OpGen Reports Second Quarter 2020 Financial Results and Provides Business Update
August 12 2020 - 3:05PM
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 six months ended June 30, 2020
and provided a business update. Total OpGen revenue for the second
quarter of 2020 was approximately $1.2 million up from $1.0 million
in the second quarter of 2019. The financial results for the three
months ended June 30, 2020 reflect the consummation of our business
combination with Curetis GmbH on April 1, 2020. OpGen’s cash as of
June 30, 2020 was approximately $12.9 million, an increase from the
$11.5 million as of March 31, 2020.
Oliver Schacht, President and CEO of OpGen
commented, “I am pleased with OpGen’s second quarter performance in
context of the unprecedented uncertainty caused by the COVID-19
pandemic and resulting pipeline delays. Operating as a combined
company, our business has grown year-over-year and we could not be
more pleased with the quick and successful integration of our
companies. Our team has worked around the clock to re-prioritize
R&D efforts to not only meet the most critical healthcare needs
relating to COVID-19, but also to ensure we are delivering
best-in-class diagnostics to our healthcare providers and
customers. Our recent agreement with the European Investment Bank
(EIB) providing us with access to an additional EUR 5 million
tranche in non-dilutive debt financing bolsters our ability to
expand efforts relating to COVID-19, as we believe crucial to be
able to rapidly and comprehensively perform infectious disease
diagnostics.”
Mr. Schacht continued, “Additionally, we are
excited and encouraged by the recently announced co-promotion
partnership with Menarini Silicon Biosystems to market and promote
Menarini’s portfolio of COVID-19 related products such as the
Healgen antibody test cassette and the Menarini CELLSEARCH CEC kit.
This partnership we believe highlights our marketing expertise and
sales capabilities to a network of infectious disease healthcare
providers and researchers across North America.”
Second Quarter and First Half 2020
Financial Results
- Total revenue for the second quarter of 2020 was approximately
$1.2 million up from $1.0 million in the second quarter of 2019.
Total revenue for the first half of 2020 was $1.8 million, compared
with $2.0 million for the first half of 2019;
- Operating expenses for the second quarter of 2020 were $7.7
million, compared with $3.6 million in the second quarter of 2019.
Operating expenses for the first half of 2020 were $12.3 million,
compared with $8.4 million for the first half of 2019;
- The net loss for the second quarter of 2020 was $7.5 million or
$0.49 per share, compared with $2.6 million or $2.94 per share in
the second quarter of 2019. The net loss for the first half of 2020
was $11.4 million or $1.00 per share, compared with a net loss of
$6.4 million or $9.54 per share for the first half of 2019;
and
- Cash and cash equivalents were $12.9 million as of June 30,
2020.
The company also announced accomplishment of the
following key milestones during the second quarter of 2020 and year
to date:
- OpGen’s subsidiary Ares Genetics GmbH continued executing in
its strategic partnering programs with globally leading IVD and
pharma companies as well as its collaborations with top-tier
medical and public health institutions. Ares Genetics completed all
three phases of the R&D program and successfully improved
performance of molecular antibiotic susceptibility prediction based
on ARESdb in its R&D collaboration with its undisclosed IVD
partner as well as signed a second technology evaluation agreement
with another undisclosed global IVD corporation. Ares Genetics
significantly advanced its own R&D programs for AI-powered
antibiotic susceptibility testing based on next-generation
sequencing and published strong results from its collaborations
with Sandoz, Johns Hopkins and Mayo Clinic as well as initiated
further commercial projects with new customers including Siemens
Technology Accelerator GmbH and AGES (Austrian Agency for Health
and Food Safety).
- Curetis has successfully completed the verification and
clinical validation testing of its proprietary, rapid SARS CoV-2
PCR test kit which it expects to CE-IVD mark in due course. The
test allows to detect SARS CoV-2 directly from patient swabs in
less than 1 hour and does not require prior RNA isolation.
- OpGen announced a strategic co-promotion partnership with
Menarini Silicon Biosystems to market and sell Menarini’s portfolio
of COVID-19 related products to infectious disease healthcare
providers and researchers in North America.
- OpGen’s subsidiary Curetis GmbH secured access to an additional
EUR 5 million tranche in non-dilutive debt financing for COVID-19
related R&D from the European Investment Bank (EIB). Curetis
can draw down the tranche at its sole discretion during a
nine-month period and the tranche will have a five-year maturity
and is interest-only until then.
- Preliminary data was released from an investigator-initiated
collaboration with Karolinska Institutet, Stockholm, Sweden, to
identify bacterial co-infections in hospitalized patients with
COVID-19 pneumonia. OpGen’s Unyvero HPN Panel for Pneumonia
identifies life-threatening bacterial co-infections in COVID-19
patients in just five hours, and Unyvero LRT and LRT BAL panels are
FDA-cleared in the U.S. for rapid detection of lower respiratory
tract infections such as pneumonia. Furthermore, performance of the
Unyvero system was highlighted in several posters and abstracts in
ASM Microbe 2020 online.
- 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 anticipates approaching a clearance decision for the
marketing submissions and applications on hold as of June 2020,
which resulted in OpGen’s original submission deadline of July 15,
2020 being extended to October 13, 2020.
- The German Federal Ministry for Economic Affairs and Energy
(BMWi) has initiated an investigation of the OpGen business
combination with Curetis under Sections 55 et seq. of the Foreign
Trade and Payments Ordinance (AWV) 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. OpGen has already responded to all questions
currently raised by the BMWi and will remain in constructive
dialogue with the BMWi with a view to completing the process as
swiftly as possible.
Mr. Schacht commented, “We continue to
anticipate an FDA clearance decision for our Acuitas AMR Gene Panel
product for isolates in the second half of 2020. Our pipeline
continues to grow with the recent strategic partnership agreement
with Menarini for the co-marketing of a portfolio of COVID-19
related products and platforms in North America. Although our
current work environment continues to be highly uncertain, with
continued investments in such strategic initiatives, we strongly
believe OpGen is well positioned to meet our long-term product and
profitability targets.”
Conference Call Information
OpGen’s management will host a conference call
today, August 12 at 4:30 p.m. ET to discuss the second quarter
financial results and other business activities, as well as answer
questions. Dial-in information is below:
|
Dial-in Information |
|
U.S. Dial-in Number: +1 (877) 705 6003 |
|
International Dial-in Number: +1 (201) 493 6725 |
|
Webcast: http://public.viavid.com/index.php?id=141125 |
|
Conference ID: 13707986 |
Following the conclusion of the conference call,
a replay will be available through August 26, 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 Information |
|
U.S. Dial-in Number: +1 (844) 512 2921 |
|
International Dial-in Number: +1 (412) 317 6671 |
|
Replay PIN: 13707986 |
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 second 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: Megan Paul Edison
Group mpaul@edisongroup.com
OpGen,
Inc. |
Consolidated
Balance Sheets |
(unaudited) |
|
|
|
|
|
|
|
June 30, 2020 |
|
December 31, 2019 |
Assets |
|
|
|
|
Current assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
12,886,547 |
|
|
$ |
2,708,223 |
|
Accounts
receivable, net |
|
|
231,427 |
|
|
|
567,811 |
|
Inventory,
net |
|
|
2,898,185 |
|
|
|
473,030 |
|
Note
receivable |
|
|
— |
|
|
|
2,521,479 |
|
Prepaid
expenses and other current assets |
|
|
810,391 |
|
|
|
396,760 |
|
Total current assets |
|
|
16,826,550 |
|
|
|
6,667,303 |
|
Property and
equipment, net |
|
|
3,587,341 |
|
|
|
130,759 |
|
Finance
lease right-of-use assets, net |
|
|
696,333 |
|
|
|
958,590 |
|
Operating
lease right-of-use assets |
|
|
1,653,603 |
|
|
|
1,043,537 |
|
Goodwill |
|
|
7,650,642 |
|
|
|
600,814 |
|
Intangible
assets, net |
|
|
15,566,528 |
|
|
|
817,550 |
|
Other
noncurrent assets |
|
|
309,347 |
|
|
|
203,271 |
|
Total assets |
|
$ |
46,290,344 |
|
|
$ |
10,421,824 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts
payable |
|
$ |
1,745,499 |
|
|
$ |
1,056,035 |
|
Accrued
compensation and benefits |
|
|
1,730,129 |
|
|
|
855,994 |
|
Accrued
liabilities |
|
|
2,514,992 |
|
|
|
1,046,661 |
|
Deferred
revenue |
|
|
393,739 |
|
|
|
9,808 |
|
Short-term
notes payable |
|
|
1,378,380 |
|
|
|
373,599 |
|
Short-term
finance lease liabilities |
|
|
432,494 |
|
|
|
579,030 |
|
Short-term
operating lease liabilities |
|
|
1,271,700 |
|
|
|
1,017,414 |
|
Total current liabilities |
|
|
9,466,933 |
|
|
|
4,938,541 |
|
Note
payable |
|
|
16,794,652 |
|
|
|
329,456 |
|
Derivative
liabilities |
|
|
234,224 |
|
|
|
— |
|
Long-term
finance lease liabilities |
|
|
135,521 |
|
|
|
313,263 |
|
Long-term
operating lease liabilities |
|
|
782,494 |
|
|
|
547,225 |
|
Other long
term liabilities |
|
|
147,977 |
|
|
|
- |
|
Total liabilities |
|
|
27,561,801 |
|
|
|
6,128,485 |
|
Commitments |
|
|
|
|
Stockholders' equity |
|
|
|
|
Preferred
stock, $0.01 par value; 10,000,000 shares authorized; none issued
and outstanding at June 30, 2020 and December 31, 2019,
respectively |
|
|
— |
|
|
|
— |
|
Common
stock, $0.01 par value; 50,000,000 shares authorized; 17,693,932
and 5,582,280 shares issued and outstanding at June 30, 2020
and December 31, 2019, respectively |
|
|
176,939 |
|
|
|
55,823 |
|
Additional
paid-in capital |
|
|
204,154,419 |
|
|
|
178,779,814 |
|
Accumulated
deficit |
|
|
(185,949,916 |
) |
|
|
(174,524,983 |
) |
Accumulated
other comprehensive income/(loss) |
|
|
347,101 |
|
|
|
(17,315 |
) |
Total stockholders’ equity |
|
|
18,728,543 |
|
|
|
4,293,339 |
|
Total liabilities and stockholders’ equity |
|
$ |
46,290,344 |
|
|
$ |
10,421,824 |
|
|
|
|
|
|
OpGen,
Inc. |
Consolidated
Statements of Operations and Comprehensive Loss |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Revenue |
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
601,304 |
|
|
$ |
504,293 |
|
|
$ |
968,237 |
|
|
$ |
1,024,470 |
|
Laboratory
services |
|
|
25,992 |
|
|
|
5,250 |
|
|
|
25,992 |
|
|
$ |
5,250 |
|
Collaboration revenue |
|
|
561,089 |
|
|
|
500,000 |
|
|
|
811,089 |
|
|
|
1,000,000 |
|
Total revenue |
|
|
1,188,385 |
|
|
|
1,009,543 |
|
|
|
1,805,318 |
|
|
|
2,029,720 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Cost of
products sold |
|
|
713,916 |
|
|
|
198,493 |
|
|
|
990,470 |
|
|
|
419,195 |
|
Cost of
services |
|
|
252,655 |
|
|
|
251,981 |
|
|
|
390,321 |
|
|
|
396,463 |
|
Research and
development |
|
|
2,979,025 |
|
|
|
1,153,584 |
|
|
|
4,196,581 |
|
|
|
2,929,966 |
|
General and
administrative |
|
|
2,491,571 |
|
|
|
1,592,845 |
|
|
|
4,193,019 |
|
|
|
3,340,430 |
|
Sales and
marketing |
|
|
1,044,032 |
|
|
|
393,567 |
|
|
|
1,326,309 |
|
|
|
765,800 |
|
Transaction
costs |
|
|
225,000 |
|
|
|
— |
|
|
|
470,322 |
|
|
|
— |
|
Impairment
of intangible assets |
|
|
— |
|
|
|
— |
|
|
|
750,596 |
|
|
|
— |
|
Impairment
of right-of-use asset |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
520,759 |
|
Total operating expenses |
|
|
7,706,199 |
|
|
|
3,590,470 |
|
|
|
12,317,618 |
|
|
|
8,372,613 |
|
Operating loss |
|
|
(6,517,814 |
) |
|
|
(2,580,927 |
) |
|
|
(10,512,300 |
) |
|
|
(6,342,893 |
) |
Other (expense) income |
|
|
|
|
|
|
|
|
Interest and
other income/(expense) |
|
|
(5,656 |
) |
|
|
15,166 |
|
|
|
81,679 |
|
|
|
(9,256 |
) |
Interest
expense |
|
|
(1,044,891 |
) |
|
|
(37,129 |
) |
|
|
(1,083,158 |
) |
|
|
(93,573 |
) |
Foreign
currency transaction losses |
|
|
(289,788 |
) |
|
|
9,879 |
|
|
|
(293,664 |
) |
|
|
(472 |
) |
Change in
fair value of derivative financial instruments |
|
|
382,511 |
|
|
|
— |
|
|
|
382,511 |
|
|
|
67 |
|
Total other expense |
|
|
(957,824 |
) |
|
|
(12,084 |
) |
|
|
(912,632 |
) |
|
|
(103,234 |
) |
Loss
before income taxes |
|
|
(7,475,638 |
) |
|
|
(2,593,011 |
) |
|
|
(11,424,932 |
) |
|
|
(6,446,127 |
) |
Provision for income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net
loss |
|
$ |
(7,475,638 |
) |
|
$ |
(2,593,011 |
) |
|
$ |
(11,424,932 |
) |
|
$ |
(6,446,127 |
) |
|
|
|
|
|
|
|
|
|
Net loss per
common share - basic and diluted |
|
$ |
(0.49 |
) |
|
$ |
(2.94 |
) |
|
$ |
(1.00 |
) |
|
$ |
(9.54 |
) |
Weighted
average shares outstanding - basic and diluted |
|
|
15,403,986 |
|
|
|
882,286 |
|
|
|
11,427,322 |
|
|
|
675,932 |
|
Net
loss |
|
$ |
(7,475,638 |
) |
|
$ |
(2,593,011 |
) |
|
$ |
(11,424,932 |
) |
|
$ |
(6,446,127 |
) |
Other
comprehensive income/(loss) - foreign currency translation |
|
|
324,939 |
|
|
|
(4,950 |
) |
|
|
364,416 |
|
|
|
(2,124 |
) |
Comprehensive loss |
|
$ |
(7,150,699 |
) |
|
$ |
(2,597,961 |
) |
|
$ |
(11,060,516 |
) |
|
$ |
(6,448,251 |
) |
|
|
|
|
|
|
|
|
|
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