Accelerate Diagnostics Reports Fourth Quarter 2019 Financial Results

TUCSON, Ariz., Feb. 27, 2020 /PRNewswire/ -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX) today announced financial results for the fourth quarter and full year ended December 31, 2019.

"Our contracted instrument trajectory continued over the course of 2019 as we doubled our global contracted instrument base by signing 304 instruments, including 137 units during the fourth quarter. Our full-year revenue was short of expectations as multi-site customers in the U.S. have taken longer than anticipated to go live and begin generating consumable revenue," said Jack Phillips, president and chief executive officer of Accelerate Diagnostics, Inc. "One of my initial areas of focus was to evaluate and re-engineer our go-live process, and I am confident the resulting improvements will help relieve our 255 U.S. instrument backlog and make the process quicker and more predictable. For clinically live accounts, I am encouraged that annual annuities are approximately $45k, proving to be predictable, and these customers are enthusiastic about the outcomes they are realizing."

Fourth Quarter 2019 Highlights

    --  Added 137 net new commercially contracted instruments, compared to 133
        in the fourth quarter of 2018.
    --  Net sales of $3.5 million, compared to $1.8 million in the fourth
        quarter of 2018, or 94% year-over-year growth.
    --  Gross margin was 44% for the quarter, compared to 29% in the fourth
        quarter of 2018. This increase was the result of lower consumable
        production costs per unit as production volumes increase. Certain
        perishable raw materials exceeded expiration and required disposal in
        the quarter. Excluding the impact of this charge, gross margin for the
        fourth quarter was 51%.
    --  Research and development (R&D) costs for the quarter were $6.2 million,
        compared to $6.9 million in the fourth quarter of 2018. We expected this
        spend to remain relatively flat on a year-over-year basis, as our R&D
        programs remain consistent.
    --  Selling, general, and administrative expenses for the quarter were $13.6
        million, compared to $13.4 million in the fourth quarter of 2018. These
        expenses remained relatively unchanged on a year-over-year basis.
    --  Net loss was $21.3 million in the fourth quarter, or $0.39 per share,
        which included $3.2 million in non-cash stock-based compensation
        expense.
    --  Net cash used in the quarter was $13.5 million, and the company ended
        the quarter with total cash, investments, and cash equivalents of $108.5
        million.

Full Year 2019 Highlights

    --  Added 304 net new commercially contracted instruments year to date,
        compared to 202 in 2018.
    --  Net sales of $9.3 million, compared to $5.7 million in 2018, or 63% year
        over year growth.
    --  Gross margin was 47%, compared to 44% in 2018. This increase was the
        result of lower consumable production costs per unit as production
        volumes increase. Certain perishable raw materials exceeded expiration
        and required disposal in the fourth quarter. Excluding the impact of
        this charge, gross margin for the year was 53%.
    --  Selling, general, and administrative expenses were $51.9 million,
        compared to $55.2 million in 2018. This decrease was driven by lower
        stock-based compensation expense in the current year.
    --  Research and development (R&D) costs were $25.3 million, compared to
        $27.6 million in 2018. We expected this spend to remain relatively flat
        on a year-over-year basis, as our R&D programs remain consistent.
    --  Net loss was $84.3 million, or $1.55 per share, which included $12.6
        million in non-cash stock-based compensation expense.
    --  Net cash used was $58.0 million, and the company ended the year with
        total cash, investments, and cash equivalents of $108.5 million.

Full financial results for the quarter and year ending December 31, 2019 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 first quarter results. To listen to the conference call, dial +1.877.883.0383 and enter the conference ID: 2860141. International participants may dial +1.412.902.6506. Please dial in 10 to 15 minutes prior to the start of the conference call. A replay of the call will be available by telephone at +1.877.344.7529 (U.S.) or +1.412.317.0088 (international) using replay code 10138283 until May 19, 2020.

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 19, 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 those, among others, about the company's placement trajectory, our belief that our re-engineered go-live process will make our implementation process quicker and more predictable, thereby relieving our backlog, our belief that annual annuities will average approximately $45,000, our expectation that customers will be enthusiastic about clinical results, and our expectation that R&D expenses will be relatively flat from 2019 to 2020. 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.


                                        
            
              CONSOLIDATED


                                       
            
              BALANCE SHEETS


                                   
            (in thousands, except share data)




                                                    
            
              December 31,


                                                       2019                 2018

                                                                            ---

                                           
            
              ASSETS



     Current assets:


      Cash and cash equivalents                                $
            61,014               $
       66,260



     Investments                                    47,437                          100,218


      Trade accounts receivable                       3,222                            1,860



     Inventory                                       8,059                            7,746



     Prepaid expenses                                  955                              980



     Other current assets                            1,165                              576




     Total current assets                          121,852                          177,640


      Property and equipment, net                     7,905                            7,303



     Right of use assets                             3,917



     Other non-current assets                          750                              322



     Total assets                                            $
            134,424              $
       185,265





                            
            
              LIABILITIES AND STOCKHOLDERS' EQUITY



     Current liabilities:



     Accounts payable                                          $
            2,351                $
       1,322



     Accrued liabilities                             3,828                            4,962



     Accrued interest                                1,262                            1,262



     Deferred revenue                                  271                              217


      Current operating lease liability                 450



      Total current liabilities                       8,162                            7,763


      Non-current operating lease
       liability                                      3,579


      Other non-current liabilities                      19                               53



     Convertible notes                             130,043                          120,074




     Total liabilities                             141,803                          127,890





     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, 2019 and 2018                   -



     Common stock, $0.001 par value;


      85,000,000 common shares
       authorized with 54,708,792
       shares issued and outstanding on
       December 31, 2019 and 75,000,000
       common shares authorized with
       54,231,876 shares issued and
       outstanding on December 31, 2018                  55                               54



     Contributed capital                           452,344                          432,885



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



     Accumulated deficit                         (414,653)                       (330,348)


      Accumulated other comprehensive
       loss                                            (58)                           (149)



      Total stockholders' equity
       (deficit)                                    (7,379)                          57,375



      Total liabilities and
       stockholders' equity (deficit)                         $
            134,424              $
       185,265



               See accompanying notes to
                consolidated financial statements.


                                                
             
                ACCELERATE DIAGNOSTICS, INC.


                                                        
             
                CONSOLIDATED


                                      
              
               STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS


                                                  
             (in thousands, except per share data)




                                                    
             
                Years Ended December 31,


                                             2019                   2018         2017

                                                                                ---

                   Net sales                           $
             9,297                                $
            5,670       $
          4,177




                   Cost of sales            4,897                              3,187                              1,002




     Gross profit                          4,400                              2,483                              3,175




                   Costs and expenses:


      Research and development             25,345                             27,638                             22,301


      Sales, general and
       administrative                      51,886                             55,214                             45,058



      Total costs and expenses             77,231                             82,852                             67,359





      Loss from operations               (72,831)                          (80,369)                          (64,184)




                   Other income (expense):


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


      Foreign currency exchange
       loss                                 (124)                             (450)                              (75)


      Interest and dividend
       income                               2,809                              2,845                                908


      Other expense, net                     (14)                              (28)                             (184)


      Total other income
       (expense), net                    (11,585)                           (7,746)                               649





      Net loss before income
       taxes                             (84,416)                          (88,115)                          (63,535)


      Benefit (provision) for
       income taxes                           111                              (211)                             (493)



     Net loss                                      $
             (84,305)                            $
            (88,326)   $
          (64,028)





      Basic and diluted net
       loss per share                                 $
             (1.55)                              $
            (1.62)     $
          (1.18)


      Weighted average shares
       outstanding                         54,506                             54,494                             54,073




                   Other comprehensive loss:



     Net loss                                      $
             (84,305)                            $
            (88,326)   $
          (64,028)


      Net unrealized gain
       (loss) on available-
       for-sale investments                   193                                 23                              (117)


      Foreign currency
       translation adjustment               (102)                             (172)                               321



      Comprehensive loss                            $
             (84,214)                            $
            (88,475)   $
          (63,824)



               See accompanying notes to
                consolidated financial statements.


                                                                                               
          
                ACCELERATE DIAGNOSTICS, INC.


                                                                                                    
             
                CONSOLIDATED


                                                                                           
          
            STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)


                                                                                                         
              (in thousands)




                            Shares        Common           Contributed           Accumulated                   Treasury                           Accumulated                       Total
                                   Stock         Capital               Deficit               stock                           Other                          Stockholders'
                                   Amount                                                                                Comprehensive                     Equity (Deficit)
                                                                                                                         Income (Loss)

                                                                                                                                                                                ---

      Balances, January 1,
       2017                 51,516                      $
       52                                                                     $
              255,257                                           $
     (177,289)       
           $                        $
      (204)  $
      77,816



     Net loss                               -                                                                                                                             (64,028)                                                         (64,028)


      Issuance of common
       stock                 3,085                  3                           83,221                                                                                                                                                 83,224


      Exercise of options
       and warrants          1,045                  1                            6,605                                                                                                                                                  6,606


      Issuance of common
       stock under
       employee purchase
       plan                     28                                                597                                                                                                                                                    597


      Unrealized loss on
       available-for-
       sale securities                       -                                                                                                                                                                         (117)                   (117)


      Foreign currency
       translation
       adjustment                            -                                                                                                                                                                           321                      321


      Cumulative impact of
       accounting change                     -                                                                                                                                (655)                                                            (655)


      Equity-based
       compensation                          -                                                         14,940                                                                                                                                  14,940



      Balances, December
       31, 2017             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)



               See accompanying notes to
                consolidated financial statements.


                                                
             
                ACCELERATE DIAGNOSTICS, INC.


                                                        
             
                CONSOLIDATED


                                                  
             
                STATEMENT OF CASH FLOWS


                                                            
              (in thousands)




                                                    
             
                Years Ended December 31,


                                             2019                   2018         2017

                                                                                ---

                   Cash flows from operating activities:



     Net loss                                      $
             (84,305)                            $
        (88,326)   $
        (64,028)


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


      Depreciation and
       amortization                         2,602                              2,561                          2,196


      Amortization of
       investment discount                  (427)                             (621)                           326


      Equity-based
       compensation expense                12,618                             14,422                         13,933


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


      Loss on disposal of
       property and equipment                 837                                678                            240



     (Increase) decrease in assets:


      Accounts receivable                 (1,362)                                86                        (1,912)



     Inventory                           (3,655)                           (4,223)                       (7,759)


      Prepaid expense and other
       assets                               (752)                             (250)                         (459)


      Increase (decrease) in liabilities:


      Accounts payable                        988                              (748)                         1,064


      Accrued liabilities                 (1,327)                             1,426                            596


      Accrued interest                          -                             1,262


      Deferred revenue and
       income                                  54                              (904)                            36


      Deferred compensation                  (34)                                32                             21



      Net cash used in
       operating activities              (64,794)                          (67,756)                      (55,746)


                   Cash flows from investing activities:


      Purchases of equipment                (330)                             (998)                       (2,966)


      Purchase of marketable
       securities                        (50,226)                         (120,556)                       (82,333)


      Proceeds from sales of
       marketable securities               14,500                              3,000                         11,522


      Maturities of marketable
       securities                          88,867                             98,416                         48,049



      Net cash provided by
       (used in) investing
       activities                          52,811                           (20,138)                      (25,728)


                   Cash flows from financing activities:


      Proceeds from issuance of
       common stock                         1,458                                583                         83,821


      Proceeds from exercise of
       options and warrants                 5,365                              3,749                          6,606


      Proceeds from issuance of
       convertible note                         -                           171,500


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


      Payment of debt issuance
       costs                                    -                           (4,992)



      Net cash provided by
       financing activities                 6,823                            125,771                         90,427




      Effect of exchange rate
       on cash                               (86)                             (130)                           316




      Increase (decrease) in
       cash and cash
       equivalents                        (5,246)                            37,747                          9,269


      Cash and cash
       equivalents, beginning
       of period                           66,260                             28,513                         19,244



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



               See accompanying notes to
                consolidated financial statements.


                                   
              
                ACCELERATE DIAGNOSTICS, INC.


                                           
              
                CONSOLIDATED


                                
              
                STATEMENT OF CASH FLOWS (CONTINUED)


                                                 
              (in thousands)




                                                          Years Ended December 31,


                                       2019                 2018       2017

                                                                      ---

                  Non-cash investing activities:


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


                  Supplemental cash flow information:


     Interest paid                            $
              4,288                          $
       2,001 
     $


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



               See accompanying notes to
                consolidated financial statements.

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SOURCE Accelerate Diagnostics, Inc.