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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, 2021
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 November 5, 2021 was: 40,550,660 shares.



Cardiovascular Systems, Inc.
Table of Contents
 
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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,
2021
June 30,
2021
ASSETS
Current assets
Cash and cash equivalents $ 66,864  $ 71,070 
Marketable securities 120,753  135,968 
Accounts receivable, net 36,449  40,033 
Inventories 33,127  32,313 
Prepaid expenses and other current assets 5,944  5,285 
Total current assets 263,137  284,669 
Property and equipment, net 28,788  28,894 
Intangible assets, net 16,772  15,376 
Other assets 23,573  23,628 
Total assets $ 332,270  $ 352,567 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable $ 12,911  $ 14,061 
Accrued expenses 27,639  38,189 
Deferred revenue 2,488  2,400 
Total current liabilities 43,038  54,650 
Long-term liabilities
Financing obligation 20,527  20,596 
Deferred revenue 1,568  2,194 
Other liabilities 3,945  4,169 
Total liabilities 69,078  81,609 
Commitments and contingencies (see Note 10)
Common stock, $0.001 par value; authorized 100,000,000 common shares; issued and outstanding 40,581,871 at September 30, 2021 and 40,215,554 at June 30, 2021, respectively
39  39 
Additional paid in capital 658,147  652,288 
Accumulated other comprehensive income (6) 11 
Accumulated deficit (394,988) (381,380)
Total stockholders’ equity 263,192  270,958 
Total liabilities and stockholders’ equity $ 332,270  $ 352,567 
The accompanying notes are an integral part of these unaudited consolidated financial statements.

3

Cardiovascular Systems, Inc.
Consolidated Statements of Operations
(Dollars in thousands, except per share and share amounts)
(Unaudited)
 
  Three Months Ended
September 30,
  2021 2020
Net revenues $ 58,370  $ 60,544 
Cost of goods sold 14,308  12,564 
Gross profit 44,062  47,980 
Expenses:
Selling, general and administrative 41,851  40,282 
Research and development 10,022  9,052 
Amortization of intangible assets 304  304 
Total expenses 52,177  49,638 
Loss from operations (8,115) (1,658)
Other (income) expense, net:
Interest expense 410  499 
Interest income and other, net (43) (144)
Total other (income) expense, net 367  355 
Loss before income taxes (8,482) (2,013)
Provision for income taxes 136  63 
Net loss $ (8,618) $ (2,076)
Basic and diluted earnings per share $ (0.22) $ (0.05)
Basic and diluted weighted average shares outstanding 39,087,472  38,683,839 
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,
2021 2020
Net loss $ (8,618) $ (2,076)
Other comprehensive loss:
Unrealized loss on available-for-sale debt securities (17) (69)
Comprehensive loss $ (8,635) $ (2,145)
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, 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.













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, 2020 39  631,559  269  (363,075) 268,792 
Stock-based compensation related to restricted stock awards, net —  4,836  —  —  4,836 
Shares withheld for payroll taxes —  —  —  (3,410) (3,410)
Employee stock purchase plan activity —  332  —  —  332 
Unrealized loss on available-for-sale debt securities —  —  (69) —  (69)
Net loss —  —  —  (2,076) (2,076)
Balances at September 30, 2020 $ 39  $ 636,727  $ 200  $ (368,561) $ 268,405 

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,
  2021 2020
Cash flows from operating activities
Net loss $ (8,618) $ (2,076)
Adjustments to reconcile net loss to net cash from operating activities
Depreciation of property and equipment 954  725 
Amortization of intangible assets 304  304 
Stock-based compensation 5,672  4,907 
Amortization of premium (accretion of discount) on marketable securities 380  215 
Other — 
Changes in assets and liabilities
Accounts receivable 3,584  (4,761)
Inventories (814) (1,446)
Prepaid expenses and other assets 28  (386)
Accounts payable (895) 1,865 
Accrued expenses and other liabilities (10,846) (1,126)
Deferred revenue (538) (383)
Net cash used in operating activities (10,784) (2,162)
Cash flows from investing activities
Purchases of property and equipment (1,103) (1,132)
Acquisitions (1,700) — 
Investments in strategic ventures (50) (2,175)
Purchases of marketable securities (38,462) (88,728)
Sales of marketable securities 6,721  2,400 
Maturities of marketable securities 46,200  2,450 
Net cash provided by (used in) investing activities 11,606  (87,185)
Cash flows from financing activities
Payments of employee taxes related to vested restricted stock (4,990) (3,410)
Exercise of stock options 12  — 
Principal payments made on financing obligation (50) (35)
Net cash used in financing activities (5,028) (3,445)
Net change in cash and cash equivalents (4,206) (92,792)
Cash and cash equivalents
Beginning of period 71,070  185,463 
End of period $ 66,864  $ 92,671 
The accompanying notes are an integral part of these unaudited consolidated financial statements.
8

CARDIOVASCULAR SYSTEMS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(For the Three Months Ended September 30, 2021 and 2020)
(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, 2021. 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,
2021 2021
Accounts receivable $ 37,917  $ 41,634 
Less: Allowance for doubtful accounts (1,468) (1,601)
   Accounts receivable, net $ 36,449  $ 40,033 


9

Inventories

Inventories consist of the following:
September 30, June 30,
2021 2021
Raw materials $ 10,688  $ 11,621 
Work in process 3,682  3,469 
Finished goods 18,757  17,223 
   Inventories $ 33,127  $ 32,313 


Property and Equipment, Net

Property and equipment consists of the following:
September 30, June 30,
2021 2021
Land $ 572  $ 572 
Building 22,420  22,420 
Equipment 21,966  21,203 
Furniture 3,376  3,376 
Leasehold improvements 804  804 
Construction in progress 2,269  2,848 
51,407  51,223 
Less: Accumulated depreciation (22,619) (22,329)
Property and equipment, net $ 28,788  $ 28,894 

Accrued Expenses

Accrued expenses consist of the following:
September 30, June 30,
2021 2021
Acquisition consideration $ 10,000  $ 10,000 
Commissions 4,350  7,869 
Salaries and bonus 3,813  11,699 
Accrued vacation 2,495  3,011 
Clinical Studies 1,511  1,478 
Accrued excise, sales and other taxes 1,330  1,464 
Other accrued expenses 4,140  2,668 
Accrued expenses $ 27,639  $ 38,189 



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 2021 2020
Peripheral $ 39,009  $ 42,932 
Coronary 19,361  17,612 
Total net revenues $ 58,370  $ 60,544 
Geography
United States $ 55,042  $ 58,831 
International 3,328  1,713 
Total net revenues $ 58,370  $ 60,544 

Revenue of $538 was recognized in the three months ended September 30, 2021 that was deferred as of June 30, 2021. As of September 30, 2021 and June 30, 2021, the Company had a liability of $1,805 and $1,985, respectively, related to estimates of variable consideration which are recorded within accounts payable on the consolidated balance sheet.

4. Acquisitions

Peripheral Support Catheters

During fiscal 2021, the Company acquired a line of peripheral support catheters from WavePoint Medical, LLC (“WavePoint”) and also engaged WavePoint to develop a portfolio of specialty catheters.

The acquisition of peripheral support catheters was accounted for as an asset acquisition. As consideration in this transaction, the Company made an upfront payment of $3,353 to WavePoint which was accounted for as a charge incurred in connection with acquired in process research and development ("IPR&D"). During the three months ended September 30, 2021, the peripheral support catheters received 510(k) clearance and the Company made an additional $1,700 payment to WavePoint which was capitalized as developed technology.

5. 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 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, 2021 June 30, 2021
Gross Carrying Amount Accumulated Amortization Net Book Value Gross Carrying Amount Accumulated Amortization Net Book Value
Developed technology $ 17,324  $ (2,257) $ 15,067  $ 15,624  $ (1,997) $ 13,627 
Patents 1,866  (811) 1,055  1,866  (780) 1,086 
Trade name 760  (110) 650  760  (97) 663 
Total intangible assets, net $ 19,950  $ (3,178) $ 16,772  $ 18,250  $ (2,874) $ 15,376 


11

Amortization expense expected for the next five years and thereafter is as follows:
Remainder of fiscal 2022 $ 1,038 
Fiscal 2023 1,381 
Fiscal 2024 1,377 
Fiscal 2025 1,374 
Fiscal 2026 1,373 
Thereafter 10,229 
$ 16,772 

6. 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”).

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 3% of the Maximum Dollar Amount upon termination of the Loan Agreement, as amended by the 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, 2021.

Financing Obligation

In March 2017, 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
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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.

Payments under the initial term of the Lease Agreement as of September 30, 2021 are as follows:
Remainder of fiscal 2022 $ 1,396 
Fiscal 2023 1,913 
Fiscal 2024 1,970 
Fiscal 2025 2,029 
Fiscal 2026 2,090 
Thereafter 13,286 
$ 22,684 

7. Marketable Securities & Fair Value Measurements

The Company’s marketable securities are classified on the consolidated balance sheet as follows:
September 30, June 30,
2021 2021
Short-term available-for-sale debt securities $ 118,294  $ 129,908 
Long-term available-for-sale debt securities 2,132  5,748 
Available-for-sale debt securities 120,426  135,656 
Mutual funds 327  312 
Total marketable securities $ 120,753  $ 135,968 



Available-for-sale debt securities are invested in the following financial instruments:
As of September 30, 2021
Amortized Cost Unrealized Gains Unrealized Losses Fair Value
Commercial paper $ 47,364  $ —  $ —  $ 47,364 
Corporate debt 54,228  (9) 54,221 
Asset backed securities 18,840  (5) 18,841 
  Total available-for-sale debt securities $ 120,432  $ $ (14) $ 120,426 

As of June 30, 2021
Amortized Cost Unrealized Gains Unrealized Losses Fair Value
Commercial paper $ 47,361  $ —  $ —  $ 47,361 
U.S. government securities 20,229  —  20,230 
Corporate debt 57,134  12  (12) 57,134 
Asset backed securities 10,922  10  (1) 10,931 
Total available-for-sale debt securities $ 135,646  $ 23  $ (13) $ 135,656 


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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, 2021
Using Inputs Considered as
Fair Value Level 1 Level 2 Level 3
Commercial paper $ 47,364  $ —  $ 47,364  $ — 
Corporate debt 54,221  —  54,221  — 
Asset backed securities 18,841  —  18,841  — 
Mutual funds 327  150  177  — 
  Total marketable securities $ 120,753  $ 150  $ 120,603  $ — 
Fair Value Measurements as of June 30, 2021
Using Inputs Considered as
Fair Value Level 1 Level 2 Level 3
Commercial paper $ 47,361  $ —  $ 47,361  $ — 
U.S. government securities 20,230  —  20,230  — 
Corporate debt 57,134  —  57,134  — 
Asset backed securities 10,931  —  10,931  — 
Mutual funds 312  136  176  — 
  Total marketable securities $ 135,968  $ 136  $ 135,832  $ — 

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, 2021. 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, 2021 and June 30, 2021, the carrying value of these investments was $12,484 and $12,458, respectively. During the three months ended September 30, 2021, no impairment indicators were noted. The Company is committed to funding an additional $1,710 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. These investments are recorded within other assets on the consolidated balance sheet.

The Company also holds strategic investments accounted for as available-for-sale debt securities, which had carrying values and approximated fair values of $8,218 and $8,199 as of September 30, 2021 and June 30, 2021, respectively. These investments are recorded within other assets on the consolidated balance sheet. 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, 2021.

8. 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.

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
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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, 2021 is as follows:
Number of
Shares
Weighted
Average  Fair
Value
Outstanding at June 30, 2021 467,942  $ 35.61 
Granted 274,733  $ 38.02 
Forfeited (8,306) $ 35.17 
Vested (192,316) $ 36.91 
Outstanding at September 30, 2021
542,053  $ 36.37 

Performance-Based Restricted Stock

The Company also grants performance-based restricted stock awards to certain executives and other management. In August 2021, the Company granted an aggregate maximum of 306,550 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, 2021 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. 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, 2024 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 $6,090, 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 2021 and 2020 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, 2020 and July 1, 2019, 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, 2023 and July 1, 2022, respectively.

Performance-based restricted stock award activity for the three months ended September 30, 2021 is as follows:
Number of
Shares
Weighted
Average  Fair
Value
Outstanding at June 30, 2021 760,584  $ 20.26 
Granted 306,550  $ 19.87 
Forfeited (73,234) $ 21.99 
Vested (147,001) $ 22.33 
Outstanding at September 30, 2021
846,899  $ 19.40 

Unrecognized stock compensation related to unvested stock awards outstanding as of September 30, 2021 was $26,041.

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9. 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 April 2024. As discussed in Note 6, 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 $128 and $126 for the three months ended September 30, 2021 and 2020, respectively. Cash paid for operating lease liabilities approximated operating lease cost for the three months ended September 30, 2021. There were $54 and $2,238 of operating lease right-of-use assets obtained in exchange for new lease liabilities during the three months ended September 30, 2021 and 2020, respectively.
September 30, June 30,
2021 2020
Right-of-use assets
Other assets $ 2,152  $ 2,212 
Operating lease liabilities
Accrued expenses 511  487 
Other liabilities 1,641  1,725 
Total operating lease liabilities $ 2,152  $ 2,212 

Future minimum lease payments under the agreements as of September 30, 2021 are as follows:
Remainder of fiscal 2022 $ 515 
Fiscal 2023 514 
Fiscal 2024 489 
Fiscal 2025 483 
Fiscal 2026 403 
Thereafter — 
Total lease payments 2,404 
Less imputed interest (252)
Total operating lease liabilities $ 2,152 

As of September 30, 2021, the weighted average remaining lease term for operating leases was 4.5 years and the weighted average discount rate used to determine operating lease liabilities was 2.51%.

10. 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 and commercial disputes. While the outcome of these matters is uncertain, the Company does not believe there are any significant matters as of September 30, 2021 that are probable or estimable, for which the outcome could have a material adverse impact on its consolidated balance sheets or statements of operations.

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11. 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,
  2021 2020
Numerator
Net loss $ (8,618) $ (2,076)
Income allocated to participating securities —  — 
Net loss available to common stockholders $ (8,618) $ (2,076)
Denominator
Weighted average common shares outstanding – basic 39,087,472  38,683,839 
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
39,087,472  38,683,839 
Earnings per common share – basic and diluted $ (0.22) $ (0.05)

(1)At September 30, 2021 and 2020, 83,834 and 42,528 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, 2021 and 2020, 313,275 and 279,019 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, 2021 and 2020, 846,899 and 761,382 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, 2021 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 this difficult disease state. 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.

In the past, 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 quarter ending June 30 representing the highest volume of cases and, therefore, the highest amount of revenue generated by us during the course of the fiscal year. While we did not experience this same pattern of seasonality in the three months ended September 30, 2020 due to the significant decrease in procedure volumes in the quarter ended June 30, 2020 due to the COVID-19 pandemic, we did experience this pattern of seasonality in the three months ended September 30, 2021, compared to the three months ended June 30, 2021. The three months ended June 30, 2021 benefited from a recovery from the COVID-19 pandemic, and the volume of procedures involving our products in the three months ended September 30, 2021 was adversely impacted primarily by hospital capacity constraints due to increased hospitalizations caused by the COVID-19 Delta variant, as well as disruption of referral patterns, deferral of elective procedures, staffing shortages and heightened summer seasonality in the quarter.

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, 2021. 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, 2021 represented 66% 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.

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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, 2021 represented approximately 28% of revenue.

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"). Sales of our products in the rest of the world, which primarily includes certain countries in Southeast Asia, Europe and the Middle East, are made through a network of distributors and sales agents. International sales during the three months ended September 30, 2021 represented approximately 6% 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 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. For example, enrollment in our ECLIPSE clinical trial was paused for several months. Other disruptions included restrictions on the ability of our personnel and personnel of our distribution partners to travel; delays in approvals by regulatory bodies; delays in product development efforts, which has also disrupted or delayed our ability to launch affected products; 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; disruptions in our relationships with our distributors due to the impact of the COVID-19 pandemic on their operations; temporary closures of our facilities; loss of employee productivity; and additional government requirements to “shelter at home” or other incremental mitigation efforts that may further impact our capacity to manufacture, sell and support the use of our products.

Throughout the pandemic, we have operated our manufacturing facilities and continued to ship product. Most of our office-based employees telecommuted, and our field employees continued to support cases in clinical settings where they were able to have access. We took 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.

We are monitoring the spread of variants, including the Delta variant, and continue to track hospitalizations resulting from these variants. 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.

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.

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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, 2021 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,
2021 2020 Percent
Change
Net revenues $ 58,370  $ 60,544  (3.6) %
Cost of goods sold 14,308  12,564  13.9 
Gross profit 44,062  47,980  (8.2)
Expenses:
Selling, general and administrative 41,851  40,282  3.9 
Research and development 10,022  9,052  10.7 
Amortization of intangible assets 304  304  — 
Total expenses 52,177  49,638  5.1 
Loss from operations (8,115) (1,658) 389.4 
Other (income) expense, net 367  355  3.4 
Loss before income taxes (8,482) (2,013) 321.4 
Provision for income taxes 136  63  115.9 
Net loss $ (8,618) $ (2,076) 315.1 


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Comparison of Three Months Ended September 30, 2021 with Three Months Ended September 30, 2020

Net revenues. Net revenues decreased by $2.1 million, or 3.6%, from $60.5 million for the three months ended September 30, 2020 to $58.4 million for the three months ended September 30, 2021. U.S. peripheral revenues decreased $4.1 million, or 9.4%, while U.S. coronary revenues increased $265,000, or 1.7%. The impact of the Delta variant of the SARS-CoV-2 virus had an impact on both therapies, especially within the hospital setting. Contributing factors to the decreased case volumes from the Delta variant were disruptions of referral patterns, deferrals of elective procedures, staffing shortages and heightened summer seasonality in the quarter ended September 30, 2021. We have also been affected by an increasingly competitive environment, although to a lesser extent than COVID-19. Increased revenue from new product launches and increased customer adoption of interventional support products partially offset the revenue declines from decreased case volumes in the peripheral franchise, while these factors fully offset decreased case volumes in the coronary franchise. International revenue was $3.3 million for the three months ended September 30, 2021, compared with international revenue of $1.7 million for the three months ended September 30, 2020. Although international sales were also impacted by the ongoing COVID-19 pandemic, increases in international sales were driven by Coronary OAS sales in Europe, a stronger recovery in Japan and the Asia Pacific region, and the commencement of sales into Canada. In the second quarter of fiscal 2022, we expect our revenue will continue to be impacted by the COVID-19 pandemic's effect on case volumes, but to a lesser degree than the three months ended September 30, 2021. Longer-term we expect revenue growth to return to recently observed normal levels driven by increasing the number of physicians using the devices; increasing the usage per physician; introducing new and improved products; generating additional clinical data; and continuing expansion into new geographies, partially offset by potential decreases in average selling prices.

Cost of Goods Sold. Cost of goods sold was $14.3 million for the three months ended September 30, 2021, an increase of 13.9% from $12.6 million for the three months ended September 30, 2020. 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 75.5% for the three months ended September 30, 2021 from 79.2% for the three months ended September 30, 2020, primarily due to increased sales of lower margin products. We expect that gross margin in the second quarter of fiscal 2022 will be similar to the gross margin in the three months ended September 30, 2021 due to a continued shift of sales mix into interventional support products and international markets in addition to declining average selling prices. Quarterly margin fluctuations could also occur based on production volumes, timing of new product introductions, sales mix, pricing changes, or other unanticipated circumstances.

Selling, General and Administrative Expenses. Our selling, general and administrative expenses were $41.9 million for the three months ended September 30, 2021, an increase of 3.9% from $40.3 million for the three months ended September 30, 2020. SG&A expense increases were led by costs associated with new product introductions and the resumption of travel-related expenditures due to increased live meetings and tradeshows, in addition to annual salary increases for our employees. These increases were partially offset by reduced commission expenses due to lower sales in the current year period. Selling, general and administrative expenses for the three months ended September 30, 2021 and 2020 include $4.5 million and $3.9 million, respectively, for stock-based compensation. We expect our selling, general and administrative expenses for the second quarter of fiscal 2022 to be greater than amounts incurred for the three months ended September 30, 2021.

Research and Development Expenses. Research and development expenses increased by 10.7%, from $9.1 million for the three months ended September 30, 2020 to $10.0 million for the three months ended September 30, 2021. 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, and to clinical trials. The increase was due to increased costs on the ECLIPSE clinical trial resulting from an increase in enrollments compared to the paused enrollment status in the prior year period. We expect a similar level of research and development expense in the second quarter of fiscal 2022 to what we incurred during the three months ended September 30, 2021. Quarterly fluctuations could occur based on the number of projects and studies, the progress of such projects and studies, the rate of study enrollment, acquisitions of IPR&D 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 $187.6 million and $207.0 million at September 30, 2021 and June 30, 2021, respectively. As of September 30, 2021, we had an accumulated deficit of $395.0 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,
2021 2020
Net cash used in operating activities $ (10,784) $ (2,162)
Net cash provided by (used in) investing activities 11,606  (87,185)
Net cash used in financing activities (5,028) (3,445)
Net change in cash and cash equivalents $ (4,206) $ (92,792)

Changes in Liquidity

Operating Activities

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.

Net cash used in operating activities was $2.2 million for the three months ended September 30, 2020, primarily due to the net loss of $2.1 million, an increase in receivables as we experienced a recovery in our sales volumes, and increased uses of cash to build inventory and diversify our products, as well as for payouts of previously accrued bonuses and commissions. The amount of cash used was partially offset by increased accounts payable due to timing of activity and payments, and non-cash expenditures for the three months ended September 30, 2020.

Investing Activities

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 in the three months ended September 30, 2021. These amounts were partially offset by a product acquisition of peripheral microcatheters and capital expenditures as we continue to grow our business.

Net cash provided by investing activities was $87.2 million for the three months ended September 30, 2020, primarily due to investing cash from our June 2020 equity offering into marketable securities. We also deployed cash into strategic investments and capital expenditures as we continue to grow our business. These uses of cash were partially offset by maturities and sales of marketable securities.

Financing Activities

Net cash used in financing activities was $5.0 million and $3.4 million for the three months ended September 30, 2021 and 2020, respectively, primarily due to the 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 return to a
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more normalized pre-pandemic level of operations and activity. 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, 2021, 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 6 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”).

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 3% of the Maximum Dollar Amount upon termination of the Loan Agreement, as amended by the 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, 2021 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,
  2021 2020
Net loss $ (8,618) $ (2,076)
Less: Other (income) expense, net 367  355 
Less: Provision for income taxes 136  63 
Loss from operations (8,115) (1,658)
Add: Stock-based compensation 5,672  4,907 
Add: Depreciation and amortization 1,258  1,029 
Adjusted EBITDA $ (1,185) $ 4,278 

Adjusted EBITDA decreased for the three months ended September 30, 2021 as compared to the three months ended September 30, 2020 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, stock-based compensation and IPR&D charges. 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.

IPR&D charges incurred in connection with asset acquisitions. We exclude charges incurred in connection with acquired IPR&D in asset acquisitions from our non-GAAP financial measures given the one-time nature of such
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expense, which is not used by our management to assess the core profitability of our business operations. There may be fiscal periods where we do not incur these charges and therefore they may not be included within the table above.

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.

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.

OFF-BALANCE SHEET ARRANGEMENTS

Since inception, we have not engaged in any off-balance sheet activities as defined in Item 303(a)(4) of Regulation S-K.

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, 2021.

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 our revenue will continue to be impacted by the COVID-19 pandemic during our second quarter, and that our revenue growth will return to recently observed normal levels longer-term; (v) our expectation that we will incur selling, general and administrative expenses in the second quarter of fiscal 2022 that are higher than the amounts incurred in the three months ended September 30, 2021; (vi) our expectation that gross margin in the second quarter of fiscal 2022 will be similar to the gross margin in the three months ended September 30, 2021; (vii) our expectation that we will incur research and development expenses in the second quarter of fiscal 2022 that are similar to amounts incurred in the three months ended September 30, 2021; (viii) our expectation that we will commercialize our newly acquired line of peripheral microcatheters in our fiscal 2022; (ix) our belief that our current cash and
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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; (x) our intention to retain any future earnings to support operations and to finance the growth and development of our business; (xi) our dividend expectations; (xii) our plan not to borrow under our loan and security agreement; and (xiii) 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.

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., Japan and other 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 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; 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, 2021 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, 2021.


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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, 2021. 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, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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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, 2021 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 2022:
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, 2021 —  —  N/A N/A
August 1 to August 31, 2021(1)
138,325  $ 36.08  N/A N/A
September 1 to September 30, 2021 —  —  N/A N/A
138,325  $ 36.08 
(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.

ITEM 4.    MINE SAFETY DISCLOSURES

None.

ITEM 5.    OTHER INFORMATION

As described in our Form 10-K filed on August 19, 2021, the term of our Corporate Integrity Agreement (the “CIA”) with the Office of Inspector General of the Department of Health and Human Services (the “OIG”) expired on June 27, 2021. We submitted a final report under the CIA to the OIG on August 25, 2021. On September 27, 2021, we received a letter from the OIG confirming that the CIA has been closed.



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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, 2021, 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.
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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 9, 2021
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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