OpGen Reports 2017 Third Quarter Financial Results and Provides Business Update
Affirms plans to release Acuitas®
Conference call begins at
“During the third quarter and recent weeks, we continued to achieve important corporate milestones in the development of our new Acuitas gene tests and informatics for multi-drug resistant organisms” said
Additional developments during the third quarter and recent weeks include:
- Advanced development of the
Acuitas AMR Gene Panelu5.47 for complicated urinary tract infections (cUTI) for release in the first half of 2018 for research and investigational use
- Produced the first
AMR Gene Paneltest kits for cUTI and clinical isolate testing
- Began analytical validation studies for the cUTI panel
- Advanced plans to begin clinical validation studies for the cUTI panel in the fourth quarter of 2017
- Continued development of genotype/phenotype predictive algorithms based on the testing of 7,400 clinical isolates from the Merck SMART surveillance network and clinical collaborators, contributing to the 15,800 isolates contained in the Acuitas Lighthouse Knowledgebase
- Achieved stated operating expense reduction during the quarter, with a 29% reduction compared with the third quarter of 2016
- Completed a
$10.0 millionpublic offering with net proceeds to OpGenof $8.8 million
2017 Third Quarter and Year-to-Date Financial Results
- Revenue: Total revenue for the three months ended September 30, 2017 was
$745,000, compared with $760,000for the three months ended September 30, 2016. Total revenue for the nine months ended September 30, 2017was $2.2 million, compared with $3.0 millionfor the nine months ended September 30, 2016.
- Operating Expenses: Operating expenses for the three months ended September 30, 2017 were
$3.9 million, compared with $5.6 millionfor the three months ended September 30, 2016. Operating expenses for the nine months ended September 30, 2017were $14.6 million, compared with $17.3 millionfor the nine months ended September 30, 2016.
- Net Loss Available to Common Stockholders: Net loss for the three months ended September 30, 2017 was
$3.3 millionor $0.07per share, compared with $4.8 millionor $0.23per share for the three months ended September 30, 2016. Net loss for the nine months ended September 30, 2017was $12.5 millionor $0.37per share, compared with $14.7 millionor $0.92per share for the nine months ended September 30, 2016.
- Cash Position: Cash and cash equivalents were $4.9 million as of
September 30, 2017, compared with $4.1 millionas of December 31, 2016.
2017 Third Quarter Enterprise Highlights and Recent Developments
$860,000CDC Contract funding development and evaluation of cloud- and mobile-based software integrating electronic patient data and local empiric treatment guidelines to support antimicrobial stewardship and infection control for low- and middle-income countries. OpGenwill work with partners TEQQA, LLCand Universidad El Bosque of Bogota, Colombialed by Maria Virginia Villegas, M.D., M.Sc. and will work to establish connectivity to WHONET, an information system developed to support the World Health Organization’s goal of global surveillance of bacterial resistance to antimicrobial agents. WHONET analyzes the data of over 4,000 laboratories worldwide and is used in more than 120 countries.
- Presented study results on the company’s new rapid test in development, the
Acuitas AMR Gene Panelu5.47, and the Acuitas Lighthouse Knowledgebase for the prediction of antibiotic susceptibility at the 2017 ASM/ESCMID Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. The semi-quantitative PCR test detects 5 bacterial pathogens in clinical isolates and urine specimens and detects 47 antimicrobial resistance genes.
“We were pleased with our financial performance during the third quarter with the significant narrowing of our net loss,” continued Mr. Jones. “We maintained product sales and collaboration revenue at
“Our Acuitas Rapid Test for cUTI is on track to be evaluated at third-party clinical sites in the fourth quarter and released for research use only in the first quarter of 2018,” added Mr. Jones. “This antimicrobial resistance test is expected to be the first of a series of
OpGen expects to advance the following business objectives through the remainder of 2017:
- Finalize initial Acuitas Lighthouse Knowledgebase antibiotic resistance prediction algorithms and begin clinical validation studies for
Acuitas AMR Gene Panelu5.47 at major academic medical centers and health systems.
- Complete analytical validation studies for the
AMR Gene Panelu5.47 to allow commercial release in Q1 2018 and FDAclinical trials during 2018.
- Enter into additional supply and cooperation agreements in support of the new Acuitas product family under development.
- Complete first program milestones in CDC contract, with our collaboration partners, for development of smartphone-based clinical decision support solutions for antimicrobial stewardship (AMS) and infection control in low- and middle-income countries.
- Continue to reduce costs and overall cash burn rate to help provide extended operating cash runway.
Conference Call Information
OpGen management will hold a conference call today beginning at 4:30 p.m. Eastern time to discuss third quarter 2017 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 the conference ID: 2498769. 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 of the conference call will be available from
This press release includes statements relating to the proceeds from the Company’s public offering and its products and services. 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
|Condensed Consolidated Balance Sheets|
|September 30, 2017||December 31, 2016|
|Cash and cash equivalents||$||4,854,031||$||4,117,324|
|Accounts receivable, net||469,954||542,420|
|Prepaid expenses and other current assets||340,923||329,646|
|Total current assets||6,126,037||5,681,758|
|Property and equipment, net||750,090||800,723|
|Intangible assets, net||1,420,136||1,620,998|
|Other noncurrent assets||321,592||279,752|
|Liabilities and Stockholders’ Equity|
|Accrued compensation and benefits||902,892||578,480|
|Short-term notes payable||1,100,012||1,023,815|
|Current maturities of long-term capital lease obligation||160,485||184,399|
|Total current liabilities||4,990,827||5,271,937|
|Long-term capital lease obligation and other noncurrent liabilities||119,764||146,543|
|Common stock, $0.01 par value; 200,000,000 shares authorized; 51,964,878 and
25,304,270 shares issued and outstanding at September 30, 2017 and
December 31, 2016, respectively
|Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and
outstanding at September 30, 2017 and December 31, 2016, respectively
|Additional paid-in capital||148,994,194||136,199,382|
|Accumulated other comprehensive (loss)/income||(7,649||)||6,176|
|Total stockholders’ equity||3,760,427||3,167,481|
|Total liabilities and stockholders’ equity||$||9,218,669||$||8,984,045|
|Condensed Consolidated Statements of Operations and Comprehensive Loss|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Cost of products sold||448,407||400,001||1,266,148||1,269,990|
|Cost of services||49,119||51,802||228,115||528,733|
|Research and development||1,513,157||2,178,818||5,397,906||6,278,829|
|General and administrative||1,600,577||1,639,996||5,319,811||4,955,096|
|Sales and marketing||330,305||1,294,640||2,345,293||4,282,628|
|Total operating expenses||3,941,565||5,565,257||14,557,273||17,315,276|
|Foreign currency transaction gains/(losses)||8,018||(1,269||)||19,636||2,293|
|Changes in fair value of warrant liabilities||97,395||-||124,139||-|
|Total other expense||(72,196||)||(42,069||)||(117,469||)||(110,591||)|
|Loss before income taxes||(3,268,647||)||(4,847,663||)||(12,454,647||)||(14,406,745||)|
|Provision for income taxes||—||—||—||—|
|Preferred stock dividends and beneficial conversion||—||—||—||(332,550||)|
|Net loss available to common stockholders||$||(3,268,647||)||$||(4,847,663||)||$||(12,454,647||)||$||(14,739,295||)|
|Net loss per common share - basic and diluted||$||(0.07||)||$||(0.23||)||$||(0.37||)||$||(0.92||)|
|Weighted average shares outstanding - basic and diluted||47,078,415||20,938,700||33,956,494||16,028,047|
|Other comprehensive (loss)/income - foreign currency translation||(6,234||)||672||(13,825||)||1,059|