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Net sales for the third quarter 2017 was
"Eight months into our launch, we are meeting or exceeding the majority of our expected commercial metrics and funnel assumptions," said
The company also reported achieving several milestones across a number of development initiatives during the quarter, highlighting the completion of the assay development phase for its upcoming kit targeting severe pneumonia. Development is also complete for two new key antibiotics for European customers that will be added to the Accelerate PhenoTest™ BC kit and submitted for CE Mark near year end. In addition, the company announced plans to develop new kits aimed at sample types for complicated urinary tract infections and intra-abdominal infections.
"Complicated urinary tract infections are a great target for us," said Dr.
Intra-abdominal infections also represent a high-acuity target for the fast, phenotypic, and fully automated antimicrobial susceptibility results offered by the company's system, Humphries said, noting that these infections often keep patients in the hospital for a week or longer when associated with highly drug-resistant organisms which can cause typical empiric therapy to fail.
President and Chief Executive Officer,
Preliminary third quarter 2017 results
- Net sales of
$828,000 compared to$24,000 in the third quarter of 2016 - Gross margin realized was 77% including inventory previously recorded as research and development (R&D) expense
- Selling, general, and administrative expenses of
$11.6 million , compared to$9.6 million in the prior year period, driven by higher personnel and customer evaluation-related costs across theU.S. andEurope - R&D expenses for the third quarter of
$6.4 million , compared to$7.9 million in the same quarter of 2016 due to clinical trial and pre-launch inventory costs incurred in the prior year period which did not repeat - Net loss of
$17 million , or$0.31 per share on weighted average basic shares of 55.3 million shares outstanding, which includes$3.5 million in non-cash stock-based compensation expense - Net cash used in the quarter was
$13.9 million , ending the quarter with total cash, and cash-equivalents from all activities of$121.3 million
Full financial results for the quarter ending
Audio Webcast and Conference Call
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About
The "ACCELERATE DIAGNOSTICS" and "ACCELERATE PHENO" and "ACCELERATE PHENOTEST" logos and marks are trademarks or registered trademarks of
For more information about the company, its products or technology, visit axdx.com.
Forward-Looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, about our projections as to when certain key business milestones may be achieved, such as the ongoing commercial launch, demand, and potential of our products or technology, the growth of the market, our estimates as to the size of our market opportunity and potential pricing, our competitive position and estimates of time reduction to results, and our future development plans and growth strategy. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Information about the risks and uncertainties faced by Accelerate Diagnostics is contained in the section captioned "Risk Factors" in the company's most recent Annual Report on Form 10-K, filed with the Securities and Exchange Commission on February 28, 2017, and in any other reports that we file with the Securities and Exchange Commission from time to time. The company's forward-looking statements could be affected by general industry and market conditions. Except as required by federal securities laws, the company undertakes no obligation to update or revise these forward-looking statements to reflect new events, uncertainties or other contingencies.
| ACCELERATE DIAGNOSTICS, INC. | ||||||||
| CONDENSED CONSOLIDATED | ||||||||
| BALANCE SHEET | ||||||||
| Unaudited | ||||||||
| (in thousands) | ||||||||
| 2017 | 2016 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 34,431 | $ | 19,244 | ||||
| Investments | 86,889 | 58,519 | ||||||
| Trade accounts receivable | 1,111 | 34 | ||||||
| Inventory | 7,341 | — | ||||||
| Prepaid expenses | 1,048 | 468 | ||||||
| Other current assets | 460 | 183 | ||||||
| Total current assets | 131,280 | 78,448 | ||||||
| Property and equipment, net | 4,690 | 4,258 | ||||||
| Intellectual property, net | 137 | 146 | ||||||
| Total assets | $ | 136,107 | $ | 82,852 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,369 | $ | 992 | ||||
| Accrued liabilities | 3,733 | 3,009 | ||||||
| Deferred revenue and income | 1,081 | 35 | ||||||
| Total current liabilities | 6,183 | 4,036 | ||||||
| Long-term deferred income | — | 1,000 | ||||||
| Total liabilities | $ | 6,183 | $ | 5,036 | ||||
| Stockholders' equity: | ||||||||
| Common stock, |
||||||||
| 75,000,000 common shares authorized with 55,397,563 shares issued and outstanding on outstanding on |
55 | 52 | ||||||
| Preferred shares, |
||||||||
| 5,000,000 preferred shares authorized and none outstanding as of and |
— | — | ||||||
| Contributed capital | 355,458 | 255,257 | ||||||
| Accumulated deficit | (225,676 | ) | (177,289 | ) | ||||
| Accumulated other comprehensive (loss) | 87 | (204 | ) | |||||
| Total stockholders' equity | 129,924 | 77,816 | ||||||
| Total liabilities and stockholders' equity | $ | 136,107 | $ | 82,852 | ||||
| ACCELERATE DIAGNOSTICS, INC. | |||||||||||||||||
| CONDENSED CONSOLIDATED | |||||||||||||||||
| STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||||||||
| Unaudited | |||||||||||||||||
| (in thousands, except per share data) | |||||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||||
| Net sales | $ | 828 | $ | 24 | $ | 2,058 | $ | 207 | |||||||||
| Cost of sales | 191 | — | 352 | — | |||||||||||||
| Gross Profit | 637 | 24 | 1,706 | 207 | |||||||||||||
| Costs and expenses: | |||||||||||||||||
| Research and development | 6,351 | 7,874 | 16,166 | 23,974 | |||||||||||||
| Sales, general and administrative | 11,601 | 9,566 | 33,589 | 26,710 | |||||||||||||
| Total costs and expenses | 17,952 | 17,440 | 49,755 | 50,684 | |||||||||||||
| Loss from operations | (17,315 | ) | (17,416 | ) | (48,049 | ) | (50,477 | ) | |||||||||
| Interest expense and other | 2 | — | (3 | ) | — | ||||||||||||
| Foreign currency exchange loss | (40 | ) | (42 | ) | (73 | ) | (115 | ) | |||||||||
| Interest and dividend income | 323 | 159 | 612 | 353 | |||||||||||||
| Total other income | 285 | 117 | 536 | 238 | |||||||||||||
| Net loss before income taxes | (17,030 | ) | (17,299 | ) | (47,513 | ) | (50,239 | ) | |||||||||
| Provision from income taxes | (45 | ) | — | (220 | ) | — | |||||||||||
| Net loss | $ | (17,075 | ) | $ | (17,299 | ) | $ | (47,733 | ) | $ | (50,239 | ) | |||||
| Basic and diluted net loss per share | $ | (0.31 | ) | $ | (0.34 | ) | $ | (0.89 | ) | $ | (0.98 | ) | |||||
| Weighted average shares outstanding | 55,316 | 51,239 | 53,603 | 51,216 | |||||||||||||
| Other comprehensive loss: | |||||||||||||||||
| Net loss | $ | (17,075 | ) | $ | (17,299 | ) | $ | (47,733 | ) | $ | (52,239 | ) | |||||
| Net unrealized gain on available-for-sale investments | (7 | ) | (70 | ) | (4 | ) | 11 | ||||||||||
| Foreign currency translation adjustment | 91 | (8 | ) | 295 | (8 | ) | |||||||||||
| Comprehensive loss | $ | (16,991 | ) | $ | (17,377 | ) | $ | (47,442 | ) | $ | (50,236 | ) | |||||
| ACCELERATE DIAGNOSTICS, INC. | ||||||||
| CONDENSED CONSOLIDATED | ||||||||
| STATEMENT OF CASH FLOWS | ||||||||
| Unaudited | ||||||||
| (in thousands) | ||||||||
| Nine Months Ended | ||||||||
| 2017 | 2016 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (47,733 | ) | $ | (50,239 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 1,595 | 1,745 | ||||||
| Amortization of intangible assets | 9 | 8 | ||||||
| Amortization of investment discount | 298 | 251 | ||||||
| Equity-based compensation | 10,970 | 6,591 | ||||||
| Realized (gain) on sale of investments | — | (6 | ) | |||||
| Loss on disposal of property & equipment | 3 | — | ||||||
| (Increase) decrease in assets: | ||||||||
| Accounts receivable | (1,077 | ) | (82 | ) | ||||
| Inventory | (7,079 | ) | — | |||||
| Prepaid expense and other | (392 | ) | 525 | |||||
| Other current assets | (277 | ) | (90 | ) | ||||
| Increase (decrease) in liabilities: | ||||||||
| Accounts payable | 359 | 103 | ||||||
| Accrued liabilities | 780 | 670 | ||||||
| Deferred revenue and income | 46 | (83 | ) | |||||
| Net cash used in operating activities | (42,498 | ) | (40,607 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchases of equipment | (2,055 | ) | (2,301 | ) | ||||
| Purchases of available-for-sale securities | (68,423 | ) | (73,585 | ) | ||||
| Sales of available-for-sale securities | 9,522 | 8,716 | ||||||
| Maturity of available-for-sale securities | 30,049 | 14,955 | ||||||
| Net cash used in investing activities | (30,907 | ) | (52,215 | ) | ||||
| Cash flows from financing activities: | ||||||||
| Issuance of common stock net issuance costs | 83,741 | 80 | ||||||
| Exercise of options and warrants | 4,562 | 864 | ||||||
| Common stock issuance costs | — | (814 | ) | |||||
| Payments on capital lease obligations | — | (13 | ) | |||||
| Recovery of related party short-swing profits | — | 866 | ||||||
| Net cash provided by financing activities | 88,303 | 983 | ||||||
| Effect of exchange rate on cash: | 289 | (15 | ) | |||||
| Increase (decrease) in cash and cash equivalents | 15,187 | (91,854 | ) | |||||
| Cash and cash equivalents, beginning of period | 19,244 | 120,585 | ||||||
| Cash and cash equivalents, end of period | $ | 34,431 | $ | 28,731 | |
|||
Investors May Contact:Laura Pierson ,Accelerate Diagnostics , +1 520 365-3100, investors@axdx.com Reporters May Contact:Andrew Chasteen ,Accelerate Diagnostics , +1 520 365-3100, achasteen@axdx.com
Source: Accelerate Diagnostics, Inc.
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