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 2022 financial and operating results. Management will
host an investor call to discuss quarterly results and provide a
business update.
“We are excited about our 2022 progress to date,
as we continue to achieve our key milestones,” said Oliver Schacht,
President & CEO of OpGen. “We started off the year with
successful V&V testing of our Unyvero A30 RQ instrument, and we
received positive interim data results of the Unyvero Urinary Tract
Infection (UTI) Panel and we are moving forward towards completing
the enrollment of the UTI clinical trial and anticipated subsequent
FDA submission in the second half of 2022.”
Dr. Schacht continued, “We are executing on our
key milestones and expanding and nurturing our network of
partnerships and collaborations. Also, we have seen over 76% growth
in direct sales in the U.S. compared to the first quarter of last
year. We are excited about the year ahead and look forward to
continuing the fight against antimicrobial resistance.”
First Quarter 2022 Financial Results of OpGen,
Inc.
- Total revenue
for the first quarter of 2022 was approximately $0.47 million,
compared with $0.83 million in the first quarter of 2021.
- Operating
expenses for the first quarter of 2022 were approximately $6.3
million, compared with $7.1 million in the first quarter of
2021.
- The net loss
available to common stockholders for the first quarter of 2022 was
approximately $6.8 million, or $0.15 per share, compared with $14.9
million, or $0.50 per share, in the first quarter of 2021. This was
primarily due to a one-time non-cash accounting charge for the
Company’s warrant inducement transaction consummated in
Q1-2021.
- Cash and cash equivalents were
approximately $30.7 million as of March 31, 2022, compared with
$36.1 million as of December 31, 2021.
“Despite the continued COVID headwinds, there
were bright spots in the growth in direct product sales in the
U.S.,” said Albert Weber, OpGen’s Chief Financial Officer. “Based
on this progress and a healthy funnel of commercial opportunities,
we remain optimistic about the future growth trajectory of the
company in the coming quarters.”
Mr. Weber also commented on the restructuring of
the repayment of the first tranche of the loan from the European
Investment Bank (EIB) to OpGen’s German subsidiary, Curetis GmbH
(Curetis). In April, OpGen announced that Curetis and the EIB plan
to restructure the repayment of the first debt tranche which became
due in April 2022. Based on this plan, the Company repaid euro 5
million in April 2022 and expects to amortize the remainder of the
debt tranche of approximately euro 8.35 million (balance as of the
twelve-month period beginning in May 2022) in monthly instalments
of about euro 0.7 million. Mr. Weber stated that, “We’ve approached
our debt repayment in a strategic way that gives us greater
flexibility to manage our cash and avoid reserving large amounts of
shares from our authorized common at a time when share price has
been under quite some pressure.”
In the reporting quarter and year to date, the
Company reached the following key milestones:
- OpGen completed
the successful verification and validation (V&V) and lifetime
testing of its Unyvero A30 RQ instruments. This testing clears the
path for the Company to finalize the new platform instrument and
prepare the build of its first set of series-ready instruments
which is expected to occur later this year.
- In February
2022, OpGen data was published in the Journal of Clinical
Microbiology for its Acuitas AMR Gene Panel Multicenter Clinical
Trial.
- OpGen received
positive interim data results on the Unyvero UTI Panel and is on
track to complete enrollment of the UTI clinical trial in the
second half of 2022 and subsequently submit to the FDA.
- Ares Genetics
and Sandoz extended their existing master services agreement until
January 31, 2025. This collaboration focuses on next-generation
sequencing (NGS) and artificial intelligence (AI) assisted
bioinformatics solutions for surveillance and drug repurposing
efforts.
- Ares Genetics
commercially launched new sequencing and analysis services
globally, which includes ARESid and ARESiss Express, aimed at
clinical microbiologists and specialists in public health and
infection prevention and control. These services are performed at
Ares Genetics’ service laboratory in Vienna, Austria and are
anticipated to be launched in the U.S. later this year.
- OpGen’s
subsidiary Curetis and the EIB plan to restructure the first
tranche of debt that came due in April 2022. Subject to
finalization of definitive legal agreements, Curetis repaid euro
5.0 million in cash in April 2022 and will pay the remainder of the
debt tranche amounting to approximately euro 8.35 million or
approximately $9 million at current foreign exchange rates.
Payments of such amount will be amortized over the course of the
next 12 month-period and paid in equal monthly installments of
approximately euro 0.7 million in cash, beginning at the end of May
2022. Interest rates on the remaining debt would remain unchanged
at 10% per annum. The equity linked percent participation interest
or PPI would increase from 0.3% to 0.75% of OpGen’s market cap as
of June 2024. The remaining two tranches of debt maturing in 2023
and 2024 are unchanged at this time.
In terms of fiscal 2022 guidance, OpGen
expects:
- U.S. direct
product sales of Unyvero and Acuitas are anticipated to grow by at
least 50%;
- Continued growth
in its European and international distribution business for Unyvero
products albeit at more moderate growth rates;
- Improved
traction of Ares Genetics related services and software solutions
business;
- Overall, 2022
revenue growth of approximately around 25% to 50% year over year
from the products and services business; and
- Potential upside
from future strategic partnering or licensing deal(s) for the
Unyvero A30 platform or the Ares database assets.
Conference Call Information
OpGen’s management will host a conference call
today, May 12th at 4:30 p.m. EDT, to go over the first quarter
financial results and business activities, as well as answer
analyst questions.
Dial-in
InformationU.S. Dial-in Number:
+1-877-704-4453International Dial-in Number:
+1-201-389-0920Webcast:
https://services.choruscall.com/mediaframe/webcast.html?webcastid=n37DadqyConference
ID: 13729189
Following the conclusion of the conference call,
a replay will be available through May 26th, 2022. 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: 13729189
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 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
the first quarter 2022 financials of OpGen 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, the
continued realization of expected benefits of our business
combination transaction with Curetis GmbH, the continued impact of
COVID-19 on the Company’s operations, financial results, and
commercialization efforts as well as on capital markets and general
economic conditions, 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,
Inc. |
Consolidated
Balance Sheets |
(unaudited) |
|
|
|
|
|
|
|
|
March 31, 2022 |
|
December 31, 2021 |
|
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
30,653,410 |
|
|
$ |
36,080,392 |
|
|
Accounts
receivable, net |
|
|
265,885 |
|
|
|
1,172,396 |
|
|
Inventory,
net |
|
|
1,361,221 |
|
|
|
1,239,456 |
|
|
Prepaid
expenses and other current assets |
|
|
1,212,195 |
|
|
|
1,250,331 |
|
|
Total current assets |
|
|
33,492,711 |
|
|
|
39,742,575 |
|
|
Property and
equipment, net |
|
|
3,721,720 |
|
|
|
4,011,748 |
|
|
Finance
lease right-of-use assets, net |
|
|
50,756 |
|
|
|
90,467 |
|
|
Operating
lease right-of-use assets |
|
|
1,706,346 |
|
|
|
1,814,396 |
|
|
Goodwill |
|
|
7,316,883 |
|
|
|
7,453,007 |
|
|
Intangible
assets, net |
|
|
14,054,168 |
|
|
|
14,530,209 |
|
|
Strategic
inventory |
|
|
3,448,808 |
|
|
|
3,472,337 |
|
|
Other
noncurrent assets |
|
|
468,041 |
|
|
|
551,794 |
|
|
Total assets |
|
$ |
64,259,433 |
|
|
$ |
71,666,533 |
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts
payable |
|
$ |
865,440 |
|
|
$ |
1,307,081 |
|
|
Accrued
compensation and benefits |
|
|
1,695,557 |
|
|
|
1,621,788 |
|
|
Accrued
liabilities |
|
|
1,582,882 |
|
|
|
1,965,845 |
|
|
Current
maturities of long-term debt |
|
|
14,394,824 |
|
|
|
14,519,113 |
|
|
Short-term
finance lease liabilities |
|
|
26,462 |
|
|
|
43,150 |
|
|
Short-term
operating lease liabilities |
|
|
447,710 |
|
|
|
459,792 |
|
|
Total current liabilities |
|
|
19,012,875 |
|
|
|
19,916,769 |
|
|
Long-term
debt, net |
|
|
7,955,483 |
|
|
|
7,176,251 |
|
|
Derivative
liabilities |
|
|
114,804 |
|
|
|
228,589 |
|
|
Long-term
finance lease liabilities |
|
|
2,803 |
|
|
|
3,644 |
|
|
Long-term
operating lease liabilities |
|
|
2,860,703 |
|
|
|
2,977,402 |
|
|
Other
long-term liabilities |
|
|
141,631 |
|
|
|
146,798 |
|
|
Total liabilities |
|
|
30,088,299 |
|
|
|
30,449,453 |
|
|
Stockholders’ equity |
|
|
|
|
|
Preferred
stock, $0.01 par value; 10,000,000 shares authorized; none issued
and outstanding at March 31, 2022 and December 31, 2021,
respectively |
|
|
— |
|
|
|
— |
|
|
Common
stock, $0.01 par value; 100,000,000 shares authorized; 46,557,750
and 46,450,250 shares issued and outstanding at March 31, 2022
and December 31, 2021, respectively |
|
|
465,578 |
|
|
|
464,503 |
|
|
Additional
paid-in capital |
|
|
275,949,034 |
|
|
|
275,708,490 |
|
|
Accumulated
deficit |
|
|
(242,345,255 |
) |
|
|
(235,541,539 |
) |
|
Accumulated
other comprehensive income |
|
|
101,777 |
|
|
|
585,626 |
|
|
Total stockholders’ equity |
|
|
34,171,134 |
|
|
|
41,217,080 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
64,259,433 |
|
|
$ |
71,666,533 |
|
|
|
|
|
|
|
|
OpGen,
Inc. |
|
Consolidated
Statements of Operations and Comprehensive Loss |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months
Ended March 31, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
Revenue |
|
|
|
|
|
Product
sales |
|
$ |
366,052 |
|
|
$ |
613,918 |
|
|
Laboratory
services |
|
|
42,929 |
|
|
|
97,726 |
|
|
Collaboration revenue |
|
|
60,764 |
|
|
|
118,072 |
|
|
Total revenue |
|
|
469,745 |
|
|
|
829,716 |
|
|
Operating expenses |
|
|
|
|
|
Cost of
products sold |
|
|
291,997 |
|
|
|
554,054 |
|
|
Cost of
services |
|
|
30,562 |
|
|
|
104,984 |
|
|
Research and
development |
|
|
2,316,441 |
|
|
|
2,813,491 |
|
|
General and
administrative |
|
|
2,625,053 |
|
|
|
2,663,657 |
|
|
Sales and
marketing |
|
|
1,051,432 |
|
|
|
899,252 |
|
|
Impairment
of right-of-use asset |
|
|
— |
|
|
|
55,496 |
|
|
Total operating expenses |
|
|
6,315,485 |
|
|
|
7,090,934 |
|
|
Operating loss |
|
|
(5,845,740 |
) |
|
|
(6,261,218 |
) |
|
Other (expense) income |
|
|
|
|
|
Warrant
inducement expense |
|
|
— |
|
|
|
(7,755,541 |
) |
|
Interest and
other income |
|
|
3,121 |
|
|
|
4,925 |
|
|
Interest
expense |
|
|
(1,269,581 |
) |
|
|
(1,164,982 |
) |
|
Foreign
currency transaction gains |
|
|
198,740 |
|
|
|
427,615 |
|
|
Change in
fair value of derivative financial instruments |
|
|
109,744 |
|
|
|
(101,390 |
) |
|
Total other expense |
|
|
(957,976 |
) |
|
|
(8,589,373 |
) |
|
Loss
before income taxes |
|
|
(6,803,716 |
) |
|
|
(14,850,591 |
) |
|
Provision for income taxes |
|
|
— |
|
|
|
— |
|
|
Net
loss |
|
$ |
(6,803,716 |
) |
|
$ |
(14,850,591 |
) |
|
Net
loss available to common stockholders |
|
$ |
(6,803,716 |
) |
|
$ |
(14,850,591 |
) |
|
Net loss per
common share - basic and diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.50 |
) |
|
Weighted
average shares outstanding - basic and diluted |
|
|
46,483,694 |
|
|
|
29,485,067 |
|
|
Net
loss |
|
$ |
(6,803,716 |
) |
|
$ |
(14,850,591 |
) |
|
Other
comprehensive loss - foreign currency translation |
|
|
(483,849 |
) |
|
|
(1,078,479 |
) |
|
Comprehensive loss |
|
$ |
(7,287,565 |
) |
|
$ |
(15,929,070 |
) |
|
|
|
|
|
|
|
OpGen:Oliver SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact:Alyssa
FactorEdison Groupafactor@edisongroup.com
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