AXDX Accelerate Diagnostics Inc

TUCSON, Ariz., Nov. 7, 2024 /PRNewswire/ -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX) today announced financial results for the third quarter ended September 30, 2024.

"We are excited by the momentum we're building across our innovation pipeline, underscored by the successful launch of the clinical trial for our WAVE^TM system and the Gram-Negative assay.  This quarter also marked a significant milestone with FDA clearance of our Accelerate Arc^TM system, a testament to our commitment to breakthrough solutions in diagnostics," commented Jack Phillips, President and CEO of Accelerate Diagnostics, Inc. "Alongside these advances, we've continued to make meaningful progress in our commercial strategy, all while exercising disciplined financial management, which we believe will help drive sustainable growth for our company," Mr. Phillips continued.

Third Quarter 2024 Operating Highlights

• Began WAVE system and Gram-Negative assay clinical trial.
  
  
• Received 510(k) clearance of the Accelerate Arc system and BC kit, an innovative, automated positive blood culture sample preparation platform.
  
  
• Continued to executed contract extensions with several strategic customers with approximately 75% of U.S. Pheno® customers secured through the anticipated WAVE commercial launch, subject to regulatory approvals.
  
  
• In the United States, added five new contracted Pheno instruments during the quarter, ending the quarter with 352 clinically live revenue-generating instruments and another 77 contracted instruments in the process of being implemented.

Third Quarter 2024 Financial Highlights

• Net sales for the quarter were $3.0 million, compared to $3.3 million for the same quarter of the prior year. The overall decline was driven by lower instrument net sales but was partially offset by an increase from consumable products of 9% compared to the same period in the prior year.
  
  
• Gross margin was approximately 29% for the quarter, compared to approximately 3% for the same quarter of the prior year. The increase in gross margin reflects both product sales mix, as well as an inventory write-down in the prior year period.
  
  
• Selling, general, and administrative (SG&A) costs for the quarter were $5.6 million, compared to $7.8 million for the same quarter of the prior year. SG&A costs include non-cash stock-based compensation of $1.0 million and $1.5 million, respectively, for the same periods. The decline in SG&A costs is primarily a result of lower employee-related expenses. 
  
  
• Research and development (R&D) costs for the quarter were $3.8 million, compared to $7.0 million for the same quarter of the prior year. R&D costs include non-cash stock-based compensation of $0.2 million and $0.3 million, respectively, for the same periods. The decline in R&D costs is primarily a result of lower third-party development costs for our WAVE system. 
  
  
• Net loss was $14.6 million for the quarter, resulting in a net loss per share of $0.59.
  
  
• Ended the quarter with total cash, cash equivalents and investment of $20.9 million, compared to $9.7 million at the start of the quarter. The increase in cash and cash equivalents reflects proceeds from our recent debt issuance of $15 million in aggregate principal, as well as $1.2 million from a refundable R&D tax offset and $0.5 million of proceeds from warrant exercises.

Year-to-date Financial 2024 Highlights

• Net sales were $8.9 million year-to-date, compared to $9.0 million for the same period of the prior year. The decrease in revenues was driven by lower consumable products sold in the current year period.
  
  
• Gross margin was approximately 25% year-to-date, compared to 21% for the same period of the prior year.
  
  
• SG&A costs year-to-date were $16.7 million, compared to $25.4 million for the same period of the prior year. SG&A costs include non-cash stock-based compensation of $2.6 million for each of these periods. The decline in SG&A costs is primarily a result of lower employee-related expenses.
  
  
• R&D costs were $12.9 million year-to-date, compared to $19.8 million for the same period of the prior year. R&D costs include non-cash stock-based compensation of $0.7 million and $1.1 million, respectively, for the same periods. The decline in R&D costs is primarily a result of lower employee-related expenses, as well as lower third-party development costs for our WAVE system.
  
  
• Net loss was $40.5 million year-to-date, resulting in a net loss per share of $1.78.

Full financial results for the quarter ended September 30, 2024 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

Management will host a conference call on Thursday, November 7, 2024, at 4:30 p.m. Eastern Time to review third quarter 2024 results.

To listen to the audio webcast online, visit ir.axdx.com. A replay of the audio webcast will be available for 30 days.

To listen by phone, dial 1.877.883.0383 and enter the Elite Entry Number: 1269422. 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 2603705 until November 28, 2024.

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 and certain impairment transactions 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 and certain impairment transactions 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 and certain impairment transactions are non-GAAP financial measures 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 and certain impairment transactions to comparable GAAP measures for the periods indicated:

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. In addition to the Accelerate Arc system, 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 Accelerate Pheno system and Accelerate PhenoTest BC kit fully automate sample preparation, identification and phenotypic antibiotic susceptibility testing in approximately seven hours directly 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.

© Copyright 2024 Accelerate Diagnostics, Inc. All Rights Reserved. The "ACCELERATE DIAGNOSTICS," "ACCELERATE PHENO," "ACCELERATE PHENOTEST," "ACCELERATE ARC" and "ACCELERATE WAVE" diamond shaped logos and marks are trademarks or registered trademarks of Accelerate Diagnostics, Inc. All other trademarks are the property of their respective owners.

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 conference call are forward-looking or may have forward-looking implications within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the company intends that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements, which can be identified by the use of words such as "may," "will," "expect," "believe," "anticipate," "estimate," or "continue," or variations thereon or comparable terminology, include but are not limited to, statements about: the company's future development plans and growth strategy, including beliefs, plans and objectives relating to its future operations, products and performance, such as the anticipated WAVE commercial launch; projections as to when certain key business milestones may be achieved; expectations regarding the potential or benefits of the company's existing and future products and technologies, including the Accelerate Wave system, such as the expectation of the performance of the Wave system based on pre-clinical trials; projections of future demand for the company's products; the company's continued investment in new product development to both enhance its existing products and bring new ones to market; the company's expectations relating to current supply chain impacts and inflationary pressures; the company's expectations regarding its commercial partnerships, including anticipated benefits from such collaborations; the company's intentions and plans relating to regulatory approvals; and the company's liquidity and capital requirements. 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: volatility throughout the global economy and the related impacts to the businesses of the company's suppliers and customers, whether due to customer demand fluctuations, supply chain constraints and inflationary pressures or otherwise; difficulties in resolving the company's continuing financial condition and ability to obtain additional capital to meet its financial obligations; the company's ability to obtain any regulatory approvals; and less than expected operating and financial benefits resulting from cost cutting measures. 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. These forward-looking statements are also based on certain additional assumptions, including, but not limited to, that the company will retain key management personnel; the company will be successful in the commercialization of its products; the company will obtain sufficient capital to commercialize its products and continue development of complementary products; the company will be successful in obtaining marketing authorization for its products from the FDA and other regulatory agencies and governing bodies; the company will be able to protect its intellectual property; the company's ability to respond effectively to technological change; the company's ability to accurately anticipate market demand for its products; and that there will be no material adverse change in the company's operations or business and general market and industry 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. Forward-looking statements speak only as of the date they are made and should not be relied upon as representing the company's plans and expectations as of any subsequent date.

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SOURCE Accelerate Diagnostics, Inc.