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Biodesix Announces Second Quarter 2023 Results and Highlights

Second quarter 2023 Core Lung Diagnostic revenue of $11.4 million increased 58% over the comparable period in 2022 and 33% over the first quarter of 2023;

Second quarter 2023 gross profit margin of 73% versus 64% for the second quarter 2022 and 65% for the first quarter 2023;

Revenue continues to track to 2023 full year guidance of $52-55 million;

Approximately $27.5 million in common shares sold under a private placement from the Company’s largest investors, Board of Directors members, and Executive Leadership team;

Multiple publications and data presentations on the clinical utility and health economic benefits of Core Lung Diagnostics tests;

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

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 second quarter ended June 30, 2023 and provided a corporate update

“I am very pleased to announce another record-setting quarter from our core lung diagnostics,” said Scott Hutton, President and Chief Executive Officer. “In addition to continued sales growth, we had a number of important publications this past quarter that highlighted the benefits to patient care of our lung diagnostic tests in a real-world, clinical setting.

We are also happy to announce the successful completion of a private placement that included some of our largest shareholders and management. All board members, all Section 16 officers, and additional members of the Biodesix leadership team participated in the round raising $27.5 million in equity funding to further support our growth. We also maintained strong cost discipline, with sustainable and improving gross margins to 73% from 65%, and reducing our Operating Expense excluding direct costs and expenses by $2.7 million, all versus first quarter 2023. We continue to focus on projects and initiatives that drive near term-revenue growth, while reducing expenses and cash burn. Overall, the progress and positive trends in our core lung diagnostics tests in the first half of the year solidifies our confidence in reaffirming our 2023 revenue guidance and making progress on our path to profitability.”

Business Highlights

Biodesix continues to publish new data supporting the value and utility of their lung diagnostics portfolio. The Company was pleased to announce the following accomplishments:

  • Published the achievement of the primary endpoint of the prospective ORACLE clinical utility study, demonstrating that use of the Nodify XL2 test resulted in a 74% decrease in unnecessary invasive procedures on patients with benign lung nodules compared to the control group;
  • Researchers from Beth Israel Deaconess, Tulane University, and Einstein Medical Center published an independent, multi-center study demonstrating that use of the Nodify XL2 test resulted in a 73% reduction in the number of invasive procedures compared to the control arm;
  • Presented new health economics data on the Nodify XL2®, Nodify CDT®, and VeriStrat® tests at the American Society of Clinical Oncology (ASCO) and the International Society for Pharmaceutical and Outcomes Research (ISPOR). These data indicate savings to the US healthcare system with use of the tests;
  • Completed enrollment of 5,000 patients with non-small cell lung cancer (NSCLC) in the large multi-center observational registry study INSIGHT. The study was designed to further validate the utility of the VeriStrat test;
  • Announced that CMS has designated the Nodify CDT Test as an Advanced Diagnostic Laboratory Test (ADLT) effective June 30, 2023. ADLT status is reserved for innovative tests with Medicare coverage that provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests.

Second Quarter 2023 Financial Results

For the three-month period ended June 30, 2023, as compared to the same period of 2022 (where applicable):

  • Total revenue of $11.9 million, an increase of 8% including COVID testing revenue in second quarter 2022, driven primarily by strong year-over-year growth in core lung diagnostics, and a 48% year-over-year increase excluding COVID testing revenues from the prior year comparison.
    • Core lung diagnostic revenue of $11.4 million reflected a year-over-year increase of 58% driven primarily by the continued adoption of Nodify Lung® nodule management tests;
    • BioPharma Services revenue of $0.4 million decreased 43% year-over-year. Timelines for existing and new agreements continue to be impacted by delayed enrollment in clinical trials; entered the third quarter of 2023 with continued strong dollars under contract;
    • COVID-19 testing revenue decreased by 100% year-over-year, the Company no longer provides COVID-19 diagnostic testing services commercially;
  • Second quarter 2023 gross profit of $8.6 million, or 73% gross margin as compared to 64% gross margin in the comparable prior year period primarily driven by growth in Lung Diagnostic Testing and optimization of testing workflows that resulted in improvements in costs per test, and the commercial discontinuation of our lower-margin COVID-19 diagnostic testing;
  • Operating expenses (excluding direct costs and expenses) of $19.6 million, an increase of approximately $1.0 million, or 5% as compared to the second quarter 2022 (includes non-cash stock compensation expense of $1.1 million as compared to $1.4 million). This increase is primarily attributable to increased sales and marketing costs to support core lung diagnostic sales growth including increased travel-related costs and marketing programs to enhance product awareness as we actively participate in an increasing number of peer-to-peer physician educational events;
  • Net loss of $13.4 million, a decrease of approximately $2.5 million, or 16%;
  • Cash and cash equivalents of $17.4 million as of June 30, 2023, a decrease of $7.9 million from March 31, 2023. This represented an improvement of approximately 56% in cash utilization versus the cash utilized in the first quarter 2023;
    • Scheduled milestone payment of $2.3 million paid in April 2023 to Integrated Diagnostics;
    • Subsequent to quarter end, raised $27.5 million in gross equity proceeds from a private placement to be used for commercial expansion of sales, research and development, and for general corporate purposes.

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 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 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)

 

 

 

 

 

 

June 30, 2023

 

 

December 31, 2022

 

Assets

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

17,409

 

 

$

43,088

 

Accounts receivable, net of allowance for doubtful accounts of $150 and $118

 

 

4,119

 

 

 

5,065

 

Other current assets

 

 

3,717

 

 

 

5,181

 

Total current assets

 

 

25,245

 

 

 

53,334

 

Non‑current assets

 

 

 

 

 

 

Property and equipment, net

 

 

18,996

 

 

 

5,848

 

Intangible assets, net

 

 

8,871

 

 

 

9,797

 

Operating lease right-of-use assets

 

 

2,492

 

 

 

2,973

 

Goodwill

 

 

15,031

 

 

 

15,031

 

Other long-term assets

 

 

6,988

 

 

 

5,923

 

Total non‑current assets

 

 

52,378

 

 

 

39,572

 

Total assets

 

$

77,623

 

 

$

92,906

 

 

 

 

 

 

 

 

Liabilities and Stockholders' (Deficit) Equity

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

3,501

 

 

$

1,685

 

Accrued liabilities

 

 

6,981

 

 

��

8,218

 

Deferred revenue

 

 

1,069

 

 

 

962

 

Current portion of operating lease liabilities

 

 

1,504

 

 

 

1,543

 

Current portion of contingent consideration

 

 

14,561

 

 

 

10,341

 

Current portion of notes payable

 

 

50

 

 

 

49

 

Other current liabilities

 

 

285

 

 

 

41

 

Total current liabilities

 

 

27,951

 

 

 

22,839

 

Non‑current liabilities

 

 

 

 

 

 

Long‑term notes payable, net of current portion

 

 

24,658

 

 

 

25,004

 

Long-term operating lease liabilities

 

 

18,808

 

 

 

5,254

 

Contingent consideration

 

 

12,303

 

 

 

18,645

 

Other long-term liabilities

 

 

896

 

 

 

558

 

Total non‑current liabilities

 

 

56,665

 

 

 

49,461

 

Total liabilities

 

 

84,616

 

 

 

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;

78,610,663 (2023) and 77,614,358 (2022) shares issued and outstanding

 

 

79

 

 

 

78

 

Additional paid‑in capital

 

 

392,406

 

 

 

387,948

 

Accumulated deficit

 

 

(399,478

)

 

 

(367,420

)

Total stockholders' (deficit) equity

 

 

(6,993

)

 

 

20,606

 

Total liabilities and stockholders' (deficit) equity

 

$

77,623

 

 

$

92,906

 

 

Biodesix, Inc.

Condensed Statements of Operations (unaudited)

(in thousands, except per share data)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

Lung diagnostic

 

$

11,449

 

 

$

7,252

 

 

$

20,081

 

 

$

11,901

 

COVID-19

 

 

 

 

 

2,954

 

 

 

13

 

 

 

3,938

 

Diagnostic testing revenue

 

 

11,449

 

 

 

10,206

 

 

 

20,094

 

 

 

15,839

 

Biopharma services

 

 

423

 

 

 

744

 

 

 

834

 

 

 

1,659

 

Total revenues

 

 

11,872

 

 

 

10,950

 

 

 

20,928

 

 

 

17,498

 

Direct costs and expenses

 

 

3,238

 

 

 

3,980

 

 

 

6,407

 

 

 

7,215

 

Research and development

 

 

2,910

 

 

 

3,361

 

 

 

6,161

 

 

 

6,567

 

Sales, marketing, general and administrative

 

 

16,651

 

 

 

15,235

 

 

 

35,640

 

 

 

29,722

 

Impairment loss on intangible assets

 

 

 

 

 

 

 

 

20

 

 

 

81

 

Total operating expenses

 

 

22,799

 

 

 

22,576

 

 

 

48,228

 

 

 

43,585

 

Loss from operations

 

 

(10,927

)

 

 

(11,626

)

 

 

(27,300

)

 

 

(26,087

)

Other (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(2,430

)

 

 

(1,346

)

 

 

(4,821

)

 

 

(2,483

)

Loss on debt extinguishments, net

 

 

 

 

 

(2,952

)

 

 

 

 

 

(2,952

)

Change in fair value of warrant liability

 

 

 

 

 

 

 

 

61

 

 

 

 

Other income, net

 

 

1

 

 

 

100

 

 

 

2

 

 

 

112

 

Total other expense

 

 

(2,429

)

 

 

(4,198

)

 

 

(4,758

)

 

 

(5,323

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(13,356

)

 

$

(15,824

)

 

$

(32,058

)

 

$

(31,410

)

Net loss per share, basic and diluted

 

$

(0.17

)

 

$

(0.40

)

 

$

(0.41

)

 

$

(0.89

)

Weighted-average shares outstanding, basic and diluted

 

 

78,506

 

 

 

39,239

 

 

 

78,138

 

 

 

35,177

 

 

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