CORRECTION – OpGen Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
- Total revenue for 2022 was approximately $2.6 million
- Balance sheet strengthened by recently closed public offering with gross proceeds of
- Conference call to be held March 29, 2023 at 4:30 p.m. ET
OpGen’s revenue for the fourth quarter of 2022 was approximately $722 thousand. Its total revenue for 2022 was approximately $2.6 million which was in line with the Company’s most recent guidance.
“Overall, in 2022 there were several business advancements for
Fourth Quarter and Full Year 2022 Financial Results of OpGen, Inc.
- Fourth quarter revenue for 2022 was approximately
$722 thousand, compared with approximately $1.4 millionin the fourth quarter of 2021. Our fourth quarter revenues, however, represent a 61% increase over our third quarter 2022 revenues of $449 thousand. For the twelve months ended December 31, 2022, total revenue was approximately $2.6 millioncompared to the twelve months ended December 31, 2021of approximately $4.3 million, which was in line with OpGen’s most recent guidance.
- Total operating expenses in the fourth quarter of 2022 were
$10.7 millioncompared to $7.2 millionfor the same quarter in 2021. This includes a one-time non-cash accounting charge for the impairment of the Company’s in-process R&D (IPR&D) indefinite-lived intangible asset of $5.4 million. For the twelve months ended December 31, 2022, operating expenses amounted to $37.2 million, compared to $27.6 millionin 2021. The full year numbers include the impairment of both goodwill as well as IPR&D totaling $12.3 million.
- Cash and cash equivalents as of
December 31, 2022were approximately $7.4 million, a decrease compared to the balance at December 31, 2021of $36.1 million.
In reporting OpGen’s fourth quarter and full year financials for 2022, Albert Weber, OpGen’s Chief Financial Officer (CFO), said, “In 2022, our operating expenses remained in line with our initial expectations and tracked well against our guidance for yearly net cash consumption. We reduced our R&D expenses significantly and also reduced our general administrative expenses. We started growing our sales and marketing expenses in line with the planned shift to more commercial operations, with a clear focus on the
“Compared to the third quarter of 2022, we achieved a 61% increase in revenue during the final quarter of 2022,” said
OpGen’s management believes that, given the abrupt change by the Chinese government in the first quarter of 2023 on their zero COVID policy, there is now a realistic opportunity for OpGen’s local partner, Beijing Clear Biotech, to initiate the outstanding clinical study in
The Company announced reaching the following key milestones, as well as recent developments in the fourth quarter of 2022 and into 2023 to date:
- On the commercial front, subsidiary Ares Genetics (Ares), announced a successful move to a new
Viennalocation and received a key patent grant in China. Ares also received the first commercial customer orders in the U.S., with revenue generation expecting to commence in the first quarter of 2023.
- With significant 28% growth in the number of datasets in the ARESdb database in the first quarter of 2023, Ares is well positioned to continue executing on plans to expand and improve the menu of its accurate AI models to predict antibiotic susceptibility from genomic data.
- Based on the final data read-out from the Unyvero UTI Panel’s clinical trial in the
U.S., OpGenis now in the process of finalizing the FDA submission package, aiming for an imminent submission of the De Novo classification request early in the second quarter of 2023.
- At the beginning of 2023, we announced that we achieved several key milestones under our Unyvero A30 platform collaboration with the
Foundation for Innovative New Diagnostics(FIND) in December 2022, which triggered a EUR 200 thousandmilestone payment received in the first quarter of 2023. Data on the final milestone deliverables under the initial contract is expected in the near term. Conditional on such successful milestone achievements, we believe there is great potential for future collaboration opportunities with FIND. Discussions have already commenced for a follow-on deal that would cover product development steps, including clinical trials and regulatory filings, as well as manufacturing scale up and preparation for launch of the Unyvero A30 in certain low- and middle-income countries.
- On the Unyvero A30 platform front, the focus is on non-dilutive partnership opportunities with other non-governmental organizations similar to FIND as well as
U.S.government entities that offer funding opportunities. We have also teamed up with a strategic advisory firm to support a Unyvero A30 specific corporate business development campaign in Chinawhere there is an attractive opportunity for us to partner with and possibly license or monetize the A30 platform.
As part of OpGen’s 2023 initiatives,
In terms of guidance for 2023, OpGen expects to:
- have a net cash consumption of around
$4.5to $5 millionper quarter from its current operations;
- maintain an active dialog with the
European Investment Bank(EIB) regarding the potential to restructure the second tranche of its loan with a principal amount of EUR 3 million, plus accumulated and deferred interest, which becomes due at the end of June 2023;
- pursue significant revenue growth opportunities, especially with Unyvero product sales and with ARESiss services, both in the
- see global revenues from our products, services and collaborations for 2023 to be in a range of approximately
$4to $5 million;
- actively pursue the commercial opportunities in our funnel, which includes proposals that we believe are currently in the final review and negotiation stages, clearly indicating significant revenue growth potential for
- following the upcoming regulatory submission of the Unyvero UTI product to the FDA based on the final UTI clinical trial data read-out, expect to enter interactive review with the FDA towards a clearance decision on the De Novo classification request.
Conference Call Information
OpGen’s management will host a conference call today, March 29th at 4:30 p.m. EDT, to discuss the fourth quarter and full-year 2022 financial results and other business activities, as well as answer questions. Dial-in information is below:
Conference Call Details
U.S. Dial-in Number: 1-877-704-4453
- International Dial-in Number:1-201-389-0920
- Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1595064&tp_key=d21054e901
- Conference ID: 13735798
U.S. Dial-in Number: 1-844-512-2921
- International Dial-in Number:1-412-317-6671
- Replay PIN: 13735798
Following the conclusion of the conference call, a replay will be available through
About OpGen, Inc.
For more information, please visit www.opgen.com.
This press release includes statements regarding the fourth quarter 2022 and full year 2022 financials of OpGen and the current business of OpGen. 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, the success of our commercialization efforts, 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 fact that we may not effectively use proceeds from recent financings, the continued impact of COVID-19 on the Company’s operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, our ability to satisfy debt obligations under our loan with the
President and CEO
OpGen Investor & Press Contact:
|Consolidated Balance Sheets|
|Cash and cash equivalents||$||7,440,030||$||36,080,392|
|Accounts receivable, net||514,372||1,172,396|
|Prepaid expenses and other current assets||1,355,949||1,250,331|
|Total current assets||10,655,488||39,742,575|
|Property and equipment, net||3,457,531||4,011,748|
|Finance lease right-of-use assets, net||3,500||90,467|
|Operating lease right-of-use assets||1,459,413||1,814,396|
|Intangible assets, net||7,440,974||14,530,209|
|Other noncurrent assets||495,629||551,794|
|Liabilities and Stockholders’ Equity|
|Accrued compensation and benefits||1,097,654||1,621,788|
|Short-term notes payable||7,023,901||14,519,113|
|Short-term finance lease liabilities||3,364||43,150|
|Short-term operating lease liabilities||377,626||459,792|
|Total current liabilities||10,591,631||19,916,769|
|Long-term finance lease liabilities||280||3,644|
|Long-term operating lease liabilities||2,566,138||2,977,402|
|Other long term liabilities||129,368||146,798|
|Additional paid-in capital||281,167,161||276,149,768|
|Accumulated other comprehensive (loss) income||(795,840||)||585,626|
|Total stockholders’ equity||7,575,548||41,217,080|
|Total liabilities and stockholders’ equity||$||25,813,149||$||71,666,533|
|Consolidated Statements of Operations and Comprehensive Loss|
|Three Months Ended
|Cost of products sold||495,009||750,896||3,319,586||2,295,828|
|Cost of services||40,955||106,388||104,405||552,620|
|Research and development, net||1,552,125||2,855,295||8,173,435||10,910,679|
|General and administrative||2,104,311||2,491,825||8,884,084||9,935,963|
|Sales and marketing||1,092,379||1,007,885||4,344,656||3,713,263|
|Impairment of right-of-use asset||—||—||—||170,714|
|Impairment of intangible assets||5,407,699||—||5,407,699||—|
|Total operating expenses||10,657,507||7,212,289||37,174,414||27,579,067|
|Gain on extinguishment of debt||—||—||—||259,353|
|Warrant inducement expense||—||—||—||(7,755,541||)|
|Interest and other income, net||18,788||3,708||46,935||45,179|
|Foreign currency transaction (losses) gains||(39,538||)||235,449||379,622||891,223|
|Change in fair value of derivative financial instruments||59,118||(7,159||)||113,741||(129,731||)|
|Total other expense||(599,243||)||(981,315||)||(2,716,112||)||(11,488,848||)|
|Loss before income taxes||(10,535,120||)||(6,768,036||)||(37,283,233||)||(34,761,884||)|
|Provision for income taxes||—||43,828||—||43,828|
|Deemed dividend on beneficial conversion feature||—||(7,166,752||)||—||(7,166,752||)|
|Net loss available to common stockholders||$||(10,535,120||)||$||(13,978,616||)||$||(37,283,233||)||$||(41,972,464||)|
|Basic and diluted net loss per share attributable to common stockholders||$||(3.87||)||$||(6.91||)||$||(15.27||)||$||(22.89||)|
|Weighted average shares outstanding - basic and diluted||2,720,574||2,022,240||2,441,580||1,833,704|
|Other comprehensive loss - foreign currency translation||866,283||(815,201||)||(1,381,466||)||(1,961,556||)|
Source: OpGen, Inc.