OpGen Reports Fourth Quarter and Full Year 2017 Financial Results and Provides a Business Update
March 15 2018 - 4:05PM
Acuitas® AMR Gene Panel u5.47
introduced for Research Use Only
OpGen, Inc. (NASDAQ:OPGN) today reported financial and operating
results for the three and 12 months ended December 31, 2017, and
provided a summary of recent business highlights. Total revenue for
the fourth quarter of 2017 was $1.0 million, compared with
$1.0 million for the fourth quarter of 2016. Total revenue for 2017
was $3.2 million, compared with $4.0 million for 2016. The net loss
for the fourth quarter of 2017 was $2.9 million, compared with
a net loss of $4.8 million for the fourth quarter of 2016. Net loss
for 2017 was $15.4 million, compared with a net loss of $19.2
million for 2016.
“During 2017 we completed the initial
development of our Acuitas® AMR Gene Panel and the Acuitas
Lighthouse® Software for management of patients with complicated
urinary tract infections (cUTI). The new Acuitas AMR Gene Panel
u5.47 test for Research Use Only (RUO) was released for commercial
sale in the first quarter of 2018 for infection control purposes
and for pharmaceutical surveillance studies,” said Evan Jones,
Chairman and CEO of OpGen. “The test detects 5 pathogens and 47
gene targets that span 600 subtypes and convey resistance to nine
classes of antibiotics directly from urine. Clinical verification
studies are underway, and we anticipate beginning clinical trials
in the second quarter in support of a 510(k) filing for clinical
use of the test with the U.S. Food and Drug Administration by the
end of the year.”
Mr. Jones continued, “Earlier this week, we announced a
collaboration with Beth Israel Deaconess Medical Center in Boston
on a clinical verification study for the Acuitas AMR Gene Panel
u5.47 test and Acuitas Lighthouse Software. This prospective
verification study is among the first to evaluate potential
diagnostic and antibiotic decision-making improvements that could
be possible using rapid molecular testing and bioinformatics.
“During the fourth quarter we were awarded a
one-year, $860,000 contract from the Centers for Disease Control
and Prevention (CDC) to develop smartphone-based clinical decision
support solutions for antimicrobial stewardship (AMS) and infection
control in low- and middle-income countries. Our work with
partners ILÚM Health Solutions, LLC, created by Merck’s Healthcare
Services and Solutions (HSS) division, and Universidad El Bosque,
in Colombia is ongoing.”
2017 Fourth Quarter and Year-end
Financial Results
- Revenue: Total revenue for the fourth quarter
of 2017 was $1.0 million, compared with $1.0 million for the
fourth quarter of 2016. Total revenue for 2017 was $3.2 million,
compared with $4.0 million for 2016.
- Operating Expenses: Operating expenses for the
fourth quarter of 2017 were $3.9 million, compared with $5.7
million for the fourth quarter of 2016. Operating expenses for 2017
were $18.5 million, compared with $23.0 million for 2016.
- Net Loss: The net loss available to common
stockholders for the fourth quarter of 2017 was $2.9 million
or $1.33 per share, compared with a net loss available to common
stockholders of $4.8 million or $5.28 per share for the fourth
quarter of 2016. Net loss available to common stockholders for 2017
was $15.4 million or $9.78 per share, compared with a net loss
available to common stockholders of $19.5 million or $27.59 per
share for 2016.
- Cash Position: Cash and cash equivalents
were $1.8 million as of December 31, 2017, compared with $4.1
million as of December 31, 2016. Subsequent to the close of the
year, the Company raised net proceeds of $10.7 million in a public
offering.
2017 Enterprise Highlights and Recent
Developments:
Highlights for recent weeks, the fourth quarter
and full year included:
- Acuitas AMR Gene Panel development program accomplishments
include: production of first RUO test kits; successful completion
of analytical verification studies; and initiation of clinical
verification studies with flagship IDN hospitals.
- Curated Acuitas Lighthouse Knowledgebase of 10,000 bacterial
isolates tested from the Merck SMART Study surveillance
network.
- In January 2018, the Company entered into a second global
supply agreement to incorporate Thermo Fisher Scientific’s
real-time PCR technology in the company’s Acuitas® AMR Gene Panel
tests. Specific products covered under these agreements
include the QuantStudio 5 Real-Time PCR System, TaqMan® Fast
Advanced Master Mix and TaqMan® Probes for quick, multiplexed gene
detection.
- Developed and presented data on rapid antibiotic prediction
capabilities.
- Completed a $12.0 million public offering with net proceeds to
OpGen of $10.7 million.
- Regained compliance with Nasdaq listing requirements for both
minimum stockholders’ equity and minimum bid price.
- Continued to achieve stated operating expense reduction during
the quarter, with a 32% reduction compared with the fourth quarter
of 2016.
“Our Acuitas Rapid Test for cUTI is expected to
be the first of a series of OpGen tests that will help address the
global antibiotic-resistance crisis by identifying
antibiotic-resistant pathogens in less than three hours.
Along with the Acuitas Lighthouse Knowledgebase, a dynamic
cloud-based information store that is continuously updated for new
resistance genes, results will help inform patient treatment,”
added Mr. Jones. “Importantly, with our recent public financing,
OpGen is on the firmest financial footing since our initial public
offering.”
2018 Outlook
OpGen expects to advance the following
business objectives during 2018 as it transitions to the commercial
phase of its molecular informatics business:
- Derive revenues from the sale of the RUO Acuitas AMR Gene Panel
u5.47 to large hospitals and pharmaceutical clinical research
organizations.
- Complete third-party RUO clinical verification studies and FDA
clinical trials to support clearance for in vitro diagnostic use of
the Acuitas AMR Gene Panel u5.47 test and the Acuitas Lighthouse
Software.
- File a 510(k) application with the FDA in the fourth quarter of
2018 for the Acuitas AMR Gene Panel u5.47 and Acuitas Lighthouse
Software to support full commercial launch for clinical use.
- Add QuantStudio™ 5 System and Qiagen EZ1 Advanced XL
revenue-generating system placements.
- Enter into additional supply and cooperation agreements in
support of the new Acuitas product family under development.
- Complete CDC Contract demonstration project in Colombia for
development of smartphone-based clinical decision support solutions
for AMS and infection control in low- and middle-income
countries.
- Continue to seek third-party funding for development
programs.
- Maintain cost reductions and overall cash burn rate to help
provide extended operating cash runway.
Conference Call Information
OpGen management will hold a conference
call today beginning at 4:30 p.m. Eastern time to discuss
fourth quarter and full year 2017 financial results and other
business activities, and answer questions. The call can be
accessed by dialing (888) 883-4599 (domestic) or (484) 653-6821
(international) and providing conference ID 8899787. 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 of the conference call will
be available from 7:30 p.m. Eastern time today through March 22,
2018 and can be accessed by dialing (855) 859-2056 (domestic)
or (404) 537-3406 (international). All listeners should provide the
conference ID: 8899787.
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. For more information, please visit
www.opgen.com.
OpGen, Acuitas, and Acuitas Lighthouse are
registered trademarks of OpGen, Inc. QuantStudio 5 Real-Time
PCR System is a registered trademark of Thermo Fisher
Scientific.
Forward-Looking Statements
This press release includes statements relating
to the Company’s 2017 financial results and 2018 outlook. 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 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
FarmerDirector, Marketing(240)
813-1284mfarmer@opgen.comInvestorRelations@opgen.com
Investor Contacts:LHA Investor
RelationsKim Sutton Golodetz(212) 838-3777kgolodetz@lhai.comorBruce
Voss(310) 691-7100bvoss@lhai.com
(Tables to follow)
OpGen, Inc. |
Consolidated Balance Sheets |
|
|
|
|
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
Assets |
|
|
|
|
|
Current
assets |
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
1,847,171 |
|
|
$ |
4,117,324 |
|
|
Accounts receivable,
net |
|
|
809,540 |
|
|
|
542,420 |
|
|
Inventory, net |
|
|
533,425 |
|
|
|
692,368 |
|
|
Prepaid expenses and
other current assets |
|
|
311,644 |
|
|
|
329,646 |
|
|
Total current
assets |
|
|
3,501,780 |
|
|
|
5,681,758 |
|
|
Property and equipment,
net |
|
|
835,537 |
|
|
|
800,723 |
|
|
Goodwill |
|
|
600,814 |
|
|
|
600,814 |
|
|
Intangible assets,
net |
|
|
1,353,182 |
|
|
|
1,620,998 |
|
|
Other noncurrent
assets |
|
|
328,600 |
|
|
|
279,752 |
|
|
Total
assets |
|
$ |
6,619,913 |
|
|
$ |
8,984,045 |
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Accounts payable |
|
$ |
1,691,712 |
|
|
$ |
2,232,563 |
|
|
Accrued compensation
and benefits |
|
|
746,924 |
|
|
|
578,480 |
|
|
Accrued
liabilities |
|
|
1,160,714 |
|
|
|
1,215,283 |
|
|
Deferred revenue |
|
|
24,442 |
|
|
|
37,397 |
|
|
Short-term notes
payable |
|
|
1,010,961 |
|
|
|
1,023,815 |
|
|
Current maturities of
long-term capital lease obligation |
|
|
154,839 |
|
|
|
184,399 |
|
|
Total current
liabilities |
|
|
4,789,592 |
|
|
|
5,271,937 |
|
|
Deferred rent |
|
|
290,719 |
|
|
|
398,084 |
|
|
Warrant liability |
|
|
8,453 |
|
|
|
— |
|
|
Long-term capital lease
obligation and other noncurrent liabilities |
|
|
130,153 |
|
|
|
146,543 |
|
|
Total
liabilities |
|
|
5,218,917 |
|
|
|
5,816,564 |
|
|
Commitments |
|
|
|
|
|
Stockholders'
equity |
|
|
|
|
|
Common stock, $0.01 par
value; 200,000,000 shares authorized; 2,265,320 and
1,012,171 shares issued and outstanding at December 31, 2017
and December 31, 2016, respectively |
|
|
22,653 |
|
|
|
10,122 |
|
|
Preferred stock, $0.01
par value; 10,000,000 shares authorized; none issued and
outstanding at December 31, 2017 and December 31, 2016,
respectively |
|
|
— |
|
|
|
— |
|
|
Additional paid-in
capital |
|
|
150,114,669 |
|
|
|
136,442,302 |
|
|
Accumulated other
comprehensive (loss)/income |
|
|
(52,367 |
) |
|
|
6,176 |
|
|
Accumulated
deficit |
|
|
(148,683,959 |
) |
|
|
(133,291,119 |
) |
|
Total
stockholders’ equity |
|
|
1,400,996 |
|
|
|
3,167,481 |
|
|
Total
liabilities and stockholders’ equity |
|
$ |
6,619,913 |
|
|
$ |
8,984,045 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OpGen, Inc. |
Consolidated Statements of Operations and
Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31, |
|
Twelve Months Ended
December 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
Revenue |
|
|
|
|
|
|
|
|
Product sales |
|
$ |
626,498 |
|
|
$ |
818,488 |
|
|
$ |
2,771,869 |
|
|
$ |
3,524,178 |
|
Laboratory
services |
|
|
935 |
|
|
|
46,774 |
|
|
|
41,960 |
|
|
|
228,904 |
|
Collaboration
revenue |
|
|
363,479 |
|
|
|
141,301 |
|
|
|
397,178 |
|
|
|
272,603 |
|
Total
revenue |
|
|
990,912 |
|
|
|
1,006,563 |
|
|
|
3,211,007 |
|
|
|
4,025,685 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
Cost of products
sold |
|
|
346,690 |
|
|
|
388,581 |
|
|
|
1,612,838 |
|
|
|
1,658,571 |
|
Cost of services |
|
|
292,223 |
|
|
|
102,600 |
|
|
|
520,338 |
|
|
|
631,333 |
|
Research and
development |
|
|
1,485,387 |
|
|
|
2,334,407 |
|
|
|
6,883,293 |
|
|
|
8,613,236 |
|
General and
administrative |
|
|
1,366,469 |
|
|
|
1,647,512 |
|
|
|
6,686,280 |
|
|
|
6,602,608 |
|
Sales and
marketing |
|
|
402,289 |
|
|
|
1,246,646 |
|
|
|
2,747,582 |
|
|
|
5,529,274 |
|
Total operating
expenses |
|
|
3,893,058 |
|
|
|
5,719,746 |
|
|
|
18,450,331 |
|
|
|
23,035,022 |
|
Operating
loss |
|
|
(2,902,146 |
) |
|
|
(4,713,183 |
) |
|
|
(15,239,324 |
) |
|
|
(19,009,337 |
) |
Other
expense |
|
|
|
|
|
|
|
|
Other
income/(expense) |
|
|
15 |
|
|
|
(2,889 |
) |
|
|
(87,255 |
) |
|
|
(5,967 |
) |
Interest expense |
|
|
(59,531 |
) |
|
|
(33,541 |
) |
|
|
(233,505 |
) |
|
|
(143,347 |
) |
Foreign currency
transaction gains/(losses) |
|
|
3,543 |
|
|
|
(10,395 |
) |
|
|
23,179 |
|
|
|
(8,102 |
) |
Changes in fair value
of warrant liabilities |
|
|
19,925 |
|
|
|
- |
|
|
|
144,064 |
|
|
|
- |
|
Total other
expense |
|
|
(36,048 |
) |
|
|
(46,825 |
) |
|
|
(153,517 |
) |
|
|
(157,416 |
) |
Loss before
income taxes |
|
|
(2,938,194 |
) |
|
|
(4,760,008 |
) |
|
|
(15,392,841 |
) |
|
|
(19,166,753 |
) |
|
|
|
|
|
|
|
|
|
Provision for
income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net
loss |
|
|
(2,938,194 |
) |
|
|
(4,760,008 |
) |
|
|
(15,392,841 |
) |
|
|
(19,166,753 |
) |
|
|
|
|
|
|
|
|
|
Preferred stock
dividends and beneficial conversion |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(332,550 |
) |
Net loss
available to common stockholders |
|
$ |
(2,938,194 |
) |
|
$ |
(4,760,008 |
) |
|
$ |
(15,392,841 |
) |
|
$ |
(19,499,303 |
) |
Net loss per common
share - basic and diluted |
|
$ |
(1.33 |
) |
|
$ |
(5.28 |
) |
|
$ |
(9.78 |
) |
|
$ |
(27.59 |
) |
Weighted average shares
outstanding - basic and diluted |
|
|
2,211,290 |
|
|
|
901,991 |
|
|
|
1,573,769 |
|
|
|
706,702 |
|
Net loss |
|
$ |
(2,938,194 |
) |
|
$ |
(4,760,008 |
) |
|
$ |
(15,392,841 |
) |
|
$ |
(19,166,753 |
) |
Other comprehensive
(loss)/income - foreign currency translation |
|
|
(44,718 |
) |
|
|
6,176 |
|
|
|
(58,543 |
) |
|
|
7,235 |
|
Comprehensive
loss |
|
$ |
(2,982,912 |
) |
|
$ |
(4,753,832 |
) |
|
$ |
(15,451,384 |
) |
|
$ |
(19,159,518 |
) |
|
|
|
|
|
|
|
|
|
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