BDSX Biodesix Inc

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024

OR

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-39659

 

 

BIODESIX, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware	20-3986492
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
919 West Dillon Rd Louisville, Colorado	80027
(Address of principal executive offices)	(Zip Code)

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

 

 

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 $0.001 per share		BDSX		The NASDAQ Global Market

 

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer		☐		Accelerated filer		☐
Non-accelerated filer		☒		Smaller reporting company		☒
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. ☐

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

Indicate by check mark whether the Registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☒ No ☐

As of October 25, 2024, the Registrant had 145,467,295 shares of common stock, $0.001 par value per share, outstanding.

 

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Table of Contents

 

		Page
PART I.	FINANCIAL INFORMATION	1
Item 1.	Financial Statements (Unaudited)	1
	Condensed Balance Sheets as of September 30, 2024 and December 31, 2023	1
	Condensed Statements of Operations for the Three and Nine Months Ended September 30, 2024 and 2023	2
	Condensed Statements Stockholders' Equity (Deficit) for the Three and Nine Months Ended September 30, 2024 and 2023	3
	Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023	5
	Notes to Condensed Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	24
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	36
Item 4.	Controls and Procedures	36
PART II.	OTHER INFORMATION	38
Item 1.	Legal Proceedings	38
Item 1A.	Risk Factors	38
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	38
Item 3.	Defaults Upon Senior Securities	39
Item 4.	Mine Safety Disclosures	39
Item 5.	Other Information	39
Item 6.	Exhibits	40
	Signature	41

 

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry that involve substantial risks and uncertainties, including but not limited to those set forth under the caption “Special Note Regarding Forward-Looking Statements” and Item 1A. “Risk Factors” of Part II of this Quarterly Report on Form 10-Q and those discussed in our other filings with the Securities and Exchange Commission (SEC), including the risks described in Item 1A. “Risk Factors” of Part I of our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed on March 1, 2024. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “should,” “will” or the negative of these terms or other similar expressions.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, factors, and assumptions described under the section titled “Risk Factors” in this Report and in the section entitled “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2023, regarding, among other things:

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These risks are not exhaustive. Other sections of this Quarterly Report on Form 10-Q may include additional factors that could harm our business and financial performance. New risk factors may emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q or to conform these statements to actual results or to changes in our expectations.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

You should read this Quarterly Report on Form 10-Q and the documents that we reference and have filed as exhibits with the understanding that our actual future results, levels of activity, performance and achievements may be different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

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PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited).

BIODESIX, INC.

Condensed Balance Sheets

(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

(in thousands, except per share data)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2024				2023				2024				2023
Revenues		$	18,151			$	13,491			$	50,894			$	34,419
Operating expenses:
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 income (expense), 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.

Condensed Statements of Stockholders' Equity (Deficit)

(in thousands)

 

		Common Stock								Additional Paid‑In				Accumulated				Total Stockholders' Equity
		Shares				Amount				Capital				Deficit				(Deficit)
Balance ‑ December 31, 2023			96,236			$	96			$	424,050			$	(419,566	)		$	4,580
Issuance of common stock, net			314				1				606				—				607
Issuance of common stock under employee stock purchase plan			216				—				282				—				282
Exercise of stock options			6				—				3				—				3
Release of restricted stock units			387				—				—				—				—
Share‑based compensation			—				—				2,640				—				2,640
Net loss			—				—				—				(13,614	)			(13,614	)
Balance ‑ March 31, 2024			97,159				97				427,581				(433,180	)			(5,502	)
Conversion of preferred stock liabilities to common stock, net			30,435				31				33,119				—				33,150
Issuance of common stock, net			17,392				17				18,181				—				18,198
Exercise of stock options			8				—				4				—				4
Release of restricted stock units			156				—				—				—				—
Share‑based compensation			—				—				1,218				—				1,218
Net loss			—				—				—				(10,808	)			(10,808	)
Balance - June 30, 2024			145,150				145				480,103				(443,988	)			36,260
Issuance of common stock, net			—				—				(15	)			—				(15	)
Issuance of common stock under employee stock purchase plan			255				—				343				—				343
Exercise of stock options			13				—				12				—				12
Release of restricted stock units			48				—				—				—				—
Share‑based compensation			—				—				1,515				—				1,515
Net loss			—				—				—				(10,258	)			(10,258	)
Balance - September 30, 2024			145,466			$	145			$	481,958			$	(454,246	)		$	27,857

 

 

 

 

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		Common Stock								Additional Paid‑In				Accumulated				Total Stockholders' (Deficit)
		Shares				Amount				Capital				Deficit				Equity
Balance ‑ December 31, 2022			77,614			$	78			$	387,948			$	(367,420	)		$	20,606
Issuance of common stock, net			—				—				(61	)			—				(61	)
Issuance of common stock under employee stock purchase plan			270				—				420				—				420
Exercise of stock options			9				—				6				—				6
Release of restricted stock units			86				—				—				—				—
Share‑based compensation			—				—				2,281				—				2,281
Net loss			—				—				—				(18,702	)			(18,702	)
Balance ‑ March 31, 2023			77,979				78				390,594				(386,122	)			4,550
Exercise of stock options			107				—				81				—				81
Release of restricted stock units			525				1				—				—				1
Issuance of warrants			—				—				674				—				674
Share‑based compensation			—				—				1,057				—				1,057
Net loss			—				—				—				(13,356	)			(13,356	)
Balance - June 30, 2023			78,611				79				392,406				(399,478	)			(6,993	)
Issuance of common stock, net			9,455				9				15,307				—				15,316
Issuance of common stock under employee stock purchase plan			167				—				223				—				223
Exercise of stock options			6				—				3				—				3
Release of restricted stock units			77				—				—				—				—
Share‑based compensation			—				—				954				—				954
Net loss			—				—				—				(10,949	)			(10,949	)
Balance - September 30, 2023			88,316			$	88			$	408,893			$	(410,427	)		$	(1,446	)

 

 

 

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BIODESIX, INC.

Condensed Statements of Cash Flows

(in thousands)

		Nine Months Ended September 30,
		2024				2023
Cash flows from operating activities
Net loss		$	(34,680	)		$	(43,007	)
Adjustments to reconcile net loss to net cash, cash equivalents, and restricted    cash used in operating activities
Depreciation and amortization			4,324				2,351
(Accretion) amortization of lease right-of-use assets			(266	)			1,851
Loss on extinguishment of liabilities			248				—
Share‑based compensation expense			5,373				4,292
Change in fair value of warrant liability, net			—				1,332
Provision for doubtful accounts			453				467
Accrued interest, amortization of debt issuance costs and other			2,167				3,954
Inventory excess and obsolescence			20				115
Impairment loss on intangible assets			135				20
Changes in operating assets and liabilities:
Accounts receivable			(810	)			(1,178	)
Other current assets			778				1,798
Other long-term assets			49				(26	)
Accounts payable and other accrued liabilities			(57	)			(247	)
Deferred revenue			273				(395	)
Contingent consideration			(23,242	)			—
Tenant improvement allowances received			—				18,323
Current and long-term operating lease liabilities			682				(237	)
Net cash and cash equivalents and restricted cash used in operating activities			(44,553	)			(10,587	)
Cash flows from investing activities
Purchase of property and equipment			(2,391	)			(19,935	)
Patent costs and intangible asset acquisition, net			(165	)			(126	)
Net cash and cash equivalents and restricted cash used in investing activities			(2,556	)			(20,061	)
Cash flows from financing activities
Proceeds from the issuance of common stock			55,625				15,316
Proceeds from issuance of common stock under employee stock purchase plan			624				643
Proceeds from exercise of stock options			19				90
Payment of contingent consideration			—				(7,591	)
Repayment of term loan and notes payable			(38	)			(36	)
Payment of debt issuance costs			(38	)			(833	)
Equity financing costs			(3,685	)			(61	)
Other			(276	)			(127	)
Net cash and cash equivalents and restricted cash provided by financing activities			52,231				7,401
Net increase (decrease) in cash and cash equivalents and restricted cash			5,122				(23,247	)
Cash, cash equivalents, and restricted cash ‑ beginning of period			26,371				43,174
Cash, cash equivalents, and restricted cash ‑ end of period		$	31,493			$	19,927

 

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BIODESIX, INC.

Statements of Cash Flows

(in thousands)

(Continued from the previous page)

Supplemental cash flow information:

		Nine Months Ended September 30,
		2024				2023
Issuance of Perceptive Warrants		$	—			$	674
Operating lease right-of-use asset obtained in exchange for lease liabilities			281				867
Finance lease right-of-use assets obtained in exchange for lease liabilities			514				773
Cash paid for interest			4,443				3,241
Purchases of property & equipment included in accounts payable and accrued liabilities			526				824

 

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BIODESIX, INC.

Notes to Unaudited Condensed Financial Statements

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