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Accelerate Diagnostics Reports Third Quarter 2019 Financial Results

TUCSON, Ariz., Nov. 7, 2019 /PRNewswire/ -- Accelerate Diagnostics, Inc. (AXDX) today announced financial results for the third quarter ended September 30, 2019.

Accelerate Diagnostics, Inc. (PRNewsfoto/Accelerate Diagnostics)

"Our placement and revenue results for the third quarter came in below our expectations due to an elongated sales cycle and the timing of commercial go-lives during the quarter," said Larry Mehren, president and chief executive officer of Accelerate Diagnostics, Inc. "However, we saw several encouraging signs of improvement during the quarter, including a record number of go-lives in September, an increasingly robust sales funnel and continued progress with our respiratory trial and in China. As momentum in placements and go-lives continues to improve, we remain on pace to achieve the low end of our 300-400 placement target. Looking ahead, we acknowledge the need for greater consistency and predictability in our results, and we are focused on improving our commercial execution under Jack Phillip's leadership, as we continue our pursuit of bringing Accelerate's life-saving technology to as many patients as possible worldwide."

Third Quarter 2019 Highlights

  • Added 37 net new commercially contracted instruments, compared to 29 in the third quarter of 2018.
  • Net sales of $2.3 million, compared to $1.4 million in the third quarter of 2018. Instrument revenue decreased year-over-year, reflecting the Company's introduction of a reagent rental business model in September of 2018. Consumable revenue grew by over 175% as compared to the third quarter of 2018 and by approximately 15% over the prior quarter.
  • Gross margin was 51% for the quarter, compared to 50% in the third quarter of 2018. This small increase was the result of lower consumable production costs per unit as production volumes increase.
  • Selling, general, and administrative expenses for the quarter were $12.7 million, compared to $12.2 million in the third quarter of 2018. This increase was driven by higher non-cash equity-based compensation expense.
  • Research and development (R&D) costs for the quarter were $6.1 million, compared to $7.9 million in the third quarter of 2018.  This decrease was the result of lower employee non-cash equity-based compensation expense.
  • Net loss was $20.4 million in the third quarter, or $0.37 per share, which included $3.1 million in non-cash stock-based compensation expense.
  • Net cash used in the quarter was $15.9 million, and the company ended the quarter with total cash, investments, and cash equivalents of $122.0 million.

Year-to-Date 2019 Highlights

  • Added 167 net new commercially contracted instruments year to date, compared to 69 for the same period from 2018.
  • Net sales of $5.8 million, compared to $3.8 million for the same period from 2018. Consumable revenue grew by over 150% through the first three quarters of 2019, compared to the same period in the prior year.
  • Gross margin was 50%, compared to 51% for the same period from 2018. This small decrease was the result of inventory timing items that did not repeat in the current year. After normalizing for the effect of these pre-FDA instrument inventory previously written off to R&D, gross margin improved by 500 basis points year-to-date due to higher consumable production levels.
  • Selling, general, and administrative expenses were $38.3 million year to date, compared to $41.8 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 $19.1 million year to date, compared to $20.7 million for the same period from 2018. This decrease was the result of lower employee non-cash equity-based compensation expense.
  • Net loss was $63.0 million year to date, or $1.16 per share, which included $9.4 million in non-cash stock-based compensation expense.
  • Net cash used year to date was $44.5 million, and the company ended the quarter with total cash, investments, and cash equivalents of $122.0 million.

Full financial results for the quarter ending September 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 first quarter results. To participate in the conference call, dial +1.877.883.0383 and enter the conference ID: 2508360. 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 10136055 until November 28, 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 November 28, 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™ 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

This press release contains forward-looking statements, which are subject to risks and uncertainties, including those described in our periodic reports and other filings with the U.S. Securities and Exchange Commission (the "SEC"). Examples of forward-looking statements include our belief that our fourth quarter momentum and sales will enable us to achieve the low end of our range for 2019 placements, and the implication that new sales management will lead to improved sales execution. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Anticipated results only reflect information available to us at this time and may differ from actual results. Except as required by federal securities laws, we undertake 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)





September 30,

December 31,


2019

2018


Unaudited


ASSETS

Current assets:



Cash and cash equivalents

$

92,938


$

66,260


Investments

28,978


100,218


Trade accounts receivable

2,642


1,860


Inventory

7,881


7,746


Prepaid expenses

1,163


980


Other current assets

793


576


Total current assets

134,395


177,640


Property and equipment, net

8,566


7,303


Right of use assets

3,834



Other non-current assets

483


322


Total assets

$

147,278


$

185,265


LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:



Accounts payable

$

2,281


$

1,322


Accrued liabilities

2,985


4,962


Accrued interest

191


1,262


Deferred revenue

250


217


Current operating lease liability

421



Total current liabilities

6,128


7,763


Non-current operating lease liability

3,458



Other non-current liabilities

28


53


Convertible notes

127,444


120,074


Total liabilities

$

137,058


$

127,890


Commitments and contingencies






Stockholders' equity:



Preferred shares, $0.001 par value;



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



Common stock, $0.001 par value;



85,000,000 common shares authorized with 54,641,187 shares issued and outstanding on September 30, 2019 and 75,000,000 common shares authorized with 54,231,876 shares issued and outstanding on December 31, 2018

55


54


Contributed capital

448,609


432,885


Treasury stock

(45,067)


(45,067)


Accumulated deficit

(393,318)


(330,348)


Accumulated other comprehensive loss

(59)


(149)


Total stockholders' equity

10,220


57,375


Total liabilities and stockholders' equity

$

147,278


$

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


Nine Months Ended


September 30,

September 30,


September 30,

September 30,


2019

2018


2019

2018

Net sales

$

2,271


$

1,355



$

5,827


$

3,848








Cost of sales

1,117


680



2,940


1,889


Gross profit

1,154


675



2,887


1,959








Costs and expenses:






Research and development

6,064


7,891



19,145


20,734


Sales, general and administrative

12,743


12,153



38,302


41,835


Total costs and expenses

18,807


20,044



57,447


62,569








Loss from operations

(17,653)


(19,369)



(54,560)


(60,610)








Other income (expense):






Interest expense

(3,598)


(3,357)



(10,585)


(6,720)


Foreign currency exchange loss

(89)


(133)



(142)


(331)


Interest income

676


908



2,329


1,983


Other expense, net

(9)




(12)


(25)


Total other expense, net

(3,020)


(2,582)



(8,410)


(5,093)








Net loss before income taxes

(20,673)


(21,951)



(62,970)


(65,703)


Benefit (provision) for income taxes

239


(147)




(432)


Net loss

$

(20,434)


$

(22,098)



$

(62,970)


$

(66,135)








Basic and diluted net loss per share

$

(0.37)


$

(0.41)



$

(1.16)


$

(1.21)


Weighted average shares outstanding

54,553


54,145



54,456


54,591








Other comprehensive loss:






Net loss

$

(20,434)


$

(22,098)



$

(62,970)


$

(66,135)


Net unrealized gain (loss) on available-for-sale investments

10


1



229


(54)


Foreign currency translation adjustment

(113)


(26)



(139)


(105)


Comprehensive loss

$

(20,537)


$

(22,123)



$

(62,880)


$

(66,294)


 

See accompanying notes to condensed consolidated financial statements.

 

ACCELERATE DIAGNOSTICS, INC.

CONDENSED CONSOLIDATED

STATEMENTS OF CASH FLOWS

Unaudited

(in thousands)




Nine Months Ended


September 30,

September 30,


2019

2018

Cash flows from operating activities:



Net loss

$

(62,970)


$

(66,135)


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



Depreciation and amortization

1,862


1,749


Amortization of investment discount

(400)


(413)


Equity-based compensation

9,409


12,476


Amortization of debt discount and issuance costs

7,370


4,529


Loss on disposal of property and equipment

577


540


(Increase) decrease in assets:



Accounts receivable

(782)


506


Inventory

(3,286)


(5,206)


Prepaid expense and other

(319)


(212)


Increase (decrease) in liabilities:



Accounts payable

788


(524)


Accrued liabilities, and other

(2,115)


(18)


Accrued interest

(1,071)


191


Deferred revenue and income

33


(918)


Deferred compensation

(25)


5


Net cash used in operating activities

(50,929)


(53,430)


Cash flows from investing activities:



Purchases of equipment

(148)


(842)


Purchase of marketable securities

(20,710)


(115,634)


Proceeds from sales of marketable securities

13,400


3,000


Maturities of marketable securities

78,922


74,496


Net cash provided by (used in) investing activities

71,464


(38,980)


Cash flows from financing activities:



Proceeds from issuance of common stock

1,363


447


Proceeds from exercise of options

4,879


3,710


Proceeds from issuance of convertible note


171,500


Prepayment of forward stock repurchase transaction


(45,069)


Payment of debt issuance costs


(4,992)


Net cash provided by financing activities

6,242


125,596





Effect of exchange rate on cash

(99)


(77)





Increase in cash and cash equivalents

26,678


33,109


Cash and cash equivalents, beginning of period

66,260


28,513


Cash and cash equivalents, end of period

$

92,938


$

61,622


 

See accompanying notes to condensed consolidated financial statements.

 

Cision

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