Financial Data and Key Metrics Changes - Total revenue for 2024 was $71.3 million, representing a 45% year-over-year growth [6][23] - Gross margins increased to 78% for the year, up from 73% in 2023 [7][25] - Adjusted EBITDA loss improved by 32% year-over-year, indicating progress towards profitability [7][28] - Net loss for Q4 2024 was $8.3 million, a 10% improvement compared to Q4 2023 [28] Business Line Data and Key Metrics Changes - Lung diagnostic testing revenue for Q4 2024 was $17.2 million, a 34% increase in revenue and test volume compared to Q4 2023 [24] - Full-year lung diagnostic testing revenues reached $64.7 million, reflecting a 43% growth [24] - Diagnostic development services revenue grew by 72% in Q4 and 70% for the full year [24] Market Data and Key Metrics Changes - The company reported a 40% growth in test volume for lung diagnostic testing in 2024 [9][24] - Approximately 49% of lung nodule patients have their first imaging workup conducted by primary care providers, indicating a significant market opportunity [11] Company Strategy and Development Direction - The company aims to expand its sales force by adding approximately six sales teammates per quarter in 2025, increasing from 71 to 95 teammates [13][31] - A new clinical study, Clarify, was launched to collect patient outcomes and clinical information, expected to provide valuable data in 2025 [14][17] - The company plans to maintain strong gross margins in the mid to upper seventies while achieving adjusted EBITDA profitability in the second half of 2025 [22][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in transforming patient care through personalized diagnostics, particularly in lung disease [7][31] - The company anticipates significant growth in 2025 driven by lung diagnostic testing and diagnostic development services [22][32] - Management highlighted the importance of addressing the unmet medical need in lung disease, with a focus on early diagnosis and treatment [8][31] Other Important Information - The company ended Q4 2024 with $26.2 million in unrestricted cash and cash equivalents [29] - A pilot program in 2024 demonstrated the effectiveness of expanding referral networks to primary care providers [12][41] Q&A Session Summary Question: Can you provide insights on revenue guidance between test business and biopharma business? - Management expects biopharma services to contribute about 8-9% of total revenue, with the majority coming from lung diagnostic services [39] Question: What are the drivers for adjusted EBITDA profitability? - Revenue growth combined with tight control on expenses will help achieve adjusted EBITDA breakeven in the second half of 2025 [40] Question: Can you elaborate on the pilot program's findings? - The pilot showed that primary care physicians were accessible and recognized the utility of the tests, leading to better patient management [42][45] Question: What is the status of the product pipeline? - No new tests will be launched in 2025, but updates on existing partnerships and studies will be provided throughout the year [54] Question: How will updates in lung cancer screening guidelines affect the company? - Management believes that any improvements in screening will significantly expand the addressable market for their services [62][66] Question: What is the expected cash burn for the year? - Management anticipates cash burn to increase in Q1 but expects to reach cash flow breakeven with existing cash on hand [106][110]

Financial Data and Key Metrics Changes - Total revenue for 2024 was $71.3 million, representing a 45% year-over-year growth [6][23] - Gross margins increased to 78% for the year, up from 73% in 2023 [7][25] - Adjusted EBITDA loss improved by 32% year-over-year, indicating progress towards profitability [7][28] Business Line Data and Key Metrics Changes - Lung diagnostic testing revenue for Q4 2024 was $17.2 million, a 34% increase from Q4 2023 [24] - Full-year lung diagnostic testing revenues reached $64.7 million, reflecting a 43% growth [24] - Diagnostic development services revenue grew by 70% year-over-year, totaling $6.6 million for the year [19][24] Market Data and Key Metrics Changes - The company reported a 40% growth in test volume for lung diagnostic testing in 2024 [9][24] - Approximately 49% of lung nodule patients have their first imaging workup conducted by primary care providers, highlighting a significant market opportunity [11] Company Strategy and Development Direction - The company aims to expand its sales force by adding approximately six sales teammates per quarter, targeting a total of 95 teammates by the end of 2025 [13][31] - A new clinical study, Clarify, was launched to collect patient outcomes and clinical information, expected to provide valuable data for future growth [14][17] - The company plans to maintain strong gross margins in the mid to upper seventies while achieving adjusted EBITDA profitability in the second half of 2025 [22][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in transforming patient care through personalized diagnostics, particularly in lung disease [7][31] - The company anticipates significant growth in 2025, driven by increased adoption of lung diagnostic tests and diagnostic development services [22][32] - Management is closely monitoring changes in the reimbursement landscape and regulatory environment, which could impact future growth [62] Other Important Information - The company ended Q4 2024 with $26.2 million in unrestricted cash and cash equivalents [29] - A pilot program demonstrated the effectiveness of expanding sales efforts into primary care, indicating a viable path for growth [12][42] Q&A Session Summary Question: Can you provide insight into revenue guidance for 2025? - Management expects biopharma services to contribute about 8-9% of total revenue, with the majority coming from lung diagnostic services, driven by volume growth rather than significant ASP changes [39][40] Question: What are the drivers for achieving adjusted EBITDA profitability? - The combination of revenue growth and tight control on expenses is expected to bridge the gap to adjusted EBITDA breakeven in the second half of 2025 [40] Question: Can you elaborate on the pilot program's outcomes? - The pilot program successfully demonstrated that primary care physicians were accessible and saw utility in the tests, leading to increased referrals [42][45] Question: What is the status of the product pipeline? - No new tests are expected to be launched in 2025, but updates on existing partnerships and studies will be provided throughout the year [54][55] Question: How will updates in lung cancer screening guidelines affect the company? - Any improvements in lung cancer screening participation will significantly expand the addressable market, as less than 10% of the screen-eligible population currently participates [64] Question: What is the expected cash burn for the year? - Management believes they can reach adjusted EBITDA breakeven with existing cash on hand, with cash burn expected to decrease throughout the year [106][109]

Revenue Growth - Biodesix reported significant growth in revenue from its Lung Diagnostic Testing and Development Services, with a focus on five blood-based tests for lung diagnostics [510]. - Total revenue for fiscal 2024 was $71.3 million, a 45% increase compared to $49.1 million in fiscal 2023 [524]. - Lung Diagnostic Testing revenue reached $64.7 million, up 43% from $45.2 million in the previous year, driven by an increase in tests delivered [525]. - Development Services revenue increased by 70% to $6.6 million, compared to $3.9 million in fiscal 2023, attributed to new agreements and an expanding business [527]. Test Innovations and Studies - The Nodify CDT Test received Advanced Diagnostic Laboratory Test (ADLT) status from CMS, recognizing its innovative nature and Medicare coverage [503]. - The ORACLE study demonstrated that patients with benign nodules managed by the Nodify XL2 test were 74% less likely to undergo unnecessary invasive procedures compared to the control group [504]. - The ongoing INSIGHT study has enrolled 5,000 patients with non-small cell lung cancer, with follow-up expected to complete by 2026, aimed at expanding clinical understanding of the VeriStrat test [503]. - Biodesix has achieved approximately 90 peer-reviewed publications for its tests, enhancing its credibility and clinical evidence base [507]. - Biodesix employs a multi-omic approach, integrating genomics, proteomics, and AI to enhance diagnostic capabilities and address complex clinical questions [494]. Financial Performance - Gross margin for fiscal 2024 was 78%, an improvement from 73% in the prior year, primarily due to growth in Lung Diagnostic Testing and optimized testing workflows [524]. - Operating expenses for fiscal 2024 totaled $105.8 million, a 17% increase from $90.4 million in fiscal 2023, driven by higher sales and marketing costs [524]. - Net loss for fiscal 2024 was $42.9 million, an improvement of 18% compared to a net loss of $52.1 million in fiscal 2023 [524]. - The Company reported net losses of $42.9 million and $52.1 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of approximately $462.5 million as of December 31, 2024 [550]. Cash and Liquidity - Cash and cash equivalents stood at $26.2 million as of December 31, 2024, following an amendment to the term loan facility to extend a $10 million loan [72]. - The Company believes it has sufficient liquidity to fund operations for at least the next 12 months following the amended debt agreement in October 2024 [551]. - Net cash used in operating activities for the year ended December 31, 2024, totaled $48.6 million, an increase of approximately $25.8 million compared to 2023, primarily due to unfavorable changes in net working capital of $33.0 million [552]. - Net cash provided by financing activities for the year ended December 31, 2024, totaled $52.1 million, an increase of $22.9 million compared to 2023, primarily from $51.3 million in net proceeds from the issuance of common stock [554]. Research and Development - The company plans to increase research and development expenses to support innovation and the development of new clinically relevant tests [507]. - Research and development expenses decreased by 4% to $9.6 million, primarily due to reduced external costs associated with clinical trials [529]. - The company expects research and development expenses to rise as it continues to innovate and expand its product offerings [520]. Debt and Interest - The Company amended the Perceptive Term Loan Facility to eliminate the Tranche C Loan revenue milestone and extend the Commitment Termination Date through December 31, 2025 [550]. - As of December 31, 2024, the outstanding balance on the Perceptive Term Loan Facility was $40.0 million, with an annual interest rate based on the greater of forward-looking one-month term SOFR or 3.0% plus an applicable margin of 9.0% [568]. - Interest expense decreased by $1.3 million or 13% for the year ended December 31, 2024, primarily related to a decline in contingent consideration balance [531]. Revenue Recognition - Revenue is recognized when customers obtain control of promised goods or services, following a five-step process [558]. - The company recognizes revenues related to blood-based lung diagnostic billings based on estimates of amounts expected to be collected from customers [559]. Company Classification - The company is classified as an "emerging growth company" and a "smaller reporting company," allowing it to take advantage of certain exemptions from public company reporting requirements [563].

Financial Results - Biodesix, Inc. announced preliminary and unaudited financial results for Q4 and the year ended December 31, 2024[4] - The press release detailing financial results is included as Exhibit 99.1[6] Company Classification - The company is classified as an emerging growth company under the Securities Act[3]

Core Insights - Biodesix, Inc. reported total revenue of $71.3 million for FY2024, representing a 45% increase compared to FY2023 [1][2] - The company achieved gross margins of 78% for FY2024, an improvement of 5 percentage points over FY2023 [1][6] - For FY2025, Biodesix anticipates total revenue between $92 million and $95 million [4] Financial Performance - Total revenue for Q4 2024 was $20.4 million, marking a 39% increase year-over-year, while total revenue for FY2024 was $71.3 million, up 45% from the previous year [6] - Lung Diagnostic Testing revenue reached $17.2 million for Q4 2024 and $64.7 million for FY2024, reflecting a 34% and 43% increase, respectively [6] - Diagnostic Development Services revenue was $3.2 million for Q4 2024 and $6.6 million for FY2024, showing a 72% and 70% increase year-over-year [6] Operational Efficiency - The company improved its gross margin to 78% for FY2024, up from 73% in the prior year, driven by growth in Lung Diagnostic testing and optimization of testing workflows [6][2] - Operating expenses for FY2024 were $90.2 million, a 17% increase from the previous year, primarily due to higher sales and marketing costs [6] Loss and Adjusted EBITDA - Biodesix reported a net loss of $42.9 million for FY2024, which is an improvement of 18% compared to the previous year [6] - Adjusted EBITDA for FY2024 was a loss of $22.1 million, reflecting a 32% improvement year-over-year [6][20] Cash Position - As of December 31, 2024, the company had cash and cash equivalents of $26.2 million [6]

Core Insights - Biodesix, Inc. will present at the TD Cowen 45th Annual Health Care Conference on March 5, 2025, with CEO Scott Hutton and CFO Robin Cowie participating in a fireside chat and hosting in-person investor meetings [1][2]. Company Overview - Biodesix is a leading diagnostic solutions company with five Medicare-covered tests for pulmonology patients, including the Nodify Lung® Nodule Risk Assessment and the IQLung™ test portfolio for lung cancer patients [3]. - The Nodify Lung® test helps evaluate the risk of malignancy in pulmonary nodules, aiding physicians in patient triage [3]. - The IQLung™ test portfolio supports treatment decisions across all stages of lung cancer and facilitates personalized treatment [3]. - Biodesix collaborates with top biopharmaceutical companies for biomarker discovery, diagnostic test development, and clinical trial support services [3].

Core Viewpoint - Biodesix, Inc. will release its financial results for Q4 and the full year of 2024 on March 3, 2025, followed by a conference call to discuss the results and provide a business update [1]. Company Overview - Biodesix is a leading diagnostic solutions company with five Medicare-covered tests for pulmonology patients [3]. - The Nodify Lung® Nodule Risk Assessment helps evaluate the risk of malignancy in pulmonary nodules, aiding physicians in patient triage [3]. - The IQLung™ test portfolio supports treatment decisions for lung cancer patients across all stages and facilitates personalized treatment [3]. - The company collaborates with top biopharmaceutical firms for biomarker discovery, diagnostic test development, and clinical trial support [3].

Core Insights - Biodesix, Inc. reported an estimated total revenue of $71.3 million for fiscal 2024, marking a 45% increase year-over-year [1][3][6] - The company achieved significant growth in its Lung Diagnostics and Biopharma Services segments, with revenues increasing by 43% and 69% respectively [3][6] - Biodesix's operational efficiencies and cost-disciplined approach contributed to its progress towards profitability [3] Financial Highlights - Total revenue for Q4 2024 is estimated at $20.4 million, a 39% increase compared to the same quarter in the previous year [6] - Lung Diagnostics revenue for Q4 2024 is estimated at $17.2 million, reflecting a 34% year-over-year increase [6] - Biopharma Services revenue for Q4 2024 is estimated at $3.2 million, showing a 68% increase from the prior year [6] - The company entered 2025 with $12.2 million under contract but not yet recognized as revenue, a 54% increase over the previous year [6] Operational Metrics - Lung Diagnostic test volumes reached 14,600 in Q4 2024, a 34% increase year-over-year [6] - For the full year 2024, Lung Diagnostic test volumes totaled 54,300, representing a 40% increase compared to the previous year [6] - As of December 31, 2024, Biodesix reported cash and cash equivalents of $26.2 million [6] Company Overview - Biodesix is a leading diagnostic solutions company with five Medicare-covered tests for pulmonology patients [4] - The Nodify Lung® Nodule Risk Assessment and IQLung™ test portfolio are key offerings that support treatment decisions for lung cancer patients [4]

Company Overview - Biodesix, Inc. (BDSX) announced a new post-market clinical validation study published in CHEST Pulmonary Journal, reaffirming the performance of its Nodify CDT blood-based lung nodule test [1][4] - The Nodify CDT test is designed to detect cancer-associated autoantibodies, aiding in the identification of potentially malignant lung nodules and helping healthcare providers prioritize further diagnostic evaluations [2][6] Stock Performance - Following the announcement, BDSX shares increased by 2.7%, closing at $1.49, although the stock has lost 24.7% over the past year compared to the industry's growth of 3.9% and the S&P 500's gain of 24.4% [3][4] Market Capitalization and Revenue Estimates - BDSX currently has a market capitalization of $210.9 million, with the Zacks Consensus Estimate for fiscal 2024 revenues at $70.6 million, indicating a growth of 43.7% from fiscal 2023 [5] Study Data and Findings - The study included 447 patients with lung nodules managed conventionally, revealing that 33% of patients with cancerous nodules received a diagnosis more than three months after detection, indicating missed opportunities for early detection [8] - The Nodify CDT test demonstrated high specificity in accurately identifying benign lung nodules, outperforming PET scans, which had more false positives, thus highlighting the test's value as a safer diagnostic tool [9] Industry Prospects - The global lung cancer screening market was valued at $3.55 billion in 2024 and is projected to reach $7.10 billion by 2032, with a CAGR of 9.1% during the forecast period [10] - The market growth is driven by increasing lung cancer incidence due to smoking, technological advancements in screening, and government support for early detection [11]

Core Insights - The article discusses the validation of the Nodify CDT blood-based lung nodule test, reaffirming its performance in detecting lung cancer through a study published in CHEST Pulmonary Journal [1] Company Overview - Biodesix, Inc. is a leading diagnostic solutions company focused on lung disease, offering five Medicare-covered tests for patients with lung diseases [2] - The company’s Nodify Lung Nodule Risk Assessment combines the Nodify CDT and Nodify XL2 tests to evaluate the risk of malignancy in pulmonary nodules, aiding physicians in patient triage [2] Test Performance - The Nodify CDT test measures levels of seven autoantibodies associated with lung cancer, providing a "rule in" test for likely cancerous nodules [1] - In a study of 447 patients, 33% of those with cancerous nodules were diagnosed more than three months after detection, indicating missed opportunities for early diagnosis [1] - The Nodify CDT test demonstrated high specificity, with a low percentage of benign nodules misclassified as high risk, outperforming positron emission tomography (PET) scans which had more false positives [1] Clinical Implications - The study suggests that the Nodify CDT test may serve as a useful adjunct in clinical practice, potentially avoiding delays in treatment for patients with cancer [1] - The findings highlight the inadequacy of relying solely on PET scans for diagnostic decision-making in lung nodule risk assessment [1]