OpGen Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
- Total combined pro-forma revenue for 2020 was approximately
- Maintained strong balance sheet with
$13.4 millioncash as of December 31, 2020
- Raised an additional
$34.7 millionof capital in the first quarter of 2021
Conference call to be held at
Fourth Quarter and Full Year 2020 Audited Financial Results of
Results in 2020 reflect the consummation of the company’s business combination with
- Total revenue for the fourth quarter of 2020 was approximately
$1.4 million, compared with approximately $0.8 millionin the fourth quarter of 2019. Total revenue for the twelve months ended December 31, 2020was $4.2 million, compared to $3.5 millionfor the twelve months ended December 31, 2019. Total proforma revenue, i.e. revenue shown as if the businesses had been combined for the respective full years, for the twelve months ended December 31, 2020was approximately $5.2 million, compared to approximately $6.1 millionfor the twelve months ended December 31, 2019.
- Operating expenses for the fourth quarter of 2020 were
$7.4 million, compared with $3.3 millionin the fourth quarter of 2019. Total operating expenses for the twelve months ended December 31, 2020were $26.9 million, compared to $15.8 millionfor the twelve months ended December 31, 2019.
- The net loss for the fourth quarter of 2020 was
$7.1 million, or $0.34per share, compared with $2.5 million, or $0.61per share, in the fourth quarter of 2019. The net loss for the twelve months ended December 31, 2020was $26.2 million, or $1.66per share, compared to $12.4 million, or $7.70per share, for the twelve months ended December 31, 2019.
The company also announced the completion of the following key milestones and recent developments in the fourth quarter and full year 2020 as well as 2021 to date, all of which it achieved despite the challenges posed by the global COVID-19 pandemic:
OpGencompleted, with one healthcare focused U.S.institutional investor, the following gross capital raises: $10 millionprivate placement priced at the market in November 2020 $25 millionregistered direct offering in February 2021priced at the market $ 9.7 millionwarrant exercise and exchange in March 2021
OpGenannounced the publication of the final study results of the Unyvero HPN Panelfor diagnosis of bacterial co-infections in ICU patients with COVID-19 pneumonia demonstrating that the panel would enable crucially important rapid diagnosis of pathogens of concern in these patients, as well as a high negative predictive value of 99.8% for pathogen detection. OpGenannounced the release of two new peer-reviewed publications, the first demonstrating that the Unyvero LRT BAL panel accurately detects 19 bacteria alongside Pneumocystis jirovecii and 10 antibiotic resistance genes directly from bronchoalveolar lavage fluid, allowing enhanced diagnosis of lower respiratory tract infections, and the second publication highlighting Ares Genetics in best practice techniques for AI-powered prediction of antibiotic susceptibility testing by next-generation sequencing.
- The Chinese regulatory authority NMPA approved the Curetis Unyvero instrument system as IVD for Chinese market with the application of Unyvero cartridge for pneumonia currently under review and pending NMPA approval.
OpGensubsidiary Curetis entered into an exclusive distribution partnership in Colombiawith Annar Health Technologies for Curetis’ Unyvero A50 platform.
- Curetis, obtained CE mark certification in the
European Unionfor its own SARS-CoV-2 Kit with PULB for the detection of SARS-CoV-2, the virus that causes COVID-19. These kits were sold to some of Curetis’ European distributors as well as used by Curetis for the SARS-CoV-2 testing service offered to regional German customers.
- OpGen’s subsidiary,
Ares Genetics GmbH, completed the transition of leadership to Dr. Arne Materna, who was appointed as Managing Director and CEO of Ares Genetics effective January 1, 2021.Ares Genetics extended its collaboration with Sandoz within its pharma partnering program and added another project with Sandoz in 2021 to assess the potential of molecular surveillance for better informed therapeutic guidance and antibiotic stewardship.
- Ares Genetics presented advances of its research use only (RUO) based ares-genetics.cloud platform for predictive antibiotic susceptibility testing (pAST) at various scientific conferences.
- Ares Genetics was granted a key patent on antimicrobial resistance prediction from genomic data, supporting the company's vision to improve guidance for antimicrobial therapy through AI-powered prediction of AMR and the discovery of diagnostic biomarkers.
- Ares Genetics joined the
JPIAMR Network for Integrating Microbial Sequencing and Platformsfor Antimicrobial Resistance (Seq4AMR). The network will provide guidelines and solutions to microbial sequencing for the detection, surveillance and management of difficult-to-treat infections caused by AMR microorganisms.
- After a three-month delay in FDA review of the
Acuitas AMR Gene Panel510(k) submission due to the FDA’s prioritization of COVID-19 and influenza related EUAs, OpGenhas received confirmation that the FDA has resumed its review of the submission. Currently, OpGenis actively engaged in receiving and responding to feedback from the FDA to facilitate a final clearance decision for the Acuitas AMR Gene Panelas soon as practicable. OpGenplans to exit its FISH business by the end of the first quarter of 2021 and in the fall of 2020 ended the Acuitas AMR Gene Panelurine trial in favor of two new upcoming U.S.clinical trials towards a future FDA submission for the Unyvero UTI (complicated urinary tract infections) and IJI (invasive joint infections) applications, respectively.
- The 90-day exclusive negotiation period that Ares Genetics had agreed to with a global leading IVD corporation partner towards a potential collaboration and licensing deal recently expired. Ares Genetics has since engaged in and continues to have multiple parallel, non-exclusive partnering and licensing discussions with potential corporate partners.
Conference Call Information
OpGen’s management will host a conference call today,
|International Dial-in Number: +1 (201) 493 6725|
|Conference ID: 13717232|
Following the conclusion of the conference call, a replay will be available through
|International Dial-in Number: +1 (412) 317 6671|
|Replay PIN: 13717232|
For more information, please visit www.opgen.com.
This press release includes statements regarding OpGen’s fourth quarter and full year 2020 results and the current business of
President and CEO
OpGen Press Contact:
FischTank Marketing and PR
OpGen Investor Contact:
|Consolidated Balance Sheets
|Cash and cash equivalents||$||13,360,463||$||2,708,223|
|Accounts receivable, net||653,104||567,811|
|Prepaid expenses and other current assets||1,388,090||396,760|
|Total current assets||16,887,643||6,667,303|
|Property and equipment, net||3,259,487||130,759|
|Finance lease right-of-use assets, net||449,628||958,590|
|Operating lease right-of-use assets||2,082,300||1,043,537|
|Intangible assets, net||16,580,963||817,550|
|Other noncurrent assets||779,953||203,271|
|Liabilities and Stockholders’ Equity|
|Accrued compensation and benefits||2,126,511||855,994|
|Short-term notes payable||699,000||373,599|
|Short-term finance lease liabilities||266,470||579,030|
|Short-term operating lease liabilities||964,434||1,017,414|
|Total current liabilities||7,372,030||4,938,541|
|Long-term finance lease liabilities||46,794||313,263|
|Long-term operating lease liabilities||1,492,544||547,225|
|Other long term liabilities||156,635||-|
|Commitments and Contingencies|
|Additional paid-in capital||219,129,045||178,779,814|
|Accumulated other comprehensive income/(loss)||2,547,182||(17,315||)|
|Total stockholders’ equity||21,191,255||4,293,339|
|Total liabilities and stockholders’ equity||$||49,751,045||$||10,421,824|
|Consolidated Statements of Operations and Comprehensive Loss
|Three Months Ended
|Cost of products sold||1,019,514||229,997||3,360,280||911,565|
|Cost of services||(61,904)||127,509||488,211||720,156|
|Research and development||3,334,581||1,051,833||9,964,720||5,121,168|
|General and administrative||2,252,233||1,351,306||8,801,661||6,252,442|
|Sales and marketing||835,112||321,966||3,094,092||1,464,721|
|Impairment of intangible assets||—||—||750,596||—|
|Impairment of right-of-use asset||101,838||—||101,838||520,759|
|Gain on sale of equipment||(100,000||)||—||(100,000||)||—|
|Total operating expenses||7,382,574||3,323,598||26,932,920||15,769,859|
|Gain on extinguishment of debt||884,970||—||884,970||—|
|Interest and other income, net||3,982||18,071||105,627||9,859|
|Foreign currency transaction (losses)/gains||(674,023||)||11,836||(1,468,855||)||2,410|
|Change in fair value of derivative financial instruments||(30,328||)||—||517,680||67|
|Total other expense||(947,698||)||(14,970||)||(3,359,962||)||(175,213||)|
|Loss before income taxes||(6,977,913||)||(2,517,894||)||(26,078,441||)||(12,446,458||)|
|Provision for income taxes||132,403||—||132,403||—|
|Net loss per common share - basic and diluted||$||(0.34||)||$||(0.61||)||$||(1.66||)||$||(7.70||)|
|Weighted average shares outstanding - basic and diluted||21,056,199||4,151,840||15,800,781||1,616,939|
|Other comprehensive income/(loss) - foreign currency translation||933,180||(9,396||)||2,564,497||(4,222||)|
Source: OpGen, Inc.