UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
_________________
FORM 8-K
_________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Securities Exchange Act of 1934
August 8, 2017
Date of Report (date of earliest event reported)
Date of Report (date of earliest event reported)
_________________
OpGen, Inc.
(Exact name of Registrant as specified in its charter)
_________________
|
Delaware
(State or other jurisdiction of incorporation or organization)
|
001-37367
(Commission
File Number)
|
06-1614015
(I.R.S. Employer
Identification Number) |
708 Quince Orchard Road, Suite 205
Gaithersburg, MD 20878
(Address of principal executive offices)
Gaithersburg, MD 20878
(Address of principal executive offices)
(240) 813-1260
(Registrant’s telephone number, including area code)
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
(Former name or former address, if changed since last report)
_________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
[_] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[_] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[_] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[_] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company [X]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [_]
Item 2.02 — Results of Operations and Financial Condition.
On August 8, 2017, OpGen, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2017. The full text of such press release is furnished as Exhibit 99.1 to this report.
Item 9.01 — Financial Statements and Exhibits.
| (d) |
Exhibits.
|
| 99.1 |
Press Release, dated August 8, 2017, issued by OpGen, Inc.
|
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| OpGen, Inc. | ||
|
Date: August 8, 2017
|
/s/ Timothy C. Dec | |
| Timothy C. Dec | ||
|
Chief Financial Officer
|
||
EXHIBIT INDEX
|
Exhibit No.
|
Document
|
|
99.1
|
Press Release, dated August 8, 2017, issued by OpGen, Inc.
|
Exhibit 99.1
OPGEN REPORTS 2017 SECOND QUARTER FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
Affirms plans to launch first Acuitas® Rapid Test in first half of 2018
Conference call begins at 4:30 p.m. Eastern time today
GAITHERSBURG, Md. (August 8, 2017) – 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 Farmer
Director, Marketing
(240) 813-1284
mfarmer@opgen.com
InvestorRelations@opgen.com
Investor Contacts:
LHA Investor Relations
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com
or
Bruce Voss
(310) 691-7100
bvoss@lhai.com
(Tables to follow)
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 outstanding at 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
|
||||