Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — Jefferies Healthcare Conference 2016
20 slides from Indivior Pharmaceuticals's conference presentation, Jun 7, 2016
Slide 1: Strengthening our global leadership in treatment of addiction
Strengthening our global leadership in treatment of addiction Jefferies Healthcare Conference New York June 7th 2016
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains certain statements that are forward-looking and which should be considered, amongst other statutory provisions, in light of the safe harbour provisions of the United States Private Securities Litigation Reform Act of 1995. By their nature, forwar
Slide 3: Indivior PLC – who we are
Indivior PLC – who we are Global Leader in Treatment of Public Company since December Opioid Dependence 2014 • 2015 Sales >$1bn • UK Domiciled • Mainly Suboxone® brand • London Listed US Based Business Experienced management team • 80% of sales in US • Built business from c.$35m (£21m) sales in • HQ
Slide 4: Addiction – A Global Epidemic affecting many millions
Addiction – A Global Epidemic affecting many millions • Our ambition is to strengthen our global leadership in addiction, growing via new product launches and geographic roll-out. • We are global leaders in treatment of opioid dependence, which affects c.23m people globally • 150m plus worldwide are
Slide 5: Our Vision
OUR VISION That all patients around the world will have unrestricted access to high quality treatment services for the chronic relapsing conditions and co-morbidities of addiction
Slide 6: Opioid Dependence
Opioid Dependence Medication assisted treatment market is very US-based currently • US accounts for substantial majority (80%+) of buprenorphine based medication assisted treatment for opioid dependency by value • Around 2.5m potential patients, the majority of whom are addicted to prescription pain
Slide 7: Ex-US markets in earlier stage of development
Ex-US markets in earlier stage of development • EU (>1m patients) differs from US as opioid-dependence mainly heroin addiction1 • Policy focused more on harm reduction for society than on patient recovery • Methadone clinics, strict supervision prevail • Volume growing slowly, value in decline due t
Slide 8: Growth continues in US
Growth continues in US “The United States is experiencing an epidemic of drug Market Growth (mgs) overdose. During 2014, 47,055 drug overdose deaths occurred, 61% (28,647) involved some type of opioid, including heroin” (Source: CDC) • Growing medically assisted treatment (MAT) based on buprenorphin
Slide 9: Indivior market share stabilized
Indivior market share stabilized Source: IDV. Note database rebased from 1/1/2016 75% • Suboxone® film remains clear leader Change to IDV 70% • 65% 60.4% Competition from 5 generic and 3 60% 55% branded bup/nal competitors but 50% these have made limited impact 45% 40% • Category pricing has been pr
Slide 10: Strong operational & financial delivery
Strong operational & financial delivery • Successful defence of Suboxone® Film share $m 2015 Initial 2015 Actual in US against increasing competition Guidance Results • 2014: 62%, 2015: 59%; Q1 2016: 60% Revenue 850-880 1,014 • Gross margin maintained at 90% Net Income 130-155 228 • Financial guidan
Slide 11: Mixed Scorecard in R&D
Mixed Scorecard in R&D Product Stage of Estimated • R&D always carries risk, and 2015-16 has seen some setbacks in Development Approval * the pipeline Buprenorphine Lifecycle • Nasal Naloxone : Suboxone® Tablet China Phase III Complete in China 2018 • RBP 6300 oral swallowable capsule of Buprenorphi
Slide 12: More on key asset – RBP-6000
More on key asset – RBP-6000 Monthly Depot Buprenorphine Objectives of development • Proven Atrigel® sub-cutaneous system • Higher patient compliance • Phase III on track – efficacy trial due to • Reduced diversion & misuse read out late Q3 2016 • Target plasma levels of buprenorphine and • Granted
Slide 13: ANDA litigation update
ANDA litigation update Timetable • 6 Generic companies seeking to commercialise generic versions of ANDA Applicant Patents asserted Trial Date 30 Month Stay Suboxone® Film in US against Filer Expires • Indivior has asserted 3 orange-book Actavis Par 3 Orange Book Nov/Dec 2015 28 Feb 2016 (Actavis) 2
Slide 14: ANDA Litigation Update
• Trial against Alvogen in the lawsuit involving the Orange ANDA Litigation Update Book-listed patents and process patents for Suboxone® Film scheduled for April 2017, with Alvogen’s 30-month • Trial in the lawsuits against Actavis and Par involving stay of FDA approval expiring October 29th, 2017.
Slide 15: Other Legal Proceedings
Other Legal Proceedings DoJ Investigation FTC & Class Action A federal criminal grand jury investigation of Indivior • Fact discovery is underway in the antitrust initiated in December 2013 is continuing, and includes class actions. marketing and promotion practices, pediatric safety claims, and ove
Slide 16: External routes to Growth
External routes to Growth Expand Global Treatment Access Inorganic Growth Strategy Expand treatment in USA = Grow the Business Development in Addiction Market • Deep understanding of science of addiction • More physicians trained and waivered and knowledge of landscape of opportunities • Increased a
Slide 17: Indivior PLC – Priorities for 2016
17 Indivior PLC – Priorities for 2016 The ANDA ruling has secured greater medium-term certainty for Company 1.Suboxone® Film 2. Develop the 3. Refinance Company 4. Expand Global Resilience pipeline ready for BD / M&A treatment Preserve leadership • Transformational • Expand business • New treatment
Slide 18: Summary
Summary We face the Our confidence in future with the strength of We look forward our IP has been to sharing our renewed progress in 2016 confidence confirmed 18
Slide 19: Indication
Indication SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Treatment should be initiated under the direction o
Slide 20: Strengthening our global leadership in Addiction Treatment
Strengthening our global leadership in Addiction Treatment