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Net sales were
"We were optimistic going into our launch year, and by most measures it was a success," said
With its initial diagnostic for antimicrobial stewardship and sepsis intervention underway, the company recently announced initiatives focused on 2018 revenue and its respiratory test, the Accelerate PhenoTest™ svBP kit, targeting severe pneumonia. Clinical trials for this new kit are expected to begin in Q2 or Q3 of 2018, followed by a submission for review by the
President and Chief Executive Officer,
Fourth Quarter 2017
- Net sales of
$2.1 million , a 54 times increase compared to the fourth quarter of 2016 - Gross margin realized was 69% including inventory previously recorded as research and development (R&D) expense
- Selling, general, and administrative expenses of
$11.5 million , compared to$10.5 million in the prior year period, driven by higher personnel and customer evaluation-related costs across theU.S. andEurope - R&D expenses for the fourth quarter of
$6.1 million , compared to$5.6 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
$15.1 million , or$0.27 per share on weighted average basic shares of 55.4 million shares outstanding, which contained$2.9 million in non-cash stock-based compensation expense - Net cash used in the quarter was
$12.1 million
Full Year 2017
- Net sales of
$4.2 million , a 17 times increase compared to the prior 2016 year - Gross margin realized was 76% including inventory previously recorded as research and development (R&D) expense
- Selling, general, and administrative expenses of
$45.1 million , compared to$37.2 million in the prior year period, driven by higher personnel and customer evaluation-related costs across theU.S. andEurope - R&D expenses for the year of
$22.3 million , compared to$29.5 million in 2016 due to clinical trial and pre-launch inventory costs incurred in the prior year period which did not repeat - Net loss of
$62.9 million , or$1.16 per share on weighted average basic shares of 54 million shares outstanding, which contained$13.9 million in non-cash stock-based compensation expense - Net cash used in the year was
$51.8 million , ending the quarter with total cash, and cash-equivalents from all activities of$109.1 million
2018 Outlook
The following forward-looking statements reflect estimates based on information as of
Full year 2018 revenue is expected to be between
Complete and audited financial results for the year and quarter ending
Audio Webcast and Conference Call
Listen to an audio webcast of the call by visiting the events section of the company's investor relations website at ir.axdx.com. A replay of the audio webcast will be available until
To participate in the conference call, dial +1.877.883.0383 and enter the conference ID: 9292688.
International participants may dial +1.412.902.6506. Please dial in 10-15 minutes prior to the start of the conference. A replay of the call will be available by telephone at +1.877.344.7529 (
About
The "ACCELERATE DIAGNOSTICS" and "ACCELERATE PHENO" and "ACCELERATE PHENOTEST" and diamond shaped logos and marks are trademarks or registered trademarks of
For more information about the company, its products or technology, visit http://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.
CONSOLIDATED
BALANCE SHEET
Preliminary Unaudited
(in thousands, except share data)
| 2017 | 2016 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 28,513 | $ | 19,244 | ||||
| Investments | 80,648 | 58,519 | ||||||
| Trade accounts receivable | 1,946 | 34 | ||||||
| Inventory | 8,063 | — | ||||||
| Prepaid expenses | 850 | 468 | ||||||
| Other current assets | 467 | 183 | ||||||
| Total current assets | 120,487 | 78,448 | ||||||
| Property and equipment, net | 4,890 | 4,258 | ||||||
| Intellectual property, net | 134 | 146 | ||||||
| Other non-current assets | 1,216 | — | ||||||
| Total assets | $ | 126,727 | $ | 82,852 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,080 | $ | 992 | ||||
| Accrued liabilities | 3,636 | 3,009 | ||||||
| Deferred revenue and income | 1,070 | 35 | ||||||
| Total current liabilities | 6,183 | 4,036 | ||||||
| Long-term deferred income | — | 1,000 | ||||||
| Other long-term liabilities | 21 | — | ||||||
| Total liabilities | $ | 6,807 | $ | 5,036 | ||||
| Stockholders' equity: | ||||||||
| Common stock, |
||||||||
| 75,000,000 common shares authorized with 55,673,810 shares issued and outstanding on |
56 | 52 | ||||||
| Preferred shares, |
||||||||
| 5,000,000 preferred shares authorized and none outstanding as of |
— | — | ||||||
| Contributed capital | 360,620 | 255,257 | ||||||
| Accumulated deficit | (240,825 | ) | (177,289 | ) | ||||
| Accumulated other comprehensive (loss) | 69 | (204 | ) | |||||
| Total stockholders' equity | 119,920 | 77,816 | ||||||
| Total liabilities and stockholders' equity | $ | 126,727 | $ | 82,852 | ||||
ACCELERATE DIAGNOSTICS, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Preliminary Unaudited
(in thousands, except per share data)
| Years Ended |
|||||||||
| 2017 | 2016 | 2015 | |||||||
| Net Sales | 4,177 | 246 | 147 | ||||||
| Cost of Sales | 1,002 | — | — | ||||||
| Gross Profit | 3,175 | 246 | 147 | ||||||
| Costs and expenses: | |||||||||
| Research and development | 22,300 | 29,564 | 27,142 | ||||||
| Sales, general and administrative | 45,057 | 37,183 | 18,554 | ||||||
| Total costs and expenses | 67,357 | 66,747 | 45,696 | ||||||
| Loss from operations | (64,182 | ) | (66,501 | ) | (45,549 | ) | |||
| Interest expense | — | — | (4 | ) | |||||
| Foreign currency exchange loss | (75 | ) | (77 | ) | (19 | ) | |||
| Interest and dividend income | 908 | 494 | 74 | ||||||
| Other expense, net | (184 | ) | (23 | ) | — | ||||
| Total other income | 649 | 394 | 51 | ||||||
| Net loss before income taxes | (63,533 | ) | (66,107 | ) | (45,498 | ) | |||
| Income tax benefit (expense) | 651 | (267 | ) | — | |||||
| Net loss | $ | (62,882 | ) | $ | (66,374 | ) | $ | (45,498 | ) |
| Basic and diluted net loss per share | $ | (1.16 | ) | $ | (1.29 | ) | $ | (1.01 | ) |
| Weighted average shares outstanding | 54,073 | 51,276 | 44,998 | ||||||
| Other comprehensive loss: | |||||||||
| Net loss | $ | (62,882 | ) | $ | (66,374 | ) | $ | (45,498 | ) |
| Net unrealized loss on available-for-sale investments | (118 | ) | (64 | ) | (20 | ) | |||
| Foreign currency translation adjustment | 391 | (128 | ) | 1 | |||||
| Comprehensive loss | $ | (62,609 | ) | $ | (66,566 | ) | $ | (45,517 | ) |
Investor and media contact:Andrew Chasteen ,Accelerate Diagnostics , +1 520 365-3100 achasteen@axdx.com Source:Accelerate Diagnostics, Inc.
