On November 1, 2024 Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company, reported its financial and operating results for the third quarter ended September 30, 2024 (Press release, Biodesix, NOV 1, 2024, View Source [SID1234647632]).

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"The Biodesix team is pleased to report another solid quarter focused on executing and delivering on our three main goals – driving revenue growth through the adoption of our lung diagnostic tests and biopharma services, continued implementation of operational efficiencies, and maintaining a cost-disciplined approach as we drive our business to profitability," said Scott Hutton, CEO of Biodesix.

"We reported 40% year-over-year growth in lung diagnostics revenue, a growing book of biopharma services contracts, sustained gross margins in the high 70% range, and improved Net Loss on our path to profitability. In addition, at the annual meeting of the American College of Chest Physicians (CHEST), we presented new clinical data on our Nodify XL2 and Nodify CDT tests, and announced a new clinical study (CLARIFY) to expand our data in diverse patient populations tested in a real-world clinical setting. Building on this momentum, we are reiterating our prior guidance of $70-$72 million for 2024 and we look forward to achieving Adjusted EBITDA profitability in the second half of 2025. At Biodesix, our tests play a vital role in treating the deadliest of all cancers. Our committed and driven team embraces the opportunity, and the responsibility, to transform the standard of care to improve outcomes for patients."

Third Quarter Ended September 30, 2024 Business Highlights

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Grew Lung Diagnostic test volume to 13,900, a 34% improvement over the third quarter of 2023.
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Quarterly gross profit margin of 77.0% versus 76.1% for the third quarter of 2023.
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Presented compelling new data at the CHEST Annual Meeting and announced the launch of a new clinical study, CLARIFY.
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New data was presented detailing the experience of healthcare providers using the Nodify Lung Nodule Risk Assessment Tests (Nodify XL2 and Nodify CDT tests) in over 35,000 patients tested in a real-world clinical setting. Results shared were consistent with prior studies, highlighting the high proportion of results that up- or down-classify patients into actionable risk categories with clear, guideline-recommended, diagnostic plans.
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The new study, CLARIFY, is designed to confirm performance of the Nodify CDT and Nodify XL2 tests in diverse patient subgroups through a retrospective chart review of up to 4,000 patients that were tested in a real-world clinical setting. The study’s intent is to expand the extensive evidence characterizing the validation and utility of Nodify Lung testing.

Third Quarter Ended September 30, 2024 Financial Highlights

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Total revenue of $18.2 million, an increase of 35% over the third quarter 2023:
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Lung Diagnostic revenue of $17.2 million reflected a year-over-year increase of 40% driven by the continued adoption of Nodify XL2 and Nodify CDT nodule risk assessment tests and strong reimbursement. However, test volumes were impacted at the end of the third quarter by disruption to patients, healthcare providers, and Biodesix teammates in the southeast due to Hurricane Helene;
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Biopharmaceutical Services revenue of $1.0 million decreased 17% year-over-year, driven by the timing of receipt of samples and shift of the completion of certain projects from the end of the third quarter into the beginning of the fourth;
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Third quarter 2024 gross profit of $14.0 million, or 77.0% gross margin compared to 76.1% gross margin in the comparable prior year period. Our steady margin performance is primarily driven by volume growth in Lung Diagnostic testing that continues to drive down the per test costs;
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Operating expenses (excluding direct costs and expenses) of $22.6 million, an increase of 29% as compared to the third quarter 2023, which includes $3.0 million of non-cash stock compensation expense and depreciation and amortization as compared to $1.7 million in third quarter of 2023. This increase is primarily attributable to an increase in sales and marketing costs to support both business lines’ sales growth to enhance product awareness and drive adoption, and an increase in depreciation expense related to the leasehold improvements in the Company’s Louisville, CO offices and laboratory which opened in January 2024;
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Net loss of $10.3 million, an improvement of 6% as compared to the same period of 2023;
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Adjusted EBITDA was a loss of $5.6 million, a slight increase over the loss of $5.4 million in the third quarter of 2023 and consistent with the second quarter of 2024;
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Cash and cash equivalents of $31.4 million as of September 30, 2024, a decrease from $42.2 million from June 30, 2024;
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Cash and cash equivalents as of September 30, 2024 includes the final milestone payment of $6.1 million for the acquisition of Integrated Diagnostics in 2018.
2024 – 2025 Financial Outlook

The Company is reiterating the 2024 revenue forecast of between $70 million and $72 million.

Conference call and webcast information

Listeners can register for the webcast via this link. Analysts who wish to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the Company’s investor relations page on the website approximately two hours after the call’s conclusion. Participants are advised to join 15 minutes prior to the start time.

For a full list of Biodesix press releases and webinars, please visit biodesix.com.