Le Lézard
Classified in: Health, Science and technology, Business, Covid-19 virus
Subjects: EARNINGS, Conference Call, Webcast

Biodesix Announces Fourth Quarter and Fiscal Year 2023 Results and Business Highlights


Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions and services company, today provided a corporate update and announced its financial and operating results for the fourth quarter and year ended December 31, 2023 (fiscal 2023).

"I am exceptionally proud of the Biodesix team and our record of accomplishments in 2023," said Scott Hutton, CEO of Biodesix. "We were focused on three goals: driving increased revenue through adoption of our Lung Diagnostic tests and Biopharmaceutical Services, implementing operational efficiencies to improve gross margins, and maintaining a strict cost discipline. I am very pleased with our significant progress on each of these goals."

Mr. Hutton continued, "The Biodesix team delivered 65% growth in Lung Diagnostic test volume for the full year 2023 and a sixth straight quarter of over 50% year-over-year growth, with the fourth quarter FY23 growing 54% over the fourth quarter of FY22. We made tremendous progress driving Lung Diagnostic test adoption in 2023, but we have just scratched the surface of a massive market opportunity addressing a critical unmet need to help improve the lives of patients with potentially cancerous lung nodules and lung cancer with our five blood-based tests. At the same time, our focus on growing Biodesix while maintaining a cost disciplined approach has resulted in a dramatic 77% gross profit margin and 55% improvement in Adjusted EBITDA in the fourth quarter FY23 compared to the fourth quarter FY22, and a clear path towards profitability. In 2024 we are committed to executing on those same three goals and we expect to deliver $65 to $68 million in total revenue."

Fourth Quarter and Full Year 2023 Financial Results

2024 Financial Outlook

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 press releases and webinars, please visit the Investors Page on biodesix.com.

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's 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's 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 Biopharma 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.

About Biodesix

Biodesix is a leading diagnostic solutions and services 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 incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLungtm strategy for lung cancer patients integrates the GeneStrat® targeted ddPCRtm 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 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. 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.

Biodesix, Inc.

Condensed Balance Sheets (unaudited)

(in thousands, except share data)

 

 

 

 

 

December 31, 2023

 

December 31, 2022

Assets

Current assets

 

 

 

 

Cash and cash equivalents

 

$

26,284

 

 

$

43,088

 

Accounts receivable, net of allowance for doubtful accounts of $65 and $118

 

 

7,679

 

 

 

5,065

 

Other current assets

 

 

5,720

 

 

 

5,181

 

Total current assets

 

 

39,683

 

 

 

53,334

 

Non?current assets

 

 

 

 

Property and equipment, net

 

 

27,867

 

 

 

5,848

 

Intangible assets, net

 

 

7,911

 

 

 

9,797

 

Operating lease right-of-use assets

 

 

1,745

 

 

 

2,973

 

Goodwill

 

 

15,031

 

 

 

15,031

 

Other long-term assets

 

 

6,859

 

 

 

5,923

 

Total non?current assets

 

 

59,413

 

 

 

39,572

 

Total assets

 

$

99,096

 

 

$

92,906

 

 

 

 

 

 

Liabilities and Stockholders' Equity

Current liabilities

 

 

 

 

Accounts payable

 

$

2,929

 

 

$

1,685

 

Accrued liabilities

 

 

7,710

 

 

 

8,218

 

Deferred revenue

 

 

324

 

 

 

962

 

Current portion of operating lease liabilities

 

 

252

 

 

 

1,543

 

Current portion of contingent consideration

 

 

21,857

 

 

 

10,341

 

Current portion of notes payable

 

 

51

 

 

 

49

 

Other current liabilities

 

 

293

 

 

 

41

 

Total current liabilities

 

 

33,416

 

 

 

22,839

 

Non?current liabilities

 

 

 

 

Long?term notes payable, net of current portion

 

 

35,225

 

 

 

25,004

 

Long-term operating lease liabilities

 

 

25,163

 

 

 

5,254

 

Contingent consideration

 

 

?

 

 

 

18,645

 

Other long-term liabilities

 

 

712

 

 

 

558

 

Total non?current liabilities

 

 

61,100

 

 

 

49,461

 

Total liabilities

 

 

94,516

 

 

 

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; 96,235,883 (2023) and 77,614,358 (2022) shares issued and outstanding

 

 

96

 

 

 

78

 

Additional paid?in capital

 

 

424,050

 

 

 

387,948

 

Accumulated deficit

 

 

(419,566

)

 

 

(367,420

)

Total stockholders' equity

 

 

4,580

 

 

 

20,606

 

Total liabilities and stockholders' equity

 

$

99,096

 

 

$

92,906

 

Biodesix, Inc.

Condensed Statements of Operations (unaudited)

(in thousands, except per share data)

 

 

Three Months Ended December 31,

 

Year Ended December 31,

 

 

2023

 

2022

 

2023

 

2022

Revenues

 

 

 

 

 

 

 

 

Lung Diagnostic

 

$

12,753

 

 

$

8,241

 

 

$

45,135

 

 

$

29,298

 

COVID-19

 

 

44

 

 

 

16

 

 

 

57

 

 

 

5,240

 

Diagnostic Testing revenue

 

 

12,797

 

 

 

8,257

 

 

 

45,192

 

 

 

34,538

 

Biopharma Services and other revenue

 

 

1,871

 

 

 

1,351

 

 

 

3,895

 

 

 

3,674

 

Total revenues

 

 

14,668

 

 

 

9,608

 

 

 

49,087

 

 

 

38,212

 

Direct costs and expenses

 

 

3,374

 

 

 

3,306

 

 

 

13,010

 

 

 

14,154

 

Research and development

 

 

1,889

 

 

 

3,565

 

 

 

9,988

 

 

 

13,102

 

Sales, marketing, general and administrative

 

 

16,251

 

 

 

16,626

 

 

 

67,387

 

 

 

61,462

 

Impairment loss on intangible assets

 

 

24

 

 

 

?

 

 

 

44

 

 

 

81

 

Total operating expenses

 

 

21,538

 

 

 

23,497

 

 

 

90,429

 

 

 

88,799

 

Loss from operations

 

 

(6,870

)

 

 

(13,889

)

 

 

(41,342

)

 

 

(50,587

)

Other (expense) income:

 

 

 

 

 

 

 

 

Interest expense

 

 

(2,329

)

 

 

(2,550

)

 

 

(9,536

)

 

 

(8,072

)

Loss on debt extinguishments, net

 

 

?

 

 

 

(3,977

)

 

 

?

 

 

 

(6,981

)

Change in fair value of warrant liability, net

 

 

58

 

 

 

84

 

 

 

(1,274

)

 

 

84

 

Other income, net

 

 

2

 

 

 

(5

)

 

 

6

 

 

 

109

 

Total other expense

 

 

(2,269

)

 

 

(6,448

)

 

 

(10,804

)

 

 

(14,860

)

 

 

 

 

 

 

 

 

 

Net loss

 

$

(9,139

)

 

$

(20,337

)

 

$

(52,146

)

 

$

(65,447

)

Net loss per share, basic and diluted

 

$

(0.10

)

 

$

(0.35

)

 

$

(0.64

)

 

$

(1.55

)

Weighted-average shares outstanding, basic and diluted

 

 

92,325

 

 

 

57,805

 

 

 

82,113

 

 

 

42,103

 

Biodesix, Inc.

Reconciliation of Net Loss to Adjusted EBITDA (unaudited)

(in thousands)

 

 

Three Months Ended December 31,

 

Year Ended December 31,

 

 

2023

 

2022

 

2023

 

2022

Net loss

 

$

(9,139

)

 

$

(20,337

)

 

$

(52,146

)

 

$

(65,447

)

Interest expense

 

 

2,329

 

 

 

2,550

 

 

 

9,536

 

 

 

8,072

 

Depreciation and amortization

 

 

977

 

 

 

898

 

 

 

3,328

 

 

 

3,597

 

Share-based compensation expense

 

 

1,081

 

 

 

2,077

 

 

 

5,373

 

 

 

5,961

 

Loss on debt extinguishments, net

 

 

?

 

 

 

3,977

 

 

 

?

 

 

 

6,981

 

COVID-19 Revenue

 

 

(44

)

 

 

(16

)

 

 

(57

)

 

 

(5,240

)

COVID-19 Direct costs and expenses

 

 

?

 

 

 

95

 

 

 

1

 

 

 

3,109

 

Change in fair value of warrant liability, net

 

 

(58

)

 

 

(84

)

 

 

1,274

 

 

 

(84

)

Other income, net

 

 

(2

)

 

 

5

 

 

 

(6

)

 

 

(109

)

Adjusted EBITDA

 

$

(4,856

)

 

$

(10,835

)

 

$

(32,697

)

 

$

(43,160

)

 


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