OpGen Reports Third Quarter 2022 Financial Results and Provides Business Update
10 Nov 2022
CollaborateFinancial Statement
OpGen Reports Third Quarter 2022 Financial Results and Provides Business Update
Completes first two commercial customer installations for Acuitas AMR Gene Panel
OpGen subsidiary, Curetis, signed collaboration agreement with BioVersys AG and R&D collaboration agreement with FIND for the Unyvero A30 RQ platform
Elects Yvonne Schlaeppi as new, independent non-executive director to the board
Management conference call scheduled for November 10, 2022, at 4:30 p.m. EST
ROCKVILLE, Md., Nov. 10, 2022 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, reported its third quarter 2022 financial and operating results. Management will host an investor call to discuss quarterly results and provide a business update.
Oliver Schacht, President & CEO of OpGen, commented, “During the third quarter we reached multiple agreements and entered into collaborations with various partners. These include our research collaboration agreement with the Belgian National Reference Center (BNRC), an R&D collaboration with FIND, our second commercial installation of the Acuitas AMR Gene Panel, a new commercial contract for Unyvero in the U.S., and a collaboration agreement with BioVersys. We are seeing progress on both the R&D and commercial fronts and look forward to the upcoming progress.”
Mr. Schacht continued, “As we proceed through 2022 and move into the calendar year of 2023, we have several upcoming catalysts and milestones to look forward to, including our UTI clinical trial data read-out and anticipated subsequent FDA submission, proceeds from the FIND collaboration as well as its potential future extension and expansion, and several potential new commercial contracts with U.S. customers across Unyvero and Acuitas products. We look forward to announcing these potential milestones as we continue to focus on building shareholder value.”
Third Quarter 2022 Financial Results of OpGen, Inc.
Total revenue for the third quarter of 2022 was approximately $0.4 million, compared with approximately $1.2 million in the third quarter of 2021. Total revenue for the nine months ended September 30, 2022 was approximately $1.9 million, compared with approximately $2.9 million for the nine months ended September 30, 2021.
Operating expenses for the third quarter of 2022 were approximately $14.0 million, compared with approximately $6.3 million in the third quarter of 2021. Operating expenses for the nine months ended September 30, 2022 were approximately $26.5 million, compared with approximately $20.4 million for the nine months ended September 30, 2021.
The net loss available to common stockholders for the third quarter of 2022 was approximately $14.1 million, or $0.30 per share, compared with approximately $6.1 million, or $0.16 per share, in the third quarter of 2021. Net loss for the nine months ended September 30, 2022 was approximately $26.7 million, compared with approximately $28.0 million for the nine months ended September 30, 2021.
Cash and cash equivalents were approximately $10.3 million as of September 30, 2022, compared with $36.1 million as of December 31, 2021.
In the third quarter and year to date, the Company reached the following key milestones:
OpGen subsidiary, Ares Genetics, signed a research collaboration agreement with the Belgian National Reference Center (BNRC) for invasive Streptococcus pneumoniae at the University Hospital Leuven.
OpGen subsidiary, Ares Genetics, launched the ARESiss isolate sequencing service in the U.S.
OpGen subsidiary, Curetis, signed an R&D collaboration agreement with FIND for the Unyvero A30 RQ platform.
OpGen subsidiary, Curetis, signed a collaboration agreement with BioVersys AG from Switzerland to use the Unyvero platform in BioVersys’ upcoming Phase II clinical trial.
OpGen received an update from Beijing Clear Biotech’s regulatory advisors about feedback from China’s NMPA regarding the Unyvero A50 pneumonia product and the need to resubmit our filing under a new electronic filing regime that NMPA has recently implemented.
This week, OpGen's board elected Yvonne Schlaeppi as a new, independent non-executive member of the Company’s board of directors. Ms. Schlaeppi brings legal, governance, life sciences and international experience to the board. Since 2011, Ms. Schlaeppi has served as a Managing Partner of Stratevise LLC, an international strategic advisory firm that she co-founded. Prior to founding Stratevise, Ms. Schlaeppi served as General Counsel at Global Enterprise Technologies, Passport & ID, a high-security document printing solutions provider and systems integrator, from 2007 to 2011, and as Executive Vice President, General Counsel and Corporate IP Officer at Organon BioSciences, a global pharmaceutical, animal health and biotech group based in the Netherlands, from 2006 until its sale in 2007. Prior to that, Ms. Schlaeppi was a partner at the Boston-based law firm of Palmer & Dodge LLP, where she served as Chairperson of that firm’s International Practice Group. Ms. Schlaeppi has been recognized by the National Association of Corporate Directors as Directorship Certified®, has served on the board of directors of several public companies and currently is a member of the board of AstroNova, Inc.
In terms of guidance, the Company anticipates:
The unblinding of data from the Unyvero UTI trial around year-end and subsequent FDA submission in 2023;
To enter into new commercial contracts in the coming months across Unyvero and Acuitas products, which contracts could have the potential to drive revenue growth for 2023;
Further developing ARES services and progressing strategic collaborations and partnerships with U.S. key accounts and leading organizations; and
Overall, 2022 revenue in a range of approximately $2.5 to $3 million from products and services as well as collaboration business globally.
OpGen will be holding a special meeting of stockholders on November 30, 2022 to vote on the proposal for a potential reverse stock split.
The Company will continue to explore additional strategic and tactical equity and debt financing opportunities as well as potential strategic alternative options throughout the remainder of the year and into 2023 to possibly further strengthen its cash position.
Conference Call Information
OpGen’s management will host a conference call today, November 10, at 4:30 p.m. EST, to discuss the third quarter financial results and business activities, as well as answer analyst questions.
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=1569725&tp_key=91a31a2b1f Conference ID:13732787 Following the conclusion of the conference call, a replay will be available through November 24th, 2022. The live, listen-only webcast of the conference call may also be accessed by visiting the Investors section of the Company’s website at www.opgen.com.
A replay of the webcast will be available following the conclusion of the call and will be archived on the Company’s website for 90 days. Replay access information is below:
Replay Details
U.S. Dial-in Number:1-844-512-2921 International Dial-in Number:1-412-317-6671 Replay PIN:13732787
About OpGen, Inc.
OpGen, Inc. (Rockville, MD, U.S.A.) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with our subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen’s current product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the ARES Technology Platform including ARESdb, NGS technology and AI-powered bioinformatics solutions for AMR surveillance, outbreak analysis, and antibiotic response prediction including ARESiss, ARESid, and AREScloud, as well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test kit.
For more information, please visit www.opgen.com.
Forward-Looking Statements
This press release includes statements regarding OpGen’s third quarter 2022 financial results 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 realization of expected benefits of our business combination transaction with Curetis GmbH, 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 European Investment Bank, the effect of the military action in Russia and Ukraine on our distributors, collaborators and service providers, our liquidity and working capital requirements, 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 OpGen's business, please review our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
OpGen, Inc.Consolidated Balance Sheets(unaudited) September 30, 2022 December 31, 2021Assets Current assets Cash and cash equivalents$10,275,654 $36,080,392 Accounts receivable, net 665,313 1,172,396 Inventory 771,864 1,239,456 Prepaid expenses and other current assets 1,678,729 1,250,331 Total current assets 13,391,560 39,742,575 Property and equipment, net 3,054,990 4,011,748 Finance lease right-of-use assets, net 4,347 90,467 Operating lease right-of-use assets 1,472,934 1,814,396 Goodwill — 7,453,007 Intangible assets, net 12,001,036 14,530,209 Strategic inventory, net 2,614,805 3,472,337 Other noncurrent assets 419,495 551,794 Total assets$ 32,959,167 $ 71,666,533 Liabilities and Stockholders’ Equity Current liabilities Accounts payable$682,592 $1,307,081 Accrued compensation and benefits 1,391,145 1,621,788 Accrued liabilities 1,046,865 1,965,845 Deferred revenue 194,960 — Short-term notes payable 8,342,715 14,519,113 Short-term finance lease liabilities 6,748 43,150 Short-term operating lease liabilities 346,629 459,792 Total current liabilities 12,011,654 19,916,769 Note payable 4,108,421 7,176,251 Derivative liabilities 146,207 228,589 Long-term finance lease liabilities 1,121 3,644 Long-term operating lease liabilities 2,631,957 2,977,402 Other long term liabilities 121,496 146,798 Total liabilities 19,020,856 30,449,453 Stockholders' equity Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at September 30, 2022 and December 31, 2021, respectively — — Common stock, $0.01 par value; 100,000,000 shares authorized; 48,338,500 and 46,450,250 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively 483,386 464,503 Additional paid-in capital 277,406,700 275,708,490 Accumulated deficit (262,289,652) (235,541,539)Accumulated other comprehensive (loss)/income (1,662,123) 585,626 Total stockholders’ equity 13,938,311 41,217,080 Total liabilities and stockholders’ equity$ 32,959,167 $ 71,666,533
OpGen, Inc.Consolidated Statements of Operations and Comprehensive Loss(unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Revenue Product sales$359,112 $643,887 $1,614,435 $1,479,270 Laboratory services 31,016 192,753 94,515 643,602 Collaboration revenue 58,585 402,492 176,713 757,591 Total revenue 448,713 1,239,132 1,885,663 2,880,463 Operating expenses Cost of products sold 1,886,191 648,298 2,824,577 1,544,932 Cost of services 17,239 203,314 63,450 446,232 Research and development, net 2,031,113 2,382,303 6,621,310 8,055,384 General and administrative 2,020,452 2,088,226 6,779,773 7,444,138 Sales and marketing 1,031,496 1,003,577 3,252,277 2,705,378 Impairment of right-of-use asset — — — 170,714 Goodwill impairment charge 6,975,520 — 6,975,520 — Total operating expenses 13,962,011 6,325,718 26,516,907 20,366,778 Operating loss (13,513,298) (5,086,586) (24,631,244) (17,486,315)Other expense Gain on extinguishment of debt — — — 259,353 Warrant inducement expense — — — (7,755,541)Interest and other income, net 11,174 31,844 28,147 41,471 Interest expense (569,306) (1,222,867) (2,618,799) (3,586,018)Foreign currency transaction gains (51,547) 229,074 419,160 655,774 Change in fair value of derivative financial instruments 18,995 (8,161) 54,623 (122,572)Total other expense (590,684) (970,110) (2,116,869) (10,507,533)Loss before income taxes (14,103,982) (6,056,696) (26,748,113) (27,993,848)Provision for income taxes — — — — Net loss$ (14,103,982) $ (6,056,696) $ (26,748,113) $ (27,993,848)Net loss available to common stockholders$ (14,103,982) $ (6,056,696) $ (26,748,113) $ (27,993,848)Basic and diluted net loss per share attributable to common stockholders$ (0.30) $ (0.16) $ (0.57) $ (0.79)Weighted average shares outstanding - basic and diluted 47,656,972 38,270,250 46,915,880 35,373,397 Net loss$(14,103,982) $(6,056,696) $(26,748,113) $(27,993,848)Other comprehensive loss - foreign currency translation (536,758) (597,527) (2,247,749) (1,146,355)Comprehensive loss$ (14,640,740) $ (6,654,223) $ (28,995,862) $ (29,140,203)
Oliver Schacht
President and CEO
InvestorRelations@opgen.com
OpGen Press Contact:
Matthew Bretzius
FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact:
Alyssa Factor
afactor@edisongroup.com
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