false000143972500014397252024-11-012024-11-01

 

 

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

November 1, 2024
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 November 1, 2024, Biodesix, Inc. (the Company) issued a press release announcing the financial and operating results of the Company for the third quarter ended September 30, 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 November 1, 2024

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: November 1, 2024

BIODESIX, INC.

 

 

 

 

By:

/s/ Robin Harper Cowie

 

Name:

Robin Harper Cowie

 

Title:

Chief Financial Officer

 

 


Exhibit 99.1

img189760734_0.jpg

Biodesix Announces Third Quarter 2024 Results and Highlights

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, CO, November 1, 2024 – 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.
o
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.
o
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:
o
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;
o
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;
o
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

)

 


v3.24.3
Document And Entity Information
Nov. 01, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Nov. 01, 2024
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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