In a release published March 29, 2023 under the same headline
by OpGen, Inc. (Nasdaq: OPGN), the financial tables were
incorrect. The corrected release follows:
- Total revenue for 2022 was
approximately $2.6 million
-
Balance sheet strengthened by recently closed public offering with
gross proceeds of $7.5 million
-
Conference call to be held March 29, 2023 at 4:30
p.m. ET
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 today its fourth quarter 2022 and full-year 2022
financial and operating results and provided a business update.
OpGen’s revenue for the fourth quarter of 2022
was approximately $722 thousand. Its total revenue for 2022
was approximately $2.6 million which was in line with the
Company’s most recent guidance.
“Overall, in 2022 there were several business
advancements for OpGen with the completion of a successful UTI
clinical trial and initial commercial contracts for our Acuitas AMR
Gene Panel in the U.S.,” said Oliver Schacht, President &
CEO of OpGen. “We believe recent milestones, as well as
upcoming near-term catalysts and continued commercialization of
approved products put OpGen in a good position to increase
revenues.”
Mr. Schacht continued, “As we proceed through
2023, we expect several announcements including commercialization
of our AI-powered NGS-based ARESiss services in the U.S., ARESdb
expansion, finalizing our Unyvero A50 UTI FDA submission, exploring
multiple collaboration and non-dilutive financing opportunities,
and updates regarding a recently initiated strategic corporate
business development campaign in China for our Unyvero A30
platform.”
Fourth Quarter and Full Year 2022
Financial Results of OpGen, Inc.
- Fourth quarter revenue for 2022 was approximately $722
thousand, compared with approximately $1.4 million in the fourth
quarter of 2021. Our fourth quarter revenues, however, represent a
61% increase over our third quarter 2022 revenues of $449 thousand.
For the twelve months ended December 31, 2022, total revenue was
approximately $2.6 million compared to the twelve months ended
December 31, 2021 of approximately $4.3 million, which was in line
with OpGen’s most recent guidance.
- Total operating expenses in the fourth quarter of 2022 were
$10.7 million compared to $7.2 million for the same quarter in
2021. This includes a one-time non-cash accounting charge for the
impairment of the Company’s in-process R&D (IPR&D)
indefinite-lived intangible asset of $5.4 million. For the twelve
months ended December 31, 2022, operating expenses amounted to
$37.2 million, compared to $27.6 million in 2021. The full year
numbers include the impairment of both goodwill as well as
IPR&D totaling $12.3 million.
- Cash and cash equivalents as of December 31, 2022 were
approximately $7.4 million, a decrease compared to the balance at
December 31, 2021 of $36.1 million.
In reporting OpGen’s fourth quarter and full
year financials for 2022, Albert Weber, OpGen’s Chief
Financial Officer (CFO), said, “In 2022, our operating expenses
remained in line with our initial expectations and tracked well
against our guidance for yearly net cash consumption. We reduced
our R&D expenses significantly and also reduced our general
administrative expenses. We started growing our sales and marketing
expenses in line with the planned shift to more commercial
operations, with a clear focus on the U.S. market.”
“Compared to the third quarter of 2022, we
achieved a 61% increase in revenue during the final quarter of
2022,” said Mr. Weber. “This increase was primarily due to the
revenue generated from the FIND collaboration project, Unyvero
product sales and revenue we received from our Acuitas AMR Gene
Panel commercial contracts.” He continued, “while we experienced an
overall revenue decline from 2021 to 2022, due to the termination
of the FISH product line and the one-off non-exclusive sale of a
portion of the ARES database, both in 2021, we are working towards
increasing product sales across all platforms (i.e. Unyvero,
Acuitas and ARES) in 2023.”
OpGen’s management believes that, given the
abrupt change by the Chinese government in the first quarter of
2023 on their zero COVID policy, there is now a realistic
opportunity for OpGen’s local partner, Beijing Clear Biotech, to
initiate the outstanding clinical study in China for the Unyvero
pneumonia product, thereby adding to the upcoming catalysts for
OpGen in 2023.
The Company announced reaching the following key
milestones, as well as recent developments in the fourth quarter of
2022 and into 2023 to date:
- On the commercial front, subsidiary Ares Genetics (Ares),
announced a successful move to a new Vienna location and received a
key patent grant in China. Ares also received the first commercial
customer orders in the U.S., with revenue generation expecting to
commence in the first quarter of 2023.
- With significant 28% growth in the number of datasets in the
ARESdb database in the first quarter of 2023, Ares is well
positioned to continue executing on plans to expand and improve the
menu of its accurate AI models to predict antibiotic susceptibility
from genomic data.
- Based on the final data read-out from the Unyvero UTI Panel’s
clinical trial in the U.S., OpGen is now in the process of
finalizing the FDA submission package, aiming for an imminent
submission of the De Novo classification request early in the
second quarter of 2023.
- At the beginning of 2023, we announced that we achieved several
key milestones under our Unyvero A30 platform collaboration with
the Foundation for Innovative New Diagnostics (FIND) in December
2022, which triggered a EUR 200 thousand milestone payment received
in the first quarter of 2023. Data on the final milestone
deliverables under the initial contract is expected in the near
term. Conditional on such successful milestone achievements, we
believe there is great potential for future collaboration
opportunities with FIND. Discussions have already commenced for a
follow-on deal that would cover product development steps,
including clinical trials and regulatory filings, as well as
manufacturing scale up and preparation for launch of the Unyvero
A30 in certain low- and middle-income countries.
- On the Unyvero A30 platform front, the focus is on non-dilutive
partnership opportunities with other non-governmental organizations
similar to FIND as well as U.S. government entities that offer
funding opportunities. We have also teamed up with a strategic
advisory firm to support a Unyvero A30 specific corporate business
development campaign in China where there is an attractive
opportunity for us to partner with and possibly license or monetize
the A30 platform.
As part of OpGen’s 2023 initiatives, Mr. Schacht
commented, “We expect future growth in the commercial roll out of
Unyvero products and the Acuitas AMR Gene Panel. We have focused on
expanding and progressing our commercial pipeline for the AMR Gene
Panel as well as Unyvero LRT and UTI and we are engaging in several
ongoing discussions with hospitals. In the post-COVID fourth
quarter of 2022 and into the first quarter of 2023, we have seen
that hospitals have a significant backlog of investment needs and
are taking longer than pre-COVID to complete contracts.
Nonetheless, OpGen has multiple contracts for Unyvero and Acuitas
that we believe are in final review with purchasing departments at
several hospitals.”
In terms of guidance for
2023, OpGen expects to:
- have a net cash consumption of around $4.5 to $5 million per
quarter from its current operations;
- maintain an active dialog with the European Investment Bank
(EIB) regarding the potential to restructure the second tranche of
its loan with a principal amount of EUR 3 million, plus accumulated
and deferred interest, which becomes due at the end of June
2023;
- pursue significant revenue growth opportunities, especially
with Unyvero product sales and with ARESiss services, both in the
U.S. and internationally;
- see global revenues from our products, services and
collaborations for 2023 to be in a range of approximately $4 to $5
million;
- actively pursue the commercial opportunities in our funnel,
which includes proposals that we believe are currently in the final
review and negotiation stages, clearly indicating significant
revenue growth potential for OpGen; and
- following the upcoming regulatory submission of the Unyvero UTI
product to the FDA based on the final UTI clinical trial data
read-out, expect to enter interactive review with the FDA towards a
clearance decision on the De Novo classification request.
Conference Call Information
OpGen’s management will host a conference call
today, March 29th at 4:30 p.m. EDT, to discuss the
fourth quarter and full-year 2022 financial results and other
business activities, as well as answer questions. Dial-in
information is below:
Conference Call Details
- U.S. Dial-in Number: 1-877-704-4453
- International Dial-in Number:1-201-389-0920
-
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1595064&tp_key=d21054e901
- Conference ID: 13735798
Replay Details
- U.S. Dial-in Number: 1-844-512-2921
- International Dial-in Number:1-412-317-6671
- Replay PIN: 13735798
Following the conclusion of the conference call,
a replay will be available through April 12, 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.
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 fourth quarter 2022 and full year 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
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, our ability to realize
any anticipated benefits from the reverse stock split, including
maintaining its listing on the Nasdaq Capital Market and attracting
new investors, 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 SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Investor & Press Contact:Alyssa
FactorEdison
Groupafactor@edisongroup.com
OpGen, Inc. |
Consolidated Balance Sheets |
(unaudited) |
|
|
|
|
|
December 31, 2022 |
|
December 31, 2021 |
Assets |
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
$ |
7,440,030 |
|
|
$ |
36,080,392 |
|
Accounts receivable, net |
|
514,372 |
|
|
|
1,172,396 |
|
Inventory, net |
|
1,345,137 |
|
|
|
1,239,456 |
|
Prepaid expenses and other
current assets |
|
1,355,949 |
|
|
|
1,250,331 |
|
Total current
assets |
|
10,655,488 |
|
|
|
39,742,575 |
|
Property and equipment, net |
|
3,457,531 |
|
|
|
4,011,748 |
|
Finance lease right-of-use
assets, net |
|
3,500 |
|
|
|
90,467 |
|
Operating lease right-of-use
assets |
|
1,459,413 |
|
|
|
1,814,396 |
|
Goodwill |
|
— |
|
|
|
7,453,007 |
|
Intangible assets, net |
|
7,440,974 |
|
|
|
14,530,209 |
|
Strategic inventory |
|
2,300,614 |
|
|
|
3,472,337 |
|
Other noncurrent assets |
|
495,629 |
|
|
|
551,794 |
|
Total
assets |
$ |
25,813,149 |
|
|
$ |
71,666,533 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current
liabilities |
|
|
|
Accounts payable |
$ |
420,821 |
|
|
$ |
1,307,081 |
|
Accrued compensation and
benefits |
|
1,097,654 |
|
|
|
1,621,788 |
|
Accrued liabilities |
|
1,526,204 |
|
|
|
1,965,845 |
|
Deferred revenue |
|
142,061 |
|
|
|
— |
|
Short-term notes payable |
|
7,023,901 |
|
|
|
14,519,113 |
|
Short-term finance lease
liabilities |
|
3,364 |
|
|
|
43,150 |
|
Short-term operating lease
liabilities |
|
377,626 |
|
|
|
459,792 |
|
Total current
liabilities |
|
10,591,631 |
|
|
|
19,916,769 |
|
Note payable |
|
4,850,686 |
|
|
|
7,176,251 |
|
Derivative liabilities |
|
99,498 |
|
|
|
228,589 |
|
Long-term finance lease
liabilities |
|
280 |
|
|
|
3,644 |
|
Long-term operating lease
liabilities |
|
2,566,138 |
|
|
|
2,977,402 |
|
Other long term liabilities |
|
129,368 |
|
|
|
146,798 |
|
Total
liabilities |
|
18,237,601 |
|
|
|
30,449,453 |
|
Stockholders'
equity |
|
|
|
Preferred stock, $0.01 par value;
10,000,000 shares authorized; none issued and outstanding at
December 31, 2022 and December 31, 2021, respectively |
|
— |
|
|
|
— |
|
Common stock, $0.01 par value;
100,000,000 shares authorized; 2,899,911 and 2,322,511 shares
issued and outstanding at December 31, 2022 and December 31,
2021, respectively |
|
28,999 |
|
|
|
23,225 |
|
Additional paid-in capital |
|
281,167,161 |
|
|
|
276,149,768 |
|
Accumulated deficit |
|
(272,824,772 |
) |
|
|
(235,541,539 |
) |
Accumulated other comprehensive
(loss) income |
|
(795,840 |
) |
|
|
585,626 |
|
Total stockholders’
equity |
|
7,575,548 |
|
|
|
41,217,080 |
|
Total liabilities and
stockholders’ equity |
$ |
25,813,149 |
|
|
$ |
71,666,533 |
|
|
|
|
|
OpGen, Inc. |
Consolidated Statements of Operations and Comprehensive
Loss |
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenue |
|
|
|
|
|
|
|
Product sales |
$ |
279,427 |
|
|
$ |
1,177,399 |
|
|
$ |
1,893,862 |
|
|
$ |
2,656,669 |
|
Laboratory services |
|
78,118 |
|
|
|
169,608 |
|
|
|
172,633 |
|
|
|
813,210 |
|
Collaboration revenue |
|
364,085 |
|
|
|
78,561 |
|
|
|
540,798 |
|
|
|
836,152 |
|
Total
revenue |
|
721,630 |
|
|
|
1,425,568 |
|
|
|
2,607,293 |
|
|
|
4,306,031 |
|
Operating
expenses |
|
|
|
|
|
|
|
Cost of products sold |
|
495,009 |
|
|
|
750,896 |
|
|
|
3,319,586 |
|
|
|
2,295,828 |
|
Cost of services |
|
40,955 |
|
|
|
106,388 |
|
|
|
104,405 |
|
|
|
552,620 |
|
Research and development,
net |
|
1,552,125 |
|
|
|
2,855,295 |
|
|
|
8,173,435 |
|
|
|
10,910,679 |
|
General and administrative |
|
2,104,311 |
|
|
|
2,491,825 |
|
|
|
8,884,084 |
|
|
|
9,935,963 |
|
Sales and marketing |
|
1,092,379 |
|
|
|
1,007,885 |
|
|
|
4,344,656 |
|
|
|
3,713,263 |
|
Impairment of right-of-use
asset |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
170,714 |
|
Impairment of intangible
assets |
|
5,407,699 |
|
|
|
— |
|
|
|
5,407,699 |
|
|
|
— |
|
Goodwill impairment charge |
|
(34,971 |
) |
|
|
— |
|
|
|
6,940,549 |
|
|
|
— |
|
Total operating
expenses |
|
10,657,507 |
|
|
|
7,212,289 |
|
|
|
37,174,414 |
|
|
|
27,579,067 |
|
Operating
loss |
|
(9,935,877 |
) |
|
|
(5,786,721 |
) |
|
|
(34,567,121 |
) |
|
|
(23,273,036 |
) |
Other
expense |
|
|
|
|
|
|
|
Gain on extinguishment of
debt |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
259,353 |
|
Warrant inducement expense |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(7,755,541 |
) |
Interest and other income,
net |
|
18,788 |
|
|
|
3,708 |
|
|
|
46,935 |
|
|
|
45,179 |
|
Interest expense |
|
(637,611 |
) |
|
|
(1,213,313 |
) |
|
|
(3,256,410 |
) |
|
|
(4,799,331 |
) |
Foreign currency transaction
(losses) gains |
|
(39,538 |
) |
|
|
235,449 |
|
|
|
379,622 |
|
|
|
891,223 |
|
Change in fair value of
derivative financial instruments |
|
59,118 |
|
|
|
(7,159 |
) |
|
|
113,741 |
|
|
|
(129,731 |
) |
Total other
expense |
|
(599,243 |
) |
|
|
(981,315 |
) |
|
|
(2,716,112 |
) |
|
|
(11,488,848 |
) |
Loss before income
taxes |
|
(10,535,120 |
) |
|
|
(6,768,036 |
) |
|
|
(37,283,233 |
) |
|
|
(34,761,884 |
) |
Provision for income
taxes |
|
— |
|
|
|
43,828 |
|
|
|
— |
|
|
|
43,828 |
|
Net loss |
|
(10,535,120 |
) |
|
|
(6,811,864 |
) |
|
|
(37,283,233 |
) |
|
|
(34,805,712 |
) |
Deemed dividend on beneficial
conversion feature |
|
— |
|
|
|
(7,166,752 |
) |
|
|
— |
|
|
|
(7,166,752 |
) |
Net loss available to
common stockholders |
$ |
(10,535,120 |
) |
|
$ |
(13,978,616 |
) |
|
$ |
(37,283,233 |
) |
|
$ |
(41,972,464 |
) |
Basic and diluted net loss per
share attributable to common stockholders |
$ |
(3.87 |
) |
|
$ |
(6.91 |
) |
|
$ |
(15.27 |
) |
|
$ |
(22.89 |
) |
Weighted average shares
outstanding - basic and diluted |
|
2,720,574 |
|
|
|
2,022,240 |
|
|
|
2,441,580 |
|
|
|
1,833,704 |
|
Net loss |
$ |
(10,535,120 |
) |
|
$ |
(6,811,864 |
) |
|
$ |
(37,283,233 |
) |
|
$ |
(34,805,712 |
) |
Other comprehensive loss -
foreign currency translation |
|
866,283 |
|
|
|
(815,201 |
) |
|
|
(1,381,466 |
) |
|
|
(1,961,556 |
) |
Comprehensive
loss |
$ |
(9,668,837 |
) |
|
$ |
(7,627,065 |
) |
|
$ |
(38,664,699 |
) |
|
$ |
(36,767,268 |
) |
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