TUCSON, Ariz., March 23, 2017 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM), a provider of instruments, reagents and services for molecular profiling applications, today reported financial results for the fourth quarter and year ended December 31, 2016.
Recent Accomplishments & Highlights:
- Signed a development, manufacturing and commercialization agreement with a wholly owned affiliate of QIAGEN, N.V.
• QIAGEN North American Holdings also made a minority investment in HTG’s common stock
• Completed technical feasibility assay for QIAGEN GeneReader next-generation sequencing platform - Obtained CE marking for the HTG EdgeSeq ALKPlus Assay for commercialization of the assay as an in vitro diagnostic (IVD) in the European Union
- Announced availability of new direct sequencing chemistry and initial DNA mutation assay as a service offering in the company’s VERI/O laboratory
- Achieved revenue of $1.5 million for the fourth quarter of 2016 compared to $1.2 million in Q4 2015
• Service revenue increased to $381,000 in the fourth quarter of 2016 from $33,000 in Q4 2015 - Achieved revenue of $5.1 million for the year ended December 31, 2016 compared to $4.0 million for the year ended December 31, 2015
• Service revenue increased to $2.4 million in 2016 from $184,000 in 2015
“In 2016, we believe HTG made significant strides in customer adoption and building a solid platform for long-term growth,” said TJ Johnson, HTG’s President and CEO.
Fourth Quarter 2016 Financial Results:
Revenue for the fourth quarter of 2016 was $1.5 million. Net loss from operations was $5.2 million for the fourth quarter of 2016, compared to $5.3 million for the fourth quarter of 2015. Net loss per share was $(0.76) for the fourth quarter of 2016 and $(0.83) for the fourth quarter of 2015.
Full Year 2016 Financial Results:
Revenue for the year ended December 31, 2016 was $5.1 million. Net loss from operations for the year ended December 31, 2016 was $24.3 million, compared to $18.9 million for the year ended December 31, 2015. Net loss per share was $(3.66) for the year ended December 31, 2016 and $(5.03) for the year ended December 31, 2015. HTG ended 2016 with $11.8 million in total cash and investments, including $7.5 million in cash and equivalents and $4.3 million in short term available-for-sale investments, and current liabilities of approximately $10.0 million plus an additional $14.0 million in long-term liabilities.
Conference Call
HTG will host an investment community conference call today beginning at 5:00 p.m. ET. Individuals interested in listening to the conference call may dial (866) 394-4225 for domestic callers, or (678) 509-7535 for international callers, conference ID 91525538, or access the webcast on the investor relations section of the Company’s website at: www.htgmolecular.com. The webcast will be available on the Company’s website for 90 days following the completion of the call.
About HTG:
Headquartered in Tucson, Arizona, HTG’s mission is to empower precision medicine at the local level. In 2013, the company commercialized its first instrument platform and a portfolio of RNA assays that leveraged HTG's original proprietary nuclease protection chemistry. Continuous improvement led to the 2014 launch of the company’s HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing. Additional information is available at www.htgmolecular.com.
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 our growth prospects, and strategic priorities. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though 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 our ability to enter into new collaborations with Pharma customers, risks associated with our ability to obtain regulatory clearances or approvals in the United States and other jurisdictions to market panels for diagnostic purposes, our ability to successfully commercialize our products; our ability to manufacture our products to meet demand; the level and availability of third party payor reimbursement for our products; our ability to effectively manage our anticipated growth; 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; requirements for 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 Securities and Exchange Commission, including without limitation our Annual Report on Form 10-K for the year ended December 31, 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
-Financial tables follow-
| HTG Molecular Diagnostics, Inc. | ||||||||||||||||
| Statements of Operations | ||||||||||||||||
| Three Months Ended December 31, | Years Ended December 31, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| (Unaudited) | ||||||||||||||||
| Revenue: | ||||||||||||||||
| Product | $ | 1,076,560 | $ | 1,182,287 | $ | 2,759,942 | $ | 3,532,028 | ||||||||
| Service | 381,221 | 33,466 | 2,372,788 | 183,758 | ||||||||||||
| Other | — | — | — | 325,789 | ||||||||||||
| Total revenue | 1,457,781 | 1,215,753 | 5,132,730 | 4,041,575 | ||||||||||||
| Cost of revenue | 1,234,429 | 796,921 | 4,135,884 | 3,335,511 | ||||||||||||
| Gross margin | 223,352 | 418,832 | 996,846 | 706,064 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Selling, general and administrative | 4,083,832 | 4,111,249 | 17,427,777 | 14,994,410 | ||||||||||||
| Research and development | 1,384,503 | 1,650,709 | 7,900,311 | 4,601,718 | ||||||||||||
| Total operating expenses | 5,468,335 | 5,761,958 | 25,328,088 | 19,596,128 | ||||||||||||
| Operating loss | (5,244,983 | ) | (5,343,126 | ) | (24,331,242 | ) | (18,890,064 | ) | ||||||||
| Loss from change in stock warrant valuation | — | — | — | (239,683 | ) | |||||||||||
| Interest expense, net | (425,649 | ) | (348,443 | ) | (1,755,053 | ) | (1,633,616 | ) | ||||||||
| Loss on settlement of convertible debt | — | — | — | (705,217 | ) | |||||||||||
| Other | 3,410 | 2,105 | 56,863 | 80,978 | ||||||||||||
| Net loss before income taxes | (5,667,222 | ) | (5,689,463 | ) | (26,029,432 | ) | (21,387,602 | ) | ||||||||
| Income taxes | 5,859 | 10,189 | 10,118 | 10,189 | ||||||||||||
| Net loss | (5,673,081 | ) | (5,699,652 | ) | (26,039,550 | ) | (21,397,791 | ) | ||||||||
| Accretion of redeemable convertible preferred stock discount, issuance costs and dividends | — | — | — | (1,328,594 | ) | |||||||||||
| Net loss attributable to common stockholders | $ | (5,673,081 | ) | $ | (5,699,652 | ) | $ | (26,039,550 | ) | $ | (22,726,385 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.76 | ) | $ | (0.83 | ) | $ | (3.66 | ) | $ | (5.03 | ) | ||||
| Shares used in computing net loss per share attributable to common stockholders, basic and diluted | 7,488,842 | 6,840,918 | 7,113,075 | 4,518,499 | ||||||||||||
| HTG Molecular Diagnostics, Inc. | ||||||||
| Balance Sheets | ||||||||
| December 31, | ||||||||
| 2016 | 2015 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,507,659 | $ | 3,293,983 | ||||
| Short-term investments available-for-sale, at fair value | 4,304,901 | 28,201,507 | ||||||
| Accounts receivable | 1,377,441 | 716,246 | ||||||
| Inventory, net | 1,511,053 | 2,201,301 | ||||||
| Prepaid expenses and other | 433,328 | 445,217 | ||||||
| Total current assets | 15,134,382 | 34,858,254 | ||||||
| Long-term investments available-for-sale, at fair value | — | 2,603,901 | ||||||
| Deferred offering costs | 49,630 | — | ||||||
| Property and equipment, net | 3,270,197 | 1,932,213 | ||||||
| Total assets | $ | 18,454,209 | $ | 39,394,368 | ||||
| Liabilities and stockholders' equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 761,663 | $ | 724,805 | ||||
| Accrued liabilities | 1,670,286 | 1,915,268 | ||||||
| Deferred revenue | 335,659 | 47,476 | ||||||
| NuvoGen obligation | 604,751 | 543,750 | ||||||
| Term loan | 6,389,782 | 3,059,068 | ||||||
| Other current liabilities | 258,850 | 29,243 | ||||||
| Total current liabilities | 10,020,991 | 6,319,610 | ||||||
| Term loan payable - non-current, net of discount and debt issuance costs | 5,389,137 | 7,737,586 | ||||||
| NuvoGen obligation - non-current, net of discount | 8,017,356 | 8,415,122 | ||||||
| Other | 619,587 | 28,652 | ||||||
| Total liabilities | 24,047,071 | 22,500,970 | ||||||
| Commitments and Contingencies | ||||||||
| Total stockholders’ equity (deficit) | (5,592,862 | ) | 16,893,398 | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 18,454,209 | $ | 39,394,368 | ||||