Full Press Release Details
Biodesix Announces Second Quarter 2021 Results and Highlights
Second Quarter 2021 Revenue of $11.9 Million Increased 180% and Lung Diagnostic Revenue of $4.8 Million Increased 109% over Second Quarter 2020
Announcing Acceleration of the Launch of the 72-hour liquid NGS Test to Early First Quarter 2022
Conference Call and Webcast Today at 4:30 p.m. ET
BOULDER, CO, August 10, 2021 - 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, 2021 and provided a corporate update.
"It was a productive quarter with 180% year over year growth in total revenue. Our first four blood-based tests which make up our core lung diagnostic testing, grew 109% year over year and 20% over the prior quarter," said Scott Hutton, CEO of Biodesix. "We expect growth in core lung diagnostic testing to continue through 2021 driven by the U.S.'s emergence from the pandemic, productivity from our growing salesforce, and our efforts to build on the body of evidence supporting the use of our tests. Beyond our currently marketed products, we also continue to develop our Diagnostic Cortex Artificial Intelligence (AI) platform and expand our pipeline of products capable of providing broad lung diagnostics to address patients' needs over the course of their disease. The launch of our 72-hour liquid NGS test is now projected for the first quarter of 2022 and will supplement our 36-hour VeriStrat and GeneStrat tests. With this accelerated launch and multiple studies underway for our Risk of Recurrence (ROR) and Primary Immune Response (PIR) tests as well as our ALTITUDE, BEACON, INSIGHT, and ORACLE prospective studies actively enrolling or following patients, we look forward to a productive and exciting second half of the year."
Second Quarter 2021 Financial Results
For the three-month period ended June 30, 2021, as compared to the same period of 2020 (where applicable):
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, August 10, 2021 at 4:30 p.m. Eastern Time.
An archived replay of the webcast will be available on the Company's website for a period of 90 days.
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 seven 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 and VeriStrat tests to support treatment decisions with results in 36 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.
Condensed Balance Sheets (unaudited)
| June 30, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 56,349 | $ | 62,126 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $168 and $180 | 5,281 | 15,304 | ||||||
| Other current assets | 6,820 | 8,710 | ||||||
| Total current assets | 68,450 | 86,140 | ||||||
| Non current assets | ||||||||
| Property and equipment, net | 3,378 | 3,178 | ||||||
| Intangible assets, net | 12,400 | 13,260 | ||||||
| Other long-term assets | 2,545 | 3,461 | ||||||
| Goodwill | 15,031 | 15,031 | ||||||
| Total non current assets | 33,354 | 34,930 | ||||||
| Total assets | $ | 101,804 | $ | 121,070 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,160 | $ | 8,964 | ||||
| Accrued liabilities | 6,198 | 7,789 | ||||||
| Deferred revenue | 2,182 | 3,532 | ||||||
| Current portion of contingent consideration | 8,626 | - | ||||||
| Current portion of notes payable | 3,106 | 11,840 | ||||||
| Total current liabilities | 21,272 | 32,125 | ||||||
| Non current liabilities | ||||||||
| Long term notes payable, net of current portion | 29,955 | 15,926 | ||||||
| Contingent consideration | 23,217 | 29,932 | ||||||
| Other long-term liabilities | 1,587 | 1,921 | ||||||
| Total non current liabilities | 54,759 | 47,779 | ||||||
| Total liabilities | 76,031 | 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; 26,948,879 (2021) and 26,561,504 (2020) shares issued and outstanding | 27 | 27 | ||||||
| Additional paid in capital | 302,923 | 299,953 | ||||||
| Accumulated deficit | (277,177 | ) | (258,814 | ) | ||||
| Total stockholders' equity | 25,773 | 41,166 | ||||||
| Total liabilities and stockholders' equity | $ | 101,804 | $ | 121,070 |
Condensed Statements of Operations (unaudited)
(in thousands, except share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues | ||||||||||||||||
| COVID-19 | $ | 6,064 | $ | 1,363 | $ | 29,296 | $ | 1,363 | ||||||||
| Lung diagnostic | 4,774 | 2,280 | 8,737 | 5,883 | ||||||||||||
| Diagnostic testing revenue | 10,838 | 3,643 | 38,033 | 7,246 | ||||||||||||
| Biopharma services | 1,047 | 596 | 2,718 | 2,089 | ||||||||||||
| Total revenues | 11,885 | 4,239 | 40,751 | 9,335 | ||||||||||||
| Direct costs and expenses | 7,085 | 1,874 | 25,303 | 3,455 | ||||||||||||
| Research and development | 3,323 | 2,107 | 6,644 | 5,007 | ||||||||||||
| Sales, marketing, general and administrative | 11,425 | 6,834 | 23,352 | 14,914 | ||||||||||||
| Change in fair value of contingent consideration | 639 | (957 | ) | 1,622 | - | |||||||||||
| Total operating expenses | 22,472 | 9,858 | 56,921 | 23,376 | ||||||||||||
| Loss from operations | (10,587 | ) | (5,619 | ) | (16,170 | ) | (14,041 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest expense | (815 | ) | (2,784 | ) | (1,466 | ) | (4,241 | ) | ||||||||
| Change in fair value of warrant liability | - | 4 | - | 55 | ||||||||||||
| Loss on debt extinguishment | - | - | (728 | ) | - | |||||||||||
| Other income, net | - | 133 | 1 | 256 | ||||||||||||
| Total other expense | (815 | ) | (2,647 | ) | (2,193 | ) | (3,930 | ) | ||||||||
| Net loss | $ | (11,402 | ) | $ | (8,266 | ) | $ | (18,363 | ) | $ | (17,971 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.41 | ) | $ | (30.06 | ) | $ | (0.68 | ) | $ | (68.85 | ) | ||||
| Weighted-average shares outstanding, basic and diluted | 27,730 | 275 | 27,020 | 261 |