Conference call to be held at 8:30 a.m. Eastern Time today
GAITHERSBURG, Md., May 13, 2021 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, reported today its financial and operating results for the three months ended March 31, 2021 and provided a business update. Total OpGen revenue for the first quarter of 2021 was approximately $830,000, up 34.5% from $617,000 in the first quarter of 2020. Cash as of March 31, 2021 was approximately $39.4 million, up significantly from the $13.4 million at year-end 2020.
Oliver Schacht, President & CEO of OpGen, commented, “We are pleased with our first quarter results and are encouraged by the growth of our products and partnerships over the last several months. This excitement encompasses the recently announced extension and expansion of our strategic collaboration with the New York State and includes winning Chinese NMPA approval for the Curetis Unyvero instrument system as we await a clearance decision for the pneumonia cartridge in China, which is currently under review and pending approval. As the pandemic’s effect on the global economy subsides, we believe our balanced product portfolio and long-term pipeline growth initiatives give us the ability to maintain momentum throughout 2021 and support our vision to be amongst the global leaders in infectious disease diagnostics.”
First Quarter 2021 Financial Results of OpGen, Inc.
The company announced accomplishment of the following key milestones and recent developments in the first quarter as well as 2021 to date:
Mr. Schacht commented, “We had a busy quarter that resulted in great progress towards the fight against AMR with multiple publications issued supporting OpGen’s products and mission, new and existing partnership growth that will help drive topline revenue and OpGen also announced regulatory progress particularly with the Chinese NMPA. We also significantly strengthened our balance sheet during the first quarter. As we push through the second quarter, we believe we can achieve an FDA clearance decision for our Acuitas AMR Gene Panel as soon as the FDA’s timelines will permit and work towards pipeline and growth objectives in the year ahead and I look forward to the company’s continued successes.”
Conference Call Information
OpGen’s management will host a conference call today, May 13 at 8:30 a.m. EDT to discuss the first quarter financial results and other business activities, as well as answer questions. Dial-in information is below:
Dial-in Information
U.S. Dial-in Number: +1-877-705-6003
International Dial-in Number: +1-201-493-6725
Webcast: http://public.viavid.com/index.php?id=144749
Conference ID: 13719409
Following the conclusion of the conference call, a replay will be available through May 27, 2021. 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 Information
U.S. Dial-in Number: +1-844-512-2921
International Dial-in Number: +1-412-317-6671
Replay PIN: 13719409
About OpGen, Inc.
OpGen, Inc. (Gaithersburg, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with 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 product portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas® Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.
For more information, please visit www.opgen.com.
Forward-Looking Statements
This press release includes statements regarding OpGen’s first quarter 2021 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, 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, including our November 2020 private placement, February 2021 Registered Direct and March 2021 warrant exercise and exchange, the realization of expected benefits of our business combination transaction with Curetis GmbH, the success of our commercialization efforts, the impact of COVID-19 on the Company’s operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, 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) | |||||||||
March 31, 2021 | December 31, 2020 | ||||||||
Assets | |||||||||
Current assets | |||||||||
Cash and cash equivalents | $ | 39,397,437 | $ | 13,360,463 | |||||
Accounts receivable, net | 485,983 | 653,104 | |||||||
Inventory, net | 1,417,440 | 1,485,986 | |||||||
Prepaid expenses and other current assets | 1,472,666 | 1,388,090 | |||||||
Total current assets | 42,773,526 | 16,887,643 | |||||||
Property and equipment, net | 3,649,747 | 3,259,487 | |||||||
Finance lease right-of-use assets, net | 338,673 | 449,628 | |||||||
Operating lease right-of-use assets | 2,383,364 | 2,082,300 | |||||||
Goodwill | 7,694,401 | 8,024,729 | |||||||
Intangible assets, net | 15,656,651 | 16,580,963 | |||||||
Strategic inventory | 2,057,016 | 1,686,342 | |||||||
Other noncurrent assets | 602,220 | 779,953 | |||||||
Total assets | $ | 75,155,598 | $ | 49,751,045 | |||||
Liabilities and Stockholders’ Equity | |||||||||
Current liabilities | |||||||||
Accounts payable | $ | 1,249,461 | $ | 1,868,666 | |||||
Accrued compensation and benefits | 2,286,441 | 2,126,511 | |||||||
Accrued liabilities | 1,712,008 | 1,437,141 | |||||||
Deferred revenue | 9,808 | 9,808 | |||||||
Current maturities of long-term debt | 282,055 | 699,000 | |||||||
Short-term finance lease liabilities | 183,533 | 266,470 | |||||||
Short-term operating lease liabilities | 849,895 | 964,434 | |||||||
Total current liabilities | 6,573,201 | 7,372,030 | |||||||
Long-term debt, net | 19,430,641 | 19,378,935 | |||||||
Derivative liabilities | 206,973 | 112,852 | |||||||
Long-term finance lease liabilities | 29,265 | 46,794 | |||||||
Long-term operating lease liabilities | 2,737,211 | 1,492,544 | |||||||
Other long term liabilities | 147,026 | 156,635 | |||||||
Total liabilities | 29,124,317 | 28,559,790 | |||||||
Stockholders’ equity | |||||||||
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at December 31, 2020 and 2019, respectively | — | — | |||||||
Common stock, $0.01 par value; 50,000,000 shares authorized; 38,266,482 and 25,085,534 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 382,665 | 250,855 | |||||||
Additional paid-in capital | 259,766,331 | 219,129,045 | |||||||
Accumulated deficit | (215,586,418 | ) | (200,735,827 | ) | |||||
Accumulated other comprehensive income | 1,468,703 | 2,547,182 | |||||||
Total stockholders’ equity | 46,031,281 | 21,191,255 | |||||||
Total liabilities and stockholders’ equity | $ | 75,155,598 | $ | 49,751,045 | |||||
OpGen, Inc. | |||||||||
Consolidated Statements of Operations and Comprehensive Loss | |||||||||
(unaudited) | |||||||||
Three Months Ended March 31, | |||||||||
2021 | 2020 | ||||||||
Revenue | |||||||||
Product sales | $ | 613,918 | $ | 366,933 | |||||
Laboratory services | 97,726 | — | |||||||
Collaboration revenue | 118,072 | 250,000 | |||||||
Total revenue | 829,716 | 616,933 | |||||||
Operating expenses | |||||||||
Cost of products sold | 554,054 | 276,554 | |||||||
Cost of services | 104,984 | 137,666 | |||||||
Research and development | 2,813,491 | 1,217,556 | |||||||
General and administrative | 2,663,657 | 1,701,448 | |||||||
Sales and marketing | 899,252 | 282,277 | |||||||
Transaction costs | — | 245,322 | |||||||
Impairment of intangibles assets | — | 750,596 | |||||||
Impairment of right-of-use asset | 55,496 | — | |||||||
Total operating expenses | 7,090,934 | 4,611,419 | |||||||
Operating loss | (6,261,218 | ) | (3,994,486 | ) | |||||
Warrant inducement expense | (7,755,541 | ) | — | ||||||
Interest and other income | 4,925 | 87,335 | |||||||
Interest expense | (1,164,982 | ) | (38,267 | ) | |||||
Foreign currency transaction gains (losses) | 427,615 | (3,876 | ) | ||||||
Change in fair value of derivative financial instruments | (101,390 | ) | — | ||||||
Total other expense | (8,589,373 | ) | 45,192 | ||||||
Loss before income taxes | (14,850,591 | ) | (3,949,294 | ) | |||||
Provision for income taxes | — | — | |||||||
Net loss | $ | (14,850,591 | ) | $ | (3,949,294 | ) | |||
Net loss available to common stockholders | $ | (14,850,591 | ) | $ | (3,949,294 | ) | |||
Net loss per common share – basic and diluted | $ | (0.50 | ) | $ | (0.53 | ) | |||
Weighted average shares outstanding – basic and diluted | 29,485,067 | 7,393,232 | |||||||
Net loss | $ | (14,850,591 | ) | $ | (3,949,294 | ) | |||
Other comprehensive loss – foreign currency translation | (1,078,479 | ) | 39,477 | ||||||
Comprehensive loss | $ | (15,929,070 | ) | $ | (3,909,817 | ) | |||
OpGen:
Oliver Schacht
President and CEO
InvestorRelations@opgen.com
OpGen Press Contact:
Matthew Bretzius
FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact:
Megan Paul
Edison Group
mpaul@edisongroup.com
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