OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and bioinformatics to
help combat infectious disease, reported today its financial and
operating results for the three and nine months ended September 30,
2020 and provided a business update. Total OpGen revenue for the
third quarter of 2020 was approximately $1.1 million, up from $0.6
million in the third quarter of 2019. The financial results for the
three months ended September 30, 2020 reflect the consummation of
our business combination with Curetis GmbH on April 1, 2020.
OpGen’s cash as of September 30, 2020 was approximately $10.5
million. The company has access to an additional $6.4 million under
its expanded ATM program and has 594,000 warrants outstanding at an
average exercise price of $2.16. In addition, the Company continues
to have access to an additional €5.0 million tranche of
non-dilutive debt financing for COVID-19 related R&D programs
from the European Investment Bank.
As previously reported, OpGen announced details
regarding a strategic reprioritization of its product portfolio,
platform pipeline and priorities going forward. This
reprioritization was based on feedback from extensive market
research, a customer survey of 150 stakeholders in the decision
making on new diagnostic platforms, and key-opinion-leader
interviews conducted by an independent market research firm over
the past two quarters. Following a review of this research, OpGen
and its board decided to consolidate the company’s product
portfolio on its proprietary Unyvero platform and unique
bioinformatics capabilities. As a result of this change in
priority, the company anticipates the following key impacts:
- Product portfolio going forward is centered around rapid,
molecular diagnostic platform offerings and increased focus on
value added bioinformatics solutions, including Ares Genetics’ next
generation sequencing-based and artificial intelligence powered AMR
and AST prediction capabilities.
- Following the successful completion of the three phases of the
partnered R&D program as announced in the during our second
quarter 2020 earnings call, Ares Genetics has recently received
formal notification from its undisclosed global leading IVD
corporation partner that they have exercised their option to
exclusively negotiate with Ares Genetics the scope and terms of a
potential exclusive license or other arrangement with Ares to Ares
Genetics’ technology in the field of human clinical diagnostics in
the coming months.
- Platform consolidation to realize significant operational
synergies and cost savings over time as fewer products and
platforms would need to be maintained from a regulatory, quality
management and logistics and service standpoint.
- Unyvero platform and product portfolio to be expanded beyond
lower respiratory tract infections such as pneumonia (LRT / LRT
BAL) to include complicated urinary tract infections (cUTI) and
invasive joint infections (IJI) in the U.S. with clinical trials
for future FDA submission and clearance anticipated to start in
2021. Similar products in both clinical indication areas using the
same sample types have already been successfully developed and
CE-IVD marked and are commercially available in Europe and other
markets.
- Recent notification from the FDA has indicated that the agency
plans to continue prioritizing emergency use authorization (EUA)
requests for diagnostic products intended to address the COVID-19
pandemic for at least the remainder of the year, which will impact
the statutory review periods for ongoing submissions. During this
time, the FDA plans to provide monthly updates regarding the
ongoing impact of such prioritization of EUAs on our Acuitas AMR
Gene Panel for Isolates submission. Despite such impact, OpGen has
remained in open and ongoing dialogue with the FDA regarding the
status of the Acuitas AMR Gene Panel for Isolates submission since
our October 2020 formal response to the FDA’s Additional
Information (AI) requests. If the Acuitas AMR Gene Panel for
Isolates is cleared by the FDA, OpGen anticipates swift commercial
launch in the U.S. in the following months.
- Legacy FISH products business including Quick FISH® and PNA
FISH® to be discontinued by mid-2021 in Europe, the U.S. and rest
of world with last production lots to be manufactured in early
2021. All customers in the U.S. and distributors in Europe have
been informed of the discontinuation and OpGen expects last
stocking orders to come in by year-end with several orders already
received.
- Acuitas AMR Gene Panel (urine) clinical trial has been
discontinued and all clinical trial sites have been notified as
focus shifts to Unyvero platform for complicated UTI indication as
well as additional future applications.
Oliver Schacht, President and CEO of OpGen
commented, “Reprioritization efforts including the consolidation of
our product portfolio highlights our focus on rapid, molecular
diagnostic offerings and bioinformatics as we look to 2021 and
beyond. Additionally, the discontinuation of the Acuitas AMR Gene
Panel (urine) clinical trial and the Legacy FISH products business
will result in significant operational synergies and cost savings
for OpGen. We believe this shift will create meaningful, long term
shareholder value for our investors, partners and healthcare
provides alike as we continue to establish ourselves as industry
leaders in molecular diagnostics and bioinformatics space.”
Third Quarter
and Nine Month
2020 Financial
Results
- Total revenue for the third quarter
of 2020 was approximately $1.1 million, up from $0.6 million in the
third quarter of 2019. Total revenue for the nine months ended
September 30, 2020 was $2.9 million, compared with $2.7 million for
the nine months ended September 30, 2019;
- Operating expenses for the third
quarter of 2020 were $7.2 million, compared with $4.1 million in
the third quarter of 2019. Operating expenses for the nine months
ended September 30, 2020 were $19.6 million, compared with $12.4
million for the nine months ended September 30, 2019;
- The net loss for the third quarter
of 2020 was $7.7 million or $0.40 per share, compared with $3.5
million or $3.95 per share in the third quarter of 2019. The net
loss for the nine months ended September 30, 2020 was $19.1 million
or $1.36 per share, compared with a net loss of $9.9 million or
$13.32 per share for the nine months ended September 30, 2019;
and
- Cash and cash equivalents were
$10.5 million as of September 30, 2020.
The company also announced accomplishment of the
following key milestones in the third quarter of 2020 and year to
date:
- OpGen’s subsidiary Curetis GmbH
obtained CE mark certification in the European Union for its own
SARS-CoV-2 Kit with PULB for the detection of SARS-CoV-2, the virus
that causes COVID-19.
- OpGen announced that subsidiary
Ares Genetics GmbH won the Austrian national digitization award and
was also nominated for the 40th Austrian Innovation Award for its
artificial intelligence powered, next-generation sequencing based
molecular antibiotic susceptibility test marketed under the brand
name ARESupa – Universal Pathogenome Assay.
- OpGen’s subsidiary Curetis GmbH was
awarded EUR 350 thousand in non-dilutive grant funding in a
collaboration project with InfectoGnostics campus at Jena
University Hospital.
- OpGen announced the award of a
German Federal Government grant to its subsidiary, Curetis GmbH,
and collaborators Carpegen GmbH and the Clinic for Small Animal
Internal Medicine of the LMU Ludwig-Maximilians University to
collaborate on a project focused on travel related and enteric
diseases in small animals.
- OpGen’s subsidiary Ares Genetics
GmbH in collaboration with researchers from the Johns Hopkins
University School of Medicine, announced the publishing of a
peer-reviewed study on modifiable risk factors for the emergence of
ceftolozane-tazobactam resistance in P. aeruginosa in the journal
Clinical Infectious Diseases.
- OpGen announced the release of a
new peer-reviewed publication that demonstrates the clinical
utility of the Unyvero LRT panel and its potential impact on
antibiotic use in hospitalized patients with suspected pneumonia
compared to treatment directed based on microbiological culture
results.
- OpGen successfully completed its
study collaboration with Karolinska Institutet on bacterial
co-infections in COVID-19 pneumonia patients and data on the
Unyvero HPN Panel was presented by the Karolinska investigators at
ECCVID 2020.
- OpGen significantly improved its
working capital position in the third quarter of 2020 through the
sale of approximately 1.8 million shares of common stock under the
company’s ATM program and the exercise of warrants from the October
2019 financing for gross proceeds of $4.3 million during the third
quarter. During the nine months ended September 30, 2020, the
Company sold approximately 11.4 million shares of common stock
under the company’s ATM program and upon exercise of warrants from
the October 2019 offering for gross proceeds of $24.4 million.
- The German Federal Ministry for
Economic Affairs and Energy (BMWi) concluded its investigation of
the OpGen business combination with Curetis with regards to its
impact on the public order and security of the Federal Republic of
Germany as well as national healthcare interests in the light of
the current COVID-19 pandemic. No further action is expected from
the Federal government on this matter.
Mr. Schacht commented, “I am pleased with our
third quarter financial results and am encouraged by the exciting
business updates that were issued this quarter including the CE
mark certification for our SARS-CoV-2 Kit, notable awards and
grants, peer-reviewed publications and the submission of our formal
response letter to the FDA, which upon continued positive
interactions with the FDA, makes us believe there should be a
near-term clearance decision once the COVID-19 related FDA delays
allow the agency to respond. In addition to the business and
pipeline progress achieved this quarter, we are excited to provide
further details about our reprioritization strategy aimed at
creating both near-term and long-term growth potential for the
company. As we wrap up 2020 OpGen is in a strong position to
achieve pipeline and growth targets in the years ahead and I look
forward to the company’s continued successes.”
Conference Call Information
OpGen’s management will host a conference call
today, November 11 at 4:30 p.m. ET to discuss the third quarter
financial results and other business activities, as well as answer
questions. Dial-in information is below:
Dial-in
InformationU.S. Dial-in Number: +1 (877) 705 6003
International Dial-in Number: +1 (201) 493 6725Webcast:
http://public.viavid.com/index.php?id=142176Conference ID:
13712431
Following the conclusion of the conference call,
a replay will be available through November 25, 2020. The live,
listen-only webcast of the conference call may also be accessed by
visiting the Investors section of the Company’s website at
www.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: +1 (844) 512
2921International Dial-in Number: +1 (412) 317 6671Replay PIN:
13712431
About OpGen, Inc.
OpGen, Inc. (Gaithersburg, MD, USA) is a
precision medicine company harnessing the power of molecular
diagnostics and bioinformatics to help combat infectious disease.
Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we
are developing and commercializing molecular microbiology solutions
helping to guide clinicians with more rapid and actionable
information about life threatening infections to improve patient
outcomes, and decrease the spread of infections caused by
multidrug-resistant microorganisms, or MDROs. OpGen’s product
portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas®
Lighthouse, and the ARES Technology Platform including ARESdb,
using NGS technology and AI-powered bioinformatics solutions for
antibiotic response prediction.
For more information, please visit
www.opgen.com.
Forward-Looking Statements
This press release includes statements regarding
OpGen’s third quarter 2020 results, the company’s strategic
portfolio and product pipeline priorities, the ongoing integration
of OpGen with its acquired subsidiaries, Curetis GmbH and Ares
Genetics GmbH, and the impact of COVID-19 on the company and
general market conditions. 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 successfully, timely and cost-effectively develop,
seek and obtain regulatory clearance for and commercialize our
product and services offerings, the rate of adoption of our
products and services by hospitals and other healthcare providers,
the realization of expected benefits of our business combination
transaction with Curetis GmbH, the success of our commercialization
efforts, the impact of COVID-19 on the Company’s operations,
financial results, and commercialization efforts as well as on
capital markets and general economic conditions, 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. 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:Oliver SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact:Megan Paul Edison
Group mpaul@edisongroup.com
OpGen,
Inc. |
Consolidated
Balance Sheets |
(unaudited) |
|
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
Assets |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
10,488,072 |
|
|
$ |
2,708,223 |
|
Accounts
receivable, net |
|
423,432 |
|
|
|
567,811 |
|
Inventory,
net |
|
2,975,060 |
|
|
|
473,030 |
|
Note
receivable |
|
— |
|
|
|
2,521,479 |
|
Prepaid
expenses and other current assets |
|
1,072,364 |
|
|
|
396,760 |
|
Total current assets |
|
14,958,928 |
|
|
|
6,667,303 |
|
Property and
equipment, net |
|
3,370,847 |
|
|
|
130,759 |
|
Finance
lease right-of-use assets, net |
|
571,329 |
|
|
|
958,590 |
|
Operating
lease right-of-use assets |
|
1,373,418 |
|
|
|
1,043,537 |
|
Goodwill |
|
8,057,894 |
|
|
|
600,814 |
|
Intangible
assets, net |
|
16,071,680 |
|
|
|
817,550 |
|
Other
noncurrent assets |
|
300,744 |
|
|
|
203,271 |
|
Total assets |
$ |
44,704,840 |
|
|
$ |
10,421,824 |
|
Liabilities and Stockholders’ Equity |
|
|
|
Current liabilities |
|
|
|
Accounts
payable |
$ |
1,240,351 |
|
|
$ |
1,056,035 |
|
Accrued
compensation and benefits |
|
2,003,002 |
|
|
|
855,994 |
|
Accrued
liabilities |
|
2,664,581 |
|
|
|
1,046,661 |
|
Deferred
revenue |
|
51,622 |
|
|
|
9,808 |
|
Short-term
notes payable |
|
1,156,517 |
|
|
|
373,599 |
|
Short-term
finance lease liabilities |
|
348,000 |
|
|
|
579,030 |
|
Short-term
operating lease liabilities |
|
1,142,435 |
|
|
|
1,017,414 |
|
Total current liabilities |
|
8,606,508 |
|
|
|
4,938,541 |
|
Note
payable |
|
18,159,433 |
|
|
|
329,456 |
|
Deriviative
liabilities |
|
74,239 |
|
|
|
— |
|
Long-term
finance lease liabilities |
|
76,701 |
|
|
|
313,263 |
|
Long-term
operating lease liabilities |
|
554,295 |
|
|
|
547,225 |
|
Other long
term liabilites |
|
154,716 |
|
|
|
- |
|
Total liabilities |
|
27,625,892 |
|
|
|
6,128,485 |
|
Commitments |
|
|
|
Stockholders' equity |
|
|
|
Preferred
stock, $0.01 par value; 10,000,000 shares authorized; none issued
and outstanding at September 30, 2020 and December 31, 2019,
respectively |
|
— |
|
|
|
— |
|
Common
stock, $0.01 par value; 50,000,000 shares authorized; 19,799,348
and 5,582,280 shares issued and outstanding at September 30,
2020 and December 31, 2019, respectively |
|
197,993 |
|
|
|
55,823 |
|
Additional
paid-in capital |
|
208,892,463 |
|
|
|
178,779,814 |
|
Accumulated
deficit |
|
(193,625,510 |
) |
|
|
(174,524,983 |
) |
Accumulated
other comprehensive income/(loss) |
|
1,614,002 |
|
|
|
(17,315 |
) |
Total stockholders’ equity |
|
17,078,948 |
|
|
|
4,293,339 |
|
Total liabilities and stockholders’ equity |
$ |
44,704,840 |
|
|
$ |
10,421,824 |
|
|
|
|
|
OpGen,
Inc. |
Consolidated
Statements of Operations and Comprehensive Loss |
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenue |
|
|
|
|
|
|
|
Product sales |
$ |
601,562 |
|
|
$ |
573,035 |
|
|
$ |
1,569,799 |
|
|
$ |
1,597,505 |
|
Laboratory
services |
|
112,892 |
|
|
|
185 |
|
|
|
138,884 |
|
|
$ |
5,435 |
|
Collaboration revenue |
|
342,311 |
|
|
|
75,000 |
|
|
|
1,153,400 |
|
|
|
1,075,000 |
|
Total revenue |
|
1,056,765 |
|
|
|
648,220 |
|
|
|
2,862,083 |
|
|
|
2,677,940 |
|
Operating expenses |
|
|
|
|
|
|
|
Cost of
products sold |
|
1,350,296 |
|
|
|
262,373 |
|
|
|
2,340,766 |
|
|
|
681,568 |
|
Cost of
services |
|
159,794 |
|
|
|
196,184 |
|
|
|
550,115 |
|
|
|
592,647 |
|
Research and
development |
|
2,433,553 |
|
|
|
1,139,369 |
|
|
|
6,630,134 |
|
|
|
4,069,335 |
|
General and
administrative |
|
2,356,413 |
|
|
|
1,560,706 |
|
|
|
6,549,432 |
|
|
|
4,901,136 |
|
Sales and
marketing |
|
932,671 |
|
|
|
376,955 |
|
|
|
2,258,980 |
|
|
|
1,142,755 |
|
Transaction
costs |
|
— |
|
|
|
538,061 |
|
|
|
470,322 |
|
|
|
538,061 |
|
Impairment
of intangible assets |
|
— |
|
|
|
— |
|
|
|
750,596 |
|
|
|
— |
|
Impairment
of right-of-use asset |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
520,759 |
|
Total operating expenses |
|
7,232,727 |
|
|
|
4,073,648 |
|
|
|
19,550,345 |
|
|
|
12,446,261 |
|
Operating loss |
|
(6,175,962 |
) |
|
|
(3,425,428 |
) |
|
|
(16,688,262 |
) |
|
|
(9,768,321 |
) |
Other (expense) income |
|
|
|
|
|
|
|
Interest and
other income/(expense) |
|
19,965 |
|
|
|
1,043 |
|
|
|
101,644 |
|
|
|
(8,213 |
) |
Interest
expense |
|
(1,183,927 |
) |
|
|
(49,099 |
) |
|
|
(2,267,085 |
) |
|
|
(142,672 |
) |
Foreign
currency transaction losses |
|
(501,168 |
) |
|
|
(8,954 |
) |
|
|
(794,832 |
) |
|
|
(9,426 |
) |
Change in
fair value of derivative financial instruments |
|
165,497 |
|
|
|
— |
|
|
|
548,008 |
|
|
|
67 |
|
Total other expense |
|
(1,499,633 |
) |
|
|
(57,010 |
) |
|
|
(2,412,265 |
) |
|
|
(160,244 |
) |
Loss
before income taxes |
|
(7,675,595 |
) |
|
|
(3,482,438 |
) |
|
|
(19,100,527 |
) |
|
|
(9,928,565 |
) |
Provision for income taxes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net
loss |
$ |
(7,675,595 |
) |
|
$ |
(3,482,438 |
) |
|
$ |
(19,100,527 |
) |
|
$ |
(9,928,565 |
) |
|
|
|
|
|
|
|
|
Net loss per
common share - basic and diluted |
$ |
(0.40 |
) |
|
$ |
(3.95 |
) |
|
$ |
(1.36 |
) |
|
$ |
(13.32 |
) |
Weighted
average shares outstanding - basic and diluted |
|
19,116,864 |
|
|
|
882,280 |
|
|
|
14,016,896 |
|
|
|
745,471 |
|
Net
loss |
$ |
(7,675,595 |
) |
|
$ |
(3,482,438 |
) |
|
$ |
(19,100,527 |
) |
|
$ |
(9,928,565 |
) |
Other
comprehensive income - foreign currency translation |
|
1,266,901 |
|
|
|
7,298 |
|
|
|
1,631,317 |
|
|
|
5,174 |
|
Comprehensive loss |
$ |
(6,408,694 |
) |
|
$ |
(3,475,140 |
) |
|
$ |
(17,469,210 |
) |
|
$ |
(9,923,391 |
) |
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