EX-99.1 2 tm2115441d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

Accelerate Diagnostics Reports First Quarter 2021 Financial Results

 

TUCSON, Ariz., May 6, 2021 -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX) today announced financial results for the first quarter for the period ended March 31, 2021.

 

“First quarter financial results were consistent with our expectations,” commented Jack Phillips, Chief Executive Officer of Accelerate Diagnostics, Inc. “We also progressed key commercial and product development programs during the quarter.”

 

First Quarter 2021 Highlights

 

·Added 2 contracted instruments and brought 12 instruments live in the U.S. in the quarter.

 

·Ended the first quarter with 274 U.S. clinically live and revenue-generating instruments, with another 111 U.S. contracted instruments in the process of being implemented and not yet revenue-generating.

 

·Net sales were $2.5 million, compared to $2.3 million in the first quarter of 2020, or an 8% increase. Instrument revenue declined while consumable revenue grew by 16%.

 

·Gross margin was 36% for the quarter, compared to 45% in the first quarter of 2020. The decline in gross margins resulted from ongoing pandemic-related impacts to manufacturing costs and other factors.

 

·Selling, general, and administrative (SG&A) costs for the quarter were $14.0 million, compared to $12.9 million from the same quarter of the prior year. SG&A costs for the quarter excluding non-cash stock-based compensation were $8.0 million, compared to $9.9 million from the same quarter of the prior year. This decrease was the result of the ongoing benefits from cost-cutting efforts put in place during 2020.

 

·Research and development (R&D) costs for the quarter were $6.9 million, compared to $5.8 million from the same quarter of the prior year. R&D costs excluding non-cash stock-based compensation expense for the quarter were $4.1 million, compared to $4.7 million from the quarter of the prior year. This decrease was the result of improved internal efficiencies and lower external study-related costs.

 

·Net loss was $24.2 million in the first quarter, resulting in $0.41 net loss per share. Net loss excluding non-cash stock-based compensation expense for the first quarter was $15.4 million.

 

·Net cash used in the quarter was $12.3 million, and the company ended the quarter with total cash, investments, and cash equivalents of $66.7 million.

 

·Closed on the first of three equal $10.7M tranches of previously announced financing.  

 

Full financial results for the quarter ending March 31, 2021 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

 

To listen to the 2021 first quarter financial results, call by phone, +1.877.883.0383 and enter Elite Entry Number: 4747452. 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 10154554 until May 27, 2021.

 

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 until August 6, 2021.

 

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

 

   Three Months Ended
March 31,
(in thousands)		 
   2021   2020 
Sales, general and administrative  $14,029   $12,943 
Non-cash equity-based compensation as a component of sales, general and administrative   5,992    3,005 
Sales, general and administrative less non-cash equity-based compensation  $8,037   $9,938 

 

   Three Months Ended March 31,
(in thousands)		 
   2021   2020 
Research and development  $6,895   $5,842 
Non-cash equity-based compensation as a component of research and development   2,746    1,123 
Research and development less non-cash equity-based compensation  $4,149   $4,719 

 

   Three Months Ended
March 31,
(in thousands)		 
   2021 
Net loss  $24,239 
Non-cash equity-based compensation as a component of net loss   8,839 
Net loss less non-cash equity-based compensation  $15,400 

 

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.

 

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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 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 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.

 

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

 

Source: Accelerate Diagnostics Inc.

 

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ACCELERATE DIAGNOSTICS, INC.

CONDENSED CONSOLIDATED

BALANCE SHEETS

(in thousands, except share data)

 

   March 31,   December 31, 
   2021   2020 
   Unaudited     
ASSETS
Current assets:          
Cash and cash equivalents  $42,726   $35,781 
Investments   23,954    32,488 
Trade accounts receivable   1,976    1,550 
Inventory   9,785    9,216 
Prepaid expenses   1,891    1,172 
Other current assets   1,479    1,780 
Total current assets   81,811    81,987 
Property and equipment, net   5,825    6,135 
Right of use assets   3,007    3,183 
Other non-current assets   2,025    2,120 
Total assets  $92,668   $93,425 
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:          
Accounts payable  $1,917   $1,290 
Accrued liabilities   3,221    2,991 
Accrued interest   191    1,262 
Deferred revenue   357    376 
Current portion of long-term debt   1,127    553 
Current operating lease liability   551    497 
Total current liabilities   7,364    6,969 
Non-current operating lease liability   2,900    3,063 
Other non-current liabilities   453    335 
Long-term debt   4,108    4,659 
Convertible notes   144,207    141,211 
Total liabilities  $159,032   $156,237 
           
Commitments and contingencies          
           
Stockholders’ deficit:          
Preferred shares, $0.001 par value;          
5,000,000 preferred shares authorized and none outstanding as of March 31, 2021 and December 31, 2020   —    — 
Common stock, $0.001 par value;          
85,000,000 common shares authorized with 59,561,357 shares issued and outstanding on March 31, 2021 and 85,000,000 common shares authorized with 57,607,939 shares issued and outstanding on December 31, 2020   60    58 
Contributed capital   495,857    475,072 
Treasury stock   (45,067)   (45,067)
Accumulated deficit   (517,205)   (492,966)
Accumulated other comprehensive income (loss)   (9)   91 
Total stockholders’ deficit   (66,364)   (62,812)
Total liabilities and stockholders’ deficit  $92,668   $93,425 

 

See accompanying notes to condensed consolidated financial statements.

 

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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, 
   2021   2020 
Net sales  $2,518   $2,342 
           
Cost of sales   1,621    1,287 
Gross profit   897    1,055 
           
Costs and expenses:          
Research and development   6,895    5,842 
Sales, general and administrative   14,029    12,943 
Total costs and expenses   20,924    18,785 
           
Loss from operations   (20,027)   (17,730)
           
Other income (expense):          
Interest expense   (4,090)   (3,749)
Foreign currency exchange loss   (159)   (128)
Interest income   43    380 
Other expense, net   (6)   (82)
Total other expense, net   (4,212)   (3,579)
           
Net loss before income taxes   (24,239)   (21,309)
Provision for income taxes   —    — 
Net loss  $(24,239)  $(21,309)
           
Basic and diluted net loss per share  $(0.41)  $(0.39)
Weighted average shares outstanding   58,520    54,837 
           
Other comprehensive loss:          
Net loss  $(24,239)  $(21,309)
Net unrealized (loss) gain on debt securities available-for-sale   (19)   223 
Foreign currency translation adjustment   (81)   (15)
Comprehensive loss  $(24,339)  $(21,101)

 

See accompanying notes to condensed consolidated financial statements.

 

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ACCELERATE DIAGNOSTICS, INC.

CONDENSED CONSOLIDATED

STATEMENTS OF CASH FLOWS

Unaudited

(in thousands)

 

   Three Months Ended 
   March 31,   March 31, 
   2021   2020 
Cash flows from operating activities:          
Net loss  $(24,239)  $(21,309)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation and amortization   659    755 
Amortization of investment discount   49    (4)
Equity-based compensation   8,839    4,199 
Amortization of debt discount and issuance costs   2,996    2,674 
Loss on disposal of property and equipment   —    432 
Contributions to deferred compensation plan   (112)   — 
(Increase) decrease in assets:          
Accounts receivable   (401)   (9)
Inventory and instruments in property and equipment   (683)   (1,735)
Prepaid expense and other   (292)   (1,011)
Increase (decrease) in liabilities:          
Accounts payable   575    968 
Accrued liabilities, and other   183    (1,475)
Accrued interest   (1,048)   (1,071)
Deferred revenue and income   (19)   (85)
Deferred compensation   118    74 
Net cash used in operating activities   (13,375)   (17,597)
           
Cash flows from investing activities:          
Purchases of equipment   —    (438)
Purchase of marketable securities   (7,307)   (21,582)
Maturities of marketable securities   15,829    16,664 
Net cash provided by (used in) investing activities   8,522    (5,356)
           
Cash flows from financing activities:          
Proceeds from issuance of common stock   10,746    111 
Proceeds from exercise of options   1,109    1,318 
Net cash provided by financing activities   11,855    1,429 
           
Effect of exchange rate on cash   (57)   (3)
           
Increase (decrease) in cash and cash equivalents   6,945    (21,527)
Cash and cash equivalents, beginning of period   35,781    61,014 
Cash and cash equivalents, end of period  $42,726   $39,487 

 

See accompanying notes to condensed consolidated financial statements.

 

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ACCELERATE DIAGNOSTICS, INC.

CONDENSED CONSOLIDATED

STATEMENTS OF CASH FLOWS (CONTINUED)

Unaudited

(in thousands)

 

   Three Months Ended 
   March 31,   March 31, 
   2021   2020 
Non-cash investing activities:          
Net transfer of instruments from inventory to property and equipment  $306   $1,282 
Supplemental cash flow information:          
Interest paid  $2,144   $2,144 
Income taxes paid, net of refunds  $—   $26 

 

See accompanying notes to condensed consolidated financial statements.

 

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