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 2021 and full-year 2021 financial and operating
results and provided a business update.
OpGen’s revenue for the fourth quarter of 2021
was approximately $1.43 million, a 5% increase from $1.35 million
in Q4 2020. Its total revenue for 2021 was approximately $4.3
million, up 2% from $4.2 million in 2020.
“We are pleased with our fourth quarter and
full-year 2021 financial picture as we look forward to our 2022
commercialization initiatives,” said Oliver Schacht, President
& CEO of OpGen. “The Company’s positive 2022 outlook is based
on OpGen’s improved cash position, existing network of
partnerships, and recent collaborations.”
“We are continuing to execute on our key
development milestones, as recently seen with the successful
completion of final verification and validation, as well as
lifetime testing of the Unyvero A30 RQ platform,” Mr. Schacht
continued. “I am pleased with our accomplishments and continue to
believe we are putting our Company in a position to succeed.”
Fourth Quarter and Full-Year 2021 Financial Results of
OpGen, Inc.
- Total revenue
for the fourth quarter of 2021 was approximately $1.43 million,
compared with $1.35 million in the fourth quarter of 2020. Total
revenue for the twelve months ended December 31, 2021 was
approximately $4.3 million, compared to $4.2 million for the twelve
months ended December 31, 2020.
- Operating
expenses for the fourth quarter of 2021 were approximately $7.3
million, compared with $7.4 million in the fourth quarter of 2020.
Total operating expenses for the twelve months ended December 31,
2021 were approximately $27.6 million, compared to $26.9 million
for the twelve months ended December 31, 2020.
- The net loss
available to common stockholders for the fourth quarter of 2021 was
approximately $14.1 million, or $0.35 per share, compared with $7.1
million, or $0.34 per share, in the fourth quarter of 2020. The net
loss available to common stockholders for the twelve months ended
December 31, 2021, was approximately $42.0 million, or $1.14 per
share, compared to $26.2 million, or $1.66 per share, for the
twelve months ended December 31, 2020. The net loss available to
common stockholders for the twelve months ended December 31, 2021,
included non-cash charges of approximately $7.8 million and $7.2
million related to the Company’s 2021 warrant inducement and 2021
preferred stock offering, respectively.
- Cash and cash equivalents were
approximately $36.1 million as of December 31, 2021, compared with
$13.4 million as of December 31, 2020.
In reporting OpGen’s Q4 2021 and full-year
financials, Albert Weber, OpGen’s Chief Financial Officer (CFO),
said, “As we have entered 2022, we see ourselves in a much better
position than a year ago.” Mr. Weber joined OpGen in January 2022.
“With existing products picking up sales and with the upcoming
product commercialization pipeline, OpGen anticipates revenue
growth to be significantly stronger in 2022 than the previous year
and expects a steady improvement in gross margins over time. We
expect our R&D, G&A and sales and marketing spend will be
mostly on par with last year. We have a solid cash position to
execute on our business plan.”
“OpGen’s revenue growth is primarily attributed
to the strong uptake in Unyvero sales in the U.S. and globally,”
said Mr. Weber. “OpGen’s top line was further supported by
significant increases in laboratory services, mainly due to COVID
testing services performed by OpGen’s subsidiaries Curetis and Ares
Genetics’ NGS-based services. Collaboration revenue declined mainly
due to conclusion of a non-recurring R&D collaboration project
at Ares Genetics and the New York State Department of Health
project; however, it was more than offset by higher lab service
revenue.”
Mr. Weber reported that OpGen continues to
explore restructuring options for the repayment of amounts due
under its loan with the European Investment Bank, including through
the payment of cash, possible amortization over time, issuance of
equity over a period of up to 24 months or a combination of both.
The Company is in discussion with the EIB as well as several other
parties relating to such repayment options. The first tranche
under the loan of approximately $15 million matures and is due in
late April 2022 followed by maturity dates in June 2023 and June
2024 of approximately $4.4 million and $7.4 million,
respectively. Such options would allow the Company to
preserve cash and help avoid conversion of the debt to equity at
this time when there are unfavorable market conditions. The
Company believes that such changes will also provide greater
flexibility and potentially help minimize dilution.
The Company announced reaching the following key
milestones, as well as recent developments in the fourth quarter
and into 2022 to date:
- OpGen made two
strategic hires as of January 1, 2022: Albert Weber joined OpGen as
CFO and Managing Director of OpGen’s subsidiary Curetis GmbH, and
Theo deVos joined as Senior Vice President of Corporate Development
and Operations for Ares Genetics in the U.S.
- OpGen received
FDA clearance for Acuitas AMR Gene Panel. Several commercial
multi-year contracts have been submitted to hospitals and labs
across the U.S. These remain subject to final negotiation. OpGen
expects its first commercial sales of the Acuitas AMR Gene Panel in
the upcoming quarter(s) of 2022.
- Enrollment for
the Unyvero Urinary Tract Infection (UTI) Panel trial is
progressing and the Company expects completing an interim data
analysis and anticipates to communicate a relevant update early in
the second quarter.
- OpGen closed a
$15 million registered direct preferred stock offering with a
single, U.S.-based, healthcare-focused institutional investor in
October 2021. The investor subsequently converted all of its
150,000 shares of preferred stock into 7.5 million shares of common
stock in December 2021, which resulted in total shares outstanding,
as of December 31, 2021, of approximately 46.5 million shares of
common stock with no preferred stock remaining outstanding.
- OpGen held a
Special Meeting of Stockholders in December 2021, where both of its
proposals were approved. The first proposal was to reduce the
stockholder approval requirement to changes in the Charter to a
majority of the outstanding shares entitled to vote. The second
proposal was an amendment to the Charter to increase the authorized
number of shares of common stock from 50 million to 100
million.
- The Ares
database access deal in the fourth quarter 2021 contributed
significantly to product revenue for the non-exclusive access to
1.1% of the ARESdb content to a leading global microbiology and In
Vitro Diagnostics (IVD) corporation.
- Ares Genetics
successfully completed the first part of a collaboration with a
leading U.S. clinical research organization (CRO) and reference lab
and has entered the next phase. During this next phase, Ares
Genetics will gain access to up to 1,000 carefully selected
proprietary genome and antibiotic susceptibility testing (AST)
datasets. Ares Genetics aims to further increase the value of
ARESdb and grow its contents in the future through strategic
collaborations and clinical trials conducted by OpGen.
- OpGen completed
successful verification and validation (V&V) testing, as well
as lifetime testing, of its Unyvero A30RQ instruments.
In outlining OpGen’s 2022 initiatives, Mr.
Schacht said, “We look forward to achieving upcoming key milestones
in the development and commercialization of our innovative
diagnostic test portfolio.” “OpGen’s recent 510(k) approval for its
Acuitas AMR Gene Panel, the commercial launch of the AREScloud web
application, and Ares Genetics’ strategic non-exclusive database
access transaction, have already set the tone for 2022,” Mr.
Schacht said. “OpGen is expecting to report results of its Chinese
clinical study once completed and pending clearance decision by the
China’s National Medical Products Administration (NMPA), its
Unyvero UTI clinical trial and anticipated FDA submission, the
Unyvero A30 platform development and partnering activities, and
Ares Genetics’ commercial expansion in Europe and the U.S.”
In terms of guidance for 2022, OpGen expects
to:
- grow its U.S.
direct product sales of Unyvero and Acuitas by 50% or greater;
- continue to grow
its European and international distribution business for Unyvero
products albeit at more moderate growth rates;
- gain significant
traction and acceleration in Ares Genetics related services and
software solutions business;
- achieve overall
revenue growth from the products and services business for 2022 in
a range of approximately around 25% to 50% year over year; and
- have significant
upside potential from revenue recognition under any potential
future strategic partnering or licensing deal for the Unyvero A30
platform or the Ares database assets.
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 2021 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:
https://viavid.webcasts.com/starthere.jsp?ei=1525984&tp_key=2d6460e1c0Conference
ID: 13726634 |
Following the conclusion of the conference call,
a replay will be available through April 12, 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: 13726634 |
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
the fourth quarter 2021 and full year 2021 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, 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) |
|
|
|
|
|
|
|
|
December 31, 2021 |
|
December 31, 2020 |
|
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
36,080,392 |
|
|
$ |
13,360,463 |
|
|
Accounts
receivable, net |
|
|
1,172,396 |
|
|
|
653,104 |
|
|
Inventory,
net |
|
|
1,239,456 |
|
|
|
1,485,986 |
|
|
Prepaid
expenses and other current assets |
|
|
1,250,331 |
|
|
|
1,388,090 |
|
|
Total current assets |
|
|
39,742,575 |
|
|
|
16,887,643 |
|
|
Property and
equipment, net |
|
|
4,011,748 |
|
|
|
3,259,487 |
|
|
Finance
lease right-of-use assets, net |
|
|
90,467 |
|
|
|
449,628 |
|
|
Operating
lease right-of-use assets |
|
|
1,814,396 |
|
|
|
2,082,300 |
|
|
Goodwill |
|
|
7,453,007 |
|
|
|
8,024,729 |
|
|
Intangible
assets, net |
|
|
14,530,209 |
|
|
|
16,580,963 |
|
|
Strategic
inventory |
|
|
3,472,337 |
|
|
|
1,686,342 |
|
|
Other
noncurrent assets |
|
|
551,794 |
|
|
|
779,953 |
|
|
Total assets |
|
$ |
71,666,533 |
|
|
$ |
49,751,045 |
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts
payable |
|
$ |
1,307,081 |
|
|
$ |
1,868,666 |
|
|
Accrued
compensation and benefits |
|
|
1,621,788 |
|
|
|
2,126,511 |
|
|
Accrued
liabilities |
|
|
1,965,845 |
|
|
|
1,437,141 |
|
|
Deferred
revenue |
|
|
— |
|
|
|
9,808 |
|
|
Short-term
notes payable |
|
|
14,519,113 |
|
|
|
699,000 |
|
|
Short-term
finance lease liabilities |
|
|
43,150 |
|
|
|
266,470 |
|
|
Short-term
operating lease liabilities |
|
|
459,792 |
|
|
|
964,434 |
|
|
Total current liabilities |
|
|
19,916,769 |
|
|
|
7,372,030 |
|
|
Note
payable |
|
|
7,176,251 |
|
|
|
19,378,935 |
|
|
Derivative
liabilities |
|
|
228,589 |
|
|
|
112,852 |
|
|
Long-term
finance lease liabilities |
|
|
3,644 |
|
|
|
46,794 |
|
|
Long-term
operating lease liabilities |
|
|
2,977,402 |
|
|
|
1,492,544 |
|
|
Other long
term liabilities |
|
|
146,798 |
|
|
|
156,635 |
|
|
Total liabilities |
|
|
30,449,453 |
|
|
|
28,559,790 |
|
|
Stockholders' equity |
|
|
|
|
|
Preferred
stock, $0.01 par value; 10,000,000 shares authorized; none issued
and outstanding at December 31, 2021 and 2020, respectively |
|
|
— |
|
|
|
— |
|
|
Common
stock, $0.01 par value; 100,000,000 shares authorized; 46,450,250
and 25,085,534 shares issued and outstanding at December 31,
2021 and 2020, respectively |
|
|
464,503 |
|
|
|
250,855 |
|
|
Additional
paid-in capital |
|
|
275,708,490 |
|
|
|
219,129,045 |
|
|
Accumulated
deficit |
|
|
(235,541,539 |
) |
|
|
(200,735,827 |
) |
|
Accumulated
other comprehensive income |
|
|
585,626 |
|
|
|
2,547,182 |
|
|
Total stockholders’ equity |
|
|
41,217,080 |
|
|
|
21,191,255 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
71,666,533 |
|
|
$ |
49,751,045 |
|
|
|
|
|
|
|
|
OpGen,
Inc. |
|
Consolidated
Statements of Operations and Comprehensive Loss |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Year Ended
December 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
Revenue |
|
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
1,177,399 |
|
|
$ |
1,134,565 |
|
|
$ |
2,656,669 |
|
|
$ |
2,704,364 |
|
|
Laboratory
services |
|
|
169,608 |
|
|
|
28,852 |
|
|
|
813,210 |
|
|
|
167,736 |
|
|
Collaboration revenue |
|
|
78,561 |
|
|
|
188,941 |
|
|
|
836,152 |
|
|
|
1,342,341 |
|
|
Total revenue |
|
|
1,425,568 |
|
|
|
1,352,358 |
|
|
|
4,306,031 |
|
|
|
4,214,441 |
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
Cost of
products sold |
|
|
750,896 |
|
|
|
1,019,514 |
|
|
|
2,295,828 |
|
|
|
3,360,280 |
|
|
Cost of
services |
|
|
106,388 |
|
|
|
(61,904 |
) |
|
|
552,620 |
|
|
|
488,211 |
|
|
Research and
development, net |
|
|
2,855,295 |
|
|
|
3,334,586 |
|
|
|
10,910,679 |
|
|
|
9,964,720 |
|
|
General and
administrative |
|
|
2,624,227 |
|
|
|
2,252,229 |
|
|
|
9,935,963 |
|
|
|
8,801,661 |
|
|
Sales and
marketing |
|
|
1,007,885 |
|
|
|
835,112 |
|
|
|
3,713,263 |
|
|
|
3,094,092 |
|
|
Transaction
costs |
|
|
— |
|
|
|
1,200 |
|
|
|
— |
|
|
|
471,522 |
|
|
Impairment
of right-of-use asset |
|
|
— |
|
|
|
101,838 |
|
|
|
170,714 |
|
|
|
101,838 |
|
|
Impairment
of intangibles assets |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
750,596 |
|
|
Gain on sale
of equipment |
|
|
— |
|
|
|
(100,000 |
) |
|
|
— |
|
|
|
(100,000 |
) |
|
Total operating expenses |
|
|
7,344,691 |
|
|
|
7,382,575 |
|
|
|
27,579,067 |
|
|
|
26,932,920 |
|
|
Operating loss |
|
|
(5,919,123 |
) |
|
|
(6,030,217 |
) |
|
|
(23,273,036 |
) |
|
|
(22,718,479 |
) |
|
Other expense |
|
|
|
|
|
|
|
|
|
Gain on
extinguishment of debt |
|
|
— |
|
|
|
884,970 |
|
|
|
259,353 |
|
|
|
884,970 |
|
|
Warrant
inducement expense |
|
|
— |
|
|
|
— |
|
|
|
(7,755,541 |
) |
|
|
— |
|
|
Interest and
other income, net |
|
|
3,708 |
|
|
|
3,983 |
|
|
|
45,179 |
|
|
|
105,627 |
|
|
Interest
expense |
|
|
(1,213,313 |
) |
|
|
(1,132,299 |
) |
|
|
(4,799,331 |
) |
|
|
(3,399,384 |
) |
|
Foreign
currency transaction gains/(losses) |
|
|
235,449 |
|
|
|
(674,023 |
) |
|
|
891,223 |
|
|
|
(1,468,855 |
) |
|
Change in
fair value of derivative financial instruments |
|
|
31,322 |
|
|
|
(30,328 |
) |
|
|
(129,731 |
) |
|
|
517,680 |
|
|
Total other expense |
|
|
(942,834 |
) |
|
|
(947,697 |
) |
|
|
(11,488,848 |
) |
|
|
(3,359,962 |
) |
|
Loss
before income taxes |
|
|
(6,861,957 |
) |
- |
|
(6,977,914 |
) |
|
|
(34,761,884 |
) |
|
|
(26,078,441 |
) |
|
Provision for income taxes |
|
|
43,828 |
|
|
|
132,403 |
|
|
|
43,828 |
|
|
|
132,403 |
|
|
Net
loss |
|
$ |
(6,905,785 |
) |
|
$ |
(7,110,317 |
) |
|
$ |
(34,805,712 |
) |
|
$ |
(26,210,844 |
) |
|
Deemed
dividend on beneficial conversion feature |
|
|
(7,166,752 |
) |
|
|
— |
|
|
|
(7,166,752 |
) |
|
|
— |
|
|
Net
loss available to common stockholders |
|
$ |
(14,072,537 |
) |
|
$ |
(7,110,317 |
) |
|
$ |
(41,972,464 |
) |
|
$ |
(26,210,844 |
) |
|
Basic and
diluted net loss per share attributable to common stockholders |
|
$ |
(0.35 |
) |
|
$ |
(0.34 |
) |
|
$ |
(1.14 |
) |
|
$ |
(1.66 |
) |
|
Weighted
average shares outstanding - basic and diluted |
|
|
40,444,815 |
|
|
|
21,056,199 |
|
|
|
36,674,083 |
|
|
|
15,800,781 |
|
|
Net
loss |
|
$ |
(6,905,785 |
) |
|
$ |
(7,110,317 |
) |
|
$ |
(34,805,712 |
) |
|
$ |
(26,210,844 |
) |
|
Other
comprehensive (loss) income - foreign currency translation |
|
|
(815,201 |
) |
|
|
933,180 |
|
|
|
(1,961,556 |
) |
|
|
2,564,497 |
|
|
Comprehensive loss |
|
$ |
(7,720,986 |
) |
|
$ |
(6,177,137 |
) |
|
$ |
(36,767,268 |
) |
|
$ |
(23,646,347 |
) |
|
|
|
|
|
|
|
|
|
|
|
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
OpGen (NASDAQ:OPGN)
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OpGen (NASDAQ:OPGN)
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From Jul 2023 to Jul 2024