4
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
or
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
(Address of principal executive offices) (Zip Code)
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading symbol(s) |
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Name of each exchange on which registered |
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(NASDAQ Capital Market) |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.): Yes ☐ No
As of May 4, 2023, the registrant had
BIOLASE, INC.
INDEX
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PART I. |
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2 |
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Item 1. |
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2 |
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Consolidated Balance Sheets as of March 31, 2023 and December 31, 2022 |
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2 |
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3 |
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4 |
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Consolidated Statements of Cash Flows for the three months ended March 31, 2023 and March 31, 2022 |
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6 |
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7 |
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Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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21 |
Item 3. |
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29 |
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Item 4. |
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29 |
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PART II |
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30 |
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Item 1. |
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30 |
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Item 1A. |
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30 |
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Item 6. |
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31 |
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33 |
1
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
BIOLASE, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited, in thousands, except per share data)
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March 31, |
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December 31, |
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2023 |
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2022 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Accounts receivable, less allowance of $ |
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Inventory |
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Prepaid expenses and other current assets |
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Total current assets |
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Property, plant, and equipment, net |
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Goodwill |
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Right of use asset |
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Other assets |
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Total assets |
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$ |
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$ |
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LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued liabilities |
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Deferred revenue, current portion |
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Current portion of term loans, net of discount |
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Total current liabilities |
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Deferred revenue |
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Warranty accrual |
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Non current term loans, net of discount |
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Non current operating lease liability |
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Other liabilities |
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Total liabilities |
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Stockholders' equity: |
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Common stock, par value $ |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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( |
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( |
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Accumulated deficit |
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( |
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( |
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Total stockholders' equity |
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Total liabilities, redeemable preferred stock and stockholders' equity |
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$ |
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$ |
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See accompanying notes to unaudited consolidated financial statements.
2
BIOLASE, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited, in thousands, except per share data)
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Three Months Ended |
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March 31, |
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2023 |
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2022 |
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Net revenue |
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$ |
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$ |
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Cost of revenue |
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Gross profit |
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Operating expenses: |
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Sales and marketing |
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General and administrative |
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Engineering and development |
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Total operating expenses |
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Loss from operations |
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( | ) |
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( | ) |
Gain (loss) on foreign currency transactions |
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( |
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Interest expense, net |
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( |
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( |
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Non-operating loss, net |
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( |
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( |
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Loss before income tax provision |
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( |
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( |
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Income tax provision |
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( |
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( |
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Net loss |
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( |
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( |
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Other comprehensive loss items: |
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Foreign currency translation adjustments |
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( |
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Comprehensive loss |
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$ |
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$ |
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Net loss |
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$ |
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$ |
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Deemed dividend on convertible preferred stock |
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( |
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Net loss attributable to common stockholders |
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$ |
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$ |
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Net loss per share attributable to common stockholders: |
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Basic and Diluted |
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$ |
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$ |
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Shares used in the calculation of net loss per share: |
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Basic and Diluted |
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See accompanying notes to unaudited consolidated financial statements.
3
BIOLASE, INC.
CONSOLIDATED STATEMENTS OF REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY
(Unaudited, in thousands)
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Stockholders' Equity |
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Common Stock |
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Additional |
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Accumulated |
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Accumulated |
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Total |
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Shares |
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Amount |
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Amount |
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Loss |
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Deficit |
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Equity |
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Balance, December 31, 2022 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Sale of common stock and pre-funded warrants, net of fees |
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— |
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— |
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Issuance of stock from |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Exercise of common stock warrants |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
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( |
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Foreign currency |
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— |
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— |
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— |
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— |
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Balance, March 31, 2023 |
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$ |
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$ |
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$ |
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$ |
( | ) |
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$ |
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See accompanying notes to unaudited consolidated financial statements.
4
BIOLASE, INC.
CONSOLIDATED STATEMENTS OF REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY
(Unaudited, in thousands)
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Mezzanine |
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Stockholders' Equity |
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Series G |
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Common Stock |
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Additional |
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Series F |
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Accumulated |
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Accumulated |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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Amount |
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Shares |
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Amount |
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Loss |
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Deficit |
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Equity |
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Balance, December 31, 2021 |
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— |
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$ |
— |
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$ |
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$ |
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— |
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$ |
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$ |
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$ |
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$ |
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Issuance of Series G Redeemable |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Conversion of Series F Convertible Preferred Stock |
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— |
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— |
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— |
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— |
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— |
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— |
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Deemed dividend on Series F Convertible Preferred Stock |
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— |
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— |
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— |
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— |
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( |
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— |
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— |
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— |
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— |
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Issuance of stock from RSUs, net |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Foreign currency translation adjustment |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
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— |
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( |
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Balance, March 31, 2022 |
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$ |
— |
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$ |
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$ |
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— |
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$ |
— |
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$ |
( |
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$ |
( |
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$ |
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See accompanying notes to unaudited consolidated financial statements.
5
BIOLASE, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in thousands)
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Three Months Ended |
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March 31, |
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2023 |
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2022 |
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Cash Flows from Operating Activities: |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities: |
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Depreciation and amortization |
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Provision (recoveries) for bad debts |
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Provision for sales returns |
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Amortization of debt issuance costs |
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Stock-based compensation |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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( |
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Inventory |
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( |
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( |
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Prepaid expenses and other current assets |
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( |
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Accounts payable and accrued liabilities |
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( |
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Deferred revenue |
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Net cash and cash equivalents used in operating activities |
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( |
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( |
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Cash Flows from Investing Activities: |
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Purchases of property, plant, and equipment |
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( |
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Net cash and cash equivalents used in investing activities |
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( |
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Cash Flows from Financing Activities: |
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Proceeds from the sale of common stock and pre-funded warrants |
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Proceeds from the exercise of common stock warrants |
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Net cash and cash equivalents provided by financing activities |
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Effect of exchange rate changes |
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( |
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(Decrease) increase in cash, cash equivalents and restricted cash |
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( |
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Cash, cash equivalents and restricted cash, beginning of period |
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Cash, cash equivalents and restricted cash, end of period |
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$ |
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$ |
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Supplemental cash flow disclosure: |
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Cash paid for interest |
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$ |
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$ |
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Cash received for interest |
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$ |
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$ |
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Cash paid (received) for income taxes |
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$ |
( |
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$ |
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Cash paid for operating leases |
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$ |
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$ |
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Non-cash right-of-use assets obtained in exchange for lease obligation |
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$ |
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$ |
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Deemed dividend on preferred stock |
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$ |
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$ |
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See accompanying notes to unaudited consolidated financial statements.
6
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 1—DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
The Company
BIOLASE, Inc. (“BIOLASE” and, together with its consolidated subsidiaries, the “Company”) is a leading provider of advanced laser systems for the dental industry. The Company develops, manufactures, markets, and sells laser systems that provide significant benefits for dental practitioners and their patients. The Company’s proprietary systems allow dentists, periodontists, endodontists, pediatric dentists, oral surgeons, and other dental specialists to perform a broad range of minimally invasive dental procedures, including cosmetic, restorative, and complex surgical applications. The Company’s laser systems are designed to provide clinically superior results for many types of dental procedures compared to those achieved with drills, scalpels, and other conventional instruments. Potential patient benefits include less pain, fewer shots, faster healing, decreased fear and anxiety, and fewer appointments. Potential practitioner benefits include improved patient care and the ability to perform a higher volume and wider variety of procedures and generate more patient referrals.
Basis of Presentation
The unaudited consolidated financial statements include the accounts of BIOLASE and its wholly-owned subsidiaries and have been prepared on a basis consistent with the December 31, 2022 audited consolidated financial statements and include all material adjustments, consisting of normal recurring adjustments and the elimination of all material intercompany transactions and balances, necessary to fairly present the information set forth therein. The unaudited consolidated financial statements do not include all the footnotes, presentations, and disclosures normally required by accounting principles generally accepted in the United States of America (“GAAP”) for complete consolidated financial statements.
The unaudited consolidated results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results for the full year. The accompanying unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the fiscal year ended December 31, 2022, included in BIOLASE’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the Securities and Exchange Commission (the “SEC”) on March 28, 2023 (the “2022 Form 10-K”).
Liquidity and Management’s Plans
The Company incurred losses from operations and used cash in operating activities for the three months ended March 31, 2023 and for the years ended December 31, 2022, 2021, and 2020. The Company’s recurring losses, level of cash used in operations, and potential need for additional capital, along with uncertainties surrounding the Company’s ability to raise additional capital, raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
As of March 31, 2023, the Company had working capital of approximately $
On January 9, 2023, BIOLASE completed a public offering, pursuant to which BIOLASE agreed to issue, in a registered direct offering,
Additional capital requirements may depend on many factors, including, among other things, the rate at which the Company’s business grows, demands for working capital, manufacturing capacity, and any acquisitions that the Company may pursue. The Company expects that it will be required to raise capital through either equity or debt offerings. The Company cannot provide assurance that it will be able to successfully enter into any such equity or debt financings in the future or that the required capital would be available on acceptable terms, if at all, or that any such financing activity would not be dilutive to its stockholders.
7
NOTE 2—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
The preparation of these consolidated financial statements in conformity with GAAP requires the Company to make estimates and assumptions that affect amounts reported in the consolidated financial statements and the accompanying notes. Significant estimates in these consolidated financial statements include allowances on accounts receivable, inventory, and deferred taxes, as well as estimates for accrued warranty expenses, goodwill and the ability of goodwill to be realized, revenue deferrals, effects of stock-based compensation and warrants, contingent liabilities, and the provision or benefit for income taxes. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may differ materially from those estimates.
Critical Accounting Policies
Information with respect to the Company’s critical accounting policies, which management believes could have the most significant effect on the Company’s reported results and require subjective or complex judgments by management, is discussed in the Company’s 2022 audited financial statements included in the 2022 Form 10-K. Management believes that there have been no significant changes during the three months ended March 31, 2023 in the Company’s critical accounting policies from those disclosed in the Company’s 2022 audited financial statements included in the 2022 Form 10-K.
Fair Value of Financial Instruments
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the principal market (or, if none exists, the most advantageous market) for the specific asset or liability at the measurement date (referred to as the “exit price”). The fair value is based on assumptions that market participants would use, including a consideration of non-performance risk. Under the accounting guidance for fair value hierarchy, there are three levels of measurement inputs. Level 1 inputs are quoted prices in active markets for identical assets or liabilities. Level 2 inputs are observable, either directly or indirectly. Level 3 inputs are unobservable due to little or no corroborating market data.
The Company’s financial instruments, consisting of cash, cash equivalents, accounts receivable, accounts payable, accrued liabilities, and the SWK Loan (as defined below) as discussed in Note 9 – Debt, approximate fair value because of the relative short maturity of these items and the market interest rates the Company could obtain.
Concentration of Credit Risk, Interest Rate Risk and Foreign Currency Exchange Rate
Financial instruments which potentially expose the Company to a concentration of credit risk consist principally of cash and cash equivalents, restricted cash, and trade accounts receivable. The Company maintains its cash and cash equivalents and restricted cash with established commercial banks. At times, balances may exceed federally insured limits. To minimize the risk associated with trade accounts receivable, management performs ongoing credit evaluations of customers’ financial condition and maintains relationships with the Company’s customers that allow management to monitor current changes in business operations so the Company can respond as needed. The Company does not, generally, require customers to provide collateral before it sells them its products. However, the Company has required certain distributors to make prepayments for significant purchases of its products.
Substantially all of the Company’s revenue is denominated in U.S. dollars, including sales to international distributors. Only a small portion of its revenue and expenses is denominated in foreign currencies, principally the Euro and Indian Rupee. The Company’s foreign currency expenditures primarily consist of the cost of maintaining offices, consulting services, and employee-related costs. During the three months ended March 31, 2023 and 2022, respectively, the Company did not enter into any hedging contracts. Future fluctuations in the value of the U.S. dollar may affect the price competitiveness of the Company’s products outside the U.S.
Recent Accounting Pronouncements
Changes to GAAP are established by the Financial Accounting Standards Board (“FASB”) in the form of accounting standards updates (“ASUs”) to the FASB’s Accounting Standards Codification (“ASC”).
The Company considers the applicability and impact of all ASUs. ASUs not listed below were assessed and determined not to be applicable or are expected to have minimal impact on the Company’s consolidated financial position and results of operations.
8
Recently Issued Accounting Standards
In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The standard’s main goal is to improve financial reporting by requiring earlier recognition of credit losses on financing receivables and other financial assets in scope and to replace the incurred loss impairment methodology under current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The Company will be required to use a forward-looking expected credit loss model for accounts receivables, loans, and other financial instruments. Credit losses relating to available-for-sale debt securities will also be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. The Company adopted this guidance effective January 1, 2023, and the adoption of this standard did not have a significant impact on its consolidated financial statements.
NOTE 3—REVENUE RECOGNITION
Contracts with Customers
Revenue for sales of products and services is derived from contracts with customers. The products and services promised in customer contracts include delivery of laser systems, imaging systems, and consumables as well as certain ancillary services such as training and extended warranties. Contracts with each customer generally state the terms of the sale, including the description, quantity and price of each product or service. Payment terms are stated in the contract and vary according to the arrangement. Because the customer typically agrees to a stated rate and price in the contract that does not vary over the life of the contract, the Company’s contracts do not contain variable consideration. The Company establishes a provision for estimated warranty expense.
Performance Obligations
At contract inception, the Company assesses the products and services promised in its contracts with customers. The Company then identifies performance obligations to transfer distinct products or services to the customers. In order to identify performance obligations, the Company considers all of the products or services promised in contracts regardless of whether they are explicitly stated or are implied by customary business practices.
Revenue from products and services transferred to customers at a single point in time accounted for
Revenue from services transferred to customers over time accounted for
Transaction Price Allocation
The transaction price for a contract is allocated to each distinct performance obligation and recognized as revenue when, or as, each performance obligation is satisfied. For contracts with multiple performance obligations, the Company allocates the contract’s transaction price to each performance obligation using the best estimate of the standalone selling price of each distinct good or service in a contract. The primary method used to estimate standalone selling price is the observable price when the good or service is sold separately in similar circumstances and to similar customers.
Significant Judgments
Revenue is recorded for extended warranties over time as the customer benefits from the warranty coverage. This revenue will be recognized equally throughout the contract period as the customer receives benefits from the Company's promise to provide such services. Revenue is recorded for product training as the customer attends a training program or upon the expiration of the obligation, which is generally after nine months.
The Company also has contracts that include both the product sales and product training as performance obligations. In those cases, the Company records revenue for product sales at the point in time when the product has been shipped. The customer obtains control of the product when it is shipped, as all shipments are made FOB shipping point, and after the customer selects its shipping
9
method and pays all shipping costs and insurance. The Company has concluded that control is transferred to the customer upon shipment.
Accounts Receivable
Accounts receivable are stated at estimated net realizable value. The allowance for doubtful accounts is based on an analysis of customer accounts and the Company’s historical experience with accounts receivable write-offs.
Contract Liabilities
The Company performs its obligations under a contract with a customer by transferring products and/or services in exchange for consideration from the customer. The Company typically invoices its customers as soon as control of an asset is transferred and a receivable for the Company is established. The Company, however, recognizes a contract liability when a customer prepays for goods and/or services, and the Company has not transferred control of the goods and/or services.
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2023 |
|
|
2022 |
|
||
Undelivered elements (training, installation, product |
|
$ |
|
|
$ |
|
||
Extended warranty contracts |
|
|
|
|
|
|
||
Total deferred revenue |
|
|
|
|
|
|
||
Less: long-term portion of deferred revenue |
|
|
( |
) |
|
|
( |
) |
Deferred revenue — current |
|
$ |
|
|
$ |
|
The balance of contract assets was immaterial as the Company did not have a significant amount of uninvoiced receivables at March 31, 2023 and December 31, 2022.
The amount of revenue recognized during the three months ended March 31, 2023 and 2022 that was included in the opening contract liability balance related to undelivered elements was $
Disaggregation of Revenue
The Company disaggregates revenue from contracts with customers into geographical regions and by the timing of when goods and services are transferred. The Company determined that disaggregating revenue into these categories depicts how the nature, amount, timing and uncertainty of revenue and cash flows are affected by regional economic factors.
The Company’s revenues related to the following geographic areas were as follows (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
United States |
|
$ |
|
|
$ |
|
||
International |
|
|
|
|
|
|
||
Total net revenue |
|
$ |
|
|
$ |
|
Information regarding revenues disaggregated by the timing of when goods and services are transferred is as follows (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Revenue recognized over time |
|
$ |
|
|
$ |
|
||
Revenue recognized at a point in time |
|
|
|
|
|
|
||
Net revenue |
|
$ |
|
|
$ |
|
10
The Company’s sales by end market were as follows (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
End-customer |
|
$ |
|
|
$ |
|
||
Distributors |
|
|
|
|
|
|
||
Net revenue |
|
$ |
|
|
$ |
|
Shipping and Handling Costs and Revenues
Shipping and freight costs are treated as fulfillment costs. For shipments to end-customers, the customer bears the shipping and freight costs and has control of the product upon shipment. For shipments to distributors, the distributor bears the shipping and freight costs, including insurance, tariffs and other import/export costs.
NOTE 4—REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
BIOLASE's board of directors (the "Board"), without further stockholder authorization, may authorize the issuance from time to time of up to
Preferred Stock
Series G Preferred Stock
On March 1, 2022, the Board declared a dividend of one one-thousandth of a share of Series G Preferred Stock, par value $
Series F Convertible Preferred Stock
On July 23, 2020, the Company consummated the sale of an aggregate of
In accordance with applicable accounting standards, the $
The Series F Preferred Stock contained a beneficial conversion feature which resulted in a deemed dividend to preferred stockholders of approximately $
The remaining shares of Series F Preferred Stock were converted into shares of BIOLASE common stock in the first quarter of 2022 with
11
Stock-Based Compensation
2002 Stock Incentive Plan
The 2002 Stock Incentive Plan (as amended effective as of May 26, 2004, November 15, 2005, May 16, 2007, May 5, 2011, June 6, 2013, October 30, 2014, April 27, 2015, and May 6, 2017, the “2002 Plan”) was replaced by the 2018 Plan (as defined below) with respect to future equity awards. Persons eligible to receive awards under the 2002 Plan included officers, employees, directors of the Company, and consultants to the Company. As of March 31, 2023, a total of
2018 Stock Incentive Plan
At the 2018 annual meeting of stockholders, the Company’s stockholders approved the 2018 Long-Term Incentive Plan (as amended effective as of September 21, 2018, May 15, 2019, May 13, 2020, and June 11, 2021, the “2018 Plan”). The purposes of the 2018 Plan are (i) to align the interests of the Company’s stockholders and recipients of awards under the 2018 Plan by increasing the proprietary interest of such recipients in the Company’s growth and success; (ii) to advance the interests of the Company by attracting and retaining non-employee directors, officers, other employees, consultants, independent contractors, and agents; and (iii) to motivate such persons to act in the long-term best interests of the Company and its stockholders.
Under the terms of the 2018 Plan, approximately
The Company recognized stock-based compensation expense of $
As of March 31, 2023 approximately $
The following table summarizes the income statement classification of compensation expense associated with share-based payments (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Cost of revenue |
|
$ |
|
|
$ |
|
||
Sales and marketing |
|
|
|
|
|
|
||
General and administrative |
|
|
|
|
|
|
||
Engineering and development |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
12
A summary of option activity for the three months ended March 31, 2023 is as follows (in thousands, except per share data):
|
|
|
|
|
Weighted |
|
Weighted |
|
|
|
|
||||
|
|
|
|
|
Average |
|
Contractual |
|
|
Aggregate |
|
||||
|
|
Shares |
|
|
Exercise |
|
Term |
|
|
Intrinsic |
|
||||
Options outstanding as of December 31, 2022 |
|
|
|
|
$ |
|
|
|
|
$ |
|
||||
Forfeited, cancelled, or expired |
|
|
|
|
$ |
|
|
— |
|
|
$ |
— |
|
||
Options outstanding as of March 31, 2023 |
|
|
|
|
$ |
|
|
|
|
$ |
|
||||
Options exercisable as of March 31, 2023 |
|
|
|
|
$ |
|
|
|
|
$ |
|
||||
Vested options expired during the period ended March 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
|
A summary of unvested stock option activity for the three months ended March 31, 2023 is as follows (in thousands, except per share data):
|
|
|
|
|
Weighted |
|
||
|
|
|
|
|
Average Grant |
|
||
|
|
Shares |
|
|
Date Fair Value |
|
||
Unvested options as of December 31, 2022 |
|
|
|
|
$ |
|
||
Vested |
|
|
|
|
$ |
|
||
Unvested options as of March 31, 2023 |
|
|
|
|
$ |
|
Fair value disclosures related to grants, exercises and vested options are as follows (in thousands, except per share amounts):
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Total fair value of stock options vested during the period |
|
$ |
|
|
$ |
|
Stock Option Activity
There were no option grants or exercises during the three months ended March 31, 2023 and 2022.
Restricted Stock Units
A summary of unvested RSU activity for the three months ended March 31, 2023 is as follows (in thousands, except per share amounts):
|
|
|
|
|
Weighted |
|
||
|
|
|
|
|
Average Grant |
|
||
|
|
Shares |
|
|
Date Fair Value |
|
||
Unvested RSUs as of December 31, 2022 |
|
|
|
|
$ |
|
||
Vested |
|
|
( |
) |
|
$ |
|
|
Unvested RSUs as of March 31, 2023 |
|
|
|
|
$ |
|
13
Warrants
The Company issues warrants to acquire shares of BIOLASE common stock as approved by the Board.
January 2023 Public Offering
On January 9, 2023, BIOLASE completed a public offering, pursuant to which BIOLASE agreed to issue, in a registered direct offering,
Based on the terms and conditions of the January 2023 public offering, the Company determined that equity classification was appropriate for the pre-funded warrants and recognized the net proceeds from the issuance of common stock and pre-funded warrants in excess of par of $
June 2022 Direct Offering and Private Placement
On June 27, 2022, the Company entered into a Securities Purchase Agreement with certain accredited institutional investors, pursuant to which the Company agreed to issue to the Purchasers (as defined therein), (i) in a registered direct offering,
Based on the terms and conditions of the June 2022 Warrants, the Company determined that equity classification was appropriate and recognized the net proceeds in excess of par of $
A summary of warrant activity for the three months ended March 31, 2023 is as follows (in thousands, except exercise price amounts):
|
|
|
|
|
Weighted |
|
||
|
|
|
|
|
Average |
|
||
|
|
Shares |
|
|
Exercise |
|
||
Warrants outstanding as of December 31, 2022 |
|
|
|
|
$ |
|
||
Granted or Issued |
|
|
|
|
$ |
|
||
Exercised |
|
|
( |
) |
|
$ |
|
|
Warrants outstanding as of March 31, 2023 |
|
|
|
|
$ |
|
||
Warrants exercisable as of March 31, 2023 |
|
|
|
|
$ |
|
||
Vested warrants expired during the period |
|
|
|
|
$ |
|
Phantom Awards and Stock Appreciation Rights
During the year ended December 31, 2022, the Company issued approximately
14
consolidated balance sheet. As of December 31, 2022, $
During the year ended December 31, 2021, the Company issued approximately
Net Loss Per Share – Basic and Diluted
Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of BIOLASE common stock outstanding for the period. In computing diluted net loss per share, the weighted average number of shares of common stock outstanding is adjusted to reflect the effect of potentially dilutive securities. Net income (loss) is adjusted for any deemed dividends to preferred stockholders to compute net income attributable to common stockholders. The January 2023 Pre-Funded Warrants were included in the calculation of basic and diluted loss per share for the period ended March 31, 2023 as the underlying warrant shares are issuable for little or no cash consideration.
Outstanding stock options, RSUs, and warrants to purchase approximately
NOTE 5—INVENTORY
Inventory is valued at the lower of cost or net realizable value and is comprised of the following (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2023 |
|
|
2022 |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work-in-process |
|
|
|
|
|
|
||
Finished goods |
|
|
|
|
|
|
||
Inventory |
|
$ |
|
|
$ |
|
Inventory has been reduced by estimates for excess and obsolete amounts totaling $
NOTE 6—PROPERTY, PLANT, AND EQUIPMENT
Property, plant, and equipment, net is comprised of the following (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2023 |
|
|
2022 |
|
||
Building |
|
$ |
|
|
$ |
|
||
Leasehold improvements |
|
|
|
|
|
|
||
Equipment and computers |
|
|
|
|
|
|
||
Furniture and fixtures |
|
|
|
|
|
|
||
Construction in progress |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
Accumulated depreciation and amortization |
|
|
( |
) |
|
|
( |
) |
Property, plant, and equipment, net before land |
|
|
|
|
|
|
||
Land |
|
|
|
|
|
|
||
Property, plant, and equipment, net |
|
$ |
|
|
$ |
|
Depreciation and amortization expense related to property, plant, and equipment totaled $
15
NOTE 7—INTANGIBLE ASSETS AND GOODWILL
The Company conducted its annual impairment test of goodwill as of September 30, 2022 and determined that there was
Due to the further decrease in the stock price of BIOLASE common stock as of March 31, 2023 decreasing the implied fair value of the business, the Company performed an additional quantitative assessment of impairment over goodwill and determined that there was
As of March 31, 2023 and December 31, 2022, the Company had goodwill of $
NOTE 8—ACCRUED LIABILITIES
Accrued liabilities are comprised of the following (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2023 |
|
|
2022 |
|
||
Payroll and benefits |
|
$ |
|
|
$ |
|
||
Warranty accrual, current portion |
|
|
|
|
|
|
||
Lease liability |
|
|
|
|
|
|
||
Accrued insurance premium |
|
|
|
|
|
|
||
Accrued professional services |
|
|
|
|
|
|
||
Taxes |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Accrued liabilities |
|
$ |
|
|
$ |
|
Changes in the initial product warranty accrual and the expenses incurred under the Company’s initial and extended warranties are included within accrued liabilities and were as follows (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Balance, beginning of period |
|
$ |
|
|
$ |
|
||
Provision for estimated warranty cost |
|
|
|
|
|
|
||
Warranty expenditures |
|
|
( |
) |
|
|
( |
) |
Balance, end of period |
|
|
|
|
|
|
||
Less: long-term portion of warranty accrual |
|
|
|
|
|
|
||
Current portion of warranty accrual |
|
$ |
|
|
$ |
|
The Company's Waterlase laser systems sold domestically are covered by a warranty against defects in material and workmanship for a period of up to
In North America and select international locations, the Company sells extended warranty contracts to its laser systems end-users that cover the period after the expiration of the Company's standard warranty coverage for its laser systems. Extended warranty
16
coverage provided under the Company's service contracts varies by the type of system and the level of service desired by the customer. Products or accessories remanufactured, refurbished, or sold by unauthorized parties, voids all warranties in place for such products and exempts the Company from liability issues relating to the use of such products.
NOTE 9—DEBT
The following table presents the details of the principal outstanding and unamortized discount (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2023 |
|
|
2022 |
|
||
SWK Loan |
|
$ |
|
|
$ |
|
||
EIDL Loan |
|
|
|
|
|
|
||
Discount and debt issuance costs on SWK Loan |
|
|
( |
) |
|
|
( |
) |
Total |
|
|
|
|
|
|
||
Current term loans, net of discount |
|
|
|
|
|
|
||
Non current term loans, net of discount |
|
$ |
|
|
$ |
|
The Company recognized approximately $
The future minimum principal and interest payments as of March 31, 2023 are as follows (in thousands):
|
|
Principal |
|
|
Interest (1) |
|
||
Remainder of 2023 |
|
$ |
|
|
$ |
|
||
2024 |
|
|
|
|
|
|
||
2025 |
|
|
|
|
|
|
||
2026 |
|
|
|
|
|
|
||
2027 and thereafter |
|
|
|
|
|
|
||
Total future payments |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
(1) Estimated using London Interbank Bank Offered Rate (“LIBOR”) as of March 31, 2023 |
|
|
|
|
|
|
Term Loan
On November 9, 2018, the Company entered into a
As of March 31, 2023, the Company was in compliance with the debt covenants of the Credit Agreement.
EIDL Loan
On May 22, 2020, the Company executed the standard loan documents required for securing a loan (the “EIDL Loan”) from the Small Business Administration (the "SBA") under its Economic Injury Disaster Loan assistance program in light of the impact of the COVID-19 pandemic on the Company’s business. The principal amount of the EIDL Loan is $
17
that it was extending the first payment due date for all loans until
NOTE 10—LEASES
The Company enters into operating leases primarily for real estate, office equipment, and fleet vehicles. Lease terms generally range from one to
On January 22, 2020, the Company entered into a
On February 4, 2020, the Company also entered into a
Information related to the Company’s right-of-use assets and related liabilities were as follows (in thousands):
|
Three Months Ended |
|
|||||
|
March 31, |
|
|||||
|
2023 |
|
|
2022 |
|
||
Cash paid for operating lease liabilities |
$ |
|
|
$ |
|
||
Right-of-use assets obtained in exchange for new operating |
$ |
|
|
$ |
|
||
Weighted-average remaining lease term |
|
|
|
||||
Weighted-average discount rate |
|
% |
|
|
% |
Lease expense consists of payments for real property, office copiers, and IT equipment. The Company recognizes payments for non-lease components such as common area maintenance in the period incurred. As of March 31, 2023, the Company had no significant leases that had not commenced.
The Company allocates lease cost amongst lease and non-lease components. The Company excludes short-term leases (those with lease terms of less than
Maturities of lease liabilities as of March 31, 2023 for leases that have commenced are as follows (in thousands):
|
|
March 31, |
|
|
2024 |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 and thereafter |
|
|
|
|
Total future minimum lease obligations |
|
|
|
|
Less imputed interest |
|
|
( |
) |
Total lease liabilities |
|
$ |
|
|
|
|
|
|
|
Current operating lease liabilities, included in |
|
$ |
|
|
Non current lease liabilities |
|
|
|
|
Total lease liabilities |
|
$ |
|
As of March 31, 2023, right-of-use assets were $
18
Rent expense totaled $
Future minimum rental commitments under lease agreements, as of March 31, 2023, with non-cancelable terms greater than one year for each of the years ending December 31 are as follows (in thousands):
|
|
|
Year Ended |
|
|
|
|
|
December 31, |
|
|
Remainder of 2023 |
|
|
$ |
|
|
2024 |
|
|
|
|
|
2025 |
|
|
|
|
|
2026 |
|
|
|
|
|
2027 and thereafter |
|
|
|
|
|
Total future minimum lease obligations |
|
|
|
|
|
Less imputed interest |
|
|
|
( |
) |
Total lease liabilities |
|
|
$ |
|
NOTE 11—SEGMENT INFORMATION
The Company currently operates in a single business segment. Management uses one measurement of profitability and does not segregate its business for internal reporting. For the three months ended March 31, 2023, sales to customers in the United States accounted for approximately
Net revenue by geographic location based on the location of customers was as follows (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
United States |
|
$ |
|
|
$ |
|
||
International |
|
|
|
|
|
|
||
Total net revenue |
|
$ |
|
|
$ |
|
Property, plant, and equipment by geographic location was as follows (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2023 |
|
|
2022 |
|
||
United States |
|
$ |
|
|
$ |
|
||
International |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
NOTE 12—CONCENTRATIONS
Revenue from the Company’s products are as follows (dollars in thousands):
|
|
Three Months Ended |
|
|||||||||||||
|
|
March 31, |
|
|||||||||||||
|
|
2023 |
|
|
2022 |
|
||||||||||
Laser systems |
|
$ |
|
|
|
% |
|
$ |
|
|
|
% |
||||
Consumables and other |
|
|
|
|
|
% |
|
|
|
|
|
% |
||||
Services |
|
|
|
|
|
% |
|
|
|
|
|
% |
||||
Total net revenue |
|
$ |
|
|
|
% |
|
$ |
|
|
|
% |
19
The Company maintains its cash and cash equivalents in money market investment accounts with established commercial banks. Such cash deposits periodically exceed the Federal Deposit Insurance Corporation insured limit.
The Company currently purchases certain key components of its products from single suppliers. Although there are a limited number of manufacturers of these key components, management believes that other suppliers could provide similar key components on comparable terms. A change in suppliers, however, could cause delays in manufacturing and a possible loss of sales, which could adversely affect the Company’s business, results of operations and financial condition.
NOTE 13—INCOME TAXES
The Company accounts for income taxes under the asset and liability method, whereby deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Management evaluates the need to establish a valuation allowance for deferred tax assets based upon the amount of existing temporary differences, the period in which they are expected to be recovered, and expected levels of taxable income. A valuation allowance to reduce deferred tax assets is established when it is “more likely than not” that some or all of the deferred tax assets will not be realized. Based on the Company’s net losses in prior years, management has determined that a full valuation allowance against the Company’s net deferred tax assets is appropriate.
Accounting for uncertainty in income taxes prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return and provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company has elected to classify interest and penalties as a component of its income tax provision. With respect to the liability for unrecognized tax benefits, including related estimates of penalties and interest, the Company did
During the three months ended March 31, 2023, the Company recorded an income tax provision of $
NOTE 14—SUBSEQUENT EVENTS
On May 4, 2023, the Company filed a registration statement on Form S-1 for the issuance of Series H Convertible Redeemable Preferred Stock with a liquidation preference of $
20
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following information should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q (this “Form 10-Q”) and our audited consolidated financial statements and related notes included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission (the “SEC”) on March 28, 2023 (the “2022 Form 10-K”).
In addition to historical information, this discussion and analysis contains “forward-looking statements” as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) that involve risks, uncertainties, and assumptions, which could cause actual results to differ materially from management's expectations. Such forward-looking statements include statements, predictions, or expectations regarding expected investment activities, future liquidity, potential collaborations, market opportunities, plans with respect to products and services, future demand for improved dental care and dental laser equipment, seasonality and the reasons therefor, operating and other expenses, anticipated cash needs, our strategy and any other statement that is not historical fact. Forward-looking statements are identified by the use of words such as “may,” “might,” “will,” “intend,” “should,” “could,” “can,” “would,” “continue,” “expect,” “believe,” “anticipate,” “estimate,” “predict,” “outlook,” “potential,” “plan,” “seek,” “forecast,” and similar expressions and variations or the negatives of these terms or other comparable terminology.
The forward-looking statements contained in this Form 10-Q are based on the expectations, estimates, projections, beliefs, and assumptions of our management based on information available to management as of the date on which this Form 10-Q was filed with the SEC, or as of the date on which the information incorporated by reference was filed with the SEC, as applicable, all of which are subject to change. Forward-looking statements are subject to risks, uncertainties, and other factors that are difficult to predict and could cause actual results to differ materially from those stated or implied by our forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to:
21
Further information about factors that could materially affect the Company, including our results of operations and financial condition, is contained under “Risk Factors” in Item 1A in the 2022 Form 10-K and Item 1A of Part II of this Form 10-Q. Except as required by law, we undertake no obligation to revise or update any forward-looking statements to reflect changed assumptions, the occurrence of anticipated or unanticipated events, new information or changes to future results over time or otherwise.
Overview
BIOLASE, Inc. (“BIOLASE” and, together with its consolidated subsidiaries, the “Company,” “we,” “our” or “us”) is a leading provider of advanced laser systems for the dental industry. We develop, manufacture, market, and sell laser systems that provide significant benefits for dental practitioners and their patients. Our proprietary systems allow dentists, periodontists, endodontists, pediatric dentists, oral surgeons, and other dental specialists to perform a broad range of minimally invasive dental procedures, including cosmetic, restorative, and complex surgical applications. Our laser systems are designed to provide clinically superior results for many types of dental procedures compared to those achieved with drills, scalpels, and other conventional instruments. Potential patient benefits include less pain, fewer shots, faster healing, decreased fear and anxiety, and fewer appointments. Potential practitioner benefits include improved patient care and the ability to perform a higher volume, and wider variety of procedures.
We offer two categories of laser system products: Waterlase (all-tissue) systems and diode (soft-tissue) systems. Our flagship brand, the Waterlase, uses a patented combination of water and laser energy and is FDA cleared for over 80 clinical indications to perform most procedures currently performed using drills, scalpels, and other traditional dental instruments for cutting soft and hard tissue. For example, Waterlase safely debrides implants without damaging or significantly affecting surface temperature and is an effective, safe solution for preserving sick implants. In addition, Waterlase disinfects root canals more efficiently than some traditional chemical methods. We offer our diode laser systems to perform soft tissue, pain therapy, and cosmetic procedures, including teeth
22
whitening. As of March 31, 2023, we maintained approximately 266 active and 25 pending United States and international patents, with the majority relating to our Waterlase technology. Our patent portfolio is regularly evaluated, and we strategically prioritize our core patents to ensure optimal Intellectual Property coverage while minimizing annual maintenance fees. From 1998 through December 31, 2022, we have sold over 45,500 laser systems in over 80 countries around the world, and we believe that Waterlase iPlus is the world’s best-selling all-tissue dental laser. Since 1998, we have been the global leading innovator, manufacturer, and marketer of dental laser systems.
We also manufacture and sell consumable products and accessories for our laser systems. Our Waterlase and diode systems use disposable laser tips of differing sizes and shapes depending on the procedure being performed. We also market flexible fibers and hand pieces that dental practitioners replace at some point after initially purchasing laser systems. For our Epic line of diode laser systems, we sell teeth whitening gel kits. During the quarter ended March 31, 2023, the sale of lasers accounted for approximately 60% of our total sales, and consumables, accessories, and services accounted for approximately 40% of our total sales.
We currently operate in a single reportable business segment. We had net revenues of $10.5 million and $10.2 million for the three months ended March 31, 2023 and 2022, respectively, and we had net losses of $5.8 million and $4.8 million for the same periods, respectively. We had total assets of $41.9 million as of March 31, 2023 and $38.2 million as of December 31, 2022.
Business and Outlook
Our Waterlase systems precisely cut hard tissue, bone, and soft tissue with minimal or no damage to surrounding tissue and dental structures. Our diode systems, which include the Epic system, are designed to complement our Waterlase systems, and are used only in soft tissue procedures, pain therapy, hygiene, and cosmetic applications, including teeth whitening. The diode systems, together with our Waterlase systems, offer practitioners a broad product line with a range of features and price points.
We also manufacture and sell consumable products and accessories for our laser systems. Our Waterlase and diode systems use disposable laser tips of differing sizes and shapes depending on the procedure being performed. We also market flexible fibers and hand pieces that dental practitioners replace at some point after initially purchasing laser systems. For our Epic systems, we sell teeth whitening gel kits.
Due to the limitations associated with traditional and alternative dental instruments, we believe there is a large market opportunity for all-tissue dental laser systems that provide superior clinical outcomes, reduce the need to use anesthesia, help reduce trauma, pain, and discomfort associated with dental procedures, and increase patient acceptance for treatment protocols.
Our strategy is to increase awareness and demand for (i) our products among dental practitioners by educating dental practitioners and patients about the clinical benefits of our product suite and (ii) our laser systems among patients by educating patients about the clinical benefits of the Waterlase and diode systems. An important goal of ours is to increase consumables revenue by selling more single-use accessories used by dental practitioners when performing procedures using our dental laser systems. In the short term, we are striving for operating excellence through lean enterprise initiatives, with a specific focus on our sales strategy and cash flow management, coupled with optimizing our engineering capabilities to develop innovative new products.
We also seek to create value through innovation and leveraging existing technologies into adjacent medical applications. We plan to expand our product line and clinical applications by developing enhancements and transformational innovations, including new clinical solutions for dental applications and for other adjacent medical applications. In particular, we believe that our existing technologies can provide significant improvements over existing standards of care in fields including ophthalmology, otolaryngology, orthopedics, podiatry, pain management, aesthetics/dermatology, veterinary, and consumer products. We plan to continue to explore potential collaborations to apply our proprietary laser technologies with expanded FDA-cleared indications to other medical applications in the future.
The Company experienced revenue growth of 3% for the three months ended March 31, 2023, compared to the same period in 2022. The Company is currently forecasting revenue for fiscal year 2023 to be significantly above fiscal year 2022, as the Company's strategy described above continues to generate sales to new customers and additional consumable sales to existing customers.
To educate providers and increase patient access to our products, over the past couple of years, we have formed specialist training programs focused on expanding awareness of the benefits of our dental lasers among dental specialists. These programs provide clinicians with an immersive training experience through peer-led learning and best practice sharing to help ensure appropriate use of Waterlase technology in clinical practices. In the fourth quarter of 2021, we launched the Epic Hygiene Academy which seeks to bring together leaders in the dental hygiene profession to provide improved continuing education in delivering superior patient care through laser technology.
23
In 2021, we designed, developed, received FDA clearance for and began production of a laser using our proprietary Er,Cr:YSGG laser technology in partnership with EdgeEndo, a leading endodontic company. The EdgePro is a state-of-the-art microfluidic irrigation device designed to clean and disinfect root canals. The partnership with EdgeEndo is our first exclusive OEM agreement.
Recent Developments
On January 9, 2023, BIOLASE completed a public offering, pursuant to which BIOLASE agreed to issue, in a registered direct offering, 17,167,855 shares of BIOLASE common stock, par value $0.001 per share, and pre-funded warrants to purchase 11,403,571 shares of BIOLASE common stock with an exercise price of $0.01 per share. The purchase price for one share of common stock was determined to be $0.35, and the purchase price for one January 2023 Pre-Funded Warrant was determined to be $0.34. BIOLASE received aggregate gross proceeds from the transactions of approximately $9.9 million, before deducting underwriting discounts and commissions and other transaction expenses paid by BIOLASE.
Critical Accounting Policies
The unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) which require us to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and revenues and expenses reported during the period. Information with respect to our critical accounting policies that we believe could have the most significant effect on our reported results and require subjective or complex judgments by management is contained in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” of the 2022 Form 10-K. There have been no significant changes during the three months ended March 31, 2023 in our critical accounting policies from those disclosed in Item 7 of the 2022 Form 10-K.
Results of Operations
The following table sets forth certain data from our unaudited operating results, expressed in thousands and as percentages of net revenue:
|
|
Three Months Ended |
||||||||||
|
|
March 31, |
||||||||||
|
|
2023 |
|
2022 |
||||||||
Net revenue |
|
$ |
10,467 |
|
100.0 |
% |
|
$ |
10,166 |
|
100.0 |
% |
Cost of revenue |
|
|
7,130 |
|
68.1 |
% |
|
|
5,437 |
|
53.5 |
% |
Gross profit |
|
|
3,337 |
|
31.9 |
% |
|
|
4,729 |
|
46.5 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing |
|
|
4,622 |
|
44.1 |
% |
|
|
4,814 |
|
47.4 |
% |
General and administrative |
|
|
2,459 |
|
23.5 |
% |
|
|
2,577 |
|
25.3 |
% |
Engineering and development |
|
|
1,547 |
|
14.8 |
% |
|
|
1,544 |
|
15.2 |
% |
Total operating expenses |
|
|
8,628 |
|
82.4 |
% |
|
|
8,935 |
|
87.9 |
% |
Loss from operations |
|
|
(5,291) |
|
(50.5) |
% |
|
|
(4,206) |
|
(41.4) |
% |
Non-operating loss, net |
|
|
(557) |
|
(5.4) |
% |
|
|
(553) |
|
(5.4) |
% |
Loss before income tax provision |
|
|
(5,848) |
|
(55.9) |
% |
|
|
(4,759) |
|
(46.8) |
% |
Income tax provision |
|
|
(1) |
|
0.0 |
% |
|
|
(17) |
|
(0.2) |
% |
Net loss |
|
$ |
(5,849) |
|
(55.9) |
% |
|
$ |
(4,776) |
|
(47.0) |
% |
Non-GAAP Disclosure
In addition to the financial information prepared in conformity with GAAP, we provide certain historical non-GAAP financial information. Management believes that these non-GAAP financial measures assist investors in making comparisons of period-to-period operating results and that, in some respects, are indicative of our ongoing core performance.
Management believes that the presentation of this non-GAAP financial information provides investors with greater transparency and facilitates comparison of operating results across a broad spectrum of companies with varying capital structures, compensation strategies, derivative instruments, and amortization methods, which provides a more complete understanding of our financial performance, competitive position, and prospects for the future. However, the non-GAAP financial measures presented in this Form 10-Q have certain limitations in that they do not reflect all of the costs associated with the operations of our business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for,
24
or as superior to, measures of financial performance prepared in accordance with GAAP. Further, the non-GAAP financial measures presented by us may be different from similarly named non-GAAP financial measures used by other companies.
Adjusted EBITDA
Management uses Adjusted EBITDA in its evaluation of our core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Adjusted EBITDA is defined as net loss before interest, taxes, depreciation and amortization, stock-based and other non-cash compensation, and the change in allowance for doubtful accounts. Management uses adjusted EBITDA in its evaluation of our core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. Further, the non-GAAP financial measures presented by us may be different from similarly named non-GAAP financial measures used by other companies.
The following table contains a reconciliation of non-GAAP Adjusted EBITDA to GAAP net loss attributable to common stockholders (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
GAAP net loss attributable to common stockholders |
|
$ |
(5,849 |
) |
|
$ |
(4,993 |
) |
Deemed dividend on convertible preferred stock |
|
|
— |
|
|
|
217 |
|
GAAP net loss |
|
$ |
(5,849 |
) |
|
$ |
(4,776 |
) |
Adjustments: |
|
|
|
|
|
|
||
Interest expense, net |
|
|
577 |
|
|
|
433 |
|
Income tax provision |
|
|
1 |
|
|
|
17 |
|
Depreciation and amortization |
|
|
149 |
|
|
|
117 |
|
Change in allowance for doubtful accounts |
|
|
(17 |
) |
|
|
84 |
|
Stock-based and other non-cash compensation |
|
|
691 |
|
|
|
209 |
|
Adjusted EBITDA |
|
$ |
(4,448 |
) |
|
$ |
(3,916 |
) |
Comparison of Results of Operations
Three Months Ended March 31, 2023 Compared with Three Months Ended March 31, 2022
Net Revenue: The following table summarizes our unaudited net revenue by category, including each category’s percentage of our total revenue, for the three months ended March 31, 2023 and 2022, as well as the amount of change and percentage of change in each revenue category (dollars in thousands):
|
|
Three Months Ended |
|
|
|
|
|
|
|
|||||||||||||||
|
|
March 31, |
|
|
Amount |
|
|
Percent |
|
|||||||||||||||
|
|
2023 |
|
|
2022 |
|
|
Change |
|
|
Change |
|
||||||||||||
Laser systems |
|
$ |
6,265 |
|
|
|
59.8 |
% |
|
$ |
6,335 |
|
|
|
62.3 |
% |
|
$ |
(70 |
) |
|
|
(1.1 |
)% |
Consumables and other |
|
|
3,033 |
|
|
|
29.0 |
% |
|
|
2,710 |
|
|
|
26.7 |
% |
|
|
323 |
|
|
|
11.9 |
% |
Services |
|
|
1,169 |
|
|
|
11.2 |
% |
|
|
1,121 |
|
|
|
11.0 |
% |
|
|
48 |
|
|
|
4.3 |
% |
Net revenue |
|
$ |
10,467 |
|
|
|
100.0 |
% |
|
$ |
10,166 |
|
|
|
100.0 |
% |
|
$ |
301 |
|
|
|
3.0 |
% |
The following table summarizes our unaudited net revenue by geographic location based on the location of customers for the three months ended March 31, 2023 and 2022, as well as the amount of change and percentage of change in each geographic revenue category (dollars in thousands):
|
|
Three Months Ended |
|
|
|
|
|
|
|
|||||||||||||||
|
|
March 31, |
|
|
Amount |
|
|
Percent |
|
|||||||||||||||
|
|
2023 |
|
|
2022 |
|
|
Change |
|
|
Change |
|
||||||||||||
United States |
|
$ |
6,758 |
|
|
|
64.6 |
% |
|
$ |
6,978 |
|
|
|
68.6 |
% |
|
$ |
(220 |
) |
|
|
(3.2 |
)% |
International |
|
|
3,709 |
|
|
|
35.4 |
% |
|
|
3,188 |
|
|
|
31.4 |
% |
|
|
521 |
|
|
|
16.3 |
% |
Net revenue |
|
$ |
10,467 |
|
|
|
100.0 |
% |
|
$ |
10,166 |
|
|
|
100.0 |
% |
|
$ |
301 |
|
|
|
3.0 |
% |
Typically, we experience fluctuations in revenue from quarter to quarter due to seasonality. Revenue in the first quarter typically is lower than average, and revenue in the fourth quarter typically is higher than average, due to the buying patterns of dental
25
practitioners. We believe that this trend exists because a significant number of dentists purchase their capital equipment towards the end of the calendar year in order to maximize their practice earnings while seeking to minimize their taxes. They often use certain tax incentives, such as accelerated depreciation methods for purchasing capital equipment, as part of their year-end tax planning. In addition, revenue in the third quarter may be affected by vacation patterns which can cause revenue to be flat or lower than in the second quarter of the year. Our historical seasonal fluctuations may also be impacted by sales promotions used by large dental distributors that encourage end-of-quarter and end-of-year buying in our industry.
Total net revenue increased by $0.3 million, or 3%, during the three months ended March 31, 2023 as compared to the same period in 2022 primarily due to an increase in Waterlase sales to customers outside the U.S., along with higher consumable sales. In the U.S., net revenue decreased by $0.2 million, or 3%, for the three months ended March 31, 2023 as compared to the same period in 2022. Outside the U.S., net revenue increased by $0.5 million, or 16%, during the three months ended March 31, 2023 as compared to the same period in 2022.
Cost of Revenue and Gross Profit: The following table summarizes our unaudited cost of revenue and gross profit for the three months ended March 31, 2023 and 2022, as well as the amount of change and percentage of change (dollars in thousands):
|
|
Three Months Ended |
|
|
|
|
|
|
|
|||||||||||||||
|
|
March 31, |
|
|
Amount |
|
|
Percent |
|
|||||||||||||||
|
|
2023 |
|
|
2022 |
|
|
Change |
|
|
Change |
|
||||||||||||
Net revenue |
|
$ |
10,467 |
|
|
|
100.0 |
% |
|
$ |
10,166 |
|
|
|
100.0 |
% |
|
$ |
301 |
|
|
|
3.0 |
% |
Cost of revenue |
|
|
7,130 |
|
|
|
68.1 |
% |
|
|
5,437 |
|
|
|
53.5 |
% |
|
|
1,693 |
|
|
|
31.1 |
% |
Gross profit |
|
$ |
3,337 |
|
|
|
31.9 |
% |
|
$ |
4,729 |
|
|
|
46.5 |
% |
|
$ |
(1,392 |
) |
|
|
(29.4 |
)% |
Gross profit as a percentage of revenue typically fluctuates with product and regional mix, selling prices, product costs and revenue levels. Gross profit for the three months ended March 31, 2023, was $3.3 million, or 32% of net revenue, a decrease of approximately $1.4 million, or 29%, as compared with gross profit of $4.7 million, or 47% of net revenue, for the same period in 2022. The decrease in gross profit is primarily due to the impact of supply chain issues we have encountered requiring us to change to new suppliers, and the effect of an increase in the percentage of our revenue generated outside the U.S., where margins are lower than our U.S. business.
Operating Expenses: The following table summarizes our unaudited operating expenses (including as a percentage of net revenue) for the three months ended March 31, 2023 and 2022, as well as the amount of change and percentage of change (dollars in thousands):
|
|
Three Months Ended |
|
|
|
|
|
|
|
|||||||||||||||
|
|
March 31, |
|
|
Amount |
|
|
Percent |
|
|||||||||||||||
|
|
2023 |
|
|
2022 |
|
|
Change |
|
|
Change |
|
||||||||||||
Sales and marketing |
|
$ |
4,622 |
|
|
|
44.2 |
% |
|
$ |
4,814 |
|
|
|
47.4 |
% |
|
$ |
(192 |
) |
|
|
(4.0 |
)% |
General and administrative |
|
|
2,459 |
|
|
|
23.4 |
% |
|
|
2,577 |
|
|
|
25.3 |
% |
|
|
(118 |
) |
|
|
(4.6 |
)% |
Engineering and development |
|
|
1,547 |
|
|
|
14.8 |
% |
|
|
1,544 |
|
|
|
15.2 |
% |
|
|
3 |
|
|
|
0.2 |
% |
Total operating expenses |
|
$ |
8,628 |
|
|
|
82.4 |
% |
|
$ |
8,935 |
|
|
|
87.9 |
% |
|
$ |
(307 |
) |
|
|
(3.4 |
)% |
Sales and Marketing Expense. Sales and marketing expenses during the three months ended March 31, 2023 decreased by $0.2 million, or 4%, as compared to the same period in 2022. This decrease is primarily due to $0.2 million in compensation costs and $0.2 million in decreased advertising costs, partially offset by $0.2 million in higher travel and tradeshow-related expenses.
General and Administrative Expense. General and administrative expenses during the three months ended March 31, 2023 decreased by $0.1 million, or 5%, compared to the same period in 2022. This decrease is primarily due to a $0.3 million decrease in legal and consulting fees, partially offset by a $0.2 million increase in stock-based compensation expense.
Engineering and Development Expense. Engineering and development expenses during the three months ended March 31, 2023 were consistent compared to the same period in 2022.
Non-Operating Income (Loss)
Loss on Foreign Currency Transactions. We realized an approximately $20 thousand gain on foreign currency transactions during the three months ended March 31, 2023 compared to an approximately $120 thousand loss on foreign currency transactions during the three months ended March 31, 2022, primarily due to exchange rate fluctuations between the U.S. dollar and Euro, as well as other foreign currencies.
26
Interest Expense, Net. Interest expense was $0.6 million during the three months ended March 31, 2023 compared to $0.4 million for the same period in 2022, an increase of 33%. This increase was due to the increasing interest rates.
Income Tax Provision. We use a discrete year-to-date method in calculating quarterly provision for income taxes. Our provision for income taxes for the three months ended March 31, 2023 was consistent with the same period in 2022. For additional information regarding income taxes, see Part I, Item I, Note 13 – Income Taxes.
Net Loss. For the reasons stated above, our net loss totaled approximately $5.8 million for the three months ended March 31, 2023 compared to a net loss of $4.8 million for the three months ended March 31, 2022.
Liquidity and Capital Resources
As of March 31, 2023, we had approximately $6.5 million in cash and cash equivalents compared to $4.2 million as of December 31, 2022. Management defines cash and cash equivalents as highly liquid deposits with original maturities of 90 days or less when purchased. The increase in cash and cash equivalents from December 31, 2022 was primarily due to $8.5 million net proceeds from the January 2023 public offering, partially offset by a net loss of $5.8 million and $0.6 million in capital expenditures during the three months ended March 31, 2023.
The following table summarizes our change in cash, cash equivalents and restricted cash (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Net cash flows used in operating activities |
|
$ |
(5,658 |
) |
|
$ |
(8,021 |
) |
Net cash flows used in investing activities |
|
|
(587 |
) |
|
|
(304 |
) |
Net cash flows provided by financing activities |
|
|
8,517 |
|
|
|
— |
|
Effect of exchange rate changes |
|
|
79 |
|
|
|
(41 |
) |
Net change in cash, cash equivalents and restricted |
|
$ |
2,351 |
|
|
$ |
(8,366 |
) |
Operating Activities
Net cash used in operating activities consists of our net loss, adjusted for our non-cash charges, plus or minus working capital changes. Cash used in operating activities for the three months ended March 31, 2023 totaled $5.7 million and was primarily comprised of our net loss of $5.8 million.
Investing Activities
Cash used in investing activities for the three months ended March 31, 2023 totaled $0.6 million and was comprised of the purchase of property, plant, and equipment. We expect cash flows used in investing activities to decrease in the remainder of 2023 due to the completion of our new training facility.
Financing Activities
Net cash provided by financing activities for the three months ended March 31, 2023 totaled $8.5 million and was derived from the net proceeds from the January 2023 public offering.
Effect of Exchange Rate
The $79 thousand effect of exchange rate on cash for the three months ended March 31, 2023 was due to recognized loss on foreign currency transactions, primarily driven by changes in the Euro during the period.
Future Liquidity Needs
As of March 31, 2023, we had working capital of approximately $13.0 million. Our principal sources of liquidity as of March 31, 2023 consisted of approximately $6.5 million in cash and cash equivalents and $5.2 million of net accounts receivable.
The Company will need to raise additional capital in the future. Additional capital requirements may depend on many factors, including, among other things, the rate at which the Company’s business grows, demands for working capital, manufacturing capacity,
27
and any acquisitions that the Company may pursue. The Company expects that it will be required to raise capital through either equity or debt offerings. The Company cannot provide assurance that it will be able to successfully enter into any such equity or debt financings in the future or that the required capital will be available on acceptable terms, if at all, or that any such financing activity will not be dilutive to its stockholders. On May 4, 2023, the Company filed a registration statement on Form S-1 for the issuance of Series H Convertible Redeemable Preferred Stock with a liquidation preference of $50.00 and warrants to purchase one-half of one share of Series H Convertible Redeemable Preferred Stock. The equity raise, which is subject to conditions including the SEC declaring the registration statement effective and market conditions, is expected to be completed in the second quarter of 2023.
The Company has historically experienced losses from operations and has used cash and cash equivalents in operating activities. To be able to discharge our liabilities and commitments in the normal course of business, we must increase sales of our products, control or potentially reduce expenses, and establish profitable operations in order to generate cash from operations or obtain additional funds when needed.
The Company’s recurring losses, level of cash used in operations, and potential need for additional capital, along with uncertainties surrounding the Company’s ability to raise additional capital, raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
In order for the Company to continue operations beyond the next 12 months and be able to discharge its liabilities and commitments in the normal course of business, it must either raise additional capital or increase sales of our products, control or potentially reduce expenses, and establish profitable operations in order to generate cash from operations or obtain additional funds when needed.
We will endeavor to improve our financial condition and ultimately improve our financial results by increasing revenues through expansion of our product offerings, continuing to expand and develop our field sales force and distributor relationships both domestically and internationally, forming strategic arrangements within the dental and medical industries, educating dental and medical patients as to the benefits of our advanced medical technologies, and reducing expenses; however, there is no assurance that will be able to improve our financial condition.
Term Loan
The information set forth in Part I, Item 1, Note 9 – Debt – Term Loan is hereby incorporated herein by reference.
EIDL Loan
The information set forth in Part I, Item 1, Note 9 – Debt – EIDL Loan is hereby incorporated herein by reference.
Equity Offering
On January 9, 2023, the Company completed a public offering and issued an aggregate of 17,167,855 shares of BIOLASE common stock at a price of $0.35 per share and pre-funded warrants to purchase 11,403,571 shares of BIOLASE common stock with an exercise price of $0.01 per share at a price of $0.34 per share. The Company received gross proceeds of approximately $9.9 million, before deducting underwriting discounts and commissions and estimated offering expenses.
Recent Accounting Pronouncements
For a description of recently issued and adopted accounting pronouncements, including the respective dates of adoption and expected effects on our results of operations and financial condition, please refer to Part I, Item 1, Note 2 – Summary of Significant Accounting Policies, which is incorporated herein by this reference.
Additional Information
BIOLASE®, ZipTip®, ezlase®, eztips®, ComfortPulse®, Waterlase®, Waterlase Dentistry®, Waterlase Express®, iLase®, iPlus®, Epic®, Epic Pro®, WCLI®, World Clinical Laser Institute®, Waterlase MD®, Waterlase Dentistry®, and EZLase® are registered trademarks of BIOLASE, and Pedolase is a trademark of BIOLASE. All other product and company names are registered trademarks or trademarks of their respective owners.
28
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Our management has evaluated, with the participation of our President and Chief Executive Officer and our Chief Financial Officer, the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this report. Based on that evaluation, our President and Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures were effective as of the end of the period covered by this report.
Changes in Internal Controls over Financial Reporting
There was no change in our internal control over financial reporting that occurred during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
29
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
The information set forth in “Legal Proceedings” in Part I, Item 3 of the 2022 Form 10-K is hereby incorporated herein by reference.
ITEM 1A. RISK FACTORS
There have been no material changes to our risk factors from those disclosed under “Risk Factors” in Part I, Item 1A of the 2022 Form 10-K. The risks and uncertainties described in the 2022 Form 10-K are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also materially adversely affect our business, financial condition, or results of operations.
30
ITEM 6. EXHIBITS
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Incorporated by Reference |
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Exhibit |
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Description |
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Filed Herewith |
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Form |
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Period Ending/Date of Report |
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Exhibit |
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Filing Date |
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3.1.1 |
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S-1, Amendment |
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12/23/2005 |
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3.1 |
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12/23/2005 |
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3.1.2 |
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8-K |
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05/10/2012 |
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3.1 |
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05/16/2012 |
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3.1.3 |
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8-A/A |
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11/04/2014 |
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3.1.3 |
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11/04/2014 |
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3.1.4 |
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S-3 |
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07/21/2017 |
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3.4 |
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07/21/2017 |
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3.1.5 |
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8-K |
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05/10/2018 |
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3.1 |
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05/11/2018 |
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3.1.6 |
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8-K |
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05/28/2020 |
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3.1 |
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06/01/2020 |
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3.1.7 |
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8-K |
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04/28/2022 |
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3.1 |
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05/02/2022 |
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3.1.8 |
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8-A |
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03/01/2022 |
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3.1 |
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03/03/2022 |
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3.1.9 |
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Certificate of Elimination of Series D, Series E and Series F Preferred Stock of the Registrant |
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8-K |
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03/01/2022 |
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3.3 |
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03/03/2022 |
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3.2 |
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Eighth Amended and Restated Bylaws of the Registrant adopted on March 1, 2022 |
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8-K |
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03/01/2022 |
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3.1 |
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03/03/2022 |
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4.1 |
|
Form of Warrant to Purchase Common Stock issued on January 11, 2023 |
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S-1/A |
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01/03/2023 |
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4.2 |
|
01/03/2023 |
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31.1 |
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X |
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31.2 |
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X |
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31
32.1 |
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* |
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32.2 |
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* |
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101 |
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The following unaudited financial information from the Company’s Quarterly Report on Form 10-Q, for the period ended March 31, 2023, formatted in XBRL (Extensible Business Reporting Language): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations and Comprehensive Loss, (iii) Consolidated Statements of Cash Flows, (iv) Notes to Consolidated Financial Statements |
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||||||||||
101.INS |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema Document |
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101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF |
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Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB |
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Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document |
||||||||||
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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* Furnished herewith
32
SIGNATURES
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 thereunto duly authorized.
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BIOLASE, INC. |
|||
|
|
|
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(Registrant) |
|||
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|
|
May 11, 2023 |
|
By: |
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/s/ JOHN R. BEAVER |
||
|
Date |
|
|
|
John R. Beaver |
||
|
|
|
|
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President and Chief Executive Officer |
||
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|
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|
|
|
|
(Principal Executive Officer) |
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May 11, 2023 |
|
|
|
/s/ JENNIFER BRIGHT |
||
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Date |
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|
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Jennifer Bright |
||
|
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|
|
Chief Financial Officer |
||
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(Principal Financial Officer and Principal Accounting Officer) |
33