OpGen Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update for OpGen and Curetis Group
- Quorum achieved for
OpGenstockholder vote on Curetisbusiness combination with 99% of votes supporting transaction
- Transaction close anticipated by early
OpGenand Curetisbusiness generated $6 millionin unaudited pro forma combined 2019 revenue (up from $4.5 millionin 2018)
- First shipments of BGI SARS-CoV-2 rapid PCR kits completed by
Curetisin Europe. Additional actions planned to address the global COVID-19 pandemic
Conference call to be held at
A quorum has been achieved for OpGen’s upcoming Special Meeting of Stockholders, scheduled for
“Together, we anticipate progressing development across our combined proprietary product portfolio. We will strive to integrate our commercial forces and R&D teams to further strengthen our position as one of the leaders in the antimicrobial resistance detection space and to contribute in the fight against the COVID-19 pandemic.”
Fourth Quarter and Full Year 2019 audited Financial Results of
- Total revenue for the fourth quarter of 2019 was
$821 thousand, compared with $759 thousandin the fourth quarter of 2018. Total revenue for the 12 months ended December 31, 2019was $3.5 million, compared to $2.9 millionfor the 12 months ended December 31, 2018. Such revenue growth was driven by Acuitas® AMR Gene Paneland Acuitas Lighthouse® revenue, which increased 147% to approximately $1.4 million, while revenues from OpGen’s rapid FISH products decreased approximately 12% to $2.1 million.
- Operating expenses for the fourth quarter of 2019 were
$3.3 million, compared with $4.4 millionin the fourth quarter of 2018. Total operating expenses for the 12 months ended December 31, 2019were $15.8 million, compared to $16.1 millionfor the 12 months ended December 31, 2018.
- The net loss for the fourth quarter of 2019 was
$2.5 millionor $0.61per share, compared with $3.7 millionor $9.37per share in the fourth quarter of 2018. The net loss for the 12 months ended December 31, 2019was $12.4 millionor $7.70per share, compared to $13.4 millionor $44.49per share for the 12 months ended December 31, 2018.
The Company also provides the following business updates and advisories.
- Submission to the
U.S. Food and Drug Administration(“FDA”) for clearance of the Acuitas® AMR Gene Panel(Isolates) for the detection of antimicrobial resistance genes in bacterial isolates is nearing completion. OpGenhas responded, and is continuing to respond, to the FDA’s additional information requests such that OpGennow anticipates it is approaching a clearance decision for the Acuitas® AMR Gene Panelfor isolates. Exact timing is unknown as a result of the COVID-19 pandemic.
- Clinical trials were initiated and have been ongoing at nine participating sites for the
Acuitas AMR Gene Panel(Urine) test. Testing and the trial have been suspended due to hospital actions to focus resources on the COVID-19 pandemic. OpGencompleted planned milestones in the groundbreaking collaboration with the New York State Department of Healthand ILÚM Health Solutions, LLC , a wholly owned subsidiary of Merck’s Healthcare Services and Solutions, to develop a state-of-the-art research program to detect, track, and manage antimicrobial-resistant infections at healthcare institutions statewide. In response to the COVID-19 emergency in New York State, testing under the program has been put on hold by the Wadsworth Center and participating hospitals. OpGenhas significantly improved its working capital position in the first quarter of 2020 through $5.1 millionof sales under the Company’s ATM program and $8.1 millionin proceeds from the exercise of warrants from the Company’s public offering in October 2019.
U.S. Patent and Trademark Office(USPTO) issued a key OpGenpatent covering the Acuitas Lighthouse® Profiling technology used in the Company’s software for tracking AMR pathogens.
The following key business updates and milestones were achieved in 2019 and year to date by
Curetislaunched the Unyvero LRT Panelfor BAL specimens in the U.S.following receipt of 510(k) clearance by the U.S.FDA in December 2019. This is the first and only FDA cleared panel for lower respiratory tract infections such as pneumonia that includes Pneumocystis jirovecii, a difficult to diagnose pathogen that is a leading cause of pneumonia in immunocompromised individuals. The highly differentiated Unyvero LRT BAL panel has been commercially available to Curetis’ U.S.customers since the end of January 2020and it is expected to substantially increase the total addressable market for the Unyvero System in the U.S. Curetishas started offering a CE-IVD real-time PCR test kit for SARS-CoV-2, the causal pathogen of Coronavirus Disease 2019 (COVID-19), that was developed and recently CE-IVD-marked by Curetis’ strategic partner BGI.
- Ares Genetics signed R&D, licensing, and option agreements and has executed on several key strategic partnerships and collaborations with Sandoz, QIAGEN, and an undisclosed global leading IVD corporation. Execution on all of these partnered programs continues within the framework of restrictions by COVID-19 measures imposed by the Austrian government.
- Ares Genetics opened an NGS service lab in
Vienna, Austriato leverage ARESdb for services to pharma and diagnostics companies as well as CROs. Curetis GmbHand Quaphaco entered into an exclusive distribution partnership for Vietnamfor an initial term of three years with Quaphaco committing to a minimum purchase totaling approximately EUR 1.9 millionduring such initial term. The regulatory filing process of all Unyvero tests in Vietnamis progressing on schedule.
Business and Operations Outlook Following the Expected Near-Term Successful Closing of the Business Combination with
Conference Call Information
OpGen’s management will host a conference call today,
International Dial-in Number: +1 (216) 562-0481
Conference ID: 3497986
Following the conclusion of the conference call, a replay will be available through
International Dial-in Number: +1 (404) 537-3406
Conference ID: 3497986
Our molecular diagnostics and informatics products, product candidates and services combine our Acuitas molecular diagnostics and
Curetis N.V.’s (Euronext: CURE) goal is to become a leading provider of innovative solutions for molecular microbiology diagnostics designed to address the global challenge of detecting severe infectious diseases and identifying antibiotic resistances in hospitalized patients.
Curetis’ Unyvero System is a versatile, fast and highly automated molecular diagnostic platform for easy-to-use, cartridge-based solutions for the comprehensive and rapid detection of pathogens and antimicrobial resistance markers in a range of severe infectious disease indications. Results are available within hours, a process that can take days or even weeks if performed with standard diagnostic procedures, thereby facilitating improved patient outcomes, stringent antibiotic stewardship and health-economic benefits. Unyvero in vitro diagnostic (IVD) products are marketed in
Curetis’ wholly-owned subsidiary
This press release includes statements relating to OpGen’s fourth quarter and full year 2019 results, the planned business combination with
No Offer or Solicitation
This press release is neither an offer to purchase, nor a solicitation of an offer to sell, any securities or the solicitation of any vote in any jurisdiction pursuant to the proposed transactions or otherwise, nor shall there be any sale, issuance or transfer or securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Additional Information and Where to Find It
In connection with the transactions contemplated by the Implementation Agreement (the definitive agreement related to the proposed business combination between the Company and
Vice President, Marketing
FischTank Marketing and PR
|Consolidated Balance Sheets|
|Cash and cash equivalents||$||2,708,223||$||4,572,487|
|Accounts receivable, net||567,811||373,858|
|Prepaid expenses and other current assets||396,760||292,918|
|Total current assets||6,667,303||5,783,010|
|Property and equipment, net||130,759||1,221,827|
|Finance lease right-of-use assets, net||958,590||—|
|Operating lease right-of-use assets||1,043,537||—|
|Intangible assets, net||817,550||1,085,366|
|Other noncurrent assets||203,271||259,346|
|Liabilities and Stockholders’ Equity|
|Accrued compensation and benefits||855,994||1,041,573|
|Short-term notes payable||373,599||398,595|
|Short-term finance lease liabilities||579,030||399,345|
|Short-term operating lease liabilities||1,017,414||—|
|Total current liabilities||4,938,541||4,381,107|
|Long-term finance lease liabilities||313,263||437,189|
|Long-term operating lease liabilities||547,225||—|
|Additional paid-in capital||178,779,814||165,396,036|
|Accumulated other comprehensive loss||(17,315||)||(13,093||)|
|Total stockholders’ equity||4,293,339||3,308,741|
|Total liabilities and stockholders’ equity||$||10,421,824||$||8,950,363|
|Consolidated Statements of Operations and Comprehensive Loss|
|Three Months Ended
|Cost of products sold||229,997||283,440||911,565||1,222,919|
|Cost of services||127,509||179,372||720,156||625,516|
|Research and development||1,051,833||1,856,126||5,121,168||5,677,243|
|General and administrative||1,351,306||1,704,094||6,252,442||7,069,315|
|Sales and marketing||321,966||414,176||1,464,721||1,531,556|
|Impairment of right-of-use asset||—||—||520,759||—|
|Total operating expenses||3,323,598||4,437,208||15,769,859||16,126,549|
|Other (expense) income|
|Interest and other income, net||18,071||174||9,859||5,384|
|Foreign currency transaction gains/(losses)||11,836||(3,875||)||2,410||(10,431||)|
|Change in fair value of derivative financial instruments||—||316||67||8,386|
|Total other expense||(14,970||)||(54,127||)||(175,213||)||(187,856||)|
|Loss before income taxes||(2,517,894||)||(3,732,376||)||(12,446,458||)||(13,368,098||)|
|Provision for income taxes||—||—||—||—|
|Net loss per common share - basic and diluted||$||(0.61||)||$||(9.37||)||$||(7.70||)||$||(44.49||)|
|Weighted average shares outstanding - basic and diluted||4,151,840||398,525||1,616,939||300,453|
|Other comprehensive (loss)/income - foreign currency translation||(9,396||)||5,745||(4,222||)||12,807|
Source: OpGen, Inc.