View:
Download DOC
Download PDF
Download XLS
                                                                                                                                                                                        

UNITED STATES
 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
Date of Report (Date of earliest event reported): August 9, 2016
_________________
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 No.)


708 Quince Orchard Road, Suite 205
Gaithersburg, MD 20878
 (Address of principal executive offices, including zip code)

(240) 813-1260
 (Registrant’s telephone number, including area code)

Not Applicable
 (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))
                                                                                                                                                                                        

Item 2.02   Results of Operations and Financial Condition.

On August 9, 2016, OpGen, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2016.  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 9, 2016, issued by OpGen, Inc.

The information included herein and in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (“Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

 
 

 

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.
 
   
By:
  
/s/ Timothy C. Dec
 
 
Name:
Timothy C. Dec
 
 
Title:
Chief Financial Officer
Date: August 9, 2016

 

 


EXHIBIT INDEX
Exhibit No.
Document
   
99.1
Press Release, dated August 9, 2016, issued by OpGen, Inc.

 
 
 
 
 
 
 
 
Exhibit 99.1
 
 


OpGen Reports 2016 Second Quarter Financial Results and Provides Business Update

 Conference call begins at 4:30 p.m. Eastern time today

GAITHERSBURG, Md. (August 9, 2016) – OpGen, Inc. (NASDAQ: OPGN) today reported financial and operational results for the three and six months ended June 30, 2016.  Highlights of the second quarter and recent weeks include:
· Achieved second quarter revenue of $1.2 million, 215% year over year growth
· Completed Intermountain Healthcare Retrospective MDRO Health Outcome Study
· Closed $10.4 million private placement

Total revenue for the second quarter of 2016 was $1.2 million, compared with $0.4 million for the second quarter of 2015, a 215% increase. Product sales and laboratory services increased to $1.1 million, compared with $0.3 million for the second quarter of 2015. The increase was primarily attributable to sales of rapid pathogen ID molecular diagnostic products following the company’s acquisition of AdvanDx in July 2015, as well as Acuitas® MDRO products and services revenue. Gross margin on product sales was 67% for the second quarter of 2016. Total operating expenses for the second quarter of 2016 were $6.2 million, compared with $3.4 million for the second quarter of 2015. The net loss attributable to common stockholders for the second quarter of 2016 was $5.4 million, or $0.37 per share, compared with a net loss attributable to common stockholders for the second quarter of 2015 of $5.4 million, or $0.84 per share. The company had cash and cash equivalents of $8.0 million as of June 30, 2016, compared with $7.8 million as of December 31, 2015.

Total revenue for the six months ended June 30, 2016 was $2.3 million, compared with $0.8 million for the same period of 2015, a 167% increase.  Revenue from product sales and laboratory services increased 277% to $2.1 million from $0.6 million in 2015 primarily as a result of sales of QuickFISH® rapid molecular diagnostic testing products following the company’s acquisition of AdvanDx in July 2015. Total operating expenses for the six months ended June 30, 2016 were $11.8 million, compared with $6.4 million for the six months ended June 30, 2015. Net loss attributable to common stockholders was $9.9 million for the six months ended June 30, 2016, or $0.73 per share, compared with a net loss attributable to common stockholders of $8.2 million for the six months ended June 30, 2015 or $2.35 per share.

“We are pleased with our continued revenue growth for the second quarter with sales of our rapid pathogen ID diagnostic products as the primary contributor,” said Evan Jones, chairman and chief executive officer of OpGen. “These results reflect the shift of our business towards rapid molecular testing to help guide antibiotic decision making. During the quarter we continued our work to build our new genomic analysis and informatics solutions for hospital and network-wide infection prevention and treatment. Achieving a key milestone in the development of our molecularAST technology we completed internal development of our new Resistome test for high resolution analysis of antibiotic resistance markers in clinical isolates. The next phase in this work is to complete the testing of thousands of pathogens to support the build-out of our Acuitas Lighthouse™ data warehouse and associated databases.
 
 
 

 

At the ECCMID meeting in April we previewed our digital imager for automation of our QuickFISH products and at ASM Microbe we began the commercial launch of Acuitas Lighthouse MDRO management platform, including Lighthouse informatics.  This platform, including our Acuitas MDRO gene tests, played a key role in a pilot study at 16 hospitals in the District of Columbia that was completed during the second quarter, where results supported continued surveillance for Superbug pathogens including carbapenem-resistant enterobacteriaceae,” Mr. Jones added.

Key developments from the second quarter of 2016 and recent weeks included:

· Completed $10.4 million private financing with Merck Global Health Innovation Fund (Merck GHI) and Sabby Management, LLC as lead investors
· Completed multi-drug resistant organisms (MDRO) health outcomes study with Intermountain Healthcare
· Completed testing and reported results on more than 1,000 patient samples from 16 hospitals in the District of Columbia in conjunction with the DCHA (District of Columbia Hospital Association) program to track the threat of potentially lethal multidrug-resistant infections in Washington, D.C.
· Presented data that support use of the Acuitas Resistome Test in epidemiological studies to aid in routine evaluations for mechanisms of resistance among carbapenem-resistant enterobacteriaceae (CRE) at ASM Microbe 2016
· Began commercial launch of the Acuitas Lighthouse portal at ASM Microbe 2016
· Researchers presented two papers at ECCMID describing rapid test results with QuickFISH and its utility in antibiotic stewardship
· Published analytical validation results for the Acuitas MDRO Gene Test in Clinical Chemistry and obtained Florida State Clinical Laboratory license
· Appointed Harry J. D’Andrea to the company’s board of directors and as chair of the Audit Committee

Conference Call and Webcast

OpGen management will hold a conference call today beginning at 4:30 p.m. Eastern time to discuss second quarter financial results and other business activities.  The call can be accessed by dialing (888) 883-4599 (domestic) or (484) 653-6821 (international) and providing passcode 54852842.

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.

A telephone replay also will be available from 7:30 p.m. E.T. through August 15, 2016 and may 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 54852842.

About MDROs

Multidrug-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 about 23,000 people die from them. The annual 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 healthcare 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, Inc. is harnessing the power of informatics and genomic analysis to provide complete solutions for patient, hospital and network-wide infection prevention and treatment. Learn more at www.opgen.com and follow OpGen on Twitter and LinkedIn.

Forward-Looking Statements 

This press release includes statements relating to the company's Acuitas MDRO, Acuitas Lighthouse and QuickFISH products and services, and 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 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.

Contacts:

OpGen
Michael Farmer
Director, Marketing
(240) 813-1284
mfarmer@opgen.com
InvestorRelations@opgen.com

Investor Relations
LHA
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com
 
Bruce Voss
(310) 691-7100
bvoss@lhai.com

OpGen Media
MacDougall Biomedical Communications
Cammy Duong
(781) 235-3060
cduong@macbiocom.com

(Tables follow)
 
 
 

 


 
OpGen, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
 
                 
   
Three Months Ended June 30,
    
Six Months Ended June 30,
  
   
2016
    
2015
    
2016
    
2015
  
                 
Revenue
                
Product sales
  
$
1,028,146
    
$
319,171
    
$
1,975,365
    
$
503,350
  
Laboratory services
    
29,674
      
28,195
      
159,094
      
63,436
  
Collaboration revenue
    
125,000
      
27,780
      
125,000
      
280,560
  
Total revenue
    
1,182,820
      
375,146
      
2,259,459
      
847,346
  
                                 
Operating expenses
                                
Cost of products sold
    
337,020
      
48,231
      
682,987
      
163,620
  
Cost of services
    
161,222
      
54,794
      
476,931
      
150,224
  
Research and development
    
2,333,584
      
999,699
      
4,287,013
      
2,108,301
  
General and administrative
    
1,777,054
      
1,420,219
      
3,315,100
      
2,079,611
  
Sales and marketing
    
1,588,553
      
905,767
      
2,987,988
      
1,929,796
  
Total operating expenses
    
6,197,433
      
3,428,710
      
11,750,019
      
6,431,552
  
Operating loss
    
(5,014,613
)
    
(3,053,564
)
    
(9,490,560
)
    
(5,584,206
)
                                 
Other income (expense)
                                
Interest expense
    
(26,649
)
    
(1,632,974
)
    
(68,383
)
    
(1,729,371
)
Foreign currency transaction gains (losses)
    
(7,766
)
    
-
      
3,562
      
-
  
Change in fair value of derivative financial instruments
    
-
      
(679,173
)
    
-
      
(647,342
)
Interest income and other expense
    
(3,874
)
    
7,127
      
(3,699
)
    
7,162
  
Total other income (expense)
    
(38,289
)
    
(2,305,020
)
    
(68,520
)
    
(2,369,551
)
Net loss
    
(5,052,902
)
    
(5,358,584
)
    
(9,559,080
)
    
(7,953,757
)
                                 
Preferred stock dividends and beneficial conversion
    
(332,550
)
    
(72,767
)
    
(332,550
)
    
(244,508
)
Net loss attributable to common stockholders
  
$
(5,385,452
)
  
$
(5,431,351
)
  
$
(9,891,630
)
  
$
(8,198,265
)
                                 
Net loss per common share - basic and diluted
  
$
(0.37
)
  
$
(0.84
)
  
$
(0.73
)
  
$
(2.35
)
Weighted average shares outstanding - basic and diluted
    
14,522,097
      
6,449,108
      
13,545,519
      
3,487,734
  
                                 
Net loss
  
$
(5,052,902
)
  
$
(5,358,584
)
  
$
(9,559,080
)
  
$
(7,953,757
)
Other comprehensive income - foreign currency translation
    
1,498
      
-
      
387
      
-
  
Comprehensive loss
  
$
(5,051,404
)
  
$
(5,358,584
)
  
$
(9,558,693
)
  
$
(7,953,757
)
 
 
 
 
 
OpGen, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(unaudited)
 
         
   
June 30, 2016
    
December 31, 2015
  
Assets
        
Current assets
        
 Cash and cash equivalents
  
$
8,025,023
    
$
7,814,220
  
 Accounts receivable, net
    
871,564
      
678,646
  
 Inventory, net
    
844,272
      
826,012
  
 Prepaid expenses and other current assets
    
561,693
      
566,239
  
 Total current assets
    
10,302,552
      
9,885,117
  
 Property and equipment, net 
    
922,157
      
1,074,710
  
 Goodwill
    
600,814
      
637,528
  
 Intangible assets, net
    
1,754,906
      
1,888,814
  
 Other noncurrent assets
    
270,412
      
270,327
  
 Total assets
  
$
13,850,841
    
$
13,756,496
  
                 
Liabilities and Stockholders’ Equity
                
Current liabilities
                
Accounts payable
  
$
1,900,844
    
$
2,285,792
  
Accrued compensation and benefits
    
942,636
      
1,081,270
  
Accrued liabilities
    
797,056
      
920,286
  
Deferred revenue
    
105,767
      
50,925
  
Short term notes payable
    
179,567
      
-
  
Current maturities of long-term capital lease obligation
    
232,824
      
251,800
  
Total current liabilities
    
4,158,694
      
4,590,073
  
                 
Deferred rent
    
527,528
      
352,985
  
Note payable
    
995,833
      
993,750
  
Long-term capital lease obligation and other noncurrent liabilities
    
224,278
      
328,642
  
Total liabilities
    
5,906,333
      
6,265,450
  
                 
Commitments and contingencies
                
Stockholders' equity
                
Common stock, $.01 par value; 200,000,000 shares authorized; 19,353,126 and 12,547,684 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively
    
193,531
      
125,477
  
Preferred stock, $0.01 par value; 10,000,000 shares authorized; 2,309,428 issued and outstanding at June 30, 2016 (none at December 31, 2015)
    
23,094
      
-
  
Additional paid-in capital
    
131,412,003
      
121,490,994
  
Accumulated other comprehensive loss
    
(672
)
    
(1,059
)
Accumulated deficit
    
(123,683,448
)
    
(114,124,366
)
Total stockholders’ equity
    
7,944,508
      
7,491,046
  
Total liabilities and stockholders’ equity
  
$
13,850,841
    
$
13,756,496
  


 
 

# # #