Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - Accelerate Diagnostics, Inc | tv506478_8k.htm |
EXHIBIT 99.1
Accelerate Diagnostics reports Q3 2018 financial results
Revenue Placements up 40 Percent in U.S., Total Revenue up 64 Percent
TUCSON, Ariz., November 6, 2018 -- Accelerate Diagnostics, Inc. today announced financial results for the quarter ending September 30, 2018. The company reported a 40% increase in U.S. instruments placed under commercial contract, and revenue for the quarter of $1.3 million, an increase of 64% from the prior year quarter. Worldwide, revenue-generating instruments combined with those under evaluation agreements grew to 458 instruments.
“We’re happy to report solid commercial growth this quarter, having enabled more hospitals than ever before to tailor antibiotic use specifically for individual patients much earlier,” said Lawrence Mehren, president and chief executive officer. “Despite a challenge for capital sales, we continue to drive clinical adoption through new acquisition options and a streamlined process. We believe the emerging clinical and economic outcome data, combined with strong customer advocacy, are compelling indicators of what is to come.”
During the third quarter, clinicians from the University of Arkansas for Medical Sciences presented independent clinical outcome data showing a 3-day reduction in hospital length of stay for patients with bacteremia after implementing the Accelerate Pheno™ system.1
The company also announced it recently engaged with the U.S. Food and Drug Administration (FDA) and proposed a plan to address variability in the quantitative reference method used to compare the performance of its new test for severe bacterial pneumonia. New pre-clinical data obtained by the company in preparation of the clinical trial showed high variability in quantitative culture methods commonly used in clinical laboratories.
“We have found that the way laboratories perform cultures on lower respiratory tract specimens varies significantly across institutions, informed by local epidemiology, patient mix and treatment models,” said Dr. Romney Humphries, chief scientific officer of Accelerate Diagnostics. “This variability, however, means the results are not translatable from one site to another, and there is no true gold standard result.” Based on the need for further collaboration with the Agency, additional development, and related trial preparation, the company now expects to start the clinical trial in Q1 of 2019.
Mr. Mehren, together with Steve Reichling, 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 November 6, 2018.
Third quarter 2018 results
| · | Revenue-generating placements in the U.S. increased by 40%. |
| · | Net sales of $1.3 million for the third quarter and $3.8 million year to date, compared to $828 thousand and $2.0 million for the same respective periods in the prior year. |
| · | Gross margin realized was 49.8% for the quarter and 50.9% year to date. |
| · | Selling, general, and administrative expenses for the quarter were $12.2 million and $41.8 million year to date as compared to $11.6 million and $33.6 million from the respective same periods in the prior year. These year-over-year increases were driven by higher personnel and customer evaluation–related costs for evaluations in the U.S. and EMEA regions. |
| · | Research and development costs for the quarter were $7.9 million and $20.7 million year to date as compared to $6.4 million and $16.2 million from the respective same periods in the prior year. These year-over-year increases are the result of additional investments in the preparation for respiratory clinical trials and expanded scientific affairs activity. |
| · | Net loss of $22.1 million in the third quarter and $66.1 million year to date, or $0.41 and $1.21 per share on weighted average basic shares outstanding of 54.1 million and 54.6 million shares, respectively. This net loss includes $3.5 million in non-cash stock-based compensation expense in the third quarter and $12.5 million year to date. |
| · | Net cash used in the quarter was $16.8 million and $50 million year to date, ending the quarter with total cash, investments, and cash equivalents from all activities of $181 million. |
Full financial results for the quarter ending September 30, 2018 will be filed on Form 10-Q through the Securities and Exchange Commission’s (SEC) website at http://www.sec.gov.
| 1 | Dare R, McCain K, Lusardi K et al. Impact of Accelerate Pheno™ Rapid Blood Culture Detection System on Laboratory and Clinical Outcomes in Bacteremic Patients. Presented as an oral presentation at ID Week™ 2018. |
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 November 26, 2018.
To participate in the conference call, dial +1.877.883.0383 and enter the conference ID: 0396861
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 10124532 until November 26, 2018.
About Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc. (Nasdaq:AXDX), is an in vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis. The Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit combine several technologies aimed at reducing the time clinicians must wait to determine the most optimal antibiotic therapy for deadly infections. The FDA cleared system and kit fully automate the sample preparation steps to report phenotypic antibiotic susceptibility results in about 7 hours direct from positive blood cultures. Recent external studies indicate the solution offers results 1-2 days faster than existing methods, enabling clinicians to optimize antibiotic selection and dosage specific to the individual patient days earlier.
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 and technology, or recent publications, 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, except share data)
| September 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Unaudited | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 61,622 | $ | 28,513 | ||||
| Investments | 118,982 | 80,648 | ||||||
| Trade accounts receivable | 1,440 | 1,946 | ||||||
| Inventory | 9,406 | 8,063 | ||||||
| Prepaid expenses | 940 | 850 | ||||||
| Other current assets | 494 | 468 | ||||||
| Total current assets | 192,884 | 120,488 | ||||||
| Property and equipment, net | 7,412 | 4,890 | ||||||
| Intellectual property, net | 119 | 134 | ||||||
| Other non-current assets | 241 | — | ||||||
| Total assets | $ | 200,656 | $ | 125,512 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,559 | $ | 2,080 | ||||
| Accrued liabilities | 3,518 | 3,636 | ||||||
| Accrued interest | 191 | — | ||||||
| Deferred revenue and income | 202 | 1,071 | ||||||
| Total current liabilities | 5,470 | 6,787 | ||||||
| Other long term liabilities | 26 | 21 | ||||||
| Convertible notes | 117,754 | — | ||||||
| Total liabilities | $ | 123,250 | $ | 6,808 | ||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred shares, $0.001 par value; | ||||||||
| 5,000,000 preferred shares authorized and none outstanding as of September 30, 2018 and December 31, 2017 | — | — | ||||||
| Common stock, $0.001 par value; | ||||||||
| 75,000,000 common shares authorized with 54,196,876 shares issued and outstanding on September 30, 2018 and 75,000,000 common shares authorized with 55,673,810 shares issued and outstanding on December 31, 2017 | 54 | 56 | ||||||
| Contributed capital | 430,734 | 360,620 | ||||||
| Treasury Stock | (45,067 | ) | — | |||||
| Accumulated deficit | (308,156 | ) | (241,972 | ) | ||||
| Accumulated other comprehensive loss | (159 | ) | — | |||||
| Total stockholders’ equity | 77,406 | 118,704 | ||||||
| Total liabilities and stockholders’ equity | $ | 200,656 | $ | 125,512 | ||||
See accompanying notes to condensed consolidated financial statements.
ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Unaudited
(in thousands, except per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | September 30, | September 30, | |||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Net sales | $ | 1,355 | $ | 828 | $ | 3,848 | $ | 2,058 | ||||||||
| Cost of sales | 680 | 191 | 1,889 | 352 | ||||||||||||
| Gross profit | 675 | 637 | 1,959 | 1,706 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Research and development | 7,891 | 6,351 | 20,734 | 16,166 | ||||||||||||
| Sales, general and administrative | 12,153 | 11,601 | 41,835 | 33,589 | ||||||||||||
| Total costs and expenses | 20,044 | 17,952 | 62,569 | 49,755 | ||||||||||||
| Loss from operations | (19,369 | ) | (17,315 | ) | (60,610 | ) | (48,049 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest expense | (3,357 | ) | — | (6,720 | ) | — | ||||||||||
| Foreign currency exchange (loss) | (133 | ) | (40 | ) | (331 | ) | (73 | ) | ||||||||
| Interest income | 908 | 323 | 1,983 | 612 | ||||||||||||
| Other income, (expense), net | — | 2 | (25 | ) | (3 | ) | ||||||||||
| Total other income (expense), net | (2,582 | ) | 285 | (5,093 | ) | 536 | ||||||||||
| Net loss before income taxes | (21,951 | ) | (17,030 | ) | (65,703 | ) | (47,513 | ) | ||||||||
| Provision for income taxes | (147 | ) | (45 | ) | (432 | ) | (220 | ) | ||||||||
| Net loss | $ | (22,098 | ) | $ | (17,075 | ) | $ | (66,135 | ) | $ | (47,733 | ) | ||||
| Basic and diluted net loss per share | $ | (0.41 | ) | $ | (0.31 | ) | $ | (1.21 | ) | $ | (0.89 | ) | ||||
| Weighted average shares outstanding | 54,145 | 55,316 | 54,591 | 53,603 | ||||||||||||
| Other comprehensive loss: | ||||||||||||||||
| Net loss | $ | (22,098 | ) | $ | (17,075 | ) | $ | (66,135 | ) | $ | (47,733 | ) | ||||
| Net unrealized (loss) gain on available-for-sale investments | 1 | (7 | ) | (54 | ) | (4 | ) | |||||||||
| Foreign currency translation adjustment | (26 | ) | 91 | (105 | ) | 295 | ||||||||||
| Comprehensive loss | $ | (22,123 | ) | $ | (16,991 | ) | $ | (66,294 | ) | $ | (47,442 | ) | ||||
See accompanying notes to condensed consolidated financial statements.
ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
(in thousands)
| Nine Months Ended | ||||||||
| September 30, | September 30, | |||||||
| 2018 | 2017 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (66,135 | ) | $ | (47,733 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 1,734 | 1,595 | ||||||
| Amortization of intangible assets | 15 | 9 | ||||||
| Amortization of investment discount | (413 | ) | 298 | |||||
| Equity-based compensation | 12,476 | 10,970 | ||||||
| Amortization of debt discount and issuance costs | 4,529 | — | ||||||
| Loss on disposal of property and equipment | 540 | 3 | ||||||
| (Increase) decrease in assets: | ||||||||
| Accounts receivable | 506 | (1,077 | ) | |||||
| Inventory | (5,206 | ) | (7,079 | ) | ||||
| Prepaid expense and other | 55 | (392 | ) | |||||
| Other current assets | (26 | ) | (277 | ) | ||||
| Other non-current assets | (241 | ) | — | |||||
| Increase (decrease) in liabilities: | ||||||||
| Accounts payable | (524 | ) | 359 | |||||
| Accrued liabilities | (18 | ) | 780 | |||||
| Accrued Interest | 191 | — | ||||||
| Deferred revenue and income | (918 | ) | 46 | |||||
| Deferred compensation | 5 | — | ||||||
| Net cash used in operating activities | (53,430 | ) | (42,498 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchases of equipment | (842 | ) | (2,055 | ) | ||||
| Purchases of available-for-sale securities | (115,634 | ) | (68,423 | ) | ||||
| Sales of available-for-sale securities | 3,000 | 9,522 | ||||||
| Maturity of available-for-sale securities | 74,496 | 30,049 | ||||||
| Net cash used in investing activities | (38,980 | ) | (30,907 | ) | ||||
| Cash flows from financing activities: | ||||||||
| Issuance of common stock net of issuance costs | 477 | 83,741 | ||||||
| Exercise of options and warrants | 3,710 | 4,562 | ||||||
| Proceeds from issuance of convertible note | 171,500 | — | ||||||
| Prepayment of forward stock repurchase transaction | (45,069 | ) | — | |||||
| Payment of debt issuance costs | (4,992 | ) | — | |||||
| Net cash provided by financing activities | 125,596 | 88,303 | ||||||
| Effect of exchange rate on cash: | (77 | ) | 289 | |||||
| Increase in cash and cash equivalents | 33,109 | 15,187 | ||||||
| Cash and cash equivalents, beginning of period | 28,513 | 19,244 | ||||||
| Cash and cash equivalents, end of period | $ | 61,622 | $ | 34,431 | ||||
| Non-cash investing activities: | ||||||||
| Transfer of instruments from inventory to property and equipment | $ | 4,061 | $ | — | ||||
| Supplemental cash flow information: | ||||||||
| Interest paid | $ | 2,001 | $ | — | ||||
| Income taxes paid | $ | 435 | $ | — | ||||
See accompanying notes to consolidated financial statements.