UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
OR
For the transition period from to .
Commission File Number
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(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to filing requirements for the past 90 days.
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Indicate the number of shares outstanding of each of the Registrant’s classes of common stock, as of the latest practicable date.
Common Stock, no par value |
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TABLE OF CONTENTS
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Management’s Discussion and Analysis of Financial Condition and Results of Operations | 32 | ||||
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PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(In thousands)
| June 30, |
| December 31, | |||
ASSETS |
| 2024 |
| 2023 | ||
(unaudited) | ||||||
Current assets: |
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Cash and cash equivalents | $ | | $ | | ||
Trade receivables — net of allowance for credit losses — 2024 — $ |
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Other receivables |
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Inventories |
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Prepaid expenses and other current assets |
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Prepaid income taxes |
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Income tax refund receivables |
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Total current assets |
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Property and equipment: |
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Land and land improvements |
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Buildings |
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Manufacturing equipment |
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Furniture and fixtures |
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Leasehold improvements |
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Construction-in-progress |
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Total property and equipment |
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Less accumulated depreciation |
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Property and equipment — net |
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Other assets: |
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Intangible assets: |
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Developed technology — net of accumulated amortization — 2024 — $ |
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Other — net of accumulated amortization — 2024 — $ |
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Goodwill |
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Deferred income tax assets |
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Right-of-use operating lease assets | | | ||||
Other assets |
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Total other assets |
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Total assets | $ | | $ | |
See condensed notes to consolidated financial statements. | (continued) |
3
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(In thousands)
| June 30, |
| December 31, | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
| 2024 |
| 2023 | ||
(unaudited) | ||||||
Current liabilities: |
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Trade payables | $ | | $ | | ||
Accrued expenses |
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Short-term operating lease liabilities | | | ||||
Income taxes payable |
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Total current liabilities |
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Long-term debt |
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Deferred income tax liabilities |
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Long-term income taxes payable |
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Liabilities related to unrecognized tax benefits |
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Deferred compensation payable |
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Deferred credits |
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Long-term operating lease liabilities | |
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Other long-term obligations |
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Total liabilities |
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Commitments and contingencies |
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Stockholders' equity: |
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Preferred stock — |
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Common stock, |
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Retained earnings |
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Accumulated other comprehensive loss |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | | $ | |
See condensed notes to consolidated financial statements. | (concluded) |
4
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(In thousands, except per share amounts - unaudited)
| Three Months Ended |
| Six Months Ended | ||||||||||
June 30, | June 30, | ||||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | ||||||
Net sales | $ | | $ | | $ | | $ | | |||||
Cost of sales |
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Gross profit |
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Operating expenses: |
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Selling, general and administrative |
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Research and development |
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Impairment charges |
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Contingent consideration expense |
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Acquired in-process research and development |
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Total operating expenses |
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Income from operations |
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Other income (expense): |
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Interest income |
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Interest expense |
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Other income (expense) — net |
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Total other expense — net |
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Income before income taxes |
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Income tax expense |
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Net income | $ | | $ | | $ | | $ | | |||||
Earnings per common share |
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Basic | $ | | $ | | $ | | $ | | |||||
Diluted | $ | | $ | | $ | | $ | | |||||
Weighted average shares outstanding |
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Basic |
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Diluted |
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See condensed notes to consolidated financial statements.
5
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In thousands - unaudited)
| Three Months Ended |
| Six Months Ended | ||||||||||
June 30, | June 30, | ||||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | ||||||
Net income | $ | | $ | | $ | | $ | | |||||
Other comprehensive income (loss): |
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Cash flow hedges |
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Income tax benefit (expense) |
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Foreign currency translation adjustment |
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Income tax benefit (expense) |
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Total other comprehensive income (loss) |
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Total comprehensive income | $ | | $ | | $ | | $ | |
See condensed notes to consolidated financial statements.
6
MERIT MEDICAL SYSTEMS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In thousands - unaudited)
Common Stock | Retained | Accumulated Other | ||||||||||||
| Shares |
| Amount |
| Earnings |
| Comprehensive Loss |
| Total | |||||
Balance — January 1, 2024 |
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Net income |
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Other comprehensive loss |
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Stock-based compensation expense |
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Options exercised |
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Issuance of common stock under Employee Stock Purchase Plan |
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Shares issued from time-vested restricted stock units | | — | — | |||||||||||
Shares surrendered in exchange for payment of payroll tax liabilities |
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Balance — March 31, 2024 |
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Net income |
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Other comprehensive loss |
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Stock-based compensation expense |
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Options exercised |
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Issuance of common stock under Employee Stock Purchase Plan |
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Shares issued from time-vested restricted stock units | | — | — | |||||||||||
Balance — June 30, 2024 |
| | $ | | $ | | $ | ( | $ | |
See condensed notes to consolidated financial statements. | (continued) |
7
MERIT MEDICAL SYSTEMS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In thousands - unaudited)
Common Stock | Retained | Accumulated Other | ||||||||||||
| Shares |
| Amount |
| Earnings |
| Comprehensive Loss |
| Total | |||||
Balance — January 1, 2023 |
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Net income |
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Other comprehensive income |
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Stock-based compensation expense |
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Options exercised |
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Issuance of common stock under Employee Stock Purchase Plan |
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Shares issued from time-vested restricted stock units | | — | — | |||||||||||
Shares surrendered in exchange for payment of payroll tax liabilities |
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Balance — March 31, 2023 |
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Net income |
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Other comprehensive income |
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Stock-based compensation expense |
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Options exercised |
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Issuance of common stock under Employee Stock Purchase Plan |
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Shares issued from time-vested restricted stock units | | — | — | |||||||||||
Balance — June 30, 2023 | | $ | | $ | | $ | ( | $ | |
See condensed notes to consolidated financial statements. | (concluded) |
8
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands - unaudited)
Six Months Ended | ||||||
June 30, | ||||||
| 2024 |
| 2023 | |||
CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net income | $ | | $ | | ||
Adjustments to reconcile net income to net cash provided by operating activities: |
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Depreciation and amortization |
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Loss on sale or abandonment of property and equipment |
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Write-off of certain intangible assets and other long-term assets |
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Acquired in-process research and development |
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Amortization of right-of-use operating lease assets | | | ||||
Fair value adjustments related to contingent consideration liabilities | | | ||||
Amortization of deferred credits |
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Amortization of long-term debt issuance costs |
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Stock-based compensation expense |
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Changes in operating assets and liabilities, net of acquisitions and divestitures: |
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Trade receivables |
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Other receivables |
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Inventories |
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Prepaid expenses and other current assets |
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Income tax refund receivables |
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Other assets |
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Trade payables |
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Accrued expenses |
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Income taxes payable |
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Deferred compensation payable |
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Operating lease liabilities | ( | ( | ||||
Other long-term obligations |
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Total adjustments |
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Net cash, cash equivalents, and restricted cash provided by operating activities |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Capital expenditures for: |
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Property and equipment |
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Intangible assets |
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Proceeds from the sale of property and equipment |
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Issuance of note receivables |
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Cash paid in acquisitions and investments, net of cash acquired |
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Net cash, cash equivalents, and restricted cash used in investing activities | $ | ( | $ | ( |
See condensed notes to consolidated financial statements. | (continued) |
9
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands - unaudited)
| Six Months Ended | |||||
June 30, | ||||||
2024 | 2023 | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: |
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Proceeds from issuance of common stock | $ | | $ | | ||
Proceeds from issuance of long-term debt |
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Payments on long-term debt | ( | ( | ||||
Long-term debt issuance costs |
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Contingent payments related to acquisitions |
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Payment of taxes related to an exchange of common stock |
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Net cash, cash equivalents, and restricted cash (used in) provided by financing activities |
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Effect of exchange rates on cash, cash equivalents, and restricted cash |
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Net increase in cash, cash equivalents and restricted cash |
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CASH, CASH EQUIVALENTS AND RESTRICTED CASH: |
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Beginning of period | | | ||||
End of period | $ | | $ | | ||
RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH TO THE CONSOLIDATED BALANCE SHEETS: | ||||||
Cash and cash equivalents | | | ||||
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Total cash, cash equivalents and restricted cash | $ | | $ | | ||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION |
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Cash paid during the period for: |
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Interest (net of capitalized interest of $ | $ | | $ | | ||
Income taxes | | | ||||
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES |
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Property and equipment purchases in accounts payable | $ | | $ | | ||
Acquisition purchases in accrued expenses and other long-term obligations | | | ||||
Right-of-use operating lease assets obtained in exchange for operating lease liabilities | | |
See condensed notes to consolidated financial statements. | (concluded) |
10
MERIT MEDICAL SYSTEMS, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Basis of Presentation and Other Items. The interim consolidated financial statements of Merit Medical Systems, Inc. ("Merit," "we" or "us") for the three and six-month periods ended June 30, 2024 and 2023 are not audited. Our consolidated financial statements are prepared in accordance with the requirements for unaudited interim periods and, consequently, do not include all disclosures required to be made in conformity with accounting principles generally accepted in the United States of America. In the opinion of our management, the accompanying consolidated financial statements contain all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of our financial position as of June 30, 2024 and December 31, 2023, and our results of operations and cash flows for the three and six-month periods ended June 30, 2024 and 2023. The results of operations for the three and six-month periods ended June 30, 2024 and 2023 are not necessarily indicative of the results for a full-year period. Amounts presented in this report are rounded, while percentages and earnings per share amounts presented are calculated from the underlying amounts. These interim consolidated financial statements should be read in conjunction with the financial statements and risk factors included in our Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Annual Report on Form 10-K”).
2. Recently Issued Accounting Standards. In November 2023, the Financial Accounting Standards Board (“FASB’) issued Accounting Standard Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires a public entity to disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods all disclosures about reportable segment’s profit or loss and assets that are currently required annually. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The provisions of this update must be applied retrospectively to all periods presented in the financial statements. We are currently assessing the anticipated impact of this standard on our consolidated financial statements.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to improve annual basis income tax disclosures related to (1) rate reconciliation, (2) income taxes paid, and (3) other disclosures related to pretax income (or loss) and income tax expense (or benefit) from continuing operations. ASU 2023-09 is effective for fiscal years beginning after December 15, 2025, with early adoption permitted. These amendments are to be applied on a prospective basis. Retrospective application is permitted. We are currently evaluating the impact this standard will have on our consolidated financial statement disclosures.
We currently believe there are no other issued and not yet effective accounting standards that are materially relevant to our financial statements.
3.
Disaggregation of Revenue
Our revenue is disaggregated based on reporting segment, product category and geographic region. We design, develop, manufacture and market medical products for interventional, diagnostic and therapeutic procedures. For financial reporting purposes, we report our operations in
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The following table presents revenue from contracts with customers by reporting segment, product category and geographic region for the three and six-month periods ended June 30, 2024 and 2023 (in thousands):
Three Months Ended | Three Months Ended | |||||||||||||||||
June 30, 2024 | June 30, 2023 | |||||||||||||||||
| United States |
| International |
| Total |
| United States |
| International |
| Total | |||||||
Cardiovascular |
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Peripheral Intervention | $ | | $ | | $ | | $ | | $ | | $ | | ||||||
Cardiac Intervention |
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Custom Procedural Solutions |
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OEM |
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Total |
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Endoscopy | ||||||||||||||||||
Endoscopy Devices |
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Total | $ | | $ | | $ | | $ | | $ | | $ | |
Six Months Ended | Six Months Ended | |||||||||||||||||
June 30, 2024 | June 30, 2023 | |||||||||||||||||
| United States |
| International |
| Total |
| United States |
| International |
| Total | |||||||
Cardiovascular |
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Peripheral Intervention | $ | | $ | | $ | | $ | | $ | | $ | | ||||||
Cardiac Intervention |
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Custom Procedural Solutions |
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OEM |
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Total |
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Endoscopy | ||||||||||||||||||
Endoscopy Devices |
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Total | $ | | $ | | $ | | $ | | $ | | $ | |
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4. Acquisitions and Investments. On May 17, 2024, Merit Medical Ireland Limited (“MM Ireland”), our indirect wholly-owned subsidiary, entered into a Subscription and Shareholder Agreement (the “CrannMed Agreement”) with CrannMed Limited, a company organized under the laws of Ireland (“CrannMed”). Pursuant to the terms of the CrannMed Agreement, MM Ireland paid €
On March 8, 2024, we entered into an asset purchase agreement with Scholten Surgical Instruments, Inc. (“SSI”) to acquire the assets associated with the Bioptome, Novatome, and Sensatome devices. The total purchase price of the SSI assets included an up-front payment of $
During March 2024, we paid $
On June 8, 2023, we entered into an asset purchase agreement with AngioDynamics, Inc. (“AngioDynamics”) to acquire the assets associated with a portfolio of dialysis catheter products and the BioSentry® Biopsy Tract Sealant System for a purchase price of $
Assets Acquired |
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Prepaid expenses | $ | | |
Inventories |
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Property and equipment | | ||
Intangible assets |
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Developed technology | | ||
Trademarks | | ||
Customer list | | ||
Goodwill | | ||
Total net assets acquired | $ | |
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We are amortizing the AngioDynamics developed technology intangible assets over
On May 4, 2023, we entered into an asset purchase agreement to acquire the assets associated with the Surfacer® Inside-Out® Access Catheter System from Bluegrass Vascular Technologies, Inc. (“Bluegrass”), for a purchase price of $
Assets Acquired |
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Inventories | $ | | |
Intangible assets |
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Developed technology | | ||
Trademarks | | ||
Goodwill | | ||
Total net assets acquired | $ | |
We are amortizing the Bluegrass developed technology intangible asset over
5. Inventories.
| June 30, 2024 |
| December 31, 2023 | |||
Finished goods | $ | | $ | | ||
Work-in-process |
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Raw materials |
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Total inventories | $ | | $ | |
6. Goodwill and Intangible Assets.
| 2024 | ||
Goodwill balance at January 1 | $ | | |
Effect of foreign exchange |
| ( | |
Goodwill balance at June 30 | $ | |
Total accumulated goodwill impairment losses aggregated to $
14
Other intangible assets at June 30, 2024 and December 31, 2023 consisted of the following (in thousands):
June 30, 2024 | |||||||||
Gross Carrying | Accumulated | Net Carrying | |||||||
| Amount |
| Amortization |
| Amount | ||||
Patents | $ | | $ | ( | $ | | |||
Distribution agreements |
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License agreements |
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Trademarks |
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Customer lists |
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Total | $ | | $ | ( | $ | |
December 31, 2023 | |||||||||
Gross Carrying | Accumulated | Net Carrying | |||||||
| Amount |
| Amortization |
| Amount | ||||
Patents | $ | | $ | ( | $ | | |||
Distribution agreements |
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License agreements |
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Trademarks |
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Customer lists |
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Total | $ | | $ | ( | $ | |
Aggregate amortization expense for the three and six-month periods ended June 30, 2024 was $
We evaluate long-lived assets, including amortizing intangible assets, for impairment whenever events or changes in circumstances indicate that their carrying amounts may not be recoverable. We perform the impairment analysis at the asset group for which the lowest level of identifiable cash flows is largely independent of the cash flows of other assets and liabilities. We determine the fair value of our amortizing assets based on estimated future cash flows discounted back to their present value using a discount rate that reflects the risk profiles of the underlying activities. We did
Estimated amortization expense for developed technology and other intangible assets for the next five years consisted of the following as of June 30, 2024 (in thousands):
| Estimated Amortization Expense | ||
Remaining 2024 | $ | | |
2025 |
| | |
2026 |
| | |
2027 | | ||
2028 |
| |
7. Income Taxes. Our provision for income taxes for the three-month periods ended June 30, 2024 and 2023 was a tax expense of $
15
The Organization for Economic Cooperation and Development (“OECD”) Pillar Two global minimum tax rules, which generally provide for a minimum effective tax rate of 15%, are intended to apply for tax years beginning in 2024. On February 2, 2023, the OECD issued administrative guidance providing transition and safe harbor rules around the implementation of the Pillar Two global minimum tax. Under a transitional safe harbor released July 17, 2023, the undertaxed profits rule top-up tax in the jurisdiction of a company's ultimate parent entity will be zero for each fiscal year of the transition period, if that jurisdiction has a corporate tax rate of at least 20%. The safe harbor transition period will apply to fiscal years beginning on or before December 31, 2025 and ending before December 31, 2026. While we expect our effective income tax rate and cash income tax payments could increase in future years as a result of the global minimum tax, we do not anticipate a material impact to our fiscal 2024 consolidated results of operations. Our assessment could be affected by legislative guidance and future enactment of additional provisions within the Pillar Two framework. We are closely monitoring developments and evaluating the impact these new rules are anticipated to have on our tax rate, including eligibility to qualify for these safe harbor rules.
8. Debt.
| June 30, 2024 |
| December 31, 2023 | |||
Term loans | $ | | $ | | ||
Convertible notes | | | ||||
Less unamortized debt issuance costs |
| ( |
| ( | ||
Total long-term debt |
| |
| | ||
Less current portion |
| — |
| — | ||
Long-term portion | $ | | $ | |
Future minimum principal payments on our long-term debt, as of June 30, 2024, were as follows (in thousands):
Years Ending | Future Minimum | ||
December 31, |
| Principal Payments | |
Remaining 2024 |
| $ | — |
2025 | — | ||
2026 | — | ||
2027 | — | ||
2028 | | ||
Thereafter | | ||
Total future minimum principal payments | $ | |
Fourth Amended and Restated Credit Agreement
On June 6, 2023, we entered into a Fourth Amended and Restated Credit Agreement (the "Fourth A&R Credit Agreement"). The Fourth A&R Credit Agreement is a syndicated loan agreement with Wells Fargo Bank, National Association and other parties. The Fourth A&R Credit Agreement amended and restated in its entirety our previously outstanding Third Amended and Restated Credit Agreement and all amendments thereto. The Fourth A&R Credit Agreement provides for a term loan of $
On December 5, 2023, we executed an amendment to the Fourth Amended Credit Agreement (as amended, the "Amended Fourth A&R Credit Agreement") to facilitate the issuance of our Convertible Notes described below. Among other things, the amendment also updated the definition of the “Applicable Margin” as used in the Amended Fourth A&R Credit Agreement to determine the interest rates and amended the financial covenants, all as described below.
16
Term loans made under the Amended Fourth A&R Credit Agreement bear interest, at our election, at either (i) the Base Rate plus the Applicable Margin (as defined in the Amended Fourth A&R Credit Agreement) or, (ii) Adjusted Term SOFR plus the Applicable Margin (as defined in the Amended Fourth A&R Credit Agreement). Revolving credit loans bear interest, at our election, at either (a) the Base Rate plus the Applicable Margin, (b) Adjusted Term SOFR plus the Applicable Margin, (c) Adjusted Eurocurrency Rate plus the Applicable Margin (as defined in the Amended Fourth A&R Credit Agreement), or (d) Adjusted Daily Simple SONIA plus the Applicable Margin (as defined in the Amended Fourth A&R Credit Agreement). Swingline loans bear interest at the Base Rate plus the Applicable Margin. Interest on each loan featuring the Base Rate and each Daily Simple SONIA Loan is due and payable on the last business day of each calendar month; interest on each loan featuring the Eurocurrency Rate and each Term SOFR Loan is due and payable on the last day of each interest period applicable thereto, and if such interest period extends over three months, at the end of each three-month interval during such interest period.
The Amended Fourth A&R Credit Agreement is collateralized by substantially all of our assets. The Amended Fourth A&R Credit Agreement contains affirmative and negative covenants, representations and warranties, events of default and other terms customary for loans of this nature. In particular, the Amended Fourth A&R Credit Agreement requires that we maintain certain financial covenants, as follows:
| Covenant Requirement | |||
Consolidated Total Net Leverage Ratio (1) |
| |||
Consolidated Senior Secured Net Leverage Ratio (2) | ||||
Consolidated Interest Coverage Ratio (3) |
|
(1) | Maximum Consolidated Total Net Leverage Ratio (as defined in the Amended Fourth A&R Credit Agreement) as of any fiscal quarter end. |
(2) | Maximum Consolidated Senior Secured Net Leverage Ratio (as defined in the Amended Fourth A&R Credit Agreement) as of any fiscal quarter end. |
(3) | Minimum ratio of Consolidated EBITDA (as defined in the Amended Fourth A&R Credit Agreement and adjusted for certain expenditures) to Consolidated Interest Expense (as defined in the Amended Fourth A&R Credit Agreement) for any period of four consecutive fiscal quarters. |
We believe we were in compliance with all covenants set forth in the Amended Fourth A&R Credit Agreement as of June 30, 2024.
As of June 30, 2024, we had outstanding borrowings of $
Convertible Notes
In December 2023, we issued convertible notes which bear interest at
17
The initial conversion rate of the notes will be
Conversion can occur at the option of the Holders at any time on or after October 1, 2028. Prior to October 1, 2028, Holders may only elect to convert the Convertible Notes under the following circumstances: (1) During the
On or after February 7, 2027, we may redeem for cash all or part of the Convertible Notes, at our option, if the last reported sales price of Common Stock has been at least
Upon conversion, Merit will (1) pay cash up to the aggregate principal amount of the Convertible Notes to be converted and (2) pay or deliver, as the case may be, cash, shares of Common Stock, or a combination of cash and shares of Common Stock, at Merit’s election, in respect of the remainder, if any, of its conversion obligation in excess of the aggregate principal amount of the Convertible Notes being converted.
Capped Call Transactions
In December 2023, in connection with the pricing of the Convertible Notes, Merit entered into privately negotiated capped call transactions (“Capped Call Transactions”) with certain of the initial purchasers and/or their respective affiliates and certain other financial institutions. The Capped Call Transactions cover, subject to customary anti-dilution adjustments, the number of shares of Common Stock initially underlying the Convertible Notes and are generally expected to reduce potential dilution to the Common Stock upon any conversion of Convertible Notes and/or offset any cash payments Merit is required to make in excess of the principal amount of converted Convertible Notes, as the case may be, with such reduction and/or offset subject to a cap, based on a cap price initially equal to approximately $
18
9.
General. Our earnings and cash flows are subject to fluctuations due to changes in interest rates and foreign currency exchange rates, and we seek to mitigate a portion of the risks attributable to those fluctuations by entering into derivative contracts. The derivative instruments we use are interest rate swaps and foreign currency forward contracts. We recognize derivative instruments as either assets or liabilities at fair value in the accompanying consolidated balance sheets, regardless of whether hedge accounting is applied. We report cash flows arising from our hedging instruments consistent with the classification of cash flows from the underlying hedged items. Accordingly, cash flows associated with our derivative contracts are classified as operating activities in the accompanying consolidated statements of cash flows.
We formally document, designate and assess the effectiveness of transactions that receive hedge accounting treatment initially and on an ongoing basis. For qualifying hedges, the change in fair value is deferred in accumulated other comprehensive income, a component of stockholders’ equity in the accompanying consolidated balance sheets, and recognized in earnings at the same time the hedged item affects earnings. Changes in the fair value of derivative instruments not designated as hedging instruments are recorded in earnings throughout the term of the derivative.
Interest Rate Risk. Our debt bears interest at variable interest rates. Therefore, we are subject to variability in the cash payable for interest expense. In order to mitigate a portion of the risk attributable to such variability, we use a hedging strategy to reduce the variability of cash flows in the interest payments associated with a portion of the variable-rate debt outstanding under our Amended Fourth A&R Credit Agreement that varies in accordance with changes in the benchmark interest rate.
Derivatives Designated as Cash Flow Hedges
On December 23, 2019, we entered into a pay-fixed, receive-variable interest rate swap with a notional amount of $
On June 30, 2024 and December 31, 2023, our interest rate swap qualified as a cash flow hedge. The fair value of our interest rate swap as of June 30, 2024 was an asset of $
Foreign Currency Risk. We operate on a global basis and are exposed to the risk that our financial condition, results of operations, and cash flows could be adversely affected by changes in foreign currency exchange rates. To reduce the potential effects of foreign currency exchange rate movements on net earnings, we enter into derivative financial instruments in the form of foreign currency exchange forward contracts with major financial institutions. Our policy is to enter into foreign currency derivative contracts with maturities of up to
19
Derivatives Designated as Cash Flow Hedges
Derivatives Not Designated as Cash Flow Hedges
Balance Sheet Presentation of Derivative Instruments. As of June 30, 2024 and December 31, 2023, all derivative instruments, both those designated as hedging instruments and those that were not designated as hedging instruments, were recorded at fair value on a gross basis on our consolidated balance sheets. We are not subject to any master netting agreements.
The fair value of derivative instruments on a gross basis was as follows on the dates indicated (in thousands):
Fair Value of Derivative Instruments Designated as Hedging Instruments |
| Balance Sheet Location |
| June 30, 2024 |
| December 31, 2023 | ||
Assets |
|
|
|
|
|
| ||
Interest rate swap |
| Prepaid expenses and other assets | $ | | $ | | ||
Foreign currency forward contracts |
| Prepaid expenses and other assets | | | ||||
Foreign currency forward contracts |
| Other assets (long-term) | |
| | |||
(Liabilities) |
|
|
|
|
|
| ||
Foreign currency forward contracts |
| Accrued expenses |
| ( |
| ( | ||
Foreign currency forward contracts |
| Other long-term obligations |
| ( |
| ( | ||
Fair Value of Derivative Instruments Not Designated as Hedging Instruments |
| Balance Sheet Location |
| June 30, 2024 |
| December 31, 2023 | ||
Assets |
|
|
|
|
|
| ||
Foreign currency forward contracts |
| Prepaid expenses and other assets | $ | | $ | | ||
(Liabilities) |
|
|
|
|
|
| ||
Foreign currency forward contracts |
| Accrued expenses |
| ( |
| ( |
20
Income Statement Presentation of Derivative Instruments.
Derivative Instruments Designated as Cash Flow Hedges
Derivative instruments designated as cash flow hedges had the following effects, before income taxes, on other comprehensive income (“OCI”), accumulated other comprehensive income (“AOCI”), and net earnings in our consolidated statements of income, consolidated statements of comprehensive income and consolidated balance sheets (in thousands):
Amount of Gain/(Loss) | Consolidated Statements | Amount of Gain/(Loss) | ||||||||||||||||||
Recognized in OCI | of Income | Reclassified from AOCI | ||||||||||||||||||
Three Months Ended June 30, |
|
| Three Months Ended June 30, | Three Months Ended June 30, | ||||||||||||||||
Derivative instrument |
| 2024 |
| 2023 |
| Location in statements of income |
| 2024 |
|
| 2023 |
| 2024 |
|
| 2023 | ||||
Interest rate swap | $ | ( | $ | | Interest expense | $ | ( | $ | ( | $ | | $ | | |||||||
Foreign currency forward contracts |
| ( |
| | Revenue |
| |
| |
| |
| | |||||||
Cost of sales |
| ( |
| ( |
| |
| |
Amount of Gain/(Loss) | Consolidated Statements | Amount of Gain/(Loss) | |||||||||||||||||||
Recognized in OCI | of Income | Reclassified from AOCI | |||||||||||||||||||
Six Months Ended June 30, | Six Months Ended June 30, | Six Months Ended June 30, |
| ||||||||||||||||||
Derivative instrument |
| 2024 |
| 2023 |
| Location in statements of income |
| 2024 |
| 2023 |
| 2024 |
|
| 2023 |
| |||||
Interest rate swap | $ | | $ | | Interest expense | $ | ( | $ | ( | $ | | $ | | ||||||||
Foreign currency forward contracts |
| |
| | Revenue |
| |
| |
| |
| | ||||||||
Cost of sales |
| ( |
| ( |
| |
| |
As of June 30, 2024, $
Derivative Instruments Not Designated as Hedging Instruments
The following gains/(losses) from these derivative instruments were recognized in our consolidated statements of income for the periods presented (in thousands):
|
| Three Months Ended June 30, |
| Six Months Ended June 30, |
| ||||||||||
Derivative Instrument |
| Location in statements of income |
| 2024 |
| 2023 |
| 2024 |
| 2023 |
| ||||
Foreign currency forward contracts |
| $ | | $ | | $ | | $ | |
21
10. Commitments and Contingencies.
Litigation. In the ordinary course of business, we are involved in various claims and litigation matters. These proceedings, actions and claims may involve product liability, intellectual property, contract disputes, employment, governmental inquiries or other matters, including the matter described below. These matters generally involve inherent uncertainties and often require prolonged periods of time to resolve. In certain proceedings, the claimants may seek damages, as well as other compensatory and equitable relief that could result in the payment of significant claims and settlements and/or the imposition of injunctions or other equitable relief. For legal matters for which our management had sufficient information to reasonably estimate our future obligations, a liability representing management’s best estimate of the probable loss, or the minimum of the range of probable losses when a best estimate within the range is not known, is recorded. The estimates are based on consultation with legal counsel, previous settlement experience and settlement strategies. If actual outcomes are less favorable than those estimated by management, additional expense may be incurred, which could unfavorably affect our financial position, results of operations and cash flows. The ultimate cost to us with respect to actions and claims could be materially different than the amount of the current estimates and accruals and could have a material adverse effect on our financial position, results of operations and cash flows. Unless included in our legal accrual, we are unable to estimate a reasonably possible loss or range of loss associated with any individual material legal proceeding. Legal costs for these matters, such as outside counsel fees and expenses, are charged to expense in the period incurred.
SEC Inquiry
We have received requests from the Division of Enforcement of the U.S. Securities and Exchange Commission (“SEC”) seeking the voluntary production of information relating to the business activities of Merit’s subsidiary in China, including interactions with hospitals and health care officials in China (the “SEC Inquiry”). We are cooperating with the requests and investigating the matter. Currently, we are unable to predict the scope, timing, significance or outcome of the SEC Inquiry or estimate a reasonably possible loss or range of loss associated with the matter. It is possible that the ultimate resolution of the SEC Inquiry, if resolved in a manner unfavorable to us, may be materially adverse to our business, financial position, results of operations or liquidity.
In management's opinion, based on its examination of these matters, its experience to date and discussions with counsel, other than the SEC Inquiry, we are not currently involved in any legal proceedings which, individually or in the aggregate, could have a material adverse effect on our financial position, results of operations or cash flows. Our management regularly assesses the risks of legal proceedings in which we are involved, and management’s view of these matters may change in the future.
22
11. Earnings Per Common Share (EPS).
Three Months Ended | Six Months Ended | ||||||||||||
June 30, | June 30, | ||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||
Net income | $ | | $ | | $ | | $ | | |||||
Average common shares outstanding |
| |
| |
| |
| | |||||
Basic EPS | $ | | $ | | $ | | $ | | |||||
Average common shares outstanding | | | | | |||||||||
Effect of dilutive stock awards | | | | | |||||||||
Total potential shares outstanding | | | | | |||||||||
Diluted EPS | $ | | $ | | $ | | $ | | |||||
Equity awards excluded as the impact was anti-dilutive (1) | | | | |
(1) | Does not reflect the impact of incremental repurchases under the treasury stock method. |
Convertible Notes
For our Convertible Notes, the dilutive effect is calculated using the if-converted method. Upon surrender of the Convertible Notes for conversion, Merit will pay cash up to the aggregate principal amount of the Notes to be converted and pay or deliver, as the case may be, cash, shares of Common Stock or a combination of cash and shares of Common Stock, at Merit’s election, in respect of the remainder, if any, of Merit’s conversion obligation in excess of the aggregate principal amount of the Convertible Notes being converted. Under the if-converted method, we include the number of shares required to satisfy the remaining conversion obligation, assuming all the Convertible Notes were converted. The average closing price of the Common Stock for the period ended June 30, 2024 was used as the basis for determining the dilutive effect on EPS. The average closing price for the Common Stock on June 30, 2024 did not exceed the conversion price of $
12. Stock-Based Compensation Expense.
Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||||
Cost of sales | ||||||||||||
Nonqualified stock options | $ | | $ | | $ | | $ | | ||||
Research and development |
|
| ||||||||||
Nonqualified stock options | |
| | |
| | ||||||
Selling, general and administrative |
|
| ||||||||||
Nonqualified stock options | |
| | |
| | ||||||
Performance-based restricted stock units | | | | | ||||||||
Restricted stock units | | | | | ||||||||
Cash-settled performance-based awards | | | | | ||||||||
Total selling, general and administrative | | | | | ||||||||
Stock-based compensation expense before taxes | $ | | $ | | $ | | $ | |
23
We recognize stock-based compensation expense (net of a forfeiture rate), for those awards which are expected to vest, on a straight-line basis over the requisite service period. We estimate the forfeiture rate based on our historical experience and expectations about future forfeitures.
Nonqualified Stock Options
During the six-month period ended June 30, 2023, we granted stock options representing
Six Months Ended | |
June 30, | |
2023 | |
Risk-free interest rate | |
Expected option term | |
Expected dividend yield | — |
Expected price volatility |
The average risk-free interest rate is determined using the U.S. Treasury rate in effect as of the date of grant, based on the expected term of the stock award. We determine the expected term of stock options using the historical exercise behavior of employees. The expected price volatility was determined using a weighted average of daily historical volatility of our stock price over the corresponding expected option term and implied volatility based on recent trends of the daily historical volatility. For awards with a vesting period, compensation expense is recognized on a straight-line basis over the service period, which corresponds to the vesting period.
As of June 30, 2024, the total remaining unrecognized compensation cost related to non-vested stock options was $
Stock-Settled Performance-Based Restricted Stock Units (“Performance Stock Units”)
During the six-month periods ended June 30, 2024 and 2023, we granted performance stock units which represented up to
We use Monte-Carlo simulations to estimate the grant-date fair value of the performance stock units linked to total shareholder return. The fair value of each performance stock unit was estimated as of the grant date using the following assumptions for awards granted in the periods indicated below:
Six Months Ended | ||||
June 30, | ||||
2024 | 2023 | |||
Risk-free interest rate |
|
| ||
Performance period |
|
| ||
Expected dividend yield |
| — |
| — |
Expected price volatility |
|
|
The risk-free interest rate of return was determined using the U.S. Treasury rate at the time of grant with a term equal to the expected term of the award. The expected volatility was based on the weighted average volatility of our stock price and the average volatility of our compensation peer group's stock price. The expected dividend yield was assumed to be
24
Compensation expense is recognized using the grant-date fair value for the number of shares that are likely to be awarded based on the performance metrics. Each reporting period, this probability assessment is updated, and cumulative adjustments are recorded based on the financial performance metrics expected to be achieved. At the end of the performance period, cumulative expense is calculated based on the actual performance metrics achieved. As of June 30, 2024, the total remaining unrecognized compensation cost related to stock-settled performance stock units was $
Cash-Settled Performance-Based Awards
During the six-month periods ended June 30, 2024 and 2023, we granted performance stock units to our Chief Executive Officer that provide for settlement in cash upon achievement of specific metrics (“Liability Awards”), with total target cash incentives in the amount of $
During the six-month periods ended June 30, 2024 and 2023, we granted additional performance stock units to certain employees that provide for settlement in cash upon our achievement of specified financial metrics. The cash payable upon vesting at the end of the service period is based upon performance against specified financial performance metrics and relative total shareholder return as compared to the rTSR, as defined in the award agreements. Compensation expense is recognized for the cash payment likely to be awarded based on the performance metrics.
The potential maximum payout of these Liability Awards is
The fair value of these Liability Awards is measured at each reporting period until the awards are settled. As of June 30, 2024 and December 31, 2023, the recorded balance associated with these Liability Awards is $
Restricted Stock Units
During the six-month periods ended June 30, 2024 and 2023, we granted restricted stock units to certain employees and and non-employee directors representing
13. Segment Reporting. We report our operations in
25
Financial information relating to our reportable operating segments and reconciliations to the consolidated totals for the three and six-month periods ended June 30, 2024 and 2023, were as follows (in thousands):
| Three Months Ended |
| Six Months Ended | |||||||||
| June 30, |
| June 30, | |||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||||
Net sales |
|
|
|
|
|
|
|
| ||||
Cardiovascular | $ | | $ | | $ | | $ | | ||||
Endoscopy |
| |
| |
| |
| | ||||
Total net sales |
| |
| |
| |
| | ||||
Income from operations |
|
|
|
|
|
|
|
| ||||
Cardiovascular |
| |
| |
| |
| | ||||
Endoscopy |
| |
| |
| |
| | ||||
Total income from operations |
| |
| |
| |
| | ||||
Total other expense — net |
| ( |
| ( |
| ( |
| ( | ||||
Income tax expense |
| |
| |
| |
| | ||||
Net income | $ | | $ | | $ | | $ | |
14. Fair Value Measurements.
Assets (Liabilities) Measured at Fair Value on a Recurring Basis
Our financial assets and (liabilities) carried at fair value and measured on a recurring basis as of June 30, 2024 and December 31, 2023 consisted of the following (in thousands):
Fair Value Measurements Using | ||||||||||||
Total Fair | Quoted prices in | Significant other | Significant | |||||||||
Value at | active markets | observable inputs | unobservable inputs | |||||||||
| June 30, 2024 |
| (Level 1) |
| (Level 2) |
| (Level 3) | |||||
Marketable securities (1) | $ | | $ | | $ | — | $ | — | ||||
Interest rate contract asset, current (2) | $ | | $ | — | $ | | $ | — | ||||
Foreign currency contract assets, current and long-term (3) | $ | | $ | — | $ | | $ | — | ||||
Foreign currency contract liabilities, current and long-term (4) | $ | ( | $ | — | $ | ( | $ | — | ||||
Contingent consideration liabilities | $ | ( | $ | — | $ | — | $ | ( |
Fair Value Measurements Using | ||||||||||||
Total Fair | Quoted prices in | Significant other | Significant | |||||||||
Value at | active markets | observable inputs | unobservable inputs | |||||||||
| December 31, 2023 |
| (Level 1) |
| (Level 2) |
| (Level 3) | |||||
Marketable securities (1) | $ | | $ | | $ | — | — | |||||
Interest rate contract asset, current (2) | $ | | $ | — | $ | | $ | — | ||||
Foreign currency contract assets, current and long-term (3) | $ | | $ | — | $ | | $ | — | ||||
Foreign currency contract liabilities, current and long-term (4) | $ | ( | $ | — | $ | ( | $ | — | ||||
Contingent consideration liabilities | $ | ( | $ | — | $ | — | $ | ( |
26
(1) | Our marketable securities, which consist entirely of available-for-sale equity securities, are valued using market prices in active markets. Level 1 instrument valuations are obtained from real-time quotes for transactions in active exchange markets involving identical assets. |
(2) | The fair value of the interest rate contract is determined using Level 2 fair value inputs and is recorded as prepaid and other current assets in the consolidated balance sheets. |
(3) | The fair value of the foreign currency contract assets (including those designated as hedging instruments and those not designated as hedging instruments) is determined using Level 2 fair value inputs and is recorded as a prepaid expense and other current asset or other long-term asset in the consolidated balance sheets. |
(4) | The fair value of the foreign currency contract liabilities (including those designated as hedging instruments and those not designated as hedging instruments) is determined using Level 2 fair value inputs and is recorded as accrued expense or other long-term obligation in the consolidated balance sheets. |
Certain of our past business combinations involve the potential for the payment of future contingent consideration, generally based on a percentage of future product sales or upon attaining specified future revenue or other milestones. The contingent consideration liability is re-measured at the estimated fair value at the end of each reporting period with the change in fair value recognized within operating expenses in the accompanying consolidated statements of income for such period. We measure the initial liability and re-measure the liability on a recurring basis using Level 3 inputs as defined under authoritative guidance for fair value measurements.
| Three Months Ended |
| Six Months Ended | |||||||||
| June 30, |
| June 30, | |||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||||
Beginning balance | $ | | $ | | $ | | $ | | ||||
| |
| |
| |
| | |||||
Contingent payments made |
| ( |
| ( |
| ( |
| ( | ||||
Ending balance | $ | | $ | | $ | | $ | |
As of June 30, 2024, $
Payments related to the settlement of the contingent consideration liability recognized at fair value as of the applicable acquisition date of $
27
The recurring Level 3 measurement of our contingent consideration liabilities included the following significant unobservable inputs at June 30, 2024 and December 31, 2023 (amounts in thousands):
Fair value at |
| ||||||||||
June 30, | Valuation | Weighted | |||||||||
Contingent consideration liability |
| 2024 |
| technique |
| Unobservable inputs |
| Range | Average(1) | ||
Revenue-based royalty payments contingent liability | $ | |
| Discounted cash flow |
| Discount rate | |||||
|
|
|
| Projected year of payments | 2024-2034 | 2028 | |||||
Revenue milestones contingent liability | $ | |
| Monte Carlo simulation |
| Discount rate | |||||
|
|
|
| Projected year of payments | 2024-2040 | 2040 | |||||
Regulatory approval contingent liability | $ | Scenario-based method | Discount rate | ||||||||
Probability of milestone payment | |||||||||||
Projected year of payment | 2024-2030 | 2030 |
Fair value at |
| ||||||||||
December 31, | Valuation | Weighted | |||||||||
Contingent consideration liability |
| 2023 |
| technique |
| Unobservable inputs |
| Range | Average(1) | ||
Revenue-based royalty payments contingent liability | $ | |
| Discounted cash flow |
| Discount rate | |||||
|
|
|
| Projected year of payments | 2024-2034 | 2028 | |||||
Revenue milestones contingent liability | $ | |
| Monte Carlo simulation |
| Discount rate | |||||
|
|
|
| Projected year of payments | 2024-2039 | 2039 | |||||
Regulatory approval contingent liability | $ | | Scenario-based method | Discount rate | |||||||
Probability of milestone payment | |||||||||||
Projected year of payment | 2024-2030 | 2030 |
(1) | Unobservable inputs were weighted by the relative fair value of the instruments. No weighted average is reported for contingent consideration liabilities without a range of unobservable inputs. |
The contingent consideration liability is re-measured to fair value each reporting period. Significant increases or decreases in projected revenues, based on our most recent internal operational budgets and long-range strategic plans, discount rates or the time until payment is made would have resulted in a significantly lower or higher fair value measurement. Our determination of the fair value of the contingent consideration liability could change in future periods based upon our ongoing evaluation of these significant unobservable inputs. We intend to record any such change in fair value to operating expenses in our consolidated statements of income.
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Fair Value of Other Assets (Liabilities)
The carrying amount of cash and cash equivalents, receivables, and trade payables approximate fair value because of the immediate, short-term maturity of these financial instruments. Our long-term debt under our Amended Fourth A&R Credit Agreement re-prices frequently due to variable rates and entails no significant changes in credit risk and, as a result, we believe the fair value of long-term debt approximates carrying value. We believe the fair value our long-term debt under our Convertible Notes approximates carrying value as the notes were issued in December 2023. The fair value of assets and liabilities whose carrying value approximates fair value is determined using Level 2 inputs, with the exception of cash and cash equivalents, which use Level 1 inputs.
We recognize or disclose the fair value of certain assets, such as non-financial assets, primarily property and equipment, right-of-use operating lease assets, equity investments, intangible assets and goodwill in connection with impairment evaluations. Such assets are reported at carrying value and are not subject to recurring fair value measurements. We review our long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Fair value is generally determined based on discounted future cash flow. All our nonrecurring valuations use significant unobservable inputs and therefore fall under Level 3 of the fair value hierarchy.
Our equity investments in privately-held companies were $
Current Expected Credit Losses
Our outstanding long-term notes receivable, including accrued interest and an allowance for current expected credit losses, were $
The table below presents a roll-forward of the allowance for current expected credit losses on our notes receivable for the three and six-month periods ended June 30, 2024 and 2023 (in thousands):
Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2024 |
| 2023 | 2024 |
| 2023 | |||||||
Beginning balance | $ | | $ | | $ | | $ | | ||||
Provision for credit loss expense | | | | | ||||||||
Ending balance | $ | | $ | | $ | | $ | |
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15. Accumulated Other Comprehensive Income (Loss).
Cash Flow Hedges |
| Foreign Currency Translation |
| Total | ||||
Balance as of April 1, 2024 | $ | | $ | ( | $ | ( | ||
Other comprehensive loss |
| ( | ( | ( | ||||
Income taxes |
| | | | ||||
Reclassifications to: | ||||||||
Revenue | ( | ( | ||||||
Cost of sales | ( | ( | ||||||
Interest expense | ( | ( | ||||||
Net other comprehensive loss | ( | ( | ( | |||||
Balance as of June 30, 2024 | $ | | $ | ( | $ | ( |
Cash Flow Hedges |
| Foreign Currency Translation |
| Total | ||||
Balance as of April 1, 2023 | $ | | $ | ( | $ | ( | ||
Other comprehensive income (loss) |
| | ( | | ||||
Income taxes |
| ( | ( | ( | ||||
Reclassifications to: | ||||||||
Revenue | ( | ( | ||||||
Cost of sales | ( | ( | ||||||
Interest expense | ( | ( | ||||||
Net other comprehensive income (loss) | | ( | | |||||
Balance as of June 30, 2023 | $ | | $ | ( | $ | ( |
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Cash Flow Hedges |
| Foreign Currency Translation |
| Total | ||||
Balance as of January 1, 2024 | $ | | $ | ( | $ | ( | ||
Other comprehensive income (loss) |
| | ( | ( | ||||
Income taxes |
| ( | | ( | ||||
Reclassifications to: | ||||||||
Revenue | ( | ( | ||||||
Cost of sales | ( | ( | ||||||
Interest expense | ( | ( | ||||||
Net other comprehensive income (loss) | | ( | ( | |||||
Balance as of June 30, 2024 | $ | | $ | ( | $ | ( |
Cash Flow Hedges |
| Foreign Currency Translation |
| Total | ||||
Balance as of January 1, 2023 | $ | | $ | ( | $ | ( | ||
Other comprehensive income |
| | | | ||||
Income taxes |
| ( | ( | ( | ||||
Reclassifications to: | ||||||||
Revenue | ( | ( | ||||||
Cost of sales | ( | ( | ||||||
Interest expense | ( | ( | ||||||
Net other comprehensive income | | | | |||||
Balance as of June 30, 2023 | $ | | $ | ( | $ | ( |
16. Subsequent Events. On July 1, 2024, we entered into an Asset Purchase Agreement (the “EGS Purchase Agreement”) with EndoGastric Solutions, Inc., a Delaware corporation (“EGS”), pursuant to which we acquired the EsophyX® Z+ device and various assets related thereto (collectively, the “EGS Acquisition”), which are designed to deliver a durable, minimally invasive non-pharmacological treatment option for patients suffering from gastroesophageal reflux disease. We acquired the purchased assets identified under the EGS Purchase Agreement for a purchase price of $
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the consolidated financial statements and related condensed notes thereto, which are included in Part I of this report. Our future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties that may adversely impact our operations and financial results. These risks and uncertainties are discussed in Part I, Item 1A “Risk Factors” in the 2023 Annual Report on Form 10-K and in Part II, Item 1A “Risk Factors” in this report.
OVERVIEW
We are a leading manufacturer and marketer of proprietary medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Our cardiovascular segment consists of four product categories: peripheral intervention, cardiac intervention, custom procedural solutions, and OEM. Within these product categories, we sell a variety of products, including cardiology and radiology devices (which assist in diagnosing and treating coronary arterial disease, peripheral vascular disease and other non-vascular diseases), as well as embolotherapeutic, cardiac rhythm management, electrophysiology, critical care, breast cancer localization and guidance, biopsy, and interventional oncology and spine devices. Our endoscopy segment consists of gastroenterology and pulmonology devices which assist in the palliative treatment of expanding esophageal, tracheobronchial and biliary strictures.
For the three-month period ended June 30, 2024, we reported sales of $338.0 million, an increase of $17.9 million or 5.6% compared to sales for the three-month period ended June 30, 2023 of $320.1 million. For the six-month period ended June 30, 2024, we reported sales of $661.5 million, an increase of $43.9 million or 7.1% compared to sales for the six-month period ended June 30, 2023 of $617.6 million. Foreign currency fluctuations (net of hedging) decreased our net sales by ($3.0) million and ($4.7) million, respectively, for the three and six-month periods ended June 30, 2024, assuming applicable foreign exchange rates in effect during the comparable prior-year periods.
Gross profit as a percentage of sales was 47.7% for the three-month periods ending June 30, 2023 and 2024. Gross profit as a percentage of sales increased to 47.3% for the six-month period ended June 30, 2024 compared to 47.1% for the six-month period ended June 30, 2023.
Net income for the three-month period ended June 30, 2024 was $35.7 million, or $0.61 per share, compared to net income of $20.2 million, or $0.35 per share, for the three-month period ended June 30, 2023. Net income for the six-month period ended June 30, 2024 was $64.0 million, or $1.09 per share, compared to net income of $40.9 million, or $0.70 per share, for the six-month period ended June 30, 2023.
Recent Developments and Trends
In addition to the trends identified in the 2023 Annual Report on Form 10-K under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Overview,” our business in 2024 has been impacted, and we believe will continue to be impacted, by the following recent developments and trends:
● | Our revenue results during the three-month period ended June 30, 2024 were driven primarily by demand in the U.S. and favorable international sales trends, particularly in our Europe, Middle East and Africa (“EMEA”) and Rest of World (“ROW”) regions. |
● | On February 28, 2024, we introduced our “Continued Growth Initiatives” Program and related financial targets for the three-year period ending December 31, 2026, which reflects our commitment to better-position Merit for long-term, sustainable growth and enhanced profitability. |
● | As of June 30, 2024, we had cash, cash equivalents, and restricted cash of $638.7 million and net available borrowing capacity of approximately $680 million. |
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RESULTS OF OPERATIONS
The following table sets forth certain operational data as a percentage of sales for the periods indicated:
| Three Months Ended | Six Months Ended | ||||||||
June 30, | June 30, | |||||||||
| 2024 |
| 2023 |
|
| 2024 |
| 2023 |
| |
Net sales |
| 100 | % | 100 | % |
| 100 | % | 100 | % |
Gross profit |
| 47.7 |
| 47.7 |
|
| 47.3 | 47.1 |
| |
Selling, general and administrative expenses |
| 28.0 |
| 31.5 |
|
| 28.6 | 30.9 |
| |
Research and development expenses |
| 6.0 |
| 6.3 |
|
| 6.3 | 6.7 |
| |
Impairment charges |
| — |
| 0.1 |
|
| — | 0.0 |
| |
Contingent consideration expense |
| 0.1 |
| 0.3 |
|
| 0.0 | 0.3 |
| |
Acquired in-process research and development expense |
| — |
| 0.5 |
| — | 0.3 |
| ||
Income from operations |
| 13.6 |
| 9.0 |
|
| 12.4 | 8.9 |
| |
Other expense — net |
| (0.0) |
| (1.2) |
|
| (0.3) | (0.8) |
| |
Income before income taxes |
| 13.6 |
| 7.8 |
|
| 12.1 | 8.2 |
| |
Net income |
| 10.6 |
| 6.3 |
|
| 9.7 | 6.6 |
|
Sales
Sales for the three-month period ended June 30, 2024 increased by 5.6%, or $17.9 million, compared to the corresponding period in 2023. Sales for the six-month period ended June 30, 2024 increased by 7.1%, or $43.9 million, compared to the corresponding period in 2023. Listed below are the sales by product category within each of our financial reporting segments for the three and six-month periods ended June 30, 2024 and 2023 (in thousands, other than percentage changes):
| Three Months Ended | Six Months Ended |
| ||||||||||||||||
| June 30, | June 30, |
| ||||||||||||||||
| % Change |
| 2024 |
| 2023 |
| % Change |
| 2024 |
| 2023 |
| |||||||
Cardiovascular | |||||||||||||||||||
Peripheral Intervention |
| 10.6 | % | $ | 139,247 | $ | 125,909 | 14.3 | % | $ | 273,873 | $ | 239,692 |
| |||||
Cardiac Intervention |
| 0.1 | % |
| 93,863 |
| 93,775 |
| 3.0 | % | 184,551 |
| 179,103 |
| |||||
Custom Procedural Solutions |
| 2.1 | % |
| 50,416 |
| 49,384 |
| 2.2 | % | 99,210 |
| 97,085 |
| |||||
OEM |
| 4.9 | % |
| 44,289 |
| 42,207 |
| 0.2 | % | 83,555 |
| 83,371 |
| |||||
Total |
| 5.3 | % |
| 327,815 |
| 311,275 |
| 7.0 | % | 641,189 |
| 599,251 |
| |||||
Endoscopy | |||||||||||||||||||
Endoscopy Devices |
| 16.0 | % |
| 10,188 |
| 8,781 |
| 10.6 | % | 20,322 |
| 18,370 |
| |||||
Total |
| 5.6 | % | $ | 338,003 | $ | 320,056 | 7.1 | % | $ | 661,511 | $ | 617,621 |
|
Cardiovascular Sales. Our cardiovascular sales for the three-month period ended June 30, 2024 were $327.8 million, up 5.3% when compared to the corresponding period of 2023 of $311.3 million. Sales for the three-month period ended June 30, 2024 were favorably affected by increased sales of:
(a) | Peripheral intervention products, which increased by $13.3 million, or 10.6%, from the corresponding period of 2023. This increase was driven primarily by increased sales of our access, biopsy, radar localization, delivery systems, and drainage products. |
(b) | Cardiac intervention products, which increased by $0.1 million, or 0.1%, from the corresponding period of 2023. This increase was driven primarily by increased sales of our cardiac rhythm management/electrophysiology (“CRM/EP”) and fluid management products, offset partially by decreased sales of our angiography and hemostasis products. |
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(c) | Custom procedural solutions products, which increased by $1.0 million, or 2.1%, from the corresponding period of 2023. This increase was driven primarily by increased sales of our kits, offset partially by decreased sales of our critical care products and procedure trays. |
(d) | OEM products, which increased by $2.1 million, or 4.9%, from the corresponding period of 2023. This increase was driven primarily by increased sales of our kits and access, fluid management, intervention, and angiography products, offset partially by decreased sales of our CRM/EP products. |
Our cardiovascular sales for the six-month period ended June 30, 2024 were $641.2 million, up 7.0% when compared to the corresponding period of 2023 of $599.3 million. Sales for the six-month period ended June 30, 2024 were favorably affected by increased sales of:
(a) | Peripheral intervention products, which increased by $34.2 million, or 14.3%, from the corresponding period of 2023. This increase was driven primarily by increased sales of our access, biopsy, delivery systems, radar localization, drainage, embolotherapy, and angiography products. |
(b) | Cardiac intervention products, which increased by $5.4 million, or 3.0%, from the corresponding period of 2023. This increase was driven primarily by increased sales of our CRM/EP, intervention, and access products, offset partially by decreased sales of our angiography products. |
(c) | Custom procedural solutions products, which increased by $2.1 million, or 2.2%, from the corresponding period of 2023. This increase was driven primarily by increased sales of our kits, offset partially by decreased sales of our procedure trays. |
(d) | OEM products, which increased by $0.2 million, or 0.2%, from the corresponding period of 2023. This increase was driven primarily by increased sales of our kits and access products, offset partially by decreased sales of our CRM/EP products. |
Endoscopy Sales. Our endoscopy sales for the three-month period ended June 30, 2024 were $10.2 million, up 16.0% when compared to sales in the corresponding period of 2023 of $8.8 million. Sales for the three-month period ended June 30, 2024 compared to the corresponding period in 2023 were favorably affected by increased sales of our EndoMAXX fully covered esophageal stent, other stents, Elation Pulmonary Balloon Dilators, and ReSolve Thoracostomy Trays.
Our endoscopy sales for the six-month period ended June 30, 2024 were $20.3 million, up 10.6%, when compared to sales in the corresponding period of 2023 of $18.4 million. Sales for the six-month period ended June 30, 2024 compared to the corresponding period in 2023 were favorably affected by increased sales of our other stents, ReSolve Thoracostomy Trays, and Elation Pulmonary Balloon Dilators, offset partially by decreased sales of our AERO Tracheobronchial Stent and probes.
Geographic Sales
Listed below are sales by geography for the three and six-month periods ended June 30, 2024 and 2023 (in thousands, other than percentage changes):
| Three Months Ended | Six Months Ended | ||||||||||||||||
| June 30, | June 30, | ||||||||||||||||
| % Change |
| 2024 |
| 2023 |
| % Change |
| 2024 |
| 2023 | |||||||
United States | 8.4 | % | $ | 194,664 | $ | 179,582 | 8.5 | % | $ | 380,758 | $ | 350,942 | ||||||
International | 2.0 | % | 143,339 | 140,474 | 5.3 | % | 280,753 | 266,679 | ||||||||||
Total |
| 5.6 | % | $ | 338,003 | $ | 320,056 | 7.1 | % | $ | 661,511 | $ | 617,621 |
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United States Sales. U.S. sales for the three-month period ended June 30, 2024 were $194.7 million, or 57.6% of net sales, up 8.4% when compared to the corresponding period of 2023. The increase in our domestic sales for the three-month period ended June 30, 2024, compared to the corresponding period of 2023 was driven primarily by our U.S. Direct and Endoscopy businesses.
U.S. sales for the six-month period ended June 30, 2024 were $380.8 million, or 57.6% of net sales, up 8.5% when compared to the corresponding period of 2023. The increase in our domestic sales for the six-month period ended June 30, 2024, compared to the corresponding period of 2023 was driven primarily by our U.S. Direct, Oncology and Endoscopy businesses.
International Sales. International sales for the three-month period ended June 30, 2024 were $143.3 million, or 42.4% of net sales, up 2.0% when compared to the corresponding period of 2023 of $140.5 million. The increase in our international sales for the three-month period ended June 30, 2024, compared to the corresponding period of 2023 included increased sales in our EMEA operations of $2.7 million or 4.5% and in our ROW operations of $2.1 million or 17.1%, offset partially by decreased sales in our Asia Pacific (“APAC”) operations of ($1.9) million or (2.8%).
International sales for the six-month period ended June 30, 2024 were $280.8 million, or 42.4% of net sales, up 5.3% when compared to the corresponding period of 2023 of $266.7 million. The increase in our international sales for the six-month period ended June 30, 2024, compared to the six-month period ended June 30, 2023, included increased sales in our EMEA operations of $5.7 million or 4.8%, in our ROW operations of $5.0 million or 22.0%, and in our APAC operations of $3.4 million or 2.7%.
Gross Profit
Our gross profit as a percentage of sales was 47.7% for both the three-month periods ended June 30, 2024 and 2023. The consistency in gross profit percentage was primarily due to increased sales combined with favorable changes in standard cost and product mix and lower obsolescence expense, offset by higher intangible amortization expense as a percentage of sales associated with acquisitions.
Our gross profit as a percentage of sales increased to 47.3% for the six-month period ended June 30, 2024, compared to 47.1% for the six-month period ended June 30, 2023. The increase in gross profit percentage was primarily due to an increase in sales combined with favorable changes in standard cost and product mix, partially offset by unfavorable manufacturing variances and higher intangible amortization expense as a percentage of sales associated with acquisitions.
Operating Expenses
Selling, General and Administrative Expense. Selling, general and administrative ("SG&A") expenses decreased ($6.3) million, or (6.3)%, for the three-month period ended June 30, 2024 compared to the corresponding period of 2023. As a percentage of sales, SG&A expenses were 28.0% for the three-month period ended June 30, 2024, compared to 31.5% for the corresponding period of 2023. For the three-month period ended June 30, 2024, SG&A expenses decreased compared to the corresponding period of 2023, primarily due to a decrease in loss on abandonment of property and equipment expense associated with the 2023 write-off of equipment related to our Spine business, a decrease in consulting costs in connection with the Foundations for Growth Program which was completed in 2023, a decrease in acquisition-related expenses associated with due diligence projects, and a decrease in costs associated with idle facilities during line transfers, offset partially by increased labor costs in our sales and marketing operations due to increased headcount to support growth and increased advertising and promotional expenses.
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SG&A expenses decreased ($2.1) million, or (1.1)%, for the six-month period ended June 30, 2024 compared to the corresponding period of 2023. As a percentage of sales, SG&A expenses were 28.6% for the six-month period ended June 30, 2024, compared to 30.9% for the corresponding period of 2023. For the six-month period ended June 30, 2024, SG&A expenses decreased compared to the corresponding period of 2023 primarily due to a decrease in loss on abandonment of property and equipment expense associated with the 2023 write-off of equipment related to our Spine business, a decrease in consulting costs in connection with the Foundations for Growth Program which was completed in 2023, and a decrease in acquisition-related expenses associated with due diligence projects, offset partially by an increase in labor-related costs in our sales and marketing operations due to increased headcount to support growth, an increase of variable compensation linked to company performance, an increase of stock-based compensation expense associated with new equity grants, and an increased investment in advertising and promotional expenses.
Research and Development Expenses. Research and development (”R&D”) expenses for the three-month period ended June 30, 2024 were $20.3 million, up 0.7%, when compared to R&D expenses in the corresponding period of 2023 of $20.1 million. For the three-month period ended June 30, 2024, R&D expenses increased compared to the corresponding period of 2023 primarily due to increased facility and support costs and increased materials for projects, offset partially by decreased regulatory costs related to implementation of the Medical Device Regulation in the E.U. and decreased costs related to clinical studies.
R&D expenses for the six-month period ended June 30, 2024 were $41.7 million, up 0.7%, when compared to R&D expenses in the corresponding period of 2023 of $41.4 million. For the six-month period ended June 30, 2024, R&D expenses increased compared to the corresponding period of 2023 primarily due to increased labor costs due to increased headcount, increased materials for projects, and increased costs related to clinical studies, offset partially by lower regulatory costs related to implementation of the Medical Device Regulation in the E.U.
Impairment Charges. For the three and six-month periods ended June 30, 2024, we recognized no impairment charges. For the three and six-month periods ended June 30, 2023, we recorded impairment charges of $270 thousand due to the acquisition and subsequent write-off of our equity investment in Bluegrass.
Contingent Consideration Expense. For the three and six-month periods ended June 30, 2024, we recognized contingent consideration expense from changes in the estimated fair value of our contingent consideration obligations stemming from our previously disclosed business acquisitions of $0.3 million and $0.2 million compared to contingent consideration expense of $1.1 million and $1.6 million for the three and six-month periods ended June 30, 2023, respectively. Expense in each period related to changes in the probability and timing of achieving certain revenue and operational milestones, as well as expense for the passage of time.
Acquired In-process Research and Development. For the three and six-month periods ended June 30, 2024, we recognized no acquired in-process research and development costs. For the three and six-month periods ended June 30, 2023 we recognized $1.6 million in acquired in-process research and development costs primarily associated with the assets we acquired from Advanced Radiation Therapy, LLC (“ART”) on May 1, 2023.
Operating Income
The following table sets forth our operating income by financial reporting segment for the three and six-month periods ended June 30, 2024 and 2023 (in thousands):
Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||||
Operating Income | ||||||||||||
Cardiovascular | $ | 42,912 | $ | 26,464 | $ | 75,819 | $ | 50,398 | ||||
Endoscopy |
| 3,034 |
| 2,348 |
| 6,049 |
| 4,797 | ||||
Total operating income | $ | 45,946 | $ | 28,812 | $ | 81,868 | $ | 55,195 |
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Cardiovascular Operating Income. Our cardiovascular operating income for the three-month period ended June 30, 2024 was $42.9 million, compared to cardiovascular operating income in the corresponding period of 2023 of $26.5 million. The increase in cardiovascular operating income during the three-month period ended June 30, 2024 compared to the corresponding period of 2023 was primarily a result of higher sales ($327.8 million compared to $311,3 million), lower SG&A expenses, lower acquired in-process research and development charges, lower impairment charges, and lower contingent consideration expense, partially offset by higher R&D expenses.
Our cardiovascular operating income for the six-month period ended June 30, 2024 was $75.8 million, compared to cardiovascular operating income in the corresponding period of 2023 of $50.4 million. The increase in cardiovascular operating income during the six-month period ended June 30, 2024 compared to the corresponding period of 2023 was primarily a result of higher sales ($641.2 million compared to $599.3 million), higher gross margin, lower SG&A, lower acquired in-process research and development charges, lower impairment charges, and lower contingent consideration expense, partially offset by higher R&D expenses.
Endoscopy Operating Income. Our endoscopy operating income for the three-month period ended June 30, 2024 was $3.0 million, compared to endoscopy operating income of $2.3 million for the corresponding period of 2023. Our endoscopy operating income for the six-month period ended June 30, 2024 was $6.0 million, compared to endoscopy operating income of $4.8 million for the corresponding period of 2023. The increase in endoscopy operating income for the three and six-month periods ended June 30, 2024 compared to the corresponding periods of 2023 was primarily a result of increased sales and lower SG&A expenses as a percentage of sales.
Other Expense – Net
Our other expense for the three-month periods ended June 30, 2024 and 2023 was $0.1 million and $3.9 million, respectively. Our other expense for the six-month periods ended June 30, 2024 and 2023 was $1.7 million and $4.8 million, respectively. The changes in other expense for the three and six-month periods ended June 30, 2024 compared to the corresponding periods of 2023 were primarily related to increased interest expense associated with the Convertible Note offering completed in December 2023, partially offset by an increase in interest income associated with higher cash and cash equivalents balances.
Effective Tax Rate
Our provision for income taxes for the three-month periods ended June 30, 2024 and 2023 was a tax expense of $10.1 million and $4.7 million, respectively, which resulted in an effective tax rate of 22.1% and 18.7%, respectively. Our provision for income taxes for the six-month periods ended June 30, 2024 and 2023 was a tax expense of $16.2 million and $9.5 million, respectively, which resulted in an effective tax rate of 20.2% and 18.8%, respectively. The increase in the effective income tax rate for the three and six-month periods ended June 30, 2024, when compared to the prior-year periods, was primarily due to decreased benefit from discrete items such as share-based compensation and deferred compensation and decreased foreign tax credit utilization. The increase in the income tax expense for the three and six-month periods ended June 30, 2024, when compared to the prior-year period, was primarily due to increased pre-tax book income.
Net Income
Our net income for the three-month periods ended June 30, 2024 and 2023 was $35.7 million and $20.2 million, respectively. The increase in our net income for the three-month period ended June 30, 2024 was primarily the result of higher sales, lower SG&A expenses, lower impairment charges, lower acquired in-process research and development charges, and lower contingent consideration expense, partially offset by higher R&D expenses and higher income tax expense.
37
Our net income for the six-month periods ended June 30, 2024 and 2023 was $64.0 million and $40.9 million, respectively. The increase in our net income for the six-month period ended June 30, 2024 was the result of several principal factors, including higher sales and gross margin, lower SG&A expenses, lower impairment charges, lower acquired in-process research and development charges, and lower contingent consideration expense, partially offset by higher R&D expenses and higher income tax expense.
LIQUIDITY AND CAPITAL RESOURCES
Capital Commitments, Contractual Obligations and Cash Flows
As of June 30, 2024 and December 31, 2023, our current assets exceeded current liabilities by $976.3 million and $904.9 million, respectively, and we had cash, cash equivalents and restricted cash of $638.7 million and $589.1 million, respectively, of which $54.0 million and $48.7 million, respectively, were held by foreign subsidiaries. We currently believe future repatriation of cash and other property held by our foreign subsidiaries will generally not be subject to U.S. federal income tax. As a result, we are not permanently reinvested with respect to our historic unremitted foreign earnings. In addition, cash held by our subsidiary in China is subject to local laws and regulations that require government approval for the transfer of such funds to entities located outside of China. As of June 30, 2024, and December 31, 2023, we had cash, cash equivalents and restricted cash of $22.0 million and $17.6 million, respectively, within our subsidiary in China.
Cash flows provided by operating activities. We generated cash from operating activities of $104.7 million and $31.8 million during the six-month periods ended June 30, 2024 and 2023, respectively. Significant factors affecting operating cash flows during these periods included:
● | Net income was $64.0 million and $40.9 million for the six-month periods ended June 30, 2024 and 2023, respectively. |
● | Cash provided by (used for) inventories was approximately $3.1 million and ($35.5) million for the six-month periods ended June 30, 2024 and 2023, respectively. The increase in inventories during 2023 was principally associated with our strategy to proactively invest in our inventory balances to encourage high customer service levels, as well as to build bridge inventory for production line transfers and increases in safety stock due to vendor supply delays. |
● | Cash used for accrued expenses was ($2.8) million and ($10.3) million for the six-month periods ended June 30, 2024 and 2023, respectively, due primarily to the timing and payment of compensation-related accruals, partially offset by an increase in accrued interest associated with the convertible debt. |
● | Cash paid for income taxes was $(22.6) million and $(17.8) million for the six-month periods ended June 30, 2024 and 2023, respectively, due primarily due to an increase in the income tax expense related to increased pre-tax book income. |
Cash flows used in investing activities. We used cash in investing activities of $38.5 million and $157.8 million for the six-month periods ended June 30, 2024 and 2023, respectively. We used cash for capital expenditures of property and equipment of $22.3 million and $18.6 million in the six-month periods ended June 30, 2024 and 2023, respectively. Capital expenditures in each period were primarily related to investments in property and equipment to support development and production of our products. Historically, we have incurred significant expenses in connection with facility construction, production automation, product development and the introduction of new products. We anticipate that we will spend approximately $50 to $60 million in 2024 for property and equipment.
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Cash outflows for the issuance of notes receivable were $6.2 million for the six-month period ended June 30, 2024 and were related to loans issued to Selio of $1.7 million, Solo Pace of $1.5 million and Fluidx of $3.0 million. Cash outflows invested in acquisitions for the six-month period ended June 30, 2024 were $8.5 million and were related to assets acquired from SSI ($3.0 million), our investments in Fluidx ($0.3 million) and CrannMed ($3.2 million), and payment of the first deferred payment from our asset purchase agreement with Restore Endosystems, LLC ($2.0 million). Cash outflows invested in acquisitions for the six-month period ended June 30, 2023 were $138.3 million and were primarily related to payments in our asset purchase agreements with AngioDynamics ($100 million), Bluegrass ($32.7 million) and ART ($1.5 million), and our investment in Solo Pace ($4.0 million).
Cash flows used in financing activities. Cash (used in) provided by financing activities for the six-month periods ended June 30, 2024 and 2023 was ($14.9) million and $141.0 million, respectively. For the six-month period ended June 30, 2024, we decreased our net borrowings under our Amended Fourth A&R Credit Agreement by ($24.1) million. During the six-month period ended June 30, 2023 we increased our net borrowings by approximately $141.8 million to finance the acquisitions of AngioDynamics and Bluegrass. We had cash proceeds from the issuance of common stock of $10.9 million and $9.5 million for the six-month periods ended June 30, 2024 and 2023, respectively, related to the exercise of non-qualified stock options. We completed payment of contingent consideration of ($0.1) million and ($3.4) million for the six-month periods ended June 30, 2024 and 2023, respectively, principally related to sales milestone payments connected to our acquisition of Brightwater Medical, Inc. in 2019.
As of June 30, 2024, we had outstanding borrowings of $822.5 million and had issued letter of credit guarantees of $2.4 million, with additional available borrowings of approximately $680 million under the Amended Fourth A&R Credit Agreement, based on the maximum net leverage ratio and the aggregate revolving credit commitment pursuant to the Amended Fourth A&R Credit Agreement. Our interest rate as of June 30, 2024 was a fixed rate of 3.0% on our Convertible Notes and a fixed rate of 3.39% with respect to the principal amount outstanding under the Amended Fourth A&R Credit Agreement as a result of an interest rate swap. Our interest rate as of December 31, 2023 was a fixed rate of 3.0% on our Convertible Notes, a fixed rate of 3.39% on $75 million as a result of an interest rate swap, and a variable floating rate of 7.21% on $24.1 million.
We currently believe that our existing cash balances, anticipated future cash flows from operations and borrowings under our long-term debt agreements will be adequate to fund our current and currently planned future operations for the next twelve months and the foreseeable future. In the event we pursue and complete significant transactions or acquisitions in the future, additional funds may be required to meet our strategic needs, which may require us to raise additional funds in the debt or equity markets.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Our financial results are affected by the selection and application of accounting policies and methods. In the six-month period ended June 30, 2024 there were no changes to the application of critical accounting policies previously disclosed in Part II, Item 7 of the 2023 Annual Report on Form 10-K.
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CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS
This report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements in this report, other than statements of historical fact, are “forward-looking statements” for purposes of these provisions, including any projections of earnings, revenues or other financial items, any statements of the plans and objectives of our management for future operations, any statements concerning proposed new products or services, any statements regarding the integration, development or commercialization of the business or any assets acquired from other parties, any statements regarding future economic conditions or performance, and any statements of assumptions underlying any of the foregoing. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “expects,” “plans,” “anticipates,” “intends,” “seeks,” “believes,” “estimates,” “potential,” “forecasts,” “continue,” or other forms of these words or similar words or expressions, or the negative thereof or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements contained herein are reasonable, there can be no assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual results will likely differ, and could differ materially, from those projected or assumed in the forward-looking statements. Investors are cautioned not to unduly rely on any such forward-looking statements.
All subsequent forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by these cautionary statements. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. All forward-looking statements included in this report are made as of the date hereof and are based on information available to us as of such date. We assume no obligation to update any forward-looking statement. If we do update or correct one or more forward-looking statements, investors and others should not conclude that we will make additional updates or corrections.
NOTICE REGARDING TRADEMARKS
This report includes trademarks, tradenames and service marks that are our property or the property of others. Solely for convenience, such trademarks and tradenames sometimes appear without any “™” or “®” symbol. However, failure to include such symbols is not intended to suggest, in any way, that we will not assert our rights or the rights of any applicable licensor, to these trademarks and tradenames.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Quantitative and qualitative disclosures about currency exchange rate risk and interest rate risk are included in Part II, Item 7A "Quantitative and Qualitative Disclosures About Market Risk" in the 2023 Annual Report on Form 10-K. In the six-month period ended June 30, 2024, there were no material changes from the information provided therein.
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ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management is responsible for establishing and maintaining adequate disclosure controls and procedures for our company. Consequently, our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures pursuant to Rule 13a-15 under the Exchange Act as of June 30, 2024. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints, and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs. Based on that evaluation, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures are designed at a reasonable assurance level and are effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
During the six-month period ended June 30, 2024, there were no changes in our internal control over financial reporting that materially affected, or were reasonably likely to materially affect, our internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934).
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
See Note 10 “Commitments and Contingencies” set forth in the notes to our consolidated financial statements included in Part I, Item 1 of this report.
ITEM 1A. RISK FACTORS
In addition to other information set forth in this report, readers should carefully consider the factors discussed in Part I, Item 1A. "Risk Factors" of our 2023 Annual Report on Form 10-K, as updated and supplemented below. Any of the risk factors disclosed in our reports could materially affect our business, financial condition or future results. The risks described here and in our 2023 Annual Report on Form 10-K are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially and adversely affect our business, financial condition and/or operating results. The discussion of the risk factors below updates the corresponding disclosure under the same headings in the 2023 Annual Report on Form 10-K and may contain material changes to the corresponding risk factor discussion in our 2023 Annual Report on Form 10-K.
We may be unable to compete in our markets, particularly if there is a significant change in practices or technology.
The markets in which our products compete are highly competitive. We face competition from many companies which are larger, better established, have greater financial, technical and other resources and possess a greater market presence than we do. Such resources and market presence may enable our competitors to more effectively market competing products or to market competing products at reduced prices in order to gain market share.
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In addition, our ability to compete successfully is dependent, in part, upon our response to changes in technology and upon our efforts to develop and market new products which achieve significant market acceptance. Companies with substantially greater resources than us are actively engaged in research and development of new methods, treatments, drugs, and procedures to treat or prevent cardiovascular disease that could limit the market for our products and eventually make some of our products obsolete. Furthermore, our existing competitors and new market entrants may respond more quickly to or integrate new or emerging technologies such as artificial intelligence and machine learning in their product offerings, which could also limit the market for our products. A reduction in demand for our products could have a material adverse effect on our business, operations or financial condition.
We rely on the proper function, availability and security of information technology systems to operate our business, and a material disruption of critical information systems or a material breach in the security of our systems may adversely affect our business and customer relationships.
We rely on information technology systems (including technology from third-party providers) to process, transmit, and store electronic information in our day-to-day operations, including sensitive personal information and proprietary or confidential information. We also rely on our technology infrastructure, among other functions, to interact with customers and suppliers, fulfill orders and bill, collect and make payments, ship products, provide support to customers, fulfill contractual obligations and otherwise conduct business. Our internal information technology systems, as well as those systems maintained by third-party providers, may be subjected to inadvertent leaks, computer viruses or other malicious code, unauthorized access attempts, and ransom or other cyber-attacks (including through phishing emails, attempts to fraudulently induce employees or others to disclose information, and the exploitation of software and operating vulnerabilities), any of which could result in data leaks or otherwise compromise our confidential or proprietary information and disrupt our operations. Cyber-attacks continue to increase in frequency, sophistication and intensity, and are becoming increasingly difficult to detect, especially as they relate to attacks on third-party providers or their vendors. Such attacks are often carried out by motivated and highly skilled actors, who are increasingly well-resourced. Geopolitical events have also increased cybersecurity risks on a global basis. Additionally, the continuing evolution of technology used by us and the third-party providers we rely upon, including cloud-based computing, data hosting and artificial intelligence, create additional exposure to security breaches and loss of access to our confidential or proprietary information. There can be no assurance that our protective measures have prevented or will prevent security breaches, any of which could have a significant impact on our business, reputation and financial condition, particularly attacks that result in our intellectual property and other confidential information being accessed or stolen.
We rely on third-party vendors to supply and support certain aspects of our information technology systems. These vendors could become vulnerable to cyber-attacks, malicious intrusions, breakdowns, interference or other significant disruptions, and their systems may contain defects in design or manufacture or other problems that could result in system disruption or compromise the information security of our own systems. In addition, we continue to grow in part through business and product acquisitions and may face risks associated with defects and vulnerabilities in the systems operated by the other parties to those transactions, or difficulties or other breakdowns or disruptions in connection with the integration of the acquired businesses and products into our information technology systems.
Cyber-attacks could also result in unauthorized access to our systems and products, including personal information of individuals, which could trigger notification requirements, encourage actions by regulatory bodies, result in adverse publicity, prompt us to offer credit support products or services to affected individuals and lead to class action or other civil litigation. If we fail to monitor, maintain or protect our information technology systems and data integrity effectively or fail to anticipate, plan for or manage significant disruptions to these systems, we could (i) lose customers, (ii) be subject to fraud, (iii) breach our agreements with or duties toward customers, physicians, other health care professionals and employees, (iv) be subject to regulatory sanctions or penalties, (v) incur expenses or lose revenues, (vi) sustain damage to our reputation, or (vii) suffer other adverse consequences. Unauthorized tampering, adulteration or interference with our products may also create issues with product functionality that could result in a loss of data, risk to patient safety, and product recalls or field actions. Any of these events could have a material adverse effect on our business, operations or financial condition.
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The SEC has adopted new rules that require us to provide greater disclosure regarding cybersecurity risk management, strategy and governance, as well as disclosure of material cybersecurity incidents. We cannot predict or estimate the amount of additional costs we will incur in order to comply with these rules or the timing of such costs. These rules may also require us to report a cybersecurity incident before we have been able to fully assess its impact or remediate the underlying issue. Efforts to comply with such reporting requirements could divert management's attention from our incident response and could potentially reveal system vulnerabilities to threat actors. Failure to timely report incidents under these or other similar rules could also result in monetary fines, sanctions or subject us to other forms of liability.
ITEM 5. OTHER INFORMATION
During the fiscal quarter ended June 30, 2024,
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ITEM 6. EXHIBITS
Exhibit No. |
| Description |
2.1 | ||
3.1 | ||
3.2 | ||
10.1 | ||
10.2 | ||
31.1 | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2 | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1 | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
32.2 | Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
101 | The following financial information from the quarterly report on Form 10-Q for the quarter ended June 30, 2024, formatted in Inline Extensible Business Reporting Language (iXBRL): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Income, (iii) Consolidated Statements of Comprehensive Income (iv) Consolidated Statements of Stockholders’ Equity, (v) Consolidated Statements of Cash Flows, and (vi) related Condensed Notes to the Unaudited Consolidated Financial Statements, tagged in detail. | |
104 |
| Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document). |
* These exhibits are incorporated herein by reference.
† Indicates management contract or compensatory plan or arrangement.
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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.
MERIT MEDICAL SYSTEMS, INC. | |||
Date: August 1, 2024 | By: | /s/ FRED P. LAMPROPOULOS | |
Fred P. Lampropoulos, President and | |||
Chief Executive Officer | |||
Date: August 1, 2024 | By: | /s/ RAUL PARRA | |
Raul Parra | |||
Chief Financial Officer and Treasurer | |||
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