OpGen Reports Fourth Quarter and Full Year 2017 Financial Results and Provides a Business Update
Fourth quarter revenue consistent with previous year; net loss decreases 38% year over year
Conference call begins at
“During 2017 we completed the initial development of our Acuitas®
Mr. Jones continued, “Earlier this week, we announced a collaboration with
“During the fourth quarter we were awarded a one-year,
2017 Fourth Quarter and Year-end Financial Results
- Revenue: Total revenue for the fourth quarter of 2017 was
$1.0 million, compared with $1.0 millionfor the fourth quarter of 2016. Total revenue for 2017 was $3.2 million, compared with $4.0 millionfor 2016.
- Operating Expenses: Operating expenses for the fourth quarter of 2017 were
$3.9 million, compared with $5.7 millionfor the fourth quarter of 2016. Operating expenses for 2017 were $18.5 million, compared with $23.0 millionfor 2016.
- Net Loss: The net loss available to common stockholders for the fourth quarter of 2017 was
$2.9 millionor $1.33per share, compared with a net loss available to common stockholders of $4.8 millionor $5.28per share for the fourth quarter of 2016. Net loss available to common stockholders for 2017 was $15.4 millionor $9.78per share, compared with a net loss available to common stockholders of $19.5 millionor $27.59per share for 2016.
- Cash Position: Cash and cash equivalents were $1.8 million as of
December 31, 2017, compared with $4.1 millionas of December 31, 2016. Subsequent to the close of the year, the Company raised net proceeds of $10.7 millionin a public offering.
2017 Enterprise Highlights and Recent Developments:
Highlights for recent weeks, the fourth quarter and full year included:
Acuitas AMR Gene Paneldevelopment program accomplishments include: production of first RUO test kits; successful completion of analytical verification studies; and initiation of clinical verification studies with flagship IDN hospitals.
- Curated Acuitas Lighthouse Knowledgebase of 10,000 bacterial isolates tested from the Merck SMART Study surveillance network.
January 2018, the Company entered into a second global supply agreement to incorporate Thermo Fisher Scientific’s real-time PCR technology in the company’s Acuitas® AMR Gene Paneltests. Specific products covered under these agreements include the QuantStudio 5 Real-Time PCR System, TaqMan® Fast Advanced Master Mix and TaqMan® Probes for quick, multiplexed gene detection.
- Developed and presented data on rapid antibiotic prediction capabilities.
- Completed a
$12.0 millionpublic offering with net proceeds to OpGenof $10.7 million.
- Regained compliance with Nasdaq listing requirements for both minimum stockholders’ equity and minimum bid price.
- Continued to achieve stated operating expense reduction during the quarter, with a 32% reduction compared with the fourth quarter of 2016.
“Our Acuitas Rapid Test for cUTI is expected to be the first of a series of
OpGen expects to advance the following business objectives during 2018 as it transitions to the commercial phase of its molecular informatics business:
- Derive revenues from the sale of the
RUO Acuitas AMR Gene Panelu5.47 to large hospitals and pharmaceutical clinical research organizations.
- Complete third-party RUO clinical verification studies and
FDAclinical trials to support clearance for in vitro diagnostic use of the Acuitas AMR Gene Panelu5.47 test and the Acuitas Lighthouse Software.
- File a 510(k) application with the
FDAin the fourth quarter of 2018 for the Acuitas AMR Gene Panelu5.47 and Acuitas Lighthouse Software to support full commercial launch for clinical use.
- Add QuantStudio™ 5 System and Qiagen EZ1 Advanced XL revenue-generating system placements.
- Enter into additional supply and cooperation agreements in support of the new Acuitas product family under development.
- Complete CDC Contract demonstration project in
Colombiafor development of smartphone-based clinical decision support solutions for AMS 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 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 fourth quarter and full year 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 conference ID 8899787. 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 Company’s 2017 financial results and 2018 outlook. 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
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|Consolidated Balance Sheets|
|Cash and cash equivalents||$||1,847,171||$||4,117,324|
|Accounts receivable, net||809,540||542,420|
|Prepaid expenses and other current assets||311,644||329,646|
|Total current assets||3,501,780||5,681,758|
|Property and equipment, net||835,537||800,723|
|Intangible assets, net||1,353,182||1,620,998|
|Other noncurrent assets||328,600||279,752|
|Liabilities and Stockholders’ Equity|
|Accrued compensation and benefits||746,924||578,480|
|Short-term notes payable||1,010,961||1,023,815|
|Current maturities of long-term capital lease obligation||154,839||184,399|
|Total current liabilities||4,789,592||5,271,937|
|Long-term capital lease obligation and other noncurrent liabilities||130,153||146,543|
|Common stock, $0.01 par value; 200,000,000 shares authorized; 2,265,320 and
1,012,171 shares issued and outstanding at December 31, 2017 and
December 31, 2016, respectively
|Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and
outstanding at December 31, 2017 and December 31, 2016, respectively
|Additional paid-in capital||150,114,669||136,442,302|
|Accumulated other comprehensive (loss)/income||(52,367||)||6,176|
|Total stockholders’ equity||1,400,996||3,167,481|
|Total liabilities and stockholders’ equity||$||6,619,913||$||8,984,045|
|Consolidated Statements of Operations and Comprehensive Loss|
|Three Months Ended December 31,||Twelve Months Ended December 31,|
|Cost of products sold||346,690||388,581||1,612,838||1,658,571|
|Cost of services||292,223||102,600||520,338||631,333|
|Research and development||1,485,387||2,334,407||6,883,293||8,613,236|
|General and administrative||1,366,469||1,647,512||6,686,280||6,602,608|
|Sales and marketing||402,289||1,246,646||2,747,582||5,529,274|
|Total operating expenses||3,893,058||5,719,746||18,450,331||23,035,022|
|Foreign currency transaction gains/(losses)||3,543||(10,395||)||23,179||(8,102||)|
|Changes in fair value of warrant liabilities||19,925||-||144,064||-|
|Total other expense||(36,048||)||(46,825||)||(153,517||)||(157,416||)|
|Loss before income taxes||(2,938,194||)||(4,760,008||)||(15,392,841||)||(19,166,753||)|
|Provision for income taxes||—||—||—||—|
|Preferred stock dividends and beneficial conversion||—||—||—||(332,550||)|
|Net loss available to common stockholders||$||(2,938,194||)||$||(4,760,008||)||$||(15,392,841||)||$||(19,499,303||)|
|Net loss per common share - basic and diluted||$||(1.33||)||$||(5.28||)||$||(9.78||)||$||(27.59||)|
|Weighted average shares outstanding - basic and diluted||2,211,290||901,991||1,573,769||706,702|
|Other comprehensive (loss)/income - foreign currency translation||(44,718||)||6,176||(58,543||)||7,235|