Accelerate Diagnostics reports Q1 2018 financial results

May 9, 2018

Accelerate Diagnostics reports Q1 2018 financial results

TUCSON, Ariz., May 09, 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.

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  

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 

Primary Logo

Source: Accelerate Diagnostics, Inc.

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