OpGen Reports Third Quarter 2021 Financial Results and Provides Business Update
November 11 2021 - 4:05PM
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 nine months ended September 30,
2021, and provided a business update. Total OpGen revenue for the
third quarter of 2021 was approximately $1.24 million, up 17% from
$1.06 million in the third quarter of 2020. Cash as of September
30, 2021, was approximately $25.4 million, up significantly from
the $13.4 million at year-end 2020, and the Company’s cash balance
was approximately $40 million in October following the closing of a
$15 million registered direct financing.
Oliver Schacht, President & CEO of OpGen,
commented, “We were able to reach major milestone developments in
the third quarter, one of which is the FDA 510(k) clearance of our
Acuitas AMR Gene Panel. This clearance has allowed us to begin
commercializing the Acuitas AMR Gene Panel right away. During this
quarter, we also launched AREScloud, our first own software suite
which allows us to further monetize the value of the ARESdb data
asset. OpGen has made major progress this quarter, transforming
from an R&D-driven company further into a commercial-stage
enterprise, and we are on the right path to continued growth and
future success.”
Third Quarter 2021 Financial Results of
OpGen, Inc.
- Total revenue for the third quarter
of 2021 was approximately $1.24 million, up 17% from $1.06 million
in the third quarter of 2020. This increase is primarily attributed
to the stronger Unyvero sales that are beginning to counteract the
loss of the FISH product line. Total revenue for the nine months
ended September 30, 2021 was approximately $2.9 million, which was
in line with revenue for the nine months ended September 30, 2020.
This seemingly unchanged revenue is primarily attributed to the
discontinuation of the FISH product line and lower Ares R&D
collaboration and New York State DOH project revenues, which were
offset by significantly increased revenues from Unyvero sales,
Curetis COVID testing, and Ares services.
- Operating expenses for the third
quarter of 2021 were approximately $6.3 million compared with $7.2
million in the third quarter of 2020. Operating expenses for the
nine months ended September 30, 2021 were approximately $20.4
million, as compared to $19.6 million for the nine months ended
September 30, 2020.
- The net loss for the third quarter
of 2021 was $6.1 million, or $0.16 per share, compared with $7.7
million, or $0.40 per share, in the third quarter of 2020. The net
loss for the nine months ended September 30, 2021 was $28.0
million, or $0.79 per share, as compared with a net loss of $19.1
million, or $1.36 per share, for the nine months ended September
30, 2020. The increase in net loss is attributable to a $7.8
million non-cash warrant inducement charge in 2021.
- Cash and cash equivalents were
$25.4 million as of September 30, 2021, compared to $13.4 million
as of December 31, 2020.
- All numbers pertaining to nine
months ended September 30, 2020 only include two quarters of
combined financials following the business combination between
OpGen and Curetis on April 1, 2020.
The company announced accomplishment of the
following key milestones and recent developments in the third
quarter as well as 2021 to date:
- OpGen received FDA clearance for
Acuitas® AMR Gene Panel, which allows testing for a comprehensive
panel of 28 AMR markers in isolated bacterial colonies from 26
different pathogens. The panel expands clinicians’ ability to
diagnose and rapidly test for potential antibiotic resistance to
select drugs in 9 classes of antibiotics. Immediately upon
receiving the FDA clearance, OpGen began a major marketing and
sales campaign across hundreds of institutions in the U.S.
- Ares Genetics, an OpGen subsidiary,
launched AREScloud, a commercial web application designed to
expedite the analysis of sequenced clinical isolates. The software
fully automates data processes and allows for comparative and
outbreak analysis. Ares Genetics is actively engaged in discussion
with clinical experts on the usage of AREScloud, in addition to
collaborating with two prominent U.S. hospitals on independent
studies to assess the platform for clinical routine use and
outbreak analysis.
- OpGen recently announced the
appointment of Albert Weber as its Chief Financial Officer,
effective January 1, 2022. Mr. Weber joins OpGen from
U.S.-German molecular diagnostics company Epigenomics, where he was
most recently Epigenomics’ Executive Officer, Executive Board
member, and EVP Finance. In addition to more than 20 years of
running the finance, accounting and controlling functions in a
Frankfurt Stock Exchange-listed molecular diagnostics company, Mr.
Weber brings a variety of experience in closing commercial
agreements, such as R&D collaborations, licensing,
distribution, and manufacturing deals, with international partners
as well as strategic M&A processes.
- OpGen announced data from a large
investigator-initiated and driven prospective controlled
multicenter study using the Unyvero HPN Panel for hospitalized
patients with suspicion of pneumonia. The study found that the
Unyvero HPN Panel not only significantly reduced inappropriate
antibiotic therapy by 45.1%, but it also reduced the overall
antibiotic therapy duration by 22.5%.
- OpGen initiated a clinical trial
for its Unyvero Urinary Tract Infection (UTI) Panel. The trial is
expected to enroll more than 1,500 prospective patient samples and
will be conducted at multiple sites in the U.S. The data from this
study will be used to support the ensuing submission to the FDA for
OpGen to seek clearance in the U.S.
- OpGen announced and closed a $15
million registered direct offering with a single healthcare-focused
institutional investor for the issuance and sale of an aggregate of
150,000 shares of convertible preferred stock and warrants to
purchase up to an aggregate of 7,500,000 shares of common
stock.
Mr. Schacht commented, “As we continue to
progress into the fourth quarter and the remainder of 2021, we are
very excited about the future of OpGen. Albert Weber joins OpGen at
a great time and will bring transatlantic CFO experience and a
long-standing track record in the molecular diagnostics industry. I
have been fortunate enough to have known Albert for the past two
decades and know the wealth of experience he brings to the team
here at OpGen. We enter the fourth quarter in a strong position
from the direct offering of $15 million. We plan to use the
proceeds to continue our commercial launch of Acuitas AMR, further
growing the Unyvero business in the U.S. and abroad and to fund
future clinical trials, as well as potential repayment of debt
obligations to EIB as we evaluate potential options to restructure
and maybe convert into equity that debt. We look forward to the
continued growth and corporate development of OpGen.”
Conference Call Information
OpGen’s management will host a conference call today, November
11th at 4:30 p.m. EST to discuss the third 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=146838Conference
ID: 13723808
Following the conclusion of the conference call,
a replay will be available through November 25, 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: 13723808
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 third 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 our financings, our ability to obtain stockholder
approval for an increase in the company’s authorized shares of
common stock or otherwise pursue alternative means for continued
financing, 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) |
|
|
|
|
|
|
|
September 30, 2021 |
|
December 31, 2020 |
Assets |
|
|
|
|
Current assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
25,352,337 |
|
|
$ |
13,360,463 |
|
Accounts receivable, net |
|
|
751,065 |
|
|
|
653,104 |
|
Inventory, net |
|
|
1,356,912 |
|
|
|
1,485,986 |
|
Prepaid expenses and other current assets |
|
|
2,319,939 |
|
|
|
1,388,090 |
|
Total current assets |
|
|
29,780,253 |
|
|
|
16,887,643 |
|
Property and equipment, net |
|
|
4,290,204 |
|
|
|
3,259,487 |
|
Finance lease right-of-use assets, net |
|
|
141,387 |
|
|
|
449,628 |
|
Operating lease right-of-use assets |
|
|
1,885,025 |
|
|
|
2,082,300 |
|
Goodwill |
|
|
7,606,071 |
|
|
|
8,024,729 |
|
Intangible assets, net |
|
|
15,050,387 |
|
|
|
16,580,963 |
|
Strategic inventory |
|
|
2,974,992 |
|
|
|
1,686,342 |
|
Other noncurrent assets |
|
|
560,599 |
|
|
|
779,953 |
|
Total assets |
|
$ |
62,288,918 |
|
|
$ |
49,751,045 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts payable |
|
$ |
1,146,895 |
|
|
$ |
1,868,666 |
|
Accrued compensation and benefits |
|
|
1,342,013 |
|
|
|
2,126,511 |
|
Accrued liabilities |
|
|
1,329,983 |
|
|
|
1,437,141 |
|
Deferred revenue |
|
|
— |
|
|
|
9,808 |
|
Current maturities of long-term debt |
|
|
14,668,424 |
|
|
|
699,000 |
|
Short-term finance lease liabilities |
|
|
68,831 |
|
|
|
266,470 |
|
Short-term operating lease liabilities |
|
|
610,336 |
|
|
|
964,434 |
|
Total current liabilities |
|
|
19,166,482 |
|
|
|
7,372,030 |
|
Long-term debt, net |
|
|
6,484,300 |
|
|
|
19,378,935 |
|
Derivative liabilities |
|
|
225,395 |
|
|
|
112,852 |
|
Long-term finance lease liabilities |
|
|
7,869 |
|
|
|
46,794 |
|
Long-term operating lease liabilities |
|
|
2,953,615 |
|
|
|
1,492,544 |
|
Other long term liabilities |
|
|
152,405 |
|
|
|
156,635 |
|
Total liabilities |
|
|
28,990,066 |
|
|
|
28,559,790 |
|
Stockholders' equity |
|
|
|
|
Preferred stock, $0.01 par value; 10,000,000 shares authorized;
none issued and outstanding at September 30, 2021 and December 31,
2020, respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.01 par value; 50,000,000 shares authorized;
38,270,250 and 25,085,534 shares issued and outstanding at
September 30, 2021 and December 31, 2020,
respectively |
|
|
382,703 |
|
|
|
250,855 |
|
Additional paid-in capital |
|
|
260,244,997 |
|
|
|
219,129,045 |
|
Accumulated deficit |
|
|
(228,729,675 |
) |
|
|
(200,735,827 |
) |
Accumulated other comprehensive income |
|
|
1,400,827 |
|
|
|
2,547,182 |
|
Total stockholders’ equity |
|
|
33,298,852 |
|
|
|
21,191,255 |
|
Total liabilities and stockholders’ equity |
|
$ |
62,288,918 |
|
|
$ |
49,751,045 |
|
|
|
|
|
|
OpGen,
Inc. |
Consolidated
Statements of Operations and Comprehensive Loss |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months
Ended September 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Revenue |
|
|
|
|
|
|
|
|
Product sales |
|
$ |
643,887 |
|
|
$ |
601,562 |
|
|
$ |
1,479,270 |
|
|
$ |
1,569,799 |
|
Laboratory services |
|
|
192,753 |
|
|
|
112,892 |
|
|
|
643,602 |
|
|
|
138,884 |
|
Collaboration revenue |
|
|
402,492 |
|
|
|
342,311 |
|
|
|
757,591 |
|
|
|
1,153,400 |
|
Total revenue |
|
|
1,239,132 |
|
|
|
1,056,765 |
|
|
|
2,880,463 |
|
|
|
2,862,083 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
648,298 |
|
|
|
1,350,296 |
|
|
|
1,544,932 |
|
|
|
2,340,766 |
|
Cost of services |
|
|
203,314 |
|
|
|
159,794 |
|
|
|
446,232 |
|
|
|
550,115 |
|
Research and development |
|
|
2,382,303 |
|
|
|
2,433,553 |
|
|
|
8,055,384 |
|
|
|
6,630,134 |
|
General and administrative |
|
|
2,088,226 |
|
|
|
2,356,413 |
|
|
|
7,444,138 |
|
|
|
6,549,432 |
|
Sales and marketing |
|
|
1,003,577 |
|
|
|
932,671 |
|
|
|
2,705,378 |
|
|
|
2,258,980 |
|
Transaction costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
470,322 |
|
Impairment of intangibles assets |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
750,596 |
|
Impairment of right-of-use asset |
|
|
— |
|
|
|
— |
|
|
|
170,714 |
|
|
|
— |
|
Total operating expenses |
|
|
6,325,718 |
|
|
|
7,232,727 |
|
|
|
20,366,778 |
|
|
|
19,550,345 |
|
Operating loss |
|
|
(5,086,586 |
) |
|
|
(6,175,962 |
) |
|
|
(17,486,315 |
) |
|
|
(16,688,262 |
) |
Other (expense) income |
|
|
|
|
|
|
|
|
Gain on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
259,353 |
|
|
|
— |
|
Warrant inducement expense |
|
|
— |
|
|
|
— |
|
|
|
(7,755,541 |
) |
|
|
— |
|
Interest and other income, net |
|
|
31,844 |
|
|
|
19,965 |
|
|
|
41,471 |
|
|
|
101,644 |
|
Interest expense |
|
|
(1,222,867 |
) |
|
|
(1,183,927 |
) |
|
|
(3,586,018 |
) |
|
|
(2,267,085 |
) |
Foreign currency transaction gains/(losses) |
|
|
229,074 |
|
|
|
(501,168 |
) |
|
|
655,774 |
|
|
|
(794,832 |
) |
Change in fair value of derivative financial instruments |
|
|
(8,161 |
) |
|
|
165,497 |
|
|
|
(122,572 |
) |
|
|
548,008 |
|
Total other expense |
|
|
(970,110 |
) |
|
|
(1,499,633 |
) |
|
|
(10,507,533 |
) |
|
|
(2,412,265 |
) |
Loss before income taxes |
|
|
(6,056,696 |
) |
|
|
(7,675,595 |
) |
|
|
(27,993,848 |
) |
|
|
(19,100,527 |
) |
Provision for income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(6,056,696 |
) |
|
$ |
(7,675,595 |
) |
|
$ |
(27,993,848 |
) |
|
$ |
(19,100,527 |
) |
Net loss available to common stockholders |
|
$ |
(6,056,696 |
) |
|
$ |
(7,675,595 |
) |
|
$ |
(27,993,848 |
) |
|
$ |
(19,100,527 |
) |
Net loss per common share - basic and diluted |
|
$ |
(0.16 |
) |
|
$ |
(0.40 |
) |
|
$ |
(0.79 |
) |
|
$ |
(1.36 |
) |
Weighted average shares outstanding - basic and diluted |
|
|
38,270,250 |
|
|
|
19,116,864 |
|
|
|
35,373,397 |
|
|
|
14,016,896 |
|
Net loss |
|
$ |
(6,056,696 |
) |
|
$ |
(7,675,595 |
) |
|
$ |
(27,993,848 |
) |
|
$ |
(19,100,527 |
) |
Other comprehensive (loss)/income - foreign currency
translation |
|
|
(597,527 |
) |
|
|
1,266,901 |
|
|
|
(1,146,355 |
) |
|
|
1,631,317 |
|
Comprehensive loss |
|
$ |
(6,654,223 |
) |
|
$ |
(6,408,694 |
) |
|
$ |
(29,140,203 |
) |
|
$ |
(17,469,210 |
) |
|
|
|
|
|
|
|
|
|
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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