OpGen Announces Preliminary Unaudited Revenue for Fiscal 2020 and Provides Business Update
January 13 2021 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and bioinformatics to
help combat infectious disease, announced today that total
pro-forma preliminary unaudited revenue (including revenue from
discontinued operations) for OpGen in 2020 was approximately $5.2
million, compared to about $6.0 million in 2019. Fourth quarter
2020 revenue for OpGen was approximately $1.3 million compared to $
0.8 million in Q4-2019. The company expects to provide fourth
quarter 2020 and full year 2020 financial results during its
upcoming earnings call in March 2021. OpGen’s cash position as of
December 31, 2020 was approximately $13.3 million, an increase from
$2.7 million in 2019.
The company also announced accomplishment of the
following key milestones and recent developments in the fourth
quarter and full year 2020 as well as 2021 to date:
- Following the announced delay in
FDA review of the Acuitas AMR Gene Panel 510(k) submission due to
the agency’s prioritization of COVID-19 related EUAs, OpGen
anticipates the re-allocation of FDA staff towards the review of
non-COVID-19 related submissions and a near term clearance decision
for the Acuitas AMR Gene Panel in Q1-2021.
- The 90-day exclusive negotiation
period with a global leading IVD corporation partner towards a
potential collaboration and licensing deal recently expired. While
a larger strategic deal and licensing agreement is not expected to
materialize with such partner in the near term, the parties
continue to discuss on a non-exclusive basis potential targeted and
focused R&D collaboration as well as possible licensing
opportunities. Ares Genetics expects to engage in multiple further
partnering and licensing discussions with additional IVD partners
that expressed interest in collaborating in the coming months.
- OpGen subsidiary Curetis entered
into exclusive distribution partnership in Colombia with Annar
Health Technologies for Curetis’ Unyvero A50 platform.
- OpGen announced the release of a
new peer-reviewed publication that demonstrates that the Unyvero
LRT BAL panel accurately detects 19 bacteria alongside Pneumocystis
jirovecii and 10 antibiotic resistance genes directly from
bronchoalveolar lavage fluid, allowing enhanced diagnosis of lower
respiratory tract infections.
- OpGen completed a $ 10 million
private placement priced at the market with one healthcare-focused
U.S. institutional investor, bringing the total amount of capital
raised in 2020 to $35.3 million, including the proceeds of the
company’s ATM facility and warrant exercises.
- Ares Genetics extended its
collaboration with Sandoz within its pharma partnering program.
Ares Genetics presented advances of its research use only (RUO)
based ares-genetics.cloud platform for predictive antibiotic
susceptibility testing (AST) at various scientific conferences and
expects granting of key patent on genetic resistance
prediction.
- OpGen’s wholly owned subsidiary,
Ares Genetics GmbH, completed the transition of leadership to Dr.
Arne Materna, who was appointed as Managing Director and CEO of
Ares Genetics effective January 1, 2021.
- OpGen’s subsidiary, Curetis GmbH,
obtained CE mark certification in the European Union for its own
SARS-CoV-2 Kit with PULB for the detection of SARS-CoV-2, the virus
that causes COVID-19.
- Streamlined portfolio of platforms
and products with focus going forward on Unyvero UTI and IJI for
upcoming clinical trials in 2021 and subsequent FDA
submissions.
- Exiting FISH business by mid 2021
and ended Acuitas AMR Gene Panel urine trial in fall of 2020.
Oliver Schacht, President & CEO of OpGen,
commented, “We are pleased with our fourth quarter and full year
2020 preliminary results and are off to a strong start into 2021.
With our new corporate strategy defined and portfolio consolidation
successfully completed, a robust cash position and strong global
partnerships, there is no doubt that our business has the potential
to grow significantly in the coming years. I am especially excited
about upcoming key milestones such as an FDA clearance decision on
the Acuitas AMR Gene Panel for isolates.”
Mr. Schacht continued, “We have strong lines of
communication open with the FDA regarding the Acuitas AMR Gene
Panel for Isolates. Based on the most recent feedback from the FDA,
we expect them to resume review activities following a COVID-19
related staffing surge, and we reiterate anticipation of a near
term clearance decision in Q1-2021 and are fully prepared to follow
with a swift commercial launch once FDA cleared. While a strategic
collaboration and licensing deal did not materialize during the
90-day exclusive negotiation period between Ares Genetics and our
IVD partner, conversations to explore further potential
collaboration opportunities continue. In addition, we are looking
forward to being able to re-engage and continue our dialog with
several additional parties based on recent inbound expressions of
interest, on a non-exclusive basis over the coming months. In
closing, we finished the year strong with a solid balance sheet,
access to additional capital and a pipeline and R&D portfolio
that allow us to develop and commercialize industry-leading,
data-driven solutions in infectious disease diagnostics.”
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
OpGen’s fourth quarter 2020 and full year results, expected FDA
review and clearance decision regarding the Acuitas AMR Gene Panel
for isolates, potential strategic partnering and licensing
opportunities for Ares Genetics, and the impact of COVID-19 on the
company and general market conditions. These statements and other
statements regarding OpGen’s Unyvero products, their
commercialization and launch, 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 fact that we may not effectively use proceeds from recent
financings, including our November 2020 private placement, the
realization of expected benefits of our business combination
transaction with Curetis GmbH, the success of our commercialization
efforts, the impact of COVID-19 on the company’s operations,
financial results, and commercialization efforts as well as on
capital markets and general economic conditions, 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 SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and PR matt@fischtankpr.com
OpGen Investor Contact:Megan Paul Edison
Group mpaul@edisongroup.com
OpGen (NASDAQ:OPGN)
Historical Stock Chart
From Jun 2024 to Jul 2024
OpGen (NASDAQ:OPGN)
Historical Stock Chart
From Jul 2023 to Jul 2024