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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 29, 2023

 

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 29, 2023, Accelerate Diagnostics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and full-year ending December 31, 2022. 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 8.01.Other Events.

 

As previously announced, on March 9, 2023, the Company entered into a Forbearance Agreement (the “Forbearance Agreement”) with (i) Indaba Capital Management, L.P. (together with its affiliates, “Indaba”), (ii) Chicago Venture Partners, LP (“CVP”), (iii) RBC CMA LLC (“RBC”), (iv) Penderfund Capital Management Ltd. (“Penderfund”), (v) Wolverine Flagship Fund Trading Limited (“Wolverine,” and collectively with Indaba, CVP, RBC, and Penderfund, the “Ad Hoc Noteholder Group”), (vi) U.S. Bank Trust Company, National Association, as successor in interest to U.S. Bank National Association, a national banking association, not in its individual capacity, but solely as trustee (the “Trustee”), and (vii) any other owner of the Company’s outstanding 2.50% Convertible Senior Notes due 2023 who executes and delivers to the Company a joinder to the Forbearance Agreement. Pursuant to the Forbearance Agreement, the members of the Ad Hoc Noteholder Group have agreed, and have directed the Trustee, to forbear from exercising their rights and remedies under that certain indenture, dated as of March 27, 2018 (the “Indenture”) by and between the Company, as issuer, and the Trustee, in connection with certain events of default under the Indenture. On March 29, 2023, the Company and the Ad Hoc Noteholder Group agreed to further extend the forbearance period under the Forbearance Agreement to 11:59 P.M. (Eastern Daylight Time) on April 5, 2023. All other terms of the Forbearance Agreement remain unchanged.

 

Item 9.01Financial Statements and Exhibits.

 

(d)           Exhibits.  

 

Exhibit    
Number   Description
99.1   Press Release, dated March 29, 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.

 

  ACCELERATE DIAGNOSTICS, INC.
(Registrant)
   
Date: March 29, 2023  
  /s/ Jack Phillips
  Jack Phillips
  President and Chief Executive Officer

 

 

 

Exhibit 99.1

 

Accelerate Diagnostics Reports Fourth Quarter and Full Year 2022 Financial Results

 

TUCSON, Ariz., March 29, 2023 -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX) today announced financial results for the fourth quarter and year ended December 31, 2022.

 

“In 2022, we achieved another year of revenue growth thanks to our base book of satisfied customers," commented Jack Phillips, Chief Executive Officer of Accelerate Diagnostics, Inc., "Though we fell short of our guidance target, we're emboldened by our new partnership with Becton Dickinson and the significant product development milestones we've achieved. The Accelerate Team is fully committed to driving growth and delivering value to our stakeholders.”

 

Fourth Quarter 2022 Highlights

 

Added 3 contracted instruments and brought 5 instruments live in the U.S. in the quarter.

 

Ended the fourth quarter with 328 U.S. clinically live and revenue-generating instruments, with another 69 U.S. contracted instruments in the process of being implemented and not yet revenue-generating.

 

Net sales were $3.0 million, compared to $3.3 million in the fourth quarter of the prior year, or a 9% decrease. This decrease was driven by the timing of capital equipment sales, while recurring revenues grew by 8% compared to the same period in the prior year.

 

Gross margin was 28% for the quarter, compared to an adjusted 35% in the fourth quarter of the prior year, excluding non-cash adjustments for inventory impairment. The decline in gross margins resulted from inflation in manufacturing related costs and other factors.

 

Selling, general, and administrative (SG&A) costs for the quarter were $8.8 million, compared to $11.5 million from the same quarter of the prior year. SG&A costs for the quarter excluding non-cash stock-based compensation were $6.8 million, compared to $8.3 million from the same quarter of the prior year. SG&A reductions over these periods were driven by streamlining our spend within the scope of our BD collaboration.

 

Research and development (R&D) costs for the quarter were $6.0 million, compared to $4.6 million from the same quarter of the prior year. R&D costs excluding non-cash stock-based compensation expense for the quarter were $5.7 million, compared to $4.8 million from the quarter of the prior year. This increase was the result of investment in our next generation AST platform.

 

GAAP net loss was $14.6 million in the fourth quarter, resulting in $0.15 net loss per share. Net loss excluding non-cash stock-based compensation expense for the fourth quarter was $12.2 million.

 

Net cash used in the quarter excluding financing was $9.8 million.

 

We continue to work with the holders of our convertible notes, which have matured, and other key stakeholders, and have agreed to an extension of the forbearance period to facilitate those continued discussions.

 

Year-to-date 2022 Highlights

 

Net sales were $12.8 million year-to-date, compared to $11.8 million from the same period of the prior year, or an 8% increase. Growth was driven from increases in recurring revenues.

 

Gross margin was 26% year-to-date, compared to an adjusted gross margin of 35% for the same period of the prior year, excluding non-cash adjustments for inventory impairment. The overall decline in gross margins resulted from ongoing pandemic-related impacts to manufacturing costs and other factors.

 

 

 

Selling, general, and administrative (SG&A) costs year-to-date were $39.2 million, compared to $49.2 million from the same period of the prior year. SG&A costs excluding non-cash stock-based compensation were $30.7 million year to date, compared to $31.6 million from the same period of the prior year.

 

Research and development (R&D) costs were $26.9 million year to date, compared to $21.9 million from the same period of the prior year. R&D costs excluding non-cash stock-based compensation expense were $25.5 million year to date, compared to $17.8 million from the same period of the prior year. These increases were the result of accelerating investment in our next generation AST platform, Wave.

 

GAAP net loss was $62.5 million year to date, resulting in $0.76 net loss per share. Net loss excluding non-cash stock-based compensation expense was $51.9 million.

 

Net cash used for the year was $50.9 million, excluding financing.

 

Ended the year with total cash, investments, and cash equivalents of $45.6 million.

 

Full financial results for the year ended December 31, 2022 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

 

To listen to the 2022 fourth quarter financial results, call by phone, +1.877.883.0383 and enter Elite Entry Number: 6648486. 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 2450672 until April 19, 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.

 

Use of 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 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 December 31,   Twelve Months Ended December 31, 
   (in thousands)   (in thousands) 
   2022   2021   2022   2021 
Sales, General and Administrative  $8,772   $11,493   $39,193   $49,236 
Non-cash equity-based compensation as a component of sales, general and administrative   1,984    3,159    8,541    17,620 
Sales, general and administrative less non-cash equity-based compensation  $6,788   $8,334   $30,652   $31,616 

 

   Three Months Ended December 31,   Twelve Months Ended December 31, 
   (in thousands)   (in thousands) 
   2022   2021   2022   2021 
Research and Development  $6,030   $4,602   $26,915   $21,943 
Non-cash equity-based compensation as a component of research and development   367    (238)   1,419    4,102 
Research and development less non-cash equity-based compensation  $5,663   $4,840   $25,496   $17,841 

 

   Three Months Ended December 31,   Twelve Months Ended December 31, 
   (in thousands)   (in thousands) 
   2022   2021   2022   2021 
Loss from operations  $(13,961)  $(19,413)  $(62,805)  $(71,560)
Non-cash equity-based compensation as a component of loss from operations   2,446    2,989    10,625    22,047 
Loss from operations less non-cash equity-based compensation  $(11,515)  $(16,424)  $(52,180)  $(49,513)

 

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 and the related web cast and conference call are forward-looking or may have forward-looking implications, such as, among others: the company’s future financial performance; the company’s future development plans and growth strategy, including plans and objectives relating to its future operations, products and performance, such as the development of the company’s next generation AST platform; the company’s expectations regarding the potential or benefits of its products and technologies; projections of future demand for the company’s products; the anticipated impacts from the COVID-19 pandemic on the company, including to its business, results of operations, cash flows and financial position, as well as the company’s future responses to the COVID-19 pandemic; the company’s expectations relating to current supply chain impacts and inflationary pressures; the company’s expectations regarding its commercial partnership with Becton, Dickinson and Company (“BD”), including anticipated benefits from such collaboration and BD’s commercialization preparations and commitment to the company’s long-term commercial partnership; the company’s expectations and plans relating to regulatory approvals, including with respect to the U.S. Food and Drug Administration and 510(k) clearance for its Accelerate Arc products; and the company’s expectations and plans regarding its financial condition, indebtedness and its liquidity and capital requirements, including, without limitation, as to the company’s ability to continue as a going concern, obligations under the company’s 2.50% Senior Convertible Notes due 2023 (“Notes”) and discussions with holders of the Notes in connection with the related forbearance agreement. Actual results or developments may differ materially from those projected or implied in these forward-looking statements due to significant risks and uncertainties, including, but not limited to: general industry and market conditions; regulatory developments; the duration and severity of the ongoing COVID-19 pandemic, including any new variants that may become predominant, any government and other third-party responses to it, the consequences for the global economy and the businesses of the company’s suppliers and customers, such as the possibility of customer demand fluctuations, supply chain constraints and inflationary pressures, and ultimate effect of the COVID-19 pandemic on the company’s business, results of operations, cash flows and financial position, as well as the company’s ability (or inability) to execute on its plans to respond to the COVID-19 pandemic; and difficulties in resolving the company’s continuing financial condition and ability to obtain additional capital to meet its financial obligations, including, without limitation, difficulties in obtaining adequate capital resources to fund the company’s operations and address its debt obligations, including under the Notes. Other important factors that could cause the company’s actual results to differ materially from those in its forward-looking statements include those discussed in the company’s filings with the Securities and Exchange Commission (the “SEC”), including in the “Risk Factors” sections of the company’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings with the SEC. 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.

CONDENSED CONSOLIDATED

BALANCE SHEETS

(in thousands, except share data)

 

   December 31, 
   2022   2021 
ASSETS
Current assets:          
Cash and cash equivalents  $34,905   $39,898 
Investments   10,656    23,720 
Trade accounts receivable, net   2,416    2,320 
Inventory   5,194    5,067 
Prepaid expenses   818    768 
Other current assets   2,025    1,558 
Total current assets   56,014    73,331 
Property and equipment, net   3,478    5,389 
Finance lease assets, net   2,422     
Operating lease right of use assets, net   1,859    2,510 
Other non-current assets   1,242    1,817 
Total assets  $65,015   $83,047 
           
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:          
Accounts payable  $4,501   $1,983 
Accrued liabilities   2,682    2,853 
Accrued interest   472    909 
Deferred revenue   547    451 
Current portion of convertible notes   56,413     
Current portion of long-term debt       80 
Finance lease, current   1,113     
Operating lease, current   829    669 
Total current liabilities   66,557    6,945 
Finance lease, non-current   782     
Operating lease, non-current   1,545    2,381 
Other non-current liabilities   874    808 
Accrued interest, related-party   663     
Long-term, debt related-party   16,858     
Convertible notes       107,984 
Total liabilities   87,279    118,118 
           
Commitments and contingencies (see note 16)          
Stockholders' deficit:          
Preferred shares, $0.001 par value;          
5,000,000 preferred shares authorized and 3,954,546 outstanding as of December 31, 2022 and 2021   4    4 
Common stock, $0.001 par value;          
200,000,000 common shares authorized with 97,477,546 shares issued and outstanding on December 31, 2022 and 100,000,000 common shares authorized with 67,649,018 shares issued and outstanding on December 31, 2021   97    68 
Contributed capital   630,341    580,652 
Treasury stock   (45,067)   (45,067)
Accumulated deficit   (607,239)   (570,668)
Accumulated other comprehensive loss   (400)   (60)
Total stockholders' deficit   (22,264)   (35,071)
Total liabilities and stockholders' deficit  $65,015   $83,047 

 

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)

 

   Years Ended December 31, 
   2022   2021   2020 
Net sales  $12,752   $11,782   $11,165 
                
Cost of sales:               
Cost of sales of products and services   9,449    7,663    6,706 
Inventory write-down       4,500     
Total cost of sales   9,449    12,163    6,706 
                
Gross profit (loss)   3,303    (381)   4,459 
                
Costs and expenses:               
Research and development   26,915    21,943    21,255 
Sales, general and administrative   39,193    49,236    46,904 
Total costs and expenses   66,108    71,179    68,159 
                
Loss from operations   (62,805)   (71,560)   (63,700)
                
Other income (expense):               
Interest expense   (2,274)   (15,545)   (15,550)
Interest expense related-party   (1,497)        
Gain on extinguishment of debt   3,565    9,793     
Foreign currency exchange gain (loss)   117    (413)   252 
Interest income   551    88    855 
Other expense, net   (227)   (20)   (60)
Total other income (expense), net   235    (6,097)   (14,503)
                
Net loss before income taxes   (62,570)   (77,657)   (78,203)
Benefit (provision) for income taxes   77    (45)   (5)
Net loss  $(62,493)  $(77,702)  $(78,208)
                
Basic and diluted net loss per share  $(0.76)  $(1.26)  $(1.40)
Weighted average shares outstanding   82,161    61,727    56,010 
                
Other comprehensive loss:               
Net loss  $(62,493)  $(77,702)  $(78,208)
Net unrealized loss on investments   (14)   (34)   (2)
Foreign currency translation adjustment   (326)   (117)   151 
Comprehensive loss  $(62,833)  $(77,853)  $(78,059)

 

See accompanying notes to condensed consolidated financial statements.

 

 

 

ACCELERATE DIAGNOSTICS, INC.

CONDENSED CONSOLIDATED

STATEMENTS OF CASH FLOWS

Unaudited

 

   Years Ended December 31, 
   2022   2021   2020 
Cash flows from operating activities:               
Net loss  $(62,493)  $(77,702)  $(78,208)
Adjustments to reconcile net loss to net cash used in operating activities:               
Depreciation and amortization   3,000    2,518    2,997 
Amortization of investment discount   98    226    99 
Equity-based compensation expense   10,625    22,047    16,464 
Amortization of debt discount and issuance costs   474    11,542    11,168 
Amortization of debt discount related party   834         
Realized loss on available-for-sale securities           3 
Unrealized loss on equity investments   211         
Loss (gain) on disposal of property and equipment   133    (75)   785 
Gain on extinguishment of debt   (3,565)   (9,793)    
Inventory write-down       4,500     
(Increase) decrease in assets:               
Contributions to deferred compensation plan   (298)   (484)   (357)
Accounts receivable   (96)   (770)   1,592 
Inventory   (236)   (415)   (1,356)
Prepaid expense and other assets   138    1,014    (2,087)
Increase (decrease) in liabilities:               
Accounts payable   2,920    273    (1,006)
Accrued liabilities and other   (861)   (469)   (909)
Accrued interest   (437)   (283)    
Accrued interest from related-party   663         
Deferred revenue and income   96    75    105 
Deferred compensation   66    473    316 
Net cash used in operating activities   (48,728)   (47,323)   (50,394)
Cash flows from investing activities:               
Purchases of equipment   (554)   (603)   (1,362)
Purchase of marketable securities   (27,506)   (30,081)   (46,933)
Proceeds from sales of marketable securities       250     
Maturities of marketable securities   40,477    38,738    61,901 
Net cash provided by investing activities   12,417    8,304    13,606 
Cash flows from financing activities:               
Proceeds from issuance of common and preferred shares, net   32,872    42,880    359 
Proceeds from exercise of options   7    1,620    6,062 
Proceeds from issuance of common stocks under employee purchase plan   224    326     
Proceeds from debt           5,578 
Payment of debt   (80)   (360)   (366)
Payments on finance leases   (1,201)        
Debt exchange and common stock issuance cost   (192)   (1,240)    
Net cash provided by financing activities   31,630    43,226    11,633 
Effect of exchange rate on cash   (312)   (90)   (78)
                
(Decrease) increase in cash and cash equivalents   (4,993)   4,117    (25,233)
Cash and cash equivalents, beginning of period   39,898    35,781    61,014 
Cash and cash equivalents, end of period  $34,905   $39,898   $35,781 
                
Non-cash investing activities:               
Net transfer of instruments from inventory to property and equipment, net  $168   $688   $1,525 
                
Non-cash financing activities:               
Extinguishment of convertible senior notes through issuance of common stock  $10,180   $38,902   $ 
Convertible notes due from related-party extinguished in connection with the exchange transaction, net of deferred issuance costs  $49,624   $   $ 
Fair value of new note from related-party issued in connection with the exchange transaction  $16,024   $   $ 
Fair value of common stock warrant issued to related-party in connection with exchange transaction  $3,753   $   $ 
Capital contribution from related-party in connection with the exchange transaction  $29,847   $   $ 
Right-of-use assets obtained in exchange for finance lease obligations  $3,096   $   $ 
                
Supplemental cash flow information:               
Interest paid  $2,214   $4,288   $4,288 
Income taxes paid, net of refunds  $   $   $43 

 

See accompanying notes to condensed consolidated financial statements.