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Biodesix Announces Fourth Quarter and Year End 2021 Results and Highlights

March 14, 2022 Off By BusinessWire

Fourth Quarter and Fiscal Year 2021 Lung Diagnostic Revenue of $5.4 Million and $18.7 Million Increased 48% and 49% over the comparable 2020 periods, respectively

Full-Scale Launch of GeneStrat NGS™ Test in January 2022

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

BOULDER, Colo.–(BUSINESS WIRE)–$BDSX #patientsfirst—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, 2021 (fiscal 2021) and provided a corporate update.

“Despite the ongoing challenges caused by the global pandemic, the fourth quarter and fiscal 2021 were very productive,” said Scott Hutton, CEO of Biodesix. “Most notably, we successfully executed on our revenue growth strategy by doubling our direct, dedicated sales force, which significantly contributed to our core lung diagnostic revenue growth of 48% and 49% for fourth quarter and fiscal 2021, respectively. We further executed on our third quarter 2021 commitment to a commercial launch of our GeneStrat NGS™ test in January 2022. From the clinical data standpoint, we presented new data during the fourth quarter of 2021 on our NodifyXL2® test from the prospective ORACLE study, and on our VeriStrat test from the prospective INSIGHT study. This new data truly underscores the value of both products in the real-world setting and adds to the body of evidence. We continue to be excited about the trajectory of the business, despite the challenges from the ongoing pandemic, which gives us confidence heading into 2022.”

Fourth Quarter and Full Year 2021 Financial Results

  • Total revenue of $7.2 million and $54.5 million for the fourth quarter and fiscal 2021, respectively;

    • Continued lung diagnostic year over year growth despite COVID-19 variant surges;
  • Core lung diagnostic revenue of $5.4 million and $18.7 million for the fourth quarter and fiscal 2021, respectively, an increase of 48% and 49% over the respective prior year comparable periods;

    • Nodify nodule management tests and sales force expansion continue to drive lung diagnostic growth;
  • BioPharma Services revenue of $1.4 million and $5.6 million for the fourth quarter and fiscal 2021, respectively, a decrease of 29% and increase 20% over the respective prior year comparable periods;
  • COVID-19 testing revenue of $0.4 million and $30.2 million for the fourth quarter and fiscal 2021, respectively, a decrease of 98% and increase 7% over the respective comparable periods in 2020;

    • Decline over the fourth quarter of 2020 commensurate with the shift away from lab-based testing and towards point-of-care and at-home rapid antigen testing during much of the back half of 2021;
  • Fourth quarter 2021 gross margin of $4.7 million or 65% as a percentage of revenue as compared to 46% 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 $16.4 million and $64.9 million for the fourth quarter and fiscal 2021, an increase of 9% and 40% over the comparable prior year periods;

    • Doubled the size of lung focused direct and dedicated sales force in 2021;
    • Includes non-cash stock compensation expense of $1.3 million and $4.9 million during fourth quarter and fiscal 2021, respectively;
  • Net loss of $13.3 million and $43.2 million for the fourth quarter and fiscal 2021, respectively, an increase of 193% and 38% over the respective comparable periods in 2020;
  • Cash and cash equivalents of $32.7 million, inclusive of a fourth quarter 2021 equity capital issuance of $15.7 million in net proceeds and the prepayment of $20 million of the 2021 Term Loan;

    • Announced a Common Stock Purchase Agreement for up to $50 million.

2022 Financial Outlook

The Company anticipates generating between $37.5 million to $39.5 million in total revenue in 2022.

Conference call and webcast information

Management will host an investor conference call and webcast today, March 14, 2022 at 8:30 a.m. Eastern Time.

Investor dial-in (domestic):

 

833-665-0678

Investor dial-in (international):

 

929-517-0173

Conference ID:

 

7394339

Webcast:

 

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

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

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 is the first company to offer eight non-invasive 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 IQLung™ strategy for lung cancer patients integrates the GeneStrat ddPCR™ test, the GeneStrat NGS™ test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an unprecedented 36-72 hours, 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. 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. 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. 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 14, 2022. 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)

 

 

As of December 31,

 

 

2021

 

2020

 

Assets

 

 

Current assets

 

 

 

 

Cash and cash equivalents

$

32,712

 

$

62,126

 

Accounts receivable, net of allowance for doubtful accounts of $158 and $180

 

3,656

 

 

15,304

 

Other current assets

 

7,245

 

 

8,710

 

Total current assets

 

43,613

 

 

86,140

 

Non-current assets

 

 

 

 

Property and equipment, net

 

4,179

 

 

3,178

 

Intangible assets, net

 

11,617

 

 

13,260

 

Goodwill

 

15,031

 

 

15,031

 

Other long-term assets

 

1,657

 

 

3,461

 

Total non-current assets

 

32,484

 

 

34,930

 

Total assets

$

76,097

 

$

121,070

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

Current liabilities

 

 

 

 

Accounts payable

$

1,662

 

$

8,964

 

Accrued liabilities

 

7,665

 

 

7,789

 

Deferred revenue

 

1,850

 

 

3,532

 

Current portion of contingent consideration

 

17,764

 

 

—

 

Current portion of notes payable

 

19

 

 

11,840

 

Total current liabilities

 

28,960

 

 

32,125

 

Non-current liabilities

 

 

 

 

Long-term notes payable, net of current portion

 

9,993

 

 

15,926

 

Contingent consideration

 

16,028

 

 

29,932

 

Other long-term liabilities

 

1,389

 

 

1,921

 

Total non-current liabilities

 

27,410

 

 

47,779

 

Total liabilities

 

56,370

 

 

79,904

 

Commitments and contingencies

 

 

 

 

Stockholders’ equity

 

 

 

 

Preferred stock, $0.001 par value, 5,000,000 authorized;

0 (2021 and 2020) issued and outstanding

 

—

 

 

—

 

Common stock, $0.001 par value, 200,000,000 authorized;

30,789,649 (2021) and 26,561,504 (2020) shares issued and outstanding

 

31

 

 

27

 

Additional paid-in capital

 

321,669

 

 

299,953

 

Accumulated deficit

 

(301,973

)

 

(258,814

)

Total stockholders’ equity

 

19,727

 

 

41,166

 

Total liabilities and stockholders’ equity

$

76,097

 

$

121,070

 

BIODESIX, INC.

 

Condensed Statements of Operations (Unaudited)

(in thousands, except per share data)

 

 

 

Three Months Ended

December 31,

 

 

Year Ended

December 31,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

COVID-19

 

$

425

 

 

$

21,434

 

 

$

30,227

 

 

$

28,340

 

Lung diagnostic

 

 

5,440

 

 

 

3,686

 

 

 

18,710

 

 

 

12,579

 

Diagnostic testing revenue

 

 

5,865

 

 

 

25,120

 

 

 

48,937

 

 

 

40,919

 

Biopharma services

 

 

1,359

 

 

 

1,908

 

 

 

5,569

 

 

 

4,638

 

Total revenues

 

 

7,224

 

 

 

27,028

 

 

 

54,506

 

 

 

45,557

 

Direct costs and expenses

 

 

2,493

 

 

 

14,652

 

 

 

30,518

 

 

 

21,998

 

Research and development

 

 

2,852

 

 

 

3,105

 

 

 

12,789

 

 

 

10,818

 

Sales, marketing, general and administrative

 

 

13,558

 

 

 

12,064

 

 

 

50,517

 

 

 

34,857

 

Change in fair value of contingent consideration

 

 

—

 

 

 

(138

)

 

 

1,622

 

 

 

818

 

Total operating expenses

 

 

18,903

 

 

 

29,683

 

 

 

95,446

 

 

 

68,491

 

Loss from operations

 

 

(11,679

)

 

 

(2,655

)

 

 

(40,940

)

 

 

(22,934

)

Other (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(1,496

)

 

 

(705

)

 

 

(4,508

)

 

 

(7,604

)

Change in fair value of warrant liability

 

 

—

 

 

 

(1,220

)

 

 

—

 

 

 

(1,252

)

(Loss) gain on debt extinguishments, net

 

 

(97

)

 

 

—

 

 

 

2,298

 

 

 

—

 

Other (expense) income, net

 

 

(10

)

 

 

45

 

 

 

(9

)

 

 

440

 

Total other expense

 

 

(1,603

)

 

 

(1,880

)

 

 

(2,219

)

 

 

(8,416

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(13,282

)

 

$

(4,535

)

 

$

(43,159

)

 

$

(31,350

)

Net loss per share, basic and diluted

 

$

(0.49

)

 

$

(0.25

)

 

$

(1.58

)

 

$

(6.48

)

Weighted-average shares outstanding, basic and diluted

 

 

27,063

 

 

 

18,431

 

 

 

27,365

 

 

 

4,838

 

 

Contacts

Media:
Bobbi Coffin

[email protected]
(303) 892-3203

Investors:
Chris Brinzey

[email protected]
(339) 970-2843