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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| | | | | |
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2024
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 001-40797
PROCEPT BioRobotics Corporation
(Exact name of registrant as specified in its charter)
| | | | | | | | | | | |
Delaware | | 26-0199180 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
| |
150 Baytech Drive | San Jose | CA | 95134 |
(Address of Principal Executive Offices) | | (Zip Code) |
(650) 232-7200
(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common stock, $0.00001 par value per share | PRCT | Nasdaq Global 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. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically Interactive Data File required to be submitted and posted 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 and post such files). Yes ☒ No ☐
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”, and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
| | | | | | | | | | | |
Large accelerated filer | ☒ | Accelerated filer | ☐ |
Non-accelerated filer | ☐ | Smaller reporting company | ☐ |
| | 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 Act). Yes ☐ No ☒
The registrant had outstanding 52,183,184 shares of common stock as of October 23, 2024.
PROCEPT BioRobotics Corporation
Form 10-Q – QUARTERLY REPORT
For the Quarter Ended September 30, 2024
TABLE OF CONTENTS
__________________
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “can”, “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. 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 timing of and our ability to obtain and maintain regulatory approvals, our commercialization, marketing and manufacturing capabilities and strategy, our expectations about the commercial success and market acceptance of our products, the sufficiency of our cash, cash equivalents and short-term investments, and the plans and objectives of management for future operations and capital expenditures are forward-looking statements.
The forward-looking statements in this Quarterly Report are only predictions and are based largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of known and unknown risks, uncertainties, and assumptions, including those described under the sections in this Quarterly Report entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management 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 Quarterly Report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely upon these forward-looking statements as predictions of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, performance, or achievements. Except as required by applicable law, we do not plan 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. We intend the forward-looking statements contained in this Quarterly Report 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”).
PROCEPT BioRobotics Corporation
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except per share data)
(unaudited)
| | | | | | | | | | | | | |
| September 30, | | December 31, | | |
| 2024 | | 2023 | | |
| | | | | |
Assets | | | | | |
Current assets: | | | | | |
Cash and cash equivalents | $ | 196,762 | | | $ | 257,222 | | | |
Accounts receivable, net | 69,048 | | | 48,376 | | | |
Inventory | 50,850 | | | 39,756 | | | |
Prepaid expenses and other current assets | 6,321 | | | 5,213 | | | |
Total current assets | 322,981 | | | 350,567 | | | |
Restricted cash, non-current | 3,038 | | | 3,038 | | | |
Property and equipment, net | 26,605 | | | 28,748 | | | |
Operating lease right-of-use assets, net | 19,267 | | | 20,241 | | | |
Intangible assets, net | 1,000 | | | 1,204 | | | |
Other assets | 1,251 | | | 919 | | | |
| | | | | |
Total assets | $ | 374,142 | | | $ | 404,717 | | | |
Liabilities and Stockholders' Equity | | | | | |
Current liabilities: | | | | | |
Accounts payable | $ | 15,088 | | | $ | 13,499 | | | |
Accrued compensation | 18,834 | | | 16,885 | | | |
Deferred revenue | 7,989 | | | 5,656 | | | |
| | | | | |
Operating lease, current | 1,839 | | | 1,683 | | | |
Loan facility derivative liability | 2,000 | | | 1,886 | | | |
Other current liabilities | 7,896 | | | 6,318 | | | |
Total current liabilities | 53,646 | | | 45,927 | | | |
Long-term debt | 51,438 | | | 51,339 | | | |
Operating lease, non-current | 27,361 | | | 26,182 | | | |
Other liabilities | 479 | | | 517 | | | |
| | | | | |
Total liabilities | 132,924 | | | 123,965 | | | |
Commitments and contingencies (see Note 11) | | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
Stockholders’ equity: | | | | | |
Preferred stock, $0.00001 par value; | | | | | |
Authorized shares: 10,000 at September 30, 2024 and December 31, 2023 | | | | | |
Issued and outstanding shares: none at September 30, 2024 and December 31, 2023 | — | | | — | | | |
Common stock, $0.00001 par value; | | | | | |
Authorized shares: 300,000 at September 30, 2024 and December 31, 2023 | | | | | |
Issued and outstanding shares: 52,146 and 50,771 at September 30, 2024 and December 31, 2023, respectively | — | | | — | | | |
Additional paid-in capital | 768,365 | | | 735,240 | | | |
Accumulated other comprehensive gain (loss) | (18) | | | 84 | | | |
Accumulated deficit | (527,129) | | | (454,572) | | | |
Total stockholders’ equity | 241,218 | | | 280,752 | | | |
Total liabilities and stockholders’ equity | $ | 374,142 | | | $ | 404,717 | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
PROCEPT BioRobotics Corporation
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, | |
| 2024 | | 2023 | | 2024 | | 2023 | | | | |
| | | | | | | | | |
Revenue | $ | 58,370 | | | $ | 35,102 | | | $ | 156,262 | | | $ | 92,610 | | | | | |
Cost of sales | 21,459 | | | 16,228 | | | 62,835 | | | 42,816 | | | | | |
Gross profit | 36,911 | | | 18,874 | | | 93,427 | | | 49,794 | | | | | |
Operating expenses: | | | | | | | | | | | |
Research and development | 16,647 | | | 11,600 | | | 47,232 | | | 33,950 | | | | | |
Selling, general and administrative | 42,691 | | | 32,883 | | | 123,099 | | | 95,457 | | | | | |
Total operating expenses | 59,338 | | | 44,483 | | | 170,331 | | | 129,407 | | | | | |
Loss from operations | (22,427) | | | (25,609) | | | (76,904) | | | (79,613) | | | | | |
Interest expense | (1,140) | | | (1,019) | | | (3,215) | | | (2,870) | | | | | |
Interest and other income, net | 2,593 | | | 2,006 | | | 7,562 | | | 4,090 | | | | | |
Net loss | $ | (20,974) | | | $ | (24,622) | | | $ | (72,557) | | | $ | (78,393) | | | | | |
Net loss per share, basic and diluted | $ | (0.40) | | | $ | (0.51) | | | $ | (1.41) | | | $ | (1.70) | | | | | |
Weighted-average common shares used to | | | | | | | | | | | |
compute net loss per share attributable to | | | | | | | | | | | |
common shareholders, basic and diluted | 52,011 | | | 48,310 | | | 51,550 | | | 46,131 | | | | | |
Other comprehensive gain (loss): | | | | | | | | | | | |
Unrealized loss on cash equivalents | (17) | | | — | | | (102) | | | — | | | | | |
Comprehensive loss | $ | (20,991) | | | $ | (24,622) | | | $ | (72,659) | | | $ | (78,393) | | | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
PROCEPT BioRobotics Corporation
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-in Capital | | Accumulated Other Comprehensive Gain (Loss) | | Accumulated Deficit | | Total Stockholders' Equity |
| Shares | | Amount | | | | |
Balance at December 31, 2023 | 50,771 | | | $ | — | | | $ | 735,240 | | | $ | 84 | | | $ | (454,572) | | | $ | 280,752 | |
Issuance of common stock under stock plans | 622 | | | — | | | 2,586 | | | — | | | — | | | 2,586 | |
Stock-based compensation expense | — | | | — | | | 6,637 | | | — | | | — | | | 6,637 | |
Unrealized gain (loss) on cash equivalents | — | | | — | | | — | | | 29 | | | — | | | 29 | |
Net loss | — | | | — | | | — | | | — | | | (25,957) | | | (25,957) | |
Balance at March 31, 2024 | 51,393 | | | $ | — | | | 744,463 | | | 113 | | | (480,529) | | | 264,047 | |
Issuance of common stock under stock plans | 507 | | | — | | | 5,296 | | | — | | | — | | | 5,296 | |
Stock-based compensation expense | — | | | — | | | 8,176 | | | — | | | — | | | 8,176 | |
Unrealized gain (loss) on cash equivalents | — | | | — | | | — | | | (114) | | | — | | | (114) | |
Net loss | — | | | — | | | — | | | — | | | (25,626) | | | (25,626) | |
Balance at June 30, 2024 | 51,900 | | | $ | — | | | 757,935 | | | (1) | | | (506,155) | | | 251,779 | |
Issuance of common stock under stock plans | 246 | | | — | | | 1,715 | | | — | | | — | | | 1,715 | |
Stock-based compensation expense | — | | | — | | | 8,715 | | | — | | | — | | | 8,715 | |
Unrealized gain (loss) on cash equivalents | — | | | — | | | — | | | (17) | | | — | | | (17) | |
Net loss | — | | | — | | | — | | | — | | | (20,974) | | | (20,974) | |
Balance at September 30, 2024 | 52,146 | | | $ | — | | | $ | 768,365 | | | $ | (18) | | | $ | (527,129) | | | $ | 241,218 | |
| | | | | | | | | | | |
| | | | | | | | | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
PROCEPT BioRobotics Corporation
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-in Capital | | Accumulated Other Comprehensive Gain (Loss) | | Accumulated Deficit | | Total Stockholders' Equity |
| Shares | | Amount | | | | |
Balance at December 31, 2022 | 44,828 | | | $ | — | | | $ | 545,753 | | | $ | (6) | | | $ | (348,675) | | | $ | 197,072 | |
Issuance of common stock under stock plans | 181 | | | — | | | 380 | | | — | | | — | | | 380 | |
Stock-based compensation expense | — | | | — | | | 4,137 | | | — | | | — | | | 4,137 | |
Unrealized gain (loss) on cash equivalents | — | | | — | | | — | | | 21 | | | — | | | 21 | |
Net loss | — | | | — | | | — | | | — | | | (28,484) | | | (28,484) | |
Balance at March 31, 2023 | 45,009 | | | $ | — | | | $ | 550,270 | | | $ | 15 | | | $ | (377,159) | | | $ | 173,126 | |
Issuance of common stock under stock plans | 262 | | | — | | | 2,430 | | | — | | | — | | | 2,430 | |
Stock-based compensation expense | — | | | — | | | 5,652 | | | — | | | — | | | 5,652 | |
Unrealized gain (loss) on cash equivalents | — | | | — | | | — | | | (21) | | | — | | | (21) | |
Net loss | — | | | — | | | — | | | — | | | (25,285) | | | (25,285) | |
Balance at June 30, 2023 | 45,271 | | | $ | — | | | $ | 558,352 | | | $ | (6) | | | $ | (402,444) | | | $ | 155,902 | |
Issuance of common stock under stock plans | 117 | | | — | | | 414 | | | — | | | — | | | 414 | |
Issuance of common stock, net of issuance costs of 10,795 | 5,085 | | | — | | | 161,705 | | | — | | | — | | | 161,705 | |
Stock-based compensation expense | — | | | — | | | 5,957 | | | — | | | — | | | 5,957 | |
Unrealized gain (loss) on cash equivalents | — | | | — | | | — | | | — | | | — | | | — | |
Net loss | — | | | — | | | — | | | — | | | (24,622) | | | (24,622) | |
Balance at September 30, 2023 | 50,473 | | | $ | — | | | $ | 726,428 | | | $ | (6) | | | $ | (427,066) | | | $ | 299,356 | |
| | | | | | | | | | | |
| | | | | | | | | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
PROCEPT BioRobotics Corporation
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
| | | | | | | | | | | | | | | |
| Nine Months Ended September 30, | | |
| 2024 | | 2023 | | | | |
| | | | | |
Cash flows from operating activities: | | | | | | | |
Net loss | $ | (72,557) | | | $ | (78,393) | | | | | |
Adjustments to reconcile net loss to cash used in operating activities: | | | | | | | |
Depreciation and amortization | 3,781 | | | 2,489 | | | | | |
Stock-based compensation expense | 22,755 | | | 14,153 | | | | | |
Change in fair value of derivative liability | 114 | | | 80 | | | | | |
Non-cash lease adjustment | (287) | | | 123 | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
Inventory write-down | 1,281 | | | 995 | | | | | |
Provision for credit losses | 456 | | | — | | | | | |
Changes in operating assets and liabilities: | | | | | | | |
Accounts receivable | (21,128) | | | (19,349) | | | | | |
Inventory | (11,438) | | | (12,937) | | | | | |
Prepaid expenses and other current assets | (1,210) | | | 2,194 | | | | | |
Other assets | (334) | | | (365) | | | | | |
Accounts payable | 3,227 | | | (87) | | | | | |
Accrued compensation | 1,949 | | | (182) | | | | | |
Accrued interest expense | 100 | | | 93 | | | | | |
Deferred revenue | 2,295 | | | 2,668 | | | | | |
Reimbursements for leasehold improvements from operating leases | 2,596 | | | 4,989 | | | | | |
| | | | | | | |
Other liabilities | 1,578 | | | 319 | | | | | |
Net cash used in operating activities | (66,822) | | | (83,210) | | | | | |
Cash flows from investing activities: | | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
Purchases of property and equipment | (3,235) | | | (16,491) | | | | | |
Net cash used in investing activities | (3,235) | | | (16,491) | | | | | |
Cash flows from financing activities: | | | | | | | |
Proceeds from the issuance of common stock, net of issuance costs | — | | | 161,705 | | | | | |
Proceeds from issuance of common stock from the exercise of stock options | 7,474 | | | 1,507 | | | | | |
Proceeds from issuance of common stock under employee stock purchase plan | 2,123 | | | 1,717 | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
Net cash provided by financing activities | 9,597 | | | 164,929 | | | | | |
Net increase (decrease) in cash, cash equivalents and restricted cash | (60,460) | | | 65,228 | | | | | |
Cash, cash equivalents and restricted cash | | | | | | | |
Beginning of the period | 260,260 | | | 225,674 | | | | | |
End of the period | $ | 199,800 | | | $ | 290,902 | | | | | |
Reconciliation of cash, cash equivalents and restricted cash to balance sheets: | | | | | | | |
Cash and cash equivalents | $ | 196,762 | | | $ | 287,087 | | | | | |
Restricted cash | 3,038 | | | 3,815 | | | | | |
Cash, cash equivalents and restricted cash in balance sheets | $ | 199,800 | | | $ | 290,902 | | | | | |
Supplemental cash flow information | | | | | | | |
Interest paid | $ | 3,046 | | | $ | 3,052 | | | | | |
Non-cash investing and financing activities | | | | | | | |
| | | | | | | |
Transfer of evaluation or rental units from inventory to property and equipment, net | $ | 13 | | | $ | (123) | | | | | |
Property and equipment included in accounts payable and accrued expenses | $ | 25 | | | $ | 7,837 | | | | | |
| | | | | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
PROCEPT BioRobotics Corporation
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. Organization
Description of Business
PROCEPT BioRobotics Corporation, or the Company, is a surgical robotics company focused on advancing patient care by developing transformative solutions in urology. It develops, manufactures and sells robotic systems, including the AquaBeam Robotic System and HYDROS Robotic System, which are advanced, image-guided, surgical robotic systems for use in minimally invasive urologic surgery, with an initial focus on treating benign prostatic hyperplasia, or BPH. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. The Company’s robotic systems employ a single-use disposable handpiece to deliver the Company’s proprietary Aquablation therapy, which combines real-time, multi-dimensional imaging, personalized treatment planning, automated robotics and heat-free waterjet ablation for targeted and rapid removal of prostate tissue. The Company received U.S. Food and Drug Administration, or FDA, clearance in December 2017 to market its first generation robot system, the AquaBeam Robotic System, pursuant to a de novo classification. On August 30, 2023, the Company received 510(k) clearance from the FDA to remove the contraindication from its labeling that restricted Aquablation therapy from treating BPH in patients that also have an active diagnosis of prostate cancer. On August 20, 2024, the Company received 510(k) clearance from the FDA for its next generation robot system, HYDROS Robotic System.
2. Summary of Significant Accounting Policies
Basis of Preparation
The condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP, and pursuant to the rules and regulations of the United States Securities and Exchange Commission or SEC. These condensed consolidated financial statements include the accounts of the Company and its consolidated subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation.
Unaudited Interim Financial Statements
The accompanying balance sheet as of September 30, 2024, the statements of operations and comprehensive loss and cash flows for the three and nine months ended September 30, 2024 and 2023, and the statements of stockholders’ equity as of September 30, 2024 and 2023, are unaudited. The financial data and other information disclosed in these notes to the financial statements related to September 30, 2024, and the three and nine months ended September 30, 2024 and 2023, are also unaudited. The accompanying balance sheet as of December 31, 2023 has been derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K (“Annual Report”) filed with the Securities and Exchange Commission.
The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to a fair statement of the Company’s financial position as of September 30, 2024, and the results of its operations and cash flows for the three and nine months ended September 30, 2024 and 2023. The results for the three and nine months ended September 30, 2024, are not necessarily indicative of results to be expected for the year ending December 31, 2024, or for any other interim period or for any future year and should be read in conjunction with the annual consolidated financial statements included in the Company’s Annual Report.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the condensed consolidated financial statements. Management uses significant judgment when making estimates related to its
valuation of inventory and accounts receivable, stock-based compensation expense, right-of-use lease asset, lease liability, valuations of loan facility derivative liability, as well as certain accrued liabilities. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates.
Accounting Policies Update
Given the release of the next generation robotic system, HYDROS Robotic System, for a limited period and on a case by case basis, the Company may enter into arrangements with existing customers to sell a HYDROS Robotic System with an exchange of a previously purchased AquaBeam Robotic System for additional consideration. The Company accounts for these transactions under ASC 606 - Revenue from Contracts with Customers. For the three and nine months ended September 30, 2024, such transactions were not material.
Recent Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board or FASB, issued Accounting Standards Update, or ASU, 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, that requires disclosure of significant segment expenses that are regularly reviewed by the chief operating decision maker and included within each reported measure of segment profit or loss. The standard also requires disclosure of the composition of other segment items included in the measure of segment profit or loss that are not separately disclosed. The new standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company plans to adopt the ASU and related updates on January 1, 2025. The Company is evaluating the impact this ASU will have on its financial statement disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which includes amendments that further enhance income tax disclosures, primarily through standardization and disaggregation of rate reconciliation categories and income taxes paid by jurisdiction. The amendments are effective for all public entities for fiscal years beginning after December 15, 2024. Early adoption is permitted and should be applied either prospectively or retrospectively. The Company plans to adopt the ASU and related updates on January 1, 2025. The Company is evaluating the impact of this ASU will have on its financial statement disclosures.
3. Fair Value Measurements
The following is a summary of assets and liabilities measured at fair value on a recurring basis (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2024 | | December 31, 2023 | | |
| Level 1 | | Level 2 | | Level 3 | | Total | | Level 1 | | Level 2 | | Level 3 | | Total | | | | | | | | |
| | | | | | | | | | | | | | | | | |
Cash and cash equivalents: | | | | | | | | | | | | | | | | | | | | | | | |
Cash | $ | 12,948 | | | $ | — | | | $ | — | | | $ | 12,948 | | | $ | 6,609 | | | $ | — | | | $ | — | | | $ | 6,609 | | | | | | | | | |
Cash equivalents | 183,814 | | | — | | | — | | | 183,814 | | | 250,613 | | | — | | | — | | | 250,613 | | | | | | | | | |
Total cash and cash equivalents | $ | 196,762 | | | $ | — | | | $ | — | | | $ | 196,762 | | | $ | 257,222 | | | $ | — | | | $ | — | | | $ | 257,222 | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
Loan facility derivative liability | $ | — | | | $ | — | | | $ | 2,000 | | | $ | 2,000 | | | $ | — | | | $ | — | | | $ | 1,886 | | | $ | 1,886 | | | | | | | | | |
Cash equivalents consist primarily of money market deposit funds and U.S. treasury bills.
There were no transfers in and out of Level 3 during the nine months ended September 30, 2024 and year ended December 31, 2023.
The following table sets forth a summary of the changes in the estimated fair value of the Company’s loan facility derivative liability, classified as Level 3 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, | |
| 2024 | | 2023 | | 2024 | | 2023 | | | | |
| | | | | | | | | |
Beginning of the period | $ | 1,942 | | | $ | 1,832 | | | $ | 1,886 | | | $ | 1,779 | | | | | |
Change in fair value | 58 | | | 27 | | | 114 | | | 80 | | | | | |
End of the period | $ | 2,000 | | | $ | 1,859 | | | $ | 2,000 | | | $ | 1,859 | | | | | |
4. Inventory
Inventory consists of the following (in thousands):
| | | | | | | | | | | | | |
| September 30, | | December 31, | | |
| 2024 | | 2023 | | |
| | | | | |
Raw materials | $ | 14,188 | | | $ | 11,832 | | | |
Work-in-process | 9,482 | | | 6,047 | | | |
Finished goods | 27,180 | | | 21,877 | | | |
Total inventory | $ | 50,850 | | | $ | 39,756 | | | |
The Company reclassified $4.9 million associated with sub-assemblies from raw materials to work-in process in the December 31, 2023 balances to conform with current year presentation.
5. Property and Equipment, Net
Property and equipment, net, consist of the following (in thousands):
| | | | | | | | | | | | | |
| September 30, | | December 31, | | |
| 2024 | | 2023 | | |
| | | | | |
Laboratory, manufacturing and computer equipment, and furniture and fixtures | $ | 19,934 | | | $ | 15,610 | | | |
Rental equipment | 785 | | | 897 | | | |
Leasehold improvements | 12,454 | | | 12,362 | | | |
Construction in progress | 210 | | | 3,548 | | | |
Total property and equipment | 33,383 | | | 32,417 | | | |
Less: accumulated depreciation and amortization | (6,778) | | | (3,669) | | | |
Total property and equipment, net | $ | 26,605 | | | $ | 28,748 | | | |
6. Long-Term Debt
In October 2022, the Company entered into a loan and security agreement (“the Loan Agreement”) with Canadian Imperial Bank of Commerce, or CIBC. The Agreement provides for a senior secured term loan facility in the aggregate principal amount of $52.0 million (the "Term Loan Facility") which was borrowed in full.
The Term Loan Facility is scheduled to mature on the fifth anniversary of the closing date (the “Maturity Date”). The Agreement provides for interest-only payments on the Term Loan Facility for the first thirty-six months following the Maturity Date (the “Initial Interest-Only Period”). The Initial Interest-Only Period will be extended to an additional twelve months if the Company achieves either (i) $200.0 million or greater in revenue in any twelve-month period or (ii) $0 or greater in EBITDA (as defined in the Loan Agreement) in any six-month period. Thereafter, amortization payments on the Term Loan Facility will be payable monthly until the Maturity Date in monthly installments equal to 20% of the then outstanding principal amount of the Term Loan Facility divided by 12 plus any accrued and unpaid interest. The Company has the option to prepay the Term Loan Facility without any prepayment charge or fee.
The loan borrowed under the Term Loan Facility bears interest at an annual rate equal to the secured overnight financing rate or SOFR (calculated based on an adjustment of .10%, .15% and .25%, respectively, for one-month,
three-month or six-month term SOFR as of a specified date, subject to a floor of 1.5%) plus an applicable margin of 2.25%.
The obligations under the Loan Agreement are secured by substantially all of the Company's assets, including its intellectual property and by a pledge all of the Company's equity interests in its U.S. subsidiaries and 65% of the Company's equity interests in its non-U.S. subsidiaries that are directly owned by the Company. The Company is obligated to maintain in deposit accounts held at the lender the lesser of (i) $90.0 million or (ii) all of its non-operating cash and allow the Company to maintain cash or cash equivalents in excess of that amount with other financial institutions.
7. Stock-Based Compensation
Total stock-based compensation recognized, before taxes, are as follows (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, | |
| 2024 | | 2023 | | 2024 | | 2023 | | | |
| | | | | | | | |
Cost of sales | $ | 1,893 | | | $ | 660 | | | $ | 4,891 | | | $ | 1,730 | | | | |
Research and development | 2,146 | | | 1,375 | | | 5,446 | | | 3,506 | | | | |
Sales, general and administrative | 5,521 | | | 3,922 | | | 15,250 | | | 10,509 | | | | |
Stock-based compensation capitalized in inventory | (1,048) | | | (631) | | | (2,832) | | | (1,592) | | | | |
Total stock-based compensation | $ | 8,512 | | | $ | 5,326 | | | $ | 22,755 | | | $ | 14,153 | | | | |
Stock Options
The Company had 6.8 million shares available for grant as of September 30, 2024 under the 2021 Equity Incentive Award Plan or the 2021 Plan.
A summary of the Company’s stock option activity and related information are as follows (options in thousands):
| | | | | | | | | | | | | | | | | | | |
| Nine Months Ended | | | | | | |
| September 30, 2024 | | | | |
| | | | | | | | | |
| Number of Shares | | Weighted-Average Exercise Price | | | | | | | | |
Outstanding, beginning of period | 5,215 | | | $ | 9.42 | | | | | | | | | |
Granted | 173 | | | 50.13 | | | | | | | | | |
Exercised | (909) | | | 8.22 | | | | | | | | | |
Forfeited | (137) | | | 20.67 | | | | | | | | | |
Outstanding, end of period | 4,342 | | | 10.93 | | | | | | | | | |
Vested and expected to vest | 4,342 | | | 10.93 | | | | | | | | | |
Exercisable | 3,724 | | | 7.66 | | | | | | | | | |
As of September 30, 2024 and December 31, 2023, the aggregate pre-tax intrinsic value of options outstanding and exercisable was $271.4 million and $144.0 million, respectively, and the aggregate pre-tax intrinsic value of options outstanding were $300.4 million and $169.5 million, respectively. The aggregate pre-tax intrinsic value of options exercised was $47.2 million and $8.9 million during the nine months ended September 30, 2024 and 2023, respectively.
As of September 30, 2024, there was a total of $9.9 million of unrecognized stock-based compensation expense related to stock options.
The fair value of the options granted to employees or directors was estimated as of the grant date using the Black-Scholes model assuming the weighted-average assumptions listed in the following table:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, | |
| 2024 | | 2023 | | 2024 | | 2023 | | | |
| | | | | | | | |
Expected life (years) | 6.0 | | 0.0 | | 6.0 | | 6.0 | | | |
Expected volatility | 57 | % | | — | % | | 57 | % | | 57 | % | | | |
Risk-free interest rate | 4.1 | % | | — | % | | 4.1 | % | | 4.0 | % | | | |
Expected dividend rate | — | % | | — | % | | — | % | | — | % | | | |
Weighted-average fair value | $ | 38.24 | | | $ | — | | | $ | 28.52 | | | $ | 21.02 | | | | |
Restricted Stock Units
A summary of the Company’s restricted stock unit, or RSU, activity and related information are as follows (RSUs in thousands):
| | | | | | | | | | | | | | | | | | | |
| Nine Months Ended | | | | | | |
| September 30, 2024 | | | | |
| | | | | | | | | |
| Number of Shares | | Weighted-Average Fair Value | | | | | | | | |
Outstanding, beginning of period | 1,565 | | | $ | 36.27 | | | | | | | | | |
Awarded | 991 | | | 50.95 | | | | | | | | | |
Forfeited | (234) | | | 39.12 | | | | | | | | | |
| | | | | | | | | | | |
Vested | (390) | | | 36.06 | | | | | | | | | |
Outstanding, end of period | 1,932 | | | 43.50 | | | | | | | | | |
As of September 30, 2024, there was a total of $70.3 million of unrecognized stock-based compensation expense related to RSUs.
Performance Stock Units
The 2021 Plan provides for issuance of performance stock units or PSUs. PSUs granted are contingent upon the achievement of predetermined market, performance, and service conditions. PSUs are awarded to executives of the Company and generally time vest over two and three years. Vesting is also generally contingent upon achievement of applicable performance metrics. PSU expense is recognized over the requisite service period.
During the nine months ended September 30, 2024, the Company awarded approximately 61,000 PSU shares with both a performance and service condition. A certain performance condition will be defined at a later date. Per ASC 718 – Compensation, Stock Compensation, these grants have not met the definition of having a grant date, and therefore, no expense has been recognized for these PSUs. Expense will be recognized when the performance condition becomes defined.
During the nine months ended September 30, 2024, the Company awarded approximately 20,000 PSU shares with both a market and service condition.
No PSU shares were forfeited or released during the three and nine months ended September 30, 2024. As of September 30, 2024, unrecognized compensation expense related to PSUs was not material.
Employee Stock Purchase Plan
As of September 30, 2024, there was approximately $1.2 million of unrecognized cost related to the Employee Stock Purchase Plan or ESPP. This cost is expected to be recognized over a weighted average period of 0.6 years. As of September 30, 2024, a total of 1.5 million shares were available for issuance under the ESPP.
The fair value of the options granted to employees was estimated as of the grant date using the Black-Scholes model assuming the weighted-average assumptions listed in the following table:
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2024 | | 2023 |
| | | |
Expected life (years) | 0.8 | | 0.8 |
Expected volatility | 53 | % | | 55 | % |
Risk-free interest rate | 5.3 | % | | 5.0 | % |
Expected dividend rate | — | % | | — | % |
Weighted-average fair value | $ | 22.10 | | | $ | 11.28 | |
8. Net Loss Per Share
Net loss per share was determined as follows (in thousands, except per share amounts):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, | |
| 2024 | | 2023 | | 2024 | | 2023 | | | |
Net loss | $ | (20,974) | | | $ | (24,622) | | | $ | (72,557) | | | $ | (78,393) | | | | |
Weighted-average common stock outstanding | 52,011 | | | 48,310 | | | 51,550 | | | 46,131 | | | | |
Net loss per share, basic and diluted | $ | (0.40) | | | $ | (0.51) | | | $ | (1.41) | | | $ | (1.70) | | | | |
The following potentially dilutive securities outstanding have been excluded from the computations of weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares, in thousands):
| | | | | | | | | | | | | | | |
| September 30, | | |
| 2024 | | 2023 | | | | |
| | | | | |
| | | | | | | |
Stock options | 4,342 | | | 5,414 | | | | | |
Restricted and performance stock units | 2,013 | | | 1,518 | | | | | |
Employee stock purchase plan | 52 | | | 177 | | | | | |
Total | 6,407 | | | 7,109 | | | | | |
9. Revenue
The following table presents revenue disaggregated by type and geography (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, | |
| 2024 | | 2023 | | 2024 | | 2023 | | | |
| | | | | | | | |
U.S. | | | | | | | | | | |
System sales and rentals | $ | 19,643 | | | $ | 13,467 | | | $ | 50,978 | | | $ | 37,065 | | | | |
Handpieces and other consumables | 29,620 | | | 17,047 | | | 81,217 | | | 42,418 | | | | |
Service | 2,952 | | | 1,811 | | | 7,888 | | | 4,545 | | | | |
Total U.S. revenue | 52,215 | | | 32,325 | | | 140,083 | | | 84,028 | | | | |
Outside of U.S. | | | | | | | | | | |
System sales and rentals | 3,155 | | | 828 | | | 7,974 | | | 3,896 | | | | |
Handpieces and other consumables | 2,616 | | | 1,651 | | | 7,230 | | | 3,826 | | | | |
Service | 384 | | | 298 | | | 975 | | | 860 | | | | |
Total outside of U.S. revenue | 6,155 | | | 2,777 | | | 16,179 | | | 8,582 | | | | |
Total revenue | $ | 58,370 | | | $ | 35,102 | | | $ | 156,262 | | | $ | 92,610 | | | | |
10. Segment, Geographical, and Customer Concentration
The Company operates as a single operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, reviews financial information on an aggregate basis for the purposes of allocating resources and evaluating financial performance. The Company’s assets are primarily based in the United States.
No customers accounted for more than 10% of revenue during the three and nine months ended September 30, 2024 and 2023.
No customer accounted for more than 10% of accounts receivable at September 30, 2024 and December 31, 2023.
The following table presents revenue by significant geographical locations for the periods indicated:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, | |
| | 2024 | | 2023 | | 2024 | | 2023 | | | |
United States | | 89 | % | | 92 | % | | 90 | % | | 91 | % | | | |
Outside the United States | | 11 | % | | 8 | % | | 10 | % | | 9 | % | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
11. Commitments and Contingencies
Guarantees and Indemnifications
In the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future. To date, the Company has not paid any material claims or been required to defend any action related to its indemnification obligations. As of September 30, 2024 and December 31, 2023, the Company does not have any material indemnification claims that were probable or reasonably possible and consequently has not recorded related liabilities.
Facility Lease
In December 2021, the Company entered into a lease for two existing buildings, comprising approximately 158,221 square feet of space, located in San Jose, California. The lease commenced in July 2022, and will continue for 122 months following thereafter, with two five year options to extend the term of the lease.
Rent expense recognized under the lease, including additional rent charges for utilities, parking, maintenance, and real estate taxes, was $2.0 million and $2.6 million for the three months ended September 30, 2024 and 2023, and was $5.4 million and $6.6 million for the nine months ended September 30, 2024 and 2023.
Future minimum annual operating lease and debt repayments are as follows (in thousands):
| | | | | | | | | | | | | | | | | |
As of September 30, 2024 | Minimum Lease Payments | | Debt Repayments | | Total |
2024 | $ | 1,043 | | | $ | — | | | $ | 1,043 | |
2025 | 4,297 | | | 4,333 | | | 8,630 | |
2026 | 4,426 | | | 26,000 | | | 30,426 | |
2027 | 4,808 | | | 21,667 | | | 26,475 | |
2028 | 4,952 | | | — | | | 4,952 | |
Thereafter | 22,297 | | | — | | | 22,297 | |
Total minimum payments | 41,823 | | | 52,000 | | | 93,823 | |
Less: amount representing interest/unamortized debt discount | (12,623) | | | (562) | | | (13,185) | |
Present value of future payments | 29,200 | | | 51,438 | | | 80,638 | |
Less: current portion | (1,839) | | | — | | | (1,839) | |
Non-current portion | $ | 27,361 | | | $ | 51,438 | | | $ | 78,799 | |
, As of September 30, 2024 and December 31, 2023, the Company’s security deposit is in the form of, and recorded as, restricted cash.
12. Defined Contribution Plan
The Company has a defined contribution retirement savings plan under Section 401(k) of the Internal Revenue Code. This plan allows eligible employees to defer a portion of their annual compensation on a pre-tax basis. Employer contributions were $0.5 million
and $0.4 million for the three months ended September 30, 2024 and 2023, and $1.8 million and $1.2 million for the nine months ended September 30, 2024 and 2023.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes included elsewhere in this report. In addition to historical financial information, the following discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results and timing of selected events may differ materially from those anticipated in these forward-looking statements as a result of many factors, including those discussed in the section titled “Risk Factors” and elsewhere in this report. Please also see the section titled “Cautionary Note Regarding Forward-Looking Statements.”
Overview
We are a surgical robotics company focused on advancing patient care by developing transformative solutions in urology. We develop, manufacture and sell robotic systems, including the AquaBeam Robotic System and HYDROS Robotic System, which are advanced, image-guided, surgical robotic systems designed for use in minimally invasive urologic surgery, with a focus on treating benign prostatic hyperplasia, or BPH. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. By 2060, it is expected that the number of men over 65 years old in the United States will double and include a corresponding increase in the number of men with enlarged prostates. Our robotic systems employ a single-use disposable handpiece to deliver our proprietary Aquablation therapy, which combines real-time, multi-dimensional imaging, personalized treatment planning, automated robotics and heat-free waterjet ablation for targeted and rapid removal of prostate tissue. We believe that Aquablation therapy represents a paradigm shift in the surgical treatment of BPH by addressing compromises associated with alternative surgical interventions. We designed Aquablation therapy to deliver effective, safe and durable outcomes for males suffering from lower urinary tract symptoms, or LUTS, due to BPH that are independent of prostate size and shape. We have developed a significant and growing body of clinical evidence, which includes approximately 150 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy. As of September 30, 2024, we had an install base of 572 robotic systems for Aquablation therapy globally, including 445 in the United States.
Our U.S. pivotal trial, the WATER study, is the only FDA pivotal study randomized against transurethral resection of prostate, or TURP, which is the historical standard of care for the surgical treatment of BPH. In this study, Aquablation therapy demonstrated superior safety and non-inferior efficacy compared to TURP across prostate sizes between 30 ml and 80 ml, and superior efficacy in a subset of patients with prostates larger than 50 ml. We have established strong relationships with key opinion leaders, or KOLs, within the urology community and collaborated with key urological societies in global markets. This support has been instrumental in facilitating broader acceptance and adoption of Aquablation therapy. As a result of our strong KOL network and our compelling clinical evidence, Aquablation therapy has been added to clinical guidelines of various professional associations, including the American Urological Association.
We manufacture the AquaBeam Robotic System, HYDROS Robotic Systems, handpieces, and other accessories at our facility in San Jose, California. This includes supporting the supply chain distribution and logistics of the various components. Components, sub-assemblies and services required to manufacture our products are purchased from numerous global suppliers. We utilize a well-known third-party logistics provider located in the United States and the Netherlands to ship our products to our customers globally.
We generated revenue of $156.3 million and incurred a net loss of $72.6 million for the nine months ended September 30, 2024, compared to revenue of $92.6 million and a net loss of $78.4 million for the nine months ended September 30, 2023. As of September 30, 2024, we had cash and cash equivalents of $196.8 million and an accumulated deficit of $527.1 million.
Recent Developments
On August 20, 2024, we announced that the FDA granted 510(k) clearance of the Company's next-generation system, the HYDROS Robotic System, for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms due to BPH. The HYDROS Robotic System includes numerous design and innovative enhancements, and introduces the FirstAssist AI feature, which is designed to help urologists interpret ultrasound images for key anatomical landmarks. Also, the HYDROS Robotic System now comes fully integrated with an advanced ultrasound system and a new digital cystoscope providing the ability to improve visualization and make setup more streamlined. Lastly, the HYDROS Robotic System handpiece is pre-assembled with a single-use digital scope eliminating the need for scope reprocessing.
Following its FDA clearance, the HYDROS Robotic System was immediately available to customers in the United States. However, to ensure a successful transition for our immediate pipeline, we will continue to offer AquaBeam Robotic Systems in the United States through the fourth quarter of 2024.
We will continue to sell AquaBeam Robotic Systems outside the United States until we receive the appropriate regulatory clearances for HYDROS Robotic Systems in foreign markets.
Additionally, on October 7, 2024, we announced that the FDA approved a pivotal Investigational Device Exemption, or IDE, clinical trial comparing Aquablation therapy to radical prostatectomy. The Company also recently received Breakthrough Device Designation to investigate the use of Aquablation therapy for localized prostate cancer treatment.
The American Cancer Society estimates that over 3.3 million men in the United States have been diagnosed with and are currently living with prostate cancer. Additionally, about 300,000 new cases of prostate cancer are diagnosed each year, with incidence rates rising by approximately 3% to 5% annually. Based on data from the National Cancer Institute’s SEER database we estimate that of these 300,000 new cases, approximately 210,000 of them are localized to the prostate, with approximately 159,600 cases being categorized as low or intermediate risk with Grade Group 1 to 3 tumors.
The trial, known as WATER IV PCa, is a global multicenter, prospective, randomized clinical study assessing the safety and efficacy of Aquablation therapy compared to radical prostatectomy in men with Grade Group 1 to 3 localized prostate cancer. There is also a co-primary endpoint based on morbidity evaluated at the six-month follow-up. A key secondary endpoint is to measure the rate of Grade Group progression in the Aquablation therapy arm, which will be evaluated at the twelve-month follow-up. The study will enroll up to 280 patients at up to 50 centers and follow them for 10 years. The patients will be randomized on a 3:1 basis, with 210 patients receiving Aquablation therapy and 70 patients receiving radical prostatectomy. Longer-term follow-up focuses on both the reduction in treatment related harm and oncologic events.
Factors Affecting Our Performance
We believe there are several important factors that have impacted and that we expect will impact our operating performance and results of operations for the foreseeable future. While these factors may present significant opportunities for us, they also pose significant risks and challenges that we must address. See the section titled “Risk Factors” for more information. These factors include:
•Grow our install base of robotic systems. As of September 30, 2024, we had an install base of 572 robotic systems globally, including 445 in the United States. In the United States, we are initially focused on driving adoption of Aquablation therapy among urologists that perform hospital-based resective BPH surgery. We are initially targeting 860 high-volume hospitals that we estimate perform, on average, more than 200 resective procedures annually and account for approximately 70% of all hospital-based resective procedures. Additionally, there are approximately 1,840 additional U.S. hospitals that perform the remaining 30% of resective BPH procedures that we are targeting. To penetrate these hospitals, we expect to continue to increase our direct team of capital sales representatives, who are focused on driving system placement within hospitals by engaging with key surgeons and decision makers to educate them about the compelling value proposition of Aquablation therapy. As we increase our install base of robotic systems, we expect our revenue to increase as a result of system sales and resulting utilization.
•Increase system utilization. Our revenue is significantly impacted by the utilization of our robotic systems. Once we place a system within a hospital our objective is to establish Aquablation therapy as the surgical treatment of choice for BPH. Within each hospital we are initially focused on targeting urologists who perform medium-to-high volumes of resective procedures and converting their resective cases to Aquablation therapy. To accomplish this, we will continue expanding our team of highly trained Aquablation representatives and clinical specialists who are focused on driving system utilization within the hospital, providing education and training support and ensuring excellent user experiences. As urologists gain experience with Aquablation therapy we expect to leverage their experiences to capture more surgical volumes and establish Aquablation therapy as the surgical standard of care.
•Reimbursement and coverage decisions by third-party payors. Healthcare providers in the United States generally rely on third-party payors, principally federal Medicare, state Medicaid and private health insurance plans, to cover all or part of the cost of procedures using Aquablation therapy. The revenue we are able to generate from sales of our products depends in large part on the availability of sufficient reimbursement from such payors. Effective in 2021, all local MACs, representing 100% of eligible Medicare patients, issued final positive local coverage determinations to provide Medicare beneficiaries with access to Aquablation therapy in all 50 states. We believe that these favorable coverage decisions have been a catalyst for hospital adoption of our robotic systems. We believe our strong body of clinical evidence and support from key societies, supplemented by the momentum from Medicare coverage, have led to favorable coverage decisions from many large commercial payors. We plan to leverage these recent successes in our active discussions with commercial payors to establish additional positive national and regional coverage policies. Outside of the United States, we have ongoing efforts in key markets to expand established coverage and further improve patient access to Aquablation therapy.
•Cost of sales. The results of our operations will depend, in part, on our ability to increase our gross margins by more effectively managing our costs to produce our robotic systems and single-use disposable handpieces, and to scale our manufacturing operations efficiently. We anticipate that as we expand our sales and marketing efforts and drive further sales growth, our purchasing costs on a per unit basis may decrease, which in turn improve our gross margin. As our commercial operations continue to grow, we expect to continue to realize operating leverage through increased scale efficiencies.
•Investment in research and development to drive continuous improvements and innovation. With the successful launch of our next generation product, the HYDROS Robotic System, we will continue developing additional and next generation technologies to support and improve Aquablation therapy to further satisfy the evolving needs of surgeons and their patients as well as to further enhance the usability and scalability of our products. We also plan to leverage our treatment data and software development capabilities to integrate and advance artificial intelligence and machine learning to enable computer-assisted anatomy recognition and improved treatment planning and personalization. Our future growth is dependent on these continuous improvements which require significant resources and investment.
Components of Our Results of Operations
Revenue
We generate our revenue primarily from recurring revenue associated with sales of our single-use disposable handpieces that are used during each surgery performed with our system. Additionally, there is a non-recurring portion of our business, which includes sales of our robotic systems. Other revenue is derived from service and repair, other consumables, and extended service contracts with new and existing customers. We expect our revenue to increase in absolute dollars for the foreseeable future as we continue to focus on driving adoption of Aquablation therapy, and increased system utilization, though it may fluctuate from quarter to quarter.
The following table presents revenue by significant geographical locations for the periods indicated:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, | |
| 2024 | | 2023 | | 2024 | | 2023 | | | |
| | | | | | | | |
United States | 89 | % | | 92 | % | | 90 | % | | 91 | % | | | |
Outside the United States | 11 | % | | 8 | % | | 10 | % | | 9 | % | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
We expect that both our U.S. and international revenue will increase in the near term as we continue to expand the install base of our robotic systems and increase the units sold of our single-use disposable handpieces. We expect our increase in revenue in absolute dollars to be larger in the United States.
Cost of Sales and Gross Margin
Cost of sales consists primarily of manufacturing overhead costs, material costs, warranty and service costs, direct labor, scrap and other direct costs such as shipping costs. A significant portion of our cost of sales currently consists of manufacturing overhead costs. These overhead costs include compensation for personnel, including stock-based compensation, facilities, equipment and operations supervision, quality assurance and material procurement. We expect our cost of sales to increase in absolute dollars for the foreseeable future primarily as, and to the extent, our revenue grows, or we make additional investments in our manufacturing capabilities, though it may fluctuate from period to period.
We calculate gross margin percentage as gross profit divided by revenue. Our gross margin has been and will continue to be affected by a variety of factors, primarily, product and geographic mix and the resulting average selling prices, production volumes, manufacturing costs and product yields, and to a lesser extent the implementation of cost reduction strategies. We expect our gross margin to increase over the long term as our production volume increases and as we spread the fixed portion of our manufacturing overhead costs over a larger number of units produced, thereby significantly reducing our per unit manufacturing costs, though it may fluctuate from quarter to quarter. Our gross margins can fluctuate due to geographic mix. To the extent we sell more systems and handpieces in the United States, we expect our margins will increase due to the higher average selling prices as compared to sales outside of the United States.
Operating Expenses
Research and Development
Research and development, or R&D, expenses consist primarily of engineering, product development, regulatory affairs, consulting services, materials, depreciation and other costs associated with products and technologies being developed. These expenses include employee and non-employee compensation, including stock-based compensation, supplies, materials, quality assurance expenses, consulting, related travel expenses and facilities expenses. We expect our R&D expenses to increase in absolute dollars for the foreseeable future as we make strategic investments in R&D, continue to develop and enhance existing products and technologies, though it may fluctuate from quarter to quarter. However, over time, we expect our R&D expenses to decrease as a percentage of revenue.
Selling, General and Administrative
Selling, general and administrative, or SG&A, expenses consist primarily of compensation for personnel, including stock-based compensation, related to selling, marketing, clinical affairs, professional education, finance, information technology, and human resource functions. SG&A expenses also include commissions, training, travel expenses, promotional activities, conferences, trade shows, professional services fees, audit fees, legal fees, insurance costs and general corporate expenses including allocated facilities-related expenses. Post-market clinical study expenses include trial design, site reimbursement, data management and travel expenses. We expect our SG&A expenses to increase in absolute dollars for the foreseeable future as we expand our commercial infrastructure in order for us to execute on our long-term growth plan, though it may fluctuate from quarter to quarter. However, over time, we expect our SG&A expenses to decrease as a percentage of revenue.
Interest and Other Income, Net
Interest Expense
Interest expense consists primarily of interest expense from our long-term debt.
Interest and Other Income, Net
Interest and other income, net, consists primarily of interest income from our cash and cash equivalents balances, and fair value adjustments from our loan facility derivative liability.
Results of Operations
The following tables show our results of operations for the periods indicated:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Change |
| 2024 | | 2023 | | $ | | % |
| (in thousands, except percentages) |
| |
Revenue | $ | 58,370 | | $ | 35,102 | | $ | 23,268 | | | 66 | % |
Cost of sales | 21,459 | | 16,228 | | 5,231 | | | 32 | |
Gross profit | 36,911 | | 18,874 | | 18,037 | | | 96 | |
Gross margin | 63 | % | | 54 | % | | | | |
| | | | | | | |
Operating expenses: | | | | | | | |
Research and development | 16,647 | | 11,600 | | 5,047 | | | 44 | |
Selling, general and administrative | 42,691 | | 32,883 | | 9,808 | | | 30 | |
Total operating expenses | 59,338 | | 44,483 | | 14,855 | | | 33 | |
Loss from operations | (22,427) | | (25,609) | | 3,182 | | | 12 | |
Interest expense | (1,140) | | (1,019) | | (121) | | | (12) | |
Interest and other income, net | 2,593 | | 2,006 | | 587 | | | 29 | |
Net loss | $ | (20,974) | | $ | (24,622) | | $ | 3,648 | | | 15 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, | | Change |
| 2024 | | 2023 | | $ | | % |
| (in thousands, except percentages) |
| |
Revenue | $ | 156,262 | | $ | 92,610 | | $ | 63,652 | | | 69 | % |
Cost of sales | 62,835 | | 42,816 | | 20,019 | | | 47 | |
Gross profit | 93,427 | | 49,794 | | 43,633 | | | 88 | |
Gross margin | 60 | % | | 54 | % | | | | |
| | | | | | | |
Operating expenses: | | | | | | | |
Research and development | 47,232 | | 33,950 | | 13,282 | | | 39 | |
Selling, general and administrative | 123,099 | | 95,457 | | 27,642 | | | 29 | |
Total operating expenses | 170,331 | | 129,407 | | 40,924 | | | 32 | |
Loss from operations | (76,904) | | (79,613) | | 2,709 | | | 3 | |
Interest expense | (3,215) | | (2,870) | | (345) | | | (12) | |
Interest and other income, net | 7,562 | | 4,090 | | 3,472 | | | 85 | |
Net loss | $ | (72,557) | | | $ | (78,393) | | $ | 5,836 | | | 7 | |
Comparison of Three and Nine Months Ended September 30, 2024 and 2023
Revenue | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Change |
| 2024 | | 2023 | | $ | | % |
| (in thousands, except percentages) |
| |
System sales and rentals | $ | 22,798 | | | $ | 14,295 | | | $ | 8,503 | | | 59 | % |
Handpieces and other consumables | 32,236 | | | 18,698 | | | 13,538 | | | 72 | |
Service | 3,336 | | | 2,109 | | | 1,227 | | | 58 | |
Total revenue | $ | 58,370 | | | $ | 35,102 | | | $ | 23,268 | | | 66 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, | | Change |
| 2024 | | 2023 | | $ | | % |
| (in thousands, except percentages) |
| |
System sales and rentals | $ | 58,952 | | | $ | 40,961 | | | $ | 17,991 | | | 44 | % |
Handpieces and other consumables | 88,447 | | | 46,244 | | | 42,203 | | | 91 | |
Service | 8,863 | | | 5,405 | | | 3,458 | | | 64 | |
Total revenue | $ | 156,262 | | | $ | 92,610 | | | $ | 63,652 | | | 69 | |
Revenue increased $23.3 million, or 66%, to $58.4 million during the three months ended September 30, 2024, compared to $35.1 million during the three months ended September 30, 2023, and increased $63.7 million, or 69%, to $156.3 million during the nine months ended September 30, 2024, compared to $92.6 million during the nine months ended September 30, 2023. The growth in revenue was primarily attributable to an increase of $19.9 million and $56.1 million in revenue derived from the United States for the three and nine months ended September 30, 2024, respectively. The increase was due to higher sales volumes of system sales, handpieces, other consumables,
and service contracts, and to a lesser extent, an increase in average selling prices on our system sales and handpieces.
Cost of Sales and Gross Margin
Cost of sales increased $5.2 million, or 32%, to $21.5 million during the three months ended September 30, 2024, compared to $16.2 million during the three months ended September 30, 2023, and increased $20.0 million, or 47%, to $62.8 million during the nine months ended September 30, 2024, compared to $42.8 million for the nine months ended September 30, 2023. The increase in cost of sales was primarily attributable to the growth in the number of units sold.
Gross margin increased to 63% during the three months ended September 30, 2024, compared to 54% for the three months ended September 30, 2023, and increased to 60% during the nine months ended September 30, 2024, compared to 54% during the nine months ended September 30, 2023. The increase in gross margin was primarily attributable to the growth in unit sales, which allowed us to spread the fixed portion of our manufacturing overhead costs over more production units, and to a lesser extent, an increase in average selling prices on both our system sales and handpieces.
Research and Development Expenses
R&D expenses increased $5.0 million, or 44%, to $16.6 million during the three months ended September 30, 2024, compared to $11.6 million during the three months ended September 30, 2023, and increased $13.3 million, or 39%, to $47.2 million during the nine months ended September 30, 2024, compared to $34.0 million for the nine months ended September 30, 2023. The increase in R&D expenses was primarily due to employee-related expenses of our R&D organization such as salaries and wages, along with an increase in consultant expenses and tooling. These expenses support ongoing product improvements and the development of our next generation robotic system.
Selling, General and Administrative Expenses
SG&A expenses increased $9.8 million, or 30%, to $42.7 million during the three months ended September 30, 2024, compared to $32.9 million during the three months ended September 30, 2023, and increased $27.6 million or 29%, to $123.1 million for the nine months ended September 30, 2024 compared to $95.5 million for the nine months ended September 30, 2023. The increase in SG&A expenses was primarily due to employee-related expenses of our sales and marketing organization such as salaries and wages and stock-based compensation expense, primarily to expand the commercial organization, and employee-related expenses of our administrative organization such as salaries and wages and stock-based compensation expense, to drive and support our growth in revenue.
Interest Expense
Interest expense increase was not material during the three months ended September 30, 2024, compared to the prior period.
Interest expense increased $0.3 million, or 12%, to $3.2 million during the nine months ended September 30, 2024, compared to $2.9 million during the nine months ended September 30, 2023. The increase in interest expense was primarily due to an increase in the interest rate as compared to the prior period.
Interest and Other Income, Net
Interest and other income, net, increased $0.6 million and $3.5 million for the three and nine months ended September 30, 2024, respectively, compared to the three and nine months ended September 30, 2023. The increase was primarily due to an increase in interest income, which was due to our increase cash balance with increases in interest rates.
Liquidity and Capital Resources
Overview
As of September 30, 2024, we had cash and cash equivalents of $196.8 million, an accumulated deficit of $527.1 million, and $52.0 million outstanding on our loan facility. We expect our expenses will increase for the foreseeable future, in particular as we continue to make substantial investments in sales and marketing, operations and research and development. Our future funding requirements will depend on many factors, including:
•the degree and rate of market acceptance of our products and Aquablation therapy;
•the scope and timing of investment in our sales force and expansion of our commercial organization;
•the scope, rate of progress and cost of our current or future clinical trials and registries;
•the cost of our research and development activities;
•the cost and timing of additional regulatory clearances or approvals;
•the costs associated with any product recall that may occur;
•the costs associated with a regulatory or government action or other litigation;
•the costs associated with the manufacturing of our products at increased production levels;
•the costs of attaining, defending and enforcing our intellectual property rights;
•whether we acquire third-party companies, products or technologies;
•the terms and timing of any other collaborative, licensing and other arrangements that we may establish;
•the emergence of competing technologies or other adverse market developments; and
•the rate at which we expand internationally.
Based on our operating plan, we currently believe that our existing cash and cash equivalents and anticipated revenue will be sufficient to meet our capital requirements and fund our operations through at least the next twelve months from the issuance date of the financial statements included in the Quarterly Report on Form 10-Q. We have based this estimate on assumptions that may prove to be wrong, and we may need to utilize additional available capital resources. If these sources are insufficient to satisfy our liquidity requirements, we may seek to sell additional equity or debt securities or obtain an additional credit facility. We may also consider raising additional capital to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons. The sale of equity and convertible debt securities may result in dilution to our stockholders and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. Debt financing, if available, may involve financial covenants or covenants restricting our operations or our ability to incur additional debt. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. Additional financing may not be available at all, or in amounts or on terms unacceptable to us. If we are unable to obtain additional financing, we may be required to delay the development, commercialization and marketing of our products. Additionally, we maintain cash balances with financial institutions in excess of insured limits.
Indebtedness
In October 2022, we entered into a loan and security agreement with Canadian Imperial Bank of Commerce. The agreement provides for a senior secured term loan facility in the aggregate principal amount of $52.0 million, which was borrowed in full.
The term loan facility is scheduled to mature on October 6, 2027, the fifth anniversary of the closing date (the “Maturity Date”). The loan and security agreement provides for interest-only payments on the term loan facility for the first thirty-six months following the closing date (the “Initial Interest-Only Period”). The Initial Interest-Only Period will be extended to an additional twelve months if we achieve either (i) $200.0 million or greater in revenue in any twelve-month period or (ii) $0 or greater in EBITDA (as defined in the loan and security agreement) in any six-month period. Thereafter, amortization payments on the loan facility will be payable monthly until the Maturity Date in monthly installments equal to 20% of the then outstanding principal amount of the loan facility divided by 12 plus any accrued and unpaid interest. We have the option to prepay the loan facility without any prepayment charge or fee.
The loan borrowed under the loan facility bears interest at an annual rate equal to the secured overnight financing rate (“SOFR”) (calculated based on an adjustment of 0.10%, 0.15% and 0.25%, respectively, for one-month, three-month or six-month term SOFR as of a specified date, subject to a floor of 1.5%) plus an applicable margin of 2.25%.
The obligations under the loan and security agreement are secured by substantially all of our assets, including its intellectual property and by a pledge all of our equity interests in its U.S. subsidiaries and 65% of our equity interests in its non-U.S. subsidiaries that are directly owned by us. We are obligated to maintain in deposit accounts held at the lender equal to at least the lesser of (i) $90.0 million or (ii) all of our non-operating cash and allow us to maintain cash or cash equivalents in excess of that amount with other financial institutions.
The loan and security agreement contains certain customary representations and warranties, affirmative and negative covenants, and events of default. Under the loan and security agreement, if we maintain less than $100.0 million in available cash, then we are required to meet either one of two financial covenants: a minimum unrestricted cash covenant or a minimum revenue and growth covenant. The minimum unrestricted cash covenant requires that we to maintain cash reserve not less than the greater of (i) $20.0 million, (ii) the absolute value of EBITDA losses (if any) for the most recent consecutive four-month period then ended or (iii) the aggregate outstanding principal amount of $52.0 million. The minimum revenue and growth covenant requires our revenue, for the consecutive twelve-month period as of each measurement date, of not less than $50.0 million and of at least 115% as of the last day of the consecutive twelve-month period of the immediately preceding year. If we maintain at least $100.0 million in available cash, then we are not required to meet such financial covenants.
Cash Flows
The following table summarizes our cash flows for the periods presented:
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| Nine Months Ended September 30, | | |
| 2024 | | 2023 | | | | |
| (in thousands) |
| |
Net cash (used in) provided by: | | | | | | | |
Operating activities | $ | (66,822) | | | $ | (83,210) | | | | | |
Investing activities | (3,235) | | | (16,491) | | | | | |
Financing activities | 9,597 | | | 164,929 | | | | | |
Net increase (decrease) in cash, cash equivalents and restricted cash | $ | (60,460) | | | $ | 65,228 | | | | | |
Net Cash Used in Operating Activities
During the nine months ended September 30, 2024, net cash used in operating activities was $66.8 million, consisting primarily of a net loss of $72.6 million and an increase in net operating assets of $22.4 million, partially offset by non-cash charges of $28.1 million. The cash used in operations was primarily due to our net loss due to the increase in operating expenses to support our commercialization and development activities. The expansion of our commercialization activities resulted in an increase in accounts receivable, inventory, and accounts payable, partially offset by reimbursements for leasehold improvements made related to our San Jose, California corporate
headquarters and increases to other liabilities and deferred revenue. Non-cash charges consisted primarily of stock-based compensation, non-cash lease expense, and depreciation.
During the nine months ended September 30, 2023, net cash used in operating activities was $83.2 million, consisting primarily of a net loss of $78.4 million and an increase in net operating assets of $22.7 million, partially offset by non-cash charges of $17.8 million. The cash used in operations was primarily due to our net loss due to the increase in operating expenses to support our commercialization and development activities. The expansion of our commercialization resulted in an increase in accounts receivable and inventory, partially offset by reimbursements for leasehold improvements made related to our San Jose, California corporate headquarters, and increases to other liabilities and deferred revenue. Non-cash charges consisted primarily of stock-based compensation, non-cash lease expense and depreciation.
Net Cash Used in by Investing Activities
During the nine months ended September 30, 2024, net cash used in investing activities was $3.2 million, consisting of purchases of property and equipment. During the nine months ended September 30, 2023, net cash used in investing activities was $16.5 million, consisting of purchases of property and equipment.
Net Cash Provided by Financing Activities
During the nine months ended September 30, 2024, net cash provided by financing activities was $9.6 million, consisting of proceeds from exercises of stock options and proceeds from the issuance of common stock under the ESPP. During the nine months ended September 30, 2023, net cash provided by financing activities was $164.9 million, consisting of proceeds from exercises of stock options, proceeds from the issuance of common stock under the ESPP, and net proceeds from the issuance of common stock from our August 2023 public offering.
Contractual Commitments and Contingencies
The information included in Note 11 to the condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q is incorporated herein by reference.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have any off-balance sheet arrangements, such as structured finance, special purpose entities or variable interest entities.
Critical Accounting Policies and Estimates
Management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenue, expenses and related disclosures. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material.
The significant accounting policies and estimates used in preparation of the unaudited condensed consolidated financial statements are described in our audited consolidated financial statements as of and for the year ended December 31, 2023, and the notes thereto, which are included in our Annual Report on Form 10-K dated February 28, 2024, or Annual Report, and in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report. There have been no material changes to our significant accounting policies during the three months ended September 30, 2024.
Recent Accounting Pronouncements
The information included in Note 2 to the condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q is incorporated herein by reference.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk
Cash and cash equivalents of $196.8 million as of September 30, 2024, consisted of securities carried at quoted market prices with an original maturity of three months or less and therefore there is minimal risk associated with fluctuating interest rates. We do not currently use or plan to use financial derivatives in our investment portfolio.
In addition, as described above under the subsection titled “Indebtedness,” amounts outstanding under our loan facility bears interest at an annual rate equal to the secured overnight financing rate ("SOFR") (calculated based on an adjustment of .10%, .15% and .25%, respectively, for one-month, three-month or six-month term SOFR as of a specified date, subject to a floor of 1.5%) plus an applicable margin of 2.25%. As a result, we are exposed to risks from changes in interest rates. We do not believe that a hypothetical 100 basis point increase or decrease in interest rates or 30-day SOFR would have had a material impact on our financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Credit Risk
We maintain our cash and cash equivalents with financial institutions in the United States, and our current deposits are in excess of insured limits. We have reviewed the financial statements of these institutions and believe they have sufficient assets and liquidity to conduct its operations in the ordinary course of business with little or no credit risk to us.
Our accounts receivable primarily relate to revenue from the sale or rental of our products. No customer accounted for greater than 10% of accounts receivable at September 30, 2024 and December 31, 2023. We believe that credit risk in our accounts receivable is mitigated by our credit evaluation process, relatively short collection terms and diversity of our customer base.
Foreign Currency Risk
A portion of our net sales and expenses are denominated in foreign currencies, most notably the Euro. Future fluctuations in the value of the U.S. Dollar may affect the price competitiveness of our products outside the United States. For direct sales outside the United States, we sell in both U.S. Dollars and local currencies, which could expose us to additional foreign currency risks, including changes in currency exchange rates. Our operating expenses in countries outside the United States, are payable in foreign currencies and therefore expose us to currency risk. We do not believe that a hypothetical 10% increase or decrease in the relative value of the U.S. dollar to other currencies would have had a material impact on our financial statements included elsewhere in this Quarterly Report on Form 10-Q.
We do not currently maintain a program to hedge exposures to non-U.S. dollar currencies.
Effects of Inflation
Inflation generally affects us by increasing our cost of labor and research and development contract costs. We do not believe that inflation had a material effect on our financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, have evaluated the effectiveness of our 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 Quarterly Report on Form 10-Q. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that, as of September 30, 2024, our disclosure controls and procedures were effective at the reasonable assurance level.
Limitations on Effectiveness of Disclosure Controls and Procedures
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended September 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II
OTHER INFORMATION
Item 1. Legal Proceeding
We are not subject to any material legal proceedings.
Item 1A. Risk Factors
Our business, financial condition and operating results are affected by a number of factors, whether currently known or unknown, including risks specific to us or the healthcare industry as well as risks that affect businesses in general. In addition to the information set forth in this Quarterly Report on Form 10-Q, you should consider carefully the factors discussed in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 28, 2024. The risks and uncertainties disclosed in such Annual Report and in this Quarterly Report could materially adversely affect our business, financial condition, cash flows or results of operations and thus our stock price. The risk factors set forth below updates, and should be read together with, the risk factors described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
Besides risk factors disclosed in the Annual Report and this Quarterly Report, additional risks and uncertainties not currently known or we currently deem to be immaterial may also materially adversely affect our business, financial condition or results of operations. These risk factors may be important to understanding other statements in this Quarterly Report and should be read in conjunction with the unaudited condensed consolidated financial statements and related notes in Part I, Item 1, “Financial Statements” and Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this Quarterly Report. Because of such risk factors, as well as other factors affecting our financial condition and operating results, past financial performance should not be considered to be a reliable indicator of future performance, and investors should not use historical trends to anticipate results or trends in future periods.
Natural or man-made disasters and other similar catastrophic events outside of our control may significantly disrupt our business, and negatively impact our business, financial condition and results of operations.
Natural or man-made disasters, including earthquakes, wildfires, floods, hurricanes, nuclear disasters, riots, acts of terrorism or other criminal activities, public health emergencies such as infectious disease outbreaks, power outages and other infrastructure failures may impact our facilities or operations or the facilities or operations of our suppliers, customers, and other business partners (including their suppliers and business partners), which could the result in a disruption in our business and operations or increase costs to operate our business. For example, following a natural disaster, and during the related recovery, our customers may limit the number of surgical procedures or elective procedures performed at their facilities due to disruptions to hospital operations or supply constraints, or patients may choose to cancel or delay such procedures even if the hospital is able to perform it. As a result, customers may reduce the number of products ordered during the disruption, including disposable handpieces, and we may experience material and adverse impacts to our business, financial condition and results of operations, even if such supply constraints would not directly impact our procedure.
Furthermore, a significant portion of our employee base, and our primary operating facility and infrastructure are centralized in Northern California. Our facility may be harmed or rendered inoperable by any such natural or catastrophic disasters, which may render it difficult or impossible for us to operate our business for some period of time. Our facilities would likely be costly to repair or replace, and any business continuity or repair efforts would likely require substantial time. Any disruptions in our operations could adversely affect our business and results of operations and harm our reputation. Moreover, although we have disaster recovery plans, they may prove inadequate. We may not carry sufficient business insurance to compensate for losses that may occur. Any such losses or damages could have a material adverse effect on our business and results of operations. In addition, the facilities of our suppliers and manufacturers may be harmed or rendered inoperable by such natural or man-made
disasters, which may cause disruptions, difficulties or otherwise materially and adversely affect our business, financial condition and results of operations.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
During the quarter ended September 30, 2024, no director or officer of the Company informed us of the adoption or termination of a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” (as each term is defined in Item 408 of Regulation S-K), except as follows:
On August 8, 2024, Reza Zadno, the Company’s Chief Executive Officer, adopted a pre-arranged written stock sale plan in accordance with Rule 10b5-1 (the “Zadno Rule 10b5-1 Plan”) under the Exchange Act, for the sale of shares of the Company’s common in the Company’s securities and is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act stock. The Zadno Rule 10b5-1 Plan was entered into during an open trading window in accordance with the Company’s policies regarding transactions. The Zadno Rule 10b5-1 Plan provides for the potential sale of up to 105,683 shares of the Company’s common stock during various specified trading periods through December 4, 2024.
On September 3, 2024, Alaleh Nouri, the Company’s Chief Legal Officer, adopted a pre-arranged written stock sale plan in accordance with Rule 10b5-1 (the “Nouri Rule 10b5-1 Plan”) under the Exchange Act, for the sale of shares of the Company’s common stock. The Nouri Rule 10b5-1 Plan was entered into during an open trading window in accordance with the Company’s policies regarding transactions in the Company’s securities and is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act. The Nouri Rule 10b5-1 Plan provides for the potential sale of up to 56,185 shares of the Company’s common stock during various specified trading periods through December 31, 2025.
Item 6. Exhibits
The following exhibits are filed or furnished as a part of, or incorporated by reference into, this Quarterly Report on Form 10-Q.
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101.INS | | Inline XBRL Instance Document – the instance document does not appear in the Interactive Data file because its XBRL tags are embedded within the Inline XBRL document. | |
101.SCH | | Inline XBRL Taxonomy Extension Schema Document. | |
101.CAL | | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | |
101.DEF | | Inline XBRL Taxonomy Extension Definition Linkbase Document. | |
101.LAB | | Inline XBRL Taxonomy Extension Label Linkbase Document. | |
101.PRE | | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | |
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*Filed herewith.
** Furnished herewith.
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: October 28, 2024
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| | PROCEPT BIOROBOTICS CORPORATION |
| | (Registrant) |
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| | /s/ Reza Zadno |
| | Reza Zadno, Ph.D. |
| | President and Chief Executive Officer |
| | (principal executive officer) |
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| | /s/ Kevin Waters |
| | Kevin Waters |
| | EVP, Chief Financial Officer |
| | (principal financial and accounting officer) |
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PROCEPT BIOROBOTICS CORPORATION 2021 EMPLOYEE STOCK PURCHASE PLAN1 ARTICLE I. PURPOSE The purposes of this PROCEPT BioRobotics Corporation 2021 Employee Stock Purchase Plan (as it may be amended or restated from time to time, the “Plan”) are to assist Eligible Employees of PROCEPT BioRobotics Corporation, a California corporation (the “Company”), and its Designated Subsidiaries in acquiring a stock ownership interest in the Company pursuant to a plan which is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423(b) of the Code, and to help Eligible Employees provide for their future security and to encourage them to remain in the employment of the Company and its Designated Subsidiaries. ARTICLE II. DEFINITIONS AND CONSTRUCTION Wherever the following terms are used in the Plan they shall have the meanings specified below, unless the context clearly indicates otherwise. The singular pronoun shall include the plural where the context so indicates. Masculine, feminine and neuter pronouns are used interchangeably and each comprehends the others. 2.1 “Administrator” shall mean the entity that conducts the general administration of the Plan as provided in Article XI. The term “Administrator” shall refer to the Committee unless the Board has assumed the authority for administration of the Plan as provided in Article XI. 2.2 “Applicable Law” shall mean the requirements relating to the administration of equity incentive plans under U.S. federal and state securities, tax and other applicable laws, rules and regulations, the applicable rules of any stock exchange or quotation system on which the Common Stock is listed or quoted and the applicable laws and rules of any foreign country or other jurisdiction where rights under this Plan are granted. 2.3 “Board” shall mean the Board of Directors of the Company. 2.4 “Change in Control” means and includes each of the following: (a) A transaction or series of transactions (other than an offering of Common Stock to the general public through a registration statement filed with the Securities and Exchange Commission or a transaction or series of transactions that meets the requirements of clauses (i) and (ii) of subsection (c) below) whereby any “person” or related “group” of “persons” (as such terms are used in Sections 13(d) and 14(d)(2) of the Exchange Act) (other than the Company, any of its Subsidiaries, an employee benefit plan maintained by the Company or any of its Subsidiaries or a “person” that, prior to such transaction, directly or indirectly controls, is controlled by, or is under common control with, the Company) directly or indirectly acquires 1 As amended effective for the November 15, 2024 and subsequent Offering Periods.
2 beneficial ownership (within the meaning of Rule 13d-3 under the Exchange Act) of securities of the Company possessing more than 50% of the total combined voting power of the Company’s securities outstanding immediately after such acquisition; or (b) During any period of two consecutive years, individuals who, at the beginning of such period, constitute the Board together with any new director(s) (other than a director designated by a person who shall have entered into an agreement with the Company to effect a transaction described in subsections (a) or (c)) whose election by the Board or nomination for election by the Company’s stockholders was approved by a vote of at least two-thirds of the directors then still in office who either were directors at the beginning of the two-year period or whose election or nomination for election was previously so approved, cease for any reason to constitute a majority thereof; or (c) The consummation by the Company (whether directly involving the Company or indirectly involving the Company through one or more intermediaries) of (x) a merger, consolidation, reorganization, or business combination or (y) a sale or other disposition of all or substantially all of the Company’s assets in any single transaction or series of related transactions or (z) the acquisition of assets or stock of another entity, in each case other than a transaction: (i) which results in the Company’s voting securities outstanding immediately before the transaction continuing to represent (either by remaining outstanding or by being converted into voting securities of the Company or the person that, as a result of the transaction, controls, directly or indirectly, the Company or owns, directly or indirectly, all or substantially all of the Company’s assets or otherwise succeeds to the business of the Company (the Company or such person, the “Successor Entity”)) directly or indirectly, at least a majority of the combined voting power of the Successor Entity’s outstanding voting securities immediately after the transaction, and (ii) after which no person or group beneficially owns voting securities representing 50% or more of the combined voting power of the Successor Entity; provided, however, that no person or group shall be treated for purposes of this clause (ii) as beneficially owning 50% or more of the combined voting power of the Successor Entity solely as a result of the voting power held in the Company prior to the consummation of the transaction. Notwithstanding the foregoing, if a Change in Control constitutes a payment event with respect to any portion of any right that constitutes “nonqualified deferred compensation,” the transaction or event constituting the Change in Control with respect to such right (or portion thereof) must also constitute a “change in control event” (as defined in Treasury Regulation §1.409A-3(i)(5)) to trigger the payment event for such right, to the extent required by Section 409A of the Code. The Administrator shall have full and final authority, which shall be exercised in its discretion, to determine conclusively whether a Change in Control has occurred pursuant to the above definition, the date of the occurrence of such Change in Control and any incidental matters relating thereto; provided that any exercise of authority in conjunction with a determination of whether a Change in Control is a “change in control event” as defined in Treasury Regulation Section 1.409A-3(i)(5) shall be consistent with such regulation.
3 2.5 “Code” shall mean the Internal Revenue Code of 1986, as amended and the regulations issued thereunder. 2.6 “Common Stock” shall mean the common stock of the Company, and such other securities of the Company that may be substituted therefor pursuant to Article VIII. 2.7 “Company” shall mean PROCEPT BioRobotics Corporation, a Delaware corporation. 2.8 “Compensation” of an Eligible Employee shall mean gross cash compensation of regular earnings or base salary received by such Eligible Employee as compensation for services to the Company or any Designated Subsidiary, including payment received under the Company’s sales variable compensation plans, prior week adjustment, overtime payments, shift differentials, vacation pay, holiday pay, jury duty pay, paid time off, funeral leave pay and military leave pay, but excluding period bonuses, one-time bonuses (e.g., retention or sign on bonuses), education or tuition reimbursements, travel expenses, business and moving reimbursements, income received in connection with any stock options, stock appreciation rights, restricted stock, restricted stock units or other compensatory equity awards, fringe benefits, other special payments or all contributions made by the Company or any Designated Subsidiary for the Employee’s benefit under any employee benefit plan now or hereafter established. The Administrator, in its discretion, may establish a different definition of Compensation for an Offering Period. 2.9 “Designated Subsidiary” shall mean any Subsidiary designated by the Administrator in accordance with Section 11.3(b). 2.10 “Effective Date” shall mean the Pricing Date, provided that the Board has adopted the Plan prior to or on such date. 2.11 “Eligible Employee” shall mean an Employee who does not, immediately after any rights under this Plan are granted, own (directly or through attribution) stock possessing 5% or more of the total combined voting power or value of all classes of Common Stock and other stock of the Company, a Parent or a Subsidiary (as determined under Section 423(b)(3) of the Code). For purposes of the foregoing sentence, the rules of Section 424(d) of the Code with regard to the attribution of stock ownership shall apply in determining the stock ownership of an individual, and stock that an Employee may purchase under outstanding options shall be treated as stock owned by the Employee; provided, however, that the Administrator may provide in an Offering Document that an Employee shall not be eligible to participate in an Offering Period if: (a) such Employee is a highly compensated employee within the meaning of Section 423(b)(4)(D) of the Code, (b) such Employee has not met a service requirement designated by the Administrator pursuant to Section 423(b)(4)(A) of the Code (which service requirement may not exceed two years), (c) such Employee’s customary employment is for 20 hours or less per week, (d) such Employee’s customary employment is for less than five months in any calendar year and/or (e) such Employee is a citizen or resident of a foreign jurisdiction and the grant of a right to purchase Common Stock under the Plan to such Employee would be prohibited under the laws of such foreign jurisdiction or the grant of a right to purchase Common Stock under the Plan to such Employee in compliance with the laws of such foreign jurisdiction
4 would cause the Plan to violate the requirements of Section 423 of the Code, as determined by the Administrator in its sole discretion; provided, further, that any exclusion in clauses (a), (b), (c), (d) or (e) shall be applied in an identical manner under each Offering Period to all Employees, in accordance with Treasury Regulation Section 1.423-2(e). 2.12 “Employee” shall mean any officer or other employee (as defined in accordance with Section 3401(c) of the Code) of the Company or any Designated Subsidiary. “Employee” shall not include any director of the Company or a Designated Subsidiary who does not render services to the Company or a Designated Subsidiary as an employee within the meaning of Section 3401(c) of the Code. For purposes of the Plan, the employment relationship shall be treated as continuing intact while the individual is on sick leave or other leave of absence approved by the Company or Designated Subsidiary and meeting the requirements of Treasury Regulation Section 1.421-1(h)(2). Where the period of leave exceeds three months and the individual’s right to reemployment is not guaranteed either by statute or by contract, the employment relationship shall be deemed to have terminated on the first day immediately following such three-month period. 2.13 “Enrollment Date” shall mean the first Trading Day of each Offering Period, unless otherwise specified in the Offering Document; provided, that the Enrollment Date for the Initial Offering Period shall be the Pricing Date. 2.14 “Exchange Act” shall mean the Securities Exchange Act of 1934, as amended from time to time. 2.15 “Fair Market Value” means, as of any date, the value of a share of Common Stock determined as follows: (a) if the Common Stock is listed on any established stock exchange, its Fair Market Value will be the closing sales price for such Common Stock as quoted on such exchange for such date, or if no sale occurred on such date, the last day preceding such date during which a sale occurred, as reported in The Wall Street Journal or another source the Administrator deems reliable; (b) if the Common Stock is not traded on a stock exchange but is quoted on a national market or other quotation system, the closing sales price on such date, or if no sales occurred on such date, then on the last date preceding such date during which a sale occurred, as reported in The Wall Street Journal or another source the Administrator deems reliable; (c) without an established market for the Common Stock, the Administrator will determine the Fair Market Value in its discretion; or (d) with respect to the Initial Offering Period, the Fair Market Value as specified in the Offering Document approved by the Administrator with respect to the Initial Offering Period. 2.16 “Initial Offering Period” means the period commencing on the Pricing Date and ending on the date set forth in the Offering Document approved by the Administrator with respect to the Initial Offering Period. 2.17 “Offering Document” shall have the meaning given to such term in Section 4.1. 2.18 “Offering Period” shall have the meaning given to such term in Section 4.1. 2.19 “Parent” shall mean any corporation, other than the Company, in an unbroken chain of corporations ending with the Company if, at the time of the determination, each of the
5 corporations other than the Company owns stock possessing 50% or more of the total combined voting power of all classes of stock in one of the other corporations in such chain. 2.20 “Participant” shall mean any Eligible Employee who has executed a subscription agreement and been granted rights to purchase Common Stock pursuant to the Plan (or, with respect to the Initial Offering Period, those Participants specified in the Offering Document approved by the Administrator with respect to the Initial Offering Period). 2.21 “Payday” means the regular and recurring established day for payment of Compensation to an Employee of the Company or any Designated Subsidiary. 2.22 “Plan” shall mean this PROCEPT BioRobotics Corporation 2021 Employee Stock Purchase Plan, as it may be amended from time to time. 2.23 “Pricing Date” means the date upon which the Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission relating to the underwritten public offering of shares of Common Stock becomes effective. 2.24 “Public Trading Date” means the first date upon which the Common Stock is listed (or approved for listing) upon notice of issuance on any securities exchange or designated (or approved for designation) upon notice of issuance as a national market security on an interdealer quotation system. 2.25 “Purchase Date” shall mean the last Trading Day of each Purchase Period. 2.26 “Purchase Period” shall refer to one or more periods within an Offering Period, as designated in the applicable Offering Document; provided, however, that, in the event no Purchase Period is designated by the Administrator in the applicable Offering Document, the Purchase Period for each Offering Period covered by such Offering Document shall be the same as the applicable Offering Period. 2.27 “Purchase Price” shall mean the purchase price designated by the Administrator in the applicable Offering Document (which purchase price shall not be less than 85% of the Fair Market Value of a Share on the Enrollment Date or on the Purchase Date, whichever is lower); provided, however, that, in the event no purchase price is designated by the Administrator in the applicable Offering Document, the purchase price for the Offering Periods covered by such Offering Document shall be 85% of the Fair Market Value of a Share on the Enrollment Date or on the Purchase Date, whichever is lower; provided, further, that the Purchase Price may be adjusted by the Administrator pursuant to Article VIII and shall not be less than the par value of a Share. 2.28 “Securities Act” shall mean the Securities Act of 1933, as amended. 2.29 “Share” shall mean a share of Common Stock. 2.30 “Subsidiary” shall mean any corporation, other than the Company, in an unbroken chain of corporations beginning with the Company if, at the time of the determination, each of the corporations other than the last corporation in an unbroken chain owns stock
6 possessing 50% or more of the total combined voting power of all classes of stock in one of the other corporations in such chain; provided, however, that a limited liability company or partnership may be treated as a Subsidiary to the extent either (a) such entity is treated as a disregarded entity under Treasury Regulation Section 301.7701-3(a) by reason of the Company or any other Subsidiary that is a corporation being the sole owner of such entity, or (b) such entity elects to be classified as a corporation under Treasury Regulation Section 301.7701-3(a) and such entity would otherwise qualify as a Subsidiary. 2.31 “Trading Day” shall mean a day on which national stock exchanges in the United States are open for trading. ARTICLE III. SHARES SUBJECT TO THE PLAN 3.1 Number of Shares. Subject to Article VIII, the aggregate number of shares of Common Stock that may be issued pursuant to rights granted under the Plan shall be 412,988 Shares. In addition to the foregoing, subject to Article VIII, on the first day of each calendar year beginning on January 1, 2022 and ending on and including January 1, 2031, the number of Shares available for issuance under the Plan shall be increased by that number of Shares equal to the lesser of (a) 1% of the aggregate number of shares of Common Stock outstanding on the final day of the immediately preceding calendar year and (b) such smaller number of Shares as determined by the Board. If any right granted under the Plan shall for any reason terminate without having been exercised, the Common Stock not purchased under such right shall again become available for issuance under the Plan. Notwithstanding anything in this Section 3.1 to the contrary, the number of Shares that may be issued or transferred pursuant to the rights granted under the Plan shall not exceed an aggregate of 10,526,315 Shares, subject to Article VIII. 3.2 Stock Distributed. Any Common Stock distributed pursuant to the Plan may consist, in whole or in part, of authorized and unissued Common Stock, treasury stock or Common Stock purchased on the open market. ARTICLE IV. OFFERING PERIODS; OFFERING DOCUMENTS; PURCHASE DATES 4.1 Offering Periods. The Administrator may from time to time grant or provide for the grant of rights to purchase Common Stock under the Plan to Eligible Employees during one or more periods (each, an “Offering Period”) selected by the Administrator. The terms and conditions applicable to each Offering Period shall be set forth in an “Offering Document” adopted by the Administrator, which Offering Document shall be in such form and shall contain such terms and conditions as the Administrator shall deem appropriate. The Administrator shall establish in each Offering Document one or more Purchase Periods during such Offering Period during which rights granted under the Plan shall be exercised and purchases of Shares carried out during such Offering Period in accordance with such Offering Document and the Plan. The provisions of separate Offering Periods under the Plan need not be identical. 4.2 Offering Documents. Each Offering Document with respect to an Offering Period shall specify (through incorporation of the provisions of this Plan by reference or otherwise):
7 (a) the length of the Offering Period, which period shall not exceed 27 months; (b) the length of the Purchase Period(s) within the Offering Period; (c) in connection with each Offering Period that contains only one Purchase Period the maximum number of Shares that may be purchased by any Eligible Employee during such Offering Period, which, in the absence of a contrary designation by the Administrator, shall be 100,000 Shares; (d) in connection with each Offering Period that contains more than one Purchase Period, the maximum aggregate number of Shares which may be purchased by any Eligible Employee during each Purchase Period, which, in the absence of a contrary designation by the Administrator, shall be 100,000 Shares; and (e) such other provisions as the Administrator determines are appropriate, subject to the Plan. ARTICLE V. ELIGIBILITY AND PARTICIPATION 5.1 Eligibility. Any Eligible Employee who shall be employed by the Company or a Designated Subsidiary on a given Enrollment Date for an Offering Period shall be eligible to participate in the Plan during such Offering Period, subject to the requirements of this Article V and the limitations imposed by Section 423(b) of the Code. 5.2 Enrollment in Plan. (a) Except as otherwise set forth herein or in an Offering Document or determined by the Administrator, an Eligible Employee may become a Participant in the Plan for an Offering Period by delivering a subscription agreement to the Company by such time prior to the Enrollment Date for such Offering Period (or such other date specified in the Offering Document) designated by the Administrator and in such form as the Company provides. (b) Each subscription agreement shall designate a whole percentage of such Eligible Employee’s Compensation to be withheld by the Company or the Designated Subsidiary employing such Eligible Employee on each Payday during the Offering Period as payroll deductions under the Plan. The designated percentage may not be less than 1% and may not be more than the maximum percentage specified by the Administrator in the applicable Offering Document (which percentage shall be 15% in the absence of any such designation). The payroll deductions made for each Participant shall be credited to an account for such Participant under the Plan and shall be deposited with the general funds of the Company. (c) A Participant may decrease the percentage of Compensation designated in his or her subscription agreement, subject to the limits of this Section 5.2, or may suspend his or her payroll deductions, at any time during an Offering Period; provided, however, that the Administrator may limit the number of changes a Participant may make to his or her payroll deduction elections during each Offering Period in the applicable Offering Document (and in the absence of any specific designation by the Administrator, a Participant shall be allowed two
8 decreases and one suspension (but no increases) to his or her payroll deduction elections during each Offering Period with respect to such Offering Period). Any such change or suspension of payroll deductions shall be effective with the first full payroll period following ten business days after the Company’s receipt of the new subscription agreement (or such shorter or longer period as may be specified by the Administrator in the applicable Offering Document). In the event a Participant suspends his or her payroll deductions, such Participant’s cumulative payroll deductions prior to the suspension shall remain in his or her account and shall be applied to the purchase of Shares on the next occurring Purchase Date and shall not be paid to such Participant unless he or she withdraws from participation in the Plan pursuant to Article VII. (d) Except as otherwise set forth in Section 5.8 or in an Offering Document or determined by the Administrator, a Participant may participate in the Plan only by means of payroll deduction and may not make contributions by lump sum payment for any Offering Period. 5.3 Payroll Deductions. Except as otherwise provided in the applicable Offering Document or Section 5.8, payroll deductions for a Participant shall commence on the first payroll following the Enrollment Date and shall end on the last payroll in the Offering Period to which the Participant’s authorization is applicable, unless sooner terminated by the Participant as provided in Article VII or suspended by the Participant or the Administrator as provided in Section 5.2 and Section 5.6, respectively. 5.4 Effect of Enrollment. A Participant’s completion of a subscription agreement will enroll such Participant in the Plan for each subsequent Offering Period on the terms contained therein until the Participant either submits a new subscription agreement, withdraws from participation under the Plan as provided in Article VII or otherwise becomes ineligible to participate in the Plan. 5.5 Limitation on Purchase of Common Stock. An Eligible Employee may be granted rights under the Plan only if such rights, together with any other rights granted to such Eligible Employee under “employee stock purchase plans” of the Company, any Parent or any Subsidiary, as specified by Section 423(b)(8) of the Code, do not permit such employee’s rights to purchase stock of the Company or any Parent or Subsidiary to accrue at a rate that exceeds $25,000 of the fair market value of such stock (determined as of the first day of the Offering Period during which such rights are granted) for each calendar year in which such rights are outstanding at any time. This limitation shall be applied in accordance with Section 423(b)(8) of the Code. 5.6 Suspension of Payroll Deductions. Notwithstanding the foregoing, to the extent necessary to comply with Section 423(b)(8) of the Code and Section 5.5 or the other limitations set forth in this Plan, a Participant’s payroll deductions may be suspended by the Administrator at any time during an Offering Period. The balance of the amount credited to the account of each Participant that has not been applied to the purchase of Shares by reason of Section 423(b)(8) of the Code, Section 5.5 or the other limitations set forth in this Plan shall be paid to such Participant in one lump sum in cash as soon as reasonably practicable after the Purchase Date.
9 5.7 Foreign Employees. In order to facilitate participation in the Plan, the Administrator may provide for such special terms applicable to Participants who are citizens or residents of a foreign jurisdiction, or who are employed by a Designated Subsidiary outside of the United States, as the Administrator may consider necessary or appropriate to accommodate differences in local law, tax policy or custom. Such special terms may not be more favorable than the terms of rights granted under the Plan to Eligible Employees who are residents of the United States. Moreover, the Administrator may approve such supplements to, or amendments, restatements or alternative versions of, this Plan as it may consider necessary or appropriate for such purposes without thereby affecting the terms of this Plan as in effect for any other purpose. No such special terms, supplements, amendments or restatements shall include any provisions that are inconsistent with the terms of this Plan as then in effect unless this Plan could have been amended to eliminate such inconsistency without further approval by the stockholders of the Company. 5.8 Leave of Absence. During unpaid leaves of absence approved by the Company meeting the requirements of Treasury Regulation Section 1.421-1(h)(2) under the Code, a Participant may continue participation in the Plan by making cash payments to the Company on his or her normal Payday equal to his or her authorized payroll deduction. ARTICLE VI. GRANT AND EXERCISE OF RIGHTS 6.1 Grant of Rights. On the Enrollment Date of each Offering Period, each Eligible Employee participating in such Offering Period shall be granted a right to purchase the maximum number of Shares specified under Section 4.2, subject to the limits in Section 5.5, and shall have the right to buy, on each Purchase Date during such Offering Period (at the applicable Purchase Price), such number of whole Shares as is determined by dividing (a) such Participant’s payroll deductions accumulated prior to such Purchase Date and retained in the Participant’s account as of the Purchase Date, by (b) the applicable Purchase Price (rounded down to the nearest Share). The right shall expire on the earlier of: (x) the last Purchase Date of such Offering Period, (y) last day of such Offering Period and (z) the date on which such Participant withdraws in accordance with Section 7.1 or Section 7.3. 6.2 Exercise of Rights. On each Purchase Date, each Participant’s accumulated payroll deductions and any other additional payments specifically provided for in the applicable Offering Document will be applied to the purchase of whole Shares, up to the maximum number of Shares permitted pursuant to the terms of the Plan and the applicable Offering Document, at the Purchase Price. No fractional Shares shall be issued upon the exercise of rights granted under the Plan, unless the Offering Document specifically provides otherwise. Any cash in lieu of fractional Shares remaining after the purchase of whole Shares upon exercise of a purchase right will be carried forward and applied toward the purchase of whole Shares for the following Offering Period. Shares issued pursuant to the Plan may be evidenced in such manner as the Administrator may determine and may be issued in certificated form or issued pursuant to book-entry procedures. 6.3 Pro Rata Allocation of Shares. If the Administrator determines that, on a given Purchase Date, the number of Shares with respect to which rights are to be exercised may exceed
10 (a) the number of Shares that were available for issuance under the Plan on the Enrollment Date of the applicable Offering Period, or (b) the number of Shares available for issuance under the Plan on such Purchase Date, the Administrator may in its sole discretion provide that the Company shall make a pro rata allocation of the Shares available for purchase on such Enrollment Date or Purchase Date, as applicable, in as uniform a manner as shall be practicable and as it shall determine in its sole discretion to be equitable among all Participants for whom rights to purchase Shares are to be exercised pursuant to this Article VI on such Purchase Date, and shall either (i) continue all Offering Periods then in effect, or (ii) terminate any or all Offering Periods then in effect pursuant to Article IX. The Company may make pro rata allocation of the Shares available on the Enrollment Date of any applicable Offering Period pursuant to the preceding sentence, notwithstanding any authorization of additional Shares for issuance under the Plan by the Company’s stockholders subsequent to such Enrollment Date. The balance of the amount credited to the account of each Participant that has not been applied to the purchase of Shares shall be paid to such Participant, without interest, in one in lieu in cash as soon as reasonably practicable after the Purchase Date. 6.4 Withholding. At the time a Participant’s rights under the Plan are exercised, in whole or in part, or at the time some or all of the Shares issued under the Plan is disposed of, the Participant must make adequate provision for the Company’s federal, state, or other tax withholding obligations, if any, that arise upon the exercise of the right or the disposition of the Shares. At any time, the Company may, but shall not be obligated to, withhold from the Participant’s compensation the amount necessary for the Company to meet applicable withholding obligations, including any withholding required to make available to the Company any tax deductions or benefits attributable to sale or early disposition of Shares by the Participant. 6.5 Conditions to Issuance of Common Stock. The Company shall not be required to issue or deliver any certificate or certificates for, or make any book entries evidencing, Shares purchased upon the exercise of rights under the Plan prior to fulfillment of all of the following conditions: (a) The admission of such Shares to listing on all stock exchanges, if any, on which the Common Stock is then listed; (b) The completion of any registration or other qualification of such Shares under any state or federal law or under the rulings or regulations of the Securities and Exchange Commission or any other governmental regulatory body, that the Administrator shall, in its absolute discretion, deem necessary or advisable; (c) The obtaining of any approval or other clearance from any state or federal governmental agency that the Administrator shall, in its absolute discretion, determine to be necessary or advisable; (d) The payment to the Company of all amounts that it is required to withhold under federal, state or local law upon exercise of the rights, if any; and
11 (e) The lapse of such reasonable period of time following the exercise of the rights as the Administrator may from time to time establish for reasons of administrative convenience. ARTICLE VII. WITHDRAWAL; CESSATION OF ELIGIBILITY 7.1 Withdrawal. A Participant may withdraw all but not less than all of the payroll deductions credited to his or her account and not yet used to exercise his or her rights under the Plan at any time by giving written notice to the Company in a form acceptable to the Company no later than two weeks prior to the end of the Offering Period or, if earlier, the end of the Purchase Period (or such shorter or longer period as may be specified by the Administrator in the Offering Document). All of the Participant’s payroll deductions credited to his or her account during the Offering Period not yet used to exercise his or her rights under the Plan shall be paid to such Participant as soon as reasonably practicable after receipt of notice of withdrawal and such Participant’s rights for the Offering Period shall be automatically terminated, and no further payroll deductions for the purchase of Shares shall be made for such Offering Period. If a Participant withdraws from an Offering Period, payroll deductions shall not resume at the beginning of the next Offering Period unless the Participant is an Eligible Employee and timely delivers to the Company a new subscription agreement. 7.2 Future Participation. A Participant’s withdrawal from an Offering Period shall not have any effect upon his or her eligibility to participate in any similar plan that may hereafter be adopted by the Company or a Designated Subsidiary or in subsequent Offering Periods that commence after the termination of the Offering Period from which the Participant withdraws. 7.3 Cessation of Eligibility. Upon a Participant’s ceasing to be an Eligible Employee for any reason, he or she shall be deemed to have elected to withdraw from the Plan pursuant to this Article VII and the payroll deductions credited to such Participant’s account during the Offering Period shall be paid to such Participant or, in the case of his or her death, to the person or persons entitled thereto under Section 12.4, as soon as reasonably practicable, and such Participant’s rights for the Offering Period shall be automatically terminated. ARTICLE VIII. ADJUSTMENTS UPON CHANGES IN STOCK 8.1 Changes in Capitalization. Subject to Section 8.3, in the event that the Administrator determines that any dividend or other distribution (whether in the form of cash, Common Stock, other securities, or other property), Change in Control, reorganization, merger, amalgamation, consolidation, combination, repurchase, recapitalization, liquidation, dissolution, or sale, transfer, exchange or other disposition of all or substantially all of the assets of the Company, or sale or exchange of Common Stock or other securities of the Company, issuance of warrants or other rights to purchase Common Stock or other securities of the Company, or other similar corporate transaction or event, as determined by the Administrator, affects the Common Stock such that an adjustment is determined by the Administrator to be appropriate in order to prevent dilution or enlargement of the benefits or potential benefits intended by the Company to be made available under the Plan or with respect to any outstanding purchase rights under the Plan, the Administrator shall make equitable adjustments, if any, to reflect such change with
12 respect to (a) the aggregate number and type of Shares (or other securities or property) that may be issued under the Plan (including, but not limited to, adjustments of the limitations in Section 3.1 and the limitations established in each Offering Document pursuant to Section 4.2 on the maximum number of Shares that may be purchased); (b) the class(es) and number of Shares and price per Share subject to outstanding rights; and (c) the Purchase Price with respect to any outstanding rights. 8.2 Other Adjustments. Subject to Section 8.3, in the event of any transaction or event described in Section 8.1 or any unusual or nonrecurring transactions or events affecting the Company, any affiliate of the Company, or the financial statements of the Company or any affiliate (including without limitation any Change in Control), or of changes in Applicable Law or accounting principles, the Administrator, in its discretion, and on such terms and conditions as it deems appropriate, is hereby authorized to take any one or more of the following actions whenever the Administrator determines that such action is appropriate in order to prevent the dilution or enlargement of the benefits or potential benefits intended to be made available under the Plan or with respect to any right under the Plan, to facilitate such transactions or events or to give effect to such changes in laws, regulations or principles: (a) To provide for either (i) termination of any outstanding right in exchange for an amount of cash, if any, equal to the amount that would have been obtained upon the exercise of such right had such right been currently exercisable or (ii) the replacement of such outstanding right with other rights or property selected by the Administrator in its sole discretion; (b) To provide that the outstanding rights under the Plan shall be assumed by the successor or survivor corporation, or a parent or subsidiary thereof, or shall be substituted for by similar rights covering the stock of the successor or survivor corporation, or a parent or subsidiary thereof, with appropriate adjustments as to the number and kind of shares and prices; (c) To make adjustments in the number and type of Shares (or other securities or property) subject to outstanding rights under the Plan and/or in the terms and conditions of outstanding rights and rights that may be granted in the future; (d) To provide that Participants’ accumulated payroll deductions may be used to purchase Common Stock prior to the next occurring Purchase Date on such date as the Administrator determines in its sole discretion and the Participants’ rights under the ongoing Offering Period(s) shall be terminated; and (e) To provide that all outstanding rights shall terminate without being exercised. 8.3 No Adjustment Under Certain Circumstances. No adjustment or action described in this Article VIII or in any other provision of the Plan shall be authorized to the extent that such adjustment or action would cause the Plan to fail to satisfy the requirements of Section 423 of the Code. 8.4 No Other Rights. Except as expressly provided in the Plan, no Participant shall have any rights by reason of any subdivision or consolidation of shares of stock of any class, the payment of any dividend, any increase or decrease in the number of shares of stock of any class or any dissolution, liquidation, merger, or consolidation of the Company or any other
13 corporation. Except as expressly provided in the Plan or pursuant to action of the Administrator under the Plan, no issuance by the Company of shares of stock of any class, or securities convertible into shares of stock of any class, shall affect, and no adjustment by reason thereof shall be made with respect to, the number of Shares subject to outstanding rights under the Plan or the Purchase Price with respect to any outstanding rights. ARTICLE IX. AMENDMENT, MODIFICATION AND TERMINATION 9.1 Amendment, Modification and Termination. The Administrator may amend, suspend or terminate the Plan at any time and from time to time; provided, however, that approval of the Company’s stockholders shall be required to amend the Plan to: (a) increase the aggregate number, or change the type, of shares that may be sold pursuant to rights under the Plan under Section 3.1 (other than an adjustment as provided by Article VIII); (b) change the Plan in any manner that would be considered the adoption of a new plan within the meaning of Treasury regulation Section 1.423-2(c)(4); or (c) change the Plan in any manner that would cause the Plan to no longer be an “employee stock purchase plan” within the meaning of Section 423(b) of the Code. 9.2 Certain Changes to Plan. Without stockholder consent and without regard to whether any Participant rights may be considered to have been adversely affected, to the extent permitted by Section 423 of the Code, the Administrator shall be entitled to change or terminate the Offering Periods, limit the frequency and/or number of changes in the amount withheld from Compensation during an Offering Period, establish the exchange ratio applicable to amounts withheld in a currency other than U.S. dollars, permit payroll withholding in excess of the amount designated by a Participant in order to adjust for delays or mistakes in the Company’s processing of payroll withholding elections, establish reasonable waiting and adjustment periods and/or accounting and crediting procedures to ensure that amounts applied toward the purchase of Common Stock for each Participant properly correspond with amounts withheld from the Participant’s Compensation, and establish such other limitations or procedures as the Administrator determines in its sole discretion to be advisable that are consistent with the Plan. 9.3 Actions In the Event of Unfavorable Financial Accounting Consequences. In the event the Administrator determines that the ongoing operation of the Plan may result in unfavorable financial accounting consequences, the Administrator may, in its discretion and, to the extent necessary or desirable, modify or amend the Plan to reduce or eliminate such accounting consequence including, but not limited to: (a) altering the Purchase Price for any Offering Period, including an Offering Period underway at the time of the change in Purchase Price; (b) shortening any Offering Period so that the Offering Period ends on a new Purchase Date, including an Offering Period underway at the time of the Administrator action; and (c) allocating Shares.
14 Such modifications or amendments shall not require stockholder approval or the consent of any Participant. 9.4 Payments Upon Termination of Plan. Upon termination of the Plan, the balance in each Participant’s Plan account shall be refunded as soon as practicable after such termination, without any interest thereon. ARTICLE X. TERM OF PLAN The Plan shall be effective on the Effective Date. The effectiveness of the Plan shall be subject to approval of the Plan by the stockholders of the Company within 12 months following the date the Plan is first approved by the Board. No right may be granted under the Plan prior to such stockholder approval. No rights may be granted under the Plan during any period of suspension of the Plan or after termination of the Plan. ARTICLE XI. ADMINISTRATION 11.1 Administrator. Unless otherwise determined by the Board, the Administrator of the Plan shall be the Compensation Committee of the Board (or another committee or a subcommittee of the Board to which the Board delegates administration of the Plan) (such committee, the “Committee”). The Board may at any time vest in the Board any authority or duties for administration of the Plan. 11.2 Action by the Administrator. Unless otherwise established by the Board or in any charter of the Administrator, a majority of the Administrator shall constitute a quorum. The acts of a majority of the members present at any meeting at which a quorum is present and, subject to Applicable Law and the Bylaws of the Company, acts approved in writing by a majority of the Administrator in lieu of a meeting, shall be deemed the acts of the Administrator. Each member of the Administrator is entitled to, in good faith, rely or act upon any report or other information furnished to that member by any officer or other employee of the Company or any Designated Subsidiary, the Company’s independent certified public accountants, or any executive compensation consultant or other professional retained by the Company to assist in the administration of the Plan. 11.3 Authority of Administrator. The Administrator shall have the power, subject to, and within the limitations of, the express provisions of the Plan: (a) To determine when and how rights to purchase Common Stock shall be granted and the provisions of each offering of such rights (which need not be identical). (b) To designate from time to time which Subsidiaries of the Company shall be Designated Subsidiaries, which designation may be made without the approval of the stockholders of the Company. (c) To construe and interpret the Plan and rights granted under it, and to establish, amend and revoke rules and regulations for its administration. The Administrator, in the exercise
15 of this power, may correct any defect, omission or inconsistency in the Plan, in a manner and to the extent it shall deem necessary or expedient to make the Plan fully effective. (d) To amend, suspend or terminate the Plan as provided in Article IX. (e) Generally, to exercise such powers and to perform such acts as the Administrator deems necessary or expedient to promote the best interests of the Company and its Subsidiaries and to carry out the intent that the Plan be treated as an “employee stock purchase plan” within the meaning of Section 423 of the Code. 11.4 Decisions Binding. The Administrator’s interpretation of the Plan, any rights granted pursuant to the Plan, any subscription agreement and all decisions and determinations by the Administrator with respect to the Plan are final, binding, and conclusive on all parties. ARTICLE XII. MISCELLANEOUS 12.1 Restriction upon Assignment. A right granted under the Plan shall not be transferable other than by will or the Applicable Laws of descent and distribution, and is exercisable during the Participant’s lifetime only by the Participant. Except as provided in Section 12.4 hereof, a right under the Plan may not be exercised to any extent except by the Participant. The Company shall not recognize and shall be under no duty to recognize any assignment or alienation of the Participant’s interest in the Plan, the Participant’s rights under the Plan or any rights thereunder. 12.2 Rights as a Stockholder. With respect to Shares subject to a right granted under the Plan, a Participant shall not be deemed to be a stockholder of the Company, and the Participant shall not have any of the rights or privileges of a stockholder, until such Shares have been issued to the Participant or his or her nominee following exercise of the Participant’s rights under the Plan. No adjustments shall be made for dividends (ordinary or extraordinary, whether in cash securities, or other property) or distribution or other rights for which the record date occurs prior to the date of such issuance, except as otherwise expressly provided herein or as determined by the Administrator. 12.3 Interest. No interest shall accrue on the payroll deductions or contributions of a Participant under the Plan. 12.4 Designation of Beneficiary. (a) A Participant may, in the manner determined by the Administrator, file a written designation of a beneficiary who is to receive any Shares and/or cash, if any, from the Participant’s account under the Plan in the event of such Participant’s death subsequent to a Purchase Date on which the Participant’s rights are exercised but prior to delivery to such Participant of such Shares and cash. In addition, a Participant may file a written designation of a beneficiary who is to receive any cash from the Participant’s account under the Plan in the event of such Participant’s death prior to exercise of the Participant’s rights under the Plan. If the Participant is married and resides in a community property state, a designation of a person other
16 than the Participant’s spouse as his or her beneficiary shall not be effective without the prior written consent of the Participant’s spouse. (b) Such designation of beneficiary may be changed by the Participant at any time by written notice to the Company. In the event of the death of a Participant and in the absence of a beneficiary validly designated under the Plan who is living at the time of such Participant’s death, the Company shall deliver such Shares and/or cash to the executor or administrator of the estate of the Participant, or if no such executor or administrator has been appointed (to the knowledge of the Company), the Company, in its discretion, may deliver such Shares and/or cash to the spouse or to any one or more dependents or relatives of the Participant, or if no spouse, dependent or relative is known to the Company, then to such other person as the Company may designate. 12.5 Notices. All notices or other communications by a Participant to the Company under or in connection with the Plan shall be deemed to have been duly given when received in the form specified by the Company at the location, or by the person, designated by the Company for the receipt thereof. 12.6 Equal Rights and Privileges. Subject to Section 5.7, all Eligible Employees will have equal rights and privileges under this Plan so that this Plan qualifies as an “employee stock purchase plan” within the meaning of Section 423 of the Code. Subject to Section 5.7, any provision of this Plan that is inconsistent with Section 423 of the Code will, without further act or amendment by the Company, the Board or the Administrator, be reformed to comply with the equal rights and privileges requirement of Section 423 of the Code. 12.7 Use of Funds. All payroll deductions received or held by the Company under the Plan may be used by the Company for any corporate purpose, and the Company shall not be obligated to segregate such payroll deductions. 12.8 Reports. Statements of account shall be given to Participants at least annually, which statements shall set forth the amounts of payroll deductions, the Purchase Price, the number of Shares purchased and the remaining cash balance, if any. 12.9 No Employment Rights. Nothing in the Plan shall be construed to give any person (including any Eligible Employee or Participant) the right to employment or service with (or to remain in the employ of) the Company or any Parent or Subsidiary thereof or affect the right of the Company or any Parent or Subsidiary thereof to terminate the employment of any person (including any Eligible Employee or Participant) at any time, with or without cause. 12.10 Notice of Disposition of Shares. Each Participant shall give prompt notice to the Company of any disposition or other transfer of any Shares purchased upon exercise of a right under the Plan if such disposition or transfer is made: (a) within two years from the Enrollment Date of the Offering Period in which the Shares were purchased or (b) within one year after the Purchase Date on which such Shares were purchased. Such notice shall specify the date of such disposition or other transfer and the amount realized, in cash, other property, assumption of indebtedness or other consideration, by the Participant in such disposition or other transfer.
17 12.11 Governing Law. The Plan and any agreements hereunder shall be administered, interpreted and enforced under the internal laws of the State of Delaware without regard to conflicts of laws thereof or of any other jurisdiction. 12.12 Electronic Forms. To the extent permitted by Applicable Law and in the discretion of the Administrator, an Eligible Employee may submit any form or notice as set forth herein by means of an electronic form approved by the Administrator. Before the commencement of an Offering Period, the Administrator shall prescribe the time limits within which any such electronic form shall be submitted to the Administrator with respect to such Offering Period in order to be a valid election.
Exhibit 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Reza Zadno, Ph.D., certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of PROCEPT BioRobotics Corporation;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
| | | | | | | | | | | |
Date: October 28, 2024 | | By: | /s/ Reza Zadno |
| | | Reza Zadno, Ph.D. |
| | | Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Kevin Waters, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of PROCEPT BioRobotics Corporation;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
| | | | | | | | | | | |
Date: October 28, 2024 | | By: | /s/ Kevin Waters |
| | | Kevin Waters |
| | | Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of PROCEPT BioRobotics Corporation (the “Company”) on Form 10-Q for the period ending September 30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.
| | | | | | | | | | | |
Date: October 28, 2024 | | By: | /s/ Reza Zadno |
| | | Reza Zadno, Ph.D. |
| | | Chief Executive Officer (Principal Executive Officer) |
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of PROCEPT BioRobotics Corporation (the “Company”) on Form 10-Q for the period ending September 30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.
| | | | | | | | | | | |
Date: October 28, 2024 | | By: | /s/ Kevin Waters |
| | | Kevin Waters |
| | | Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
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v3.24.3
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 196,762
|
$ 257,222
|
Accounts receivable, net |
69,048
|
48,376
|
Inventory |
50,850
|
39,756
|
Prepaid expenses and other current assets |
6,321
|
5,213
|
Total current assets |
322,981
|
350,567
|
Restricted cash, non-current |
3,038
|
3,038
|
Property and equipment, net |
26,605
|
28,748
|
Operating lease right-of-use assets, net |
19,267
|
20,241
|
Intangible assets, net |
1,000
|
1,204
|
Other assets |
1,251
|
919
|
Total assets |
374,142
|
404,717
|
Current liabilities: |
|
|
Accounts payable |
15,088
|
13,499
|
Accrued compensation |
18,834
|
16,885
|
Deferred revenue |
7,989
|
5,656
|
Operating lease, current |
1,839
|
1,683
|
Loan facility derivative liability |
2,000
|
1,886
|
Other current liabilities |
7,896
|
6,318
|
Total current liabilities |
53,646
|
45,927
|
Long-term debt |
51,438
|
51,339
|
Operating lease, non-current |
27,361
|
26,182
|
Other liabilities |
479
|
517
|
Total liabilities |
132,924
|
123,965
|
Commitments and contingencies (see Note 11) |
|
|
Stockholders’ equity: |
|
|
Preferred stock, $0.00001 par value; Authorized shares: 10,000 at September 30, 2024 and December 31, 2023, Issued and outstanding shares: none at September 30, 2024 and December 31, 2023 |
0
|
0
|
Common stock, $0.00001 par value; Authorized shares: 300,000 at September 30, 2024 and December 31, 2023, Issued and outstanding shares: 51,900 and 50,771 at September 30, 2024 and December 31, 2023, respectively |
0
|
0
|
Additional paid-in capital |
768,365
|
735,240
|
Accumulated other comprehensive gain (loss) |
(18)
|
84
|
Accumulated deficit |
(527,129)
|
(454,572)
|
Total stockholders’ equity |
241,218
|
280,752
|
Total liabilities and stockholders’ equity |
$ 374,142
|
$ 404,717
|
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v3.24.3
Condensed Consolidated Balance Sheets - Parenthetical - $ / shares
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Preferred Stock, par value (in dollars per share) |
$ 0.00001
|
$ 0.00001
|
Preferred Stock, shares authorized (in shares) |
10,000,000
|
10,000,000
|
Preferred Stock, shares issued (in shares) |
0
|
0
|
Preferred Stock, shares outstanding (in shares) |
0
|
0
|
Common stock, par value (in dollars per share) |
$ 0.00001
|
$ 0.00001
|
Common stock, shares authorized (in shares) |
300,000,000
|
300,000,000
|
Common stock, shares issued (in shares) |
52,146,000
|
50,771,000
|
Common stock, shares outstanding (in shares) |
52,146,000
|
50,771,000
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.3
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Revenue |
$ 58,370
|
$ 35,102
|
$ 156,262
|
$ 92,610
|
Cost of sales |
21,459
|
16,228
|
62,835
|
42,816
|
Gross profit |
36,911
|
18,874
|
93,427
|
49,794
|
Operating expenses: |
|
|
|
|
Research and development |
16,647
|
11,600
|
47,232
|
33,950
|
Selling, general and administrative |
42,691
|
32,883
|
123,099
|
95,457
|
Total operating expenses |
59,338
|
44,483
|
170,331
|
129,407
|
Loss from operations |
(22,427)
|
(25,609)
|
(76,904)
|
(79,613)
|
Interest expense |
(1,140)
|
(1,019)
|
(3,215)
|
(2,870)
|
Interest and other income, net |
2,593
|
2,006
|
7,562
|
4,090
|
Net loss |
$ (20,974)
|
$ (24,622)
|
$ (72,557)
|
$ (78,393)
|
Net loss per share, basic (in dollars per share) |
$ (0.40)
|
$ (0.51)
|
$ (1.41)
|
$ (1.70)
|
Net loss per share, diluted (in dollars per share) |
$ (0.40)
|
$ (0.51)
|
$ (1.41)
|
$ (1.70)
|
Weighted-average common shares used to compute net loss per share attributable to |
|
|
|
|
Common shareholders, basic (in shares) |
52,011
|
48,310
|
51,550
|
46,131
|
Common shareholders, diluted (in shares) |
52,011
|
48,310
|
51,550
|
46,131
|
Other comprehensive gain (loss): |
|
|
|
|
Unrealized loss on cash equivalents |
$ (17)
|
$ 0
|
$ (102)
|
$ 0
|
Comprehensive loss |
$ (20,991)
|
$ (24,622)
|
$ (72,659)
|
$ (78,393)
|
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v3.24.3
Condensed Consolidated Statements of Stockholders’ Equity - USD ($) shares in Thousands, $ in Thousands |
Total |
Common Stock |
Additional Paid-in Capital |
Accumulated Other Comprehensive Gain (Loss) |
Accumulated Deficit |
Balance at the beginning of the period (in shares) at Dec. 31, 2022 |
|
44,828
|
|
|
|
Balance at the beginning of the period at Dec. 31, 2022 |
$ 197,072
|
$ 0
|
$ 545,753
|
$ (6)
|
$ (348,675)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
Issuance of common stock under stock plans (in shares) |
|
181
|
|
|
|
Issuance of common stock under stock plans |
380
|
|
380
|
|
|
Stock-based compensation expense |
4,137
|
|
4,137
|
|
|
Unrealized gain (loss) on cash equivalents |
21
|
|
|
21
|
|
Net loss |
(28,484)
|
|
|
|
(28,484)
|
Balance at the end of the period (in shares) at Mar. 31, 2023 |
|
45,009
|
|
|
|
Balance at the end of the period at Mar. 31, 2023 |
173,126
|
$ 0
|
550,270
|
15
|
(377,159)
|
Balance at the beginning of the period (in shares) at Dec. 31, 2022 |
|
44,828
|
|
|
|
Balance at the beginning of the period at Dec. 31, 2022 |
197,072
|
$ 0
|
545,753
|
(6)
|
(348,675)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
Unrealized gain (loss) on cash equivalents |
0
|
|
|
|
|
Net loss |
(78,393)
|
|
|
|
|
Balance at the end of the period (in shares) at Sep. 30, 2023 |
|
50,473
|
|
|
|
Balance at the end of the period at Sep. 30, 2023 |
299,356
|
$ 0
|
726,428
|
(6)
|
(427,066)
|
Balance at the beginning of the period (in shares) at Mar. 31, 2023 |
|
45,009
|
|
|
|
Balance at the beginning of the period at Mar. 31, 2023 |
173,126
|
$ 0
|
550,270
|
15
|
(377,159)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
Issuance of common stock under stock plans (in shares) |
|
262
|
|
|
|
Issuance of common stock under stock plans |
2,430
|
|
2,430
|
|
|
Stock-based compensation expense |
5,652
|
|
5,652
|
|
|
Unrealized gain (loss) on cash equivalents |
(21)
|
|
|
(21)
|
|
Net loss |
(25,285)
|
|
|
|
(25,285)
|
Balance at the end of the period (in shares) at Jun. 30, 2023 |
|
45,271
|
|
|
|
Balance at the end of the period at Jun. 30, 2023 |
155,902
|
$ 0
|
558,352
|
(6)
|
(402,444)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
Issuance of common stock under stock plans (in shares) |
|
117
|
|
|
|
Issuance of common stock under stock plans |
414
|
|
414
|
|
|
Issuance of common stock, net of issuance costs (in shares) |
|
5,085
|
|
|
|
Issuance of common stock, net of issuance costs of 10,795 |
161,705
|
|
161,705
|
|
|
Stock-based compensation expense |
5,957
|
|
5,957
|
|
|
Unrealized gain (loss) on cash equivalents |
0
|
|
|
0
|
|
Net loss |
(24,622)
|
|
|
|
(24,622)
|
Balance at the end of the period (in shares) at Sep. 30, 2023 |
|
50,473
|
|
|
|
Balance at the end of the period at Sep. 30, 2023 |
$ 299,356
|
$ 0
|
726,428
|
(6)
|
(427,066)
|
Balance at the beginning of the period (in shares) at Dec. 31, 2023 |
50,771
|
50,771
|
|
|
|
Balance at the beginning of the period at Dec. 31, 2023 |
$ 280,752
|
$ 0
|
735,240
|
84
|
(454,572)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
Issuance of common stock under stock plans (in shares) |
|
622
|
|
|
|
Issuance of common stock under stock plans |
2,586
|
|
2,586
|
|
|
Stock-based compensation expense |
6,637
|
|
6,637
|
|
|
Unrealized gain (loss) on cash equivalents |
29
|
|
|
29
|
|
Net loss |
(25,957)
|
|
|
|
(25,957)
|
Balance at the end of the period (in shares) at Mar. 31, 2024 |
|
51,393
|
|
|
|
Balance at the end of the period at Mar. 31, 2024 |
$ 264,047
|
$ 0
|
744,463
|
113
|
(480,529)
|
Balance at the beginning of the period (in shares) at Dec. 31, 2023 |
50,771
|
50,771
|
|
|
|
Balance at the beginning of the period at Dec. 31, 2023 |
$ 280,752
|
$ 0
|
735,240
|
84
|
(454,572)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
Unrealized gain (loss) on cash equivalents |
(102)
|
|
|
|
|
Net loss |
$ (72,557)
|
|
|
|
|
Balance at the end of the period (in shares) at Sep. 30, 2024 |
52,146
|
52,146
|
|
|
|
Balance at the end of the period at Sep. 30, 2024 |
$ 241,218
|
$ 0
|
768,365
|
(18)
|
(527,129)
|
Balance at the beginning of the period (in shares) at Mar. 31, 2024 |
|
51,393
|
|
|
|
Balance at the beginning of the period at Mar. 31, 2024 |
264,047
|
$ 0
|
744,463
|
113
|
(480,529)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
Issuance of common stock under stock plans (in shares) |
|
507
|
|
|
|
Issuance of common stock under stock plans |
5,296
|
|
5,296
|
|
|
Stock-based compensation expense |
8,176
|
|
8,176
|
|
|
Unrealized gain (loss) on cash equivalents |
(114)
|
|
|
(114)
|
|
Net loss |
(25,626)
|
|
|
|
(25,626)
|
Balance at the end of the period (in shares) at Jun. 30, 2024 |
|
51,900
|
|
|
|
Balance at the end of the period at Jun. 30, 2024 |
251,779
|
$ 0
|
757,935
|
(1)
|
(506,155)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
Issuance of common stock under stock plans (in shares) |
|
246
|
|
|
|
Issuance of common stock under stock plans |
1,715
|
|
1,715
|
|
|
Stock-based compensation expense |
8,715
|
|
8,715
|
|
|
Unrealized gain (loss) on cash equivalents |
(17)
|
|
|
(17)
|
|
Net loss |
$ (20,974)
|
|
|
|
(20,974)
|
Balance at the end of the period (in shares) at Sep. 30, 2024 |
52,146
|
52,146
|
|
|
|
Balance at the end of the period at Sep. 30, 2024 |
$ 241,218
|
$ 0
|
$ 768,365
|
$ (18)
|
$ (527,129)
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement, classified as other.
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- DefinitionNumber of shares of common stock outstanding. Common stock represent the ownership interest in a corporation.
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v3.24.3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Cash flows from operating activities: |
|
|
Net loss |
$ (72,557)
|
$ (78,393)
|
Adjustments to reconcile net loss to cash used in operating activities: |
|
|
Depreciation and amortization |
3,781
|
2,489
|
Stock-based compensation expense |
22,755
|
14,153
|
Change in fair value of derivative liability |
114
|
80
|
Non-cash lease adjustment |
(287)
|
123
|
Inventory write-down |
1,281
|
995
|
Provision for credit losses |
456
|
0
|
Changes in operating assets and liabilities: |
|
|
Accounts receivable |
(21,128)
|
(19,349)
|
Inventory |
(11,438)
|
(12,937)
|
Prepaid expenses and other current assets |
(1,210)
|
2,194
|
Other assets |
(334)
|
(365)
|
Accounts payable |
3,227
|
(87)
|
Accrued compensation |
1,949
|
(182)
|
Accrued interest expense |
100
|
93
|
Deferred revenue |
2,295
|
2,668
|
Reimbursements for leasehold improvements from operating leases |
2,596
|
4,989
|
Other liabilities |
1,578
|
319
|
Net cash used in operating activities |
(66,822)
|
(83,210)
|
Cash flows from investing activities: |
|
|
Purchases of property and equipment |
(3,235)
|
(16,491)
|
Net cash used in investing activities |
(3,235)
|
(16,491)
|
Cash flows from financing activities: |
|
|
Proceeds from the issuance of common stock, net of issuance costs |
0
|
161,705
|
Proceeds from issuance of common stock from the exercise of stock options |
7,474
|
1,507
|
Proceeds from issuance of common stock under employee stock purchase plan |
2,123
|
1,717
|
Net cash provided by financing activities |
9,597
|
164,929
|
Net increase (decrease) in cash, cash equivalents and restricted cash |
(60,460)
|
65,228
|
Beginning of the period |
260,260
|
225,674
|
End of the period |
199,800
|
290,902
|
Reconciliation of cash, cash equivalents and restricted cash to balance sheets: |
|
|
Cash and cash equivalents |
196,762
|
287,087
|
Restricted cash |
3,038
|
3,815
|
Cash, cash equivalents and restricted cash in balance sheets |
199,800
|
290,902
|
Supplemental cash flow information |
|
|
Interest paid |
3,046
|
3,052
|
Non-cash investing and financing activities |
|
|
Transfer of evaluation or rental units from inventory to property and equipment, net |
13
|
(123)
|
Property and equipment included in accounts payable and accrued expenses |
$ 25
|
$ 7,837
|
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v3.24.3
Organization
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Organization |
Organization Description of Business PROCEPT BioRobotics Corporation, or the Company, is a surgical robotics company focused on advancing patient care by developing transformative solutions in urology. It develops, manufactures and sells robotic systems, including the AquaBeam Robotic System and HYDROS Robotic System, which are advanced, image-guided, surgical robotic systems for use in minimally invasive urologic surgery, with an initial focus on treating benign prostatic hyperplasia, or BPH. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. The Company’s robotic systems employ a single-use disposable handpiece to deliver the Company’s proprietary Aquablation therapy, which combines real-time, multi-dimensional imaging, personalized treatment planning, automated robotics and heat-free waterjet ablation for targeted and rapid removal of prostate tissue. The Company received U.S. Food and Drug Administration, or FDA, clearance in December 2017 to market its first generation robot system, the AquaBeam Robotic System, pursuant to a de novo classification. On August 30, 2023, the Company received 510(k) clearance from the FDA to remove the contraindication from its labeling that restricted Aquablation therapy from treating BPH in patients that also have an active diagnosis of prostate cancer. On August 20, 2024, the Company received 510(k) clearance from the FDA for its next generation robot system, HYDROS Robotic System.
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v3.24.3
Summary of Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
Summary of Significant Accounting Policies Basis of Preparation The condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP, and pursuant to the rules and regulations of the United States Securities and Exchange Commission or SEC. These condensed consolidated financial statements include the accounts of the Company and its consolidated subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation.
Unaudited Interim Financial Statements The accompanying balance sheet as of September 30, 2024, the statements of operations and comprehensive loss and cash flows for the three and nine months ended September 30, 2024 and 2023, and the statements of stockholders’ equity as of September 30, 2024 and 2023, are unaudited. The financial data and other information disclosed in these notes to the financial statements related to September 30, 2024, and the three and nine months ended September 30, 2024 and 2023, are also unaudited. The accompanying balance sheet as of December 31, 2023 has been derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K (“Annual Report”) filed with the Securities and Exchange Commission.
The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to a fair statement of the Company’s financial position as of September 30, 2024, and the results of its operations and cash flows for the three and nine months ended September 30, 2024 and 2023. The results for the three and nine months ended September 30, 2024, are not necessarily indicative of results to be expected for the year ending December 31, 2024, or for any other interim period or for any future year and should be read in conjunction with the annual consolidated financial statements included in the Company’s Annual Report. Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the condensed consolidated financial statements. Management uses significant judgment when making estimates related to its valuation of inventory and accounts receivable, stock-based compensation expense, right-of-use lease asset, lease liability, valuations of loan facility derivative liability, as well as certain accrued liabilities. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates. Accounting Policies Update Given the release of the next generation robotic system, HYDROS Robotic System, for a limited period and on a case by case basis, the Company may enter into arrangements with existing customers to sell a HYDROS Robotic System with an exchange of a previously purchased AquaBeam Robotic System for additional consideration. The Company accounts for these transactions under ASC 606 - Revenue from Contracts with Customers. For the three and nine months ended September 30, 2024, such transactions were not material. Recent Accounting Pronouncements In November 2023, the Financial Accounting Standards Board or FASB, issued Accounting Standards Update, or ASU, 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, that requires disclosure of significant segment expenses that are regularly reviewed by the chief operating decision maker and included within each reported measure of segment profit or loss. The standard also requires disclosure of the composition of other segment items included in the measure of segment profit or loss that are not separately disclosed. The new standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company plans to adopt the ASU and related updates on January 1, 2025. The Company is evaluating the impact this ASU will have on its financial statement disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which includes amendments that further enhance income tax disclosures, primarily through standardization and disaggregation of rate reconciliation categories and income taxes paid by jurisdiction. The amendments are effective for all public entities for fiscal years beginning after December 15, 2024. Early adoption is permitted and should be applied either prospectively or retrospectively. The Company plans to adopt the ASU and related updates on January 1, 2025. The Company is evaluating the impact of this ASU will have on its financial statement disclosures.
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v3.24.3
Fair Value Measurements
|
9 Months Ended |
Sep. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
Fair Value Measurements The following is a summary of assets and liabilities measured at fair value on a recurring basis (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | September 30, 2024 | | December 31, 2023 | | | | Level 1 | | Level 2 | | Level 3 | | Total | | Level 1 | | Level 2 | | Level 3 | | Total | | | | | | | | | | | | | | | | | | | | | | | | | | | Cash and cash equivalents: | | | | | | | | | | | | | | | | | | | | | | | | Cash | $ | 12,948 | | | $ | — | | | $ | — | | | $ | 12,948 | | | $ | 6,609 | | | $ | — | | | $ | — | | | $ | 6,609 | | | | | | | | | | Cash equivalents | 183,814 | | | — | | | — | | | 183,814 | | | 250,613 | | | — | | | — | | | 250,613 | | | | | | | | | | Total cash and cash equivalents | $ | 196,762 | | | $ | — | | | $ | — | | | $ | 196,762 | | | $ | 257,222 | | | $ | — | | | $ | — | | | $ | 257,222 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Loan facility derivative liability | $ | — | | | $ | — | | | $ | 2,000 | | | $ | 2,000 | | | $ | — | | | $ | — | | | $ | 1,886 | | | $ | 1,886 | | | | | | | | | |
Cash equivalents consist primarily of money market deposit funds and U.S. treasury bills. There were no transfers in and out of Level 3 during the nine months ended September 30, 2024 and year ended December 31, 2023. The following table sets forth a summary of the changes in the estimated fair value of the Company’s loan facility derivative liability, classified as Level 3 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | | | | | | | | | | | | | | Beginning of the period | $ | 1,942 | | | $ | 1,832 | | | $ | 1,886 | | | $ | 1,779 | | | | | | Change in fair value | 58 | | | 27 | | | 114 | | | 80 | | | | | | End of the period | $ | 2,000 | | | $ | 1,859 | | | $ | 2,000 | | | $ | 1,859 | | | | | |
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v3.24.3
Inventory
|
9 Months Ended |
Sep. 30, 2024 |
Inventory Disclosure [Abstract] |
|
Inventory |
Inventory Inventory consists of the following (in thousands): | | | | | | | | | | | | | | | September 30, | | December 31, | | | | 2024 | | 2023 | | | | | | | | | Raw materials | $ | 14,188 | | | $ | 11,832 | | | | Work-in-process | 9,482 | | | 6,047 | | | | Finished goods | 27,180 | | | 21,877 | | | | Total inventory | $ | 50,850 | | | $ | 39,756 | | | |
The Company reclassified $4.9 million associated with sub-assemblies from raw materials to work-in process in the December 31, 2023 balances to conform with current year presentation.
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v3.24.3
Property and Equipment, Net
|
9 Months Ended |
Sep. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
Property and Equipment, Net |
Property and Equipment, Net Property and equipment, net, consist of the following (in thousands): | | | | | | | | | | | | | | | September 30, | | December 31, | | | | 2024 | | 2023 | | | | | | | | | Laboratory, manufacturing and computer equipment, and furniture and fixtures | $ | 19,934 | | | $ | 15,610 | | | | Rental equipment | 785 | | | 897 | | | | Leasehold improvements | 12,454 | | | 12,362 | | | | Construction in progress | 210 | | | 3,548 | | | | Total property and equipment | 33,383 | | | 32,417 | | | | Less: accumulated depreciation and amortization | (6,778) | | | (3,669) | | | | Total property and equipment, net | $ | 26,605 | | | $ | 28,748 | | | |
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.24.3
Long-Term Debt
|
9 Months Ended |
Sep. 30, 2024 |
Debt Disclosure [Abstract] |
|
Long-Term Debt |
Long-Term Debt In October 2022, the Company entered into a loan and security agreement (“the Loan Agreement”) with Canadian Imperial Bank of Commerce, or CIBC. The Agreement provides for a senior secured term loan facility in the aggregate principal amount of $52.0 million (the "Term Loan Facility") which was borrowed in full. The Term Loan Facility is scheduled to mature on the fifth anniversary of the closing date (the “Maturity Date”). The Agreement provides for interest-only payments on the Term Loan Facility for the first thirty-six months following the Maturity Date (the “Initial Interest-Only Period”). The Initial Interest-Only Period will be extended to an additional twelve months if the Company achieves either (i) $200.0 million or greater in revenue in any twelve-month period or (ii) $0 or greater in EBITDA (as defined in the Loan Agreement) in any six-month period. Thereafter, amortization payments on the Term Loan Facility will be payable monthly until the Maturity Date in monthly installments equal to 20% of the then outstanding principal amount of the Term Loan Facility divided by 12 plus any accrued and unpaid interest. The Company has the option to prepay the Term Loan Facility without any prepayment charge or fee. The loan borrowed under the Term Loan Facility bears interest at an annual rate equal to the secured overnight financing rate or SOFR (calculated based on an adjustment of .10%, .15% and .25%, respectively, for one-month, three-month or six-month term SOFR as of a specified date, subject to a floor of 1.5%) plus an applicable margin of 2.25%. The obligations under the Loan Agreement are secured by substantially all of the Company's assets, including its intellectual property and by a pledge all of the Company's equity interests in its U.S. subsidiaries and 65% of the Company's equity interests in its non-U.S. subsidiaries that are directly owned by the Company. The Company is obligated to maintain in deposit accounts held at the lender the lesser of (i) $90.0 million or (ii) all of its non-operating cash and allow the Company to maintain cash or cash equivalents in excess of that amount with other financial institutions.
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v3.24.3
Stock-Based Compensation
|
9 Months Ended |
Sep. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Stock-Based Compensation |
Stock-Based Compensation Total stock-based compensation recognized, before taxes, are as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | | | | | | | | | | | | Cost of sales | $ | 1,893 | | | $ | 660 | | | $ | 4,891 | | | $ | 1,730 | | | | | Research and development | 2,146 | | | 1,375 | | | 5,446 | | | 3,506 | | | | | Sales, general and administrative | 5,521 | | | 3,922 | | | 15,250 | | | 10,509 | | | | | Stock-based compensation capitalized in inventory | (1,048) | | | (631) | | | (2,832) | | | (1,592) | | | | | Total stock-based compensation | $ | 8,512 | | | $ | 5,326 | | | $ | 22,755 | | | $ | 14,153 | | | | |
Stock Options The Company had 6.8 million shares available for grant as of September 30, 2024 under the 2021 Equity Incentive Award Plan or the 2021 Plan. A summary of the Company’s stock option activity and related information are as follows (options in thousands): | | | | | | | | | | | | | | | | | | | | | Nine Months Ended | | | | | | | | September 30, 2024 | | | | | | | | | | | | | | | | Number of Shares | | Weighted-Average Exercise Price | | | | | | | | | Outstanding, beginning of period | 5,215 | | | $ | 9.42 | | | | | | | | | | Granted | 173 | | | 50.13 | | | | | | | | | | Exercised | (909) | | | 8.22 | | | | | | | | | | Forfeited | (137) | | | 20.67 | | | | | | | | | | Outstanding, end of period | 4,342 | | | 10.93 | | | | | | | | | | Vested and expected to vest | 4,342 | | | 10.93 | | | | | | | | | | Exercisable | 3,724 | | | 7.66 | | | | | | | | | |
As of September 30, 2024 and December 31, 2023, the aggregate pre-tax intrinsic value of options outstanding and exercisable was $271.4 million and $144.0 million, respectively, and the aggregate pre-tax intrinsic value of options outstanding were $300.4 million and $169.5 million, respectively. The aggregate pre-tax intrinsic value of options exercised was $47.2 million and $8.9 million during the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, there was a total of $9.9 million of unrecognized stock-based compensation expense related to stock options. The fair value of the options granted to employees or directors was estimated as of the grant date using the Black-Scholes model assuming the weighted-average assumptions listed in the following table: | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | | | | | | | | | | | | Expected life (years) | 6.0 | | 0.0 | | 6.0 | | 6.0 | | | | Expected volatility | 57 | % | | — | % | | 57 | % | | 57 | % | | | | Risk-free interest rate | 4.1 | % | | — | % | | 4.1 | % | | 4.0 | % | | | | Expected dividend rate | — | % | | — | % | | — | % | | — | % | | | | Weighted-average fair value | $ | 38.24 | | | $ | — | | | $ | 28.52 | | | $ | 21.02 | | | | |
Restricted Stock Units A summary of the Company’s restricted stock unit, or RSU, activity and related information are as follows (RSUs in thousands): | | | | | | | | | | | | | | | | | | | | | Nine Months Ended | | | | | | | | September 30, 2024 | | | | | | | | | | | | | | | | Number of Shares | | Weighted-Average Fair Value | | | | | | | | | Outstanding, beginning of period | 1,565 | | | $ | 36.27 | | | | | | | | | | Awarded | 991 | | | 50.95 | | | | | | | | | | Forfeited | (234) | | | 39.12 | | | | | | | | | | | | | | | | | | | | | | Vested | (390) | | | 36.06 | | | | | | | | | | Outstanding, end of period | 1,932 | | | 43.50 | | | | | | | | | |
As of September 30, 2024, there was a total of $70.3 million of unrecognized stock-based compensation expense related to RSUs. Performance Stock Units The 2021 Plan provides for issuance of performance stock units or PSUs. PSUs granted are contingent upon the achievement of predetermined market, performance, and service conditions. PSUs are awarded to executives of the Company and generally time vest over two and three years. Vesting is also generally contingent upon achievement of applicable performance metrics. PSU expense is recognized over the requisite service period.
During the nine months ended September 30, 2024, the Company awarded approximately 61,000 PSU shares with both a performance and service condition. A certain performance condition will be defined at a later date. Per ASC 718 – Compensation, Stock Compensation, these grants have not met the definition of having a grant date, and therefore, no expense has been recognized for these PSUs. Expense will be recognized when the performance condition becomes defined.
During the nine months ended September 30, 2024, the Company awarded approximately 20,000 PSU shares with both a market and service condition.
No PSU shares were forfeited or released during the three and nine months ended September 30, 2024. As of September 30, 2024, unrecognized compensation expense related to PSUs was not material. Employee Stock Purchase Plan As of September 30, 2024, there was approximately $1.2 million of unrecognized cost related to the Employee Stock Purchase Plan or ESPP. This cost is expected to be recognized over a weighted average period of 0.6 years. As of September 30, 2024, a total of 1.5 million shares were available for issuance under the ESPP. The fair value of the options granted to employees was estimated as of the grant date using the Black-Scholes model assuming the weighted-average assumptions listed in the following table: | | | | | | | | | | | | | Nine Months Ended September 30, | | 2024 | | 2023 | | | | | Expected life (years) | 0.8 | | 0.8 | Expected volatility | 53 | % | | 55 | % | Risk-free interest rate | 5.3 | % | | 5.0 | % | Expected dividend rate | — | % | | — | % | Weighted-average fair value | $ | 22.10 | | | $ | 11.28 | |
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- DefinitionThe entire disclosure for shareholders' equity and share-based payment arrangement. Includes, but is not limited to, disclosure of policy and terms of share-based payment arrangement, deferred compensation arrangement, and employee stock purchase plan (ESPP).
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v3.24.3
Net Loss Per Share
|
9 Months Ended |
Sep. 30, 2024 |
Equity [Abstract] |
|
Net Loss Per Share |
Net Loss Per Share Net loss per share was determined as follows (in thousands, except per share amounts): | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | | | Net loss | $ | (20,974) | | | $ | (24,622) | | | $ | (72,557) | | | $ | (78,393) | | | | | Weighted-average common stock outstanding | 52,011 | | | 48,310 | | | 51,550 | | | 46,131 | | | | | Net loss per share, basic and diluted | $ | (0.40) | | | $ | (0.51) | | | $ | (1.41) | | | $ | (1.70) | | | | |
The following potentially dilutive securities outstanding have been excluded from the computations of weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares, in thousands): | | | | | | | | | | | | | | | | | September 30, | | | | 2024 | | 2023 | | | | | | | | | | | | | | | | | | | Stock options | 4,342 | | | 5,414 | | | | | | Restricted and performance stock units | 2,013 | | | 1,518 | | | | | | Employee stock purchase plan | 52 | | | 177 | | | | | | Total | 6,407 | | | 7,109 | | | | | |
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- DefinitionThe entire disclosure for earnings per share.
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v3.24.3
Revenue
|
9 Months Ended |
Sep. 30, 2024 |
Revenue from Contract with Customer [Abstract] |
|
Revenue |
Revenue The following table presents revenue disaggregated by type and geography (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | | | | | | | | | | | | U.S. | | | | | | | | | | | System sales and rentals | $ | 19,643 | | | $ | 13,467 | | | $ | 50,978 | | | $ | 37,065 | | | | | Handpieces and other consumables | 29,620 | | | 17,047 | | | 81,217 | | | 42,418 | | | | | Service | 2,952 | | | 1,811 | | | 7,888 | | | 4,545 | | | | | Total U.S. revenue | 52,215 | | | 32,325 | | | 140,083 | | | 84,028 | | | | | Outside of U.S. | | | | | | | | | | | System sales and rentals | 3,155 | | | 828 | | | 7,974 | | | 3,896 | | | | | Handpieces and other consumables | 2,616 | | | 1,651 | | | 7,230 | | | 3,826 | | | | | Service | 384 | | | 298 | | | 975 | | | 860 | | | | | Total outside of U.S. revenue | 6,155 | | | 2,777 | | | 16,179 | | | 8,582 | | | | | Total revenue | $ | 58,370 | | | $ | 35,102 | | | $ | 156,262 | | | $ | 92,610 | | | | |
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v3.24.3
Segment, Geographical, and Customer Concentration
|
9 Months Ended |
Sep. 30, 2024 |
Segment Reporting [Abstract] |
|
Segment, Geographical, and Customer Concentration |
Segment, Geographical, and Customer Concentration The Company operates as a single operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, reviews financial information on an aggregate basis for the purposes of allocating resources and evaluating financial performance. The Company’s assets are primarily based in the United States. No customers accounted for more than 10% of revenue during the three and nine months ended September 30, 2024 and 2023. No customer accounted for more than 10% of accounts receivable at September 30, 2024 and December 31, 2023. The following table presents revenue by significant geographical locations for the periods indicated: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | | 2024 | | 2023 | | 2024 | | 2023 | | | | United States | | 89 | % | | 92 | % | | 90 | % | | 91 | % | | | | Outside the United States | | 11 | % | | 8 | % | | 10 | % | | 9 | % | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Segment, Geographical, and Customer Concentration |
Segment, Geographical, and Customer Concentration The Company operates as a single operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, reviews financial information on an aggregate basis for the purposes of allocating resources and evaluating financial performance. The Company’s assets are primarily based in the United States. No customers accounted for more than 10% of revenue during the three and nine months ended September 30, 2024 and 2023. No customer accounted for more than 10% of accounts receivable at September 30, 2024 and December 31, 2023. The following table presents revenue by significant geographical locations for the periods indicated: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | | 2024 | | 2023 | | 2024 | | 2023 | | | | United States | | 89 | % | | 92 | % | | 90 | % | | 91 | % | | | | Outside the United States | | 11 | % | | 8 | % | | 10 | % | | 9 | % | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
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- DefinitionThe entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.
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v3.24.3
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
Commitments and Contingencies Guarantees and Indemnifications In the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future. To date, the Company has not paid any material claims or been required to defend any action related to its indemnification obligations. As of September 30, 2024 and December 31, 2023, the Company does not have any material indemnification claims that were probable or reasonably possible and consequently has not recorded related liabilities. Facility Lease In December 2021, the Company entered into a lease for two existing buildings, comprising approximately 158,221 square feet of space, located in San Jose, California. The lease commenced in July 2022, and will continue for 122 months following thereafter, with two five year options to extend the term of the lease. Rent expense recognized under the lease, including additional rent charges for utilities, parking, maintenance, and real estate taxes, was $2.0 million and $2.6 million for the three months ended September 30, 2024 and 2023, and was $5.4 million and $6.6 million for the nine months ended September 30, 2024 and 2023. Future minimum annual operating lease and debt repayments are as follows (in thousands): | | | | | | | | | | | | | | | | | | As of September 30, 2024 | Minimum Lease Payments | | Debt Repayments | | Total | 2024 | $ | 1,043 | | | $ | — | | | $ | 1,043 | | 2025 | 4,297 | | | 4,333 | | | 8,630 | | 2026 | 4,426 | | | 26,000 | | | 30,426 | | 2027 | 4,808 | | | 21,667 | | | 26,475 | | 2028 | 4,952 | | | — | | | 4,952 | | Thereafter | 22,297 | | | — | | | 22,297 | | Total minimum payments | 41,823 | | | 52,000 | | | 93,823 | | Less: amount representing interest/unamortized debt discount | (12,623) | | | (562) | | | (13,185) | | Present value of future payments | 29,200 | | | 51,438 | | | 80,638 | | Less: current portion | (1,839) | | | — | | | (1,839) | | Non-current portion | $ | 27,361 | | | $ | 51,438 | | | $ | 78,799 | | , As of September 30, 2024 and December 31, 2023, the Company’s security deposit is in the form of, and recorded as, restricted cash.
|
Commitments and Contingencies |
Commitments and Contingencies Guarantees and Indemnifications In the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future. To date, the Company has not paid any material claims or been required to defend any action related to its indemnification obligations. As of September 30, 2024 and December 31, 2023, the Company does not have any material indemnification claims that were probable or reasonably possible and consequently has not recorded related liabilities. Facility Lease In December 2021, the Company entered into a lease for two existing buildings, comprising approximately 158,221 square feet of space, located in San Jose, California. The lease commenced in July 2022, and will continue for 122 months following thereafter, with two five year options to extend the term of the lease. Rent expense recognized under the lease, including additional rent charges for utilities, parking, maintenance, and real estate taxes, was $2.0 million and $2.6 million for the three months ended September 30, 2024 and 2023, and was $5.4 million and $6.6 million for the nine months ended September 30, 2024 and 2023. Future minimum annual operating lease and debt repayments are as follows (in thousands): | | | | | | | | | | | | | | | | | | As of September 30, 2024 | Minimum Lease Payments | | Debt Repayments | | Total | 2024 | $ | 1,043 | | | $ | — | | | $ | 1,043 | | 2025 | 4,297 | | | 4,333 | | | 8,630 | | 2026 | 4,426 | | | 26,000 | | | 30,426 | | 2027 | 4,808 | | | 21,667 | | | 26,475 | | 2028 | 4,952 | | | — | | | 4,952 | | Thereafter | 22,297 | | | — | | | 22,297 | | Total minimum payments | 41,823 | | | 52,000 | | | 93,823 | | Less: amount representing interest/unamortized debt discount | (12,623) | | | (562) | | | (13,185) | | Present value of future payments | 29,200 | | | 51,438 | | | 80,638 | | Less: current portion | (1,839) | | | — | | | (1,839) | | Non-current portion | $ | 27,361 | | | $ | 51,438 | | | $ | 78,799 | | , As of September 30, 2024 and December 31, 2023, the Company’s security deposit is in the form of, and recorded as, restricted cash.
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- DefinitionThe entire disclosure for commitments and contingencies.
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- DefinitionThe entire disclosure for operating leases of lessee. Includes, but is not limited to, description of operating lease and maturity analysis of operating lease liability.
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v3.24.3
Defined Contribution Plan
|
9 Months Ended |
Sep. 30, 2024 |
Retirement Benefits [Abstract] |
|
Defined Contribution Plan |
Defined Contribution Plan The Company has a defined contribution retirement savings plan under Section 401(k) of the Internal Revenue Code. This plan allows eligible employees to defer a portion of their annual compensation on a pre-tax basis. Employer contributions were $0.5 million and $0.4 million for the three months ended September 30, 2024 and 2023, and $1.8 million and $1.2 million for the nine months ended September 30, 2024 and 2023.
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v3.24.3
Pay vs Performance Disclosure - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Pay vs Performance Disclosure |
|
|
|
|
|
|
|
|
Net loss |
$ (20,974)
|
$ (25,626)
|
$ (25,957)
|
$ (24,622)
|
$ (25,285)
|
$ (28,484)
|
$ (72,557)
|
$ (78,393)
|
X |
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v3.24.3
Insider Trading Arrangements
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024
shares
|
Sep. 30, 2024
shares
|
Trading Arrangements, by Individual |
|
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Non-Rule 10b5-1 Arrangement Adopted |
false
|
|
Rule 10b5-1 Arrangement Terminated |
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|
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|
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Reza Zadno [Member] |
|
|
Trading Arrangements, by Individual |
|
|
Material Terms of Trading Arrangement |
|
On August 8, 2024, Reza Zadno, the Company’s Chief Executive Officer, adopted a pre-arranged written stock sale plan in accordance with Rule 10b5-1 (the “Zadno Rule 10b5-1 Plan”) under the Exchange Act, for the sale of shares of the Company’s common in the Company’s securities and is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act stock. The Zadno Rule 10b5-1 Plan was entered into during an open trading window in accordance with the Company’s policies regarding transactions. The Zadno Rule 10b5-1 Plan provides for the potential sale of up to 105,683 shares of the Company’s common stock during various specified trading periods through December 4, 2024.
|
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Reza Zadno
|
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Title |
Company’s Chief Executive Officer
|
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Rule 10b5-1 Arrangement Adopted |
true
|
|
Adoption Date |
August 8, 2024
|
|
Expiration Date |
December 4, 2024
|
|
Arrangement Duration |
118 days
|
|
Aggregate Available |
105,683
|
105,683
|
Alaleh Nouri [Member] |
|
|
Trading Arrangements, by Individual |
|
|
Material Terms of Trading Arrangement |
|
On September 3, 2024, Alaleh Nouri, the Company’s Chief Legal Officer, adopted a pre-arranged written stock sale plan in accordance with Rule 10b5-1 (the “Nouri Rule 10b5-1 Plan”) under the Exchange Act, for the sale of shares of the Company’s common stock. The Nouri Rule 10b5-1 Plan was entered into during an open trading window in accordance with the Company’s policies regarding transactions in the Company’s securities and is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act. The Nouri Rule 10b5-1 Plan provides for the potential sale of up to 56,185 shares of the Company’s common stock during various specified trading periods through December 31, 2025.
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Rule 10b5-1 Arrangement Adopted |
true
|
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Adoption Date |
September 3, 2024
|
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Expiration Date |
December 31, 2025
|
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Arrangement Duration |
484 days
|
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56,185
|
56,185
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v3.24.3
Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis of Preparation The condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP, and pursuant to the rules and regulations of the United States Securities and Exchange Commission or SEC. These condensed consolidated financial statements include the accounts of the Company and its consolidated subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation.
|
Use of Estimates |
Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the condensed consolidated financial statements. Management uses significant judgment when making estimates related to its valuation of inventory and accounts receivable, stock-based compensation expense, right-of-use lease asset, lease liability, valuations of loan facility derivative liability, as well as certain accrued liabilities. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates.
|
Accounting Policies Update |
Accounting Policies Update Given the release of the next generation robotic system, HYDROS Robotic System, for a limited period and on a case by case basis, the Company may enter into arrangements with existing customers to sell a HYDROS Robotic System with an exchange of a previously purchased AquaBeam Robotic System for additional consideration. The Company accounts for these transactions under ASC 606 - Revenue from Contracts with Customers. For the three and nine months ended September 30, 2024, such transactions were not material.
|
Recent Accounting Pronouncements |
Recent Accounting Pronouncements In November 2023, the Financial Accounting Standards Board or FASB, issued Accounting Standards Update, or ASU, 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, that requires disclosure of significant segment expenses that are regularly reviewed by the chief operating decision maker and included within each reported measure of segment profit or loss. The standard also requires disclosure of the composition of other segment items included in the measure of segment profit or loss that are not separately disclosed. The new standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company plans to adopt the ASU and related updates on January 1, 2025. The Company is evaluating the impact this ASU will have on its financial statement disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which includes amendments that further enhance income tax disclosures, primarily through standardization and disaggregation of rate reconciliation categories and income taxes paid by jurisdiction. The amendments are effective for all public entities for fiscal years beginning after December 15, 2024. Early adoption is permitted and should be applied either prospectively or retrospectively. The Company plans to adopt the ASU and related updates on January 1, 2025. The Company is evaluating the impact of this ASU will have on its financial statement disclosures.
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v3.24.3
Fair Value Measurements (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis |
The following is a summary of assets and liabilities measured at fair value on a recurring basis (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | September 30, 2024 | | December 31, 2023 | | | | Level 1 | | Level 2 | | Level 3 | | Total | | Level 1 | | Level 2 | | Level 3 | | Total | | | | | | | | | | | | | | | | | | | | | | | | | | | Cash and cash equivalents: | | | | | | | | | | | | | | | | | | | | | | | | Cash | $ | 12,948 | | | $ | — | | | $ | — | | | $ | 12,948 | | | $ | 6,609 | | | $ | — | | | $ | — | | | $ | 6,609 | | | | | | | | | | Cash equivalents | 183,814 | | | — | | | — | | | 183,814 | | | 250,613 | | | — | | | — | | | 250,613 | | | | | | | | | | Total cash and cash equivalents | $ | 196,762 | | | $ | — | | | $ | — | | | $ | 196,762 | | | $ | 257,222 | | | $ | — | | | $ | — | | | $ | 257,222 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Loan facility derivative liability | $ | — | | | $ | — | | | $ | 2,000 | | | $ | 2,000 | | | $ | — | | | $ | — | | | $ | 1,886 | | | $ | 1,886 | | | | | | | | | |
|
Schedule of Derivative Liabilities at Fair Value |
The following table sets forth a summary of the changes in the estimated fair value of the Company’s loan facility derivative liability, classified as Level 3 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | | | | | | | | | | | | | | Beginning of the period | $ | 1,942 | | | $ | 1,832 | | | $ | 1,886 | | | $ | 1,779 | | | | | | Change in fair value | 58 | | | 27 | | | 114 | | | 80 | | | | | | End of the period | $ | 2,000 | | | $ | 1,859 | | | $ | 2,000 | | | $ | 1,859 | | | | | |
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v3.24.3
Inventory (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Inventory Disclosure [Abstract] |
|
Schedule of Inventory |
Inventory consists of the following (in thousands): | | | | | | | | | | | | | | | September 30, | | December 31, | | | | 2024 | | 2023 | | | | | | | | | Raw materials | $ | 14,188 | | | $ | 11,832 | | | | Work-in-process | 9,482 | | | 6,047 | | | | Finished goods | 27,180 | | | 21,877 | | | | Total inventory | $ | 50,850 | | | $ | 39,756 | | | |
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v3.24.3
Property and Equipment, Net (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Property and Equipment, Net |
Property and equipment, net, consist of the following (in thousands): | | | | | | | | | | | | | | | September 30, | | December 31, | | | | 2024 | | 2023 | | | | | | | | | Laboratory, manufacturing and computer equipment, and furniture and fixtures | $ | 19,934 | | | $ | 15,610 | | | | Rental equipment | 785 | | | 897 | | | | Leasehold improvements | 12,454 | | | 12,362 | | | | Construction in progress | 210 | | | 3,548 | | | | Total property and equipment | 33,383 | | | 32,417 | | | | Less: accumulated depreciation and amortization | (6,778) | | | (3,669) | | | | Total property and equipment, net | $ | 26,605 | | | $ | 28,748 | | | |
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v3.24.3
Stock-Based Compensation (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Share-based Payment Arrangement, Expensed and Capitalized, Amount |
Total stock-based compensation recognized, before taxes, are as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | | | | | | | | | | | | Cost of sales | $ | 1,893 | | | $ | 660 | | | $ | 4,891 | | | $ | 1,730 | | | | | Research and development | 2,146 | | | 1,375 | | | 5,446 | | | 3,506 | | | | | Sales, general and administrative | 5,521 | | | 3,922 | | | 15,250 | | | 10,509 | | | | | Stock-based compensation capitalized in inventory | (1,048) | | | (631) | | | (2,832) | | | (1,592) | | | | | Total stock-based compensation | $ | 8,512 | | | $ | 5,326 | | | $ | 22,755 | | | $ | 14,153 | | | | |
|
Schedule of Stock Option Activity and Related Information |
A summary of the Company’s stock option activity and related information are as follows (options in thousands): | | | | | | | | | | | | | | | | | | | | | Nine Months Ended | | | | | | | | September 30, 2024 | | | | | | | | | | | | | | | | Number of Shares | | Weighted-Average Exercise Price | | | | | | | | | Outstanding, beginning of period | 5,215 | | | $ | 9.42 | | | | | | | | | | Granted | 173 | | | 50.13 | | | | | | | | | | Exercised | (909) | | | 8.22 | | | | | | | | | | Forfeited | (137) | | | 20.67 | | | | | | | | | | Outstanding, end of period | 4,342 | | | 10.93 | | | | | | | | | | Vested and expected to vest | 4,342 | | | 10.93 | | | | | | | | | | Exercisable | 3,724 | | | 7.66 | | | | | | | | | |
|
Schedule of Fair Value Assumptions |
The fair value of the options granted to employees or directors was estimated as of the grant date using the Black-Scholes model assuming the weighted-average assumptions listed in the following table: | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | | | | | | | | | | | | Expected life (years) | 6.0 | | 0.0 | | 6.0 | | 6.0 | | | | Expected volatility | 57 | % | | — | % | | 57 | % | | 57 | % | | | | Risk-free interest rate | 4.1 | % | | — | % | | 4.1 | % | | 4.0 | % | | | | Expected dividend rate | — | % | | — | % | | — | % | | — | % | | | | Weighted-average fair value | $ | 38.24 | | | $ | — | | | $ | 28.52 | | | $ | 21.02 | | | | |
The fair value of the options granted to employees was estimated as of the grant date using the Black-Scholes model assuming the weighted-average assumptions listed in the following table: | | | | | | | | | | | | | Nine Months Ended September 30, | | 2024 | | 2023 | | | | | Expected life (years) | 0.8 | | 0.8 | Expected volatility | 53 | % | | 55 | % | Risk-free interest rate | 5.3 | % | | 5.0 | % | Expected dividend rate | — | % | | — | % | Weighted-average fair value | $ | 22.10 | | | $ | 11.28 | |
|
Schedule of Restricted Stock Unit Activity |
A summary of the Company’s restricted stock unit, or RSU, activity and related information are as follows (RSUs in thousands): | | | | | | | | | | | | | | | | | | | | | Nine Months Ended | | | | | | | | September 30, 2024 | | | | | | | | | | | | | | | | Number of Shares | | Weighted-Average Fair Value | | | | | | | | | Outstanding, beginning of period | 1,565 | | | $ | 36.27 | | | | | | | | | | Awarded | 991 | | | 50.95 | | | | | | | | | | Forfeited | (234) | | | 39.12 | | | | | | | | | | | | | | | | | | | | | | Vested | (390) | | | 36.06 | | | | | | | | | | Outstanding, end of period | 1,932 | | | 43.50 | | | | | | | | | |
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v3.24.3
Net Loss Per Share (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Equity [Abstract] |
|
Schedule of Loss Per Share, Basic |
Net loss per share was determined as follows (in thousands, except per share amounts): | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | | | Net loss | $ | (20,974) | | | $ | (24,622) | | | $ | (72,557) | | | $ | (78,393) | | | | | Weighted-average common stock outstanding | 52,011 | | | 48,310 | | | 51,550 | | | 46,131 | | | | | Net loss per share, basic and diluted | $ | (0.40) | | | $ | (0.51) | | | $ | (1.41) | | | $ | (1.70) | | | | |
|
Schedule of Loss Per Share, Diluted |
Net loss per share was determined as follows (in thousands, except per share amounts): | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | | | Net loss | $ | (20,974) | | | $ | (24,622) | | | $ | (72,557) | | | $ | (78,393) | | | | | Weighted-average common stock outstanding | 52,011 | | | 48,310 | | | 51,550 | | | 46,131 | | | | | Net loss per share, basic and diluted | $ | (0.40) | | | $ | (0.51) | | | $ | (1.41) | | | $ | (1.70) | | | | |
|
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share |
The following potentially dilutive securities outstanding have been excluded from the computations of weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares, in thousands): | | | | | | | | | | | | | | | | | September 30, | | | | 2024 | | 2023 | | | | | | | | | | | | | | | | | | | Stock options | 4,342 | | | 5,414 | | | | | | Restricted and performance stock units | 2,013 | | | 1,518 | | | | | | Employee stock purchase plan | 52 | | | 177 | | | | | | Total | 6,407 | | | 7,109 | | | | | |
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v3.24.3
Revenue (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Revenue from Contract with Customer [Abstract] |
|
Schedule of Revenue from External Customers by Geographic Areas |
The following table presents revenue disaggregated by type and geography (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | | | | | | | | | | | | U.S. | | | | | | | | | | | System sales and rentals | $ | 19,643 | | | $ | 13,467 | | | $ | 50,978 | | | $ | 37,065 | | | | | Handpieces and other consumables | 29,620 | | | 17,047 | | | 81,217 | | | 42,418 | | | | | Service | 2,952 | | | 1,811 | | | 7,888 | | | 4,545 | | | | | Total U.S. revenue | 52,215 | | | 32,325 | | | 140,083 | | | 84,028 | | | | | Outside of U.S. | | | | | | | | | | | System sales and rentals | 3,155 | | | 828 | | | 7,974 | | | 3,896 | | | | | Handpieces and other consumables | 2,616 | | | 1,651 | | | 7,230 | | | 3,826 | | | | | Service | 384 | | | 298 | | | 975 | | | 860 | | | | | Total outside of U.S. revenue | 6,155 | | | 2,777 | | | 16,179 | | | 8,582 | | | | | Total revenue | $ | 58,370 | | | $ | 35,102 | | | $ | 156,262 | | | $ | 92,610 | | | | |
The following table presents revenue by significant geographical locations for the periods indicated: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | | 2024 | | 2023 | | 2024 | | 2023 | | | | United States | | 89 | % | | 92 | % | | 90 | % | | 91 | % | | | | Outside the United States | | 11 | % | | 8 | % | | 10 | % | | 9 | % | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Schedule of Revenue from External Customers by Products and Services |
The following table presents revenue disaggregated by type and geography (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | | | | | | | | | | | | U.S. | | | | | | | | | | | System sales and rentals | $ | 19,643 | | | $ | 13,467 | | | $ | 50,978 | | | $ | 37,065 | | | | | Handpieces and other consumables | 29,620 | | | 17,047 | | | 81,217 | | | 42,418 | | | | | Service | 2,952 | | | 1,811 | | | 7,888 | | | 4,545 | | | | | Total U.S. revenue | 52,215 | | | 32,325 | | | 140,083 | | | 84,028 | | | | | Outside of U.S. | | | | | | | | | | | System sales and rentals | 3,155 | | | 828 | | | 7,974 | | | 3,896 | | | | | Handpieces and other consumables | 2,616 | | | 1,651 | | | 7,230 | | | 3,826 | | | | | Service | 384 | | | 298 | | | 975 | | | 860 | | | | | Total outside of U.S. revenue | 6,155 | | | 2,777 | | | 16,179 | | | 8,582 | | | | | Total revenue | $ | 58,370 | | | $ | 35,102 | | | $ | 156,262 | | | $ | 92,610 | | | | |
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v3.24.3
Segment, Geographical, and Customer Concentration (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Segment Reporting [Abstract] |
|
Schedule of Revenue from External Customers by Geographic Areas |
The following table presents revenue disaggregated by type and geography (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | | | | | | | | | | | | U.S. | | | | | | | | | | | System sales and rentals | $ | 19,643 | | | $ | 13,467 | | | $ | 50,978 | | | $ | 37,065 | | | | | Handpieces and other consumables | 29,620 | | | 17,047 | | | 81,217 | | | 42,418 | | | | | Service | 2,952 | | | 1,811 | | | 7,888 | | | 4,545 | | | | | Total U.S. revenue | 52,215 | | | 32,325 | | | 140,083 | | | 84,028 | | | | | Outside of U.S. | | | | | | | | | | | System sales and rentals | 3,155 | | | 828 | | | 7,974 | | | 3,896 | | | | | Handpieces and other consumables | 2,616 | | | 1,651 | | | 7,230 | | | 3,826 | | | | | Service | 384 | | | 298 | | | 975 | | | 860 | | | | | Total outside of U.S. revenue | 6,155 | | | 2,777 | | | 16,179 | | | 8,582 | | | | | Total revenue | $ | 58,370 | | | $ | 35,102 | | | $ | 156,262 | | | $ | 92,610 | | | | |
The following table presents revenue by significant geographical locations for the periods indicated: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | | 2024 | | 2023 | | 2024 | | 2023 | | | | United States | | 89 | % | | 92 | % | | 90 | % | | 91 | % | | | | Outside the United States | | 11 | % | | 8 | % | | 10 | % | | 9 | % | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
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v3.24.3
Commitments and Contingencies (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Schedule of Future Minimum Lease Payments |
Future minimum annual operating lease and debt repayments are as follows (in thousands): | | | | | | | | | | | | | | | | | | As of September 30, 2024 | Minimum Lease Payments | | Debt Repayments | | Total | 2024 | $ | 1,043 | | | $ | — | | | $ | 1,043 | | 2025 | 4,297 | | | 4,333 | | | 8,630 | | 2026 | 4,426 | | | 26,000 | | | 30,426 | | 2027 | 4,808 | | | 21,667 | | | 26,475 | | 2028 | 4,952 | | | — | | | 4,952 | | Thereafter | 22,297 | | | — | | | 22,297 | | Total minimum payments | 41,823 | | | 52,000 | | | 93,823 | | Less: amount representing interest/unamortized debt discount | (12,623) | | | (562) | | | (13,185) | | Present value of future payments | 29,200 | | | 51,438 | | | 80,638 | | Less: current portion | (1,839) | | | — | | | (1,839) | | Non-current portion | $ | 27,361 | | | $ | 51,438 | | | $ | 78,799 | | ,
|
Schedule of Maturities of Long-term Debt |
Future minimum annual operating lease and debt repayments are as follows (in thousands): | | | | | | | | | | | | | | | | | | As of September 30, 2024 | Minimum Lease Payments | | Debt Repayments | | Total | 2024 | $ | 1,043 | | | $ | — | | | $ | 1,043 | | 2025 | 4,297 | | | 4,333 | | | 8,630 | | 2026 | 4,426 | | | 26,000 | | | 30,426 | | 2027 | 4,808 | | | 21,667 | | | 26,475 | | 2028 | 4,952 | | | — | | | 4,952 | | Thereafter | 22,297 | | | — | | | 22,297 | | Total minimum payments | 41,823 | | | 52,000 | | | 93,823 | | Less: amount representing interest/unamortized debt discount | (12,623) | | | (562) | | | (13,185) | | Present value of future payments | 29,200 | | | 51,438 | | | 80,638 | | Less: current portion | (1,839) | | | — | | | (1,839) | | Non-current portion | $ | 27,361 | | | $ | 51,438 | | | $ | 78,799 | | ,
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v3.24.3
Fair Value Measurements - Fair Value (Details) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Sep. 30, 2023 |
Fair Value Disclosure, Asset and Liability, Not Measured at Fair Value [Line Items] |
|
|
|
Total cash and cash equivalents |
$ 196,762
|
$ 257,222
|
$ 287,087
|
Derivative liability, statement of financial position |
Loan facility derivative liability
|
Loan facility derivative liability
|
|
Fair Value, Measurements, Recurring |
|
|
|
Fair Value Disclosure, Asset and Liability, Not Measured at Fair Value [Line Items] |
|
|
|
Cash |
$ 12,948
|
$ 6,609
|
|
Cash equivalents |
183,814
|
250,613
|
|
Total cash and cash equivalents |
196,762
|
257,222
|
|
Loan facility derivative liability |
2,000
|
1,886
|
|
Level 1 | Fair Value, Measurements, Recurring |
|
|
|
Fair Value Disclosure, Asset and Liability, Not Measured at Fair Value [Line Items] |
|
|
|
Cash |
12,948
|
6,609
|
|
Cash equivalents |
183,814
|
250,613
|
|
Total cash and cash equivalents |
196,762
|
257,222
|
|
Loan facility derivative liability |
0
|
0
|
|
Level 2 | Fair Value, Measurements, Recurring |
|
|
|
Fair Value Disclosure, Asset and Liability, Not Measured at Fair Value [Line Items] |
|
|
|
Cash |
0
|
0
|
|
Cash equivalents |
0
|
0
|
|
Total cash and cash equivalents |
0
|
0
|
|
Loan facility derivative liability |
0
|
0
|
|
Level 3 | Fair Value, Measurements, Recurring |
|
|
|
Fair Value Disclosure, Asset and Liability, Not Measured at Fair Value [Line Items] |
|
|
|
Cash |
0
|
0
|
|
Cash equivalents |
0
|
0
|
|
Total cash and cash equivalents |
0
|
0
|
|
Loan facility derivative liability |
$ 2,000
|
$ 1,886
|
|
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|
v3.24.3
Fair Value Measurements - Fair Value, Inputs, Level 3 - Fair Value, Measurements, Recurring (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Fair Value Disclosure, Asset and Liability, Not Measured at Fair Value [Line Items] |
|
|
|
|
Fair value, net derivative asset (liability), recurring basis, unobservable input reconciliation, gain (loss), statement of income or comprehensive income |
Change in fair value of derivative liability
|
Change in fair value of derivative liability
|
Change in fair value of derivative liability
|
Change in fair value of derivative liability
|
Fair Value, Measurements, Recurring |
|
|
|
|
Fair Value Disclosure, Asset and Liability, Not Measured at Fair Value [Line Items] |
|
|
|
|
Beginning of the period |
$ 1,942
|
$ 1,832
|
$ 1,886
|
$ 1,779
|
Change in fair value |
58
|
27
|
114
|
80
|
End of the period |
$ 2,000
|
$ 1,859
|
$ 2,000
|
$ 1,859
|
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v3.24.3
Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Inventory Disclosure [Abstract] |
|
|
Raw materials |
$ 14,188
|
$ 11,832
|
Work-in-process |
9,482
|
6,047
|
Finished goods |
27,180
|
21,877
|
Total inventory |
$ 50,850
|
$ 39,756
|
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v3.24.3
Property and Equipment, Net (Details) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Construction in progress |
|
|
Total property and equipment |
$ 33,383
|
$ 32,417
|
Less: accumulated depreciation and amortization |
(6,778)
|
(3,669)
|
Total property and equipment, net |
26,605
|
28,748
|
Laboratory, manufacturing and computer equipment, and furniture and fixtures |
|
|
Construction in progress |
|
|
Total property and equipment |
19,934
|
15,610
|
Rental equipment |
|
|
Construction in progress |
|
|
Total property and equipment |
785
|
897
|
Leasehold improvements |
|
|
Construction in progress |
|
|
Total property and equipment |
12,454
|
12,362
|
Construction in progress |
|
|
Construction in progress |
|
|
Total property and equipment |
$ 210
|
$ 3,548
|
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v3.24.3
Long-Term Debt (Details) - Canadian Imperial Bank of Commerce - Senior Loans - USD ($)
|
1 Months Ended |
12 Months Ended |
24 Months Ended |
Oct. 31, 2022 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Line of Credit Facility [Line Items] |
|
|
|
Aggregate principal amount |
$ 52,000,000
|
|
|
Debt instrument, covenant compliance interest-only period term |
36 months
|
|
|
Debt instrument, covenant compliance interest-only period renewal term |
12 months
|
|
|
Debt instrument, covenant compliance, revenue threshold amount |
|
|
$ 200,000,000
|
Debt instrument, covenant compliance, EBITDA threshold amount |
|
$ 0
|
|
Debt instrument, convertible, threshold percentage of stock price trigger |
20.00%
|
|
|
Deposits |
$ 90,000,000
|
|
|
Non-US |
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
Pledged subsidiary equity interests in non -US subsidiaries, percent |
65.00%
|
|
|
Secured Overnight Financing Rate One Month Term |
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
Facility interest, spread on base rate |
0.10%
|
|
|
Secured Overnight Financing Rate Three Month Term |
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
Facility interest, spread on base rate |
0.15%
|
|
|
Secured Overnight Financing Rate Six Month Term |
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
Facility interest, spread on base rate |
0.25%
|
|
|
Secured Overnight Financing Rate Floor Rate |
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
Facility interest, spread on base rate |
1.50%
|
|
|
Secured Overnight Financing Rate Margin Rate |
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
Facility interest, spread on base rate |
2.25%
|
|
|
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v3.24.3
Stock-Based Compensation - Schedule of Share-Based Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation |
$ 8,512
|
$ 5,326
|
$ 22,755
|
$ 14,153
|
Stock-based compensation capitalized in inventory |
(1,048)
|
(631)
|
(2,832)
|
(1,592)
|
Cost of sales |
|
|
|
|
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation |
1,893
|
660
|
4,891
|
1,730
|
Research and development |
|
|
|
|
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation |
2,146
|
1,375
|
5,446
|
3,506
|
Sales, general and administrative |
|
|
|
|
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
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$ 5,521
|
$ 3,922
|
$ 15,250
|
$ 10,509
|
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v3.24.3
Stock-Based Compensation - Narrative (Details) - USD ($) $ in Millions |
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2024 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Share-based Compensation Arrangements |
|
|
|
|
Options outstanding and exercisable, aggregate intrinsic value |
$ 271.4
|
$ 271.4
|
|
$ 144.0
|
Options outstanding, aggregate intrinsic value |
300.4
|
300.4
|
|
$ 169.5
|
Options exercised in the period, intrinsic value |
|
47.2
|
$ 8.9
|
|
Unrecognized compensation cost |
9.9
|
9.9
|
|
|
Restricted and performance stock units |
|
|
|
|
Share-based Compensation Arrangements |
|
|
|
|
Unrecognized compensation cost |
$ 70.3
|
$ 70.3
|
|
|
Forfeited or released (in shares) |
|
234,000
|
|
|
2021 Equity Incentive Award Plan |
|
|
|
|
Share-based Compensation Arrangements |
|
|
|
|
Shares available for grant (in shares) |
6,800,000
|
6,800,000
|
|
|
2021 Equity Incentive Award Plan | Maximum |
|
|
|
|
Share-based Compensation Arrangements |
|
|
|
|
Award vesting period (in years) |
|
3 years
|
|
|
2021 Equity Incentive Award Plan | Performance Stock Units |
|
|
|
|
Share-based Compensation Arrangements |
|
|
|
|
Forfeited or released (in shares) |
0
|
0
|
|
|
2021 Equity Incentive Award Plan | Performance Stock Units | Minimum |
|
|
|
|
Share-based Compensation Arrangements |
|
|
|
|
Award vesting period (in years) |
|
2 years
|
|
|
Employee stock purchase plan |
|
|
|
|
Share-based Compensation Arrangements |
|
|
|
|
Shares available for grant (in shares) |
1,500,000
|
1,500,000
|
|
|
Unrecognized compensation cost |
$ 1.2
|
$ 1.2
|
|
|
Average vesting period for unrecognized compensation cost (in years) |
|
7 months 6 days
|
|
|
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v3.24.3
Stock-Based Compensation - Schedule of Stock Option Activity (Details) - Stock options - $ / shares
|
9 Months Ended |
Sep. 30, 2024 |
Number of Shares |
|
Outstanding, beginning of period (in shares) |
5,215,000
|
Granted (in shares) |
173,000
|
Exercised (in shares) |
(909,000)
|
Forfeited (in shares) |
(137,000)
|
Outstanding, end of period (in shares) |
4,342,000
|
Vested and expected to vest (in shares) |
4,342,000
|
Exercisable (in shares) |
3,724,000
|
Weighted-Average Exercise Price |
|
Outstanding, beginning of period (in dollars per share) |
$ 9.42
|
Granted (in dollars per share) |
50.13
|
Exercised (in dollars per share) |
8.22
|
Forfeited (in dollars per share) |
20.67
|
Outstanding, end of period (in dollars per share) |
10.93
|
Vested and expected to vest (in dollars per share) |
10.93
|
Exercisable (in dollars per share) |
$ 7.66
|
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v3.24.3
Net Loss Per Share - Net loss per share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Equity [Abstract] |
|
|
|
|
|
|
|
|
Net loss |
$ (20,974)
|
$ (25,626)
|
$ (25,957)
|
$ (24,622)
|
$ (25,285)
|
$ (28,484)
|
$ (72,557)
|
$ (78,393)
|
Weighted-average common stock outstanding, basic (in shares) |
52,011
|
|
|
48,310
|
|
|
51,550
|
46,131
|
Weighted-average common stock outstanding, diluted (in shares) |
52,011
|
|
|
48,310
|
|
|
51,550
|
46,131
|
Net loss per share, basic (in dollars per share) |
$ (0.40)
|
|
|
$ (0.51)
|
|
|
$ (1.41)
|
$ (1.70)
|
Net loss per share, diluted (in dollars per share) |
$ (0.40)
|
|
|
$ (0.51)
|
|
|
$ (1.41)
|
$ (1.70)
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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Net Loss Per Share - Potentially Dilutive Securities (Details) - shares shares in Thousands |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive securities excluded from computation of earnings per share, amount (in shares) |
6,407
|
7,109
|
Stock options |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive securities excluded from computation of earnings per share, amount (in shares) |
4,342
|
5,414
|
Restricted and performance stock units |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive securities excluded from computation of earnings per share, amount (in shares) |
2,013
|
1,518
|
Employee stock purchase plan |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive securities excluded from computation of earnings per share, amount (in shares) |
52
|
177
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v3.24.3
Revenue (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenue |
$ 58,370
|
$ 35,102
|
$ 156,262
|
$ 92,610
|
U.S. |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenue |
52,215
|
32,325
|
140,083
|
84,028
|
Outside of U.S. |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenue |
6,155
|
2,777
|
16,179
|
8,582
|
System sales and rentals | U.S. |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenue |
19,643
|
13,467
|
50,978
|
37,065
|
System sales and rentals | Outside of U.S. |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenue |
3,155
|
828
|
7,974
|
3,896
|
Handpieces and other consumables | U.S. |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenue |
29,620
|
17,047
|
81,217
|
42,418
|
Handpieces and other consumables | Outside of U.S. |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenue |
2,616
|
1,651
|
7,230
|
3,826
|
Service | U.S. |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenue |
2,952
|
1,811
|
7,888
|
4,545
|
Service | Outside of U.S. |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenue |
$ 384
|
$ 298
|
$ 975
|
$ 860
|
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v3.24.3
Segment, Geographical, and Customer Concentration (Details)
|
3 Months Ended |
9 Months Ended |
12 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Revenue Benchmark | Geographic Concentration Risk | U.S. |
|
|
|
|
|
Segment Reporting, Revenue Reconciling Item [Line Items] |
|
|
|
|
|
Revenue by significant geographical locations outside the United States |
89.00%
|
92.00%
|
90.00%
|
91.00%
|
|
Revenue Benchmark | Geographic Concentration Risk | Outside of U.S. |
|
|
|
|
|
Segment Reporting, Revenue Reconciling Item [Line Items] |
|
|
|
|
|
Revenue by significant geographical locations outside the United States |
11.00%
|
8.00%
|
10.00%
|
9.00%
|
|
Customer 1 | Accounts Receivable | Customer Concentration Risk |
|
|
|
|
|
Segment Reporting, Revenue Reconciling Item [Line Items] |
|
|
|
|
|
Revenue by significant geographical locations outside the United States |
|
|
10.00%
|
|
10.00%
|
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v3.24.3
Commitments and Contingencies - Future Minimum Lease Payments and Long-Term Debt Maturities (Details) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Minimum Lease Payments |
|
|
2024 |
$ 1,043
|
|
2025 |
4,297
|
|
2026 |
4,426
|
|
2027 |
4,808
|
|
2028 |
4,952
|
|
Thereafter |
22,297
|
|
Total minimum payments |
41,823
|
|
Less: amount representing interest/unamortized debt discount |
(12,623)
|
|
Present value of future payments |
29,200
|
|
Less: current portion |
(1,839)
|
$ (1,683)
|
Non-current portion |
27,361
|
26,182
|
Debt Repayments |
|
|
2024 |
0
|
|
2025 |
4,333
|
|
2026 |
26,000
|
|
2027 |
21,667
|
|
2028 |
0
|
|
Thereafter |
0
|
|
Total minimum payments |
52,000
|
|
Less: amount representing interest/unamortized debt discount |
(562)
|
|
Present value of future payments |
51,438
|
|
Less: current portion |
0
|
|
Long-term debt |
51,438
|
$ 51,339
|
Total |
|
|
2024 |
1,043
|
|
2025 |
8,630
|
|
2026 |
30,426
|
|
2027 |
26,475
|
|
2028 |
4,952
|
|
Thereafter |
22,297
|
|
Total minimum payments |
93,823
|
|
Less: amount representing interest/unamortized debt discount |
(13,185)
|
|
Present value of future payments |
80,638
|
|
Less: current portion |
(1,839)
|
|
Non-current portion |
$ 78,799
|
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