OpGen Reports 2017 Second Quarter Financial Results and Provides Business Update
August 08 2017 - 3:01PM
Affirms plans to launch first
Acuitas® Rapid Test in first half of 2018
OpGen, Inc. (NASDAQ:OPGN) reports financial and operational results
for the three and six months ended June 30, 2017, and provides a
summary of recent business highlights.
“During the second quarter and recent weeks we
achieved important milestones in the development of our first
Acuitas® Rapid Test and the Acuitas Lighthouse Knowledgebase,” said
Evan Jones, Chairman and CEO of OpGen. “We completed design of our
new rapid test for complicated urinary tract infections and the
associated Acuitas Lighthouse Knowledgebase for predicting
antibiotic susceptibility using resistance gene test results. We
are completing development and initial verification activities with
a goal of having test kits for clinical evaluation in third-party
sites during the fourth quarter of 2017.”
Additional developments during the second
quarter and recent weeks include:
- Completed a $10.0 million public offering with net proceeds to
OpGen of $8.7 million.
- Entered into a global supply agreement with Thermo Fisher
Scientific to use their technology to support the commercialization
of OpGen’s rapid molecular products and informatics system.
- Completed development of genotype/phenotype predictive
algorithms based on testing of seven thousand clinical isolates
from the Merck SMART surveillance network and clinical
collaborators adding to the eleven thousand isolates in the Acuitas
Lighthouse Knowledgebase.
- Advanced development of the Acuitas Rapid Test for complicated
urinary tract infections (cUTI) for launch in the first half of
2018 for research use.
- Took steps to reduce our operating expenses by approximately
25% to 30% in the second half of 2017, as compared to the first
half of the year, including the planned consolidation of
FDA-cleared and CE mark manufacturing and distribution to
Gaithersburg.
2017 Second Quarter and Year-to-Date
Financial Results
- Revenue: Total revenue for the three months
ended June 30, 2017 was $0.7 million compared with $1.2
million for the three months ended June 30, 2016. Total revenue for
the six months ended June 30, 2017 was $1.5 million compared with
$2.3 million for the six months ended June 30, 2016.
- Operating Expenses: Operating expenses for the
three months ended June 30, 2017 were $4.9 million
compared with $6.2 million for the three months ended June 30,
2016. Operating expenses for the six months ended June 30, 2017
were $10.6 million compared with $11.8 million for the six months
ended June 30, 2016.
- Net Loss: Net loss for the three months
ended June 30, 2017 was $4.2 million compared with $5.1
million for the three months ended June 30, 2016. Net loss for the
six months ended June 30, 2017 was $9.2 million compared with $9.6
million for the six months ended June 30, 2016.
- Cash Position: Cash and cash equivalents
were $0.2 million as of June 30, 2017 compared with $4.1
million as of December 31, 2016. Subsequent to the close of
the quarter, OpGen raised net proceeds of $8.7 million in a public
offering.
2017 Second Quarter Enterprise
Highlights and Recent Developments
- Received the 2nd annual Ignaz Semmelweis Award by the Committee
to Reduce Infection Deaths for OpGen’s commitment to safe medical
care through the development of rapid diagnostics to combat
multidrug-resistant infections.
- Received approval from the New York State Department of Health
for the Acuitas MDRO Gene Test for use by physicians and healthcare
providers in that state.
- Presented data at ASM Microbe and ECCMID 2017 meetings
demonstrating the performance of the Acuitas Lighthouse
Knowledgebase for predicting antibiotic susceptibility from
antibiotic resistance gene profiles.
- Strengthened the Company’s governance team with the appointment
of life sciences industry veteran Tina S. Nova, Ph.D. to the Board
of Directors.
- Published in Infection Control & Hospital Epidemiology a
citywide evaluation of Washington, D.C.’s healthcare facilities to
gauge the prevalence of Carbapenem-Resistant Enterobacteriaceae
(CRE) throughout the District of Columbia
utilizing OpGen’s Acuitas DNA tests and Acuitas Lighthouse
Knowledgebase.
“We were pleased to raise gross proceeds of
$10.0 million in July from new and existing shareholders, and from
members of senior management,” continued Mr. Jones. “Participants
in this offering are providing OpGen with a strong vote of
confidence and financial resources for the development of our
Acuitas Rapid Test and our Acuitas Lighthouse Knowledgebase.
The first of our Rapid Tests is expected to be tested at
third-party clinical evaluation sites in the fourth quarter and
launched as an RUO test in the first half of 2018.”
“We have taken steps to align expenses with our
goals, and second quarter financial results showed evidence of
progress. Compared with the first quarter of 2017 we reduced
operating expenses by nearly $1 million while generally maintaining
revenue. We have begun to consolidate our manufacturing
footprint and focus research and development expenses to the
Acuitas Rapid Test. We expect a decrease in operating expenses of
approximately 25% to 30% in the second half of 2017, as compared to
the first half, which is a reduction of $4 million to $5 million of
annualized operating expenses, and a marked improvement in our cash
burn.”
“The Acuitas Rapid Test for cUTIs is expected to
be the first of a series of OpGen tests that will address the
global antibiotic resistance crisis by identifying antibiotic
resistant pathogens in less than three hours, and the Acuitas
Lighthouse Knowledgebase is a dynamic cloud-based information store
that is continuously updated for new resistance genes, which will
help inform proper patient treatments,” Mr. Jones concluded.
Conference Call Information
OpGen management will hold a conference
call today beginning at 4:30 p.m. Eastern time to discuss
second quarter 2017 financial results and other business
activities, and answer questions. The call can be accessed by
dialing (888) 883-4599 (domestic) or (484) 653-6821 (international)
and providing passcode 61883667. A live webcast of the
conference call can be accessed by visiting the Investor Relations
section of the company’s website at http://ir.opgen.com. A
replay of the webcast will be available shortly after the
conclusion of the call on the company’s website for 90 days.
A telephone replay of the conference call will
be available from 7:30 p.m. Eastern time today through August 15,
2017 and can be accessed by dialing (855) 859-2056 (domestic)
or (404) 537-3406 (international). All listeners should provide
passcode 61883667.
About OpGen
OpGen, Inc. is harnessing the power of
informatics and genomic analysis to provide complete solutions for
patient, hospital and network-wide infection prevention and
treatment. For more information, please visit
www.opgen.com.
OpGen, Acuitas, Acuitas Lighthouse and
QuickFISH are registered trademarks of OpGen, Inc.
Forward-Looking Statements
This press release includes statements relating
to the proceeds from the Company’s public offering and its products
and services. 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, 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 success of our
commercialization efforts, 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 (SEC). 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 Contact:Michael
FarmerDirector, Marketing(240)
813-1284mfarmer@opgen.comInvestorRelations@opgen.com
Investor Contacts:LHA Investor
RelationsKim Sutton Golodetz(212) 838-3777kgolodetz@lhai.comorBruce
Voss(310) 691-7100bvoss@lhai.com
(Tables to follow)
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OpGen, Inc. |
Condensed Consolidated Statements of
Operations and Comprehensive Loss |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Revenue |
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
681,127 |
|
|
$ |
1,028,146 |
|
|
$ |
1,415,629 |
|
|
$ |
1,975,365 |
|
Laboratory services |
|
|
15,850 |
|
|
|
29,674 |
|
|
|
31,955 |
|
|
|
159,094 |
|
Collaboration revenue |
|
|
6,233 |
|
|
|
125,000 |
|
|
|
27,397 |
|
|
|
125,000 |
|
Total revenue |
|
|
703,210 |
|
|
|
1,182,820 |
|
|
|
1,474,981 |
|
|
|
2,259,459 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Cost of
products sold |
|
|
392,791 |
|
|
|
337,020 |
|
|
|
817,741 |
|
|
|
682,987 |
|
Cost of
services |
|
|
78,763 |
|
|
|
161,222 |
|
|
|
178,996 |
|
|
|
476,931 |
|
Research
and development |
|
|
1,762,234 |
|
|
|
2,333,584 |
|
|
|
3,884,749 |
|
|
|
4,287,013 |
|
General
and administrative |
|
|
1,750,018 |
|
|
|
1,777,054 |
|
|
|
3,719,234 |
|
|
|
3,315,100 |
|
Sales
and marketing |
|
|
909,402 |
|
|
|
1,588,553 |
|
|
|
2,014,988 |
|
|
|
2,987,988 |
|
Total operating expenses |
|
|
4,893,208 |
|
|
|
6,197,433 |
|
|
|
10,615,708 |
|
|
|
11,750,019 |
|
Operating loss |
|
|
(4,189,998 |
) |
|
|
(5,014,613 |
) |
|
|
(9,140,727 |
) |
|
|
(9,490,560 |
) |
Other expense |
|
|
|
|
|
|
|
|
Interest
and other income/(expense) |
|
|
22 |
|
|
|
(3,874 |
) |
|
|
43 |
|
|
|
(3,699 |
) |
Interest
expense |
|
|
(53,813 |
) |
|
|
(26,649 |
) |
|
|
(83,657 |
) |
|
|
(68,383 |
) |
Foreign
currency transaction gains/(losses) |
|
|
8,998 |
|
|
|
(7,766 |
) |
|
|
11,618 |
|
|
|
3,562 |
|
Changes
in fair value of warrant and conversion option liabilities
|
|
|
26,744 |
|
|
|
— |
|
|
|
26,744 |
|
|
|
— |
|
Total other expense |
|
|
(18,049 |
) |
|
|
(38,289 |
) |
|
|
(45,252 |
) |
|
|
(68,520 |
) |
Loss before income taxes |
|
|
(4,208,047 |
) |
|
|
(5,052,902 |
) |
|
|
(9,185,979 |
) |
|
|
(9,559,080 |
) |
|
|
|
|
|
|
|
|
|
Provision for income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
|
(4,208,047 |
) |
|
|
(5,052,902 |
) |
|
|
(9,185,979 |
) |
|
|
(9,559,080 |
) |
|
|
|
|
|
|
|
|
|
Preferred stock dividends and beneficial conversion |
|
|
— |
|
|
|
(332,550 |
) |
|
|
— |
|
|
|
(332,550 |
) |
Net loss available to common stockholders |
|
$ |
(4,208,047 |
) |
|
$ |
(5,385,452 |
) |
|
$ |
(9,185,979 |
) |
|
$ |
(9,891,630 |
) |
Net loss
per common share - basic and diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.74 |
) |
Weighted
average shares outstanding - basic and diluted |
|
|
28,210,657 |
|
|
|
14,522,097 |
|
|
|
27,161,931 |
|
|
|
13,545,519 |
|
Net
loss |
|
$ |
(4,208,047 |
) |
|
$ |
(5,052,902 |
) |
|
$ |
(9,185,979 |
) |
|
$ |
(9,559,080 |
) |
Other
comprehensive (loss)/income - foreign currency translation |
|
|
(3,834 |
) |
|
|
1,498 |
|
|
|
(7,591 |
) |
|
|
387 |
|
Comprehensive loss |
|
$ |
(4,211,881 |
) |
|
$ |
(5,051,404 |
) |
|
$ |
(9,193,570 |
) |
|
$ |
(9,558,693 |
) |
OpGen, Inc. |
Condensed Consolidated Balance
Sheets |
(unaudited) |
|
|
|
June 30, 2017 |
|
December 31, 2016 |
|
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
211,683 |
|
|
$ |
4,117,324 |
|
|
Accounts
receivable, net |
|
|
411,762 |
|
|
|
542,420 |
|
|
Inventory, net |
|
|
578,903 |
|
|
|
692,368 |
|
|
Prepaid
expenses and other current assets |
|
|
423,477 |
|
|
|
329,646 |
|
|
Total current assets |
|
|
1,625,825 |
|
|
|
5,681,758 |
|
|
Property
and equipment, net |
|
|
784,333 |
|
|
|
800,723 |
|
|
Deferred
offering costs |
|
|
179,150 |
|
|
|
— |
|
|
Goodwill |
|
|
600,814 |
|
|
|
600,814 |
|
|
Intangible assets, net |
|
|
1,487,090 |
|
|
|
1,620,998 |
|
|
Other
noncurrent assets |
|
|
313,828 |
|
|
|
279,752 |
|
|
Total assets |
|
$ |
4,991,040 |
|
|
$ |
8,984,045 |
|
|
Liabilities and Stockholders’ (Deficit)
Equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts
payable |
|
$ |
2,907,190 |
|
|
$ |
2,232,563 |
|
|
Accrued
compensation and benefits |
|
|
798,069 |
|
|
|
578,480 |
|
|
Accrued
liabilities |
|
|
972,632 |
|
|
|
1,215,283 |
|
|
Deferred
revenue |
|
|
37,760 |
|
|
|
37,397 |
|
|
Short-term notes payable |
|
|
629,702 |
|
|
|
1,023,815 |
|
|
Current
maturities of long-term capital lease obligation |
|
|
168,831 |
|
|
|
184,399 |
|
|
Total current liabilities |
|
|
5,514,184 |
|
|
|
5,271,937 |
|
|
Deferred
rent |
|
|
347,648 |
|
|
|
398,084 |
|
|
Warrant
liability |
|
|
89,291 |
|
|
|
— |
|
|
Note
payable |
|
|
904,475 |
|
|
|
— |
|
|
Long-term capital lease obligation and other noncurrent
liabilities |
|
|
273,208 |
|
|
|
146,543 |
|
|
Total liabilities |
|
|
7,128,806 |
|
|
|
5,816,564 |
|
|
Commitments |
|
|
|
|
|
Stockholders' (deficit) equity |
|
|
|
|
|
Common
stock, $0.01 par value; 200,000,000 shares authorized; 29,365,741
and 25,304,270 shares issued and outstanding at
June 30, 2017 and December 31, 2016,
respectively |
|
|
293,657 |
|
|
|
253,042 |
|
|
Preferred stock, $0.01 par value; 10,000,000 shares authorized;
none issued and outstandingat June 30, 2017 and
December 31, 2016, respectively |
|
|
— |
|
|
|
— |
|
|
Additional paid-in capital |
|
|
140,047,090 |
|
|
|
136,199,382 |
|
|
Accumulated other comprehensive (loss)/income |
|
|
(1,415 |
) |
|
|
6,176 |
|
|
Accumulated deficit |
|
|
(142,477,098 |
) |
|
|
(133,291,119 |
) |
|
Total stockholders’ (deficit) equity |
|
|
(2,137,766 |
) |
|
|
3,167,481 |
|
|
Total liabilities and stockholders’ (deficit)
equity |
|
$ |
4,991,040 |
|
|
$ |
8,984,045 |
|
|
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