BDSX Biodesix Inc

 

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. ☐

 

 

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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)

 

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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

 

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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

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Third Quarter Ended September 30, 2024 Financial Highlights

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

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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

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“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

 

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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

 

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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

 

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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	)

 

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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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