OpGen Reports First Quarter 2019 Financial Results and Provides Business Update
May 14 2019 - 3:01PM
OpGen, Inc. (NASDAQ: OPGN) today reported financial and operating
results for the three months ended March 31, 2019 and provided a
business update. Total revenue for the first quarter of 2019 was
$1.0 million, compared with $0.85 million for the first quarter of
2018. Recent business highlights include:
- Submission, on May 13, 2019, of 510(k) application to the U.S.
Food and Drug Administration (“FDA”) for clearance of the Acuitas®
AMR Gene Panel test for the detection of antimicrobial resistance
genes in bacterial isolates;
- Advancement of the collaboration with the New York State
Department of Health (“DOH”) and ILÚM Health Solutions, LLC
(“ILÚM”), a wholly owned subsidiary of Merck’s Healthcare Services
and Solutions, LLC;
- Achievement of first program milestone of $500,000 for New York
State Infectious Disease Digital Health Initiative demonstration
project, following installation of Acuitas
systems at New York City metro area health
systems and the Wadsworth Laboratories;
- Publication of data supporting prediction of antibiotic
resistance using the company’s Acuitas® AMR Gene Panel and Acuitas
Lighthouse Software in the April issue of Antimicrobial
Agents and Chemotherapy, a peer-reviewed
scientific journal of the American Society for Microbiology;
- Presentation of OpGen rapid diagnostic ID products to key
opinion leaders during an event co-hosted with ILÚM at the VIII
International Symposium on Hospital Acquired Infections and
Antimicrobial Stewardship, held in Cali, Colombia;
- Completion of public offering of common stock with gross
proceeds of $5.4 million in March 2019.
“We have achieved several critical milestones to
start the year, led by the submission of our first FDA 510(k)
application for testing of antimicrobial resistance genes in
bacterial isolates. We expect the process with the FDA to be
completed in 2019 and have already started preparing for this key
product launch,” said Evan Jones, Chairman and CEO of OpGen.
“Simultaneously, we are working to complete two
additional 510(k) submissions for our lead rapid molecular
diagnostic test, the Acuitas AMR Gene Panel (Urine) and the Acuitas
Lighthouse Software. The clinical trials to support these
submissions are anticipated to begin by the end of the second
quarter. We plan to complete these trials in the third quarter of
2019 and will prepare the 510(k) submissions shortly
thereafter.”
“To support the anticipated launch of these
tests and informatics, we have established a robust network of
hospitals and strategic industry players. We are particularly
pleased with the advancement of the New York State Digital Health
Initiative and continue to work closely with ILÚM and the New York
State DOH to expand the impact of this important project. We are
confident that we are well-positioned to execute on a successful
commercial launch, as we aim to bring these products to more
hospitals around the world,” Evan Jones concluded.
First Quarter 2019 Financial Results
- Total revenue for the first quarter of 2019 was $1.0 million,
compared with $0.85 million for the first quarter of 2018;
- Operating expenses for the first quarter 2019 were $4.8
million, compared with $3.9 million for the first quarter of 2018.
The increase was primarily due to an increase in research and
development expense associated with the Acuitas AMR Gene Panel
clinical trials and $0.5 million of non-cash impairment expense
related to the Company’s Woburn, Massachusetts office right-of-use
asset;
- The net loss for the first quarter of 2019 was $3.9 million or
$0.41 per share, compared with a net loss of $3.0 million or $0.75
per share for the first quarter of 2018;
- Cash and cash equivalents were $6.0 million as of March 31,
2019.
Business and Operations Outlook
- Complete clinical evaluations and file De Novo 510(k)
applications with the FDA for the Acuitas AMR Gene Panel (Urine)
and the Acuitas Lighthouse Software for rapid testing of urine
specimens and prediction of antibiotic resistance to front-line
antibiotics;
- Continue to install Acuitas AMR Gene Panel systems in support
of Research Use Only sales and full launch following first FDA
clearance;
- Expand commercial activities to support FDA clearance and
launch of the Acuitas AMR Gene Panel products;
- Present clinical verification study results for the Acuitas AMR
Gene Panel (Urine) at the ASM Microbe conference in June 2019;
and
- Commercialize rapid testing products in South America, using
Colombia as a springboard.
Conference Call Information
OpGen management will hold a conference call today, May 14, 2019
at 4:30 p.m. ET to discuss first quarter 2019 financial results and
other business activities, and answer questions.
Dial-in Information
U.S. Dial-In Number: (844)-420-8185 International Dial-In
Number: (216)-562-0481 Conference ID: 6190299Webcast URL:
https://edge.media-server.com/m6/p/yxqz4fc4
Replay Dial-in Information
U.S. Dial-In Number: (855)-859-2056 International Dial-In
Number: (404)-537-3406 Conference ID: 6190299
A live webcast of the conference call can be
accessed by visiting the Investor Relations section of the
company’s website at www.ir.opgen.com. A replay of
the webcast will be available shortly after the conclusion of the
call for 90 days.
About OpGen
OpGen, Inc. is a precision medicine company
harnessing the power of molecular diagnostics and informatics to
help combat infectious disease. We are developing molecular
information products and services for global healthcare settings,
helping to guide clinicians with more rapid and actionable
information about life threatening infections, improve patient
outcomes, and decrease the spread of infections caused by
multidrug-resistant microorganisms, or MDROs.
Our molecular diagnostics and informatics
products, product candidates and services combine our Acuitas
molecular diagnostics and Acuitas Lighthouse informatics platform
for use with our proprietary, curated MDRO knowledgebase. We are
working to deliver our products and services, some in development,
to a global network of customers and partners. The Acuitas AMR Gene
Panel (RUO) is intended for Research Use Only and is not for use in
diagnostic procedures. The Acuitas Lighthouse Software is not
distributed commercially for antibiotic resistance prediction and
is not for use in diagnostic procedures. For more information,
please visit www.opgen.com.
OpGen, Acuitas, and Acuitas Lighthouse are registered trademarks
of OpGen, Inc.
Forward-Looking Statements
This press release includes statements relating
to OpGen’s outlook for 2019. 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 timely and cost- effectively seek and obtain
regulatory clearance for and commercialize our product and services
offerings, our ability to successfully complete the demonstration
project portion of the New York State Infectious Disease Digital
Health Initiative, 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, including
our Annual Report on Form 10-K for the year ended December 31,
2018, and subsequent filings. 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 Vice
President, Marketing (240) 813-1284 mfarmer@opgen.com
InvestorRelations@opgen.com
Press Contact: Matthew
Bretzius FischTank Marketing and PR
matt@fischtankpr.com
Investor Contacts:Joe Green Edison
Group jgreen@edisongroup.com
OpGen, Inc. |
Condensed Consolidated Balance Sheets
(unaudited) |
|
|
|
|
|
March 31, 2019 |
|
December 31, 2018 |
|
|
|
|
Assets |
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
$ |
6,011,508 |
|
|
$ |
4,572,487 |
|
Accounts receivable, net |
|
813,260 |
|
|
|
373,858 |
|
Inventory, net |
|
498,852 |
|
|
|
543,747 |
|
Prepaid expenses and other
current assets |
|
162,178 |
|
|
|
292,918 |
|
Total current
assets |
|
7,485,798 |
|
|
|
5,783,010 |
|
Property and equipment, net |
|
248,167 |
|
|
|
1,221,827 |
|
Finance lease right-of-use
assets, net |
|
961,418 |
|
|
|
— |
|
Operating lease right-of-use
assets |
|
1,546,155 |
|
|
|
— |
|
Goodwill |
|
600,814 |
|
|
|
600,814 |
|
Intangible assets, net |
|
1,018,412 |
|
|
|
1,085,366 |
|
Other noncurrent assets |
|
230,310 |
|
|
|
259,346 |
|
Total
assets |
$ |
12,091,074 |
|
|
$ |
8,950,363 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
Accounts payable |
$ |
1,528,814 |
|
|
$ |
1,623,751 |
|
Accrued compensation and
benefits |
|
1,223,083 |
|
|
|
1,041,573 |
|
Accrued liabilities |
|
950,156 |
|
|
|
902,019 |
|
Deferred revenue |
|
9,993 |
|
|
|
15,824 |
|
Short-term notes payable |
|
347,778 |
|
|
|
398,595 |
|
Short-term finance lease
liabilities |
|
492,300 |
|
|
|
399,345 |
|
Short-term operating lease
liabilities |
|
930,887 |
|
|
|
— |
|
Total current
liabilities |
|
5,483,011 |
|
|
|
4,381,107 |
|
Deferred rent |
|
— |
|
|
|
162,919 |
|
Note payable |
|
494,285 |
|
|
|
660,340 |
|
Warrant liability |
|
— |
|
|
|
67 |
|
Long-term finance lease
liabilities |
|
452,089 |
|
|
|
437,189 |
|
Long-term operating lease
liabilities |
|
1,322,696 |
|
|
|
— |
|
Total
liabilities |
|
7,752,081 |
|
|
|
5,641,622 |
|
Commitments |
|
|
|
|
|
|
|
Stockholders'
equity |
|
|
|
|
|
|
|
Common stock, $0.01 par value;
50,000,000 shares authorized; 17,645,720 and |
|
|
|
|
|
|
|
8,645,720 shares issued and
outstanding at March 31, 2019 and |
|
|
|
|
|
|
|
December 31, 2018, respectively |
|
176,457 |
|
|
|
86,457 |
|
Preferred stock, $0.01 par value;
10,000,000 shares authorized; none issued and |
|
|
|
|
|
|
|
outstanding at March 31, 2019 and
December 31, 2018, respectively |
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
170,104,444 |
|
|
|
165,313,902 |
|
Accumulated other comprehensive
loss |
|
(10,267 |
) |
|
|
(13,093 |
) |
Accumulated deficit |
|
(165,931,641 |
) |
|
|
(162,078,525 |
) |
Total stockholders’
equity |
|
4,338,993 |
|
|
|
3,308,741 |
|
Total liabilities and
stockholders’ equity |
$ |
12,091,074 |
|
|
$ |
8,950,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
OpGen, Inc. |
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(unaudited) |
|
|
Three Months Ended March 31, |
|
|
2019 |
|
|
|
2018 |
|
Revenue |
|
|
Product sales |
$ |
520,177 |
|
|
$ |
633,496 |
|
Laboratory services |
|
— |
|
|
|
8,690 |
|
Collaboration revenue |
|
500,000 |
|
|
|
204,040 |
|
Total revenue |
|
1,020,177 |
|
|
|
846,226 |
|
Operating expenses |
|
|
|
|
|
|
|
Cost of products sold |
|
220,702 |
|
|
|
342,832 |
|
Cost of services |
|
144,482 |
|
|
|
168,553 |
|
Research and development |
|
1,776,382 |
|
|
|
1,230,429 |
|
General and administrative |
|
1,747,585 |
|
|
|
1,790,522 |
|
Sales and marketing |
|
372,233 |
|
|
|
329,773 |
|
Impairment of right-of-use asset |
|
520,759 |
|
|
|
— |
|
Total operating expenses |
|
4,782,143 |
|
|
|
3,862,109 |
|
Operating loss |
|
(3,761,966 |
) |
|
|
(3,015,883 |
) |
Other (expense) income |
|
|
|
|
|
|
|
Other (expense) income |
|
(24,422 |
) |
|
|
5,298 |
|
Interest expense |
|
(56,444 |
) |
|
|
(57,846 |
) |
Foreign currency transaction (losses) gains |
|
(10,351 |
) |
|
|
12,181 |
|
Change in fair value of derivative financial instruments |
|
67 |
|
|
|
8,166 |
|
Total other expense |
|
(91,150 |
) |
|
|
(32,201 |
) |
Loss before income taxes |
|
(3,853,116 |
) |
|
|
(3,048,084 |
) |
Provision for income taxes |
|
— |
|
|
|
— |
|
Net loss |
|
(3,853,116 |
) |
|
|
(3,048,084 |
) |
Net loss available to common stockholders |
$ |
(3,853,116 |
) |
|
$ |
(3,048,084 |
) |
Net loss per common share - basic and diluted |
$ |
(0.41 |
) |
|
$ |
(0.75 |
) |
Weighted average shares outstanding - basic and diluted |
|
9,345,720 |
|
|
|
4,055,715 |
|
Net loss |
$ |
(3,853,116 |
) |
|
$ |
(3,048,084 |
) |
Other comprehensive gain (loss) - foreign currency
translations |
|
2,826 |
|
|
|
(12,579 |
) |
Comprehensive loss |
$ |
(3,850,290 |
) |
|
$ |
(3,060,663 |
) |
|
|
|
|
|
|
|
|
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