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      Accelerate Diagnostics Reports Second Quarter 2022 Financial Results

      Accelerate Diagnostics, Inc. (PRNewsfoto/Accelerate Diagnostics)

      News provided by

      Accelerate Diagnostics, Inc.

      Aug 15, 2022, 08:15 ET

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      TUCSON, Ariz., Aug. 15, 2022 /PRNewswire/ -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX) today announced financial results for the second quarter for the period ended June 30, 2022.

      "In addition to a solid quarter, I am pleased to announce that we will be joining forces with Becton Dickinson to commercialize our products globally," commented Jack Phillips, Chief Executive Officer of Accelerate Diagnostics, Inc.  "Our global commercial partnership with BD comes at a time when the hospital selling environment is improving, we are firing on all cylinders in R&D and are taking meaningful steps to improve our balance sheet.  These are exciting times for our company."

      Second Quarter 2022 Highlights

      • Added 8 contracted instruments and brought 3 instruments live in the U.S. in the quarter.
      • Ended the second quarter with 316 U.S. clinically live and revenue-generating instruments, with another 78 U.S. contracted instruments in the process of being implemented and not yet revenue-generating.
      • Net sales were $3.9 million, compared to $2.8 million in the second quarter of the prior year, or a 39% increase.  Growth was driven by increases in both capital and recurring revenues.
      • Gross margin was 28% for the quarter, compared to 38% in the second quarter of the prior year.  The decline in gross margins resulted from inflation to manufacturing costs and other factors.
      • Selling, general, and administrative (SG&A) costs for the quarter were $11.5 million, compared to $12.9 million from the same quarter of the prior year. SG&A costs for the quarter excluding non-cash stock-based compensation were $8.3 million, compared to $7.7 million from the same quarter of the prior year. This decrease was driven by continued benefit from cost cutting efforts. 
      • Research and development (R&D) costs for the quarter were $7.6 million, compared to $5.7 million from the same quarter of the prior year. R&D costs excluding non-cash stock-based compensation expense for the quarter were $7.0 million, compared to $4.4 million from the quarter of the prior year. This increase was the result of investment in our next generation AST platform. 
      • Net loss was $17.8 million in the second quarter, resulting in $0.23 net loss per share. Net loss excluding non-cash stock-based compensation expense for the second quarter was $13.8 million.
      • Net cash used in the quarter excluding financing was $13.6 million.
      • Signed an agreement in August 2022 to exchange $50 million of convertible debt due March 2023 for a term loan due in five years with no cash interest due during the term.  After this transaction, approximately $56 million of the original $172 million convertible debt remains due.

      Year-to-date 2022 Highlights

      • Net sales were $6.8 million year-to-date, compared to $5.3 million from the same period of the prior year, or a 28% increase.  Growth was driven by increases in both capital and recurring revenues.
      • Gross margin was 28% year-to-date, compared to 37% from the same period of the prior year.  The decline in gross margins resulted from ongoing pandemic-related impacts to manufacturing costs and other factors.
      • Selling, general, and administrative (SG&A) costs year-to-date were $22.2 million, compared to $26.9 million from the same period of the prior year.  SG&A costs excluding non-cash stock-based compensation were $16.5 million year to date, compared to $15.8 million from the same period of the prior year. This small increase was the result of higher professional services fees paid in the first quarter, partially offset by a decrease in the second quarter driven by cost savings efforts. 
      • Research and development (R&D) costs were $13.6 million year to date, compared to $12.6 million from the same period of the prior year.  R&D costs excluding non-cash stock-based compensation expense were $12.7 million year to date, compared to $8.6 million from the same period of the prior year.  This increase was the result of investment in our next generation AST platform.
      • Net loss was $32.0 million year to date, resulting in $0.44 net loss per share. Net loss excluding non-cash stock-based compensation expense was $25.0 million.
      • Net cash used excluding financing was $26.8 million
      • Ended the quarter with total cash, investments, and cash equivalents of $36.8 million.

      Full financial results for the quarter ending June 30, 2022 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

      To listen to the 2022 second quarter financial results, call by phone, +1.877.883.0383 and enter Elite Entry Number: 8181593. 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 5773022 until September 6, 2022.

      This conference call will also be webcast and can be accessed from the company's website at ir.axdx.com. A replay of the audio webcast will be available until November 15, 2022.

      Use of Non-GAAP Financial Measures

      This press release contains certain financial measures that are not recognized measures under accounting principles generally accepted in the United States of America ("GAAP"), which include SG&A, R&D, and Net income (loss) amounts excluding stock-based compensation expenses. 

      Our management and board of directors use expenses excluding the cost of stock-based compensation to understand and evaluate our operating performance and trends, to prepare and approve our annual budget and to develop short-term and long-term operating and financing plans. Accordingly, we believe that expenses excluding the cost of stock-based compensation provides useful information for investors in understanding and evaluating our operating results in the same manner as our management and our board of directors. Expenses excluding the cost of stock-based compensation is a non-GAAP financial measure and should be considered in addition to, not as superior to, or as a substitute for, SG&A expenses, R&D expenses, and net income (loss) reported in accordance with GAAP. The following tables present a reconciliation of SG&A expenses, R&D expenses and net income (loss) excluding stock-based compensation to comparable GAAP measures for the periods indicated:


      Three Months Ended June 30,

      Six Months Ended June 30,


      (in thousands)

      (in thousands)


      2022

      2021

      2022

      2021

      Sales, General and Administrative

      $         11,493

      $        12,910

      $         22,167

      $         26,938

      Non-cash equity-based compensation as a component of sales, general and administrative

      3,204

      5,188

      5,646

      11,180

      Sales, general and administrative less non-cash equity-based compensation

      $           8,289

      $          7,722

      $         16,521

      $         15,758





      Three Months Ended June 30,

      Six Months Ended June 30,


      (in thousands)

      (in thousands)


      2022

      2021

      2022

      2021

      Research and Development

      $                7,576

      $               5,733

      $              13,600

      $              12,629

      Non-cash equity-based compensation as a component of research and development

      539

      1,328

      901

      4,074

      Research and development less non-cash equity-based compensation

      $                7,037

      $               4,405

      $              12,699

      $                8,555







      Three Months Ended June 30,

      Six Months Ended June 30,


      (in thousands)

      (in thousands)


      2022

      2021

      2022

      2021

      Loss from operations

      $             (17,989)

      $            (17,590)

      $             (33,884)

      $             (37,616)

      Non-cash equity-based compensation as a component of loss from operations

      3,971

      6,590

      6,950

      15,429

      Loss from operations less non-cash equity-based compensation

      $             (14,018)

      $            (11,000)

      $             (26,934)

      $             (22,187)






      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 or may have forward looking implications, such as, among others, Mr. Phillip's statements regarding the hospital selling environment improving and the productivity of our research and development activities. 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 14, 2022, 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 SHEETS

      (in thousands, except share data)



      June 30,

      December 31,


      2022

      2021


      Unaudited


      ASSETS

      Current assets:



      Cash and cash equivalents

      $4,581

      $39,898

      Investments

      32,191

      23,720

      Trade accounts receivable, net

      2,935

      2,320

      Inventory

      5,304

      5,067

      Prepaid expenses

      1,429

      768

      Other current assets

      1,619

      1,558

      Total current assets

      48,059

      73,331

      Property and equipment, net

      4,097

      5,389

      Finance lease assets, net

      2,538

      —

      Operating lease right of use assets, net

      2,181

      2,510

      Other non-current assets

      1,851

      1,817

      Total assets

      $58,726

      $83,047

      LIABILITIES AND STOCKHOLDERS' DEFICIT

      Current liabilities:



      Accounts payable

      $2,221

      $1,983

      Accrued liabilities

      5,654

      2,853

      Accrued interest

      746

      909

      Deferred revenue

      335

      451

      Current portion of long-term debt

      84

      80

      Finance lease, current

      953

      —

      Operating lease, current

      732

      669

      Total current liabilities

      10,725

      6,945

      Finance lease, non-current

      1,383

      —

      Operating lease, non-current

      1,997

      2,381

      Other non-current liabilities

      757

      808

      Convertible notes

      105,828

      107,984

      Total liabilities

      $120,690

      $118,118




      Commitments and contingencies






      Stockholders' deficit:



      Preferred shares, $0.001 par value;



      5,000,000 preferred shares authorized and 3,954,546 outstanding as of June 30, 2022 and December 31, 2021

      4

      4

      Common stock, $0.001 par value;



      200,000,000 common shares authorized with 79,701,428 shares issued and outstanding on June 30, 2022 and 100,000,000 common shares authorized with 67,649,018 shares issued and outstanding on December 31, 2021

      80

      68

      Contributed capital

      560,185

      580,652

      Treasury stock

      (45,067)

      (45,067)

      Accumulated deficit

      (576,734)

      (570,668)

      Accumulated other comprehensive loss

      (432)

      (60)

      Total stockholders' deficit

      (61,964)

      (35,071)

      Total liabilities and stockholders' deficit

      $58,726

      $83,047

      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,


      2022

      2021


      2022

      2021

      Net sales

      $3,861

      $2,798


      $6,820

      $5,316







      Cost of sales

      2,781

      1,745


      4,937

      3,365

      Gross profit

      1,080

      1,053


      1,883

      1,951







      Costs and expenses:






      Research and development

      7,576

      5,733


      13,600

      12,629

      Sales, general and administrative

      11,493

      12,910


      22,167

      26,938

      Total costs and expenses

      19,069

      18,643


      35,767

      39,567







      Loss from operations

      (17,989)

      (17,590)


      (33,884)

      (37,616)







      Other income (expense):






      Interest expense

      (713)

      (4,177)


      (1,630)

      (8,267)

      Gain on extinguishment of debt

      919

      —


      3,565

      —

      Foreign currency exchange gain (loss)

      31

      —


      40

      (159)

      Interest income

      56

      12


      78

      55

      Other (expense) income, net

      (107)

      81


      (157)

      74

      Total other income (expense), net

      186

      (4,084)


      1,896

      (8,297)







      Net loss before income taxes

      (17,803)

      (21,674)


      (31,988)

      (45,913)

      Provision for income taxes

      —

      —


      —

      —

      Net loss

      $(17,803)

      $(21,674)


      $(31,988)

      $(45,913)







      Basic and diluted net loss per share

      $(0.23)

      $(0.36)


      $(0.44)

      $(0.77)

      Weighted average shares outstanding

      76,231

      61,049


      71,998

      59,790







      Other comprehensive loss:






      Net loss

      $(17,803)

      $(21,674)


      $(31,988)

      $(45,913)

      Net unrealized (loss) gain on debt securities available-for-sale

      (39)

      1


      (132)

      (18)

      Foreign currency translation adjustment

      (161)

      21


      (240)

      (60)

      Comprehensive loss

      $(18,003)

      $(21,652)


      $(32,360)

      $(45,991)

      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,


      2022

      2021

      Cash flows from operating activities:



      Net loss

      $(31,988)

      $(45,913)

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



      Depreciation and amortization

      1,435

      1,248

      Amortization of investment discount

      79

      97

      Equity-based compensation

      6,950

      15,429

      Amortization of debt discount and issuance costs

      284

      6,079

      Loss (gain) on disposal of property and equipment

      283

      (100)

      Unrealized loss on equity investments

      157

      —

      Gain on extinguishment of debt

      (3,565)

      —

      (Increase) decrease in assets:



      Contributions to deferred compensation plan

      (110)

      (236)

      Accounts receivable

      (615)

      (564)

      Inventory

      (416)

      (524)

      Prepaid expense and other

      (719)

      60

      Increase (decrease) in liabilities:



      Accounts payable

      658

      564

      Accrued liabilities

      2,288

      736

      Accrued interest

      (159)

      45

      Deferred revenue and income

      (116)

      (94)

      Deferred compensation

      (51)

      245

      Net cash used in operating activities

      (25,605)

      (22,928)




      Cash flows from investing activities:



      Purchases of equipment

      (447)

      (29)

      Purchase of marketable securities

      (27,504)

      (15,699)

      Maturities of marketable securities

      18,738

      23,993

      Net cash (used in) provided by investing activities

      (9,213)

      8,265




      Cash flows from financing activities:



      Proceeds from issuance of common stock

      —

      22,122

      Payments on finance leases

      (424)

      —

      Proceeds from exercise of options

      7

      1,222

      Proceeds from issuance of common stocks under employee purchase plan

      137

      161

      Net cash (used in) provided by financing activities

      (280)

      23,505




      Effect of exchange rate on cash

      (219)

      (43)




      (Decrease) increase in cash and cash equivalents

      (35,317)

      8,799

      Cash and cash equivalents, beginning of period

      39,898

      35,781

      Cash and cash equivalents, end of period

      $4,581

      $44,580

      See accompanying notes to condensed consolidated financial statements.

      ACCELERATE DIAGNOSTICS, INC.

      CONDENSED CONSOLIDATED

      STATEMENTS OF CASH FLOWS (CONTINUED)

      Unaudited

      (in thousands)



      Six Months Ended


      June 30,

      June 30,


      2022

      2021

      Non-cash investing activities:



      Net transfer of instruments from inventory to property and equipment

      $202

      $500

      Supplemental cash flow information:



      Interest paid

      $1,506

      $2,144

      Extinguishment of Convertible Senior Notes through issuance of common stock

      $10,180

      $—

      See accompanying notes to condensed consolidated financial statements.

      SOURCE Accelerate Diagnostics, Inc.

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