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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_______________________________
FORM 8-K
_______________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): September 11, 2024
_____________________________
Endo, Inc.
(Exact name of registrant as specified in its charter)
_______________________________
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Delaware | 333-280767 | 30-1390281 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
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1400 Atwater Drive | |
Malvern, | Pennsylvania | 19355 |
(Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code 484-216-0000
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act: None (1)
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(1) | On June 28, 2024, Endo, Inc. common stock was quoted and began trading on the OTCQX® Best Market under the symbol “NDOI.” |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
☐ Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01. Regulation FD Disclosure.
On September 11, 2024, and from time to time following that date, Endo, Inc. (the “Company”) intends to make a presentation to certain investors and analysts (the “Presentation”), a copy of which is furnished as Exhibit 99.1 hereto and is incorporated herein by reference. The Presentation will also be available on the Company’s website at www.endo.com.
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”). The Company utilizes these financial measures, commonly referred to as “non-GAAP,” as supplements to financial measures determined in accordance with GAAP when evaluating the Company’s operating performance and the Company believes that they will be used by certain investors to measure the Company’s operating results. The Company believes that presenting these non-GAAP financial measures provides useful information about the Company’s performance across reporting periods on a consistent basis by excluding certain items, which may be favorable or unfavorable, pursuant to the procedure described in the succeeding paragraph.
The initial identification and review of the adjustments necessary to arrive at these non-GAAP financial measures are performed by a team of finance professionals led by the Chief Accounting Officer in accordance with the Company’s Non-GAAP Policy, which is reviewed and approved annually by the Audit & Finance Committee of the Company’s Board of Directors. Company tax professionals review and determine the tax effect of adjusted pre-tax income at applicable tax rates and other tax adjustments as described below. Proposed adjustments, along with any items considered but excluded, are presented to the Chief Accounting Officer, Chief Financial Officer and/or the Chief Executive Officer for their consideration. The non-GAAP adjustments are presented to the Audit & Finance Committee on a quarterly basis as part of the Company’s standard procedures for preparation and review of the earnings release and other quarterly materials.
These non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with GAAP. The Company’s definition of these non-GAAP financial measures may differ from similarly titled measures used by others. The definitions of the most commonly used non-GAAP financial measures are presented below.
Adjusted net income, Adjusted Gross Profit and Adjusted Operating Expenses
Adjusted net income, Adjusted Gross Profit and Adjusted Operating Expenses are presented as non-GAAP measures and are reconciled to their corresponding GAAP measures of Net income (loss), Gross Profit, defined as revenues less cost of revenues, and Operating Expenses, defined as the sum of (i) Selling, general and administrative; (ii) Research and development; (iii) Acquired in-process research and development; (iv) Litigation-related and other contingencies, net; (v) Asset impairment charges; and (vi) Acquisition related and integration items, net.
Adjustments, to the extent they apply to the corresponding GAAP amounts, may include, but are not limited to expense or income related to: acquisitions and divestitures, such as amortization of intangible assets and of inventory step-up adjustments, certain employee-related charges, including earn-outs, separation, retention, or relocation costs, changes in the fair value of contingent consideration, transaction costs of executed deals, and integration or disintegration-related costs; certain amounts related to strategic review initiatives; certain cost reduction initiatives such as separation benefits, continuity payments, other exit costs; asset impairment charges; certain costs incurred in connection with debt or equity-financing activities, such as non-capitalizable transaction costs incurred in connection with a successful financing transaction and gains or losses associated with early repayments, extinguishment or modification of our debt instruments; litigation-related and other contingent matters; certain legal costs; gains or losses from the sales of businesses and other assets; gains or losses associated with discontinued operations, net of tax; foreign currency gains or losses on intercompany financing arrangements; reorganization items, net; the tax effect of adjusted pre-tax income at applicable tax rates and other tax adjustments; and certain other items.
Adjusted gross margin
Adjusted gross margin represents total revenues less cost of revenues prepared in accordance with GAAP and adjusted for the certain items enumerated above under the heading “Adjusted net income” to the extent such items relate to cost of revenues. Such items may include, but are not limited to, expenses or income related to: acquisitions and divestitures, such as amortization of intangible assets and of inventory step-up adjustments, certain employee-related charges, including earn-outs, separation, retention, or relocation costs, certain amounts related to strategic review initiatives; certain cost reduction initiatives such as separation benefits, continuity payments, contract termination costs and other exit costs; certain integration or disintegration efforts; certain amounts related to strategic review initiatives; amortization of intangible assets and of inventory step-up adjustments; and certain other items.
Adjusted operating expenses
Adjusted operating expenses represent operating expenses prepared in accordance with GAAP and adjusted for certain items enumerated above under the heading “Adjusted net income” to the extent such items relate to operating expenses. Such items may include, but are not limited to expenses or income related to: acquisitions and divestitures, such as certain employee-related charges, including earn-outs, separation, retention, or relocation costs, transaction costs and changes in the fair value of contingent consideration; cost reduction and integration-related initiatives such as separation benefits, continuity payments, other exit costs; certain integration or disintegration efforts; certain amounts related to strategic review initiatives; asset impairment charges; amortization of intangible assets; inventory step-up recorded as part of our acquisitions; litigation-related and other contingent matters; certain legal costs; certain costs incurred in connection with debt or equity-financing activities, such as non-capitalizable transaction costs incurred in connection with a successful financing transaction and gains or losses associated with early repayments, extinguishment or modification of our debt instruments; and certain other items.
Adjusted income taxes and Adjusted effective tax rate
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. Adjustments are then made for certain items relating to prior years and for tax planning actions that are expected to be distortive to the underlying effective tax rate and trend in the effective tax rate. The most directly comparable GAAP financial measure for Adjusted income taxes is Income tax expense (benefit), prepared in accordance with GAAP. The Adjusted effective tax rate represents the rate generated when dividing Adjusted income taxes by the amount of adjusted pre-tax income.
EBITDA and Adjusted EBITDA
EBITDA represents Net income (loss) before Interest expense, net; Income tax expense; depreciation; and amortization, each prepared in accordance with GAAP. Adjusted EBITDA further adjusts EBITDA by excluding those items enumerated above under the heading “Adjusted net income,” without duplication, and stock-based compensation costs.
Because adjusted financial measures exclude the effect of items that will increase or decrease the Company’s reported results of operations, the Company strongly encourages investors to review the Company’s consolidated financial statements and publicly filed reports in their entirety. Investors are also encouraged to review the reconciliation of the non-GAAP financial measures used in the Presentation to their most directly comparable GAAP financial measures as included in the Presentation.
The information in this Item 7.01 and in Exhibit 99.1 attached hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information contained in this Item 7.01 and in Exhibit 99.1 attached hereto shall not be incorporated into any registration statement or other document filed by the Company with the U.S. Securities and Exchange Commission under the Securities Act of 1933, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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Number | Description |
99.1 | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
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ENDO, INC. |
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By: | /s/ Matthew J. Maletta |
Name: | Matthew J. Maletta |
Title: | Executive Vice President, Chief Legal Officer and Secretary |
Dated: September 11, 2024
1 Endo Investor Presentation September 2024
2 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, any statements relating to listing, uplisting, or trading on a national securities exchange, business plans, business growth, growth strategies, cash flow generation, commercial or manufacturing capabilities, intellectual property, litigation, product development, product pipeline, product launches and any other statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential," "target" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: timing of receipt of required approvals and satisfaction of other customary conditions for listing on a national securities exchange; timing or results of any potential future litigation, investigations, claims, actual or contingent liabilities; changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition such as those related to XIAFLEX®; the timing and uncertainty of the results of both the research and development and regulatory processes, including regulatory approvals; health care and cost containment reforms, including government pricing, tax and reimbursement policies litigation; the performance including the approval, introduction and consumer and physician acceptance of current and new products; the performance of third parties upon whom we rely for goods and services; issues associated with our supply chain; our ability to develop and expand our product pipeline and to continue to develop the market for XIAFLEX® and other branded, sterile injectable or unbranded products; the effectiveness of advertising and other promotional campaigns; the timely and successful implementation of any business development and/or strategic priorities; uncertainty associated with the identification of and successful consummation and execution of external corporate development initiatives and strategic partnering transactions; and our ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo’s public filings with the U.S. Securities and Exchange Commission (the "SEC"), including the discussion under the heading “Risk Factors” in Endo’s most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo’s Form S-1/A. Cautionary Note Regarding Forward-Looking Statements ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial.
3 This presentation may refer to non-GAAP financial measures, including, among others, adjusted earnings before interest, taxes, depreciation and amortization (“adjusted EBITDA”), adjusted net income, adjusted gross profit, adjusted gross margin and adjusted operating expenses that are not prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and that may be different from non-GAAP financial measures used by other companies. Endo utilizes these financial measures because ( i) they are used by Endo, along with financial measures in accordance with GAAP, to evaluate Endo’s operating performance; (ii) Endo believes that they will be used by certain investors to measure Endo’s operating results; (iii) the Compensation & Human Capital Committee of Endo’s Board of Directors uses adjusted EBITDA, or similar measures, in assessing the performance and compensation of substantially all of Endo’s employees, including executive officers. Endo believes that presenting these non-GAAP measures provides useful information about Endo’s per formance across reporting periods on a consistent basis by excluding certain items, which may be favorable or unfavorable, pursuant to certain specified procedures. These non-GAAP measures should be considered supplemental to and not a substitute for financial information prepared in accordance with GAAP. Endo’s definition of these non-GAAP measures may differ from similarly titled measures used by others. Refer to the Second Quarter Results slides for a reconciliation of these non-GAAP financial measures to the most directly comparable GAAP metric. Non-GAAP Financial Measures ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial.
4 Business Overview ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial.
5©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. Endo emerged from its financial restructuring with strong cash flow generation, a focused portfolio and poised for growth Strong cash flow generation Focused portfolio Poised for growth August 2022 April 2024 June 2024 July 2024 4Q 2024 Endo International plc (EIP) files for Chapter 11 Endo, Inc. commences operations with recapitalized balance sheet and free of legacy overhangs [a] Endo, Inc. begins trading on OTCQX® Best Market (TCKR: NDOI) Endo, Inc. becomes SEC registrant (Form S-1 declared effective) Endo, Inc. projected uplisting to a National Stock Exchange [a] Endo, Inc. acquired substantially all of EIP’s assets through the Chapter 11 process, free and clear of material legacy l iabilities
6 Significantly lower funded debt Funded Indebtedness Meaningful improvement in net leverage Net Leverage Lower annual interest paymentsInterest Payments > $8.0B $2.5B > 10.0x ~3.5x > $500M ~$230M Pre-Emergence June 30, 2024 Elimination of overhang and related cost Litigation & Tax Uncertainties Multiple Resolved in Bankruptcy Endo has an unencumbered balance sheet and is free of legacy overhangs ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial.
7 Endo has a strong foundation to drive growth ~180 Products Available to Patients and Providers 2.6M Prescriptions Dispensed Each Month 60+ Products in Pipeline ~225K US Patients Treated with XIAFLEX® >95% U.S. Hospitals Using Endo Products ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. ~3,000 Global Team Members
8 Endo operates across four businesses Branded Pharmaceuticals Innovative therapies for certain specialty areas Sterile Injectables Critical medicines for hospitals Generic Pharmaceuticals High-quality low-cost medicines International Pharmaceuticals Innovative medicines for Canadian market 2023: $859M | 43% | 53% $430M | 21% | 37% $650M | 32% | 37% $73M | 4% | 23% REVENUE | % REVENUE | OPERATING MARGIN % [a] GROWTH BUSINESSES ESTABLISHED BUSINESSES ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. [a] Operating margin % is calculated as segment adjusted income from continuing operations before income taxes divided by segment revenues. Segment adjusted net income from continuing operations before income taxes is broken out between the Successor and Predecessor periods and defined in Note 6. Segment Results of the Condensed Consolidated Financial Statements included in Form 10-Q for Endo, Inc., filed on August 29, 2024. 1H‘24: $426M | 49% | 57% $189M | 22% | 33% $213M | 25% | 27% $38M | 4% | 23% 1H‘24: $ 615M | 71% | 50% 2023: $1,289M | 64% | 48% 1H‘24: $251M | 29% | 26% 2023: $723M | 36% | 35%
9 Endo has a strong platform to drive growth and create value Durable XIAFLEX® Pipeline in a Product Platform Injectable Solutions Growth Platform Proven and Scalable Capabilities Innovative pipeline of > 50 projects & acute care capabilities with potential to generate sustainable future revenue growth Commercial expertise, product development know-how, and modernized manufacturing Unencumbered Balance Sheet & Strong Cash Flow Meaningfully improved balance sheet and cash generative business enables growth investments Growing on-market indications and attractive future indications with durable intellectual property estate ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial.
10 Branded Pharmaceuticals: Durable XIAFLEX platform & extensive specialty product expertise ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. Specialty Products Legacy Products 2023: $859M 1H24: $426M ▪ Differentiated and durable portfolio of specialty urology, orthopedic and endocrinology products anchored by XIAFLEX® for Peyronie’s Disease (urology) and Dupuytren’s Contracture (orthopedics) ▪ Strong commercial capabilities with extensive Specialty product distribution network and sales force reach ▪ Ongoing commercial and R&D investment expected to drive Specialty growth ▪ Diverse set of Legacy products across multiple therapeutic areas that require minimal promotional spend and other direct costs and generate strong free cash flow BUSINESS OVERVIEW & CAPABILITIES REVENUE KEY PRODUCTS L e g a c y S p e c ia lt y
11©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. XIAFLEX ® On-market Growth Strategy XDC Strategies to Grow XDC Motivate patients to effectively advocate for XIAFLEX through DTC campaigns Inspire fellows and new users to make XIAFLEX their preferred treatment strategy Advance current injectors to use XIAFLEX as their first- line treatment in PIP joint Proactively educate HCPs and office staff to operationalize XIAFLEX 1 2 3 4 XIAFLEX is the only nonsurgical treatment option for patients with Dupuytren’s contracture DEFINITIONS: DC – Dupuytren’s Contracture, XDC – XIAFLEX for Dupuytren’s Contracture, PIP – proximal interphalangeal joints XIAFLEX Peyronie’s Disease Indication Represents Endo’s Single Largest Branded Product XPD XPD Strategies to Grow XPD Drive diagnosis & treatment requests through DTC advertising Enhance the XIAFLEX experience by leveraging Endo Advantage and driving commitment to the full XIAFLEX cycle Increase prescribing breadth and depth through an improved HCP learning experience 1 2 3 XIAFLEX is only nonsurgical treatment option for patients with Peyronie’s Disease XPD
12 Progressing XIAFLEX® development pipeline Indication Pre- clinical Phase I Phase 2 Phase 3 Target Launch Patients Under Treatment Condition Information Plantar Fibromatosis 2027 ~200,000 • Painful condition caused by collagen nodules of the plantar surface of the foot • Phase 3 initiated Q4’23 Plantar Fasciitis 2029 ~415,000 • Trauma and damage of plantar fascia causing heel pain and loss of mobility • Phase 2 recruitment completed Q2’24, ahead of schedule. Top-line readout expected late ‘24 Arthrofibrosis of the Knee post Knee Arthroplasty >2030 > 60,000 • Limited mobility 4-6 weeks post total knee replacement from collagen scar tissue build-up • IND submission targeted for 1H 2025 Multiple Others • Multiple programs in pre-clinical stage primarily in orthopedic care and other therapeutic areas Current Development Programs ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial.
13©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. XIAFLEX® is Anchored by a Durable IP Estate Protected by robust patent estate ▪ Current patent estate not limited by indication extends through late-2030’s ▪ Method of use patents on future indications expected to extend through early-2040’s & beyond Competitor development of a non-recombinant biosimilar utilizing Endo’s cell line would be challenging as the company holds it physically under lock and key. Competitor development of recombinant-biosimilar requires extensive investment and time ▪ Enzyme-based products, like XIAFLEX®, work locally, preventing PK assessment. Clinical studies required to demonstrate safety & potency. Requires complex formulation, manufacturing and analytical capabilities ▪ Not aware of any approved or filed collagenase or enzyme-based biosimilar products in U.S. Illustrative recombinant-biosimilar development estimate based upon a product which is locally acting for which PK assessment is not possible to demonstrate similarity. CMC ~3 years Pre-Clinical 1-2 years Clinical 3 - 4 years FDA ~1 years
14 Sterile Injectables: Growing pipeline and scalable acute care capabilities ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. ~40 products including: Adrenalin® (epinephrine injection, USP) VASOSTRICT® (vasopressin injection, USP) 2023: $430M 1H24: $189M ▪ Broad portfolio of ~40 on-market hospital-based products for critical care and testing, maternal health and anesthesia ▪ Robust pipeline of > 50 projects with >60% ready-to-use (RTU) and other differentiated products ▪ Scalable acute care development and commercial capabilities with modernized manufacturing ▪ Collaborative engagement with hospitals and healthcare systems to reduce complexity and develop innovations that add value BUSINESS OVERVIEW & CAPABILITIES REVENUE KEY PRODUCTS In je c ta b le S o lu ti o n s
15 Sterile Injectable New Product Pipeline 85% 15% >50 Projects RTUs Complex Injectables Traditional AP-Rated Vials Drug/Device Combination LESS DIFFERENTIATED MORE DIFFERENTIATED Sterile Injectable Product Pipeline (1) Planned 2024 product launches3-4 (1) Pipeline data as of July 31, 2024 SI Development SI Filed Sterile projects added to the pipeline YTD’24 5 Sterile projects added to the pipeline since Q1’22 28 Ready to Use (RTU) and differentiated products in SI pipeline~60% ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial.
16 Established Businesses: Stable cash flows and targeted investments ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. ~85 Products 2023: $650M 1H24: $214M ▪ Broad portfolio of commercial products across multiple dosage forms ▪ Discrete portfolio of planned new product launches ▪ Commercial expertise and optimized manufacturing network and overall cost structure BUSINESS OVERVIEW & CAPABILITIES REVENUE KEY PRODUCTS ~40 Products 2023: $73M 1H24: $38M ▪ Highly scalable, asset-light business model ▪ Broad portfolio of new product launches and mature products ▪ Expanding portfolio across multiple therapeutic areas via Business Development & Licensing G e n e ri c s In te rn a ti o n a l
17 Endo has a strong platform to drive growth and create value Durable XIAFLEX® Pipeline in a Product Platform Injectable Solutions Growth Platform Proven and Scalable Capabilities Innovative pipeline of > 50 projects & acute care capabilities with potential to generate sustainable future revenue growth Commercial expertise, product development know-how, and modernized manufacturing Unencumbered Balance Sheet & Strong Cash Flow Meaningfully improved balance sheet and cash generative business enables growth investments Growing on-market indications and attractive future indications with durable intellectual property estate ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial.
18 Second Quarter Results ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial.
19©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. Q2 2024 Financial Results [a] Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP metric are included herein. [b] Total operating expenses is calculated as the total of: (i) Selling, general and administrative; (ii) Research and development; (iii) Acquired in-process research and development; (iv) Litigation-related and other contingencies, net; [c] Refer to slide 21 for calculation of this value. $ millions Q2 2024 (Combined) [c] Q2 2023 Branded Pharmaceuticals $225 $212 Sterile Injectables $ 91 $137 Generic Pharmaceuticals $110 $179 International Pharmaceuticals $21 $19 Total Revenues, Net $447 $547 Adjusted Gross Margin % [a] 69 % 69 % Adjusted Operating Expenses [a] [b] $147 $147 Adjusted EBITDA [a] $176 $243 Adjusted Net Income [a] $105 $231
20©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. Q2 2024 Revenue ($ million) $117 $127 $48 $35 $47 $63 $212 $225 Q2 2023 Q2 2024 YoY % Change 6% 33% -27% 8%[a] XIAFLEX XIAFLEX® revenues increased in-line with expectations primarily due to higher average net selling price and underlying demand. Volume increased 8% compared to Q1’24 and decreased slightly compared to Q2’23 due to changes in channel inventory. Non-XIAFLEX Specialty Products (includes SUPPRELIN® LA and Other Specialty) The decrease in Specialty Products revenues was primarily due to decreased SUPPRELIN® LA revenues, primarily driven by lower volumes, and lower NASCOBAL® Nasal Spray revenues due to generic competition. Established Products Established Products revenues increased primarily due to $10 million in non- recurring, non-cash adjustments in both Q2’24 and Q2’23 related to previously discontinued products as well as increased revenues related to products that experienced temporary supply disruptions in 2023. [a] Q2 2024 revenue growth was ~4% after excluding the impact of a $4M vial wastage rebate reserve in Q2 2023 that was reversed in Q4 2023 following application of final rebate determination. Branded Pharmaceuticals
21 Sterile Injectables $21$19 $99 $86 $80 $24 $179 $110 $104 $91 $33 $137 Q2 2023 Q2 2024 ©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. Q2 2024 Revenue ($ million) Sterile Injectables revenues decreased 34% primarily due to non-recurring settlement payment in 2023 and competitive pressures in 2024, partially offset by incremental revenues in 2024 from 2023 new product launches. Q2 2023 Q2 2024 Generic revenues decreased 38% primarily due to increased competitive pressure across multiple products, including varenicline tablets and dexlansoprazole delayed release capsules, partially offset by increased revenues from Lidocaine patch. Q2 2023 Q2 2024 International revenues increased 10% primarily due to increased volumes across multiple products. Other Generic Products Varenicline & Dexlansoprazole SI Products Settlement Payment Generic Pharmaceuticals International Pharmaceuticals
22©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. Q2 2024 Financial Results [a] As required by GAAP, due to the application of Fresh Start Accounting, results for the quarter must be presented separately for the predecessor period from April 1, 2024 through April 23, 2024 (the “Predecessor” period) and the successor three months ended June 30, 2024 (the “Successor” period). However, to facilitate comparison of our operating results against the relevant prior periods the Company has combined the results of the Predecessor and Successor periods as non-GAAP measures (“combined” results). [b] Total operating expenses is calculated as the total of: (i) Selling, general and administrative; (ii) Research and development; (iii) Acquired in-process research and development; (iv) Litigation-related and other contingencies, net; (v) Asset impairment charges; and (vi) Acquisition related and integration items, net. [c] Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP metric are included herein. $ millions Q2 2024 (Successor) Q2 2024 (Predecessor) Q2 2024 (Combined)[a] Q2 2023 Branded Pharmaceuticals $146 $79 $225 $212 Sterile Injectables $ 56 $ 34 $ 90 $137 Generic Pharmaceuticals $ 70 $ 40 $110 $179 International Pharmaceuticals $ 12 $ 9 $ 21 $ 19 Total Revenues, net $ 284 $ 162 $ 446 $ 547 Adjusted Gross Margin % [c] 67% 72% 69% 69% Adjusted Operating Expenses [b] [c] $ 113 $ 34 $ 147 $ 147 Adjusted EBITDA [c] $ 90 $ 86 $ 176 $ 243 Adjusted Net Income [c] $ 28 $ 77 $ 105 $ 231
23©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. Q2 2024 Non-GAAP Reconciliations – Adjusted EBITDA The following table provides a reconciliation of Net (loss) income (GAAP) to Adjusted EBITDA (non-GAAP): Successor Predecessor (a) $ 000s Three Months Ended June 30, 2024 Period From April 1, 2024 through April 23, 2024 Three Months Ended June 30, 2023 Net (loss) income (GAAP) $ (148,776) $ 6,527,548 $ 23,438 Income tax (benefit) expense, net (63,981) 50,629 10,279 Interest expense (income), net 44,669 (3) 120 Depreciation and amortization 60,352 18,030 $ 77,130 EBITDA (non-GAAP) $ (107,736) $ 6,596,204 $ 110,967 Asset impairment charges — 1,799 — Acquisition & Divestitures 191,857 (817) 365 Restructuring or similar transactions 5,324 — 14,281 Reorganization items, net — (6,328,145) 84,267 Other 246 282 32,964 Discontinued Operations — (183,234) 573 Adjusted EBITDA (non-GAAP) $ 89,691 $ 86,089 $ 243,417 (a) Certain prior period non-GAAP adjustments have been reclassified to conform to the current period presentation.
24©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. Q2 2024 Non-GAAP Reconciliations – Adjusted Net Income The following table provides a reconciliation of Net (Loss) income (GAAP) to Adjusted Net Income (non-GAAP) (in thousands): Successor Predecessor (a) $ 000s Three Months Ended June 30, 2024 Period From April 1, 2024 through April 23, 2024 Three Months Ended June 30, 2023 Net (Loss) income (GAAP) $ (148,776) $ 6,527,548 $ 23,438 Non-GAAP adjustments: Asset impairment charges — 1,799 — Acquisition & Divestitures 240,938 14,264 64,915 Restructuring or similar transactions 5,324 1 14,281 Reorganization items, net — (6,328,145) 84,267 Other 246 32 34,582 Tax adjustments (69,610) 44,307 8,649 Discontinued Operations — (183,234) 573 Adjusted Net Income (non-GAAP) $ 28,122 $ 76,572 $ 230,705 (a) Certain prior period non-GAAP adjustments have been reclassified to conform to the current period presentation.
25©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. Q2 2024 Non-GAAP Reconciliations – Select Other Income Statement Data The following tables provide detailed reconciliations of select other income statement data between the GAAP and non-GAAP measure (in thousands): Period From April 1, 2024 through April 23, 2024 (Predecessor) $ 000s Cost of revenues Gross profit (a) Gross margin (a) Total operating expenses (b) Reorganization items, net Other (income) expense, net Income tax expense Reported (GAAP) $ 60,539 $ 101,928 63 % $ 35,624 $ (6,328,145) $ (492) $ 50,629 Items impacting comparability: Asset impairment charges — — (1,799) — — — Acquisition & Divestitures (15,081) 15,081 818 — — — Restructuring or similar transactions (1) 1 — — — — Reorganization items, net — — — 6,328,145 — — Other — — (778) — 746 — Tax adjustments — — — — — (44,309) Non-GAAP $ 45,457 $ 117,010 72 % $ 33,865 $ — $ 254 $ 6,320 Three Months Ended June 30, 2024 (Successor) $ 000s Cost of revenues Gross profit (a) Gross margin (a) Total operating expenses (b) Reorganization items, net Other expense, net Income tax (benefit) expense Reported (GAAP) $ 333,695 $ (49,532) (17)% $ 118,310 $ — $ 246 $ (63,981) Items impacting comparability: Acquisition & Divestitures (3) (241,068) 241,068 130 — — — Restructuring or similar transactions (4) (7) 7 (5,317) — — — Other (6) — — — — (246) — Tax adjustments (7) — — — — — 69,610 Non-GAAP $ 92,620 $ 191,543 67 % $ 113,123 $ — $ — $ 5,629
26©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. Q2 2024 Non-GAAP Reconciliations – Select Other Income Statement Data (cont’d) The following tables provide detailed reconciliations of select other income statement data between the GAAP and non-GAAP measure (in thousands): Three Months Ended June 30, 2023 (c) $ 000s Cost of revenues Gross profit (a) Gross margin (a) Total operating expenses (b) Reorganization items, net Other expense (income), net Income tax expense Reported (GAAP) $ 233,852 $ 313,000 57 % $ 194,144 $ 84,267 $ 299 $ 10,279 Items impacting comparability: Acquisition & Divestitures (64,550) 64,550 (365) — — — Restructuring or similar transactions (489) 488 (13,793) — — — Reorganization items, net — — — (84,267) — — Other — — (32,660) — (1,922) — Tax adjustments — — — — — (8,649) Non-GAAP $ 168,813 $ 378,038 69 % $ 147,326 $ — $ (1,623) $ 1,630 (a) Gross profit is calculated as total revenues less cost of revenues. Gross margin is calculated as gross profit divided by total revenues. Adjusted gross profit is calculated as total revenues less adjusted cost of sales. Adjusted gross margin is calculated as adjusted gross profit divide d by total revenues. (b) Total operating expenses is calculated as the total of: ( i) Selling, general and administrative; (ii) Research and development; (iii) Acquired in-process research and development; (iv) Litigation-related and other contingencies, net; (v) Asset impairment charges; and (vi) Acquisition related and integration items, net. (c) Certain prior period non-GAAP adjustments have been reclassified to conform to the current period presentation.
27 Appendix
28©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial. Recently Launched DTC Campaign Emboldens DC Patients Be informed. Assert yourself. Don’t settle. Launched June 2024 Helping Patients Take Charge of Their DC Treatment Options It’s in your hands Call to Action: 5 Simple Reminders I don’t want surgery for my contracture I don’t want to wait for my contracture to get worse I want treatment with minimal downtime I want a non-surgical treatment If non-surgical treatment isn’t offered, I will get a second opinion • TV – National broadcast, streaming services, and online • Full digital media ecosystem – social media, digital, and search advertising 1 2 3 4 5
32©2024 Endo, Inc. or one of its affiliates. All rights reserved. Proprietary and confident ial.
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