Endo Reports Third-Quarter 2021 Financial Results And Raises 2021 Financial Guidance
Endo International reported Q3 2021 financial results, revealing total revenues of $772 million, a 22% increase year-over-year, driven by growth in Sterile Injectables and Generic Pharmaceuticals. The reported loss from continuing operations improved to $49 million, a 29% decrease from last year. Adjusted income surged 55% to $189 million, with adjusted diluted net income per share rising 54% to $0.80. Endo raised its full-year guidance for revenues and adjusted EBITDA, reflecting a positive outlook amidst ongoing COVID-19 uncertainties.
- Total revenues increased 22% to $772 million in Q3 2021.
- Adjusted income from continuing operations rose 55% to $189 million.
- Adjusted diluted net income per share increased 54% to $0.80.
- Raised full-year financial guidance for revenues and adjusted EBITDA.
- Reported loss from continuing operations was $49 million.
- Higher litigation-related costs and asset impairment charges impacted earnings.
DUBLIN, Nov. 4, 2021 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today reported financial results for the third-quarter ended September 30, 2021.
"We delivered strong third-quarter results driven by outstanding execution across all of our businesses. As a result of our year-to-date performance and our expectations for the remainder of 2021, we are raising our full-year 2021 financial guidance," said Blaise Coleman, President and Chief Executive Officer at Endo. "Additionally, we are pleased with our progress against our strategic priorities including our efforts to expand and enhance our portfolio with the recent launch of varenicline tablets, the only available FDA approved generic version of Chantix®, and the continued positive market response to QWO®."
THIRD-QUARTER FINANCIAL PERFORMANCE
(in thousands, except per share amounts) | |||||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||
2021 | 2020 | Change | 2021 | 2020 | Change | ||||||||||||||||
Total Revenues, Net | $ | 772,028 | $ | 634,860 | 22 | % | $ | 2,203,777 | $ | 2,142,853 | 3 | % | |||||||||
Reported (Loss) Income from Continuing Operations | $ | (49,289) | $ | (68,974) | (29) | % | $ | (12,414) | $ | 106,217 | NM | ||||||||||
Reported Diluted Weighted Average Shares | 233,578 | 230,040 | 2 | % | 232,487 | 233,379 | — | % | |||||||||||||
Reported Diluted Net (Loss) Income per Share from Continuing Operations | $ | (0.21) | $ | (0.30) | (30) | % | $ | (0.05) | $ | 0.46 | NM | ||||||||||
Reported Net (Loss) Income | $ | (77,207) | $ | (75,887) | 2 | % | $ | (51,183) | $ | 64,601 | NM | ||||||||||
Adjusted Income from Continuing Operations (2) | $ | 189,277 | $ | 122,275 | 55 | % | $ | 516,315 | $ | 494,375 | 4 | % | |||||||||
Adjusted Diluted Weighted Average Shares (1)(2) | 235,527 | 233,442 | 1 | % | 236,538 | 233,379 | 1 | % | |||||||||||||
Adjusted Diluted Net Income per Share from Continuing Operations (2) | $ | 0.80 | $ | 0.52 | 54 | % | $ | 2.18 | $ | 2.12 | 3 | % | |||||||||
Adjusted EBITDA (2) | $ | 386,883 | $ | 286,700 | 35 | % | $ | 1,094,298 | $ | 1,044,307 | 5 | % | |||||||||
__________ | |
(1) | Reported Diluted Net (Loss) Income per Share from Continuing Operations is computed based on weighted average shares outstanding and, if there is income from continuing operations during the period, the dilutive impact of ordinary share equivalents outstanding during the period. In the case of Adjusted Diluted Weighted Average Shares, Adjusted Income from Continuing Operations is used in determining whether to include such dilutive impact. |
(2) | The information presented in the table above includes non-GAAP financial measures such as "Adjusted Income from Continuing Operations," "Adjusted Diluted Weighted Average Shares," "Adjusted Diluted Net Income per Share from Continuing Operations" and "Adjusted EBITDA." Refer to the "Supplemental Financial Information" section below for reconciliations of certain non-GAAP financial measures to the most directly comparable GAAP financial measures. |
CONSOLIDATED RESULTS
Total revenues were
Reported loss from continuing operations in third-quarter 2021 was
Adjusted income from continuing operations in third-quarter 2021 was
BRANDED PHARMACEUTICALS SEGMENT
Third-quarter 2021 Branded Pharmaceuticals segment revenues were
Specialty Products revenues increased
STERILE INJECTABLES SEGMENT
Third-quarter 2021 Sterile Injectables segment revenues were
GENERIC PHARMACEUTICALS SEGMENT
Third-quarter 2021 Generic Pharmaceuticals segment revenues were
INTERNATIONAL PHARMACEUTICALS SEGMENT
Third-quarter 2021 International Pharmaceuticals segment revenues were
2021 FINANCIAL GUIDANCE
Endo is updating its financial guidance for the full-year ending December 31, 2021 by raising the expected ranges regarding revenues, adjusted diluted net income per share from continuing operations and adjusted EBITDA. The guidance below contemplates a range of potential outcomes that reflect uncertainties in certain key assumptions including, among other things, uncertainties related to the COVID-19 pandemic. These statements are forward-looking, and actual results may differ materially from Endo's expectations, as further discussed below under the heading "Cautionary Note Regarding Forward-Looking Statements."
Full-Year 2021 | |||
Prior | Current | ||
Total Revenues, Net | |||
Adjusted EBITDA | |||
Adjusted Diluted Net Income per Share from Continuing Operations | |||
Assumptions: | |||
Adjusted Gross Margin | ~ | ~ | |
Adjusted Operating Expenses as a Percentage of Total Revenues, Net | ~ | ~ | |
Adjusted Interest Expense | ~ | ~ | |
Adjusted Effective Tax Rate | ~ | ~ | |
Adjusted Diluted Weighted Average Shares | ~239M | ~236M | |
BALANCE SHEET, LIQUIDITY AND OTHER UPDATES
As of September 30, 2021, the Company had approximately
Third-quarter 2021 net cash provided by operating activities was
Additionally, in October 2021, the Company completed the previously announced sale of its manufacturing site in Chestnut Ridge, NY, which included, among other assets, U.S. generic retail products and related product inventory to subsidiaries of Strides Pharma Science Limited for approximately
CONFERENCE CALL INFORMATION
Endo will conduct a conference call with financial analysts to discuss this press release tomorrow, November 5, 2021, at 7:30 a.m. ET. The dial-in number to access the call is U.S./Canada (866) 497-0462, International (678) 509-7598, and the passcode is 6052178. Please dial in 10 minutes prior to the scheduled start time.
A replay of the call will be available from November 5, 2021 at 10:30 a.m. ET until 9:30 a.m. ET on November 12, 2021 by dialing U.S./Canada (855) 859-2056 International (404) 537-3406, and entering the passcode 6052178.
A simultaneous webcast of the call can be accessed by visiting http://investor.endo.com/events-and-presentations. In addition, a replay of the webcast will be available on the Company website for one year following the event.
Chantix® is a registered trademark of Pfizer Inc.
FINANCIAL SCHEDULES
The following table presents Endo's unaudited Total revenues, net for the three and nine months ended September 30, 2021 and 2020 (dollars in thousands):
Three Months Ended September 30, | Percent | Nine Months Ended September 30, | Percent | ||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||||
Branded Pharmaceuticals: | |||||||||||||||||||||
Specialty Products: | |||||||||||||||||||||
XIAFLEX® | $ | 105,509 | $ | 88,167 | 20 | % | $ | 312,266 | $ | 211,022 | 48 | % | |||||||||
SUPPRELIN® LA | 30,069 | 28,229 | 7 | % | 85,665 | 63,344 | 35 | % | |||||||||||||
Other Specialty (1) | 26,339 | 23,724 | 11 | % | 74,407 | 68,795 | 8 | % | |||||||||||||
Total Specialty Products | $ | 161,917 | $ | 140,120 | 16 | % | $ | 472,338 | $ | 343,161 | 38 | % | |||||||||
Established Products: | |||||||||||||||||||||
PERCOCET® | $ | 26,914 | $ | 27,508 | (2) | % | $ | 78,695 | $ | 82,789 | (5) | % | |||||||||
TESTOPEL® | 11,686 | 18,068 | (35) | % | 32,314 | 26,877 | 20 | % | |||||||||||||
Other Established (2) | 30,460 | 37,986 | (20) | % | 82,305 | 104,449 | (21) | % | |||||||||||||
Total Established Products | $ | 69,060 | $ | 83,562 | (17) | % | $ | 193,314 | $ | 214,115 | (10) | % | |||||||||
Total Branded Pharmaceuticals (3) | $ | 230,977 | $ | 223,682 | 3 | % | $ | 665,652 | $ | 557,276 | 19 | % | |||||||||
Sterile Injectables: | |||||||||||||||||||||
VASOSTRICT® | $ | 255,697 | $ | 155,412 | 65 | % | $ | 676,764 | $ | 572,530 | 18 | % | |||||||||
ADRENALIN® | 28,722 | 30,662 | (6) | % | 88,136 | 120,335 | (27) | % | |||||||||||||
Other Sterile Injectables (4) | 59,234 | 65,319 | (9) | % | 182,098 | 214,132 | (15) | % | |||||||||||||
Total Sterile Injectables (3) | $ | 343,653 | $ | 251,393 | 37 | % | $ | 946,998 | $ | 906,997 | 4 | % | |||||||||
Total Generic Pharmaceuticals | $ | 174,306 | $ | 135,508 | 29 | % | $ | 522,451 | $ | 602,670 | (13) | % | |||||||||
Total International Pharmaceuticals | $ | 23,092 | $ | 24,277 | (5) | % | $ | 68,676 | $ | 75,910 | (10) | % | |||||||||
Total revenues, net | $ | 772,028 | $ | 634,860 | 22 | % | $ | 2,203,777 | $ | 2,142,853 | 3 | % | |||||||||
__________ | |
(1) | Products included within Other Specialty include NASCOBAL® Nasal Spray, AVEED® and QWO®. |
(2) | Products included within Other Established include, but are not limited to, EDEX® and LIDODERM®. |
(3) | Individual products presented above represent the top two performing products in each product category for either the three or nine months ended September 30, 2021 and/or any product having revenues in excess of |
(4) | Products included within Other Sterile Injectables include ertapenem for injection, APLISOL® and others. |
The following table presents unaudited Condensed Consolidated Statement of Operations data for the three and nine months ended September 30, 2021 and 2020 (in thousands, except per share data):
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
TOTAL REVENUES, NET | $ | 772,028 | $ | 634,860 | $ | 2,203,777 | $ | 2,142,853 | |||||||
COSTS AND EXPENSES: | |||||||||||||||
Cost of revenues | 286,068 | 348,077 | 909,841 | 1,072,972 | |||||||||||
Selling, general and administrative | 246,864 | 182,259 | 611,657 | 522,285 | |||||||||||
Research and development | 25,616 | 32,055 | 90,024 | 94,165 | |||||||||||
Litigation-related and other contingencies, net | 83,495 | 1,810 | 119,327 | (23,938) | |||||||||||
Asset impairment charges | 42,155 | 8,412 | 50,393 | 106,197 | |||||||||||
Acquisition-related and integration items, net | (1,432) | (1,407) | (6,357) | 17,100 | |||||||||||
Interest expense, net | 142,958 | 135,648 | 418,852 | 397,689 | |||||||||||
Loss on extinguishment of debt | — | — | 13,753 | — | |||||||||||
Other income, net | (5,955) | (7,194) | (4,671) | (25,318) | |||||||||||
(LOSS) INCOME FROM CONTINUING OPERATIONS BEFORE INCOME TAX | $ | (47,741) | $ | (64,800) | $ | 958 | $ | (18,299) | |||||||
INCOME TAX EXPENSE (BENEFIT) | 1,548 | 4,174 | 13,372 | (124,516) | |||||||||||
(LOSS) INCOME FROM CONTINUING OPERATIONS | $ | (49,289) | $ | (68,974) | $ | (12,414) | $ | 106,217 | |||||||
DISCONTINUED OPERATIONS, NET OF TAX | (27,918) | (6,913) | (38,769) | (41,616) | |||||||||||
NET (LOSS) INCOME | $ | (77,207) | $ | (75,887) | $ | (51,183) | $ | 64,601 | |||||||
NET (LOSS) INCOME PER SHARE—BASIC: | |||||||||||||||
Continuing operations | $ | (0.21) | $ | (0.30) | $ | (0.05) | $ | 0.46 | |||||||
Discontinued operations | (0.12) | (0.03) | (0.17) | (0.18) | |||||||||||
Basic | $ | (0.33) | $ | (0.33) | $ | (0.22) | $ | 0.28 | |||||||
NET (LOSS) INCOME PER SHARE—DILUTED: | |||||||||||||||
Continuing operations | $ | (0.21) | $ | (0.30) | $ | (0.05) | $ | 0.46 | |||||||
Discontinued operations | (0.12) | (0.03) | (0.17) | (0.18) | |||||||||||
Diluted | $ | (0.33) | $ | (0.33) | $ | (0.22) | $ | 0.28 | |||||||
WEIGHTED AVERAGE SHARES: | |||||||||||||||
Basic | 233,578 | 230,040 | 232,487 | 228,985 | |||||||||||
Diluted | 233,578 | 230,040 | 232,487 | 233,379 | |||||||||||
The following table presents unaudited Condensed Consolidated Balance Sheet data at September 30, 2021 and December 31, 2020 (in thousands):
September 30, | December 31, | ||||||
ASSETS | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 1,568,665 | $ | 1,213,437 | |||
Restricted cash and cash equivalents | 131,605 | 171,563 | |||||
Accounts receivable | 533,827 | 511,262 | |||||
Inventories, net | 297,302 | 352,260 | |||||
Assets held for sale | 39,952 | — | |||||
Other current assets | 177,595 | 164,736 | |||||
Total current assets | $ | 2,748,946 | $ | 2,413,258 | |||
TOTAL NON-CURRENT ASSETS | 6,497,606 | 6,851,379 | |||||
TOTAL ASSETS | $ | 9,246,552 | $ | 9,264,637 | |||
LIABILITIES AND SHAREHOLDERS' DEFICIT | |||||||
CURRENT LIABILITIES: | |||||||
Accounts payable and accrued expenses, including legal settlement accruals | $ | 1,316,842 | $ | 1,208,061 | |||
Liabilities held for sale | 3,055 | — | |||||
Other current liabilities | 234,372 | 45,763 | |||||
Total current liabilities | $ | 1,554,269 | $ | 1,253,824 | |||
LONG-TERM DEBT, LESS CURRENT PORTION, NET | 8,050,874 | 8,280,578 | |||||
OTHER LIABILITIES | 331,726 | 378,174 | |||||
SHAREHOLDERS' DEFICIT | (690,317) | (647,939) | |||||
TOTAL LIABILITIES AND SHAREHOLDERS' DEFICIT | $ | 9,246,552 | $ | 9,264,637 | |||
The following table presents unaudited Condensed Consolidated Statement of Cash Flow data for the nine months ended September 30, 2021 and 2020 (in thousands):
Nine Months Ended September 30, | |||||||
2021 | 2020 | ||||||
OPERATING ACTIVITIES: | |||||||
Net (loss) income | $ | (51,183) | $ | 64,601 | |||
Adjustments to reconcile Net (loss) income to Net cash provided by operating activities: | |||||||
Depreciation and amortization | 350,455 | 391,463 | |||||
Asset impairment charges | 50,393 | 106,197 | |||||
Other, including cash payments to claimants from Qualified Settlement Funds | 111,249 | (272,818) | |||||
Net cash provided by operating activities | $ | 460,914 | $ | 289,443 | |||
INVESTING ACTIVITIES: | |||||||
Capital expenditures, excluding capitalized interest | $ | (61,496) | $ | (52,692) | |||
Acquisitions, including in-process research and development, net of cash and restricted cash acquired | (5,000) | — | |||||
Proceeds from sale of business and other assets, net | 1,357 | 6,377 | |||||
Other | (5,207) | (3,915) | |||||
Net cash used in investing activities | $ | (70,346) | $ | (50,230) | |||
FINANCING ACTIVITIES: | |||||||
Payments on borrowings, net | $ | (49,541) | $ | (86,887) | |||
Other | (25,995) | (11,470) | |||||
Net cash used in financing activities | $ | (75,536) | $ | (98,357) | |||
Effect of foreign exchange rate | 238 | (458) | |||||
NET INCREASE IN CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS | $ | 315,270 | $ | 140,398 | |||
CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS, BEGINNING OF PERIOD | 1,385,000 | 1,720,388 | |||||
CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS, END OF PERIOD | $ | 1,700,270 | $ | 1,860,786 | |||
SUPPLEMENTAL FINANCIAL INFORMATION
To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial measures. For additional information on the Company's use of such non-GAAP financial measures, refer to Endo's Current Report on Form 8-K furnished today to the U.S. Securities and Exchange Commission, which includes an explanation of the Company's reasons for using non-GAAP measures.
The tables below provide reconciliations of certain of the Company's non-GAAP financial measures to their most directly comparable GAAP amounts. Refer to the "Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures" section below for additional details regarding the adjustments to the non-GAAP financial measures detailed throughout this Supplemental Financial Information section.
Reconciliation of EBITDA and Adjusted EBITDA (non-GAAP)
The following table provides a reconciliation of Net (loss) income (GAAP) to Adjusted EBITDA (non-GAAP) for the three and nine months ended September 30, 2021 and 2020 (in thousands):
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Net (loss) income (GAAP) | $ | (77,207) | $ | (75,887) | $ | (51,183) | $ | 64,601 | |||||||
Income tax expense (benefit) | 1,548 | 4,174 | 13,372 | (124,516) | |||||||||||
Interest expense, net | 142,958 | 135,648 | 418,852 | 397,689 | |||||||||||
Depreciation and amortization (14) | 106,402 | 120,974 | 328,126 | 376,787 | |||||||||||
EBITDA (non-GAAP) | $ | 173,701 | $ | 184,909 | $ | 709,167 | $ | 714,561 | |||||||
Upfront and milestone-related payments (2) | $ | 525 | $ | 275 | $ | 6,206 | $ | 2,469 | |||||||
Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (3) | 19,829 | 67,692 | 58,632 | 100,356 | |||||||||||
Certain litigation-related and other contingencies, net (4) | 83,495 | 1,810 | 119,327 | (23,938) | |||||||||||
Certain legal costs (5) | 38,842 | 18,343 | 82,961 | 51,884 | |||||||||||
Asset impairment charges (6) | 42,155 | 8,412 | 50,393 | 106,197 | |||||||||||
Acquisition-related and integration costs (7) | 3 | — | 414 | — | |||||||||||
Fair value of contingent consideration (8) | (1,435) | (1,407) | (6,771) | 17,100 | |||||||||||
Loss on extinguishment of debt (9) | — | — | 13,753 | — | |||||||||||
Share-based compensation (14) | 7,800 | 6,585 | 22,237 | 28,262 | |||||||||||
Other income, net (15) | (5,955) | (7,194) | (4,671) | (25,318) | |||||||||||
Other (10) | 5 | 362 | 3,881 | 31,118 | |||||||||||
Discontinued operations, net of tax (12) | 27,918 | 6,913 | 38,769 | 41,616 | |||||||||||
Adjusted EBITDA (non-GAAP) | $ | 386,883 | $ | 286,700 | $ | 1,094,298 | $ | 1,044,307 | |||||||
Reconciliation of Adjusted Income from Continuing Operations (non-GAAP)
The following table provides a reconciliation of the Company's (Loss) income from continuing operations (GAAP) to Adjusted income from continuing operations (non-GAAP) for the three and nine months ended September 30, 2021 and 2020 (in thousands):
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
(Loss) income from continuing operations (GAAP) | $ | (49,289) | $ | (68,974) | $ | (12,414) | $ | 106,217 | |||||||
Non-GAAP adjustments: | |||||||||||||||
Amortization of intangible assets (1) | 91,901 | 104,066 | 281,101 | 325,801 | |||||||||||
Upfront and milestone-related payments (2) | 525 | 275 | 6,206 | 2,469 | |||||||||||
Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (3) | 19,829 | 67,692 | 58,632 | 100,356 | |||||||||||
Certain litigation-related and other contingencies, net (4) | 83,495 | 1,810 | 119,327 | (23,938) | |||||||||||
Certain legal costs (5) | 38,842 | 18,343 | 82,961 | 51,884 | |||||||||||
Asset impairment charges (6) | 42,155 | 8,412 | 50,393 | 106,197 | |||||||||||
Acquisition-related and integration costs (7) | 3 | — | 414 | — | |||||||||||
Fair value of contingent consideration (8) | (1,435) | (1,407) | (6,771) | 17,100 | |||||||||||
Loss on extinguishment of debt (9) | — | — | 13,753 | — | |||||||||||
Other (10) | (6,926) | (1,898) | (545) | 13,437 | |||||||||||
Tax adjustments (11) | (29,823) | (6,044) | (76,742) | (205,148) | |||||||||||
Adjusted income from continuing operations (non-GAAP) | $ | 189,277 | $ | 122,275 | $ | 516,315 | $ | 494,375 | |||||||
Reconciliation of Other Adjusted Income Statement Data (non-GAAP)
The following tables provide detailed reconciliations of various other income statement data between the GAAP and non-GAAP amounts for the three and nine months ended September 30, 2021 and 2020 (in thousands, except per share data):
Three Months Ended September 30, 2021 | |||||||||||||||||||||||||||||||
Total | Cost of | Gross | Gross | Total | Operating | Operating | Operating | Other | (Loss) | Income | Effective | (Loss) | Discontinued | Net (loss) | Diluted net | ||||||||||||||||
Reported (GAAP) | 62.9 % | 51.4 % | $ 89,262 | 11.6 % | $ (47,741) | $ 1,548 | (3.2)% | $ (49,289) | $ (27,918) | $ (0.21) | |||||||||||||||||||||
Items impacting comparability: | |||||||||||||||||||||||||||||||
Amortization of intangible assets (1) | - | (91,901) | 91,901 | - | 91,901 | - | 91,901 | - | 91,901 | - | 91,901 | ||||||||||||||||||||
Upfront and milestone-related payments (2) | - | (525) | 525 | - | 525 | - | 525 | - | 525 | - | 525 | ||||||||||||||||||||
Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (3) | - | 10,259 | (10,259) | (30,088) | 19,829 | - | 19,829 | - | 19,829 | - | 19,829 | ||||||||||||||||||||
Certain litigation-related and other contingencies, net (4) | - | - | - | (83,495) | 83,495 | - | 83,495 | - | 83,495 | - | 83,495 | ||||||||||||||||||||
Certain legal costs (5) | - | - | - | (38,842) | 38,842 | - | 38,842 | - | 38,842 | - | 38,842 | ||||||||||||||||||||
Asset impairment charges (6) | - | - | - | (42,155) | 42,155 | - | 42,155 | - | 42,155 | - | 42,155 | ||||||||||||||||||||
Acquisition-related and integration costs (7) | - | - | - | (3) | 3 | - | 3 | - | 3 | - | 3 | ||||||||||||||||||||
Fair value of contingent consideration (8) | - | - | - | 1,435 | (1,435) | - | (1,435) | - | (1,435) | - | (1,435) | ||||||||||||||||||||
Other (10) | - | - | - | - | - | 6,926 | (6,926) | - | (6,926) | - | (6,926) | ||||||||||||||||||||
Tax adjustments (11) | - | - | - | - | - | - | - | 29,823 | (29,823) | - | (29,823) | ||||||||||||||||||||
Exclude discontinued operations, net of tax (12) | - | - | - | - | - | - | - | - | - | 27,918 | 27,918 | ||||||||||||||||||||
After considering items (non-GAAP) | 73.6 % | 26.4 % | $ 364,577 | 47.2 % | $ 220,648 | 14.2 % | $ 189,277 | $ - | $ 0.80 | ||||||||||||||||||||||
Three Months Ended September 30, 2020 | |||||||||||||||||||||||||||||||
Total | Cost of | Gross | Gross | Total | Operating | Operating | Operating | Other | (Loss) | Income | Effective | (Loss) | Discontinued | Net (loss) | Diluted net | ||||||||||||||||
Reported (GAAP) | 45.2 % | 35.1 % | $ 63,654 | 10.0 % | $ (64,800) | $ 4,174 | (6.4)% | $ (68,974) | $ (6,913) | $ (0.30) | |||||||||||||||||||||
Items impacting comparability: | |||||||||||||||||||||||||||||||
Amortization of intangible assets (1) | - | (104,066) | 104,066 | - | 104,066 | - | 104,066 | - | 104,066 | - | 104,066 | ||||||||||||||||||||
Upfront and milestone-related payments (2) | - | (125) | 125 | (150) | 275 | - | 275 | - | 275 | - | 275 | ||||||||||||||||||||
Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (3) | - | (36,550) | 36,550 | (31,142) | 67,692 | - | 67,692 | - | 67,692 | - | 67,692 | ||||||||||||||||||||
Certain litigation-related and other contingencies, net (4) | - | - | - | (1,810) | 1,810 | - | 1,810 | - | 1,810 | - | 1,810 | ||||||||||||||||||||
Certain legal costs (5) | - | - | - | (18,343) | 18,343 | - | 18,343 | - | 18,343 | - | 18,343 | ||||||||||||||||||||
Asset impairment charges (6) | - | - | - | (8,412) | 8,412 | - | 8,412 | - | 8,412 | - | 8,412 | ||||||||||||||||||||
Fair value of contingent consideration (8) | - | - | - | 1,407 | (1,407) | - | (1,407) | - | (1,407) | - | (1,407) | ||||||||||||||||||||
Other (10) | - | - | - | (369) | 369 | 2,267 | (1,898) | - | (1,898) | - | (1,898) | ||||||||||||||||||||
Tax adjustments (11) | - | - | - | - | - | - | - | 6,044 | (6,044) | - | (6,044) | ||||||||||||||||||||
Exclude discontinued operations, net of tax (12) | - | - | - | - | - | - | - | - | - | 6,913 | 6,913 | ||||||||||||||||||||
After considering items (non-GAAP) | 67.3 % | 25.9 % | $ 263,214 | 41.5 % | $ 132,493 | 7.7 % | $ 122,275 | $ - | $ 0.52 | ||||||||||||||||||||||
Nine Months Ended September 30, 2021 | |||||||||||||||||||||||||||||||
Total | Cost of | Gross | Gross | Total | Operating | Operating | Operating | Other | Income | Income | Effective | (Loss) | Discontinued | Net (loss) | Diluted net | ||||||||||||||||
Reported (GAAP) | 58.7 % | 39.3 % | $ 428,892 | 19.5 % | $ 958 | 1,395.8 % | $ (12,414) | $ (38,769) | $ (0.05) | ||||||||||||||||||||||
Items impacting comparability: | |||||||||||||||||||||||||||||||
Amortization of intangible assets (1) | - | (281,101) | 281,101 | - | 281,101 | - | 281,101 | - | 281,101 | - | 281,101 | ||||||||||||||||||||
Upfront and milestone-related payments (2) | - | (1,176) | 1,176 | (5,030) | 6,206 | - | 6,206 | - | 6,206 | - | 6,206 | ||||||||||||||||||||
Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (3) | - | (10,007) | 10,007 | (48,625) | 58,632 | - | 58,632 | - | 58,632 | - | 58,632 | ||||||||||||||||||||
Certain litigation-related and other contingencies, net (4) | - | - | - | (119,327) | 119,327 | - | 119,327 | - | 119,327 | - | 119,327 | ||||||||||||||||||||
Certain legal costs (5) | - | - | - | (82,961) | 82,961 | - | 82,961 | - | 82,961 | - | 82,961 | ||||||||||||||||||||
Asset impairment charges (6) | - | - | - | (50,393) | 50,393 | - | 50,393 | - | 50,393 | - | 50,393 | ||||||||||||||||||||
Acquisition-related and integration costs (7) | - | - | - | (414) | 414 | - | 414 | - | 414 | - | 414 | ||||||||||||||||||||
Fair value of contingent consideration (8) | - | - | - | 6,771 | (6,771) | - | (6,771) | - | (6,771) | - | (6,771) | ||||||||||||||||||||
Loss on extinguishment of debt (9) | - | - | - | - | - | (13,753) | 13,753 | - | 13,753 | - | 13,753 | ||||||||||||||||||||
Other (10) | - | - | - | (3,879) | 3,879 | 4,424 | (545) | - | (545) | - | (545) | ||||||||||||||||||||
Tax adjustments (11) | - | - | - | - | - | - | - | 76,742 | (76,742) | - | (76,742) | ||||||||||||||||||||
Exclude discontinued operations, net of tax (12) | - | - | - | - | - | - | - | - | - | 38,769 | 38,769 | ||||||||||||||||||||
After considering items (non-GAAP) | 72.0 % | 25.5 % | 46.5 % | $ 606,429 | 14.9 % | $ 516,315 | $ - | $ 2.18 | |||||||||||||||||||||||
Nine Months Ended September 30, 2020 | |||||||||||||||||||||||||||||||
Total | Cost of | Gross | Gross | Total | Operating | Operating | Operating | Other | (Loss) | Income | Effective | Income | Discontinued | Net income | Diluted net | ||||||||||||||||
Reported (GAAP) | 49.9 % | 33.4 % | $ 354,072 | 16.5 % | $ (18,299) | 680.5 % | $ 106,217 | $ (41,616) | $ 64,601 | $ 0.46 | |||||||||||||||||||||
Items impacting comparability: | |||||||||||||||||||||||||||||||
Amortization of intangible assets (1) | - | (325,801) | 325,801 | - | 325,801 | - | 325,801 | - | 325,801 | - | 325,801 | ||||||||||||||||||||
Upfront and milestone-related payments (2) | - | (792) | 792 | (1,677) | 2,469 | - | 2,469 | - | 2,469 | - | 2,469 | ||||||||||||||||||||
Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives (3) | - | (43,692) | 43,692 | (56,664) | 100,356 | - | 100,356 | - | 100,356 | - | 100,356 | ||||||||||||||||||||
Certain litigation-related and other contingencies, net (4) | - | - | - | 23,938 | (23,938) | - | (23,938) | - | (23,938) | - | (23,938) | ||||||||||||||||||||
Certain legal costs (5) | - | - | - | (51,884) | 51,884 | - | 51,884 | - | 51,884 | - | 51,884 | ||||||||||||||||||||
Asset impairment charges (6) | - | - | - | (106,197) | 106,197 | - | 106,197 | - | 106,197 | - | 106,197 | ||||||||||||||||||||
Fair value of contingent consideration (8) | - | - | - | (17,100) | 17,100 | - | 17,100 | - | 17,100 | - | 17,100 | ||||||||||||||||||||
Other (10) | - | - | - | (31,118) | 31,118 | 17,681 | 13,437 | - | 13,437 | - | 13,437 | ||||||||||||||||||||
Tax adjustments (11) | - | - | - | - | - | - | - | 205,148 | (205,148) | - | (205,148) | ||||||||||||||||||||
Exclude discontinued operations, net of tax (12) | - | - | - | - | - | - | - | - | - | 41,616 | 41,616 | ||||||||||||||||||||
After considering items (non-GAAP) | $ 702,687 | 67.2 % | 22.2 % | $ 965,059 | 45.0 % | $ 575,007 | $ 80,632 | 14.0 % | $ 494,375 | $ - | $ 494,375 | $ 2.12 | |||||||||||||||||||
Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures
Notes to certain line items included in the reconciliations of the GAAP financial measures to the non-GAAP financial measures for the three and nine months ended September 30, 2021 and 2020 are as follows:
(1) | To exclude amortization expense related to intangible assets. | |||||||||||||||
(2) | Adjustments for upfront and milestone-related payments to partners included the following (in thousands): | |||||||||||||||
Three Months Ended September 30, | ||||||||||||||||
2021 | 2020 | |||||||||||||||
Cost of revenues | Operating | Cost of revenues | Operating | |||||||||||||
Sales-based | $ | 525 | $ | — | $ | 125 | $ | — | ||||||||
Development-based | — | — | — | 150 | ||||||||||||
Total | $ | 525 | $ | — | $ | 125 | $ | 150 | ||||||||
Nine Months Ended September 30, | ||||||||||||||||
2021 | 2020 | |||||||||||||||
Cost of revenues | Operating | Cost of revenues | Operating | |||||||||||||
Sales-based | $ | 1,176 | $ | — | $ | 792 | $ | — | ||||||||
Development-based | — | 5,030 | — | 1,677 | ||||||||||||
Total | $ | 1,176 | $ | 5,030 | $ | 792 | $ | 1,677 | ||||||||
(3) | Adjustments for amounts related to continuity and separation benefits, cost reductions and strategic review initiatives included the following (in thousands): | |||||||||||||||
Three Months Ended September 30, | ||||||||||||||||
2021 | 2020 | |||||||||||||||
Cost of revenues | Operating | Cost of revenues | Operating | |||||||||||||
Continuity and separation benefits | $ | (16,106) | $ | 4,823 | $ | 32,048 | $ | 25,906 | ||||||||
Accelerated depreciation | 5,128 | 1,223 | 4,502 | 1,789 | ||||||||||||
Other, including strategic review initiatives | 719 | 24,042 | — | 3,447 | ||||||||||||
Total | $ | (10,259) | $ | 30,088 | $ | 36,550 | $ | 31,142 | ||||||||
Nine Months Ended September 30, | ||||||||||||||||
2021 | 2020 | |||||||||||||||
Cost of revenues | Operating | Cost of revenues | Operating | |||||||||||||
Continuity and separation benefits | $ | (13,827) | $ | 12,660 | $ | 33,190 | $ | 42,681 | ||||||||
Accelerated depreciation | 17,322 | 5,008 | 10,528 | 4,148 | ||||||||||||
Other, including strategic review initiatives | 6,512 | 30,957 | (26) | 9,835 | ||||||||||||
Total | $ | 10,007 | $ | 48,625 | $ | 43,692 | $ | 56,664 | ||||||||
The amounts in the tables above include adjustments related to previously announced restructuring activities, certain continuity and transitional compensation arrangements, certain other cost reduction initiatives and certain strategic review initiatives. | ||||||||||||||||
(4) | To exclude adjustments to accruals for litigation-related settlement charges and certain settlement proceeds related to suits filed by subsidiaries. | |||||||||||||||
(5) | To exclude opioid-related legal expenses. | |||||||||||||||
(6) | Adjustments for asset impairment charges included the following (in thousands): | |||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Goodwill impairment charges | $ | — | $ | — | $ | — | $ | 32,786 | ||||||||
Other intangible asset impairment charges | — | 2,020 | 7,811 | 65,771 | ||||||||||||
Property, plant and equipment impairment charges | — | — | 427 | 1,248 | ||||||||||||
Operating lease right-of-use asset impairment charges | — | 6,392 | — | 6,392 | ||||||||||||
Disposal group impairment charges | 42,155 | — | 42,155 | — | ||||||||||||
Total | $ | 42,155 | $ | 8,412 | $ | 50,393 | $ | 106,197 | ||||||||
(7) | To exclude integration costs. | |||||||||||||||
(8) | To exclude the impact of changes in the fair value of contingent consideration liabilities resulting from changes to estimates regarding the timing and amount of the future revenues of the underlying products and changes in other assumptions impacting the probability of incurring, and extent to which the Company could incur, related contingent obligations. | |||||||||||||||
(9) | To exclude the loss on the extinguishment of debt associated with the Company's March 2021 refinancing transactions. | |||||||||||||||
(10) | The Other rows included in each of the above reconciliations of GAAP financial measures to non-GAAP financial measures (except for the reconciliations of Net (loss) income (GAAP) to Adjusted EBITDA (non-GAAP)) include the following (in thousands): | |||||||||||||||
Three Months Ended September 30, | ||||||||||||||||
2021 | 2020 | |||||||||||||||
Operating | Other non- | Operating | Other non- | |||||||||||||
Foreign currency impact related to the re-measurement of intercompany debt instruments | $ | — | $ | (2,036) | $ | — | $ | 1,663 | ||||||||
Debt modification costs | — | — | 369 | — | ||||||||||||
Other miscellaneous | — | (4,890) | — | (3,930) | ||||||||||||
Total | $ | — | $ | (6,926) | $ | 369 | $ | (2,267) | ||||||||
Nine Months Ended September 30, | ||||||||||||||||
2021 | 2020 | |||||||||||||||
Operating | Other non- | Operating | Other non- | |||||||||||||
Foreign currency impact related to the re-measurement of intercompany debt instruments | $ | — | $ | 466 | $ | — | $ | (2,426) | ||||||||
Gain on sale of business and other assets | — | — | — | (11,325) | ||||||||||||
Debt modification costs | 3,879 | — | 31,118 | — | ||||||||||||
Other miscellaneous | — | (4,890) | — | (3,930) | ||||||||||||
Total | $ | 3,879 | $ | (4,424) | $ | 31,118 | $ | (17,681) | ||||||||
The Other row included in the reconciliations of Net (loss) income (GAAP) to Adjusted EBITDA (non-GAAP) primarily relates to the items enumerated in the foregoing "Operating expenses" columns. | ||||||||||||||||
(11) | Adjusted income taxes are calculated by tax effecting adjusted pre-tax income and permanent book-tax differences at the applicable effective tax rate that will be determined by reference to statutory tax rates in the relevant jurisdictions in which the Company operates. Adjusted income taxes include current and deferred income tax expense commensurate with the non-GAAP measure of profitability. | |||||||||||||||
(12) | To exclude the results of the businesses reported as discontinued operations, net of tax. | |||||||||||||||
(13) | Calculated as income or loss from continuing operations divided by the applicable weighted average share number. The applicable weighted average share numbers are as follows (in thousands): | |||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||
GAAP | 233,578 | 230,040 | 232,487 | 233,379 | ||||||||
Non-GAAP Adjusted | 235,527 | 233,442 | 236,538 | 233,379 | ||||||||
(14) | Depreciation and amortization and Share-based compensation per the Adjusted EBITDA reconciliations do not include amounts reflected in other lines of the reconciliations, including Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives. | |||||||||||
(15) | To exclude Other income, net per the Condensed Consolidated Statements of Operations. | |||||||||||
Reconciliation of Net Debt Leverage Ratio (non-GAAP)
The following table provides a reconciliation of the Company's Net income (GAAP) to Adjusted EBITDA (non-GAAP) for the twelve months ended September 30, 2021 (in thousands) and the calculation of the Company's Net Debt Leverage Ratio (non-GAAP):
Twelve Months | |||
Net income (GAAP) | $ | 68,160 | |
Income tax benefit | (136,094) | ||
Interest expense, net | 554,102 | ||
Depreciation and amortization (14) | 447,688 | ||
EBITDA (non-GAAP) | $ | 933,856 | |
Upfront and milestone-related payments | $ | 38,812 | |
Amounts related to continuity and separation benefits, cost reductions and strategic review initiatives | 84,558 | ||
Certain litigation-related and other contingencies, net | 124,216 | ||
Certain legal costs | 98,896 | ||
Asset impairment charges | 64,540 | ||
Acquisition-related and integration costs | 610 | ||
Fair value of contingent consideration | (7,518) | ||
Loss on extinguishment of debt | 13,753 | ||
Share-based compensation (14) | 30,142 | ||
Other income, net | (463) | ||
Other | 3,858 | ||
Discontinued operations, net of tax | 60,673 | ||
Adjusted EBITDA (non-GAAP) | $ | 1,445,933 | |
Calculation of Net Debt: | |||
Debt | $ | 8,274,016 | |
Cash (excluding Restricted Cash) | 1,568,665 | ||
Net Debt (non-GAAP) | $ | 6,705,351 | |
Calculation of Net Debt Leverage: | |||
Net Debt Leverage Ratio (non-GAAP) | 4.6 | ||
Non-GAAP Financial Measures
The Company utilizes certain financial measures that are not prescribed by or prepared in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP net income and its components and diluted net income per share amounts. Despite the importance of these measures to management in goal setting and performance measurement, the company stresses that these are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. Because of the non-standardized definitions, non-GAAP adjusted EBITDA and non-GAAP adjusted net income from continuing operations and its components (unlike GAAP net income from continuing operations and its components) may not be comparable to the calculation of similar measures of other companies. These non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses performance.
Investors are encouraged to review the reconciliations of the non-GAAP financial measures used in this press release to their most directly comparable GAAP financial measures. However, the Company does not provide reconciliations of projected non-GAAP financial measures to GAAP financial measures, nor does it provide comparable projected GAAP financial measures for such projected non-GAAP financial measures. The Company is unable to provide such reconciliations without unreasonable efforts due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations, including adjustments that could be made for asset impairments, contingent consideration adjustments, legal settlements, gain / loss on extinguishment of debt, adjustments to inventory and other charges reflected in the reconciliation of historic numbers, the amounts of which could be significant.
See Endo's Current Report on Form 8-K furnished today to the U.S. Securities and Exchange Commission for an explanation of Endo's non-GAAP financial measures.
About Endo International plc
Endo (NASDAQ: ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from a global team of passionate employees collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation, including, but not limited to, the statements by Mr. Coleman, as well as other statements regarding product development, product launches and product demand, the expansion and enhancement of our product portfolio, market potential, progress on our strategic priorities, the status and outcome of litigation, financial guidance for full-year 2021 or any other future period, the impact of and response to the COVID-19 pandemic, the status of our contingency planning, including any potential bankruptcy filing, and any other statements that refer to our expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because forecasts are inherently estimates that cannot be made with precision, Endo's performance at times differs materially from its estimates and targets, and Endo often does not know what the actual results will be until after the end of the applicable reporting period. Therefore, Endo will not report or comment on its progress during a current quarter except through public announcement. Any statement made by others with respect to progress during a current quarter cannot be attributed to Endo. All forward-looking statements in this press release reflect Endo's current analysis of existing trends and information and represent Endo's judgment only as of the date of this press release. Actual results may differ materially and adversely from current expectations based on a number of factors affecting Endo's businesses, including, among other things, the following: the outcome of our strategic review, contingency planning and any potential restructuring or bankruptcy filing; the timing, impact or results of any pending or future litigation, investigations or claims or actual or contingent liabilities, settlement discussions, negotiations or other adverse proceedings, including pending and future opioid-related matters, pending tax matters with the IRS and proceedings that involve key products such as VASOSTRICT®; our ability to satisfy judgments or settlements or pursue appeals including bonding requirements; our ability to adjust to changing market conditions; our ability to attract and retain key personnel; our inability to maintain compliance with financial covenants and operating obligations which would expose us to potential events of default under our outstanding indebtedness; our ability to incur additional debt or equity financing for working capital, capital expenditures, business development, debt service requirements, acquisitions or general corporate or other purposes; our ability to refinance our indebtedness; a significant reduction in our short-term or long-term revenues which could cause us to be unable to fund our operations and liquidity needs or repay indebtedness; supply chain interruptions or difficulties; changes in competitive or market conditions; changes in legislation or regulatory developments; our ability to obtain and maintain adequate protection for our intellectual property rights; the timing and uncertainty of the results of both the research and development and regulatory processes, including regulatory decisions, product recalls, withdrawals and other unusual items; domestic and foreign health care and cost containment reforms, including government pricing, tax and reimbursement policies; technological advances and patents obtained by competitors; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; the effectiveness of advertising and other promotional campaigns; the timely and successful implementation of any strategic initiatives; unfavorable publicity regarding the misuse of opioids; the uncertainty associated with the identification of and successful consummation and execution of external corporate development initiatives and strategic partnering transactions; our ability to advance our strategic priorities, develop our product pipeline and continue to develop the market for QWO® and other products; and our ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. In addition, U.S. and international economic conditions, including consumer confidence and debt levels, taxation, changes in interest and currency exchange rates, international relations, capital and credit availability, the status of financial markets and institutions, the impact of and response to the ongoing COVID-19 pandemic and the impact of continued economic volatility, can materially affect our results. The occurrence or possibility of any such result has caused us to engage, and may result in further engagement in strategic reviews that ultimately may result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. Those remedial measures could include a potential bankruptcy filing (which, if it occurred, would subject us to additional risks and uncertainties that could adversely affect our business prospects and ability to continue as a going concern), corporate reorganization or restructuring activities involving all or a portion of our business, asset sales or other divestitures, cost-saving initiatives or other corporate realignments, seeking strategic partnerships and exiting certain product or geographic markets. Some of these measures could take significant time to implement and others may require judicial or other third-party approval. Any such actions may be complex, could entail significant costs and charges or could otherwise negatively impact shareholder value, and there can be no assurance that we will be able to accomplish any of these alternatives on terms acceptable to us, or at all, or that they will result in their intended benefits. Therefore, the reader is cautioned not to rely on these forward-looking statements. Endo expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law.
Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo, as well as Endo's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in Endo's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. Copies of Endo's press releases and additional information about Endo are available at www.endo.com or you can contact the Endo Investor Relations Department by calling 845-364-4833.
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SOURCE Endo International plc
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