Biodesix Announces Second Quarter 2024 Results and Highlights
Q2 2024 revenue grew 51% over Q2 2023 to
Q2 2024 gross profit margin of 78.4%, a 5.7% improvement from Q2 2023;
Raises full-year 2024 revenue guidance to
Q2 24 Net loss, including certain non-cash items, and Adjusted EBITDA improved by 19% and 38% over Q2 2023;
Conference Call and Webcast Today at
“The second quarter marks sustained excellence in our execution, resulting in outstanding revenue growth coupled with consistently strong gross margins, and continued improvement on our path to profitability,” said
“It is important to note that our industry-leading commercial engine is continuing to drive market adoption of our five on-market lung diagnostic tests. These tests are transforming the diagnosis and treatment of patients with lung cancer. We have an incredible team of professionals dedicated and driven to making a difference in patients’ lives. I continue to be thankful for the team and our intentional focus on workplace culture so that we attract and retain the best talent.”
Second Quarter Ended
- Named to Inc. Magazine’s 2024 Best Workplaces list. The ranking is based on a comprehensive, data- driven measurement process through anonymous employee surveys to identify which American companies have excelled in creating high-engagement workplaces and excellent company cultures.
- Grew Lung Diagnostic test volume to 13,900, a 42% improvement over the second quarter of 2023 and 17% over the first quarter of 2024.
- Quarterly gross profit margin of 78.4% versus 72.7% for the second quarter of 2023 and 78.6% for the first quarter of 2024.
-
Presented compelling new data1 at the
American Thoracic Society (ATS) Conference ,May 2024 , that highlighted the Nodify XL2 test and its ability to identify benign nodules in patients with emphysema, demonstrating further test utility in patients with common comorbidities. -
Peer-reviewed data was published in June in the Annals of Oncology2 that highlight the role of
Biodesix diagnostic services in monitoring efficacy of new therapeutic regimens.
Second Quarter Ended
-
Total revenue of
$17.9 million , an increase of 51% over the second quarter 2023. This results in now eight consecutive quarters of over 40% revenue growth and is driven by strong year-over-year growth in both lines of business:-
Lung Diagnostic revenue of
$16.5 million reflected a year-over-year increase of 44% driven primarily by the continued adoption of Nodify Lung® nodule risk assessment tests; -
Biopharmaceutical Services of
$1.4 million increased 228% year-over-year, a result of both delivering against the Company’s book of contracted business and securing new agreements;
-
Lung Diagnostic revenue of
-
Second quarter 2024 gross profit of
$14.0 million , or 78.4% gross margin compared to 72.7% 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 increased process efficiencies in the Company’s Biopharmaceutical Services business; -
Operating expenses (excluding direct costs and expenses) of
$22.3 million , an increase of approximately$2.7 million , or 14% as compared to the second quarter 2023 (includes$2.7 million of non-cash stock compensation expense, depreciation and amortization, and asset impairment as compared to$1.9 million ). This increase is primarily attributable to an increase in sales and marketing costs to support lung diagnostic sales growth to enhance product awareness and drive adoption, an increase in depreciation expense related to the leasehold improvements in the Company’s newLouisville, Colorado offices and laboratory, partially offset by a decrease in research and development and general and administrative costs; -
Net loss of
$10.8 million , an improvement of approximately$2.5 million , or 19% as compared to the same period of 2023. Net loss included$0.6 million of one-time cash and non-cash Other Expenses, net primarily related to our probability of not utilizing the Lincoln Park Capital Equity Line of Credit prior to expiration and costs associated with debt-extinguishment; -
Adjusted EBITDA was a loss of
$5.6 million , an improvement of$3.5 million , or 38% over the second quarter of 2023 and fifth straight quarter of year-over-year improvement in Adjusted EBITDA; -
Cash and cash equivalents of
$42.2 million as ofJune 30, 2024 , an increase of$30.7 million fromMarch 31, 2024 ;-
Cash and cash equivalents as of
June 30, 2024 , includes$55.0 million in gross proceeds raised from an oversubscribed and upsized offering of common stock and concurrent private placement completed onApril 5, 2024 . -
Includes the second quarter scheduled milestone payment of
$5.3 million and pre-payment of the third quarter$8.4 million scheduled milestone payment paid inApril 2024 for the acquisition ofIntegrated Diagnostics in 2018. The pre-payment of the third quarter milestone resulted in cash savings from interest that was eliminated by the pre-payment. The Company has one final payment of$6.1 million remaining, which does not accrue interest and is expected to be paid at the end of the third quarter 2024.
-
Cash and cash equivalents as of
2024 Financial Outlook
The Company is increasing its 2024 revenue forecast and now expects to generate between
Conference call and webcast information
Listeners can register for the webcast via this link. Analysts who wish 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 relations page on the website approximately two hours after the call’s conclusion. Participants are advised to join 15 minutes prior to the start time.
For a full list of
About
The
Footnotes:
1. Performance comparison of blood-based integrated classifier for lung nodule risk stratification in patients with versus without emphysema.
2. “Amivantamab plus lazertinib versus osimertinib in first-line EGFR-mutant advanced non-small-cell lung cancer with biomarkers of high-risk disease: a secondary analysis from MARIPOSA,” Annals of Oncology,
Use of Non-GAAP Financial Measure
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 Biopharmaceutical 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.
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.
Condensed Balance Sheets (unaudited) (in thousands, except share data) |
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Assets |
||||||||
Current assets |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
42,219 |
|
|
$ |
26,284 |
|
Accounts receivable, net of allowance for credit losses of |
|
|
10,128 |
|
|
|
7,679 |
|
Other current assets |
|
|
5,232 |
|
|
|
5,720 |
|
Total current assets |
|
|
57,579 |
|
|
|
39,683 |
|
Non-current assets |
|
|
|
|
||||
Property and equipment, net |
|
|
28,019 |
|
|
|
27,867 |
|
Intangible assets, net |
|
|
6,884 |
|
|
|
7,911 |
|
Operating lease right-of-use assets |
|
|
1,767 |
|
|
|
1,745 |
|
|
|
|
15,031 |
|
|
|
15,031 |
|
Other long-term assets |
|
|
6,561 |
|
|
|
6,859 |
|
Total non-current assets |
|
|
58,262 |
|
|
|
59,413 |
|
Total assets |
|
$ |
115,841 |
|
|
$ |
99,096 |
|
|
|
|
|
|
||||
Liabilities and Stockholders' Equity |
||||||||
Current liabilities |
|
|
|
|
||||
Accounts payable |
|
$ |
2,220 |
|
|
$ |
2,929 |
|
Accrued liabilities |
|
|
8,324 |
|
|
|
7,710 |
|
Deferred revenue |
|
|
447 |
|
|
|
324 |
|
Current portion of operating lease liabilities |
|
|
300 |
|
|
|
252 |
|
Current portion of contingent consideration |
|
|
5,838 |
|
|
|
21,857 |
|
Current portion of notes payable |
|
|
37 |
|
|
|
51 |
|
Other current liabilities |
|
|
386 |
|
|
|
293 |
|
Total current liabilities |
|
|
17,552 |
|
|
|
33,416 |
|
Non-current liabilities |
|
|
|
|
||||
Long-term notes payable, net of current portion |
|
|
35,807 |
|
|
|
35,225 |
|
Long-term operating lease liabilities |
|
|
25,478 |
|
|
|
25,163 |
|
Other long-term liabilities |
|
|
744 |
|
|
|
712 |
|
Total non-current liabilities |
|
|
62,029 |
|
|
|
61,100 |
|
Total liabilities |
|
|
79,581 |
|
|
|
94,516 |
|
Commitments and contingencies |
|
|
|
|
||||
Stockholders' equity |
|
|
|
|
||||
Preferred stock, |
|
|
— |
|
|
|
— |
|
Common stock, |
|
|
145 |
|
|
|
96 |
|
Additional paid-in capital |
|
|
480,103 |
|
|
|
424,050 |
|
Accumulated deficit |
|
|
(443,988 |
) |
|
|
(419,566 |
) |
Total stockholders' equity |
|
|
36,260 |
|
|
|
4,580 |
|
Total liabilities and stockholders' equity |
|
$ |
115,841 |
|
|
$ |
99,096 |
|
Condensed Statements of Operations (unaudited) (in thousands, except per share data) |
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Three Months Ended
|
|
|
Six Months Ended
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
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Revenues |
|
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|
|
|
|
|
|
||||||||
Diagnostic Testing revenue |
|
$ |
16,539 |
|
|
$ |
11,449 |
|
|
$ |
30,335 |
|
|
$ |
20,094 |
|
Biopharmaceutical Services and other revenue |
|
|
1,386 |
|
|
|
423 |
|
|
|
2,408 |
|
|
|
834 |
|
Total revenues |
|
|
17,925 |
|
|
|
11,872 |
|
|
|
32,743 |
|
|
|
20,928 |
|
Direct costs and expenses |
|
|
3,877 |
|
|
|
3,238 |
|
|
|
7,052 |
|
|
|
6,407 |
|
Research and development |
|
|
2,558 |
|
|
|
2,910 |
|
|
|
4,598 |
|
|
|
6,161 |
|
Sales, marketing, general and administrative |
|
|
19,660 |
|
|
|
16,651 |
|
|
|
40,216 |
|
|
|
35,640 |
|
Impairment loss on intangible assets |
|
|
67 |
|
|
|
— |
|
|
|
135 |
|
|
|
20 |
|
Total operating expenses |
|
|
26,162 |
|
|
|
22,799 |
|
|
|
52,001 |
|
|
|
48,228 |
|
Loss from operations |
|
|
(8,237 |
) |
|
|
(10,927 |
) |
|
|
(19,258 |
) |
|
|
(27,300 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
|
||||||||
Interest expense |
|
|
(1,936 |
) |
|
|
(2,430 |
) |
|
|
(4,465 |
) |
|
|
(4,821 |
) |
Loss on extinguishment of liabilities |
|
|
(248 |
) |
|
|
— |
|
|
|
(248 |
) |
|
|
— |
|
Change in fair value of warrant liability, net |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
61 |
|
Other (expense) income, net |
|
|
(387 |
) |
|
|
1 |
|
|
|
(451 |
) |
|
|
2 |
|
Total other expense |
|
|
(2,571 |
) |
|
|
(2,429 |
) |
|
|
(5,164 |
) |
|
|
(4,758 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(10,808 |
) |
|
$ |
(13,356 |
) |
|
$ |
(24,422 |
) |
|
$ |
(32,058 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.08 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.41 |
) |
Weighted-average shares outstanding, basic and diluted |
|
|
127,168 |
|
|
|
78,506 |
|
|
|
112,167 |
|
|
|
78,138 |
|
Reconciliation of Net Loss to Adjusted EBITDA (unaudited) (in thousands) |
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|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Net loss |
|
$ |
(10,808 |
) |
|
$ |
(13,356 |
) |
|
$ |
(24,422 |
) |
|
$ |
(32,058 |
) |
Interest expense |
|
|
1,936 |
|
|
|
2,430 |
|
|
|
4,465 |
|
|
|
4,821 |
|
Depreciation and amortization |
|
|
1,412 |
|
|
|
784 |
|
|
|
2,832 |
|
|
|
1,569 |
|
Share-based compensation expense |
|
|
1,218 |
|
|
|
1,057 |
|
|
|
3,858 |
|
|
|
3,338 |
|
Loss on extinguishment of liabilities |
|
|
248 |
|
|
|
— |
|
|
|
248 |
|
|
|
— |
|
COVID-19 Revenue |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(13 |
) |
COVID-19 Direct costs and expenses |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1 |
|
Change in fair value of warrant liability, net |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(61 |
) |
Other expense (income), net |
|
|
387 |
|
|
|
(1 |
) |
|
|
451 |
|
|
|
(2 |
) |
Adjusted EBITDA |
|
$ |
(5,607 |
) |
|
$ |
(9,086 |
) |
|
$ |
(12,568 |
) |
|
$ |
(22,405 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240807088406/en/
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