0001439725falseBIODESIX INC00014397252023-08-072023-08-07

 

 

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

August 7, 2023
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.)

 

2970 Wilderness Place, Suite 100 Boulder, Colorado (Address of Principal Executive Office)	80301 (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 August 7, 2023, Biodesix, Inc. (the Company) issued a press release announcing the financial and operating results of the Company for the second quarter ended June 30, 2023. 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 August 7, 2023
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: August 7, 2023	BIODESIX, INC.
	By:	/s/ Robin Harper Cowie
	Name:	Robin Harper Cowie
	Title:	Chief Financial Officer

 

 

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Exhibit 99.1

 

Biodesix Announces Second Quarter 2023 Results and Highlights

Second quarter 2023 Core Lung Diagnostic revenue of $11.4 million increased 58% over the comparable period in 2022 and 33% over the first quarter of 2023;

Second quarter 2023 gross profit margin of 73% versus 64% for the second quarter 2022 and 65% for the first quarter 2023;

Revenue continues to track to 2023 full year guidance of $52-55 million;

Approximately $27.5 million in common shares sold under a private placement from the Company’s largest investors, Board of Directors members, and Executive Leadership team;

Multiple publications and data presentations on the clinical utility and health economic benefits of Core Lung Diagnostics tests;

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

BOULDER, CO, August 7, 2023 – Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, today announced its financial and operating results for the second quarter ended June 30, 2023 and provided a corporate update

“I am very pleased to announce another record-setting quarter from our core lung diagnostics,” said Scott Hutton, President and Chief Executive Officer. “In addition to continued sales growth, we had a number of important publications this past quarter that highlighted the benefits to patient care of our lung diagnostic tests in a real-world, clinical setting.

We are also happy to announce the successful completion of a private placement that included some of our largest shareholders and management. All board members, all Section 16 officers, and additional members of the Biodesix leadership team participated in the round raising $27.5 million in equity funding to further support our growth. We also maintained strong cost discipline, with sustainable and improving gross margins to 73% from 65%, and reducing our Operating Expense excluding direct costs and expenses by $2.7 million, all versus first quarter 2023. We continue to focus on projects and initiatives that drive near term-revenue growth, while reducing expenses and cash burn. Overall, the progress and positive trends in our core lung diagnostics tests in the first half of the year solidifies our confidence in reaffirming our 2023 revenue guidance and making progress on our path to profitability.”

Business Highlights

Biodesix continues to publish new data supporting the value and utility of their lung diagnostics portfolio. The Company was pleased to announce the following accomplishments:

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Second Quarter 2023 Financial Results

For the three-month period ended June 30, 2023, as compared to the same period of 2022 (where applicable):

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2023 Financial Outlook

The Company reaffirms our 2023 financial outlook and expects to generate between $52 million and $55 million in total revenue in 2023.

Conference call and webcast information

Listeners can register for the webcast via this link. Analysts wishing 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 website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

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

About Biodesix

Biodesix is a leading data-driven diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, 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™ strategy 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 with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, visit biodesix.com.

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 the COVID-19 pandemic on Biodesix and its operations, its possible or assumed future results of operations, including descriptions of its revenues, profitability, outlook, and overall business strategy. 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’s most recent annual report on Form 10-K, filed March 6, 2023 or subsequent quarterly reports on Form 10-Q during 2023, 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.

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Contacts:

Media:

Robbie Lunt

robbie.lunt@biodesix.com

1-(866)-432-5930

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)

 

		June 30, 2023				December 31, 2022
Assets
Current assets
Cash and cash equivalents		$	17,409			$	43,088
Accounts receivable, net of allowance for doubtful accounts of $150 and $118			4,119				5,065
Other current assets			3,717				5,181
Total current assets			25,245				53,334
Non‑current assets
Property and equipment, net			18,996				5,848
Intangible assets, net			8,871				9,797
Operating lease right-of-use assets			2,492				2,973
Goodwill			15,031				15,031
Other long-term assets			6,988				5,923
Total non‑current assets			52,378				39,572
Total assets		$	77,623			$	92,906
Liabilities and Stockholders' (Deficit) Equity
Current liabilities
Accounts payable		$	3,501			$	1,685
Accrued liabilities			6,981				8,218
Deferred revenue			1,069				962
Current portion of operating lease liabilities			1,504				1,543
Current portion of contingent consideration			14,561				10,341
Current portion of notes payable			50				49
Other current liabilities			285				41
Total current liabilities			27,951				22,839
Non‑current liabilities
Long‑term notes payable, net of current portion			24,658				25,004
Long-term operating lease liabilities			18,808				5,254
Contingent consideration			12,303				18,645
Other long-term liabilities			896				558
Total non‑current liabilities			56,665				49,461
Total liabilities			84,616				72,300
Commitments and contingencies
Stockholders' equity
Preferred stock, $0.001 par value, 5,000,000 authorized;     0 (2023 and 2022) issued and outstanding			—				—
Common stock, $0.001 par value, 200,000,000 authorized;     78,610,663 (2023) and 77,614,358 (2022) shares issued and outstanding			79				78
Additional paid‑in capital			392,406				387,948
Accumulated deficit			(399,478	)			(367,420	)
Total stockholders' (deficit) equity			(6,993	)			20,606
Total liabilities and stockholders' (deficit) equity		$	77,623			$	92,906

 

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Biodesix, Inc.

Condensed Statements of Operations (unaudited)

(in thousands, except per share data)

 

		Three Months Ended June 30,								Six Months Ended June 30,
		2023				2022				2023				2022
Revenues
Lung diagnostic		$	11,449			$	7,252			$	20,081			$	11,901
COVID-19			—				2,954				13				3,938
Diagnostic testing revenue			11,449				10,206				20,094				15,839
Biopharma services			423				744				834				1,659
Total revenues			11,872				10,950				20,928				17,498
Direct costs and expenses			3,238				3,980				6,407				7,215
Research and development			2,910				3,361				6,161				6,567
Sales, marketing, general and administrative			16,651				15,235				35,640				29,722
Impairment loss on intangible assets			—				—				20				81
Total operating expenses			22,799				22,576				48,228				43,585
Loss from operations			(10,927	)			(11,626	)			(27,300	)			(26,087	)
Other (expense) income:
Interest expense			(2,430	)			(1,346	)			(4,821	)			(2,483	)
Loss on debt extinguishments, net			—				(2,952	)			—				(2,952	)
Change in fair value of warrant liability			—				—				61				—
Other income, net			1				100				2				112
Total other expense			(2,429	)			(4,198	)			(4,758	)			(5,323	)
Net loss		$	(13,356	)		$	(15,824	)		$	(32,058	)		$	(31,410	)
Net loss per share, basic and diluted		$	(0.17	)		$	(0.40	)		$	(0.41	)		$	(0.89	)
Weighted-average shares outstanding, basic and diluted			78,506				39,239				78,138				35,177

 

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