OpGen Reports 2016 Second Quarter Financial Results and Provides Business Update
August 09 2016 - 4:02PM
OpGen, Inc. (NASDAQ:OPGN) today reported financial and operational
results for the three and six months ended June 30, 2016.
Highlights of the second quarter and recent weeks include:
- Achieved second quarter revenue of $1.2 million, 215% year over
year growth
- Completed Intermountain Healthcare Retrospective MDRO Health
Outcome Study
- Closed $10.4 million private placement
Total revenue for the second quarter of 2016 was $1.2 million,
compared with $0.4 million for the second quarter of 2015, a
215% increase. Product sales and laboratory services increased to
$1.1 million, compared with $0.3 million for the second quarter of
2015. The increase was primarily attributable to sales of rapid
pathogen ID molecular diagnostic products following the company’s
acquisition of AdvanDx in July 2015, as well as Acuitas® MDRO
products and services revenue. Gross margin on product sales was
67% for the second quarter of 2016. Total operating expenses for
the second quarter of 2016 were $6.2 million, compared
with $3.4 million for the second quarter of 2015. The net
loss attributable to common stockholders for the second quarter of
2016 was $5.4 million, or $0.37 per share, compared with a net loss
attributable to common stockholders for the second quarter of 2015
of $5.4 million, or $0.84 per share. The company had cash and cash
equivalents of $8.0 million as of June 30, 2016, compared with $7.8
million as of December 31, 2015.
Total revenue for the six months ended June 30, 2016 was $2.3
million, compared with $0.8 million for the same period of 2015, a
167% increase. Revenue from product sales and laboratory services
increased 277% to $2.1 million from $0.6 million in 2015 primarily
as a result of sales of QuickFISH® rapid molecular diagnostic
testing products following the company’s acquisition of AdvanDx in
July 2015. Total operating expenses for the six months ended June
30, 2016 were $11.8 million, compared with $6.4 million for the six
months ended June 30, 2015. Net loss attributable to common
stockholders was $9.9 million for the six months ended June 30,
2016, or $0.73 per share, compared with a net loss attributable to
common stockholders of $8.2 million for the six months ended June
30, 2015 or $2.35 per share.
“We are pleased with our continued revenue growth for the second
quarter with sales of our rapid pathogen ID diagnostic products as
the primary contributor,” said Evan Jones, chairman and chief
executive officer of OpGen. “These results reflect the shift of our
business towards rapid molecular testing to help guide antibiotic
decision making. During the quarter we continued our work to build
our new genomic analysis and informatics solutions for hospital and
network-wide infection prevention and treatment. Achieving a key
milestone in the development of our molecularAST technology we
completed internal development of our new Resistome test for high
resolution analysis of antibiotic resistance markers in clinical
isolates. The next phase in this work is to complete the testing of
thousands of pathogens to support the build-out of our Acuitas
Lighthouse™ data warehouse and associated databases.
At the ECCMID meeting in April we previewed our digital imager
for automation of our QuickFISH products and at ASM Microbe we
began the commercial launch of Acuitas Lighthouse MDRO management
platform, including Lighthouse informatics. This platform,
including our Acuitas MDRO gene tests, played a key role in a pilot
study at 16 hospitals in the District of Columbia that was
completed during the second quarter, where results supported
continued surveillance for Superbug pathogens including
carbapenem-resistant enterobacteriaceae,” Mr. Jones added.
Key developments from the second quarter of 2016 and recent
weeks included:
- Completed $10.4 million private financing with Merck Global
Health Innovation Fund (Merck GHI) and Sabby Management, LLC as
lead investors
- Completed multi-drug resistant organisms (MDRO) health outcomes
study with Intermountain Healthcare
- Completed testing and reported results on more than 1,000
patient samples from 16 hospitals in the District of Columbia in
conjunction with the DCHA (District of Columbia Hospital
Association) program to track the threat of potentially lethal
multidrug-resistant infections in Washington, D.C.
- Presented data that support use of the Acuitas Resistome Test
in epidemiological studies to aid in routine evaluations for
mechanisms of resistance among carbapenem-resistant
enterobacteriaceae (CRE) at ASM Microbe 2016
- Began commercial launch of the Acuitas Lighthouse portal at ASM
Microbe 2016
- Researchers presented two papers at ECCMID describing rapid
test results with QuickFISH and its utility in antibiotic
stewardship
- Published analytical validation results for the Acuitas MDRO
Gene Test in Clinical Chemistry and obtained Florida State Clinical
Laboratory license
- Appointed Harry J. D’Andrea to the company’s board of directors
and as chair of the Audit Committee
Conference Call and Webcast
OpGen management will hold a conference call today beginning at
4:30 p.m. Eastern time to discuss second quarter financial results
and other business activities. The call can be accessed by
dialing (888) 883-4599 (domestic) or (484) 653-6821 (international)
and providing passcode 54852842.
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.
A telephone replay also will be available from 7:30 p.m. E.T.
through August 15, 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 54852842.
About MDROs
Multidrug-resistant organisms (MDROs) are common bacteria that
have developed resistance to multiple classes of antibiotics. They
are a leading cause of hospital-acquired infections and are
associated with an increase in morbidity and mortality. Each year
more than 2 million Americans acquire infections that are resistant
to antibiotics and about 23,000 people die from them. The annual
cost of treating these infections is estimated to be between $20
billion to $35 billion. Asymptomatic carriers are at a higher risk
of an MDRO infection and become reservoirs for transmission to
other patients in healthcare systems if not accurately identified
early. Since there are many types of antibiotic-resistant
organisms, and the way they cause disease is dictated by their
genetics, knowing the exact genetic profile of these organisms is a
key step to preventing their ability to infect.
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.
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.
Contacts:
OpGenMichael FarmerDirector, Marketing(240)
813-1284mfarmer@opgen.comInvestorRelations@opgen.com
Investor RelationsLHAKim Sutton Golodetz(212)
838-3777kgolodetz@lhai.comBruce Voss(310)
691-7100bvoss@lhai.com
OpGen MediaMacDougall Biomedical
CommunicationsCammy Duong(781) 235-3060cduong@macbiocom.com
(Tables follow)
OpGen, Inc. and Subsidiaries |
Condensed Consolidated Statements of
Operations and Comprehensive Loss |
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
|
Product sales |
$ |
1,028,146 |
|
|
$ |
319,171 |
|
|
$ |
1,975,365 |
|
|
$ |
503,350 |
|
Laboratory services |
|
29,674 |
|
|
|
28,195 |
|
|
|
159,094 |
|
|
|
63,436 |
|
Collaboration revenue |
|
125,000 |
|
|
|
27,780 |
|
|
|
125,000 |
|
|
|
280,560 |
|
Total revenue |
|
1,182,820 |
|
|
|
375,146 |
|
|
|
2,259,459 |
|
|
|
847,346 |
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
Cost
of products sold |
|
337,020 |
|
|
|
48,231 |
|
|
|
682,987 |
|
|
|
163,620 |
|
Cost
of services |
|
161,222 |
|
|
|
54,794 |
|
|
|
476,931 |
|
|
|
150,224 |
|
Research and development |
|
2,333,584 |
|
|
|
999,699 |
|
|
|
4,287,013 |
|
|
|
2,108,301 |
|
General and administrative |
|
1,777,054 |
|
|
|
1,420,219 |
|
|
|
3,315,100 |
|
|
|
2,079,611 |
|
Sales
and marketing |
|
1,588,553 |
|
|
|
905,767 |
|
|
|
2,987,988 |
|
|
|
1,929,796 |
|
Total operating expenses |
|
6,197,433 |
|
|
|
3,428,710 |
|
|
|
11,750,019 |
|
|
|
6,431,552 |
|
Operating loss |
|
(5,014,613 |
) |
|
|
(3,053,564 |
) |
|
|
(9,490,560 |
) |
|
|
(5,584,206 |
) |
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
Interest expense |
|
(26,649 |
) |
|
|
(1,632,974 |
) |
|
|
(68,383 |
) |
|
|
(1,729,371 |
) |
Foreign currency transaction gains (losses) |
|
(7,766 |
) |
|
|
- |
|
|
|
3,562 |
|
|
|
- |
|
Change
in fair value of derivative financial instruments |
|
- |
|
|
|
(679,173 |
) |
|
|
- |
|
|
|
(647,342 |
) |
Interest income and other expense |
|
(3,874 |
) |
|
|
7,127 |
|
|
|
(3,699 |
) |
|
|
7,162 |
|
Total other income (expense) |
|
(38,289 |
) |
|
|
(2,305,020 |
) |
|
|
(68,520 |
) |
|
|
(2,369,551 |
) |
Net loss |
|
(5,052,902 |
) |
|
|
(5,358,584 |
) |
|
|
(9,559,080 |
) |
|
|
(7,953,757 |
) |
|
|
|
|
|
|
|
|
Preferred stock dividends and beneficial conversion |
|
(332,550 |
) |
|
|
(72,767 |
) |
|
|
(332,550 |
) |
|
|
(244,508 |
) |
Net loss attributable to common stockholders |
$ |
(5,385,452 |
) |
|
$ |
(5,431,351 |
) |
|
$ |
(9,891,630 |
) |
|
$ |
(8,198,265 |
) |
|
|
|
|
|
|
|
|
Net
loss per common share - basic and diluted |
$ |
(0.37 |
) |
|
$ |
(0.84 |
) |
|
$ |
(0.73 |
) |
|
$ |
(2.35 |
) |
Weighted average shares outstanding - basic and diluted |
|
14,522,097 |
|
|
|
6,449,108 |
|
|
|
13,545,519 |
|
|
|
3,487,734 |
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(5,052,902 |
) |
|
$ |
(5,358,584 |
) |
|
$ |
(9,559,080 |
) |
|
$ |
(7,953,757 |
) |
Other comprehensive
income - foreign currency translation |
|
1,498 |
|
|
|
- |
|
|
|
387 |
|
|
|
- |
|
Comprehensive
loss |
$ |
(5,051,404 |
) |
|
$ |
(5,358,584 |
) |
|
$ |
(9,558,693 |
) |
|
$ |
(7,953,757 |
) |
|
|
|
|
|
|
|
|
OpGen, Inc. and Subsidiaries |
|
Condensed Consolidated Balance Sheets |
|
(unaudited) |
|
|
|
|
|
|
|
|
June 30, 2016 |
|
December
31, 2015 |
|
|
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and
cash equivalents |
$ |
8,025,023 |
|
|
$ |
7,814,220 |
|
|
|
Accounts
receivable, net |
|
871,564 |
|
|
|
678,646 |
|
|
|
Inventory,
net |
|
844,272 |
|
|
|
826,012 |
|
|
|
Prepaid
expenses and other current assets |
|
561,693 |
|
|
|
566,239 |
|
|
|
Total current assets |
|
10,302,552 |
|
|
|
9,885,117 |
|
|
|
Property
and equipment, net |
|
922,157 |
|
|
|
1,074,710 |
|
|
|
Goodwill |
|
600,814 |
|
|
|
637,528 |
|
|
|
Intangible
assets, net |
|
1,754,906 |
|
|
|
1,888,814 |
|
|
|
Other
noncurrent assets |
|
270,412 |
|
|
|
270,327 |
|
|
|
Total assets |
$ |
13,850,841 |
|
|
$ |
13,756,496 |
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
$ |
1,900,844 |
|
|
$ |
2,285,792 |
|
|
|
Accrued compensation and benefits |
|
942,636 |
|
|
|
1,081,270 |
|
|
|
Accrued liabilities |
|
797,056 |
|
|
|
920,286 |
|
|
|
Deferred revenue |
|
105,767 |
|
|
|
50,925 |
|
|
|
Short
term notes payable |
|
179,567 |
|
|
|
- |
|
|
|
Current maturities of long-term capital lease obligation |
|
232,824 |
|
|
|
251,800 |
|
|
|
Total current liabilities |
|
4,158,694 |
|
|
|
4,590,073 |
|
|
|
|
|
|
|
|
|
Deferred rent |
|
527,528 |
|
|
|
352,985 |
|
|
|
Note
payable |
|
995,833 |
|
|
|
993,750 |
|
|
|
Long-term capital lease obligation and other noncurrent
liabilities |
|
224,278 |
|
|
|
328,642 |
|
|
|
Total liabilities |
|
5,906,333 |
|
|
|
6,265,450 |
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
Common stock, $.01 par value; 200,000,000 shares authorized;
19,353,126 and 12,547,684 shares issued and outstanding at June 30,
2016 and December 31, 2015, respectively |
|
193,531 |
|
|
|
125,477 |
|
|
|
Preferred stock, $0.01 par value; 10,000,000 shares authorized;
2,309,428 issued and outstanding at June 30, 2016 (none at December
31, 2015) |
|
23,094 |
|
|
|
- |
|
|
|
Additional paid-in capital |
|
131,412,003 |
|
|
|
121,490,994 |
|
|
|
Accumulated other comprehensive loss |
|
(672 |
) |
|
|
(1,059 |
) |
|
|
Accumulated deficit |
|
(123,683,448 |
) |
|
|
(114,124,366 |
) |
|
|
Total stockholders’ equity |
|
7,944,508 |
|
|
|
7,491,046 |
|
|
|
Total liabilities and stockholders’ equity |
$ |
13,850,841 |
|
|
$ |
13,756,496 |
|
|
|
|
|
|
|
|
|
OpGen (NASDAQ:OPGN)
Historical Stock Chart
From Jun 2024 to Jul 2024
OpGen (NASDAQ:OPGN)
Historical Stock Chart
From Jul 2023 to Jul 2024