UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
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)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
(Address of principal executive offices) |
(Zip Code) |
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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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 April 28, 2023, the registrant had
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PART I. |
FINANCIAL INFORMATION |
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Item 1. |
6 |
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6 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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8 |
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10 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
11 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
27 |
Item 3. |
36 |
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Item 4. |
36 |
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PART II. |
OTHER INFORMATION |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
The following discussion and analysis should be read together with our condensed consolidated financial statements and the condensed notes to those statements included elsewhere in this report. This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, that are based on our management’s beliefs and assumptions and on information currently available to our management. In this report, “we,” “us” and “our” refer to RxSight, Inc., a Delaware corporation, and its consolidated subsidiaries.
Forward-looking statements include, but are not limited to, statements concerning the following:
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Forward-looking statements include statements that are not historical facts and can be identified by terminology such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” or “continue,” or the negative of such terms and other same terminology.
Forward-looking statements involve known and unknown risks, uncertainties, and other 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. We discuss these risks in greater detail in Part II, Item 1A, “Risk Factors,” elsewhere in this report. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for us to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
The forward-looking statements made in this report relate only to events as of the date on which the statements are made. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
DISCUSSION AND ANALYSIS OF OUR FINANCIAL CONDITION
Our discussion and analysis of our financial condition and results of operations is based upon our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate our estimates including those related to revenue recognition, the realization of income tax assets and estimates of tax liabilities, and obsolete, excess and slow-moving inventory. We base our estimates on historical experience and on various other assumptions we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities not readily apparent from other sources. Actual results may differ materially from these estimates. Our critical accounting policies and estimates are discussed in the Company’s Annual Report on Form 10-K filed with the SEC on March 6, 2023.
INDUSTRY, BUSINESS AND MARKET DATA
This report also contains estimates, projections and other information concerning our industry, our business, and market opportunity, including data regarding the estimated size of the market. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources.
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TRADEMARKS, SERVICE MARKS AND TRADE NAMES
This report contains references to trademarks and service marks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this report may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that the applicable licensor will not assert, to the fullest extent under applicable law, its rights to these trademarks and trade names. We do not intend our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of it by, any other companies.
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Item 1: Financial Statements (Unaudited)
RxSIGHT, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
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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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(Unaudited) |
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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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Short-term investments |
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Accounts receivable |
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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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Operating leases right-of-use assets |
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Restricted cash |
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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 expenses and other current liabilities |
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Lease liabilities |
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Total current liabilities |
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Long-term lease liabilities |
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Term loan, net |
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Total liabilities |
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) |
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Stockholders' equity: |
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Common stock, $ |
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Preferred stock, $ |
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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 and stockholders' equity |
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$ |
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$ |
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See accompanying notes to unaudited condensed consolidated financial statements.
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RxSIGHT, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS (UNAUDITED)
(In thousands, except share and per share amounts)
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Three Months Ended March 31, |
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2023 |
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2022 |
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Sales |
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$ |
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$ |
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Cost of sales |
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Gross profit |
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Operating expenses: |
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Selling, general and administrative |
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Research and development |
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Total operating expenses |
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Loss from operations |
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( |
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Other income (expense), net: |
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Interest expense |
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( |
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Interest and other income |
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Loss before income taxes |
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( |
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Income tax expense |
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Net loss |
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$ |
( |
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$ |
( |
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Other comprehensive income (loss) |
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Unrealized gain (loss) on short-term investments |
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( |
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Foreign currency translation gain (loss) |
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( |
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Total other comprehensive income (loss) |
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( |
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Comprehensive loss |
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$ |
( |
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$ |
( |
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Net loss per share: |
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Basic & diluted |
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$ |
( |
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$ |
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Weighted-average shares used in computing net loss per share: |
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Attributable to common stock, basic & diluted |
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See accompanying notes to unaudited condensed consolidated financial statements.
7 |
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RxSIGHT, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(UNAUDITED)
(In thousands, except number of shares)
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Three Months Ended March 31, 2023 |
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Common stock |
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Additional paid-in |
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Accumulated other |
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Accumulated |
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Total stockholders' |
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Shares |
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Amount |
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capital |
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comprehensive loss |
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deficit |
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equity |
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Balance at 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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Shares issued for the exercise of stock options |
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— |
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— |
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— |
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Shares redeemed for employee tax withholdings |
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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 expense |
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— |
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— |
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— |
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— |
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Issuance of common stock for public offering, net of underwriting discounts, commissions and offering costs |
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— |
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— |
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Issuance of common stock for at-the-market offerings, |
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— |
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— |
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Unrealized gain on short-term investments |
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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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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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( |
) |
Balance at 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 condensed consolidated financial statements
8 |
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RxSIGHT, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(UNAUDITED)
(In thousands, except number of shares)
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Three Months Ended March 31, 2022 |
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Common stock |
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Additional paid-in |
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Accumulated other |
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Accumulated |
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Total stockholders' |
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Shares |
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Amount |
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capital |
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comprehensive loss |
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deficit |
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equity |
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Balance at 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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Shares issued for the exercise of stock options |
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— |
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— |
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— |
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Shares redeemed for employee tax withholdings |
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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 expense |
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— |
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— |
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— |
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— |
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Unrealized loss on short-term investments |
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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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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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Balance at 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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See accompanying notes to unaudited condensed consolidated financial statements
9 |
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RxSIGHT, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(In thousands)
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Three Months Ended March 31, |
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2023 |
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2022 |
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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 and amortization |
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Amortization of right-of-use lease assets |
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Amortization of debt issuance costs and premium |
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Amortization of discount on short-term investments |
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( |
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( |
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Stock-based compensation |
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Provision for excess and obsolete inventory |
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Change in operating assets and liabilities: |
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Accounts receivable |
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( |
) |
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( |
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Inventories |
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( |
) |
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( |
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Prepaid and other assets |
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( |
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Accounts payable |
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Accrued expenses and other liabilities |
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( |
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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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Investing Activities: |
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Purchase of property and equipment |
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( |
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( |
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Maturity of short-term investments |
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Purchases of short-term investments |
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( |
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( |
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Net cash (used in) provided by investing activities |
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( |
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Financing Activities: |
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Proceeds from exercise of stock options |
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Proceeds from issuance of common stock from public offering |
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Proceeds from issuance of common stock for at-the-market offerings |
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Payments for employee taxes related to stock compensation |
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( |
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( |
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Principal payments on finance lease liabilities |
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( |
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( |
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Payments of deferred offering costs |
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( |
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Net cash provided by (used in) financing activities |
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( |
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Effect of foreign exchange rate on cash, cash equivalents and restricted cash |
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( |
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Net decrease in cash, cash equivalents and restricted cash |
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( |
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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 disclosure of cash flow information: |
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Cash paid for amounts included in the measurement of lease liabilities: |
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Operating cash flows from operating leases |
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Cash paid for income taxes |
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Cash paid for interest on financing leases |
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Cash paid for interest on term loan |
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Non-cash investing and financing activities: |
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Right-of-use assets obtained in exchange for lease obligations: |
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Operating lease |
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Finance lease |
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Lease obligations recorded for right-of-use assets: |
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Operating lease |
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Finance lease |
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Acquisition of property and equipment included in accounts payable and accrued expenses |
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Deferred offering costs included in accounts payable and accrued liabilities |
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Reclassification of deferred financing costs |
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( |
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See accompanying notes to unaudited condensed consolidated financial statements.
10 |
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RxSIGHT, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 1 - Organization and Basis of Presentation
Description of Business
RxSight®, Inc. (the “Company”) is a Delaware corporation headquartered in Aliso Viejo, California with
The Company’s products, which include the light adjustable lens (“LAL®”) and a specially designed machine for delivering light to the eye, the Light Delivery Device (“LDD”), are approved by the United States (“U.S.”) Food and Drug Administration (“FDA”) primarily for sale in the U.S. and have regulatory approval in the U.S., Europe, Canada and Mexico. The Company began marketing its products in 2019. The LAL is a premium intraocular lens (“IOL”) which is partially reimbursable under Medicare. The Company competes with other IOLs in the premium market.
The accompanying unaudited condensed consolidated financial statements include the accounts of RxSight, Inc. and its wholly owned subsidiaries, RxSight, B.V. and RxSight GmbH. All significant inter-company balances and transactions have been eliminated in consolidation.
Basis of Presentation and Principles of Consolidation
The Company’s condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”). Accordingly, the accompanying unaudited condensed consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The unaudited interim financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The December 31, 2022 balance sheet data was derived from audited financial statements; however, the accompanying notes to the condensed consolidated financial statements do not include all of the annual disclosures required under GAAP and should be read in conjunction with the audited consolidated financial statements included in the Company’s 2022 Annual Report on Form 10-K filed with the SEC on March 6, 2023. The operating results presented in these unaudited condensed consolidated financial statements are not necessarily indicative of the results that may be expected for any future periods.
Operating Segments
The Company determined its operating segment on the same basis that it uses to evaluate its performance internally. The Company’s chief operating decision-maker (“CODM”), its Chief Executive Officer, reviews its consolidated operating results for the purpose of allocating resources and evaluating financial performance.
The Company determined that it operates and manages its business (including its non-U.S. subsidiaries) in
Liquidity
Shelf Registration Statement
On August 8, 2022, the Company filed a $
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Company also filed a prospectus supplement to sell up to an aggregate value of $
ATM Offering
As of March 31, 2023, through the ATM offering, a total of
Public Offering
On
As of March 31, 2023 and December 31, 2022 the Company had cash, cash equivalents and short-term investments of $
The Company began generating revenue from its principal operations in 2019. The Company has a limited operating history, and the revenue and income potential of the Company’s business and market are unproven. The Company has experienced recurring net losses and negative cash flows from operating activities since its inception. For the three months ended March 31, 2023 and 2022, the Company incurred losses from operations of $
The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company believes that existing cash resources will be sufficient to meet projected operating requirements for at least 12 months from the date of issuance of the accompanying condensed consolidated financial statements, though the Company expects to continue to incur operating losses and negative cash flows. The Company plans to continue to fund its losses fr