0001104659-22-031513.txt : 20220308 0001104659-22-031513.hdr.sgml : 20220308 20220308161157 ACCESSION NUMBER: 0001104659-22-031513 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20220308 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220308 DATE AS OF CHANGE: 20220308 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: 22721853 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 tm228658d1_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) March 8, 2022

 

Accelerate Diagnostics, Inc.

(Exact name of registrant as specified in 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 2.02.Results of Operations and Financial Condition.

 

On March 8, 2022, Accelerate Diagnostics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and full-year ending December 31, 2021. 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, date March 8, 2022
     
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: March 8, 2022  
  /s/ Steve Reichling
  Steve Reichling
  Chief Financial Officer

 

 

 EX-99.1 2 tm228658d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

  

Accelerate Diagnostics Reports Fourth Quarter and Full-Year 2021 Financial Results

 

TUCSON, Ariz., March 8, 2022 -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX) today announced financial results for the fourth quarter and full year ended December 31, 2021.

 

Jack Phillips, Chief Executive Officer of Accelerate Diagnostics, Inc, commented, " the addition of new contracts, clinically live customers, and new prospects to our sales funnel, made the fourth quarter our most commercially productive quarter of the year. Strong R&D execution in 2021 has enabled the sale and early marketing of our expanded product portfolio. The new PhenoAST Test Kit is being well received in the market, and customer interest for Accelerate Arc is accelerating ahead of our launch later this month. We expect continued improvement in our level of commercial activity on the back of strong interest in these new products and an improved hospital environment in 2022.”

  

Fourth Quarter 2021 Highlights

 

·Added 16 contracted instruments in the quarter and brought 13 instruments live in the U.S.

 

·Additionally, contracted 14 Pheno instruments with distributors and new customers in EMEA in the quarter.

 

·Ended the fourth quarter with 313 U.S. live revenue-generating instruments, with another 81 U.S. contracted Pheno instruments not yet live.

 

·Net sales of $3.3 million, compared to $3.1 million in the fourth quarter of 2020, or a 6% increase.

 

·Gross margin excluding non-cash adjustments to inventory valuation was 35% for the quarter, compared to 37% in the fourth quarter of 2020. This decrease was the result of pandemic-related effects on manufacturing.

 

·Selling, general, and administrative expenses for the quarter were $11.5 million, compared to $11.2 million in the fourth quarter of 2020. This slight increase was driven by the timing of spend related to sales and marketing.

 

·Research and development (R&D) costs for the quarter were $4.6 million, compared to $5.1 million in the fourth quarter of 2020. This decrease was the result of Arc costs decreasing in the period partially offset by increases in Pheno II program investment.

 

·Net loss was $22.8 million in the fourth quarter, or $0.34 per share, which included $3.0 million in non-cash stock-based compensation expense and $4.5 million from a non-cash inventory write-down. Net loss excluding non-cash charges was $15.3 million in the fourth quarter, or $0.23 per share.

 

·Net cash used in the quarter was $13.3 million, and the company ended the quarter with total cash, investments, and cash equivalents of $63.6 million.

 

2021 Full Year Highlights

 

·Net sales were $11.8 million for the year as compared to $11.2 million from the same period in the prior year, or 5% growth.

 

·Gross margin excluding non-cash adjustments to inventory valuation was 35% for the year, compared to 40% for the prior year. This decrease was the result of pandemic-related effects on manufacturing.

 

·Selling, general, and administrative expenses were $49.2 million for the year, compared to $46.9 million in 2020. This increase was driven by increases to non-cash stock-based compensation expense. Excluding this non-cash expense, SG&A decreased year-over-year due to cost savings initiatives.

 

·Research and development (R&D) costs were $21.9 million year-to-date, compared to $21.3 million in 2020. This slight increase was the result of costs to complete Arc development and Pheno II program investment.

 

·Net loss was $77.7 million, or $1.26 per share, which included $22.0 million in non-cash stock-based compensation expense and a $4.5 million non-cash inventory write-down. Net loss excluding non-cash charges was $51.2 million, or $0.83 per share.

 

·Net cash used was $47.2 million, and the company ended the year with total cash, investments, and cash equivalents of $63.6 million.

  

Full financial results for the year ending December 31, 2021, 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 2021 results. To listen to the 2021 fourth quarter and full year 2021 financial results call by phone, +1.877.883.0383 and enter Elite Entry Number: 8732862.  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 7365004 until March 29, 2022.

 

This conference call will also be webcast and can be accessed from the “Investors” section of the company’s website at ir.axdx.com. A replay of the audio webcast will be available until June 8, 2022.

 

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 “ACCELERATE ARC” 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 strong research and development initiatives enabling sales of new products, customer interest in PhenoAST and Accelerate Arc leading to future sales, the expected launch of the Accelerate Arc instrument in March 2022, and our expectation for improved commercial activity because of strong interest in our new products and an improved hospital environment in 2022. 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 2, 2021, 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.

 

###

 

For further information: Investor Inquiries & Media Contact: Laura Pierson, Accelerate Diagnostics, +1 520 365-3100, investors@axdx.com

 

Source: Accelerate Diagnostics Inc.

 

 

 

 

ACCELERATE DIAGNOSTICS, INC.

CONSOLIDATED

BALANCE SHEETS

(in thousands, except share data)

 

   December 31, 
   2021   2020 
ASSETS
Current assets:          
Cash and cash equivalents  $39,898   $35,781 
Investments   23,720    32,488 
Trade accounts receivable   2,320    1,550 
Inventory   5,067    9,216 
Prepaid expenses   768    1,172 
Other current assets   1,558    1,780 
Total current assets   73,331    81,987 
Property and equipment, net   5,389    6,135 
Right of use assets   2,510    3,183 
Other non-current assets   1,817    2,120 
Total assets  $83,047   $93,425 
           
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:          
Accounts payable  $1,983   $1,290 
Accrued liabilities   2,853    2,991 
Accrued interest   909    1,262 
Deferred revenue   451    376 
Current portion of long-term debt   80    553 
Current operating lease liability   669    497 
Total current liabilities   6,945    6,969 
Non-current operating lease liability   2,381    3,063 
Other non-current liabilities   808    335 
Long-term debt   —    4,659 
Convertible notes   107,984    141,211 
Total liabilities   118,118    156,237 
           
Commitments and contingencies          
           
Stockholders' deficit:          
Preferred shares, $0.001 par value;          
5,000,000 preferred shares authorized and 3,954,546 outstanding as of December 31, 2021 and 5,000,000 preferred shares authorized and none outstanding as of December 31, 2020   4    — 
Common stock, $0.001 par value;          
100,000,000 common shares authorized with 67,649,018 shares issued and outstanding on December 31, 2021 and 85,000,000 common shares authorized with 57,607,939 shares issued and outstanding on December 31, 2020   68    58 
Contributed capital   580,652    475,072 
Treasury stock   (45,067)   (45,067)
Accumulated deficit   (570,668)   (492,966)
Accumulated other comprehensive loss   (60)   91 
Total stockholders' deficit   (35,071)   (62,812)
Total liabilities and stockholders' deficit  $83,047   $93,425 

 

 

 

 

ACCELERATE DIAGNOSTICS, INC.

CONSOLIDATED

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except per share data)

 

   Years Ended December 31, 
   2021   2020   2019 
Net sales  $11,782   $11,165   $9,297 
                
Cost of sales:               
Cost of sales of products and services   7,663    6,706    4,897 
Inventory write-down   4,500    —    — 
Total cost of sales   12,163    6,706    4,897 
                
Gross profit   (381)   4,459    4,400 
                
Costs and expenses:               
Research and development   21,943    21,255    25,345 
Sales, general and administrative   49,236    46,904    51,886 
Total costs and expenses   71,179    68,159    77,231 
                
Loss from operations   (71,560)   (63,700)   (72,831)
                
Other income (expense):               
Interest expense   (15,545)   (15,550)   (14,256)
Gain on extinguishment of debt   9,793    —    — 
Foreign currency exchange (loss) gain   (413)   252    (124)
Interest and dividend income   88    855    2,809 
Other expense, net   (20)   (60)   (14)
Total other expense, net   (6,097)   (14,503)   (11,585)
                
Net loss before income taxes   (77,657)   (78,203)   (84,416)
(Provision) benefit for income taxes   (45)   (5)   111 
Net loss  $(77,702)  $(78,208)  $(84,305)
                
Basic and diluted net loss per share  $(1.26)  $(1.40)  $(1.55)
Weighted average shares outstanding   61,727    56,010    54,506 
                
Other comprehensive loss:               
Net loss  $(77,702)  $(78,208)  $(84,305)
Net unrealized (loss) gain on investments   (34)   (2)   193 
Foreign currency translation adjustment   (117)   151    (102)
Comprehensive loss  $(77,853)  $(78,059)  $(84,214)

 

 

 

 

 

ACCELERATE DIAGNOSTICS, INC.

CONSOLIDATED

STATEMENTS OF STOCKHOLDERS’ DEFICIT

(in thousands)

 

  

Preferred

Shares

  

Preferred

Stock

Amount

  

Common

Shares

  

Common

Stock

Amount

  

Contributed

Capital

   Accumulated Deficit  

Treasury

stock

  

Accumulated

Other

Comprehensive

Income (Loss)

  

Total

Stockholders’

Equity (Deficit)

 
Balances, January 1, 2019   —    —    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 investments   —    —    —    —    —    —    —    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 gain on investments   —    —    —    —    —    —    —    (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)
Net loss   —    —    —    —    —    (77,702)   —    —    (77,702)
Issuance of common stock   —    —    4,937    5    32,400    —    —    —    32,405 
Exchange of common stock for preferred   —    —    (2,643)   (3)   (20,297)   —    —    —    (20,300)
Issuance of preferred stock   3,955    4    —    —    30,446    —    —    —    30,450 
Exercise of options and restricted stock awards issued   —    —    1,090    1    1,619    —    —    —    1,620 
Issuance of common stock under employee purchase plan   —    —    54    —    326    —    —    —    326 
Unrealized loss on investments   —    —    —    —    —    —    —    (34)   (34)
Foreign currency translation adjustment   —    —    —    —    —    —    —    (117)   (117)
Issuance of shares in exchange for Convertible Senior Notes   —    —    6,603    7    38,896    —    —    —    38,903 
Equity-based compensation   —    —    —    —    22,190    —    —    —    22,190 
Balances, December 31, 2021  $3,955   $4   $67,649   $68   $580,652   $(570,668)  $(45,067)  $(60)  $(35,071)

 

 

 

 

ACCELERATE DIAGNOSTICS, INC.

CONSOLIDATED

STATEMENT OF CASH FLOWS

(in thousands)

 

   Years Ended December 31, 
   2021   2020   2019 
Cash flows from operating activities:               
Net loss  $(77,702)  $(78,208)  $(84,305)
Adjustments to reconcile net loss to net cash used in operating activities:               
Depreciation and amortization   2,518    2,997    2,602 
Amortization of investment discount   226    99    (427)
Equity-based compensation expense   22,047    16,464    12,618 
Amortization of debt discount and issuance costs   11,542    11,168    9,969 
Realized loss on available-for-sale securities   —    3    — 
(Gain) loss on disposal of property and equipment   (75)   785    837 
Contributions to deferred compensation plan   (484)   (357)   — 
Gain on extinguishment of debt   (9,793)   —    — 
Inventory write-down   4,500    —    — 
(Increase) decrease in assets:               
Accounts receivable   (770)   1,592    (1,362)
Inventory   (415)   (1,356)   (3,655)
Prepaid expense and other assets   1,014    (2,087)   (752)
Increase (decrease) in liabilities:               
Accounts payable   273    (1,006)   988 
Accrued liabilities   (469)   (909)   (1,327)
Accrued interest   (283)   —    — 
Deferred revenue and income   75    105    54 
Deferred compensation   473    316    (34)
Net cash used in operating activities   (47,323)   (50,394)   (64,794)
Cash flows from investing activities:               
Purchases of equipment   (603)   (1,362)   (330)
Purchase of marketable securities   (30,081)   (46,933)   (50,226)
Proceeds from sales of marketable securities   250    —    14,500 
Maturities of marketable securities   38,738    61,901    88,867 
Net cash provided by investing activities   8,304    13,606    52,811 
Cash flows from financing activities:               
Proceeds from issuance of common and preferred shares   42,880    359    1,458 
Proceeds from exercise of options   1,620    5,703    4,907 
Proceeds from issuance of common stocks under employee purchase plan   326    359    458 
Proceeds from debt   —    5,578    — 
Payment of debt   (360)   (366)   — 
Common stock issuance cost   (325)   —    — 
Payment of costs related to debt exchange   (915)   —    — 
Net cash provided by financing activities   43,226    11,633    6,823 
                
Effect of exchange rate on cash   (90)   (78)   (86)
                
Increase (decrease) in cash and cash equivalents   4,117    (25,233)   (5,246)
Cash and cash equivalents, beginning of period   35,781    61,014    66,260 
Cash and cash equivalents, end of period  $39,898   $35,781   $61,014 

 

 

 

 

 

ACCELERATE DIAGNOSTICS, INC.

CONSOLIDATED

STATEMENT OF CASH FLOWS (CONTINUED)

(in thousands)

   Years Ended December 31, 
   2021   2020   2019 
Non-cash investing activities:               
Net transfer of instruments from inventory to property and equipment  $688   $1,525   $3,361 
Supplemental cash flow information:               
Interest paid  $4,288   $4,288   $4,288 
Income taxes paid, net of refunds  $—   $43   $41 

 

See accompanying notes to consolidated financial statements.

 

 

 

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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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