Biodesix partners with three leading Lung Health organizations to bring education and advocacy to healthcare professionals and patients LOUISVILLE, Colo., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostics solutions company, announced three Colorado-based events in October for healthcare professionals and community members to collaborate, learn, and advocate for lung health. First Event: October 9th APAPP Know Your Nodules Event at Biodesix Head Office in Louisville, CO T ...

Core Viewpoint - Biodesix, Inc. announced a one-for-twenty reverse stock split effective September 15, 2025, aimed at reducing the number of outstanding shares and potentially improving the stock's market perception [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split was approved by stockholders on May 20, 2025, with the final ratio determined by the board of directors [2]. - The number of shares will decrease from approximately 156 million to about 8 million, with adjustments for fractional shares [2]. - The reverse stock split will not change stockholders' percentage ownership interests, except for fractional shares, which will be compensated in cash [3]. Group 2: Impact on Equity Incentive Plans - The number of shares available under the Company's equity incentive plans and the exercise prices of outstanding options and warrants will be proportionately adjusted [4]. Group 3: Administrative Process - Computershare Trust Company, N.A. will act as the transfer agent, managing the transition to post-split shares without requiring action from registered stockholders [5]. - Stockholders with certificated shares will receive instructions from Computershare on how to surrender their pre-split shares [5]. Group 4: Company Overview - Biodesix is a leader in personalized diagnostics, focusing on improving clinical care and outcomes for patients, particularly in lung disease [7].

Core Viewpoint - Biodesix, Inc. will participate in Lake Street Capital Markets' 9th Annual Best Ideas Growth (BIG9) Conference, with CFO Robin Cowie hosting in-person 1x1 investor meetings on September 11, 2025 [1]. Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients [2]. - The company offers diagnostic tests such as Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance, which assist in clinical decision-making for lung disease [2]. - Biodesix Development Services support biopharmaceutical and life sciences institutions in developing diagnostic tests, tools, and therapeutics [2].

Core Insights - Biodesix has been designated as a Thermo Fisher Scientific Center of Excellence (COE), enhancing its role in advancing NGS-based diagnostics for solid tumors [1][2] - The collaboration with Thermo Fisher has led to the validation of the Oncomine Dx Express Test, which is crucial for the FDA approval of the Genexus Dx Integrated Sequencer [2][3] - Biodesix aims to expand its molecular diagnostic and NGS testing capabilities, particularly in tissue-based profiling, as part of its commitment to improving cancer diagnosis and care [3] Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients, particularly in lung disease [4] - The company offers diagnostic tests such as Nodify Lung® Nodule Risk Assessment and IQLung Cancer Treatment Guidance, which support personalized care [4] - Biodesix Development Services provide scientific, technological, and operational capabilities to biopharmaceutical and life sciences institutions [4] Thermo Fisher COE Network - The Thermo Fisher NGS COE Network collaborates with global institutions to develop and refine the Ion Torrent™ Oncomine™ solutions portfolio [5] - This network aims to accelerate oncology research and advance precision medicine through strategic alliances [5]

Summary of Biodesix (BDSX) FY Conference Call - August 12, 2025 Company Overview - Biodesix is a blood-based diagnostic company with a primary focus on lung cancer and a broader interest in pan-cancer through biopharmaceutical partnerships [3][4] Business Model and Product Offering - The company has five on-market tests, all covered by Medicare for lung disease patients, including two pre-cancer diagnostic tests and three post-cancer genomic and proteomic tests [3][4] - The proprietary proteomic test, Verastrat, assists physicians in determining the best treatment options for patients [4] Second Quarter Performance - The second quarter results exceeded expectations, attributed to a strategic shift towards primary care [5][6] - The company aims to leverage pulmonology networks to enhance patient referrals for testing, addressing concerns about delays in cancer diagnosis [6][7] Sales Strategy and Workforce Expansion - The sales force is expanding, with plans to increase from 74 to 85 representatives by the end of Q3 and 95 by Q4 [16][17] - The productivity of sales representatives has remained consistent, and the company is optimistic about future growth [12][17] Digital Integration and Efficiency - The transition from paper-based to digital ordering systems has improved efficiency and customer satisfaction, leading to increased reorder rates [26][27] - The company is working on further EMR integrations to streamline the ordering process [29][30] Biopharmaceutical Partnerships - The biopharma segment is growing, with $12.5 million in revenue under contract but not yet recognized [32] - The team has maintained high productivity and is focused on building long-term relationships with pharmaceutical partners [34][35] Research and Development Focus - R&D expenses have increased, primarily due to ongoing studies like Clarify and the development of the Verastrat test [48][49] - The company is working on a joint proteomic-genomic MRD test with Memorial Sloan Kettering, expected to be available in RUO capacity by the end of the year [41][42] Market Opportunities and Challenges - The company sees significant growth potential in lung cancer screening, despite current infrastructure challenges faced by pulmonologists [55][56] - The upcoming updates to clinical guidelines in 2025 may provide additional opportunities for the company [52][54] Financial Position and Future Outlook - Biodesix has approximately $20 million in cash and is exploring options to manage cash burn while aiming for adjusted EBITDA profitability [60][61] - The company is focused on growth rather than cost-cutting, with a strong emphasis on maintaining high gross margins [67][68] Key Takeaways - Biodesix is positioned for growth in the lung cancer diagnostic market, with a strong product offering and expanding sales force - The transition to digital ordering and ongoing biopharma partnerships are critical to enhancing operational efficiency and revenue generation - The company is optimistic about future developments in R&D and market opportunities, despite current financial challenges and industry dynamics [66][68]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $20 million, representing a 12% increase year over year [18] - Gross margin improved to 80%, up 150 basis points from 78.4% in Q2 2024 [19] - Net loss for Q2 2025 was $11.5 million, an increase of 6% year over year [20] - Adjusted EBITDA loss was $7.2 million, which is a 29% increase year over year [20] - Cash used from operations improved by 23% to $6.6 million compared to $8.6 million in Q2 2024 [20] Business Line Data and Key Metrics Changes - Lung diagnostic testing revenue was $17.9 million from approximately 15,100 tests, compared to $16.5 million from approximately 13,900 tests in Q2 2024, representing 9% growth in test volumes and 8% growth in revenue [18] - Development services revenue grew by 53% year over year to $2.1 million [18][16] Market Data and Key Metrics Changes - The company ended Q2 2025 with $12.5 million under contract for development services, marking a 54% increase year over year and an all-time high [18][16] - The average number of sales representatives in the field was 74, with plans to increase to 83-87 in Q3 and 93-97 in Q4 [10][21] Company Strategy and Development Direction - The company aims to grow top-line revenue, improve operational effectiveness, and achieve positive adjusted EBITDA by Q4 2025 [5] - A territory-based sales strategy was implemented to engage pulmonologists and their referral networks, addressing nearly 50% of patients with lung nodules managed by primary care [7][6] - The company is focused on expanding its clinical evidence base and pipeline, with multiple presentations at key conferences [12][13][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the primary care strategy, noting that feedback from pulmonologists supports the approach [30] - The company anticipates continued growth in the development services segment, particularly in Q4 due to pharmaceutical budget cycles [45] - Management remains optimistic about achieving adjusted EBITDA positivity in Q4 2025, driven primarily by revenue growth [21][40] Other Important Information - The company has made significant progress in clinical studies, including the ALPITUDE study, which has reached patient enrollment requirements [23][12] - The company was recognized as a top workplace for the second consecutive year, reflecting its strong culture and team [24] Q&A Session Summary Question: Can you unpack the primary care opportunity and your confidence in the strategy? - Management indicated that confidence has increased due to broader experiences and consistent feedback from pulmonologists [30][29] Question: What trends are seen in electronic ordering utilization? - Management noted that electronic ordering has improved compliance and reduced test cancellations, enhancing efficiency [36][35] Question: How will the company bridge to EBITDA positivity in Q4? - The primary driver will be revenue growth from an increased number of sales representatives, with no major cost-cutting measures planned [40][42] Question: What is the outlook for development services revenue? - Management expects an uptick in Q4 due to the typical cadence of pharmaceutical companies' budgeting [45] Question: What is the growth outlook for primary care orders? - Management stated that while primary care orders have increased significantly, forecasting the exact mix with pulmonology is challenging [60][59] Question: What are the capital needs over the next year and a half? - Management is focused on achieving both adjusted EBITDA and cash flow breakeven with existing plans [71] Question: How confident is the company in maintaining $1 million per rep productivity? - Management expressed confidence based on pilot program results, indicating potential for higher productivity in some territories [73][75]

[Special Note Regarding Forward-Looking Statements](index=3&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This report contains forward-looking statements involving substantial risks and uncertainties regarding future financial condition, operations, strategy, and management objectives - This report contains forward-looking statements involving substantial risks and uncertainties, including future financial condition, results of operations, business strategy, and management objectives. These statements are based on current expectations and projections, but actual results may differ materially due to various factors[8](index=8&type=chunk)[9](index=9&type=chunk)[10](index=10&type=chunk) - Key risks include inability to achieve profitability, difficulties in market acceptance and managing growth, failure to retain personnel or maintain biopharmaceutical relationships, significant fluctuations in operating results, product performance issues, supply chain vulnerabilities, and impacts from external events like pandemics or disasters[9](index=9&type=chunk) - Additional risks encompass debt financing restrictions, need for additional capital, acquisition challenges, uncertainty of insurance coverage and reimbursement, future healthcare reforms, compliance with various laws, ability to develop and obtain regulatory approval for new diagnostic tests, potential product recalls, intellectual property litigation, stock price volatility, and reliance on critical accounting policies[14](index=14&type=chunk) PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Biodesix, Inc.'s unaudited condensed financial statements for the periods ended June 30, 2025, and December 31, 2024, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes explaining significant accounting policies, financial instrument fair values, debt, leases, equity, revenue recognition, share-based compensation, income taxes, segment reporting, and commitments and contingencies [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) Presents the company's financial position, detailing assets, liabilities, and stockholders' equity at specific dates Condensed Balance Sheets (in thousands) | (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | **Assets** | | | | Total current assets | $32,445 | $39,484 | | Total non-current assets | $55,295 | $57,760 | | **Total assets** | **$87,740** | **$97,244** | | **Liabilities** | | | | Total current liabilities | $15,160 | $14,317 | | Total non-current liabilities | $71,442 | $62,051 | | **Total liabilities** | **$86,602** | **$76,368** | | **Stockholders' Equity** | | | | Total stockholders' equity | $1,138 | $20,876 | - Total assets decreased by **$9.5 million** from **$97.2 million** at December 31, 2024, to **$87.7 million** at June 30, 2025, primarily driven by a decrease in cash and cash equivalents and accounts receivable[17](index=17&type=chunk) - Total stockholders' equity significantly decreased from **$20.9 million** at December 31, 2024, to **$1.1 million** at June 30, 2025, largely due to accumulated deficit[17](index=17&type=chunk) [Condensed Statements of Operations](index=7&type=section&id=Condensed%20Statements%20of%20Operations) Details the company's revenues, expenses, and net loss over specific reporting periods, including per share data Condensed Statements of Operations (in thousands, except per share data) | (in thousands, except per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenues | $20,018 | $17,925 | $37,976 | $32,743 | | Total operating expenses | $29,737 | $26,162 | $56,831 | $52,001 | | Loss from operations | $(9,719) | $(8,237) | $(18,855) | $(19,258) | | Total other expense | $(1,749) | $(2,571) | $(3,714) | $(5,164) | | Net loss | $(11,468) | $(10,808) | $(22,569) | $(24,422) | | Net loss per share, basic and diluted | $(0.08) | $(0.08) | $(0.15) | $(0.22) | - Revenues increased by **12% to $20.0 million** for the three months ended June 30, 2025, compared to **$17.9 million** in the prior year, and by **16% to $38.0 million** for the six months ended June 30, 2025, compared to **$32.7 million** in the prior year[19](index=19&type=chunk) - Net loss increased by **6% to $11.5 million** for the three months ended June 30, 2025, from **$10.8 million** in the prior year, but decreased by **8% to $22.6 million** for the six months ended June 30, 2025, from **$24.4 million** in the prior year[19](index=19&type=chunk) [Condensed Statements of Stockholders' Equity (Deficit)](index=8&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) Outlines changes in equity components: common stock, additional paid-in capital, and accumulated deficit Condensed Statements of Stockholders' Equity (Deficit) (in thousands) | (in thousands) | Balance - December 31, 2024 | Balance - June 30, 2025 | | :--------------- | :-------------------------- | :---------------------- | | Common Stock | $145 | $146 | | Additional Paid-In Capital | $483,228 | $486,058 | | Accumulated Deficit | $(462,497) | $(485,066) | | Total Stockholders' Equity | $20,876 | $1,138 | - Total stockholders' equity decreased significantly from **$20.9 million** at December 31, 2024, to **$1.1 million** at June 30, 2025, primarily due to a net loss of **$11.1 million** in Q1 2025 and **$11.5 million** in Q2 2025, partially offset by share-based compensation and warrant reclassifications[22](index=22&type=chunk) [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Summarizes the cash inflows and outflows from operating, investing, and financing activities over specific periods Condensed Statements of Cash Flows (in thousands) | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(15,170) | $(33,882) | | Net cash used in investing activities | $(232) | $(2,270) | | Net cash provided by financing activities | $9,886 | $52,087 | | Net decrease (increase) in cash, cash equivalents, and restricted cash | $(5,516) | $15,935 | | Cash, cash equivalents, and restricted cash - end of period | $20,816 | $42,306 | - Net cash used in operating activities decreased significantly to **$15.2 million** for the six months ended June 30, 2025, from **$33.9 million** in the prior year, primarily due to favorable changes in net working capital, including a decrease in contingent consideration payments[24](index=24&type=chunk)[206](index=206&type=chunk) - Net cash provided by financing activities decreased to **$9.9 million** for the six months ended June 30, 2025, from **$52.1 million** in the prior year, mainly due to **$10.0 million** from the Tranche C loan and **$0.3 million** from ESPP, compared to **$51.3 million** from common stock issuance in the prior year[24](index=24&type=chunk)[208](index=208&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) [Note 1 – Organization and Description of Business](index=11&type=section&id=Note%201%20%E2%80%93%20Organization%20and%20Description%20of%20Business) Describes Biodesix, Inc.'s core business: multi-omic lung diagnostic tests and development services - Biodesix, Inc. is a diagnostic solutions company headquartered in Colorado, developing diagnostic tests using a multi-omic approach to improve clinical care for patients[29](index=29&type=chunk) - The company derives revenue from two sources: Biodesix Diagnostic Tests (five blood-based lung diagnostic tests) and Biodesix Development Services (diagnostic testing services for biopharmaceutical, life sciences, and diagnostic companies)[29](index=29&type=chunk) - Diagnostic tests include Nodify CDT® and Nodify XL2® for nodule management, and GeneStrat® ddPCR, GeneStrat NGS®, and VeriStrat® for lung cancer treatment and monitoring, all offering timely results to guide physician decisions[30](index=30&type=chunk)[31](index=31&type=chunk) [Note 2 – Summary of Significant Accounting Policies and Other Information](index=11&type=section&id=Note%202%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies%20and%20Other%20Information) Outlines key accounting principles and practices, including credit and supply chain risks - The unaudited condensed financial statements are prepared in accordance with Form 10-Q and Rule 10-01 of Regulation S-X, reflecting normal recurring adjustments, and should be read with the Annual Report on Form 10-K for the year ended December 31, 2024[32](index=32&type=chunk) - The company faces credit risk concentration with cash and cash equivalents held at one major financial institution and supply chain risk from single-source suppliers for key test components[36](index=36&type=chunk)[37](index=37&type=chunk) - Inventory, primarily material supplies, was **$1.6 million** at June 30, 2025, up from **$1.0 million** at December 31, 2024, with an insignificant reserve for excess inventory[41](index=41&type=chunk) - The company began making discretionary employer matching contributions to its 401(k) retirement plan in 2025, totaling **$0.1 million** for the three months and **$0.4 million** for the six months ended June 30, 2025[48](index=48&type=chunk) [Note 3 - Recently Issued Accounting Standards](index=15&type=section&id=Note%203%20-%20Recently%20Issued%20Accounting%20Standards) Discusses recently issued FASB accounting standards and their potential impact on financial statements - The FASB issued ASU 2023-09 (Income Taxes) effective January 1, 2025, for annual periods and January 1, 2026, for interim periods, requiring improved transparency in income tax disclosures[49](index=49&type=chunk) - The FASB issued ASU 2024-03 (Disaggregation of Income Statement Expenses) effective January 1, 2027, for annual periods and January 1, 2028, for interim periods, requiring more detailed expense disclosures[50](index=50&type=chunk) - The Company is currently evaluating both ASU 2023-09 and ASU 2024-03 to assess their overall impact on its financial statements[49](index=49&type=chunk)[50](index=50&type=chunk) [Note 4 - Fair Value](index=15&type=section&id=Note%204%20-%20Fair%20Value) Details fair value measurements of financial instruments, including borrowings and warrant liabilities Fair Value of Borrowings (in thousands) | (in thousands) | June 30, 2025 (Carrying Value) | June 30, 2025 (Fair Value) | December 31, 2024 (Carrying Value) | December 31, 2024 (Fair Value) | | :--------------- | :----------------------------- | :------------------------- | :--------------------------------- | :----------------------------- | | Borrowings | $46,798 | $46,866 | $36,429 | $37,484 | - The fair value of borrowings, primarily the Perceptive Term Loan Facility, is classified as **Level 2** and approximates its carrying value[51](index=51&type=chunk) - Warrant liabilities and contingent value rights, classified as **Level 3**, were **zero** as of June 30, 2025, and December 31, 2024. The Tranche C Warrants were reclassified to additional paid-in capital after the Tranche C loan draw in May 2025[54](index=54&type=chunk)[59](index=59&type=chunk) - The Company recorded a gain of **$0.1 million** and a loss of **$0.3 million** for the three and six months ended June 30, 2025, respectively, due to changes in the fair value of warrant liabilities[60](index=60&type=chunk) - Contingent consideration related to the Indi acquisition was fully paid by September 30, 2024, with no remaining obligations[64](index=64&type=chunk) [Note 5 – Supplementary Balance Sheet Information](index=20&type=section&id=Note%205%20%E2%80%93%20Supplementary%20Balance%20Sheet%20Information) Provides additional details on property, equipment, intangible assets, and accrued liabilities Supplementary Balance Sheet Information (in thousands) | (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Property and equipment, net | $26,135 | $27,828 | | Intangible assets, net | $4,871 | $5,874 | | Accrued liabilities | $9,684 | $10,064 | - Net property and equipment decreased by **$1.7 million**, and net intangible assets decreased by **$1.0 million** from December 31, 2024, to June 30, 2025[67](index=67&type=chunk)[68](index=68&type=chunk) - Accrued liabilities decreased slightly from **$10.1 million** at December 31, 2024, to **$9.7 million** at June 30, 2025, with compensation-related accruals being the largest component[69](index=69&type=chunk) [Note 6 – Debt](index=22&type=section&id=Note%206%20%E2%80%93%20Debt) Details debt obligations, including the Perceptive Term Loan Facility, its terms, and covenant compliance Debt Information (in thousands) | (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Perceptive Term Loan Facility | $50,000 | $40,000 | | Long-term notes payable | $46,782 | $36,408 | | Total scheduled principal repayments (maturities) | $50,016 | N/A | | - Remainder of 2025 | $10 | N/A | | - 2026 | $6 | N/A | | - 2027 and thereafter | $50,000 | N/A | - The Company drew the **$10.0 million** Tranche C loan under the Perceptive Term Loan Facility on May 8, 2025, bringing the total facility outstanding to **$50.0 million**. The loan matures on November 21, 2027, with principal due at maturity[72](index=72&type=chunk) - The Perceptive Term Loan Facility accrues interest at an annual rate of one-month term SOFR (or **3.0%**) plus **9.0%**, resulting in a stated interest rate of approximately **13.3%** as of June 30, 2025[73](index=73&type=chunk) - The Credit Agreement includes financial covenants requiring a minimum cash balance of **$2.5 million** and specific minimum net revenue thresholds, which have been amended multiple times. As of June 30, 2025, the Company was in compliance with all covenants[79](index=79&type=chunk)[88](index=88&type=chunk) [Note 7 – Leases](index=26&type=section&id=Note%207%20%E2%80%93%20Leases) Outlines lease obligations, including headquarters lease, future minimum payments, and weighted-average terms Lease Obligations (in thousands) | (in thousands) | June 30, 2025 | | :--------------- | :------------ | | Total future minimum lease payments | $42,441 | | Less amount representing interest | $(17,098) | | Total lease liabilities | $25,343 | | Weighted-average remaining lease term | 9.6 years | | Weighted-average discount rate | 11.4% | - The Company relocated its corporate headquarters and laboratory facilities to Louisville, Colorado, in January 2024, under a **12-year lease agreement** with two renewal options[91](index=91&type=chunk)[92](index=92&type=chunk) - Operating lease expense for all operating leases was **$0.6 million** and **$1.2 million** for the three and six months ended June 30, 2025, respectively[95](index=95&type=chunk) [Note 8 – Equity](index=28&type=section&id=Note%208%20%E2%80%93%20Equity) Details equity changes, including Nasdaq delisting notice, ATM program, and warrant modifications - On March 24, 2025, the Company received a Nasdaq delisting notice for failing to meet the minimum **$1.00** bid price requirement. It has until September 22, 2025, to regain compliance, with options including a reverse stock split[98](index=98&type=chunk) - The Company has a 2024 At-The-Market (ATM) Program allowing the issuance and sale of up to **$50.0 million** in common stock, with **$50.0 million** remaining available as of June 30, 2025[99](index=99&type=chunk)[202](index=202&type=chunk) - In connection with the Tranche C loan draw in May 2025, the exercise price for the Perceptive Warrant and First Amendment Warrants was modified to **$0.4191**, resulting in a **$0.2 million** increase in fair value recorded as a debt issuance cost and increase to Additional Paid-In Capital[106](index=106&type=chunk) [Note 9 – Revenue and Accounts Receivable Credit Concentration](index=30&type=section&id=Note%209%20%E2%80%93%20Revenue%20and%20Accounts%20Receivable%20Credit%20Concentration) Analyzes revenue by diagnostic tests and development services, highlighting growth and customer concentrations Revenue by Source (in thousands) | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Diagnostic Tests | $17,898 | $16,539 | $34,215 | $30,335 | | Development Services | $2,120 | $1,386 | $3,761 | $2,408 | | Total revenues | $20,018 | $17,925 | $37,976 | $32,743 | - Diagnostic Tests revenue increased by **8%** and **13%** for the three and six months ended June 30, 2025, respectively, primarily driven by increased Nodify Lung Nodule Risk Assessment testing[113](index=113&type=chunk)[184](index=184&type=chunk) - Development Services revenue increased by **53%** and **56%** for the three and six months ended June 30, 2025, respectively, due to an expanding book of business and new agreements[113](index=113&type=chunk)[185](index=185&type=chunk) Revenue Concentration by Customer (as % of total revenue) | Customer (as % of total revenue) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | United Healthcare | 11% | 13% | 6% | 12% | | Medicare | 33% | 41% | 35% | 41% | Accounts Receivable Concentration by Customer (as % of total accounts receivable) | Customer (as % of total accounts receivable) | June 30, 2025 | December 31, 2024 | | :----------------------------------------- | :------------ | :---------------- | | Medicare | 24% | 21% | | Daiichi Sankyo | —% | 14% | [Note 10 – Share-Based Compensation](index=32&type=section&id=Note%2010%20%E2%80%93%20Share-Based%20Compensation) Reports share-based compensation expense, including program terminations and unrecognized future expenses Share-Based Compensation Expense (in thousands) | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total share-based compensation expense | $1,039 | $1,218 | $2,011 | $3,858 | - Total share-based compensation expense decreased by **15%** for the three months and **48%** for the six months ended June 30, 2025, compared to the same periods in 2024[118](index=118&type=chunk) - The Bonus-to-Options Program was terminated for fiscal year 2025, resulting in **zero expense** for the three and six months ended June 30, 2025, compared to **$0.2 million** and **$0.4 million** in the prior year periods[122](index=122&type=chunk) - As of June 30, 2025, unrecognized share-based compensation expense for options and RSUs was approximately **$5.7 million**, expected to be amortized over the next **2.3 years**[118](index=118&type=chunk) [Note 11 – Net Loss per Common Share](index=35&type=section&id=Note%2011%20%E2%80%93%20Net%20Loss%20per%20Common%20Share) Presents basic and diluted net loss per common share and weighted-average shares outstanding Net Loss per Common Share (in thousands, except per share amounts) | (in thousands, except per share amounts) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss attributable to common stockholders | $(11,468) | $(10,808) | $(22,569) | $(24,422) | | Weighted-average shares outstanding | 146,656 | 127,168 | 146,328 | 112,167 | | Net loss per share, basic and diluted | $(0.08) | $(0.08) | $(0.15) | $(0.22) | - Basic and diluted net loss per share remained at **$(0.08)** for the three months ended June 30, 2025 and 2024. For the six months, it improved from **$(0.22)** in 2024 to **$(0.15)** in 2025[127](index=127&type=chunk) - Outstanding common stock equivalents, including options, ESPP shares, warrants, and restricted stock units, totaling **19.2 million** for the six months ended June 30, 2025, were excluded from diluted EPS calculations as their inclusion would be anti-dilutive[127](index=127&type=chunk) [Note 12 – Income Taxes](index=35&type=section&id=Note%2012%20%E2%80%93%20Income%20Taxes) Discusses income tax position, including net taxable losses, valuation allowance, and recent tax legislation - The Company has incurred net taxable losses since inception and has recorded no provision for income taxes, nor paid any cash for income taxes during the reported periods[128](index=128&type=chunk) - The One Big Beautiful Bill Act (OBBBA), enacted July 4, 2025, repeals the capitalization requirement for domestic R&E expenditures, includes depreciation and amortization addback for Section 163(j) interest deduction, and extends 100% bonus depreciation[128](index=128&type=chunk)[130](index=130&type=chunk) - Despite the OBBBA, the Company maintains a full valuation allowance against its deferred tax assets, so the act is not expected to materially impact deferred tax balances as of December 31, 2025[130](index=130&type=chunk) [Note 13 – Segment Reporting](index=36&type=section&id=Note%2013%20%E2%80%93%20Segment%20Reporting) Confirms single operating segment, with resource allocation and performance assessed by net income or loss - The Company operates as a single operating segment, with its Chief Executive Officer and Chief Financial Officer acting as the chief operating decision-makers (CODM)[131](index=131&type=chunk) - The CODM assesses resource allocation and performance based on net income or loss, as both Diagnostic Tests and Development Services revenue streams utilize the same equipment and resources[131](index=131&type=chunk)[133](index=133&type=chunk) - Substantially all revenue and long-lived assets are derived from or located in the United States[132](index=132&type=chunk) [Note 14 – Commitments and Contingencies](index=37&type=section&id=Note%2014%20%E2%80%93%20Commitments%20and%20Contingencies) Outlines co-development and license agreements, royalty expenses, and confirms no material legal proceedings - The Company has a co-development agreement with AVEO for ficlatuzumab, where Biodesix is entitled to a **10% royalty** of net sales and **25%** of license income after opting out of development costs in December 2020. No royalties or expenses were recorded for the reported periods[136](index=136&type=chunk)[137](index=137&type=chunk) - License agreements include a non-exclusive license with Bio-Rad for ddPCR technology (extended to August 2026), a royalty-bearing license with CellCarta for the Nodify XL2 test (**0.675% royalty**), and a license for the Nodify CDT test (**8% royalty** on non-screening tests)[138](index=138&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk) - Royalty expenses for CellCarta License were **$0.1 million** (Q2 2025) and **$0.2 million** (YTD 2025), and for Nodify CDT test were **$0.4 million** (Q2 2025) and **$0.8 million** (YTD 2025)[139](index=139&type=chunk)[140](index=140&type=chunk) - The Company is not currently a party to any legal proceedings that would have a material adverse effect on its business, results of operations, financial condition, or cash flows[141](index=141&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=39&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Biodesix, Inc.'s financial condition and results of operations for the three and six months ended June 30, 2025, compared to the prior year. It covers the company's business overview, key performance factors, recent financial highlights, detailed analysis of revenue and expenses, liquidity, capital resources, contractual obligations, critical accounting policies, and implications of its emerging growth and smaller reporting company status [Overview](index=39&type=section&id=Overview) Describes Biodesix's multi-omic diagnostic solutions for lung diseases and development services - Biodesix is a diagnostic solutions company focused on personalized diagnostics to improve patient care, utilizing a multi-omic approach (genomics, proteomics, radiomics) combined with AI[146](index=146&type=chunk)[148](index=148&type=chunk)[155](index=155&type=chunk) - The company offers five blood-based lung diagnostic tests: Nodify CDT® and Nodify XL2® for nodule risk assessment, and GeneStrat® ddPCR, GeneStrat NGS®, and VeriStrat® for lung cancer treatment and monitoring (IQLung™ strategy)[149](index=149&type=chunk)[150](index=150&type=chunk)[151](index=151&type=chunk)[153](index=153&type=chunk) - Biodesix Development Services provide scientific, technological, and operational capabilities to biopharmaceutical, life sciences, and research institutions, supporting therapeutic clinical trials, diagnostic validation, and discovery[154](index=154&type=chunk) [Factors Affecting Our Performance](index=41&type=section&id=Factors%20Affecting%20Our%20Performance) Identifies key drivers and challenges influencing performance, including payer coverage, R&D, and customer mix - Revenue and growth are significantly impacted by the ability to obtain and maintain broad coverage and adequate reimbursement from third-party payers (commercial and government), with retrospective adjustments posing a risk[159](index=159&type=chunk) - Investment in clinical studies (e.g., INSIGHT, ALTITUDE, CLARIFY) and product innovation is crucial for supporting growth, expanding payer coverage, driving commercial adoption, and securing regulatory approvals[158](index=158&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk) - Performance is also affected by testing volume and customer mix, with biopharmaceutical sample testing currently yielding a significantly higher average selling price than clinical tests[159](index=159&type=chunk) - The company is collaborating with Memorial Sloan Kettering Cancer Center (MSK) and Bio-Rad on new diagnostic tests, including a novel molecular minimal residual disease (MRD) test, to improve cancer treatment[164](index=164&type=chunk) [Second Quarter 2025 Financial and Operational Highlights](index=43&type=section&id=Second%20Quarter%202025%20Financial%20and%20Operational%20Highlights) Summarizes key financial and operational achievements for Q2 2025, including revenue and margin improvement Second Quarter 2025 Financial and Operational Highlights | Metric | Q2 2025 | Q2 2024 | Change (%) | | :----- | :------ | :------ | :--------- | | Total revenue | $20.0M | $17.9M | +12% | | Lung Diagnostic Testing revenue | $17.9M | $16.5M | +8% | | Development Services revenue | $2.1M | $1.4M | +53% | | Gross margin | $16.0M (80%) | N/A | +150 bps | | Operating expenses (excl. direct costs) | $25.7M | N/A | +15% | | Net loss | $11.5M | $10.8M | +6% | | Cash and cash equivalents (as of June 30, 2025) | $20.7M | N/A | +$3.1M (from Mar 31, 2025) | - The increase in operating expenses is primarily due to the planned expansion of the sales team to support Lung Diagnostic sales growth and enhance market awareness[171](index=171&type=chunk) - Gross margin improved by **150 basis points to 80%** in Q2 2025, driven by growth in Lung Diagnostic testing and optimization of testing workflows[171](index=171&type=chunk) [Components of Operating Results](index=45&type=section&id=Components%20of%20Operating%20Results) Explains revenue and expense categories constituting operating results and their expected trends - Revenues are derived from Diagnostic Tests (lung diagnostic testing services) and Development Services (diagnostic testing for biopharmaceutical, life sciences, and diagnostic companies)[167](index=167&type=chunk) - Direct costs and expenses include materials, labor, benefits, share-based compensation, equipment, infrastructure, and royalty fees, expected to increase with test volume but decrease per test due to efficiencies[170](index=170&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk) - Research and development expenses, a significant portion of operating expenses, include internal and external costs for technology development, clinical trials, and product candidates, expected to increase in dollars but decrease as a percentage of revenue long-term[174](index=174&type=chunk)[175](index=175&type=chunk)[176](index=176&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk) - Sales, marketing, general, and administrative expenses are expected to increase in dollars due to sales force expansion, increased market presence, and public company operating costs, but decrease as a percentage of revenue long-term[179](index=179&type=chunk)[180](index=180&type=chunk) [Results of Operations](index=48&type=section&id=Results%20of%20Operations) Provides a detailed comparative analysis of revenues, expenses, and net loss for the reported periods Results of Operations - Three Months Ended June 30 (in thousands) | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change ($) | Change (%) | | :--------------- | :------------------------------- | :------------------------------- | :--------- | :--------- | | Revenues | $20,018 | $17,925 | $2,093 | 12% | | Direct costs and expenses | $4,031 | $3,877 | $154 | 4% | | Research and development | $3,269 | $2,558 | $711 | 28% | | Sales, marketing, general and administrative | $22,411 | $19,660 | $2,751 | 14% | | Loss from operations | $(9,719) | $(8,237) | $(1,482) | (18)% | | Net loss | $(11,468) | $(10,808) | $(660) | (6)% | Results of Operations - Six Months Ended June 30 (in thousands) | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :--------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Revenues | $37,976 | $32,743 | $5,233 | 16% | | Direct costs and expenses | $7,734 | $7,052 | $682 | 10% | | Research and development | $6,139 | $4,598 | $1,541 | 34% | | Sales, marketing, general and administrative | $42,859 | $40,216 | $2,643 | 7% | | Loss from operations | $(18,855) | $(19,258) | $403 | 2% | | Net loss | $(22,569) | $(24,422) | $1,853 | 8% | - Research and development expenses increased by **28% (QoQ)** and **34% (YoY)** primarily due to higher employee compensation and benefits from increased headcount and variable compensation, as well as increased external clinical trial costs[187](index=187&type=chunk) - Interest expense decreased by **$0.9 million (YoY)** for the six months ended June 30, 2025, mainly due to the full payment of contingent consideration interest in 2024[190](index=190&type=chunk) - A gain of **$0.1 million** and a loss of **$0.3 million** were recorded for the three and six months ended June 30, 2025, respectively, due to changes in the fair value of warrant liability, following the Tranche C loan draw and warrant exercise price modification[192](index=192&type=chunk)[193](index=193&type=chunk)[194](index=194&type=chunk) [Liquidity and Capital Resources](index=52&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses ability to meet financial obligations, detailing funding sources and cash flow trends - The Company has funded operations through common stock sales, convertible preferred stock sales, diagnostic testing and services revenue, and indebtedness, and has not yet generated positive cash flows from operations[196](index=196&type=chunk) - Key financing activities include drawing the **$10.0 million** Tranche C loan under the Perceptive Term Loan Facility in May 2025 and having **$50.0 million** available under the 2024 ATM Program as of June 30, 2025[198](index=198&type=chunk)[202](index=202&type=chunk)[204](index=204&type=chunk) - On March 24, 2025, the Company received a Nasdaq delisting notice for its common stock trading below **$1.00** per share and has until September 22, 2025, to regain compliance, potentially through a reverse stock split[205](index=205&type=chunk) - Net cash used in operating activities decreased by **$18.7 million** for the six months ended June 30, 2025, compared to the prior year, primarily due to favorable changes in net working capital, including reduced contingent consideration payments[206](index=206&type=chunk) [Contractual Obligations and Commitments](index=55&type=section&id=Contractual%20Obligations%20and%20Commitments) Summarizes significant contractual obligations, including borrowings, interest, and lease payments by maturity Contractual Obligations and Commitments (in thousands) | (in thousands) | Total | Less than 1 year | 1 to 3 years | 4 to 5 years | More than 5 years | | :--------------- | :---- | :--------------- | :----------- | :----------- | :---------------- | | Borrowings and interest | $66,364 | $6,774 | $59,590 | $0 | $0 | | Operating lease obligations | $42,441 | $4,033 | $8,196 | $8,500 | $21,712 | | Finance lease obligations | $1,129 | $721 | $408 | $0 | $0 | | Total | $109,934 | $11,528 | $68,194 | $8,500 | $21,712 | - The largest contractual obligations are borrowings and interest, totaling **$66.4 million**, with the majority (**$59.6 million**) due in **1 to 3 years**, primarily related to the Perceptive Term Loan Facility[209](index=209&type=chunk) - Operating lease obligations total **$42.4 million**, with significant amounts due in **more than 5 years ($21.7 million)**, reflecting the long-term nature of the Louisville, Colorado facility lease[209](index=209&type=chunk) [Off-Balance Sheet Arrangements](index=55&type=section&id=Off-Balance%20Sheet%20Arrangements) Confirms the absence of off-balance sheet arrangements materially impacting financial position - As of June 30, 2025, the Company has not entered into any off-balance sheet arrangements[210](index=210&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=55&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Highlights accounting policies requiring significant judgment and estimates, especially revenue recognition - Revenue recognition is a critical accounting policy, requiring significant management judgment in estimating collectible amounts for diagnostic tests based on factors like payer type, payment history, and contract status[212](index=212&type=chunk)[213](index=213&type=chunk) - Development Services revenue is recognized upon delivery of testing results or achievement of contractual milestones, typically from large biopharmaceutical companies where collectability is reasonably assured[215](index=215&type=chunk) [Implications of Being an Emerging Growth Company and Smaller Reporting Company](index=56&type=section&id=Implications%20of%20Being%20an%20Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company) Explains regulatory exemptions and reduced disclosure requirements for EGC and smaller reporting companies - As an 'emerging growth company' (EGC) under the JOBS Act, Biodesix benefits from exemptions from certain public company reporting requirements, including an audit of internal control over financial reporting and reduced executive compensation disclosures[216](index=216&type=chunk) - The Company has elected the extended transition period for complying with new or revised accounting standards, which may affect comparability with other public companies[217](index=217&type=chunk) - Biodesix is also a 'smaller reporting company,' allowing for reduced disclosure obligations, such as providing only two years of audited financial statements[219](index=219&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=56&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the Company's exposure to market risks, primarily focusing on interest rate risk related to its cash, cash equivalents, and outstanding indebtedness, particularly the Perceptive Term Loan Facility - The Company is exposed to interest rate risk primarily from its cash and cash equivalents, marketable securities, and the **$50.0 million** outstanding Perceptive Term Loan Facility, which has a variable interest rate[221](index=221&type=chunk) - A hypothetical **100 basis point** increase in interest rates would result in an estimated **$0.5 million** impact per year on the Company's financial position and results of operations, based on the current Perceptive Term Loan principal[223](index=223&type=chunk) - The Company has not historically used derivative agreements like interest rate caps or swaps to manage its floating interest rate exposure[221](index=221&type=chunk) [Item 4. Controls and Procedures](index=56&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of the Company's disclosure controls and procedures, confirming their effectiveness at a reasonable assurance level as of June 30, 2025, and stating no material changes to internal control over financial reporting during the quarter - The Company's disclosure controls and procedures were evaluated by the CEO and CFO and concluded to be effective at the reasonable assurance level as of June 30, 2025[227](index=227&type=chunk) - Disclosure controls are designed to ensure information required for SEC reports is recorded, processed, summarized, and reported timely, providing reasonable, not absolute, assurance[224](index=224&type=chunk) - There were no changes to the Company's internal control over financial reporting during the three months ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, these controls[228](index=228&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=59&type=section&id=Item%201.%20Legal%20Proceedings) This section confirms that the Company is not currently involved in any legal proceedings that would individually or collectively have a material adverse effect on its business, financial condition, results of operations, or cash flows - The Company is not presently a party to any legal proceedings that, if determined adversely, would have a material adverse effect on its business, results of operations, financial condition, or cash flows[231](index=231&type=chunk) [Item 1A. Risk Factors](index=59&type=section&id=Item%201A.%20Risk%20Factors) This section updates the risk factors from the Annual Report on Form 10-K, highlighting new or materially changed risks related to the Company's Nasdaq listing compliance, potential impacts of U.S. trade policies, and the evolving regulatory landscape for laboratory developed tests (LDTs) by the FDA - The Company received a Nasdaq delisting notice on March 24, 2025, for failing to meet the minimum **$1.00** bid price requirement and has until September 22, 2025, to regain compliance, with a reverse stock split being a potential option[234](index=234&type=chunk) - There is significant uncertainty regarding U.S. trade policies, tariffs, and trade barriers, which could negatively impact global economic conditions, financial markets, and the Company's business[236](index=236&type=chunk) - The FDA finalized a rule on May 6, 2024, to phase out its enforcement discretion for laboratory developed tests (LDTs) over four years, potentially subjecting the Company's tests to medical device regulations, including premarket review and quality systems requirements[241](index=241&type=chunk)[250](index=250&type=chunk)[251](index=251&type=chunk) - A U.S. District Court struck down the FDA's final rule on March 31, 2025, concluding it exceeded FDA's statutory jurisdiction, vacating and remanding it for further consideration. However, new legislation or administrative changes could still impose similar requirements[243](index=243&type=chunk)[244](index=244&type=chunk)[253](index=253&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=65&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states that there were no unregistered sales of equity securities or use of proceeds during the reporting period - None[257](index=257&type=chunk) [Item 3. Defaults Upon Senior Securities](index=65&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section confirms that there were no defaults upon senior securities during the reporting period - None[258](index=258&type=chunk) [Item 4. Mine Safety Disclosures](index=65&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the Company - Not applicable[259](index=259&type=chunk) [Item 5. Other Information](index=65&type=section&id=Item%205.%20Other%20Information) This section states that no directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025 - None of the Company's directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[260](index=260&type=chunk) [Item 6. Exhibits](index=66&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed or furnished with the Quarterly Report on Form 10-Q, including certifications from the Principal Executive Officer and Principal Financial Officer, and XBRL-related documents Exhibits Filed with Form 10-Q | Exhibit Number | Description | | :------------- | :---------- | | 31.1* | Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | 31.2* | Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | 32.1** | Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | | 32.2** | Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | | 101.INS* | Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document | | 101.SCH* | Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signature](index=67&type=section&id=Signature) This section contains the signature of the Company's Chief Accounting Officer, Christopher C. Vazquez, certifying the filing of the report on behalf of Biodesix, Inc - The report is signed by Christopher C. Vazquez, Chief Accounting Officer (Principal Accounting Officer) of Biodesix, Inc., on August 7, 2025[267](index=267&type=chunk)

Core Viewpoint - Biodesix, Inc. reported strong financial results for Q2 2025, with a revenue increase of 12% year-over-year, reaching $20.0 million, and reaffirmed its full-year revenue guidance of $80-85 million [1][6]. Financial Performance - Q2 2025 revenue was $20.0 million, a 12% increase compared to Q2 2024 [1][4]. - Gross profit margin for Q2 2025 was 80%, reflecting a 150-basis point improvement from the previous year [1][11]. - Development Services revenue grew by 53% year-over-year, reaching $2.1 million [5][20]. - Lung Diagnostic Testing revenue was $17.9 million, an 8% increase from the prior year, driven by an increase in total tests delivered [5][20]. - Adjusted EBITDA loss for Q2 2025 was $7.2 million, a 29% increase in loss compared to the same period last year [11][22]. Business Highlights - The sales team expanded to an average of 74 representatives, a 21% increase from the previous year [5]. - Primary care ordering of lung diagnostic tests increased over 100% compared to pre-pilot program levels in 2024 [5]. - The company achieved an all-time high in development services business dollars under contract, totaling $12.5 million, up 54% year-over-year [5]. - Digital ordering initiatives saw a 63% increase over the prior year [5]. - The company reached patient enrollment requirements for its ALTITUDE trial in July 2025 [5]. Future Outlook - The company is positioned to achieve Adjusted EBITDA positivity in Q4 2025, supported by sales team expansion and operational effectiveness [2]. - Biodesix maintains confidence in achieving its full-year revenue guidance of $80-85 million, indicating a focus on sustainable long-term growth [2][6].

[Q2 2025 Earnings Release Highlights](index=1&type=section&id=Q2%202025%20Earnings%20Release%20Highlights) [Executive Summary](index=1&type=section&id=Executive%20Summary) Biodesix reported strong Q2 2025 results with total revenue up 12% to $20 million, an 80% gross margin, and reaffirmed full-year guidance, expecting Q4 adjusted EBITDA profitability [Q2 2025 Financial Performance Overview](index=1&type=section&id=Q2%202025%20Financial%20Performance%20Overview) Q2 2025 Key Financial Metrics | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------- | :-------- | :-------- | :----------- | | Total Revenue | $20.0M | $17.9M | +12% | | Gross Profit Margin | 80% | 78.5% | +150 bps | [Operational and Strategic Achievements](index=1&type=section&id=Operational%20and%20Strategic%20Achievements) - The company expanded its commercial focus to primary care physicians managing **50% of lung nodule patients**, observing a significant increase in test orders from this network[2](index=2&type=chunk) - Development services revenue increased by **53% year-over-year**, with contract value growing by **54%**[2](index=2&type=chunk) - The company anticipates achieving adjusted EBITDA profitability in Q4 through sales team expansion, enhanced sales representative productivity, robust service business growth, and operational efficiencies[2](index=2&type=chunk) [Full-Year 2025 Financial Outlook](index=1&type=section&id=Full-Year%202025%20Financial%20Outlook) - The company reaffirmed its full-year 2025 total revenue guidance of **$80 million to $85 million**[1](index=1&type=chunk) [Company Information](index=2&type=section&id=Company%20Information) [About Biodesix](index=2&type=section&id=About%20Biodesix) Biodesix is a leading diagnostic solutions company improving patient care and outcomes for lung diseases through its Nodify Lung® and IQLung® tests, also offering development services for diagnostic test and therapy advancement - Biodesix is a leading diagnostic solutions company focused on improving patient clinical care and outcomes[8](index=8&type=chunk) - Its diagnostic tests, including Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance, support personalized care and treatment decisions for lung disease patients[8](index=8&type=chunk) - Development services provide scientific, technical, and operational capabilities to biopharmaceutical, life science, and research organizations for advancing diagnostic tests, tools, and therapies[8](index=8&type=chunk) [Trademarks](index=2&type=section&id=Trademarks) Biodesix, Biodesix Logo, Nodify Lung, and IQLung are trademarks or registered trademarks of Biodesix - Biodesix, Biodesix Logo, Nodify Lung, and IQLung are trademarks or registered trademarks of Biodesix[9](index=9&type=chunk) [Q2 2025 Business Highlights](index=1&type=section&id=Second%20Quarter%20Ended%20June%2030%2C%202025%20Business%20Highlights) Biodesix achieved significant Q2 2025 business growth and strategic progress, including sales team expansion, increased primary care physician orders, record development services contracts, and clinical data milestones - The sales team expanded to an average of **74 sales representatives**, a **21% year-over-year increase** (adding 13 representatives)[5](index=5&type=chunk) - Orders for lung diagnostic tests from primary care physicians increased by **over 100% year-over-year**, exceeding pre-2024 pilot program levels[5](index=5&type=chunk) - Development services contract value reached a record **$12.5 million**, representing a **54% year-over-year increase**[5](index=5&type=chunk) - Digital orders, including EMR integrations, increased by **63% year-over-year**[5](index=5&type=chunk) - New clinical and economic data supporting the Nodify Lung® test were presented at the ISPOR 2025 Annual Meeting and ATS 2025 International Conference[5](index=5&type=chunk) - The ALTITUDE prospective, randomized controlled trial met patient enrollment requirements in July 2025, with patient follow-up expected to continue for approximately one year[5](index=5&type=chunk) - Data from three pipeline initiatives were presented at the AACR, ASCO, and ASMS annual meetings, including combined genomic and proteomic MRD testing, VeriStrat test application in first-line immunotherapy selection, and VeriStrat test use in hormone-resistant cancers[5](index=5&type=chunk) [Q2 2025 Detailed Financial Results](index=1&type=section&id=Second%20Quarter%20Ended%20June%2030%2C%202025%20Financial%20Results) [Revenue Performance](index=2&type=section&id=Revenue%20Performance) Q2 2025 total revenue reached $20 million, a 12% year-over-year increase, driven by 8% growth in lung diagnostic testing and 53% in development services revenue Q2 2025 Revenue Breakdown | Revenue Type | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :-------------------- | :----------------- | :----------------- | :--------- | | Total Revenue | $20.0 | $17.9 | +12% | | Lung Diagnostic Testing | $17.9 | $16.5 | +8% | | Development Services | $2.1 | $1.4 | +53% | [Gross Margin and Operating Expenses](index=2&type=section&id=Gross%20Margin%20and%20Operating%20Expenses) Q2 gross margin improved to 80%, up 150 basis points, due to lung diagnostic test growth and workflow optimization, while operating expenses rose 15% from sales team expansion Q2 2025 Gross Margin and Operating Expenses | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :-------------------- | :----------------- | :----------------- | :--------- | | Gross Margin | $16.0 (80%) | N/A (78.5%) | +150 bps | | Operating Expenses | $25.7 | N/A | +15% | | Non-cash Stock Comp. | $1.0 | N/A | -15% | - Gross margin improvement was primarily driven by growth in lung diagnostic testing, reduced per-test costs from workflow optimization, and continued expansion of development services[10](index=10&type=chunk) - Increased operating expenses were primarily due to sales team expansion to support lung diagnostic sales growth, enhance market awareness, and boost product adoption, leading to higher selling and marketing costs[10](index=10&type=chunk) [Net Loss and Adjusted EBITDA](index=2&type=section&id=Net%20Loss%20and%20Adjusted%20EBITDA) Q2 net loss increased 6% to $11.5 million, and adjusted EBITDA loss widened 29% to $7.2 million Q2 2025 Net Loss and Adjusted EBITDA | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :-------------------- | :----------------- | :----------------- | :--------- | | Net Loss | $(11.5) | $(10.8) | +6% | | Adjusted EBITDA | $(7.2) | $(5.6) | +29% | [Cash and Cash Equivalents](index=2&type=section&id=Cash%20and%20Cash%20Equivalents) Cash and cash equivalents totaled $20.7 million as of June 30, 2025, an increase of $3.1 million from March 31, 2025 Cash and Cash Equivalents | Metric | As of June 30, 2025 (Millions) | As of March 31, 2025 (Millions) | Change | | :-------------------- | :----------------------------- | :------------------------------ | :----- | | Cash and Cash Equivalents | $20.7 | $17.6 (implied) | +$3.1M | [2025 Financial Outlook](index=2&type=section&id=2025%20Financial%20Outlook) The company reaffirmed its full-year 2025 financial outlook, projecting total revenue between $80 million and $85 million - The company reaffirmed its 2025 total revenue expectation of **$80 million to $85 million**[6](index=6&type=chunk) [Use of Non-GAAP Financial Measures](index=3&type=section&id=Use%20of%20Non-GAAP%20Financial%20Measure) [Adjusted EBITDA](index=3&type=section&id=Adjusted%20EBITDA) Adjusted EBITDA is a key non-GAAP metric used by Biodesix management for financial performance assessment and internal planning, derived from net loss by excluding specific non-cash and non-recurring items to provide a comparable operational overview - Adjusted EBITDA is a key metric used by company management for evaluating financial performance, internal planning, and forecasting[12](index=12&type=chunk) - This metric helps investors assess ongoing operating results and trends, facilitating comparisons with other companies[11](index=11&type=chunk) - Calculated by adjusting net loss to exclude interest, income tax expense, depreciation and amortization, share-based compensation expense, loss on extinguishment of debt, net change in fair value of warrant liability, other net income, and other non-recurring items[14](index=14&type=chunk) [Note Regarding Forward-Looking Statements](index=3&type=section&id=Note%20Regarding%20Forward-Looking%20Statements) This press release contains forward-looking statements protected by the Private Securities Litigation Reform Act of 1995, involving significant risks and uncertainties, with actual results potentially differing materially from current expectations due to various factors, including those in company filings - This press release contains forward-looking statements protected by the Private Securities Litigation Reform Act of 1995, involving significant risks and uncertainties[15](index=15&type=chunk) - Forward-looking statements are based on current management expectations, and actual results and performance may differ materially from projections due to various factors[15](index=15&type=chunk) - Readers should refer to the risk factors section in the company's latest 10-K annual report and 10-Q quarterly reports for additional factors that could cause actual results to differ[15](index=15&type=chunk) [Contacts](index=5&type=section&id=Contacts) Provides contact information for media and investor relations - Media Contact: Natalie St. Denis (natalie.stdenis@biodesix.com, (720) 925-9285)[16](index=16&type=chunk) - Investor Contact: Chris Brinzey (chris.brinzey@icrhealthcare.com, (339) 970-2843)[16](index=16&type=chunk) [Unaudited Financial Statements](index=6&type=section&id=Unaudited%20Financial%20Statements) [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2025, Biodesix reported total assets of $87.74 million, total liabilities of $86.602 million, and total stockholders' equity of $1.138 million, reflecting decreases in assets and equity and an increase in liabilities compared to December 31, 2024 Condensed Balance Sheet Key Data | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Total Assets | $87,740 | $97,244 | | Total Liabilities | $86,602 | $76,368 | | Total Stockholders' Equity | $1,138 | $20,876 | | Cash and Cash Equivalents | $20,728 | $26,245 | | Long-term notes payable, net | $46,782 | $36,408 | [Condensed Statements of Operations](index=7&type=section&id=Condensed%20Statements%20of%20Operations) Q2 2025 total revenue was $20.018 million, with a net loss of $11.468 million and basic and diluted net loss per share of $0.08, indicating revenue growth but also an expanded net loss year-over-year Condensed Statements of Operations Key Data | Metric (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total Revenues | $20,018 | $17,925 | $37,976 | $32,743 | | Diagnostic Tests Revenue | $17,898 | $16,539 | $34,214 | $30,335 | | Development Services Revenue | $2,120 | $1,386 | $3,762 | $2,408 | | Net Loss | $(11,468) | $(10,808) | $(22,569) | $(24,422) | | Net Loss per Share (basic & diluted) | $(0.08) | $(0.08) | $(0.15) | $(0.22) | [Reconciliation of Net Loss to Adjusted EBITDA](index=8&type=section&id=Reconciliation%20of%20Net%20Loss%20to%20Adjusted%20EBITDA) Q2 2025 adjusted EBITDA loss widened to $7.213 million from $5.607 million in Q2 2024, with the reconciliation detailing adjustments from net loss Reconciliation of Net Loss to Adjusted EBITDA | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net Loss | $(11,468) | $(10,808) | $(22,569) | $(24,422) | | Interest expense | $1,898 | $1,936 | $3,583 | $4,465 | | Depreciation and amortization | $1,436 | $1,412 | $2,876 | $2,832 | | Share-based compensation expense | $1,039 | $1,218 | $2,011 | $3,858 | | Adjusted EBITDA | $(7,213) | $(5,607) | $(13,409) | $(12,568) |

Company Overview - Biodesix, Inc. is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients [3] - The company offers diagnostic tests such as Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance, which aid in clinical decision-making for lung disease [3] Upcoming Event - Scott Hutton, CEO, and Robin Cowie, CFO, will present in a fireside chat and conduct in-person 1x1 investor meetings at the Canaccord Genuity 45 Annual Growth Conference on August 12, 2025 [1] - The fireside chat is scheduled for 4:30 PM ET and will be held in Boston, MA [2] - The presentation will be available for live webcast and replay on the company's website [2]