0001104659-20-026168.txt : 20200227 0001104659-20-026168.hdr.sgml : 20200227 20200227160748 ACCESSION NUMBER: 0001104659-20-026168 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20200227 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20200227 DATE AS OF CHANGE: 20200227 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: 20662013 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 tm2011141d1_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) February 27, 2020

 

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 February 27, 2020, Accelerate Diagnostics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ending December 31, 2019 and full-year 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 February 27, 2020
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.

 

 

ACCELERATE DIAGNOSTICS, INC.

(Registrant)

Date: February 27, 2020  
   
  /s/ Steve Reichling
 

Steve Reichling

Chief Financial Officer

 

 

 

 EX-99.1 2 tm2011141d1_ex99-1.htm EXHIBIT 99.1

EXHIBIT 99.1

 

Accelerate Diagnostics Reports Fourth Quarter 2019 Financial Results

 

TUCSON, Ariz., February 27, 2020 -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX) today announced financial results for the fourth quarter and full year ended December 31, 2019.

 

“Our contracted instrument trajectory continued over the course of 2019 as we doubled our global contracted instrument base by signing 304 instruments, including 137 units during the fourth quarter. Our full-year revenue was short of expectations as multi-site customers in the U.S. have taken longer than anticipated to go live and begin generating consumable revenue,” said Jack Phillips, president and chief executive officer of Accelerate Diagnostics, Inc. “One of my initial areas of focus was to evaluate and re-engineer our go-live process, and I am confident the resulting improvements will help relieve our 255 U.S. instrument backlog and make the process quicker and more predictable. For clinically live accounts, I am encouraged that annual annuities are approximately $45k, proving to be predictable, and these customers are enthusiastic about the outcomes they are realizing.”

  

Fourth Quarter 2019 Highlights

 

·Added 137 net new commercially contracted instruments, compared to 133 in the fourth quarter of 2018.

 

·Net sales of $3.5 million, compared to $1.8 million in the fourth quarter of 2018, or 94% year-over-year growth.

 

·Gross margin was 44% for the quarter, compared to 29% in the fourth quarter of 2018. This increase was the result of lower consumable production costs per unit as production volumes increase. Certain perishable raw materials exceeded expiration and required disposal in the quarter. Excluding the impact of this charge, gross margin for the fourth quarter was 51%.

 

·Research and development (R&D) costs for the quarter were $6.2 million, compared to $6.9 million in the fourth quarter of 2018. We expected this spend to remain relatively flat on a year-over-year basis, as our R&D programs remain consistent.

 

·Selling, general, and administrative expenses for the quarter were $13.6 million, compared to $13.4 million in the fourth quarter of 2018. These expenses remained relatively unchanged on a year-over-year basis.

 

·Net loss was $21.3 million in the fourth quarter, or $0.39 per share, which included $3.2 million in non-cash stock-based compensation expense.

 

·Net cash used in the quarter was $13.5 million, and the company ended the quarter with total cash, investments, and cash equivalents of $108.5 million.

  

Full Year 2019 Highlights

 

·Added 304 net new commercially contracted instruments year to date, compared to 202 in 2018.

 

·Net sales of $9.3 million, compared to $5.7 million in 2018, or 63% year over year growth.

 

·Gross margin was 47%, compared to 44% in 2018. This increase was the result of lower consumable production costs per unit as production volumes increase. Certain perishable raw materials exceeded expiration and required disposal in the fourth quarter. Excluding the impact of this charge, gross margin for the year was 53%.

 

·Selling, general, and administrative expenses were $51.9 million, compared to $55.2 million in 2018. This decrease was driven by lower stock-based compensation expense in the current year.

 

·Research and development (R&D) costs were $25.3 million, compared to $27.6 million in 2018. We expected this spend to remain relatively flat on a year-over-year basis, as our R&D programs remain consistent.

 

·Net loss was $84.3 million, or $1.55 per share, which included $12.6 million in non-cash stock-based compensation expense.

 

·Net cash used was $58.0 million, and the company ended the year with total cash, investments, and cash equivalents of $108.5 million.

  

Full financial results for the quarter and year ending December 31, 2019 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 first quarter results. To listen to the conference call, dial +1.877.883.0383 and enter the conference ID: 2860141. 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 10138283 until May 19, 2020.

 

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 19, 2020.

  

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 those, among others, about the company’s placement trajectory, our belief that our re-engineered go-live process will make our implementation process quicker and more predictable, thereby relieving our backlog, our belief that annual annuities will average approximately $45,000, our expectation that customers will be enthusiastic about clinical results, and our expectation that R&D expenses will be relatively flat from 2019 to 2020. 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.

 

###

 

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.

CONSOLIDATED

BALANCE SHEETS

(in thousands, except share data)

 

   December 31, 
   2019   2018 
ASSETS          
Current assets:          
Cash and cash equivalents  $61,014   $66,260 
Investments   47,437    100,218 
Trade accounts receivable   3,222    1,860 
Inventory   8,059    7,746 
Prepaid expenses   955    980 
Other current assets   1,165    576 
Total current assets   121,852    177,640 
Property and equipment, net   7,905    7,303 
Right of use assets   3,917    — 
Other non-current assets   750    322 
Total assets  $134,424   $185,265 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
Current liabilities:          
Accounts payable  $2,351   $1,322 
Accrued liabilities   3,828    4,962 
Accrued interest   1,262    1,262 
Deferred revenue   271    217 
Current operating lease liability   450    — 
Total current liabilities   8,162    7,763 
Non-current operating lease liability   3,579    — 
Other non-current liabilities   19    53 
Convertible notes   130,043    120,074 
Total liabilities   141,803    127,890 
           
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, 2019 and 2018   —    — 
Common stock, $0.001 par value;          
85,000,000 common shares authorized with 54,708,792 shares issued and outstanding on December 31, 2019 and 75,000,000 common shares authorized with 54,231,876 shares issued and outstanding on December 31, 2018   55    54 
Contributed capital   452,344    432,885 
Treasury stock   (45,067)   (45,067)
Accumulated deficit   (414,653)   (330,348)
Accumulated other comprehensive loss   (58)   (149)
Total stockholders' equity (deficit)   (7,379)   57,375 
Total liabilities and stockholders' equity (deficit)  $134,424   $185,265 

  

See accompanying notes to consolidated financial statements.

 

 

 

 

 

ACCELERATE DIAGNOSTICS, INC.

CONSOLIDATED

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except per share data)

 

   Years Ended December 31, 
   2019   2018   2017 
Net sales  $9,297   $5,670   $4,177 
                
Cost of sales   4,897    3,187    1,002 
Gross profit   4,400    2,483    3,175 
                
Costs and expenses:               
Research and development   25,345    27,638    22,301 
Sales, general and administrative   51,886    55,214    45,058 
Total costs and expenses   77,231    82,852    67,359 
                
Loss from operations   (72,831)   (80,369)   (64,184)
                
Other income (expense):               
Interest expense   (14,256)   (10,113)   — 
Foreign currency exchange loss   (124)   (450)   (75)
Interest and dividend income   2,809    2,845    908 
Other expense, net   (14)   (28)   (184)
Total other income (expense), net   (11,585)   (7,746)   649 
                
Net loss before income taxes   (84,416)   (88,115)   (63,535)
Benefit (provision) for income taxes   111    (211)   (493)
Net loss  $(84,305)  $(88,326)  $(64,028)
                
Basic and diluted net loss per share  $(1.55)  $(1.62)  $(1.18)
Weighted average shares outstanding   54,506    54,494    54,073 
                
Other comprehensive loss:               
Net loss  $(84,305)  $(88,326)  $(64,028)
Net unrealized gain (loss) on available-for-sale investments   193    23    (117)
Foreign currency translation adjustment   (102)   (172)   321 
Comprehensive loss  $(84,214)  $(88,475)  $(63,824)

 

See accompanying notes to consolidated financial statements.

 

 

 

  

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, 2017   51,516   $52   $255,257   $(177,289)  $—   $(204)  $77,816 
Net loss   —    —    —    (64,028)   —    —    (64,028)
Issuance of common stock   3,085    3    83,221    —    —    —    83,224 
Exercise of options and warrants   1,045    1    6,605    —    —    —    6,606 
Issuance of common stock under employee purchase plan   28    —    597    —    —    —    597 
Unrealized loss on available-for-sale securities   —    —    —    —    —    (117)   (117)
Foreign currency translation adjustment   —    —    —    —    —    321    321 
Cumulative impact of accounting change   —    —    —    (655)   —    —    (655)
Equity-based compensation   —    —    14,940    —    —    —    14,940 
Balances, December 31, 2017   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)

  

See accompanying notes to consolidated financial statements.

 

 

 

 

 

ACCELERATE DIAGNOSTICS, INC.

CONSOLIDATED

STATEMENT OF CASH FLOWS

(in thousands)

 

   Years Ended December 31, 
   2019   2018   2017 
Cash flows from operating activities:               
Net loss  $(84,305)  $(88,326)  $(64,028)
Adjustments to reconcile net loss to net cash used in operating activities:               
Depreciation and amortization   2,602    2,561    2,196 
Amortization of investment discount   (427)   (621)   326 
Equity-based compensation expense   12,618    14,422    13,933 
Amortization of debt discount and issuance costs   9,969    6,849    — 
Loss on disposal of property and equipment   837    678    240 
(Increase) decrease in assets:               
Accounts receivable   (1,362)   86    (1,912)
Inventory   (3,655)   (4,223)   (7,759)
Prepaid expense and other assets   (752)   (250)   (459)
Increase (decrease) in liabilities:               
Accounts payable   988    (748)   1,064 
Accrued liabilities   (1,327)   1,426    596 
Accrued interest   —    1,262    — 
Deferred revenue and income   54    (904)   36 
Deferred compensation   (34)   32    21 
Net cash used in operating activities   (64,794)   (67,756)   (55,746)
Cash flows from investing activities:               
Purchases of equipment   (330)   (998)   (2,966)
Purchase of marketable securities   (50,226)   (120,556)   (82,333)
Proceeds from sales of marketable securities   14,500    3,000    11,522 
Maturities of marketable securities   88,867    98,416    48,049 
Net cash provided by (used in) investing activities   52,811    (20,138)   (25,728)
Cash flows from financing activities:               
Proceeds from issuance of common stock   1,458    583    83,821 
Proceeds from exercise of options and warrants   5,365    3,749    6,606 
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   6,823    125,771    90,427 
                
Effect of exchange rate on cash   (86)   (130)   316 
                
Increase (decrease) in cash and cash equivalents   (5,246)   37,747    9,269 
Cash and cash equivalents, beginning of period   66,260    28,513    19,244 
Cash and cash equivalents, end of period  $61,014   $66,260   $28,513 

 

See accompanying notes to consolidated financial statements.

 

 

 

 

 

ACCELERATE DIAGNOSTICS, INC.

CONSOLIDATED

STATEMENT OF CASH FLOWS (CONTINUED)

(in thousands)

 

   Years Ended December 31, 
   2019   2018   2017 
Non-cash investing activities:               
Transfer of instruments from inventory to property and equipment  $3,361   $4,767   $— 
Supplemental cash flow information:               
Interest paid  $4,288   $2,001   $— 
Income taxes paid, net of refunds  $41   $651   $— 

  

See accompanying notes to consolidated financial statements.

 

 

 

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Cover
Feb. 27, 2020
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Feb. 27, 2020
Entity File Number 001-31822
Entity Registrant Name Accelerate Diagnostics, Inc.
Entity Central Index Key 0000727207
Entity Tax Identification Number 84-1072256
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 3950 South Country Club Road
Entity Address, Address Line Two Suite 470
Entity Address, City or Town Tucson
Entity Address, State or Province AZ
Entity Address, Postal Zip Code 85714
City Area Code 520
Local Phone Number 365-3100
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.001 par value per share
Trading Symbol AXDX
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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