Accelerate Diagnostics Reports Fourth Quarter and Full-Year 2020 Financial Results

TUCSON, Ariz., Feb. 23, 2021 /PRNewswire/ -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX) today announced financial results for the fourth quarter and full year ended December 31, 2020.

"We were pleased with the improvement in our go-live execution over the course of 2020, which drove a material increase in our live instruments in the fourth quarter and led to a 63% increase in our revenue-generating installed base during the year," commented Jack Phillips, Chief Executive Officer of Accelerate Diagnostics, Inc. "We also saw modest improvements in the demand environment during the quarter, although new instrument placements continued to be challenged due to pandemic-related headwinds, including limited salesforce access to potential customer sites and hospital decision-makers' strong focus on COVID-19. Entering 2021, we are optimistic about an improving hospital selling environment as we leverage our improved sales and implementation processes and plan to bring our exciting new product launches to market."

Fourth Quarter 2020 Highlights

    --  Added 21 contracted instruments in the quarter and brought 45
        instruments live in the U.S.
    --  Ended the fourth quarter with 268 U.S. live revenue-generating
        instruments, with another 133 U.S. contracted Pheno instruments not yet
        live.
    --  Net sales of $3.1 million, compared to $3.5 million in the fourth
        quarter of 2019, or a 10% decline, due to an international capital deal
        in the fourth quarter of 2019 that did not repeat in the current year.
    --  Gross margin was 37% for the quarter, compared to 44% in the fourth
        quarter of 2019. This decrease was the result of pandemic-related
        effects on manufacturing, restructuring charges in EMEA, and dilution
        due to capital deals in the quarter.
    --  Selling, general, and administrative expenses for the quarter were $11.2
        million, compared to $13.6 million in the fourth quarter of 2019. This
        decrease was driven by pandemic-related reductions in sales and
        marketing spend related to travel and trade shows.
    --  Research and development (R&D) costs for the quarter were $5.1 million,
        compared to $6.2 million in the fourth quarter of 2019. This decrease
        was the result of increased efficiencies and lower external study spend.
    --  Net loss was $18.9 million in the fourth quarter, or $0.33 per share,
        which included $4.2 million in non-cash stock-based compensation
        expense.
    --  Net cash used in the quarter was $9.2 million, and the company ended the
        quarter with total cash, investments, and cash equivalents of $68.3
        million.

2020 Full Year Highlights

    --  Net sales were $11.2 million for the year as compared to $9.3 million
        from the same period in the prior year, or 20% growth.
    --  Gross margin was 40% for the year, compared to 47% for the prior year.
        This decrease was the result of pandemic-related effects on
        manufacturing, restructuring charges in EMEA, and dilution due to
        capital deals during the year.
    --  Selling, general, and administrative expenses were $46.9 million for the
        year, compared to $51.9 million in 2019. This decrease was driven by
        pandemic-related reductions in sales and marketing spend related to
        travel and trade shows.
    --  Research and development (R&D) costs were $21.3 million year-to-date,
        compared to $25.4 million in 2019. This decrease was the result of
        increased efficiencies and lower external study spend.
    --  Net loss was $78.2 million for the year, or $1.40 per share, which
        included $16.5 million in non-cash stock-based compensation expense.
    --  Net cash used was $40.2 million, and the company ended the quarter with
        total cash, investments, and cash equivalents of $68.3 million.

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

Audio Webcast and Conference Call

The company will host a conference call at 4:30PM ET today to review its fourth quarter and full year 2020 results. To listen to the 2020 fourth quarter and full year 2020 financial results call by phone, +1.877.883.0383 and enter the conference ID: 9000762. 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 the replay code 10151395 until March 16, 2021.

This conference call will also be webcast and can be accessed from the "Investors" section of the company's website at axdx.com/investors. A replay of the audio webcast will be available until May 24, 2021.

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 regarding our optimism that our selling environment will improve in 2021, and our plan to bring new products to market. 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.

Source: Accelerate Diagnostics Inc.




                                   
            
              ACCELERATE DIAGNOSTICS, INC.


                                           
            
              CONSOLIDATED


                                          
            
              BALANCE SHEETS


                                      
            (in thousands, except share data)




                                                            
            
              December 31,



                                                               2020                2019

                                                                                   ---

             
            
              ASSETS



     Current assets:


      Cash and cash equivalents                                       $
            35,781               $
       61,014



     Investments                                            32,488                          47,437


      Trade accounts receivable                               1,550                           3,222



     Inventory                                               9,216                           8,059



     Prepaid expenses                                        1,172                             955



     Other current assets                                    1,780                           1,165




     Total current assets                                   81,987                         121,852


      Property and equipment, net                             6,135                           7,905



     Right of use assets                                     3,183                           3,917


      Other non-current assets                                2,120                             750




     Total assets                                                    $
            93,425              $
       134,424





                 LIABILITIES AND STOCKHOLDERS' EQUITY



     Current liabilities:



     Accounts payable                                                 $
            1,290                $
       2,351



     Accrued liabilities                                     2,991                           3,828



     Accrued interest                                        1,262                           1,262



     Deferred revenue                                          376                             271


      Current portion of long-term
       debt                                                     553


      Current operating lease
       liability                                                497                             450



      Total current liabilities                               6,969                           8,162


      Non-current operating lease
       liability                                              3,063                           3,579


      Other non-current liabilities                             335                              19



     Long-term debt                                          4,659



     Convertible notes                                     141,211                         130,043




     Total liabilities                                     156,237                         141,803





     Commitments and contingencies





     Stockholders' equity (deficit):



     Preferred shares, $0.001 par value;


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



     Common stock, $0.001 par value;


      85,000,000 common shares
       authorized with 57,607,939
       shares issued and outstanding
       on December 31, 2020 and
       85,000,000 common shares
       authorized with 54,708,792
       shares issued and outstanding
       on December 31, 2019                                      58                              55



     Contributed capital                                   475,072                         452,344



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



     Accumulated deficit                                 (492,966)                      (414,653)


      Accumulated other
       comprehensive loss                                        91                            (58)



      Total stockholders' equity
       (deficit)                                           (62,812)                        (7,379)



      Total liabilities and
       stockholders' equity
       (deficit)                                                      $
            93,425              $
       134,424







                                               
             
                ACCELERATE DIAGNOSTICS, INC.


                                                      
              
                CONSOLIDATED


                                     
              
               STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS


                                                 
             (in thousands, except per share data)




                                                    
              
                Years Ended December 31,



                                               2020                   2019        2018

                                                                                 ---

                   Net sales                           $
              11,165                               $
          9,297       $
          5,670




                   Cost of sales              6,706                             4,897                            3,187




     Gross profit                            4,459                             4,400                            2,483





     
                Costs and expenses:


      Research and development               21,255                            25,345                           27,638


      Sales, general and
       administrative                        46,904                            51,886                           55,214



      Total costs and expenses               68,159                            77,231                           82,852





      Loss from operations                 (63,700)                         (72,831)                         (80,369)




                   Other income (expense):



     Interest expense                     (15,550)                         (14,256)                         (10,113)


      Foreign currency exchange
       gain (loss)                              252                             (124)                           (450)


      Interest and dividend
       income                                   855                             2,809                            2,845


      Other expense, net                       (60)                             (14)                            (28)



      Total other expense, net             (14,503)                         (11,585)                          (7,746)





      Net loss before income
       taxes                               (78,203)                         (84,416)                         (88,115)


      Benefit (provision) for
       income taxes                             (5)                              111                            (211)




     Net loss                                       $
              (78,208)                           $
          (84,305)   $
          (88,326)





      Basic and diluted net loss
       per share                                       $
              (1.40)                             $
          (1.55)     $
          (1.62)


      Weighted average shares
       outstanding                           56,010                            54,506                           54,494




                   Other comprehensive loss:



     Net loss                                       $
              (78,208)                           $
          (84,305)   $
          (88,326)


      Net unrealized (loss) gain
       on available-for-sale
       investments                              (2)                              193                               23


      Foreign currency
       translation adjustment                   151                             (102)                           (172)



      Comprehensive loss                             $
              (78,059)                           $
          (84,214)   $
          (88,475)







                                                                                              
            
               ACCELERATE DIAGNOSTICS, INC.


                                                                                                     
            
                CONSOLIDATED


                                                                                      
              
             STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)


                                                                                                         
              (in thousands)




                            Shares      Common Contributed                Accumulated       Treasury                         Accumulated                              Total
                                                               Deficit
                                      Stock    Capital                                stock                             Other                             Stockholders'

                                      Amount                                                                        Comprehensive                       Equity (Deficit)

                                                                                                                    Income (Loss)

                                                                                                                                                                       ---

      Balances, January 1,
       2018                 55,674                          $
         56                                               $
              360,620                                        $
       (241,972)              
            $                  
     $       $
     118,704



     Net loss                   -                                                                                                                                (88,326)                                               (88,326)


      Exercise of options
       and restricted
       stock awards issued     382                                                        3,749                                                                                                                               3,749


      Issuance of common
       stock under
       employee purchase
       plan                     35                                                          583                                                                                                                                 583


      Unrealized gain on
       available-for-
       sale securities           -                                                                                                                                                                              23                23


      Foreign currency
       translation
       adjustment                -                                                                                                                                                                           (172)            (172)


      Repurchase of common
       stock under Prepaid
       Forward contract    (1,859)                     (2)                                                                                                                        (45,067)                                 (45,069)


      Issuance of
       convertible note          -                                                      53,283                                                                                                                              53,283


      Cumulative impact of
       accounting change         -                                                                                                                                      (50)                                                   (50)


      Equity-based
       compensation              -                                                      14,650                                                                                                                              14,650



      Balances, December
       31, 2018             54,232                       54                              432,885                                                                    (330,348)      (45,067)                   (149)           57,375



     Net loss                   -                                                                                                                                (84,305)                                               (84,305)


      Issuance of common
       stock                    56                                                        1,000                                                                                                                               1,000


      Exercise of options
       and restricted
       stock awards issued     396                        1                                5,364                                                                                                                               5,365


      Issuance of common
       stock under
       employee purchase
       plan                     25                                                          458                                                                                                                                 458


      Unrealized gain on
       available-for-
       sale securities           -                                                                                                                                                                             193               193


      Foreign currency
       translation
       adjustment                -                                                                                                                                                                           (102)            (102)


      Equity-based
       compensation              -                                                      12,637                                                                                                                              12,637



      Balances, December
       31, 2019             54,709                       55                              452,344                                                                    (414,653)      (45,067)                    (58)          (7,379)



     Net loss                   -                                                                                                                                (78,208)                                               (78,208)


      Exercise of options
       and restricted
       stock awards issued   2,858                        3                                6,059                                                                                                                               6,062


      Issuance of common
       stock under
       employee purchase
       plan                     41                                                          359                                                                                                                                 359


      Unrealized loss on
       available-for-
       sale securities           -                                                                                                                                                                             (2)              (2)


      Foreign currency
       translation
       adjustment                -                                                                                                                                                                             151               151


      Cumulative impact of
       accounting change         -                                                                                                                                     (105)                                                  (105)


      Equity-based
       compensation              -                                                      16,310                                                                                                                              16,310



      Balances, December
       31, 2020                    $
       57,608                         $
           58                                                                         $
              475,072                $
     (492,966)            $
          (45,067)     $
     91            $
     (62,812)





                                              
              
              ACCELERATE DIAGNOSTICS, INC.


                                                      
            
                CONSOLIDATED


                                                 
             
               STATEMENT OF CASH FLOWS


                                                           
             (in thousands)




                                                    
            
                Years Ended December 31,



                                              2020                  2019        2018

                                                                               ---

                   Cash flows from operating activities:



     Net loss                                       $
            (78,208)                           $
        (84,305)   $
        (88,326)


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


          Depreciation and
           amortization                      2,997                            2,602                          2,561


          Amortization of investment
           discount                             99                            (427)                         (621)


          Equity-based compensation
           expense                          16,464                           12,618                         14,422


          Amortization of debt
           discount and issuance
           costs                            11,168                            9,969                          6,849


          Realized loss on
           available-for-sale
           securities                            3


          Loss on disposal of
           property and equipment              785                              837                            678


      Contributions to deferred
       compensation plan                     (357)



     (Increase) decrease in assets:


          Accounts receivable                1,592                          (1,362)                            86



         Inventory                        (1,356)                         (3,655)                       (4,223)


          Prepaid expense and other
           assets                          (2,087)                           (752)                         (250)


      Increase (decrease) in liabilities:


          Accounts payable                 (1,006)                             988                          (748)


          Accrued liabilities                (909)                         (1,327)                         1,426


          Accrued interest                       -                                                         1,262


          Deferred revenue and
           income                              105                               54                          (904)


          Deferred compensation                316                             (34)                            32



      Net cash used in operating
       activities                         (50,394)                        (64,794)                       (67,756)


                   Cash flows from investing activities:


      Purchases of equipment               (1,362)                           (330)                         (998)


      Purchase of marketable
       securities                         (46,933)                        (50,226)                      (120,556)


      Proceeds from sales of
       marketable securities                     -                          14,500                          3,000


      Maturities of marketable
       securities                           61,901                           88,867                         98,416



      Net cash provided by (used
       in) investing activities             13,606                           52,811                       (20,138)


                   Cash flows from financing activities:


      Proceeds from issuance of
       common stock                            362                            1,458                            583


      Proceeds from exercise of
       options and warrants                  6,059                            5,365                          3,749


      Proceeds from issuance of
       convertible note                          -                                                       171,500


      Proceeds from debt                     5,578



     Payment of debt                        (366)


      Prepayment of forward
       stock repurchase
       transaction                               -                                                      (45,069)


      Payment of debt issuance
       costs                                     -                                                       (4,992)



      Net cash provided by
       financing activities                 11,633                            6,823                        125,771




      Effect of exchange rate on
       cash                                   (78)                            (86)                         (130)




      Increase (decrease) in
       cash and cash equivalents          (25,233)                         (5,246)                        37,747


      Cash and cash equivalents,
       beginning of period                  61,014                           66,260                         28,513



      Cash and cash equivalents,
       end of period                                   $
            35,781                              $
        61,014     $
         66,260







                                   
              
                ACCELERATE DIAGNOSTICS, INC.


                                           
              
                CONSOLIDATED


                                
              
                STATEMENT OF CASH FLOWS (CONTINUED)


                                                 
              (in thousands)




                                                                 Years Ended December 31,



                                       2020                 2019      2018

                                                                     ---

                  Non-cash investing activities:


     Transfer of
      instruments from
      inventory to
      property and
      equipment                               $
              1,525                         $
            3,361 $
       4,767


                  Supplemental cash flow information:


     Interest paid                            $
              4,288                         $
            4,288 $
       2,001


     Income taxes paid,
      net of refunds                             $
              43                            $
            41   $
       651




                          
              See accompanying notes to consolidated financial statements.

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SOURCE Accelerate Diagnostics, Inc.