OpGen Reports First Quarter 2023 Financial Results and Provides Business Update
May 15 2023 - 4:15PM
OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision
medicine company harnessing the power of molecular diagnostics and
bioinformatics to help combat infectious disease, reported its
first quarter 2023 financial and operating results. Management will
host an investor call to discuss quarterly results and provide a
business update.
Oliver Schacht, President & CEO of OpGen,
commented, “The beginning of this year has been a news rich period.
It's clear the momentum during the first quarter has carried over
to the second quarter. We look forward to our near-term strategic
goals and continue to focus on executing on our operational and
commercial plans.”
Mr. Schacht continued, “We continue to see
revenue growth opportunities for our Unyvero products and Ares
Genetics’ services globally and especially here in the U.S. We
recently announced our distribution partnership for Unyvero
products with Fisher Healthcare, and we believe will create
traction and momentum for our Unyvero sales in the U.S. under this
distribution partnership in the coming quarters and beyond.”
First Quarter 2023 Financial Results of OpGen,
Inc.
- Total revenue
for the first quarter of 2023 was approximately $0.91 million, an
increase of approximately 94% over the company’s revenue of $0.47
million in the first quarter of 2022. Compared to the fourth
quarter 2022 revenue of $0.72 million, OpGen achieved a 26% revenue
increase in the first quarter of 2023.
- Total operating
expenses decreased in the first quarter of 2023 to $6.0 million
compared to $6.3 million for the same quarter in 2022.
- Cash and cash equivalents were
approximately $7.0 million as of March 31, 2023, compared with $7.4
million as of December 31, 2022.
During the year to date period, the Company
reached the following key milestones:
- OpGen
subsidiary, Curetis, met all remaining key milestones in its
R&D collaboration project with the Foundation for Innovative
New Diagnostics (FIND).
- Signed a
short-term expansion of Curetis’ R&D collaboration with FIND.
The work already completed under the collaboration was expanded by
three work packages, which increased total project volume to up to
approximately $913 thousand in revenue.
- Submitted a De
Novo classification request to the FDA for the marketing
authorization of Unyvero Urinary Tract Infection (UTI) panel. The
Company received confirmation from the FDA that the submission is
complete, and that they have initiated substantive review. If
cleared, the Unyvero UTI would become the first ever rapid
multiplex sample-to-answer IVD test for urinary tract infections
available in the U.S.
- Entered a
non-exclusive distribution agreement with Fisher Healthcare, a part
of Thermo Fisher Scientific. This agreement is for the distribution
of the Unyvero A50 platform and in vitro diagnostic tests for
pneumonia and urinary tract infections.
- Entered into a
strategic advisory agreement to support Unyvero A30 corporate
business development in China and engage in frequent, ongoing
dialog with our Chinese partners.
- OpGen
subsidiary, Ares Genetics, announced that they were granted a key
patent in China. The patent covers the identification and
diagnostic use of genomic variants for the diagnosis of antibiotic
resistant bacteria infections.
- Closed $7.5
million and $3.5 million public offerings with net proceeds to be
used, among other things, for the support of commercialization of
the Acuitas AMR Gene Panel, products on the Unyvero platform,
development of the ARES database, and to support direct sales and
marketing as well as repayment of certain indebtedness to the
EIB.
The Company reiterates and updates its guidance
for 2023 as follows:
- net cash
consumption of around $4.5 to $5 million per quarter from its
current operations;
- continue
pursuing significant revenue growth opportunities, especially with
Unyvero product sales and ARESiss services, both in the U.S. and
internationally;
- actively pursue
the commercial opportunities in our funnel;
- expect global
revenues from our products, services and collaborations for 2023 to
be in the range of approximately $4 to $5 million;
- engage in interactive review with
the FDA towards a clearance decision on the De Novo classification
request for the Unyvero UTI panel;
- recognize approximately $180
thousand in the second quarter for the additional work packages
from the FIND collaboration;
- expect continued revenue generation
and growth under the collaboration between Curetis and BioVersys
during 2023 and 2024 as the BioVersys clinical trial
progresses;
- prioritize non-dilutive financing
with several multi-million dollar proposals already submitted or
currently being prepared for submission, recognizing that the
Company needs a strong balance sheet to support and provide
co-funding for projects under any such agreements.
Conference Call Information
OpGen’s management will host a conference call
today, May 15, 2023 at 4:30 p.m. EST, to review the first quarter
2023 financial results and business activities, as well as answer
analyst questions.
Conference Call Details |
|
U.S. Dial-in Number: |
1-877-704-4453 |
International Dial-in
Number: |
1-201-389-0920 |
Conference ID: |
13738364 |
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1611539&tp_key=76976884dc |
Following the conclusion of the conference call, a replay will
be available through May 29th, 2023. 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 Details |
|
U.S. Dial-in Number: |
1-844-512-2921 |
International Dial-in
Number: |
1-412-317-6671 |
Replay PIN: |
13738364 |
|
|
About OpGen, Inc.
OpGen, Inc. (Rockville, Md., U.S.A.) 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 current
product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the
ARES Technology Platform including ARESdb, NGS technology and
AI-powered bioinformatics solutions for antibiotic response
prediction including ARESiss, ARESid, ARESasp, and AREScloud, as
well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test
kit.
For more information, please visit www.opgen.com
Forward-Looking Statements
This press release includes statements regarding
the first quarter 2023 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, the success of our commercialization efforts, 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, our
ability to satisfy debt obligations under our loan with the
European Investment Bank, the effect of the military action in
Russia and Ukraine on our distributors, collaborators and service
providers, our liquidity and working capital requirements, 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 Investor & Press Contact: Alyssa
Factor Edison Group afactor@edisongroup.com
OpGen, Inc. and Subsidiaries |
Consolidated Balance Sheets |
(unaudited) |
|
|
|
|
|
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
Assets |
|
|
|
|
Current
assets |
|
|
|
|
Cash and cash equivalents |
$ |
7,039,375 |
|
|
$ |
7,440,030 |
|
|
Accounts receivable, net |
|
666,765 |
|
|
|
514,372 |
|
|
Inventory, net |
|
1,577,762 |
|
|
|
1,345,137 |
|
|
Prepaid expenses and other
current assets |
|
1,455,815 |
|
|
|
1,355,949 |
|
|
Total current
assets |
|
10,739,717 |
|
|
|
10,655,488 |
|
|
Property and equipment,
net |
|
3,666,823 |
|
|
|
3,457,531 |
|
|
Finance lease right-of-use
assets, net |
|
2,671 |
|
|
|
3,500 |
|
|
Operating lease right-of-use
assets |
|
2,139,974 |
|
|
|
1,459,413 |
|
|
Intangible assets, net |
|
7,398,333 |
|
|
|
7,440,974 |
|
|
Strategic inventory, net |
|
2,066,795 |
|
|
|
2,300,614 |
|
|
Other noncurrent assets |
|
497,055 |
|
|
|
495,629 |
|
|
Total
assets |
$ |
26,511,368 |
|
|
$ |
25,813,149 |
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current
liabilities |
|
|
|
Accounts payable |
$ |
266,637 |
|
|
$ |
420,821 |
|
|
Accrued compensation and
benefits |
|
1,424,602 |
|
|
|
1,097,654 |
|
|
Accrued liabilities |
|
1,436,014 |
|
|
|
1,526,204 |
|
|
Deferred revenue |
|
46,003 |
|
|
|
142,061 |
|
|
Current maturities of
long-term debt |
|
4,959,417 |
|
|
|
7,023,901 |
|
|
Short-term finance lease
liabilities |
|
2,803 |
|
|
|
3,364 |
|
|
Short-term operating lease
liabilities |
|
500,994 |
|
|
|
377,626 |
|
|
Total current
liabilities |
|
8,636,470 |
|
|
|
10,591,631 |
|
|
Long-term debt, net |
|
5,358,433 |
|
|
|
4,850,686 |
|
|
Long-term finance lease
liabilities |
|
— |
|
|
|
280 |
|
|
Long-term operating lease
liabilities |
|
3,121,433 |
|
|
|
2,566,138 |
|
|
Derivative liabilities |
|
88,635 |
|
|
|
99,498 |
|
|
Other long-term
liabilities |
|
129,213 |
|
|
|
129,368 |
|
|
Total
liabilities |
|
17,334,184 |
|
|
|
18,237,601 |
|
|
Stockholders’
equity |
|
|
|
Preferred stock, $0.01 par
value; 10,000,000 shares authorized; none issued and outstanding at
March 31, 2023 and December 31, 2022 |
|
— |
|
|
|
— |
|
|
Common stock, $0.01 par value;
100,000,000 shares authorized; 5,495,546 and 2,899,911 shares
issued and outstanding at March 31, 2023 and December 31,
2022, respectively |
|
54,955 |
|
|
|
28,999 |
|
|
Additional paid-in
capital |
|
288,326,377 |
|
|
|
281,167,161 |
|
|
Accumulated deficit |
|
(278,561,375 |
) |
|
|
(272,824,772 |
) |
|
Accumulated other
comprehensive loss |
|
(642,773 |
) |
|
|
(795,840 |
) |
|
Total stockholders’
equity |
|
9,177,184 |
|
|
|
7,575,548 |
|
|
Total liabilities and
stockholders’ equity |
$ |
26,511,368 |
|
|
$ |
25,813,149 |
|
|
OpGen, Inc. and Subsidiaries |
Consolidated Statements of Operations and Comprehensive
Loss |
(unaudited) |
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
|
Revenue |
|
|
Product sales |
$ |
410,897 |
|
|
$ |
366,052 |
|
|
Laboratory services |
|
21,673 |
|
|
|
42,929 |
|
|
Collaboration revenue |
|
480,874 |
|
|
|
60,764 |
|
|
Total
revenue |
|
913,444 |
|
|
|
469,745 |
|
|
Operating
expenses |
|
|
Cost of products sold |
|
592,378 |
|
|
|
291,997 |
|
|
Cost of services |
|
128,306 |
|
|
|
30,562 |
|
|
Research and development,
net |
|
1,812,831 |
|
|
|
2,316,441 |
|
|
General and
administrative |
|
2,423,953 |
|
|
|
2,625,053 |
|
|
Sales and marketing |
|
1,026,087 |
|
|
|
1,051,432 |
|
|
Total operating
expenses |
|
5,983,555 |
|
|
|
6,315,485 |
|
|
Operating
loss |
|
(5,070,111 |
) |
|
|
(5,845,740 |
) |
|
Other (expense)
income |
|
|
Interest and other income |
|
30,106 |
|
|
|
3,121 |
|
|
Interest expense |
|
(617,298 |
) |
|
|
(1,269,581 |
) |
|
Foreign currency transaction
(losses) gains |
|
(91,994 |
) |
|
|
198,740 |
|
|
Change in fair value of
derivative financial instruments |
|
12,694 |
|
|
|
109,744 |
|
|
Total other
expense |
|
(666,492 |
) |
|
|
(957,976 |
) |
|
Loss before income
taxes |
|
(5,736,603 |
) |
|
|
(6,803,716 |
) |
|
Provision for income
taxes |
|
— |
|
|
|
— |
|
|
Net loss |
$ |
(5,736,603 |
) |
|
$ |
(6,803,716 |
) |
|
Net loss available to
common stockholders |
$ |
(5,736,603 |
) |
|
$ |
(6,803,716 |
) |
|
Basic and diluted net loss per
share attributable to common stockholders |
$ |
(1.25 |
) |
|
$ |
(2.93 |
) |
|
Weighted average shares
outstanding - basic and diluted |
|
4,577,269 |
|
|
|
2,324,184 |
|
|
Net loss |
$ |
(5,736,603 |
) |
|
$ |
(6,803,716 |
) |
|
Other comprehensive income
(loss) - foreign currency translation |
|
153,067 |
|
|
|
(483,849 |
) |
|
Comprehensive
loss |
$ |
(5,583,536 |
) |
|
$ |
(7,287,565 |
) |
|
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