OpGen Reports Second Quarter 2019 Financial Results and Provides Business Update
August 07 2019 - 3:05PM
OpGen, Inc. (NASDAQ: OPGN) today reported financial and
operating results for the three and six months ended June 30, 2019
and provided a business update. Total revenue for the second
quarter of 2019 was $1.0 million, compared with $0.8 million for
the second quarter of 2018. Recent business highlights include:
- Submission and ongoing review of 510(k) pre-market notification
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;
- Initiation of testing to support de novo submission for our
lead rapid molecular diagnostic test, the Acuitas AMR Gene Panel
Urine;
- Achievement of second $500,000 program milestone under the New
York State Infectious Disease Digital Health Initiative
demonstration project;
- Presentation of new data demonstrating the potential clinical
utility of Acuitas AMR Gene Panel and Acuitas
Lighthouse® for antibiotic-resistant urinary tract infection
patient management and for rapid carbapenem-resistant bacteria
outbreak detection during a podium presentation at ASM Microbe
2019;
- Presentation of data by collaborator, Geisinger, obtained from
the first multisite assessment evaluating the potential clinical
utility of OpGen’s Acuitas AMR Gene Panel using clinical
samples presented at ASM Microbe 2019;
- Advancement of South America initiative to commercialize rapid
testing products, marked by the closing of OpGen’s first customer
accounts in Colombia; and
- Launch of new OpGen website and branding to reflect our
transformation into an innovative commercial organization and
leader in precision medicine.
“During the second quarter, we continued to
execute against OpGen’s highest priority of bringing our novel
Acuitas AMR Gene Panel and Acuitas Lighthouse Software to market.
We engaged in ongoing dialogue with the FDA regarding our recent
510(k) submission for the Acuitas AMR Gene Panel for use with
bacterial isolates. We are encouraged by our interactions with the
Agency and we are continuing to work towards receiving our first
FDA clearance during 2019,” said Evan Jones, Chairman and CEO of
OpGen.
“We are also working to complete two (2)
additional FDA pre-market submissions for our lead rapid molecular
diagnostic test, the Acuitas AMR Gene Panel Urine, and for the
Acuitas Lighthouse Software. We have begun testing to support the
AMR Gene Panel Urine submission, and we plan to complete the trials
and make an initial FDA submission by year-end or in the first
quarter of 2020.”
“Finally, we continued to build commercial
momentum in preparation of our anticipated receipt of regulatory
clearance. To meet our capital needs, which will enable us to
pursue the development and regulatory work to complete our
additional FDA filings and, once clearance is received, execute a
successful commercial launch, we are considering multiple
alternatives ranging from strategic financings to other potential
transactions. This consideration includes potential partnering
arrangements and business combination transactions in order to
obtain sufficient financing so we can continue to deliver distinct
and differentiated precision medicine capabilities and maximize our
shareholder value.” Evan Jones concluded.
2019 Second Quarter and First Half
Financial Results
- Total revenue for the second quarter of 2019 was $1.0 million,
compared with $0.8 million for the second quarter of 2018. Total
revenue for the first half of 2019 was $2.0 million, compared
with $1.6 million for the first half of 2018;
- Operating expenses for the second quarter 2019 were $3.6
million, compared with $4.0 million for the second quarter of 2018.
Operating expenses for the first half of 2019 were $8.4
million, compared with $7.9 million for the first half of
2018;
- The net loss for the second quarter of 2019 was $2.6 million or
$0.15 per share, compared with a net loss of $3.3 million or $0.57
per share for the second quarter of 2018. The net loss for the
first half of 2019 was $6.4 million or $0.48 per
share, compared with a net loss of $6.4
million or $1.29 per share for the first half of
2018; and
- Cash and cash equivalents were $3.1 million as of June 30,
2019.
Business and Operations
Outlook
- Obtain FDA clearance to market the Acuitas AMR Gene Panel for
use with bacterial isolates;
- Complete clinical studies and file de novo submissions 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 (“RUO”) sales and full launch following first
FDA clearance;
- Expand commercial activities to support FDA clearance and
launch of the Acuitas AMR Gene Panel products;
- Enter data collection phase for New York State Infectious
Disease Digital Health Initiative demonstration project; and
- Commercialize rapid testing products in South America, using
Colombia as a springboard.
Annual Meeting
We are holding our Annual Meeting of
stockholders on August 22, 2019 and are asking our stockholders to
approve a reverse stock split proposal to help us maintain our
Nasdaq Capital Market listing and position the Company to pursue
potential partnering arrangements and business combination
transactions.
Conference Call Information
OpGen management will hold a conference call
today, August 7, 2019 at 4:30 p.m. ET to discuss second 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: 7288909 Webcast URL:
https://edge.media-server.com/mmc/p/6grvivzp
Replay Dial-in
Information U.S. Dial-In Number: (855)-859-2056
International Dial-In Number: (404)-537-3406 Conference ID:
7288909
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 and 2020. 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 FarmerVice 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) |
|
|
|
|
|
|
|
|
June 30, 2019 |
|
December 31, 2018 |
|
Assets |
|
|
|
|
|
Current
assets |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
3,055,894 |
|
|
$ |
4,572,487 |
|
|
Accounts receivable, net |
|
|
772,914 |
|
|
|
373,858 |
|
|
Inventory, net |
|
|
567,422 |
|
|
|
543,747 |
|
|
Prepaid expenses and other
current assets |
|
|
178,356 |
|
|
|
292,918 |
|
|
Total current
assets |
|
|
4,574,586 |
|
|
|
5,783,010 |
|
|
Property and equipment, net |
|
|
197,502 |
|
|
|
1,221,827 |
|
|
Finance lease right-of-use
assets, net |
|
|
984,742 |
|
|
|
— |
|
|
Operating lease right-of-use
assets |
|
|
1,381,830 |
|
|
|
— |
|
|
Goodwill |
|
|
600,814 |
|
|
|
600,814 |
|
|
Intangible assets, net |
|
|
951,458 |
|
|
|
1,085,366 |
|
|
Other noncurrent assets |
|
|
241,182 |
|
|
|
259,346 |
|
|
Total
assets |
|
$ |
8,932,114 |
|
|
$ |
8,950,363 |
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Accounts payable |
|
$ |
1,258,908 |
|
|
$ |
1,623,751 |
|
|
Accrued compensation and
benefits |
|
|
1,190,500 |
|
|
|
1,041,573 |
|
|
Accrued liabilities |
|
|
820,667 |
|
|
|
902,019 |
|
|
Deferred revenue |
|
|
9,993 |
|
|
|
15,824 |
|
|
Short-term notes payable |
|
|
343,330 |
|
|
|
398,595 |
|
|
Short-term finance lease
liabilities |
|
|
576,322 |
|
|
|
399,345 |
|
|
Short-term operating lease
liabilities |
|
|
958,992 |
|
|
|
— |
|
|
Total current
liabilities |
|
|
5,158,712 |
|
|
|
4,381,107 |
|
|
Deferred rent |
|
|
— |
|
|
|
162,919 |
|
|
Note payable |
|
|
494,897 |
|
|
|
660,340 |
|
|
Warrant liability |
|
|
— |
|
|
|
67 |
|
|
Long-term finance lease
liabilities |
|
|
379,825 |
|
|
|
437,189 |
|
|
Long-term operating lease
liabilities |
|
|
1,071,677 |
|
|
|
— |
|
|
Total
liabilities |
|
|
7,105,111 |
|
|
|
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 June 30, 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
June 30, 2019 and December 31, 2018, respectively |
|
|
— |
|
|
|
— |
|
|
Additional paid-in capital |
|
|
170,190,415 |
|
|
|
165,313,902 |
|
|
Accumulated other comprehensive
loss |
|
|
(15,217 |
) |
|
|
(13,093 |
) |
|
Accumulated deficit |
|
|
(168,524,652 |
) |
|
|
(162,078,525 |
) |
|
Total stockholders’
equity |
|
|
1,827,003 |
|
|
|
3,308,741 |
|
|
Total liabilities and
stockholders’ equity |
|
$ |
8,932,114 |
|
|
$ |
8,950,363 |
|
|
|
|
|
|
|
|
|
|
|
|
OpGen,
Inc. |
Condensed
Consolidated Statements of Operations and Comprehensive
Loss |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
Revenue |
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
504,293 |
|
|
$ |
632,525 |
|
|
$ |
1,024,470 |
|
|
$ |
1,266,021 |
|
|
Laboratory services |
|
|
5,250 |
|
|
|
1,100 |
|
|
|
5,250 |
|
|
|
9,790 |
|
|
Collaboration revenue |
|
|
500,000 |
|
|
|
155,276 |
|
|
|
1,000,000 |
|
|
|
359,316 |
|
|
Total
revenue |
|
|
1,009,543 |
|
|
|
788,901 |
|
|
|
2,029,720 |
|
|
|
1,635,127 |
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
198,493 |
|
|
|
303,663 |
|
|
|
419,195 |
|
|
|
646,495 |
|
|
Cost of services |
|
|
251,981 |
|
|
|
179,402 |
|
|
|
396,463 |
|
|
|
347,955 |
|
|
Research and development |
|
|
1,153,584 |
|
|
|
1,304,388 |
|
|
|
2,929,966 |
|
|
|
2,534,817 |
|
|
General and administrative |
|
|
1,592,845 |
|
|
|
1,831,063 |
|
|
|
3,340,430 |
|
|
|
3,621,585 |
|
|
Sales and marketing |
|
|
393,567 |
|
|
|
426,297 |
|
|
|
765,800 |
|
|
|
756,070 |
|
|
Impairment of right-of-use
asset |
|
|
— |
|
|
|
— |
|
|
|
520,759 |
|
|
|
|
Total operating
expenses |
|
|
3,590,470 |
|
|
|
4,044,813 |
|
|
|
8,372,613 |
|
|
|
7,906,922 |
|
|
Operating
loss |
|
|
(2,580,927 |
) |
|
|
(3,255,912 |
) |
|
|
(6,342,893 |
) |
|
|
(6,271,795 |
) |
|
Other (expense)
income |
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
15,166 |
|
|
|
5 |
|
|
|
(9,256 |
) |
|
|
5,303 |
|
|
Interest expense |
|
|
(37,129 |
) |
|
|
(54,533 |
) |
|
|
(93,573 |
) |
|
|
(112,379 |
) |
|
Foreign currency transaction
gains (losses) |
|
|
9,879 |
|
|
|
(21,762 |
) |
|
|
(472 |
) |
|
|
(9,581 |
) |
|
Change in fair value of
derivative financial instruments |
|
|
— |
|
|
|
(11 |
) |
|
|
67 |
|
|
|
8,155 |
|
|
Total other
expense |
|
|
(12,084 |
) |
|
|
(76,301 |
) |
|
|
(103,234 |
) |
|
|
(108,502 |
) |
|
Loss before income
taxes |
|
|
(2,593,011 |
) |
|
|
(3,332,213 |
) |
|
|
(6,446,127 |
) |
|
|
(6,380,297 |
) |
|
Provision for income
taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Net loss |
|
|
(2,593,011 |
) |
|
|
(3,332,213 |
) |
|
|
(6,446,127 |
) |
|
|
(6,380,297 |
) |
|
Net loss available to
common stockholders |
|
$ |
(2,593,011 |
) |
|
$ |
(3,332,213 |
) |
|
$ |
(6,446,127 |
) |
|
$ |
(6,380,297 |
) |
|
Net loss per common share - basic
and diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.57 |
) |
|
$ |
(0.48 |
) |
|
$ |
(1.29 |
) |
|
Weighted average shares
outstanding - basic and diluted |
|
|
17,645,720 |
|
|
|
5,826,947 |
|
|
|
13,518,648 |
|
|
|
4,950,517 |
|
|
Net loss |
|
$ |
(2,593,011 |
) |
|
$ |
(3,332,213 |
) |
|
$ |
(6,446,127 |
) |
|
$ |
(6,380,297 |
) |
|
Other comprehensive (loss)
gain - foreign currency translations |
|
|
(4,950 |
) |
|
|
18,113 |
|
|
|
(2,124 |
) |
|
|
5,534 |
|
|
Comprehensive
loss |
|
$ |
(2,597,961 |
) |
|
$ |
(3,314,100 |
) |
|
$ |
(6,448,251 |
) |
|
$ |
(6,374,763 |
) |
|
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