OpGen Announces Preliminary Unaudited Revenue and Cash Position for First Quarter 2020 and Provides Business Update
April 14 2020 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and informatics to
help combat infectious disease, announced today that total revenue
for the first quarter of 2020 was approximately $617,000 down from
$1.0 million in the first quarter of 2019, excluding revenues from
the Curetis businesses, which was acquired upon closing of the
business combination on April 1, 2020. Cash as of March 31, 2020
was approximately $11.5 million, up significantly from the $2.7
million as of December 31, 2019.
The company also announced accomplishment of the
following key milestones, including key business milestones
achieved by Curetis and Ares Genetics in the first quarter of
2020:
- Successful completion of the business combination between
Curetis and OpGen on April 1, 2020. At the closing, William E.
Rhodes III, the former chairman of the Supervisory Board of Curetis
N.V., was appointed chairman of the board of OpGen, and Oliver
Schacht, PhD, the former Chief Executive Officer of Curetis N.V.,
was appointed the President and Chief Executive Officer of OpGen
and to the board of directors;
- The newly formed board of directors of OpGen now also includes
Evan Jones, former Chairman and CEO of OpGen, Don Elsey, Mario
Crovetto and Prabhavathi Fernandes, PhD;
- OpGen significantly improved its working capital position in
the first quarter of 2020 through the sale of approximately 2.8
million shares of common stock for gross proceeds of $5.8 million
of sales under the company’s ATM program and the sale of
approximately 4.1 million shares of common stock for gross proceeds
of $8.1 million from the exercise of warrants from the company’s
public offering in October 2019;
- OpGen expects that its submission to the U.S. Food and Drug
Administration (“FDA”) for clearance of the Acuitas® AMR Gene Panel
(Isolates) for the detection of antimicrobial resistance genes in
bacterial isolates is nearing completion. OpGen has responded, and
is continuing to respond, to the FDA’s additional information
requests and now anticipates approaching a clearance decision for
the Acuitas® AMR Gene Panel for isolates. Exact timing is unknown
as a result of the COVID-19 pandemic;
- Clinical trial enrollment was active during the first quarter
of 2020 at all nine participating sites for the Acuitas® AMR Gene
Panel (Urine) test. Testing and the trial have been suspended due
to hospital actions to focus resources on the COVID-19
pandemic;
- OpGen successfully achieved the first year final milestone in
this collaboration with the New York State Department of Health and
ILÚM Health Solutions, LLC, a wholly-owned subsidiary of Merck’s
Healthcare Services and Solutions, to develop a state-of-the-art
research program to detect, track, and manage
antimicrobial-resistant infections at healthcare institutions
statewide. In response to the COVID-19 emergency in New York State,
testing under the program has been put on hold by the Wadsworth
Center and participating hospitals;
- Acuitas Lighthouse® was utilized in a research study conducted
by the Mayo Clinic to predict phenotypic resistance and
antimicrobial susceptibility among clinical isolates, with findings
published in Diagnostic Microbiology & Infectious Disease;
- Curetis, Ares Genetics, and BGI announced a partnership around
BGI’s CoV-2 test kit commercialization in Europe; Curetis has begun
selling the BGI CoV-2 product via its distribution network in EMEA
during Q1 2020; and
- Curetis and Quaphaco entered into an exclusive three-year
distribution partnership for the Unyvero product line in Vietnam;
the contract includes minimum commitments by Quaphaco totaling
approximately $ 2.1 million over the initial three-year term.
OpGen revenue during the first quarter of 2020
can be attributed to Acuitas® AMR Gene Panel and Acuitas
Lighthouse® revenue, which was approximately $254,000, while
revenues from the company’s rapid FISH products decreased to
$363,000. The company expects to provide full first quarter 2020
financial results during its first quarter 2020 earnings call in
early May of this year.
Oliver Schacht, President and CEO of OpGen
commented, “In light of the unprecedented crisis situation with
COVID-19, we were pleased with the robust first quarter 2020
initial results. We have been humbled and extremely encouraged by
the dedication and hard work put in place by all our employees
globally during these extraordinary times. Going forward and once
this crisis is behind us, we anticipate dynamic growth in our
business trajectory following the expected near-term FDA clearance
decision of our Acuitas® AMR Gene Panel. We also expect the CoV-2
test kit sales in Europe to continue contributing to our top-line
revenue in Q2 of 2020.”
Schacht continued, “Now operating as one
combined company, OpGen with its group companies Curetis and Ares
Genetics boast strong proprietary assets for developing and
commercializing innovative, data-driven solutions in infectious
disease diagnostics, and we look forward to the continued
integration of our businesses over the coming weeks and
months.”
The preliminary financial results are estimates
prior to the completion of OpGen’s financial closing
procedures and review procedures by its external auditors and
therefore may be subject to adjustment when the actual results are
available.
About OpGen, Inc.
OpGen, Inc. (Gaithersburg, MD, USA) is a
precision medicine company harnessing the power of molecular
diagnostics and bioinformatics to help combat infectious disease.
Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we
are developing and commercializing molecular microbiology solutions
helping to guide clinicians with more rapid and actionable
information about life threatening infections to improve patient
outcomes, and decrease the spread of infections caused by
multidrug-resistant microorganisms, or MDROs. OpGen’s product
portfolio includes Unyvero, Acuitas® AMR Gene Panel and Acuitas
Lighthouse®, and the ARES Technology Platform including ARESdb,
using NGS technology and AI-powered bioinformatics solutions for
antibiotic response prediction.
For more information, please visit
www.opgen.com.
Forward-Looking Statements
This press release includes statements regarding
the pursuit of FDA clearance for the Acuitas® AMR Gene Panel for
use with bacterial isolates, the integration of OpGen with its
acquired subsidiaries, Curetis GmbH and Ares Genetics GmbH, and
activities related to the company’s products and services. These
statements and other statements regarding OpGen’s future plans and
goals constitute "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934 and are intended to qualify for the
safe harbor from liability established by the Private Securities
Litigation Reform Act of 1995. Such statements are subject to risks
and uncertainties that are often difficult to predict, are beyond
our control, and which may cause results to differ materially from
expectations. Factors that could cause our results to differ
materially from those described include, but are not limited to,
our ability to successfully, timely and cost-effectively develop,
seek and obtain regulatory clearance for and commercialize our
product and services offerings, the rate of adoption of our
products and services by hospitals and other healthcare providers,
the realization of expected benefits of our business combination
transaction with Curetis GmbH, the success of our commercialization
efforts, the effect on our business of existing and new regulatory
requirements, and other economic and competitive factors. For a
discussion of the most significant risks and uncertainties
associated with OpGen's business, please review our filings with
the Securities and Exchange Commission. You are cautioned not to
place undue reliance on these forward-looking statements, which are
based on our expectations as of the date of this press release and
speak only as of the date of this press release. We undertake no
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
OpGen: Oliver Schacht President and CEO
InvestorRelations@opgen.com
OpGen Press Contact: Matthew Bretzius
FischTank Marketing and
PR matt@fischtankpr.com
OpGen Investor Contact: Joe Green Edison
Group jgreen@edisongroup.com
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