0001104659-19-061079.txt : 20191107 0001104659-19-061079.hdr.sgml : 20191107 20191107160039 ACCESSION NUMBER: 0001104659-19-061079 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20191107 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20191107 DATE AS OF CHANGE: 20191107 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Accelerate Diagnostics, Inc CENTRAL INDEX KEY: 0000727207 STANDARD INDUSTRIAL CLASSIFICATION: LABORATORY ANALYTICAL INSTRUMENTS [3826] IRS NUMBER: 841072256 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-31822 FILM NUMBER: 191200165 BUSINESS ADDRESS: STREET 1: 3950 S. COUNTRY CLUB ROAD #470 STREET 2: BUILDING 3-307 CITY: TUCSON STATE: AZ ZIP: 85714 BUSINESS PHONE: 303-863-8088 MAIL ADDRESS: STREET 1: 3950 S. COUNTRY CLUB ROAD #470 STREET 2: BUILDING 3-307 CITY: TUCSON STATE: AZ ZIP: 85714 FORMER COMPANY: FORMER CONFORMED NAME: ACCELR8 TECHNOLOGY CORP DATE OF NAME CHANGE: 19920703 FORMER COMPANY: FORMER CONFORMED NAME: HYDRO SEEK INC DATE OF NAME CHANGE: 19880802 8-K 1 tm1922209d1_8k.htm FORM 8-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported) November 7, 2019

 

Accelerate Diagnostics, Inc.
(Exact name of registrant as specified in its charter)
 
Delaware
(State or other jurisdiction of incorporation)

 

001-31822 84-1072256
(Commission File Number) (IRS Employer Identification No.)
   
3950 South Country Club Road, Suite 470, Tucson, Arizona 85714
(Address of principal executive offices) (Zip Code)

 

(520) 365-3100
(Registrant’s telephone number, including area code)
 
Not Applicable
(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol Name of each exchange on which registered
Common Stock, $0.001 par value per share AXDX

The Nasdaq Stock Market LLC

(The Nasdaq Capital Market)

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

Item 2.02Results of Operations and Financial Condition.

 

On November 7, 2019, Accelerate Diagnostics, Inc. (the “Company”) issued a press release announcing its financial results of operations for the quarter ending September 30, 2019. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference in its entirety.

 

In accordance with General Instruction B.2 for Form 8-K, the information in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01Financial Statements and Exhibits.

 

(d)Exhibits.

 

Exhibit  
Number Description                                                                 
   
99.1

Press Release, dated November 7, 2019

   
104

Cover Page Interactive Data File (cover page XBRL tags are embedded within the Inline XBRL document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

Date: November 7, 2019

ACCELERATE DIAGNOSTICS, INC.

(Registrant)

 

/s/ Steve Reichling                          

Steve Reichling

Chief Financial Officer

 

 

 

 

 

 

 

 EX-99.1 2 tm1922209d1_ex99-1.htm EXHIBIT 99.1

EXHIBIT 99.1

 

Accelerate Diagnostics Reports Third Quarter 2019 Financial Results

 

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

 

“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.

 

###

 

Investor Inquiries:

Laura Pierson, Accelerate Diagnostics, +1 520 365-3100, investors@axdx.com

 

Media Contact:

Andrew Chasteen, Accelerate Diagnostics, +1 520 365-3100, achasteen@axdx.com

 

Source: Accelerate Diagnostics Inc.

 

 

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.

 

 

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