Attached files
| file | filename |
|---|---|
| EX-99.2 - EXHIBIT 99.2 - Accelerate Diagnostics, Inc | tv494106_ex99-2.htm |
| 8-K - FORM 8-K - Accelerate Diagnostics, Inc | tv494106_8k.htm |
Exhibit 99.1
Accelerate Diagnostics reports Q1 2018 financial results
TUCSON, Ariz., May 9, 2018 (GLOBE NEWSWIRE) -- Accelerate Diagnostics, Inc. today announced financial results for the quarter ending March 31, 2018. The company generated revenue of $801,000, up 51% from the prior year, and reported signed agreements for 345 instruments. Contracts for customer evaluations total 256 instruments while revenue generating placements grew to 89 across the U.S. and European regions.
“The team made considerable commercial and development progress to start the year, increasing awareness and adoption of the Accelerate Pheno™ system, and expanding its capability beyond bloodstream infections and sepsis to include patients with severe bacterial pneumonia,” said Lawrence Mehren, President and CEO. “By giving physicians the ability to optimize antibiotic therapy at least two days earlier, we continue to move closer to achieving our mission to dramatically improve outcomes for patients with these life-threatening infections.”
The company highlighted 12 recent customer studies shared at ECCMID, the European Congress of Clinical Microbiology and Infectious Diseases. These studies, all related to the Accelerate Pheno™ system, were shared at the congress by hospitals in Italy, Germany, Sweden, and the United States.
The company also reported progress on development of its severe bacterial pneumonia kit including alignment with the U.S. Food and Drug Administration (FDA) on a shorter and less complex, 510(k) regulatory pathway, for the test, along with the addition of two new pathogens and three additional antibiotics. The expected start of the U.S. clinical trial remains in late Q2 to Q3.
Mr. Mehren, together with Steve Reichling, the company’s Chief Financial Officer, will host a conference call to review the financial results, commercial progress, and development updates at 4:15 p.m. Eastern Time on May 9, 2018.
First quarter 2018 results
| · | Net sales of $801,000 compared to $530,000 in the first quarter of 2017 |
| · | Gross margin realized was 39%, impacted by one-time charges reported for the quarter |
| · | Selling, general, and administrative expenses of $14.4 million, compared to $10.5 million in the prior year period, driven by higher personnel and customer evaluation-related costs across the U.S. and Europe |
| · | R&D expenses for the first quarter of $6.8 million, compared to $4.3 million in the same quarter of 2017 due to investments made in preparation for activities related to the U.S. clinical trial for respiratory |
| · | Net loss of $20.8 million, or $0.37 per share on weighted average basic shares of 55.6 million shares outstanding, which includes $5.6 million in non-cash stock-based compensation expense |
| · | Net cash used in the quarter was $16.2 million, ending the quarter with total cash, investments, and cash-equivalents from all activities of $193.6 million |
Full financial results for the quarter ending March 31, 2018 will be filed on Form 10-Q through the Securities and Exchange Commission’s (SEC) website at http://www.sec.gov.
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 August 9, 2018.
To participate in the conference call, dial +1.877.883.0383 and enter the conference ID: 8101976.
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 (U.S.) or +1.412.317.0088 (international) using access code 10119275 until May 30, 2018.
About Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc. (Nasdaq:AXDX), is an in vitro diagnostics company dedicated to providing solutions for the global challenge of antibiotic resistance and healthcare-associated infections. The company recently obtained FDA marketing authorization for antimicrobial susceptibility testing direct from positive blood culture samples using its Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit. The system and kit leverage proprietary molecular identification methods and morphokinetic cellular analysis (MCA) to provide minimum inhibitory concentrations for a range of applicable antibiotics. The fully-automated system is designed to eliminate the lengthy culture and sample preparation steps required prior to antimicrobial susceptibility testing. Recent market studies suggest the solution offers results 1-2 days faster than conventional methods, enabling clinicians to optimize antibiotic selection, dosage, and infusion strategy specific to the individual patient and their infection.
The “ACCELERATE DIAGNOSTICS” and “ACCELERATE PHENO” and “ACCELERATE PHENOTEST” and diamond shaped logos and marks are trademarks or registered trademarks of Accelerate Diagnostics, Inc.
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, the 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 March 1, 2018, 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.
###
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.
ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
BALANCE SHEET
(in thousands)
| March 31, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Unaudited | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 126,847 | $ | 28,513 | ||||
| Investments | 66,754 | 80,648 | ||||||
| Trade accounts receivable | 1,065 | 1,946 | ||||||
| Inventory | 10,127 | 8,063 | ||||||
| Prepaid expenses | 1,538 | 850 | ||||||
| Other current assets | 804 | 468 | ||||||
| Total current assets | 207,135 | 120,488 | ||||||
| Property and equipment, net | 5,851 | 4,890 | ||||||
| Intellectual property, net | 129 | 134 | ||||||
| Total assets | $ | 213,115 | $ | 125,512 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,758 | $ | 2,080 | ||||
| Accrued liabilities | 4,578 | 3,636 | ||||||
| Deferred revenue and income | 117 | 1,071 | ||||||
| Total current liabilities | 7,453 | 6,787 | ||||||
| Other long term liabilities | 25 | 21 | ||||||
| Convertible notes | 99,162 | — | ||||||
| Total liabilities | $ | 106,640 | $ | 6,808 | ||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred shares, $0.001 par value; | ||||||||
| 5,000,000 preferred shares authorized and none outstanding as of March 31, 2018 and December 31, 2017 | — | — | ||||||
| Common stock, $0.001 par value; | ||||||||
| 75,000,000 common shares authorized with 53,950,083 shares issued and outstanding on March 31, 2018 and 75,000,000 authorized with 55,673,810 shares issued and outstanding on December 31, 2017 | 54 | 56 | ||||||
| Contributed capital | 414,262 | 360,620 | ||||||
| Treasury Stock | (45,067 | ) | — | |||||
| Accumulated deficit | (262,833 | ) | (241,972 | ) | ||||
| Accumulated other comprehensive loss | 59 | — | ||||||
| Total stockholders’ equity | 106,475 | 118,704 | ||||||
| Total liabilities and stockholders’ equity | $ | 213,115 | $ | 125,512 | ||||
See accompanying notes to consolidated financial statements.
ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Unaudited
(in thousands, except per share data)
| Three Months Ended | ||||||||
| March 31, | March 31, | |||||||
| 2018 | 2017 | |||||||
| Net sales | $ | 801 | $ | 530 | ||||
| Cost of sales | 492 | 26 | ||||||
| Gross profit | 309 | 504 | ||||||
| Costs and expenses: | ||||||||
| Research and development | 6,782 | 4,288 | ||||||
| Sales, general and administrative | 14,353 | 10,526 | ||||||
| Total costs and expenses | 21,135 | 14,814 | ||||||
| Loss from operations | (20,826 | (14,310 | ) | |||||
| Other income (expense): | ||||||||
| Interest expense | (158 | ) | — | |||||
| Foreign currency exchange gain (loss) | 55 | (26 | ) | |||||
| Interest income | 301 | 136 | ||||||
| Total other income, net | 198 | 110 | ||||||
| Net loss before income taxes | (20,628 | ) | (14,200 | ) | ||||
| Provision for income taxes | (184 | ) | — | |||||
| Net loss | $ | (20,812 | ) | $ | (14,200 | ) | ||
| Basic and diluted net loss per share | $ | (0.37 | ) | $ | (0.27 | ) | ||
| Weighted average shares outstanding | 55,640 | 51,887 | ||||||
| Other comprehensive loss: | ||||||||
| Net loss | $ | (20,812 | ) | $ | (14,200 | ) | ||
| Net unrealized (loss) gain on available-for-sale investments | (53 | ) | 11 | |||||
| Foreign currency translation adjustment | 112 | 56 | ||||||
| Comprehensive loss | $ | (20,753 | ) | $ | (14,133 | ) | ||
See accompanying notes to consolidated financial statements.
ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENT OF CASH FLOWS
Unaudited
(in thousands)
| Three Months Ended | ||||||||
| March 31, | March 31, | |||||||
| 2018 | 2017 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (20,812 | ) | $ | (14,200 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 539 | 505 | ||||||
| Amortization of intangible assets | 5 | 3 | ||||||
| Amortization of investment discount | 19 | 121 | ||||||
| Equity-based compensation | 5,602 | 3,215 | ||||||
| Non-cash interest expense | 158 | — | ||||||
| Loss on disposal of property and equipment | 11 | — | ||||||
| (Increase) decrease in assets: | ||||||||
| Accounts receivable | 881 | (522 | ) | |||||
| Inventory | (1,917 | ) | (4,155 | ) | ||||
| Prepaid expense and other | (653 | ) | (457 | ) | ||||
| Other current assets | (336 | ) | (280 | ) | ||||
| Increase (decrease) in liabilities: | ||||||||
| Accounts payable | 701 | 276 | ||||||
| Accrued liabilities | 733 | (4 | ) | |||||
| Deferred revenue and income | (1,003 | ) | 29 | |||||
| Deferred compensation | 4 | — | ||||||
| Net cash used in operating activities | (16,068 | ) | (15,469 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchases of equipment | (1,294 | ) | (229 | ) | ||||
| Purchases of available-for-sale securities | (9,356 | ) | (4,562 | ) | ||||
| Sales of available-for-sale securities | 3,000 | — | ||||||
| Maturity of available-for-sale securities | 20,125 | 8,845 | ||||||
| Net cash provided in investing activities | 12,475 | 4,054 | ||||||
| Cash flows from financing activities: | ||||||||
| Issuance of common stock net of issuance costs | 134 | 189 | ||||||
| Exercise of options and warrants | 1,112 | 1,844 | ||||||
| Proceeds from issuance of convertible note | 150,000 | — | ||||||
| Prepayment of forward stock repurchase transaction | (45,069 | ) | — | |||||
| Payment of debt issuance costs | (4,330 | ) | — | |||||
| Net cash provided by financing activities | 101,847 | 2,033 | ||||||
| Effect of exchange rate on cash: | 80 | 55 | ||||||
| Increase (decrease) in cash and cash equivalents | 98,334 | (9,327 | ) | |||||
| Cash and cash equivalents, beginning of period | 28,513 | 19,244 | ||||||
| Cash and cash equivalents, end of period | $ | 126,847 | $ | 9,917 | ||||