OpGen Reports 2016 Third Quarter Financial Results and Provides Business Update
October 24 2016 - 4:01PM
OpGen, Inc. (NASDAQ:OPGN) today reported financial and operational
results for the three and nine months ended September 30, 2016.
Highlights of the third quarter and recent weeks include:
- Third-quarter revenues of $0.8 million, a 23% decrease over
prior year
- Nine-month revenues of $3.0 million, a 65% increase over prior
year
- Automated QuickFISH® Pathogen ID clinical trial anticipated to
begin Q1 2017
- Acuitas Lighthouse® rapid antibiotic resistance test and
knowledgebase development underway
- Initial Intermountain Healthcare Retrospective Study results
presented
Total revenue for the third quarter of 2016 was
$0.8 million, compared with $1.0 million for the third quarter of
2015, a 23% decrease. Product sales and laboratory services
decreased to $0.8 million, compared with $1.0 million for the third
quarter of 2015. The decrease was attributable to decreased rapid
pathogen ID and legacy genome mapping product sales. Gross margin
on product sales was 45% for the third quarter of 2016. Total
operating expenses for the third quarter of 2016 were $5.6 million,
compared with $5.6 million for the third quarter of 2015. The net
loss attributable to common stockholders for the third quarter of
2016 was $4.8 million, or $0.23 per share, compared with a net loss
attributable to common stockholders for the third quarter of 2015
of $4.7 million, or $0.38 per share. The company had cash and cash
equivalents of $4.3 million as of September 30, 2016, compared with
$7.8 million as of December 31, 2015.
Total revenue for the nine months ended September
30, 2016 was $3.0 million, compared with $1.8 million for the same
period of 2015, a 65% increase. Revenue from product sales and
laboratory services increased 90% to $2.9 million from $1.5 million
in 2015 primarily as a result of sales of rapid pathogen ID testing
products. Gross margin on product sales was 53% for the nine months
ended September 30, 2016. Total operating expenses for the nine
months ended September 30, 2016 were $17.3 million, compared with
$12.1 million for the nine months ended September 30, 2015. Net
loss attributable to common stockholders was $14.7 million for the
nine months ended September 30, 2016, or $0.92 per share, compared
with a net loss attributable to common stockholders of $12.9
million for the nine months ended September 30, 2015 or $2.00 per
share.
“During the quarter we continued to make progress
developing our genomics and informatics business. Nine-month
revenue increased 65% to $3.0 million and we continued to progress
a number of key strategic initiatives. In the area of rapid
antibiotic decision-making, our automated rapid pathogen ID system
is on track to begin 510(k) clinical trials in Q1 2017 and
development of our mAST™ antibiotic resistance testing solution is
underway. We have begun testing thousands of pathogens to support
development of our Acuitas Lighthouse rapid antibiotic resistance
test and knowledge base following the successful verification of
our expanded Resistome test and the initial performance
confirmation of our mAST genotype/phenotype predictive algorithms.
These products and services are being developed to address the
large and growing global antibiotic resistance testing
opportunity,” said Evan Jones, chairman and chief executive officer
of OpGen.
“We continue to work closely with large healthcare
providers and hospital networks to demonstrate the benefits of our
integrated informatics and genomic products and services. At IDWeek
2016 we anticipate the presentation of additional data from these
collaborative efforts as we work to transform acute care infectious
disease monitoring with our Acuitas Lighthouse offerings.”
Mr. Jones concluded, “During the third quarter our
revenues, were negatively impacted by several items. These included
the timing of sales, the phase-out of our legacy whole genome
mapping products, and supply chain issues for our rapid pathogen ID
products. We have addressed the supply chain issues and, looking
forward, we anticipate a stable recurring revenue base from our
rapid pathogen ID testing products and growing contribution to
revenue from our new product sales and service offerings.”
Conference Call and Webcast
OpGen management will hold a conference call today
beginning at 4:30 p.m. (EDT) to discuss third quarter 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 4676290. 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 from 7:30
p.m. E.T. through October 29, 2016 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 4676290.
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 Acuitas® MDRO, Acuitas Lighthouse® and QuickFISH®
products and services, and commercialization plans for these
products and services. 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, 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. and
SubsidiariesCondensed Consolidated Statements of
Operations and Comprehensive
Loss(unaudited)
|
|
Three Months
EndedSeptember 30, |
|
|
Nine Months
EndedSeptember 30, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
730,325 |
|
|
$ |
929,241 |
|
|
$ |
2,705,690 |
|
|
$ |
1,432,592 |
|
Laboratory services |
|
|
23,036 |
|
|
|
23,765 |
|
|
|
182,130 |
|
|
|
87,201 |
|
Collaboration revenue |
|
|
6,302 |
|
|
|
27,780 |
|
|
|
131,302 |
|
|
|
308,340 |
|
Total
revenue |
|
|
759,663 |
|
|
|
980,786 |
|
|
|
3,019,122 |
|
|
|
1,828,133 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
400,001 |
|
|
|
624,635 |
|
|
|
1,269,990 |
|
|
|
788,256 |
|
Cost of services |
|
|
51,802 |
|
|
|
48,467 |
|
|
|
528,733 |
|
|
|
198,691 |
|
Research and
development |
|
|
2,178,818 |
|
|
|
1,788,748 |
|
|
|
6,278,829 |
|
|
|
3,897,049 |
|
General and
administrative |
|
|
1,639,996 |
|
|
|
1,614,532 |
|
|
|
4,955,096 |
|
|
|
3,694,143 |
|
Sales and marketing |
|
|
1,294,640 |
|
|
|
1,032,759 |
|
|
|
4,282,628 |
|
|
|
2,962,555 |
|
Transaction expenses |
|
|
— |
|
|
|
525,596 |
|
|
|
— |
|
|
|
525,596 |
|
Total operating
expenses |
|
|
5,565,257 |
|
|
|
5,634,737 |
|
|
|
17,315,276 |
|
|
|
12,066,290 |
|
Operating
loss |
|
|
(4,805,594 |
) |
|
|
(4,653,951 |
) |
|
|
(14,296,154 |
) |
|
|
(10,238,157 |
) |
Other
expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other
income/(expense) |
|
|
623 |
|
|
|
2,513 |
|
|
|
(3,078 |
) |
|
|
9,675 |
|
Interest expense |
|
|
(41,423 |
) |
|
|
(17,482 |
) |
|
|
(109,806 |
) |
|
|
(1,746,853 |
) |
Foreign currency
transaction (losses)/gains |
|
|
(1,269 |
) |
|
|
— |
|
|
|
2,293 |
|
|
|
— |
|
Change in fair value of
derivative financial instruments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(647,342 |
) |
Total other
expense |
|
|
(42,069 |
) |
|
|
(14,969 |
) |
|
|
(110,591 |
) |
|
|
(2,384,520 |
) |
Loss before income
taxes |
|
|
(4,847,663 |
) |
|
|
(4,668,920 |
) |
|
|
(14,406,745 |
) |
|
|
(12,622,677 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for
income taxes |
|
|
— |
|
|
|
1,662 |
|
|
|
— |
|
|
|
1,662 |
|
Net
loss |
|
|
(4,847,663 |
) |
|
|
(4,670,582 |
) |
|
|
(14,406,745 |
) |
|
|
(12,624,339 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock dividends
and beneficial conversion |
|
|
— |
|
|
|
— |
|
|
|
(332,550 |
) |
|
|
(244,508 |
) |
Net loss available
to common stockholders |
|
$ |
(4,847,663 |
) |
|
$ |
(4,670,582 |
) |
|
$ |
(14,739,295 |
) |
|
$ |
(12,868,847 |
) |
Net loss per common share
- basic and diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.92 |
) |
|
$ |
(2.00 |
) |
Weighted average shares
outstanding - basic and diluted |
|
|
20,938,700 |
|
|
|
12,261,238 |
|
|
|
16,028,047 |
|
|
|
6,444,373 |
|
Net loss |
|
$ |
(4,847,663 |
) |
|
$ |
(4,670,582 |
) |
|
$ |
(14,406,745 |
) |
|
$ |
(12,624,339 |
) |
Other comprehensive
income/(loss) - foreign currency translation |
|
|
1,498 |
|
|
|
(49 |
) |
|
|
387 |
|
|
|
(49 |
) |
Comprehensive
loss |
|
$ |
(4,846,165 |
) |
|
$ |
(4,670,631 |
) |
|
$ |
(14,406,358 |
) |
|
$ |
(12,624,388 |
) |
OpGen, Inc. and
SubsidiariesCondensed Consolidated Balance
Sheets(unaudited)
|
|
September 30, 2016 |
|
|
December 31, 2015 |
|
Assets |
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
4,260,905 |
|
|
$ |
7,814,220 |
|
Accounts receivable,
net |
|
|
446,686 |
|
|
|
678,646 |
|
Inventory, net |
|
|
830,205 |
|
|
|
826,012 |
|
Prepaid expenses and other
current assets |
|
|
478,683 |
|
|
|
566,239 |
|
Total current
assets |
|
|
6,016,479 |
|
|
|
9,885,117 |
|
Property and equipment,
net |
|
|
862,643 |
|
|
|
1,074,710 |
|
Goodwill |
|
|
600,814 |
|
|
|
637,528 |
|
Intangible assets,
net |
|
|
1,687,952 |
|
|
|
1,888,814 |
|
Deferred offering
costs |
|
|
137,178 |
|
|
|
— |
|
Other noncurrent
assets |
|
|
270,464 |
|
|
|
270,327 |
|
Total
assets |
|
$ |
9,575,530 |
|
|
$ |
13,756,496 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,936,012 |
|
|
$ |
2,285,792 |
|
Accrued compensation and
benefits |
|
|
1,230,502 |
|
|
|
1,081,270 |
|
Accrued liabilities |
|
|
1,155,317 |
|
|
|
920,286 |
|
Deferred revenue |
|
|
64,424 |
|
|
|
50,925 |
|
Short term notes
payable |
|
|
1,099,974 |
|
|
|
— |
|
Current maturities of
long-term capital lease obligation |
|
|
207,820 |
|
|
|
251,800 |
|
Total current
liabilities |
|
|
5,694,049 |
|
|
|
4,590,073 |
|
Deferred rent |
|
|
421,913 |
|
|
|
352,985 |
|
Note payable |
|
|
— |
|
|
|
993,750 |
|
Long-term capital lease
obligation and other noncurrent liabilities |
|
|
184,391 |
|
|
|
328,642 |
|
Total
liabilities |
|
|
6,300,353 |
|
|
|
6,265,450 |
|
Stockholders'
equity |
|
|
|
|
|
|
|
|
Common stock, $.01 par
value; 200,000,000 shares authorized; 21,690,555 and 12,547,684
shares issued and outstanding at September 30, 2016 and
December 31, 2015, respectively |
|
|
216,905 |
|
|
|
125,477 |
|
Preferred stock, $0.01 par
value; 10,000,000 shares authorized; none issued and outstanding at
September 30, 2016 and December 31, 2015,
respectively |
|
|
— |
|
|
|
— |
|
Additional paid-in
capital |
|
|
131,590,858 |
|
|
|
121,490,994 |
|
Accumulated other
comprehensive gain/(loss) |
|
|
— |
|
|
|
(1,059 |
) |
Accumulated deficit |
|
|
(128,532,586 |
) |
|
|
(114,124,366 |
) |
Total
stockholders’ equity |
|
|
3,275,177 |
|
|
|
7,491,046 |
|
Total liabilities
and stockholders’ equity |
|
$ |
9,575,530 |
|
|
$ |
13,756,496 |
|
OpGen Contact:
Michael Farmer
Director, Marketing
(240) 813-1284
mfarmer@opgen.com
InvestorRelations@opgen.com
Investor and Media Contact:
MacDougall Biomedical Communications
Cammy Duong
(781) 235-3060
cduong@macbiocom.com
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