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.

Accelerate Diagnostics, Inc. (PRNewsfoto/Accelerate Diagnostics)

"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.

 

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SOURCE Accelerate Diagnostics, Inc.

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