OpGen Reports Third Quarter 2019 Financial Results and Provides Business Update
22% Revenue Increase Year-to-Date
Update on Announced Agreement to Combine Business with
Conference call to be held at
OpGen andCuretis N.V. entered into the Implementation Agreement to combine the businesses ofOpGen andCuretis GmbH that will lead to, when closed, a commercial-stage, transatlantic diagnostics company focused on data-driven solutions for molecular microbiology;- Ongoing activities to support the 510(k) pre-market notification to the U.S. Food and Drug Administration (“FDA”) for clearance of the Acuitas® AMR Gene Panel test for the detection of antimicrobial resistance genes in bacterial isolates filed in
May 2019 ; - Initiation during November of clinical trials to support De Novo submission for our lead rapid molecular diagnostic test, the Acuitas AMR Gene Panel Urine;
- Achievement of planned program milestones under the
New York State Infectious Disease Digital Health Initiative demonstration project; - The allowance by the U.S. Patent and Trademark Office (USPTO) for a key
OpGen patent covering the Acuitas Lighthouse® Profiling technology used in the Company’s software for tracking AMR pathogens; - The presentation of preliminary Acuitas®
AMR Gene Panel data for detecting urinary tract infections (UTI) at IDWeek 2019. The data demonstrate the concordance ofAcuitas AMR Gene Panel results with conventional urine culture results and prediction of antimicrobial resistance using the Acuitas® Lighthouse Software; - Completion of a public offering with gross proceeds of
$9.4 million . The Company intends to use a portion of the proceeds to complete the business combination withCuretis GmbH along with other planned business activities.
Mr. Jones continued, “OpGen’s business had continued success during the third quarter with the achievement of key business milestones and significant progress towards gaining the first
“We look forward to the completion of the business combination with
Third Quarter and Nine Month 2019 Financial Results
- Total revenue for the third quarter of 2019 was
$648 thousand , compared with$552 thousand in the third quarter of 2018. Total revenue for the nine months endedSeptember 30, 2019 was$2.7 million , compared to$2.2 million for the nine months endedSeptember 30, 2018 ; - Operating expenses for the third quarter of 2019 were
$4.1 million , compared with$3.8 million in the third quarter of 2018. Total operating expenses for the nine months endedSeptember 30, 2019 were$12.4 million , compared to$11.7 million for the nine months endedSeptember 30, 2018 ; - The net loss for the third quarter of 2019 was
$3.5 million or$3.95 per share, compared with$3.3 million or$10.67 per share in the third quarter of 2018. The net loss for the nine months endedSeptember 30, 2019 was$9.9 million or$13.32 per share, compared to$9.6 million or$36.09 per share for the period endingSeptember 30, 2018 .
Business and Operations Outlook
We anticipate achieving the following:
- Complete planned business combination with
Curetis in the first quarter of 2020; - Obtain
FDA clearance to market theAcuitas AMR Gene Panel for use with bacterial Isolates; - Complete clinical studies and file De Novo submissions with the
FDA for the Acuitas AMR Gene Panel Urine and the Acuitas Lighthouse Software for rapid testing of urine specimens and prediction of antibiotic resistance to front-line antibiotics; and - Complete data collection phase for
New York State Infectious Disease Digital Health Initiative demonstration project.
Conference Call Information
OpGen’s management will host a conference call today,
Dial-in Information
International Dial-in Number: +1 (216) 562-0481
Webcast: https://edge.media-server.com/mmc/p/p64ma2dv
Conference ID: 2899666
Following the conclusion of the conference call, a replay will be available through
Replay Information
International Dial-in Number: +1 (404) 537-3406
Conference ID: 2899666
About
Our molecular diagnostics and informatics products, product candidates and services combine our Acuitas molecular diagnostics and
Forward-Looking Statements
This press release includes statements relating to the completion of the business combination with
OpGen Contact:
Vice President, Marketing
(240) 813-1284
mfarmer@opgen.com
Press Contact:
FischTank Marketing and PR
matt@fischtankpr.com
Investor Contact:
Edison Group
jgreen@edisongroup.com
| OpGen, Inc. | ||||||||||
| Condensed Consolidated Balance Sheets | ||||||||||
| September 30, 2019 | December 31, 2018 | |||||||||
| Assets | (Unaudited) | |||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | $ | 626,420 | $ | 4,572,487 | ||||||
| Accounts receivable, net | 377,284 | 373,858 | ||||||||
| Inventory, net | 468,374 | 543,747 | ||||||||
| Prepaid expenses and other current assets | 533,411 | 292,918 | ||||||||
| Total current assets | 2,005,489 | 5,783,010 | ||||||||
| Property and equipment, net | 201,762 | 1,221,827 | ||||||||
| Finance lease right-of-use assets, net | 1,096,472 | — | ||||||||
| Operating lease right-of-use assets | 1,214,482 | — | ||||||||
| Goodwill | 600,814 | 600,814 | ||||||||
| Intangible assets, net | 884,504 | 1,085,366 | ||||||||
| Other noncurrent assets | 426,629 | 259,346 | ||||||||
| Total assets | $ | 6,430,152 | $ | 8,950,363 | ||||||
| Liabilities and Stockholders’ Equity (Deficit) | ||||||||||
| Current liabilities | ||||||||||
| Accounts payable | $ | 1,872,762 | $ | 1,623,751 | ||||||
| Accrued compensation and benefits | 1,387,498 | 1,041,573 | ||||||||
| Accrued liabilities | 1,040,562 | 902,019 | ||||||||
| Deferred revenue | 9,808 | 15,824 | ||||||||
| Short-term notes payable | 508,292 | 398,595 | ||||||||
| Short-term finance lease liabilities | 627,620 | 399,345 | ||||||||
| Short-term operating lease liabilities | 987,833 | — | ||||||||
| Total current liabilities | 6,434,375 | 4,381,107 | ||||||||
| Deferred rent | — | 162,919 | ||||||||
| Note payable | 328,843 | 660,340 | ||||||||
| Warrant liability | — | 67 | ||||||||
| Long-term finance lease liabilities | 411,103 | 437,189 | ||||||||
| Long-term operating lease liabilities | 812,801 | — | ||||||||
| Total liabilities | 7,987,122 | 5,641,622 | ||||||||
| Commitments | ||||||||||
| Stockholders' equity (deficit) | ||||||||||
| Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at September 30, 2019 and December 31, 2018, respectively |
— | — | ||||||||
| Common stock, $0.01 par value; 50,000,000 shares authorized; 882,268 and 432,286 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively |
8,823 | 4,323 | ||||||||
| Additional paid-in capital | 170,449,216 | 165,396,036 | ||||||||
| Accumulated deficit | (172,007,090 | ) | (162,078,525 | ) | ||||||
| Accumulated other comprehensive loss | (7,919 | ) | (13,093 | ) | ||||||
| Total stockholders’ equity (deficit) | (1,556,970 | ) | 3,308,741 | |||||||
| Total liabilities and stockholders’ equity (deficit) | $ | 6,430,152 | $ | 8,950,363 | ||||||
| OpGen, Inc. | ||||||||||||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||||
| (unaudited) | ||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||||
| Revenue | ||||||||||||||||||
| Product sales | $ | 573,035 | $ | 539,856 | $ | 1,597,505 | $ | 1,805,877 | ||||||||||
| Laboratory services | 185 | 12,365 | 5,435 | 22,155 | ||||||||||||||
| Collaboration revenue | 75,000 | — | 1,075,000 | 359,316 | ||||||||||||||
| Total revenue | 648,220 | 552,221 | 2,677,940 | 2,187,348 | ||||||||||||||
| Operating expenses | ||||||||||||||||||
| Cost of products sold | 262,373 | 292,984 | 681,568 | 939,479 | ||||||||||||||
| Cost of services | 196,184 | 98,189 | 592,647 | 446,144 | ||||||||||||||
| Research and development | 1,139,369 | 1,286,300 | 4,069,335 | 3,821,117 | ||||||||||||||
| General and administrative | 1,560,706 | 1,743,636 | 4,901,136 | 5,365,221 | ||||||||||||||
| Sales and marketing | 376,955 | 361,310 | 1,142,755 | 1,117,380 | ||||||||||||||
| Transaction costs | 538,061 | — | 538,061 | — | ||||||||||||||
| Impairment of right-of-use asset | — | — | 520,759 | — | ||||||||||||||
| Total operating expenses | 4,073,648 | 3,782,419 | 12,446,261 | 11,689,341 | ||||||||||||||
| Operating loss | (3,425,428 | ) | (3,230,198 | ) | (9,768,321 | ) | (9,501,993 | ) | ||||||||||
| Other (expense) income | ||||||||||||||||||
| Other income (expense) | 1,043 | (93 | ) | (8,213 | ) | 5,210 | ||||||||||||
| Interest expense | (49,099 | ) | (28,074 | ) | (142,672 | ) | (140,453 | ) | ||||||||||
| Foreign currency transaction gains (losses) | (8,954 | ) | 3,025 | (9,426 | ) | (6,556 | ) | |||||||||||
| Change in fair value of derivative financial instruments | — | (85 | ) | 67 | 8,070 | |||||||||||||
| Total other expense | (57,010 | ) | (25,227 | ) | (160,244 | ) | (133,729 | ) | ||||||||||
| Loss before income taxes | (3,482,438 | ) | (3,255,425 | ) | (9,928,565 | ) | (9,635,722 | ) | ||||||||||
| Provision for income taxes | — | — | — | — | ||||||||||||||
| Net loss | (3,482,438 | ) | (3,255,425 | ) | (9,928,565 | ) | (9,635,722 | ) | ||||||||||
| Net loss available to common stockholders | $ | (3,482,438 | ) | $ | (3,255,425 | ) | $ | (9,928,565 | ) | $ | (9,635,722 | ) | ||||||
| Net loss per common share - basic and diluted | $ | (3.95 | ) | $ | (10.67 | ) | $ | (13.32 | ) | $ | (36.09 | ) | ||||||
| Weighted average shares outstanding - basic and diluted | 882,280 | 305,187 | 745,471 | 266,997 | ||||||||||||||
| Net loss | $ | (3,482,438 | ) | $ | (3,255,425 | ) | $ | (9,928,565 | ) | $ | (9,635,722 | ) | ||||||
| Other comprehensive gain foreign currency translations | 7,298 | 1,528 | 5,174 | 7,062 | ||||||||||||||
| Comprehensive loss | $ | (3,475,140 | ) | $ | (3,253,897 | ) | $ | (9,923,391 | ) | $ | (9,628,660 | ) | ||||||
Source: OpGen, Inc.