OpGen Reports 2017 Second Quarter Financial Results and Provides Business Update
Affirms plans to launch first Acuitas® Rapid Test in first half of 2018
Conference call begins at
“During the second quarter and recent weeks we achieved important milestones in the development of our first Acuitas® Rapid Test and the Acuitas Lighthouse Knowledgebase,” said
Additional developments during the second quarter and recent weeks include:
- Completed a
$10.0 millionpublic offering with net proceeds to OpGenof $8.7 million.
- Entered into a global supply agreement with
Thermo Fisher Scientificto use their technology to support the commercialization of OpGen’s rapid molecular products and informatics system.
- Completed development of genotype/phenotype predictive algorithms based on testing of seven thousand clinical isolates from the Merck SMART surveillance network and clinical collaborators adding to the eleven thousand isolates in the Acuitas Lighthouse Knowledgebase.
- Advanced development of the Acuitas Rapid Test for complicated urinary tract infections (cUTI) for launch in the first half of 2018 for research use.
- Took steps to reduce our operating expenses by approximately 25% to 30% in the second half of 2017, as compared to the first half of the year, including the planned consolidation of
FDA-cleared and CE mark manufacturing and distribution to Gaithersburg.
2017 Second Quarter and Year-to-Date Financial Results
- Revenue: Total revenue for the three months ended June 30, 2017 was
$0.7 millioncompared with $1.2 millionfor the three months ended June 30, 2016. Total revenue for the six months ended June 30, 2017was $1.5 millioncompared with $2.3 millionfor the six months ended June 30, 2016.
- Operating Expenses: Operating expenses for the three months ended June 30, 2017 were
$4.9 millioncompared with $6.2 millionfor the three months ended June 30, 2016. Operating expenses for the six months ended June 30, 2017were $10.6 millioncompared with $11.8 millionfor the six months ended June 30, 2016.
- Net Loss: Net loss for the three months ended June 30, 2017 was
$4.2 millioncompared with $5.1 millionfor the three months ended June 30, 2016. Net loss for the six months ended June 30, 2017was $9.2 millioncompared with $9.6 millionfor the six months ended June 30, 2016.
- Cash Position: Cash and cash equivalents were $0.2 million as of
June 30, 2017compared with $4.1 millionas of December 31, 2016. Subsequent to the close of the quarter, OpGenraised net proceeds of $8.7 millionin a public offering.
2017 Second Quarter Enterprise Highlights and Recent Developments
- Received the 2nd annual Ignaz Semmelweis Award by the Committee to Reduce Infection Deaths for OpGen’s commitment to safe medical care through the development of rapid diagnostics to combat multidrug-resistant infections.
- Received approval from the
New York State Department of Health for the Acuitas MDRO Gene Testfor use by physicians and healthcare providers in that state.
- Presented data at ASM Microbe and ECCMID 2017 meetings demonstrating the performance of the Acuitas Lighthouse Knowledgebase for predicting antibiotic susceptibility from antibiotic resistance gene profiles.
- Strengthened the Company’s governance team with the appointment of life sciences industry veteran
Tina S. Nova, Ph.D. to the Board of Directors.
- Published in Infection Control & Hospital Epidemiology a citywide evaluation of
Washington, D.C.’s healthcare facilities to gauge the prevalence of Carbapenem-Resistant Enterobacteriaceae (CRE) throughout the District of Columbiautilizing OpGen’s Acuitas DNA tests and Acuitas Lighthouse Knowledgebase.
“We were pleased to raise gross proceeds of
“We have taken steps to align expenses with our goals, and second quarter financial results showed evidence of progress. Compared with the first quarter of 2017 we reduced operating expenses by nearly
“The Acuitas Rapid Test for cUTIs is expected to be the first of a series of
Conference Call Information
OpGen management will hold a conference call today beginning at 4:30 p.m. Eastern time to discuss second 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 passcode 61883667. 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
(Tables to follow)
|Condensed Consolidated Statements of Operations and Comprehensive Loss|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Cost of products sold||392,791||337,020||817,741||682,987|
|Cost of services||78,763||161,222||178,996||476,931|
|Research and development||1,762,234||2,333,584||3,884,749||4,287,013|
|General and administrative||1,750,018||1,777,054||3,719,234||3,315,100|
|Sales and marketing||909,402||1,588,553||2,014,988||2,987,988|
|Total operating expenses||4,893,208||6,197,433||10,615,708||11,750,019|
|Interest and other income/(expense)||22||(3,874||)||43||(3,699||)|
|Foreign currency transaction gains/(losses)||8,998||(7,766||)||11,618||3,562|
|Changes in fair value of warrant and conversion option liabilities||26,744||—||26,744||—|
|Total other expense||(18,049||)||(38,289||)||(45,252||)||(68,520||)|
|Loss before income taxes||(4,208,047||)||(5,052,902||)||(9,185,979||)||(9,559,080||)|
|Provision for income taxes||—||—||—||—|
|Preferred stock dividends and beneficial conversion||—||(332,550||)||—||(332,550||)|
|Net loss available to common stockholders||$||(4,208,047||)||$||(5,385,452||)||$||(9,185,979||)||$||(9,891,630||)|
|Net loss per common share - basic and diluted||$||(0.15||)||$||(0.37||)||$||(0.34||)||$||(0.74||)|
|Weighted average shares outstanding - basic and diluted||28,210,657||14,522,097||27,161,931||13,545,519|
|Other comprehensive (loss)/income - foreign currency translation||(3,834||)||1,498||(7,591||)||387|
|Condensed Consolidated Balance Sheets|
|June 30, 2017||December 31, 2016|
|Cash and cash equivalents||$||211,683||$||4,117,324|
|Accounts receivable, net||411,762||542,420|
|Prepaid expenses and other current assets||423,477||329,646|
|Total current assets||1,625,825||5,681,758|
|Property and equipment, net||784,333||800,723|
|Deferred offering costs||179,150||—|
|Intangible assets, net||1,487,090||1,620,998|
|Other noncurrent assets||313,828||279,752|
|Liabilities and Stockholders’ (Deficit) Equity|
|Accrued compensation and benefits||798,069||578,480|
|Short-term notes payable||629,702||1,023,815|
|Current maturities of long-term capital lease obligation||168,831||184,399|
|Total current liabilities||5,514,184||5,271,937|
|Long-term capital lease obligation and other noncurrent liabilities||273,208||146,543|
|Stockholders' (deficit) equity|
|Common stock, $0.01 par value; 200,000,000 shares authorized; 29,365,741 and
25,304,270 shares issued and outstanding at June 30, 2017 and
December 31, 2016, respectively
|Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding
at June 30, 2017 and December 31, 2016, respectively
|Additional paid-in capital||140,047,090||136,199,382|
|Accumulated other comprehensive (loss)/income||(1,415||)||6,176|
|Total stockholders’ (deficit) equity||(2,137,766||)||3,167,481|
|Total liabilities and stockholders’ (deficit) equity||$||4,991,040||$||8,984,045|