8-K
BIODESIX INC (BDSX)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)of the Securities Exchange Act of 1934
March 14, 2022Date of Report (Date of earliest event reported)
Biodesix, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-39659 | 20-3986492 |
|---|---|---|
| (State or other jurisdiction<br>of incorporation) | (Commission<br>File Number) | (I.R.S. Employer<br>Identification No.) |
| 2970 Wilderness Place, Suite 100<br><br>Boulder, Colorado<br><br>(Address of Principal Executive Office) | 80301<br><br>(Zip Code) | |
| --- | --- |
Registrant’s telephone number, including area code: (303)
417-0500
Not Applicable (Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value of $0.001 per share | BDSX | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On March 14, 2022, Biodesix, Inc. (the Company) issued a press release announcing the financial and operating results of the Company for the fourth quarter and year ended December 31, 2021. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
The information contained in Item 2.02 to this Current Report on Form 8-K and Exhibit 99.1 attached hereto is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such document or filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits:
| No. | Exhibit |
|---|---|
| 99.1 | Press Release issued by Biodesix, Inc. dated March 14, 2022 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: March 14, 2022 | BIODESIX, INC. | |
|---|---|---|
| By: | /s/ Robin Harper Cowie | |
| Name: | Robin Harper Cowie | |
| Title: | Chief Financial Officer |
EX-99.1
Exhibit 99.1
Biodesix Announces Fourth Quarter and Year End 2021 Results and Highlights
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, CO, March 14, 2022 – 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/n9jcchdt |
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.
Contacts:
Media:
Bobbi Coffin
bobbi.coffin@biodesix.com
(303) 892-3203
Investors:
Chris Brinzey
chris.brinzey@westwicke.com
(339) 970-2843
BIODESIX, INC.
Condensed Balance Sheets (Unaudited)
(in thousands, except share data)
| 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 |
All values are in US Dollars.
BIODESIX, INC.
Condensed Statements of Operations (Unaudited)
(in thousands, except per share data)
| Three Months Ended December 31, | Year Ended<br>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 |