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Biodesix Announces Third Quarter 2021 Results and Highlights

Third Quarter 2021 Lung Diagnostic Revenue of $4.5 Million Increased 51% over Third Quarter 2020

Company launches 72-hour Next Generation Sequencing (NGS) test

Conference Call and Webcast Today at 9:00 a.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 third quarter ended September 30, 2021 and provided a corporate update.

“The third quarter was highlighted by the growth of our core lung diagnostics and biopharma service product offerings, which grew year-over-year 51% and 133% respectively, despite the headwinds from the COVID-19 Delta variant, offset by expected reductions in COVID-19 testing from increased vaccination rates and adoption of non-laboratory testing,” said Scott Hutton, CEO of Biodesix. “Driven by the productivity from our growing sales force, and expanding body of clinical evidence supporting the value of our tests, we expect growth in core lung diagnostics testing to continue through the remainder of the year and into 2022. We are very pleased with the initial results from the ORACLE study recently presented at CHEST as they demonstrate that the Nodify XL2® test is performing as expected in the clinic, is changing physician decisions, and reducing unnecessary interventions on benign nodules. In addition to the CHEST and other data releases this quarter, we are pleased to announce that we have launched our 72-hour liquid NGS test ahead of schedule to a select group of physicians, with broad US launch still anticipated for the first quarter of 2022. Given the material progress made across all aspects of our base business this past quarter, we look forward to finishing strong through the end of 2021.”

Third Quarter 2021 Financial Results

For the three-month period ended September 30, 2021, as compared to the same period of 2020 (where applicable):

  • Total revenue of $6.5 million was driven by our core lung diagnostic revenue of $4.5 million, an increase of 51%;
    • Continued lung diagnostic year over year growth despite recent surges in COVID-19 Delta variant;
    • Lung diagnostic growth driven primarily from sales of Nodify nodule management tests and sales force expansion;
  • Services revenue of $1.5 million, an increase of 133%;
    • Clinical trial services showed improvement and we expect further recovery in clinical trial enrollments in remainder of 2021;
  • COVID-19 testing revenue of $0.5 million, a decline of 91%;
    • Decline commensurate with our prior commentary on the expectation of COVID-19 testing declines, excluding any potential impact of the Biden administration COVID-19 Action Plan;
  • Gross margin was $3.8 million or 58% as a percentage of revenue as compared to 40% in the quarter ended June 30, 2021, primarily as a result of the mix shift of sales to higher margin lung diagnostic and services;
  • Operating expenses (excluding direct costs and expenses) of $16.9 million, which includes an investment in the planned expansion of our sales force, increased 46%;
    • Remain on track to double size of lung focused direct and dedicated sales force in 2021;
    • Includes non-cash stock compensation expense of $1.4 million;
  • Recorded a non-cash gain of $3.1 million in the period associated with our PPP loan forgiveness from the Small Business Administration;
  • Net loss of $11.5 million, an increase of 30%; and
  • Cash and cash equivalents of $47.9 million.

For a full list of Biodesix’s press releases and webinars, please visit Biodesix.com.

Conference call and webcast information

Management will host an investor conference call and webcast today, November 15, 2021 at 9:00 a.m. Eastern Time.

Investor dial-in (domestic):

       

833-665-0678

Investor dial-in (international):

       

929-517-0173

Conference ID:

       

9692532

Webcast:

       

https://edge.media-server.com/mmc/p/n9jcchdt

An archived replay of the webcast will be available on the Company’s website for a period of 90 days.

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 is the first company to offer eight non-invasive tests for patients with diseases of the lung. Biodesix launched the SARS-CoV-2 ddPCR™ test, the Platelia SARS-CoV-2 Total Ab, and the cPass™ SARS-CoV-2 Neutralization Antibody test (cPass™ Neutralization Test Kit, GenScript, Inc,) in response to the global pandemic and virus that impacts the lung and causes COVID-19. The blood-based Biodesix Lung Reflex® strategy for lung cancer patients integrates the GeneStrat®, GeneStrat NGS™, and VeriStrat® tests to support treatment decisions with results in 72 hours, expediting time to treatment. 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. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI 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, it is 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. 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 16, 2021 or subsequent quarterly reports on Form 10-Q during 2021, 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)

 

 

 

September 30,

2021

 

 

December 31,

2020

 

Assets

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

47,913

 

 

$

62,126

 

Accounts receivable, net of allowance for doubtful accounts of $168 and $180

 

 

2,784

 

 

 

15,304

 

Other current assets

 

 

5,748

 

 

 

8,710

 

Total current assets

 

 

56,445

 

 

 

86,140

 

Non‑current assets

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

4,432

 

 

 

3,178

 

Intangible assets, net

 

 

11,992

 

 

 

13,260

 

Other long-term assets

 

 

2,097

 

 

 

3,461

 

Goodwill

 

 

15,031

 

 

 

15,031

 

Total non-current assets

 

 

33,552

 

 

 

34,930

 

Total assets

 

$

89,997

 

 

$

121,070

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,600

 

 

$

8,964

 

Accrued liabilities

 

 

6,279

 

 

 

7,789

 

Deferred revenue

 

 

1,760

 

 

 

3,532

 

Current portion of contingent consideration

 

 

13,128

 

 

 

 

Current portion of notes payable

 

 

20

 

 

 

11,840

 

Total current liabilities

 

 

22,787

 

 

 

32,125

 

Non‑current liabilities

 

 

 

 

 

 

 

 

Long‑term notes payable, net of current portion

 

 

29,975

 

 

 

15,926

 

Contingent consideration

 

 

19,722

 

 

 

29,932

 

Other long-term liabilities

 

 

1,480

 

 

 

1,921

 

Total non-current liabilities

 

 

51,177

 

 

 

47,779

 

Total liabilities

 

 

73,964

 

 

 

79,904

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders' equity

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value, 5,000,000 shares authorized; 0 (2021 and 2020) shares issued and outstanding

 

 

 

 

 

 

Common stock, $0.001 par value, 200,000,000 shares authorized; 27,020,070 (2021) and 26,561,504 (2020) shares issued and outstanding

 

 

27

 

 

 

27

 

Additional paid-in capital

 

 

304,697

 

 

 

299,953

 

Accumulated deficit

 

 

(288,691

)

 

 

(258,814

)

Total stockholders' equity

 

 

16,033

 

 

 

41,166

 

Total liabilities and stockholders' equity

 

$

89,997

 

 

$

121,070

 

Biodesix, Inc.

Condensed Statements of Operations (unaudited)

(in thousands, except per share data)

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

COVID-19

 

$

506

 

 

$

5,543

 

 

$

29,802

 

 

$

6,906

 

Lung diagnostic

 

 

4,533

 

 

 

3,009

 

 

 

13,270

 

 

 

8,892

 

Diagnostic testing revenue

 

 

5,039

 

 

 

8,552

 

 

 

43,072

 

 

 

15,798

 

Biopharma services

 

 

1,492

 

 

 

641

 

 

 

4,210

 

 

 

2,730

 

Total revenues

 

 

6,531

 

 

 

9,193

 

 

 

47,282

 

 

 

18,528

 

Direct costs and expenses

 

 

2,722

 

 

 

3,891

 

 

 

28,025

 

 

 

7,346

 

Research and development

 

 

3,293

 

 

 

2,706

 

 

 

9,937

 

 

 

7,713

 

Sales, marketing, general and administrative

 

 

13,607

 

 

 

7,879

 

 

 

36,959

 

 

 

22,793

 

Change in fair value of contingent consideration

 

 

 

 

 

957

 

 

 

1,622

 

 

 

957

 

Total operating expenses

 

 

19,622

 

 

 

15,433

 

 

 

76,543

 

 

 

38,809

 

Loss from operations

 

 

(13,091

)

 

 

(6,240

)

 

 

(29,261

)

 

 

(20,281

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(1,546

)

 

 

(2,658

)

 

 

(3,012

)

 

 

(6,899

)

Change in fair value of warrant liability

 

 

 

 

 

(24

)

 

 

 

 

 

31

 

Gain on debt extinguishment, net

 

 

3,123

 

 

 

 

 

 

2,395

 

 

 

 

Other income, net

 

 

 

 

 

77

 

 

 

1

 

 

 

332

 

Total other expense

 

 

1,577

 

 

 

(2,605

)

 

 

(616

)

 

 

(6,536

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(11,514

)

 

$

(8,845

)

 

$

(29,877

)

 

$

(26,817

)

Net loss per share, basic and diluted

 

$

(0.41

)

 

$

(31.93

)

 

$

(1.09

)

 

$

(99.69

)

Weighted-average shares outstanding, basic and diluted

 

 

28,051

 

 

 

277

 

 

 

27,467

 

 

 

269

 

 

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