Accelerate Diagnostics Announces First Quarter Financial Results and Provides COVID-19 Business Updates

TUCSON, Ariz., May 7, 2020 /PRNewswire/ -- Accelerate Diagnostics, Inc. (NASDAQ: AXDX), today announced financial results for the quarter ending March 31, 2020 and provided a business update regarding the impact of the ongoing COVID-19 pandemic on the Company's operations.

"Our first quarter got off to a solid start, as sales, new contracts, and go-lives all progressed as anticipated through January and February. As we moved into March, hospitals began shifting their focus toward preparing for and treating COVID-19 patients, and these shifting priorities, along with meaningful restrictions on hospital access, led to lower-than-expected new contracts and go-lives for the quarter," commented Jack Phillips, Chief Executive Officer of Accelerate Diagnostics, Inc. "However, we are adapting our business to maximize our commercial execution in the near term, and we will continue to work diligently on our longer-term initiatives to strengthen our commercial foundation and expand our portfolio of innovative, life-saving products."

2020 First Quarter Financial and Operational Highlights

    --  Added 13 net new global commercially contracted instruments, including
        21 new U.S. contracted instruments.
    --  Live U.S. Pheno instruments at the end of the first quarter were 197,
        with another 239 U.S. contracted Pheno instruments not yet live.
    --  Net sales for the first quarter of $2.3 million, compared to $1.8
        million in the first quarter of 2019.
    --  Gross margin was 45% for the quarter, compared to 48% in the first
        quarter of 2019.
    --  Selling, general, and administrative expenses for the quarter were $12.9
        million, compared to $12.7 million in the first quarter of 2019.
    --  Research and development (R&D) costs for the quarter were $5.8 million,
        compared to $6.9 million in the first quarter of 2019.
    --  Net loss was $21.3 million in the first quarter, or $0.39 per share,
        which included $4.2 million in non-cash stock-based compensation
        expense.
    --  Net cash used in the quarter was $16.4 million, and the Company ended
        the quarter with total cash, investments, and cash equivalents of $92.0
        million.
    --  Entered into a commercial collaboration agreement with BioCheck, Inc.,
        San Francisco, U.S., including their affiliate, Sophonix Ltd., Beijing,
        China, to sell serology-based SARS-COV-2 antibody tests (IgG and IgM) in
        the U.S. and EMEA, as disclosed in a press release dated April 14th,
        2020.

Full financial results for the quarter ending March 31, 2020 will be filed on Form 10-Q through the Securities and Exchange Commission's (SEC) website at http://www.sec.gov.

First Quarter 2020 Results Conference Call Information

The company will review full financial results for the first quarter of 2020 after the market close on Thursday, May 7, 2020. The company's management will host a conference call at 4:30 p.m. Eastern Time that same day to review the results. To listen to the audio webcast online, visit ir.axdx.com. A replay of the audio webcast will be available until August 7, 2020.

To listen by phone, dial +1.877.883.0383 and enter the conference ID: 8692081
International participants may dial +1.412.317.6506. 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 the replay code 10141855 until May 21, 2020.

About Accelerate Diagnostics, Inc.

Accelerate Diagnostics, Inc. 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 approximately 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, among others, Mr. Phillips statements about adapting our business to maximize our commercial execution in the near term and our longer-term initiative to strengthen our commercial foundation and expand our portfolio of products. 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 27, 2020, and in any other reports that the company files with the Securities and Exchange Commission. 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


                                            
            (in thousands, except share data)




                                                        March 31,                       December 31,


                                                             2020                                2019


                                                   Unaudited


                                                    
            
              ASSETS



     Current assets:


      Cash and cash
       equivalents                                                                  $
            39,487              $
       61,014



     Investments                                          52,525                                         47,437


      Trade accounts
       receivable                                           3,143                                          3,222



     Inventory                                             8,527                                          8,059


      Prepaid expenses                                      1,771                                            955


      Other current assets                                  1,291                                          1,165


      Total current assets                                106,744                                        121,852


      Property and
       equipment, net                                       8,639                                          7,905


      Right of use assets                                   3,742                                          3,917


      Other non-current
       assets                                                 868                                            750



     Total assets                                                                 $
            119,993             $
       134,424




                                       
          
              LIABILITIES AND STOCKHOLDERS' EQUITY



     Current liabilities:


      Accounts payable                                                               $
            3,401               $
       2,351


      Accrued liabilities                                   2,428                                          3,828


      Accrued interest                                        191                                          1,262


      Deferred revenue                                        186                                            271


      Current operating
       lease liability                                        453                                            450


      Total current
       liabilities                                          6,659                                          8,162


      Non-current operating
       lease liability                                      3,466                                          3,579


      Other non-current
       liabilities                                             93                                             19


      Convertible notes                                   132,717                                        130,043


      Total liabilities                                                            $
            142,935             $
       141,803





     Commitments and contingencies





     Stockholders' deficit:


      Preferred shares, $0.001 par value;


      5,000,000 preferred
       shares authorized and
       none outstanding as
       of March 31, 2020 and
       December 31, 2019                                        -



     Common stock, $0.001 par value;


      85,000,000 common
       shares authorized                      December 31, 2019
       with 54,993,588
       shares issued and
       outstanding on March
       31, 2020 and
       85,000,000 common
       shares authorized
       with 54,708,792
       shares issued and
       outstanding on                                          55                                             55


      Contributed capital                                 457,987                                        452,344


      Treasury stock                                     (45,067)                                      (45,067)


      Accumulated deficit                               (436,067)                                     (414,653)


      Accumulated other
       comprehensive income
       (loss)                                                 150                                           (58)


      Total stockholders'
       deficit                                           (22,942)                                       (7,379)


      Total liabilities and
       stockholders' deficit                                                       $
            119,993             $
       134,424



               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


                                                                      March 31,                           March 31,


                                                                           2020                                 2019



     
                Net sales                                                                      $
              2,342                $
         1,750





     
                Cost of sales                                          1,287                                            916



     Gross profit                                                        1,055                                            834





     
                Costs and expenses:



     Research and development                                            5,842                                          6,933



     Sales, general and administrative                                  12,943                                         12,723



     Total costs and expenses                                           18,785                                         19,656





     Loss from operations                                             (17,730)                                      (18,822)





     
                Other income (expense):



     Interest expense                                                  (3,749)                                       (3,459)



     Foreign currency exchange loss                                      (128)                                          (59)



     Interest income                                                       380                                            842



     Other expense, net                                                   (82)                                           (2)



     Total other expense, net                                          (3,579)                                       (2,678)





     Net loss before income taxes                                     (21,309)                                      (21,500)



     Provision for income taxes                                              -                                         (221)



     Net loss                                                                                 $
              (21,309)            $
         (21,721)




      Basic and diluted net loss per share                                                       $
              (0.39)              $
         (0.40)


      Weighted average shares outstanding                                54,837                                         54,337





     
                Other comprehensive loss:



     Net loss                                                                                 $
              (21,309)            $
         (21,721)


      Net unrealized gain on debt securities
       available-for-sale                                                   223                                            121


      Foreign currency translation adjustment                              (15)                                          (76)



     Comprehensive loss                                                                       $
              (21,101)            $
         (21,676)



               See accompanying notes to condensed
                consolidated financial statements.


                                              
              
           ACCELERATE DIAGNOSTICS, INC.


                                                 
              
           CONDENSED CONSOLIDATED


                                                
              
           STATEMENTS OF CASH FLOWS


                                                        
         
                Unaudited


                                                            
         (in thousands)




                                                                                Three Months Ended


                                                               March 31,                           March 31,


                                                                    2020                                 2019


                   Cash flows from operating activities:



     Net loss                                                                          $
              (21,309)            $
        (21,721)


      Adjustments to reconcile net loss to net cash
       used in operating activities:


      Depreciation and amortization                                  755                                            626


      Amortization of investment
       discount                                                      (4)                                         (180)


      Equity-based compensation                                    4,199                                          3,397


      Provision for bad debt expense                                   8


      Amortization of debt discount
       and issuance costs                                          2,674                                          2,387


      Unrealized loss on equity
       investments                                                     8


      Realized loss (gain) on sale
       of investments                                                  3                                            (2)


      Loss on disposal of property
       and equipment                                                 432                                            329



     (Increase) decrease in assets:



     Accounts receivable                                            (9)                                          (90)



     Inventory                                                  (1,735)                                       (1,567)


      Prepaid expense and other                                  (1,030)                                       (1,041)



     Increase (decrease) in liabilities:



     Accounts payable                                               968                                          1,151


      Accrued liabilities, and other                             (1,475)                                       (1,790)



     Accrued interest                                           (1,071)                                       (1,071)


      Deferred revenue and income                                   (85)                                            74


      Deferred compensation                                           74                                            (7)


      Net cash used in operating
       activities                                               (17,597)                                      (19,505)




                   Cash flows from investing activities:


      Purchases of equipment                                       (438)                                          (37)


      Purchase of marketable
       securities                                               (21,582)                                      (12,826)


      Proceeds from sales of
       marketable securities                                           -                                         9,000


      Maturities of marketable
       securities                                                 16,664                                         28,662


      Net cash (used in) provided by
       investing activities                                      (5,356)                                        24,799




                   Cash flows from financing activities:


      Proceeds from issuance of
       common stock                                                  111                                            139


      Proceeds from exercise of
       options                                                     1,318                                          3,677


      Net cash provided by financing
       activities                                                  1,429                                          3,816




      Effect of exchange rate on
       cash                                                          (3)                                          (61)




      (Decrease) increase in cash
       and cash equivalents                                     (21,527)                                         9,049


      Cash and cash equivalents,
       beginning of period                                        61,014                                         66,260


      Cash and cash equivalents, end
       of period                                                                          $
              39,487               $
        75,309



               See accompanying notes to condensed
                consolidated financial statements.


                                         
              
            ACCELERATE DIAGNOSTICS, INC.


                                            
              
            CONDENSED CONSOLIDATED


                                     
              
            STATEMENTS OF CASH FLOWS (CONTINUED)


                                                   
          
                Unaudited


                                                       
          (in thousands)




                                                                           Three Months Ended


                                                           March 31,                          March 31,


                                                                2020                                2019


                   Non-cash investing activities:


      Transfer of instruments
       from inventory to
       property and equipment                                                          $
             1,282    $
         769


                   Supplemental cash flow information:



     Interest paid                                                                    $
             2,144  $
         2,144


      Income taxes paid, net of
       refunds                                                                            $
             26      $
         2



               See accompanying notes to condensed
                consolidated financial statements.


                      
              
              ACCELERATE DIAGNOSTICS, INC.


                         
              
              CONDENSED CONSOLIDATED


                  
              
              STATEMENTS OF STOCKHOLDERS' DEFICIT


                               
            
                Unaudited


                                   
            (in thousands)




                                                           Three Months Ended


                                                             March 31,


                                        2020                   2019


                  Common stock shares
                   outstanding


     Beginning                        54,709                          54,232


      Exercise
      of
      options                            270                             215


      Issuance
      of
      common
      stock
      under
      employee
      purchase
      plan                                15                               7


     Ending                           54,994                          54,454




                  Common stock


     Beginning                                      $
              55               $
          54


     Ending                                         $
              55               $
          54




                  Contributed capital


     Beginning                                 $
              452,344            $
        432,885


      Exercise
      of
      options                          1,318                           3,677


      Issuance
      of
      common
      stock
      under
      employee
      purchase
      plan                               111                             139


     Equity
      based
      compensation                     4,214                           3,453


     Ending                                    $
              457,987            $
        440,154



               See accompanying notes to
                consolidated financial statements.


                                  
              
                ACCELERATE DIAGNOSTICS, INC.


                                     
              
                CONDENSED CONSOLIDATED


                        
              
                STATEMENTS OF STOCKHOLDERS' DEFICIT (CONTINUED)


                                           
              
                Unaudited


                                               
              (in thousands)




                                                                             Three Months Ended


                                                         
              
                March 31,


                                                           2020                     2019



     
                Accumulated deficit



     Beginning                                                   $
              (414,653)             $
          (330,348)


      Cumulative effect of accounting changes             (105)



     Net loss                                         (21,309)                           (21,721)



     Ending                                                      $
              (436,067)             $
          (352,069)





     
                Treasury stock



     Beginning                                                    $
              (45,067)              $
          (45,067)



     Ending                                                       $
              (45,067)              $
          (45,067)




                   Accumulated other comprehensive (loss) income



     Beginning                                                        $
              (58)                 $
          (149)


      Net unrealized gain on debt securities
       available-for-sale                                   223                                 121


      Foreign currency translation adjustment              (15)                               (76)



     Ending                                                            $
              150                  $
          (104)




                   Total stockholders' (deficit)                   $
              (22,942)                $
          42,968



               See accompanying notes to
                consolidated financial statements.

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