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

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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

Stock

Amount

Contributed

Capital

Accumulated
Deficit

Treasury

stock

Accumulated

Other

Comprehensive

Income (Loss)

Total

Stockholders'

Equity (Deficit)

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.

Accelerate Diagnostics Inc

NASDAQ:AXDX

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Analytical Laboratory Instrument Manufacturing
Manufacturing
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Health Technology, Biotechnology, Medical Specialties, Manufacturing, Analytical Laboratory Instrument Manufacturing
US
Tucson

About AXDX

accelerate diagnostics, inc. (nasdaq:axdx), is an in vitro diagnostics company focused on developing and commercializing innovative systems for the rapid identification and antimicrobial susceptibility testing of infectious pathogens. the company's revolutionary id/ast platform utilizes a proprietary process with both genomic and phenotypic detection technologies that significantly decreases time to result while achieving high sensitivity and specificity. in addition to the id/ast development pipeline, the company also owns and licenses its proprietary optichem™ surface coatings technology, which has numerous applications for binding in bio-analytical systems, such as microarrays.