Financial Performance - Net sales for Q3 2024 were $3.0 million, a decline from $3.3 million in the same quarter of the prior year, driven by lower instrument sales but partially offset by a 9% increase in consumable product sales [5] - Gross margin improved significantly to 29% in Q3 2024, compared to 3% in the same quarter of the prior year, due to a better product sales mix and an inventory write-down in the prior year [6] - Net loss for Q3 2024 was $14.6 million, resulting in a net loss per share of $0.59 [8] - Year-to-date net sales for 2024 were $8.9 million, slightly down from $9.0 million in the same period of the prior year, primarily due to lower consumable product sales [9] - Year-to-date net loss for 2024 was $40.5 million, resulting in a net loss per share of $1.78 [11] Operational Highlights - The company began clinical trials for its WAVE system and Gram-Negative assay, marking a significant step in its innovation pipeline [3] - Received FDA 510(k) clearance for the Accelerate Arc system and BC kit, an automated positive blood culture sample preparation platform [3] - Secured contract extensions with approximately 75% of U.S. Pheno customers, positioning the company for the anticipated WAVE commercial launch [3] - Added five new contracted Pheno instruments in the U.S., ending the quarter with 352 clinically live revenue-generating instruments and 77 contracted instruments in the process of being implemented [4] Cash and Liquidity - Ended Q3 2024 with total cash, cash equivalents, and investments of $20.9 million, up from $9.7 million at the start of the quarter, driven by a $15 million debt issuance and other financial activities [9] - Cash flows from financing activities provided $27.6 million, primarily from the issuance of Units and Notes [27] Product and Technology - The Accelerate Arc system, along with the Accelerate Pheno system and Accelerate PhenoTest BC kit, aims to reduce the time clinicians wait to determine optimal antibiotic therapy for deadly infections, offering results 1–2 days faster than existing methods [18] - The company continues to focus on addressing global challenges such as antibiotic resistance and sepsis through its innovative diagnostic solutions [18]

Conference Call Details - Accelerate Diagnostics Inc will host a conference call on November 7 2024 at 4:30 PM Eastern Time to review 2024 third quarter results [1] - The audio webcast can be accessed online at ir axdx com with a replay available for 30 days [1] - Participants can dial +1 877 883 0383 (US) or +1 412 902 6506 (International) using Elite Entry Number 1269422 to listen by phone [1] - A replay of the call will be available by telephone at +1 877 344 7529 (US) or +1 412 317 0088 (International) using replay code 2603705 until November 28 2024 [1] Company Overview - Accelerate Diagnostics Inc is an in vitro diagnostics company focused on addressing antibiotic resistance and sepsis [2] - The company offers the Accelerate Arc system Accelerate Pheno system and Accelerate PhenoTest BC kit which combine technologies to reduce the time clinicians wait to determine optimal antibiotic therapy [2] - The FDA-cleared Accelerate Pheno system and Accelerate PhenoTest BC kit automate sample preparation identification and phenotypic antibiotic susceptibility testing in approximately seven hours directly from positive blood cultures [2] - Recent studies indicate the solution provides results 1–2 days faster than existing methods enabling earlier optimization of antibiotic selection and dosage [2] - The FDA-cleared Accelerate Arc and BC kit platform is an automated positive blood culture sample preparation platform for use with Bruker's MALDI Biotyper CA System and MBT-CA Sepsityper software extension [2] Trademarks and Additional Information - The company holds trademarks for "ACCELERATE DIAGNOSTICS" "ACCELERATE PHENO" "ACCELERATE PHENOTEST" "ACCELERATE ARC" and "ACCELERATE WAVE" [3] - More information about the company its products and technology can be found at axdx com [3]

Product Overview - The Accelerate Arc system is an automated platform designed for rapid microbial identification directly from positive blood culture samples, eliminating the need for overnight culture methods [1][2] - The system is FDA-cleared and works in conjunction with Bruker's MALDI Biotyper® CA System and MBT-CA Sepsityper® software extension [1] - It is designed to leverage Bruker's MBT-CA reference library for rapid identification, with future integration planned for the Accelerate WAVE™ system, which is currently in clinical trials [2][8] Clinical and Operational Benefits - The Accelerate Arc system reduces wait time for microbial identification results, which is critical in the fight against sepsis and antimicrobial resistance (AMR) [2] - By providing rapid identification and future antibiotic susceptibility testing (AST) results, clinicians can optimize antibiotic therapy sooner, improving patient outcomes and reducing hospital costs [2] - The system replaces labor-intensive Laboratory Developed Test (LDT) sample preparation methods, aligning with increased FDA regulations on LDT usage [3] Company Background - Accelerate Diagnostics, Inc is an in vitro diagnostics company focused on addressing antibiotic resistance and sepsis [4] - The company's product portfolio includes the Accelerate Pheno system and Accelerate PhenoTest® BC kit, which automate sample preparation, identification, and phenotypic antibiotic susceptibility testing in approximately seven hours [4] - External studies indicate that the Accelerate Pheno system provides results 1–2 days faster than existing methods, enabling earlier optimization of antibiotic therapy [4] Future Developments - The Accelerate WAVE™ system, currently in clinical trials, aims to achieve a target time-to-result of 4.5 hours on average, further enhancing rapid diagnostics capabilities [8]

Core Insights - Accelerate Diagnostics, Inc. (AXDX) has successfully completed the pre-clinical trial of its WAVE system, demonstrating strong performance and reliability, which positions the company to advance to clinical trials and commercialization [1][4] Company Developments - The WAVE system is designed for rapid antimicrobial susceptibility testing (AST) from positive blood culture bottles and bacterial isolates, providing results in an average of 4.5 hours [2] - The pre-clinical trial involved 1,570 WAVE results compared to the Broth Microdilution reference method, achieving an overall Essential Agreement (EA) and Categorical Agreement (CA) of approximately 95% [4] - In April 2024, the company announced a 510(k) submission to the FDA for its Accelerate Arc system and BC kit, which is an automated platform for positive blood culture sample preparation [7] Industry Context - The global Antimicrobial Susceptibility Testing market was valued at $3.79 billion in 2023 and is projected to reach $5.69 billion by 2031, growing at a CAGR of 5.2%, driven by the increasing burden of antimicrobial resistance and the rise in infectious diseases [5] - The World Health Organization estimates that sepsis affects 49 million people globally each year, leading to approximately 11 million deaths, with significant healthcare costs in the U.S. reaching around $62 billion [3] Market Performance - Year to date, shares of AXDX have decreased by 55.3%, contrasting with the industry growth of 4.7% [8] - Accelerate Diagnostics currently holds a Zacks Rank 2 (Buy), indicating positive market sentiment [9]

Financial Data and Key Metrics Changes - Net sales for Q2 2024 were approximately $3 million, an increase from approximately $2.9 million in the same period last year, driven by low double-digit growth in recurring consumable net sales [15] - Gross margin decreased to approximately 23% from approximately 27% year-over-year, attributed to product mix [15] - Selling, general and administrative (SG&A) expenses were approximately $5.4 million, down from $7.6 million in the prior year, reflecting lower employee-related expenses [15] - Research and development (R&D) expenses were $3.9 million, down from $5.8 million, due to lower third-party development expenses for the Wave program [15] - The net loss for the quarter was approximately $11.6 million, resulting in a net loss per share of $0.50 [15] Business Line Data and Key Metrics Changes - The Wave program is positioned to disrupt the antimicrobial susceptibility testing market, with a focus on both positive blood culture and traditional isolated colony testing [5][6] - The preclinical trial for the Wave platform showed approximately 95% essential and categorical agreement across 20 antibiotics, indicating strong clinical performance [8] Market Data and Key Metrics Changes - The combined global antimicrobial susceptibility testing (AST) market is estimated at $2 billion, with Wave offering a competitive cost structure and faster results [6] Company Strategy and Development Direction - The company aims to leverage its position in the positive blood culture market, expand into isolate susceptibility testing, and apply holographic imaging technology to other diagnostic areas [10][12] - The strategic roadmap includes launching Wave with regulatory clearances, expanding assay offerings, and focusing on operational and development milestones to maximize value [10][12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the Wave platform's potential to address significant healthcare issues related to bacterial antimicrobial resistance, with a focus on rapid susceptibility testing [30][31] - The company has secured additional capital to fund operations through 2025, allowing for continued development and clinical trials [13][31] Other Important Information - The preclinical trial success has set the stage for an imminent clinical trial, with systems installed at four external sites [9] - Approximately 75% of the U.S. customer base is signed to longer-term contracts ahead of the Wave commercial launch [10] Q&A Session Summary Question: What levels of essential agreement and categorical agreement are needed for the clinical trial? - Management indicated that the FDA requires performance above 89.9% for approval, and the preclinical trial results were in the mid-90s, providing confidence for the upcoming clinical trial [20][21] Question: What led to the decision to focus on achieving milestones before working with strategic partners? - Management noted that securing funding and demonstrating the platform's capabilities through preclinical results would maximize value for stakeholders before engaging with strategic partners [22][24] Question: Can you help bridge the cash balance to your target of funding through 2025? - Management confirmed a pro forma cash balance in the mid-$25 million range and highlighted significant cost-cutting initiatives that have reduced cash burn, aiming for an operating cash burn target of about $5 million [25][28]

Core Insights - Accelerate Diagnostics reported a quarterly loss of $0.50 per share, which was better than the Zacks Consensus Estimate of a loss of $0.55, and a significant improvement from a loss of $2.36 per share a year ago, indicating a 78.8% year-over-year improvement [1] - The company posted revenues of $2.99 million for the quarter, slightly missing the Zacks Consensus Estimate by 0.47%, but showing a year-over-year increase from $2.92 million [1] - The stock has underperformed significantly, losing about 65.6% since the beginning of the year, while the S&P 500 has gained 9% [2] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.49 on revenues of $3 million, and for the current fiscal year, it is -$2.37 on revenues of $12.3 million [4] - The estimate revisions trend for Accelerate Diagnostics is mixed, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [4] Industry Context - The Medical - Instruments industry, to which Accelerate Diagnostics belongs, is currently ranked in the top 42% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [5] - Another company in the same industry, Neuronetics, is expected to report a quarterly loss of $0.27 per share, reflecting a year-over-year change of -58.8%, with revenues projected at $18.76 million, up 6.5% from the previous year [5][6]

Sales Performance - For the three months ended June 30, 2024, net sales increased to $2,986,000, a 2% increase from $2,921,000 in the same period of 2023, primarily due to higher sales of Accelerate PhenoTest consumables[226]. - For the six months ended June 30, 2024, net sales reached $5,907,000, reflecting a 3% increase from $5,733,000 in the same period of 2023[226]. Product Development and Launches - The Accelerate Pheno system and Accelerate PhenoTest BC Kit have been marketed since 2017, generating revenue primarily from instrument sales and single-use consumable test kits[215]. - The Accelerate Arc system and BC Kit were launched in 2022, with ongoing discussions with the FDA regarding U.S. commercialization as Class I devices exempt from 510(k) clearance requirements[218][219]. - A collaboration with Bruker Corporation was announced in November 2023 to validate the use of the Accelerate Arc system with Bruker's MALDI Biotyper system for microbial identification[222]. - The Accelerate WAVE system, currently in development, aims to deliver AST results within an average of 4.5 hours, enhancing the speed of diagnostics[223]. - The Accelerate WAVE system is expected to process five PBC assays or ten Isolated Colony assays per module, addressing the majority of microbiology lab volumes and workflows[225]. - The company anticipates significant workflow benefits for microbiology labs by offering consolidated PBC and Isolate susceptibility testing on a single rapid AST diagnostic[225]. - The company believes that the cost to produce Accelerate WAVE assays will be significantly lower than the standard costing for the Accelerate PhenoTest BC Kit, potentially improving the company's margin profile[225]. Financial Performance - For the three months ended June 30, 2024, cost of sales increased by $188, or 9%, compared to the same period in 2023, primarily due to higher manufacturing costs and increased volume of consumables sold[228]. - Gross profit for the three months ended June 30, 2024, decreased by $123, or 15%, compared to the same period in 2023, with gross margins of 23% in 2024 versus 27% in 2023[230]. - Research and development expenses for the three months ended June 30, 2024, decreased by $1,917, or 33%, compared to the same period in 2023, mainly due to lower third-party costs for the development of the Accelerate WAVE system[231]. - Sales, general and administrative expenses for the three months ended June 30, 2024, decreased by $2,185, or 29%, compared to the same period in 2023, attributed to lower legal and professional service fees[236]. - Loss from operations for the three months ended June 30, 2024, improved by $3,979, or 32%, compared to the same period in 2023, driven by reduced sales, general and administrative expenses[238]. - The company reported a net loss of $25.8 million and negative cash flows from operations of $16.0 million for the six months ended June 30, 2024[242]. - The accumulated deficit totaled $694.7 million as of June 30, 2024[242]. - Non-cash equity-based compensation as a component of gross profit decreased by $64, or 65%, for the three months ended June 30, 2024, compared to the same period in 2023[230]. - Total other expense, net, decreased by $17,012, or 85%, for the three months ended June 30, 2024, compared to the same period in 2023, primarily due to the completion of restructuring transactions[240]. Restructuring and Financing - The company completed restructuring transactions in June 2023, which included a loss on extinguishment of debt totaling $6.6 million[243]. - The Company completed a public offering in January 2024, generating net proceeds of $11.0 million, with an additional $2.7 million from the Schuler Trust's purchase of Units[244]. - As of June 30, 2024, the Company had $9.7 million in cash and cash equivalents, a decrease of $3.5 million from $13.2 million at December 31, 2023, primarily due to cash used in operations[245]. - The Company has a total contractual material cash requirement of $92.8 million, with $1.1 million due in 2024 and $78.8 million due in 2026[254]. - Net cash used in operating activities for the six months ended June 30, 2024, was $16.0 million, an improvement from $24.2 million in the same period of 2023[258]. - The Company provided $12.8 million in net cash from financing activities for the six months ended June 30, 2024, primarily from the sale and issuance of Units and Pre-Funded Units[262]. - The Company issued $66.9 million in 5.00% Notes on June 9, 2023, which mature on December 15, 2026, and bear interest payable in kind[263]. - The Company is actively exploring additional funding options to secure necessary capital for operations, with substantial doubt about its ability to continue as a going concern within the next twelve months[251]. - The Company has a purchase obligation of $11.9 million for raw materials, with delivery required by March 15, 2027[255]. - The Company has experienced significant increases in federal fund rates, impacting the cost of debt financing and overall financial conditions[248]. - The Company exchanged approximately $55.9 million of 2.50% Notes for approximately $56.9 million of 5.00% Notes, including accrued interest, and settled the outstanding balance of 2.50% Notes for approximately $0.8 million[267]. - As of June 30, 2024, $69.2 million of 5.00% Notes were outstanding[267]. - In January 2024, the Company completed a Public Units Offering consisting of 6.8 million units at a public offering price of $1.50, generating gross proceeds of approximately $10.2 million[271]. - The Schuler Trust purchased 1.2 million Units at a price of $1.73 per Unit, satisfying a purchase obligation and generating additional gross proceeds of approximately $2.0 million[274]. - Aggregate net proceeds from the January 2024 Public Units Offering and private placement offering for the six months ended June 30, 2024, were approximately $13.7 million[275]. - The Company amended the Schuler Purchase Obligation in December 2023, extending the investment deadline to February 15, 2024, with a commitment for the Schuler Trust to purchase $2.0 million at the public offering price if gross proceeds exceeded $10.0 million[270]. - The Company issued approximately 0.5 million shares of common stock to the Schuler Trust for proceeds of $4.0 million in June 2023[268]. - The exercise price for Common Warrants issued in the January 2024 Public Units Offering is $1.65 per share, and they are exercisable for five years[273]. - The Schuler Trust agreed to purchase an additional 1.6 million Units at a price of $1.73 per Unit on or before May 20, 2024, generating approximately $2.7 million[275]. - The Company had no off-balance sheet arrangements as of June 30, 2024[276].

Core Insights - Accelerate Diagnostics, Inc. reported a successful pre-clinical trial for its WAVE System and Gram-Negative Positive Blood Culture assay, indicating strong analytical performance [1][2] - The company raised an additional $15 million from existing noteholders, which is expected to fund operations through 2025 and support strategic milestones for the WAVE program [1][3] Second Quarter 2024 Operating Highlights - The WAVE program achieved a successful pre-clinical trial with 1,570 WAVE results showing approximately 95% Essential and Categorical Agreements compared to Broth Microdilution [2] - Contract extensions were executed with several strategic customers, securing about 75% of the U.S. Pheno customer base for longer-term contracts ahead of the WAVE commercial launch [2] - The company added five new contracted Pheno instruments, ending the quarter with 350 clinically live revenue-generating instruments and 74 contracted instruments in implementation [2] Second Quarter 2024 Financial Highlights - Net sales for the quarter were $3.0 million, a slight increase from $2.9 million in the same quarter of the previous year [4] - Revenues from consumable products increased by 12% compared to the prior year [4] - Gross margin was approximately 23%, down from 27% in the same quarter of the previous year, attributed to a lower capital instrument product sales mix [4] - SG&A costs decreased to $5.4 million from $7.6 million year-over-year, reflecting lower employee-related expenses [4] - R&D costs were $3.9 million, down from $5.8 million in the prior year, due to reduced third-party development costs for the WAVE system [4] - The net loss for the quarter was $11.6 million, with a net loss per share of $0.50 [4] Year-to-date Financial Highlights - Year-to-date net sales reached $5.9 million, compared to $5.7 million for the same period last year, driven by higher consumable product sales [5] - Gross margin improved to approximately 24% year-to-date, compared to 23% for the same period last year [5] - Year-to-date SG&A costs were $11.1 million, down from $17.7 million, due to lower employee-related expenses [5] - R&D costs year-to-date were $9.1 million, down from $12.8 million, also due to lower employee-related expenses and third-party development costs [5] - The year-to-date net loss was $25.8 million, resulting in a net loss per share of $1.16 [5]

Financial Performance - Net sales for Q2 2024 were $3.0 million, a 3.4% increase from $2.9 million in Q2 2023, with revenues from consumable products rising by 12% year-over-year[3] - Year-to-date net sales reached $5.9 million, a slight increase from $5.7 million in the same period of the prior year, driven by higher consumable product sales[6] - Net sales for the six months ended June 30, 2024, were $5,907 million, compared to $5,733 million for the same period in 2023, representing an increase of 3.0%[23] Profitability - Gross margin for Q2 2024 was approximately 23%, down from 27% in Q2 2023, attributed to a lower sales mix of capital instruments[3] - Gross profit for the six months ended June 30, 2024, was $1,399 million, down from $1,810 million in 2023, a decrease of 22.7%[23] - The net loss for Q2 2024 was $11.6 million, resulting in a net loss per share of $0.50[5] - The net loss for the six months ended June 30, 2024, was $25,818 million, compared to a net loss of $49,530 million for the same period in 2023, a reduction of 47.9%[23] - The company reported a basic and diluted net loss per share of $1.16 for the six months ended June 30, 2024, compared to $4.75 in 2023[23] Expenses - SG&A costs decreased to $5.4 million in Q2 2024 from $7.6 million in Q2 2023, reflecting lower employee-related expenses[3] - R&D costs for Q2 2024 were $3.9 million, down from $5.8 million in Q2 2023, due to reduced third-party development costs for the WAVE system[4] - Research and development expenses for the six months ended June 30, 2024, were $9,076 million, down from $12,788 million in 2023, a decrease of 29.0%[23] Cash and Liquidity - The company ended Q2 2024 with total cash and cash equivalents of $9.7 million, down from $15.8 million at the beginning of the quarter[5] - Total current assets decreased from $24,466 million in December 2023 to $17,170 million in June 2024, a decline of approximately 29.9%[19] - The company had cash and cash equivalents of $8,588 million as of June 30, 2024, down from $12,138 million in December 2023, a decrease of 29.5%[19] - Cash flows used in operating activities for the six months ended June 30, 2024, were $16,035 million, compared to $24,188 million in 2023, a decrease of 33.8%[25] Liabilities and Stockholders' Equity - Total liabilities increased from $51,254 million in December 2023 to $57,754 million in June 2024, an increase of approximately 12.3%[19] - Total stockholders' deficit increased from $19,888 million in December 2023 to $34,887 million in June 2024[21] Financing Activities - The company raised $15 million from existing noteholders, which is expected to fund operations through 2025[3] - Net cash provided by financing activities was $12,835 million, an increase from $9,729 million in the previous period[27] - Proceeds from the issuance of Units amounted to $10,232 million, while issuance costs were $884 million[27] - The capital contribution from the exchange of secured notes and accrued interest was $25,363 million[27] - The company incurred transaction costs related to debt and equity issuances amounting to $3,731 million[27] Operational Highlights - The WAVE program achieved a 95% overall Essential and Categorical Agreement in pre-clinical trials, demonstrating strong analytical performance[2] - Five new contracted Pheno instruments were added in the U.S. during Q2 2024, bringing the total to 350 clinically live revenue-generating instruments[2]

Company Overview - Accelerate Diagnostics, Inc. is focused on in vitro diagnostics, addressing global challenges related to antibiotic resistance and sepsis [2] - The company offers the Accelerate Pheno® system and Accelerate PhenoTest® BC kit, which aim to reduce the time required for clinicians to determine optimal antibiotic therapy for severe infections [2] Product Details - The FDA-cleared Accelerate Pheno® system and kit automate sample preparation, providing phenotypic antibiotic susceptibility results in approximately 7 hours from positive blood cultures [2] - External studies suggest that this solution delivers results 1-2 days faster than traditional methods, allowing for earlier optimization of antibiotic selection and dosage tailored to individual patients [2]