OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and informatics to
help combat infectious disease, reported today its stand-alone
financial and operating results for the three months ended March
31, 2020 and provided a business update. Total OpGen revenue for
the first quarter of 2020 was approximately $617,000 down from $1.0
million in the first quarter of 2019. Revenue from Curetis and
Ares, OpGen’s wholly owned subsidiaries, was approximately $900,000
for the first quarter generating a pro-forma combined unaudited
revenue of over $1.5 million. OpGen’s cash as of March 31, 2020 was
approximately $11.5 million, up significantly from the $2.7 million
as of December 31, 2019. This amount did not include the
approximately $900,000 in cash held by Curetis and Ares at March
31, 2020.
Oliver Schacht, President and CEO of OpGen
commented, “Despite the unprecedented global crisis situation with
COVID-19, we are pleased with our first quarter results and remain
confident in the strength of our 2020 pipeline. We acknowledge that
this is an ever-changing situation and are prepared to mitigate any
further potential impact that COVID-19 might have on our global
operations. We would like to reassure you that as a company we are
resilient and OpGen with its subsidiaries Curetis and Ares Genetics
boasts a strong proprietary product portfolio that is extremely
agile, flexible and has elements in place to rapidly identity,
develop and create potential offerings needed to address future
infectious disease outbreaks.”
Mr. Schacht continued, “We expect the CoV-2
rapid PCR test kit sales in Europe to continue contributing
positively to our top-line revenue in Q2 of 2020. Since mid-March
2020, we sold approximately 15,000 CoV-2 tests into our
distribution network. Additionally, we recently announced our
collaboration with Sweden’s Karolinska Institutet to test COVID-19
pneumonia patients with Unyvero HPN panel for bacterial
co-infections. Due to the nature of the CoV-2 virus, we believe it
is crucial to be able to rapidly detect a comprehensive spectrum of
bacterial and fungal pathogens and antibiotic resistance markers in
lower respiratory tract specimens that could be a critical
factor in saving patients lives during the ongoing pandemic. The
study has already started and we expect to see initial results in
the coming weeks.”
First Quarter 2020 Financial Results of
OpGen, Inc. Stand-alone
- Total revenue for the first quarter of 2020 was approximately
$617,000 down from $1.0 million in the first quarter of 2019. This
decrease can be attributed to Acuitas AMR Gene Panel and Acuitas®
Lighthouse revenue, which was approximately $254,000, while
revenues from the company’s rapid FISH products decreased to
$363,000. Curetis and Ares revenue was approximately $900,000 for
the first quarter generating a pro forma combined unaudited revenue
of over $1.5 million.
- Operating expenses for the first quarter of 2020 were $4.6
million, compared with $4.8 million in the first quarter of
2019.
- The net loss for the first quarter of 2020 was $3.9 million or
$0.53 per share, compared with $3.9 million or $8.25 per share in
the first quarter of 2019.
The Company also provided the following business
updates that were achieved during the first quarter of 2020:
- Successful closure of the business combination between OpGen
and Curetis on April 1, 2020. At the closing, William E. Rhodes
III, the former chairman of the Supervisory Board of Curetis N.V.,
was appointed chairman of the board of OpGen, and Oliver Schacht,
Ph.D., the former Chief Executive Officer of Curetis N.V., was
appointed the President and Chief Executive Officer of OpGen and to
the board of directors;
- The newly formed board of directors of OpGen now also includes
Evan Jones, former Chairman and CEO of OpGen, Don Elsey, Mario
Crovetto, and Prabhavathi Fernandes, PhD;
- Announced the start of an investigator initiated collaboration
with Karolinska Institutet, Sweden, to identify bacterial
co-infections in patients admitted to the ICU for COVID-19
pneumonia using the Unyvero HPN panel;
- OpGen significantly improved its working capital position in
the first quarter of 2020 through $5.8 million of sales under the
company’s ATM program and $8.1 million in proceeds from the
exercise of warrants issued in the company’s public offering in
October 2019;
- Clinical trials were initiated during the first quarter of 2020
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;
- Acuitas Lighthouse® was utilized in a research study conducted
by the Mayo Clinic to predict phenotypic resistance and
antimicrobial susceptibility among clinical isolates, with findings
published in Diagnostic Microbiology & Infectious Disease;
and
- Curetis, Ares Genetics, and BGI announced a partnership around
BGI’s CoV-2 test kit commercialization in Europe; Curetis has begun
selling the BGI CoV-2 product via its distribution network in EMEA
during Q1 2020 and to date has sold over 15,000 tests into its
distribution network.
Additional key business updates and strategic
milestones include:
- OpGen’ expects that its 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 and now anticipates approaching a clearance decision for
the Acuitas® AMR Gene Panel for isolates. Exact timing is unknown
as a result of the COVID-19 pandemic;
- OpGen successfully achieved the last of the first year
milestones in the groundbreaking collaboration with the New York
State Department of Health and ILÚM Health Solutions, LLC, 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; however, the
parties are currently engaged in active negotiations and
discussions for a second year of the collaboration and expect to
resume the project and expand it into its second year once the
COVID-19 situation permits;
- OpGen’s subsidiary Ares Genetics in April announced that a
study on the feasibility and potential of antibiotic susceptibility
testing and bacterial pathogen identification using next-generation
sequencing (NGS) has been pre-published in the Journal of Clinical
Microbiology. The study was performed by Ares Genetics GmbH and
Curetis GmbH, and scientists at the Max Perutz Labs (Austria), a
joint venture of the University of Vienna and the Medical
University of Vienna, and the Mayo Clinic (Rochester, MN, U.S.A.);
and
- Curetis and Quaphaco entered into an exclusive three-year
distribution partnership for the Unyvero product line in Vietnam;
the contract includes minimum commitments by Quaphaco totaling
approximately $ 2.1 million over the initial three-year term.
Mr. Schacht continued, “We have a strong
pipeline heading into the second quarter of 2020 despite the unique
market challenges presented at this time. With the anticipated near
term FDA clearance decision and subsequent launch of our Acuitas
AMR Gene Panel product for isolate and the exciting combination of
the Acuitas Lighthouse® database with the ARESdb, our strong,
proprietary product pipeline attests to our ability to deliver
premier AI-powered bioinformatics solutions and diagnostic
products. We are especially excited about an upcoming major
milestone in the Ares collaboration with its strategic R&D
collaboration partner, a leading global IVD corporation, where
completion of the R&D phase is expected for the third quarter
this year. The IVD corporate partner has pre-funded an option which
upon exercise would then grant it 90 days of exclusive negotiations
with Ares regarding a potential future partnering and licensing
deal.”
Conference Call Information
OpGen’s management will host a conference call
today, May 7 at 4:30 p.m. ET to discuss first 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 (844) 420-8185International Dial-in Number: +1 (216)
562-0481Webcast:
https://edge.media-server.com/mmc/p/iggnmjimConference ID:
8595009
Following the conclusion of the conference call,
a replay will be available through May 14, 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 (855) 859-2056International Dial-in Number: +1 (404)
537-3406Conference ID: 8595009
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 first quarter 2020 results, the integration of Opgen with
its acquired subsidiaries, Curetis GmbH and Ares Genetics GmbH, the
current business and strategic initiatives of OpGen, 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 Schacht President and CEO
InvestorRelations@opgen.com
OpGen Press Contact: Matthew Bretzius
FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact: Joe Green Edison
Group jgreen@edisongroup.com
OpGen, Inc. |
Consolidated Balance Sheets |
(unaudited) |
|
|
|
|
|
|
|
March 31, 2020 |
|
December 31, 2019 |
Assets |
|
|
|
|
Current
assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
11,469,455 |
|
|
$ |
2,708,223 |
|
Accounts receivable, net |
|
|
165,931 |
|
|
|
567,811 |
|
Inventory, net |
|
|
436,683 |
|
|
|
473,030 |
|
Note receivable |
|
|
4,808,712 |
|
|
|
2,521,479 |
|
Prepaid expenses and other
current assets |
|
|
264,013 |
|
|
|
396,760 |
|
Total current
assets |
|
|
17,144,794 |
|
|
|
6,667,303 |
|
Property and equipment, net |
|
|
102,579 |
|
|
|
130,759 |
|
Finance lease right-of-use
assets, net |
|
|
826,243 |
|
|
|
958,590 |
|
Operating lease right-of-use
assets |
|
|
885,882 |
|
|
|
1,043,537 |
|
Goodwill |
|
|
600,814 |
|
|
|
600,814 |
|
Intangible assets, net |
|
|
— |
|
|
|
817,550 |
|
Other noncurrent assets |
|
|
203,212 |
|
|
|
203,271 |
|
Total
assets |
|
$ |
19,763,524 |
|
|
$ |
10,421,824 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
Current
liabilities |
|
|
|
|
Accounts payable |
|
$ |
1,054,261 |
|
|
$ |
1,056,035 |
|
Accrued compensation and
benefits |
|
|
988,291 |
|
|
|
855,994 |
|
Accrued liabilities |
|
|
1,047,019 |
|
|
|
1,046,661 |
|
Deferred revenue |
|
|
9,808 |
|
|
|
9,808 |
|
Short-term notes payable |
|
|
348,494 |
|
|
|
373,599 |
|
Short-term finance lease
liabilities |
|
|
517,042 |
|
|
|
579,030 |
|
Short-term operating lease
liabilities |
|
|
947,610 |
|
|
|
1,017,414 |
|
Total current
liabilities |
|
|
4,912,525 |
|
|
|
4,938,541 |
|
Note payable |
|
|
163,401 |
|
|
|
329,456 |
|
Long-term finance lease
liabilities |
|
|
212,798 |
|
|
|
313,263 |
|
Long-term operating lease
liabilities |
|
|
392,106 |
|
|
|
547,225 |
|
Total
liabilities |
|
|
5,680,830 |
|
|
|
6,128,485 |
|
Stockholders'
equity |
|
|
|
|
Preferred stock, $0.01 par value;
10,000,000 shares authorized; none issued and outstanding at
March 31, 2020 and December 31, 2019, respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.01 par value;
50,000,000 shares authorized; 12,468,214 and 5,582,280
shares issued and outstanding at March 31, 2020 and
December 31, 2019, respectively |
|
|
124,682 |
|
|
|
55,823 |
|
Additional paid-in capital |
|
|
192,410,127 |
|
|
|
178,779,814 |
|
Accumulated deficit |
|
|
(178,474,277 |
) |
|
|
(174,524,983 |
) |
Accumulated other comprehensive
income/(loss) |
|
|
22,162 |
|
|
|
(17,315 |
) |
Total stockholders’
equity |
|
|
14,082,694 |
|
|
|
4,293,339 |
|
Total liabilities and
stockholders’ equity |
|
$ |
19,763,524 |
|
|
$ |
10,421,824 |
|
OpGen,
Inc. |
Consolidated
Statements of Operations and Comprehensive Loss |
(unaudited) |
|
|
Three Months
Ended March 31, |
|
|
|
2020 |
|
|
|
2019 |
|
Revenue |
|
|
|
|
Product sales |
|
$ |
366,933 |
|
|
$ |
520,177 |
|
Collaboration revenue |
|
|
250,000 |
|
|
|
500,000 |
|
Total
revenue |
|
|
616,933 |
|
|
|
1,020,177 |
|
Operating
expenses |
|
|
|
|
Cost of products sold |
|
|
276,554 |
|
|
|
220,702 |
|
Cost of services |
|
|
137,666 |
|
|
|
144,482 |
|
Research and development |
|
|
1,217,556 |
|
|
|
1,776,382 |
|
General and administrative |
|
|
1,701,448 |
|
|
|
1,747,585 |
|
Sales and marketing |
|
|
282,277 |
|
|
|
372,233 |
|
Transaction costs |
|
|
245,322 |
|
|
|
— |
|
Impairment of intangible
assets |
|
|
750,596 |
|
|
|
— |
|
Impairment of right-of-use
asset |
|
|
— |
|
|
|
520,759 |
|
Total operating
expenses |
|
|
4,611,419 |
|
|
|
4,782,143 |
|
Operating
loss |
|
|
(3,994,486 |
) |
|
|
(3,761,966 |
) |
Other income
(expense) |
|
|
|
|
Interest and other income
(expense) |
|
|
87,335 |
|
|
|
(24,422 |
) |
Interest expense |
|
|
(38,267 |
) |
|
|
(56,444 |
) |
Foreign currency transaction
losses |
|
|
(3,876 |
) |
|
|
(10,351 |
) |
Change in fair value of
derivative financial instruments |
|
|
— |
|
|
|
67 |
|
Total other income
(expense) |
|
|
45,192 |
|
|
|
(91,150 |
) |
Loss before income
taxes |
|
|
(3,949,294 |
) |
|
|
(3,853,116 |
) |
Provision for income
taxes |
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(3,949,294 |
) |
|
$ |
(3,853,116 |
) |
|
|
|
|
|
Net loss per common share - basic
and diluted |
|
$ |
(0.53 |
) |
|
$ |
(8.25 |
) |
Weighted average shares
outstanding - basic and diluted |
|
|
7,393,232 |
|
|
|
467,286 |
|
Net loss |
|
$ |
(3,949,294 |
) |
|
$ |
(3,853,116 |
) |
Other comprehensive income -
foreign currency translation |
|
|
39,477 |
|
|
|
2,826 |
|
Comprehensive
loss |
|
$ |
(3,909,817 |
) |
|
$ |
(3,850,290 |
) |
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