OpGen Reports Third Quarter 2020 Financial Results and Provides Business Update
OpGentakes strategic steps to expand the Unyvero platform and product pipeline, to focus on the pending Acuitas AMR Gene Panel(isolates) FDA clearance and expects to invest significantly in bioinformatics OpGensubsidiary Ares Genetics received notification of exercise of option to negotiate for a potential future license by its IVD Partner OpGenhas discontinued Acuitas AMR Gene Panel(urine) clinical trial and will discontinue FISH product line globally by mid-2021
- Total Revenue for Q3 2020 was approximately
$1.1 million dollars
- Maintained strong balance sheet with
$10.5 million cash as of September 30, 2020
Conference call to be held at
As previously reported,
- Product portfolio going forward is centered around rapid, molecular diagnostic platform offerings and increased focus on value added bioinformatics solutions, including Ares Genetics’ next generation sequencing-based and artificial intelligence powered AMR and AST prediction capabilities.
- Following the successful completion of the three phases of the partnered R&D program as announced in the during our second quarter 2020 earnings call, Ares Genetics has recently received formal notification from its undisclosed global leading IVD corporation partner that they have exercised their option to exclusively negotiate with Ares Genetics the scope and terms of a potential exclusive license or other arrangement with Ares to Ares Genetics’ technology in the field of human clinical diagnostics in the coming months.
- Platform consolidation to realize significant operational synergies and cost savings over time as fewer products and platforms would need to be maintained from a regulatory, quality management and logistics and service standpoint.
- Unyvero platform and product portfolio to be expanded beyond lower respiratory tract infections such as pneumonia (LRT / LRT BAL) to include complicated urinary tract infections (cUTI) and invasive joint infections (IJI) in the
U.S.with clinical trials for future FDA submission and clearance anticipated to start in 2021. Similar products in both clinical indication areas using the same sample types have already been successfully developed and CE-IVD marked and are commercially available in Europeand other markets.
- Recent notification from the FDA has indicated that the agency plans to continue prioritizing emergency use authorization (EUA) requests for diagnostic products intended to address the COVID-19 pandemic for at least the remainder of the year, which will impact the statutory review periods for ongoing submissions. During this time, the FDA plans to provide monthly updates regarding the ongoing impact of such prioritization of EUAs on our
Acuitas AMR Gene Panelfor Isolates submission. Despite such impact, OpGenhas remained in open and ongoing dialogue with the FDA regarding the status of the Acuitas AMR Gene Panelfor Isolates submission since our October 2020formal response to the FDA’s Additional Information (AI) requests. If the Acuitas AMR Gene Panelfor Isolates is cleared by the FDA, OpGenanticipates swift commercial launch in the U.S.in the following months.
- Legacy FISH products business including Quick FISH® and PNA FISH® to be discontinued by mid-2021 in
Europe, the U.S.and rest of world with last production lots to be manufactured in early 2021. All customers in the U.S.and distributors in Europehave been informed of the discontinuation and OpGenexpects last stocking orders to come in by year-end with several orders already received. Acuitas AMR Gene Panel(urine) clinical trial has been discontinued and all clinical trial sites have been notified as focus shifts to Unyvero platform for complicated UTI indication as well as additional future applications.
Third Quarter and Nine Month 2020 Financial Results
- Total revenue for the third quarter of 2020 was approximately
$1.1 million, up from $0.6 millionin the third quarter of 2019. Total revenue for the nine months ended September 30, 2020was $2.9 million, compared with $2.7 millionfor the nine months ended September 30, 2019;
- Operating expenses for the third quarter of 2020 were
$7.2 million, compared with $4.1 millionin the third quarter of 2019. Operating expenses for the nine months ended September 30, 2020were $19.6 million, compared with $12.4 millionfor the nine months ended September 30, 2019;
- The net loss for the third quarter of 2020 was
$7.7 millionor $0.40per share, compared with $3.5 millionor $3.95per share in the third quarter of 2019. The net loss for the nine months ended September 30, 2020was $19.1 millionor $1.36per share, compared with a net loss of $9.9 millionor $13.32per share for the nine months ended September 30, 2019; and
- Cash and cash equivalents were
$10.5 millionas of September 30, 2020.
The company also announced accomplishment of the following key milestones in the third quarter of 2020 and year to date:
- OpGen’s subsidiary
Curetis GmbHobtained 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. OpGenannounced that subsidiary Ares Genetics GmbHwon the Austrian national digitization award and was also nominated for the 40th Austrian Innovation Award for its artificial intelligence powered, next-generation sequencing based molecular antibiotic susceptibility test marketed under the brand name ARESupa – Universal Pathogenome Assay.
- OpGen’s subsidiary
Curetis GmbHwas awarded EUR 350 thousandin non-dilutive grant funding in a collaboration project with InfectoGnostics campus at Jena University Hospital. OpGenannounced the award of a German Federal Government grant to its subsidiary, Curetis GmbH, and collaborators Carpegen GmbHand the Clinic for Small Animal Internal Medicine of the LMU Ludwig-Maximilians Universityto collaborate on a project focused on travel related and enteric diseases in small animals.
- OpGen’s subsidiary
Ares Genetics GmbHin collaboration with researchers from the Johns Hopkins University School of Medicine, announced the publishing of a peer-reviewed study on modifiable risk factors for the emergence of ceftolozane-tazobactam resistance in P. aeruginosa in the journal Clinical Infectious Diseases. OpGenannounced the release of a new peer-reviewed publication that demonstrates the clinical utility of the Unyvero LRT panel and its potential impact on antibiotic use in hospitalized patients with suspected pneumonia compared to treatment directed based on microbiological culture results. OpGensuccessfully completed its study collaboration with Karolinska Institutet on bacterial co-infections in COVID-19 pneumonia patients and data on the Unyvero HPN Panelwas presented by the Karolinska investigators at ECCVID 2020. OpGensignificantly improved its working capital position in the third quarter of 2020 through the sale of approximately 1.8 million shares of common stock under the company’s ATM program and the exercise of warrants from the October 2019financing for gross proceeds of $4.3 millionduring the third quarter. During the nine months ended September 30, 2020, the Company sold approximately 11.4 million shares of common stock under the company’s ATM program and upon exercise of warrants from the October 2019offering for gross proceeds of $24.4 million. The German Federal Ministry for Economic Affairs and Energy(BMWi) concluded its investigation of the OpGenbusiness combination with Curetis with regards to its impact on the public order and security of the Federal Republicof Germany as well as national healthcare interests in the light of the current COVID-19 pandemic. No further action is expected from the Federal government on this matter.
Conference Call Information
OpGen’s management will host a conference call today,
International Dial-in Number: +1 (201) 493 6725
Conference ID: 13712431
Following the conclusion of the conference call, a replay will be available through
International Dial-in Number: +1 (412) 317 6671
Replay PIN: 13712431
For more information, please visit www.opgen.com.
This press release includes statements regarding OpGen’s third quarter 2020 results, the company’s strategic portfolio and product pipeline priorities, the ongoing integration of
President and CEO
OpGen Press Contact:
FischTank Marketing and PR
OpGen Investor Contact:
|Consolidated Balance Sheets|
|Cash and cash equivalents||$||10,488,072||$||2,708,223|
|Accounts receivable, net||423,432||567,811|
|Prepaid expenses and other current assets||1,072,364||396,760|
|Total current assets||14,958,928||6,667,303|
|Property and equipment, net||3,370,847||130,759|
|Finance lease right-of-use assets, net||571,329||958,590|
|Operating lease right-of-use assets||1,373,418||1,043,537|
|Intangible assets, net||16,071,680||817,550|
|Other noncurrent assets||300,744||203,271|
|Liabilities and Stockholders’ Equity|
|Accrued compensation and benefits||2,003,002||855,994|
|Short-term notes payable||1,156,517||373,599|
|Short-term finance lease liabilities||348,000||579,030|
|Short-term operating lease liabilities||1,142,435||1,017,414|
|Total current liabilities||8,606,508||4,938,541|
|Long-term finance lease liabilities||76,701||313,263|
|Long-term operating lease liabilities||554,295||547,225|
|Other long term liabilites||154,716||-|
|Additional paid-in capital||208,892,463||178,779,814|
|Accumulated other comprehensive income/(loss)||1,614,002||(17,315||)|
|Total stockholders’ equity||17,078,948||4,293,339|
|Total liabilities and stockholders’ equity||$||44,704,840||$||10,421,824|
|Consolidated Statements of Operations and Comprehensive Loss|
|Three Months Ended
||Nine Months Ended
|Cost of products sold||1,350,296||262,373||2,340,766||681,568|
|Cost of services||159,794||196,184||550,115||592,647|
|Research and development||2,433,553||1,139,369||6,630,134||4,069,335|
|General and administrative||2,356,413||1,560,706||6,549,432||4,901,136|
|Sales and marketing||932,671||376,955||2,258,980||1,142,755|
|Impairment of intangible assets||—||—||750,596||—|
|Impairment of right-of-use asset||—||—||—||520,759|
|Total operating expenses||7,232,727||4,073,648||19,550,345||12,446,261|
|Other (expense) income|
|Interest and other income/(expense)||19,965||1,043||101,644||(8,213||)|
|Foreign currency transaction losses||(501,168||)||(8,954||)||(794,832||)||(9,426||)|
|Change in fair value of derivative financial instruments||165,497||—||548,008||67|
|Total other expense||(1,499,633||)||(57,010||)||(2,412,265||)||(160,244||)|
|Loss before income taxes||(7,675,595||)||(3,482,438||)||(19,100,527||)||(9,928,565||)|
|Provision for income taxes||—||—||—||—|
|Net loss per common share - basic and diluted||$||(0.40||)||$||(3.95||)||$||(1.36||)||$||(13.32||)|
|Weighted average shares outstanding - basic and diluted||19,116,864||882,280||14,016,896||745,471|
|Other comprehensive income - foreign currency translation||1,266,901||7,298||1,631,317||5,174|
Source: OpGen, Inc.