0001104659-23-059128.txt : 20230511 0001104659-23-059128.hdr.sgml : 20230511 20230511160711 ACCESSION NUMBER: 0001104659-23-059128 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20230511 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230511 DATE AS OF CHANGE: 20230511 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: 23910989 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 tm2315491d1_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) May 11, 2023

 

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:

 

  ¨ 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 May 11, 2023, Accelerate Diagnostics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ending March 31, 2023. 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 May 11, 2023 
     
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: May 11, 2023

ACCELERATE DIAGNOSTICS, INC.

  (Registrant) 
   
  /s/ David Patience
  David Patience
  Chief Financial Officer

 

 

 

 EX-99.1 2 tm2315491d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

Accelerate Diagnostics Reports First Quarter 2023 Financial Results

 

TUCSON, Ariz., May 11, 2023 -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX) today announced financial results for the first quarter for the period ended March 31, 2023.

 

“Our first quarter results are in line with expectations, and I am optimistic about the remainder of 2023 and beyond,” commented Jack Phillips, Chief Executive Officer of Accelerate Diagnostics, Inc. “We are encouraged by our partnership with Becton Dickinson, which is gaining momentum, solidifying market share, and opening avenues for innovation and growth. I am particularly excited about the incredible advancements the development team has made on our next-generation platform Wave, a breakthrough technology promising to expand our microbiology footprint and effect lasting change on patient care. These combined with the pending debt restructuring to resolve our near-term financial concerns better positions us for continued success.”

 

First Quarter 2023 Operating Highlights:

 

·Added 3 contracted instruments and brought 10 instruments live in the U.S. in the quarter.

 

·Ended the first quarter with 338 U.S. clinically live and revenue-generating instruments, with another 62 U.S. contracted instruments in the process of being implemented and not yet revenue-generating.

 

·Continued to make progress on our debt restructuring, to extend a portion of the current maturity, lower our overall debt outstanding and simplify our capital structure.

 

·Encouraging commercial partnership progress with BD is seeing meaningful funnel stage progression which has led to a significant increase in quotes and contracts being developed and presented.

 

·Strong R&D progress with Wave, next generation susceptibility, with instrument reliability is very good, and the data being produced is quite promising.

 

First Quarter 2023 Financial Highlights:

 

·Net sales were $2.8 million, compared to $3.0 million in the first quarter of 2022. While this decrease was driven by lower customer contracting in the quarter, recurring revenues were up 6% compared to the same quarter of the prior year.

 

·Gross margin was 36% for the quarter, compared to 27% in the first quarter of 2022. The increase in gross margin resulted from product mix of capital instrument sales.

 

·Selling, general, and administrative (SG&A) costs for the quarter were $10.1 million, compared to $10.7 million from the same quarter of the prior year. SG&A costs for the quarter excluding non-cash stock-based compensation were $10.2 million, compared to $8.2 million from the same quarter of the prior year. SG&A expenses increased over the previous year due to professional fees related to the debt restructuring.

 

·Research and development (R&D) costs for the quarter were $7.0 million, compared to $6.0 million the same quarter of the prior year. R&D costs, excluding non-cash stock-based compensation expense, for the quarter were $6.4 million, compared to $5.7 million from the quarter of the prior year. R&D expenses increased due to further progress with our next generation instrument, Wave.

 

·Net loss was $16.8 million in the first quarter, resulting in $0.17 net loss per share.

 

·Net cash used in the quarter was $13.7 million, and the company ended the quarter with total cash, investments, and cash equivalents of $31.9 million.

 

1 

 

 

Full financial results for the quarter ending March 31, 2023, 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 Today at 4:30 p.m. Eastern Time

 

To listen to the 2023 first quarter financial results, call by phone, +1.877.883.0383 and enter Elite Entry Number: 1816344. 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 9071320 until May 25, 2023.

 

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 for 30 days.

 

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 operating income (loss) amounts excluding stock-based compensation expenses.

 

Our management and board of directors use expenses excluding the cost of stock-based compensation (net of forfeitures) 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 operating income (loss) reported in accordance with GAAP. The following tables present a reconciliation of SG&A expenses, R&D expenses and operating income (loss) excluding stock-based compensation to comparable GAAP measures for the periods indicated:

 

   Three Months Ended
March 31,
(in thousands)		 
   2023   2022 
Sales, general and administrative  $10,105   $10,673 
Non-cash equity-based compensation as a component of sales, general and administrative   (140)   2,442 
Sales, general and administrative less non-cash equity-based compensation  $10,245   $8,231 

 

   Three Months Ended
March 31,
(in thousands)		 
   2023   2022 
Research and development  $6,968   $6,024 
Non-cash equity-based compensation as a component of research and development   605    362 
Research and development less non-cash equity-based compensation  $6,363   $5,662 

 

   Three Months Ended
March 31,
(in thousands)		 
   2023   2022 
Loss from operations  $16,062   $15,895 
Non-cash equity-based compensation as a component of loss from operations   555    2,979 
Loss from operations less non-cash equity-based compensation  $15,507   $12,916 

 

2 

 

 

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 Arc™ system are designed to reduce the time clinicians must wait to determine the most optimal antibiotic therapy for bacteremic patients. These diagnostic systems are designed to serve clinical laboratories with automated solutions to expedite time to identification and antimicrobial susceptibility test (AST) results directly from positive blood culture samples. Multiple external studies have proven that Accelerate solutions deliver results 1 to 2 days faster than existing methods, enabling clinicians to optimize antibiotic selection and dosage specific to the individual patient’s infection, 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 or may have forward-looking implications. 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 31, 2023, 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.

 

3 

 

 

ACCELERATE DIAGNOSTICS, INC. 

CONDENSED CONSOLIDATED 

BALANCE SHEETS 

(in thousands, except share data)

 

   March 31,   December 31, 
   2023   2022 
   Unaudited     
ASSETS
Current assets:          
Cash and cash equivalents  $29,408   $34,905 
Investments   2,457    10,656 
Trade accounts receivable   2,427    2,416 
Inventory   5,270    5,194 
Prepaid expenses   1,697    818 
Other current assets   1,575    2,025 
Total current assets   42,834    56,014 
Property and equipment, net   3,216    3,478 
Finance lease assets, net   2,161    2,422 
Operating lease right of use assets, net   1,696    1,859 
Other non-current assets   1,095    1,242 
Total assets  $51,002   $65,015 
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:          
Accounts payable  $3,524   $4,501 
Accrued liabilities   4,836    2,682 
Accrued interest   707    472 
Deferred revenue   468    547 
Current portion of convertible notes   56,595    56,413 
Current portion of finance lease   1,113    1,113 
Current operating lease liability   882    829 
Total current liabilities   68,125    66,557 
Finance lease, non-current   705    782 
Operating lease liability, non-current   1,308    1,545 
Other non-current liabilities   1,055    874 
Accrued interest, related-party   1,104    663 
Long-term, debt related-party   17,430    16,858 
Total liabilities  $89,727   $87,279 
           
Commitments and contingencies          
           
Stockholders’ deficit:          
Preferred shares, $0.001 par value;          
5,000,000 preferred shares authorized and 3,954,546 outstanding as of March 31, 2023 and December 31, 2022   4    4 
Common stock, $0.001 par value;          
200,000,000 common shares authorized with 99,628,248 shares issued and outstanding on March 31, 2023 and 200,000,000 common shares authorized with 97,477,546 shares issued and outstanding on December 31, 2022   100    97 
Contributed capital   630,903    630,341 
Treasury stock   (45,067)   (45,067)
Accumulated deficit   (624,034)   (607,239)
Accumulated other comprehensive loss   (631)   (400)
Total stockholders’ deficit   (38,725)   (22,264)
Total liabilities and stockholders’ deficit  $51,002   $65,015 

 

4 

 

 

ACCELERATE DIAGNOSTICS, INC. 

CONDENSED CONSOLIDATED 

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS 

Unaudited 

(in thousands, except per share data)

 

   Three Months Ended 
   March 31,   March 31, 
   2023   2022 
Net sales  $2,812   $2,958 
           
Cost of sales   1,801    2,156 
Gross profit   1,011    802 
           
Costs and expenses:          
Research and development   6,968    6,024 
Sales, general and administrative   10,105    10,673 
Total costs and expenses   17,073    16,697 
           
Loss from operations   (16,062)   (15,895)
           
Other income (expense):          
Interest expense   (418)   (917)
Interest expense related party   (1,013)   — 
Gain on extinguishment of debt   —    3,366 
Foreign currency exchange loss   233    9 
Interest income   420    22 
Other expense, net   45    (50)
Total other income (expense), net   (733)   2,430 
           
Net loss before income taxes   (16,795)   (13,465)
Provision for income taxes   —    — 
Net loss  $(16,795)  $(13,465)
           
Basic and diluted net loss per share  $(0.17)  $(0.20)
Weighted average shares outstanding   98,301    67,755 
           
Other comprehensive loss:          
Net loss  $(16,795)  $(13,465)
Net unrealized loss on debt securities available-for-sale   24    (93)
Foreign currency translation adjustment   (255)   (79)
Comprehensive loss  $(17,026)  $(13,637)

 

5 

 

 

ACCELERATE DIAGNOSTICS, INC. 

CONDENSED CONSOLIDATED 

STATEMENTS OF CASH FLOWS 

Unaudited 

(in thousands)

 

   Three Months Ended 
   March 31,   March 31, 
   2023   2022 
Cash flows from operating activities:          
Net loss  $(16,795)  $(13,465)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation and amortization   802    616 
Amortization of investment discount   0    54 
Equity-based compensation   555    2,979 
Amortization of debt discount and issuance costs   182    162 
Amortization of debt discount related party   572    0 
(Gain) Loss on disposal of property and equipment   11    152 
Unrealized G/L equity investments   (50)   0 
Gain on extinguishment of debt   0    (3,366)
(Increase) decrease in assets:          
Contributions to deferred compensation plan   0    (5)
Accounts receivable   (11)   206 
Inventory   (140)   (653)
Prepaid expense and other   (239)   (714)
Increase (decrease) in liabilities:          
Accounts payable   (977)   1,154 
Accrued liabilities   1,945    1,081 
Accrued interest   235    (751)
Accrued interest from related party   441    0 
Deferred revenue and income   (79)   (53)
Deferred compensation   181    (3)
Net cash used in operating activities   (13,367)   (12,606)
           
Cash flows from investing activities:          
Purchases of equipment   (12)   (447)
Purchase of marketable securities   0    (24,144)
Maturities of marketable securities   8,221    10,950 
Net cash (used in) provided by investing activities   8,209    (13,641)
           
Cash flows from financing activities:          
Proceeds from issuance of common stock   0    0 
Proceeds from exercise of options   0    0 
Payments on capital lease obligations   (77)   0 
Proceeds from issuance of common stocks under employee purchase plan   0    77 
Net cash provided by financing activities   (77)   77 
           
Effect of exchange rate on cash   (262)   (74)
           
(Decrease) increase in cash and cash equivalents   (5,497)   (26,244)
Cash and cash equivalents, beginning of period   34,905    39,898 
Cash and cash equivalents, end of period  $29,408   $13,654 

 

6 

 

 

ACCELERATE DIAGNOSTICS, INC. 

CONDENSED CONSOLIDATED 

STATEMENTS OF CASH FLOWS (CONTINUED) 

Unaudited 

(in thousands)

 

   Three Months Ended 
   March 31,   March 31, 
   2023   2022 
Non-cash investing activities:          
Net transfer of instruments from inventory to property and equipment  $71   $220 
Supplemental cash flow information:          
Interest paid  $0   $1,506 
Extinguishment of Convertible Senior Notes through issuance of common stock  $0   $1,258 

 

See accompanying notes to condensed consolidated financial statements.

 

7 

 

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