INTEGRA LIFESCIENCES HOLDINGS CORP - Quarter Report: 2021 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
| ☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | ||||
For the quarterly period ended June 30, 2021
or
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | ||||
For the transition period from to
COMMISSION FILE NO. 0-26224
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
| Delaware | 51-0317849 | |||||||||||||
| (STATE OR OTHER JURISDICTION OF INCORPORATION OR ORGANIZATION) | (I.R.S. EMPLOYER IDENTIFICATION NO.) | |||||||||||||
| 1100 Campus Road | 08540 | |||||||||||||
| Princeton | , | New Jersey | (ZIP CODE) | |||||||||||
| (ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) | ||||||||||||||
Registrant's Telephone Number, Including Area Code: (609) 275-0500
Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report:
Securities registered pursuant to Section 12(b) of the Act:
| TITLE OF EACH CLASS | TRADING SYMBOL | NAME OF EACH EXCHANGE ON WHICH REGISTERED | ||||||
| Common Stock, Par Value $.01 Per Share | IART | Nasdaq Global Select Market | ||||||
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of large accelerated filer, accelerated filer, smaller reporting company, and "emerging growth company" in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☒ | Accelerated filer | ☐ | ||||||||
| Non-accelerated filer | ☐ | Smaller reporting company | ☐ | ||||||||
| Emerging growth company | ☐ | ||||||||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☐ No ☒
The number of shares of the registrant’s Common Stock, $0.01 par value, outstanding as of July 27, 2021 was 84,579,542.
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
INDEX
| Page Number | |||||
| EX-101 INSTANCE DOCUMENT | |||||
| EX-101 SCHEMA DOCUMENT | |||||
| EX-101 CALCULATION LINKBASE DOCUMENT | |||||
| EX-101 DEFINITION LINKBASE DOCUMENT | |||||
| EX-101 LABELS LINKBASE DOCUMENT | |||||
| EX-101 PRESENTATION LINKBASE DOCUMENT | |||||
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE INCOME / (LOSS)
(UNAUDITED)
(Dollars in thousands, except per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| Total revenue, net | $ | 389,992 | $ | 258,665 | $ | 750,063 | $ | 612,989 | |||||||||||||||
| Costs and expenses: | |||||||||||||||||||||||
| Cost of goods sold | 151,267 | 105,478 | 297,090 | 238,954 | |||||||||||||||||||
| Research and development | 20,121 | 14,926 | 42,495 | 35,742 | |||||||||||||||||||
| Selling, general and administrative | 162,552 | 116,108 | 319,185 | 282,060 | |||||||||||||||||||
| Intangible asset amortization | 4,198 | 8,073 | 8,725 | 15,050 | |||||||||||||||||||
| Total costs and expenses | 338,138 | 244,585 | 667,495 | 571,806 | |||||||||||||||||||
| Operating income | 51,854 | 14,080 | 82,568 | 41,183 | |||||||||||||||||||
| Interest income | 1,764 | 2,281 | 3,512 | 4,851 | |||||||||||||||||||
| Interest expense | (13,149) | (15,682) | (26,078) | (33,434) | |||||||||||||||||||
| Gain (loss) from the sale of business | (679) | — | 42,197 | — | |||||||||||||||||||
| Other income, net | 5,034 | 972 | 9,903 | 493 | |||||||||||||||||||
| Income before income taxes | 44,824 | 1,651 | 112,102 | 13,093 | |||||||||||||||||||
| Provision for income taxes | 9,756 | 2,020 | 31,640 | 4,282 | |||||||||||||||||||
| Net income (loss) | $ | 35,068 | $ | (369) | $ | 80,462 | $ | 8,811 | |||||||||||||||
| Net income per share | |||||||||||||||||||||||
| Basic | $ | 0.41 | $ | (0.00) | $ | 0.95 | $ | 0.10 | |||||||||||||||
| Diluted | $ | 0.41 | $ | (0.00) | $ | 0.94 | $ | 0.10 | |||||||||||||||
| Weighted average common shares outstanding (See Note 13): | |||||||||||||||||||||||
| Basic | 84,687 | 84,706 | 84,593 | 84,955 | |||||||||||||||||||
| Diluted | 85,340 | 84,706 | 85,324 | 85,548 | |||||||||||||||||||
| Comprehensive income (loss) (See Note 14) | 28,731 | 1,095 | 104,558 | $ | (17,912) | ||||||||||||||||||
The accompanying unaudited notes are an integral part of these condensed consolidated financial statements.
4
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(Dollars in thousands, except per share amounts)
| June 30, 2021 | December 31, 2020 | ||||||||||
| ASSETS | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 397,414 | $ | 470,166 | |||||||
Trade accounts receivable, net of allowances of $6,687 and $6,439 | 229,823 | 225,532 | |||||||||
| Inventories, net | 323,618 | 310,117 | |||||||||
| Prepaid expenses and other current assets | 81,527 | 69,282 | |||||||||
| Assets held for sale | — | 162,105 | |||||||||
| Total current assets | 1,032,382 | 1,237,202 | |||||||||
| Property, plant and equipment, net | 295,759 | 287,529 | |||||||||
| Right of use asset - operating leases | 89,174 | 83,635 | |||||||||
| Intangible assets, net | 1,178,884 | 989,436 | |||||||||
| Goodwill | 1,015,638 | 932,367 | |||||||||
| Deferred tax assets, net | 80,086 | 73,690 | |||||||||
| Other assets | 20,864 | 11,277 | |||||||||
| Total assets | $ | 3,712,787 | $ | 3,615,136 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Current portion of borrowings under senior credit facility | $ | 45,000 | $ | 33,750 | |||||||
| Current portion of borrowings under securitization facility | — | 112,500 | |||||||||
| Current portion of lease liability - operating leases | 13,987 | 12,818 | |||||||||
| Accounts payable, trade | 65,512 | 54,608 | |||||||||
| Income taxes payable | 17,112 | — | |||||||||
| Contract liabilities | 5,890 | 5,275 | |||||||||
| Accrued compensation | 72,047 | 76,117 | |||||||||
| Accrued expenses and other current liabilities | 99,208 | 94,194 | |||||||||
| Liabilities held for sale | — | 11,751 | |||||||||
| Total current liabilities | 318,756 | 401,013 | |||||||||
| Long-term borrowings under senior credit facility | 823,208 | 933,387 | |||||||||
| Long-term borrowings under securitization facility | 112,500 | — | |||||||||
| Long-term convertible securities | 562,968 | 474,834 | |||||||||
| Lease liability - operating leases | 95,196 | 88,118 | |||||||||
| Deferred tax liabilities | 63,447 | 16,190 | |||||||||
| Other liabilities | 161,731 | 186,727 | |||||||||
| Total liabilities | 2,137,806 | 2,100,269 | |||||||||
| Stockholders’ equity: | |||||||||||
Preferred stock; no par value; 15,000 authorized shares; none outstanding | — | — | |||||||||
Common stock; $0.01 par value; 240,000 authorized shares; 89,474 and 89,251 issued at June 30, 2021 and December 31, 2020, respectively | 895 | 893 | |||||||||
| Additional paid-in capital | 1,248,555 | 1,290,909 | |||||||||
Treasury stock, at cost; 4,899 shares and 4,914 shares at June 30, 2021 and December 31, 2020, respectively | (234,461) | (235,141) | |||||||||
| Accumulated other comprehensive loss | (49,963) | (74,059) | |||||||||
| Retained earnings | 609,955 | 532,265 | |||||||||
| Total stockholders’ equity | 1,574,981 | 1,514,867 | |||||||||
| Total liabilities and stockholders’ equity | $ | 3,712,787 | $ | 3,615,136 | |||||||
The accompanying unaudited notes are an integral part of these condensed consolidated financial statements.
5
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(Dollars in thousands)
| Six Months Ended June 30, | |||||||||||
| 2021 | 2020 | ||||||||||
| OPERATING ACTIVITIES: | |||||||||||
| Net income | $ | 80,462 | $ | 8,811 | |||||||
| Adjustments to reconcile net income to net cash provided by operating activities: | |||||||||||
| Depreciation and amortization | 58,968 | 58,826 | |||||||||
| Non-cash impairment charges | 2,754 | — | |||||||||
| Deferred income tax (benefit) provision | (4,907) | (401) | |||||||||
| Share-based compensation | 22,033 | 8,922 | |||||||||
| Amortization of debt issuance costs and expenses associated with debt refinancing | 3,569 | 5,551 | |||||||||
| Non-cash lease expense | 2,528 | 1,760 | |||||||||
| Accretion of bond issuance discount | — | 6,780 | |||||||||
| Loss on disposal of property and equipment | 86 | 517 | |||||||||
| Gain from the sale of business | (42,197) | — | |||||||||
| Change in fair value of contingent consideration and others | (385) | (708) | |||||||||
| Changes in assets and liabilities: | |||||||||||
| Accounts receivable | 10,802 | 95,293 | |||||||||
| Inventories | 2,893 | (47,041) | |||||||||
| Prepaid expenses and other current assets | (8,061) | 2,191 | |||||||||
| Other non-current assets | 4,067 | 6,149 | |||||||||
| Accounts payable, accrued expenses and other current liabilities | 27,277 | (88,671) | |||||||||
| Other non-current liabilities | 482 | (4,048) | |||||||||
| Net cash provided by operating activities | 160,371 | 53,931 | |||||||||
| INVESTING ACTIVITIES: | |||||||||||
| Purchases of property and equipment | (13,309) | (23,736) | |||||||||
| Proceeds from sale of Extremity Orthopedics business | 191,736 | — | |||||||||
| Proceeds from sale of property and equipment | — | 3,302 | |||||||||
| Cash (paid) provided for business acquisitions, net of cash acquired | (303,910) | — | |||||||||
| Acquired in-process research and development | — | (5,000) | |||||||||
| Net cash used in investing activities | (125,483) | (25,434) | |||||||||
| FINANCING ACTIVITIES: | |||||||||||
| Proceeds from borrowings of long-term indebtedness | 2,200 | 127,700 | |||||||||
| Payments on debt | (102,200) | (388,500) | |||||||||
| Purchase of option hedge on convertible notes | — | (104,248) | |||||||||
| Proceeds from convertible notes issuance | — | 575,000 | |||||||||
| Proceeds from sale of stock purchase warrants | — | 44,563 | |||||||||
| Payment of debt issuance costs | (249) | (20,264) | |||||||||
| Purchases of treasury stock | — | (100,000) | |||||||||
| Proceeds from exercised stock options | 3,603 | 3,598 | |||||||||
| Cash taxes paid in net equity settlement | (3,844) | (4,397) | |||||||||
| Net cash (used) provided by financing activities | (100,490) | 133,452 | |||||||||
| Effect of exchange rate changes on cash and cash equivalents | (7,150) | 121 | |||||||||
| Net increase in cash and cash equivalents | (72,752) | 162,070 | |||||||||
| Cash and cash equivalents at beginning of period | 470,166 | 198,911 | |||||||||
| Cash and cash equivalents at end of period | $ | 397,414 | $ | 360,981 | |||||||
The accompanying unaudited notes are an integral part of these condensed consolidated financial statements.
6
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDER'S EQUITY
(UNAUDITED)
(Dollars in thousands, except per share amounts)
| Six Months Ended June 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||
| Common Stock | Treasury Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Retained Earnings | Total Equity | ||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||||||
| Balance, January 1, 2021 | 89,251 | $ | 893 | (4,914) | $ | (235,141) | $ | 1,290,909 | $ | (74,059) | $ | 532,265 | $ | 1,514,867 | |||||||||||||||||||||||||||||||||
| Net income | — | — | — | — | — | — | 45,394 | 45,394 | |||||||||||||||||||||||||||||||||||||||
| Other comprehensive income, net of tax | — | — | — | — | — | 30,432 | — | 30,432 | |||||||||||||||||||||||||||||||||||||||
| Issuance of common stock through employee stock purchase plan | 18 | — | — | — | 1,127 | — | — | 1,127 | |||||||||||||||||||||||||||||||||||||||
| Issuance of common stock for vesting of share based awards, net of shares withheld for taxes | 137 | 1 | 15 | 680 | (3,222) | — | — | (2,541) | |||||||||||||||||||||||||||||||||||||||
| Share-based compensation | — | — | — | — | 6,098 | — | — | 6,098 | |||||||||||||||||||||||||||||||||||||||
| Adoption of Update No. 2020-06 | — | — | — | — | (63,274) | — | (2,772) | (66,046) | |||||||||||||||||||||||||||||||||||||||
| Balance, March 31, 2021 | 89,406 | 894 | (4,899) | (234,461) | 1,231,638 | (43,627) | 574,887 | 1,529,331 | |||||||||||||||||||||||||||||||||||||||
| Net income | — | — | — | — | — | — | 35,068 | 35,068 | |||||||||||||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | — | — | — | — | — | (6,336) | — | (6,336) | |||||||||||||||||||||||||||||||||||||||
| Issuance of common stock for vesting of share based awards, net of shares withheld for taxes | 68 | 1 | — | — | 1,175 | — | — | 1,176 | |||||||||||||||||||||||||||||||||||||||
| Share-based compensation | — | — | — | — | 15,742 | — | — | 15,742 | |||||||||||||||||||||||||||||||||||||||
| Balance, June 30, 2021 | 89,474 | $ | 895 | (4,899) | $ | (234,461) | $ | 1,248,555 | $ | (49,963) | $ | 609,955 | $ | 1,574,981 | |||||||||||||||||||||||||||||||||
| Six Months Ended June 30, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||
| Common Stock | Treasury Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Retained Earnings | Total Equity | ||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||||||
| Balance, January 1, 2020 | 88,735 | $ | 887 | (2,865) | $ | (119,943) | $ | 1,213,620 | $ | (76,401) | $ | 398,573 | $ | 1,416,736 | |||||||||||||||||||||||||||||||||
| Net income | — | — | — | — | — | — | 9,180 | 9,180 | |||||||||||||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | — | — | — | — | — | (28,187) | — | (28,187) | |||||||||||||||||||||||||||||||||||||||
| Issuance of common stock through employee stock purchase plan | 13 | — | — | — | 694 | — | — | 694 | |||||||||||||||||||||||||||||||||||||||
| Issuance of common stock for vesting of share based awards, net of shares withheld for taxes | 357 | 2 | 10 | 476 | (3,217) | — | — | (2,739) | |||||||||||||||||||||||||||||||||||||||
| Share-based compensation | — | — | — | — | 3,781 | — | — | 3,781 | |||||||||||||||||||||||||||||||||||||||
| Share repurchase and equity component of the convertible note issuance, net | — | — | (135) | (7,632) | 42,538 | — | — | 34,906 | |||||||||||||||||||||||||||||||||||||||
| Accelerated shares repurchased | — | — | (1,304) | (75,407) | (16,961) | — | — | (92,368) | |||||||||||||||||||||||||||||||||||||||
| — | — | — | — | — | — | (200) | (200) | ||||||||||||||||||||||||||||||||||||||||
| Balance, March 31, 2020 | 89,105 | $ | 889 | (4,294) | $ | (202,506) | $ | 1,240,455 | $ | (104,588) | $ | 407,553 | $ | 1,341,803 | |||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | — | — | (369) | (369) | |||||||||||||||||||||||||||||||||||||||
| Other comprehensive income, net of tax | — | — | — | — | — | 1,464 | — | 1,464 | |||||||||||||||||||||||||||||||||||||||
| Issuance of common stock for vesting of share based awards, net of shares withheld for taxes | 84 | 3 | — | (35) | 1,282 | — | — | 1,250 | |||||||||||||||||||||||||||||||||||||||
| Share-based compensation | — | — | — | — | 4,948 | — | — | 4,948 | |||||||||||||||||||||||||||||||||||||||
| Accelerated shares repurchased | — | — | (621) | (32,685) | 32,685 | — | — | — | |||||||||||||||||||||||||||||||||||||||
| Balance, June 30, 2020 | 89,189 | 892 | (4,915) | (235,226) | 1,279,370 | (103,124) | 407,184 | 1,349,096 | |||||||||||||||||||||||||||||||||||||||
The accompanying unaudited notes are an integral part of these condensed consolidated financial statements.
7
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1. BASIS OF PRESENTATION
General
The terms “we,” “our,” “us,” “Company” and “Integra” refer to Integra LifeSciences Holdings Corporation, a Delaware corporation, and its subsidiaries unless the context suggests otherwise.
In the opinion of management, the June 30, 2021 unaudited condensed consolidated financial statements contain all adjustments (consisting only of normal recurring adjustments) necessary for a fair statement of the financial position, statement of changes in shareholder's equity, results of operations and cash flows of the Company. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s consolidated financial statements for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K. The December 31, 2020 consolidated balance sheet was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States. Operating results for the three and six month period ended June 30, 2021 are not necessarily indicative of the results to be expected for the entire year.
The preparation of consolidated financial statements is in conformity with generally accepted accounting principles in the United States ("GAAP") which requires management to make estimates and assumptions that affect the reported amount of assets and liabilities, the disclosure of contingent liabilities, and the reported amounts of revenues and expenses. Significant estimates affecting amounts reported or disclosed in the consolidated financial statements include allowances for doubtful accounts receivable and sales returns and allowances, net realizable value of inventories, valuation of intangible assets including amortization periods for acquired intangible assets, discount rates and estimated projected cash flows used to value and test impairments of long-lived assets and goodwill, estimates of projected cash flows and depreciation and amortization periods for long-lived assets, computation of taxes, valuation allowances recorded against deferred tax assets, the valuation of stock-based compensation, valuation of derivative instruments, valuation of contingent liabilities, the fair value of debt instruments and loss contingencies. These estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the current circumstances. Actual results could differ from these estimates.
Risks and Uncertainties
The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. During the beginning of 2020, the Company's customers diverted resources to treat COVID-19 patients and deferred or canceled elective or non-emergent surgical procedures, all of which impacted hospitals' abilities to meet their obligations, including to the Company. Towards the end of 2020 and during the first half of 2021, procedural volumes relevant to the Company’s products steadily increased and, in some geographic areas, began to approach normalized levels. However, on-going uncertainty persists about the continuing sustainability of those procedural volumes as virus outbreaks constrain healthcare networks. Furthermore, capital markets and economies worldwide have also been negatively impacted by the COVID-19 pandemic, and it is possible that it could cause a local and/or global economic recession. Such economic disruption has had an adverse effect on the Company's business as customers curtailed and reduced capital and overall spending. Policymakers around the globe have responded with fiscal policy actions to support the healthcare industry and the economy as a whole. The magnitude and overall effectiveness of these actions remains uncertain. The severity of the impact of the COVID-19 pandemic on the Company's business will depend on a number of factors, including, but not limited to, duration of the pandemic, including resurgences, new variants or strains, impact of government regulations, the speed and effectiveness of vaccine distribution, vaccine adoption rates and the direct and indirect economic effects of the pandemic and containment measures. The Company's future results of operations and liquidity could be adversely impacted by delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions and uncertain demand, and the impact of any initiatives or programs that the Company may undertake to address financial and operations challenges faced by its customers. During the first half of 2021, the Company's revenues were still impacted due to COVID-19 resurgences and lower surgical procedural volumes, though not to the levels seen in early 2020. As a result, the Company has continued to manage its operating costs in this environment. Even after the COVID-19 pandemic and government responses thereto have subsided, residual economic and other effects may have an impact on the demand for post-pandemic surgery levels that are difficult to predict.
8
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
Recent Accounting Pronouncements
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The ASU is intended to improve financial reporting by requiring timelier recording of credit losses on loans and other financial instruments held by financial institutions and other organizations. The ASU requires the measurement of all expected credit losses for financial assets including trade receivables held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Financial institutions and other organizations will now use forward-looking information to better inform their credit loss estimates. The ASU became effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company adopted this guidance on January 1, 2020 using a modified retrospective transition method which requires a cumulative-effect adjustment to the opening balance of retained earnings to be recognized on the date of adoption with no change to financial results reported in prior periods. The cumulative-effect adjustment recorded on January 1, 2020 is not material. The adoption of this ASU did not have a significant impact on the Company's consolidated financial statements and related disclosures.
The Company's exposure to credit losses may increase if its customers are adversely affected by changes in healthcare laws, coverage, and reimbursement, economic pressures or uncertainty associated with local or global economic recessions, disruption associated with the COVID-19 pandemic, and other customer-specific factors. Although the Company has historically not experienced significant credit losses, it is possible that there could be an adverse impact due to customer and governmental responses to the COVID-19 pandemic.
In August 2018, the FASB issued ASU 2018-14, Compensation-Retirement Benefits-Defined Benefit Plans-General (Subtopic 715-20): Disclosure Framework-Changes to the Disclosure Requirements for Defined Benefit Plans. This guidance modifies the disclosure requirements for employers that sponsor defined benefit pension or other postretirement plans. The ASU is effective for fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. Early adoption was permitted. The Company adopted this guidance during the year ended December 31, 2020. The adoption of this guidance did not have a significant impact on the Company's consolidated financial statements and related disclosures.
In August 2018, the FASB issued ASU 2018-15, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40), relating to a customer's accounting for implementation, set-up, and other upfront costs incurred in a cloud computing arrangement that is hosted by a vendor (e.g., a service contract). Under this guidance, a customer will apply the same criteria for capitalizing implementation costs as it would for an arrangement that has a software license. The new guidance also prescribes the balance sheet, income statement, and cash flow classification of the capitalized implementation costs and related amortization expense, and requires additional quantitative and qualitative disclosures. The ASU is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company adopted this guidance on January 1, 2020 using a prospective transition method. The adoption of this guidance did not have a significant impact on the Company's consolidated financial statements and related disclosures.
In December 2019, the FASB issued ASU 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes, intended to simplify the accounting for income taxes by eliminating certain exceptions related to the approach for intra-period tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. This guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. The standard is effective for annual periods beginning after December 15, 2020 and interim periods within, with early adoption permitted. The Company adopted ASU No. 2019-12 as of January 1, 2021. Adoption of the standard requires certain changes to be made prospectively, with some changes to be made retrospectively. The adoption of this guidance did not have a material impact on the Company's results or financial position.
In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform, which provides optional guidance for a limited period of time to ease the potential burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting. This amendment applies to all entities, subject to meeting certain criteria, that have contracts, hedging relationships, and other transactions that reference London Inter-Bank Offered Rate ("LIBOR") or another reference rate expected to be discontinued because of reference rate reform. This ASU is effective immediately and may be applied prospectively to contract modifications made and hedging relationships entered into or evaluated on or before December 31, 2022. In January 2021, the FASB also issued ASU 2021-01, Reference Rate Reform- Scope which clarified certain optional expedients and exceptions to entities that are affected because of the reference rate reform. The amendments in this ASU affect the guidance in ASU 2020-04 and are effective in the same timeframe as ASU 2020-04. The Company is currently assessing the impact that this ASU will have on its consolidated financial statements and related disclosures.
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INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
In August 2020, the FASB issued ASU 2020-06, Debt- Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging Contracts in Entity's Own Equity (Subtopic 815-40)-Accounting for Convertible Instruments and Contracts in an Entity's Own Equity. The guidance simplifies accounting for convertible instruments by removing major separation models required under current GAAP. Consequently, more convertible debt instruments will be reported as a single liability instrument with no separate accounting for embedded conversion features. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, which will permit more equity contracts to qualify. The guidance also simplifies the diluted net income per share calculation in certain areas. The ASU will be effective for annual and interim periods beginning after December 15, 2021, and early adoption is permitted for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years using either the modified retrospective or full retrospective method.
As detailed in Note 6 – Debt, on February 4, 2020, the Company issued $575.0 million aggregate principal amount of its 0.5% Convertible Senior Notes due 2025 (the "2025 Notes"). The 2025 Notes are subject to the guidance included in ASU 2020-06. The Company adopted this guidance on January 1, 2021 using the modified retrospective approach which resulted in a cumulative-effect adjustment that increased (decreased) the following consolidated balance sheet accounts:
| ADJUSTMENT | CONSOLIDATED BALANCE SHEET CLASSIFICATION | AMOUNT (in millions) | ||||||||||||
| Deferred tax impact of cumulative-effect adjustment | Deferred tax liabilities | $ | (20.6) | |||||||||||
| Debt discount reclassification | Long-term convertible securities | 89.1 | ||||||||||||
| Equity issuance costs reclassification | Long-term convertible securities | (2.5) | ||||||||||||
| Debt discount amortization and equity costs reclassification, net of tax | Retained Earnings | (2.8) | ||||||||||||
| Net impact of cumulative-effect adjustment | Additional paid-in capital | (63.3) | ||||||||||||
Upon adoption of this ASU 2020-06, the Company’s Convertible Senior Notes were reflected entirely as a liability since the embedded conversion feature will no longer be separately presented within stockholders’ equity. On December 9, 2020, the Company made an irrevocable election under the indenture to require the principal portion of its convertible senior notes to be settled in cash and any excess in shares. Following the irrevocable notice, only the amounts settled in excess of the principal will be considered in diluted earnings per share under the “if-converted” method. Additionally, from January 1, 2021, the Company is no longer incurring non-cash interest expense for the amortization of debt discount, therefore the interest expense for the 2025 Notes, which is included in the interest expense on the consolidated statements of operations and comprehensive loss, is lower as compared to the fiscal year of 2020.
In October 2020, the FASB issued ASU 2020-10, Codification Improvements, which updates various codification topics by clarifying or improving disclosure requirements to align with the SEC’s regulations. The ASU will be effective for the Company for annual and interim periods beginning after January 1, 2021. The Company adopted this standard on the January 1, 2021. The adoption of this guidance did not have a material impact on the Company's results, financial position or disclosures.
In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options which provides guidance to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. The amendments in this ASU No. 2021-04 are effective for all entities for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years, with early adoption permitted, including interim periods within those fiscal years. The amendment currently has no impact to the Company as the effect will largely depend on the terms of written call options or financings issued or modified in the future.
There are no other recently issued accounting pronouncements that are expected to have any significant effect on the Company's financial position, results of operations or cash flows.
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INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
2. ACQUISITIONS AND DIVESTITURES
Sale of Extremity Orthopedics Business
On January 4, 2021, the Company completed its previously announced sale of its Extremity Orthopedics business to Smith & Nephew USD Limited ("Smith & Nephew"). The transaction included the sale of the Company's upper and lower Extremity Orthopedics product portfolio, including ankle and shoulder arthroplasty and hand and wrist product lines. The Company received an aggregate purchase price of $240.0 million from Smith and Nephew and concurrently paid $41.5 million to the Consortium of Focused Orthopedists, LLC ("CFO") effectively terminating the licensing agreement between Integra and CFO relating to the development of shoulder arthroplasty products.
Assets and liabilities divested consisted of the following as of December 31, 2020 (dollar amounts in thousands):
| Prepaid expenses and other current assets | $ | 713 | |||
| Right of use asset-operating leases and Other assets | 3,186 | ||||
| Deferred tax assets | 6,589 | ||||
| Intangible assets, net | 13,332 | ||||
| Property, plant and equipment, net | 37,893 | ||||
| Goodwill | 47,546 | ||||
| Inventories | 52,845 | ||||
| Total assets held for sale | $ | 162,104 | |||
| Other liabilities | 336 | ||||
| Current portion of lease liability - operating leases | 539 | ||||
| Accrued compensation | 1,767 | ||||
| Deferred tax liabilities | 3,440 | ||||
| Lease liability - operating leases | 5,669 | ||||
| Total liabilities held for sale | $ | 11,751 | |||
The Divestiture does not represent a strategic shift that will have a major effect on the Company's operations and financial statements. Goodwill was allocated to the assets and liabilities divested using the relative fair value method of the Extremity Orthopedics business to the Company's Tissue Technologies reporting unit. In connection with the sale, the Company recognized a loss of $0.7 million associated with certain working capital adjustments and gain of $42.2 million that is presented in Gain from the sale of business in the consolidated statement of operations for the three and six months ended June 30, 2021. The net proceeds are subject to adjustments based on changes in the actual closing net working capital. The purchase price is preliminary pending finalization of potential working capital adjustments.
The Company also entered into a transition services agreement ("TSA") with Smith & Nephew which requires the Company to provide certain services on behalf of Smith & Nephew for the duration of the period subsequent to the sale of the business as defined in the agreement. The Company recognized a payable due to Smith & Nephew of $10.9 million as of June 30, 2021, included in the consolidated balance sheet within accrued expenses and other current liabilities respectively.
ACell Inc. Acquisition
On January 20, 2021, the Company acquired ACell Inc. (the "ACell Acquisition") for an acquisition purchase price of $306.9 million plus contingent consideration of up to $100 million, that may be payable upon achieving certain revenue-based performance milestones in 2022, 2023 and 2025. The final working capital adjustments of $1.3 million was finalized and paid as of June 30, 2021; however certain amounts relating to tax related matters have not been finalized. The finalization of these matters may result in changes to goodwill. ACell was a privately-held company that offered a portfolio of regenerative products for complex wound management, including developing and commercializing products based on MatriStem Urinary Bladder Matrix ("UBM"), a technology platform derived from porcine urinary bladder extracellular matrix.
Assets Acquired and Liabilities Assumed at Fair Value
The ACell Acquisition has been accounted for using the acquisition method of accounting. This method requires that assets acquired and liabilities assumed in a business combination are recognized at their fair values as of the acquisition date.
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INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
The following table summarizes the preliminary fair values of the assets acquired and liabilities assumed at the acquisition date:
| Dollars in thousands | Preliminary Valuation as of June 30, 2021 | Weighted Average Life | |||||||||
| Current assets: | |||||||||||
| Cash | $ | 2,726 | |||||||||
| Trade accounts receivable, net | 16,469 | ||||||||||
| Inventories, net | 18,299 | ||||||||||
| Prepaids expenses and other current assets | 1,498 | ||||||||||
| Total current assets | 38,992 | ||||||||||
| Property, plant and equipment, net | 13,769 | ||||||||||
| Intangible assets | 245,000 | 13-14 years | |||||||||
| Goodwill | 94,298 | ||||||||||
| Right of use asset - operating leases | 9,259 | ||||||||||
| Deferred tax assets | 9,768 | ||||||||||
| Other assets | 148 | ||||||||||
| Total assets acquired | 411,234 | ||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 718 | |||||||||
| Accrued expenses | 5,966 | ||||||||||
| Current portion of lease liability - operating leases | 1,673 | ||||||||||
| Total current liabilities | 8,357 | ||||||||||
| Other long-term liability | 276 | ||||||||||
| Lease liability - operating leases | 7,585 | ||||||||||
| Deferred tax liability | 64,178 | ||||||||||
| Contingent consideration | 23,900 | ||||||||||
| Total liabilities assumed | 104,296 | ||||||||||
| Net assets acquired | $ | 306,938 | |||||||||
Intangible Assets
The estimated fair value of the developed technology acquired was determined using the multi-period excess earnings method of the income approach, which estimates value based on the present value of future economic benefits. Some of the more significant assumptions inherent in the development of those asset valuations include the estimated net cash flows for each year for each product including net revenues, cost of sales, R&D costs, selling and marketing costs, the appropriate discount rate to select in order to measure the risk inherent in each future cash flow stream, the assessment of each asset’s life cycle, and competitive trends impacting the asset and each cash flow stream.
The Company used a discount rate of 8.5% to arrive at the present value for the acquired intangible assets to reflect the rate of return a market participant would expect to earn and incremental commercial uncertainty in the cash flow projections. No assurances can be given that the underlying assumptions used to prepare the discounted cash flow analysis will not change. For these and other reasons, actual results may vary significantly from estimated results.
Goodwill
The Company allocated goodwill related to the ACell Acquisition to the Tissue Technologies segment. Goodwill is the excess of the consideration transferred over the net assets recognized and represents the expected synergies of the combined company and assembled workforce. Goodwill recognized as a result of this acquisition is non-deductible for income tax purposes.
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INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
Contingent Consideration
As part of the acquisition, the Company is required to pay the former shareholders of ACell up to $100 million based on the achievement of certain revenue-based performance milestones in 2022, 2023, and 2025. The Company used iterations of the Monte Carlo simulation to calculate the fair value of the contingent consideration that considered the possible outcomes of scenarios related to each specific milestone. The Company estimated the fair value of the contingent consideration to be $23.9 million at the acquisition date. The estimated fair value as of June 30, 2021 was $23.5 million. This amount is included in other liabilities at June 30, 2021 in the consolidated balance sheets of the Company.
The Company determines the acquisition date fair value of contingent consideration obligations using a Monte Carlo simulation, as well as significant unobservable inputs, reflecting the Company’s assessment of the assumptions market participants would use to value these liabilities. The fair value measurement is based on significant inputs not observable in the market and thus represents a Level 3 measurement as defined using the fair value concepts in ASC 820. The resultant most likely payouts are discounted using an appropriate effective annual interest rate. At each reporting date, the contingent consideration obligation will be revalued to estimated fair value and changes in fair value will be reflected as income or expense in our consolidated statement of operations. Changes in the fair value of the contingent considerations may result from changes in discount periods and rates and changes in the timing and amount of revenue estimates.
Deferred Tax Liabilities
Deferred tax liabilities result from identifiable intangible assets’ fair value adjustments. These adjustments create excess book basis over tax basis which is tax-effected by the statutory tax rates of applicable jurisdictions.
Pro Forma Results (unaudited)
Pro forma revenues for the three months ended June 30, 2021 and 2020 were $390.0 million and $269.6 million, respectively. Pro forma revenues for the six months ended June 30, 2021 and 2020 were $754.7 million and $646.9 million, respectively. Pro forma net income and earnings per share are not presented for this acquisition as they are not material.
3. REVENUES FROM CONTRACTS WITH CUSTOMERS
Summary of Accounting Policies on Revenue Recognition
Revenue is recognized upon the transfer of control of promised products or services to the customers in an amount that reflects the consideration the Company expects to receive in exchange for those products and services.
Performance Obligations
The Company's performance obligations consist mainly of transferring control of goods and services identified in the contracts, purchase orders, or invoices. The Company has no significant multi-element contracts with customers.
Significant Judgments
Usage-based royalties and licenses are estimated based on the provisions of contracts with customers and recognized in the same period that the royalty-based products are sold by the Company and the Company's strategic partners. The Company estimates and recognizes royalty revenue based upon communication with licensees, historical information, and expected sales trends. Differences between actual reported licensee sales and those that were estimated are adjusted in the period in which they become known, which is typically the following quarter. Historically, such adjustments have not been significant.
The Company estimates returns, price concessions, and discount allowances using the expected value method based on historical trends and other known factors. Rebate allowances are estimated using the most likely method based on each customer contract.
The Company's return policy, as set forth in its product catalogs and sales invoices, requires review and authorization in advance prior to the return of product. Upon the authorization, a credit will be issued for the goods returned within a set amount of days from the shipment, which is generally ninety days.
The Company disregards the effects of a financing component if the Company expects, at contract inception, that the period between the transfer and customer payment for the goods or services will be one year or less. The Company has no significant revenues recognized on payments expected to be received more than one year after the transfer of control of products or services to customers.
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INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
Contract Asset and Liability
Revenues recognized from the Company's private label business that are not invoiced to the customers as a result of recognizing revenue over time are recorded as a contract asset included in the prepaid expenses and other current assets account in the consolidated balance sheet.
Other operating revenues may include fees received under service agreements. Non-refundable fees received under multiple-period service agreements are recognized as revenue as the Company satisfies the performance obligations to the other party. A portion of the transaction price allocated to the performance obligations to be satisfied in the future periods is recognized as contract liability.
The following table summarizes the changes in the contract asset and liability balances for the six months ended June 30, 2021:
| Contract Asset | |||||
| Contract asset, January 1, 2021 | $ | 7,430 | |||
| Transferred to trade receivable of contract asset included in beginning of the year contract asset | (7,430) | ||||
| Contract asset, net of transferred to trade receivables on contracts during the period | 7,952 | ||||
Contract asset, June 30, 2021 | $ | 7,952 | |||
| Contract Liability | |||||
| Contract liability, January 1, 2021 | $ | 11,961 | |||
| Recognition of revenue included in beginning of year contract liability | (2,838) | ||||
| Contract liability, net of revenue recognized on contracts during the period | 3,102 | ||||
| Foreign currency translation | (125) | ||||
Contract liability, June 30, 2021 | $ | 12,100 | |||
At June 30, 2021, the short-term portion of the contract liability of $5.9 million and the long-term portion of $6.2 million were included in accrued expenses and other current liabilities and other liabilities, respectively, in the consolidated balance sheet.
As of June 30, 2021, the Company is expected to recognize approximately 49% of unsatisfied (or partially unsatisfied) performance obligations as revenue within twelve months, with the remaining balance to be recognized thereafter.
Shipping and Handling Fees
The Company elected to account for shipping and handling activities as a fulfillment cost rather than a separate performance obligation. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of underlying products is transferred to the customer. The related shipping and freight charges incurred by the Company are included in the cost of goods sold.
Product Warranties
Certain of the Company's medical devices, including monitoring systems and neurosurgical systems, are designed to operate over long periods of time. These products are sold with warranties which may extend for up to two years from the date of purchase. The warranties are not considered a separate performance obligation. The Company estimates its product warranties using the expected value method based on historical trends and other known factors. The Company includes them in accrued expenses and other current liabilities in the consolidated balance sheet.
Taxes Collected from Customers
The Company elected to exclude from the measurement of the transaction price all taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction and collected by the entity from a customer.
14
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
Disaggregated Revenue
The following table presents revenues disaggregated by the major sources of revenues for the three and six months ended June 30, 2021 and 2020 (dollar amounts in thousands):
| Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | ||||||||||||||||||||
| Neurosurgery | $ | 202,600 | $ | 141,430 | $ | 391,854 | $ | 326,373 | |||||||||||||||
| Instruments | 54,237 | 28,348 | 106,224 | 74,845 | |||||||||||||||||||
| Total Codman Specialty Surgical | 256,837 | 169,778 | 498,078 | 401,218 | |||||||||||||||||||
Wound Reconstruction and Care(2) | 102,616 | 56,291 | 191,314 | 128,558 | |||||||||||||||||||
Extremity Orthopedics(1) | — | 11,162 | — | 32,634 | |||||||||||||||||||
| Private Label | 30,539 | 21,434 | 60,671 | 50,579 | |||||||||||||||||||
| Total Tissue Technologies | 133,155 | 88,887 | 251,985 | 211,771 | |||||||||||||||||||
| Total revenue | $ | 389,992 | $ | 258,665 | $ | 750,063 | $ | 612,989 | |||||||||||||||
(1) On January 4, 2021, the Company completed its previously announced sale of its Extremity Orthopedics business. In conjunction with the sale of this business, the Company rebranded the Orthopedics and Tissue Technologies segment as Tissue Technologies in the first quarter of 2021. See Note 2. Acquisitions and Divestitures, for details.
(2) See Note 2. Acquisitions and Divestitures, for details around the ACell Inc. Acquisition.
See Note 15, Segment and Geographical Information, for details of revenues based on the location of the customer.
4. INVENTORIES
Inventories, net consisted of the following:
| Dollars in thousands | June 30, 2021 | December 31, 2020 | |||||||||
| Finished goods | $ | 180,835 | $ | 180,301 | |||||||
| Work in process | 61,987 | 53,336 | |||||||||
| Raw materials | 80,796 | 76,480 | |||||||||
| Total inventories, net | $ | 323,618 | $ | 310,117 | |||||||
At December 31, 2020, $52.8 million of inventories, net was presented separately as "Assets held for sale" in conjunction with the sale of the Extremity Orthopedics business.
5. GOODWILL AND OTHER INTANGIBLE ASSETS
Goodwill
Changes in the carrying amount of goodwill for the six-month period ended June 30, 2021 were as follows:
| Dollars in thousands | Codman Specialty Surgical | Tissue Technologies | Total | ||||||||||||||
| Goodwill at December 31, 2020 | $ | 671,975 | $ | 260,392 | $ | 932,367 | |||||||||||
| ACell Acquisition | — | 94,298 | 94,298 | ||||||||||||||
| Foreign currency translation | (7,218) | (3,809) | (11,027) | ||||||||||||||
| Goodwill at June 30, 2021 | $ | 664,757 | $ | 350,881 | $ | 1,015,638 | |||||||||||
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INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
The components of the Company’s identifiable intangible assets were as follows:
| June 30, 2021 | |||||||||||||||||||||||
| Dollars in thousands | Weighted Average Life | Cost | Accumulated Amortization | Net | |||||||||||||||||||
| Completed technology | 18 years | $ | 1,125,279 | $ | (274,287) | $ | 850,992 | ||||||||||||||||
| Customer relationships | 12 years | $ | 212,572 | $ | (137,897) | $ | 74,675 | ||||||||||||||||
| Trademarks/brand names | 28 years | $ | 99,319 | $ | (29,866) | $ | 69,453 | ||||||||||||||||
| Codman tradename | Indefinite | $ | 166,651 | $ | — | $ | 166,651 | ||||||||||||||||
| Supplier relationships | 30 years | $ | 30,211 | $ | (15,691) | $ | 14,520 | ||||||||||||||||
| All other | 11 years | $ | 6,473 | $ | (3,880) | $ | 2,593 | ||||||||||||||||
| $ | 1,640,505 | $ | (461,621) | $ | 1,178,884 | ||||||||||||||||||
| December 31, 2020 | |||||||||||||||||||||||
| Dollars in thousands | Weighted Average Life | Cost | Accumulated Amortization | Net | |||||||||||||||||||
| Completed technology | 19 years | $ | 896,478 | $ | (248,088) | $ | 648,390 | ||||||||||||||||
| Customer relationships | 12 years | 213,270 | (132,838) | 80,432 | |||||||||||||||||||
| Trademarks/brand names | 28 years | 104,209 | (31,767) | 72,442 | |||||||||||||||||||
| Codman tradename | Indefinite | 170,226 | — | 170,226 | |||||||||||||||||||
| Supplier relationships | 27 years | 30,211 | (15,203) | 15,008 | |||||||||||||||||||
All other (1) | 4 years | 6,693 | (3,755) | 2,938 | |||||||||||||||||||
| $ | 1,421,087 | $ | (431,651) | $ | 989,436 | ||||||||||||||||||
(1) Prior period amounts were reclassified as it relates to All other within this table to conform to the current period presentation.
The increase in the Company's identifiable intangible assets at June 30, 2021 as compared to the year ended December 31, 2020, was primarily driven from intangible assets acquired in conjunction with the ACell Inc. acquisition. See Note 2, Acquisitions and Divestitures, for details.
Based on quarter-end exchange rates, amortization expense (including amounts reported in cost of product revenues) is expected to be approximately $40.6 million for the remainder of 2021, $79.1 million in 2022, $78.4 million in 2023, $77.7 million in 2024, $77.7 million in 2025, $77.5 million in 2026 and $585.7 million thereafter.
6. DEBT
Amendment to the Sixth Amended and Restated Senior Credit Agreement
On February 3, 2020, the Company entered into the sixth amendment and restatement (the "February 2020 Amendment") of its Senior Credit Facility (the "Senior Credit Facility") with a syndicate of lending banks with Bank of America, N.A., as Administrative Agent. The February 2020 Amendment extended the maturity date to February 3, 2025. The Company continues to have the aggregate principal amount of up to approximately $2.2 billion available to it through the following facilities: (i) a $877.5 million Term Loan facility, and (ii) a $1.3 billion revolving credit facility, which includes a $60 million sublimit for the issuance of standby letters of credit and a $60 million sublimit for swingline loans.
On July 14, 2020, the Company entered into an amendment (the "July 2020 Amendment") to the February 2020 Amendment of the Senior Credit Facility to increase financial flexibility in light of the unprecedented impact and uncertainty of the COVID-19 pandemic on the global economy. The July 2020 amendment does not increase the Company’s total indebtedness.
In connection with the July 2020 amendment, the Company’s maximum consolidated total leverage ratio in the financial covenants (as defined in the Senior Credit Facility) was modified to the following:
| Fiscal Quarter | Maximum Consolidated Total Leverage Ratio | |||||||
| Execution of July 2020 Amendment through June 30, 2021 | 5.50 to 1.00 | |||||||
| September 30, 2021 through June 30, 2022 | 5.00 to 1.00 | |||||||
| September 30, 2022 through June 30, 2023 | 4.50 to 1.00 | |||||||
| September 30, 2023 and the last day of each fiscal quarter thereafter | 4.00 to 1.00 | |||||||
16
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
Borrowings under the Senior Credit Facility bear interest, at the Company’s option, at a rate equal to the following:
i.the Eurodollar Rate (as defined in the amendment and restatement) in effect from time to time plus the applicable rate (ranging from 1.00% to 2.25%), or
ii.the highest of:
1.the weighted average overnight Federal funds rate, as published by the Federal Reserve Bank of New York, plus 0.50%
2.the prime lending rate of Bank of America, N.A. or
3.the one-month Eurodollar Rate plus 1.00%
The applicable rates are based on the Company’s consolidated total leverage ratio (defined as the ratio of (a) consolidated funded indebtedness as of such date less cash that is not subject to any restriction on the use or investment thereof to (b) consolidated EBITDA as defined by the July 2020 amendment, for the period of four consecutive fiscal quarters ending on such date).
The Company will pay an annual commitment fee (ranging from 0.15% to 0.30%), based on the Company's consolidated total leverage ratio, on the amount available for borrowing under the revolving credit facility.
The Senior Credit Facility is collateralized by substantially all of the assets of the Company’s U.S. subsidiaries, excluding intangible assets. The Senior Credit Facility is subject to various financial and negative covenants and at June 30, 2021, the Company was in compliance with all such covenants. In connection with the February 2020 Amendment, the Company capitalized $4.6 million of financing costs in connection with modification of the Senior Credit Facility and wrote off $1.2 million of previously capitalized financing costs during the first quarter of 2020. In connection with the July 2020 amendment, the Company expensed $3.3 million of incremental financing costs in connection with the modification of the Senior Credit Facility during the third quarter of 2020.
At June 30, 2021 and December 31, 2020, there was $8.8 million and $97.5 million, respectively, outstanding under the revolving credit component of the Senior Credit Facility at weighted average interest rates of 1.5%. At June 30, 2021 and December 31, 2020, there was $866.3 million and $877.5 million, respectively, outstanding under the Term Loan component of the Senior Credit Facility at a weighted average interest rate of 1.5%. At June 30, 2021, $45.0 million of the Term Loan component of the Senior Credit Facility is classified as current on the consolidated balance sheet.
The fair value of outstanding borrowings of the Senior Credit Facility's revolving credit and Term Loan components at June 30, 2021 were $8.6 million and $850.4 million, respectively. These fair values were determined by using a discounted cash flow model based on current market interest rates available to the Company. These inputs are corroborated by observable market data for similar liabilities and therefore classified within Level 2 of the fair value hierarchy. Level 2 inputs represent inputs that are observable for the asset or liability, either directly or indirectly, and are other than active market observable inputs that reflect unadjusted quoted prices for identical assets or liabilities.
Letters of credit outstanding as of June 30, 2021 and December 31, 2020 totaled $1.6 million. There were no amounts drawn as of June 30, 2021.
Contractual repayments of the Term Loan component of the Senior Credit Facility are due as follows:
Quarter Ended June 30, 2021 | Principal Repayment | |||||||
| Dollars in thousands | ||||||||
| Remainder of 2021 | $ | 22,500 | ||||||
| 2022 | $ | 45,000 | ||||||
| 2023 | $ | 61,875 | ||||||
| 2024 | $ | 67,500 | ||||||
| 2025 | $ | 669,375 | ||||||
| $ | 866,250 | |||||||
The outstanding balance of the revolving credit component of the Senior Credit Facility is due on February 3, 2025.
17
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
Convertible Senior Notes
On February 4, 2020, the Company issued $575.0 million aggregate principal amount of its 0.5% Convertible Senior Notes due 2025 (the "2025 Notes"). The 2025 Notes will mature on August 15, 2025 and bear interest at a rate of 0.5% per annum payable semi-annually in arrears, unless earlier converted, repurchased or redeemed in accordance with the terms of the Notes. The portion of debt proceeds that was classified as equity at the time of the offering was $104.5 million. The effective interest rate implicit in the liability component was 4.2%. In connection with this offering, the Company capitalized $13.2 million of financing fees.
The 2025 Notes are senior, unsecured obligations of the Company, and are convertible into cash and shares of its common stock based on initial conversion rate, subject to adjustment of 13.5739 shares per $1,000 principal amounts of the 2025 Notes (which represents an initial conversion price of $73.67 per share). The 2025 Notes convert only in the following circumstances: (1) if the closing price of the Company's common stock has been at least 130% of the conversion price during the period; (2) if the average trading price per $1,000 principal amount of the 2025 Notes is less than or equal to 98% of the average conversion value of the 2025 Notes during a period as defined in the indenture; (3) at any time on or after February 20, 2023; or (4) if specified corporate transactions occur. As of June 30, 2021, none of these conditions existed with respect to the 2025 Notes and as a result the 2025 Notes are classified as long term.
On December 9, 2020, the Company entered into the First Supplemental Indenture to the original agreement dated as of February 4, 2020 between the Company and Citibank, N.A., as trustee, governing the Company’s outstanding 2025 Notes. The Company irrevocably elected (1) to eliminate the Company’s option to choose physical settlement on any conversion of the 2025 Notes that occurs on or after the date of the First Supplemental Indenture and (2) with respect to any Combination Settlement for a conversion of the 2025 Notes, the Specified Dollar Amount that will be settled in cash per $1,000 principal amount of the 2025 Notes shall be no lower than $1,000.
Holders of the Notes will have the right to require the Company to repurchase for cash all or a portion of their Notes at 100% of their principal amount, plus any accrued and unpaid interest, upon the occurrence of a fundamental change (as defined in the indenture relating to the Notes). The Company will also be required to increase the conversion rate for holders who convert their Notes in connection with certain fundamental changes occurring prior to the maturity date or following delivery by the Company of a notice of redemption.
In connection with the issuance of the 2025 Notes, the Company entered into call transactions and warrant transactions, primarily with affiliates of the initial purchasers of the 2025 Notes (the “hedge participants”). The cost of the call transactions was $104.2 million for the 2025 Notes. The Company received $44.5 million of proceeds from the warrant transactions for the 2025 Notes. The call transactions involved purchasing call options from the hedge participants, and the warrant transactions involved selling call options to the hedge participants with a higher strike price than the purchased call options. The initial strike price of the call transactions was $73.67, subject to anti-dilution adjustments substantially similar to those in the 2025 Notes. The initial strike price of the warrant transactions was $113.34 for the 2025 Notes, subject to customary anti-dilution adjustments.
At December 31, 2020, the carrying amount of the liability component was $485.9 million, the remaining unamortized discount was $89.1 million, and the principal amount outstanding was $575.0 million. On January 1, 2021, the Company adopted ASU 2020-06 using the modified retrospective method. See Note 1, Basis of Presentation, for further details. At June 30, 2021, in conjunction with the adoption of the ASU, the carrying amount of the liability was $575.0 million. The fair value of the 2025 Notes at June 30, 2021 was $630.7 million. Factors that the Company considered when estimating the fair value of the 2025 Notes included recent quoted market prices or dealer quote. The level of the 2025 Notes is considered as Level 1.
On January 1, 2021, the Company adopted ASU 2020-06 using the modified retrospective method. See Note 1, Basis of Presentation, for further details. As a result of the adoption of the ASU, the Company recognized only cash interest related to the contractual interest coupon of $1.4 million on the 2025 Notes for the six months ended June 30, 2021. Prior to the adoption, during the six months ended June 30, 2020, the Company recognized cash interest of $1.2 million and amortization of the discount on the liability component of $6.8 million for a total interest charge of $8.0 million on the 2020 Notes.
18
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
Securitization Facility
During the fourth quarter of 2018, the Company entered into an accounts receivable securitization facility (the "Securitization Facility") under which accounts receivable of certain domestic subsidiaries are sold on a non-recourse basis to a special purpose entity (“SPE”), which is a bankruptcy-remote, consolidated subsidiary of the Company. Accordingly, the assets of the SPE are not available to satisfy the obligations of the Company or any of its subsidiaries. From time to time, the SPE may finance such accounts receivable with a revolving loan facility secured by a pledge of such accounts receivable. The amount of outstanding borrowings on the Securitization Facility at any one time is limited to $150.0 million. The Securitization Facility Agreement ("Securitization Agreement") governing the Securitization Facility contains certain covenants and termination events. An occurrence of an event of default or a termination event under this Securitization Agreement may give rise to the right of its counterparty to terminate this facility. As of June 30, 2021, the Company was in compliance with the covenants and none of the termination events had occurred.
On May 28, 2021, the Company entered into an amendment (the "May 2021 Amendment") of the Securitization Facility which extended the maturity date from December 21, 2021 to May 28, 2024. The May 2021 amendment does not increase the Company’s total indebtedness.
At June 30, 2021 and December 31, 2020, the Company had $112.5 million, respectively, of outstanding borrowings under its Securitization Facility at a weighted average interest rate of 1.2% and 1.3%, respectively. The fair value of the outstanding borrowing of the Securitization Facility at June 30, 2021 was $110.3 million. These fair values were determined by using a discounted cash flow model based on current market interest rates available to the Company. These inputs are corroborated by observable market data for similar liabilities and therefore classified within Level 2 of the fair value hierarchy. Level 2 inputs represent inputs that are observable for the asset or liability, either directly or indirectly, and are other than active market observable inputs that reflect unadjusted quoted prices for identical assets or liabilities.
7. DERIVATIVE INSTRUMENTS
Interest Rate Hedging
The Company’s interest rate risk relates to U.S. dollar denominated variable interest rate borrowings. The Company uses interest rate swap derivative instruments to manage earnings and cash flow exposure resulting from changes in interest rates. These interest rate swaps apply a fixed interest rate on a portion of the Company's expected LIBOR-indexed floating-rate borrowings.
19
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
The Company held the following interest rate swaps as of June 30, 2021 and December 31, 2020 (dollar amounts in thousands):
| June 30, 2021 | December 31, 2020 | June 30, 2021 | December 31, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||
| Hedged Item | Notional Amount | Designation Date | Effective Date | Termination Date | Fixed Interest Rate | Estimated Fair Value | ||||||||||||||||||||||||||||||||||||||||||||
| Asset (Liability) | ||||||||||||||||||||||||||||||||||||||||||||||||||
| 1-month USD LIBOR Loan | $ | — | $ | 100,000 | March 27, 2017 | December 31, 2017 | June 30, 2021 | 1.971 | % | $ | — | $ | (929) | |||||||||||||||||||||||||||||||||||||
| 1-month USD LIBOR Loan | 300,000 | 300,000 | December 13, 2017 | January 1, 2018 | December 31, 2022 | 2.201 | % | (9,122) | (12,557) | |||||||||||||||||||||||||||||||||||||||||
| 1-month USD LIBOR Loan | 150,000 | 150,000 | December 13, 2017 | July 1, 2019 | June 30, 2024 | 2.423 | % | (8,692) | (11,502) | |||||||||||||||||||||||||||||||||||||||||
| 1-month USD LIBOR Loan | 200,000 | 200,000 | December 13, 2017 | January 1, 2018 | December 31, 2024 | 2.313 | % | (11,856) | (16,243) | |||||||||||||||||||||||||||||||||||||||||
| 1-month USD LIBOR Loan | 75,000 | 75,000 | October 10, 2018 | July 1, 2020 | June 30, 2025 | 3.220 | % | (7,595) | (9,836) | |||||||||||||||||||||||||||||||||||||||||
| 1-month USD LIBOR Loan | 75,000 | 75,000 | October 10, 2018 | July 1, 2020 | June 30, 2025 | 3.199 | % | (7,553) | (9,826) | |||||||||||||||||||||||||||||||||||||||||
| 1-month USD LIBOR Loan | 75,000 | 75,000 | October 10, 2018 | July 1, 2020 | June 30, 2025 | 3.209 | % | (7,541) | (9,783) | |||||||||||||||||||||||||||||||||||||||||
| 1-month USD LIBOR Loan | 100,000 | 100,000 | December 18, 2018 | December 30, 2022 | December 31, 2027 | 2.885 | % | (7,703) | (10,407) | |||||||||||||||||||||||||||||||||||||||||
| 1-month USD LIBOR Loan | 100,000 | 100,000 | December 18, 2018 | December 30, 2022 | December 31, 2027 | 2.867 | % | (7,592) | (10,431) | |||||||||||||||||||||||||||||||||||||||||
| 1-month USD LIBOR Loan | 575,000 | 575,000 | December 15, 2020 | July 31, 2025 | December 31, 2027 | 1.415 | % | 3,931 | (1,907) | |||||||||||||||||||||||||||||||||||||||||
| 1-month USD LIBOR Loan | 125,000 | 125,000 | December 15, 2020 | July 1, 2025 | December 31, 2027 | 1.404 | % | 987 | (348) | |||||||||||||||||||||||||||||||||||||||||
| $ | 1,775,000 | $ | 1,875,000 | $ | (62,736) | $ | (93,769) | |||||||||||||||||||||||||||||||||||||||||||
The Company has designated these derivative instruments as cash flow hedges. The Company assesses the effectiveness of these derivative instruments and has recorded the changes in the fair value of the derivative instrument designated as a cash flow hedge as unrealized gains or losses in accumulated other comprehensive loss (“AOCL”), net of tax, until the hedged item affected earnings, at which point any gain or loss was reclassified to earnings. If the hedged cash flow does not occur, or if it becomes probable that it will not occur, the Company will reclassify the remaining amount of any gain or loss on the related cash flow hedge recorded in AOCL to interest expense at that time.
Foreign Currency Hedging
From time to time, the Company enters into foreign currency hedge contracts intended to protect the U.S. dollar value of certain forecasted foreign currency denominated transactions. The Company assesses the effectiveness of the contracts that are designated as hedging instruments. The changes in fair value of foreign currency cash flow hedges are recorded in AOCL, net of tax. Those amounts are subsequently reclassified to earnings from AOCL as impacted by the hedged item when the hedged item affects earnings. If the hedged forecasted transaction does not occur or if it becomes probable that it will not occur, the Company will reclassify the amount of any gain or loss on the related cash flow hedge to earnings at that time. For contracts not designated as hedging instruments, the changes in fair value of the contracts are recognized in other income, net in the consolidated statements of operation, along with the offsetting foreign currency gain or loss on the underlying assets or liabilities.
During the fourth quarter of 2020, the Company entered into foreign currency forward contracts, with a notional amount of $9.7 million to mitigate the foreign exchange risk related to certain intercompany loans denominated in Canadian Dollar ("CAD") and intercompany receivables denominated in Japanese Yen ("JPY"). The contracts are not designated as hedging instruments. The Company recognized a $0.3 million loss from the change in fair value of the contracts, which was included in other income, net in the consolidated statement of operations as of June 30, 2021. The Company subsequently settled its foreign currency forward contracts associated with the intercompany receivables denominated in JPY during the first quarter of 2021. The fair value of the foreign currency forward contracts denominated in CAD was $0.3 million as of June 30, 2021.
20
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
During the second quarter of 2021, the Company entered into a foreign currency swap, with a notional of $7.3 million to mitigate the risk from fluctuations in foreign currency exchange rates associated with certain intercompany loan denominated in Japanese Yen ("JPY"). In a foreign currency swap transaction, the Company agrees with another party to exchange, at specified intervals, the difference between one currency and another currency at a fixed exchange rate, generally set at inception, calculated by reference to an agreed upon notional amount. The notional amount of each currency is exchanged at the inception and termination of the currency swap by each party. The change in fair value of the foreign currency swap was not material for the period.
The success of the Company’s hedging program depends, in part, on forecasts of certain activity denominated in foreign currency. The Company may experience unanticipated currency exchange gains or losses to the extent that there are differences between forecasted and actual activities during periods of currency volatility. In addition, changes in currency exchange rates related to any unhedged transactions may affect earnings and cash flows.
Cross-Currency Rate Swaps
On October 2, 2017, the Company entered into cross-currency swap agreements to convert a notional amount of $300.0 million equivalent to 291.2 million of Swiss Francs ("CHF") denominated intercompany loans into U.S. dollars. The CHF-denominated intercompany loans were the result of the purchase of intellectual property by a subsidiary in Switzerland as part of an acquisition.
On December 21, 2020, the Company entered into cross-currency swap agreements to convert a notional amount of $471.6 million equivalent to 420.1 million of a CHF-denominated intercompany loan into U.S. dollars. The CHF-denominated intercompany loan was the result of an intra-entity transfer of certain intellectual property rights to a subsidiary in Switzerland completed during the fourth quarter of 2020. The intercompany loan requires quarterly payments of CHF 5.8 million plus accrued interest. As a result, the aggregate notional amount of the related cross-currency swaps will decrease by a corresponding amount.
The objective of these cross-currency swaps is to reduce volatility of earnings and cash flows associated with changes in the foreign currency exchange rate. Under the terms of these contracts, which have been designated as cash flow hedges, the Company will make interest payments in Swiss Francs and receive interest in U.S. dollars. Upon the maturity of these contracts, the Company will pay the principal amount of the loans in Swiss Francs and receive U.S. dollars from the counterparties.
The Company held the following cross-currency rate swaps as of June 30, 2021 and December 31, 2020 (dollar amounts in thousands):
| June 30, 2021 | December 31, 2020 | June 30, 2021 | December 31, 2020 | |||||||||||||||||||||||||||||||||||||||||
| Effective Date | Termination Date | Fixed Rate | Aggregate Notional Amount | Fair Value Asset (Liability) | ||||||||||||||||||||||||||||||||||||||||
| Pay CHF | October 2, 2017 | October 2, 2021 | 1.85% | CHF | 48,533 | 48,533 | (2,228) | (4,335) | ||||||||||||||||||||||||||||||||||||
| Receive U.S.$ | 4.46% | $ | 50,000 | 50,000 | ||||||||||||||||||||||||||||||||||||||||
| Pay CHF | October 2, 2017 | October 2, 2022 | 1.95% | CHF | 145,598 | 145,598 | (4,641) | (11,262) | ||||||||||||||||||||||||||||||||||||
| Receive U.S.$ | 4.52% | $ | 150,000 | 150,000 | ||||||||||||||||||||||||||||||||||||||||
| Pay CHF | December 21, 2020 | December 20, 2025 | 3.00% | CHF | 408,637 | 420,137 | 10,124 | (7,843) | ||||||||||||||||||||||||||||||||||||
| Receive U.S.$ | 3.98% | $ | 458,730 | 471,640 | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 3,255 | $ | (23,441) | ||||||||||||||||||||||||||||||||||||||||
The cross-currency swaps are carried on the consolidated balance sheet at fair value, and changes in the fair values are recorded as unrealized gains or losses in AOCL. For the three and six months ended June 30, 2021, the Company recorded a loss of $12.9 million and a gain of $30.0 million, respectively, in other income, net related to change in fair value related to the foreign currency rate translation to offset the gains or losses recognized on the intercompany loans. For the three and six months ended June 30, 2020, the Company recorded losses of $3.4 million and $5.1 million, respectively, in other income, net related to change in fair value related to the foreign currency rate translation to offset the gains recognized on the intercompany loans.
For the three and six months ended June 30, 2021, the Company recorded a loss of $11.0 million and a gain of $29.2 million in AOCL, respectively, related to change in fair value of the cross-currency swaps. For the three and six months ended June 30, 2020, the Company recorded a loss of $2.3 million and a gain of $3.6 million in AOCL, respectively, related to change in fair value of the cross-currency swaps.
21
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
For the three and six months ended June 30, 2021, the Company recorded gains of $1.3 million and $2.5 million, respectively, in other income, net included in the consolidated statements of operations related to the interest rate differential of the cross-currency swaps. For the three and six months ended June 30, 2020, the Company recorded gains of $1.5 million and $3.0 million, respectively, in other income, net included in the consolidated statements of operations related to the interest rate differential of the cross-currency swaps.
The estimated gain that is expected to be reclassified to other income (expense), net from AOCL as of June 30, 2021 within the next twelve months is $7.0 million. As of June 30, 2021, the Company does not expect any gains or losses will be reclassified into earnings as a result of the discontinuance of these cash flow hedges because the original forecasted transaction will not occur.
Net Investment Hedges
The Company manages certain foreign exchange risks through a variety of strategies, including hedging. The Company is exposed to foreign exchange risk from its international operations through foreign currency purchases, net investments in foreign subsidiaries, and foreign currency assets and liabilities created in the normal course of business. On October 1, 2018 and December 16, 2020, the Company entered into cross-currency swap agreements designated as net investment hedges to partially offset the effects of foreign currency on foreign subsidiaries.
The Company held the following cross-currency rate swaps designated as net investment hedges as of June 30, 2021 and December 31, 2020, respectively (dollar amounts in thousands):
June 30, 2021 | December 31, 2020 | ||||||||||||||||||||||||||||||||||||||||
| Effective Date | Termination Date | Fixed Rate | Aggregate Notional Amount | Fair Value Asset (Liability) | |||||||||||||||||||||||||||||||||||||
| Pay EUR | October 3, 2018 | September 30, 2021 | —% | EUR | 44,859 | $ | (864) | $ | (1,884) | ||||||||||||||||||||||||||||||||
| Receive U.S.$ | 3.01% | $ | 52,000 | ||||||||||||||||||||||||||||||||||||||
| Pay EUR | October 3, 2018 | September 30, 2023 | —% | EUR | 51,760 | 901 | (450) | ||||||||||||||||||||||||||||||||||
| Receive U.S.$ | 2.57% | $ | 60,000 | ||||||||||||||||||||||||||||||||||||||
| Pay EUR | October 3, 2018 | September 30, 2025 | —% | EUR | 38,820 | 849 | 92 | ||||||||||||||||||||||||||||||||||
| Receive U.S.$ | 2.19% | $ | 45,000 | ||||||||||||||||||||||||||||||||||||||
| Pay CHF | December 16, 2020 | December 16, 2027 | —% | CHF | 222,300 | 3,292 | (3,794) | ||||||||||||||||||||||||||||||||||
| Receive U.S.$ | 1.10% | $ | 250,000 | ||||||||||||||||||||||||||||||||||||||
| Total | $ | 4,178 | $ | (6,036) | |||||||||||||||||||||||||||||||||||||
The cross-currency swaps were carried on the consolidated balance sheet at fair value and changes in the fair values were recorded as unrealized gains or losses in AOCL. For the three and six months ended June 30, 2021, the Company recorded gains of $0.1 million and $13.7 million, respectively, in AOCL related to the change in fair value of the cross-currency swaps. For the three and six months ended June 30, 2020, the Company recorded a loss of $2.5 million and a gain of $16.4 million, respectively, in AOCL related to the change in fair value of the cross-currency swaps.
For the three and six months ended June 30, 2021, the Company recorded gains of $1.7 million and $3.4 million in interest income included in the consolidated statements of operations related to the interest rate differential of the cross-currency swaps. For the three and six months ended June 30, 2020, the Company recorded gains of $2.2 million and $4.4 million in interest income included in the consolidated statements of operations related to the interest rate differential of the cross-currency swaps.
The estimated gain that is expected to be reclassified to interest income from AOCL as of June 30, 2021 within the next twelve months is $4.5 million.
Counterparty Credit Risk
The Company manages its concentration of counterparty credit risk on its derivative instruments by limiting acceptable counterparties to a group of major financial institutions with investment grade credit ratings, and by actively monitoring their credit ratings and outstanding positions on an ongoing basis. Therefore, the Company considers the credit risk of the counterparties to be low. Furthermore, none of the Company’s derivative transactions are subject to collateral or other security arrangements, and none contain provisions that depend upon the Company’s credit ratings from any credit rating agency.
22
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
Fair Value of Derivative Instruments
The Company has classified all of its derivative instruments within Level 2 of the fair value hierarchy because observable inputs are available for substantially the full term of the derivative instruments. The fair values of the interest rate swaps and cross-currency swaps were developed using a market approach based on publicly available market yield curves and the terms of the swap. The Company performs ongoing assessments of counterparty credit risk.
The following table summarizes the fair value for derivatives designated as hedging instruments in the condensed consolidated balance sheets as of June 30, 2021 and December 31, 2020:
| Fair Value as of | ||||||||||||||
Location on Balance Sheet (1): | June 30, 2021 | December 31, 2020 | ||||||||||||
| Dollars in thousands | ||||||||||||||
| Derivatives designated as hedges — Assets: | ||||||||||||||
| Prepaid expenses and other current assets | ||||||||||||||
| Cash Flow Hedges | ||||||||||||||
| Cross-currency swap | $ | 9,206 | $ | 7,623 | ||||||||||
| Net Investment Hedges | ||||||||||||||
| Cross-currency swap | 5,345 | 5,297 | ||||||||||||
| Other assets | ||||||||||||||
| Cash Flow Hedges | ||||||||||||||
Interest rate swap(2) | 4,918 | — | ||||||||||||
| Cross-currency swap | 4,605 | — | ||||||||||||
| Net Investment Hedges | ||||||||||||||
| Cross-currency swap | 505 | — | ||||||||||||
| Total derivatives designated as hedges — Assets | $ | 24,579 | $ | 12,920 | ||||||||||
| Derivatives designated as hedges — Liabilities: | ||||||||||||||
| Accrued expenses and other current liabilities | ||||||||||||||
| Cash Flow Hedges | ||||||||||||||
Interest rate swap(2) | $ | 21,003 | $ | 22,033 | ||||||||||
| Cross-currency swap | 2,228 | 4,335 | ||||||||||||
| Net Investment Hedges | ||||||||||||||
| Cross-currency swap | 864 | 1,884 | ||||||||||||
| Other liabilities | ||||||||||||||
| Cash Flow Hedges | ||||||||||||||
Interest rate swap(2) | 46,651 | 71,736 | ||||||||||||
| Cross-currency swap | 8,328 | 26,728 | ||||||||||||
| Net Investment Hedges | ||||||||||||||
| Cross-currency swap | 808 | 9,449 | ||||||||||||
| Total derivatives designated as hedges — Liabilities | $ | 79,882 | $ | 136,165 | ||||||||||
(1) The Company classifies derivative assets and liabilities as current based on the cash flows expected to be incurred within the following 12 months.
(2) At June 30, 2021 and December 31, 2020, the total notional amounts related to the Company’s interest rate swaps were $1.8 billion and $1.9 billion, respectively.
23
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
The following presents the effect of derivative instruments designated as cash flow hedges on the accompanying condensed consolidated statement of operations during the three and six months ended June 30, 2021 and 2020:
| Dollars in thousands | Balance in AOCL Beginning of Quarter | Amount of Gain (Loss) Recognized in AOCL | Amount of Gain (Loss) Reclassified from AOCL into Earnings | Balance in AOCL End of Quarter | Location in Statements of Operations | ||||||||||||||||||||||||
| Three Months Ended June 30, 2021 | |||||||||||||||||||||||||||||
| Cash Flow Hedges | |||||||||||||||||||||||||||||
| Interest rate swap | $ | (53,546) | $ | (15,013) | $ | (5,823) | $ | (62,736) | Interest expense | ||||||||||||||||||||
| Cross-currency swap | (5,029) | (10,969) | (11,635) | (4,363) | Other income (expense),net | ||||||||||||||||||||||||
| Net Investment Hedges | |||||||||||||||||||||||||||||
| Cross-currency swap | (429) | 88 | 1,737 | (2,078) | Interest income | ||||||||||||||||||||||||
| $ | (59,004) | $ | (25,894) | $ | (15,721) | $ | (69,177) | ||||||||||||||||||||||
| Three Months Ended June 30, 2020 | |||||||||||||||||||||||||||||
| Cash Flow Hedges | |||||||||||||||||||||||||||||
| Interest rate swap | $ | (95,753) | $ | (9,988) | $ | (3,614) | $ | (102,127) | Interest expense | ||||||||||||||||||||
| Cross-currency swap | 6,266 | (2,322) | (1,899) | 5,843 | Other income (expense),net | ||||||||||||||||||||||||
| Net Investment Hedges | |||||||||||||||||||||||||||||
| Cross-currency swap | 26,946 | (2,543) | 2,179 | 22,224 | Interest income | ||||||||||||||||||||||||
| $ | (62,541) | $ | (14,853) | $ | (3,334) | $ | (74,060) | ||||||||||||||||||||||
| Dollars in thousands | Balance in AOCL Beginning of Year | Amount of Gain (Loss) Recognized in AOCL | Amount of Gain (Loss) Reclassified from AOCL into Earnings | Balance in AOCL End of Quarter | Location in Statements of Operations | ||||||||||||||||||||||||
| Six Months Ended June 30, 2021 | |||||||||||||||||||||||||||||
| Cash Flow Hedges | |||||||||||||||||||||||||||||
| Interest rate swap | $ | (93,769) | $ | 19,505 | $ | (11,528) | $ | (62,736) | Interest expense | ||||||||||||||||||||
| Cross-currency swap | (1,073) | 29,225 | 32,515 | (4,363) | Other income (expense),net | ||||||||||||||||||||||||
| Net Investment Hedges | |||||||||||||||||||||||||||||
| Cross-currency swap | (12,291) | 13,661 | 3,448 | (2,078) | Interest income | ||||||||||||||||||||||||
| $ | (107,133) | $ | 62,391 | $ | 24,435 | $ | (69,177) | ||||||||||||||||||||||
| Six Months Ended June 30, 2020 | |||||||||||||||||||||||||||||
| Cash Flow Hedges | |||||||||||||||||||||||||||||
| Interest rate swap | $ | (45,146) | $ | (61,637) | $ | (4,656) | $ | (102,127) | Interest expense | ||||||||||||||||||||
| Cross-currency swap | 177 | 3,585 | (2,081) | 5,843 | Other income (expense), net | ||||||||||||||||||||||||
| Net Investment Hedges | |||||||||||||||||||||||||||||
| Cross-currency swap | 10,229 | 16,357 | 4,362 | 22,224 | Interest income | ||||||||||||||||||||||||
| $ | (34,740) | $ | (41,695) | $ | (2,375) | $ | (74,060) | ||||||||||||||||||||||
8. STOCK-BASED COMPENSATION
As of June 30, 2021, the Company had stock options, restricted stock awards, performance stock awards, contract stock awards and restricted stock unit awards outstanding under the 2003 Equity Incentive Plan (the “2003 Plan”). The 2000 and 2001 Equity Incentive Plans were terminated as of February 19, 2021, and no further awards may be issued under the plans.
Stock options issued under the 2003 Plan become exercisable over specified periods, generally within four years from the date of grant for officers and employees, within one year from date of grant for directors which generally expire eight years from the grant date for employees, and from to ten years for directors and certain executive officers, except in certain instances that result in accelerated vesting due to death, disability, retirement age or change in-control provisions within their grant agreements. The Company values stock option grants using the binomial distribution model. Restricted stock issued under the Plans vests over specified periods, generally three years after the date of grant. The vesting of performance stock issued under the Plans is subject to service and performance conditions.
24
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
Stock Options
As of June 30, 2021, there were approximately $4.6 million of total unrecognized compensation costs related to unvested stock options. These costs are expected to be recognized over a weighted-average period of approximately three years. There were 149,558 stock options granted during the six months ended June 30, 2021. For the six months ended June 30, 2021, the weighted average grant date fair value for stock options was $22.59 per option.
Awards of Restricted Stock and Performance Stock
Performance stock and restricted stock awards generally have requisite service periods of three years, except in certain instances that result in accelerated vesting due to death, disability, retirement age provision or change in-control provisions in their grant agreements. Performance stock units are subject to graded vesting conditions based on revenue goals of the Company. The Company expenses the fair value of restricted stock awards on a straight-line basis over the requisite service period. As of June 30, 2021, there was approximately $32.9 million of total unrecognized compensation costs related to these unvested awards. The Company expects to recognize these costs over a weighted-average period of approximately two years. The Company granted 242,464 restricted stock awards and 176,147 performance stock awards during the six months ended June 30, 2021. For the six months ended June 30, 2021, the weighted average grant date fair value for restricted stock awards and performance stock units was $68.21 and $68.10 per award, respectively.
The Company also maintains an Employee Stock Purchase Plan (the “ESPP”), which provides eligible employees with the opportunity to acquire shares of common stock at periodic intervals by means of accumulated payroll deductions. The ESPP is a non-compensatory plan based on its terms.
9. RETIREMENT PLANS
The Company maintains defined benefit pension plans that cover certain employees in France, Japan, Germany and Switzerland.
Net periodic benefit costs for the Company’s defined benefit pension plans for three and the six months ended June 30, 2021 were $0.6 million and $1.2 million. The components of the net periodic benefit costs other than the service cost component of $0.8 million and $1.7 million for the three and six months ended June 30, 2021, are included in other income (expense), net in the consolidated statements of operations.
Net periodic benefit costs for the Company’s defined benefit pension plans for the three and six months ended June 30, 2020 were $1.0 million and $1.9 million, respectively. The components of the net periodic benefit costs other than the service cost component of $0.9 million and $1.9 million for the three and six months ended June 30, 2020, respectively, are included in other income (expense), net in the consolidated statements of operations.
The estimated fair values of plan assets were $33.8 million and $37.8 million as of June 30, 2021 and December 31, 2020, respectively. The net plan assets of the pension plans are invested in common trusts as of June 30, 2021 and December 31, 2020. Common trusts are classified as Level 2 in the fair value hierarchy. The fair value of common trusts is valued at the net asset value based on the fair values of the underlying investments of the trusts as determined by the sponsor of the trusts. The investment strategy of the Company's defined benefit plans is both to meet the liabilities of the plans as they fall due and to maximize the return on invested assets within an appropriate risk profile.
Deferred Compensation Plan
The Company maintains a Deferred Compensation Plan in which certain employees of the Company may defer the payment and taxation of up to 75% of their base salary and up to 100% of bonus amounts and other eligible cash compensation.
During the first quarter of 2020, employees participating in the Company's deferred compensation plan began to defer their compensation. This deferred compensation is invested in funds offered under this plan and is valued based on Level 1 measurements in the fair value hierarchy. Assets of the Company's deferred compensation plan are included in other current assets and recorded at fair value based on their quoted market prices. The fair value of these assets were $3.2 million and $2.0 million as of June 30, 2021 and December 31, 2020, respectively. Offsetting liabilities relating to the deferred compensation plan are included in Other liabilities.
10. LEASES AND RELATED PARTY LEASES
The Company leases administrative, manufacturing, research and distribution facilities and vehicles through operating lease agreements. The Company has no finance leases as of June 30, 2021. Many of the Company's leases include both lease (e.g., fixed payments including rent) and non-lease components (e.g., common-area or other maintenance costs). For vehicles, the Company has elected the practical expedient to group lease and non-lease components.
25
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
Most facility leases include one or more options to renew. The exercise of lease renewal options is typically at the Company's sole discretion, therefore, the majority of renewals to extend the lease terms are not included in the Right of Use ("ROU") assets and lease liabilities as they are not reasonably certain of exercise. The Company regularly evaluates renewal options and when they are reasonably certain of exercise, the renewal period is included in the lease term.
As most of the Company's leases do not provide an implicit rate, the Company uses a collateralized incremental borrowing rate based on the information available at the lease commencement date in determining the present value of the lease payments.
Total operating lease expense for the six months ended June 30, 2021 and June 30, 2020 was $10.6 million and $9.7 million respectively, which includes $0.1 million, in related party operating lease expense.
Supplemental balance sheet information related to operating leases were as follows:
| Dollars in thousands, except lease term and discount rate | June 30, 2021 | December 31, 2020 | |||||||||
| ROU assets | $ | 89,174 | $ | 83,635 | |||||||
| Current lease liabilities | 13,987 | 12,818 | |||||||||
| Non-current lease liabilities | 95,196 | 88,118 | |||||||||
| Total lease liabilities | $ | 109,183 | $ | 100,936 | |||||||
| Weighted average remaining lease term (in years): | |||||||||||
| Leased facilities | 11.3 years | 11.6 years | |||||||||
| Leased vehicles | 2.3 years | 2.3 years | |||||||||
| Weighted average discount rate: | |||||||||||
| Leased facilities | 5.0 | % | 4.6 | % | |||||||
| Leased vehicles | 2.7 | % | 2.3 | % | |||||||
Supplemental cash flow information related to leases for the six months ended June 30, 2021 and 2020 were as follows:
| Dollars in thousands | June 30, 2021 | June 30, 2020 | |||||||||
| Cash paid for amounts included in the measurement of lease liabilities: | |||||||||||
| Operating cash flows from operating leases | $ | 7,019 | $ | 6,728 | |||||||
| ROU assets obtained in exchange for lease liabilities: | |||||||||||
| Operating leases | $ | 10,528 | $ | 6,007 | |||||||
Future minimum lease payments under operating leases at June 30, 2021 were as follows:
| Dollars in thousands | Related Parties | Third Parties | Total | ||||||||||||||
| 2021 | $ | 148 | $ | 7,973 | $ | 8,121 | |||||||||||
| 2022 | 296 | 16,833 | 17,129 | ||||||||||||||
| 2023 | 296 | 13,945 | 14,241 | ||||||||||||||
| 2024 | 296 | 11,461 | 11,757 | ||||||||||||||
| 2025 | 296 | 10,835 | 11,131 | ||||||||||||||
| 2026 | 296 | 9,553 | 9,849 | ||||||||||||||
| Thereafter | 837 | 72,887 | 73,724 | ||||||||||||||
| Total minimum lease payments | $ | 2,465 | $ | 143,487 | $ | 145,952 | |||||||||||
| Less: Imputed interest | 36,769 | ||||||||||||||||
| Total lease liabilities | 109,183 | ||||||||||||||||
| Less: Current lease liabilities | 13,987 | ||||||||||||||||
| Long-term lease liabilities | 95,196 | ||||||||||||||||
26
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
Related Party Leases
The Company leases its manufacturing facility in Plainsboro, New Jersey, from a general partnership that is 50% owned by a corporation whose shareholders are trusts, whose beneficiaries include family members of the Company’s principal stockholder and former director. The term of the current lease agreement is through October 31, 2029 at an annual rate of approximately $0.3 million per year. The current lease agreement also provides (i) a 5-year renewal option for the Company to extend the lease from November 1, 2029 through October 31, 2034 at the fair market rental rate of the premises, and (ii) another 5-year renewal option to extend the lease from November 1, 2034 through October 31, 2039 at the fair market rental rate of the premises.
11. TREASURY STOCK
As of June 30, 2021 and December 31, 2020, there were 4.9 million shares of treasury stock outstanding with a cost of $234.5 million and $235.1 million, respectively, at a weighted average cost per share of $47.86.
On December 7, 2020, the Board of Directors of the Company authorized the Company to repurchase up to $225.0 million of the Company’s common stock. The program allows the Company to repurchase its shares opportunistically from time to time. The repurchase authorization expires in December 2022. The Company has $225.0 million remaining under the share repurchase of its Common Stock. The price and timing of any future purchases under the share repurchase program will depend on factors such as levels of cash generation from operations, the volume of stock option exercises by employees, cash requirements for acquisitions, dividends, economic and market conditions and stock price.
During the twelve months ended December 31, 2020, the Company repurchased 2.1 million shares of Integra’s common stock as part of the previous share repurchase authorization. The Company utilized $100.0 million of net proceeds from the offering of the Convertible Senior Notes to execute the share repurchase transactions. This included $7.6 million from certain purchasers of the convertible notes in conjunction with the closing of the offering. On February 5, 2020, the Company entered into a $92.4 million accelerated share repurchase ("ASR") to complete the remaining $100.0 million of share repurchase. The Company received 1.3 million shares at inception of the ASR, which represented approximately 80% of the expected total shares. Upon settlement of the ASR in June 2020, the Company received an additional 0.6 million shares determined using the volume-weighted average price of the Company's common stock during the term of the transaction.
12. INCOME TAXES
The following table provides a summary of the Company's effective tax rate:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| Reported tax rate | 21.8 | % | 122.4 | % | 28.2 | % | 32.7 | % | |||||||||||||||
The Company’s effective income tax rates for the three months ended June 30, 2021 and 2020 were 21.8% and 122.4%, respectively. For the three months ended June 30, 2021, the primary driver of the lower tax rate is due to mix of income impacted by the COVID-19 pandemic. For the three months ended June 30, 2020, the primary drivers of the higher tax rate was lower income impacted by the COVID-19 pandemic and a $3.4 million valuation allowance on certain foreign deferred tax assets.
The Company's effective income tax rates for the six months ended June 30, 2021 and 2020 were 28.2% and 32.7%, respectively. For the six months ended June 30, 2021, the primary drivers of the lower tax rate were mix of income in lower-taxes jurisdictions, offset by the tax impact of the gain on the sale of the Extremity and Orthopedics business which was completed during the first quarter of 2021. For the six months ended June 30, 2020, the primary drivers of the higher tax rate were lower book income in lower-taxed jurisdictions and a $3.4 million valuation allowance on certain foreign deferred tax assets as the Company determined that it was no longer more likely than not that these foreign deferred tax assets would be realized due to the adverse impact of the COVID-19 pandemic in certain jurisdictions.
As of June 30, 2021, the Company has not provided deferred income taxes on unrepatriated earnings from foreign subsidiaries as they are deemed indefinitely reinvested. Such taxes would primarily be attributable to foreign withholding taxes and local income taxes when such earnings are distributed. As such, the Company has determined the tax impact of repatriating these earnings would not be material as of June 30, 2021. The Company does not anticipate the need to repatriate earnings from foreign subsidiaries as a result of the impact of the COVID-19 pandemic.
27
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
13. NET INCOME PER SHARE
Basic and diluted net income per share was as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| Dollars in thousands, except per share amounts | 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
| Basic net income per share: | |||||||||||||||||||||||
| Net income (loss) | $ | 35,068 | $ | (369) | $ | 80,462 | $ | 8,811 | |||||||||||||||
| Weighted average common shares outstanding | 84,687 | 84,706 | 84,593 | 84,955 | |||||||||||||||||||
| Basic net income per common share | $ | 0.41 | $ | (0.00) | $ | 0.95 | $ | 0.10 | |||||||||||||||
| Diluted net income per share: | |||||||||||||||||||||||
| Net income (loss) | $ | 35,068 | $ | (369) | $ | 80,462 | $ | 8,811 | |||||||||||||||
| Weighted average common shares outstanding — Basic | 84,687 | 84,706 | 84,593 | 84,955 | |||||||||||||||||||
| Effect of dilutive securities: | |||||||||||||||||||||||
| Stock options and restricted stock | 653 | — | 731 | 593 | |||||||||||||||||||
| Weighted average common shares for diluted earnings per share | 85,340 | 84,706 | 85,324 | 85,548 | |||||||||||||||||||
| Diluted net income per common share | $ | 0.41 | $ | 0.00 | $ | 0.94 | $ | 0.10 | |||||||||||||||
Common stock of approximately 0.1 million and 0.5 million shares at June 30, 2021, and 2020, respectively that are issuable through exercise of dilutive securities were not included in the computation of diluted net income per share because their effect would have been anti-dilutive.
Performance Shares and Restricted Units that entitle the holders to approximately 0.5 million shares of common stock are included in the basic and diluted weighted average shares outstanding calculation from their date of issuance because no further consideration is due related to the issuance of the underlying common shares.
Based on the adoption of ASU 2020-06, as the principal amount of the 2025 Notes will be paid in cash and only the conversion spread is settled in shares, the Company will be utilizing the if-converted method and only includes the net number of incremental shares that would be issued upon conversion.
14. ACCUMULATED OTHER COMPREHENSIVE LOSS
Comprehensive income (loss) for the six months ended June 30, 2021 and 2020 was as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| Dollars in thousands | 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
| Net income (loss) | $ | 35,068 | $ | (369) | $ | 80,462 | $ | 8,811 | |||||||||||||||
| Foreign currency translation adjustment | 1,558 | 10,433 | (5,243) | 3,620 | |||||||||||||||||||
| Change in unrealized loss on derivatives, net of tax | (7,804) | (8,830) | 29,111 | (30,136) | |||||||||||||||||||
| Pension liability adjustment, net of tax | (91) | (139) | 228 | (207) | |||||||||||||||||||
| Comprehensive income (loss), net | $ | 28,731 | $ | 1,095 | $ | 104,558 | $ | (17,912) | |||||||||||||||
28
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
Changes in accumulated other comprehensive loss by component between December 31, 2020 and June 30, 2021 are presented in the table below, net of tax:
| Dollars in thousands | Gains and Losses on Derivatives | Defined Benefit Pension Items | Foreign Currency Items | Total | ||||||||||||||||||||||
| Balance at January 1, 2021 | $ | (82,249) | $ | (5,105) | $ | 13,295 | $ | (74,059) | ||||||||||||||||||
| Other comprehensive income (loss) | 47,885 | 228 | (5,243) | 42,870 | ||||||||||||||||||||||
| Less: Amounts reclassified from accumulated other comprehensive loss | 18,774 | — | — | 18,774 | ||||||||||||||||||||||
| Net current-period other comprehensive income (loss) | 29,111 | 228 | (5,243) | 24,096 | ||||||||||||||||||||||
| Balance at June 30, 2021 | $ | (53,138) | $ | (4,877) | $ | 8,052 | $ | (49,963) | ||||||||||||||||||
For the six months ended June 30, 2021, the Company reclassified a gain of $25.0 million and a loss of $6.2 million from accumulated other comprehensive loss to other income (expense), net and interest income.
15. SEGMENT AND GEOGRAPHIC INFORMATION
The Company internally manages two global reportable segments and reports the results of its businesses to its chief operating decision maker. The two reportable segments and their activities are described below.
•The Codman Specialty Surgical segment includes (i) the Neurosurgery business, which sells a full line of products for neurosurgery and neuro critical care such as tissue ablation equipment, dural repair products, cerebral spinal fluid management devices, intracranial monitoring equipment, and cranial stabilization equipment and (ii) the instruments business, which sells more than 40,000 instrument patterns and surgical and lighting products to hospitals, surgery centers, dental, podiatry, and veterinary offices.
•The Tissue Technologies segment includes such offerings as skin and wound repair, bone grafts, and nerve and tendon repair products. In conjunction with the sale of the Extremity Orthopedics business, the Company rebranded the Orthopedics and Tissue Technologies segment as Tissue Technologies in the first quarter of 2021.
The Corporate and other category includes (i) various executive, finance, human resource, information systems and legal functions, (ii) brand management, and (iii) share-based compensation costs.
The operating results of the various reportable segments as presented are not comparable to one another because (i) certain operating segments are more dependent than others on corporate functions for unallocated general and administrative and/or operational manufacturing functions and (ii) the Company does not allocate certain manufacturing costs and general and administrative costs to the operating segment results. Net sales and profit by each reportable segment for the three and six months ended June 30, 2021 and 2020 are as follows :
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| Dollars in thousands | 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
| Segment Net Sales | |||||||||||||||||||||||
| Codman Specialty Surgical | $ | 256,837 | $ | 169,778 | $ | 498,078 | $ | 401,218 | |||||||||||||||
Tissue Technologies | 133,155 | 88,887 | 251,985 | 211,771 | |||||||||||||||||||
| Total revenues | $ | 389,992 | $ | 258,665 | $ | 750,063 | $ | 612,989 | |||||||||||||||
| Segment Profit | |||||||||||||||||||||||
| Codman Specialty Surgical | $ | 113,996 | $ | 65,256 | $ | 220,774 | $ | 152,491 | |||||||||||||||
Tissue Technologies | 64,413 | 28,688 | 114,424 | 59,958 | |||||||||||||||||||
| Segment profit | 178,409 | 93,944 | 335,198 | 212,449 | |||||||||||||||||||
| Amortization | (4,198) | (8,073) | (8,725) | (15,050) | |||||||||||||||||||
| Corporate and other | (122,357) | (71,791) | (243,905) | (156,216) | |||||||||||||||||||
| Operating income | $ | 51,854 | $ | 14,080 | $ | 82,568 | $ | 41,183 | |||||||||||||||
The Company does not allocate any assets to the reportable segments. No asset information is reported to the chief operating decision maker and disclosed in the financial information for each segment.
29
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
The Company attributes revenues to geographic areas based on the location of the customer. Total revenue by major geographic area consisted of the following:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| Dollars in thousands | 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
| United States | $ | 278,186 | $ | 181,850 | $ | 525,979 | $ | 428,702 | |||||||||||||||
| Europe | 48,437 | 32,026 | 94,256 | 77,922 | |||||||||||||||||||
| Asia Pacific | 44,306 | 33,501 | 91,601 | 73,461 | |||||||||||||||||||
| Rest of World | 19,063 | 11,288 | 38,227 | 32,904 | |||||||||||||||||||
| Total Revenues | $ | 389,992 | $ | 258,665 | $ | 750,063 | $ | 612,989 | |||||||||||||||
16. COMMITMENTS AND CONTINGENCIES
In consideration for certain technology, manufacturing, distribution, selling rights and licenses granted to the Company, the Company has agreed to pay royalties on sales of certain products that it sells. The royalty payments that the Company made under these agreements were not significant for any of the periods presented.
The Company is subject to various claims, lawsuits and proceedings in the ordinary course of the Company's business, including claims by current or former employees, distributors and competitors and with respect to its products and product liability claims, lawsuits and proceedings, some of which have been settled by the Company. In the opinion of management, such claims are either adequately covered by insurance or otherwise indemnified, or are not expected, individually or in the aggregate, to result in a material, adverse effect on the Company's financial condition. However, it is possible that the Company's results of operations, financial position and cash flows in a particular period could be materially affected by these contingencies.
The Company accrues for loss contingencies when it is deemed probable that a loss has been incurred and that loss is estimable. The amounts accrued are based on the full amount of the estimated loss before considering insurance proceeds and do not include an estimate for legal fees expected to be incurred in connection with the loss contingency. The Company consistently accrues legal fees expected to be incurred in connection with loss contingencies as those fees are incurred by outside counsel as a period cost.
Contingent Consideration
The Company determined the fair value of contingent consideration during the six month period ended June 30, 2021 and June 30, 2020 to reflect the change in estimates, additions, payments, transfers and the time value of money during the period.
A reconciliation of the opening balances to the closing balances of these Level 3 measurements for the six months ended June 30, 2021 and June 30, 2020 is as follows (in thousands):
| Six Months Ended June 30, 2021 | Contingent Consideration Liability Related to Acquisition of: | |||||||||||||||||||||||||||||||||||||
| Arkis | Location in Financial Statements | Derma Sciences | ACell Inc. (See Note 2) | Location in Financial Statements | ||||||||||||||||||||||||||||||||||
| Short-term | Long-term | Long-term | Long-term | |||||||||||||||||||||||||||||||||||
| Balance as of January 1, 2021 | $ | 3,415 | $ | 11,746 | $ | 230 | $ | — | ||||||||||||||||||||||||||||||
| Additions from acquisition of ACell | — | — | — | 23,900 | ||||||||||||||||||||||||||||||||||
| Transfers | (3,432) | 3,432 | — | — | ||||||||||||||||||||||||||||||||||
| Gain (loss) from change in fair value of contingent consideration liabilities | 17 | $ | (402) | Research and development | — | (400) | Selling, general and administrative | |||||||||||||||||||||||||||||||
| Balance as of June 30, 2021 | $ | — | $ | 14,776 | $ | 230 | $ | 23,500 | ||||||||||||||||||||||||||||||
| Six Months Ended June 30, 2020 | Contingent Consideration Liability Related to Acquisition of: | |||||||||||||||||||
| Arkis | Derma Sciences | Location in Financial Statements | ||||||||||||||||||
| Long-term | Long-term | |||||||||||||||||||
| Balance as of January 1, 2020 | $ | 14,210 | $ | 230 | ||||||||||||||||
| Loss from change in fair value of contingent consideration liabilities | (708) | — | Research and development | |||||||||||||||||
| Balance as of June 30, 2020 | $ | 13,502 | $ | 230 | ||||||||||||||||
30
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (continued)
Arkis BioSciences Inc.
On July 29, 2019, the Company acquired Arkis BioSciences Inc. ("Arkis") for an acquisition purchase price of $30.6 million (the "Arkis Acquisition") plus contingent consideration of up to $25.5 million, that may be payable based on the successful completion of certain development and commercial milestones. Arkis was a privately-held company that marketed the CerebroFlo® external ventricular drainage (EVD) catheter with Endexo® technology, a permanent additive designed to reduce the potential for catheter obstruction due to thrombus formation.
As part of the acquisition, the Company is required to pay the former shareholders of Arkis up to $25.5 million based on the timing of certain development milestones of $10.0 million and commercial sales milestones of $15.5 million, respectively. The Company used a probability weighted income approach to calculate the fair value of the contingent consideration that considered the possible outcomes of scenarios related to each specified milestone. The Company estimated the fair value of the contingent consideration to be $13.1 million at the acquisition date. The estimated fair value as of June 30, 2021 and June 30, 2020 was $14.8 million and $13.5 million, respectively. The Company recorded $14.8 million and $13.5 million in other liabilities at June 30, 2021 and June 30, 2020, respectively, in the consolidated balance sheet of the Company.
Derma Sciences
The Company assumed contingent consideration incurred by Derma Sciences, Inc. ("Derma Sciences") related to its acquisitions of BioD and the intellectual property related to Medihoney products. The Company accounted for the contingent liabilities by recording their fair value on the date of the acquisition based on a probability weighted income approach. The Company has already paid $33.3 million related to the aforementioned contingent liabilities. One contingent liability remains which relates to net sales of Medihoney products exceeding certain amounts defined in the agreement between the Company and Derma Sciences. The potential maximum undiscounted payment amounts to $3.0 million. The estimated fair value as of June 30, 2021 and June 30, 2020 was $0.2 million.
31
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of the Company's financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the related notes thereto appearing elsewhere in this report and our consolidated financial statements for the year ended December 31, 2020 included in our Annual Report on Form 10-K.
We have made statements in this report which constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). These forward-looking statements are subject to a number of risks, uncertainties and assumptions about the Company and other matters. These forward-looking statements include, but are not limited to, statements related to the Company's expectations regarding the potential impacts of the COVID-19 pandemic on our business, financial condition, and results of operations. These statements should, therefore, be considered in light of various important factors, including, but not limited to, the following: the Company's ability to recover to normalized procedure volume in the midst of the COVID-19 pandemic; the risk that the COVID-19 pandemic could lead to further material delays and cancellations of, or reduced demand for, procedures; curtailed or delayed capital spending by the Company's customers; disruption to the Company's supply chain; closures of our facilities; delays in gathering clinical evidence; diversion of management and other resources to respond to the COVID-19 outbreak; the impact of global and regional economic and credit market conditions on healthcare spending; the risk that the COVID-19 virus disrupts local economies and causes economies in our key markets to enter prolonged recessions. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors, including but not limited to those set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, and under the heading "Risk Factors" in this report. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
You can identify these forward-looking statements by forward-looking words such as “believe,” “may,” “might,” “could,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “seek,” “plan,” “expect,” “should,” “would” and similar expressions in this report.
GENERAL
Integra, headquartered in Princeton, New Jersey, is a world leader in medical technology. The Company was founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue. Since then, Integra has developed numerous product lines from this technology for applications ranging from burn and deep tissue wounds, to the repair of dura mater in the brain, as well as nerves and tendons. The Company has expanded its base regenerative technology business to include surgical instruments, neurosurgical products and advanced wound care through a combination of several global acquisitions and development of products internally to further meet the needs of its customers and impact patient care.
Integra manufactures and sells products in two reportable business segments: Codman Specialty Surgical and Tissue Technologies. In conjunction with the sale of the Extremity and Orthopedics business, the Company rebranded the Orthopedics and Tissue Technologies segment as Tissue Technologies in the first quarter of 2021. See Note 2. Acquisitions and Divestitures, for details. Our Codman Specialty Surgical products comprise of specialty surgical implants and instrumentation for a broad range of specialties. This segment includes products and solutions for dural access and repair, instruments, advanced energy, cerebral spinal fluid ("CSF") management and neuro monitoring including market leading product portfolios used in neurosurgery operation suites and critical care units. Codman Specialty Surgical products are sold through a combination of directly employed sales representatives, distributors and wholesalers, depending on the customer call point. Our Tissue Technologies product portfolios consist of differentiated regenerative technology products for soft tissue repair and tissue regeneration products, and surgical reconstruction. This business also includes private label sales of a broad set of our regenerative and wound care medicine technologies. Tissue Technologies products are sold through directly employed sales representatives and distributors focused on their respective surgical specialties, and strategic partners.
We have key manufacturing and research facilities located in California, Indiana, Maryland, Massachusetts, New Jersey, Ohio, Tennessee, Canada, France, Germany, Ireland, Puerto Rico and Switzerland. We also source most of our handheld surgical instruments, and dural sealant products through specialized third-party vendors.
Integra is committed to delivering high quality products that positively impact the lives of millions of patients and their families. We focus on four key pillars of our strategy: 1) enabling an execution-focused culture, 2) optimizing relevant scale, 3) advancing innovation and agility, and 4) leading in customer experience. We believe that by sharpening our focus on these areas through improved planning and communication, optimization of our infrastructure, and strategically aligned tuck-in acquisitions, we can build scale, increase competitiveness and achieve our long-term goals.
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To this end, the executive leadership team has established the following key priorities aligned to the following areas of focus:
Strategic Acquisitions. An important part of the Company's strategy is pursuing strategic transactions and licensing agreements that increase relevant scale in the clinical areas in which Integra competes. In December 2020, Integra entered into a merger agreement to acquire ACell, Inc., an innovative regenerative medicine company specializing in the manufacture of porcine urinary bladder extracellular matrices. This acquisition, which closed on January 20, 2021, expands our product offering of regenerative technology and is complementary to Integra’s existing tissue technologies portfolio. The acquisition also supports our long-term growth and profitability strategy with a financial profile similar to Integra’s tissue products. In 2021, we are focused on the integration of ACell Inc., into our Tissue Technologies business segment, while also continuing the development of regenerative tissue products for complex wound management that will benefit the expanded portfolio. See Note 2, Acquisitions and Divestitures, for details.
Portfolio Optimization and New Product Introductions. We are investing in innovative product development to drive a multi-generational pipeline for our key product franchises. Our product development efforts span across our key global franchises focused on potential for significant returns on investment. We continue to advance the development of pioneering technologies from our 2019 acquisitions, Arkis Biosciences, Inc. and Rebound Therapeutics Corporation. In addition to new product development, we are funding studies to gather clinical evidence to support launches, ensure market access and improve reimbursement for existing products. We continue to identify ways of optimizing our portfolio including identifying low-growth, low-margin products and product franchises for discontinuation.
In January 2021, we completed the sale of our Extremity Orthopedics business for approximately $240 million in cash subject to finalization of working capital adjustments. This transaction enables us to increase our investments in our core Neurosurgery and Tissue Technology businesses which will strengthen our existing leadership positions in both areas, fund pipeline opportunities to drive future growth and expand our addressable markets. See Note 2, Acquisitions and Divestitures for details.
Commercial Channel Investments. With acquisitions, new product introductions and a broad portfolio of products, investing in our sales channels is a core part of our strategy to create specialization and greater focus on reaching new and existing customers and addressing their needs. To support our commercial efforts in Tissue Technologies, we expanded our two-tier specialist model to increase our presence in focused segments. We created a virtual selling organization to help serve the evolving needs of our customers. Internationally, we have increased our commercial resources significantly in key emerging markets and are making investments to support our sales organization and maximize our commercial opportunities. These strong investments in our international sales channel position us well for expansion and long-term growth. In addition, we continue to build upon our leadership brands across our product franchises to enable us to engage customers through enterprise-wide contracts.
Customer Experience. We aspire to be ranked as a best-in-class provider and are committed to strengthen our relationships with all customers. We continue to invest in technologies, systems and processes to enhance the customer experience. Additionally, we launched new digital programs, resources and virtual product training to drive continued customer familiarity with our growing portfolio of medical technologies globally.
Clinical and Product Development Activities
We continue to invest in collecting clinical evidence to support the Company's existing products and new product launches, and to ensure that we obtain market access for broader and more cost-effective solutions. In each area, we continue to benefit from products launched over the past several years.
Within our Codman Specialty Surgical segment, the Company received FDA clearance in 2020 to treat malignant and benign tumors, but not limited to meningiomas and gliomas, for its CUSA® Clarity Ultrasonic Surgical Aspirator System, the first and only ultrasonic tissue ablation system with this specific indication. The FDA clearance is based on a wealth of peer-reviewed clinical publications and 40 years of surgical cases involving resection of brain and spinal tumors.
Additionally, the Company continued to reap the benefits of our product launches from the prior year from the Codman Specialty Surgical segment, including our new electrosurgery generator and irrigator system, an innovative customer-centric toolkit for our Certas™ Plus Programmable Valve along with additional shunt configurations. In Japan, we are experiencing strong growth as a result of the successful launch of DuraGen® in mid-2019, which is the first and only collagen xenograft approved for use as a dural substitute in the country. We are focused on the development of core clinical applications in our electromechanical technologies portfolio. Also, we updated our CUSA Clarity platform to incorporate a new ultrasonic handpiece, surgical tips and integrated electrosurgical capabilities. We continue to work with several instrument partners to bring new surgical instrument platforms to the market. This enables us to add new instruments with minimal expense and invest in ongoing development, such as our next generation of LED technology with our DUO LED Surgical Headlight System.
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We advanced the early-stage technology platforms we acquired during 2019. Through the Arkis Biosciences acquisition, we added a platform technology, CerebroFlo® external ventricular drainage (EVD) catheter with Endexo® technology, a permanent additive designed to reduce the potential for catheter obstruction due to thrombus formation. The CerebroFlo® EVD Catheter has demonstrated an average of 99% less thrombus accumulation onto its surface, in vitro, compared to a market leading EVD catheter. We acquired Rebound Therapeutics, a company that specialized in single-use medical devices that enable minimally invasive access with enhanced lighting and visualization to the neurosurgery suite and launched the MIRROR registry to collect data on this new device. These new platforms provide us with the opportunity to expand into new, faster growth therapeutic areas such as intracerebral hemorrhage and minimally invasive neurosurgery.
Within our Tissue Technologies segment, we recently completed one of the largest diabetic foot ulcers (DFU) randomized controlled trials (RCTs) of PriMatrix® Dermal Repair Scaffold for the management of DFU. This multi-center study enrolled more than 225 patients with chronic DFU's over the course of 12-week treatments and 4-week follow-up phases. The results of this study, which was published in the Journal of Wound Care, demonstrated that PriMatrix® plus standard of care (SOC) consisting of sharp debridement, infection elimination, use of dressings and offloading was significantly more likely to achieve complete wound closure compared with SOC alone, with a median number of one application of the product. In 2020, we announced positive clinical and economic data on Integra® Bilayer Wound Matrix ("IBWM") in complex lower extremity reconstruction based on two retrospective studies recently published in Plastic and Reconstructive Surgery, the official journal of the American Society of Plastic Surgeons. As surgeons look for ways to efficiently and effectively repair and close wounds during these challenging times, IBWM helps address the efficiency needed in operating rooms by reducing both the operating time and costs to hospitals and patients.
COVID-19 Pandemic
During this global crisis, the Company's focus remained on supporting patients, providing customers with life-saving products, and protecting the well-being of our employees. The rapid and evolving spread of the virus has resulted in an unprecedented challenge to the global healthcare industry, as medical resources were reallocated to fight COVID-19. During the first half of 2020, in response to the pandemic, we acted swiftly by implementing protocols to ensure continuity of our manufacturing and distribution sites around the world and to provide for the safety of our employees. During the second half of 2020, the Company's revenues were still impacted due to COVID-19 resurgences, though not to the levels seen in the first half of 2020.
During the first half of 2021, our business segments were well positioned to capitalize on the improving demand driven by the ongoing global market recovery. We saw particularly healthy order activity in products used in neurosurgery, instruments, burn, trauma and surgical reconstruction as markets gradually recovered. Areas such as capital equipment and our international indirect markets are still early in their recovery, but are reporting encouraging trends. We remain confident that the underlying markets in which the Company competes remain attractive over the long term. We also remain focused on managing the business for the long-term, including preserving full time jobs needed to support the rebound in surgical procedure volumes. The Company's adaptability and resiliency in the face of this unprecedented crisis is made possible in part by prior investments in technology infrastructure and operations, as well as our talented and committed global workforce.
Capital markets and worldwide economies have also been significantly impacted by the COVID-19 pandemic, and it is possible that it could cause a local and/or global economic recession. Any such economic recession could have a material adverse effect on the Company's long-term business as hospitals curtail and reduce capital as well as overall spending. The COVID-19 pandemic and local actions, such as “shelter-in-place” orders and restrictions on travel and access to our customers or temporary closures of our facilities or the facilities of our suppliers and their contract manufacturers, could further significantly impact our sales and our ability to ship our products and supply our customers. Any of these events could negatively impact the number of surgical and medical intervention procedures performed and have a material adverse effect on our business, financial condition, results of operations, or cash flows.
FDA Matters
We manufacture and distribute products derived from human tissue for which FDA has specific regulations governing human cells, tissues and cellular and tissue-based products, or HCT/Ps. An HCT/P is a product containing or consisting of human cells or tissue intended for transplantation into a human patient.
On June 22, 2015, the FDA issued an Untitled Letter (the "Untitled Letter") alleging that BioD's morselized amniotic membrane tissue-based products do not meet the criteria for regulation as HCT/Ps solely under Section 361 of the Public Health Services Act ("Section 361") and that, as a result, BioD would need a biologics license to lawfully market those morselized products. Since the issuance of the Untitled Letter, BioD and the Company have made known to the FDA their disagreement with the FDA’s assertion that certain products are more than minimally manipulated. The FDA has not changed its position that certain of the BioD acquired products are not eligible for marketing solely under Section 361. In July, 2020, the FDA issued the final guidance document related to human tissue titled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use” (the “HCT/P Final Guidance”). This Guidance document supersedes the November 2017 guidance by the same title.
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The HCT/P Final Guidance maintains the FDA’s position that products such as the Company’s morselized amniotic membrane tissue-based products do not meet the criteria for regulation solely as HCT/Ps. In addition, in the November 2017 guidance, the FDA articulated a risk-based approach to enforcement and, while some uses for amniotic membrane tissue-based products would have as much as thirty-six months of enforcement discretion, other high risk uses could be subject to immediate enforcement action. The revised final guidance of July 2020 maintained this approach and extended the discretionary enforcement period to May 31, 2021.
Rather than the risk of enforcement action, the Company discontinued manufacturing all morselized amniotic membrane tissue-based products prior to May 31, 2021. We no longer distribute these products. As of June 30, 2021, the Company has not received any further notice of enforcement action from the FDA regarding its morselized amniotic membrane tissue-based products.
Revenues from the now discontinued BioD morselized amniotic membrane-based products for the six months ended June 30, 2021 were less than 1.0% of consolidated revenues.
On March 7, 2019, TEI Biosciences, Inc. a subsidiary of the Company received a Warning Letter (the “Warning Letter”), dated March 6, 2019, from the FDA. The warning letter relates to quality systems issues at our manufacturing facility located in Boston, Massachusetts. The letter resulted from an inspection held at that facility in October and November 2018 and did not identify any new observations that were not already provided in the Form 483 that followed the inspection. The Company submitted its initial response to the FDA Warning Letter on March 28, 2019 and provides regular progress reports to the FDA as to its corrective actions and, since the conclusion of the inspection, has undertaken significant efforts to remediate the observations and continues to do so. The warning letter does not restrict the Company’s ability to manufacture or ship products or require the recall of any products. Nor does it restrict our ability to seek FDA 510(k) clearance of products. The letter states that requests for Certificates to Foreign Governments would not be granted. However, due to our progress reports, the FDA agreed to resume issuing Certificates to Foreign Governments to TEI due to substantial progress and the length of time it takes to resolve the Warning Letter. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. The TEI Boston facility manufactures extracellular bovine matrix (EBM) products. The Company does not expect to incur material incremental expense for remediation activities. We cannot, however, give any assurances that the FDA will be satisfied with our response to the Warning Letter or as to the expected date of the resolution of the matters included in the letter. Until the issues cited in the letter are resolved to the FDA’s satisfaction, the FDA may initiate additional regulatory action without further notice. Any adverse regulatory action, depending on its magnitude, may restrict us from effectively manufacturing, marketing and selling our products and could have a material adverse effect on our business, financial condition and results of operations.
Revenues of products manufactured in the TEI Boston facility for the six months ended June 30, 2021 were approximately 4.5% of consolidated revenues.
ACQUISITIONS & DIVESTITURES
Divestiture
On January 4, 2021, the Company completed its previously announced sale of its Extremity Orthopedics business to Smith & Nephew USD Limited. The transaction included the sale of the Company's upper and lower Extremity Orthopedics product portfolio, including ankle and shoulder arthroplasty and hand and wrist product lines. The Company received an aggregate purchase price of $240.0 million from Smith and Nephew and concurrently paid $41.5 million to the Consortium of Focused Orthopedists, LLC ("CFO") effectively terminating the licensing agreement between Integra and CFO relating to the development of shoulder arthroplasty products. The Company recognized a gain of $42.2 million in connection with the sale that is presented in Gain from the sale of business in the consolidated statement of operations for the year ended June 30, 2021. See Note 2- Acquisitions and Divestitures for details.
Acquisition
On January 20, 2021, the Company acquired ACell Inc. for an acquisition purchase price of $306.9 million plus contingent consideration of up to $100 million, that may be payable upon achieving certain revenue-based performance milestones in 2022, 2023 and 2025. ACell was a privately-held company that offered a portfolio of regenerative products for complex wound management, including developing and commercializing products based on MatriStem Urinary Bladder Matrix ("UBM"), a technology platform derived from porcine urinary bladder extracellular matrix. See Note 2- Acquisitions and Divestitures for details.
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OPTIMIZATION AND INTEGRATION ACTIVITIES
As a result of our ongoing acquisition strategy and significant growth in recent years, we have undertaken cost-saving initiatives to consolidate manufacturing operations, distribution facilities and transfer activities, implement a common ERP system, eliminate duplicative positions, realign various sales and marketing activities, and expand and upgrade production capacity for our regenerative technology products. These efforts are expected to continue and while we expect a positive impact from ongoing restructuring, integration, and manufacturing transfer and expansion activities, such results remain uncertain.
RESULTS OF OPERATIONS
Executive Summary
Net income for the three months ended June 30, 2021 was $35.1 million, or $0.41 per diluted share, as compared to $(0.4) million or $(0.00) per diluted share for the three months ended June 30, 2020. The net income for the three months ended June 30, 2021, was primarily driven by increase in revenues due to procedure recovery experienced in the current year as compared to the height of the COVID-19 pandemic in the first half of 2020.
Net income for the six months ended June 30, 2021 was $80.5 million, or $0.94 per diluted share, as compared to $8.8 million or $0.10 per diluted share for the six months ended June 30, 2020. The net income for the six months ended June 30, 2021 was primarily driven by higher revenue relating to surgical procedure recovery for the first half of 2021 and increase in non-operating income due to the gain of $42.2 million recognized in the first quarter of 2021 as a result of the sale of the Extremity Orthopedics business.
Special Charges
Income before taxes includes the following special charges:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| Dollars in thousands | 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
Acquisition, divestiture and integration-related charges(1) | $ | 10,776 | $ | 6,542 | $ | (16,225) | $ | 12,708 | |||||||||||||||
| Structural optimization charges | 4,409 | 1,230 | 8,355 | 4,471 | |||||||||||||||||||
| EU medical device regulation | 3,415 | 884 | 9,163 | 3,071 | |||||||||||||||||||
| Discontinued product lines charges | 303 | 1,302 | 336 | 4,487 | |||||||||||||||||||
| Convertible debt non-cash interest expense | — | 4,250 | — | 6,780 | |||||||||||||||||||
| Expenses related to debt refinancing | — | — | — | 2,740 | |||||||||||||||||||
COVID-19 pandemic related charges(2) | — | (869) | — | 3,836 | |||||||||||||||||||
| Total | $ | 18,903 | $ | 13,339 | $ | 1,629 | $ | 38,093 | |||||||||||||||
(1) The Company completed its sale of its Extremity Orthopedics business and recognized a gain of $42.2 million for the six months ended June 30, 2021 which was partially offset by other acquisition, divestiture and integration-related charges. See Note 2. Acquisitions and Divestitures for details.
(2) Charges relate to business interruptions and costs associated with the COVID-19 pandemic which impacted the Company's operations globally, partially offset by Coronavirus government relief programs in the prior year.
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The items reported above are reflected in the condensed consolidated statements of operations as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| Dollars in thousands | 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
| Cost of goods sold | $ | 10,724 | $ | 6,300 | $ | 20,903 | $ | 15,607 | |||||||||||||||
| Research and development | 2,108 | 624 | 7,623 | (427) | |||||||||||||||||||
| Selling, general and administrative | 6,563 | 2,164 | 18,057 | 13,394 | |||||||||||||||||||
Interest expense(1) | — | 4,251 | — | 9,519 | |||||||||||||||||||
| Gain from the sale of business | 679 | — | (42,197) | — | |||||||||||||||||||
| Other income | (1,171) | — | (2,757) | $ | — | ||||||||||||||||||
| Total | $ | 18,903 | $ | 13,339 | $ | 1,629 | $ | 38,093 | |||||||||||||||
(1) Upon adoption of ASU No. 2020-06, the Company will no longer incur non-cash interest expense for the amortization of debt discount. See Note 1. Basis of Presentation, for details.
We typically define special charges as items for which the amounts and/or timing of such expenses may vary significantly from period to period, depending upon our acquisition, divestiture, integration and restructuring activities, and for which the amounts are non-cash in nature, or for which the amounts are not expected to recur at the same magnitude. We believe that given our ongoing strategy of seeking acquisitions, our continuing focus on rationalizing our existing manufacturing and distribution infrastructure and our continuing review of various product lines in relation to our current business strategy, some of the special charges discussed above could recur with similar materiality in the future.
We believe that the separate identification of these special charges provides important supplemental information to investors regarding financial and business trends relating to our financial condition and results of operations. Investors may find this information useful in assessing comparability of our operating performance from period to period, against the business model objectives that management has established, and against other companies in our industry. We provide this information to investors so that they can analyze our operating results in the same way that management does and to use this information in their assessment of our core business and valuation of Integra.
Revenues and Gross Margin
The Company's revenues and gross margin on product revenues were as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| Dollars in thousands | 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
| Segment Net Sales | |||||||||||||||||||||||
| Codman Specialty Surgical | $ | 256,837 | $ | 169,778 | $ | 498,078 | $ | 401,218 | |||||||||||||||
| Tissue Technologies | 133,155 | 88,887 | 251,985 | 211,771 | |||||||||||||||||||
| Total revenues | $ | 389,992 | $ | 258,665 | $ | 750,063 | 612,989 | ||||||||||||||||
| Cost of goods sold | 151,267 | 105,478 | 297,090 | 238,954 | |||||||||||||||||||
| Gross margin on total revenues | $ | 238,725 | $ | 153,187 | $ | 452,973 | $ | 374,035 | |||||||||||||||
| Gross margin as a percentage of total revenues | 61.2 | % | 59.2 | % | 60.4 | % | 61.0 | % | |||||||||||||||
Three Months Ended June 30, 2021 as Compared to Three Months Ended June 30, 2020
Revenues
For the three months ended June 30, 2021, total revenues increased by $131.3 million to $390.0 million from $258.7 million for the same period in 2020. Domestic revenues increased by $96.3 million, or 53.0%, to $278.2 million and were 71.3% of total revenues for the three months ended June 30, 2021 compared to $181.9 million during the same period in the prior year. International revenues increased by $35.0 million or 45.6% to $111.8 million for the three months ended June 30, 2021 compared to $76.8 million during the same period in the prior year. The increase in revenues globally were primarily as a result of the recovery experienced from the COVID-19 pandemic across all franchises compared to the prior year due to rebound in surgical procedure volumes. Foreign exchange fluctuations had a favorable impact of $6.0 million on revenues for the quarter.
In the Codman Specialty Surgical segment ("CSS"), revenues were $256.8 million which was an increase of $87.1 million, or 51.3% as compared to the prior-year period. The Neurosurgery and Instrument portfolios increased high-double digits as a result of the recovery experienced from the COVID-19 pandemic.
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In the Tissue Technologies ("TT") segment, revenues were $133.2 million which was an increase of $44.3 million, or 49.8% from the prior-year period. The Wound Reconstruction and Private Label portfolios increased high-double digits as a result of the recovery experienced from the COVID-19 pandemic. Additionally, our TT segment revenue reflect the acquisition of ACell Inc. which was completed on January 20, 2021 and the sale of the Company's Extremity Orthopedics product portfolio which occurred on January 4, 2021.
We continue to closely monitor local, regional, and global COVID-19 surges as well as new variants of the virus for an impact on procedures during Q2 2021 and beyond. The reallocation of hospital resources to treat COVID-19 may continue to cause a financial strain on healthcare systems and reduce procedural volumes. Additionally, the Company does not expect all markets and product lines to improve at the same rate based on the level of recurrence of COVID-19 and its associated impact on the pace of procedure recovery and economic normalization.
Gross Margin
Gross margin increased to $238.7 million for the three months ended June 30, 2021, an increase of $85.5 from $153.2 million for the same period in 2020. Gross margin as a percentage of revenues increased to 61.2% for the second quarter of 2021 from 59.2% in the same period last year. This increase was mainly attributable to our strong revenue recovery from the disruption caused by the COVID-19 pandemic during the same period in the prior year, as well as due to favorable U.S. product mix and improved manufacturing utilization.
Operating Expenses
The following is a summary of operating expenses as a percent of total revenues:
| Three Months Ended June 30, | |||||||||||
| 2021 | 2020 | ||||||||||
| Research and development | 5.2 | % | 5.8 | % | |||||||
| Selling, general and administrative | 41.7 | % | 44.9 | % | |||||||
| Intangible asset amortization | 1.1 | % | 3.1 | % | |||||||
| Total operating expenses | 48.0 | % | 53.8 | % | |||||||
Total operating expenses, which consist of research and development, selling, general and administrative, and amortization expenses, increased by $47.8 million, or 34.4% to $186.9 million in the three months ended June 30, 2021, compared to $139.1 million in the same period in 2020. The increase in operating expenses compared to the prior year was primarily due to an increase in research and development, selling, general and administrative costs partially offset by a decrease in amortization expense. The Company continues to manage and prioritize it operating costs closely given the continued uncertainty of COVID-19. We also benefited from cost synergies as a result of the ACell Inc. acquisition the sale of the Extremity Orthopedic business.
Research and Development
Research and development expenses for the three months ended June 30, 2021 increased by $5.2 million as compared to the same period in the prior year.
Selling, General and Administrative
Selling, general and administrative costs increased by $46.4 million as compared to the same period in the prior year driven primarily due to costs associated with higher employee related costs, higher incentive and stock-based compensation, increased variable selling costs, as well as increased outside spending as revenue recovered.
Intangible Asset Amortization
Amortization expense (excluding amounts reported in cost of product revenues for technology-based intangible assets) for the three months ended June 30, 2021 was $4.2 million compared to $8.1 million for the same period in prior year primarily due to a reduction in amortization expense associated with intangible assets sold in conjunction with the sale of the Extremity and Orthopedics business during the current year.
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Non-Operating Income and Expenses
The following is a summary of non-operating income and expenses:
| Three Months Ended June 30, | |||||||||||
| Dollars in thousands | 2021 | 2020 | |||||||||
| Interest income | $ | 1,764 | $ | 2,281 | |||||||
| Interest expense | (13,149) | (15,682) | |||||||||
| Gain (loss) from the sale of business | (679) | — | |||||||||
| Other income, net | 5,034 | 972 | |||||||||
| Total non-operating income and expense | $ | (7,030) | $ | (12,429) | |||||||
Interest Income
Interest income for the three months ended June 30, 2021 decreased by $0.5 million as compared to the same period last year.
Interest Expense
Interest expense for the three months ended June 30, 2021 decreased by $2.5 million as compared to the same period in the prior year primarily due to the elimination of the non-cash interest expense as the result of the adoption ASU 2020-06 and the expenses associated with Amended and Restated Senior Credit Agreement which occurred in the prior period. See Note 1. Basis of Presentation for details in relation to the adoption of ASU 2020-06.
Other Income, net
Other income, net for the three months ended June 30, 2021 increased by $4.1 million compared to the same period in the prior year primarily due to income associated with the transition services agreement from the divestiture of the Extremity Orthopedics business and and higher income from additional cross currency swaps that were entered into during Q4 2020.
Income Taxes
| Three Months Ended June 30, | |||||||||||
| Dollars in thousands | 2021 | 2020 | |||||||||
| Income before income taxes | $ | 44,824 | $ | 1,651 | |||||||
| Income tax (benefit) expense | 9,756 | 2,020 | |||||||||
| Effective tax rate | 21.8 | % | 122.4 | % | |||||||
The Company’s effective income tax rates for the three months ended June 30, 2021 and 2020 were 21.8% and 122.4%, respectively.
For the three months ended June 30, 2021, the primary driver of the lower tax rate is due to mix of income impacted by the COVID-19 pandemic.
For the three months ended June 30, 2020, the primary drivers of the higher tax rate were lower income impacted by the COVID-19 pandemic, in addition to a $3.4 million valuation allowance on certain foreign deferred tax assets.
The effective tax rate may vary from period to period depending on, among other factors, the geographic and business mix of taxable earnings and losses, tax planning and settlements with various taxing authorities. We consider these factors and others, including the Company's history of generating taxable earnings, in assessing our ability to realize tax assets on a quarterly basis.
While it is often difficult to predict the outcome or the timing of the resolution of a particular matter with the various federal, state, and foreign tax authorities, we believe that our reserves reflect the most probable outcome of known tax contingencies. Settlement of a particular issue would usually require the use of cash. A favorable resolution would be recognized as a reduction to our annual effective tax rate in the year of resolution. The Company's tax reserves are presented in the balance sheet within other liabilities, except for amounts relating to items that we expect to pay in the coming year, which would be classified as current income taxes payable.
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Six Months Ended June 30, 2021 as Compared to Six Months Ended June 30, 2020
Revenues and Gross Margin
For the six months ended June 30, 2021, total revenues increased by $137.1 million to $750.1 million from $613.0 million for the same period in 2020. Domestic revenues increased by $97.3 million, or 23%, to $526.0 million and were 70% of total revenues for the six months ended June 30, 2021. International revenues increased by $39.8 million, or 22% to $224.1 million for the six months ended June 30, 2021 compared to $184.3 million during the same period in the prior year. The net increase of $137.1 million was a result of the recovery experienced from the COVID-19 pandemic across all franchises compared to the prior year due to rebound in surgical procedure volumes. Foreign exchange fluctuations had a favorable impact of $11.9 million on revenues for the year.
Codman Specialty Surgical revenues were $498.1 million, an increase of $96.9 million, or 24.1% from the prior-year period. The Neurosurgery and Instrument portfolios increased high-double digits as a result of the recovery experienced from the COVID-19 pandemic.
Tissue Technologies revenues were $252.0 million, an increase of $40.2 million, or 19.0% from the prior-year period. The Wound Reconstruction and Private Label portfolios increased high-double digits as a result of the recovery experienced from the COVID-19 pandemic. Additionally, our TT segment revenue reflect the acquisition of ACell Inc. which was completed on January 20, 2021 and the sale of the Company's Extremity Orthopedics product portfolio which occurred on January 4, 2021.
Gross Margin
Gross margin was $453.0 million for the six-month period ended June 30, 2021, an increase of $78.9 million from $374.0 million for the same period last year. Gross margin as a percentage of total revenue decreased to 60.4% for the six months ended June 30, 2021 from 61.0% in the same period last year. The decrease in gross margin percentage was due to increased amortization associated with technology-based intangible assets and inventory step-up amortization in connection with the ACell Inc. acquisition.
Operating Expenses
The following is a summary of operating expenses as a percent of total revenues:
| Six Months Ended June 30, | |||||||||||
| 2021 | 2020 | ||||||||||
| Research and development | 5.7 | % | 5.8 | % | |||||||
| Selling, general and administrative | 42.6 | % | 46.0 | % | |||||||
| Intangible asset amortization | 1.2 | % | 2.5 | % | |||||||
| Total operating expenses | 49.5 | % | 54.3 | % | |||||||
Total operating expenses, which consist of selling, general and administrative expenses, research and development expenses, IPR&D expense and amortization expenses, increased by $37.6 million, or 11.3% to $370.4 million in the six months ended June 30, 2021, compared to $332.9 million in the same period in 2020.
Selling, General and Administrative
Selling, general and administrative costs increased by $37.1 million as compared to the same period in the prior year driven primarily due to costs associated with higher employee related costs, higher incentive and stock-based compensation, increased variable selling costs, as well as increased outside spending as revenue recovered.
Intangible Asset Amortization
Amortization expense (excluding amounts reported in cost of product revenues for technology-based intangible assets) for the six months ended June 30, 2021 was $8.7 million compared to $15.1 million for the same period in prior year primarily due to a reduction in amortization expense associated with intangible assets sold in conjunction with the sale of the Extremity and Orthopedics business during the current year and accelerated amortization expense associated with an intangible asset recorded in the prior year.
We expect total annual amortization expense to be approximately $40.6 million for the remainder of 2021, $79.1 million in 2022, $78.4 million in 2023, $77.7 million in 2024, $77.7 million in 2025, $77.5 million in 2026 and $585.7 million thereafter.
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Non-Operating Income and Expenses
The following is a summary of non-operating income and expenses:
| Six Months Ended June 30, | |||||||||||
| Dollars in thousands | 2021 | 2020 | |||||||||
| Interest income | $ | 3,512 | $ | 4,851 | |||||||
| Interest expense | (26,078) | (33,434) | |||||||||
| Gain from the sale of business | 42,197 | — | |||||||||
| Other income, net | 9,903 | 493 | |||||||||
| Total non-operating income and expense | $ | 29,534 | $ | (28,090) | |||||||
Interest Income
Interest income for the six months ended June 30, 2021 decreased by $1.3 million as compared to the same period last year primarily due to the settlement of cross-currency swaps designated as net investment hedges during Q4 2020.
Interest Expense
Interest expense for the six months ended June 30, 2021 decreased by $7.4 million as compared to the same period last year primarily due to the elimination of the non-cash interest expense as the result of the adoption ASU 2020-06 and the expenses associated with Amended and Restated Senior Credit Agreement which occurred in the prior period. See Note 1. Basis of Presentation for details in relation to the adoption of ASU 2020-06.
Gain from the sale of business
On January 4, 2021, the Company completed its sale of its Extremity Orthopedics business and recognized a gain of $42.2 million in the first quarter of the current year.
Other Income, net
Other income, net for the six months ended June 30, 2021, increased by $9.4 million primarily due to income associated with the transition services agreement with Smith and Nephew and higher income from additional cross currency swaps that were entered into during Q4 2020.
Income Taxes
| Six Months Ended June 30, | |||||||||||
| Dollars in thousands | 2021 | 2020 | |||||||||
| Income before income taxes | $ | 112,102 | $ | 13,093 | |||||||
| Income tax (benefit) expense | 31,640 | 4,282 | |||||||||
| Effective tax rate | 28.2 | % | 32.7 | % | |||||||
The Company’s effective income tax rates for the six months ended June 30, 2021 and 2020 were 28.2% and 32.7%, respectively.
For the six months ended June 30, 2021, the primary drivers of the lower tax rate was mix of income in lower-taxed jurisdictions, offset by the tax impact of the gain on sale of its Extremity Orthopedics business which was completed during the first quarter of 2021. For the six months ended June 30, 2020, the primary drivers of the higher tax rate were lower book income in lower-taxed jurisdictions and a $3.4 million valuation allowance on certain foreign deferred tax assets, as the Company determined that it is no longer more likely than not that these foreign deferred tax assets would be realized due to the adverse impact of the COVID-19 pandemic in certain jurisdictions.
The Company expects its effective income tax rate for the full year to be approximately 24.8%, driven primarily by the jurisdictional mix of income and the tax impact of the gain from the sale of its Extremity Orthopedic business, which closed during the first quarter.
The effective tax rate may vary from period to period depending on, among other factors, the geographic and business mix of taxable earnings and losses, tax planning and settlements with various taxing authorities. We consider these factors and others, including the Company's history of generating taxable earnings, in assessing our ability to realize tax assets on a quarterly basis.
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While it is often difficult to predict the outcome or the timing of the resolution of a particular matter with the various federal, state, and foreign tax authorities, we believe that our reserves reflect the most probable outcome of known tax contingencies. Settlement of a particular issue would usually require the use of cash. Favorable resolution would be recognized as a reduction to our annual effective tax rate in the year of resolution. The tax reserves are presented in the balance sheet within other liabilities, except for amounts relating to items we expect to pay in the coming year, which would be classified as current income taxes payable.
GEOGRAPHIC PRODUCT REVENUES AND OPERATIONS
The Company attributes revenues to geographic areas based on the location of the customer. Total revenue by major geographic area consisted of the following:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| Dollars in thousands | 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
| United States | $ | 278,186 | $ | 181,850 | $ | 525,979 | $ | 428,702 | |||||||||||||||
| Europe | 48,437 | 32,026 | 94,256 | 77,922 | |||||||||||||||||||
| Asia Pacific | 44,306 | 33,501 | 91,601 | 73,461 | |||||||||||||||||||
| Rest of World | 19,063 | 11,288 | 38,227 | 32,904 | |||||||||||||||||||
| Total Revenues | $ | 389,992 | $ | 258,665 | $ | 750,063 | $ | 612,989 | |||||||||||||||
The Company generates significant revenues outside the U.S., a portion of which are U.S. dollar-denominated transactions conducted with customers that generate revenue in currencies other than the U.S. dollar. As a result, currency fluctuations between the U.S. dollar and the currencies in which those customers do business could have an impact on the demand for the Company's products in foreign countries. Local economic conditions, regulatory compliance or political considerations, the effectiveness of our sales representatives and distributors, local competition and changes in local medical practice all may combine to affect our sales into markets outside the U.S.
Domestic revenues increased by $96.3 million for the three months ended June 30, 2021 compared to the same period last year. European sales increased by $16.4 million for the three months ended June 30, 2021 compared to the same period last year. Sales to customers in Asia Pacific increased by $10.8 million for the three months ended June 30, 2021. The Rest of the World for the three months ended June 30, 2021 increased by $7.8 million compared to the same period last year. The increase in revenues globally were primarily as a result of the recovery experienced from the COVID-19 pandemic across all franchises compared to the prior year due to rebound in surgical procedure volumes.
Domestic revenues increased by $97.3 million for the six months ended June 30, 2021 compared to the same period last year. European sales increased by $16.3 million for the six months ended June 30, 2021 compared to the same period last year. Sales to customers in Asia Pacific increased by $18.1 million for the six months ended June 30, 2021. The Rest of the World for the six months ended June 30, 2021 increased by $5.3 million compared to the same period last year. The increase in revenues globally were primarily as a result of the recovery experienced from the COVID-19 pandemic across all franchises compared to the prior year due to rebound in surgical procedure volumes.
LIQUIDITY AND CAPITAL RESOURCES
Working Capital
The working capital as of June 30, 2021 and December 31, 2020 was $713.6 million and $836.2 million, respectively. Working capital consists of total current assets less total current liabilities as presented in the consolidated balance sheets.
Cash and Marketable Securities
The Company had cash and cash equivalents totaling approximately $397.4 million and $470.2 million at June 30, 2021 and December 31, 2020 respectively, which are valued based on Level 1 measurements in the fair value hierarchy. At June 30, 2021, our non-U.S. subsidiaries held approximately $290.8 million of cash and cash equivalents that are available for use outside the U.S. The Company asserts that it has the ability and intends to indefinitely reinvest the undistributed earnings from its foreign operations unless there is no material tax cost to remit the earnings into the U.S. The Company does not anticipate the need to repatriate earnings from foreign subsidiaries as a result of the impact of the COVID-19 pandemic.
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Cash Flows
| Six Months Ended June 30, | |||||||||||
| Dollars in thousands | 2021 | 2020 | |||||||||
| Net cash provided by operating activities | $ | 160,371 | $ | 53,931 | |||||||
| Net cash used in investing activities | (125,483) | (25,434) | |||||||||
| Net cash (used) provided by financing activities | (100,490) | 133,452 | |||||||||
| Effect of exchange rate fluctuations on cash | (7,150) | 121 | |||||||||
Cash Flows Provided by Operating Activities
Operating cash flows for the six months ended June 30, 2021 increased by $106.4 million compared to the same period in 2020. Net income after removing the impact of the gain on sale of business and non-cash adjustments increased for the six months ended June 30, 2021 by approximately $32.9 million as compared to the same period in 2020 primarily due to the revenue recovery in the current year as compared to the height of the COVID-19 pandemic in the first half of the 2020. The changes in assets and liabilities, net of business acquisitions, increased cash flows by $37.5 million as compared to the decrease of $36.1 million for the same period in 2020. The increase in 2021 is attributable to a reduction in inventories mainly driven by higher revenues in the first half of 2021, an increase in accounts payables, accrued expenses and other current liabilities partially offset by an increase in accounts receivable due to continued collection efforts.
Operating cash flows for the six months ended June 30, 2020 decreased compared to the same period in 2019. Net income after non-cash adjustments decreased for the six months ended June 30, 2020 by approximately $37.7 million compared to the same period in 2019 primarily due to adverse effects of the COVID-19 pandemic. The changes in assets and liabilities, net of business acquisitions, decreased cash flows from operating activities by $36.1 million for the six months ended June 30, 2020 compared to a decrease of $49.8 million for the same period in 2019. The decrease in 2020 is attributable to an increase in inventory to ensure an adequate safety stock of select products as surgical procedures continue to recover from levels experienced in the second quarter. In addition, decreases were also driven by reduced payables offset by decreases in accounts receivable due to lower revenue and continued collection efforts.
Cash Flows Used in Investing Activities
During the six months ended June 30, 2021, we paid a net cash amount of $303.9 million in relation to the acquisition of ACell Inc. and received net proceeds of $191.7 million for the sale of the Extremity Orthopedics business. The Company also paid for $13.3 million capital expenditures to support operations improvement initiatives at a number of our manufacturing facilities and other information technology investments.
During the six months ended June 30, 2020, the Company paid $23.7 million for capital expenditures, most of which were directed to our facilities located in Mansfield, MA, Boston, MA, Memphis, TN, and Princeton, NJ.
Cash Flows Used in Financing Activities
Uses of cash from financing activities in the six months ended June 30, 2021 were repayments of $102.2 million under our Senior Credit Facility and Securitization Facility. In addition, the Company had $3.8 million in cash taxes paid in net equity settlement. These uses were offset by $3.6 million proceeds from the exercise of stock options and $2.2 million borrowings under our Securitization Facility.
Sources of cash from financing activities in the six months ended June 30, 2020 were $515.3 million proceeds from the issuance of Convertible Senior Notes including the call and warrant transactions, $127.7 million borrowing under our Senior Credit Facility and Securitization Facility. These were offset by repayments of $388.5 million on the revolving portion of our Senior Credit Facility and Securitization Facility, $20.3 million debt issuance costs related to the Amended and Restated Senior Credit Agreement and the issuance of Convertible Senior Notes and $100.0 million purchases of treasury stock.
Amended and Restated Senior Credit Agreement, Convertible Senior Notes, Securitization and Related Hedging Activities
See Note 6, Debt to the current period’s condensed consolidated financial statements for a discussion of our Amended and Restated Senior Credit Agreement, Convertible Senior Notes and Securitization Facility and Note 7, Derivative Instruments for discussion of our hedging activities. We are forecasting that for the next twelve months, sales and earnings will be sufficient to remain in compliance with our financial covenants under the terms of the February 2020 Amendment and July 2020 Amendment to the Senior Credit Facility.
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Share Repurchase Plan
On December 7, 2020, the Board of Directors authorized the Company to repurchase up to $225 million of the Company’s common stock. The program allows the Company to repurchase its shares opportunistically from time to time. The repurchase authorization expires in December 2022. The Company has $225 million remaining under the share repurchase of its Common Stock. The price and timing of any future purchases under the share repurchase program will depend on factors such as levels of cash generation from operations, the volume of stock option exercises by employees, cash requirements for acquisitions, dividends, economic and market conditions and stock price.
During the year ended December 31, 2020, the Company repurchased 2.1 million shares of Integra’s common stock as a part of our previous share repurchase authorization. The Company utilized $100.0 million of net proceeds from the offering of the Convertible Senior Notes to execute the share repurchase transactions. This included $7.6 million from certain purchasers of the convertible notes in conjunction with the closing of the offering. On February 5, 2020, the Company entered into a $92.4 million accelerated share repurchase ("ASR") to complete the remaining $100.0 million of share repurchase. The Company received 1.3 million shares through the ASR, which represented approximately 80% of the expected total shares. Upon settlement of the ASR in June 2020, the Company received an additional 0.6 million shares determined using the volume-weighted average price of the Company's common stock during the term of the transaction.
Dividend Policy
The Company has not paid any cash dividends on our common stock since our formation. Our Senior Credit Facility limits the amount of dividends that we may pay. Any future determinations to pay cash dividends on our common stock will be at the discretion of the Board and will depend upon our financial condition, results of operations, cash flows and other factors deemed relevant by the Board.
Capital Resources
We believe that our cash and available borrowings under the Senior Credit Facility are sufficient to finance our operations and capital expenditures for the foreseeable future. Our future capital requirements will depend on many factors, including the growth of our business, the timing and introduction of new products and investments, strategic plans and acquisitions, among others. Additional sources of liquidity available to us include short term borrowings and the issuance of long term debt and equity securities.
Off-Balance Sheet Arrangements
We do not have any off–balance sheet financing arrangements during the six months ended June 30, 2021 that have or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to our interests.
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Contractual Obligations and Commitments
As of June 30, 2021, the Company is obligated to pay the following amounts under various agreements:
| Payments Due by Calendar Year | |||||||||||||||||||||||||||||
| Dollars in millions | Total | Remaining 2021 | 2022-2023 | 2024-2025 | Thereafter | ||||||||||||||||||||||||
| Revolving Credit Facility (1) | $ | 8.8 | $ | — | $ | — | $ | 8.8 | $ | — | |||||||||||||||||||
| Term Loan | 866.3 | 22.5 | 106.9 | 736.9 | — | ||||||||||||||||||||||||
| Securitization Facility (1) | 112.5 | — | — | 112.5 | — | ||||||||||||||||||||||||
| Convertible Debt (4) | 575.0 | — | — | 575.0 | — | ||||||||||||||||||||||||
| Interest (2) | 40.8 | 6.3 | 23.3 | 11.2 | — | ||||||||||||||||||||||||
| Employment Agreements (3) | 0.5 | 0.5 | — | — | — | ||||||||||||||||||||||||
| Operating Leases | 146.0 | 8.1 | 31.4 | 22.9 | 83.6 | ||||||||||||||||||||||||
| Purchase Obligations | 4.4 | 1.1 | 3.3 | — | — | ||||||||||||||||||||||||
| Other | 3.6 | 0.4 | 1.1 | 2.1 | — | ||||||||||||||||||||||||
| Total | $ | 1,757.9 | $ | 38.9 | $ | 166.0 | $ | 1,469.4 | $ | 83.6 | |||||||||||||||||||
(1) The Company may borrow and make payments against the revolving credit portion of its Senior Credit Facility and Securitization Facility from time to time and considers all of the outstanding amounts to be long term based on its current intent and ability to repay the borrowing outside of the next twelve-month period.
(2) Interest is calculated on the term loan portion of the Senior Credit Facility based on LIBOR plus the spread paid by the Company. As the revolving credit facility and Securitization Facility can be repaid at any time, no interest has been included in the calculation.
(3) Amounts shown under Employment Agreements do not include compensation resulting from a change in control.
(4) On February 4, 2020, the Company issued $575.0 million aggregate principal amount of its of 0.5% Convertible Senior Notes due 2025 (the "2025 Notes"). The 2025 Notes will mature on August 15, 2025 and bear interest at a rate of 0.5% per annum payable semi-annually in arrears, unless earlier converted, repurchased or redeemed in accordance with the terms of the Notes. See Note 6, Debt, for the details on the 2025 Notes.
The Company has excluded its contingent consideration obligation related to prior and current year acquisitions from the contractual obligations table above; this liability had a total estimated fair value of $38.5 million at June 30, 2021. This liability has been excluded because the amount to be paid or the potential payment date is not fixed.
The Company has excluded its future pension contribution obligations from the table above. This has been excluded because the future amounts to be paid and the potential payment dates are not fixed.
The Company has excluded the liability for uncertain tax benefits from the contractual obligations table above, including interest and penalties, totaling $0.8 million at June 30, 2021. This liability for uncertain tax benefits has been excluded because we cannot make a reliable estimate of the period in which the uncertain tax benefits may be realized.
OTHER MATTERS
Critical Accounting Estimates
The critical accounting estimates included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2020 have not materially changed.
Recently Issued Accounting Standards
Information regarding new accounting pronouncements is included in Note 1 - Basis of Presentation to the current period’s condensed consolidated financial statements.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to various market risks, including changes in foreign currency exchange rates and interest rates that could adversely affect our results of operations and financial condition. To manage the volatility relating to these typical business exposures, we may enter into various derivative transactions when appropriate. We do not hold or issue derivative instruments for trading or other speculative purposes.
Foreign Currency Exchange and Other Rate Risks
We operate on a global basis and are exposed to the risk that changes in foreign currency exchange rates could adversely affect our financial condition, results of operations and cash flows. We are primarily exposed to foreign currency exchange rate risk with respect to transactions and net assets denominated in Euros ("EUR"), British pounds ("GBP"), Swiss francs ("CHF"), Canadian dollars, Japanese yen, Mexican pesos, Brazilian reais, Australian dollars and Chinese yuan. We manage the foreign currency exposure centrally, on a combined basis, which allows us to net exposures and to take advantage of any natural offsets. To mitigate the impact of currency fluctuations on transactions denominated in nonfunctional currencies, we periodically enter into derivative financial instruments in the form of foreign currency exchange forward contracts with major financial institutions. We temporarily record realized and unrealized gains and losses on these contracts that qualify as cash flow hedges in other comprehensive income, and then recognize them in other income or expense when the hedged item affects net earnings.
From time to time, we enter into foreign currency forward exchange contracts to manage currency exposures for transactions denominated in a currency other than an entity’s functional currency. As a result, the impact of foreign currency gains/losses recognized in earnings are partially offset by gains/losses on the related foreign currency forward exchange contracts in the same reporting period. Refer to Note 7, Derivative Instruments for further information.
We maintain written policies and procedures governing our risk management activities. With respect to derivatives, changes in hedged items are generally expected to be completely offset by changes in the fair value of hedge instruments. Consequently, foreign currency exchange contracts would not subject us to material risk due to exchange rate movements, because gains and losses on these contracts offset gains and losses on the assets, liabilities or transactions being hedged.
The results of operations discussed herein have not been materially affected by inflation.
Interest Rate Risk
Cash and Cash Equivalents - We are exposed to the risk of interest rate fluctuations on the interest income earned on our cash and cash equivalents. A hypothetical 100 basis points movement in interest rates applicable to our cash and cash equivalents outstanding at June 30, 2021 would increase interest income by approximately $4.0 million on an annual basis. No significant decrease in interest income would be expected as our cash balances are earning interest at rates of approximately one basis point. We are subject to foreign currency exchange risk with respect to cash balances maintained in foreign currencies.
Debt - Our interest rate risk relates primarily to U.S. dollar LIBOR-indexed borrowings. We use interest rate swap derivative instruments to manage our earnings and cash flow exposure to changes in interest rates. These interest rate swaps fix the interest rate on a portion of our expected LIBOR-indexed floating-rate borrowings. These interest rate swaps were designated as cash flow hedges as of March 31, 2021. The total notional amounts related to the Company’s interest rate swaps were $1.8 billion with $875.0 million effective as of June 30, 2021. Based on our outstanding borrowings at June 30, 2021, a 100 basis points change in interest rates would have impacted interest expense on the unhedged portion of the debt by $1.1 million on an annualized basis.See Note 7, Derivative Instruments, for the details of interest rate swaps.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
The Company maintains disclosure controls and procedures that are designed to provide reasonable assurance that information required to be disclosed in our Exchange Act report is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. Disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Management has designed our disclosure controls and procedures to provide reasonable assurance of achieving the desired control objectives.
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As required by Exchange Act Rule 13a-15(b), the Company has carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of June 30, 2021. Based upon this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of June 30, 2021 to provide such reasonable assurance.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) that occurred during the quarter ended June 30, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
In response to business integration activities, the Company has and will continue to further align and streamline the design and operation of the financial control environment to be responsive to the changing business model.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Information pertaining to legal proceedings can be found in Note 16. Commitment and Contingencies.
ITEM 1A. RISK FACTORS
There have been no material changes in the Company's risk factors included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and subsequent periodic reports filed with the Securities and Exchange Commission pursuant to the Securities Exchange Act of 1934, as amended.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Information pertaining to our common stock under the repurchase program can be found in Note 11. Treasury Stock.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Not applicable.
ITEM 6. EXHIBITS
Reference is hereby made to the Exhibit Index on page 49. | ||
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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.
| INTEGRA LIFESCIENCES HOLDINGS CORPORATION | |||||||||||
| Date: | July 29, 2021 | /s/ Peter J. Arduini | |||||||||
| Peter J. Arduini | |||||||||||
| President and Chief Executive Officer | |||||||||||
| (Principal Executive Officer) | |||||||||||
| Date: | July 29, 2021 | /s/ Carrie L. Anderson | |||||||||
| Carrie L. Anderson | |||||||||||
| Executive Vice President, Chief Financial Officer, and Treasurer | |||||||||||
| (Principal Financial Officer) | |||||||||||
| Date: | July 29, 2021 | /s/ Jeffrey A. Mosebrook | |||||||||
| Jeffrey A. Mosebrook | |||||||||||
| Senior Vice President, Finance | |||||||||||
| (Principal Accounting Officer) | |||||||||||
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| Exhibits | ||||||||
| *10.1 | ||||||||
| *31.1 | ||||||||
| *31.2 | ||||||||
| *32.1 | ||||||||
| *32.2 | ||||||||
| *†101.INS | XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | |||||||
| *†101.SCH | XBRL Taxonomy Extension Schema Document | |||||||
| *†101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | |||||||
| *†101.DEF | XBRL Definition Linkbase Document | |||||||
| *†101.LAB | XBRL Taxonomy Extension Labels Linkbase Document | |||||||
| *†101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | |||||||
| * | Filed herewith | ||||
| # | Indicates a management contract or compensatory plan or arrangement. | ||||
† The financial information of Integra LifeSciences Holdings Corporation Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 filed on July 29, 2021 formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Statements of Operations and Comprehensive Income, (ii) the Condensed Consolidated Balance Sheets, (iii) Parenthetical Data to the Condensed Consolidated Balance Sheets, (iv) the Condensed Consolidated Statements of Cash Flows, and (v) Notes to Condensed Consolidated Financial Statements, is furnished electronically herewith.
49