Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $18 million, representing a 21% increase year over year [22] - Lung diagnostic testing revenue was $16.3 million, reflecting an 18% growth, with test volumes increasing by 16% [22][24] - Gross margin improved to 79.4%, up from 78.6% in Q1 2024 [23] - Net loss for Q1 2025 was $11.1 million, an 18% improvement year over year [24] - Adjusted EBITDA loss was $6.2 million, an 11% improvement year over year [24] Business Line Data and Key Metrics Changes - Lung diagnostics revenue grew by 18%, marking the sixteenth consecutive quarter of over 15% year-over-year growth [5] - Development services revenue reached $1.7 million, a 61% increase compared to Q1 2024 [20] - The pipeline for development services ended Q1 with $10.9 million under contract, a 21% increase year over year [23] Market Data and Key Metrics Changes - The company is focusing on expanding its presence in the primary care market, which is expected to enhance patient access to lung diagnostics [9][12] - Digital test ordering increased by 58% over the last year, with customer retention for digital ordering being 40% higher than for non-digital ordering [8] Company Strategy and Development Direction - The company aims to achieve positive adjusted EBITDA by Q4 2025 while focusing on revenue growth and operational efficiencies [4][26] - A shift to a territory-based sales approach has been implemented to enhance market penetration in both pulmonology and primary care [9][11] - The company is exploring the integration of AI and radiomics into its diagnostic offerings to improve clinical workflows [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving adjusted EBITDA positivity in Q4 2025 despite current challenges in the sales force expansion [24][44] - The company is optimistic about the growth potential in the primary care market, supported by positive feedback from pulmonologists [42][61] - Management acknowledged the need for careful monitoring of expenses while ramping up the sales team to meet growth targets [78] Other Important Information - The company has been recognized as a top workplace for the second consecutive year in 2025, highlighting its strong team culture [28] - The company plans to hold an R&D day in the fall to provide further insights into its pipeline and progress [20] Q&A Session Summary Question: Can you elaborate on the sales force changes and hiring challenges? - Management noted that the shift to primary care required a different hiring profile, which took longer than anticipated to finalize [32][34] Question: What is the outlook for Q2 and the rest of the year? - Management expects to have 70 to 75 sales reps in Q2, with plans to increase to 85 in Q3 and 95 in Q4 [39] Question: How are primary care physicians responding to the technology? - Early feedback indicates that primary care physicians are aware of the patient population and are interested in utilizing the diagnostic tests [41][61] Question: What is the impact of the $10 million loan on capital needs? - The additional capital provides more flexibility and confidence in achieving breakeven while supporting commercial expansion and pipeline activities [44][45] Question: How does the sales force configuration affect territory management? - Each territory will have a pulmonology sales consultant, with associate sales consultants supporting them based on specific needs and test volumes [92][93]

Financial Performance - Total revenue for Q1 2025 was $18.0 million, representing a 21% increase compared to the same period in 2024[165] - Diagnostic Testing revenue reached $16.3 million for Q1 2025, an 18% increase year-over-year, primarily driven by an increase in total tests delivered[165] - Development Services revenue was $1.7 million for Q1 2025, an increase of 61% compared to the same period in 2024[170] - Gross margin for Q1 2025 was $14.3 million, or 79.4%, compared to 78.6% in the prior year, driven by growth in diagnostic testing and optimization of testing workflows[170] - Total revenues for Q1 2025 were $17.958 million, a 21% increase from $14.818 million in Q1 2024[181] - Diagnostic Tests revenue increased by $2.5 million or 18% in Q1 2025, primarily due to a $2.7 million increase in the Nodify Lung Nodule Risk Assessment testing strategy[183] - Net loss for Q1 2025 was $11.1 million, an improvement of 18% compared to a net loss of $13.6 million in Q1 2024[181] Research and Development - The ongoing INSIGHT study has enrolled 5,000 patients with non-small cell lung cancer, with expected follow-up completion by 2026[160] - The company aims to develop a new molecular minimal residual disease (MRD) test in collaboration with Memorial Sloan Kettering Cancer Center[163] - The ALTITUDE study seeks to further demonstrate the utility of the Nodify CDT and XL2 tests, enhancing clinical validation[161] - Research and development expenses rose by $0.8 million or 41% in Q1 2025, attributed to increased internal compensation and external clinical trial costs[186] - Total external research and development costs increased by $364 thousand or 42% in Q1 2025 compared to Q1 2024[187] Operational Efficiency - The Nodify CDT and XL2 tests have an average turnaround time of one and five business days, respectively, providing timely results for lung cancer diagnosis[149] - The GeneStrat ddPCR test can be used multiple times per patient to monitor changes in mutation status, enhancing treatment decision-making[152] - Operating expenses (excluding direct costs) were $23.4 million for Q1 2025, a 3% increase from the prior year, with R&D costs increasing by $900 thousand[170] Financial Position and Cash Flow - Cash and cash equivalents were $17.6 million as of March 31, 2025, with a pro forma cash balance of $27.6 million after receiving $10 million from a loan facility[170] - The Company recorded a net cash flow used in operating activities of $8.6 million for the three months ended March 31, 2025, a decrease of approximately $6.7 million compared to $15.3 million for the same period in 2024[202] - The net decrease in cash and cash equivalents and restricted cash was $8.6 million for the three months ended March 31, 2025, compared to a decrease of $14.8 million for the same period in 2024[202] - The Company raised net proceeds of approximately $51.3 million from an underwritten offering of common stock and a concurrent private placement on April 9, 2024[196] - The Company has a total of $54.4 million in borrowings and interest obligations, with $5.4 million due within one year[205] - The Company amended the Credit Agreement to extend the Tranche C Loan availability to December 31, 2025, with a total amount of $10.0 million[199] - The Company recorded a $0.4 million loss due to changes in the fair value of warrant liability during the three months ended March 31, 2025[190] - The Company had net cash provided by financing activities of $0.1 million for the three months ended March 31, 2025, a decrease of $0.7 million compared to the same period in 2024[204] Compliance and Regulatory - The Company is subject to a compliance period until September 22, 2025, to regain compliance with Nasdaq's Minimum Bid Price Requirement of $1.00 per share[200] - The Company has remaining available capacity for share issuances of up to $50.0 million under the 2024 ATM Program as of March 31, 2025[198] - The company will remain an emerging growth company until it exceeds $1.24 billion in annual revenue or meets other specified criteria[214] - The company is classified as a "smaller reporting company" and will maintain this status until certain market value and revenue thresholds are met[215] Interest and Market Risk - As of March 31, 2025, the company had $40.0 million outstanding on the Perceptive Term Loan Facility, with an annual interest rate of at least 3.0% plus a margin of 9.0%[217] - A hypothetical 100 basis point increase in interest rates would result in an estimated $0.4 million impact per year on the company's financial position[219] - The company has not entered into derivative agreements to manage floating interest rate exposure[217] - The company maintains cash and cash equivalents primarily at one U.S. financial institution, monitoring credit quality continuously[218] - The company is exposed to market risk due to potential adverse changes in financial market prices and rates[216] - The company has opted for reduced disclosure requirements available to emerging growth companies, complicating financial comparisons with other public companies[213]

Exhibit 99.1 Biodesix Announces First Quarter 2025 Results and Highlights Total Q1 2025 Revenue of $18.0 million, an increase of 21% over Q1 2024; Gross margins of 79.4% for Q1 2025; Q1 2025 Net loss improved by 18% compared to Q1 2024; "In the second half of 2024, we conducted a commercial pilot to explore the expansion of our commercial reach to include pulmonology and the select primary care physicians in their referral network. The goal of the pilot was to assess our ability to effectively access the ~5 ...

Core Insights - Biodesix, Inc. reported a total revenue of $18.0 million for Q1 2025, marking a 21% increase compared to Q1 2024 [1][3] - The company achieved gross margins of 79.4% in Q1 2025, an improvement from 78.6% in the prior year [3] - Net loss for Q1 2025 was $11.1 million, which is an 18% improvement over the same period last year [3][10] - The revenue guidance for 2025 has been updated to a range of $80-85 million [4] Financial Performance - Diagnostic Testing revenue reached $16.3 million in Q1 2025, an 18% increase year-over-year, driven by a rise in total tests delivered [3] - Development Services revenue surged by 61% to $1.7 million in Q1 2025 compared to the prior year [3] - Operating expenses for Q1 2025 were $23.4 million, a 3% increase from the previous year, primarily due to a $900 thousand rise in Research and Development costs [3] Strategic Initiatives - The company has restructured its sales team into a territory-based model to enhance access to patients with lung nodules, following a successful commercial pilot [2] - Biodesix aims to achieve Adjusted EBITDA positivity in Q4 2025, despite being approximately one quarter behind in its commercial plan [2][4] - The company strengthened its cash position by drawing down $10 million from its term loan facility, raising its pro forma cash balance to $27.6 million [2][10]

Core Viewpoint - Biodesix, Inc. will release its financial results for Q1 2025 on May 13, 2025, and will host a conference call to discuss these results and provide a business update [1] Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients, particularly in lung disease [3] - The company markets diagnostic tests such as Nodify Lung® Nodule Risk Assessment and IQLung™ Cancer Treatment Guidance, which support clinical decisions for personalized care [3] - Biodesix also offers Diagnostic Development Services to biopharmaceutical, life sciences, and research institutions, enhancing their capabilities in developing diagnostic tests and therapeutics [3]

Core Insights - The ctMoniTR Project has shown a strong association between changes in circulating tumor DNA (ctDNA) levels and treatment outcomes, indicating potential integration of ctDNA analysis in therapeutic development and clinical cancer care [1][2] - Biodesix and Bio-Rad Laboratories collaborated on this project, utilizing Bio-Rad's Droplet Digital™ PCR technology to detect ctDNA from patient samples [3][4] - Biodesix is actively involved in ctDNA testing and is exploring its combination with proteomics for detecting molecular residual disease (MRD), with advancements to be presented at the upcoming AACR Annual Meeting [4] Company Overview - Biodesix, Inc. is a leading diagnostics solutions company focused on improving clinical care and outcomes for patients, offering diagnostic tests that support personalized care [7] - Bio-Rad Laboratories, Inc. is a leader in life science research and clinical diagnostics, with approximately 7,700 employees and $2.7 billion in revenues in 2023, serving a wide range of customers including universities and biopharmaceutical companies [8]

Biodesix, Inc. (BDSX) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of a changing earni ...

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].