Cardiovascular Systems Inc - Quarter Report: 2022 September (Form 10-Q)
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, 2022
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 No. 000-52082
____________________________________________________
CARDIOVASCULAR SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
____________________________________________________
| Delaware | 41-1698056 | |||||||
| (State or other jurisdiction of | (IRS Employer | |||||||
| incorporation or organization) | Identification No.) | |||||||
1225 Old Highway 8 Northwest
St. Paul, Minnesota 55112-6416
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code: (651) 259-1600
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||||||
| Common Stock, One-tenth of One Cent ($0.001) Par Value Per Share | CSII | The Nasdaq Stock Market LLC | ||||||
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 x No ¨
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x 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,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | x | 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. o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No x
The number of shares outstanding of the registrant’s Common Stock, $0.001 par value per share, as of October 31, 2022 was: 41,882,246 shares.
Cardiovascular Systems, Inc.
Table of Contents
| PAGE | |||||
2
PART I. — FINANCIAL INFORMATION
ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Cardiovascular Systems, Inc.
Consolidated Balance Sheets
(Dollars in thousands, except per share and share amounts)
(Unaudited)
| September 30, 2022 | June 30, 2022 | ||||||||||
| ASSETS | |||||||||||
| Current assets | |||||||||||
| Cash and cash equivalents | $ | 62,850 | $ | 66,424 | |||||||
| Marketable securities | 80,898 | 93,409 | |||||||||
| Accounts receivable, net | 40,259 | 39,678 | |||||||||
| Inventories | 37,944 | 34,567 | |||||||||
| Prepaid expenses and other current assets | 9,125 | 7,768 | |||||||||
| Total current assets | 231,076 | 241,846 | |||||||||
| Property and equipment, net | 28,959 | 29,035 | |||||||||
| Intangible assets, net | 15,388 | 15,734 | |||||||||
| Strategic investments | 34,027 | 33,425 | |||||||||
| Other assets | 2,588 | 2,637 | |||||||||
| Total assets | $ | 312,038 | $ | 322,677 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current liabilities | |||||||||||
| Accounts payable | $ | 16,757 | $ | 14,383 | |||||||
| Accrued expenses | 19,704 | 23,464 | |||||||||
| Deferred revenue | 694 | 2,107 | |||||||||
| Total current liabilities | 37,155 | 39,954 | |||||||||
| Long-term liabilities | |||||||||||
| Financing obligation | 20,208 | 20,298 | |||||||||
| Other liabilities | 12,522 | 12,945 | |||||||||
| Total liabilities | 69,885 | 73,197 | |||||||||
| Commitments and contingencies (see Note 9) | |||||||||||
Common stock, $0.001 par value; authorized 100,000,000 common shares; issued and outstanding 41,892,615 at September 30, 2022 and 40,965,202 at June 30, 2022, respectively | 40 | 40 | |||||||||
| Additional paid in capital | 677,886 | 673,388 | |||||||||
| Accumulated other comprehensive income | (271) | (268) | |||||||||
| Accumulated deficit | (435,502) | (423,680) | |||||||||
| Total stockholders’ equity | 242,153 | 249,480 | |||||||||
| Total liabilities and stockholders’ equity | $ | 312,038 | $ | 322,677 | |||||||
The accompanying notes are an integral part of these unaudited consolidated financial statements.
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Cardiovascular Systems, Inc.
Consolidated Statements of Operations
(Dollars in thousands, except per share and share amounts)
(Unaudited)
| Three Months Ended | |||||||||||
| September 30, | |||||||||||
| 2022 | 2021 | ||||||||||
| Net revenues | $ | 59,673 | $ | 58,370 | |||||||
| Cost of goods sold | 16,698 | 14,308 | |||||||||
| Gross profit | 42,975 | 44,062 | |||||||||
| Expenses: | |||||||||||
| Selling, general and administrative | 44,475 | 41,851 | |||||||||
| Research and development | 9,056 | 10,022 | |||||||||
| Amortization of intangible assets | 346 | 304 | |||||||||
| Total expenses | 53,877 | 52,177 | |||||||||
| Loss from operations | (10,902) | (8,115) | |||||||||
| Other (income) expense, net: | |||||||||||
| Interest expense | 406 | 410 | |||||||||
| Interest income and other, net | (658) | (43) | |||||||||
| Total other (income) expense, net | (252) | 367 | |||||||||
| Loss before income taxes | (10,650) | (8,482) | |||||||||
| (Benefit) provision for income taxes | (19) | 136 | |||||||||
| Net loss | $ | (10,631) | $ | (8,618) | |||||||
| Basic and diluted earnings per share | $ | (0.27) | $ | (0.22) | |||||||
| Basic and diluted weighted average shares outstanding | 39,607,022 | 39,087,472 | |||||||||
The accompanying notes are an integral part of these unaudited consolidated financial statements.
4
Cardiovascular Systems, Inc.
Consolidated Statements of Comprehensive Income
(Dollars in thousands)
(Unaudited)
| Three Months Ended | |||||||||||
| September 30, | |||||||||||
| 2022 | 2021 | ||||||||||
| Net loss | $ | (10,631) | $ | (8,618) | |||||||
| Other comprehensive loss: | |||||||||||
| Unrealized loss on available-for-sale debt securities | 3 | (17) | |||||||||
| Foreign currency translation adjustments | (6) | — | |||||||||
| Comprehensive loss | $ | (10,634) | $ | (8,635) | |||||||
The accompanying notes are an integral part of these unaudited consolidated financial statements.
5
Cardiovascular Systems, Inc.
Consolidated Statements of Changes in Stockholders’ Equity
(Dollars in thousands, except per share amounts)
(Unaudited)
| Common Stock | Additional Paid In Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Total | |||||||||||||||||||||||||
| Balances at June 30, 2022 | $ | 40 | $ | 673,388 | $ | (268) | $ | (423,680) | $ | 249,480 | |||||||||||||||||||
| Stock-based compensation related to restricted stock awards, net | — | 4,324 | — | — | 4,324 | ||||||||||||||||||||||||
| Shares withheld for payroll taxes | — | — | — | (1,191) | (1,191) | ||||||||||||||||||||||||
| Employee stock purchase plan activity | — | 174 | — | — | 174 | ||||||||||||||||||||||||
| Unrealized gain on available-for-sale debt securities | — | — | 3 | — | 3 | ||||||||||||||||||||||||
| Foreign currency translation adjustments | — | — | (6) | — | (6) | ||||||||||||||||||||||||
| Net loss | — | — | — | (10,631) | (10,631) | ||||||||||||||||||||||||
| Balances at September 30, 2022 | $ | 40 | $ | 677,886 | $ | (271) | $ | (435,502) | $ | 242,153 | |||||||||||||||||||
The accompanying notes are an integral part of these unaudited consolidated financial statements.
6
Cardiovascular Systems, Inc.
Consolidated Statements of Changes in Stockholders’ Equity
(Dollars in thousands, except per share amounts)
(Unaudited)
| Common Stock | Additional Paid In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total | |||||||||||||||||||||||||
| Balances at June 30, 2021 | $ | 39 | $ | 652,288 | $ | 11 | $ | (381,380) | $ | 270,958 | |||||||||||||||||||
| Stock-based compensation related to restricted stock awards, net | — | 5,523 | — | — | 5,523 | ||||||||||||||||||||||||
| Shares withheld for payroll taxes | — | — | — | (4,990) | (4,990) | ||||||||||||||||||||||||
| Employee stock purchase plan activity | — | 324 | — | — | 324 | ||||||||||||||||||||||||
| Unrealized loss on available-for-sale debt securities | — | — | (17) | — | (17) | ||||||||||||||||||||||||
| Exercise of stock options | — | 12 | — | — | 12 | ||||||||||||||||||||||||
| Net loss | — | — | — | (8,618) | (8,618) | ||||||||||||||||||||||||
| Balances at September 30, 2021 | $ | 39 | $ | 658,147 | $ | (6) | $ | (394,988) | $ | 263,192 | |||||||||||||||||||
The accompanying notes are an integral part of these unaudited consolidated financial statements.
7
Cardiovascular Systems, Inc.
Consolidated Statements of Cash Flows
(Dollars in thousands)
(Unaudited)
| Three Months Ended | |||||||||||
| September 30, | |||||||||||
| 2022 | 2021 | ||||||||||
| Cash flows from operating activities | |||||||||||
| Net loss | $ | (10,631) | $ | (8,618) | |||||||
| Adjustments to reconcile net loss to net cash from operating activities | |||||||||||
| Depreciation of property and equipment | 874 | 954 | |||||||||
| Amortization of intangible assets | 346 | 304 | |||||||||
| Stock-based compensation | 4,438 | 5,672 | |||||||||
| Amortization of premium (accretion of discount) on marketable securities | (184) | 380 | |||||||||
| Other | (27) | 5 | |||||||||
| Changes in assets and liabilities | |||||||||||
| Accounts receivable | (587) | 3,584 | |||||||||
| Inventories | (3,377) | (814) | |||||||||
| Prepaid expenses and other assets | (1,127) | 28 | |||||||||
| Accounts payable | 2,264 | (895) | |||||||||
| Accrued expenses and other liabilities | (4,228) | (10,846) | |||||||||
| Deferred revenue | (1,413) | (538) | |||||||||
| Net cash used in operating activities | (13,652) | (10,784) | |||||||||
| Cash flows from investing activities | |||||||||||
| Purchases of property and equipment | (688) | (1,103) | |||||||||
| Acquisitions | — | (1,700) | |||||||||
| Investments in strategic ventures | (575) | (50) | |||||||||
| Purchases of marketable securities | (31,763) | (38,462) | |||||||||
| Sales of marketable securities | 11,989 | 6,721 | |||||||||
| Maturities of marketable securities | 32,375 | 46,200 | |||||||||
| Net cash provided by investing activities | 11,338 | 11,606 | |||||||||
| Cash flows from financing activities | |||||||||||
| Payments of employee taxes related to vested restricted stock | (1,191) | (4,990) | |||||||||
| Exercise of stock options | — | 12 | |||||||||
| Principal payments made on financing obligation | (69) | (50) | |||||||||
| Net cash used in financing activities | (1,260) | (5,028) | |||||||||
| Net change in cash and cash equivalents | (3,574) | (4,206) | |||||||||
| Cash and cash equivalents | |||||||||||
| Beginning of period | 66,424 | 71,070 | |||||||||
| End of period | $ | 62,850 | $ | 66,864 | |||||||
The accompanying notes are an integral part of these unaudited consolidated financial statements.
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CARDIOVASCULAR SYSTEMS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(For the Three Months Ended September 30, 2022 and 2021)
(Dollars in thousands, except per share and share amounts)
(Unaudited)
1. Basis of Presentation
Cardiovascular Systems, Inc. (the “Company”), based in St. Paul, Minnesota, is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The Company’s Orbital Atherectomy Systems (“OAS”) treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives.
The Company prepared the unaudited interim consolidated financial statements and related unaudited financial information in the footnotes in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. The year-end consolidated balance sheet was derived from the Company’s audited consolidated financial statements, but does not include all disclosures as required by GAAP. These interim consolidated financial statements reflect all adjustments consisting of normal recurring accruals, which, in the opinion of management, are necessary for a fair statement of the Company’s consolidated financial position, the results of its operations, its changes in stockholders’ equity, and its cash flows for the interim periods. These interim consolidated financial statements should be read in conjunction with the consolidated annual financial statements and the notes thereto included in the Company's Annual Report on Form 10-K for the year ended June 30, 2022. The nature of the Company’s business is such that the results of any interim period may not be indicative of the results to be expected for the entire year.
The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company has been impacted by the COVID-19 pandemic. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company's business, results of operations and financial condition, including sales, expenses, reserves and allowances, manufacturing, clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat COVID-19, as well as the economic impact on the Company's customers and markets. The Company has made estimates of the impact of COVID-19 within these consolidated financial statements and there may be changes to those estimates in future periods. Actual results could differ from those estimates.
2. Selected Consolidated Financial Statement Information
Accounts Receivable, Net
Accounts receivable consists of the following:
| September 30, | June 30, | ||||||||||
| 2022 | 2022 | ||||||||||
| Accounts receivable | $ | 41,561 | $ | 40,974 | |||||||
| Less: Allowance for doubtful accounts | (1,302) | (1,296) | |||||||||
| Accounts receivable, net | $ | 40,259 | $ | 39,678 | |||||||
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Inventories
Inventories consist of the following:
| September 30, | June 30, | ||||||||||
| 2022 | 2022 | ||||||||||
| Raw materials | $ | 14,274 | $ | 13,780 | |||||||
| Work in process | 3,832 | 2,785 | |||||||||
| Finished goods | 19,838 | 18,002 | |||||||||
| Inventories | $ | 37,944 | $ | 34,567 | |||||||
The total inventory reserve at September 30, 2022 and June 30, 2022 was $3,761 and $4,128, respectively.
Property and Equipment, Net
Property and equipment consists of the following:
| September 30, | June 30, | ||||||||||
| 2022 | 2022 | ||||||||||
| Land | $ | 572 | $ | 572 | |||||||
| Building | 22,420 | 22,420 | |||||||||
| Equipment | 24,741 | 24,340 | |||||||||
| Furniture | 3,376 | 3,376 | |||||||||
| Leasehold improvements | 812 | 812 | |||||||||
| Construction in progress | 3,067 | 2,670 | |||||||||
| 54,988 | 54,190 | ||||||||||
| Less: Accumulated depreciation | (26,029) | (25,155) | |||||||||
| Property and equipment, net | $ | 28,959 | $ | 29,035 | |||||||
Accrued Expenses
Accrued expenses consist of the following:
| September 30, | June 30, | ||||||||||
| 2022 | 2022 | ||||||||||
| Salaries and bonus | 6,197 | 8,082 | |||||||||
| Commissions | 5,797 | 8,104 | |||||||||
| Accrued vacation | 2,280 | 2,345 | |||||||||
| Accrued excise, sales and other taxes | 967 | 953 | |||||||||
| Clinical studies | 902 | 1,082 | |||||||||
| Other | 3,561 | 2,898 | |||||||||
| Accrued expenses | $ | 19,704 | $ | 23,464 | |||||||
Other Liabilities
WIRION Acquisition Consideration
Following the successful completion of the manufacturing transfer of the WIRION system to the Company, the Company has agreed to pay an additional consideration of $10,000, half of which may be paid by the Company through an issuance of shares of its common stock. The Company reviewed this liability in response to the voluntary recall of the WIRION system and determined that it remains probable and appropriately recorded in other liabilities as of September 30, 2022, although this payment will be made at a later date than originally anticipated due to the recall.
10
3. Revenue
The following table disaggregates the Company’s net revenues by product category and geography for the following periods:
| Three Months Ended | |||||||||||
| September 30, | |||||||||||
| Product Category | 2022 | 2021 | |||||||||
| Peripheral | $ | 38,784 | $ | 39,009 | |||||||
| Coronary | 20,889 | 19,361 | |||||||||
| Total net revenues | $ | 59,673 | $ | 58,370 | |||||||
| Geography | |||||||||||
| United States | $ | 55,027 | $ | 55,042 | |||||||
| International | 4,646 | 3,328 | |||||||||
| Total net revenues | $ | 59,673 | $ | 58,370 | |||||||
Revenue of $1,413 was recognized in the three months ended September 30, 2022 that was deferred as of June 30, 2022. As of September 30, 2022 and June 30, 2022, the Company had a liability of $1,499 and $1,315, respectively, related to estimates of variable consideration which are recorded within accounts payable on the consolidated balance sheet.
4. Intangible Assets
The Company’s finite-lived intangible assets are stated at cost less accumulated amortization and include developed technology and trade name assets acquired in asset acquisitions, as well as costs incurred to obtain patents. Developed technology and trade name assets are amortized over 10 years to 15 years. Patent costs are amortized beginning at the time of patent approval over a useful life not exceeding 20 years.
The components of intangible assets, net are as follows:
| September 30, 2022 | June 30, 2022 | ||||||||||||||||||||||
| Gross Carrying Amount | Accumulated Amortization | Net Book Value | Gross Carrying Amount | Accumulated Amortization | Net Book Value | ||||||||||||||||||
| Developed technology | $ | 17,324 | $ | (3,468) | $ | 13,856 | $ | 17,324 | $ | (3,165) | $ | 14,159 | |||||||||||
| Patents | 1,866 | (933) | 933 | 1,866 | (903) | 963 | |||||||||||||||||
| Trade name | 760 | (161) | 599 | 760 | (148) | 612 | |||||||||||||||||
| Total intangible assets, net | $ | 19,950 | $ | (4,562) | $ | 15,388 | $ | 19,950 | $ | (4,216) | $ | 15,734 | |||||||||||
Amortization expense expected for the next five years and thereafter is as follows:
| Remainder of fiscal 2023 | $ | 1,035 | |||
| Fiscal 2024 | 1,377 | ||||
| Fiscal 2025 | 1,374 | ||||
| Fiscal 2026 | 1,373 | ||||
| Fiscal 2027 | 1,371 | ||||
| Thereafter | 8,858 | ||||
| $ | 15,388 | ||||
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5. Debt
Revolving Credit Facility
In March 2017, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Silicon Valley Bank (“SVB”). In March 2020, the Company entered into the First Amendment to the Loan Agreement (the "Amendment"). The Amendment extended the maturity date of the Loan Agreement by two years, to March 31, 2022, and increased the maximum amount available under the senior, secured revolving credit facility (the “Revolver”) to $50,000 (the “Maximum Dollar Amount”). In March 2022, the Company entered into the Second Amendment to the Loan Agreement (the "Second Amendment"). The Second Amendment extended the maturity date of the Loan Agreement by one year, to March 31, 2023.
Advances under the Revolver may be made from time to time up to the Maximum Dollar Amount, subject to certain borrowing limitations. The Revolver bears interest at a floating per annum rate equal to the Wall Street Journal prime rate, less 0.75%. Interest on borrowings is due monthly and the principal balance is due at maturity. Upon the Revolver’s maturity, any outstanding principal balance, unpaid accrued interest, and all other obligations under the Revolver will be due and payable. The Company will incur a fee equal to 1.5% of the Maximum Dollar Amount upon termination of the Loan Agreement, as amended by the Second Amendment (the "Amended Loan Agreement"), or the Revolver for any reason prior to the date that is fifteen days prior to the maturity date, unless refinanced with SVB.
The Company’s obligations under the Amended Loan Agreement are secured by certain of the Company’s assets, including, among other things, accounts receivable, deposit accounts, inventory, equipment, general intangibles and records pertaining to the foregoing. The collateral does not include the Company’s intellectual property, but the Company has agreed not to encumber its intellectual property without the consent of SVB. The Amended Loan Agreement contains customary covenants limiting the Company’s ability to, among other things, incur debt or liens, make certain investments and loans, enter into transactions with affiliates, undergo certain fundamental changes, dispose of assets, or change the nature of its business. In addition, the Amended Loan Agreement contains financial covenants requiring the Company to maintain, at all times when any amounts are outstanding under the Revolver, either (i) minimum unrestricted cash at SVB and unused availability on the Revolver of at least $10,000 or (ii) minimum trailing three-month Adjusted EBITDA of $1,000. If the Company does not comply with the various covenants under the Amended Loan Agreement or an event of default under the Amended Loan Agreement occurs, such as a material adverse change, the interest rate on outstanding amounts will increase by 5% and SVB may, subject to various customary cure rights and the other terms and conditions of the Amended Loan Agreement, decline to provide additional advances under the Revolver, require the immediate payment of all amounts outstanding under the Revolver, and foreclose on all collateral.
The Company is required to pay a fee equal to 0.15% per annum on the unused portion of the Revolver, payable quarterly in arrears. The Company is not obligated to draw any funds under the Revolver and has not done so under the Revolver since entering into the Loan Agreement. No amounts are outstanding as of September 30, 2022.
Financing Obligation
In connection with the sale of the Company’s headquarters facility in St. Paul, Minnesota (the “Facility”), the Company entered into a Lease Agreement to lease the Facility. The Lease Agreement has an initial term of 15 years, with four consecutive renewal options of 5 years each at the Company’s option, with a base annual rent in the first year of $1,638 and annual escalations of 3% thereafter. Rent during subsequent renewal terms will be at the then fair market rental rate. As the lease terms resulted in a capital lease classification, the Company accounted for the sale and leaseback of the Facility as a financing transaction where the assets remain on the Company’s balance sheet and a financing obligation was recorded for $20,944. As lease payments are made, they will be allocated between interest expense and a reduction of the financing obligation, resulting in a value of the financing obligation that is equivalent to the net book value of the assets at the end of the lease term. The effective interest rate is 7.89%. At the end of the lease (including any renewal option terms), the Company will remove the assets and financing obligation from its balance sheet.
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Payments under the initial term of the Lease Agreement as of September 30, 2022 are as follows:
| Remainder of fiscal 2023 | $ | 1,438 | |||
| Fiscal 2024 | 1,970 | ||||
| Fiscal 2025 | 2,029 | ||||
| Fiscal 2026 | 2,090 | ||||
| Fiscal 2027 | 2,153 | ||||
| Thereafter | 11,133 | ||||
| $ | 20,813 | ||||
6. Marketable Securities & Fair Value Measurements
The Company’s marketable securities are classified on the consolidated balance sheet as follows:
| September 30, | June 30, | ||||||||||
| 2022 | 2022 | ||||||||||
| Short-term available-for-sale debt securities | $ | 78,361 | $ | 88,375 | |||||||
| Long-term available-for-sale debt securities | 2,318 | 4,810 | |||||||||
| Available-for-sale debt securities | 80,679 | 93,185 | |||||||||
| Mutual funds | 219 | 224 | |||||||||
| Total marketable securities | $ | 80,898 | $ | 93,409 | |||||||
Available-for-sale debt securities are invested in the following financial instruments:
As of September 30, 2022 | |||||||||||||||||||||||
| Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | ||||||||||||||||||||
| Commercial paper | $ | 33,575 | $ | — | $ | — | $ | 33,575 | |||||||||||||||
| U.S. government securities | 24,058 | 3 | (75) | 23,986 | |||||||||||||||||||
| Corporate debt | 18,539 | — | (162) | 18,377 | |||||||||||||||||||
| Asset backed securities | 4,771 | — | (30) | 4,741 | |||||||||||||||||||
| Total available-for-sale debt securities | $ | 80,943 | $ | 3 | $ | (267) | $ | 80,679 | |||||||||||||||
As of June 30, 2022 | |||||||||||||||||||||||
| Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | ||||||||||||||||||||
| Commercial paper | $ | 36,800 | $ | — | $ | — | $ | 36,800 | |||||||||||||||
| U.S. government securities | 14,994 | — | (67) | 14,927 | |||||||||||||||||||
| Corporate debt | 27,193 | — | (142) | 27,051 | |||||||||||||||||||
| Asset backed securities | 14,465 | — | (58) | 14,407 | |||||||||||||||||||
| Total available-for-sale debt securities | $ | 93,452 | $ | — | $ | (267) | $ | 93,185 | |||||||||||||||
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The following table provides information by level for the Company’s marketable securities that were measured at fair value on a recurring basis:
Fair Value Measurements as of September 30, 2022 Using Inputs Considered as | |||||||||||||||||||||||
| Fair Value | Level 1 | Level 2 | Level 3 | ||||||||||||||||||||
| Commercial paper | $ | 33,575 | $ | — | $ | 33,575 | $ | — | |||||||||||||||
| U.S. government securities | 23,986 | — | 23,986 | — | |||||||||||||||||||
| Corporate debt | 18,377 | — | 18,377 | — | |||||||||||||||||||
| Asset backed securities | 4,741 | — | 4,741 | — | |||||||||||||||||||
| Mutual funds | 219 | 103 | 116 | — | |||||||||||||||||||
| Total marketable securities | $ | 80,898 | $ | 103 | $ | 80,795 | $ | — | |||||||||||||||
Fair Value Measurements as of June 30, 2022 Using Inputs Considered as | |||||||||||||||||||||||
| Fair Value | Level 1 | Level 2 | Level 3 | ||||||||||||||||||||
| Commercial paper | $ | 36,800 | $ | — | $ | 36,800 | $ | — | |||||||||||||||
| U.S. government securities | 14,927 | — | 14,927 | — | |||||||||||||||||||
| Corporate debt | 27,051 | — | 27,051 | — | |||||||||||||||||||
| Asset backed securities | 14,407 | — | 14,407 | — | |||||||||||||||||||
| Mutual funds | 224 | 108 | 116 | — | |||||||||||||||||||
| Total marketable securities | $ | 93,409 | $ | 108 | $ | 93,301 | $ | — | |||||||||||||||
The Company’s marketable securities classified within Level 1 are valued using real-time quotes for transactions in active exchange markets. Marketable securities within Level 2 are valued using readily available pricing sources. There were no transfers of assets between Level 1 and Level 2 of the fair value measurement hierarchy during the three months ended September 30, 2022. Any transfers between levels would be recognized on the date of the event or when a change in circumstances causes a transfer.
Strategic Investments
The Company holds equity investments that do not have readily determined fair values. The Company has elected to measure these investments at cost minus impairment, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer. Impairment is reviewed each reporting period by performing a qualitative assessment considering impairment indicators to evaluate whether the investment is impaired.
As of September 30, 2022 and June 30, 2022, the carrying value of these investments was $12,312 and $12,333, respectively. During the three months ended September 30, 2022, no impairment indicators were noted. The Company is committed to funding an additional $1,410 into these investments in the future. The Company holds options to acquire all outstanding equity or certain developed technologies with respect to some of these strategic investments.
The Company also holds strategic investments accounted for as available-for-sale debt securities, which had carrying values and approximated fair values of $21,715 and $21,092 as of September 30, 2022 and June 30, 2022, respectively. The fair values of these investments are measured using Level 3 inputs and are not included in the tables above. Impairment is assessed similar to the Company's other strategic investments and no impairment indicators were noted during the three months ended September 30, 2022.
7. Stock-Based Compensation
On November 15, 2017, the Company’s stockholders approved the 2017 Equity Incentive Plan (the “2017 Plan”) for the purpose of granting equity awards to employees, directors and consultants. On March 12, 2020, the Company’s Board of Directors approved the Amended and Restated 2017 Equity Incentive Plan, which amends the 2017 Plan (the "Amended 2017 Plan"). On August 19, 2021, the Company's Board of Directors adopted a further amendment to the Amended 2017 Plan, which was approved by the Company's stockholders on November 11, 2021, that increased the number of shares available for issuance under the Amended 2017 Plan by 1,700,000 shares. As amended, the 2017 Plan allows for the granting of up to 3,607,523 shares of common stock as approved by the Board of Directors or committees thereof in the form of nonqualified or incentive
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stock options, restricted stock awards, restricted stock unit awards, performance share awards, performance unit awards or stock appreciation rights to officers, directors, consultants and employees of the Company. As of September 30, 2022, there were 1,065,622 shares available for grant under the 2017 Plan.
Equity awards classified as restricted stock and performance-based restricted stock are treated as issued shares when granted; however, these shares are not included in the computation of basic weighted average shares outstanding. When shares vest, unless the holder elects to pay the payroll tax liability in cash or through a sale of shares, the Company withholds the appropriate amount of shares to settle the payroll tax liability, on behalf of the individual receiving the shares, as an adjustment to accumulated deficit.
Restricted Stock
The value of each restricted stock award is equal to the fair market value of the Company’s common stock at the date of grant. Vesting of time-based restricted stock awards ranges from one year to three years. The estimated fair value of restricted stock awards, including the effect of estimated forfeitures, is recognized on a straight-line basis over the restricted stock’s vesting period.
Restricted stock award activity for the three months ended September 30, 2022 is as follows:
| Number of Shares | Weighted Average Fair Value | ||||||||||
Outstanding at June 30, 2022 | 678,899 | $ | 28.88 | ||||||||
| Granted | 648,605 | $ | 16.55 | ||||||||
| Forfeited | (38,966) | $ | 25.01 | ||||||||
| Vested | (189,683) | $ | 36.23 | ||||||||
Outstanding at September 30, 2022 | 1,098,855 | $ | 20.47 | ||||||||
The Company also grants performance-based restricted stock awards to certain executives and other management, as summarized below.
Performance-Based Restricted Stock - Total Shareholder Return
In August 2022, the Company granted an aggregate maximum of 303,272 shares that vest based on the Company’s total shareholder return relative to total shareholder return of the Company’s peer group (a market condition), as measured by the closing prices of the stock of the Company and the peer group members for the 90 trading days preceding July 1, 2022 compared to the closing prices of the stock of the Company and the peer group members for the 90 trading days preceding July 1, 2025. Vesting of these awards will be determined on the date that the Company’s Annual Report on Form 10-K for the fiscal year ending June 30, 2025 is filed.
To calculate the estimated fair value of these restricted stock awards with market conditions, the Company uses a Monte Carlo simulation, which uses the expected average stock prices to estimate the expected number of shares that will vest. The Monte Carlo simulation resulted in an aggregate fair value of approximately $2,800, which the Company will recognize as expense using the straight-line method over the period that the awards are expected to vest. Stock-based compensation expense related to an award with a market condition will be recognized regardless of whether the market condition is satisfied, provided that the requisite service has been provided.
Performance-based restricted stock awards granted in fiscal 2022 and 2021 that are outstanding vest based on the Company’s total shareholder return relative to total shareholder return of the Company’s peer group (a market condition), as measured by the closing prices of the stock of the Company and the peer group members for the 90 trading days preceding July 1, 2021 and July 1, 2020, respectively, compared to the closing prices of the stock of the Company and the peer group members for the 90 trading days preceding July 1, 2024 and July 1, 2023, respectively.
Performance-Based Restricted Stock - Revenue
In August 2022, the Company granted an aggregate maximum of 303,244 shares that vest based on the Company’s average annual revenue growth during the performance period. Annual revenue growth is measured as the percentage increase in the revenue reported in the Form 10-K for each of the fiscal years ending June 30, 2023, 2024 and 2025, compared to the revenue reported in the Form 10-K for each preceding fiscal year. Vesting of these awards will be determined on the date that the
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Company’s Annual Report on Form 10-K for the fiscal year ending June 30, 2025 is filed. The Company recognizes expense for awards with performance conditions when it concludes that it is probable that the performance condition will be achieved. Probability is assessed at each reporting period and expense is adjusted for such changes accordingly with a cumulative catch up adjustment.
Performance-based restricted stock award activity for the three months ended September 30, 2022 is as follows:
| Number of Shares | Weighted Average Fair Value | ||||||||||
Outstanding at June 30, 2022 | 744,215 | $ | 19.89 | ||||||||
| Granted | 606,516 | $ | 16.55 | ||||||||
| Forfeited | (218,625) | $ | 29.34 | ||||||||
| Vested | — | $ | — | ||||||||
Outstanding at September 30, 2022 | 1,132,106 | $ | 16.27 | ||||||||
Unrecognized stock compensation related to unvested stock awards outstanding as of September 30, 2022 was $25,252.
8. Leases
The Company leases its Texas manufacturing facility under an operating lease agreement which expires in April 2026. The Company also leases office equipment under lease agreements that expire at various dates through December 2026. As discussed in Note 5, the Company also leases its Minnesota headquarters facility which is accounted for as a financing obligation.
Operating lease right-of-use assets and liabilities are recognized based on the present value of future minimum lease payments over the lease term at commencement dates. The Company considers fixed or variable payment terms, prepayments, incentives, and options to extend, terminate or purchase. Renewal, termination or purchase options affect the lease term used for determining lease asset value only if the option is reasonably certain to be exercised. The Company uses its incremental borrowing rate based on information available at the lease commencement date in determining the present value of lease payments unless the lease provides an implicit interest rate.
Operating lease cost is classified within the consolidated statement of operations based on the nature of the leased asset. The Company's operating lease cost was $135 and $128 for the three months ended September 30, 2022 and 2021, respectively. Cash paid for operating lease liabilities approximated operating lease cost for the three months ended September 30, 2022. There were $24 and $54 of operating lease right-of-use assets obtained in exchange for new lease liabilities during the three months ended September 30, 2022 and 2021, respectively.
| September 30, | June 30, | ||||||||||
| 2022 | 2022 | ||||||||||
| Right-of-use assets | |||||||||||
| Other assets | $ | 1,753 | $ | 1,852 | |||||||
| Operating lease liabilities | |||||||||||
| Accrued expenses | 530 | 526 | |||||||||
| Other liabilities | 1,224 | 1,326 | |||||||||
| Total operating lease liabilities | $ | 1,754 | $ | 1,852 | |||||||
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Future minimum lease payments under the agreements as of September 30, 2022 are as follows:
| Remainder of fiscal 2023 | $ | 405 | |||
| Fiscal 2024 | 513 | ||||
| Fiscal 2025 | 501 | ||||
| Fiscal 2026 | 413 | ||||
| Fiscal 2027 | 3 | ||||
| Total lease payments | 1,835 | ||||
| Less imputed interest | (81) | ||||
| Total operating lease liabilities | $ | 1,754 | |||
As of September 30, 2022, the weighted average remaining lease term for operating leases was 3.5 years and the weighted average discount rate used to determine operating lease liabilities was 2.55%.
9. Commitment and Contingencies
In the ordinary conduct of business, the Company is subject to various lawsuits and claims covering a wide range of matters including, but not limited to, employment claims, commercial disputes and product liability claims. While the outcome of these matters is uncertain, the Company does not believe there are any significant matters as of September 30, 2022 that are probable or estimable, for which the outcome could have a material adverse impact on its consolidated balance sheets or statements of operations.
10. Earnings Per Share
The following table presents a reconciliation of the numerators and denominators used in the basic and diluted earnings per common share computations (in thousands except share and per share amounts):
| Three Months Ended | |||||||||||
| September 30, | |||||||||||
| 2022 | 2021 | ||||||||||
| Numerator | |||||||||||
| Net loss | $ | (10,631) | $ | (8,618) | |||||||
| Income allocated to participating securities | — | — | |||||||||
| Net loss available to common stockholders | $ | (10,631) | $ | (8,618) | |||||||
| Denominator | |||||||||||
| Weighted average common shares outstanding – basic | 39,607,022 | 39,087,472 | |||||||||
Effect of dilutive stock options(1) | — | — | |||||||||
Effect of dilutive restricted stock units(2) | — | — | |||||||||
Effect of performance-based restricted stock awards(3) | — | — | |||||||||
Weighted average common shares outstanding – diluted | 39,607,022 | 39,087,472 | |||||||||
| Earnings per common share – basic and diluted | $ | (0.27) | $ | (0.22) | |||||||
(1)At September 30, 2022 and 2021, 69,493 and 83,834 stock options, respectively, were outstanding. The effect of the shares that would be issued upon exercise of these options has been excluded from the calculation of diluted loss per share for all periods presented because those shares are anti-dilutive.
(2)At September 30, 2022 and 2021, 279,657 and 313,275 additional shares of common stock, respectively, were issuable upon the settlement of outstanding restricted stock units. The effect of the shares that would be issued upon settlement of these restricted stock units has been excluded from the calculation of diluted loss per share for all periods presented because those shares are anti-dilutive.
(3)At September 30, 2022 and 2021, 1,132,106 and 846,899 performance-based restricted stock awards, respectively, were outstanding. The effect of the potential vesting of these awards has been excluded from the calculation of diluted loss per share for all periods presented because those shares are anti-dilutive.
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes appearing under Item 1 of Part I of this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and expected financial results, includes forward-looking statements that involve risks and uncertainties. You should review the “Risk Factors” discussed in our Annual Report on Form 10-K for the year ended June 30, 2022 and subsequent Quarterly Reports on Form 10-Q, including in Item 1A of Part II of this Quarterly Report on Form 10-Q, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
OVERVIEW
We are a medical technology company leading the way in the effort to successfully treat patients suffering from peripheral and coronary artery diseases, including those with arterial calcium, the most difficult form of arterial disease to treat. We are committed to clinical rigor, constant innovation and a defining drive to set the industry standard to deliver safe and effective medical devices that improve the lives of patients facing these difficult disease states. We have developed patented orbital atherectomy systems (“OAS”) for both peripheral and coronary clinical applications. The primary base of our business is catheter-based platforms capable of treating a broad range of vessel sizes and plaque types, including calcified plaque, which address many of the limitations associated with other treatment alternatives.
We have observed some degree of seasonality in our business, as there tends to be a lower number of procedures that use our products during the three months ending September 30. Interventional procedure volume usually grows throughout the course of the fiscal year, with the three months ending June 30 usually representing the highest volume of cases and, therefore, the highest amount of revenue generated by us during the course of the fiscal year.
Peripheral
Our peripheral artery disease (“PAD”) products are catheter-based platforms capable of treating a broad range of plaque types in leg arteries both above and below the knee, including calcified plaque, and address many of the limitations associated with other existing surgical, catheter and pharmacological treatment alternatives. The micro-invasive devices use small access sheaths that can provide procedural benefits, allow physicians to treat PAD patients in even the small and tortuous vessels located below the knee, and facilitate access through alternative sites in the ankle, foot and wrist, as well as in the groin.
The United States Food and Drug Administration (“FDA”) has granted us 510(k) clearances for our Peripheral OAS as a therapy in patients with PAD, as discussed in Item 1 of Part I of our Annual Report on Form 10-K for the year ended June 30, 2022. We refer to these products in this Quarterly Report on Form 10-Q as the “Peripheral OAS.” In addition to our Peripheral OAS, we also offer support products within the peripheral space. Peripheral sales in the United States during the three months ended September 30, 2022 represented approximately 65% of revenue.
Coronary
Our coronary artery disease (“CAD”) product, the Diamondback 360 Coronary OAS (“Coronary OAS”), is a catheter-based platform designed to facilitate stent delivery in patients with CAD who are acceptable candidates for percutaneous transluminal coronary angioplasty or stenting due to de novo, severely calcified coronary artery lesions. The Coronary OAS design is similar to technology used in our Peripheral OAS, customized specifically for the coronary application. In addition to the Coronary OAS, we also offer support products within the coronary space as we expand treatment to a broader patient population with complex coronary artery disease.
We have received premarket approval (“PMA”) from the FDA to market the Coronary OAS as a treatment for severely calcified coronary arteries. Coronary sales in the United States during the three months ended September 30, 2022 represented approximately 27% of revenue.
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International
We serve a growing patient population globally through an expanding distribution and sales network. Sales of our approved products in Japan are made through our exclusive Japan distributor, Medikit Co., Ltd. ("Medikit"). Our distribution agreement with Medikit expires in February 2023 and we are currently in negotiations for the continued distribution of our products in Japan. Sales of our products in the rest of the world, which primarily includes certain countries in Southeast Asia, Europe, Latin America and the Middle East and Canada, are made through a network of distributors and sales agents. International sales during the three months ended September 30, 2022 represented approximately 8% of revenue.
Impact of COVID-19
The COVID-19 pandemic in the United States and internationally has caused us to experience ongoing disruptions in the procedures using our products. Procedures have been postponed, and may continue to be postponed, as a result of reduced availability of physicians or lab space to treat patients, the lack of personal protective equipment and active virus test kits, different treatment prioritizations, increased cost pressures and burdens on the overall healthcare infrastructure that result in reallocation of resources, customer staffing shortages, and governmental guidelines and restrictions. In addition, patients have elected to defer or avoid treatment for procedures that use our products due to anxiety about the potential spread of COVID-19 in facilities. Finally, our personnel and the personnel of our distribution partners and sales agents experienced restrictions on their ability to access many customers, hospitals, labs and other medical facilities for sales activities, training and case support as they may have been deemed to be “non-essential” personnel by those facilities, and there has been a reduction in procedure activity in these accounts.
In addition to the impact on procedure volumes, we experienced other disruptions as a result of the COVID-19 pandemic in fiscal 2022, such as the reallocation of company resources from our strategic priorities; supply chain disruptions that limited, delayed or prevented us from acquiring the components used to develop and manufacture our products or ship those products once manufactured; and decreased employee productivity. Some of these disruptions continued into the first quarter of fiscal 2023, although to a lesser extent than we experienced in the first quarter of fiscal 2022.
Throughout the pandemic, we have operated our manufacturing facilities and continued to ship product. Most of our office-based employees have telecommuted, and our field employees have continued to support cases in clinical settings where they are able to have access. We took and continue to take several actions intended to protect the health and well-being of our workforce and our customers. We will continue to monitor developments at the local, state and national levels in order to ensure that we and our employees have current information for purposes of making decisions in the dynamic and unpredictable environment and that we comply with applicable requirements.
Throughout the COVID-19 pandemic, we have observed the impact from the spread of some variants, and the fluctuations in hospitalizations resulting from these variants. For example, there were significant disruptions in procedures that occurred in the first quarter of fiscal 2022 due to the Delta variant outbreak and in the second and third quarters of fiscal 2022 due to the Omicron variant outbreak. Many factors may increase or decrease procedure volumes, which would have an impact on our revenue and financial results, including vaccination levels and mandates, the spread of new, more viral or deadly variants of the SARS-CoV-2 virus, easing of social restrictions and government restrictions on elective and semi-elective cases, level of patient anxiety, medical facility and workforce capacity, and sales representative access to facilities to support cases. We continue to monitor the spread of variants and track hospitalizations resulting from variants of the SARS-CoV-2 virus.
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CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES
Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of our consolidated financial statements requires us to make estimates, assumptions and judgments that affect amounts reported in those statements. Our estimates, assumptions and judgments, including those related to revenue recognition, deferred revenue and stock-based compensation, are updated as appropriate at least quarterly. We use authoritative pronouncements, our technical accounting knowledge, cumulative business experience, judgment and other factors in the selection and application of our accounting policies. While we believe that the estimates, assumptions and judgments that we use in preparing our consolidated financial statements are appropriate, these estimates, assumptions and judgments are subject to factors and uncertainties regarding their outcome. Therefore, actual results may materially differ from these estimates.
Some of our significant accounting policies require us to make subjective or complex judgments or estimates. An accounting estimate is considered to be critical if it meets both of the following criteria: (1) the estimate requires assumptions about matters that are highly uncertain at the time the accounting estimate is made, and (2) different estimates that reasonably could have been used, or changes in the estimate that are reasonably likely to occur from period to period, would have a material impact on the presentation of our financial condition, results of operations, or cash flows.
Our critical accounting policies are identified in Item 7 of Part II of our Annual Report on Form 10-K for the fiscal year ended June 30, 2022 under the heading “Critical Accounting Policies and Significant Judgments and Estimates.”
RESULTS OF OPERATIONS
The following table sets forth our results of operations expressed as dollar amounts (in thousands) and the changes between the specified periods expressed as percent increases or decreases:
| Three Months Ended September 30, | |||||||||||||||||
| 2022 | 2021 | Percent Change | |||||||||||||||
| Net revenues | $ | 59,673 | $ | 58,370 | 2.2 | % | |||||||||||
| Cost of goods sold | 16,698 | 14,308 | 16.7 | ||||||||||||||
| Gross profit | 42,975 | 44,062 | (2.5) | ||||||||||||||
| Expenses: | |||||||||||||||||
| Selling, general and administrative | 44,475 | 41,851 | 6.3 | ||||||||||||||
| Research and development | 9,056 | 10,022 | (9.6) | ||||||||||||||
| Amortization of intangible assets | 346 | 304 | 13.8 | ||||||||||||||
| Total expenses | 53,877 | 52,177 | 3.3 | ||||||||||||||
| Loss from operations | (10,902) | (8,115) | 34.3 | ||||||||||||||
| Other (income) expense, net | (252) | 367 | (168.7) | ||||||||||||||
| Loss before income taxes | (10,650) | (8,482) | 25.6 | ||||||||||||||
| (Benefit) provision for income taxes | (19) | 136 | (114.0) | ||||||||||||||
| Net loss | $ | (10,631) | $ | (8,618) | 23.4 | ||||||||||||
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Comparison of Three Months Ended September 30, 2022 with Three Months Ended September 30, 2021
Net revenues. Net revenues increased by $1.3 million, or 2.2%, from $58.4 million for the three months ended September 30, 2021 to $59.7 million for the three months ended September 30, 2022. U.S. peripheral revenues decreased $0.2 million, or 0.6%, while U.S. coronary revenues increased $0.2 million, or 1.3%. Both therapies continue to be adversely affected by labor shortages and turnover in the health care workforce. We have also been adversely affected by an increasingly competitive environment and reimbursement pressures in the office-based lab setting. Increased revenue from increased customer adoption of interventional support products partially offset the revenue declines from decreased case volumes in the peripheral and coronary franchises. International revenue was $4.6 million for the three months ended September 30, 2022, compared with international revenue of $3.3 million for the three months ended September 30, 2021. Increases in international sales were driven by increased adoption in Europe and Canada, and the commencement of sales into other territories, as well as an increase in deferred revenue recognized. In the second quarter of fiscal 2023, we expect to resume growing revenue, driven by increasing the number of physicians using the devices we sell; increasing the usage per physician; the use of new and improved products, such as the Scoreflex NC scoring balloon, JADE balloons, ViperCross Microcatheters, and the 2.00 Max Crown for Peripheral OAS; and continuing expansion into new geographies, partially offset by potential decreases in average selling prices. However, ongoing factors such as staffing and supply shortages and competitive and reimbursement pressures may continue to have an adverse impact.
Cost of Goods Sold. Cost of goods sold was $16.7 million for the three months ended September 30, 2022, an increase of 16.7% from $14.3 million for the three months ended September 30, 2021. These amounts represent the cost of materials, labor and overhead for single-use catheters, guide wires, pumps, and other ancillary products. Gross margin decreased to 72.0% for the three months ended September 30, 2022 from 75.5% for the three months ended September 30, 2021. The increase in cost of goods sold and decrease in gross margin was primarily due to increased sales of lower margin products, as well as increased freight costs. We expect that gross margin in the second quarter of fiscal 2023 will be higher than the three months ended September 30, 2022 due to an expected increase in device sales. We anticipate that there will be a continued shift of sales mix into interventional support products and international markets in addition to declining average selling prices, which will also impact gross margins. Quarterly margin fluctuations could also occur based on production volumes, timing of new product introductions, sales mix, pricing changes, the impact of inflation or other unanticipated circumstances.
Selling, General and Administrative Expenses. Our selling, general and administrative expenses were $44.5 million for the three months ended September 30, 2022, an increase of 6.3% from $41.9 million for the three months ended September 30, 2021. Selling, general and administrative expense increases were led by costs associated with incentive compensation expense, travel-related expenditures and tradeshows. Selling, general and administrative expenses for the three months ended September 30, 2022 and 2021 include $3.7 million and $4.5 million, respectively, for stock-based compensation. We expect our selling, general and administrative expenses for the second quarter of fiscal 2023 to be slightly less than amounts incurred for the three months ended September 30, 2022. Quarterly fluctuations could occur based on the level of net revenue, which could be materially impacted by the factors noted above, as well as inflation.
Research and Development Expenses. Research and development expenses decreased by 9.6%, from $10.0 million for the three months ended September 30, 2021 to $9.1 million for the three months ended September 30, 2022. Research and development expenses relate to specific projects to develop new products or expand into new markets, such as the development of new versions of the Peripheral and Coronary OAS, shaft designs and crown designs, and expanded product offerings, including our percutaneous ventricular assist device, and to clinical trials. The decrease was primarily due to decreased costs on the ECLIPSE clinical trial and timing of costs associated with the development activities of our percutaneous ventricular assist device. We expect an increase in research and development expense in the second quarter of fiscal 2023 from what we incurred during the three months ended September 30, 2022. Quarterly fluctuations could occur based on the number of projects and studies, the progress of such projects and studies, the rate of study enrollment, the impact of inflation, acquisitions of in process research and development and possible charges in connection with those acquisitions, and the timing of expenditures.
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LIQUIDITY AND CAPITAL RESOURCES
We had cash, cash equivalents and highly liquid marketable securities of $143.7 million and $159.8 million at September 30, 2022 and June 30, 2022, respectively. As of September 30, 2022, we had an accumulated deficit of $435.5 million. We have historically funded our operating losses primarily from the issuance of common and preferred stock, convertible promissory notes, and debt.
A summary of our cash flow activities (in thousands) is as follows:
| Three Months Ended | |||||||||||
| September 30, | |||||||||||
| 2022 | 2021 | ||||||||||
| Net cash used in operating activities | $ | (13,652) | $ | (10,784) | |||||||
| Net cash provided by investing activities | 11,338 | 11,606 | |||||||||
| Net cash used in financing activities | (1,260) | (5,028) | |||||||||
| Net change in cash and cash equivalents | $ | (3,574) | $ | (4,206) | |||||||
Changes in Liquidity
Operating Activities
Net cash used in operating activities was $13.7 million for the three months ended September 30, 2022, primarily due to the net loss of $10.6 million, and $8.5 million relating to changes in working capital as a result of the payout of annual bonuses and commissions, increased uses of cash to build inventory as we diversify our product offerings, partially offset by non-cash expenditures for the three months ended September 30, 2022.
Net cash used in operating activities was $10.8 million for the three months ended September 30, 2021, primarily due to the net loss of $8.6 million, and $9.5 million relating to changes in working capital as a result of the payout of annual bonuses and commissions, partially offset by non-cash expenditures for the three months ended September 30, 2021.
Investing Activities
Net cash provided by investing activities was $11.3 million for the three months ended September 30, 2022, as maturities and sales of marketable securities exceeded marketable security purchases. These amounts were partially offset by additional payments relating to strategic investments and capital expenditures as we continue to grow our business.
Net cash provided by investing activities was $11.6 million for the three months ended September 30, 2021, as maturities and sales of marketable securities exceeded marketable security purchases during this period. These amounts were partially offset by a product acquisition of peripheral microcatheters and capital expenditures as we continued to grow our business.
Financing Activities
Net cash used in financing activities was $1.3 million and $5.0 million for the three months ended September 30, 2022 and 2021, respectively, primarily due to payment of payroll taxes on the employee vesting of stock awards.
Our future liquidity and capital requirements will be influenced by numerous factors, including the extent and duration of future operating losses, the level and timing of future sales and expenditures, the results and scope of ongoing research and product development programs, working capital required to support our business operations, the receipt of and time required to obtain regulatory clearances and approvals, our sales and marketing programs, the continuing acceptance of our products in the marketplace, competing technologies, market and regulatory developments, ongoing facility requirements, potential strategic transactions (including the potential acquisition of, or investments in, businesses, technologies and products), international expansion, the existence, defense and resolution of legal proceedings, and the severity and duration of the COVID-19 pandemic. As discussed in the "Overview" above, the total impact of disruptions from COVID-19 has had a material impact on our financial condition and results of operations, but once the pandemic subsides, we expect our U.S. business to improve. We will continue to closely monitor our liquidity and capital resources through the disruption caused by COVID-19 and will continue to evaluate our financial position to assess additional spending reductions and our liquidity needs. As of September 30,
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2022, we believe our current cash, cash equivalents and marketable securities will be sufficient to fund working capital requirements, including open purchase commitments, capital expenditures and operations for the foreseeable future, including at least the next twelve months, as well as to fund payments under our lease agreements, payments under development agreements and future payments relating to our asset acquisition of the WIRION embolic protection system. If needed, we have the ability to borrow under our senior, secured revolving credit facility. We intend to retain any future earnings to support operations and to finance the growth and development of our business. We do not anticipate paying any dividends in the foreseeable future.
Facility Sale and Lease
On December 29, 2016, we entered into a Purchase and Sale Agreement, as subsequently amended (collectively, the “Sale Agreement”), with Krishna Holdings, LLC (“Krishna”), providing for the sale to Krishna of our headquarters facility in St. Paul, Minnesota (the “Facility”) for a cash purchase price of $21.5 million. On March 30, 2017, the sale of the Facility under the Sale Agreement closed. We received proceeds of approximately $20.9 million ($21.5 million less $556,000 of transaction expenses). In connection with the closing of the facility sale, we entered into a Lease Agreement (the “Lease Agreement”) with Krishna Holdings, LLC, Apex Holdings, LLC, Kashi Associates, LLC, Keva Holdings, LLC, S&V Ventures, LLC, Polo Group LLC, SPAV Holdings LLC, Star Associates LLC, and The Global Villa, LLC. The Lease Agreement has an initial term of fifteen years, with four consecutive renewal options of five years each, with a base annual rent in the first year of $1.6 million and annual escalations of 3%. See Note 5 to our Consolidated Financial Statements included in Item 1 of Part I of this Quarterly Report on Form 10-Q for additional discussion.
Revolving Credit Facility
In March 2017, we entered into a Loan and Security Agreement (the “Loan Agreement”) with Silicon Valley Bank (“SVB”). In March 2020, we entered into the First Amendment to the Loan Agreement (the "Amendment"). The Amendment extended the maturity date of the Loan Agreement by two years, to March 31, 2022, and increased the maximum amount available under the senior, secured revolving credit facility (the "Revolver") to $50.0 million (the “Maximum Dollar Amount”). In March 2022, the Company entered into the Second Amendment to the Loan Agreement (the "Second Amendment"). The Second Amendment extended the maturity date of the Loan Agreement by one year, to March 31, 2023.
Advances under the Revolver may be made from time to time up to the Maximum Dollar Amount, subject to certain borrowing limitations. The Revolver bears interest at a floating per annum rate equal to the Wall Street Journal prime rate, less 0.75%. Interest on borrowings is due monthly and the principal balance is due at maturity. Upon the Revolver’s maturity, any outstanding principal balance, unpaid accrued interest, and all other obligations under the Revolver will be due and payable. We will incur a fee equal to 1.5% of the Maximum Dollar Amount upon termination of the Loan Agreement, as amended by the Second Amendment (the "Amended Loan Agreement"), or the Revolver for any reason prior to the date that is fifteen days prior to the maturity date, unless refinanced with SVB.
Our obligations under the Amended Loan Agreement are secured by certain of our assets, including, among other things, accounts receivable, deposit accounts, inventory, equipment, general intangibles and records pertaining to the foregoing. The collateral does not include our intellectual property, but we agreed not to encumber our intellectual property without the consent of SVB. The Amended Loan Agreement contains customary covenants limiting our ability to, among other things, incur debt or liens, make certain investments and loans, enter into transactions with affiliates, undergo certain fundamental changes, dispose of assets, or change the nature of our business. In addition, the Amended Loan Agreement contains financial covenants requiring us to maintain, at all times when any amounts are outstanding under the Revolver, either (i) minimum unrestricted cash at SVB and unused availability on the Revolver of at least $10.0 million or (ii) minimum trailing three-month Adjusted EBITDA (as defined in the Amended Loan Agreement) of $1.0 million. If we do not comply with the various covenants under the Amended Loan Agreement or an event of default under the Amended Loan Agreement occurs, such as a material adverse change, the interest rate on outstanding amounts will increase by 5% and SVB may, subject to various customary cure rights and the other terms and conditions of the Amended Loan Agreement, decline to provide additional advances under the Revolver, require the immediate payment of all amounts outstanding under the Revolver, and foreclose on all collateral.
We are required to pay a fee equal to 0.15% per annum on the unused portion of the Revolver, payable quarterly in arrears. We are not obligated to draw any funds under the Revolver and have not done so under the Revolver since entering into the Loan Agreement. No amounts were outstanding as of September 30, 2022 and we currently do not have plans to borrow under the Amended Loan Agreement.
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NON-GAAP FINANCIAL INFORMATION
To supplement our condensed consolidated financial statements prepared in accordance with GAAP, our management uses a non-GAAP financial measure referred to as “Adjusted EBITDA.” Reconciliations of this non-GAAP measure to the most comparable U.S. GAAP measure for the respective periods can be found in the following table. In addition, an explanation of the manner in which our management uses this measure to conduct and evaluate our business, the economic substance behind our management's decision to use this measure, the substantive reasons why our management believes that this measure provides useful information to investors, the material limitations associated with the use of this measure and the manner in which our management compensates for those limitations is included following the reconciliation table.
| Three Months Ended | |||||||||||
| September 30, | |||||||||||
| 2022 | 2021 | ||||||||||
| Net loss | $ | (10,631) | $ | (8,618) | |||||||
| Less: Other (income) expense, net | (252) | 367 | |||||||||
| Less: (Benefit) provision for income taxes | (19) | 136 | |||||||||
| Loss from operations | (10,902) | (8,115) | |||||||||
| Add: Stock-based compensation | 4,438 | 5,672 | |||||||||
| Add: Depreciation and amortization | 1,220 | 1,258 | |||||||||
| Adjusted EBITDA | $ | (5,244) | $ | (1,185) | |||||||
Adjusted EBITDA decreased for the three months ended September 30, 2022 as compared to the three months ended September 30, 2021 primarily due to a greater loss from operations in the current year.
Use and Economic Substance of Non-GAAP Financial Measures Used and Usefulness of Such Non-GAAP Financial Measures to Investors
We use Adjusted EBITDA as a supplemental measure of performance and believe this measure facilitates operating performance comparisons from period to period and company to company by factoring out potential differences caused by depreciation and amortization expense, and stock-based compensation. Our management uses Adjusted EBITDA to analyze the underlying trends in our business, assess the performance of our core operations, establish operational goals and forecasts that are used to allocate resources and evaluate our performance period over period and in relation to our competitors’ operating results. Additionally, our management is partially evaluated on the basis of Adjusted EBITDA when determining achievement of their incentive compensation performance targets. Management does not use this Adjusted EBITDA measure as a liquidity measure or in the calculation of our financial covenants under the revolving credit facility with Silicon Valley Bank.
We believe that presenting Adjusted EBITDA provides investors greater transparency to the information used by our management for its financial and operational decision-making and allows investors to see our results “through the eyes” of management. We also believe that providing this information better enables our investors to understand our operating performance and evaluate the methodology used by our management to evaluate and measure such performance.
The following is an explanation of each of the items that management excluded from Adjusted EBITDA and the reasons for excluding each of these individual items:
•Stock-based compensation. We exclude stock-based compensation expense from our non-GAAP financial measures primarily because such expense, while constituting an ongoing and recurring expense, is not an expense that requires cash settlement.
•Depreciation and amortization expense. We exclude depreciation and amortization expense from our non-GAAP financial measures primarily because such expenses, while constituting ongoing and recurring expenses, are not expenses that require cash settlement and are not used by our management to assess the core profitability of our business operations.
Our management also believes that excluding these above items from our non-GAAP results is useful to investors to understand our operational performance, liquidity and ability to make additional investments in our company.
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Material Limitations Associated with the Use of Non-GAAP Financial Measures and Manner in which We Compensate for these Limitations
Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for our financial results prepared in accordance with GAAP. Some of the limitations associated with our use of these non-GAAP financial measures are:
•Items such as stock-based compensation do not directly affect our cash flow position; however, such items reflect economic costs to us and are not reflected in our Adjusted EBITDA, and therefore these non-GAAP measures do not reflect the full economic effect of these items.
•Non-GAAP financial measures are not based on any comprehensive set of accounting rules or principles and therefore other companies may calculate similarly titled non-GAAP financial measures differently than we do, limiting the usefulness of those measures for comparative purposes.
•Our management exercises judgment in determining which types of charges or other items should be excluded from the non-GAAP financial measures we use. We compensate for these limitations by relying primarily upon our GAAP results and using non-GAAP financial measures only supplementally.
We provide detailed reconciliations of each non-GAAP measure to its most directly comparable GAAP measure. We encourage investors to review these reconciliations. We qualify our use of non-GAAP financial measures with cautionary statements as set forth above.
INFLATION
We do not believe that inflation had a material impact on our business and operating results during the periods presented.
RECENT ACCOUNTING PRONOUNCEMENTS
For a description of recent accounting pronouncements, see Note 1 to the Consolidated Financial Statements included in Item 8 of Part II of our Annual Report on Form 10-K for the year ended June 30, 2022.
PRIVATE SECURITIES LITIGATION REFORM ACT
The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Such “forward-looking” information is included in this Quarterly Report on Form 10-Q and in other materials filed or to be filed by us with the SEC (as well as information included in oral statements or other written statements made or to be made by us). Forward-looking statements include all statements based on future expectations. This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties, including, but not limited to, (i) our expectations regarding the impact of the COVID-19 pandemic on our operations; (ii) our expectation of continued sales of our products internationally, including the specific products to be sold, the territories in which such products will be sold, the timing of such sales, and whether such sales will be through distributors or directly by us; (iii) seasonality in our business; (iv) our expectation that we will resume growing revenue in the second quarter of fiscal 2023; (v) our expectation that we will incur selling, general and administrative expenses in the second quarter of fiscal 2023 that are slightly lower than the amounts incurred in the three months ended September 30, 2022; (vi) our expectation that gross margin in the second quarter of fiscal 2023 will be higher than the gross margin in the three months ended September 30, 2022; (vii) our expectation that we will incur research and development expenses in the second quarter of fiscal 2023 that are higher than the amounts incurred in the three months ended September 30, 2022; (viii) our belief that our current cash and cash equivalents will be sufficient to fund working capital requirements, capital expenditures and operations for the foreseeable future, as well as to fund certain other anticipated expenses; (ix) our intention to retain any future earnings to support operations and to finance the growth and development of our business; (x) our dividend expectations; (xi) our plan not to borrow under our loan and security agreement; and (xii) the anticipated impact of adoption of recent accounting pronouncements on our financial statements.
In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are only predictions and are not guarantees of performance. These statements are based on our management’s beliefs and assumptions, which in turn are based on their interpretation of currently available information.
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These statements involve known and unknown risks, uncertainties and other factors that may cause our results or our industry’s actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These factors include the ongoing COVID-19 pandemic and the impact and scope thereof on us, our distribution partners, the supply chain and physicians and facilities, including government actions related to the COVID-19 outbreak, material delays and cancellations of procedures, delayed spending by healthcare providers, and distributor and supply chain disruptions; regulatory developments, clearances and approvals; approval of our products for distribution outside of the United States; approval of products for reimbursement and the level of reimbursement in the U.S. and foreign countries; dependence on market growth; agreements with third parties to sell their products; the ability of us and our distribution partners to successfully launch our products outside of the United States; our ability to maintain third-party supplier relationships and renew existing purchase agreements; our ability to maintain our relationships and agreements with distribution partners; the experience of physicians regarding the effectiveness and reliability of the products we sell; the reluctance of physicians, hospitals and other organizations to accept new products; the potential for unanticipated delays in enrolling medical centers and patients for clinical trials; actual clinical trial and study results; the impact of competitive products and pricing; our ability to comply with the financial covenants in our loan and security agreement and to make payments under and comply with the lease agreement for our corporate headquarters; unanticipated developments affecting our estimates regarding expenses, future revenues and capital requirements; the difficulty of successfully managing operating costs; our ability to manage our sales force strategy; actual research and development efforts and needs, including the timing of product development programs; successful collaboration on the development of new products; agreements with development partners, advisors and other third parties; the ability of us and these third parties to meet developmental, contractual and other milestones; contractual rights and obligations; technical challenges; our ability to obtain and maintain intellectual property protection for product candidates; fluctuations in results and expenses based on new product introductions, sales mix, unanticipated warranty claims, and the timing of project expenditures; our ability to manage costs; our actual financial resources and our ability to obtain additional financing; investigations or litigation threatened or initiated against us; court rulings and future actions by the FDA and other regulatory bodies; international trade developments; the effects of hurricanes, flooding, and other natural disasters on our business; the impact of federal corporate tax reform on our business, operations and financial statements; shutdowns of the U.S. federal government; the potential impact of any future strategic transactions; and general economic conditions.
These and additional risks and uncertainties are described more fully in our Annual Report on Form 10-K for the year ended June 30, 2022 and subsequent Quarterly Reports on Form 10-Q, including in Item 1A of Part II of this Quarterly Report on Form 10-Q. Copies of filings made with the SEC are available through the SEC’s electronic data gathering analysis and retrieval system (EDGAR) at www.sec.gov.
You should read these risk factors and the other cautionary statements made in this Quarterly Report on Form 10-Q as being applicable to all related forward-looking statements wherever they appear in this Quarterly Report on Form 10-Q. We cannot assure you that the forward-looking statements in this Quarterly Report on Form 10-Q will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should read this Quarterly Report on Form 10-Q completely. Other than as required by law, we undertake no obligation to update these forward-looking statements, even though our situation may change in the future.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Other than the negative impact the COVID-19 pandemic has had and will continue to have on our business and results of operations as discussed elsewhere in this Quarterly Report on Form 10-Q, there have been no material changes in our primary risk exposures or management of market risks from those disclosed in our Annual Report on Form 10-K for the year ended June 30, 2022.
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ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our Chief Executive Officer and Chief Financial Officer, referred to collectively herein as the Certifying Officers, are responsible for establishing and maintaining our disclosure controls and procedures. The Certifying Officers have reviewed and evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of September 30, 2022. Based on that review and evaluation, which included inquiries made to certain other of our employees, the Certifying Officers have concluded that, as of the end of the period covered by this report, our disclosure controls and procedures, as designed and implemented, are effective.
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 three months ended September 30, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. — OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 1A. RISK FACTORS
In addition to the other information set forth in this Quarterly Report on Form 10-Q, including the important information in the section entitled “Private Securities Litigation Reform Act,” you should carefully consider the “Risk Factors” in our Annual Report on Form 10-K for the year ended June 30, 2022 for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in this Quarterly Report on Form 10-Q and materially adversely affect our business, financial condition and/or future operating results. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also might materially adversely affect our business, financial condition and/or operating results.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Company Repurchases of Equity Securities
The following table presents information with respect to purchases made by us of our common stock during the first quarter of fiscal 2023:
| Total Number of Shares Purchased | Average Price Paid per Share | Total Number of Shares Purchased as part of Publicly Announced Plans or Programs | Approximate Dollar Value of Shares that May Yet Be Purchased under the Plan or Programs | ||||||||||||||||||||
July 1 to July 31, 2022(1) | 7,094 | $ | 15.18 | N/A | N/A | ||||||||||||||||||
August 1 to August 31, 2022(1) | 65,434 | 16.64 | N/A | N/A | |||||||||||||||||||
| September 1 to September 30, 2022 | — | — | N/A | N/A | |||||||||||||||||||
| 72,528 | $ | 16.50 | |||||||||||||||||||||
(1) Comprised of shares withheld pursuant to the terms of restricted stock awards under our stock-based compensation plans to offset tax withholding obligations that occur upon vesting and release of shares. The value of the shares withheld is the closing price of our common stock on the date the relevant transaction occurs.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
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ITEM 4. MINE SAFETY DISCLOSURES
None.
ITEM 5. OTHER INFORMATION
None.
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ITEM 6. EXHIBITS
| Exhibit No. | Description | |||||||
| 31.1* | ||||||||
| 31.2* | ||||||||
| 32.1** | ||||||||
| 32.2** | ||||||||
| 101* | Financial statements from the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2022, formatted in Inline XBRL: (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations, (iii) the Consolidated Statements of Comprehensive Income, (iv) the Consolidated Statements of Changes in Stockholders’ Equity, (v) the Consolidated Statements of Cash Flows, and (vi) the Notes to Financial Statements. | |||||||
| 104* | Cover page interactive data file (formatted in Inline XBRL and contained in Exhibit 101). | |||||||
_______________________
* Filed herewith.
** Furnished herewith.
† Compensatory plan or agreement.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.
Dated: November 3, 2022 | CARDIOVASCULAR SYSTEMS, INC. | ||||||||||
| By | /s/ Scott R. Ward | ||||||||||
| Scott R. Ward | |||||||||||
| Chairman, President and Chief Executive Officer | |||||||||||
| (Principal Executive Officer) | |||||||||||
| By | /s/ Jeffrey S. Points | ||||||||||
| Jeffrey S. Points | |||||||||||
| Chief Financial Officer | |||||||||||
| (Principal Financial and Accounting Officer) | |||||||||||
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