Q3 2020 Earnings Report
endo.com
Forward Looking Statements; Non-GAAP Financial Measures
This presentation contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1 995 and Canadian securities legislation.
Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future projects" or
similar expressions are forward looking statements. Because these statements reflect our current views, expectations and beli efs concerning future events, these forward looking statements involve risks and uncertainties. Although Endo believes that these forward looking statements and informat ion are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward looking statements or inf ormation in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo with securities regulators in the Unite d States and Canada including under the caption "Risk Factors" in Endo's Form 10-K, Form 10-Q and Form 8-K filings, as applicable, with the Securities and Exchange Commission and with securities regulators in Canada on System for Electronic Document Analysis and Retrieval ("SEDAR") and as otherwise enumerated herein or therein, c ould affect Endo's future financial results and could cause Endo's actual results to differ materially from those expressed in any forward looking statements. Th e forward looking statements in this presentation are qualified by these risk factors. Endo assumes no obligation to publicly update any forward looking statement s, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities law.
This presentation may refer to non-GAAP financial measures, including, among others, adjusted diluted net income per share from continuing operations, adjusted EBITDA, adjusted income from continuing operations, adjusted gross margin, adjusted operating expenses, adjusted effective ta x rate, adjusted revenue and adjusted weighted average diluted shares that are not prepared in accordance with accounting principles generally accepted in the Unit ed States 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 investor s to measure Endo's operating results; (iii) the Compensation Committee of Endo's Board of Directors uses adjusted diluted net income per share from continuing operations and adjusted EBITDA, or measures derived from such, in assessing the performance and compensation of substantially all of Endo's employees, including executiv e officers and (iv) Endo's leverage ratio, as defined by Endo's credit agreement, is calculated based on non-GAAP financial measures. Endo believes that presenting these non-GAAP measures provides useful information about Endo's performance 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 in formation prepared in accordance with GAAP. Endo's definition of these non-GAAP measures may differ from similarly titled measures used by others. Investors are encouraged to review Endo's current
report on Form 8-K furnished to the SEC on Nov 5, 2020, including exhibit 99.1 thereto, for Endo's definition of the non-GAAP financial measures in this presentation as well as a reconciliation of these non-GAAP financial measures to the most directly comparable GAAP measures.
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Today's Agenda
- Strategic Updates
- Business Performance
- Pipeline Update
- Financial Results & Guidance
- Q&A
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Our Strategic Priorities
Expand &
Enhance Our
Portfolio
We are investing to build a more differentiated and durable portfolio that
benefits our customers and creates sustainable long- term value.
Reinvent How We Work
We are embracing the future by accelerating new ways of working to
better serve our customers, promote innovation, and improve productivity.
Be A Force
For Good
We are committed to the adoption of more sustainable practices
that positively impact our stakeholders, including the promotion of diversity & inclusion in all we do.
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Recent actions in support of our strategic priorities
Business Transformation
- Optimize generics operations by exiting 4 sites in U.S. and India
- Improve flexibility and reduce certain costs through global business process service providers
- Fully integrate commercial, R&D, & operations functions, respectively, to increase effectiveness and drive efficiencies
- Savings reinvested to expand and enhance our portfolio
Enhance Portfolio
- Acquire BioSpecifics to enhance profitability of XIAFLEX® and Qwo™
- Immediately accretive deal and immediately enhances adjusted EBITDA
- ~$540M purchase price (net of cash, cash equivalents and investments acquired); transaction funded with cash on hand
- Transaction expected to close late Q4'20
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Q3 2020 Snapshot
Revenues (US $M) | Q3 2020 | Q3 2019 |
Branded Pharmaceuticals | $224 | $217 |
Sterile Injectables | $251 | $264 |
Generic Pharmaceuticals | $136 | $218 |
International Pharmaceuticals | $ 24 | $ 30 |
Total Revenues | $635 | $729 |
Adjusted EBITDA | $287 | $336 |
Table may not total due to rounding
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Q3 2020 Performance (Reported Revenues in $ Millions)
Branded Pharmaceuticals
$217m | $224m | Y-o-Y Change | ||||||||||
$85m | $84m | Branded Pharm. | 3% | |||||||||
Specialty Products | 6% | |||||||||||
$132m | $140m | XIAFLEX® | 7% | |||||||||
Established Products | -2% | |||||||||||
Q3 2019 | Q3 2020 | Established Products | Specialty Products | |||||||||
- Increase in Specialty Products driven by price and volume
- Decrease in Established Products due to ongoing competitive pressures
Sterile Injectables
Y-o-Y Change | ||||||||
Sterile Injectables | -5% | |||||||
$264m | $251m | |||||||
VASOSTRICT® | 20% | |||||||
ADRENALIN® | -24% | |||||||
Q3 2019 | Q3 2020 | |||||||
APLISOL® | -66% | |||||||
- Increase in VASOSTRICT due to price and volume
- Decrease in ADRENALIN driven by lower price due to the impact of competition
-
Decrease in APLISOL driven by lower market volumes and a nonrecurring restocking event in
Q3'19
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Q3 2020 Performance (Reported Revenues in $ Millions)
Generic Pharmaceuticals
Y-o-Y Change | ||||
$218m | Generic | -38% | ||
Pharmaceuticals | ||||
$136m | ||||
Q3 2019 | Q3 2020 |
- Decrease due to ongoing competitive pressure on certain key generic products
International Pharmaceuticals
Y-o-Y Change | ► Decrease primarily due to ongoing generic | ||||
competition | |||||
$30m | $24m | International | -20% | ||
Pharmaceuticals* | |||||
Q3 2019 | Q3 2020 |
* Includes sales from Endo Ventures Limited
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Ongoing Clinical Trials & Data Generation Studies
Product/Area | Study # | Pre- | Phase I/IB | Phase II/IIB | Phase | Filed | Updates | |
Clinical | III/IIIB | |||||||
105 | Plantar | Interim Analysis results expected in | ||||||
Fibromatosis | Q1 2021 | |||||||
XIAFLEX® | ||||||||
210 | Adhesive Capsulitis | First patient enrolled in Jul-2020 | ||||||
VASOSTRICT® | PS4229- | PK study on plasma | Last patient enrollment expected in late | |||||
clearance of vasopressin | ||||||||
101 | in healthy volunteers | Q4 2020 | ||||||
Product/Area | Study # | Data Generation Studies | Area of study | |||
212 | Mechanism of action | |||||
Open label study using CCH in the buttocks and thighs | Terminated due to delays caused by | |||||
COVID-19 | ||||||
224 | Grid technique for buttocks and thigh cellulite | Different injection technique | ||||
QWOTM | 213 | |||||
Extensively study the histopathologic effects of CCH in humans | Mechanism of action | |||||
305 | REAL world Phase 3b study for treatment of mild to moderate cellulite in thighs or buttocks of | Real world buttock and thigh cellulite | ||||
non-obese subjects | patients | |||||
304 | Five year extension trial following Phase II cellulite subjects (follow-on to RELEASE-I and | Duration of effect | ||||
RELEASE-II studies) | ||||||
QwoTM mechanism of action (MOA) from 213 and other studies. |
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Sterile Injectables and Generics Pipeline
Reflects Ongoing Evolution to Focus on Sterile Injectables
Pending filings - by Product Category | R&D Pipeline - by Product Category | ||||||
12% | |||||||
16% | Generic Retail | 58% | 26% | Generic Retail | |||
Generic Specialty | Generic Specialty | ||||||
73% | Sterile Injectables | 16% | Sterile Injectables | ||||
(RTU) |
~50 Pending filings, ~1/2 ANDAs FTF/FTM | ~40 Projects in Development |
- Planning to launch approximately 10 products in 2020
- 1st product from strategic relationship with Nevakar approved in October 2020, launch expected in the near-term
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Q3 2020: Financial Results (Continuing Operations*)
US GAAP | Non-GAAP | ||||
(US $, and Shares in millions) | Q3 '20 | Q3 '19 | Q3 '20 | Q3 '19 | |
Total Revenues, net | $635 | $729 | $635 | $729 | |
Gross Margin % | 45.2% | 46.6% | 67.3% | 64.9% | |
Operating Income | $64 | $129 | $263 | $309 | |
(Loss) Income | ($69) | ($41) | $122 | $153 | |
Effective Tax Rate | (6.4%) | (72.1%) | 7.7% | 10.3% | |
Diluted Net (Loss) Income per Share | ($0.30) | ($0.18) | $0.52 | $0.66 | |
Weighted Average Diluted Shares Outstanding | 230 | 227 | 233 | 231 | |
* Continuing Operations excludes ASTORA (formerly known as AMS Women's Health)
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Financial Impact of Planned Strategic Actions
(US $ in millions) | ||||||||
Cumulative Cash Savings[a] | 2020 | 2021 | 2022 | 2023 | ||||
Cost of sales | $ | - | $ | - | $ | 27-30 | $ | 66-70 |
Operating expenses | - | 10-15 | 18-20 | 20-25 | ||||
Total | $ | - | $ 10-15 | $ 45-50 | $ 85-95 | |||
One-time Charges[a] | 2020[b] | 2021 | 2022 | 2023 | ||||
Cash restructuring charges | $ | 55-60 | $ | 40-45 | $ | 5 | $ | - |
Asset impairments | 7 | - | - | - | ||||
Accelerated depreciation | 21 | 25-30 | 10-15 | - | ||||
Total | $ | 83-88 | $ 65-75 | $ 15-20 | $ | - | ||
- Represents full year estimates
- Approximately $67 million of one-time charges was recorded in the third quarter of 2020 which included approximately $54 million and $13 million of cash and non-cash restructuring charges, respectively.
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FY'20 Financial Guidance (Continuing Operations*)
Measure | FY'20 (Prior) | FY'20 (Current) | |||
Total Revenues, net | $2.60B | - $2.70B | $2.75B | - $2.80B | |
Adjusted EBITDA | $1.19B | - $1.23B | $1.30B | - $1.32B | |
Adjusted Diluted Net Income per Share | $2.00 | - $2.15 | $2.50 | - $2.55 | |
The Company's FY'20 Financial Guidance is Based on the Following Assumptions:
Measure | FY'20 (Prior) | FY'20 (Current) | |
Adjusted Gross Margin | ~66.5% to ~67.0% | ~67.0% | |
Adjusted operating expenses as a percentage of revenue | ~25.0% to ~25.5% | ~23.5% | |
Adjusted interest expense | ~$530M to ~$535M | ~$525M | |
Adjusted effective tax rate | ~14.0% to ~15.0% | ~13.5% | |
Adjusted diluted shares outstanding | ~234M | ~234M | |
* Continuing Operations excludes ASTORA (formerly known as AMS Women's Health)
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FY'20 Segment Revenue Guidance
Segment | FY'20 vs. FY'19 % Change | FY'20 vs. FY'19 % Change |
(Prior) | (Current) | |
Branded Pharmaceuticals | Mid teens decline | High single to low double digit decline |
Sterile Injectables | Mid single digit growth | High single digit growth |
Generic Pharmaceuticals | Mid teens decline | Mid teens decline |
International Pharmaceuticals | Mid 20s decline | High teens decline |
Total Enterprise | High single digit decline | Mid single digit decline |
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Cash Flow Prior to Debt Payments
YTD Q3'20 | FY 2020 Guidance | FY 2020 Guidance | |||||
(Current) | (Prior) | ||||||
US $M | Actual | Low | High | Low | High | ||
Adjusted EBITDA | $1,044 | $1,300 | $1,320 | $1,190 | $1,230 | ||
Cash Interest | ($376) | ~($550) | ~($550) | ||||
Changes in Net Working Capital | ($98) | ~($50) | ~($30) | ||||
Cash Taxes, net refund (payments) | $17 | ~$50 | ~$50 | ||||
Other [1] | ($74) | ~($75) | ~($120) | ||||
Cash Flow from Operations - Pre-Mesh and Other Settlements | $514 | $675 | $695 | $540 | $580 | ||
Non Mesh/Opioid Settlement Payments, net[2] | ($20) | ~($20) | ~($40) | ||||
Opioids Related Legal Expense/Cash Distributions for Settlements[3] | ($54) | ~($80) | ~($80) | ||||
Cash Distributions to Settle Mesh Claims[4] | ($151) | ~($270) | ~($500) | ||||
Cash Flow from Operations | $289 | $305 | $325 | ($80) | ($40) | ||
Change in Restricted Cash - Mesh Related | $107 | ~$130 | ~$240 | ||||
Capital Expenditures | ($55) | ~($80) | ~($85) | ||||
Other[5] | ($33) | ~($40) | ~($15) | ||||
Unrestricted Cash Flow Prior to Debt Payments | $308 | $315 | $335 | $60 | $100 | ||
Memo: Unrestricted Cash Disbursements - Mesh [6] | ($44) | ($140) | ($260) |
- Includes certain payments for cost reduction initiatives, contingent consideration, milestone, as well as changes in certain other assets and liabilities which provided or used cash.
- Represents legal settlements that Endo paid excluding mesh and opioid matters.
- Represents payments related to opioid legal expense, as well as cash payment to settle opioid product liabilities.
- Represents direct payments and payments from Qualified Settlement Funds to settle mesh product liabilities, as well as mesh related legal expenses.
- Includes contingent consideration (CFF) for certain products, financing fees, and certain other items.
- Represents the sum of the cash distributions to settle mesh claims and the change in restricted cash - mesh related.
Table may not total due to rounding
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Q&A
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Appendix
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Cash Conversion Cycle
We use days sales outstanding (DSO), days inventory outstanding (DIO) and days payable outstanding (DPO), the sum of which is the cash conversion cycle, to evaluate our working capital performance. The following table summarizes the details of the financial metrics used to calculate these working capital performance statistics for the quarters ended September 30, 2020, June 30, 2020, March 31, 2020, December 31, 2019, and September 30, 2019 (in thousands except for ratios):
Sep 30, | Jun 30, | Mar 31, | Dec 31, | Sep 30, | |||||||||
2020 | 2020 | 2020 | 2019 | 2019 | |||||||||
Total Revenue | $ | 634,860 | $ | 687,588 | $ | 820,405 | $ | 764,800 | $ | 729,426 | |||
•Accounts Receivable, net of allowance | $ | 473,368 | $ | 271,893 | $ | 536,903 | $ | 467,953 | $ | 420,195 | |||
•Less: Returns and allowances | $ | (205,962) | $ | (217,198) | $ | (213,756) | $ | (206,248) | $ | (208,264) | |||
DSO | Accounts Receivable, adjusted for non-cash items | $ | 267,406 | $ | 54,695 | $ | 323,147 | $ | 261,705 | $ | 211,931 | ||
Total revenues per day | $ | 6,901 | $ | 7,556 | $ | 9,015 | $ | 8,313 | $ | 7,929 | |||
DSO | 39 | 7 | 36 | 31 | 27 | ||||||||
•Inventories, net | $ | 354,903 | $ | 330,540 | $ | 324,962 | $ | 327,865 | $ | 338,513 | |||
•Plus: Long-term inventory | $ | 34,633 | $ | 34,340 | $ | 31,055 | $ | 29,046 | $ | 23,680 | |||
DIO | Inventory, adjusted for long-term and non-cash items | $ | 389,536 | $ | 364,880 | $ | 356,017 | $ | 356,911 | $ | 362,193 | ||
Total revenues per day | $ | 6,901 | $ | 7,556 | $ | 9,015 | $ | 8,313 | $ | 7,929 | |||
DIO | 56 | 48 | 39 | 43 | 46 | ||||||||
•Trade Accounts Payable | $ | 104,621 | $ | 113,049 | $ | 88,211 | $ | 101,532 | $ | 110,074 | |||
•Plus: Accrued Royalties and Partner Payables | $ | 61,355 | $ | 70,953 | $ | 116,702 | $ | 115,816 | $ | 111,347 | |||
DPO | •Plus: Accrued Rebates and Chargebacks paid in cash | $ | 121,854 | $ | 109,721 | $ | 117,393 | $ | 130,650 | $ | 141,762 | ||
Trade Accounts Payable, adjusted for royalties and rebates | $ | 287,830 | $ | 293,723 | $ | 322,306 | $ | 347,998 | $ | 363,183 | |||
Total revenues per day | $ | 6,901 | $ | 7,556 | $ | 9,015 | $ | 8,313 | $ | 7,929 | |||
DPO | 42 | 39 | 36 | 42 | 46 | ||||||||
Cash Conversion Cycle | 53 | 17 | 40 | 33 | 27 | ||||||||
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Endo International plc published this content on 06 November 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 November 2020 22:22:03 UTC