OpGen Reports Second Quarter 2018 Financial Results And Provides Business Update
Revenue increases 12% to
Conference call begins at
“During the second quarter we continued to advance development of our lead rapid test, the Acuitas®
“At the ASM Microbe conference in June we presented positive data from our ongoing clinical verification studies for the
Mr. Jones continued, “At ASM Microbe we also presented results of a prospective clinical trial evaluating the impact of using rapid diagnostic testing for the identification and treatment of bacteremia and fungemia in hospital intensive care units in
2018 Second Quarter and First Half Financial Results
- Revenue: Total revenue for the second quarter of 2018 was
$0.8 million, compared with $0.7 millionfor the second quarter of 2017. Total revenue for the first half of 2018 was $1.6 million, compared with $1.5 millionfor the first half of 2017.
- Operating Expenses: Operating expenses for the second quarter of 2018 were
$4.0 million, compared with $4.9 millionfor the second quarter of 2017. Operating expenses for the first half of 2018 were $7.9 million, compared with $10.6 millionfor the first half of 2017.
- Net Loss: The net loss for the second quarter of 2018 was
$3.3 millionor $0.57per share, compared with a net loss of $4.2 millionor $3.73per share for the second quarter of 2017. The net loss for the first half of 2018 was $6.4 millionor $1.29per share, compared with a net loss of $9.2 millionor $8.45per share for the first half of 2017.
- Cash Position: Cash and cash equivalents were $7.4 million as of
June 30, 2018, compared with $1.8 millionas of December 31, 2017.
Second Quarter 2018 Enterprise Highlights and Recent Developments:
Summary highlights from the second quarter and recent weeks included:
- Completed preliminary reviews with the
FDAresulting in plans to file two 510(k) submissions for the Acuitas AMR Gene Panelu5.47, one for bacterial isolates and a second de novo submission for urine specimens and a separate de novo 510(k) submission for the Acuitas Lighthouse Software.
- Completed planning for the
Acuitas AMR Gene Panel(Isolates) 510(k) FDAsubmission with testing of approximately 900 stock bacterial isolates and analytical validation testing of IUO product to begin during August.
- Expanded the
OpGen Clinical Advisory Boardand Medical Affairs team with the addition of Patricia Simner, Ph.D. D(ABMM), Associate Professor of Pathology, Director of Bacteriology and Parasitology, the Johns Hopkins Medical Institutions, as an advisor to the company.
- Achieved development milestone in CDC funded program for development of smartphone-based clinical decision support software with hospital testing underway in
- Presented data at ASM Microbe 2018 demonstrating 91% to 100% accuracy for predicting antibiotic resistance using the Acuitas®
AMR Gene Panelu5.47 (RUO).
- Presented data at ASM Microbe 2018 from a prospective clinical trial in
Colombiademonstrating a 57% improvement in survival and reductions in antibiotic usage with the Company’s QuickFISH rapid diagnostic test.
- Reported successful analytical validation and clinical verification results for the
Acuitas AMR Gene Panelu5.47 (RUO).
- Modified the terms of the debt held by
Merck Global Health Innovation Fundto extend the note’s maturity and satisfy interest payments with issuance of Company’s common stock.
- Continued to achieve stated operating expense reduction, down 17% compared with the second quarter of 2017 and down 26% for the six (6) months ended
June 30, 2018as compared to the six (6) months ended June 30, 2017.
“We made solid progress with research and development, operations and expense reduction during the quarter. We are encouraged by the progress to date with our
OpGen expects to achieve the following business objectives during the remainder of 2018 as it transitions to the commercial phase of its molecular informatics business:
- Derive revenue from the sale of the
RUO Acuitas AMR Gene Panelu5.47 to large hospitals, pharmaceutical companies and clinical research organizations.
- Complete third-party clinical verification studies and clinical trials to support
FDAclearance for IVD use of the Acuitas AMR Gene Panelu5.47 test and the Acuitas Lighthouse Software.
- File a first 510(k) submission with the
FDAin the fourth quarter of 2018 for the Acuitas AMR Gene Panelu5.47 (IVD) to support full commercial launch for clinical use.
- Add QuantStudio 5® and EZ1 Advanced XL® revenue-generating system placements.
- Enter into additional supply and cooperation agreements in support of the new Acuitas product family under development.
- Decommission the company’s CLIA laboratory operations in the third quarter of 2018 to provide incremental resources in support of efforts to gain
FDAclearance for the company’s new Acuitas products.
- Complete CDC contract demonstration in
Colombiafor development of smartphone-based clinical decision support solutions for anti-microbial stewardship and infection control in low- and middle-income countries.
- Continue to seek third-party funding for development programs.
- Maintain cost reductions and overall cash burn rate to extend operating cash runway.
Conference Call Information
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, and answer questions. The call can be accessed by dialing (888) 883-4599 (domestic) or (484) 653-6821 (international) and providing conference ID: 9795495. A live webcast of the conference call can be accessed by visiting the Investor Relations section of the company’s website at www.ir.opgen.com. A replay of the webcast will be available shortly after the conclusion of the call for 90 days.
A telephone replay of the conference call will be available from
This press release includes statements relating to OpGen’s second quarter 2018 and six months 2018 results. 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
(Tables to follow)
|Condensed Consolidated Balance Sheets|
|June 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||7,428,993||$||1,847,171|
|Accounts receivable, net||516,472||809,540|
|Prepaid expenses and other current assets||525,484||311,644|
|Total current assets||9,085,372||3,501,780|
|Property and equipment, net||932,215||835,537|
|Intangible assets, net||1,219,274||1,353,182|
|Other noncurrent assets||289,032||328,601|
|Liabilities and Stockholders’ Equity|
|Accrued compensation and benefits||868,802||746,924|
|Short-term notes payable||476,567||1,010,961|
|Current maturities of long-term capital lease obligations||248,305||154,839|
|Total current liabilities||4,268,320||4,789,592|
|Long-term capital lease obligations and other noncurrent liabilities||403,291||130,153|
|Common stock, $0.01 par value; 50,000,000 shares authorized; 6,067,039 and
2,265,320 shares issued and outstanding at June 30, 2018 and
December 31, 2017, respectively
|Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and
outstanding at June 30, 2018 and December 31, 2017, respectively
|Additional paid-in capital||161,449,185||150,114,671|
|Accumulated other comprehensive loss||(20,366||)||(25,900||)|
|Total stockholders’ equity||6,398,765||1,400,997|
|Total liabilities and stockholders’ equity||$||12,126,707||$||6,619,914|
|Condensed Consolidated Statements of Operations and Comprehensive Loss|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Cost of products sold||303,663||392,791||646,495||817,741|
|Cost of services||179,402||78,763||347,955||178,996|
|Research and development||1,308,388||1,762,234||2,538,817||3,884,749|
|General and administrative||1,827,063||1,750,018||3,617,585||3,719,234|
|Sales and marketing||426,297||909,402||756,070||2,014,988|
|Total operating expenses||4,044,813||4,893,208||7,906,922||10,615,708|
|Interest and other income||5||22||5,303||43|
|Foreign currency transaction (losses)/gains||(21,762||)||8,998||(9,581||)||11,618|
|Change in fair value of derivative financial instruments||(11||)||26,744||8,155||26,744|
|Total other expense||(76,301||)||(18,049||)||(108,502||)||(45,252||)|
|Loss before income taxes||(3,332,213||)||(4,208,047||)||(6,380,297||)||(9,185,979||)|
|Provision for income taxes||—||—||—||—|
|Net loss available to common stockholders||$||(3,332,213||)||$||(4,208,047||)||$||(6,380,297||)||$||(9,185,979||)|
|Net loss per common share - basic and diluted||$||(0.57||)||$||(3.73||)||$||(1.29||)||$||(8.45||)|
|Weighted average shares outstanding - basic and diluted||5,826,947||1,128,426||4,950,517||1,086,477|
|Other comprehensive loss - foreign currency translation||18,113||(3,834||)||5,534||(7,591||)|
Source: OpGen, Inc.