HTG Molecular Diagnostics Reports Second Quarter 2020 Results
Recent Accomplishments & Highlights:
- Entered into a 10-year Commercialization and Distribution Agreement (Master Agreement) with
QIAGEN Manchester Limited (QIAGEN), providing the foundation for HTG and QIAGEN to combine their technological and commercial strengths with the goal to offer pharmaceutical companies global development, distribution and commercialization capabilities for companion diagnostic assays developed on the HTG EdgeSeq platform.
- Introduced three previously released research use only (RUO) assays for use with the Thermo Fisher Scientific Ion Torrent Ion S5 next-generation sequencing (NGS) platform. With the release of the
HTG EdgeSeq Precision Immuno-Oncology Panel , theHTG EdgeSeq Mouse MRNA Tumor Response Panel and theHTG EdgeSeq Autoimmune Panel , HTG’s entire RUO profiling assay menu is now available on both the Illumina and Thermo Fisher Scientific NGS platforms.
- Announced the launch of the new HTG EdgeSeq Pan B-Cell Lymphoma Panel, which is commercially available for purchase in kit form or as a service in HTG’s VERI/O laboratory.
The HTG EdgeSeq Pan B-Cell Lymphoma Panel is an RUO panel designed to provide molecular characterization of aggressive lymphomas by allowing researchers to measure the expression of genes associated with the aggressive lymphoma transcriptome.
- Signed three new European distributor agreements to promote HTG products and services in Nordic and Eastern European Countries with BioNordika (
Denmark ), Explorea (Czech Republic ), and ELTA 90 (Bulgaria ).
- HTG’s EdgeSeq technology was highlighted in posters presented by partners at both the American Association for Cancer Research (AACR) and the
American Society of Clinical Oncology (ASCO) 2020 virtual meetings.
- Secured a $10.0 million senior term loan from
Silicon Valley Bank . Proceeds from the senior term loan were used to pay off the principal balances outstanding on HTG’s term loan withMidCap Financial and its subordinated convertible promissory note held byQIAGEN North American Holdings, Inc. The duration of the senior term loan is 42 months, with interest only payments throughJune 30, 2021 plus additional months under certain conditions.
“The COVID-19 pandemic continued to have a negative impact on our business and that of our customers in the second quarter of 2020 and we believe it will continue to have a negative impact likely through at least the remainder of 2020 as a number of our larger customers have communicated their intentions to remain operating at partial capacity or with limited external visitors through the end of the year,” said
Second Quarter 2020 Financial Highlights:
Total revenue for the quarter ended
Product and product-related services revenue was
Collaborative development services revenue for the quarter ended
Net loss from operations for the quarter ended
Cash, cash equivalents and short-term available-for-sale securities totaled
Conference Call and Webcast:
HTG will host a conference call for the investment community today beginning at
| Date: | ||
| Time: | ||
| Toll Free: | (877) 407-0789 | |
| International: | (201) 689-8562 | |
| Conference ID: | 13706480 | |
| Webcast: | http://public.viavid.com/index.php?id=140583 | |
| About HTG: | ||
| HTG is focused on NGS-based molecular profiling. The company’s proprietary HTG EdgeSeq technology automates complex, highly multiplexed molecular profiling from solid and liquid samples, even when limited in amount. HTG’s customers use its technology to identify biomarkers important for precision medicine, to understand the clinical relevance of these discoveries, and ultimately to identify treatment options. Its mission is to empower precision medicine. | ||
Safe Harbor Statement:
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential benefits of the Master Agreement with QIAGEN, the anticipated duration of the impact of the COVID-19 pandemic on our business, our being on track to deliver development milestones, and our expectations for increased demand for our products and services in the future and our ability to meet those demands and for growth in our business. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, risks associated with the impact of the COVID-19 pandemic on us and our customers; the risk that we may not establish new and significant collaboration development arrangements; risks associated with our ability to successfully commercialize our products; the risk that our products and services may not be adopted by biopharmaceutical companies or other customers as anticipated, or at all; our ability to manufacture our products to meet demand; the level and availability of third party payor reimbursement for our products; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; competition in our industry; additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims. These and other factors are described in greater detail in our filings with the
Contact:
Phone: (617) 430-7577
Email: arr@lifesciadvisors.com
-Financial tables follow-
| Condensed Consolidated Statements of Operations | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended |
Six Months Ended |
|||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product and product-related services | $ | 1,728,526 | $ | 4,424,368 | $ | 3,716,663 | $ | 7,086,873 | ||||||||
| Collaborative development services | 234,768 | 1,371,952 | 472,105 | 1,912,272 | ||||||||||||
| Total revenue | 1,963,294 | 5,796,320 | 4,188,768 | 8,999,145 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of product and product-related services revenue | 974,642 | 2,508,371 | 1,990,134 | 4,553,898 | ||||||||||||
| Selling, general and administrative | 4,255,485 | 4,740,710 | 8,930,748 | 9,141,576 | ||||||||||||
| Research and development | 1,732,776 | 3,253,639 | 3,659,051 | 5,328,387 | ||||||||||||
| Total operating expenses | 6,962,903 | 10,502,720 | 14,579,933 | 19,023,861 | ||||||||||||
| Operating loss | (4,999,609 | ) | (4,706,400 | ) | (10,391,165 | ) | (10,024,716 | ) | ||||||||
| Other expense, net | (182,757 | ) | (84,022 | ) | (243,923 | ) | (136,552 | ) | ||||||||
| Loss on extinguishment of MidCap Credit Facility and QNAH Convertible Note | (522,394 | ) | — | (522,394 | ) | — | ||||||||||
| Net loss before income taxes | (5,704,760 | ) | (4,790,422 | ) | (11,157,482 | ) | (10,161,268 | ) | ||||||||
| Provision for income taxes | (5,791 | ) | (6,848 | ) | (10,967 | ) | (6,848 | ) | ||||||||
| Net loss | $ | (5,710,551 | ) | $ | (4,797,270 | ) | $ | (11,168,449 | ) | $ | (10,168,116 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.09 | ) | $ | (0.17 | ) | $ | (0.17 | ) | $ | (0.36 | ) | ||||
| Shares used in computing net loss per share, basic and diluted | 65,757,458 | 28,657,384 | 65,162,695 | 28,629,189 | ||||||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| 2020 | 2019 | |||||||
| Assets | (Unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 21,014,375 | $ | 7,619,748 | ||||
| Short-term investments available-for-sale, at fair value | 11,852,173 | 25,410,222 | ||||||
| Restricted cash | — | 3,270,247 | ||||||
| Accounts receivable | 1,011,462 | 3,164,176 | ||||||
| Inventory, net | 1,388,570 | 1,269,667 | ||||||
| Prepaid expenses and other | 1,236,192 | 633,522 | ||||||
| Total current assets | 36,502,772 | 41,367,582 | ||||||
| Operating lease right-of-use assets | 905,459 | 1,209,145 | ||||||
| Property and equipment, net | 1,825,191 | 2,240,133 | ||||||
| Other non-current assets | 69,365 | 302,409 | ||||||
| Total assets | $ | 39,302,787 | $ | 45,119,269 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 927,829 | $ | 1,662,583 | ||||
| Accrued liabilities | 947,382 | 1,870,296 | ||||||
| Contract liabilities - current | 418,874 | 426,014 | ||||||
| NuvoGen obligation - current | 863,611 | 1,152,233 | ||||||
| Short-term debt, net | 1,143,011 | 2,987,667 | ||||||
| Operating lease liabilities - current | 584,073 | 758,932 | ||||||
| Other current liabilities | 30,983 | 41,134 | ||||||
| Total current liabilities | 4,915,763 | 8,898,859 | ||||||
| NuvoGen obligation - non-current, net of discount | 4,359,218 | 4,498,777 | ||||||
| Long-term debt, net | 10,705,219 | 6,871,545 | ||||||
| Operating lease liabilities - non-current | 453,404 | 636,340 | ||||||
| Other non-current liabilities | 185,276 | 244,114 | ||||||
| Total liabilities | 20,618,880 | 21,149,635 | ||||||
| Commitments and Contingencies | ||||||||
| Total stockholders’ equity | 18,683,907 | 23,969,634 | ||||||
| Total liabilities and stockholders' equity | $ | 39,302,787 | $ | 45,119,269 | ||||
Source: HTG Molecular Diagnostics, Inc.