OpGen, Inc. (NASDAQ: OPGN), a precision medicine company harnessing
the power of molecular diagnostics and informatics to help combat
infectious disease, reported today its audited stand-alone
financial and operating results for the three and 12 months ended
December 31, 2019 and provided a business update. Total OpGen
revenue for the fourth quarter of 2019 was $821 thousand, compared
with $759 thousand for the fourth quarter of 2018, an 8.1%
increase. Total revenue for 2019 was $3.5 million compared with
$2.9 million reported for 2018, an 18.7% increase. Combined
unaudited pro forma revenue for the OpGen and Curetis business was
approximately $6 million in 2019 revenue up from approximately $4.5
million in 2018, a 33% increase.
A quorum has been achieved for OpGen’s upcoming
Special Meeting of Stockholders, scheduled for March 30, 2020, at
which stockholders will vote on the business combination
transaction with Curetis. As of March 23, 2020, more than 99% of
votes cast support approval of the business combination
transaction. OpGen anticipates receiving formal approval of the
transaction at the upcoming Special Meeting on March 30. As
previously announced, on March 10, 2020, Curetis N.V. shareholders
voted to approve the transaction, making the approval of OpGen’s
shareholders the last major hurdle to closing the planned business
combination. The Company anticipates closing the business
combination transaction by early April 2020 following its approval
at the Special Meeting. The expected near-term completion of this
combination follows the successful addition of $22.6 million in
working capital over the last six months which has supported the
continued execution of both companies’ business plans and provides
significant funding for the combined company going forward.
Evan Jones, Chairman and CEO of OpGen, stated,
“We are pleased with OpGen’s fourth quarter and fiscal year 2019
results and are truly excited to see the imminent completion of our
business combination with Curetis. We have successfully executed on
all steps needed to satisfy the conditions to closing the
transaction and expect our stockholders to approve the transaction
in the near term. Thus, we look forward to our combined 2020 growth
and corporate development.”
Mr. Jones continued, “These are unprecedented
times with the COVID-19 pandemic impacting society and businesses
globally. Curetis took early action to supply the BGI SARS-CoV-2
rapid PCR test kit in Europe, and first shipments of product were
completed this week. Together at OpGen and Curetis we are
mobilizing our companies to help make a difference in the fight
against this new virus. Operations and programs have been impacted
by the government, societal, and internal corporate actions to help
combat the pandemic; however, both companies are currently
supplying all of their products as needed to our healthcare
customers.
“Together, we anticipate progressing development
across our combined proprietary product portfolio. We will strive
to integrate our commercial forces and R&D teams to further
strengthen our position as one of the leaders in the antimicrobial
resistance detection space and to contribute in the fight against
the COVID-19 pandemic.”
Fourth Quarter and Full Year 2019
audited Financial Results of OpGen, Inc. Stand-alone
- Total revenue for the fourth
quarter of 2019 was $821 thousand, compared with $759 thousand in
the fourth quarter of 2018. Total revenue for the 12 months ended
December 31, 2019 was $3.5 million, compared to $2.9 million for
the 12 months ended December 31, 2018. Such revenue growth was
driven by Acuitas® AMR Gene Panel and Acuitas Lighthouse® revenue,
which increased 147% to approximately $1.4 million, while revenues
from OpGen’s rapid FISH products decreased approximately 12% to
$2.1 million.
- Operating expenses for the fourth
quarter of 2019 were $3.3 million, compared with $4.4 million in
the fourth quarter of 2018. Total operating expenses for the 12
months ended December 31, 2019 were $15.8 million, compared to
$16.1 million for the 12 months ended December 31, 2018.
- The net loss for the fourth quarter
of 2019 was $2.5 million or $0.61 per share, compared with $3.7
million or $9.37 per share in the fourth quarter of 2018. The net
loss for the 12 months ended December 31, 2019 was $12.4 million or
$7.70 per share, compared to $13.4 million or $44.49 per share for
the 12 months ended December 31, 2018.
The Company also provides the following
business updates and advisories.
- Submission to the U.S. Food and
Drug Administration (“FDA”) for clearance of the Acuitas® AMR Gene
Panel (Isolates) for the detection of antimicrobial resistance
genes in bacterial isolates is nearing completion. OpGen has
responded, and is continuing to respond, to the FDA’s additional
information requests such that OpGen now anticipates it is
approaching a clearance decision for the Acuitas® AMR Gene Panel
for isolates. Exact timing is unknown as a result of the COVID-19
pandemic.
- Clinical trials were initiated and
have been ongoing at nine participating sites for the Acuitas AMR
Gene Panel (Urine) test. Testing and the trial have been suspended
due to hospital actions to focus resources on the COVID-19
pandemic.
- OpGen completed planned milestones
in the groundbreaking collaboration with the New York State
Department of Health and ILÚM Health Solutions, LLC , a wholly
owned subsidiary of Merck’s Healthcare Services and Solutions, to
develop a state-of-the-art research program to detect, track, and
manage antimicrobial-resistant infections at healthcare
institutions statewide. In response to the COVID-19 emergency in
New York State, testing under the program has been put on hold by
the Wadsworth Center and participating hospitals.
- OpGen has significantly improved
its working capital position in the first quarter of 2020 through
$5.1 million of sales under the Company’s ATM program and $8.1
million in proceeds from the exercise of warrants from the
Company’s public offering in October 2019.
- The U.S. Patent and Trademark
Office (USPTO) issued a key OpGen patent covering the Acuitas
Lighthouse® Profiling technology used in the Company’s software for
tracking AMR pathogens.
The following key business updates and
milestones were achieved in 2019 and year to date by Curetis and
Ares Genetics, which, going forward, will be operating as wholly
owned subsidiaries of OpGen, Inc.
- Curetis launched the Unyvero LRT
Panel for BAL specimens in the U.S. following receipt of 510(k)
clearance by the U.S. FDA in December 2019. This is the first and
only FDA cleared panel for lower respiratory tract infections such
as pneumonia that includes Pneumocystis jirovecii, a difficult to
diagnose pathogen that is a leading cause of pneumonia in
immunocompromised individuals. The highly differentiated Unyvero
LRT BAL panel has been commercially available to Curetis’ U.S.
customers since the end of January 2020 and it is expected to
substantially increase the total addressable market for the Unyvero
System in the U.S.
- Curetis has started offering a
CE-IVD real-time PCR test kit for SARS-CoV-2, the causal pathogen
of Coronavirus Disease 2019 (COVID-19), that was developed and
recently CE-IVD-marked by Curetis’ strategic partner BGI.
- Ares Genetics signed R&D,
licensing, and option agreements and has executed on several key
strategic partnerships and collaborations with Sandoz, QIAGEN, and
an undisclosed global leading IVD corporation. Execution on all of
these partnered programs continues within the framework of
restrictions by COVID-19 measures imposed by the Austrian
government.
- Ares Genetics opened an NGS service
lab in Vienna, Austria to leverage ARESdb for services to pharma
and diagnostics companies as well as CROs.
- Curetis GmbH and Quaphaco entered
into an exclusive distribution partnership for Vietnam for an
initial term of three years with Quaphaco committing to a minimum
purchase totaling approximately EUR 1.9 million during such initial
term. The regulatory filing process of all Unyvero tests in Vietnam
is progressing on schedule.
Mr. Jones continued, “The launch of the Curetis
Unyvero LRT BAL application as an FDA-cleared molecular diagnostic
pneumonia panel opens the market opportunity for this important new
test. With the expected surge of hospitalized patients in ICUs
globally (many ventilated) with COVID-19 viral infections, the
anticipated rise in bacterial pneumonia as a likely complication,
and expected to lead to significant co-morbidity in many cases, the
Unyvero lower respiratory tract infection test could become an
important tool for hospitals combating the anticipated surge of
severe COVID-19 cases. The anticipated FDA clearance and launch of
our Acuitas AMR Gene Panel product for isolates during 2020, and
the exciting combination of the Acuitas Lighthouse® database with
the ARESdb attest to our ability to deliver premier AI-powered
bioinformatics solutions and diagnostic products.”
Mr. Jones continued, “Heading into 2020, we will
continue to provide leading data-driven solutions to physicians and
patients as shown through Curetis’ offering BGI’s CE-IVD real-time
PCR test kit for SARS-CoV-2. We anticipate this test in combination
with the Unyvero HPN panel for bacterial and fungal lower
respiratory infections will bring diagnostic efficiency and improve
care for patients suffering from COVID-19 at this time.”
Business and Operations Outlook
Following the Expected Near-Term Successful Closing of the Business
Combination with Curetis
Operations for OpGen and Curetis are currently
impacted by global stay-at-home restrictions, travel restrictions,
and associated supply chain disruptions. The Company is currently
reevaluating all program activities and prioritizing activities and
actions in response to the global COVID-19 pandemic. The Company
has sufficient cash and access to capital to continue operations in
the near and medium term. Additional guidance will be provided
following the completion of the planned business combination of
OpGen and Curetis.
Conference Call Information
OpGen’s management will host a conference call
today, March 24 at 4:30 p.m. ET to discuss fourth quarter and full
year 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/n7dop5wxConference ID:
3497986
Following the conclusion of the conference call,
a replay will be available through March 31, 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: (855) 859-2056International Dial-in Number: +1 (404)
537-3406Conference ID: 3497986
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.
About Curetis
Curetis N.V.’s (Euronext: CURE) goal is to
become a leading provider of innovative solutions for molecular
microbiology diagnostics designed to address the global challenge
of detecting severe infectious diseases and identifying antibiotic
resistances in hospitalized patients.
Curetis’ Unyvero System is a versatile, fast and
highly automated molecular diagnostic platform for easy-to-use,
cartridge-based solutions for the comprehensive and rapid detection
of pathogens and antimicrobial resistance markers in a range of
severe infectious disease indications. Results are available within
hours, a process that can take days or even weeks if performed with
standard diagnostic procedures, thereby facilitating improved
patient outcomes, stringent antibiotic stewardship and
health-economic benefits. Unyvero in vitro diagnostic (IVD)
products are marketed in Europe, the Middle East, Asia and the
U.S.
Curetis’ wholly-owned subsidiary Ares Genetics
GmbH offers next-generation solutions for infectious disease
diagnostics and therapeutics. The ARES Technology Platform combines
what the Company believes to be the most comprehensive database
worldwide on the genetics of antimicrobial resistances, ARESdb,
with advanced bioinformatics and artificial intelligence.
For further information, please visit
www.curetis.com and www.ares-genetics.com.
Forward-Looking Statements
This press release includes statements relating
to OpGen’s fourth quarter and full year 2019 results, the planned
business combination with Curetis, and the current business of
OpGen and Curetis. 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 OpGen’s
at-the-market offering that commenced in February 2020 and recent
warrant exercises and that we may not use such proceeds
effectively, OpGen’s ability to successfully combine the businesses
of OpGen and Curetis, comply with the complexities of a global
business, achieve the expected synergies, and implement the
combined company’s strategic and business goals, the impact of the
COVID-19 pandemic on our business and operations, risks and
uncertainites associated with market conditions, OpGen’s ability to
successfully, 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. 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.
No Offer or Solicitation
This press release is neither an offer to
purchase, nor a solicitation of an offer to sell, any securities or
the solicitation of any vote in any jurisdiction pursuant to the
proposed transactions or otherwise, nor shall there be any sale,
issuance or transfer or securities in any jurisdiction in
contravention of applicable law. No offer of securities shall be
made except by means of a prospectus meeting the requirements of
Section 10 of the Securities Act of 1933, as amended.
Additional Information and Where to Find
It
In connection with the transactions contemplated
by the Implementation Agreement (the definitive agreement related
to the proposed business combination between the Company and
Curetis GmbH), a Registration Statement on Form S-4 (File No.
333-234657) has been filed with and declared effective by the
Securities and Exchange Commission (the “SEC”). Investors and
security holders are encouraged to read the registration statement
and any other relevant documents filed with the SEC, including the
proxy statement that forms a part of the registration statement.
Such documents contain important information about the proposed
transaction. The definitive proxy statement was first mailed to
stockholders of the Company on or about January 27, 2020. This
communication is not a substitute for the registration statement,
the proxy statement or any other document that OpGen may send to
its stockholders in connection with the proposed transaction.
Investors and security holders will be able to obtain the documents
free of charge at the SEC’s website, www.sec.gov, or from the
Company at its website, www.opgen.com.
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. |
Consolidated Balance Sheets |
|
|
|
|
|
|
|
2019 |
|
|
|
2018 |
|
Assets |
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
$ |
2,708,223 |
|
|
$ |
4,572,487 |
|
Accounts receivable, net |
|
567,811 |
|
|
|
373,858 |
|
Inventory, net |
|
473,030 |
|
|
|
543,747 |
|
Note receivable |
|
2,521,479 |
|
|
|
— |
|
Prepaid expenses and other
current assets |
|
396,760 |
|
|
|
292,918 |
|
Total current
assets |
|
6,667,303 |
|
|
|
5,783,010 |
|
Property and equipment, net |
|
130,759 |
|
|
|
1,221,827 |
|
Finance lease right-of-use
assets, net |
|
958,590 |
|
|
|
— |
|
Operating lease right-of-use
assets |
|
1,043,537 |
|
|
|
— |
|
Goodwill |
|
600,814 |
|
|
|
600,814 |
|
Intangible assets, net |
|
817,550 |
|
|
|
1,085,366 |
|
Other noncurrent assets |
|
203,271 |
|
|
|
259,346 |
|
Total
assets |
$ |
10,421,824 |
|
|
$ |
8,950,363 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current
liabilities |
|
|
|
Accounts payable |
$ |
1,056,035 |
|
|
$ |
1,623,751 |
|
Accrued compensation and
benefits |
|
855,994 |
|
|
|
1,041,573 |
|
Accrued liabilities |
|
1,046,661 |
|
|
|
902,019 |
|
Deferred revenue |
|
9,808 |
|
|
|
15,824 |
|
Short-term notes payable |
|
373,599 |
|
|
|
398,595 |
|
Short-term finance lease
liabilities |
|
579,030 |
|
|
|
399,345 |
|
Short-term operating lease
liabilities |
|
1,017,414 |
|
|
|
— |
|
Total current
liabilities |
|
4,938,541 |
|
|
|
4,381,107 |
|
Deferred rent |
|
— |
|
|
|
162,919 |
|
Note payable |
|
329,456 |
|
|
|
660,340 |
|
Warrant liability |
|
— |
|
|
|
67 |
|
Long-term finance lease
liabilities |
|
313,263 |
|
|
|
437,189 |
|
Long-term operating lease
liabilities |
|
547,225 |
|
|
|
— |
|
Total
liabilities |
|
6,128,485 |
|
|
|
5,641,622 |
|
Commitments |
|
|
|
Stockholders'
equity |
|
|
|
Preferred stock, $0.01 par value;
10,000,000 shares authorized; none issued and outstanding at
December 31, 2019 and December 31, 2018, respectively |
|
— |
|
|
|
— |
|
Common stock, $0.01 par value;
50,000,000 shares authorized; 5,582,280 and 432,286 shares issued
and outstanding at December 31, 2019 and December 31,
2018, respectively |
|
55,823 |
|
|
|
4,323 |
|
Additional paid-in capital |
|
178,779,814 |
|
|
|
165,396,036 |
|
Accumulated deficit |
|
(174,524,983 |
) |
|
|
(162,078,525 |
) |
Accumulated other comprehensive
loss |
|
(17,315 |
) |
|
|
(13,093 |
) |
Total stockholders’
equity |
|
4,293,339 |
|
|
|
3,308,741 |
|
Total liabilities and
stockholders’ equity |
$ |
10,421,824 |
|
|
$ |
8,950,363 |
|
OpGen,
Inc. |
Consolidated
Statements of Operations and Comprehensive Loss |
|
|
Three Months
Ended December 31, |
|
Year Ended
December 31, |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Revenue |
|
|
|
|
|
|
|
Product sales |
$ |
570,674 |
|
|
$ |
589,749 |
|
|
$ |
2,168,179 |
|
|
$ |
2,395,626 |
|
Laboratory services |
|
— |
|
|
|
12,510 |
|
|
|
5,435 |
|
|
|
34,665 |
|
Collaboration revenue |
|
250,000 |
|
|
|
156,700 |
|
|
|
1,325,000 |
|
|
|
516,016 |
|
Total
revenue |
|
820,674 |
|
|
|
758,959 |
|
|
|
3,498,614 |
|
|
|
2,946,307 |
|
Operating
expenses |
|
|
|
|
|
|
|
Cost of products sold |
|
229,997 |
|
|
|
283,440 |
|
|
|
911,565 |
|
|
|
1,222,919 |
|
Cost of services |
|
127,509 |
|
|
|
179,372 |
|
|
|
720,156 |
|
|
|
625,516 |
|
Research and development |
|
1,051,833 |
|
|
|
1,856,126 |
|
|
|
5,121,168 |
|
|
|
5,677,243 |
|
General and administrative |
|
1,351,306 |
|
|
|
1,704,094 |
|
|
|
6,252,442 |
|
|
|
7,069,315 |
|
Sales and marketing |
|
321,966 |
|
|
|
414,176 |
|
|
|
1,464,721 |
|
|
|
1,531,556 |
|
Transaction costs |
|
240,987 |
|
|
|
— |
|
|
|
779,048 |
|
|
|
— |
|
Impairment of right-of-use
asset |
|
— |
|
|
|
— |
|
|
|
520,759 |
|
|
|
— |
|
Total operating
expenses |
|
3,323,598 |
|
|
|
4,437,208 |
|
|
|
15,769,859 |
|
|
|
16,126,549 |
|
Operating
loss |
|
(2,502,924 |
) |
|
|
(3,678,249 |
) |
|
|
(12,271,245 |
) |
|
|
(13,180,242 |
) |
Other (expense)
income |
|
|
|
|
|
|
|
Interest and other income,
net |
|
18,071 |
|
|
|
174 |
|
|
|
9,859 |
|
|
|
5,384 |
|
Interest expense |
|
(44,877 |
) |
|
|
(50,742 |
) |
|
|
(187,549 |
) |
|
|
(191,195 |
) |
Foreign currency transaction
gains/(losses) |
|
11,836 |
|
|
|
(3,875 |
) |
|
|
2,410 |
|
|
|
(10,431 |
) |
Change in fair value of
derivative financial instruments |
|
— |
|
|
|
316 |
|
|
|
67 |
|
|
|
8,386 |
|
Total other
expense |
|
(14,970 |
) |
|
|
(54,127 |
) |
|
|
(175,213 |
) |
|
|
(187,856 |
) |
Loss before income
taxes |
|
(2,517,894 |
) |
|
|
(3,732,376 |
) |
|
|
(12,446,458 |
) |
|
|
(13,368,098 |
) |
Provision for income
taxes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
$ |
(2,517,894 |
) |
|
$ |
(3,732,376 |
) |
|
$ |
(12,446,458 |
) |
|
$ |
(13,368,098 |
) |
Net loss per common share - basic
and diluted |
$ |
(0.61 |
) |
|
$ |
(9.37 |
) |
|
$ |
(7.70 |
) |
|
$ |
(44.49 |
) |
Weighted average shares
outstanding - basic and diluted |
|
4,151,840 |
|
|
|
398,525 |
|
|
|
1,616,939 |
|
|
|
300,453 |
|
Net loss |
$ |
(2,517,894 |
) |
|
$ |
(3,732,376 |
) |
|
$ |
(12,446,458 |
) |
|
$ |
(13,368,098 |
) |
Other comprehensive (loss)/income
- foreign currency translation |
|
(9,396 |
) |
|
|
5,745 |
|
|
|
(4,222 |
) |
|
|
12,807 |
|
Comprehensive
loss |
$ |
(2,527,290 |
) |
|
$ |
(3,726,631 |
) |
|
$ |
(12,450,680 |
) |
|
$ |
(13,355,291 |
) |
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