UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For the quarterly period ended
or
For the transition period from to
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Securities registered pursuant to Section 12(b) of the Act:
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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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Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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 April 30, 2023, there were
Table of Contents
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Condensed Statements of Changes in Stockholders’ Equity (Unaudited) |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (the “Quarterly Report”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Quarterly Report, including without limitation statements regarding our business model and strategic plans for our products, technologies and business, including our implementation thereof; the impact on our business, financial condition and results of operation from the global COVID-19 pandemic and related macroeconomic conditions; the timing of and our ability to obtain and maintain regulatory approvals and certifications; our expectations about our ability to successfully develop and commercialize our next generation system, the ALLY® Adaptive Cataract Treatment System (“ALLY System”), and the timing thereof; the sufficiency of our cash and cash equivalents; and the plans and objectives of management for future operations and capital expenditures are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
Without limiting the foregoing, in some cases, you can identify forward-looking statements by terms such as “aim”, “may,” “will,” “should,” “expect,” “exploring,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “seeks,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. No forward-looking statement is a guarantee of future results, performance, or achievements, and one should avoid placing undue reliance on such statements.
Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified in Part I. Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and Part II. Item 1A. “Risk Factors” in this Quarterly Report. These risks and uncertainties include, but are not limited to:
iii
Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.
You should read this Quarterly Report and the documents that we reference in this Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we have no obligation to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Unless otherwise stated or the context requires otherwise, references to “LENSAR,” the “Company,” “we,” “us,” and “our,” refer to LENSAR, Inc.
We own or have rights to certain trademarks, trade names, copyrights and other intellectual property used in our business, including LENSAR, the LENSAR logo, LENSAR Cataract Laser with Augmented Reality logo, Streamline, IntelliAxis, IntelliAxis Refractive Capsulorhexis, and ALLY Adaptive Cataract Treatment System, each of which is considered a trademark. All other company names, product names, trade names and trademarks included in this Quarterly Report are trademarks, registered trademarks or trade names of their respective owners.
iv
RISK FACTOR SUMMARY
Our business is subject to numerous risks and uncertainties, including those described in Part II, Item 1A. “Risk Factors” in this Quarterly Report. You should carefully consider these risks and uncertainties when investing in our common stock. The principal risks and uncertainties affecting our business include the following:
v
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements.
LENSAR, Inc.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share amounts)
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Three Months Ended |
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2023 |
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2022 |
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Revenue |
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Product |
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$ |
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$ |
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Lease |
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Service |
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Total revenue |
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Cost of revenue (exclusive of amortization) |
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Product |
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Lease |
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Service |
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Total cost of revenue |
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Operating expenses |
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Selling, general and administrative expenses |
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Research and development expenses |
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Amortization of intangible assets |
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Operating loss |
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( |
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( |
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Other income |
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Other income, net |
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Net loss |
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$ |
( |
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$ |
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Net loss per share: |
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Basic and diluted |
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$ |
( |
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$ |
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Weighted-average number of shares used in calculation of net loss per share: |
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Basic and diluted |
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The accompanying notes are an integral part of these condensed financial statements
1
LENSAR, Inc.
CONDENSED BALANCE SHEETS
(Unaudited)
(In thousands, except per share amounts)
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March 31, 2023 |
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December 31, 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, net of allowance of $ |
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Notes receivable, net of allowance of $ |
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Inventories |
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Prepaid and other current assets |
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Total current assets |
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Property and equipment, net |
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Equipment under lease, net |
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Notes and other receivables, long-term, net of allowance of $ |
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Intangible assets, net |
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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 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 |
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Operating lease liabilities |
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Total current liabilities |
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Long-term operating lease liabilities |
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Other long-term liabilities |
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Total liabilities |
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(Note 8) |
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Stockholders’ equity: |
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Preferred stock, par value $ |
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Common stock, par value $ |
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Additional paid-in capital |
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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 and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed financial statements
2
LENSAR, Inc.
CONDENSED 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 used in operating activities: |
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Depreciation |
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Amortization of intangible assets |
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Non-cash operating lease cost |
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Provision for expected credit losses |
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( |
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Stock-based compensation expense |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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Prepaid and other current assets |
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( |
) |
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Inventories |
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( |
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Accounts payable |
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( |
) |
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Accrued liabilities |
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( |
) |
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( |
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Other |
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( |
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Net cash 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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Purchase of property and equipment |
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( |
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( |
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Net cash used in investing activities |
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( |
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( |
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Net decrease in cash and cash equivalents |
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( |
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( |
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Cash and cash equivalents at beginning of the period |
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Cash and cash equivalents at end of the period |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed financial statements
3
LENSAR, Inc.
CONDENSED STATEMENTS OF CASH FLOWS, continued
(Unaudited)
(In thousands)
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Three Months Ended |
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2023 |
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2022 |
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Supplemental cash flow information |
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Cash paid for interest |
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$ |
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$ |
— |
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Supplemental schedule of non-cash investing and financing activities |
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Transfer from Inventories to Equipment under lease, net |
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$ |
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$ |
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Transfer from (to) Inventories to (from) Property and equipment, net |
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$ |
( |
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$ |
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The accompanying notes are an integral part of these condensed financial statements
4
LENSAR, Inc.
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
(In thousands)
|
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Common Stock |
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Additional |
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Accumulated |
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Total |
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Shares |
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Amount |
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Capital |
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Deficit |
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Equity |
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Balance as of December 31, 2022 |
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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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Common stock issued |
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— |
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— |
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— |
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— |
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Restricted stock awards cancelled |
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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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( |
) |
Balance as of March 31, 2023 |
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$ |
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$ |
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$ |
( |
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$ |
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Additional |
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Total |
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Common Stock |
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Paid-in |
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Accumulated |
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Stockholders’ |
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Shares |
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Amount |
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Capital |
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Deficit |
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Equity |
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Balance as of December 31, 2021 |
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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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Restricted stock awards cancelled |
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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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( |
) |
Balance as of March 31, 2022 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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The accompanying notes are an integral part of these condensed financial statements
5
NOTES TO CONDENSED INTERIM FINANCIAL STATEMENTS
(Unaudited)
(Dollars and shares in thousands)
Note 1. Overview and Basis of Presentation
Overview and Organization
LENSAR, Inc. (“LENSAR” or the “Company”) is a global medical device business focused on the design, development and commercialization of advanced technology for the treatment of cataracts and management of astigmatism to achieve improved visual outcomes for patients. The Company is a public company whose stock is listed and trading under the symbol “LNSR” on The Nasdaq Stock Market LLC (“Nasdaq”). The Company’s revenue is derived from the sale and lease of the Company’s laser systems, which may include equipment, a consumable referred to as the Patient Interface Device (“PID”), procedure licenses, training, installation, limited warranty and maintenance agreements through extended warranty. The Company has developed its next-generation ALLY® Adaptive Cataract Treatment System (“ALLY System”), which combines all of the features from the LENSAR Laser System with a dual-pulse laser, integrated in a small, compact cataract treatment system that is designed to allow surgeons to perform a sterile femtosecond laser assisted cataract procedure in a single operating room or in-office surgical suite. The ALLY System, which has received clearance from the U.S. Food and Drug Administration (“FDA”), enables cataract surgeons to complete the femtosecond-laser-assisted cataract surgery (“FLACS”) procedure in a single, sterile environment. The Company executed a controlled and targeted initial launch of the ALLY System beginning in August 2022. The ALLY System is now available to U.S. cataract surgeons and has also received regulatory clearance in India. In addition, we submitted the ALLY System for certification in the European Union, or EU, in September 2022 and intend to submit additional marketing or certification applications outside the United States in an effort to commercialize the ALLY System in additional countries and operating regions. The Company’s ability to place systems in 2022 was limited by supply chain constraints that delayed the delivery of certain ALLY System raw materials and the completion and testing of ALLY Systems for use as launch-stock inventory.
The Company has incurred recurring losses and operating cash outflows since its inception and, as of March 31, 2023, had an accumulated deficit of $
Management believes the Company’s cash and cash equivalents on hand, together with cash generated from the future sale and lease of products and expected issuance and sale of preferred stock and warrants, will provide sufficient funds for its operating, investing, and financing cash flows for a period of at least twelve months from the date of issuance of these financial statements. Refer to Note 12, Subsequent Event, for further details related to the Company’s entrance into a Securities Purchase Agreement, dated as of
6
NOTES TO CONDENSED INTERIM FINANCIAL STATEMENTS
(Unaudited)
(Dollars and shares in thousands)
Basis of Presentation
These condensed financial statements of the Company are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and pursuant to the regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information and, therefore, omit or condense certain footnotes and other information normally included. The condensed financial statements include all adjustments (consisting only of normal recurring adjustments) that management of the Company believes are necessary for a fair statement of the periods presented. These interim financial results are not necessarily indicative of results expected for the full fiscal year. The December 31, 2022 condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP.
The accompanying unaudited condensed financial statements and related financial information should be read in conjunction with the Company’s annual audited financial statements and the related notes thereto for the fiscal year ended December 31, 2022, included in the Annual Report on Form 10-K (the “Annual Report”) as filed with the SEC.
Note 2. Summary of Significant Accounting Policies
Other than policies noted below, there have been no significant changes to the significant accounting policies disclosed in Note 2, Summary of Significant Accounting Policies, of the annual audited financial statements included in the Annual Report.
Accounting Estimates
The preparation of condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes to the condensed financial statements. The accounting estimates that require management’s most significant, difficult and subjective judgments include, but are not limited to, revenue recognition and allowance for expected credit losses, the valuation of notes receivable and inventory, the assessment of recoverability of intangible assets and their estimated useful lives, the valuation and recognition of stock-based compensation, operating lease right-of-use assets and liabilities, and the recognition and measurement of current and deferred income tax assets and liabilities. Management evaluates its estimates on an ongoing basis as there are changes in circumstances, facts, and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from these estimates.
The COVID-19 pandemic and global macroeconomic conditions originating during the pandemic continue to directly and indirectly impact the Company’s business, results of operations and financial condition, including revenue, expenses, reserves and allowances. The Company continues to monitor developments that are highly uncertain, including supply chain disruptions and price increases, as well as the economic impact on domestic and international suppliers, customers, and markets. The Company assessed certain accounting matters that require consideration of forecasted financial information, including, but not limited to, its current expected credit losses, the carrying value of the Company's intangible assets and other long-lived assets, and valuation allowances in context with the information reasonably available to the Company and the unknown future impacts of COVID-19 as of March 31, 2023 and through the date of this report. As a result of these assessments, there were no impairments or material increases in expected credit losses or valuation allowances that impacted the Company's condensed financial statements as of and for the three months ended March 31, 2023 and 2022. However, the Company's future assessment of the magnitude and duration of COVID-19, as well as other factors, could result in material impacts to the condensed financial statements in future reporting periods.
As of the date of issuance of these unaudited condensed interim financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update estimates, judgments or revise the carrying value of any assets or liabilities.
Fair Value Measurement
The fair value of the Company’s financial instruments are estimates of the amounts that would be received if the Company were to sell an asset or the Company paid to transfer a liability in an orderly transaction between market participants at the measurement date or exit price. The assets and liabilities are categorized and disclosed in one of the following three categories:
7
NOTES TO CONDENSED INTERIM FINANCIAL STATEMENTS
(Unaudited)
(Dollars and shares in thousands)
Fair value measurements are classified in their entirety based on the lowest level of input that is significant to their fair value measurement.
The carrying value of the Company’s cash, cash equivalents, accounts receivable, accounts payable, accrued liabilities, and other current liabilities approximate fair value based on the short-term maturities of these instruments. The carrying value of the Company’s notes receivable also approximates fair value based on the associated credit risk.
Income Taxes
Income tax expense/(benefit) from continuing operations for the three months ended March 31, 2023 and 2022 was $
Recently Issued Accounting Pronouncements Not Yet Adopted
The Company reviewed recent pronouncements issued by the FASB and other authoritative standards groups with future effective dates and concluded the pronouncements are either not applicable to the Company or are not expected to have a material impact on the Company’s financial position or results of operations.
Note 3. Revenue from Contracts with Customers
Disaggregation of Revenue
The following table summarizes the Company’s product and service revenue disaggregated by geographic region, which is determined based on customer location, for the three months ended March 31, 2023 and 2022:
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Three Months Ended |
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2023 |
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2022 |
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United States |
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$ |
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$ |
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South Korea |
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Europe |
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Asia (excluding South Korea) |
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Other |
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Total1 |
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$ |
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$ |
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Contract Balances
The following table provides information about receivables and contract liabilities from contracts with customers:
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Classification |
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As of |
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As of |
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Accounts receivable, current |
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Accounts receivable, net |
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$ |
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$ |
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Notes receivable, current |
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Notes receivable, net |
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$ |
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$ |
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Notes receivable, long-term |
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Notes and other receivables, long-term, net |
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$ |
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$ |
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Contract asset, current |
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Prepaid and other current assets |
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$ |
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$ |
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Deferred revenue, current |
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Deferred revenue |
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$ |
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$ |
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Deferred revenue, non-current |
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Other long-term liabilities |
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$ |
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$ |
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Contract liability, long-term |
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Other long-term liabilities |
|
$ |
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$ |
|
Accounts Receivables, Net – Accounts receivables, net, include amounts billed and due from customers. The amounts due are stated at their net estimated realizable value and are classified as current or noncurrent based on the timing of when the Company expects to receive payment. Most customers are on pre-paid or
8
NOTES TO CONDENSED INTERIM FINANCIAL STATEMENTS
(Unaudited)
(Dollars and shares in thousands)
maintains an allowance for expected credit losses to provide for the estimated amount of receivables that will not be collected. The allowance is based upon an assessment of customer credit worthiness, historical payment experience, the age of outstanding receivables, collateral to the extent applicable and reflects the possible impact of current conditions and reasonable forecasts not already reflected in historical loss information.
The following table summarizes the activity in the allowance for accounts receivable:
|
|
Amount |
|
|
Accounts receivable, allowance for credit losses as of |
|
$ |
|
|
Provision for credit losses |
|
|
( |
) |
Write-offs |
|
|
|
|
Accounts receivable, allowance for credit losses as of |
|
$ |
|
|
|
|
|
|
|
Accounts receivable, allowance for credit losses as of |
|
$ |
|
|
Provision for credit losses |
|
|
|
|
Write-offs |
|
|
( |
) |
Accounts receivable, allowance for credit losses as of |
|
$ |
|
Notes Receivables, Net – Notes receivable, net includes amounts billed and due from customers under extended payment terms with a significant financing component. Interest rates on notes receivable range from
The following table summarizes the activity in the allowance for notes receivable:
|
|
Amount |
|
|
Notes receivable, allowance for credit losses as of |
|
$ |
|
|
Provision for credit losses |
|
|
|
|
Write-offs |
|
|
|
|
Notes receivable, allowance for credit losses as of |
|
$ |
|
|
|
|
|
|
|
Notes receivable, allowance for credit losses as of |
|
$ |
|
|
Provision for credit losses |
|
|
|
|
Write-offs |
|
|
( |
) |
Notes receivable, allowance for credit losses as of |
|
$ |
|
Contract Assets – The Company's contract assets represent revenue recognized for performance obligations completed before an unconditional right to payment exists, and therefore invoicing has not yet occurred. The Company classifies contract assets in Prepaid and other current assets in the Company's condensed balance sheets.
The following table provides information about contract assets from contracts with customers:
|
|
Amount |
|
|
Contract assets as of December 31, 2022 |
|
$ |
|
|
Contract assets recognized |
|
|
|
|
Payments received |
|
|
( |
) |
Contract assets as of March 31, 2023 |
|
$ |
|
9
NOTES TO CONDENSED INTERIM FINANCIAL STATEMENTS
(Unaudited)
(Dollars and shares in thousands)
Contract Liabilities – The Company’s contract liabilities represent services and products sold to customers for which the performance obligation has not been completed by the Company. The Company classifies contract liabilities as current or noncurrent based on the timing of when it expects to recognize revenue. The noncurrent portion of contract liabilities is included in other long-term liabilities in the Company’s condensed balance sheets.
The following table provides information about contract liabilities from contracts with customers:
|
|
Amount |
|
|
Contract liabilities as of December 31, 2022 |
|
$ |
|
|
Billings not yet recognized as revenue |
|
|
|
|
Beginning contract liabilities recognized as revenue |
|
|
( |
) |
Contract liabilities as of March 31, 2023 |
|
$ |
|
|
|
|
|
|
|
Contract liabilities as of December 31, 2021 |
|
$ |
|
|
Billings not yet recognized as revenue |
|
|
|
|
Beginning contract liabilities recognized as revenue |
|
|
( |
) |
Contract liabilities as of March 31, 2022 |
|
$ |
|
Transaction Price Allocated to Future Performance Obligations
At March 31, 2023, the revenue expected to be recognized in future periods related to performance obligations that are unsatisfied for executed contracts with an original duration of one year or more was approximately $
Note 4. Inventories
Inventory balances were as follows:
|
|
As of |
|
|
As of |
|
||
Finished Goods |
|
$ |
|
|
$ |
|
||
Work-in-process |
|
|
|
|
|
|
||
Raw Materials |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
Note 5. Leases
Lessor Arrangements
The Company has operating leases for the LENSAR Laser System. The Company’s leases have remaining lease terms of less than
|
|
Three Months Ended |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Lease revenue |
|
$ |
|
|
$ |
|
10
NOTES TO CONDENSED INTERIM FINANCIAL STATEMENTS
(Unaudited)
(Dollars and shares in thousands)
Note 6. Intangible Assets
The components of intangible assets were as follows:
|
|
As of March 31, 2023 |
|
|
As of December 31, 2022 |
|
||||||||||||||||||
|
|
Gross |
|
|
Accumulated |
|
|
Net |
|
|
Gross |
|
|
Accumulated |
|
|
Net |
|
||||||
Finite-lived intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Customer relationships 1,2 |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |