OpGen Reports 2016 Third Quarter Financial Results and Provides Business Update

GAITHERSBURG, Md., Oct. 24, 2016 (GLOBE NEWSWIRE) — OpGen, Inc. (NASDAQ:OPGN) today reported financial and operational results for the three and nine months ended September 30, 2016. Highlights of the third quarter and recent weeks include:

  • Third-quarter revenues of $0.8 million, a 23% decrease over prior year
  • Nine-month revenues of $3.0 million, a 65% increase over prior year
  • Automated QuickFISH® Pathogen ID clinical trial anticipated to begin Q1 2017
  • Acuitas Lighthouse® rapid antibiotic resistance test and knowledgebase development underway
  • Initial Intermountain Healthcare Retrospective Study results presented

Total revenue for the third quarter of 2016 was $0.8 million, compared with $1.0 million for the third quarter of 2015, a 23% decrease. Product sales and laboratory services decreased to $0.8 million, compared with $1.0 million for the third quarter of 2015. The decrease was attributable to decreased rapid pathogen ID and legacy genome mapping product sales. Gross margin on product sales was 45% for the third quarter of 2016. Total operating expenses for the third quarter of 2016 were $5.6 million, compared with $5.6 million for the third quarter of 2015. The net loss attributable to common stockholders for the third quarter of 2016 was $4.8 million, or $0.23 per share, compared with a net loss attributable to common stockholders for the third quarter of 2015 of $4.7 million, or $0.38 per share. The company had cash and cash equivalents of $4.3 million as of September 30, 2016, compared with $7.8 million as of December 31, 2015.

Total revenue for the nine months ended September 30, 2016 was $3.0 million, compared with $1.8 million for the same period of 2015, a 65% increase. Revenue from product sales and laboratory services increased 90% to $2.9 million from $1.5 million in 2015 primarily as a result of sales of rapid pathogen ID testing products. Gross margin on product sales was 53% for the nine months ended September 30, 2016. Total operating expenses for the nine months ended September 30, 2016 were $17.3 million, compared with $12.1 million for the nine months ended September 30, 2015. Net loss attributable to common stockholders was $14.7 million for the nine months ended September 30, 2016, or $0.92 per share, compared with a net loss attributable to common stockholders of $12.9 million for the nine months ended September 30, 2015 or $2.00 per share.

“During the quarter we continued to make progress developing our genomics and informatics business. Nine-month revenue increased 65% to $3.0 million and we continued to progress a number of key strategic initiatives. In the area of rapid antibiotic decision-making, our automated rapid pathogen ID system is on track to begin 510(k) clinical trials in Q1 2017 and development of our mAST™ antibiotic resistance testing solution is underway. We have begun testing thousands of pathogens to support development of our Acuitas Lighthouse rapid antibiotic resistance test and knowledge base following the successful verification of our expanded Resistome test and the initial performance confirmation of our mAST genotype/phenotype predictive algorithms. These products and services are being developed to address the large and growing global antibiotic resistance testing opportunity,” said Evan Jones, chairman and chief executive officer of OpGen.

“We continue to work closely with large healthcare providers and hospital networks to demonstrate the benefits of our integrated informatics and genomic products and services. At IDWeek 2016 we anticipate the presentation of additional data from these collaborative efforts as we work to transform acute care infectious disease monitoring with our Acuitas Lighthouse offerings.”

Mr. Jones concluded, “During the third quarter our revenues, were negatively impacted by several items. These included the timing of sales, the phase-out of our legacy whole genome mapping products, and supply chain issues for our rapid pathogen ID products. We have addressed the supply chain issues and, looking forward, we anticipate a stable recurring revenue base from our rapid pathogen ID testing products and growing contribution to revenue from our new product sales and service offerings.”

Conference Call and Webcast

OpGen management will hold a conference call today beginning at 4:30 p.m. (EDT) to discuss third quarter financial results and other business activities.  The call can be accessed by dialing 844-420-8185 (domestic) or 216-562-0481 (international) and providing passcode 4676290. 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 also will be available from 7:30 p.m. E.T. through October 29, 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 4676290.

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.

OpGen, Acuitas MDRO, Acuitas Lighthouse and QuickFISH are registered trademarks of OpGen, Inc.

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.

OpGen, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)

    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
    2016     2015     2016     2015  
Revenue                                
Product sales   $ 730,325     $ 929,241     $ 2,705,690     $ 1,432,592  
Laboratory services     23,036       23,765       182,130       87,201  
Collaboration revenue     6,302       27,780       131,302       308,340  
Total revenue     759,663       980,786       3,019,122       1,828,133  
Operating expenses                                
Cost of products sold     400,001       624,635       1,269,990       788,256  
Cost of services     51,802       48,467       528,733       198,691  
Research and development     2,178,818       1,788,748       6,278,829       3,897,049  
General and administrative     1,639,996       1,614,532       4,955,096       3,694,143  
Sales and marketing     1,294,640       1,032,759       4,282,628       2,962,555  
Transaction expenses           525,596             525,596  
Total operating expenses     5,565,257       5,634,737       17,315,276       12,066,290  
Operating loss     (4,805,594 )     (4,653,951 )     (14,296,154 )     (10,238,157 )
Other expense                                
Interest and other income/(expense)     623       2,513       (3,078 )     9,675  
Interest expense     (41,423 )     (17,482 )     (109,806 )     (1,746,853 )
Foreign currency transaction (losses)/gains     (1,269 )           2,293        
Change in fair value of derivative financial instruments                       (647,342 )
Total other expense     (42,069 )     (14,969 )     (110,591 )     (2,384,520 )
Loss before income taxes     (4,847,663 )     (4,668,920 )     (14,406,745 )     (12,622,677 )
                                 
Provision for income taxes           1,662             1,662  
Net loss     (4,847,663 )     (4,670,582 )     (14,406,745 )     (12,624,339 )
                                 
Preferred stock dividends and beneficial conversion                 (332,550 )     (244,508 )
Net loss available to common stockholders   $ (4,847,663 )   $ (4,670,582 )   $ (14,739,295 )   $ (12,868,847 )
Net loss per common share – basic and diluted   $ (0.23 )   $ (0.38 )   $ (0.92 )   $ (2.00 )
Weighted average shares outstanding – basic and diluted     20,938,700       12,261,238       16,028,047       6,444,373  
Net loss   $ (4,847,663 )   $ (4,670,582 )   $ (14,406,745 )   $ (12,624,339 )
Other comprehensive income/(loss) – foreign currency translation     1,498       (49 )     387       (49 )
Comprehensive loss   $ (4,846,165 )   $ (4,670,631 )   $ (14,406,358 )   $ (12,624,388 )


OpGen, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(unaudited)

    September 30, 2016     December 31, 2015  
Assets                
Current assets                
Cash and cash equivalents   $ 4,260,905     $ 7,814,220  
Accounts receivable, net     446,686       678,646  
Inventory, net     830,205       826,012  
Prepaid expenses and other current assets     478,683       566,239  
Total current assets     6,016,479       9,885,117  
Property and equipment, net     862,643       1,074,710  
Goodwill     600,814       637,528  
Intangible assets, net     1,687,952       1,888,814  
Deferred offering costs     137,178        
Other noncurrent assets     270,464       270,327  
Total assets   $ 9,575,530     $ 13,756,496  
Liabilities and Stockholders’ Equity                
Current liabilities                
Accounts payable   $ 1,936,012     $ 2,285,792  
Accrued compensation and benefits     1,230,502       1,081,270  
Accrued liabilities     1,155,317       920,286  
Deferred revenue     64,424       50,925  
Short term notes payable     1,099,974        
Current maturities of long-term capital lease obligation     207,820       251,800  
Total current liabilities     5,694,049       4,590,073  
Deferred rent     421,913       352,985  
Note payable           993,750  
Long-term capital lease obligation and other noncurrent liabilities     184,391       328,642  
Total liabilities     6,300,353       6,265,450  
Stockholders’ equity                
Common stock, $.01 par value; 200,000,000 shares authorized; 21,690,555 and 12,547,684 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively     216,905       125,477  
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at September 30, 2016 and December 31, 2015, respectively            
Additional paid-in capital     131,590,858       121,490,994  
Accumulated other comprehensive gain/(loss)           (1,059 )
Accumulated deficit     (128,532,586 )     (114,124,366 )
Total stockholders’ equity     3,275,177       7,491,046  
Total liabilities and stockholders’ equity   $ 9,575,530     $ 13,756,496  

 

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

Investor and Media Contact: 
MacDougall Biomedical Communications
Cammy Duong
(781) 235-3060
cduong@macbiocom.com