OpGen Announces 2016 Fourth Quarter and Year End Financial Results
March 23 2017 - 4:01PM
OpGen, Inc. (NASDAQ:OPGN) today reported financial and operational
results for the fourth quarter and year ended December 31,
2016 and summarized 2016 business highlights. Total revenue
for the full year ended December 31, 2016 was $4.0 million, a 27%
increase from $3.2 million recorded for the full year ended
December 31, 2015. Net loss for the full year ended December
31, 2016 was $19.2 million compared with $17.4 million in 2015.
“In 2016 our investments in genomics and informatics for
infectious disease management issues caused by multi-drug resistant
organisms began to pay off. We successfully moved our Acuitas
Rapid Test for drug resistant genes and pathogens and our Acuitas
Lighthouse antibiotic resistance prediction technology to the
development phase. Later this year we anticipate the first clinical
evaluations of this breakthrough new technology along with the
release of RUO test kits,” said Evan Jones, Chairman & CEO of
OpGen. “We also achieved key milestones including a strategic
research collaboration with Merck and compelling data on health
outcomes from our partnerships with distinguished U.S. health
systems and collaborators.”
2016 Year End and Fourth Quarter Financial
Results
- Revenue: Total revenue for the full year
ended December 31, 2016 was $4.0 million, a 27% increase
from the $3.2 million in 2015. Total revenue for the
fourth quarter of 2016 was $1.0 million, a decrease of 24%
from $1.3 million in the fourth quarter of 2015 and an
increase of 32% from the $0.8 million in the third quarter of
2016.
- Operating Expenses: Operating expenses for the
full year ended December 31, 2016 were $23.0 million
compared with $18.2 million in 2015. Operating expenses for the
fourth quarter of 2016 were $5.7 million compared with $6.2 million
in the fourth quarter of 2015.
- Net Loss: Net loss for the full year
ended December 31, 2016 was $19.2 million compared with
$17.4 million in 2015. Net loss for the fourth quarter of 2016 was
$4.8 million compared to $4.7 million in the fourth quarter of
2015.
- Cash Position: Cash and cash equivalents
were $4.1 million as of December 31,
2016 compared with $4.3 million as of September
30, 2016.
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 the Acuitas Rapid Test and 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.
- Participated with the District of Columbia Hospital
Association 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 a $10.4 million Private Placement in the second
quarter and raised $4.7 million during the fourth quarter
of 2016 under a previously announced “at the market” (ATM)
offering.
- 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 we are focused on advancing the development of the
Acuitas brand of rapid diagnostic products alongside the Acuitas
Lighthouse Knowledgebase with a goal of implementing the technology
for external research use in the second half of the year,”
continued Mr. Jones. “We are also working to further accelerate the
growth of our business in the United States and international
markets. We anticipate sharing additional commercial,
technical and health outcomes data that support our position and
capabilities as they become available.”
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 10,000 multidrug
resistant organisms to support initial development of the first
Acuitas Rapid Test kits and deployment of the Acuitas Lighthouse
Knowledgebase.
- Completion of initial Acuitas Rapid Test development and
Acuitas Lighthouse genotype/phenotype predictive algorithms and
clinical performance verification.
- Presentation of Acuitas Rapid Test and 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 the
Acuitas Rapid Test.
- Establishment of distribution and partner relationships to
support commercialization of the Acuitas Rapid Test and
the Acuitas Lighthouse Knowledgebase in international
markets.
- Establishment of Acuitas Rapid Test early access and
performance verification programs to support regulatory approval
clinical trials and publications.
- Continued efforts to obtain third party development funding for
Acuitas Rapid Test and Acuitas Lighthouse Knowledgebase development
and deployment.
Conference Call Information
OpGen management will hold a conference call today
beginning at 4:30 p.m. (EDT) to discuss fourth quarter
and year end financial results and other business
activities. The call can be accessed by dialing 844-420-8185
(domestic) or 216-562-0481 (international) and providing passcode
87850606. A live webcast of the conference call can be
accessed by visiting the Investor Relations section of the
company’s website at http://ir.opgen.com. A replay of the
webcast will be available shortly after the conclusion of the call
on the company’s website for 90 days.
A telephone replay also will be available at 7:30 p.m. ET
through March 28, 2017 and may be accessed by dialing
855-859-2056 from within the U.S. or 404-537-3406 from outside the
U.S. All listeners should provide passcode 87850606.
About OpGenOpGen, 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 StatementsThis 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, Inc. |
Consolidated Statements of Operations and
Comprehensive Loss |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
Revenue |
|
|
|
|
|
|
|
|
|
Product sales |
|
$818,488 |
|
|
$1,268,550 |
|
|
$3,524,178 |
|
|
$2,701,142 |
|
|
Laboratory
services |
|
|
46,774 |
|
|
|
33,275 |
|
|
|
228,904 |
|
|
|
120,476 |
|
|
Collaboration
revenue |
|
|
141,301 |
|
|
|
27,762 |
|
|
|
272,603 |
|
|
|
336,102 |
|
|
Total
revenue |
|
|
1,006,563 |
|
|
|
1,329,587 |
|
|
|
4,025,685 |
|
|
|
3,157,720 |
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
Cost of products
sold |
|
|
388,581 |
|
|
|
391,515 |
|
|
|
1,658,571 |
|
|
|
1,179,771 |
|
|
Cost of services |
|
|
102,600 |
|
|
|
169,111 |
|
|
|
631,333 |
|
|
|
367,802 |
|
|
Research and
development |
|
|
2,334,407 |
|
|
|
2,105,892 |
|
|
|
8,613,236 |
|
|
|
6,002,941 |
|
|
General and
administrative |
|
|
1,647,512 |
|
|
|
2,140,499 |
|
|
|
6,602,608 |
|
|
|
5,834,642 |
|
|
Sales and
marketing |
|
|
1,246,646 |
|
|
|
1,342,889 |
|
|
|
5,529,274 |
|
|
|
4,305,444 |
|
|
Transaction
expenses |
|
|
— |
|
|
|
687 |
|
|
|
— |
|
|
|
526,283 |
|
|
Total operating
expenses |
|
|
5,719,746 |
|
|
|
6,150,593 |
|
|
|
23,035,022 |
|
|
|
18,216,883 |
|
|
Operating
loss |
|
|
(4,713,183) |
|
|
|
(4,821,006) |
|
|
|
(19,009,337) |
|
|
|
(15,059,163) |
|
|
Other
expense |
|
|
|
|
|
|
|
|
|
Interest and other
(expense)/income |
|
|
(2,889) |
|
|
|
1,411 |
|
|
|
(5,967) |
|
|
|
26,657 |
|
|
Interest expense |
|
|
(33,541) |
|
|
|
(38,896) |
|
|
|
(143,347) |
|
|
|
(1,801,320) |
|
|
Foreign currency
transaction losses |
|
|
(10,395) |
|
|
|
— |
|
|
|
(8,102) |
|
|
|
— |
|
|
Change in fair value of
derivative financial instruments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(647,342) |
|
|
Total other
expense |
|
|
(46,825) |
|
|
|
(37,485) |
|
|
|
(157,416) |
|
|
|
(2,422,005) |
|
|
Loss before
income taxes |
|
|
(4,760,008) |
|
|
|
(4,858,491) |
|
|
|
(19,166,753) |
|
|
|
(17,481,168) |
|
|
|
|
|
|
|
|
|
|
|
|
Provision for
income taxes |
|
|
— |
|
|
|
(130,757) |
|
|
|
— |
|
|
|
(129,095) |
|
|
Net
loss |
|
|
(4,760,008) |
|
|
|
(4,727,734) |
|
|
|
(19,166,753) |
|
|
|
(17,352,073) |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock
dividends and beneficial conversion |
|
|
— |
|
|
|
— |
|
|
|
(332,550) |
|
|
|
(243,762) |
|
|
Net loss
available to common stockholders |
|
$(4,760,008) |
|
|
$(4,727,734) |
|
|
$(19,499,303) |
|
|
$(17,595,835) |
|
|
Net loss per common
share - basic and diluted |
|
$(0.21) |
|
|
$(0.38) |
|
|
$(1.10) |
|
|
$(2.20) |
|
|
Weighted average shares
outstanding - basic and diluted |
|
|
22,549,773 |
|
|
|
12,540,755 |
|
|
|
17,667,557 |
|
|
|
7,980,995 |
|
|
Net loss |
|
$(4,760,008) |
|
|
$(4,727,734) |
|
|
$(19,166,753) |
|
|
$(17,352,073) |
|
|
Other comprehensive
income/(loss) - foreign currency translation |
|
|
6,176 |
|
|
|
(1,010) |
|
|
|
7,235 |
|
|
|
(1,059) |
|
|
Comprehensive
loss |
|
$(4,753,832) |
|
|
$(4,728,744) |
|
|
$(19,159,518) |
|
|
$(17,353,132) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OpGen, Inc. |
|
Consolidated Balance Sheets |
|
(unaudited) |
|
|
|
|
|
December 31, 2016 |
|
|
December 31, 2015 |
|
Assets |
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
4,117,324 |
|
|
$ |
7,814,220 |
|
Accounts receivable,
net |
|
|
542,420 |
|
|
|
678,646 |
|
Inventory, net |
|
|
692,368 |
|
|
|
826,012 |
|
Prepaid expenses and
other current assets |
|
|
329,646 |
|
|
|
566,239 |
|
Total current
assets |
|
|
5,681,758 |
|
|
|
9,885,117 |
|
Property and equipment,
net |
|
|
800,723 |
|
|
|
1,074,710 |
|
Goodwill |
|
|
600,814 |
|
|
|
637,528 |
|
Intangible assets,
net |
|
|
1,620,998 |
|
|
|
1,888,814 |
|
Other noncurrent
assets |
|
|
279,752 |
|
|
|
270,327 |
|
Total
assets |
|
$ |
8,984,045 |
|
|
$ |
13,756,496 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,232,563 |
|
|
$ |
2,285,792 |
|
Accrued compensation
and benefits |
|
|
578,480 |
|
|
|
1,081,270 |
|
Accrued
liabilities |
|
|
1,215,283 |
|
|
|
920,286 |
|
Deferred revenue |
|
|
37,397 |
|
|
|
50,925 |
|
Short-term notes
payable |
|
|
1,023,815 |
|
|
|
— |
|
Current maturities of
long-term capital lease obligation |
|
|
184,399 |
|
|
|
251,800 |
|
Total current
liabilities |
|
|
5,271,937 |
|
|
|
4,590,073 |
|
Deferred rent |
|
|
398,084 |
|
|
|
352,985 |
|
Note payable |
|
|
— |
|
|
|
993,750 |
|
Long-term capital lease
obligation and other noncurrent liabilities |
|
|
146,543 |
|
|
|
328,642 |
|
Total
liabilities |
|
|
5,816,564 |
|
|
|
6,265,450 |
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity |
|
|
|
|
|
|
|
|
Common stock, $0.01 par
value; 200,000,000 shares authorized; 25,304,270 and
12,547,684 shares issued and outstanding at December 31, 2016
and December 31, 2015, respectively |
|
|
253,042 |
|
|
|
125,477 |
|
Preferred stock, $0.01
par value; 10,000,000 shares authorized; none issued andoutstanding
at December 31, 2016 and December 31, 2015, respectively |
|
|
— |
|
|
|
— |
|
Additional paid-in
capital |
|
|
136,199,382 |
|
|
|
121,490,994 |
|
Accumulated other
comprehensive income/(loss) |
|
|
6,176 |
|
|
|
(1,059 |
) |
Accumulated
deficit |
|
|
(133,291,119 |
) |
|
|
(114,124,366 |
) |
Total
stockholders’ equity |
|
|
3,167,481 |
|
|
|
7,491,046 |
|
Total
liabilities and stockholders’ equity |
|
$ |
8,984,045 |
|
|
$ |
13,756,496 |
|
|
|
|
|
|
|
|
|
|
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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