shares.

MDxHealth Announces SelectMDx included in Dutch Reimbursement System

On April 20, 2018, MDxHealth announced the company's non-invasive liquid biopsy test SelectMDx has been included in the Dutch Diagnosis Related Group reimbursement system.

The Dutch reimbursement system specifies the reimbursable amounts for 30,000 different treatments and is regulated by the Dutch Healthcare Authority. Reimbursement amounts are directly negotiated between the healthcare insurers and the healthcare providers. Several Dutch hospitals have already incorporated the SelectMDx test in their prostate cancer diagnostic workflow.

Management stated that the inclusion in the Dutch Reimbursement System serves as another step in the company’s strategy to increase the adoption and acceptance of the SelectMDx test in Europe among urologists and payors.

MDxHealth Announces Capital Raise

In March 2018, MDxHealth announced the completion of a capital raise on March 26, 2018. The company issued nearly 10 million new ordinary shares of common stock for gross proceeds of approximately $44 million.

In addition to the outstanding shares, the total number of outstanding warrants is approximately 4.4 million.

The proceeds are expected to be used to support the company's growth strategy that includes adoption of its commercial tests with urologists and payors in the US and Europe, studies and tests for expanding the clinical indications for SelectMDx and supporting the further commercial roll-out of AssureMDx, as well as launching InformMDx. Also the company will be expanding the usability of the company’s tests by porting them onto IVD sample-to-answer platforms.

MDxHealth Announces SelectMDx included in 2018 European Urology Guidelines

In March 2018, MDxHealth announced SelectMDx, the company's non-invasive liquid biopsy test has been included in the 2018 European Association of Urology guidelines.

Typically, the guidelines assist clinicians in making informed treatment decisions, taking into account the available scientific data. The inclusion of SelectMDx in the European guidelines should drive adoption of the test in EU member states, as well as contribute to drive payor adoption.

Management stated that this milestone is in line with the company’s strategy to increase the adoption of SelectMDx in Europe and the US.

MDxHealth Announces Milestone Achieved for its SelectMDx Liquid Biopsy Test

On March 19, 2018, MDxHealth announced SelectMDx, the company's non-invasive liquid biopsy test that helps to identify patients at increased risk of having aggressive prostate cancer, has been included in the 2018 European Association of Urology (EAU) guidelines.

Management believes is an important milestone to drive increased adoption of SelectMDx in Europe and the US. The inclusion in the EAU guidelines show the clinical value of SelectMDx as a non-invasive method of identifying men at high risk of having the aggressive and potentially lethal form of prostate cancer and men at low risk who may forego a painful biopsy, preventing over diagnosis and over treatment.

Company Description

MDxHealth, headquartered in Herstal, Belgium, was established in 2003. The company maintains a US headquarters in Irvine, CA, and operates a CLIA (Clinical Laboratory Improvement Act) diagnostic laboratory in Irvine, California, and a laboratory in Nijmegen, the Netherlands.

The company has developed noninvasive diagnostics based on epigenetics, which uses selected biomarkers to detect the presence of cancer and gauge the extent of its progress by analyzing a patients’ tissue, blood or urine samples. Biomarkers are measurable structures or processes in the body that indicate the presence of a disease and, potentially, the effects of treatments for that disease.

MDx’s lead product, ConfirmMDx, was launched in 2012. ConfirmMDx, analyzes a biopsy tissue sample from suspected prostate cancer cases who have tested negative. As initial biopsies (as well as follow-up ones) can be inconclusive, repeat biopsies are frequently performed to verify or rule out a diagnosis of prostate cancer. Confirm MDx can confirm a true negative biopsy, sparing the patient the ordeal and risks of unnecessary repeat biopsies. It can also identify cases of undetected cancer.

SelectMDx was launched in Europe in 2015 and in the US in March 2016. Select MDx, an initial diagnostic tool, analyzes a patient’s urine and identifies patients at low risk for prostate cancer, as well as patients at high risk for undetected aggressive prostate cancer that should be treated with greater urgency.

MDx is also developing AssureMDx, a bladder cancer test, and is exploring diagnostics for kidney cancer. The company has developed markers for non-urologic – colon, brain and cervical – cancers that have been licensed to other diagnostic companies, adding royalties and milestone payments to its potential revenue stream.

At current incidence rates, the number of US men diagnosed with prostate cancer could rise to 255,000 by 2050, up from an estimated 181,000 in 2016. Almost three million men in the US who have been diagnosed with prostate cancer at some point in their lives are alive today. Roughly 26,000 US patients will succumb to the disease in 2016 We believe that the statistics for Western Europe are comparable.

As non-invasive and inexpensive diagnostics, ConfirmMDx and SelectMDx could significantly reduce the cost of prostate cancer diagnosis by enabling patients to avoid biopsies − they cost the US healthcare system around $4 billion annually − and improve outcomes by identifying cases of potentially lethal fast growing disease more quickly.

Company Reports

Updated Research Report (Dated 03/05/2018)

Updated Research Note (Dated 01/11/2018)

Updated Research Note (Dated 11/07/2017)

Updated Research Report (Dated 09/12/2017)

Updated Research Report (Dated 05/23/2017)

Updated Research Report (Dated 08/24/2016)

Initial Research Report (Dated 05/05/2016)


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