OpGen Reports First Quarter 2021 Financial Results and Provides Business Update
May 13 2021 - 7:30AM
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 months ended March 31, 2021 and
provided a business update. Total OpGen revenue for the first
quarter of 2021 was approximately $830,000, up 34.5% from $617,000
in the first quarter of 2020. Cash as of March 31, 2021 was
approximately $39.4 million, up significantly from the $13.4
million at year-end 2020.
Oliver Schacht, President & CEO of OpGen,
commented, “We are pleased with our first quarter results and are
encouraged by the growth of our products and partnerships over the
last several months. This excitement encompasses the recently
announced extension and expansion of our strategic collaboration
with the New York State and includes winning Chinese NMPA approval
for the Curetis Unyvero instrument system as we await a clearance
decision for the pneumonia cartridge in China, which is currently
under review and pending approval. As the pandemic's effect on the
global economy subsides, we believe our balanced product portfolio
and long-term pipeline growth initiatives give us the ability to
maintain momentum throughout 2021 and support our vision to be
amongst the global leaders in infectious disease diagnostics.”
First Quarter 2021 Financial Results of
OpGen, Inc.
- Total revenue for the first quarter
of 2021 was approximately $830,000 up 34.5% from $617,000 in the
first quarter of 2020. This can be attributed to the business
combination with Curetis which closed at the beginning of the
second quarter of 2020.
- Operating expenses for the first
quarter of 2021 were $7.1 compared with $4.6 million in the first
quarter of 2020.
- The net loss for the first quarter
of 2021 was $14.9 or $0.50 per share, compared with $3.9 million or
$0.53 per share in the first quarter of 2020.
- Cash and cash equivalents were
$39.4 million as of March 31, 2021 compared to $13.4 million as of
December 31, 2020.
The company announced accomplishment of the
following key milestones and recent developments in the first
quarter as well as 2021 to date:
- Following the
previously announced resumption of the FDA’s review of the Acuitas
AMR Gene Panel 510(k) submission, which had been delayed due to the
FDA’s prioritization of COVID-19 related emergency use
authorizations, OpGen has worked closely with the FDA’s review team
to address any remaining edits and comments by the FDA to key
documents such as the intended use statement, instructions for use,
electronic user guide and others. The FDA recently informed OpGen
that completion of its review would require additional time due to
the current public health crisis. The FDA further informed OpGen
that it intends to provide its written feedback to specific
documents by the end of May 2021 and to complete its review by the
end of August 2021. As of today, OpGen has already received
feedback from the FDA on most of the aforementioned key documents
under review. The FDA also clarified that these timelines can be
affected by various factors including the FDA’s other workload and
public health priorities. Although the FDA has not committed to a
clearance decision timeline, OpGen will continue to proactively
engage with the FDA in order to facilitate a final clearance
decision.
- OpGen announced
signing an extension and expansion agreement for its strategic
collaboration with the New York State Department of Health (“DOH”)
by another six months through September 30, 2021 with the focus of
expanding the reach of the platform, increasing the volume of
testing, and enhancing data collection.
- OpGen received
Chinese NMPA approval for the IVD use of the Curetis Unyvero
instrument system for the Chinese market with the application of
the Unyvero cartridge for pneumonia currently under review and
pending approval.
- OpGen subsidiary
Curetis prepared and submitted a pre-submission request to the FDA
to discuss and align on regulatory pathway and clinical trial
design for the Unyvero UTI application. Due to the COVID pandemic,
FDA has provided written feedback only in lieu of a meeting.
- OpGen subsidiary
Curetis has continued to provide SARS-CoV-2 testing services,
serving the community as a confirmatory PCR test lab for several
local SARS-CoV-2 screening test centers.
- OpGen subsidiary
Curetis entered into exclusive distribution partnership in Colombia
with Annar Health Technologies for Curetis’ Unyvero A50
platform.
- OpGen announced
the results from its highly attended webinar titled “Pneumonia
Diagnosis: Bacterial Superinfection in COVID-19 Patients,” where
two infectious disease professionals presented their independent
study results from the Unyvero Hospitalized Pneumonia (HPN) and
Unyvero Lower Respiratory (LRT BAL) panels, demonstrating the
importance of distinguishing COVID-19 patients with bacterial
superinfection early and accurately, and highlighted that Unyvero
detected bacterial pathogens up to 7 days earlier and would have
enabled prompt and appropriate targeted antibiotics in 41.3% of
cases and reduced time to appropriate therapy by 25.7 hours.
- OpGen announced
publication of final study results of the Unyvero HPN Panel for
Diagnosis of Bacterial Co-Infections in ICU Patients with COVID-19
pneumonia showcasing that high negative predictive value of 99.8%
may allow for reduction in unnecessary antibiotic use and support
antibiotic stewardship efforts.
- Several
scientific contributions illustrating the benefits of the Unyvero
Lower Respiratory panels and the utility of the Acuitas AMR Gene
Panel will be presented at the World Microbe Forum, June 20-24,
2021.
- OpGen subsidiary
Ares Genetics announced publication of a study introducing best
practice techniques for AI-powered prediction of antibiotic
susceptibility testing which aimed at advancing good machine
learning practices (GMLP) for WGS-based AST by describing best
practice techniques for training and evaluation of predictive
models, as well as introducing an optimized model architecture to
reduce bias and promote robustness.
- OpGen subsidiary
Ares Genetics signed several agreements with early access customers
for the new Ares universal pathogen assay (ARESupa). The initial
version of this target enrichment NGS panel is aimed at enabling
testing for pathogens and AMR in native specimens and covers over
6,000 genetic markers for AMR selected from ARESdb.
- OpGen subsidiary
Ares Genetics will be presenting at the upcoming Amazon Web
Services (AWS) Healthcare & life Sciences Virtual Symposium on
May 27, 2021 on “Bridging limitations in NGS-based infectious
disease testing using machine learning.”
- OpGen completed
a $25 million registered direct offering priced at the market with
one healthcare-focused U.S. institutional investor, as well as a
warrant exercise and exchange deal for proceeds of $ 9.7
million.
Mr. Schacht commented, “We had a busy quarter
that resulted in great progress towards the fight against AMR with
multiple publications issued supporting OpGen’s products and
mission, new and existing partnership growth that will help drive
topline revenue and OpGen also announced regulatory progress
particularly with the Chinese NMPA. We also significantly
strengthened our balance sheet during the first quarter. As we push
through the second quarter, we believe we can achieve an FDA
clearance decision for our Acuitas AMR Gene Panel as soon as the
FDA’s timelines will permit and work towards pipeline and growth
objectives in the year ahead and I look forward to the company’s
continued successes.”
Conference Call Information
OpGen’s management will host a conference call
today, May 13 at 8:30 a.m. EDT to discuss the 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:
+1-877-705-6003International Dial-in Number:
+1-201-493-6725Webcast:
http://public.viavid.com/index.php?id=144749Conference
ID: 13719409
Following the conclusion of the conference call,
a replay will be available through May 27, 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 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: 13719409
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 2021 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,
Inc. |
Consolidated
Balance Sheets |
(unaudited) |
|
|
|
|
|
|
|
|
March 31, 2021 |
|
December 31, 2020 |
|
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
39,397,437 |
|
|
$ |
13,360,463 |
|
|
Accounts
receivable, net |
|
|
485,983 |
|
|
|
653,104 |
|
|
Inventory,
net |
|
|
1,417,440 |
|
|
|
1,485,986 |
|
|
Prepaid
expenses and other current assets |
|
|
1,472,666 |
|
|
|
1,388,090 |
|
|
Total current assets |
|
|
42,773,526 |
|
|
|
16,887,643 |
|
|
Property and
equipment, net |
|
|
3,649,747 |
|
|
|
3,259,487 |
|
|
Finance
lease right-of-use assets, net |
|
|
338,673 |
|
|
|
449,628 |
|
|
Operating
lease right-of-use assets |
|
|
2,383,364 |
|
|
|
2,082,300 |
|
|
Goodwill |
|
|
7,694,401 |
|
|
|
8,024,729 |
|
|
Intangible
assets, net |
|
|
15,656,651 |
|
|
|
16,580,963 |
|
|
Strategic
inventory |
|
|
2,057,016 |
|
|
|
1,686,342 |
|
|
Other
noncurrent assets |
|
|
602,220 |
|
|
|
779,953 |
|
|
Total assets |
|
$ |
75,155,598 |
|
|
$ |
49,751,045 |
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts
payable |
|
$ |
1,249,461 |
|
|
$ |
1,868,666 |
|
|
Accrued
compensation and benefits |
|
|
2,286,441 |
|
|
|
2,126,511 |
|
|
Accrued
liabilities |
|
|
1,712,008 |
|
|
|
1,437,141 |
|
|
Deferred
revenue |
|
|
9,808 |
|
|
|
9,808 |
|
|
Current
maturities of long-term debt |
|
|
282,055 |
|
|
|
699,000 |
|
|
Short-term
finance lease liabilities |
|
|
183,533 |
|
|
|
266,470 |
|
|
Short-term
operating lease liabilities |
|
|
849,895 |
|
|
|
964,434 |
|
|
Total current liabilities |
|
|
6,573,201 |
|
|
|
7,372,030 |
|
|
Long-term
debt, net |
|
|
19,430,641 |
|
|
|
19,378,935 |
|
|
Derivative
liabilities |
|
|
206,973 |
|
|
|
112,852 |
|
|
Long-term
finance lease liabilities |
|
|
29,265 |
|
|
|
46,794 |
|
|
Long-term
operating lease liabilities |
|
|
2,737,211 |
|
|
|
1,492,544 |
|
|
Other long
term liabilities |
|
|
147,026 |
|
|
|
156,635 |
|
|
Total liabilities |
|
|
29,124,317 |
|
|
|
28,559,790 |
|
|
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; 38,266,482
and 25,085,534 shares issued and outstanding at March 31, 2021
and December 31, 2020, respectively |
|
|
382,665 |
|
|
|
250,855 |
|
|
Additional
paid-in capital |
|
|
259,766,331 |
|
|
|
219,129,045 |
|
|
Accumulated
deficit |
|
|
(215,586,418 |
) |
|
|
(200,735,827 |
) |
|
Accumulated
other comprehensive income |
|
|
1,468,703 |
|
|
|
2,547,182 |
|
|
Total stockholders’ equity |
|
|
46,031,281 |
|
|
|
21,191,255 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
75,155,598 |
|
|
$ |
49,751,045 |
|
|
|
|
|
|
|
|
OpGen,
Inc. |
Consolidated
Statements of Operations and Comprehensive Loss |
(unaudited) |
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
Revenue |
|
|
|
|
|
Product
sales |
|
$ |
613,918 |
|
|
$ |
366,933 |
|
|
Laboratory
services |
|
|
97,726 |
|
|
|
— |
|
|
Collaboration revenue |
|
|
118,072 |
|
|
|
250,000 |
|
|
Total revenue |
|
|
829,716 |
|
|
|
616,933 |
|
|
Operating expenses |
|
|
|
|
|
Cost of
products sold |
|
|
554,054 |
|
|
|
276,554 |
|
|
Cost of
services |
|
|
104,984 |
|
|
|
137,666 |
|
|
Research and
development |
|
|
2,813,491 |
|
|
|
1,217,556 |
|
|
General and
administrative |
|
|
2,663,657 |
|
|
|
1,701,448 |
|
|
Sales and
marketing |
|
|
899,252 |
|
|
|
282,277 |
|
|
Transaction
costs |
|
|
— |
|
|
|
245,322 |
|
|
Impairment
of intangibles assets |
|
|
— |
|
|
|
750,596 |
|
|
Impairment
of right-of-use asset |
|
|
55,496 |
|
|
|
— |
|
|
Total operating expenses |
|
|
7,090,934 |
|
|
|
4,611,419 |
|
|
Operating loss |
|
|
(6,261,218 |
) |
|
|
(3,994,486 |
) |
|
Warrant
inducement expense |
|
|
(7,755,541 |
) |
|
|
— |
|
|
Interest and
other income |
|
|
4,925 |
|
|
|
87,335 |
|
|
Interest
expense |
|
|
(1,164,982 |
) |
|
|
(38,267 |
) |
|
Foreign
currency transaction gains (losses) |
|
|
427,615 |
|
|
|
(3,876 |
) |
|
Change in
fair value of derivative financial instruments |
|
|
(101,390 |
) |
|
|
— |
|
|
Total other expense |
|
|
(8,589,373 |
) |
|
|
45,192 |
|
|
Loss
before income taxes |
|
|
(14,850,591 |
) |
|
|
(3,949,294 |
) |
|
Provision for income taxes |
|
|
— |
|
|
|
— |
|
|
Net
loss |
|
$ |
(14,850,591 |
) |
|
$ |
(3,949,294 |
) |
|
Net
loss available to common stockholders |
|
$ |
(14,850,591 |
) |
|
$ |
(3,949,294 |
) |
|
Net loss per
common share - basic and diluted |
|
$ |
(0.50 |
) |
|
$ |
(0.53 |
) |
|
Weighted
average shares outstanding - basic and diluted |
|
|
29,485,067 |
|
|
|
7,393,232 |
|
|
Net
loss |
|
$ |
(14,850,591 |
) |
|
$ |
(3,949,294 |
) |
|
Other
comprehensive loss - foreign currency translation |
|
|
(1,078,479 |
) |
|
|
39,477 |
|
|
Comprehensive loss |
|
$ |
(15,929,070 |
) |
|
$ |
(3,909,817 |
) |
|
|
|
|
|
|
|
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
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