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8-K - 8-K - Endo International plcendp-20200805.htm

Exhibit 99.1
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ENDO REPORTS SECOND-QUARTER 2020 FINANCIAL RESULTS
— Revenues decreased 2% to $688 million compared to prior year —
— On July 6, 2020, U.S. FDA approved Qwo™ (collagenase clostridium histolyticum-aaes), the first injectable treatment for cellulite —
DUBLIN, August 5, 2020 -- Endo International plc (NASDAQ: ENDP) today reported financial results for the second quarter ended June 30, 2020.
“I’m proud of what our team delivered in the second quarter. Our Branded Pharmaceuticals segment performed better than previously guided as COVID-19 related restrictions and physician office closures began easing throughout the quarter. Additionally, our Sterile Injectables segment delivered strong revenue growth versus prior year as customers built significant inventory levels of products used to treat certain COVID-19 patients,” said Blaise Coleman, President and Chief Executive Officer at Endo. “I want to thank our team members for their tireless work and dedication to meeting our customers’ needs in a challenging environment.”
Mr. Coleman continued, “With the recent FDA approval of QWO and Endo’s impending entry into the US medical aesthetics market, we are ready to embark on the next phase of our transformation. We have evolved our strategic priorities to focus on expanding and enhancing our portfolio of life-enhancing products while accelerating new ways to better serve our customers and to improve productivity. We look forward to executing against these priorities as we seek to realize Endo’s full potential.”
SECOND-QUARTER FINANCIAL PERFORMANCE
(in thousands, except per share amounts)
Three Months Ended June 30,Six Months Ended June 30,
20202019 (1)Change20202019 (1)Change
Total Revenues, Net$687,588  $699,727  (2)%$1,507,993  $1,420,138  %
Reported Income (Loss) from Continuing Operations$17,610  $(98,052) NM$175,191  $(110,664) NM
Reported Diluted Weighted Average Shares233,681  226,221  %233,348  225,408  %
Reported Diluted Net Income (Loss) per Share from Continuing Operations$0.08  $(0.43) NM$0.75  $(0.49) NM
Reported Net Income (Loss)$10,558  $(106,005) NM$140,488  $(124,578) NM
Adjusted Income from Continuing Operations$151,700  $139,388  %$372,100  $278,161  34 %
Adjusted Diluted Weighted Average Shares (2)233,681  232,713  — %233,348  232,174  %
Adjusted Diluted Net Income per Share from Continuing Operations$0.65  $0.60  %$1.59  $1.20  33 %
Adjusted EBITDA$336,481  $326,084  %$757,607  $677,180  12 %
__________
(1)Certain prior period adjusted amounts have been revised as a result of a change in the Company’s definition of its adjusted financial metrics. Refer to the “Supplemental Financial Information” section below for additional discussion.
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(2)Reported Diluted Net Income (Loss) 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.
CONSOLIDATED RESULTS
Total revenues were $688 million in second-quarter 2020, a decrease of 2% compared to $700 million during the same period in 2019. This result was primarily attributable to decreased Branded Pharmaceuticals segment revenues due to reduced physician office activity and patient office visits compared to prior year because of the COVID-19 pandemic. This decrease was largely offset by an increase in Sterile Injectables segment revenues due to significant channel inventory stocking of products used to treat certain patients infected with COVID-19.
Reported income from continuing operations in second-quarter 2020 was $18 million compared to reported loss from continuing operations of $98 million during the same period in 2019. This result was primarily attributable to lower asset impairment charges. Reported diluted net income per share from continuing operations in second-quarter 2020 was $0.08 compared to reported diluted net loss per share from continuing operations of $0.43 in second-quarter 2019.
Adjusted income from continuing operations in second-quarter 2020 was $152 million compared to $139 million in second-quarter 2019. This increase was primarily attributable to lower second-quarter 2020 operating expenses. Adjusted diluted net income per share from continuing operations in second-quarter 2020 was $0.65 compared to $0.60 in second-quarter 2019.
BRANDED PHARMACEUTICALS SEGMENT
Second-quarter 2020 Branded Pharmaceuticals segment revenues were $130 million, a decrease of 38% compared to $209 million during second-quarter 2019. This decrease was primarily attributable to reduced volumes caused by the COVID-19 pandemic.
Specialty Products revenues decreased 45% to $69 million in second-quarter 2020 compared to $124 million in second-quarter 2019, with sales of XIAFLEX® decreasing 55% to $34 million compared to $75 million in second-quarter 2019. This decrease was primarily a result of physician office closures and a decline in patients electing to be treated because of the COVID-19 pandemic. Established Products revenues decreased 28% to $61 million in second-quarter 2020 compared to $85 million in second-quarter 2019 due to competitive pressures and a temporary product supply disruption, which has been resolved.
On July 6, 2020, the U.S. Food and Drug Administration (FDA) approved QWO (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in the buttocks of adult women. QWO is the first FDA-approved injectable treatment for cellulite and is expected to be available throughout the United States beginning in spring 2021.
STERILE INJECTABLES SEGMENT
Second-quarter 2020 Sterile Injectables segment revenues were $319 million, an increase of 31% compared to $244 million during second-quarter 2019. This increase was primarily driven by significant channel inventory stocking of VASOSTRICT® in anticipation of treating vasodilatory shock in patients infected with COVID-19.
GENERIC PHARMACEUTICALS SEGMENT
Second-quarter 2020 Generic Pharmaceuticals segment revenues were $216 million, a decrease of 1% compared to $218 million during second-quarter 2019. This decrease was primarily attributable to continued competitive pressures on certain key products, which were partially offset by recent product launches.
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INTERNATIONAL PHARMACEUTICALS SEGMENT
Second-quarter 2020 International Pharmaceuticals segment revenues decreased 20% to $23 million compared to $29 million during second-quarter 2019.
THIRD-QUARTER AND FULL YEAR 2020 GUIDANCE
Endo is providing financial guidance for third-quarter and full year 2020. The third-quarter financial guidance reflects the anticipated unfavorable impact of new competitive events in Endo’s Generic Pharmaceuticals segment and significant VASOSTRICT channel destocking. The outlook ranges below also reflect a number of other assumptions that are subject to change including, among other things, uncertainties related to the COVID-19 pandemic and the Company’s expectation of a return to more normalized customer purchasing patterns during the fourth quarter 2020. The Company estimates:
Third-Quarter 2020Full Year 2020
Total Revenues, Net$515M to $550M$2.60B to $2.70B
Adjusted EBITDA$175M to $200M$1.19B to $1.23B
Adjusted Diluted Net Income per Share from Continuing Operations$0.08 to $0.13$2.00 to $2.15
Adjusted Gross Margin~64.0% to ~65.0%~66.5% to ~67.0%
Adjusted Operating Expenses as a Percentage of Total Revenues, Net~34.0%~25.0% to ~25.5%
Adjusted Interest Expense~$140M~$530M to ~$535M
Adjusted Effective Tax Rate~7.5% to ~8.5%~14.0% to ~15.0%
Adjusted Diluted Weighted Average Shares~234M~234M
BALANCE SHEET, LIQUIDITY AND OTHER UPDATES
As of June 30, 2020, the Company had approximately $1.8 billion in unrestricted cash; $8.3 billion of debt; and a net debt to adjusted EBITDA ratio of 4.5.
Second-quarter 2020 cash provided by operating activities was $304 million, compared to $177 million of net cash provided by operating activities during second-quarter 2019.
CONFERENCE CALL INFORMATION
Endo will conduct a conference call with financial analysts to discuss this press release tomorrow at 7:00 a.m. EDT. The dial-in number to access the call is U.S./Canada (866) 497-0462, International (678) 509-7598, and the passcode is 2058864. Please dial in 10 minutes prior to the scheduled start time.
A replay of the call will be available from August 6, 2020 at 10:00 a.m. ET until 10:00 a.m. ET on August 13, 2020 by dialing U.S./Canada (855) 859-2056, International (404) 537-3406, and entering the passcode 2058864.
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.
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FINANCIAL SCHEDULES
The following table presents Endo's unaudited Total revenues, net for the three and six months ended June 30, 2020 and 2019 (dollars in thousands):
Three Months Ended June 30,Percent GrowthSix Months Ended June 30,Percent Growth
2020201920202019
Branded Pharmaceuticals:
Specialty Products:
XIAFLEX®$33,783  $74,855  (55)%$122,855  $143,362  (14)%
SUPPRELIN® LA15,395  23,714  (35)%35,115  45,770  (23)%
Other Specialty (1)19,566  25,524  (23)%45,071  49,927  (10)%
Total Specialty Products$68,744  $124,093  (45)%$203,041  $239,059  (15)%
Established Products:
PERCOCET®$27,578  $28,878  (5)%$55,281  $59,638  (7)%
LIDODERM®7,056  9,051  (22)%14,279  17,120  (17)%
EDEX®6,604  7,662  (14)%15,172  13,633  11 %
Other Established (2)19,539  39,329  (50)%45,821  83,088  (45)%
Total Established Products$60,777  $84,920  (28)%$130,553  $173,479  (25)%
Total Branded Pharmaceuticals (3)$129,521  $209,013  (38)%$333,594  $412,538  (19)%
Sterile Injectables:
VASOSTRICT®$214,214  $116,026  85 %$417,118  $255,163  63 %
ADRENALIN®33,161  45,835  (28)%89,673  93,157  (4)%
Ertapenem for injection11,990  25,547  (53)%29,864  57,766  (48)%
APLISOL®6,511  15,530  (58)%16,378  27,911  (41)%
Other Sterile Injectables (4)53,338  41,342  29 %102,571  80,331  28 %
Total Sterile Injectables (3)$319,214  $244,280  31 %$655,604  $514,328  27 %
Total Generic Pharmaceuticals$215,879  $217,784  (1)%$467,162  $436,310  %
Total International Pharmaceuticals$22,974  $28,650  (20)%$51,633  $56,962  (9)%
Total revenues, net$687,588  $699,727  (2)%$1,507,993  $1,420,138  %
__________
(1)Products included within Other Specialty are NASCOBAL® Nasal Spray and AVEED®.
(2)Products included within Other Established include, but are not limited to, TESTOPEL®.
(3)Individual products presented above represent the top two performing products in each product category for either the three or six months ended June 30, 2020 and/or any product having revenues in excess of $25 million during any quarterly period in 2020 or 2019.
(4)Products included within Other Sterile Injectables include ephedrine sulfate injection and others.
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The following table presents unaudited Condensed Consolidated Statement of Operations data for the three and six months ended June 30, 2020 and 2019 (in thousands, except per share data):
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
TOTAL REVENUES, NET$687,588  $699,727  $1,507,993  $1,420,138  
COSTS AND EXPENSES:
Cost of revenues336,096  388,208  724,895  780,117  
Selling, general and administrative173,258  152,297  340,026  303,420  
Research and development30,495  26,348  62,110  59,834  
Litigation-related and other contingencies, net(8,572) 10,315  (25,748) 10,321  
Asset impairment charges—  88,438  97,785  253,886  
Acquisition-related and integration items, net6,045  (5,507) 18,507  (43,008) 
Interest expense, net129,164  134,809  262,041  267,484  
Gain on extinguishment of debt—  —  —  (119,828) 
Other (income) expense, net(4,150) (597) (18,124) 4,205  
INCOME (LOSS) FROM CONTINUING OPERATIONS BEFORE INCOME TAX$25,252  $(94,584) $46,501  $(96,293) 
INCOME TAX EXPENSE (BENEFIT)7,642  3,468  (128,690) 14,371  
INCOME (LOSS) FROM CONTINUING OPERATIONS$17,610  $(98,052) $175,191  $(110,664) 
DISCONTINUED OPERATIONS, NET OF TAX(7,052) (7,953) (34,703) (13,914) 
NET INCOME (LOSS)$10,558  $(106,005) $140,488  $(124,578) 
NET INCOME (LOSS) PER SHARE—BASIC:
Continuing operations$0.08  $(0.43) $0.77  $(0.49) 
Discontinued operations(0.03) (0.04) (0.16) (0.06) 
Basic$0.05  $(0.47) $0.61  $(0.55) 
NET INCOME (LOSS) PER SHARE—DILUTED:
Continuing operations$0.08  $(0.43) $0.75  $(0.49) 
Discontinued operations(0.03) (0.04) (0.15) (0.06) 
Diluted$0.05  $(0.47) $0.60  $(0.55) 
WEIGHTED AVERAGE SHARES:
Basic229,716  226,221  228,457  225,408  
Diluted233,681  226,221  233,348  225,408  
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The following table presents unaudited Condensed Consolidated Balance Sheet data at June 30, 2020 and December 31, 2019 (in thousands):
June 30, 2020December 31, 2019
ASSETS
CURRENT ASSETS:
Cash and cash equivalents$1,780,087  $1,454,531  
Restricted cash and cash equivalents180,730  247,457  
Accounts receivable271,893  467,953  
Inventories, net330,540  327,865  
Other current assets122,894  88,412  
Total current assets$2,686,144  $2,586,218  
TOTAL NON-CURRENT ASSETS6,478,990  6,803,309  
TOTAL ASSETS$9,165,134  $9,389,527  
LIABILITIES AND SHAREHOLDERS' DEFICIT
CURRENT LIABILITIES:
Accounts payable and accrued expenses, including legal settlement accruals$1,175,241  $1,412,954  
Other current liabilities47,170  47,335  
Total current liabilities$1,222,411  $1,460,289  
LONG-TERM DEBT, LESS CURRENT PORTION, NET8,302,595  8,359,899  
OTHER LIABILITIES354,995  435,883  
SHAREHOLDERS' DEFICIT(714,867) (866,544) 
TOTAL LIABILITIES AND SHAREHOLDERS' DEFICIT$9,165,134  $9,389,527  
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The following table presents unaudited Condensed Consolidated Statement of Cash Flow data for the six months ended June 30, 2020 and 2019 (in thousands):
Six Months Ended June 30,
20202019
OPERATING ACTIVITIES:
Net income (loss)$140,488  $(124,578) 
Adjustments to reconcile Net income (loss) to Net cash provided by operating activities:
Depreciation and amortization264,198  320,788  
Asset impairment charges97,785  253,886  
Other, including cash payments to claimants from Qualified Settlement Funds(135,583) (363,494) 
Net cash provided by operating activities$366,888  $86,602  
INVESTING ACTIVITIES:
Purchases of property, plant and equipment, excluding capitalized interest$(36,305) $(23,632) 
Proceeds from sale of business and other assets, net6,017  2,594  
Other(1,125) (1,278) 
Net cash used in investing activities$(31,413) $(22,316) 
FINANCING ACTIVITIES:
(Payments on) proceeds from borrowings, net$(66,685) $257,605  
Other(9,046) (22,676) 
Net cash (used in) provided by financing activities$(75,731) $234,929  
Effect of foreign exchange rate(915) 841  
NET INCREASE IN CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS$258,829  $300,056  
CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS, BEGINNING OF PERIOD1,720,388  1,476,837  
CASH, CASH EQUIVALENTS, RESTRICTED CASH AND RESTRICTED CASH EQUIVALENTS, END OF PERIOD$1,979,217  $1,776,893  
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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.
Effective January 1, 2020, the Company revised its definition of its adjusted financial metrics to exclude certain legal costs. The Company believes that such costs are not indicative of business performance and that excluding them more accurately reflects the Company’s results and better enables management to compare financial results between periods. As a result of this change, the Company’s adjusted financial metrics now exclude opioid-related legal expenses. Prior period adjusted results throughout this document have also been adjusted to reflect this change. The impact of excluding these costs during the three and six months ended June 30, 2020 and 2019 is reflected in the Certain legal costs lines of each of the following reconciliation tables.
Reconciliation of EBITDA and Adjusted EBITDA (non-GAAP)
The following table provides a reconciliation of Net income (loss) (GAAP) to Adjusted EBITDA (non-GAAP) for the three and six months ended June 30, 2020 and 2019 (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Net income (loss) (GAAP)$10,558  $(106,005) $140,488  $(124,578) 
Income tax expense (benefit)7,642  3,468  (128,690) 14,371  
Interest expense, net129,164  134,809  262,041  267,484  
Depreciation and amortization (13)120,855  158,055  255,813  320,788  
EBITDA (non-GAAP)$268,219  $190,327  $529,652  $478,065  
Upfront and milestone-related payments (2)444  1,444  2,194  2,383  
Continuity and separation benefits and other cost reductions (3)9,444  2,124  32,664  4,149  
Certain litigation-related and other contingencies, net (4)(8,572) 10,315  (25,748) 10,321  
Certain legal costs (5)18,005  18,984  33,541  35,673  
Asset impairment charges (6)—  88,438  97,785  253,886  
Fair value of contingent consideration (7)6,045  (5,507) 18,507  (43,008) 
Gain on extinguishment of debt (8)—  —  —  (119,828) 
Share-based compensation (13)9,222  12,600  21,677  37,333  
Other (income) expense, net (14)(4,150) (597) (18,124) 4,205  
Other (9)30,772   30,756  87  
Discontinued operations, net of tax (11)7,052  7,953  34,703  13,914  
Adjusted EBITDA (non-GAAP)$336,481  $326,084  $757,607  $677,180  
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Reconciliation of Adjusted Income from Continuing Operations (non-GAAP)
The following table provides a reconciliation of the Company’s Income (loss) from continuing operations (GAAP) to Adjusted income from continuing operations (non-GAAP) for the three and six months ended June 30, 2020 and 2019 (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Income (loss) from continuing operations (GAAP)$17,610  $(98,052) $175,191  $(110,664) 
Non-GAAP adjustments:
Amortization of intangible assets (1)104,498  140,418  221,735  286,017  
Upfront and milestone-related payments (2)444  1,444  2,194  2,383  
Continuity and separation benefits and other cost reductions (3)9,444  2,124  32,664  4,149  
Certain litigation-related and other contingencies, net (4)(8,572) 10,315  (25,748) 10,321  
Certain legal costs (5)18,005  18,984  33,541  35,673  
Asset impairment charges (6)—  88,438  97,785  253,886  
Fair value of contingent consideration (7)6,045  (5,507) 18,507  (43,008) 
Gain on extinguishment of debt (8)—  —  —  (119,828) 
Other (9)29,755  86  15,335  1,620  
Tax adjustments (10)(25,529) (18,862) (199,104) (42,388) 
Adjusted income from continuing operations (non-GAAP)$151,700  $139,388  $372,100  $278,161  
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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 six months ended June 30, 2020 and 2019 (in thousands, except per share data):
Three Months Ended June 30, 2020
Total revenues, netCost of revenuesGross marginGross margin %Total operating expensesOperating expense to revenue %Operating income from continuing operationsOperating margin %Other non-operating expense, netIncome from continuing operations before income taxIncome tax expenseEffective tax rateIncome from continuing operationsDiscontinued operations, net of taxNet incomeDiluted net income per share from continuing operations (12)
Reported (GAAP)$687,588  $336,096  $351,492  51.1 %$201,226  29.3 %$150,266  21.9 %$125,014  $25,252  $7,642  30.3 %$17,610  $(7,052) $10,558  $0.08  
Items impacting comparability:
Amortization of intangible assets (1)—  (104,498) 104,498  —  104,498  —  104,498  —  104,498  —  104,498  
Upfront and milestone-related payments (2)—  (125) 125  (319) 444  —  444  —  444  —  444  
Continuity and separation benefits and other cost reductions (3)—  (904) 904  (8,540) 9,444  —  9,444  —  9,444  —  9,444  
Certain litigation-related and other contingencies, net (4)—  —  —  8,572  (8,572) —  (8,572) —  (8,572) —  (8,572) 
Certain legal costs (5)—  —  —  (18,005) 18,005  —  18,005  —  18,005  —  18,005  
Fair value of contingent consideration (7)—  —  —  (6,045) 6,045  —  6,045  —  6,045  —  6,045  
Other (9)—  —  —  (30,749) 30,749  994  29,755  —  29,755  —  29,755  
Tax adjustments (10)—  —  —  —  —  —  —  25,529  (25,529) —  (25,529) 
Exclude discontinued operations, net of tax (11)—  —  —  —  —  —  —  —  —  7,052  7,052  
After considering items (non-GAAP)$687,588  $230,569  $457,019  66.5 %$146,140  21.3 %$310,879  45.2 %$126,008  $184,871  $33,171  17.9 %$151,700  $—  $151,700  $0.65  
Three Months Ended June 30, 2019
Total revenues, netCost of revenuesGross marginGross margin %Total operating expensesOperating expense to revenue %Operating income from continuing operationsOperating margin %Other non-operating expense, net(Loss) income from continuing operations before income taxIncome tax expenseEffective tax rate(Loss) income from continuing operationsDiscontinued operations, net of taxNet (loss) incomeDiluted net (loss) income per share from continuing operations (12)
Reported (GAAP)$699,727  $388,208  $311,519  44.5 %$271,891  38.9 %$39,628  5.7 %$134,212  $(94,584) $3,468  (3.7)%$(98,052) $(7,953) $(106,005) $(0.43) 
Items impacting comparability:
Amortization of intangible assets (1)—  (140,418) 140,418  —  140,418  —  140,418  —  140,418  —  140,418  
Upfront and milestone-related payments (2)—  (739) 739  (705) 1,444  —  1,444  —  1,444  —  1,444  
Continuity and separation benefits and other cost reductions (3)—  —  —  (2,124) 2,124  —  2,124  —  2,124  —  2,124  
Certain litigation-related and other contingencies, net (4)—  —  —  (10,315) 10,315  —  10,315  —  10,315  —  10,315  
Certain legal costs (5)—  —  —  (18,984) 18,984  —  18,984  —  18,984  —  18,984  
Asset impairment charges (6)—  —  —  (88,438) 88,438  —  88,438  —  88,438  —  88,438  
Fair value of contingent consideration (7)—  —  —  5,507  (5,507) —  (5,507) —  (5,507) —  (5,507) 
Other (9)—  —  —  175  (175) (261) 86  —  86  —  86  
Tax adjustments (10)—  —  —  —  —  —  —  18,862  (18,862) —  (18,862) 
Exclude discontinued operations, net of tax (11)—  —  —  —  —  —  —  —  —  7,953  7,953  
After considering items (non-GAAP)$699,727  $247,051  $452,676  64.7 %$157,007  22.4 %$295,669  42.3 %$133,951  $161,718  $22,330  13.8 %$139,388  $—  $139,388  $0.60  
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Six Months Ended June 30, 2020
Total revenues, netCost of revenuesGross marginGross margin %Total operating expensesOperating expense to revenue %Operating income from continuing operationsOperating margin %Other non-operating expense, netIncome from continuing operations before income taxIncome tax (benefit) expenseEffective tax rateIncome from continuing operationsDiscontinued operations, net of taxNet incomeDiluted net income per share from continuing operations (12)
Reported (GAAP)$1,507,993  $724,895  $783,098  51.9 %$492,680  32.7 %$290,418  19.3 %$243,917  $46,501  $(128,690) (276.7)%$175,191  $(34,703) $140,488  $0.75  
Items impacting comparability:
Amortization of intangible assets (1)—  (221,735) 221,735  —  221,735  —  221,735  —  221,735  —  221,735  
Upfront and milestone-related payments (2)—  (667) 667  (1,527) 2,194  —  2,194  —  2,194  —  2,194  
Continuity and separation benefits and other cost reductions (3)—  (7,142) 7,142  (25,522) 32,664  —  32,664  —  32,664  —  32,664  
Certain litigation-related and other contingencies, net (4)—  —  —  25,748  (25,748) —  (25,748) —  (25,748) —  (25,748) 
Certain legal costs (5)—  —  —  (33,541) 33,541  —  33,541  —  33,541  —  33,541  
Asset impairment charges (6)—  —  —  (97,785) 97,785  —  97,785  —  97,785  —  97,785  
Fair value of contingent consideration (7)—  —  —  (18,507) 18,507  —  18,507  —  18,507  —  18,507  
Other (9)—  —  —  (30,749) 30,749  15,414  15,335  —  15,335  —  15,335  
Tax adjustments (10)—  —  —  —  —  —  —  199,104  (199,104) —  (199,104) 
Exclude discontinued operations, net of tax (11)—  —  —  —  —  —  —  —  —  34,703  34,703  
After considering items (non-GAAP)$1,507,993  $495,351  $1,012,642  67.2 %$310,797  20.6 %$701,845  46.5 %$259,331  $442,514  $70,414  15.9 %$372,100  $—  $372,100  $1.59  
Six Months Ended June 30, 2019
Total revenues, netCost of revenuesGross marginGross margin %Total operating expensesOperating expense to revenue %Operating income from continuing operationsOperating margin %Other non-operating expense, net(Loss) income from continuing operations before income taxIncome tax expenseEffective tax rate(Loss) income from continuing operationsDiscontinued operations, net of taxNet (loss) incomeDiluted net (loss) income per share from continuing operations (12)
Reported (GAAP)$1,420,138  $780,117  $640,021  45.1 %$584,453  41.2 %$55,568  3.9 %$151,861  $(96,293) $14,371  (14.9)%$(110,664) $(13,914) $(124,578) $(0.49) 
Items impacting comparability:
Amortization of intangible assets (1)—  (286,017) 286,017  —  286,017  —  286,017  —  286,017  —  286,017  
Upfront and milestone-related payments (2)—  (1,400) 1,400  (983) 2,383  —  2,383  —  2,383  —  2,383  
Continuity and separation benefits and other cost reductions (3)—  —  —  (4,149) 4,149  —  4,149  —  4,149  —  4,149  
Certain litigation-related and other contingencies, net (4)—  —  —  (10,321) 10,321  —  10,321  —  10,321  —  10,321  
Certain legal costs (5)—  —  —  (35,673) 35,673  —  35,673  —  35,673  —  35,673  
Asset impairment charges (6)—  —  —  (253,886) 253,886  —  253,886  —  253,886  —  253,886  
Fair value of contingent consideration (7)—  —  —  43,008  (43,008) —  (43,008) —  (43,008) —  (43,008) 
Gain on extinguishment of debt (8)—  —  —  —  —  119,828  (119,828) —  (119,828) —  (119,828) 
Other (9)—  —  —  175  (175) (1,795) 1,620  —  1,620  —  1,620  
Tax adjustments (10)—  —  —  —  —  —  —  42,388  (42,388) —  (42,388) 
Exclude discontinued operations, net of tax (11)—  —  —  —  —  —  —  —  —  13,914  13,914  
After considering items (non-GAAP)$1,420,138  $492,700  $927,438  65.3 %$322,624  22.7 %$604,814  42.6 %$269,894  $334,920  $56,759  16.9 %$278,161  $—  $278,161  $1.20  
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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 six months ended June 30, 2020 and 2019 are as follows:
(1)Adjustments for amortization of commercial intangible assets included the following (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Amortization of intangible assets excluding fair value step-up from contingent consideration$103,681  $134,473  $220,101  $271,338  
Amortization of intangible assets related to fair value step-up from contingent consideration817  5,945  1,634  14,679  
Total$104,498  $140,418  $221,735  $286,017  
(2)Adjustments for upfront and milestone-related payments to partners included the following (in thousands):
Three Months Ended June 30,
20202019
Cost of revenuesOperating expensesCost of revenuesOperating expenses
Sales-based$125  $—  $739  $—  
Development-based—  319  —  705  
Total$125  $319  $739  $705  
Six Months Ended June 30,
20202019
Cost of revenuesOperating expensesCost of revenuesOperating expenses
Sales-based$667  $—  $1,400  $—  
Development-based—  1,527  —  983  
Total$667  $1,527  $1,400  $983  
(3)Adjustments for continuity and separation benefits and other cost reductions included the following (in thousands):
Three Months Ended June 30,
20202019
Cost of revenuesOperating expensesCost of revenuesOperating expenses
Continuity and separation benefits$515  $3,606  $—  $410  
Accelerated depreciation charges1,347  408  —  —  
Other(958) 4,526  —  1,714  
Total$904  $8,540  $—  $2,124  
Six Months Ended June 30,
20202019
Cost of revenuesOperating expensesCost of revenuesOperating expenses
Continuity and separation benefits$1,142  $16,775  $—  $2,212  
Accelerated depreciation charges6,026  2,359  —  —  
Other(26) 6,388  —  1,937  
Total$7,142  $25,522  $—  $4,149  
Included within the Continuity and separation benefits line are costs associated with certain continuity and transitional compensation arrangements for certain senior management of the Company.
(4)To exclude adjustments to accruals for litigation-related settlement charges and certain settlement proceeds related to suits filed by subsidiaries.
(5)To exclude opioid-related legal expenses.
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(6)Adjustments for asset impairment charges included the following (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Goodwill impairment charges$—  $65,108  $32,786  $151,108  
Other intangible asset impairment charges—  21,699  63,751  100,399  
Property, plant and equipment impairment charges—  1,631  1,248  2,379  
Total asset impairment charges$—  $88,438  $97,785  $253,886  
(7)To exclude the impact of changes in the fair value of contingent consideration liabilities resulting from changes to our estimates regarding the timing and amount of the future revenues of the underlying products and changes in other assumptions impacting the probability of incurring, and extent to which the Company could incur, related contingent obligations.
(8)To exclude the gain on the extinguishment of debt associated with the Company’s March 2019 refinancing.
(9)The Other row included in each of the above reconciliations of GAAP financial measures to Non-GAAP financial measures (except for the reconciliations of Net income (loss) (GAAP) to Adjusted EBITDA (non-GAAP)) includes the following (in thousands):
Three Months Ended June 30,
20202019
Operating expensesOther non-operating expensesOperating expensesOther non-operating expenses
Foreign currency impact related to the re-measurement of intercompany debt instruments$—  $3,005  $—  $2,262  
(Gain) loss on sale of business and other assets—  (3,999) —  (2,001) 
Debt modification costs30,749  —  —  —  
Other miscellaneous—  —  (175) —  
Total$30,749  $(994) $(175) $261  
Six Months Ended June 30,
20202019
Operating expensesOther non-operating expensesOperating expensesOther non-operating expenses
Foreign currency impact related to the re-measurement of intercompany debt instruments$—  $(4,089) $—  $3,796  
(Gain) loss on sale of business and other assets—  (11,325) —  (2,001) 
Debt modification costs30,749  —  —  —  
Other miscellaneous—  —  (175) —  
Total$30,749  $(15,414) $(175) $1,795  
The Other row included in the reconciliations of Net income (loss) (GAAP) to Adjusted EBITDA (non-GAAP) primarily relates to the items enumerated in the foregoing "Operating expenses" columns.
(10)Adjusted income taxes are calculated by tax effecting adjusted pre-tax income and permanent book-tax differences at the applicable effective tax rate that will be determined by reference to statutory tax rates in the relevant jurisdictions in which the Company operates. Adjusted income taxes include current and deferred income tax expense commensurate with the non-GAAP measure of profitability.
(11)To exclude the results of the businesses reported as discontinued operations, net of tax.
(12)Calculated as Net (loss) income from continuing operations divided by the applicable weighted average share number. The applicable weighted average share numbers are as follows (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
GAAP233,681  226,221  233,348  225,408  
Non-GAAP Adjusted233,681  232,713  233,348  232,174  
(13)Depreciation and amortization and Share-based compensation per the Adjusted EBITDA reconciliations do not include amounts reflected in other lines of the reconciliations, including Continuity and separation benefits and other cost reductions.
(14)To exclude Other (income) expense, net per the Condensed Consolidated Statements of Operations.
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Reconciliation of Net Debt Leverage Ratio (non-GAAP)
The following table provides a reconciliation of the Company’s Net income (loss) (GAAP) to Adjusted EBITDA (non-GAAP) for the twelve months ended June 30, 2020 (in thousands) and the calculation of the Company’s Net Debt Leverage Ratio (non-GAAP):
Twelve Months Ended June 30, 2020
Net loss (GAAP)$(157,570) 
Income tax benefit(127,381) 
Interest expense, net533,291  
Depreciation and amortization (13)547,887  
EBITDA (non-GAAP)$796,227  
Upfront and milestone-related payments$6,434  
Continuity and separation benefits and other cost reductions63,113  
Certain litigation-related and other contingencies, net(24,858) 
Certain legal costs63,150  
Asset impairment charges369,981  
Fair value of contingent consideration15,417  
Share-based compensation (13)43,486  
Other income, net(5,652) 
Other44,460  
Discontinued operations, net of tax82,841  
Adjusted EBITDA (non-GAAP)$1,454,599  
Calculation of Net Debt:
Debt$8,336,745  
Cash (excluding Restricted Cash)1,780,087  
Net Debt (non-GAAP)$6,556,658  
Calculation of Net Debt Leverage:
Net Debt Leverage Ratio (non-GAAP)4.5  
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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 International plc (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. Endo has global headquarters in Dublin, Ireland and U.S. headquarters in Malvern, Pennsylvania.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including but not limited to the statements by Mr. Coleman, as well as other statements regarding product development, market potential, corporate strategy, optimization efforts, expected growth and regulatory approvals, together with Endo’s net income per share from continuing operations amounts, product net sales, revenue forecasts, the impact of and response to the COVID-19 pandemic and any other statements that refer to Endo’s expected, estimated or anticipated future results. 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.
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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 from current expectations based on a number of factors affecting Endo’s businesses, including, among other things, the following: changing competitive, market and regulatory conditions; changes in legislation; Endo’s ability to obtain and maintain adequate protection for its 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 strategic initiatives; the timing or results of any pending or future litigation, investigations or claims or actual or contingent liabilities, settlement discussions, negotiations or other adverse proceedings; unfavorable publicity regarding the misuse of opioids; timing and uncertainty of any acquisition, including the possibility that various closing conditions may not be satisfied or waived, uncertainty surrounding the successful integration of any acquired business and failure to achieve the expected financial and commercial results from such acquisition; the uncertainty associated with the identification of and successful consummation and execution of external corporate development initiatives and strategic partnering transactions; and Endo’s 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 higher unemployment, political instability, financial hardship, 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, fluctuations or devaluations in the value of sovereign government debt, the impact of and response to the COVID-19 pandemic and the impact of continued economic volatility, can materially affect Endo’s results. 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 the above-referenced risk factors and other risk factors 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. 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.
SOURCE Endo International plc
Media: Heather Zoumas-Lubeski, (484) 216-6829; Investors: Pravesh Khandelwal, (845)-364-4833
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