OpGen Reports First Quarter 2018 Financial Results and Provides a Business Update
Revenue increases 10% to
Conference call begins at
“During the quarter our development efforts advanced for our Acuitas®
“At last month’s
Mr. Jones continued, “During the quarter, we announced a collaboration with
“In April, we announced successful completion of a prospective clinical trial evaluating the impact of using rapid diagnostic testing for identification and treatment of bacteremia and fungemia in hospital intensive care units in
2018 First Quarter Financial Results
- Revenue: Total revenue for the first quarter of 2018 was
$0.85 million , compared with$0.77 million for the first quarter of 2017. - Operating Expenses: Operating expenses for the first quarter of 2018 were
$3.9 million , compared with$5.7 million for the first quarter of 2017. - Net Loss: The net loss available to common stockholders for the first quarter of 2018 was
$3.0 million or$0.75 per share, compared with a net loss available to common stockholders of$5.0 million or$4.77 per share for the first quarter of 2017. - Cash Position: Cash and cash equivalents were $10.3 million as of
March 31, 2018 , compared with$1.8 million as ofDecember 31, 2017 . During the first quarter, the Company raised net proceeds of$10.7 million in a public offering.
First Quarter 2018 Enterprise Highlights and Recent Developments:
Additional highlights from the first quarter and recent weeks included:
- Reported successful analytical validation and clinical verification results for the
Acuitas AMR Gene Panel u5.47 (RUO). - Entered into a second global supply agreement to incorporate Thermo Fisher Scientific’s real-time PCR technology in our
Acuitas AMR Gene Panel tests. Products covered under these agreements include the QuantStudio® 5 Real-Time PCR System, TaqMan® Fast Advanced Master Mix and TaqMan® Probes for quick, multiplexed gene detection. - Completed a
$12.0 million public offering with net proceeds toOpGen of$10.7 million . - Regained compliance with Nasdaq listing requirements for both minimum stockholders’ equity and minimum bid price.
- Continued to achieve stated operating expense reduction during the quarter, with a 33% reduction compared with the first quarter of 2017.
“We made solid progress with our research and development, operations, and financial activities during the quarter. We are encouraged by the progress to date with our
2018 Outlook
OpGen expects to advance the following business objectives during the remainder of 2018 as it transitions to the commercial phase of its molecular informatics business:
- Derive revenues from the sale of the
RUO Acuitas AMR Gene Panel u5.47 to large hospitals, pharmaceutical companies and clinical research organizations. - Complete third-party clinical verification studies and
FDA clinical trials to support clearance for in vitro diagnostic use of theAcuitas AMR Gene Panel u5.47 test and the Acuitas Lighthouse Software. - File a first 510(k) application with the
FDA in the fourth quarter for theAcuitas AMR Gene Panel u5.47 (IVD) to support full commercial launch for clinical use. - Add QuantStudio 5 System and QIAGEN EZ1 Advanced XL revenue-generating system placements.
- Enter into additional supply and cooperation agreements in support of the new Acuitas product family under development.
- Complete CDC contract demonstration project in
Colombia for development of smartphone-based clinical decision support solutions for anti-microbial stewardship and infection control in low- and middle-income countries. - Continue to seek third-party funding for development programs.
- Maintain cost reductions and overall cash burn rate to extend operating cash runway.
Conference Call Information
OpGen management will hold a conference call today beginning at 4:30 p.m. Eastern time to discuss first quarter financial results and other business activities, and answer questions. The call can be accessed by dialing (888) 883-4599 (domestic) or (484) 653-6821 (international) and providing conference ID 1082196. A live webcast of the conference call can be accessed by visiting the Investor Relations section of the company’s website at http://ir.opgen.com. A replay of the webcast will be available shortly after the conclusion of the call for 90 days.
A telephone replay of the conference call will be available from
About OpGen
Forward-Looking Statements
This press release includes statements relating to OpGen’s first quarter 2018 results and 2018 outlook. 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 success of our commercialization efforts, 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 Contact:
Vice President, Marketing
(240) 813-1284
mfarmer@opgen.com
InvestorRelations@opgen.com
Investor Contacts:
LHA Investor Relations
(212) 838-3777
kgolodetz@lhai.com
or
(310) 691-7100
bvoss@lhai.com
(Tables to follow)
| OpGen, Inc. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (unaudited) | ||||||||
| March 31, 2018 | December 31, 2017 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 10,291,532 | $ | 1,847,171 | ||||
| Accounts receivable, net | 591,492 | 809,540 | ||||||
| Inventory, net | 509,057 | 533,425 | ||||||
| Prepaid expenses and other current assets | 237,997 | 311,644 | ||||||
| Total current assets | 11,630,078 | 3,501,780 | ||||||
| Property and equipment, net | 828,120 | 835,537 | ||||||
| Goodwill | 600,814 | 600,814 | ||||||
| Intangible assets, net | 1,286,228 | 1,353,182 | ||||||
| Other noncurrent assets | 266,112 | 328,601 | ||||||
| Total assets | $ | 14,611,352 | $ | 6,619,914 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,443,857 | $ | 1,691,712 | ||||
| Accrued compensation and benefits | 1,003,418 | 746,924 | ||||||
| Accrued liabilities | 1,098,986 | 1,160,714 | ||||||
| Deferred revenue | 23,040 | 24,442 | ||||||
| Short-term notes payable | 983,131 | 1,010,961 | ||||||
| Current maturities of long-term capital lease obligation | 191,755 | 154,839 | ||||||
| Total current liabilities | 4,744,187 | 4,789,592 | ||||||
| Deferred rent | 261,791 | 290,719 | ||||||
| Warrant liability | 287 | 8,453 | ||||||
| Long-term capital lease obligation and other noncurrent liabilities | 305,163 | 130,153 | ||||||
| Total liabilities | 5,311,428 | 5,218,917 | ||||||
| Commitments (Note 9) | ||||||||
| Stockholders' equity | ||||||||
| Common stock, $0.01 par value; 50,000,000 shares authorized; 5,289,919 and 2,265,320 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively |
52,899 | 22,653 | ||||||
| Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at March 31, 2018 and December 31, 2017, respectively |
— | — | ||||||
| Additional paid-in capital | 161,044,016 | 150,114,671 | ||||||
| Accumulated other comprehensive loss | (38,479 | ) | (25,900 | ) | ||||
| Accumulated deficit | (151,758,512 | ) | (148,710,427 | ) | ||||
| Total stockholders’ equity | 9,299,924 | 1,400,997 | ||||||
| Total liabilities and stockholders’ equity | $ | 14,611,352 | $ | 6,619,914 | ||||
| OpGen, Inc. | ||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||
| (unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2018 |
2017 |
|||||||
| Revenue | ||||||||
| Product sales | $ | 633,496 | $ | 734,502 | ||||
| Laboratory services | 8,690 | 16,105 | ||||||
| Collaboration revenue | 204,040 | 21,164 | ||||||
| Total revenue | 846,226 | 771,771 | ||||||
| Operating expenses | ||||||||
| Cost of products sold | 342,832 | 424,950 | ||||||
| Cost of services | 168,553 | 100,233 | ||||||
| Research and development | 1,230,429 | 2,122,515 | ||||||
| General and administrative | 1,790,522 | 1,969,216 | ||||||
| Sales and marketing | 329,773 | 1,105,586 | ||||||
| Total operating expenses | 3,862,109 | 5,722,500 | ||||||
| Operating loss | (3,015,883 | ) | (4,950,729 | ) | ||||
| Other (expense)/income | ||||||||
| Interest and other expense | 5,298 | 21 | ||||||
| Interest expense | (57,846 | ) | (29,844 | ) | ||||
| Foreign currency transaction losses | 12,181 | 2,620 | ||||||
| Change in fair value of derivative financial instruments | 8,166 | — | ||||||
| Total other expense | (32,201 | ) | (27,203 | ) | ||||
| Loss before income taxes | (3,048,084 | ) | (4,977,932 | ) | ||||
| Provision for income taxes | — | — | ||||||
| Net loss | (3,048,084 | ) | (4,977,932 | ) | ||||
| Net loss available to common stockholders | $ | (3,048,084 | ) | $ | (4,977,932 | ) | ||
| Net loss per common share - basic and diluted | $ | (0.75 | ) | $ | (4.77 | ) | ||
| Weighted average shares outstanding - basic and diluted | 4,055,715 | 1,043,178 | ||||||
| Net loss | $ | (3,048,084 | ) | $ | (4,977,932 | ) | ||
| Other comprehensive loss - foreign currency translation | (12,579 | ) | (3,757 | ) | ||||
| Comprehensive loss | $ | (3,060,663 | ) | $ | (4,981,689 | ) | ||