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OpGen Reports Second Quarter 2022 Financial Results and Provides Business Update

·12-min read
OpGen, Inc.
OpGen, Inc.
  • Total Q2 2022 revenues of $1.0 million with product sales a key growth driver

  • First two commercial customer contracts for Acuitas AMR Gene Panel signed in June and July 2022

  • Requested additional 180-day period to regain compliance with Nasdaq minimum bid price rule

  • Management conference call scheduled for August 11th, 2022, at 4:30 p.m. EDT

ROCKVILLE, Md., Aug. 11, 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 second 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, “We are pleased with the progress we’ve made in the first half of 2022, which includes signing two commercial contracts for our Acuitas AMR Gene Panel with two major U.S. hospitals. Additionally, we have added a fourth trial site and continued enrollment towards our 1,500th patient sample for the clinical trial for Unyvero Urinary Tract Infection (UTI) Panel. We anticipate completing the enrollment and expect final data read out in the second half of this year towards an FDA submission.”

Dr. Schacht continued, “Overall we are tracking well against our R&D milestones and continue to progress on the commercial front with significant growth in direct product sales year over year. We look forward to continuing to update on our progress and continue the fight against antimicrobial resistance.”

Second Quarter and First Half 2022 Financial Results of OpGen, Inc.

  • Total revenue for the second quarter of 2022 was approximately $1.0 million, compared with approximately $0.8 million in the second quarter of 2021. Total revenue for the first half of 2022 was approximately $1.4 million, as compared to approximately $1.6 million for the first half of 2021.

  • Operating expenses for the second quarter of 2022 were approximately $6.2 million, compared with approximately $7.0 million in the second quarter of 2021. Operating expenses for the first half of 2022 were approximately $12.6 million, compared with approximately $14.0 million in the first half of 2021.

  • The net loss available to common stockholders for the second quarter of 2022 was approximately $5.8 million, or $0.13 per share, compared with approximately $7.1 million, or $0.19 per share, in the second quarter of 2021. The net loss available to common stockholders for the first half of 2022 was approximately $12.6 million, or $0.27 per share, compared with approximately $21.9 million, or $0.65 per share, in the first half of 2021.

  • Cash and cash equivalents were approximately $16.6 million as of June 30, 2022, compared with $36.1 million as of December 31, 2021.

In the reporting quarter and year to date, the Company reached the following key milestones:

  • OpGen signed its first two commercial customer contracts for the Acuitas AMR Gene Panel in June and July 2022 with a major 1,000+ bed teaching hospital in the Northeast and a renowned 400+ bed children’s hospital in the Midwest

  • OpGen subsidiary Ares Genetics extended its collaboration agreement with Sandoz until 2025, to drive cutting-edge digital solutions in the global fight against antimicrobial resistance (AMR)

  • OpGen subsidiary Ares Genetics also commercially launched new sequencing and analysis services globally, which includes ARESid and ARESiss Express

  • OpGen announced interim analysis results from its clinical trial for Unyvero UTI Panel and added a fourth trial site

  • OpGen to date has enrolled over 1,300 patient samples in the clinical trial for Unyvero UTI Panel and is on track towards the enrollment goal of 1,500 prospective patient samples

  • OpGen subsidiary Curetis and Leader Life Sciences entered into a Unyvero distribution partnership within the United Arab Emirates and Qatar for a total value of approximately $1 million in revenue during the initial three-year term

  • OpGen subsidiary Curetis and Keis Group entered into a three-year exclusive Unyvero distribution partnership in Kosovo based on Keis’ successfully won tender for Unyvero products

  • OpGen and Menarini expanded their distribution agreement to increase the annual minimum revenue commitment by Menarini in the next two years, in addition to the sale of around 70 installed Unyvero systems across nine European countries at residual fair market value from OpGen’s subsidiary Curetis to Menarini

  • OpGen announced publication of results from a major prospective, multi center, randomized and interventional clinical study using Unyvero Hospitalized Pneumonia (HPN) Panel in The Lancet Respiratory Medicine that demonstrated Unyvero decreases the duration of inappropriate antibiotic therapy in hospitalized patients with pneumonia

  • OpGen announced publication of results of Unyvero HPN Panel for detection of bacterial respiratory tract pathogens from serial specimens collected from hospitalized COVID-19 patients at Karolinska University Hospital (Sweden), confirming the ability of Unyvero in detecting potential pneumonia pathogens earlier than culture

  • OpGen commenced a new At The Market (ATM) sales facility for up to approximately $10.7 million, pursuant to which the Company may sell, from time to time, in an “at the market” offering shares of its common stock. While no shares were sold under this new ATM in H1 2022, in July and August to date the Company has sold approximately 1.7 million new shares of its common stock for gross proceeds of approximately $1 million.

  • OpGen requested an additional 180-day period from Nasdaq to regain compliance with the $1.00 minimum bid price rule and expects their decision by the end of August.

In terms of fiscal 2022 guidance, OpGen expects:

  • U.S. direct product sales of Unyvero and Acuitas are anticipated to contribute to growth

  • Continuous increase in its European and international distribution business for Unyvero products

  • Expand Ares Genetics strategic collaborations and partnerships and launch U.S. Next Generation Sequencing lab services in Q3 2022

  • Overall, 2022 revenue growth of approximately 25% year over year from the products and services business globally

Conference Call Information

OpGen’s management will host a conference call today, August 11th at 4:30 p.m. EDT, to go over the second quarter and first half of 2022 financial results and business activities, as well as answer analyst questions.

 

Dial-in Information

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=1556114&tp_key=e1546ec0f5

Conference ID: 13730742

 

Following the conclusion of the conference call, a replay will be available through August 25th, 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 Information

U.S. Dial-in Number: +1-844-512-2921

International Dial-in Number: +1-412-317-6671

Replay PIN: 13730742

 

About OpGen, Inc. OpGen, Inc. (Rockville, MD, USA) 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 product portfolio includes Unyvero®, Acuitas® AMR Gene Panel 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 the second quarter and first half 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 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)

 

 

 

 

 

 

 

June 30, 2022

 

December 31, 2021

Assets

 

 

 

 

Current assets

 

 

 

 

Cash and cash equivalents

 

$

16,586,577

 

 

$

36,080,392

 

Accounts receivable, net

 

 

738,148

 

 

 

1,172,396

 

Inventory, net

 

 

1,196,956

 

 

 

1,239,456

 

Prepaid expenses and other current assets

 

 

1,687,564

 

 

 

1,250,331

 

Total current assets

 

 

20,209,245

 

 

 

39,742,575

 

Property and equipment, net

 

 

3,209,311

 

 

 

4,011,748

 

Finance lease right-of-use assets, net

 

 

19,660

 

 

 

90,467

 

Operating lease right-of-use assets

 

 

1,582,325

 

 

 

1,814,396

 

Goodwill

 

 

6,884,915

 

 

 

7,453,007

 

Intangible assets, net

 

 

12,969,215

 

 

 

14,530,209

 

Strategic inventory

 

 

3,492,602

 

 

 

3,472,337

 

Other noncurrent assets

 

 

441,320

 

 

 

551,794

 

Total assets

 

$

48,808,593

 

 

$

71,666,533

 

Liabilities and Stockholders’ Equity

 

 

 

 

Current liabilities

 

 

 

 

Accounts payable

 

$

731,845

 

 

$

1,307,081

 

Accrued compensation and benefits

 

 

1,575,299

 

 

 

1,621,788

 

Accrued liabilities

 

 

788,153

 

 

 

1,965,845

 

Current maturities of long-term debt

 

 

10,887,469

 

 

 

14,519,113

 

Short-term finance lease liabilities

 

 

16,731

 

 

 

43,150

 

Short-term operating lease liabilities

 

 

394,027

 

 

 

459,792

 

Total current liabilities

 

 

14,393,524

 

 

 

19,916,769

 

Long-term debt, net

 

 

4,024,413

 

 

 

7,176,251

 

Derivative liabilities

 

 

175,498

 

 

 

228,589

 

Long-term finance lease liabilities

 

 

1,962

 

 

 

3,644

 

Long-term operating lease liabilities

 

 

2,721,233

 

 

 

2,977,402

 

Other long-term liabilities

 

 

130,983

 

 

 

146,798

 

Total liabilities

 

 

21,447,613

 

 

 

30,449,453

 

Stockholders' equity

 

 

 

 

Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at June 30, 2022 and December 31, 2021, respectively

 

 

 

 

 

 

Common stock, $0.01 par value; 100,000,000 shares authorized; 46,623,618 and 46,450,250 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively

 

 

466,237

 

 

 

464,503

 

Additional paid-in capital

 

 

276,205,778

 

 

 

275,708,490

 

Accumulated deficit

 

 

(248,185,670

)

 

 

(235,541,539

)

Accumulated other comprehensive (loss)/income

 

 

(1,125,365

)

 

 

585,626

 

Total stockholders’ equity

 

 

27,360,980

 

 

 

41,217,080

 

Total liabilities and stockholders’ equity

 

$

48,808,593

 

 

$

71,666,533

 

 

 

 

 

 


 

 

OpGen, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2022

 

 

 

2021

 

 

 

2022

 

 

 

2021

 

Revenue

 

 

 

 

 

 

 

 

Product sales

 

$

889,271

 

 

$

307,804

 

 

$

1,255,323

 

 

$

835,383

 

Laboratory services

 

 

20,570

 

 

 

266,784

 

 

 

63,499

 

 

 

450,849

 

Collaboration revenue

 

 

57,364

 

 

 

237,027

 

 

 

118,128

 

 

 

355,099

 

Total revenue

 

 

967,205

 

 

 

811,615

 

 

 

1,436,950

 

 

 

1,641,331

 

Operating expenses

 

 

 

 

 

 

 

 

Cost of products sold

 

 

646,389

 

 

 

342,580

 

 

 

938,386

 

 

 

896,634

 

Cost of services

 

 

15,650

 

 

 

137,934

 

 

 

46,212

 

 

 

242,918

 

Research and development, net

 

 

2,273,756

 

 

 

2,859,590

 

 

 

4,590,197

 

 

 

5,673,081

 

General and administrative

 

 

2,134,266

 

 

 

2,692,255

 

 

 

4,759,319

 

 

 

5,355,912

 

Sales and marketing

 

 

1,169,349

 

 

 

802,549

 

 

 

2,220,781

 

 

 

1,701,801

 

Impairment of right-of-use asset

 

 

 

 

 

115,218

 

 

 

 

 

 

170,714

 

Total operating expenses

 

 

6,239,410

 

 

 

6,950,126

 

 

 

12,554,895

 

 

 

14,041,060

 

Operating loss

 

 

(5,272,205

)

 

 

(6,138,511

)

 

 

(11,117,945

)

 

 

(12,399,729

)

Other expense

 

 

 

 

 

 

 

 

Gain on extinguishment of debt

 

 

 

 

 

259,353

 

 

 

 

 

 

259,353

 

Warrant inducement expense

 

 

 

 

 

 

 

 

 

 

 

(7,755,541

)

Interest and other income, net

 

 

13,851

 

 

 

4,702

 

 

 

16,972

 

 

 

9,627

 

Interest expense

 

 

(779,912

)

 

 

(1,198,169

)

 

 

(2,049,493

)

 

 

(2,363,151

)

Foreign currency transaction gains/(losses)

 

 

271,967

 

 

 

(915

)

 

 

470,707

 

 

 

426,700

 

Change in fair value of derivative financial instruments

 

 

(74,116

)

 

 

(13,021

)

 

 

35,628

 

 

 

(114,411

)

Total other expense

 

 

(568,210

)

 

 

(948,050

)

 

 

(1,526,186

)

 

 

(9,537,423

)

Loss before income taxes

 

 

(5,840,415

)

 

 

(7,086,561

)

 

 

(12,644,131

)

 

 

(21,937,152

)

Provision for income taxes

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(5,840,415

)

 

$

(7,086,561

)

 

$

(12,644,131

)

 

$

(21,937,152

)

Net loss available to common stockholders

 

$

(5,840,415

)

 

$

(7,086,561

)

 

$

(12,644,131

)

 

$

(21,937,152

)

Basic and diluted net loss per share attributable to common stockholders

 

$

(0.13

)

 

$

(0.19

)

 

$

(0.27

)

 

$

(0.65

)

Weighted average shares outstanding - basic and diluted

 

 

46,574,512

 

 

 

38,268,293

 

 

 

46,529,718

 

 

 

33,900,964

 

Net loss

 

$

(5,840,415

)

 

$

(7,086,561

)

 

$

(12,644,131

)

 

$

(21,937,152

)

Other comprehensive loss - foreign currency translation

 

 

(1,227,142

)

 

 

529,651

 

 

 

(1,710,991

)

 

 

(548,828

)

Comprehensive loss

 

$

(7,067,557

)

 

$

(6,556,910

)

 

$

(14,355,122

)

 

$

(22,485,980

)

 

 

 

 

 

 

 

 

 


OpGen:
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
Edison Group
afactor@edisongroup.com