OpGen, Inc. (NASDAQ:OPGN), an early commercial-stage company using
molecular testing and bioinformatics to help guide antibiotic
therapy and to assist healthcare providers combat multi-drug
resistant infections, today reported financial results for the
three and nine months ended September 30, 2015. Highlights of the
third quarter of 2015 and recent weeks include:
- OpGen chosen to track the threat of potentially lethal
multi-drug resistant infectious in a major metro region; government
funded program to commence in November
- Acquired AdvanDx, Inc., a market leader in rapid molecular
testing for microorganism identification
- Completed a $6 million financing with Merck Global Health
Innovation Fund, LLC (Merck GHI)
Financial Results
Total revenue for the third quarter of 2015 was $1.0 million,
compared with $0.8 million for the third quarter of 2014. The 17.5%
increase in revenue includes $0.8 million in sales of QuickFISH™
rapid molecular diagnostics products as a result of the Company's
acquisition of AdvanDx in July, 2015. Total operating expenses for
the third quarter of 2015 were $5.0 million, compared with $2.2
million for the third quarter of 2014. The increase reflects
inclusion of $1.3 million of AdvanDx operating expenses and $0.5
million of transaction-related costs associated with the AdvanDx
acquisition.
The net loss for the third quarter of 2015 was $4.7 million,
compared with a net loss for the third quarter of 2014 of $1.6
million. Net loss attributable to common stockholders for the third
quarter of 2015 was $4.7 million, or $0.38 per share, compared with
a net loss attributable to common stockholders for the third
quarter of 2014 of $1.8 million, or $4.92 per share.
Total revenue for the nine months ended September 30, 2015 was
$1.8 million, compared with $3.0 million for the same period of
2014. Revenue from product sales and laboratory services increased
24.5% to $1.5 million from $1.2 million in 2014 primarily as a
result of sales of QuickFISH rapid molecular diagnostic testing
products. Collaboration revenues decreased to $0.3 million from
$1.8 million as a result of nearing completion of a technology
development agreement. Total operating expenses for the nine months
ended September 30, 2015 were $11.2 million, compared with $6.6
million for the nine months ended September 30, 2014. The increase
reflects the inclusion of $1.3 million of AdvanDx costs, $0.8
million of public company costs, $1.0 million of stock-based
compensation costs and $0.5 million in transaction costs associated
with the AdvanDx acquisition.
Net loss was $12.6 million for the first nine months of 2015,
compared with a net loss of $4.3 million for the first nine months
of 2014. Net loss attributable to common stockholders was $12.9
million for the nine months ended September 30, 2015, or $2.00 per
share, compared with a net loss attributable to common stockholders
of $4.7 million for the nine months ended September 30, 2014, or
$13.03 per share.
The Company had cash and cash equivalents of $11.2 million as of
September 30, 2015, compared with $0.7 million as of December 31,
2014. During the quarter the Company completed a $6.0 million
financing with Merck GHI, pursuant to which Merck GHI purchased
1,136,364 shares of OpGen common stock at a price of $4.40 per
share, and OpGen issued Merck GHI a senior secured promissory note
in the principal amount of $1.0 million with a two-year maturity
from the date of issuance. The Company also has $0.5 million
in capital lease obligations of which $0.2 million are current
maturities.
Management Commentary
"The third quarter and recent weeks were a productive time for
OpGen as we continued to execute on our plans to build a leading
company helping to improve antibiotic therapy and combat
drug-resistant infections," said Evan Jones, the Company's chairman
and chief executive officer.
Mr. Jones continued, "We are well positioned with FDA-cleared
molecular diagnostic tests for rapid pathogen identification, CLIA
lab-based tests for MDRO drug resistance testing and our Acuitas
Lighthouse bioinformatics for reporting and helping interpret
patient and lab data. Our sales and marketing organization, which
now numbers 13, is trained on both the Acuitas MDRO test offerings
and the QuickFISH tests. With our commercial organization in
place and a number of planned new products in development, we are
well positioned to grow revenue in the coming years," Mr. Jones
concluded.
Commenting on the third quarter financial results, Tim Dec, the
Company's chief financial officer, said, "Our third quarter
financial results reflect the operations of AdvanDx beginning July
14, the date the transaction closed. The revenue growth in the
quarter highlights the transition of the company's business to
proprietary, high-margin diagnostic products from our legacy genome
mapping products and collaborative research activities. Our
expenses reflect the increased investments in both infrastructure
and human capital to support our planned growth."
Conference Call and Webcast
OpGen management will host a conference call to discuss third
quarter financial results and answer questions today at 4:30 p.m.
Eastern time.
To access the conference call, U.S.-based participants should
dial (888) 883-4599 and international participants should dial
(484) 653-6821. All participants should provide the following
passcode: 63158584. Following the conclusion of the conference
call, a replay will be available through November 18, 2015 and can
be accessed by dialing (855) 859-2056 from within the U.S. or (404)
537-3406 from outside the U.S. All listeners should provide
passcode 63158584. Individuals interested in listening to the
live conference call via the Internet may do so by logging on to
the Investor Relations portion of the Company's website at
www.opgen.com.
About MDROs
Multi-drug resistant organisms (MDROs) are common bacteria that
have developed resistance to multiple classes of antibiotics. They
are a leading cause of hospital-acquired infections and are
associated with an increase in morbidity and mortality. Each year,
more than 2 million Americans acquire infections that are resistant
to antibiotics and every year in the U.S., about 23,000 people die
from them. The cost of treating these infections is estimated to be
between $20 billion to $35 billion. Asymptomatic carriers are at a
higher risk of an MDRO infection and become reservoirs for
transmission to other patients in health care systems if not
accurately identified early. Since there are many types of
antibiotic-resistant organisms, and the way they cause disease is
dictated by their genetics, knowing the exact genetic profile of
these organisms is a key step to preventing their ability to
infect.
About OpGen
OpGen is an early-stage company using rapid molecular testing
and bioinformatics to help guide antibiotic therapy and to assist
healthcare providers to combat multi-drug resistant infections, or
MDROs. OpGen's lead products are its QuickFISH® and PNAFISH
products, which are advanced in vitro diagnostic kits for the
diagnosis and prevention of infectious diseases, the Acuitas® MDRO
Gene Test, a CLIA lab-based test that provides a profile of MDRO
resistant genes from patients screened for colonization or
infection and the Acuitas Lighthouse to aid in the interpretation
of MDRO diagnostic test results. The company develops, markets and
sells its products principally for use in hospitals and clinical
laboratories in the United States and internationally. Learn
more at www.opgen.com
Forward-Looking Statements
This press release includes statements relating to the company's
Acuitas MDRO Gene Test and Acuitas Lighthouse MDRO Management
System and QuickFISH products commercialization plans for these
products and services. These statements and other statements
regarding our 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 rate of adoption of
our products and services by hospitals, 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.
(Tables to follow)
OpGen,
Inc. |
Condensed Consolidated
Balance Sheets |
(unaudited) |
|
|
|
|
September 30,
2015 |
December 31,
2014 |
Assets |
|
|
Current assets |
|
|
Cash and cash equivalents |
$ 11,187,129 |
$ 749,517 |
Accounts receivable, net |
553,938 |
503,983 |
Inventory, net |
1,155,488 |
369,742 |
Prepaid expenses and other
current assets |
538,312 |
90,233 |
Total current
assets |
13,434,867 |
1,713,475 |
|
|
|
Property and equipment,
net |
1,021,971 |
587,956 |
Deferred IPO issuance
costs |
-- |
296,041 |
Intangible assets, net |
1,955,769 |
-- |
Goodwill |
291,747 |
-- |
Other noncurrent assets |
293,135 |
57,459 |
Total
assets |
$ 16,997,489 |
$ 2,654,931 |
|
|
|
Liabilities, Redeemable Preferred
Stock and Stockholders' Equity (Deficit) |
|
|
Current liabilities |
|
|
Accounts payable |
$ 1,274,657 |
$ 1,160,081 |
Accrued compensation and benefits |
840,637 |
423,099 |
Accrued liabilities |
1,232,328 |
993,657 |
Deferred revenue |
158,860 |
339,171 |
Short-term notes payable |
1,250 |
1,505,000 |
Current maturities of long-term capital lease
obligation |
227,049 |
100,499 |
Short-term convertible notes, net of
discounts |
-- |
1,500,000 |
Total current
liabilities |
3,734,781 |
6,021,507 |
|
|
|
Note payable |
1,000,000 |
-- |
Long-term capital lease obligations and other
noncurrent liabilities |
317,854 |
134,149 |
Total liabilities |
5,052,635 |
6,155,656 |
|
|
|
Commitments and contingencies (Note
10) |
|
|
|
|
|
Redeemable convertible preferred
stock |
|
|
Series A redeemable convertible preferred
stock, $.01 par value; 6,000,000 shares authorized; 3,999,864
shares issued and outstanding at December 31, 2014 (none at
September 30, 2015); aggregate liquidation preference of $7,999,728
at December 31, 2014 (none at September 30, 2015) |
-- |
4,564,899 |
Total redeemable convertible
preferred stock |
-- |
4,564,899 |
|
|
|
Stockholders' equtiy
(deficit) |
|
|
Common stock, $.01 par value; 200,000,000
shares authorized; 12,539,704 and 493,178 shares issued and
outstanding at September 30, 2015 and December 31, 2014,
respectively |
125,397 |
4,932 |
Additional paid-in capital |
121,216,140 |
88,701,737 |
Accumulated other comprehensive loss |
(49) |
-- |
Accumulated deficit |
(109,396,634) |
(96,772,293) |
Total stockholders' equity
(deficit) |
11,944,854 |
(8,065,624) |
|
|
|
Total liabilities, redeemable
preferred stock and stockholders' equity (deficit) |
$ 16,997,489 |
$ 2,654,931 |
|
|
|
|
|
|
OpGen,
Inc. |
Condensed Consolidated
Statements of Operations and Comprehensive Loss |
(unaudited) |
|
|
|
|
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
|
2015 |
2014 |
2015 |
2014 |
|
|
|
|
|
Revenue |
|
|
|
|
Product sales |
$ 929,241 |
$ 268,854 |
$ 1,432,592 |
$ 841,567 |
Laboratory services |
23,765 |
88,190 |
87,201 |
379,339 |
Collaboration revenue |
27,780 |
477,780 |
308,340 |
1,783,340 |
Total revenue |
980,786 |
834,824 |
1,828,133 |
3,004,246 |
|
|
|
|
|
Cost of products sold (excluding depreciation
and amortization) |
562,694 |
101,425 |
712,016 |
276,831 |
Cost of services (excluding depreciation and
amortization) |
46,634 |
129,120 |
191,738 |
336,616 |
Total costs of sales (excluding
depreciation and amortization) |
609,328 |
230,545 |
903,754 |
613,447 |
Gross profit |
371,458 |
604,279 |
924,379 |
2,390,799 |
|
|
|
|
|
Operating expenses |
|
|
|
|
Research and development |
1,724,127 |
1,029,650 |
3,741,247 |
3,075,420 |
General and administrative |
1,610,828 |
555,444 |
3,687,313 |
1,590,085 |
Sales and marketing |
979,681 |
459,064 |
2,815,976 |
1,486,801 |
Depreciation and amortization |
185,177 |
141,060 |
392,404 |
461,432 |
Transaction expenses |
525,596 |
-- |
525,596 |
-- |
Total operating
expenses |
5,025,409 |
2,185,218 |
11,162,536 |
6,613,738 |
Operating loss |
(4,653,951) |
(1,580,939) |
(10,238,157) |
(4,222,939) |
|
|
|
|
|
Other income (expense) |
|
|
|
|
Interest income |
2,513 |
37 |
9,675 |
120 |
Interest expense |
(17,482) |
(32,331) |
(1,746,853) |
(47,468) |
Change in fair value of derivative financial
instruments and other |
-- |
4,400 |
(647,342) |
4,400 |
Total other income
(expense) |
(14,969) |
(27,894) |
(2,384,520) |
(42,948) |
Loss before income
taxes |
(4,668,920) |
(1,608,833) |
(12,622,677) |
(4,265,887) |
|
|
|
|
|
Provision for income
taxes |
1,662 |
-- |
1,662 |
-- |
Net loss |
(4,670,582) |
(1,608,833) |
(12,624,339) |
(4,265,887) |
|
|
|
|
|
Preferred stock dividends |
-- |
(175,246) |
(244,508) |
(458,799) |
Net loss available to common
stockholders |
$ (4,670,582) |
$ (1,784,079) |
$
(12,868,847) |
$ (4,724,686) |
|
|
|
|
|
Net loss per common share - basic and
diluted |
$ (0.38) |
$ (4.92) |
$ (2.00) |
$ (13.03) |
Weighted average shares outstanding - basic
and diluted |
12,261,238 |
362,537 |
6,444,373 |
362,537 |
|
|
|
|
|
Net loss |
(4,670,582) |
(1,608,833) |
(12,624,339) |
(4,265,887) |
Other comprehensive loss - foreign currency
translation |
(49) |
-- |
(49) |
-- |
Comprehensive loss |
$ (4,670,631) |
$ (1,608,833) |
$
(12,624,388) |
$ (4,265,887) |
|
|
|
|
|
CONTACT: OpGen
Michael Farmer
Director, Marketing
(240) 813-1284
mfarmer@opgen.com
InvestorRelations@opgen.com
Investors
LHA
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com
or
Bruce Voss
(310) 691-7100
bvoss@lhai.com
Media
Lisa Guiterman
(301) 217-9353
lisa.guiterman@gmail.com
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