OpGen Reports Third Quarter 2019 Financial Results and Provides Business Update
November 06 2019 - 3:05PM
OpGen, Inc. (NASDAQ: OPGN) today reported financial and operating
results for the three and nine months ended September 30, 2019 and
provided a business update. Total nine-month revenue was $2.7
million compared with $2.2 million in 2018, a 22.4% increase. Total
revenue for the third quarter of 2019 was $648 thousand, compared
with $552 thousand for the third quarter of 2018, a 17.4% increase.
Recent business highlights include:
- OpGen and Curetis N.V. entered into the Implementation
Agreement to combine the businesses of OpGen and Curetis GmbH that
will lead to, when closed, a commercial-stage, transatlantic
diagnostics company focused on data-driven solutions for molecular
microbiology;
- Ongoing activities to support the 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
filed in May 2019;
- Initiation during November of clinical trials to support De
Novo submission for our lead rapid molecular diagnostic test, the
Acuitas AMR Gene Panel Urine;
- Achievement of planned program milestones under the New York
State Infectious Disease Digital Health Initiative demonstration
project;
- The allowance by the U.S. Patent and Trademark Office (USPTO)
for a key OpGen patent covering the Acuitas Lighthouse® Profiling
technology used in the Company’s software for tracking AMR
pathogens;
- The presentation of preliminary Acuitas® AMR Gene Panel data
for detecting urinary tract infections (UTI) at IDWeek 2019. The
data demonstrate the concordance of Acuitas AMR Gene Panel results
with conventional urine culture results and prediction of
antimicrobial resistance using the Acuitas® Lighthouse
Software;
- Completion of a public offering with gross proceeds of $9.4
million. The Company intends to use a portion of the proceeds to
complete the business combination with Curetis GmbH along with
other planned business activities.
Evan Jones, Chairman and CEO of OpGen, stated,
“The third quarter of 2019 saw a number of highlights for OpGen,
most notably the transformative announcement of the planned
business combination with Curetis. We believe combining the two
companies will be a win for shareholders of both companies, with an
expanded and proprietary product portfolio and a solid growth
profile.”
Mr. Jones continued, “OpGen’s business had
continued success during the third quarter with the achievement of
key business milestones and significant progress towards gaining
the first FDA clearance for our Acuitas products. We are encouraged
by the positive preliminary data presented at IDWeek 2019 and the
recent favorable actions by the USPTO.”
“We look forward to the completion of the
business combination with Curetis, expected in early 2020. The
outlook for OpGen’s products continues to improve and we look
forward to further strengthening of our combined businesses through
the planned business combination,” concluded Mr. Jones.
Third Quarter and Nine Month 2019
Financial Results
- Total revenue for the third quarter of 2019 was $648 thousand,
compared with $552 thousand in the third quarter of 2018. Total
revenue for the nine months ended September 30, 2019 was $2.7
million, compared to $2.2 million for the nine months ended
September 30, 2018;
- Operating expenses for the third quarter of 2019 were $4.1
million, compared with $3.8 million in the third quarter of 2018.
Total operating expenses for the nine months ended September 30,
2019 were $12.4 million, compared to $11.7 million for the nine
months ended September 30, 2018;
- The net loss for the third quarter of 2019 was $3.5 million or
$3.95 per share, compared with $3.3 million or $10.67 per share in
the third quarter of 2018. The net loss for the nine months ended
September 30, 2019 was $9.9 million or $13.32 per share, compared
to $9.6 million or $36.09 per share for the period ending September
30, 2018.
Business and Operations
Outlook
We anticipate achieving the following:
- Complete planned business combination with Curetis in the first
quarter of 2020;
- 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; and
- Complete data collection phase for New York State Infectious
Disease Digital Health Initiative demonstration project.
Conference Call Information
OpGen’s management will host a conference call
today, November 6 at 4:30 p.m. ET to discuss third quarter 2019
financial results and other business activities, as well as answer
questions. Dial-in information is below:
Dial-in InformationU.S. Dial-in
Number: (844) 420-8185International Dial-in Number: +1 (216)
562-0481Webcast:
https://edge.media-server.com/mmc/p/p64ma2dvConference ID:
2899666
Following the conclusion of the conference call,
a replay will be available through November 13, 2019. The live,
listen-only webcast of the conference call may also be accessed by
visiting the Investors section of the Company’s website at
ir.opgen.com. A replay of the webcast will be available following
the conclusion of the call and will be archived on the Company’s
website for 90 days. Replay access information is below:
Replay InformationU.S. Dial-in
Number: (855) 859-2056International Dial-in Number: +1 (404)
537-3406Conference ID: 2899666
About OpGenOpGen, 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 the completion of the business combination with Curetis N.V.,
pursuit of FDA clearance for the Acuitas AMR Gene Panel for use
with bacterial Isolates, the use of proceeds from the October 2019
public offering and the activities related to the Company's
products and services. 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,
the fact that we have broad discretion as to the use of proceeds
from the October 2019 public offering and that we may not use the
proceeds effectively; risks and uncertainties associated with
market conditions, OpGen’s ability to successfully and timely seek
approval of, and obtain approval of its stockholders for the
business combination with Curetis N.V., satisfy the closing
conditions under the Implementation Agreement, successfully combine
the businesses of OpGen and Curetis GmbH, comply with the
complexities of a global business, achieve the synergies we expect,
successfully implement the combined company’s strategic and
business goals and objectives, advance our current and planned
510(k) clearance submissions with the FDA, and continue our
activities under the New York State Infectious Disease Digital
Health Initiative. 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
FarmerVice President, Marketing(240) 813-1284mfarmer@opgen.com
Press Contact:Matthew
BretziusFischTank Marketing and PRmatt@fischtankpr.com
Investor Contact:Joe
GreenEdison Groupjgreen@edisongroup.com
OpGen,
Inc. |
|
Condensed
Consolidated Balance Sheets |
|
|
|
|
|
|
|
|
|
|
September 30, 2019 |
|
December 31, 2018 |
|
|
Assets |
|
(Unaudited) |
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
626,420 |
|
|
$ |
4,572,487 |
|
|
|
Accounts
receivable, net |
|
|
377,284 |
|
|
|
373,858 |
|
|
|
Inventory,
net |
|
|
468,374 |
|
|
|
543,747 |
|
|
|
Prepaid
expenses and other current assets |
|
|
533,411 |
|
|
|
292,918 |
|
|
|
Total current assets |
|
|
2,005,489 |
|
|
|
5,783,010 |
|
|
|
Property and
equipment, net |
|
|
201,762 |
|
|
|
1,221,827 |
|
|
|
Finance
lease right-of-use assets, net |
|
|
1,096,472 |
|
|
|
— |
|
|
|
Operating
lease right-of-use assets |
|
|
1,214,482 |
|
|
|
— |
|
|
|
Goodwill |
|
|
600,814 |
|
|
|
600,814 |
|
|
|
Intangible
assets, net |
|
|
884,504 |
|
|
|
1,085,366 |
|
|
|
Other
noncurrent assets |
|
|
426,629 |
|
|
|
259,346 |
|
|
|
Total assets |
|
$ |
6,430,152 |
|
|
$ |
8,950,363 |
|
|
|
Liabilities and Stockholders’ Equity
(Deficit) |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,872,762 |
|
|
$ |
1,623,751 |
|
|
|
Accrued
compensation and benefits |
|
|
1,387,498 |
|
|
|
1,041,573 |
|
|
|
Accrued
liabilities |
|
|
1,040,562 |
|
|
|
902,019 |
|
|
|
Deferred
revenue |
|
|
9,808 |
|
|
|
15,824 |
|
|
|
Short-term
notes payable |
|
|
508,292 |
|
|
|
398,595 |
|
|
|
Short-term
finance lease liabilities |
|
|
627,620 |
|
|
|
399,345 |
|
|
|
Short-term
operating lease liabilities |
|
|
987,833 |
|
|
|
— |
|
|
|
Total current liabilities |
|
|
6,434,375 |
|
|
|
4,381,107 |
|
|
|
Deferred
rent |
|
|
— |
|
|
|
162,919 |
|
|
|
Note
payable |
|
|
328,843 |
|
|
|
660,340 |
|
|
|
Warrant
liability |
|
|
— |
|
|
|
67 |
|
|
|
Long-term
finance lease liabilities |
|
|
411,103 |
|
|
|
437,189 |
|
|
|
Long-term
operating lease liabilities |
|
|
812,801 |
|
|
|
— |
|
|
|
Total liabilities |
|
|
7,987,122 |
|
|
|
5,641,622 |
|
|
|
Commitments |
|
|
|
|
|
|
Stockholders' equity (deficit) |
|
|
|
|
|
|
Preferred
stock, $0.01 par value; 10,000,000 shares authorized; none issued
and outstanding at September 30, 2019 and December 31,
2018, respectively |
|
|
— |
|
|
|
— |
|
|
|
Common
stock, $0.01 par value; 50,000,000 shares authorized; 882,268 and
432,286 shares issued and outstanding at September 30, 2019
and December 31, 2018, respectively |
|
|
8,823 |
|
|
|
4,323 |
|
|
|
Additional
paid-in capital |
|
|
170,449,216 |
|
|
|
165,396,036 |
|
|
|
Accumulated
deficit |
|
|
(172,007,090 |
) |
|
|
(162,078,525 |
) |
|
|
Accumulated
other comprehensive loss |
|
|
(7,919 |
) |
|
|
(13,093 |
) |
|
|
Total stockholders’ equity (deficit) |
|
|
(1,556,970 |
) |
|
|
3,308,741 |
|
|
|
Total liabilities and stockholders’ equity
(deficit) |
|
$ |
6,430,152 |
|
|
$ |
8,950,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OpGen,
Inc. |
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
573,035 |
|
|
$ |
539,856 |
|
|
$ |
1,597,505 |
|
|
$ |
1,805,877 |
|
|
|
Laboratory
services |
|
|
185 |
|
|
|
12,365 |
|
|
|
5,435 |
|
|
|
22,155 |
|
|
|
Collaboration revenue |
|
|
75,000 |
|
|
|
— |
|
|
|
1,075,000 |
|
|
|
359,316 |
|
|
|
Total revenue |
|
|
648,220 |
|
|
|
552,221 |
|
|
|
2,677,940 |
|
|
|
2,187,348 |
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
Cost of
products sold |
|
|
262,373 |
|
|
|
292,984 |
|
|
|
681,568 |
|
|
|
939,479 |
|
|
|
Cost of
services |
|
|
196,184 |
|
|
|
98,189 |
|
|
|
592,647 |
|
|
|
446,144 |
|
|
|
Research and
development |
|
|
1,139,369 |
|
|
|
1,286,300 |
|
|
|
4,069,335 |
|
|
|
3,821,117 |
|
|
|
General and
administrative |
|
|
1,560,706 |
|
|
|
1,743,636 |
|
|
|
4,901,136 |
|
|
|
5,365,221 |
|
|
|
Sales and
marketing |
|
|
376,955 |
|
|
|
361,310 |
|
|
|
1,142,755 |
|
|
|
1,117,380 |
|
|
|
Transaction
costs |
|
|
538,061 |
|
|
|
— |
|
|
|
538,061 |
|
|
|
— |
|
|
|
Impairment
of right-of-use asset |
|
|
— |
|
|
|
— |
|
|
|
520,759 |
|
|
|
— |
|
|
|
Total operating expenses |
|
|
4,073,648 |
|
|
|
3,782,419 |
|
|
|
12,446,261 |
|
|
|
11,689,341 |
|
|
|
Operating loss |
|
|
(3,425,428 |
) |
|
|
(3,230,198 |
) |
|
|
(9,768,321 |
) |
|
|
(9,501,993 |
) |
|
|
Other (expense) income |
|
|
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
1,043 |
|
|
|
(93 |
) |
|
|
(8,213 |
) |
|
|
5,210 |
|
|
|
Interest
expense |
|
|
(49,099 |
) |
|
|
(28,074 |
) |
|
|
(142,672 |
) |
|
|
(140,453 |
) |
|
|
Foreign
currency transaction gains (losses) |
|
|
(8,954 |
) |
|
|
3,025 |
|
|
|
(9,426 |
) |
|
|
(6,556 |
) |
|
|
Change in
fair value of derivative financial instruments |
|
|
— |
|
|
|
(85 |
) |
|
|
67 |
|
|
|
8,070 |
|
|
|
Total other expense |
|
|
(57,010 |
) |
|
|
(25,227 |
) |
|
|
(160,244 |
) |
|
|
(133,729 |
) |
|
|
Loss
before income taxes |
|
|
(3,482,438 |
) |
|
|
(3,255,425 |
) |
|
|
(9,928,565 |
) |
|
|
(9,635,722 |
) |
|
|
Provision for income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
Net
loss |
|
|
(3,482,438 |
) |
|
|
(3,255,425 |
) |
|
|
(9,928,565 |
) |
|
|
(9,635,722 |
) |
|
|
Net
loss available to common stockholders |
|
$ |
(3,482,438 |
) |
|
$ |
(3,255,425 |
) |
|
$ |
(9,928,565 |
) |
|
$ |
(9,635,722 |
) |
|
|
Net loss per
common share - basic and diluted |
|
$ |
(3.95 |
) |
|
$ |
(10.67 |
) |
|
$ |
(13.32 |
) |
|
$ |
(36.09 |
) |
|
|
Weighted
average shares outstanding - basic and diluted |
|
|
882,280 |
|
|
|
305,187 |
|
|
|
745,471 |
|
|
|
266,997 |
|
|
|
Net
loss |
|
$ |
(3,482,438 |
) |
|
$ |
(3,255,425 |
) |
|
$ |
(9,928,565 |
) |
|
$ |
(9,635,722 |
) |
|
|
Other
comprehensive gain foreign currency translations |
|
|
7,298 |
|
|
|
1,528 |
|
|
|
5,174 |
|
|
|
7,062 |
|
|
|
Comprehensive loss |
|
$ |
(3,475,140 |
) |
|
$ |
(3,253,897 |
) |
|
$ |
(9,923,391 |
) |
|
$ |
(9,628,660 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
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