OpGen Reports Second Quarter 2021 Financial Results and Provides Business Update
August 12 2021 - 4:15PM
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, 2021
and provided a business update. Total OpGen revenue for the second
quarter of 2021 was approximately $0.8 million, down 32% from $1.2
million in the second quarter of 2020. Cash as of June 30, 2021 was
approximately $31.2 million, up significantly from the $13.4
million at year-end 2020.
Oliver Schacht, President & CEO of OpGen,
commented, “We are continuing to execute on our key development
milestones as recently seen with our assembly of 10 final
pre-series release analyzers of the Unyvero A30 RQ platform. In
this growth-oriented quarter we presented key clinical data at
several conferences, provided an update to our robust R&D
pipeline, and successfully completed a move to our new corporate
headquarters. I am pleased with our accomplishments and continue to
believe we are putting our company in a position to succeed.”
Second Quarter 2021 Financial Results of
OpGen, Inc.
- Total revenue for the second
quarter of 2021 was approximately $0.8 million, down 32% from $1.2
million in the second quarter of 2020. This decrease is primarily
attributable to exiting the FISH business at the end of the first
quarter of 2021 as well as the conclusion of non-recurring
partnering revenues from a completed R&D collaboration at Ares
Genetics in 2020. Total revenue for the first half of 2021 was
approximately $1.6 million, as compared to $1.8 million for the
first half of 2020. This decrease is primarily attributable to a
decline of $0.4 million in revenue due to our exit from the FISH
business and a decline of $0.5 million in revenue due to the
conclusion of non-recurring partnering revenues from a completed
R&D collaboration at Ares Genetics in 2020 offset by an
increase in lab service revenue of $0.4 million and a $0.3 million
increase in Unyvero product revenue.
- Operating expenses for the second
quarter of 2021 were approximately $7.0 million compared with $7.7
million in the second quarter of 2020. Operating expenses for the
first half of 2021 were approximately $14.0 million, as compared to
$12.3 million for the first half of 2020.
- The net loss for the second quarter
of 2021 was $7.1 million, or $0.19 per share, compared with $7.5
million, or $0.49 per share, in the second quarter of 2020. The net
loss for the first half of 2021 was $21.9 million, or $0.65 per
share, as compared with a net loss of $11.4 million, or $1.00 per
share, for the first half of 2020;
- Cash and cash equivalents were
$31.2 million as of June 30, 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 second
quarter as well as 2021 to date:
- Curetis, an OpGen subsidiary,
successfully achieved a key development milestone by completing the
assembly of 10 final pre-series release Unyvero A30 RQ analyzers.
The systems have now commenced final verification and validation
testing. The Unyvero A30 RQ platform can be made available to third
party development and commercialization partners and licensees for
their own assay menu and product portfolio. Discussions are
currently ongoing with several potential platform partners for
various content-and-licensing or partnering scopes.
- OpGen submitted an updated 510(k)
summary to the FDA for our Acuitas AMR Gene Panel for Isolates in
June 2021. We believe the FDA has provided substantive feedback on
all key documents, including the Package Insert, Electronic User
Guide, and Operator Manual in May. The FDA previously stated that
they expect to complete its review by the end of August 2021. Since
such communications, there have been no changes to the timeline,
and the FDA has not provided any additional requests or questions.
The FDA previously clarified that their 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
timeline, we currently expect to see a completed review based on
this timeline.
- OpGen completed the move of its
U.S. headquarters, labs, and operations to a new facility in
Rockville, Maryland. The 10,000 square foot facility results in net
savings of approximately $0.6 million annually in operating
efficiencies and reduced rent. Going forward, all Unyvero
cartridges, as well as Acuitas consumables, will be stocked and
shipped directly from the new Rockville based facility.
- OpGen announced
prospective clinical data on the Unyvero LRT BAL at the June 29,
2021 webinar titled “One Academic Medical Center's Experience with
the Unyvero Multiplex Platform for Testing Bronchoalveolar Lavage
Fluids: Analytical and Clinical Assessment”, which studied patients
in the intensive care unit for whom bronchoalveolar lavage (BAL)
specimen was ordered for diagnostic purpose and prospectively
evaluated with the Unyvero LRT BAL panel in conjunction with
quantitative bacterial culture and antimicrobial susceptibility
testing. The clinical impact of the Unyvero results on antibiotic
stewardship and patient management were discussed and acted upon in
real-time, enabling earlier adjustment of antimicrobial therapy in
53% of cases.
- Dr. Cory Hale, Infectious Disease
Clinical Pharmacist at the Penn State Health Milton S. Hershey
Medical Center, presented on Unyvero LRT at the virtual World
Microbe Forum 2021. In their talk titled “Antimicrobial Stewardship
Opportunities Using Results from a Multiplex Molecular Lower
Respiratory Tract Panel as Compared to Conventional Culture”, their
data characterized the potential impact of Unyvero LRT on
antibiotic therapy in patients being treated for pneumonia.
Retrospective chart reviews were performed in 92 of these patients,
including 51 critically ill ICU patients and 39 pediatric patients.
They reported complete agreement between Unyvero LRT and culture
results in 50% of cases, and in 45.7% of cases, Unyvero yielded
more information than culture. This demonstrates the potential
value that Unyvero LRT could bring in clinical patient
management.
- An ‘i-poster’ presented at the virtual World Microbe Forum 2021
by Dr. Drew Bell of Indiana University School of Medicine, titled
“Clinical Evaluation of a Multiplex Molecular Diagnostic Lower
Respiratory Tract Panel for Bronchoalveolar Lavage Specimens,”
demonstrated that the Unyvero LRT BAL provided a basis for
appropriate escalation and de-escalation of antibiotic therapies in
42% of cases, reducing time to appropriate therapy by 31
hours.
- Ares Genetics, an OpGen subsidiary,
recently entered into several additional collaborations that are
expected to help expand the ARESdb as a curated AMR marker
database. These additional collaborations include on the one hand,
a scientific and clinical project with UPMC, Pittsburgh, PA and on
the other hand a strategic collaboration with a leading U.S. CRO
and reference lab. Under the latter collaboration agreement Ares
Genetics will be able to select a large number of clinical isolates
to augment and grow its unique ARESdb with curated data sets. In
return Ares has committed to providing certain next generation
sequencing (NGS) services to the collaboration partner. Several
additional collaboration and licensing agreements are currently in
various stages of negotiation and pricing discussions.
- Dr. Johannes
Weinberger, NGS Lab Director at Ares Genetics provided an update on
their culture-free genomic assay for AMR surveillance via virtual
presentation at a conference sponsored by Twist Bioscience. Dr.
Weinberger commented that “The sensitivity for AMR marker detection
in native urine samples from septic patients with confirmed
mono-infections in our study was determined to be between 94% and
100% when compared to comparator data obtained from whole genome
sequencing of the corresponding bacterial isolate.”
- Dr. Arne
Materna, CEO of Ares Genetics, presented virtually at the
Genomics-Track discussion at the Amazon Web Services healthcare
& life sciences symposium. Dr. Materna discussed that the Ares
universal pathogenome assay (ARESupa), is currently being evaluated
in a paid-for early access program for which Ares has already
signed up five public health organizations from different European
countries.
- Dr. Materna
presented preliminary data of an ongoing, multicenter validation of
long-read nanopore sequencing of clinical isolates through two
virtual seminars, furthering OpGen’s R&D updates. Ares Genetics
is conducting the multicenter validation by Oxford Nanopore
Technology (ONT) in combination with AREScloud for data analysis.
AREScloud assisted conversion of ONT data into clinically and
epidemiologically relevant information proved highly accurate for
participating labs, with consistent average accuracies of 100% for
pathogen identification, up to 97% for AMR marker detection, and up
to 100% for predictive antimicrobial susceptibility testing
(AST).
Mr. Schacht commented, “As we continue into the
third quarter, we are waiting for the FDA to complete their review
of our AMR Gene Panel for Isolates. We are also in regular dialog
with the Chinese NMPA via our strategic partner Beijing Clear Bio.
The Chinese NMPA recently requested supplemental clinical data to
be generated and submitted in China, and we are working with our
partners to finalize study design and swift study execution in due
course. We are also working diligently on finding a new Chief
Financial Officer to join the OpGen team following the resignation
of our current CFO Tim Dec. Together with our board, we are
continuing to evaluate alternatives for financing the future growth
of OpGen and believe these are steps that will help drive the
company forward and on its desired path.”
Conference Call Information
OpGen’s management will host a conference call
today, August 12 at 4:30 p.m. EDT to discuss the second quarter
financial results and other business activities, as well as answer
questions. Dial-in information is below:
Dial-in
InformationU.S. Dial-in Number:
+1-800-458-4121International Dial-in Number:
+1-323-794-2093Webcast:
http://public.viavid.com/index.php?id=146054Conference
ID: 7301173
Following the conclusion of the conference call,
a replay will be available through August 26, 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: 7301173
About OpGen, Inc.
OpGen, Inc. (Rockville, MD, USA) is a precision
medicine company harnessing the power of molecular diagnostics and
bioinformatics to help combat infectious disease. Along with our
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 and first half of 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 our
financings, 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) |
|
|
|
|
|
|
|
|
June 30, 2021 |
|
December 31, 2020 |
|
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
31,182,385 |
|
|
$ |
13,360,463 |
|
|
Accounts
receivable, net |
|
|
472,567 |
|
|
|
653,104 |
|
|
Inventory,
net |
|
|
1,333,880 |
|
|
|
1,485,986 |
|
|
Prepaid
expenses and other current assets |
|
|
2,081,549 |
|
|
|
1,388,090 |
|
|
Total current assets |
|
|
35,070,381 |
|
|
|
16,887,643 |
|
|
Property and
equipment, net |
|
|
4,223,155 |
|
|
|
3,259,487 |
|
|
Finance
lease right-of-use assets, net |
|
|
227,209 |
|
|
|
449,628 |
|
|
Operating
lease right-of-use assets |
|
|
2,038,073 |
|
|
|
2,082,300 |
|
|
Goodwill |
|
|
7,790,595 |
|
|
|
8,024,729 |
|
|
Intangible
assets, net |
|
|
15,662,324 |
|
|
|
16,580,963 |
|
|
Strategic
inventory |
|
|
2,995,436 |
|
|
|
1,686,342 |
|
|
Other
noncurrent assets |
|
|
555,190 |
|
|
|
779,953 |
|
|
Total assets |
|
$ |
68,562,363 |
|
|
$ |
49,751,045 |
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts
payable |
|
$ |
1,207,113 |
|
|
$ |
1,868,666 |
|
|
Accrued
compensation and benefits |
|
|
1,541,898 |
|
|
|
2,126,511 |
|
|
Accrued
liabilities |
|
|
1,137,196 |
|
|
|
1,437,141 |
|
|
Deferred
revenue |
|
|
— |
|
|
|
9,808 |
|
|
Current
maturities of long-term debt |
|
|
— |
|
|
|
699,000 |
|
|
Short-term
finance lease liabilities |
|
|
116,829 |
|
|
|
266,470 |
|
|
Short-term
operating lease liabilities |
|
|
854,233 |
|
|
|
964,434 |
|
|
Total current liabilities |
|
|
4,857,269 |
|
|
|
7,372,030 |
|
|
Long-term
debt, net |
|
|
20,670,941 |
|
|
|
19,378,935 |
|
|
Derivative
liabilities |
|
|
222,387 |
|
|
|
112,852 |
|
|
Long-term
finance lease liabilities |
|
|
18,693 |
|
|
|
46,794 |
|
|
Long-term
operating lease liabilities |
|
|
2,910,810 |
|
|
|
1,492,544 |
|
|
Other long
term liabilities |
|
|
146,344 |
|
|
|
156,635 |
|
|
Total liabilities |
|
|
28,826,444 |
|
|
|
28,559,790 |
|
|
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; 38,270,250
and 25,085,534 shares issued and outstanding at June 30, 2021
and December 31, 2020, respectively |
|
|
382,703 |
|
|
|
250,855 |
|
|
Additional
paid-in capital |
|
|
260,027,841 |
|
|
|
219,129,045 |
|
|
Accumulated
deficit |
|
|
(222,672,979 |
) |
|
|
(200,735,827 |
) |
|
Accumulated
other comprehensive income |
|
|
1,998,354 |
|
|
|
2,547,182 |
|
|
Total stockholders’ equity |
|
|
39,735,919 |
|
|
|
21,191,255 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
68,562,363 |
|
|
$ |
49,751,045 |
|
|
|
|
|
|
|
|
OpGen,
Inc. |
|
|
Consolidated
Statements of Operations and Comprehensive Loss |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months
Ended June 30, |
|
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
307,804 |
|
|
$ |
601,304 |
|
|
$ |
835,383 |
|
|
$ |
968,237 |
|
|
|
Laboratory
services |
|
|
266,784 |
|
|
|
25,992 |
|
|
|
450,849 |
|
|
|
25,992 |
|
|
|
Collaboration revenue |
|
|
237,027 |
|
|
|
561,089 |
|
|
|
355,099 |
|
|
|
811,089 |
|
|
|
Total revenue |
|
|
811,615 |
|
|
|
1,188,385 |
|
|
|
1,641,331 |
|
|
|
1,805,318 |
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
Cost of
products sold |
|
|
342,580 |
|
|
|
713,916 |
|
|
|
896,634 |
|
|
|
990,470 |
|
|
|
Cost of
services |
|
|
137,934 |
|
|
|
252,655 |
|
|
|
242,918 |
|
|
|
390,321 |
|
|
|
Research and
development |
|
|
2,859,590 |
|
|
|
2,979,025 |
|
|
|
5,673,081 |
|
|
|
4,196,581 |
|
|
|
General and
administrative |
|
|
2,692,255 |
|
|
|
2,491,571 |
|
|
|
5,355,912 |
|
|
|
4,193,019 |
|
|
|
Sales and
marketing |
|
|
802,549 |
|
|
|
1,044,032 |
|
|
|
1,701,801 |
|
|
|
1,326,309 |
|
|
|
Transaction
costs |
|
|
— |
|
|
|
225,000 |
|
|
|
— |
|
|
|
470,322 |
|
|
|
Impairment
of intangibles assets |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
750,596 |
|
|
|
Impairment
of right-of-use asset |
|
|
115,218 |
|
|
|
— |
|
|
|
170,714 |
|
|
|
— |
|
|
|
Total operating expenses |
|
|
6,950,126 |
|
|
|
7,706,199 |
|
|
|
14,041,060 |
|
|
|
12,317,618 |
|
|
|
Operating loss |
|
|
(6,138,511 |
) |
|
|
(6,517,814 |
) |
|
|
(12,399,729 |
) |
|
|
(10,512,300 |
) |
|
|
Other (expense) income |
|
|
|
|
|
|
|
|
|
|
Gain on
extinguishment of debt |
|
|
259,353 |
|
|
|
— |
|
|
|
259,353 |
|
|
|
— |
|
|
|
Warrant
inducement expense |
|
|
— |
|
|
|
— |
|
|
|
(7,755,541 |
) |
|
|
— |
|
|
|
Interest and
other income, net |
|
|
4,702 |
|
|
|
(5,656 |
) |
|
|
9,627 |
|
|
|
81,679 |
|
|
|
Interest
expense |
|
|
(1,198,169 |
) |
|
|
(1,044,891 |
) |
|
|
(2,363,151 |
) |
|
|
(1,083,158 |
) |
|
|
Foreign
currency transaction gains/(losses) |
|
|
(915 |
) |
|
|
(289,788 |
) |
|
|
426,700 |
|
|
|
(293,664 |
) |
|
|
Change in
fair value of derivative financial instruments |
|
|
(13,021 |
) |
|
|
382,511 |
|
|
|
(114,411 |
) |
|
|
382,511 |
|
|
|
Total other expense |
|
|
(948,050 |
) |
|
|
(957,824 |
) |
|
|
(9,537,423 |
) |
|
|
(912,632 |
) |
|
|
Loss
before income taxes |
|
|
(7,086,561 |
) |
|
|
(7,475,638 |
) |
|
|
(21,937,152 |
) |
|
|
(11,424,932 |
) |
|
|
Provision for income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
Net
loss |
|
$ |
(7,086,561 |
) |
|
$ |
(7,475,638 |
) |
|
$ |
(21,937,152 |
) |
|
$ |
(11,424,932 |
) |
|
|
Net
loss available to common stockholders |
|
$ |
(7,086,561 |
) |
|
$ |
(7,475,638 |
) |
|
$ |
(21,937,152 |
) |
|
$ |
(11,424,932 |
) |
|
|
Net loss per
common share - basic and diluted |
|
$ |
(0.19 |
) |
|
$ |
(0.49 |
) |
|
$ |
(0.65 |
) |
|
$ |
(1.00 |
) |
|
|
Weighted
average shares outstanding - basic and diluted |
|
|
38,268,293 |
|
|
|
15,403,986 |
|
|
|
33,900,964 |
|
|
|
11,427,322 |
|
|
|
Net
loss |
|
$ |
(7,086,561 |
) |
|
$ |
(7,475,638 |
) |
|
$ |
(21,937,152 |
) |
|
$ |
(11,424,932 |
) |
|
|
Other
comprehensive (loss)/income - foreign currency translation |
|
|
529,651 |
|
|
|
324,939 |
|
|
|
(548,828 |
) |
|
|
364,416 |
|
|
|
Comprehensive loss |
|
$ |
(6,556,910 |
) |
|
$ |
(7,150,699 |
) |
|
$ |
(22,485,980 |
) |
|
$ |
(11,060,516 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
OpGen:Oliver SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact:Max
ColbertEdison Groupmcolbert@edisongroup.com
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