8-K

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 4, 2022
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. ☐

Item 2.02. Results of Operations and Financial Condition.

On August 4, 2022, Biodesix, Inc. (the Company) issued a press release announcing the financial and operating results of the Company for the second quarter ended June 30, 2022. 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 4, 2022
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: August 4, 2022	BIODESIX, INC.
	By:	/s/ Robin Harper Cowie
	Name:	Robin Harper Cowie
	Title:	Chief Financial Officer

EX-99.1

Exhibit 99.1

 

Biodesix Announces Second Quarter 2022 Results and Highlights

Second quarter 2022 core Lung Diagnostic revenue of $7.3 million increased 52% over the comparable period in 2021;

Received Medicare coverage for the Nodify CDT® Lung Nodule Test;

Announced strategic arrangements during the quarter (Royal Philips, Memorial Sloan Kettering Cancer Center and Bio-Rad);

Reaffirm 2022 revenue outlook of between $37.5 million and $39.5 million;

Conference Call and Webcast Today at 8:00 a.m. ET

BOULDER, CO, August 4, 2022 –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 second quarter ended June 30, 2022 and provided a corporate update.

“We are thrilled to announce strong growth from our core lung diagnostic testing, with an increase in revenue of 52% over the second quarter of 2021 and 56% over the first quarter of 2022,” said Scott Hutton, CEO of Biodesix. “With the recent Medicare coverage of the Nodify CDT® test, all five of our core lung diagnostic tests are now covered, which will help drive adoption of the test and improve margins over the long term.

In addition, we announced two exciting corporate arrangements. The first, announced with Royal Phillips, integrates our Nodify Lung® tests into its Lung Cancer Orchestrator patient management system to help facilitate digital ordering of the tests following detection of a lung nodule with the ultimate goal of improving patient care and outcomes. The second, announced with Memorial Sloan Kettering Cancer Center and Bio-Rad Laboratories, allows us to leverage the capabilities of these leading organizations to potentially bring new transformative diagnostics to market, including our initial intention to co-develop a molecular minimal residual disease (MRD) test for solid tumors.

Overall, our progress and positive trends in our core lung diagnostics tests in the first half of the year solidifies our confidence  in reaffirming our 2022 revenue guidance.”

Second Quarter 2022 Financial Results

For the three-month period ended June 30, 2022, as compared to the same period of 2021 (where applicable):

•Total revenue of $11.0 million, a decrease of 8%, driven primarily by an anticipated year-over-year decline in COVID-19 diagnostic testing revenue, offset by strong year-over-year growth in core lung diagnostics:

oCore lung diagnostic revenue of $7.3 million, reflected a year-over-year increase of 52% that was driven primarily by the increased adoption of Nodify Lung nodule management tests (Nodify CDT & Nodify XL2 tests);

oCOVID-19 testing revenue of $3.0 million reflected a year-over-year decrease of 51% that was driven by the shift to at-home rapid antigen testing;

oBioPharma Services revenue of $0.7 million decreased 29% year-over-year. COVID-related delays in clinical study enrollment and sample shipping logistics have begun to recover but are still impacting timelines for existing and new agreements;

•Second quarter 2022 gross margin of $7.0 million, or 64% as a percentage of revenue as compared to 40% in the comparable prior year period primarily driven by the shift of sales to higher-margin core lung diagnostics and away from lower-margin COVID-19 testing;

•Operating expenses (excluding direct costs and expenses) of $18.6 million, an increase of 21% driven primarily by growth in sales and marketing to drive our growth in core lung diagnostics sales as well as the recent GeneStrat NGS™ commercial launch;

oIncludes non-cash stock compensation expense of $1.4 million as compared to $0.5 million;

•Net loss of $15.8 million, an increase of 39%, driven primarily by the loss on extinguishment charge resulting from the restructuring of the contingent consideration agreement with Integrated Diagnostics (Indi);

•Cash and cash equivalents of $28.7 million, inclusive of $5.1 million in restricted cash, as of June 30;

oRaised net proceeds of $27.3 million during the quarter through debt and equity offerings;

oIncludes principal payment of $3.0 million on the 2021 Term Loan and $2.0 million for scheduled milestone payment in April 2022 to Indi.

2022 Financial Outlook

The Company reaffirms its 2022 financial outlook and expects to generate between $37.5 million and $39.5 million in total revenue in 2022.

Conference call and webcast information

Management will host an investor conference call and webcast today, August 4, 2022 at 8:00 a.m. Eastern Time.

Investor dial-in (domestic):	800-715-9871
Investor dial-in (international):	646-307-1963
Conference ID:	8620846
Webcast:	https://edge.media-server.com/mmc/p/rf64jw58

An archived replay of the webcast will be available on the Company’s website for a period of 90 days.

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 is the first company to offer eight non-invasive 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 incidental 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® ddPCR™ test, the GeneStrat NGS™ test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an unprecedented 36-72 hours, expediting 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. Biodesix launched the SARS-CoV-2 ddPCR™ test, the Platelia SARS-CoV-2 Total Ab, and the cPass™ SARS-CoV-2 Neutralization Antibody test (cPass™ Neutralization Test Kit, GenScript, Inc,) in response to the global pandemic and virus that impacts the lung and causes COVID-19. 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, it is 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 14, 2022 or subsequent quarterly reports on Form 10-Q during 2022, 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:

Bobbi Coffin

bobbi.coffin@biodesix.com

(303) 892-3203

Investors:

Chris Brinzey

chris.brinzey@westwicke.com

(339) 970-2843

Biodesix, Inc.

Condensed Balance Sheets (unaudited)

(in thousands, except share data)

	June 30, 2022			December 31, 2021
Assets
Current assets
Cash and cash equivalents	$	23,586		$	32,712
Accounts receivable, net of allowance for doubtful accounts of $52 and $158		5,452			3,656
Other current assets		6,019			7,245
Total current assets		35,057			43,613
Non‑current assets
Restricted cash		5,000			—
Property and equipment, net		3,950			4,179
Intangible assets, net		10,688			11,617
Operating lease right-of-use assets		3,952			—
Goodwill		15,031			15,031
Other long-term assets		1,551			1,657
Total non‑current assets		40,172			32,484
Total assets	$	75,229		$	76,097
Liabilities and Stockholders' Equity
Current liabilities
Accounts payable	$	1,791		$	1,662
Accrued liabilities		6,667			7,665
Deferred revenue		2,230			1,850
Current portion of operating lease liabilities		1,315			—
Current portion of contingent consideration		8,151			17,764
Current portion of notes payable		11,771			19
Other current liabilities		1,149			—
Total current liabilities		33,074			28,960
Non‑current liabilities
Long‑term notes payable, net of current portion		8,596			9,993
Long-term operating lease liabilities		2,902			—
Contingent consideration		22,916			16,028
Other long-term liabilities		70			1,389
Total non‑current liabilities		34,484			27,410
Total liabilities		67,558			56,370
Commitments and contingencies
Stockholders' equity
Preferred stock, $0.001 par value, 5,000,000 shares authorized;     0 (2022 and 2021) shares issued and outstanding		—			—
Common stock, $0.001 par value, 200,000,000 shares authorized;     39,978,844 (2022) and 30,789,649 (2021) shares issued and outstanding		40			31
Additional paid‑in capital		341,014			321,669
Accumulated deficit		(333,383	)		(301,973	)
Total stockholders' equity		7,671			19,727
Total liabilities and stockholders' equity	$	75,229		$	76,097

Biodesix, Inc.

Condensed Statements of Operations (unaudited)

(in thousands, except per share data)

	Three Months Ended June 30,						Six Months Ended June 30,
	2022			2021			2022			2021
Revenues
COVID-19	$	2,954		$	6,064		$	3,938		$	29,296
Lung diagnostic		7,252			4,774			11,901			8,737
Diagnostic testing revenue		10,206			10,838			15,839			38,033
Biopharma services		744			1,047			1,659			2,718
Total revenues		10,950			11,885			17,498			40,751
Direct costs and expenses		3,980			7,085			7,215			25,303
Research and development		3,361			3,323			6,567			6,644
Sales, marketing, general and administrative		15,235			11,425			29,722			23,352
Change in fair value of contingent consideration		—			639			—			1,622
Impairment loss on intangible assets		—			—			81			—
Total operating expenses		22,576			22,472			43,585			56,921
Loss from operations		(11,626	)		(10,587	)		(26,087	)		(16,170	)
Other (expense) income:
Interest expense		(1,346	)		(815	)		(2,483	)		(1,466	)
Loss on extinguishment of liabilities		(2,952	)		—			(2,952	)		(728	)
Other income, net		100			—			112			1
Total other expense		(4,198	)		(815	)		(5,323	)		(2,193	)
Net loss	$	(15,824	)	$	(11,402	)	$	(31,410	)	$	(18,363	)
Net loss per share, basic and diluted	$	(0.40	)	$	(0.41	)	$	(0.89	)	$	(0.68	)
Weighted-average shares outstanding, basic and diluted		39,239			27,730			35,177			27,020

XML

Document And Entity Information	Aug. 04, 2022
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 04, 2022
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	2970 Wilderness Place
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	Boulder
Entity Address, State or Province	CO
Entity Address, Postal Zip Code	80301
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