Press Releases - Biodesix

Biodesix Announces First Quarter 2023 Results and Highlights

Written by Biodesix | May 11, 2023 12:00:00 PM
May 11, 2023 at 4:01 PM EDT

  First quarter 2023 Core Lung Diagnostic revenue of $8.6 million increased 86% over the comparable period in 2022;

Record number of Core Lung Diagnostic tests delivered in Company history;

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

BOULDER, Colo.--(BUSINESS WIRE)--May 11, 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 first quarter ended March 31, 2023 and provided a corporate update.

“Throughout the quarter we continued to make excellent progress and I am pleased with the start to the year. Looking at our financial performance, we reported total revenue of $9.1 million for the first quarter 2023, which represents growth of 38% compared to the first quarter of 2022, while core lung diagnostic revenue of $8.6 million grew by 86% over the comparable period,” said Scott Hutton, President and Chief Executive Officer. “Importantly, the momentum seen in the first quarter and the continued growth in our core lung diagnostic testing business clearly indicates the clinical need and growing acceptance of our on-market tests.”

First Quarter 2023 Financial Results

For the three-month period ended March 31, 2023, as compared to the same period of 2022 (where applicable):

  • Total revenue of $9.1 million, an increase of 38%, driven primarily by strong year-over-year growth in core lung diagnostics:
    • Core lung diagnostic revenue of $8.6 million reflected a year-over-year increase of 86% driven primarily by the continued adoption of Nodify Lung® nodule management tests;
    • BioPharma Services revenue of $0.4 million decreased 55% year-over-year. Timelines for existing and new agreements continue to be impacted by delayed enrollment in clinical trials; entered the second quarter of 2023 with continued strong dollars under contract;
    • COVID-19 testing revenue decreased by 99% year-over-year, and consistent with our revenue guidance. In connection with the expected expiration of the Public Health Emergency declaration, the Company will no longer provide COVID-19 diagnostic testing services commercially;
  • First quarter 2023 gross profit of $5.9 million, or 65% gross margin as compared to 51% gross margin in the comparable prior year period 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 $22.3 million, an increase of approximately $4.5 million, or 25% as compared to the first quarter 2022 (includes non-cash stock compensation expense of $2.3 million as compared to $1.3 million);
    • Approximately $3.0 million of the increase was attributable to increased sales and marketing costs to support core lung diagnostic sales growth including growth in the sales force, increased travel-related costs, and marketing programs to enhance product awareness;
    • Approximately $1.6 million was associated with increased general and administrative expenses primarily associated with non-cash stock compensation costs;
  • Net loss of $18.7 million and basic and diluted net loss per share of $0.24;
  • Cash and cash equivalents of $25.3 million as of March 31, 2023;
    • Scheduled milestone payment of $2.2 million paid in January 2023 to Integrated Diagnostics.

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 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.

 

Biodesix, Inc.

Condensed Balance Sheets (unaudited)

(in thousands, except share data)

 

 

 

 

 

 

March 31, 2023

 

 

December 31, 2022

 

Assets

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

25,275

 

 

$

43,088

 

Accounts receivable, net of allowance for doubtful accounts of $200 and $118

 

 

4,901

 

 

 

5,065

 

Other current assets

 

 

4,608

 

 

 

5,181

 

Total current assets

 

 

34,784

 

 

 

53,334

 

Non‑current assets

 

 

 

 

 

 

Property and equipment, net

 

 

13,097

 

 

 

5,848

 

Intangible assets, net

 

 

9,311

 

 

 

9,797

 

Operating lease right-of-use assets

 

 

2,194

 

 

 

2,973

 

Goodwill

 

 

15,031

 

 

 

15,031

 

Other long-term assets

 

 

6,376

 

 

 

5,923

 

Total non‑current assets

 

 

46,009

 

 

 

39,572

 

Total assets

 

$

80,793

 

 

$

92,906

 

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

1,563

 

 

$

1,685

 

Accrued liabilities

 

 

5,740

 

 

 

8,218

 

Deferred revenue

 

 

1,133

 

 

 

962

 

Current portion of operating lease liabilities

 

 

1,762

 

 

 

1,543

 

Current portion of contingent consideration

 

 

11,706

 

 

 

10,341

 

Current portion of notes payable

 

 

50

 

 

 

49

 

Other current liabilities

 

 

144

 

 

 

41

 

Total current liabilities

 

 

22,098

 

 

 

22,839

 

Non‑current liabilities

 

 

 

 

 

 

Long‑term notes payable, net of current portion

 

 

25,084

 

 

 

25,004

 

Long-term operating lease liabilities

 

 

12,039

 

 

 

5,254

 

Contingent consideration

 

 

16,374

 

 

 

18,645

 

Other long-term liabilities

 

 

648

 

 

 

558

 

Total non‑current liabilities

 

 

54,145

 

 

 

49,461

 

Total liabilities

 

 

76,243

 

 

 

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;
77,979,376 (2023) and 77,614,358 (2022) shares issued and outstanding

 

 

78

 

 

 

78

 

Additional paid‑in capital

 

 

390,594

 

 

 

387,948

 

Accumulated deficit

 

 

(386,122

)

 

 

(367,420

)

Total stockholders' equity

 

 

4,550

 

 

 

20,606

 

Total liabilities and stockholders' equity

 

$

80,793

 

 

$

92,906

 
                 

Biodesix, Inc.

Condensed Statements of Operations (unaudited)

(in thousands, except per share data)
       

 

 

Three Months Ended March 31,

 

 

 

2023

 

 

2022

 

Revenues

 

 

 

 

 

 

COVID-19

 

$

13

 

 

$

984

 

Lung diagnostic

 

 

8,632

 

 

 

4,649

 

Diagnostic testing revenue

 

 

8,645

 

 

 

5,633

 

Biopharma services

 

 

411

 

 

 

915

 

Total revenues

 

 

9,056

 

 

 

6,548

 

Direct costs and expenses

 

 

3,169

 

 

 

3,235

 

Research and development

 

 

3,251

 

 

 

3,206

 

Sales, marketing, general and administrative

 

 

18,989

 

 

 

14,487

 

Impairment loss on intangible assets

 

 

20

 

 

 

81

 

Total operating expenses

 

 

25,429

 

 

 

21,009

 

Loss from operations

 

 

(16,373

)

 

 

(14,461

)

Other (expense) income:

 

 

 

 

 

 

Interest expense

 

 

(2,391

)

 

 

(1,137

)

Change in fair value of warrant liability

 

 

61

 

 

 

—

 

Other income, net

 

 

1

 

 

 

12

 

Total other expense

 

 

(2,329

)

 

 

(1,125

)

 

 

 

 

 

 

 

Net loss

 

$

(18,702

)

 

$

(15,586

)

Net loss per share, basic and diluted

 

$

(0.24

)

 

$

(0.50

)

Weighted-average shares outstanding, basic and diluted

 

 

77,765

 

 

 

31,070

 

 

Media:
Robin Harper Cowie
robin.cowie@biodesix.com
(720) 509-8841

Investors:
Chris Brinzey
chris.brinzey@westwicke.com
(339) 970-2843

Source: Biodesix, Inc.
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