EX-99.1 2 tm2035235d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1 

 

Accelerate Diagnostics Reports Second Quarter 2020 Financial Results & Announces New Product Offering

 

TUCSON, Ariz., August 6, 2020 -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX) today announced financial results for the second quarter ended June 30, 2020.

 

“While the progress of new contracts and go-lives continued to be slowed by the effects of the pandemic, utilization within our existing base of live Pheno instruments continued to prove durable during the second quarter,” commented Jack Phillips, President and CEO of Accelerate Diagnostics, Inc. “Despite these external disruptions, our internal R&D teams have made considerable progress, enabling today’s announcement of several new products as part of our enhanced portfolio strategy. These include the immediate launch of an AST-only test kit and the imminent launch of a new workflow instrument, the PhenoPrep, the first application of which is enabling automated rapid MALDI identification results. We also entered into an exclusive supply and collaboration arrangement with Ascend Diagnostics to commercialize a complementary desktop MALDI instrument. We are excited about these new additions to our product portfolio and believe they will help position Accelerate for sustained success and more rapid adoption of our technology as the market continues to recover from the unprecedented impacts of COVID-19.”

 

Second Quarter 2020 Highlights

 

·Added 6 new contracted instruments in the quarter and brought 6 instruments live, including 4 in the U.S.

 

·Ended the second quarter with 201 U.S. live revenue-generating instruments, with another 213 U.S. contracted Pheno instruments not yet live.

 

·Net sales of $2.1 million, compared to $1.8 million in the second quarter of 2019, or 17% growth.

 

·Gross margin was 45.0% for the quarter, compared to 50% in the second quarter of 2019. This decrease was the result of lower absorption of labor and overhead costs in the current quarter.

 

·Selling, general, and administrative expenses for the quarter were $11.3 million, compared to $12.8 million in the second quarter of 2019. This decrease was driven by pandemic-related reductions in sales and marketing spend related to travel and trade shows.

 

·Research and development (R&D) costs for the quarter were $5.3 million, compared to $6.1 million in the second quarter of 2019. This decrease was the result of increased efficiencies and lower external study spend.

 

·Net loss was $19.2 million in the second quarter, or $0.35 per share, which included $3.4 million in non-cash stock-based compensation expense.

 

·Net cash used in the quarter was $8.1 million, and the company ended the quarter with total cash, investments, and cash equivalents of $88.7 million.

 

·Launched PhenoAST Test, an AST-only test kit, and announced the upcoming launch of PhenoPrep instrument in Q1 2021

 

·Entered into exclusive supply and collaboration agreement with Ascend Diagnostics to commercialize a desktop MALDI system.

 

·Recently submitted final FDA Emergency Use Authorization review items and data for the MS Fast fully-automated chemiluminescence immunoassay analyzer and SARS-CoV-2 tests for the detection of IgG and IgM.

 

 

Year to Date 2020 Highlights

 

·Net sales were $4.4 million year-to-date as compared to $3.6 million from the same period in the prior year, or 22% growth.

 

·Gross margin was 45.0% year-to-date, compared to 49% from the same period in the prior year. This decrease was the result of lower absorption of labor and overhead costs in the first half of 2020.

 

·Selling, general, and administrative expenses were $24.3 million year-to-date, compared to $25.6 million from the same period in the prior year. This decrease was driven by pandemic-related reductions in sales and marketing spend related to travel and trade shows.

 

·Research and development (R&D) costs were $11.2 million year-to-date, compared to $13.1 million from the same period in the prior year. This decrease was the result of increased efficiencies and lower external study spend.

 

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·Net loss was $40.5 million year-to-date, or $0.74 per share, which included $7.6 million in non-cash stock-based compensation expense.

 

·Net cash used was $24.5 million year-to-date, and the company ended the quarter with total cash, investments, and cash equivalents of $88.7 million.

 

Full financial results for the quarter ending June 30, 2020 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

 

The company will host a conference call at 4:30PM ET today to review its second quarter results. To participate in the conference call, dial +1.877.883.0383 and enter the conference ID: 6487727. 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 10145894 until August 27, 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 November 7, 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, among others, Mr. Phillips statements about adapting our business to maximize our commercial execution in the near term and our longer-term initiative to strengthen our commercial foundation and expand our portfolio of products. 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.

 

 

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 SHEET

(in thousands, except share data)

 

   June 30,   December 31, 
   2020   2019 
   Unaudited     
ASSETS
Current assets:          
Cash and cash equivalents  $47,368   $61,014 
Investments   41,326    47,437 
Trade accounts receivable   2,592    3,222 
Inventory   8,723    8,059 
Prepaid expenses   1,400    955 
Other current assets   1,099    1,165 
Total current assets   102,508    121,852 
Property and equipment, net   8,004    7,905 
Right of use assets   3,569    3,917 
Other non-current assets   734    750 
Total assets  $114,815   $134,424 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:          
Accounts payable  $2,702   $2,351 
Accrued liabilities   3,346    3,828 
Accrued interest   1,262    1,262 
Deferred revenue   232    271 
Current portion of long-term debt   2,129     
Current operating lease liability   447    450 
Total current liabilities   10,118    8,162 
Non-current operating lease liability   3,366    3,579 
Other non-current liabilities   190    19 
Long-term debt   2,662     
Convertible notes   135,469    130,043 
Total liabilities  $151,805   $141,803 
           
Commitments and contingencies          
           
Stockholders’ deficit:          
Preferred shares, $0.001 par value;          
5,000,000 preferred shares authorized and none outstanding as of June 30, 2020 and December 31, 2019        
Common stock, $0.001 par value;          
85,000,000 common shares authorized with 56,249,482 shares issued and outstanding on June 30, 2020 and 85,000,000 common shares authorized with 54,708,792 shares issued and outstanding on December 31, 2019   56    55 
Contributed capital   463,178    452,344 
Treasury stock   (45,067)   (45,067)
Accumulated deficit   (455,297)   (414,653)
Accumulated other comprehensive income (loss)   140    (58)
Total stockholders’ deficit   (36,990)   (7,379)
Total liabilities and stockholders’ deficit  $114,815   $134,424 

 

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   Six Months Ended 
   June 30,   June 30,   June 30,   June 30, 
   2020   2019   2020   2019 
Net sales  $2,125   $1,806   $4,468   $3,557 
                     
Cost of sales   1,171    907    2,459    1,823 
Gross profit   954    899    2,009    1,734 
                     
Costs and expenses:                    
Research and development   5,347    6,149    11,189    13,083 
Sales, general and administrative   11,332    12,837    24,275    25,559 
Total costs and expenses   16,679    18,986    35,464    38,642 
                     
Loss from operations   (15,725)   (18,087)   (33,455)   (36,908)
                     
Other income (expense):                    
Interest expense   (3,835)   (3,528)   (7,584)   (6,987)
Foreign currency exchange gain (loss)   91    6    (37)   (53)
Interest income   224    812    604    1,653 
Other income (expense), net   15    (1)   (67)   (3)
Total other expense, net   (3,505)   (2,711)   (7,084)   (5,390)
                     
Net loss before income taxes   (19,230)   (20,798)   (40,539)   (42,298)
Provision for income taxes       (17)       (238)
Net loss  $(19,230)  $(20,815)  $(40,539)  $(42,536)
                     
Basic and diluted net loss per share  $(0.35)  $(0.38)  $(0.74)  $(0.78)
Weighted average shares outstanding   55,445    54,476    55,139    54,407 
                     
Other comprehensive loss:                    
Net loss  $(19,230)  $(20,815)  $(40,539)  $(42,536)
Net unrealized gain (loss) on debt securities available-for-sale   (44)   98    179    219 
Foreign currency translation adjustment   34    50    19    (26)
Comprehensive loss  $(19,240)  $(20,667)  $(40,341)  $(42,343)

 

See accompanying notes to condensed consolidated financial statements.

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ACCELERATE DIAGNOSTICS, INC.

CONDENSED CONSOLIDATED

STATEMENTS OF CASH FLOWS

Unaudited

(in thousands)

 

   Six Months Ended 
   June 30,   June 30, 
   2020   2019 
Cash flows from operating activities:          
Net loss  $(40,539)  $(42,536)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation and amortization   1,571    1,236 
Amortization of investment discount   13    (320)
Equity-based compensation   7,615    6,278 
Amortization of debt discount and issuance costs   5,426    4,843 
Realized loss on sale of investments   3     
Loss on disposal of property and equipment   527    407 
Contributions to deferred compensation plan   (160)    
(Increase) decrease in assets:          
Accounts receivable   550    (51)
Inventory   (1,979)   (2,217)
Prepaid expense and other   (363)   (588)
Increase (decrease) in liabilities:          
Accounts payable   390    476 
Accrued liabilities, and other   (581)   (1,110)
Deferred revenue and income   (39)   38 
Deferred compensation   171    (18)
Net cash used in operating activities   (27,395)   (33,562)
           
Cash flows from investing activities:          
Purchases of equipment   (643)   (76)
Purchase of marketable securities   (21,509)   (17,601)
Proceeds from sales of marketable securities       13,400 
Maturities of marketable securities   27,844    54,447 
Net cash provided by investing activities   5,692    50,170 
           
Cash flows from financing activities:          
Proceeds from issuance of common stock   216    251 
Proceeds from exercise of options   3,031    4,369 
Proceeds from debt   4,791     
Net cash provided by financing activities   8,038    4,620 
           
Effect of exchange rate on cash   19    (19)
           
(Decrease) increase in cash and cash equivalents   (13,646)   21,209 
Cash and cash equivalents, beginning of period   61,014    66,260 
Cash and cash equivalents, end of period  $47,368   $87,469 

 

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)

 

   Six Months Ended 
   June 30,   June 30, 
   2020   2019 
Non-cash investing activities:          
Transfer of instruments from inventory to property and equipment  $1,288   $1,715 
Supplemental cash flow information:          
Interest paid  $2,144   $2,144 
Income taxes paid, net of refunds  $26   $9 

 

See accompanying notes to condensed consolidated financial statements.

 

 

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