OpGen Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
March 25 2021 - 4:01PM
OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and bioinformatics to
help combat infectious disease, reported today financial and
operating results for the three and twelve months ended December
31, 2020 and provided a business update. Total pro-forma combined
revenue for OpGen in 2020 was approximately $5.2 million, compared
to approximately $6.1 million in 2019. Fourth quarter 2020 revenue
for OpGen was approximately $1.4 million compared to approximately
$0.8 million in the fourth quarter of 2019. OpGen’s cash position
as of December 31, 2020 was approximately $13.4 million. During the
first quarter of 2021 to date, OpGen successfully raised an
additional $34.7 million of capital from equity financings.
Mr. Schacht, OpGen’s Chief Executive Officer,
commented, "We are pleased with our execution throughout the year
and ended 2020 on a strong note with a solid quarter and strong
cash position following our recent capital raises. We made
substantial progress across our key products and showed investors
that our diversified product portfolio has the potential to support
an attractive combination of revenue and partnership growth driven
by recent awards and publications. The strength of our core
business and the anticipated FDA clearance decision for the Acuitas
AMR Gene Panel for Isolates gives us confidence in our ability to
maintain momentum throughout 2021. This will support our vision to
be the global leaders in molecular microbiology focusing on AMR
diagnostics and bioinformatics."
Fourth Quarter and Full Year 2020
Audited Financial Results of OpGen, Inc. Results in 2020
reflect the consummation of the company’s business combination with
Curetis GmbH on April 1, 2020. Figures for 2019 are for the OpGen
on a stand-alone basis only.
- Total revenue for the fourth quarter of 2020 was approximately
$1.4 million, compared with approximately $0.8 million in the
fourth quarter of 2019. Total revenue for the twelve months ended
December 31, 2020 was $4.2 million, compared to $3.5 million for
the twelve months ended December 31, 2019. Total proforma revenue,
i.e. revenue shown as if the businesses had been combined for the
respective full years, for the twelve months ended December 31,
2020 was approximately $5.2 million, compared to approximately $6.1
million for the twelve months ended December 31, 2019.
- Operating expenses for the fourth quarter of 2020 were $7.4
million, compared with $3.3 million in the fourth quarter of 2019.
Total operating expenses for the twelve months ended December 31,
2020 were $26.9 million, compared to $15.8 million for the twelve
months ended December 31, 2019.
- The net loss for the fourth quarter of 2020 was $7.1 million,
or $0.34 per share, compared with $2.5 million, or $0.61 per share,
in the fourth quarter of 2019. The net loss for the twelve months
ended December 31, 2020 was $26.2 million, or $1.66 per share,
compared to $12.4 million, or $7.70 per share, for the twelve
months ended December 31, 2019.
The company also announced the completion of the
following key milestones and recent developments in the fourth
quarter and full year 2020 as well as 2021 to date, all of which it
achieved despite the challenges posed by the global COVID-19
pandemic:
- OpGen completed, with one healthcare focused U.S. institutional
investor, the following gross capital raises:
- $10 million private placement priced at the market in November
2020
- $25 million registered direct offering in February 2021 priced
at the market
- $ 9.7 million warrant exercise and exchange in March 2021
- OpGen announced the publication of the final study results of
the Unyvero HPN Panel for diagnosis of bacterial co-infections in
ICU patients with COVID-19 pneumonia demonstrating that the panel
would enable crucially important rapid diagnosis of pathogens of
concern in these patients, as well as a high negative predictive
value of 99.8% for pathogen detection.
- OpGen announced the release of two new peer-reviewed
publications, the first demonstrating that the Unyvero LRT BAL
panel accurately detects 19 bacteria alongside Pneumocystis
jirovecii and 10 antibiotic resistance genes directly from
bronchoalveolar lavage fluid, allowing enhanced diagnosis of lower
respiratory tract infections, and the second publication
highlighting Ares Genetics in best practice techniques for
AI-powered prediction of antibiotic susceptibility testing by
next-generation sequencing.
- The Chinese regulatory authority NMPA approved the Curetis
Unyvero instrument system as IVD for Chinese market with the
application of Unyvero cartridge for pneumonia currently under
review and pending NMPA approval.
- OpGen subsidiary Curetis entered into an exclusive distribution
partnership in Colombia with Annar Health Technologies for Curetis’
Unyvero A50 platform.
- Curetis, 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. These kits were sold to
some of Curetis’ European distributors as well as used by Curetis
for the SARS-CoV-2 testing service offered to regional German
customers.
- OpGen’s subsidiary, Ares Genetics GmbH, completed the
transition of leadership to Dr. Arne Materna, who was appointed as
Managing Director and CEO of Ares Genetics effective January 1,
2021.Ares Genetics extended its collaboration with Sandoz within
its pharma partnering program and added another project with Sandoz
in 2021 to assess the potential of molecular surveillance for
better informed therapeutic guidance and antibiotic
stewardship.
- Ares Genetics presented advances of its research use only (RUO)
based ares-genetics.cloud platform for predictive antibiotic
susceptibility testing (pAST) at various scientific
conferences.
- Ares Genetics was granted a key patent on antimicrobial
resistance prediction from genomic data, supporting the company's
vision to improve guidance for antimicrobial therapy through
AI-powered prediction of AMR and the discovery of diagnostic
biomarkers.
- Ares Genetics joined the JPIAMR Network for Integrating
Microbial Sequencing and Platforms for Antimicrobial Resistance
(Seq4AMR). The network will provide guidelines and solutions to
microbial sequencing for the detection, surveillance and management
of difficult-to-treat infections caused by AMR microorganisms.
- After a three-month delay in FDA review of the Acuitas AMR Gene
Panel 510(k) submission due to the FDA’s prioritization of COVID-19
and influenza related EUAs, OpGen has received confirmation that
the FDA has resumed its review of the submission. Currently, OpGen
is actively engaged in receiving and responding to feedback from
the FDA to facilitate a final clearance decision for the Acuitas
AMR Gene Panel as soon as practicable.
- OpGen plans to exit its FISH business by the end of the first
quarter of 2021 and in the fall of 2020 ended the Acuitas AMR Gene
Panel urine trial in favor of two new upcoming U.S. clinical trials
towards a future FDA submission for the Unyvero UTI (complicated
urinary tract infections) and IJI (invasive joint infections)
applications, respectively.
- The 90-day exclusive negotiation period that Ares Genetics had
agreed to with a global leading IVD corporation partner towards a
potential collaboration and licensing deal recently expired. Ares
Genetics has since engaged in and continues to have multiple
parallel, non-exclusive partnering and licensing discussions with
potential corporate partners.
Mr. Schacht continued: "Despite the
unprecedented and industry wide delays in FDA review of non
COVID-19 related submissions, we are confident in our anticipation
of a clearance decision as soon as practicable for the FDA’s staff
for the Acuitas AMR Gene Panel with the FDA actively engaged in the
review of the submission. Our Unyvero business remains our core
focus for the near-term. Following the most recent capital raises,
OpGen maintains a strong cash position of almost $40 million,
despite the ongoing challenges presented to the business. The
Company continues to see strong growth potential across our
portfolio and additional partnership opportunities that further
demonstrate the strength of our model.”
Conference Call Information
OpGen’s management will host a conference call
today, March 25 at 4:30 p.m. ET to discuss the fourth quarter and
full year 2020 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=143832 |
|
Conference ID: 13717232 |
Following the conclusion of the conference call,
a replay will be available through April 8, 2021. 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 under Financials & Filings. 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: 13717232 |
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 fourth quarter and full year 2020 results and the current
business of OpGen. 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 fact that we may not
effectively use proceeds from recent financings, including our
November 2020 private placement, February 2021 Registered Direct
and March 2021 warrant exercise and exchange, 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 |
|
|
December 31, 2020 |
|
|
December 31, 2019 |
|
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
13,360,463 |
|
|
$ |
2,708,223 |
|
Accounts receivable, net |
653,104 |
|
|
567,811 |
|
Inventory, net |
1,485,986 |
|
|
473,030 |
|
Note receivable |
— |
|
|
2,521,479 |
|
Prepaid expenses and other current assets |
1,388,090 |
|
|
396,760 |
|
Total current assets |
16,887,643 |
|
|
6,667,303 |
|
Property and equipment, net |
3,259,487 |
|
|
130,759 |
|
Finance lease right-of-use assets, net |
449,628 |
|
|
958,590 |
|
Operating lease right-of-use assets |
2,082,300 |
|
|
1,043,537 |
|
Goodwill |
8,024,729 |
|
|
600,814 |
|
Intangible assets, net |
16,580,963 |
|
|
817,550 |
|
Strategic Inventory |
1,686,342 |
|
|
— |
|
Other noncurrent assets |
779,953 |
|
|
203,271 |
|
Total assets |
$ |
49,751,045 |
|
|
$ |
10,421,824 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
$ |
1,868,666 |
|
|
$ |
1,056,035 |
|
Accrued compensation and benefits |
2,126,511 |
|
|
855,994 |
|
Accrued liabilities |
1,437,141 |
|
|
1,046,661 |
|
Deferred revenue |
9,808 |
|
|
9,808 |
|
Short-term notes payable |
699,000 |
|
|
373,599 |
|
Short-term finance lease liabilities |
266,470 |
|
|
579,030 |
|
Short-term operating lease liabilities |
964,434 |
|
|
1,017,414 |
|
Total current liabilities |
7,372,030 |
|
|
4,938,541 |
|
Note payable |
19,378,935 |
|
|
329,456 |
|
Derivative liabilities |
112,852 |
|
|
— |
|
Long-term finance lease liabilities |
46,794 |
|
|
313,263 |
|
Long-term operating lease liabilities |
1,492,544 |
|
|
547,225 |
|
Other long term liabilities |
156,635 |
|
|
- |
|
Total liabilities |
28,559,790 |
|
|
6,128,485 |
|
Commitments and Contingencies |
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
Preferred stock, $0.01 par value; 10,000,000 shares authorized;
none issued and outstanding at December 31, 2020 and 2019,
respectively |
— |
|
|
— |
|
Common stock, $0.01 par value; 50,000,000 shares authorized;
25,085,534 and 5,582,280 shares issued and outstanding at
December 31, 2020 and December 31, 2019,
respectively |
250,855 |
|
|
55,823 |
|
Additional paid-in capital |
219,129,045 |
|
|
178,779,814 |
|
Accumulated deficit |
(200,735,827 |
) |
|
(174,524,983 |
) |
Accumulated other comprehensive income/(loss) |
2,547,182 |
|
|
(17,315 |
) |
Total stockholders’ equity |
21,191,255 |
|
|
4,293,339 |
|
Total liabilities and stockholders’ equity |
$ |
49,751,045 |
|
|
$ |
10,421,824 |
|
|
|
|
OpGen, Inc. |
Consolidated Statements of Operations and Comprehensive
Loss |
(unaudited) |
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
Product sales |
$ |
1,134,566 |
|
|
$ |
570,674 |
|
|
$ |
2,704,364 |
|
|
$ |
2,168,179 |
|
Laboratory services |
28,852 |
|
|
— |
|
|
167,736 |
|
|
$ |
5,435 |
|
Collaboration revenue |
188,941 |
|
|
250,000 |
|
|
1,342,341 |
|
|
1,325,000 |
|
Total revenue |
1,352,359 |
|
|
820,674 |
|
|
4,214,441 |
|
|
3,498,614 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
1,019,514 |
|
|
229,997 |
|
|
3,360,280 |
|
|
911,565 |
|
Cost of services |
(61,904) |
|
|
127,509 |
|
|
488,211 |
|
|
720,156 |
|
Research and development |
3,334,581 |
|
|
1,051,833 |
|
|
9,964,720 |
|
|
5,121,168 |
|
General and administrative |
2,252,233 |
|
|
1,351,306 |
|
|
8,801,661 |
|
|
6,252,442 |
|
Sales and marketing |
835,112 |
|
|
321,966 |
|
|
3,094,092 |
|
|
1,464,721 |
|
Transaction costs |
1,200 |
|
|
240,987 |
|
|
471,522 |
|
|
779,048 |
|
Impairment of intangible assets |
— |
|
|
— |
|
|
750,596 |
|
|
— |
|
Impairment of right-of-use asset |
101,838 |
|
|
— |
|
|
101,838 |
|
|
520,759 |
|
Gain on sale of equipment |
(100,000 |
) |
|
— |
|
|
(100,000 |
) |
|
— |
|
Total operating expenses |
7,382,574 |
|
|
3,323,598 |
|
|
26,932,920 |
|
|
15,769,859 |
|
Operating loss |
(6,030,215 |
) |
|
(2,502,924 |
) |
|
(22,718,479 |
) |
|
(12,271,245 |
) |
Other expense |
|
|
|
|
|
|
|
|
|
|
|
Gain on extinguishment of debt |
884,970 |
|
|
— |
|
|
884,970 |
|
|
— |
|
Interest and other income, net |
3,982 |
|
|
18,071 |
|
|
105,627 |
|
|
9,859 |
|
Interest expense |
(1,132,299 |
) |
|
(44,877 |
) |
|
(3,399,384 |
) |
|
(187,549 |
) |
Foreign currency transaction (losses)/gains |
(674,023 |
) |
|
11,836 |
|
|
(1,468,855 |
) |
|
2,410 |
|
Change in fair value of derivative financial instruments |
(30,328 |
) |
|
— |
|
|
517,680 |
|
|
67 |
|
Total other expense |
(947,698 |
) |
|
(14,970 |
) |
|
(3,359,962 |
) |
|
(175,213 |
) |
Loss before income taxes |
(6,977,913 |
) |
|
(2,517,894 |
) |
|
(26,078,441 |
) |
|
(12,446,458 |
) |
Provision for income taxes |
132,403 |
|
|
— |
|
|
132,403 |
|
|
— |
|
Net loss |
$ |
(7,110,316 |
) |
|
$ |
(2,517,894 |
) |
|
$ |
(26,210,844 |
) |
|
$ |
(12,446,458 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share - basic and diluted |
$ |
(0.34 |
) |
|
$ |
(0.61 |
) |
|
$ |
(1.66 |
) |
|
$ |
(7.70 |
) |
Weighted average shares outstanding - basic and diluted |
21,056,199 |
|
|
4,151,840 |
|
|
15,800,781 |
|
|
1,616,939 |
|
Net loss |
$ |
(7,110,316 |
) |
|
$ |
(2,517,894 |
) |
|
$ |
(26,210,844 |
) |
|
$ |
(12,446,458 |
) |
Other comprehensive income/(loss) - foreign currency
translation |
933,180 |
|
|
(9,396 |
) |
|
2,564,497 |
|
|
(4,222 |
) |
Comprehensive loss |
$ |
(6,177,136 |
) |
|
$ |
(2,527,290 |
) |
|
$ |
(23,646,347 |
) |
|
$ |
(12,450,680 |
) |
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