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 11, 2022
_______________________________
(Exact name of registrant as specified in its charter)
_______________________________
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
(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:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
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).
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 January 11, 2022, 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 | |||||
| 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.
| ENDO INTERNATIONAL PLC | |||||
| By: | /s/ Matthew J. Maletta | ||||
| Name: | Matthew J. Maletta | ||||
| Title: | Executive Vice President, Chief Legal Officer and Company Secretary | ||||
Dated: January 11, 2022
©2022 Endo International plc or one of its affiliates. All rights reservedendo.com J.P. Morgan Healthcare Conference Blaise Coleman, President & CEO
©2022 Endo International plc or one of its affiliates. All rights reserved 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 or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," “guidance,” "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this presentation reflect Endo's current expectati ons of future events based on existing trends and information and represent Endo's judgment only as of the date of this presentation. Actual results may differ materially and adversely from current expectations based on a number of factors affecting Endo's businesses, including, among other things, the following: the outcome of our strategic review, conti ngency planning and any potential restructuring; the timing, impact or results of any pending or future litigation, investigations, claims or actual or contingent l iabilities, settlement discussions, negotiations or other adverse proceedings; our ability to satisfy judgments or settlements or pursue appeals including bonding requirements; our ability to adjust to changi ng market conditions; our abil ity to attract and retain key personnel; our inability to maintain compliance with financial covenants and operating obligations which would expose us to p otential events of default under our outstanding indebtedness; our ability to incur additional debt or equity financing for working capital, capital expenditures, business de velopment, debt service requirements, acquisitions or general corporate or other purposes; our ability to refinance our indebtedness; a significant reduction in our short -term or long-term revenues which could cause us to be unable to fund our operations and liquidity needs or repay indebtedness. The occurrence or possibil ity of any such result has caused us to engag e, and may result in further engagement in strategic reviews that ultimately may result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. Those remedial measures could include a potential corporate reorganization, restructuring or bankruptcy fi l ing involving all or a p ortion of our business, asset sales or other divestitures, cost-saving initiatives, corporate realignments or strategic partnerships. Some of these measures could take significant time to implement and others may require judicial or other third-party approval. Any such actions may be complex, could entail significant costs and charges or could otherwise negatively impact shareholder value, and there can be no assurance that we will be able to accomplish any of these alternatives on terms acceptable to us, or at all, or that they wil l result in their intended benefits. Therefore, the reader is cautioned not to rely on these forward-looking statements. Endo expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issu ed by Endo, as well as Endo's public periodic fi l ings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the head ing "Risk Factors" in Endo's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other fi l ings with the U.S. Securities and Exchange Commission. Forward Looking Statements 2
©2022 Endo International plc or one of its affiliates. All rights reserved Endo: A Diversified Specialty Pharmaceutical Company Endo is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from a global team of passionate team members collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Our Vision Helping everyone we serve live their best life. Our Mission We develop and deliver life-enhancing products through focused execution. Our Businesses Medical Aesthetics Sterile Injectables Generic Pharmaceuticals Medical Therapeutics Branded Pharmaceuticals 3
©2022 Endo International plc or one of its affiliates. All rights reserved4 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.
©2022 Endo International plc or one of its affiliates. All rights reserved5 1 Represents percentage sales of overall reported sales 2 2021E amounts derived using revenue mid-points consistent with guidance provided on 11/4/2021 Our Branded Business Today Medical Therapeutics + Medical Aesthetics 30% 1 2021 Q3 YTD Revenue ► Specialty products portfolio revenue CAGR of 14%; XIAFLEX® CAGR of 19% 2017–2021E2 ► Broad portfolio of branded specialty products with urology and orthopedics focus ► Blazing new trails for non-surgical interventions ► Launched 1st commercial product QWO for cellulite in Q1’21 ► Emerging non-surgical body contouring market has grown nearly 500% in the last 5 years ► Creating new category to tap into this opportunity ► Credentialed medical aesthetics sales & marketing team ► Scalable commercial infrastructure to support aesthetics product portfolio Medical Therapeutics Medical Aesthetics
©2022 Endo International plc or one of its affiliates. All rights reserved Current On-market Indications 6 *Multiple additional indications under review XIAFLEX®: Maximizing for Long Term Value Indication Pre-Clinical Phase I/IB Phase II/IIB Phase III/IIIB Filed Updates Plantar Fibromatosis ► Phase II study initiated; last patient in expected in 4Q’22 Adhesive Capsulitis ► Phase II study top line results expected in 3Q’22 Multiple ► Programsin pre-clinical stage primarily in orthopedic care Current Development Programs* Dupuytren’s Contracture ► New unbranded 2022 campaign featuring real patients ► Campaign intended to further increase condition awareness Peyronie’s Disease ► Condition awareness campaign: specific request for XIAFLEX® honored about 65-70% of the time by HCP ► Opportunity to further “medicalize” the situation
©2022 Endo International plc or one of its affiliates. All rights reserved *Unaided awareness. Based on Q3 2021 ATU survey of 200 aesthetic clinicians QWO® in 2021: Building the foundation in Medical Aesthetics >1,800 ACCOUNTS Trained and Certified >7.3 BILLION Media Impressions >220 Total media placements QWO has the highest top of mind awareness in the cellulite category* More patients are bringing up cellulite to their HCPs Majority of HCPs are aware of Endo Aesthetics as an aesthetic product manufacturer (aided) 7
©2022 Endo International plc or one of its affiliates. All rights reserved QWO®: Focus on Creating Cornerstone Cellulite Treatment Ongoing Studies & Data Generation 224 CCH injected in grid pattern in non- obese subjects w ith mild to moderate cellulite of the thigh/buttocks Final results expected in Q1’22 213 Extensively study the histopathologic effects of QWO in humans Study complete, Final results under preparation 305 REAL w orld Phase 3b study for treatment of mild to moderate cellulite in thighs or buttocks of non-obese subjects Study complete. Final results to be presented at Dallas Cosmetic Surgery and Medicine Meeting (DCS 2022) in Mar-22 304 Three-year extension trial follow ing Phase II cellulite subjects (follow -on to RELEASE- I and RELEASE-II studies) Year 3 follow -up ongoing; Final results expected in Q1’22 8 Consumer Activation Physician Education & Practice Integration
©2022 Endo International plc or one of its affiliates. All rights reserved9 1 Represents percentage sales of overall reported sales 2 2021E amounts derived using revenue mid-points consistent with guidance provided on 11/4/2021 Our Sterile Business Today 43% 1 2021 Q3 YTD Revenue ► Revenue CAGR of 13% 2017–2021E2 ► Vasostrict represents ~70% of Q3’21 YTD segment sales; potential for loss of exclusivity in early 2022 ► Diversified manufacturing network anchored on 100 year plus legacy of quality and track record of reliability in our flagship Rochester, MI facility ► Expanding already robust complex injectable capabilities ► Established and proven commercial capabilities ► Products touch patients from birth to critical care ► Utilized by every U.S. healthcare system
©2022 Endo International plc or one of its affiliates. All rights reserved Q3’21 YTD Pending Filings – by Product Category Sterile Injectables and Generics Pipeline Reflects Focus on More Durable and Differentiated Sterile Products 68% 17% 15% Generic Retail Generic Specialty Sterile Injectables RTUs Long Acting Injectables Traditional AP-Rated Vials Drug/Dev ice Combination Less differentiated More differentiated Sterile Injectable Product Continuum Pipeline Highlights ► Launched 7 products in 2021 across the generic & sterile businesses; 1 launch in 2022 year-to-date ► >85% of projects in development are Sterile Injectables; ~ 2/3rd in ready-to-use or other differentiated products ► Sterile Injectable projects in development increased by >30% ► Remain highly active on external business development opportunities to further expand and enhance our pipeline ~50 Pending filings, ~50% ANDAs FTF/FTM Q3’21 YTD R&D Pipeline – by Product Category 2% 13% 85% Generic Retail Generic Specialty Sterile Injectables ~40 Projects in Development 10
©2022 Endo International plc or one of its affiliates. All rights reserved11 1 Represents percentage sales of overall reported sales 2 2021E amounts derived using revenue mid-points consistent with guidance provided on 11/4/2021 Our Generics Business Today 24% 1 2021 Q3 YTD Revenue ► Focus on differentiated generics and authorized generics driving significant value ► High-quality, lower cost manufacturing footprint & resilient supply chain ► High value launches including lubiprostone capsules and varenicline tablets in 2021 ► Greater than 50% pipeline comprised of first-to- file/first-to-market opportunities, ► Revenue decline at CAGR of 18% 2017–2021E2; Optimizing operations to improve efficiency
©2022 Endo International plc or one of its affiliates. All rights reserved Expand & Enhance Our Portfolio Reinvent How We Work Be A Force For Good 12 Our Focus in 2022 ► Investing to enhance our portfolio and capabilities • Focused on Medical Therapeutics, Medical Aesthetics and Sterile Injectables ► Continue to evolve our ways of working ► Continue sustainability focus ► Maintain financial flexibility and disciplined capital allocation
©2022 Endo International plc or one of its affiliates. All rights reservedendo.com 1 Thank you