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): January 7, 2019
_______________________________
ENDO INTERNATIONAL PLC
(Exact Name of Registrant as Specified in Its Charter)
_______________________________
Ireland | 001-36326 | 68-0683755 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
First Floor, Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, Ireland | Not Applicable |
(Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code 011-353-1-268-2000
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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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).
o 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. o
Item 7.01. Regulation FD Disclosure.
On January 7, 2019, Endo International plc (the “Company”) intends to make a presentation at the J.P. Morgan Healthcare Conference (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 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. |
Number | Description |
99.1 | |
SIGNATURE
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.
ENDO INTERNATIONAL PLC | |
By: | /s/ Matthew J. Maletta |
Name: | Matthew J. Maletta |
Title: | Executive Vice President, Chief Legal Officer |
Dated: January 7, 2019
Endo International plc J.P. Morgan Healthcare Conference Paul Campanelli, President & CEO January 7, 2019 ©2018 Endo Pharmaceuticals, Inc. All rights reserved 0
Forward Looking Statements; Non-GAAP Financial Measures This presentation contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 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 projected views, expectations and beliefs concerning future events, these forward looking statements involve risks and uncertainties. Although Endo believes that these forward looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward looking statements or information in this presentation. Investors should note that many factors, as more fully described in the documents filed by Endo with securities regulators in the United 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, could affect Endo’s future financial results and could cause Endo’s actual results to differ materially from those expressed in any forward looking statements. The forward looking statements in this presentation are qualified by these risk factors. 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 law. ©2018 Endo Pharmaceuticals, Inc. All rights reserved 1
Strategic Priority Execution has Led to Smaller but Stronger Company. Continuing to Focus Investments on Differentiated Products to Drive Growth 1 2 3 Reshape our Organization Build Our Portfolio and Drive Margin Expansion for Success Capabilities for the Future and De-Lever y Simplify our business through y Enhance Generics pipeline through y Focus on differentiated/ centralization and unification investment in hard-to-produce assets intelligent product selection & technologies y Drive productivity improvements y Drive EBITDA margin improvements y Transform Branded business into a through operational execution and y Create a New Endo Culture highly focused Specialty business continuous improvements y Divest non-core assets y De-lever 3-4x range over time; committed to a highly disciplined capital allocation approach ©2018 Endo Pharmaceuticals, Inc. All rights reserved 2
Endo Focused on Expansion of Sterile Injectables, Specialty Businesses and High-Value Generics International U.S. Branded – U.S. Branded Pharmaceuticals: 29% Specialty & Established: Specialty & $108m 5% $633m Established 3Q18 Total YTD Sales: U.S. Generic $2,161m U.S. Branded Sales Pharmaceuticals: 35% U.S. Branded – Sterile $748m 31% Sterile Injectables: Injectables $671m International U.S. Branded – U.S. Pharmaceuticals: 27% Specialty & Established: 7% $729m Generics $189m 3Q17 Total YTD Sales: U.S. Branded – $2,700m Sterile Injectables: Sales U.S. Generic 21% 45% $554m International Pharmaceuticals: $1,228m ©2018 Endo Pharmaceuticals, Inc. All rights reserved 3
Branded Specialty business led by Xiaflex® growth. Preparing for commercialization of CCH y Strong specialty franchise U.S. Branded focused on high margin branded Specialty Branded Revenue ($M) Specialty & products to treat conditions in urology Established and men’s health, orthopedics and $150 endocrinology $128M y Xiaflex® 22% Q3 revenue growth. $114M U.S. Branded Strong market penetration, with room for growth in both Peyronie’s Disease Sterile and Dupuytren’s Contracture $100 Injectables Xiaflex (+22%) y Positioned to enter medical aesthetics with the first non-invasive injectable treatment for cellulite U.S. y Strong commercial, marketing $50 Generics and distribution capabilities that will be leveraged for expansion into medical aesthetics Other Specialty (+4%) y U.S. Branded Specialty & Established International revenue of $234M (Q3’17) and $220M $0 (Q3’18), reduction driven by 2017 Q3'17 Q3'18 voluntary withdrawal of OPANA® ER ©2018 Endo Pharmaceuticals, Inc. All rights reserved 4
U.S. Branded Sterile Injectable 2018 YTD Revenue Growth of >20% y Trusted manufacturer & Revenue ($M) U.S. Branded distributor of Sterile Injectable Specialty & products to hospital/critical care $250 Established setting $237M y Currently offer 32 products, $202M U.S. Branded anchored by Vasostrict® $200 Vasostrict (+6%) Sterile y Plan to expand sterile footprint & Injectables capabilities through planned Q1 $150 2019 acquisition of Somerset and the Nevakar licensing agreement Adrenalin (+40%) $100 U.S. y Positioned to expand 505(b) (2) Generics products and to grow through expanding Ready-to-Use (RTU) and other higher-value products $50 in hospital setting Other (+26%) International $0 Q3'17 Q3'18 ©2018 Endo Pharmaceuticals, Inc. All rights reserved 5
U.S Generics: Proven Expertise in First-to-File & First-to-Market Applications y Focused on technically challenging, high barrier generic U.S. Branded products across multiple therapeutic areas Revenue ($M) Specialty & Established y Product rationalization and operational efficiencies have $350 improved product profitability $295M $300 y ~90 ANDA’s filed w/ FDA; ~1/3 are FTF/FTM U.S. Branded $258M Sterile y Expect 2019 to be transitional year as delayed competition is $250 Injectables realized with key Par product launches expected in late ‘19 $200 U.S. IQVIA Generics Sales ($ in Billions) U.S. $7.1 $150 $6.2 Generics $100 $4.1 $2.7 $50 $2.6 International $0 GEP $2.2 Q3'17 Q3'18 Source: IQVIA NSP Sales Data as of 9/30/18 [a] Par excludes Branded generic products (e.g., Vasostrict) included in our U.S. Sterile Injectables business ©2018 Endo Pharmaceuticals, Inc. All rights reserved 6
Key Growth Drivers y Xiaflex for Peyronie’s Disease & Dupuytren’s Contracture: continued investment in consumer activation strategies; 22% growth YTD ‘18, primarily demand driven y CCH for the treatment of cellulite: expect BLA filing in 2H19, commercial launch in 2H20. Exploring Ex-US options y Somerset Acquisition: expect Q1’19 close with significant expansion of sterile portfolio y Nevakar Licensing Agreement: 5 differentiated 505(b)(2) products expected in late 2020 to provide potential new treatments in the hospital and critical care environment y Select FTF/FTM Generic settlements or agreements: Product FY’17 IQVIA/Brand Sales Settlement/Terms DEXILANT® (dexlansoprazole) ~$1,200m Confidential terms AFINITOR® (everolimus) ~$800m Confidential terms AMITIZA® (lubiprostone) ~$500m Q1 2021 CIPRODEX® (ciprofloxacin; dexamethasone otic suspension) ~$450m 2020 KUVAN® (sapropterin) ~$400m Q4 2020 GATTEX® (teduglutide) ~$300m Confidential terms SABRIL® (vigabatrin tablets) ~$200m Confidential terms ©2018 Endo Pharmaceuticals, Inc. All rights reserved 7
Positive Results from Phase 3 RELEASE-1 AND RELEASE-2 Studies No Cellulite Therapy Currently in Market Has Been Studied as Extensively as CCH for Cellulite Innovative Measurements Scale Efficacy was assessed by both clinicians and patients using photonumeric cellulite severity scale developed by Endo and third-party experts and the LargestLargest CeCellulitellulite Trial scales were developed while consulting with the US Food and Drug EEverver ConductedConducted Administration (FDA). The validated Endo Cellulite Severity Scale used in the Phase 3 trial was 845 accepted by and presented at 5 prestigious, peer-reviewed congresses, including the International Society for Pharmacoeconomics and Outcomes Women Enrolled Research 18 and older Moderate and Severe Cellulite Photonumeric Cellulite Severity Scale (PCSS) is a 5-point scale ranging from 0 (no cellulite) to 4 (severe cellulite) Photonumeric Cellulite Severity Scale (PCSS) RELEASE-1 and RELEASE-2 are two identical multicenter, randomized, double-blind, placebo-controlled studies Studies placed no limits on BMI, weight, and cellulite severity ©2018 Endo Pharmaceuticals, Inc. All rights reserved 8
Phase 3: RELEASE-1 AND RELEASE-2 Studies Primary Endpoint Key Secondary Subject Endpoints 2-Level Composite Response Patient Assessment 10% RELEASE-1 RELEASE-2 9% Subject 1-level Response Patient- Subject 1-level Response Patient- 8% Reported Photonumeric Cellulite Reported Photonumeric Cellulite Severity Scale in Target Buttock Severity Scale in Target Buttock 7% (PR-PCSS) (PR-PCSS) Treatment Placebo Treatment Placebo 6% 54.3% 36.2% 57.9% 29.6% 5% 4% Subject Global Aesthetic Improvement 3% RELEASE-1 RELEASE-2 2% “Improved” or “Very Improved” or “Improved” or “Very Improved” “Very Much Improved” or “Very Much Improved” 1% in Target Buttock in Target Buttock 0% Treatment Placebo Treatment Placebo CCH Placebo CCH Placebo 73.3% 43.2% 67.8% 24.1% P=0.006 P=0.002 RELEASE-1 RELEASE-2 RELEASE-1 met 8 of 8 secondary endpoints Assessments were measured by a two-level response in both the RELEASE-2 met 7 of 8 secondary endpoints. 1 secondary endpoint, Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level composite response for non-target buttock, was not statistically and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) significant (p = 0.03) scores. Most adverse events (AEs) were mild to moderate and primarily limited to the local injection area. The most common AEs were injection site bruising, injection site pain, injection site discoloration, injection site nodule and injection site pruritus. Source: Endo Phase 3 Studies of CCH in Patients with Cellulite; PRNewswire, November 7, 2018. ©2018 Endo Pharmaceuticals, Inc. All rights reserved 9
CCH for Cellulite Patients Who Saw Improvement Were Substantially Happier. Improvement Seen with 1st Injection More Than 7 Out of 10 Subjects Saw a 1- Improvement After First Injection level Improvement in PR-PCSS in a Buttock CCH for Cellulite Placebo Patients who received CCH in the trial and saw Respondents in the study saw a significant a 1-level improvement in the PR-PCSS saw a separation from placebo after the 1st injection substantial increase (statistically significant against placebo, p<0.01) in PR-CIS Happy scores Additional Studies in Development Study 209 – Study focused on dosing and injection technique Study 212 – Open-label study focused on non-obese subjects with less severe cellulite Source: Endo Phase 3 Studies of CCH in Patients with Cellulite ©2018 Endo Pharmaceuticals, Inc. All rights reserved 10
Phase 3 - 2-PT Composite Change Day 1 Day 71 Source: Endo Phase 3 Studies of CCH in Patients with Cellulite ©2018 Endo Pharmaceuticals, Inc. All rights reserved 11
Phase 3 - 2-PT Composite Change Day 1 Day 71 Source: Endo Phase 3 Studies of CCH in Patients with Cellulite ©2018 Endo Pharmaceuticals, Inc. All rights reserved 12
Phase 3 - 1-PT Composite Change Day 1 Day 71 Source: Endo Phase 3 Studies of CCH in Patients with Cellulite ©2018 Endo Pharmaceuticals, Inc. All rights reserved 13
~ 6 Million U.S. Women are Potential Candidates for Cellulite Treatment U.S. Women Aged 25-541 64MM Age cohort most likely to treat cellulite Target BMI 18.5-29.92,3 42MM | 65% Predict normal and overweight patients will be interested HH Income $75K+1,3 20MM | 47% Consumers need disposable income to spend on treatment Self-Identify Cellulite3 10MM | 52% 52% of consumers acknowledge they have cellulite Bothered by Cellulite 6MM | 62%2,3 Consumers must be bothered by their cellulite to consider treatment 6MM Potential Candidates (36% are aesthetics- experienced) Potential market size may increase to over 11MM if the age range is increased to 21-59 Source 1: US Census Data, Release date December 2014 as more younger women are interested in treatment Source 2 US CDC Body Mass Index Values, 2007 – 2010 Source 3 Endo Custom Quantitative Market Opportunity Consumer Market Research 2017 (Screener & Sampled Universe) ©2018 Endo Pharmaceuticals, Inc. All rights reserved 14
Successful Execution on Strategic Priorities to Date, but Journey Continues y Significant progress achieved through the first phase of our multi-year turnaround plan y Transitioning to the next phase of our plan with a focus on continuing to build our portfolio and capabilities for the future y Continued strong liquidity profile and disciplined capital allocation approach; committed to de-leveraging overtime ©2018 Endo Pharmaceuticals, Inc. All rights reserved 15
©2018 Endo Pharmaceuticals, Inc. All rights reserved 16