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Biodesix Announces Third Quarter 2024 Results and Highlights

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Biodesix (NASDAQ: BDSX) reported Q3 2024 financial results with revenue growing 35% year-over-year to $18.2 million. Lung Diagnostic revenue increased 40% to $17.2 million, while Biopharmaceutical Services revenue decreased 17% to $1.0 million. The company achieved a gross profit margin of 77.0%, up from 76.1% in Q3 2023. Net loss improved by 6% compared to Q3 2023. Lung Diagnostic test volume grew 34% to 13,900 tests. The company reiterated its 2024 revenue guidance of $70-72 million and expects to achieve Adjusted EBITDA profitability in H2 2025.

Biodesix (NASDAQ: BDSX) ha riportato i risultati finanziari del terzo trimestre del 2024, con un fatturato in crescita del 35% anno su anno a $18,2 milioni. Il fatturato dei Diagnostici Polmonari è aumentato del 40% a $17,2 milioni, mentre il fatturato dei Servizi Biofarmaceutici è diminuito del 17% a $1,0 milione. L'azienda ha raggiunto un margine di profitto lordo del 77,0%, in aumento rispetto al 76,1% del terzo trimestre del 2023. La perdita netta è migliorata del 6% rispetto al terzo trimestre del 2023. Il volume dei test diagnostici polmonari è cresciuto del 34% a 13.900 test. L'azienda ha ribadito le sue previsioni di fatturato per il 2024 di $70-72 milioni e si aspetta di raggiungere la redditività dell'EBITDA rettificato nella seconda metà del 2025.

Biodesix (NASDAQ: BDSX) reportó los resultados financieros del tercer trimestre de 2024, con un crecimiento de ingresos del 35% interanual, alcanzando $18,2 millones. Los ingresos por Diagnósticos Pulmonares aumentaron un 40%, alcanzando $17,2 millones, mientras que los ingresos por Servicios Biofarmacéuticos disminuyeron un 17% a $1,0 millón. La compañía logró un margen de utilidad bruta del 77,0%, en comparación con el 76,1% del tercer trimestre de 2023. La pérdida neta mejoró en un 6% respecto al tercer trimestre de 2023. El volumen de pruebas de diagnóstico pulmonar creció un 34%, alcanzando 13,900 pruebas. La empresa reiteró su guía de ingresos para 2024 de $70-72 millones y espera alcanzar la rentabilidad del EBITDA ajustado en la segunda mitad de 2025.

Biodesix (NASDAQ: BDSX)는 2024년 3분기 재무 결과를 발표했으며, 수익이 전년 대비 35% 증가하여 $18.2백만에 도달했습니다. 폐 진단 수익은 40% 증가하여 $17.2백만에 이르렀고, 생물의약 서비스 수익은 17% 감소하여 $1.0백만이 되었습니다. 회사는 3분기 2023년의 76.1%에서 증가한 77.0%의 총 이익률을 달성했습니다. 순손실은 2023년 3분기 대비 6% 개선되었습니다. 폐 진단 검사량은 34% 증가하여 13,900건에 달했습니다. 회사는 2024년 매출 가이드를 $70-72백만으로 재확인했으며, 2025년 하반기에는 조정된 EBITDA 수익성을 달성할 것으로 기대하고 있습니다.

Biodesix (NASDAQ: BDSX) a publié ses résultats financiers pour le troisième trimestre 2024, avec un chiffre d'affaires en hausse de 35% par rapport à l'année précédente, atteignant $18,2 millions. Les revenus des diagnostics pulmonaires ont augmenté de 40%, atteignant $17,2 millions, tandis que les revenus des services biopharmaceutiques ont diminué de 17% pour s'établir à $1,0 million. L'entreprise a enregistré une marge brute de 77,0%, en hausse par rapport à 76,1% au troisième trimestre 2023. La perte nette a diminué de 6% par rapport au troisième trimestre 2023. Le volume des tests de diagnostic pulmonaire a augmenté de 34% pour atteindre 13 900 tests. L'entreprise a réaffirmé ses prévisions de chiffre d'affaires pour 2024 entre $70-72 millions et s'attend à atteindre la rentabilité de l'EBITDA ajusté au second semestre 2025.

Biodesix (NASDAQ: BDSX) hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht, mit einem Umsatzwachstum von 35% im Vergleich zum Vorjahr auf $18,2 Millionen. Der Umsatz im Bereich Lung Diagnostics stieg um 40% auf $17,2 Millionen, während der Umsatz im Bereich biopharmazeutische Dienstleistungen um 17% auf $1,0 Millionen zurückging. Das Unternehmen erreichte eine Bruttomarge von 77,0%, gegenüber 76,1% im dritten Quartal 2023. Der Nettoverlust verbesserte sich um 6% im Vergleich zum dritten Quartal 2023. Das Testvolumen für Lung Diagnostics wuchs um 34% auf 13.900 Tests. Das Unternehmen bekräftigte seine Umsatzprognose für 2024 von $70-72 Millionen und erwartet, in der zweiten Hälfte von 2025 die Profitabilität des bereinigten EBITDA zu erreichen.

Positive
  • Revenue growth of 35% YoY to $18.2 million
  • Lung Diagnostic revenue increased 40% YoY
  • Gross profit margin improved to 77.0% from 76.1%
  • Net loss improved by 6% compared to Q3 2023
  • Lung Diagnostic test volume grew 34% to 13,900 tests
Negative
  • Biopharmaceutical Services revenue decreased 17% YoY
  • Operating expenses increased 29% compared to Q3 2023
  • Cash and cash equivalents decreased to $31.4M from $42.2M in Q2 2024
  • Adjusted EBITDA loss of $5.6M, slightly worse than Q3 2023

Insights

The Q3 results show notable progress in Biodesix's financial performance, with revenue growing 35% year-over-year to $18.2 million. The core Lung Diagnostic segment demonstrated strong momentum with 40% growth, though Biopharmaceutical Services saw a temporary decline. The improved gross margin of 77.0% reflects operational efficiency gains.

While still operating at a loss of $10.3 million, the 6% improvement in net loss and maintained guidance of $70-72 million for 2024 signal steady progress. However, the cash position declined to $31.4 million from $42.2 million quarter-over-quarter, partly due to a $6.1 million milestone payment. The path to projected Adjusted EBITDA profitability in H2 2025 requires careful cash management and continued revenue growth.

The 34% growth in Lung Diagnostic test volume to 13,900 tests demonstrates strong market adoption of the Nodify platform. The new CLARIFY study announcement is strategically important as it aims to validate test performance across diverse patient populations, potentially expanding market reach. The real-world data presented at CHEST from 35,000 patients reinforces clinical utility and could drive further adoption.

Hurricane Helene's impact on Q3 test volumes highlights operational vulnerabilities, but the temporary nature suggests minimal long-term effects. The high gross margins indicate scalable test processing infrastructure, important for sustaining growth while moving toward profitability.

Q3 2024 revenue grew 35% over Q3 2023 to $18.2 million;

Q3 2024 gross profit margin of 77.0%, up from 76.1% in Q3 2023;

Q3 2024 Net loss improved by 6% compared to Q3 2023;

Conference Call and Webcast Today at 8:30 a.m. ET

LOUISVILLE, Colo., Nov. 01, 2024 (GLOBE NEWSWIRE) -- Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company, today announced its financial and operating results for the third quarter ended September 30, 2024.

“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

  • Grew Lung Diagnostic test volume to 13,900, a 34% improvement over the third quarter of 2023.
  • Quarterly gross profit margin of 77.0% versus 76.1% for the third quarter of 2023.
  • Presented compelling new data at the CHEST Annual Meeting and announced the launch of a new clinical study, CLARIFY.
    • 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.
    • 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

  • Total revenue of $18.2 million, an increase of 35% over the third quarter 2023:
    • 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;
    • 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;
  • 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;
  • 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;
  • Net loss of $10.3 million, an improvement of 6% as compared to the same period of 2023;
  • 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;
  • Cash and cash equivalents of $31.4 million as of September 30, 2024, a decrease from $42.2 million from June 30, 2024;
    • 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.

About Biodesix

Biodesix is a leading diagnostic solutions company with five Medicare-covered tests available for patients with lung diseases. The blood-based Nodify Lung® Nodule Risk Assessment, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood-based IQLung™ test portfolio for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS® test, and the VeriStrat® test to support treatment decisions across all stages of lung cancer and expedite personalized treatment. In addition, Biodesix collaborates with the world’s leading biopharmaceutical companies to provide biomarker discovery, diagnostic test development, and clinical trial support services. For more information about Biodesix, visit biodesix.com.

Trademarks: Biodesix, Nodify Lung, Nodify XL2, Nodify CDT, IQLung, GeneStrat, GeneStrat NGS, and VeriStrat are trademarks or registered trademarks of Biodesix, Inc. The ddPCR technology is a trademark of Bio-Rad Laboratories, Inc.

Use of Non-GAAP Financial Measure

Biodesix reported results are presented in accordance with generally accepted accounting principles in the United States (GAAP). Biodesix has provided in this press release financial information that has not been prepared in accordance with GAAP. Biodesix uses the non-GAAP financial measure, Adjusted EBITDA, internally in analyzing its financial results and believes that use of this non-GAAP financial measure is useful to investors as an additional tool to evaluate ongoing operating results and trends and in comparing Biodesix financial results with other companies in its industry, many of which present similar non-GAAP financial measures. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP financial measures and should be read only in conjunction with Biodesix financial statements prepared in accordance with GAAP. A reconciliation of Biodesix historical non-GAAP financial measure to the most directly comparable GAAP measure has been provided in the financial statement tables included in this press release, and investors are encouraged to review the reconciliation.

Adjusted EBITDA is a key performance measure that our management uses to assess our financial performance and is also used for internal planning and forecasting purposes. We believe that this non-GAAP financial measure is useful to investors and other interested parties in analyzing our financial performance because it provides a comparable overview of our operations across historical periods. In addition, we believe that providing Adjusted EBITDA, together with a reconciliation of Net loss to Adjusted EBITDA, helps investors make comparisons between our Company and other companies that may have different capital structures, different tax rates, and/or different forms of employee compensation.

Adjusted EBITDA is used by our management team as an additional measure of our performance for purposes of business decision-making, including managing expenditures. Period-to-period comparisons of Adjusted EBITDA help our management identify additional trends in our financial results that may not be shown solely by period- to-period comparisons of Net loss or Loss from operations. Our management recognizes that Adjusted EBITDA has inherent limitations because of the excluded items and may not be directly comparable to similarly titled metrics used by other companies.

We calculate Adjusted EBITDA as Net loss adjusted to exclude interest, income tax expense, if any, depreciation and amortization, share-based compensation expense, loss on debt extinguishments, net, COVID-19 revenue, COVID-19 direct costs and expenses, change in fair value of warrant liabilities, net, other income, net, and other non-recurring items. Non-recurring items are excluded as they are not representative of our underlying operating performance. We also exclude revenue and direct costs and expenses associated with COVID-19 because we believe that these revenues and expenses do not reflect expected future operating results as they do not represent our Lung Diagnostic and Biopharmaceutical Services business. Adjusted EBITDA should be viewed as a measure of operating performance that is a supplement to, and not a substitute for Loss from operations, Net loss, and other GAAP measures.

Note Regarding Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. Biodesix has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions. Forward-looking statements may include information concerning the impact of backlog and the timing and assumptions regarding collection of revenues on projections, availability of funds and future capital including under the term loan facility, expectations regarding revenue and margin growth and its impact on profitability, and the impact of a pandemic, epidemic, or outbreak, including the COVID-19 pandemic, on Biodesix and its operations and financial performance. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. The Company's ability to continue as a going concern could cause actual results to differ materially from those contemplated in this press release and additionally, other factors that could cause actual results to differ materially from those contemplated in this press release can be found in the Risk Factors section of Biodesix most recent annual report on Form 10-K, filed March 1, 2024 or subsequent quarterly reports on Form 10-Q during 2024, if applicable. Biodesix undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

Contacts:
Media:
Natalie St. Denis
natalie.stdenis@
biodesix.com
(720) 925-9285

Investors:
Chris Brinzey
chris.brinzey@
westwicke.com
(339) 970-2843


Biodesix, Inc.
Condensed Balance Sheets (unaudited)
(in thousands, except share data)
    
  September 30, 2024  December 31, 2023 
Assets 
Current assets      
Cash and cash equivalents $31,406  $26,284 
Accounts receivable, net of allowance for credit losses of $246 and $65  8,036   7,679 
Other current assets  4,575   5,720 
Total current assets  44,017   39,683 
Non-current assets      
Property and equipment, net  28,683   27,867 
Intangible assets, net  6,438   7,911 
Operating lease right-of-use assets  1,918   1,745 
Goodwill  15,031   15,031 
Other long-term assets  6,656   6,859 
Total non-current assets  58,726   59,413 
Total assets $102,743  $99,096 
       
Liabilities and Stockholders' Equity 
Current liabilities      
Accounts payable $2,537  $2,929 
Accrued liabilities  8,553   7,710 
Deferred revenue  676   324 
Current portion of operating lease liabilities  624   252 
Current portion of contingent consideration     21,857 
Current portion of notes payable  29   51 
Other current liabilities  544   293 
Total current liabilities  12,963   33,416 
Non-current liabilities      
Long-term notes payable, net of current portion  36,112   35,225 
Long-term operating lease liabilities  25,191   25,163 
Other long-term liabilities  620   712 
Total non-current liabilities  61,923   61,100 
Total liabilities  74,886   94,516 
Commitments and contingencies      
Stockholders' equity      
Preferred stock, $0.001 par value, 5,000,000 authorized;
0 (2024 and 2023) issued and outstanding
      
Common stock, $0.001 par value, 200,000,000 authorized;
145,465,941 (2024) and 96,235,883 (2023) shares issued and outstanding
  145   96 
Additional paid-in capital  481,958   424,050 
Accumulated deficit  (454,246)  (419,566)
Total stockholders' equity  27,857   4,580 
Total liabilities and stockholders' equity $102,743  $99,096 


Biodesix, Inc.
Condensed Statements of Operations (unaudited)
(in thousands, except per share data)
 
  Three Months Ended September 30,  Nine Months Ended September 30, 
  2024  2023  2024  2023 
Revenues            
Diagnostic Testing revenue $17,168  $12,301  $47,503  $32,395 
Biopharmaceutical Services and other revenue  983   1,190   3,391   2,024 
Total revenues  18,151   13,491   50,894   34,419 
Direct costs and expenses  4,179   3,229   11,231   9,636 
Research and development  2,547   1,938   7,145   8,099 
Sales, marketing, general and administrative  20,016   15,496   60,232   51,136 
Impairment loss on intangible assets        135   20 
Total operating expenses  26,742   20,663   78,743   68,891 
Loss from operations  (8,591)  (7,172)  (27,849)  (34,472)
Other (expense) income:            
Interest expense  (2,041)  (2,386)  (6,506)  (7,207)
Loss on extinguishment of liabilities        (248)   
Change in fair value of warrant liability, net     (1,393)     (1,332)
Other (expense) income, net  374   2   (77)  4 
Total other expense  (1,667)  (3,777)  (6,831)  (8,535)
             
             
Net loss $(10,258) $(10,949) $(34,680) $(43,007)
Net loss per share, basic and diluted $(0.07) $(0.14) $(0.28) $(0.55)
Weighted-average shares outstanding, basic and diluted  146,296   79,709   123,634   78,672 


Biodesix, Inc.
Reconciliation of Net Loss to Adjusted EBITDA (unaudited)
(in thousands)
 
 Three Months Ended September 30,  Nine Months Ended September 30, 
 2024  2023  2024  2023 
Net loss$(10,258) $(10,949) $(34,680) $(43,007)
Interest expense 2,041   2,386   6,506   7,207 
Depreciation and amortization 1,492   782   4,324   2,351 
Share-based compensation expense 1,515   954   5,373   4,292 
Loss on extinguishment of liabilities       248    
COVID-19 Revenue          (13)
COVID-19 Direct costs and expenses          1 
Change in fair value of warrant liability, net    1,393      1,332 
Other expense (income), net (374)  (2)  77   (4)
Adjusted EBITDA$(5,584) $(5,436) $(18,152) $(27,841)

FAQ

What was Biodesix (BDSX) revenue in Q3 2024?

Biodesix reported revenue of $18.2 million in Q3 2024, representing a 35% increase compared to Q3 2023.

When does Biodesix (BDSX) expect to achieve Adjusted EBITDA profitability?

Biodesix expects to achieve Adjusted EBITDA profitability in the second half of 2025.

What is Biodesix's (BDSX) revenue guidance for 2024?

Biodesix reiterated its 2024 revenue guidance of between $70 million and $72 million.

How many Lung Diagnostic tests did Biodesix (BDSX) perform in Q3 2024?

Biodesix performed 13,900 Lung Diagnostic tests in Q3 2024, a 34% increase compared to Q3 2023.

Biodesix, Inc.

NASDAQ:BDSX

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Diagnostics & Research
Services-medical Laboratories
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United States of America
LOUISVILLE