Accelerate Diagnostics Reports Second Quarter 2019 Financial Results

TUCSON, Ariz., Aug. 8, 2019 /PRNewswire/ -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX) today announced financial results for the second quarter ended June 30, 2019.

"We achieved mixed results in the second quarter, as revenue and placements were both lighter than anticipated due to lower-than-expected capital sales in our EMEA region," commented Lawrence Mehren, President and CEO of Accelerate Diagnostics, Inc. "However, we were encouraged by our commercial progress during the quarter, highlighted by 30% sequential growth in consumable sales and by our signing of the Mayo Clinic as a key reference customer. We expect our increasingly strong customer pipeline to drive higher placements in the second half of the year, particularly in Q4, and are confident that consumable revenues will continue to ramp higher as an ever-increasing number of new customers go clinically live."

Second Quarter 2019 Highlights

    --  Added 55 net new commercially contracted instruments, compared to 29 in
        the second quarter of 2018.
    --  Net sales of $1.8 million, compared to $1.7 million in the second
        quarter of 2018. Instrument revenue decreased year-over-year while
        consumable revenue grew meaningfully over the same time period,
        reflecting the company's change to a reagent rental business model
        starting Q3 of 2018. Consumable revenue grew by over 125% as compared
        the second quarter of 2018 and by approximately 30% over the prior
        quarter.
    --  Gross margin was 50% for the quarter, compared to 58% in the second
        quarter of 2018. This decrease was the result of one-time inventory
        timing benefits in the prior year which did not repeat in the current
        year.
    --  Selling, general, and administrative expenses for the quarter were $12.8
        million, compared to $15.3 million in the second quarter of 2018. This
        decrease was driven by lower stock-based compensation expense in the
        current year.
    --  Research and development (R&D) costs for the quarter were $6.1 million,
        compared to $6.1 million in the second quarter of 2018. R&D expense were
        materially unchanged due to a stable product development program.
    --  Net loss was $20.8 million in the second quarter, or $0.38 per share,
        which included $2.9 million in non-cash stock-based compensation
        expense.
    --  Net cash used in the quarter was $13.0 million, and the company ended
        the quarter with total cash, investments, and cash equivalents of $137.8
        million.

Year to Date 2019 Highlights

    --  Added 130 net new commercially contracted instruments year to date,
        compared to 40 for the same period from 2018.
    --  Net sales of $3.6 million year to date, compared to $2.5 million for the
        same period from 2018. Instrument revenue decreased while consumable
        revenue grew steadily reflecting the company's change to a reagent
        rental business model starting Q3 of 2018. Consumable revenue grew by
        over 125% year to date compared to the same period in the prior year.
    --  Gross margin was 49% year to date, compared to 51% for the same period
        from 2018. This decrease was in part due to one-time inventory timing
        benefits in the prior year that did repeat in the current year. After
        excluding the impacts of pre-FDA inventory previously written off to
        R&D, gross margin improved by 300 basis points year to date to due to
        higher test kit production levels.
    --  Selling, general, and administrative expenses were $25.6 million year to
        date, compared to $29.7 million for the same period from 2018. This
        decrease was driven by lower stock-based compensation expense in the
        current year.
    --  Research and development (R&D) costs were $13.1 million year to date,
        compared to $12.8 million for the same period from 2018. R&D expense
        remain unchanged due to a stable product development program.
    --  Net loss was $42.5 million year to date, or $0.78 per share, which
        included $6.3 million in non-cash stock-based compensation expense.
    --  Net cash used year to date was $28.6 million, and the company ended the
        quarter with total cash, investments, and cash equivalents of $137.8
        million.

Full financial results for the quarter ending June 30, 2019 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

The company will host a conference call at 4:30PM ET today to review its second quarter results. To participate in the conference call, dial +1.877.883.0383 and enter the conference ID: 8768870. 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 10132228 until August 29, 2019.

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 August 29, 2019.

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(TM) system and Accelerate PhenoTest(TM) 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 projections as to when certain key business milestones may be achieved, the potential of the company's products or technology, the growth of the market, the company's estimates as to the size of its market opportunity and potential pricing, the company's competitive position and estimates of time reduction to results, and its 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, 2019, 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)




                                                         June 30,                       December 31,


                                                             2019                                2018

                                                                                                 ---

                                                   Unaudited


                                                    
            
              ASSETS



     Current assets:


      Cash and cash
       equivalents                                                                  $
            87,469              $
       66,260



     Investments                                          50,349                                        100,218


      Trade accounts
       receivable                                           1,911                                          1,860



     Inventory                                             8,298                                          7,746


      Prepaid expenses                                      1,342                                            980


      Other current assets                                    805                                            576



      Total current assets                                150,174                                        177,640


      Property and
       equipment, net                                       7,624                                          7,303


      Right of use assets                                     375


      Other non-current
       assets                                                 471                                            322



     Total assets                                                                 $
            158,644             $
       185,265



                                      
           
              LIABILITIES AND STOCKHOLDERS' EQUITY



     Current liabilities:


      Accounts payable                                                               $
            1,819               $
       1,322


      Accrued liabilities                                   3,976                                          4,962


      Accrued interest                                      1,262                                          1,262


      Deferred revenue and
       income                                                 255                                            217


      Current operating
       lease liability                                        200



      Total current
       liabilities                                          7,512                                          7,763


      Non-current operating
       lease liability                                        175


      Other non-current
       liabilities                                             35                                             53


      Convertible notes                                   124,917                                        120,074


      Total liabilities                                                            $
            132,639             $
       127,890




     Commitments and contingencies





     Stockholders' equity:


      Preferred shares, $0.001 par value;


      5,000,000 preferred
       shares authorized and
       none outstanding as
       of June 30, 2019 and
       December 31, 2018                                        -



     Common stock, $0.001 par value;


      85,000,000 common
       shares authorized                       December 31, 2018
       with 54,512,492
       shares issued and
       outstanding on June
       30, 2019 and
       75,000,000 common
       shares authorized
       with 54,231,876
       shares issued and
       outstanding on                                          55                                             54


      Contributed capital                                 443,857                                        432,885


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


      Accumulated deficit                               (372,884)                                     (330,348)


      Accumulated other
       comprehensive income
       (loss)                                                  44                                          (149)


      Total stockholders'
       equity                                              26,005                                         57,375



      Total liabilities and
       stockholders' equity                                                        $
            158,644             $
       185,265



               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                                                                              Six Months Ended


                                             June 30,                   June 30,                                       June 30,                      June 30,


                                                 2019                        2018                                            2019                           2018

                                                                                                                                                          ---

                   Net sales                                   $
              1,806                                                                  $
         1,692                              $
          3,557      $
           2,493




                   Cost of sales                  907                                     717                                                                         1,823       1,210



     Gross profit                                899                                     975                                                                         1,734       1,283




                   Costs and expenses:


      Research and development                  6,149                                   6,060                                                                        13,083      12,842


      Sales, general and
       administrative                          12,837                                  15,330                                                                        25,559      29,682



      Total costs and expenses                 18,986                                  21,390                                                                        38,642      42,524





      Loss from operations                   (18,087)                               (20,415)                                                                     (36,908)   (41,241)




                   Other income (expense):


      Interest expense                        (3,528)                                (3,205)                                                                      (6,987)    (3,363)


      Foreign currency exchange
       (loss) gain                                  6                                   (253)                                                                         (53)      (198)


      Interest income                             812                                     774                                                                         1,653       1,075


      Other expense, net                          (1)                                   (25)                                                                          (3)       (25)



      Total other expense, net                (2,711)                                (2,709)                                                                      (5,390)    (2,511)





      Net loss before income
       taxes                                 (20,798)                               (23,124)                                                                     (42,298)   (43,752)


      Provision for income
       taxes                                     (17)                                  (101)                                                                        (238)      (285)



     Net loss                                              $
              (20,815)                                                              $
         (23,225)                          $
          (42,536)   $
          (44,037)





      Basic and diluted net
       loss per share                                         $
              (0.38)                                                                $
         (0.43)                            $
          (0.78)     $
          (0.80)


      Weighted average shares
       outstanding                             54,476                                  54,003                                                                        54,407      54,821




                   Other comprehensive loss:



     Net loss                                              $
              (20,815)                                                              $
         (23,225)                          $
          (42,536)   $
          (44,037)


      Net unrealized gain
       (loss) on available-
       for-sale investments                        98                                     (2)                                                                          219        (55)


      Foreign currency
       translation adjustment                      50                                   (191)                                                                         (26)       (79)



      Comprehensive loss                                    $
              (20,667)                                                              $
         (23,418)                          $
          (42,343)   $
          (44,171)



               See accompanying notes to condensed
                consolidated financial statements.


                                             
              
           ACCELERATE DIAGNOSTICS, INC.


                                                
              
           CONDENSED CONSOLIDATED


                                               
              
           STATEMENTS OF CASH FLOWS


                                                       
         
                Unaudited


                                                           
         (in thousands)




                                                                               Six Months Ended


                                                             June 30,                           June 30,


                                                                 2019                                2018

                                                                                                     ---

                   Cash flows from operating activities:



     Net loss                                                                      $
              (42,536)            $
        (44,037)


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


      Depreciation and
       amortization                                             1,236                                         1,082


      Amortization of investment
       discount                                                 (320)                                        (146)


      Equity-based compensation                                 6,278                                         9,011


      Amortization of debt
       discount and issuance costs                              4,843                                         2,273


      Loss on disposal of property
       and equipment                                              407                                           266



     (Increase) decrease in assets:


      Accounts receivable                                        (51)                                          123



     Inventory                                               (2,217)                                      (4,334)


      Prepaid expense and other                                 (588)                                        (697)



     Increase (decrease) in liabilities:



     Accounts payable                                            476                                           206


      Accrued liabilities, and
       other                                                  (1,110)                                          661



     Accrued interest                                              -                                        1,105


      Deferred revenue and income                                  38                                         (935)


      Deferred compensation                                      (18)                                            5



      Net cash used in operating
       activities                                            (33,562)                                     (35,417)


                   Cash flows from investing activities:


      Purchases of equipment                                     (76)                                        (702)


      Purchase of marketable
       securities                                            (17,601)                                     (91,272)


      Proceeds from sales of
       marketable securities                                   13,400                                         3,000


      Maturities of marketable
       securities                                              54,447                                        38,272



      Net cash provided by (used
       in) investing activities                                50,170                                      (50,702)


                   Cash flows from financing activities:


      Proceeds from issuance of
       common stock                                               251                                           276


      Proceeds from exercise of
       options                                                  4,369                                         2,757


      Proceeds from issuance of
       convertible note                                             -                                      171,499


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


      Payment of debt issuance
       costs                                                        -                                      (4,991)



      Net cash provided by
       financing activities                                     4,620                                       124,472




      Effect of exchange rate on
       cash                                                      (19)                                         (56)




      Increase in cash and cash
       equivalents                                             21,209                                        38,297


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



      Cash and cash equivalents,
       end of period                                                                  $
              87,469               $
        66,810



               See accompanying notes to condensed
                consolidated financial statements.

View original content to download multimedia:http://www.prnewswire.com/news-releases/accelerate-diagnostics-reports-second-quarter-2019-financial-results-300899128.html

SOURCE Accelerate Diagnostics, Inc.