OpGen Reports Second Quarter 2022 Financial Results and Provides Business Update
August 11 2022 - 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
second quarter 2022 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, “We are pleased with the progress we’ve made in the
first half of 2022, which includes signing two commercial contracts
for our Acuitas AMR Gene Panel with two major U.S. hospitals.
Additionally, we have added a fourth trial site and continued
enrollment towards our 1,500th patient sample for the clinical
trial for Unyvero Urinary Tract Infection (UTI) Panel. We
anticipate completing the enrollment and expect final data read out
in the second half of this year towards an FDA submission.”
Dr. Schacht continued, “Overall we are tracking
well against our R&D milestones and continue to progress on the
commercial front with significant growth in direct product sales
year over year. We look forward to continuing to update on our
progress and continue the fight against antimicrobial
resistance.”
Second Quarter and First Half 2022 Financial Results of
OpGen, Inc.
- Total revenue
for the second quarter of 2022 was approximately $1.0 million,
compared with approximately $0.8 million in the second quarter of
2021. Total revenue for the first half of 2022 was approximately
$1.4 million, as compared to approximately $1.6 million for the
first half of
2021.
- Operating
expenses for the second quarter of 2022 were approximately $6.2
million, compared with approximately $7.0 million in the second
quarter of 2021. Operating expenses for the first half of 2022 were
approximately $12.6 million, compared with approximately $14.0
million in the first half of 2021.
- The net loss
available to common stockholders for the second quarter of 2022 was
approximately $5.8 million, or $0.13 per share, compared with
approximately $7.1 million, or $0.19 per share, in the second
quarter of 2021. The net loss available to common stockholders for
the first half of 2022 was approximately $12.6 million, or $0.27
per share, compared with approximately $21.9 million, or $0.65 per
share, in the first half of 2021.
- Cash and cash equivalents were
approximately $16.6 million as of June 30, 2022, compared with
$36.1 million as of December 31, 2021.
In the reporting quarter and year to date, the
Company reached the following key milestones:
- OpGen signed its
first two commercial customer contracts for the Acuitas AMR Gene
Panel in June and July 2022 with a major 1,000+ bed teaching
hospital in the Northeast and a renowned 400+ bed children’s
hospital in the Midwest
- OpGen subsidiary
Ares Genetics extended its collaboration agreement with Sandoz
until 2025, to drive cutting-edge digital solutions in the global
fight against antimicrobial resistance (AMR)
- OpGen subsidiary
Ares Genetics also commercially launched new sequencing and
analysis services globally, which includes ARESid and ARESiss
Express
- OpGen announced interim analysis
results from its clinical trial for Unyvero UTI Panel and added a
fourth trial site
- OpGen to date has enrolled over
1,300 patient samples in the clinical trial for Unyvero UTI Panel
and is on track towards the enrollment goal of 1,500 prospective
patient samples
- OpGen subsidiary
Curetis and Leader Life Sciences entered into a Unyvero
distribution partnership within the United Arab Emirates and Qatar
for a total value of approximately $1 million in revenue during the
initial three-year term
- OpGen subsidiary
Curetis and Keis Group entered into a three-year exclusive Unyvero
distribution partnership in Kosovo based on Keis’ successfully won
tender for Unyvero products
- OpGen and
Menarini expanded their distribution agreement to increase the
annual minimum revenue commitment by Menarini in the next two
years, in addition to the sale of around 70 installed Unyvero
systems across nine European countries at residual fair market
value from OpGen’s subsidiary Curetis to Menarini
- OpGen announced
publication of results from a major prospective, multi center,
randomized and interventional clinical study using Unyvero
Hospitalized Pneumonia (HPN) Panel in The Lancet Respiratory
Medicine that demonstrated Unyvero decreases the duration of
inappropriate antibiotic therapy in hospitalized patients with
pneumonia
- OpGen announced
publication of results of Unyvero HPN Panel for detection of
bacterial respiratory tract pathogens from serial specimens
collected from hospitalized COVID-19 patients at Karolinska
University Hospital (Sweden), confirming the ability of Unyvero in
detecting potential pneumonia pathogens earlier than culture
- OpGen commenced
a new At The Market (ATM) sales facility for up to approximately
$10.7 million, pursuant to which the Company may sell, from time to
time, in an “at the market” offering shares of its common stock.
While no shares were sold under this new ATM in H1 2022, in July
and August to date the Company has sold approximately 1.7 million
new shares of its common stock for gross proceeds of approximately
$1 million.
- OpGen requested
an additional 180-day period from Nasdaq to regain compliance with
the $1.00 minimum bid price rule and expects their decision by the
end of August.
In terms of fiscal 2022 guidance, OpGen
expects:
- U.S. direct
product sales of Unyvero and Acuitas are anticipated to contribute
to growth
- Continuous
increase in its European and international distribution business
for Unyvero products
- Expand Ares
Genetics strategic collaborations and partnerships and launch U.S.
Next Generation Sequencing lab services in Q3 2022
- Overall, 2022
revenue growth of approximately 25% year over year from the
products and services business globally
Conference Call Information
OpGen’s management will host a conference call
today, August 11th at 4:30 p.m. EDT, to go over the second quarter
and first half of 2022 financial results and business activities,
as well as answer analyst questions.
|
Dial-in Information |
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=1556114&tp_key=e1546ec0f5 |
Conference ID: 13730742 |
|
Following the conclusion of the conference call,
a replay will be available through August 25th, 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 Information |
U.S. Dial-in Number: +1-844-512-2921 |
International Dial-in Number: +1-412-317-6671 |
Replay PIN: 13730742 |
|
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 second quarter and first half 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) |
|
|
|
|
|
|
|
June 30, 2022 |
|
December 31, 2021 |
Assets |
|
|
|
|
Current assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
16,586,577 |
|
|
$ |
36,080,392 |
|
Accounts receivable, net |
|
|
738,148 |
|
|
|
1,172,396 |
|
Inventory, net |
|
|
1,196,956 |
|
|
|
1,239,456 |
|
Prepaid expenses and other current assets |
|
|
1,687,564 |
|
|
|
1,250,331 |
|
Total current assets |
|
|
20,209,245 |
|
|
|
39,742,575 |
|
Property and equipment, net |
|
|
3,209,311 |
|
|
|
4,011,748 |
|
Finance lease right-of-use assets, net |
|
|
19,660 |
|
|
|
90,467 |
|
Operating lease right-of-use assets |
|
|
1,582,325 |
|
|
|
1,814,396 |
|
Goodwill |
|
|
6,884,915 |
|
|
|
7,453,007 |
|
Intangible assets, net |
|
|
12,969,215 |
|
|
|
14,530,209 |
|
Strategic inventory |
|
|
3,492,602 |
|
|
|
3,472,337 |
|
Other noncurrent assets |
|
|
441,320 |
|
|
|
551,794 |
|
Total assets |
|
$ |
48,808,593 |
|
|
$ |
71,666,533 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts payable |
|
$ |
731,845 |
|
|
$ |
1,307,081 |
|
Accrued compensation and benefits |
|
|
1,575,299 |
|
|
|
1,621,788 |
|
Accrued liabilities |
|
|
788,153 |
|
|
|
1,965,845 |
|
Current maturities of long-term debt |
|
|
10,887,469 |
|
|
|
14,519,113 |
|
Short-term finance lease liabilities |
|
|
16,731 |
|
|
|
43,150 |
|
Short-term operating lease liabilities |
|
|
394,027 |
|
|
|
459,792 |
|
Total current liabilities |
|
|
14,393,524 |
|
|
|
19,916,769 |
|
Long-term debt, net |
|
|
4,024,413 |
|
|
|
7,176,251 |
|
Derivative liabilities |
|
|
175,498 |
|
|
|
228,589 |
|
Long-term finance lease liabilities |
|
|
1,962 |
|
|
|
3,644 |
|
Long-term operating lease liabilities |
|
|
2,721,233 |
|
|
|
2,977,402 |
|
Other long-term liabilities |
|
|
130,983 |
|
|
|
146,798 |
|
Total liabilities |
|
|
21,447,613 |
|
|
|
30,449,453 |
|
Stockholders' equity |
|
|
|
|
Preferred stock, $0.01 par value; 10,000,000 shares authorized;
none issued and outstanding at June 30, 2022 and December 31, 2021,
respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.01 par value; 100,000,000 shares authorized;
46,623,618 and 46,450,250 shares issued and outstanding at
June 30, 2022 and December 31, 2021, respectively |
|
|
466,237 |
|
|
|
464,503 |
|
Additional paid-in capital |
|
|
276,205,778 |
|
|
|
275,708,490 |
|
Accumulated deficit |
|
|
(248,185,670 |
) |
|
|
(235,541,539 |
) |
Accumulated other comprehensive (loss)/income |
|
|
(1,125,365 |
) |
|
|
585,626 |
|
Total stockholders’ equity |
|
|
27,360,980 |
|
|
|
41,217,080 |
|
Total liabilities and stockholders’ equity |
|
$ |
48,808,593 |
|
|
$ |
71,666,533 |
|
|
|
|
|
|
|
|
OpGen, Inc. |
Consolidated Statements of Operations and Comprehensive
Loss |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenue |
|
|
|
|
|
|
|
|
Product sales |
|
$ |
889,271 |
|
|
$ |
307,804 |
|
|
$ |
1,255,323 |
|
|
$ |
835,383 |
|
Laboratory services |
|
|
20,570 |
|
|
|
266,784 |
|
|
|
63,499 |
|
|
|
450,849 |
|
Collaboration revenue |
|
|
57,364 |
|
|
|
237,027 |
|
|
|
118,128 |
|
|
|
355,099 |
|
Total revenue |
|
|
967,205 |
|
|
|
811,615 |
|
|
|
1,436,950 |
|
|
|
1,641,331 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
646,389 |
|
|
|
342,580 |
|
|
|
938,386 |
|
|
|
896,634 |
|
Cost of services |
|
|
15,650 |
|
|
|
137,934 |
|
|
|
46,212 |
|
|
|
242,918 |
|
Research and development, net |
|
|
2,273,756 |
|
|
|
2,859,590 |
|
|
|
4,590,197 |
|
|
|
5,673,081 |
|
General and administrative |
|
|
2,134,266 |
|
|
|
2,692,255 |
|
|
|
4,759,319 |
|
|
|
5,355,912 |
|
Sales and marketing |
|
|
1,169,349 |
|
|
|
802,549 |
|
|
|
2,220,781 |
|
|
|
1,701,801 |
|
Impairment of right-of-use asset |
|
|
— |
|
|
|
115,218 |
|
|
|
— |
|
|
|
170,714 |
|
Total operating expenses |
|
|
6,239,410 |
|
|
|
6,950,126 |
|
|
|
12,554,895 |
|
|
|
14,041,060 |
|
Operating loss |
|
|
(5,272,205 |
) |
|
|
(6,138,511 |
) |
|
|
(11,117,945 |
) |
|
|
(12,399,729 |
) |
Other expense |
|
|
|
|
|
|
|
|
Gain on extinguishment of debt |
|
|
— |
|
|
|
259,353 |
|
|
|
— |
|
|
|
259,353 |
|
Warrant inducement expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(7,755,541 |
) |
Interest and other income, net |
|
|
13,851 |
|
|
|
4,702 |
|
|
|
16,972 |
|
|
|
9,627 |
|
Interest expense |
|
|
(779,912 |
) |
|
|
(1,198,169 |
) |
|
|
(2,049,493 |
) |
|
|
(2,363,151 |
) |
Foreign currency transaction gains/(losses) |
|
|
271,967 |
|
|
|
(915 |
) |
|
|
470,707 |
|
|
|
426,700 |
|
Change in fair value of derivative financial instruments |
|
|
(74,116 |
) |
|
|
(13,021 |
) |
|
|
35,628 |
|
|
|
(114,411 |
) |
Total other expense |
|
|
(568,210 |
) |
|
|
(948,050 |
) |
|
|
(1,526,186 |
) |
|
|
(9,537,423 |
) |
Loss before income taxes |
|
|
(5,840,415 |
) |
|
|
(7,086,561 |
) |
|
|
(12,644,131 |
) |
|
|
(21,937,152 |
) |
Provision for income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(5,840,415 |
) |
|
$ |
(7,086,561 |
) |
|
$ |
(12,644,131 |
) |
|
$ |
(21,937,152 |
) |
Net loss available to common stockholders |
|
$ |
(5,840,415 |
) |
|
$ |
(7,086,561 |
) |
|
$ |
(12,644,131 |
) |
|
$ |
(21,937,152 |
) |
Basic and diluted net loss per share attributable to common
stockholders |
|
$ |
(0.13 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.65 |
) |
Weighted average shares outstanding - basic and diluted |
|
|
46,574,512 |
|
|
|
38,268,293 |
|
|
|
46,529,718 |
|
|
|
33,900,964 |
|
Net loss |
|
$ |
(5,840,415 |
) |
|
$ |
(7,086,561 |
) |
|
$ |
(12,644,131 |
) |
|
$ |
(21,937,152 |
) |
Other comprehensive loss - foreign currency translation |
|
|
(1,227,142 |
) |
|
|
529,651 |
|
|
|
(1,710,991 |
) |
|
|
(548,828 |
) |
Comprehensive loss |
|
$ |
(7,067,557 |
) |
|
$ |
(6,556,910 |
) |
|
$ |
(14,355,122 |
) |
|
$ |
(22,485,980 |
) |
|
|
|
|
|
|
|
|
|
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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