NEWS RELEASE
REGULATED
INFORMATION
INTERIM
TRADING UPDATE
MDxHealth Provides
First Quarter 2018 Business Update
IRVINE, CA, and
HERSTAL, BELGIUM - 07:00 CEST, April 24, 2018 - MDxHealth SA
("MDxHealth, or the "Company"), (Euronext: MDXH.BR), today issued
its business update for the first quarter ended March 31, 2018.
Dr. Jan Groen,
Chief Executive Officer of MDxHealth, commented: "In the first
quarter of 2018, we delivered strong growth in both patient test
volumes and revenues. In particular, we are very pleased with the
50% growth of ConfirmMDx volumes compared to Q1 2017. In line with
our growth strategy we are also seeing strong volume growth for our
liquid biopsy test SelectMDx, with volumes nearly tripling in
Europe. Going forward we expect the recent inclusion of this
product in the European Association of Urology (EAU) clinical
guidelines to contribute to continued growth and adoption of the
test in Europe.
"Despite a strong first quarter,
we do not yet have full visibility on revenue projections going
forward, however we remain confident in the positive outlook
for the year and achieving higher levels of testing volume and
product revenue compared to 2017. We will continue to keep
the market updated as the year progresses."
Financial
highlights
- Total revenue of $9.7 million, up
50% from $6.5 million in Q1 2017
- Product revenue of $7.9 million,
up 60% from $4.9 million in Q1 2017
- Operating loss of $6.7 million
compared to $5.8 million in Q1 2017
- Cash and cash equivalents of
$51.3 million as of March 31, 2018
Operational
highlights
-
Total global patient test volume of 9,300, up
55% from 6,000 in Q1 2017
-
Six new payor contracts, four for ConfirmMDx and
two for SelectMDx
-
Existing Brain Cancer Biomarker license with
LabCorp expanded globally
Summary by
product
ConfirmMDx®
- Total global patient test volume
grew to almost 5,800 in the first three months of 2018 from 3,800
in the same period last year, up more than 50%, including 640 tests
associated with clinical studies initiated in 2017
- Four new US payor contracts for
ConfirmMDx, including two with Blue Cross Blue Shield Association®
licensees.
-
ConfirmMDx evaluation study for Predicting
Repeat Prostate Biopsy Outcome in African American Men presented at
the 28th IPCU meeting
24-28 January in Vial, Colorado, US
https://grandroundsinurology.com/ipcu-2018/
SelectMDx®
- Strong growth for SelectMDx with
total global commercial test volume of 3,500 in the first three
months of 2018 versus 2,100 in the same period last year,
representing an increase of 62%, excluding an additional 1,000
non-billable study cases
- SelectMDx US patient test volume
up 47% to over 2,700 compared to nearly 1,900 in 2017
- In March, SelectMDx was included
in the 2018 EAU guidelines which assist clinicians in making
informed treatment decisions, taking into account the available
scientific data. The inclusion of SelectMDx in the EAU guidelines
will enable faster adoption of the test in EU member states
specific guidelines and contribute to drive payor adoption
- EU SelectMDx commercial test
volume almost tripled to 720 patients tested compared to 270 in
2017. The total EU lab testing throughput in Q1 was 1,720 cases
including 1,000 non-billable tests related to reimbursement and
registration studies
- Two new US military hospitals
payor contracts for SelectMDx
- Commercial service agreement
signed with Fondazione Luigi Maria Monti - Istituto
Dermopatico dell' Immacolata (IDI), a leading research
Hospital in Rome, to provide SelectMDx® for Prostate
Cancer as a service test
Summary of
patient test volume by product
Product by territory |
Q1 2018 |
Q1 2017 |
Change as a % |
ConfirmMDx US |
5,794 |
3,848 |
51% |
SelectMDx US |
2,749 |
1,872 |
47% |
SelectMDx EU |
720 |
270 |
167% |
Total |
9,263 |
5,990 |
55% |
Other business
highlights
-
MDxHealth has broadened its existing license
with LabCorp for rights to certain patents owned and controlled by
MDxHealth relating to the MGMT biomarker for use in oncology,
including testing for patients with brain cancer, such as
Glioblastoma (GBM). LabCorp's rights are exclusive, subject
to certain limited exceptions. Under the terms of the expanded
license agreement, which previously covered the US and Canada only,
but is now worldwide, MDxHealth is entitled to receive an upfront
payment and royalties on sales and may be entitled to receive
additional license fees, subject to certain conditions.
-
Development of a liquid biopsy test to guide
treatment-decision for castration-resistant prostate cancer (CRPC)
patients (The Prostate, vol, no, 2018)
-
Presentation of AssureMDx for Bladder Cancer
multicenter hematuria study at the EAU conference in Copenhagen on
16-22 March, 2018
Post Period
Events
Key non-audited financial information as of March
31, 2018
Amounts in USD as at, and for the
three months ended March 31, 2018:
('000 USD) |
March 31, 2018 |
March 31, 2017 |
Change |
Change as a % |
Revenues |
9,741 |
6,478 |
3,263 |
50.4% |
EBITDA Income (Loss) |
(6,234) |
(5,401) |
(833) |
-15.4% |
EBIT Operating Income (Loss) |
(6,715) |
(5,847) |
(868) |
-14.8% |
Net Profit (Loss) |
(6,713) |
(5,837) |
(876) |
-15% |
Cash and cash equivalents |
51,325 |
22,478 |
28,847 |
128.3% |
Total revenue
for the first quarter was $9.7 million compared to $6.5 million
during the same period in 2017. Included in the total revenue for
the first quarter is a license fee payment of $0.5 million. Product
revenue from ConfirmMDx and SelectMDX amounted to $7.9 million and
increased 60% from $4.9 million a year earlier. Revenue from
ConfirmMDx represented 91% of product revenue.
Operating
expenses in the first quarter were $13 million, up $3.3 million
over the same period last year. The increase in operating costs can
be primarily attributed to expansion of the Company's commercial
operations to accelerate sales of the ConfirmMDx and support the
launch of SelectMDx for Prostate Cancer, including the building out
of a global sales force.
Operating loss
(EBIT) and net loss for the first quarter were $6.7 million, an
increase over the same period in 2017 reflecting primarily further
investment in commercialization.
Cash and cash
equivalents as of March 31, 2018 were $51.3 million. In March
2018, the Company raised $44 million (€36 million) in gross
proceeds by means of a private placement of 9,989,881 new shares at
an issue price of EUR 3.60 per share through an accelerated book
building
Q2 and 2018
Outlook
The Company remains confident that
ConfirmMDx will continue to drive momentum in the mid-term and
increase market share. In the longer term, the Company expects
SelectMDx to increasingly contribute to overall growth alongside
numerous value creating inflection points due in the coming years.
The Company is positive about the outlook for the current year and
believes it can achieve a higher level of Product and Services
revenue growth than in 2017. The Company will continue to update
the market as the year progresses.
The Company has a clear growth
strategy for 2018 and beyond. This is centred around four key
pillars:
- Driving adoption of the Company's commercial
tests with urologists and payors
- Expanding the clinical indications for
SelectMDx
- Porting MDxHealth tests onto IVD sample-to-answer
platforms to increase usability
- Leveraging our product offering through
partnering with pharmaceutical companies
This will be driven by:
-
Increase in private payor coverage in the US for
ConfirmMDx and SelectMDx
-
Submission of SelectMDx clinical data package in
2018 in consideration for Medicare coverage through a Local
Coverage Determination (LCD).
-
Publication of clinical utility studies and
budget impact studies to secure more contracts with private payors
for SelectMDx
-
Releasing the results of the prospective 4M
study, comparing SelectMDx with the PHi test,
combined with mpMRI and histopathology in the course of H1 2018.
These data are key to inclusion in US clinical guidelines and
driving payor adoption
-
Expanded market opportunity for SelectMDx in
active monitoring and primary care settings expected to quadruple
the market opportunity for SelectMDx in the mid-term to more than 2
million patients annually in the US and a similar number for
Europe
-
MDxHealth will continue to leverage its
biomarker portfolio and expand its capabilities towards the
pharmaceutical industry
-
The company will further develop its new
diagnostic companion blood test, MonitorMDx for Prostate Cancer to
guide the personalized treatment of castration resistant prostate
cancer patients building on the very encouraging results of the
study published in The Prostate on January 12,
2018
About MDxHealth
MDxHealth is a multinational
healthcare company that provides actionable molecular diagnostic
information to personalize the diagnosis and treatment of cancer.
The company's tests are based on proprietary genetic, epigenetic
(methylation) and other molecular technologies and assist
physicians with the diagnosis of urologic cancers, prognosis of
recurrence risk, and prediction of response to a specific therapy.
The Company's European headquarters are in Herstal, Belgium, with
laboratory operations in Nijmegen, The Netherlands, and US
headquarters and laboratory operations based in Irvine, California.
For more information, visit mdxhealth.com and follow us on social
media at: twitter.com/mdxhealth, facebook.com/mdxhealth and
linkedin.com/company/mdxhealth.
For more information:
MDxHealth
Dr. Jan Groen, CEO
US: +1 949 812 6979
BE: +32 4 364 20 70
info@mdxhealth.com
|
Jean-Marc Roelandt, CFO
BE: +32 (0) 4 364 20 70
NL: +31 (0) 88 327 2727
IR@mdxhealth.com |
Consilium Strategic Communications
Amber Fennell, Chris Welsh & Hendrik Thys
UK: +44 20 3709 5701
mdxhealth@consilium-comms.com
|
LifeSpring LifeSciences Communication,
Leon Melens
NL: +31 6 538 16 427
lmelens@lifespring.nl
|
*The SelectMDx
IVD PCR kit is not available in all geographies and/or may not be
approved for all uses discussed in this press release. It is
currently not available for use in the United States.
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. This press release does
not constitute an offer or invitation for the sale or purchase of
securities or assets of MDxHealth in any jurisdiction. No
securities of MDxHealth may be offered or sold within the United
States without registration under the U.S. Securities Act of 1933,
as amended, or in compliance with an exemption therefrom, and in
accordance with any applicable U.S. securities laws.
NOTE: The MDxHealth logo,
MDxHealth, ConfirmMDx, SelectMDx, AssureMDx, PredictMDx and
UrNCollect are trademarks or registered trademarks of MDxHealth SA.
All other trademarks and service marks are the property of their
respective owners.
MDxHealth_Q1 Trading
update_EN_2018
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announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: MDxHealth (R) via Globenewswire
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