Full Press Release Details
Accelerate Diagnostics reports Q2 2018
Revenue up 142 Percent, Global install
TUCSON, Ariz., August 6, 2018 - Accelerate Diagnostics, Inc.
today announced financial results for the quarter ending June 30, 2018. The company posted revenue of $1.7 million, up 142% from
the prior year quarter, and reported a record number of new agreements signed in the quarter bringing the global total to 430 instruments.
Contracts for customer evaluations total 312 instruments while commercial placements grew to 118 across the U.S., European, and
Middle East regions.
"We're excited to report a record number of new
customer agreements this quarter," said Lawrence Mehren, President and CEO. "While not yet fully translated into revenue,
this sales momentum, strong customer advocacy, and upcoming clinical outcome data are quite encouraging."
In addition, the company reported securing new agreements with
prominent group purchasing organizations during the quarter. The agreements, covering approximately 1,400 hospitals, add additional
value to member hospitals and aim to streamline the adoption process.
The company also announced progress on the 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, and clinical trial for the test. The expected start of the U.S. clinical trial is on or before our 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 August 6, 2018.
Second quarter 2018 results
Full financial results for the quarter ending June 30, 2018
will be filed on Form 10-Q through the Securities and Exchange Commission's (SEC) website at http://www.sec.gov. The company
anticipates filing on August 7, 2018. Investors are cautioned not to place undue reliance on these preliminary and unaudited estimates in the
event of material changes.
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: 6994802
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 10120739 until August 27, 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 sepsis, antibiotic resistance
and healthcare-associated infections. Every 3-4 seconds someone dies from sepsis. In the United States, sepsis remains a leading
cause of death, taking more lives than HIV, breast cancer, and prostate cancer combined. Bacteria are the most common cause of
the serious infections that lead to sepsis, and continue to develop resistance to antibiotics. These antibiotic resistant bacteria
further complicate the treatment approach for physicians who already wait days for lab results to determine which antibiotics are
likely to be effective against the infection.
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 these infections. The FDA cleared system and kit fully automate the sample preparation
steps to report phenotypic antibiotic susceptibility results within 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 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
| June 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Unaudited | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 66,810 | $ | 28,513 | ||||
| Investments | 130,594 | 80,648 | ||||||
| Trade accounts receivable | 1,823 | 1,946 | ||||||
| Inventory | 11,317 | 8,063 | ||||||
| Prepaid expenses | 1,421 | 850 | ||||||
| Other current assets | 643 | 468 | ||||||
| Total current assets | 212,608 | 120,488 | ||||||
| Property and equipment, net | 5,443 | 4,890 | ||||||
| Intellectual property, net | 124 | 134 | ||||||
| Other non-current assets | 78 | - | ||||||
| Total assets | $ | 218,253 | $ | 125,512 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,355 | $ | 2,080 | ||||
| Accrued liabilities | 5,302 | 3,636 | ||||||
| Deferred revenue and income | 185 | 1,071 | ||||||
| Total current liabilities | 7,842 | 6,787 | ||||||
| Other long term liabilities | 26 | 21 | ||||||
| Convertible notes | 115,499 | - | ||||||
| Total liabilities | $ | 123,367 | $ | 6,808 | ||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred shares, $0.001 par value; 5,000,000 preferred shares authorized and none outstanding as of June 30, 2018 and December 31, 2017 | - | - | ||||||
| Common stock, $0.001 par value; 75,000,000 common shares authorized with 54,090,575 shares issued and outstanding on June 30, 2018 and 75,000,000 authorized with 55,673,810 shares issued and outstanding on December 31, 2017 | 54 | 56 | ||||||
| Contributed capital | 426,091 | 360,620 | ||||||
| Treasury Stock | (45,067 | ) | - | |||||
| Accumulated deficit | (286,058 | ) | (241,972 | ) | ||||
| Accumulated other comprehensive loss | (134 | ) | - | |||||
| Total stockholders' equity | 94,886 | 118,704 | ||||||
| Total liabilities and stockholders' equity | $ | 218,253 | $ | 125,512 |
ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE
(in thousands, except per share data)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | June 30, | June 30, | |||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Net sales | $ | 1,692 | $ | 699 | $ | 2,493 | $ | 1,230 | ||||||||
| Cost of sales | 717 | 135 | 1,210 | 161 | ||||||||||||
| Gross profit | 975 | 564 | 1,283 | 1,069 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Research and development | 6,060 | 5,527 | 12,842 | 9,815 | ||||||||||||
| Sales, general and administrative | 15,330 | 11,460 | 29,682 | 21,988 | ||||||||||||
| Total costs and expenses | 21,390 | 16,987 | 42,524 | 31,803 | ||||||||||||
| Loss from operations | (20,415 | ) | (16,423 | ) | (41,241 | ) | (30,734 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest expense | (3,205 | ) | - | (3,363 | ) | - | ||||||||||
| Foreign currency exchange (loss) | (253 | ) | (7 | ) | (198 | ) | (33 | ) | ||||||||
| Interest income | 774 | 153 | 1,075 | 290 | ||||||||||||
| Other expense, net | (25 | ) | (5 | ) | (25 | ) | (5 | ) | ||||||||
| Total other income (expense), net | (2,709 | ) | 141 | (2,511 | ) | 252 | ||||||||||
| Net loss before income taxes | (23,124 | ) | (16,282 | ) | (43,752 | ) | (30,482 | ) | ||||||||
| Provision for income taxes | (101 | ) | (175 | ) | (285 | ) | (175 | ) | ||||||||
| Net loss | $ | (23,225 | ) | $ | (16,457 | ) | $ | (44,037 | ) | $ | (30,657 | ) | ||||
| Basic and diluted net loss per share | $ | (0.43 | ) | $ | (0.31 | ) | $ | (0.80 | ) | $ | (0.58 | ) | ||||
| Weighted average shares outstanding | 54,003 | 53,568 | 54,821 | 52,732 | ||||||||||||
| Other comprehensive loss: | ||||||||||||||||
| Net loss | $ | (23,225 | ) | $ | (16,457 | ) | $ | (44,037 | ) | $ | (30,657 | ) | ||||
| Net unrealized (loss) gain on available-for-sale investments | (2 | ) | 3 | (55 | ) | 3 | ||||||||||
| Foreign currency translation adjustment | (191 | ) | 204 | (79 | ) | 204 | ||||||||||
| Comprehensive loss | $ | (23,418 | ) | $ | (16,250 | ) | $ | (44,171 | ) | $ | (30,450 | ) |
ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
| Six Months Ended | ||||||||
| June 30, | June 30, | |||||||
| 2018 | 2017 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (44,037 | ) | $ | (30,657 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 1,072 | 1,045 | ||||||
| Amortization of intangible assets | 10 | 6 | ||||||
| Amortization of investment discount | (146 | ) | 219 | |||||
| Equity-based compensation | 9,011 | 7,450 | ||||||
| Amortization of debt discount and issuance costs | 2,273 | - | ||||||
| Loss on disposal of property and equipment | 266 | 5 | ||||||
| (Increase) decrease in assets: | ||||||||
| Accounts receivable | 123 | (648 | ) | |||||
| Inventory | (3,138 | ) | (5,537 | ) | ||||
| Prepaid expense and other | (444 | ) | (624 | ) | ||||
| Other current assets | (175 | ) | (313 | ) | ||||
| Other non-current assets | (78 | ) | - | |||||
| Increase (decrease) in liabilities: | ||||||||
| Accounts payable | 206 | 528 | ||||||
| Accrued liabilities | 661 | 392 | ||||||
| Accrued Interest | 1,105 | - | ||||||
| Deferred revenue and income | (935 | ) | 43 | |||||
| Deferred compensation | 5 | - | ||||||
| Net cash used in operating activities | (34,221 | ) | (28,091 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchases of equipment | (1,898 | ) | (1,643 | ) | ||||
| Purchases of available-for-sale securities | (91,272 | ) | (39,342 | ) | ||||
| Sales of available-for-sale securities | 3,000 | 6,522 | ||||||
| Maturity of available-for-sale securities | 38,272 | 18,449 | ||||||
| Net cash used in investing activities | (51,898 | ) | (16,014 | ) | ||||
| Cash flows from financing activities: | ||||||||
| Issuance of common stock net of issuance costs | 276 | 83,854 | ||||||
| Exercise of options and warrants | 2,757 | 3,418 | ||||||
| Proceeds from issuance of convertible note | 171,499 | - | ||||||
| Prepayment of forward stock repurchase transaction | (45,069 | ) | - | |||||
| Payment of debt issuance costs | (4,991 | ) | - | |||||
| Net cash provided by financing activities | 124,472 | 87,272 | ||||||
| Effect of exchange rate on cash: | (56 | ) | 198 | |||||
| Increase in cash and cash equivalents | 38,297 | 43,365 | ||||||
| Cash and cash equivalents, beginning of period | 28,513 | 19,244 | ||||||
| Cash and cash equivalents, end of period | $ | 66,810 | $ | 62,609 |