OpGen Reports Third Quarter 2019 Financial Results and Provides Business Update
11.06.19
22% Revenue Increase Year-to-Date
Update on Announced Agreement to Combine Business with Curetis
Conference call to be held at 4:30 p.m. Eastern Time today
GAITHERSBURG, Md., Nov. 06, 2019 (GLOBE NEWSWIRE) -- OpGen, Inc. (NASDAQ: OPGN) today reported financial and operating results for the three and nine months ended September 30, 2019 and provided a business update. Total nine-month revenue was $2.7 million compared with $2.2 million in 2018, a 22.4% increase. Total revenue for the third quarter of 2019 was $648 thousand, compared with $552 thousand for the third quarter of 2018, a 17.4% increase. Recent business highlights include:
OpGen and Curetis N.V. entered into the Implementation Agreement to combine the businesses of OpGen and Curetis 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 of Acuitas 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 with Curetis GmbH along with other planned business activities.
Evan Jones, Chairman and CEO of OpGen, stated, “The third quarter of 2019 saw a number of highlights for OpGen, most notably the transformative announcement of the planned business combination with Curetis. We believe combining the two companies will be a win for shareholders of both companies, with an expanded and proprietary product portfolio and a solid growth profile.”
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 FDA clearance for our Acuitas products. We are encouraged by the positive preliminary data presented at IDWeek 2019 and the recent favorable actions by the USPTO.”
“We look forward to the completion of the business combination with Curetis, expected in early 2020. The outlook for OpGen’s products continues to improve and we look forward to further strengthening of our combined businesses through the planned business combination,” concluded Mr. Jones.
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 ended September 30, 2019 was $2.7 million, compared to $2.2 million for the nine months ended September 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 ended September 30, 2019 were $12.4 million, compared to $11.7 million for the nine months ended September 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 ended September 30, 2019 was $9.9 million or $13.32 per share, compared to $9.6 million or $36.09 per share for the period ending September 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 the Acuitas 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, November 6 at 4:30 p.m. ET to discuss third quarter 2019 financial results and other business activities, as well as answer questions. Dial-in information is below: