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

TUCSON, Ariz., Feb. 23, 2021 /PRNewswire/ -- Accelerate Diagnostics, Inc. 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.

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