Accelerate Diagnostics, Inc.
Nov 2, 2017

Accelerate Diagnostics reports Q3 2017 financial results

TUCSON, Ariz., Nov. 02, 2017 (GLOBE NEWSWIRE) -- Accelerate Diagnostics, Inc. today announced preliminary financial results for the quarter ending September 30, 2017.  The company further reported signed agreements for 295 instruments year to date; contracts for customer evaluations total 239 instruments while revenue generating placements grew to 56 across the U.S., European, and Middle East regions.

Net sales for the third quarter 2017 was $828,000 compared to $24,000 in the third quarter of 2016. The increase was driven by sales of the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit.

"Eight months into our launch, we are meeting or exceeding the majority of our expected commercial metrics and funnel assumptions," said Lawrence Mehren, President and CEO. "While we would prefer the rate of conversions to be faster, we believe the number of qualified prospects and evaluation contracts, conversion win rate, pricing, and other measures confirm the value of the company and its products."

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. Romney Humphries, Chief Science Officer for Accelerate. "Often these organisms are multi-drug resistant, cost an estimated $14 billion in the United States, and may lead to urosepsis, a potentially fatal condition."

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, Lawrence Mehren, and Chief Financial Officer, Steve Reichling, will host a conference call to review the financial results, commercial progress, and development updates at 4:15 p.m. Eastern Time on November 2, 2017.

Preliminary third quarter 2017 results

Full financial results for the quarter ending September 30, 2017 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 November 7th. Investors are cautioned not to place undue reliance on these preliminary 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 November 16, 2017.

To participate in the conference call, dial +1.877.883.0383 and enter the conference ID: 3435682.

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 10112771 until November 16, 2017.

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" 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, 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)
 
 September 30,December 31,
 20172016
ASSETS
Current assets:  
Cash and cash equivalents$34,431  $19,244  
Investments86,889  58,519  
Trade accounts receivable1,111  34  
Inventory7,341    
Prepaid expenses1,048  468  
Other current assets460  183  
Total current assets131,280  78,448  
Property and equipment, net4,690  4,258  
Intellectual property, net137  146  
Total assets$136,107  $82,852  
   
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:  
Accounts payable$1,369  $992  
Accrued liabilities3,733  3,009  
Deferred revenue and income1,081  35  
Total current liabilities6,183  4,036  
Long-term deferred income  1,000  
Total liabilities$6,183  $5,036  
   
   
   
Stockholders' equity:  
Common stock, $0.001 par value;  
75,000,000 common shares authorized with 55,397,563 shares issued and outstanding
on September 30, 2017 and 75,000,000 authorized with 51,516,309 shares issued and
outstanding on December 31, 2016
55  52  
Preferred shares, $0.001 par value;  
5,000,000 preferred shares authorized and none outstanding as of September 30, 2017
and December 31, 2016
    
Contributed capital355,458   255,257  
Accumulated deficit(225,676) (177,289) 
Accumulated other comprehensive (loss)87  (204) 
Total stockholders' equity129,924  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
 September 30,September 30, September 30,September 30,
 20172016 20172016
Net sales$828   $24   $2,058   $207  
      
Cost of sales191     352    
Gross Profit637  24   1,706  207  
      
Costs and expenses:     
Research and development6,351  7,874   16,166  23,974  
Sales, general and administrative11,601  9,566   33,589  26,710  
Total costs and expenses17,952  17,440   49,755   50,684  
      
Loss from operations(17,315) (17,416)  (48,049) (50,477) 
       
Interest expense and other2     (3)   
Foreign currency exchange loss(40) (42)  (73) (115) 
Interest and dividend income323  159   612  353  
Total other income285  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 outstanding55,316  51,239   53,603  51,216  
      
Other comprehensive loss:     
Net loss$(17,075)  $(17,299)  $(47,733)  $(52,239) 
Net unrealized gain on available-for-sale investments(7) (70)  (4) 11  
Foreign currency translation adjustment91  (8)  295  (8) 
Comprehensive loss$(16,991)  $(17,377)  $(47,442)  $(50,236) 


ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENT OF CASH FLOWS
Unaudited
(in thousands)
 
 Nine Months Ended
 September 30,September 30,
 20172016
Cash flows from operating activities:  
Net loss$(47,733)  $(50,239) 
Adjustments to reconcile net loss to net cash used in operating activities:  
Depreciation1,595  1,745  
Amortization of intangible assets9  8  
Amortization of investment discount298  251  
Equity-based compensation10,970  6,591  
Realized (gain) on sale of investments  (6) 
Loss on disposal of property & equipment3    
(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 payable359  103  
Accrued liabilities 780  670  
Deferred revenue and income46  (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 securities9,522  8,716  
Maturity of available-for-sale securities30,049  14,955  
Net cash used in investing activities(30,907) (52,215) 
Cash flows from financing activities:  
Issuance of common stock net issuance costs83,741  80  
Exercise of options and warrants4,562  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 activities88,303  983  
   
Effect of exchange rate on cash:289  (15) 
   
Increase (decrease) in cash and cash equivalents15,187  (91,854) 
Cash and cash equivalents, beginning of period19,244  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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