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DUBLIN, March 6, 2024 /CNW/ -- Endo International plc (OTC: ENDPQ) today reported financial results for the fourth-quarter ended December 31, 2023.
FOURTH-QUARTER FINANCIAL PERFORMANCE
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| (in thousands, except per share amounts)
|
| Three Months Ended December 31,
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|
|
| Year Ended December 31,
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|
|
| 2023
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| 2022
|
| Change
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| 2023
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| 2022
|
| Change
| Total Revenues, Net
| $ 497,734
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| $ 555,812
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| (10) %
|
| $ 2,011,518
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| $ 2,318,875
|
| (13) %
| Reported Loss from Continuing Operations
| $ (2,441,038)
|
| $ (245,163)
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| NM
|
| $ (2,447,786)
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| $ (2,909,618)
|
| (16) %
| Reported Diluted Weighted Average Shares
| 235,220
|
| 235,205
|
| — %
|
| 235,219
|
| 234,840
|
| — %
| Reported Diluted Net Loss per Share from Continuing Operations (1)
| $ (10.38)
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| $ (1.04)
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| NM
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| $ (10.41)
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| $ (12.39)
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| (16) %
| Reported Net Loss
| $ (2,441,483)
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| $ (243,535)
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| NM
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| $ (2,449,807)
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| $ (2,923,105)
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| (16) %
| Adjusted Income from Continuing Operations (2)(3)
| $ 151,060
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| $ 189,529
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| (20) %
|
| $ 706,534
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| $ 463,858
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| 52 %
| Adjusted Diluted Weighted Average Shares (1)(2)
| 235,220
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| 236,500
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| (1) %
|
| 235,441
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| 236,404
|
| — %
| Adjusted Diluted Net Income per Share from Continuing Operations (2)(3)
| $ 0.64
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| $ 0.80
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| (20) %
|
| $ 3.00
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| $ 1.96
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| 53 %
| Adjusted EBITDA (2)(3)
| $ 166,341
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| $ 210,102
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| (21) %
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| $ 761,838
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| $ 892,050
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| (15) %
|
__________
(1)
| Reported Diluted Net 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.
| (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.
| (3)
| Effective January 1, 2022, these non-GAAP financial measures now include acquired in-process research and development charges which were previously excluded under Endo's legacy non-GAAP policy. Refer to note (13) in the "Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures" section below for additional discussion.
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CONSOLIDATED FINANCIAL RESULTS
Total revenues were $498 million in fourth-quarter 2023, a decrease of 10% compared to $556 million in fourth-quarter 2022. This decrease was primarily attributable to decreased revenues from the Generic Pharmaceuticals and Sterile Injectables segments, partially offset by increased revenues from the Branded Pharmaceuticals segment.
Reported loss from continuing operations in fourth-quarter 2023 was $2,441 million compared to reported loss from continuing operations of $245 million in fourth-quarter 2022. This change was driven by adjustments to our estimated allowed claims, including with respect to certain litigation matters and debt obligations. The allowed claims will be reduced to reflect actual payments upon Chapter 11 emergence, which is expected to occur in second-quarter 2024.
Adjusted income from continuing operations in fourth-quarter 2023 was $151 million compared to $190 million in fourth-quarter 2022. This change was primarily driven by decreased revenues.
BRANDED PHARMACEUTICALS SEGMENT
Fourth-quarter 2023 Branded Pharmaceuticals segment revenues were $246 million compared to $224 million during fourth-quarter 2022.
Specialty Products revenues increased 16% to $188 million in fourth-quarter 2023 compared to $162 million in fourth-quarter 2022. This change was primarily due to an increase in XIAFLEX® revenues, partially offset by a decrease in SUPPRELIN® LA revenues mainly driven by lower volumes. Fourth-quarter 2023 XIAFLEX® revenues were $148 million, a 29% increase compared to fourth-quarter 2022 driven by increased net selling price and increased volumes. The increase in net selling price was primarily attributable to reversing approximately $14 million of reserves recorded during the first three quarters of 2023 following application of the final Inflation Reduction Act vial-wastage rebate determination.
STERILE INJECTABLES SEGMENT
Fourth-quarter 2023 Sterile Injectables segment revenues were $96 million, a decrease of 11% compared to $108 million during fourth-quarter 2022. This decrease was primarily attributable to competitive pressure on VASOSTRICT® and ADRENALIN®.
GENERIC PHARMACEUTICALS SEGMENT
Fourth-quarter 2023 Generic Pharmaceuticals segment revenues were $139 million, a decrease of 32% compared to $205 million during fourth-quarter 2022. This decrease was primarily attributable to competitive pressure on varenicline tablets, the generic version of Chantix®, and lubiprostone capsules, the authorized generic of Mallinckrodt's Amitiza®, partially offset by revenue from dexlansoprazole delayed release capsules, the generic version of Dexilant®, which launched during fourth-quarter 2022.
INTERNATIONAL PHARMACEUTICALS SEGMENT
Fourth-quarter 2023 International Pharmaceuticals segment revenues were $17 million, a decrease of 14% compared to $20 million during fourth-quarter 2022. This decrease was primarily attributable to competitive pressure on several products.
2024 FINANCIAL EXPECTATIONS
Endo is providing financial guidance for the full-year ending December 31, 2024, which contemplates key uncertainties, including competitive assumptions related to VASOSTRICT® ready-to-use, ADRENALIN ® and generic Dexilant ® products. All financial expectations provided by Endo are forward-looking, and actual results may differ materially from such expectations, as further discussed below under the heading "Cautionary Note Regarding Forward-Looking Statements."
| Full-Year 2024
Adjusted Results
| ($ in millions)
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|
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| Total Revenues, Net
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| $1,685 - $1,770
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| EBITDA
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| $615 - $645
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| Assumptions:
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| Segment Revenues:
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| Branded Pharmaceuticals
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| $860 - $905
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| Sterile Injectables
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| $370 - $390
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| Generic Pharmaceuticals
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| $395 - $415
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| International Pharmaceuticals
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| $60
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| Gross Margin as a Percentage of Total Revenues, Net
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| ~67%
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| Operating Expenses
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| $585 - $605
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CASH, CASH FLOW AND OTHER UPDATES
As of December 31, 2023, the Company had approximately $778 million in unrestricted cash and cash equivalents. Fourth-quarter 2023 net cash provided by operating activities was approximately $115 million compared to approximately $110 million net cash provided by operating activities during fourth-quarter 2022.
Amitiza® is a registered trademark of a Mallinckrodt company.
Dexilant® is a registered trademark of Takeda Pharmaceutical U.S.A., Inc.
Chantix® is a registered trademark of Pfizer Inc.
FINANCIAL SCHEDULES
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| The following table presents Endo's unaudited Total revenues, net for the three months and years ended December 31, 2023 and 2022 (dollars in thousands):
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|
| Three Months Ended December 31,
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| Percent
Growth
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| Year Ended December 31,
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| Percent
Growth
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| 2023
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| 2022
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|
| 2023
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| 2022
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| Branded Pharmaceuticals:
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|
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| Specialty Products:
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| XIAFLEX®
| $ 147,760
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| $ 114,304
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| 29 %
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| $ 475,014
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| $ 438,680
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| 8 %
| SUPPRELIN® LA
| 23,459
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| 28,159
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| (17) %
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| 96,849
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| 113,011
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| (14) %
| Other Specialty (1)
| 16,515
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| 19,986
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| (17) %
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| 73,797
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| 70,009
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| 5 %
| Total Specialty Products
| $ 187,734
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| $ 162,449
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| 16 %
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| $ 645,660
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| $ 621,700
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| 4 %
| Established Products:
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| PERCOCET®
| $ 27,584
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| $ 26,460
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| 4 %
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| $ 106,375
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| $ 103,943
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| 2 %
| TESTOPEL®
| 10,265
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| 10,396
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| (1) %
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| 42,464
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| 38,727
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| 10 %
| Other Established (2)
| 20,186
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| 24,523
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| (18) %
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| 64,588
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| 86,772
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| (26) %
| Total Established Products
| $ 58,035
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| $ 61,379
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| (5) %
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| $ 213,427
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| $ 229,442
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| (7) %
| Total Branded Pharmaceuticals (3)
| $ 245,769
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| $ 223,828
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| 10 %
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| $ 859,087
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| $ 851,142
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| 1 %
| Sterile Injectables:
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| ADRENALIN®
| $ 24,329
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| $ 28,790
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| (15) %
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| $ 99,910
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| $ 114,304
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| (13) %
| VASOSTRICT®
| 21,983
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| 28,479
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| (23) %
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| 93,180
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| 253,696
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| (63) %
| Other Sterile Injectables (4)
| 49,587
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| 50,472
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| (2) %
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| 236,473
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| 221,633
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| 7 %
| Total Sterile Injectables (3)
| $ 95,899
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| $ 107,741
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| (11) %
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| $ 429,563
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| $ 589,633
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| (27) %
| Total Generic Pharmaceuticals (5)
| $ 139,211
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| $ 204,701
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| (32) %
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| $ 650,352
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| $ 795,457
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| (18) %
| Total International Pharmaceuticals (6)
| $ 16,855
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| $ 19,542
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| (14) %
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| $ 72,516
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| $ 82,643
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| (12) %
| Total revenues, net
| $ 497,734
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| $ 555,812
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| (10) %
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| $ 2,011,518
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| $ 2,318,875
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| (13) %
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__________
(1)
| Products included within Other Specialty include AVEED®, NASCOBAL® Nasal Spray and QWO®.
| (2)
| Products included within Other Established include, but are not limited to, EDEX®.
| (3)
| Individual products presented above represent the top two performing products in each product category for the year ended December 31, 2023 and/or any product having revenues in excess of and/or any product having revenues in excess of $25 million during any completed quarterly period in 2023 or 2022.
| (4)
| No individual product within Other Sterile Injectables has exceeded 5% of consolidated total revenues for the periods presented.
| (5)
| The Generic Pharmaceuticals segment is comprised of a portfolio of products that are generic versions of branded products, are distributed primarily through the same wholesalers, generally have limited or no intellectual property protection and are sold within the U.S. Varenicline tablets (Endo's generic version of Pfizer Inc.'s Chantix®), which launched in September 2021, made up less than 5% and 16% for the three months ended December 31, 2023 and 2022, respectively, and 8% and 13% for the years ended December 31, 2023 and 2022, respectively, of consolidated total revenues. Dexlansoprazole delayed release capsules (Endo's generic version of Takeda Pharmaceuticals USA, Inc.'s Dexilant®), which launched in November 2022, made up 6% for the quarter and full-year ended December 31, 2023 of consolidated total revenues. No other individual product within this segment has exceeded 5% of consolidated total revenues for the periods presented.
| (6)
| The International Pharmaceuticals segment, which accounted for less than 5% of consolidated total revenues for each of the periods presented, includes a variety of specialty pharmaceutical products sold outside the U.S., primarily in Canada through Endo's operating company Paladin Labs Inc.
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The following table presents unaudited Condensed Consolidated Statement of Operations data for the three months and years ended December 31, 2023 and 2022 (in thousands, except per share data):
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|
| Three Months Ended December 31,
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| Year Ended December 31,
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| 2023
|
| 2022
|
| 2023
|
| 2022
| TOTAL REVENUES, NET
| $ 497,734
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| $ 555,812
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| $ 2,011,518
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| $ 2,318,875
| COSTS AND EXPENSES:
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|
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| Cost of revenues
| 249,535
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| 294,266
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| 946,415
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| 1,092,499
| Selling, general and administrative
| 140,433
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| 176,957
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| 567,727
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| 777,169
| Research and development
| 28,140
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| 30,230
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| 115,462
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| 128,033
| Acquired in-process research and development
| —
|
| —
|
| —
|
| 68,700
| Litigation-related and other contingencies, net
| 1,556,773
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| 33,984
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| 1,611,090
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| 478,722
| Asset impairment charges
| 357
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| 191,530
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| 503
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| 2,142,746
| Acquisition-related and integration items, net
| 148
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| 1,359
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| 1,972
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| 408
| Interest (income) expense, net
| (239)
|
| 290
|
| —
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| 349,776
| Reorganization items, net
| 942,382
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| 78,766
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| 1,169,961
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| 202,978
| Other income, net
| (7,525)
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| (11,907)
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| (9,688)
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| (34,054)
| LOSS FROM CONTINUING OPERATIONS BEFORE INCOME TAX
| $ (2,412,270)
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| $ (239,663)
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| $ (2,391,924)
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| $ (2,888,102)
| INCOME TAX EXPENSE
| 28,768
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| 5,500
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| 55,862
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| 21,516
| LOSS FROM CONTINUING OPERATIONS
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| Related companies: | Endo International plc |
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