OpGen Reports Preliminary Fourth Quarter and Full Year 2016 Financial Results
27 January 2017 - 9:38AM
OpGen, Inc. (NASDAQ:OPGN) today announced preliminary unaudited
results for the fourth quarter and full year ended December 31,
2016, and summarized 2016 business highlights. Total revenue
for the full year ended December 31, 2016 was approximately $4.0
million, a 27% increase from the $3.2 million recorded for the full
year ended December 31, 2015. Total revenue for the fourth quarter
of 2016 is expected to be approximately $1.0 million, a decrease of
approximately 24% from $1.3 million in the fourth quarter of 2015
and an increase of 32% from the $0.8 million recorded in the third
quarter of 2016.
The Company disclosed the following estimated, unaudited
operating expenses for the fourth quarter of 2016 and the full year
ended December 31, 2016. Operating expenses for the full year
ended December 31, 2016 are expected to be in the range of
approximately $22.8 million and $23.3 million. Full year 2016
operating expenses at the midpoint of the range represents an
increase of approximately 27% from $18.2 million in the full year
2015. Operating expenses for the fourth quarter of 2016 are
expected to be in the range of approximately $5.5 million and $6.0
million. Fourth quarter 2016 operating expenses at the midpoint of
the range represents an increase of approximately 3% from $5.6
million in the third quarter of 2016 and a decrease of
approximately 7% from $6.2 million in the fourth quarter of
2015.
Net loss for the full year ended December 31, 2016 is expected
to be in the range of approximately $19.0 million and $19.5
million. Full year 2016 net loss at the midpoint of the range
represents an increase in the net loss of approximately 11% from
$17.4 million in the full year 2015. Net loss for the fourth
quarter of 2016 is expected to be in the range of approximately
$4.6 million and $5.1 million. Fourth quarter 2016 net loss at the
midpoint of the range represents no change from $4.8 million in the
third quarter of 2016 and an increase in the net loss of
approximately 3% from $4.7 million in the fourth quarter of 2015.
Net loss for the fourth quarter of 2016 and the full year ended
December 31, 2016 are subject to change as the Company completes
its impairment testing of the intangible assets acquired as part of
the purchase of AdvanDx in July 2015. The Company’s
intangible assets, net, balance as of September 30, 2016 was $1.7
million. Any impairment in intangible assets would represent a
non-cash operating expense.
Cash and cash equivalents were approximately $4.1 million as of
December 31, 2016 compared with $4.3 million as of September 30,
2016.
“During 2016, we continued to build our unique position helping
to address the rising global antibiotic resistance crisis,” stated
Evan Jones, Chairman & CEO. “We invested heavily to solidify
our leadership in leveraging genomics and informatics to help
combat urgent infectious disease management issues caused by
multi-drug resistant organisms. From an operations perspective, we
finished the fourth quarter with steady results for our core
QuickFISH® business, and building interest for our Acuitas®
Lighthouse service offerings. We achieved key technical milestones
for our lead genome-based antibiotic decision making products and
participated in the development of compelling data from
distinguished US health systems and collaborators that position us
well going into 2017.”
2016 Enterprise Highlights and Recent Developments:
- Announced collaboration with Merck to develop novel rapid
diagnostics and informatics tools to combat antibiotic
resistance. The companies will collaborate to support OpGen’s
development of rapid DNA tests and a genomic knowledgebase of
antibiotic-resistant pathogens for predicting antibiotic
susceptibility based on test results. Under the terms of the
agreement, Merck will provide access to its archive of over 200,000
bacterial pathogens gathered over the last 15 years through the
Study for Monitoring Antimicrobial Resistance Trends (SMART), one
of the world’s largest surveillance studies of antimicrobial
resistance.
- Successfully moved Acuitas mAST™ genome-based antibiotic
resistance analysis technology from research into development
phase, including transitioning our informatics infrastructure and
genomic development engine into production and initial performance
verification of top pathogens.
- Progressed automated QuickFISH Pathogen ID product development
for positive blood culture specimens in anticipation of FDA 510(k)
clinical trials. In early 2017, determined to delay production
scale-up and clinical trial investment to allow work on new
pathogen ID and quantitation opportunities, to conserve cash, and
to provide incremental resources to the Acuitas mAST
project.
- Participated with the District of Columbia as key technology
provider to complete the first citywide quantification of
multidrug-resistant organism (MDRO) prevalence in Washington, D.C.
healthcare facilities. The results revealed the prevalence of
carbapenem-resistant enterobacteriaceae (CRE) and other
carbapenem-resistant organisms (CRO) was 5.1% and 6.4%,
respectively.
- Announced completion of the Intermountain Healthcare
retrospective MDRO health outcomes study. The study is the largest
of its kind conducted in an integrated health system and is
anticipated to provide significant insights into how healthcare
systems can reduce infections and improve health outcomes.
- Completed $10.4 million Private Placement in the second quarter
and raised $4.7 million during the fourth quarter of 2016 under
previously announced ATM “at the market” program.
- Participated in nine posters and oral presentations at major
medical meetings and published analytical validation results for
the Acuitas MDRO Gene Test.
2017 Outlook
“During 2017, our focus will continue to be on the development
of our Acuitas mAST rapid DNA tests and the Acuitas Lighthouse
Knowledgebase with a goal of transitioning to external clinical
trials and subsequent full commercialization, in conjunction with
receipt of appropriate regulatory clearances,” continued Mr. Jones.
“We anticipate growth from our Acuitas Lighthouse Knowledgebase
enabled CLIA lab services for MDRO surveillance and a continuation
of historical revenue trends from our QuickFISH products.”
In the fight to help address the global antibiotic resistance
crisis, OpGen expects to advance the following business objectives
in 2017:
- Genomic and antibiotic resistance testing of approximately
10,000 multidrug resistant organisms to support initial development
of the first Acuitas mAST test kits and deployment of the Acuitas
Lighthouse Knowledgebase.
- Completion of initial Acuitas mAST test development including
genotype/phenotype predictive algorithms and performance
verification.
- Presentation of Acuitas mAST performance data at medical
meetings and in peer reviewed journals.
- Announcement of in vitro diagnostic instrument supply and
cooperation agreement to support global commercialization of
Acuitas mAST test.
- Establishment of distribution and partner relationships to
support commercialization of Acuitas mAST and the Acuitas
Lighthouse knowledgebase in international markets.
- Establishment of Acuitas mAST early access and performance
verification programs to support regulatory approval clinical
trials and publications.
- Continued efforts to obtain third party development funding for
Acuitas test and Lighthouse Knowledgebase development and
deployment.
Complete 2016 full year and fourth quarter financial results
will be announced in March in conjunction with the company’s fourth
quarter and fiscal year 2016 financial results conference call.
This press release contains certain preliminary financial
results for the company. These results could change as a result of
further review by the company’s management and the independent
auditors. The decision to delay production scale-up and clinical
trial investment for the automated QuickFISH pathogen ID product
will likely lead to an impairment charge on the intangible assets
that were acquired as a part of the purchase of AdvanDx in July
2015. The amount and timing of such a potential charge has
not been determined.
About OpGen
OpGen, Inc. is harnessing the power of informatics and genomic
analysis to provide complete solutions for patient, hospital and
network-wide infection prevention and treatment. Learn more
at www.opgen.com and follow OpGen on Twitter and
LinkedIn.
OpGen, Acuitas MDRO, Acuitas Lighthouse and QuickFISH are
registered trademarks of OpGen, Inc.
Forward-Looking Statements
This press release includes statements relating to the
company's products and services, its commercialization plans
for these products and services, and its product and services
development efforts. These statements and other statements
regarding our 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 approval for and commercialize our product and services
offerings, the rate of adoption of our products and services by
hospitals and other healthcare providers, 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 (SEC). 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 Contact:
Michael Farmer
Director, Marketing
240-813-1284
mfarmer@opgen.com
InvestorRelations@opgen.com
OpGen Investor and Media Contact:
MacDougall Biomedical Communications
Cammy Duong
781-591-3443
cduong@macbiocom.com
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