0001439725false00014397252025-03-032025-03-03

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

March 3, 2025
Date of Report (Date of earliest event reported)

Biodesix, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

001-39659

20-3986492

(State or other jurisdiction
of incorporation)

(Commission
File Number)

(I.R.S. Employer
Identification No.)

 

919 West Dillon Rd

Louisville, Colorado

(Address of Principal Executive Office)

80027

(Zip Code)

 

Registrant’s telephone number, including area code: (303) 417-0500

Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value of $0.001 per share

 

BDSX

 

The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 


 

Item 2.02. Results of Operations and Financial Condition.

On March 3, 2025, Biodesix, Inc. (the Company) issued a press release announcing the financial and operating results of the Company for the fourth quarter and fiscal year ended December 31, 2024. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

The information contained in Item 2.02 to this Current Report on Form 8-K and Exhibit 99.1 attached hereto is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such document or filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits:

No.

 

Exhibit

99.1

 

Press Release issued by Biodesix, Inc. dated March 3, 2025

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 


 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: March 3, 2025

BIODESIX, INC.

 

 

 

 

By:

/s/ Robin Harper Cowie

 

Name:

Robin Harper Cowie

 

Title:

Chief Financial Officer

 

 


Exhibit 99.1

img189760734_0.jpg

Biodesix Announces Fourth Quarter and Fiscal Year 2024 Results

Total Revenue of $71.3 million for FY2024, growing 45% over FY2023;

Gross margins of 78% for FY2024, up 5% points over FY2023;

FY2025 Total Revenue Guidance of $92-95 million;

Conference Call and Webcast Today at 4:30 p.m. ET

LOUISVILLE, CO, March 3, 2025 – Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company, today announced its financial and operating results for the fourth quarter and year ended December 31, 2024 (fiscal 2024).

"Biodesix concluded a strong 2024, advancing our key initiatives and delivering on our financial and operational goals," said Scott Hutton, Chief Executive Officer. "We exceeded our revenue targets, with total revenue reaching $71.3 million, driven by a 43% increase in Lung Diagnostics and a 70% growth in Biopharma Services. Our team successfully implemented operational efficiencies improving our Gross Margins to 78% for the year, strengthened clinical and commercial capabilities, and secured new partnerships and reimbursement coverage. We are well-positioned for continued growth and success and expect that 2025 will be a transformative year for Biodesix."

Fourth Quarter and Full Year 2024 Financial Results

Total revenue of $20.4 million and $71.3 million for the fourth quarter and fiscal 2024, respectively, an increase of 39% and 45% over the respective prior year comparable periods;
o
Lung Diagnostic Testing revenue of $17.2 million and $64.7 million for the fourth quarter and fiscal 2024, respectively, an increase of 34% and 43% over the respective prior year comparable periods; primarily driven by an increase in total tests delivered;
o
Diagnostic Development Services revenue of $3.2 million and $6.6 million for the fourth quarter and fiscal 2024, respectively, an increase of 72% and 70% over the respective prior year comparable periods;
Gross margin was $16.1 million or 79% and $55.8 million or 78% for the fourth quarter and fiscal 2024, respectively, as a percentage of revenue compared to 77% and 73% in the prior year comparable periods, primarily driven by growth in Lung Diagnostic testing and optimization of testing workflows that resulted in improvements in costs per test and the ongoing expansion of our Diagnostic Development Services business;
Operating expenses (excluding direct costs and expenses) of $22.7 million and $90.2 million for the fourth quarter and fiscal 2024, an increase of 25% and 17% over the respective prior year comparable periods;
o
Increase in operating expenses is primarily attributed to an increase in sales and marketing costs to support Lung Diagnostic sales growth, as well as to enhance Biodesix awareness and drive product adoption;
o
Includes non-cash stock compensation expense of $1.3 million and $6.6 million during the fourth quarter and fiscal 2024, respectively, an increase of 17% and 24% over the respective prior year comparable periods;
Net loss of $8.3 million and $42.9 million for the fourth quarter and fiscal 2024, respectively, an improvement of 10% and 18% over the respective prior year comparable periods;
Adjusted EBITDA was a loss of $3.9 million and $22.1 million for the fourth quarter and fiscal 2024, respectively, an improvement of 19% and 32% over the respective prior year comparable periods;
Cash and cash equivalents of $26.2 million as of December 31, 2024. Subsequent to quarter end, we amended our term loan facility with Perceptive Advisors to extend the availability of the $10 million Tranche C loan.


 

2025 Financial Outlook

The Company anticipates generating between $92 million to $95 million in total revenue in 2025.

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, driven to improve clinical care and outcomes for patients. ​Biodesix Diagnostic Tests, marketed as Nodify Lung® Nodule Risk Assessment and IQLung™ Cancer Treatment Guidance, support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Diagnostic Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. ​For more information, visit biodesix.com.

Trademarks: Biodesix, Biodesix Logo, Nodify Lung, and IQLung are trademarks or registered trademarks of Biodesix, 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 Testing and Diagnostic Development 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, the anticipated impact and benefits of new clinical data, reimbursement coverage and research partnerships, and the impact of a pandemic, epidemic, or outbreak 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. 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 3, 2025. 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@icrhealthcare.com

(339) 970-2843

 


 

Biodesix, Inc.

Condensed Balance Sheets (unaudited)

(in thousands, except share data)

 

 

 

 

 

 

 

December 31, 2024

 

 

December 31, 2023

 

Assets

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

26,245

 

 

$

26,284

 

Accounts receivable, net of allowance for credit losses of $481 and $65

 

 

8,603

 

 

 

7,679

 

Other current assets

 

 

4,636

 

 

 

5,720

 

Total current assets

 

 

39,484

 

 

 

39,683

 

Non‑current assets

 

 

 

 

 

 

Property and equipment, net

 

 

27,828

 

 

 

27,867

 

Intangible assets, net

 

 

5,874

 

 

 

7,911

 

Operating lease right-of-use assets

 

 

1,767

 

 

 

1,745

 

Goodwill

 

 

15,031

 

 

 

15,031

 

Other long-term assets

 

 

7,260

 

 

 

6,859

 

Total non‑current assets

 

 

57,760

 

 

 

59,413

 

Total assets

 

$

97,244

 

 

$

99,096

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

2,194

 

 

$

2,929

 

Accrued liabilities

 

 

10,064

 

 

 

7,710

 

Deferred revenue

 

 

678

 

 

 

324

 

Current portion of operating lease liabilities

 

 

719

 

 

 

252

 

Current portion of contingent consideration

 

 

 

 

 

21,857

 

Current portion of notes payable

 

 

21

 

 

 

51

 

Other current liabilities

 

 

641

 

 

 

293

 

Total current liabilities

 

 

14,317

 

 

 

33,416

 

Non‑current liabilities

 

 

 

 

 

 

Long‑term notes payable, net of current portion

 

 

36,408

 

 

 

35,225

 

Long-term operating lease liabilities

 

 

24,828

 

 

 

25,163

 

Other long-term liabilities

 

 

815

 

 

 

712

 

Total non‑current liabilities

 

 

62,051

 

 

 

61,100

 

Total liabilities

 

 

76,368

 

 

 

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;
   145,491,569 (2024) and 96,235,883 (2023) shares issued and outstanding

 

 

145

 

 

 

96

 

Additional paid‑in capital

 

 

483,228

 

 

 

424,050

 

Accumulated deficit

 

 

(462,497

)

 

 

(419,566

)

Total stockholders' equity

 

 

20,876

 

 

 

4,580

 

Total liabilities and stockholders' equity

 

$

97,244

 

 

$

99,096

 

 


 

Biodesix, Inc.

Condensed Statements of Operations (unaudited)

(in thousands, except per share data)

 

 

 

Three Months Ended December 31,

 

 

Year Ended December 31,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

Lung Diagnostic Testing

 

$

17,205

 

 

$

12,797

 

 

$

64,708

 

 

$

45,192

 

Development Services

 

 

3,224

 

 

 

1,871

 

 

 

6,615

 

 

 

3,895

 

Total revenues

 

 

20,429

 

 

 

14,668

 

 

 

71,323

 

 

 

49,087

 

Direct costs and expenses

 

 

4,342

 

 

 

3,374

 

 

 

15,573

 

 

 

13,010

 

Research and development

 

 

2,414

 

 

 

1,889

 

 

 

9,559

 

 

 

9,988

 

Sales, marketing, general and administrative

 

 

20,219

 

 

 

16,251

 

 

 

80,451

 

 

 

67,387

 

Impairment loss on intangible assets

 

 

103

 

 

 

24

 

 

 

238

 

 

 

44

 

Total operating expenses

 

 

27,078

 

 

 

21,538

 

 

 

105,821

 

 

 

90,429

 

Loss from operations

 

 

(6,649

)

 

 

(6,870

)

 

 

(34,498

)

 

 

(41,342

)

Other (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(1,752

)

 

 

(2,329

)

 

 

(8,258

)

 

 

(9,536

)

Loss on extinguishment of liabilities

 

 

 

 

 

 

 

 

(248

)

 

 

 

Change in fair value of warrant liability, net

 

 

 

 

 

58

 

 

 

 

 

 

(1,274

)

Other income, net

 

 

150

 

 

 

2

 

 

 

73

 

 

 

6

 

Total other expense

 

 

(1,602

)

 

 

(2,269

)

 

 

(8,433

)

 

 

(10,804

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(8,251

)

 

$

(9,139

)

 

$

(42,931

)

 

$

(52,146

)

Net loss per share, basic and diluted

 

$

(0.06

)

 

$

(0.10

)

 

$

(0.33

)

 

$

(0.64

)

Weighted-average shares outstanding, basic and diluted

 

 

146,603

 

 

 

92,325

 

 

 

129,670

 

 

 

82,113

 

 


 

Biodesix, Inc.

Reconciliation of Net Loss to Adjusted EBITDA (unaudited)

(in thousands)

 

 

Three Months Ended December 31,

 

 

Year Ended December 31,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Net loss

$

(8,251

)

 

$

(9,139

)

 

$

(42,931

)

 

$

(52,146

)

Interest expense

 

1,752

 

 

 

2,329

 

 

 

8,258

 

 

 

9,536

 

Depreciation and amortization

 

1,449

 

 

 

977

 

 

 

5,773

 

 

 

3,328

 

Share-based compensation expense

 

1,265

 

 

 

1,081

 

 

 

6,638

 

 

 

5,373

 

Loss on extinguishment of liabilities

 

 

 

 

 

 

 

248

 

 

 

 

COVID-19 Revenue

 

 

 

 

(44

)

 

 

 

 

 

(57

)

COVID-19 Direct costs and expenses

 

 

 

 

 

 

 

 

 

 

1

 

Change in fair value of warrant liability, net

 

 

 

 

(58

)

 

 

 

 

 

1,274

 

Other income, net

 

(150

)

 

 

(2

)

 

 

(73

)

 

 

(6

)

Adjusted EBITDA

$

(3,935

)

 

$

(4,856

)

 

$

(22,087

)

 

$

(32,697

)

 


v3.25.0.1
Document And Entity Information
Mar. 03, 2025
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Mar. 03, 2025
Entity Registrant Name Biodesix, Inc.
Entity Central Index Key 0001439725
Entity File Number 001-39659
Entity Incorporation State Country Code DE
Entity Tax Identification Number 20-3986492
Entity Address, Address Line One 919 West Dillon Rd
Entity Address, City or Town Louisville
Entity Address, State or Province CO
Entity Address, Postal Zip Code 80027
City Area Code (303)
Local Phone Number 417-0500
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company true
Entity Ex Transition Period false
Security 12b Title Common Stock, par value of $0.001 per share
Trading Symbol BDSX
Security Exchange Name NASDAQ

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