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8-K
0001439725false00014397252023-03-062023-03-06

 

 

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

March 6, 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. ☐

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

On March 6, 2023, Biodesix, Inc. (the Company) issued a press release announcing the financial and operating results of the Company for the fourth quarter and year ended December 31, 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 March 6, 2023

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: March 6, 2023

BIODESIX, INC.

 

 

 

 

By:

/s/ Robin Harper Cowie

 

Name:

Robin Harper Cowie

 

Title:

Chief Financial Officer

 

 
EX-99

Exhibit 99.1

https://cdn.kscope.io/abaf6c25206e67830347d6a74af44cff-img189760734_0.jpg 

Biodesix Announces Fourth Quarter and Fiscal Year End 2022 Results and Highlights

Fourth Quarter and Fiscal Year 2022 Core Lung Diagnostic Revenue of $8.2 Million and $29.3 Million Increased 51% and 57% over the comparable 2021 periods, respectively

2023 Total Revenue Guidance Expected to be Between $52 Million and $55 Million - Mid-point of the range represents growth in excess of 60% over 2022 revenues excluding revenues from COVID-19 testing

Conference Call and Webcast Today at 8:30 a.m. ET

BOULDER, CO, March 6, 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 fourth quarter and year ended December 31, 2022 (fiscal 2022) and provided a corporate update.

“It has been a productive year for Biodesix, and I am extremely proud of our team’s performance. 2022 saw a significant increase in adoption of our core lung diagnostics business, growing test volume by 54% and revenue 57% year over year. In addition, we continued to produce compelling clinical utility data, expand reimbursement coverage including Medicare coverage of our Nodify CDT® test and new private coverage policies for our Nodify XL2® test.” said Scott Hutton, CEO of Biodesix. “Our strong performance and positive momentum gives us continued confidence for 2023.”

 

Fourth Quarter and Full Year 2022 Financial Results

•
Total revenue of $9.6 million and $38.2 million for the fourth quarter and fiscal 2022, respectively, an increase of 33% and decrease of 30% over the respective prior year comparable periods;
o
Continued growth in core lung diagnostic sales, offset by the expected year-over-year decline in COVID-19 revenue due to the decrease in testing across the year.
•
Core lung diagnostic revenue of $8.2 million and $29.3 million for the fourth quarter and fiscal 2022, respectively, an increase of 51% and 57% over the respective prior year comparable periods;
o
Strong year-over-year performance in core lung diagnostics primarily driven by the increased adoption of Nodify Lung® nodule management tests and, the highest total tests delivered in Company history.
•
COVID-19 testing revenue declined to an immaterial amount for the fourth quarter and $5.2 million for fiscal 2022, a decrease of 96% and 83% over the respective prior year comparable periods;
o
Commensurate with prior guidance resulting from the increase in COVID-19 vaccination rates across the U.S. and the adoption and availability of at-home testing, including the expiration of our most significant testing contracts.
•
Biopharma Services revenue of $1.4 million and $3.7 million for the fourth quarter and fiscal 2022, respectively, a decrease of 1% and 34% over the respective prior year comparable periods;
o
Clinical trial enrollment and shipping logistics continue to recover but are still impacting timelines for existing and new agreements;
o
Entering 2023 with highest dollars under contract in Company history, including both prospective and retrospective studies.

 

 

•
Gross margin was $6.3 million or 66% and $24.1 million or 63% for the fourth quarter and fiscal 2022, respectively, as a percentage of revenue compared to 65% and 44% in the comparable prior year periods, primarily driven by the mix 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 $20.2 million and $74.6 million for the fourth quarter and fiscal 2022, an increase of 23% and 15% over the respective prior year comparable periods;
o
Increase in operating expenses is primarily from increased sales and marketing expense from the hiring of new sales reps, increased travel-related costs as access to physicians returned to pre-pandemic levels, and increases in other non-employee related costs all resulting from year-over-year growth in core lung diagnostic revenue;
o
Includes non-cash stock compensation expense of $2.1 million and $6.0 million during fourth quarter and fiscal 2022, respectively.
•
Net loss of $20.3 million and $65.4 million for the fourth quarter and fiscal 2022, respectively, an increase of 53% and 52% over the respective prior year comparable periods;
o
Includes loss on debt extinguishment and modification of $4.0 million and $7.0 million in the fourth quarter and fiscal 2022, respectively;
o
Fiscal 2021 included gain on debt extinguishment and modification of $2.3 million.
•
Cash and cash equivalents of $43.1 million as of December 31, 2022;
o
Raised $65.7 million of net proceeds during the quarter through debt and equity offerings and utilized $23.9 million to extinguish outstanding debt.

2023 Financial Outlook

•
The Company anticipates generating between $52 million to $55 million in total revenue in 2023;
o
Guidance represents anticipated 36-44% growth over 2022 total revenue from Lung Diagnostic testing, Biopharmaceutical Services and COVID-19 testing;
o
Excluding 2022 COVID-19 testing revenue, Guidance represents anticipated 58-67% growth.

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 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. 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:

Robin Harper Cowie

robin.cowie@biodesix.com

(720) 509-8841

Investors:

Chris Brinzey

chris.brinzey@westwicke.com

(339) 970-2843

 

 

 

Biodesix, Inc.

Condensed Balance Sheets (unaudited)

(in thousands, except share data)

 

 

 

As of December 31,

 

 

 

2022

 

 

2021

 

Assets

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

43,088

 

 

$

32,712

 

Accounts receivable, net of allowance for doubtful accounts of $118 and $158

 

 

5,065

 

 

 

3,656

 

Other current assets

 

 

5,181

 

 

 

7,245

 

Total current assets

 

 

53,334

 

 

 

43,613

 

Non‑current assets

 

 

 

 

 

 

Property and equipment, net

 

 

5,848

 

 

 

4,179

 

Intangible assets, net

 

 

9,797

 

 

 

11,617

 

Operating lease right-of-use assets

 

 

2,973

 

 

 

—

 

Goodwill

 

 

15,031

 

 

 

15,031

 

Other long-term assets

 

 

5,923

 

 

 

1,657

 

Total non‑current assets

 

 

39,572

 

 

 

32,484

 

Total assets

 

$

92,906

 

 

$

76,097

 

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

1,685

 

 

$

1,662

 

Accrued liabilities

 

 

8,218

 

 

 

7,665

 

Deferred revenue

 

 

962

 

 

 

1,850

 

Current portion of operating lease liabilities

 

 

1,543

 

 

 

—

 

Current portion of contingent consideration

 

 

10,341

 

 

 

17,764

 

Current portion of notes payable

 

 

49

 

 

 

19

 

Other current liabilities

 

 

41

 

 

 

—

 

Total current liabilities

 

 

22,839

 

 

 

28,960

 

Non‑current liabilities

 

 

 

 

 

 

Long‑term notes payable, net of current portion

 

 

25,004

 

 

 

9,993

 

Long-term operating lease liabilities

 

 

5,254

 

 

 

—

 

Contingent consideration

 

 

18,645

 

 

 

16,028

 

Other long-term liabilities

 

 

558

 

 

 

1,389

 

Total non‑current liabilities

 

 

49,461

 

 

 

27,410

 

Total liabilities

 

 

72,300

 

 

 

56,370

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders' equity

 

 

 

 

 

 

Preferred stock, $0.001 par value, 5,000,000 authorized;
    0 (2022 and 2021) issued and outstanding

 

 

—

 

 

 

—

 

Common stock, $0.001 par value, 200,000,000 authorized;
    77,614,358 (2022) and 30,789,649 (2021) shares issued and outstanding

 

 

78

 

 

 

31

 

Additional paid‑in capital

 

 

387,948

 

 

 

321,669

 

Accumulated deficit

 

 

(367,420

)

 

 

(301,973

)

Total stockholders' equity

 

 

20,606

 

 

 

19,727

 

Total liabilities and stockholders' equity

 

$

92,906

 

 

$

76,097

 

 

 

 

Biodesix, Inc.

Condensed Statements of Operations (unaudited)

(in thousands, except per share data)

 

 

 

Three Months Ended December 31,

 

 

Year Ended December 31,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

COVID-19

 

$

16

 

 

$

425

 

 

$

5,240

 

 

$

30,227

 

Lung diagnostic

 

 

8,241

 

 

 

5,439

 

 

 

29,298

 

 

 

18,710

 

Diagnostic testing revenue

 

 

8,257

 

 

 

5,864

 

 

 

34,538

 

 

 

48,937

 

Biopharma services

 

 

1,351

 

 

 

1,359

 

 

 

3,674

 

 

 

5,569

 

Total revenues

 

 

9,608

 

 

 

7,223

 

 

 

38,212

 

 

 

54,506

 

Direct costs and expenses

 

 

3,306

 

 

 

2,493

 

 

 

14,154

 

 

 

30,518

 

Research and development

 

 

3,565

 

 

 

2,852

 

 

 

13,102

 

 

 

12,789

 

Sales, marketing, general and administrative

 

 

16,626

 

 

 

13,558

 

 

 

61,462

 

 

 

50,517

 

Change in fair value of contingent consideration

 

 

—

 

 

 

—

 

 

 

—

 

 

 

1,622

 

Impairment loss on intangible assets

 

 

—

 

 

 

—

 

 

 

81

 

 

 

—

 

Total operating expenses

 

 

23,497

 

 

 

18,903

 

 

 

88,799

 

 

 

95,446

 

Loss from operations

 

 

(13,889

)

 

 

(11,680

)

 

 

(50,587

)

 

 

(40,940

)

Other (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(2,550

)

 

 

(1,496

)

 

 

(8,072

)

 

 

(4,508

)

(Loss) gain on debt extinguishments, net

 

 

(3,977

)

 

 

(97

)

 

 

(6,981

)

 

 

2,298

 

Change in fair value of warrant liability

 

 

84

 

 

 

—

 

 

 

84

 

 

 

—

 

Other (expense) income, net

 

 

(5

)

 

 

(10

)

 

 

109

 

 

 

(9

)

Total other expense

 

 

(6,448

)

 

 

(1,603

)

 

 

(14,860

)

 

 

(2,219

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(20,337

)

 

$

(13,283

)

 

$

(65,447

)

 

$

(43,159

)

Net loss per share, basic and diluted

 

$

(0.35

)

 

$

(0.49

)

 

$

(1.55

)

 

$

(1.58

)

Weighted-average shares outstanding, basic and diluted

 

 

57,805

 

 

 

27,063

 

 

 

42,103

 

 

 

27,365