Mayne Pharma Group Ltd. · ASX:MYX
Mayne Pharma — Investor Day (May 2017)
110 slides from Mayne Pharma's investor day presentation, May 1, 2017
Slide 1: Building our Tomorrow
For personal use only Building our Tomorrow Mayne Pharma Group Limited - Investor Day 1 May 2017 1
Slide 2: Disclaimer
Disclaimer For personal use only ● The information provided is general in nature and is in summary form only. It is not complete and should be read in conjunction with the company’s audited Financial Statements and market disclosures. This material is not intended to be relied upon as advice to inve
Slide 3: Agenda
Agenda For personal use only Scott Richards 1 Introduction Chief Executive Officer Stefan Cross 2 Generic Products Division Chief Commercial Officer Craig Boyd 3 Specialty Brands Division EVP, Specialty Brands John Ross 4 Metrics Contract Services President, Mayne Pharma USA John Ross 5 Global Opera
Slide 4: Introduction
For personal use only 1 Introduction Scott Richards
Slide 5: Vision
VISION For personal use only At Mayne Pharma we are focused on delivering a healthier tomorrow. We believe that everyone deserves medicines that are better, safer and more affordable. That’s why our people are determined to create clever, innovative products and services for our changing world. 5
Slide 6: Business snapshot
Business snapshot For personal use only Mayne Pharma’s focus ~A$600m 70+ marketed and 50+ Products sold in annualised 1H17 Hard to develop and pipeline products 10+ countries revenues manufacture products that bring therapeutic value to patients and payers High quality contract services and manufact
Slide 7: US is the largest pharmaceutical market in the world
US is the largest pharmaceutical market in the world… For personal use only Global IMS sales by geography in 2016 (US$bn) 462 117 90 43 32 29 27 21 19 14 US China Japan Germany France Italy UK Spain Canada Australia % of total 42% 11% 8% 4% 3% 3% 2% 2% 2% 1% global market US pharma market size (US$b
Slide 8: …with the greatest generic penetration rate
…with the greatest generic penetration rate For personal use only Generic penetration by volume 89% 73% 66% 64% 55% 52% 51% 41% 28% US Germany UK Canada Australia France Spain Italy Japan Source: Study report for the European Generic Medicines Association and public presentations. US generic pharma
Slide 9: Our transformation over the last years
Our transformation over the last 5 years… For personal use only ~A$600m revenue Mayne Pharma in 2012 55+ products A$100m+ spent on marketed in the US expansion capex ~A$50m revenue 750+ ~A$30m R&D employees spend No products directly A$2-3m spent on marketed in the US maintenance capex A$4.0m R&D 18
Slide 10: …has delivered value for shareholders
…has delivered value for shareholders… For personal use only Mkt cap 2.5 A$2bn 2.0 Mkt cap A$500m Share price (A$) 1.5 Mkt cap A$130m 1.0 Mkt cap A$50m 0.5 Share price up 400% over last 5 years 0.0 Apr-12 Jun-12 Aug-12 Oct-12 Dec-12 Feb-13 Apr-13 Jun-13 Aug-13 Oct-13 Dec-13 Feb-14 Apr-14 Jun-14 Aug-
Slide 11: …and outstanding financial performance
…and outstanding financial performance Revenue (A$m) Underlying EBITDA1 and margins (A$m) For personal use only EBITDA EBITDA margin 590 37% $600 $250 40% 33% $500 $200 28% 26% 30% $400 22% $150 $300 267 20% $100 217 $200 143 141 83 10% $100 $50 89 18 40 36 $0 $0 – FY13 FY14 FY15 FY16 1H17 Ann FY13
Slide 12: Strong performance across the business
Strong performance across the business Revenue (A$m) Gross profit (A$m) For personal use only 445.2 251.6 ● Develops, markets and distributes Generic generic products in the US 106.8 60.8 Products 58.2 38.5 ● Strong growth driven by new Division product launches and acquisitions FY15 FY16 1H17 Ann F
Slide 13: The key trends relevant to Mayne Pharma are generally supportive
The key trends relevant to Mayne Pharma are generally supportive… For personal use only Macro trends ? Increased demand for Uncertain US Increased demand for generics medicines government framework to lower healthcare costs Generic Products Specialty Brands Contract Services Growing industry segment
Slide 14: Regulatory environment is complex, anticipated impact is minor
…and, while the regulatory environment is complex, the anticipated impact is minor Impact on For personal use only Topic Event Mayne Pharma view Mayne Pharma ● President Trump is seeking to “repeal ● Unclear what Trump’s next move and replace” Obamacare will be, but any change is unlikely to ● Force
Slide 15: We have a clear strategic ambition to 2021
We have a clear strategic ambition to 2021… For personal use only ● Triple size of the business in revenue terms to >A$1.5bn ● Double digit CAGR EPS growth ● R&D investment to return to ~8-10% of group revenue ● New products to drive revenue and earnings growth (US$7bn pipeline1) ● Business developm
Slide 16: Competitive advantages
…and to achieve this ambition we will utilise our competitive advantages… For personal use only Supply chain and alliance management Patient and Commercial M&A agility and M&A agility and prescriber execution integration know- integration intimacy and the how linkage to R&D Intellectual property exp
Slide 17: Niche but diversified segment platform
…leveraging our niche but diversified segment platform… For personal use only Participation of MYX across the pharmaceutical value chain Formulation Clinical Distribution, sales Research & analytics development Manufacturing & marketing Metrics Contract Services New Chemical Entities Specialty Brand
Slide 18: Synergy benefits
…that delivers a number of important synergy benefits… Generic Speciality Contract For personal use only Products Brands Services Synergies Earning stream diversification and stability ü ü ü Efficiency sharing of central functions across BUs ü ü ü ü ü ü Scale Cost effective access to capital Stronge
Slide 19: Experienced leadership team
…and is underpinned by an experienced leadership team For personal use only Scott Richards Stefan Cross Chief Executive Officer Chief Commerical Officer Actavis, Hospira, FH Faulding & Co. Hospira, FH Faulding & Co Nick Freeman* Dr Ilana Stancovski Group CFO & Company Secretary EVP, Chief Scientific
Slide 20: Our progress has been positive so far
Our progress has been positive so far For personal use only ● Acquisition of generic product portfolio from Teva and Allergan US Generic ● Expansion of generics pipeline through strategic alliances (eg. Mithra, Corium) Products expansion ● Launch of first Paragraph IV opportunity, dofetilide, which
Slide 21: Generic Products Division (GPD)
For personal use only 2 Generic Products Division (GPD) Stefan Cross
Slide 22: Generic Products overview
Generic Products overview For personal use only Top 25 retail generics business and top 2 oral contraceptives supplier in the US Diversified portfolio with the largest product dofetilide representing 17% of 1H17 revenue Becoming a leading 50+ marketed products including 21 oral contraceptives generi
Slide 23: Rapidly growing diversified portfolio with limited generic competitors
Rapidly growing diversified portfolio with limited number of generic competitors For personal use only 1HFY17 GPD revenue by family GPD revenue and gross profit % (US$m)2 Other (45+ Dofetilide products) 17% 400 70% Microgestin 66% US$168m 13% 350 335.6 60% Butalbital / 56% 57% 57% APAP / Caffeine 30
Slide 24: Second largest provider of generic oral contraceptives in the US
Second largest provider of generic oral contraceptives in the US For personal use only Top 10 US Oral Contraceptive suppliers (TRx million prescriptions) #2 supplier in the US oral contraceptive market 34.6 21 marketed oral contraceptives 6 pipeline women’s health products targeting markets with >US
Slide 25: Key market trends relevant to Generic Products
Key market trends relevant to Generic Products Growing For personal use only industry segment Generics market expected to increase by a CAGR of 5% to 20201 Increasing industry consolidation Consolidation across generics industry – providing opportunities for growth Faster pathway to market Increased
Slide 26: US generic market pricing dynamics
US generic market pricing dynamics Dofetilide generic entrant market share1 For personal use only (TRx prescriptions) 100% 80% Generic 60% 40% 20% Branded 0% Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 Apr-17 Typical price reduction post g
Slide 27: GPD drivers of success
GPD drivers of success For personal use only Multichannel strategy Portfolio selection Patient and M&A agility and underpinned by Commercial prescriber execution integration know- R&D platform intimacy and the how linkage to R&D Complementary business Drug delivery development technology Supply chai
Slide 28: Attractive pipeline to drive future growth
Attractive pipeline to drive future growth For personal use only Today Future Total US pharma market Strategic fit 6 launches 2,500+ molecules expected this US$465bn Profitability 19 filed calendar year products with First to market including a Target Markets >US$1.3 billion US$250m first Retail cha
Slide 29: Mayne Pharma participates in only 9% of the retail generics market
Mayne Pharma participates in only 9% of the total retail generics market For personal use only Total US generic retail Mayne Pharma accessible market - US$49.2 billion1 market - US$4.3 billion Mayne Pharma Current Mayne Pharma accessible market US$4.3bn Gx value US$0.5bn Product opportunity ~9% ~13%
Slide 30: Multichannel strategy to drive growth
Multichannel strategy to drive growth For personal use only US generic sales by channel Recent channel consolidation ● There has been both consolidation and vertical integration, spanning wholesalers, retailers, Pharmacy Benefit Managers (PBMs) and global distributors 25% Retail 1 Wholesalers Non-re
Slide 31: Commercial execution – dofetilide first-to-market launch
Commercial execution – case study of dofetilide first-to-market launch For personal use only Pre-Approval ● Significant pre-launch planning activities 6 June 2016 ● Mayne Pharma receives first generic approval to Pfizer’s US$200m Tikosyn® brand (dofetilide) ● Awarded 180-days of market exclusivity r
Slide 32: Commercial execution – success with new product launches
Commercial execution – success with new product launches For personal use only 62% 24% product product market share, market share, 2 generic 6 generic companies companies 61% 21% product product market share, market share, sole generic 3 generic company, companies, launched Feb launched Jan 2017 201
Slide 33: Almost half of the top products have leading market shares
Almost half of the top 20 products have leading market shares For personal use only Mayne Pharma’s market position in top 20 products (NSP ext units, last quarter market share) #4+ #3 5% 20% #1 We are a top 3 player 45% in 95% of our top 20 products #2 30% Source: IMS Health, MAT February 2017. 33
Slide 34: Strong market share from top products
Commercial execution – strong market share from top 5 products For personal use only Top 5 generic portfolio product market share (TRx prescriptions) 70% 62% 60% 50% 46% 40% 38% 30% 31% 27% 20% 10% 0% Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 Apr-17 BAC family Clonidine Dofetilide Methylphenidate Mi
Slide 35: Supply chain excellence
Supply chain excellence – scaled and ready for continued growth For personal use only In readiness for the Teva product portfolio, Mayne Pharma upgraded all aspects of the supply chain ● Organisation focused on continual reduction of COGS 1 ● Active Pharmaceutical Ingredient (API) cost reduction on
Slide 36: Key takeaways – Generic Products
Key takeaways – Generic Products For personal use only Top 25 retail Diversified generics portfolio with business and leading market top 2 oral shares contraceptives supplier in the US Cost savings of Targeting double US$12m expected digit 5-year to be extracted revenue CAGR - from Teva product driv
Slide 37: Specialty Brands Division (SBD)
For personal use only 3 Specialty Brands Division (SBD) Craig Boyd
Slide 38: Specialty Brands overview
Specialty Brands overview For personal use only Portfolio of differentiated, patent-protected dermatology brands – Doryx® MPC, Fabior®, Sorilux® Highly motivated 66 person sales team delivering ahead of targets Leveraging our Proven ability to successfully launch new brands and defend a dermatology
Slide 39: Key market trends relevant to Specialty Brands
Key market trends relevant to Specialty Brands For personal use only Increased demand for clinically Favourable growth tailwinds in dermatology market differentiated drugs Shifting channels Continued growth of the specialty pharmacy channel Greater clinical evidence Requirement for greater demonstra
Slide 40: US Dermatology market overview
US Dermatology market overview For personal use only Dermatology disorders – patient prevalence in the US (millions) l Dermatology pharmaceutical market size 56 estimated at ~US$14bn l Acne and psoriasis sub markets represent ~30% of the total dermatology market value l Acne and psoriasis prevalent
Slide 41: SBD drivers of success
SBD drivers of success For personal use only Clinically differentiated products bringing therapeutic value to patients Clinical Commercial development execution excellence Intellectual property Drug delivery expertise technology expertise Portfolio selection Patient access underpinned by programs R&
Slide 42: Doxycycline franchise has delivered sustained revenue and earnings
Doxycycline franchise has delivered sustained revenue and earnings over time 1985 Jul 2013 Aug 2016 For personal use only Doryx® 100mg capsule Doryx® 200mg tablet Doryx® MPC 120mg tablet Doxycycline franchise sales launched launched launched by Mayne Pharma (US$m) Branded 2005 Aug 2015 Doryx® 75mg a
Slide 43: Doryx MPC – new formulation
Doryx® MPC – new formulation that further retards the release of doxycycline in the stomach For personal use only ~15 minute delay The modified polymer coat further delays absorption of Doryx® MPC into the GI tract by approximately 15 minutes 43
Slide 44: Doryx MPC competes in the tetracycline acne market
Doryx® MPC competes in the tetracycline acne market For personal use only Average TRx Mkt Product Company Molecule Form IP / week share Doryx® 3 additional patents Doxycycline Tablet MR 1,900 MPC with 2034 expiry Doryx® Doxycycline Tablet MR 250 8% Generics launched Authorised Doxycycline Tablet MR
Slide 45: Doryx MPC a material part of the doxycycline franchise
Doryx® MPC has become a material part of the doxycycline franchise driving overall growth For personal use only Doxycycline franchise weekly TRx (brand and generic) (4 week rolling) 6,000 Generic event on Doryx® 50mg and 200mg Launch of Doryx® MPC 120mg 5,000 4,000 3,000 2,000 1,000 Jan-16 Feb-16 Ma
Slide 46: Fabior and Doryx are highly complementary acne products
Fabior® and Doryx® are highly complementary acne products US acne market by value First line acne treatment For personal use only Acne Fabior Oral 4% Mild Moderate Severe 14% 32% BP BP + Retinoid + Oral antibiotic Isotretinoin US$4.6bn 22% Doryx BP + Retinoid + Retinoid + Oral antibiotic BP + Antibi
Slide 47: Fabior – the only topical retinoid in a foam formulation
Fabior® – the only topical retinoid in a foam formulation For personal use only Fabior® can be applied to skin of the face and upper trunk 47
Slide 48: Fabior marketing aid – launched January 2017
Fabior® marketing aid – launched January 2017 For personal use only 48
Slide 49: Fabior competes in the topical retinoid acne market
Fabior® competes in the topical retinoid acne market Product Company Molecule Form Average TRx / Mkt IP For personal use only week share Fabior® Tazarotene Foam 1,200 1% Patent expires 2030 Tazorac Tazarotene Gel / cream 6,000 5% Generics launched Epiduo / Adapalene / Epiduo Benzoyl Gel 19,000 17% M
Slide 50: Sorilux – the only vitamin-D, non steroid foam
Sorilux® – the only vitamin-D, non steroid foam for the treatment of scalp and body psoriasis For personal use only Sorilux® can be applied to the scalp and body 50
Slide 51: Sorilux marketing aid – launched January 2017
Sorilux® marketing aid – launched January 2017 For personal use only Sorilux® Foam delivers effective FOR SCALP AND BODY PSORIASIS, treatment for scalp psoriasis SORILUX FOAM DELIVERS SORILUX Foam was evaluated as monotherapy for treat psoriasis of the scalp in a multicenter, randomized, doub study i
Slide 52: Sorilux competes in the topical Vitamin D psoriasis market
Sorilux® competes in the topical Vitamin D psoriasis market For personal use only Product Company Molecule Form Average TRx / Mkt IP week share Patents expire 2026 Sorilux® Calcipotrene Foam 230 2% and 2028 Betamethasone Enstillar Foam 1,800 12% Multiple patents / calcipotrene Betamethasone Suspensi
Slide 53: Fabior and Sorilux gaining significant prescriber adoption
Fabior® and Sorilux® are both gaining significant prescriber adoption Fabior® weekly TRx since launch For personal use only (4 week rolling) 1,400 Mayne Pharma launches Fabior® 1,200 1,000 800 Previous peak Fabior® TRx volume was 537 in Jun 2014 600 400 200 0 Feb-15 Apr-15 Jun-15 Aug-15 Oct-15 Dec-1
Slide 54: Multifaceted marketing campaigns driving sales force effectiveness
Multifaceted marketing campaigns driving sales force effectiveness For personal use only Marketing Patient materials Medical focus liaison Field sales team Marketing support tools Patient savings Telesales cards Trade Websites sales Key opinion Managed Access and leaders / care support advisory Conf
Slide 55: Expanding specialty brand portfolio
Mayne Pharma will expand its specialty brand portfolio through organic and inorganic initiatives For personal use only TODAY FUTURE Dermatology Dermatology Doryx® Doryx® Doryx® MPC Doryx® MPC Fabior® Fabior® Sorilux® Sorilux® Foam products Infectious Oncology Eg. BCCNS1 diseases SUBA®-Itraconazole T
Slide 56: Key takeaways – Specialty Brands
Key takeaways – Specialty Brands For personal use only Portfolio of clinically Business now differentiated positioned for products that strong future bring therapeutic growth value to patients Expand product Driving category portfolio through leadership in internal product dermatology development, i
Slide 57: Metrics Contract Services
For personal use only 4 Metrics Contract Services John Ross
Slide 58: Metrics Contract Services overview
Metrics Contract Services overview For personal use only 20+ year history in contract services 100+ high quality and long term ’fee for service’ clients base across the pharmaceutical and biotechnology sectors Leading oral dosage form Supported by 130 analytical chemists and formulators CDMO for nov
Slide 59: Key market trends relevant to Contract Services
Key market trends relevant to Contract Services For personal use only Evolving needs of contract manufacturing Propensity to outsource continues to rise in target segments customers Consolidation of commercial CMOs Increasing Increasing regulatory hurdles regulatory requirements Challenges for low-c
Slide 60: Contract services market
Contract services market The Contract Services market has grown into a substantial market as a result of pharmaceutical companies outsourcing drug development For personal use only activities to leverage capabilities, resources and technologies of CDMOs and CROs with specialist expertise Discovery D
Slide 61: CDMO market is highly fragmented with attractive fundamentals
CDMO market is highly fragmented with attractive fundamentals For personal use only Top 5 Global CMO market share ● US CDMO market continues to grow 6-7% per annum CMO Market share ● US$140b global R&D spend for Catalent 5% pharmaceutical and biotechnology industry of which ~30% outsourced Patheon 4
Slide 62: MCS drivers of success
MCS drivers of success For personal use only Technical and regulatory expertise Scientific Commercial excellence execution Concept to commercialisation Flexible quality pathway systems Delivery reliability to improve Potent handling robustness and capabilities cost 62
Slide 63: Diversified client portfolio with strong financial performance
Diversified client portfolio with strong historical financial performance For personal use only MCS sales by service area (1H17) MCS revenue and gross profit % (US$m)1 45 42.4 60% 36% Formulation development 54% 55% 40 Analytical services 50% 35.6 50% 64% 35 46% 30 28.3 40% 26.1 25 MCS customer mix
Slide 64: MCS products at all stages of development
MCS products at all stages of development For personal use only Potential pipeline of future commercial manufacturing contracts Phase I Phase II Phase III Commercial1 Products 34 37 27 23 Clients 27 27 23 13 1. Mayne Pharma provides analytical services for these commercial clients. 64
Slide 65: MCS outlook remains very strong
MCS outlook remains very strong with key performance indicators trending favourably For personal use only Increasing project value 17 commercial Committed business reflecting later stage, manufacturing quotes pipeline1 up 25% over higher margin with peak unit last 12 months development work demand ~
Slide 66: Investing for growth
Investing for growth For personal use only Increased capacity Expanding capabilities Operational efficiencies ● New stability storage ● Multi-particulate coating ● Analytical services revenue facility, triples current per employee increased 20% capacity ● Bead-coating fluid bed since implementing a
Slide 67: Greenville capital investment program progressing to plan
Greenville capital investment program progressing to plan For personal use only New fluid bed spray coater now installed in development New stability centre facility at Greenville laboratories in Greenville 67
Slide 68: Key takeaways – Metrics Contract Services
Key takeaways – Metrics Contract Services For personal use only Redevelopment of Strong revenue Greenville facilities and earnings creating significantly momentum expanded capacity for MCS Broadening oral Scope for “bolt-on” solid dose acquisitions in a capabilities highly fragmented through facilit
Slide 69: Global Operational excellence
For personal use only 5 Global Operational excellence John Ross
Slide 70: Operational excellence overview
Operational excellence overview For personal use only Outstanding track record with FDA and TGA Successful transition of acquired Teva product portfolio with no supply chain disruptions Lost time injury frequency rate reduced by 25% in 2016 versus Focus on efficiency, prior year quality, cost contro
Slide 71: Operational excellence drivers of success
Operational excellence drivers of success For personal use only Supply chain and alliance management Cost and Continuous Patient and M&A agility and productivity process prescriber integration improvementknow- improvement intimacy and the how linkage to R&D Product quality Drug delivery technology L
Slide 72: Key achievements
Key achievements Improvement Benefit For personal use only ● Strategic API sourcing function ● Consolidation of global purchasing of API sourcing established in advance of Teva portfolio API acquisition ● Key contributor to Teva deal synergies ● Strengthened supply team and Tech transfer connectivit
Slide 73: Supply chain built around quality and reliability
Supply chain built around quality and reliability For personal use only Major API Suppliers Key CMO Suppliers Quality Product Reliable Supply Internal Supply FTC Transitional Supply Greenville, NC Salisbury, Australia 73
Slide 74: Teva technology transfer status
Teva technology transfer status For personal use only Products to be transferred Forecast approvals 4x FY18 Amethia Lo Fentanyl Buccal 5x FY19 Azurette Maytessa 1x FY20 Budesonide ER Microgestin® 1/20 Camila Microgestin® 1/20 FE Microgestin® 1.5/30 4x FY18 Carbidopa/Levodopa Microgestin® 1.5/30 FE 5
Slide 75: Significant investment in commercial manufacturing – Greenville
Significant investment in commercial manufacturing Greenville site expansion For personal use only Summary Benefits of site expansion ● US$80m new solid oral dose ● More than doubles operational footprint to 225,000ft2 125,000ft2 manufacturing facility in ● Creates new capacity and capability in the
Slide 76: Significant investment in commercial manufacturing – Salisbury
Significant investment in commercial manufacturing Salisbury site expansion For personal use only Summary Benefits of site expansion ● A$25m investment in Salisbury to ● Creates additional modified-release manufacturing capacity expand fluid bed processing capacity to support expected growth in curr
Slide 77: Long-term vision for operational excellence
Long-term vision for operational excellence For personal use only Drive cost Deliver on price, improvements quality and and asset availability to meet utilisation customer efficiency expectations Develop Enhance processes organisational around product competency in Lean supply, production manufactur
Slide 78: Research & Development
For personal use only 6 Research & Development Ilana Stancovski
Slide 79: R&D overview
R&D overview For personal use only 65 R&D team members in Australia and US Expanding core capabilities – modified-release, potent, improved bioavailability, foam Increasing focus on complex co-development programs ‘Portfolio centric‘ and generic programs with clinical end point studies approach to p
Slide 80: Key recent achievements
Key recent achievements For personal use only Product IP Alliances Jun 16 Jul 16 Feb 17 Approval and launch of A$26m settlement on patent Strategic alliance with dofetilide capsules – first litigation with Forest Formulytica – exclusive Mayne Pharma PIV product Laboratories partner for development i
Slide 81: R&D drivers of success
R&D drivers of success For personal use only Agility Alliance Formulation Formulation partnerships development capability Intellectual property Drug delivery expertise technology expertise Clinical Portfolio development selection capabilities 81
Slide 82: Focused portfolio selection – generics
Focused portfolio selection leverages capabilities globally - generics Generic portfolio selection considerations For personal use only Strategic fit Profitability Total US pharma market 2,500+ molecules First to market US$465bn First to File Patent / PIV complexity Target Markets Retail channel Gov
Slide 83: Focused portfolio selection – specialty brands
Focused portfolio selection leverages capabilities globally – specialty brands Specialty Brands therapeutic focus Development of branded products For personal use only High Biologic Dermatology New Chemical Entity Doryx® Doryx® MPC Repurposing drugs Fabior® Combination drugs for new indications Sori
Slide 84: Increasing complexity of dosage forms in product portfolio
Increasing complexity of dosage forms in product portfolio Pipeline products For personal use only Marketed product examples 2012 Today1 Other differentiated dosage Cyclosporine soft gel capsule - 5 forms Development and manufacturing complexity Hormonal device - - 1 Foam Fabior®, Sorilux® - 3 Deliv
Slide 85: Foams – a new complex delivery platform
Foams – a new complex delivery platform Foam platform opportunities For personal use only Why foams? ● Fits therapeutic focus in dermatology ● Product development and manufacturing complexity Improved formulations Through improved efficacy, ● Elegant delivery mechanism tolerability and / or ease of
Slide 86: R&D strategic alliances expanding capabilities
R&D strategic alliances expanding capabilities Alliances established in the last 12 months For personal use only ● Manufacturing ● Focused on ● Provides ● Provides ● Clinical ● Provides and development development of alternative drug alternative drug development differentiated API Complementary capa
Slide 87: Steady stream of product launches driving earnings growth
Steady stream of product launches driving earnings growth Sales from new product launches since Generic Products Specialty Brands FY14 (US$m)1 For personal use only ● Doxycycline hyclate 75mg, 100mg and 150mg DR tablets 140 FY14 ● Erythromycin 250mg DR capsules 120 ● Oxycodone oral solution 100 FY15
Slide 88: Mature US generic pipeline
Mature US generic pipeline US filed pipeline by # of generic competitors (US$m) US to be filed pipeline by # of generic For personal use only competitors (US$ millions) Expected launch in 2017 700 7,000 600 US filed pipeline targeting markets 6,000 with IMS Sales >US$1.3bn 5+ Gx 500 5,000 400 3 Gx 4
Slide 89: R&D risk varies across the business segments
R&D risk varies across the business segments For personal use only Specialty Brands Generic Products High Development risk Low High Capital intensity Low Branded product portfolio Generic product portfolio On-market 3 On-market 50 + Pipeline 2 Pipeline 40 + 0 20 40 60 0 20 40 60 R&D investment areas
Slide 90: SUBA-Itraconazole franchise has multiple opportunities for growth
SUBA-Itraconazole franchise has multiple opportunities for growth… For personal use only Anti-fungal Oncology ● Itraconazole is a broad spectrum anti-fungal used ● Itrazoconazole has anti-cancer properties based to treat both superficial and systemic infections on inhibition of the Hedgehog Signalin
Slide 91: Strong results from Phase IIb study in BCCNS
…and achieved strong results from Phase IIb Study in BCCNS For personal use only ● High unmet clinical need in patients with BCCNS with standard of care being surgical excision Indication ● Annual US population estimates for BCCNS (Gorlin) ~10,000 ● Independent analysis of the target lesions reporte
Slide 92: Key takeaways – R&D
Key takeaways – R&D For personal use only Greater Targeting 6 investment in launches in 2017 early stage brand with >US$500m programs and in IMS sales complex generic programs Pipeline expansion Selective strategic through internal alliances to broaden development, co- capability set development and
Slide 93: Corporate & Business Development
For personal use only 7 Corporate & Business Development Peter Paltoglou
Slide 94: Corporate & Business Development overview
Corporate & Business Development overview For personal use only Global CBD team covering US, AU and ROW business development initiatives Proven track record to build scale, capability and value A$1bn+ invested in M&A since 2012 Enabling growth across all business units Augmenting drug delivery platf
Slide 95: Focused corporate strategy with defined playbook
Focused corporate strategy with defined playbook to build scale and capability across key business units For personal use only EXPANSION STEP-OUT CORE Generic Leverage partners Consider adjacent • Complex technology technologies • Alternative dosage opportunities selectively e.g. potent and modified
Slide 96: Current corporate trends shaping strategic agenda
Current corporate trends greatly shaping Mayne Pharma’s strategic agenda Trends over the past years… …is driving prevailing corporate activity For personal use only Poor performance has led to mgmt change Mega-deals created scaled organisations Companies have undertaken strategic reviews leading to
Slide 97: Fragmented generics market provides opportunity for growth
Fragmented generics market provides opportunity for growth For personal use only Top 30 US Generics players (Sales US$m) Top 5 generic players account for ~50% of the total market1 Glenmark Sun Pharma Prasco Dr Reddy Impax Perrigo Aurobindo Alovogen Teva Mylan Endo Lupin Novartis Amneal Apotex Hikma
Slide 98: Corporate & Business Development drivers of success
Corporate & Business Development drivers of success For personal use only Leveraging new alliance platforms Enhancing and Patient and M&A agility and establishing M&A agility and prescriber integration know- business models integration intimacy and the how linkage to R&D Deep focus on shareholder Dr
Slide 99: Filtering process for new opportunities
Mayne Pharma’s filtering process for new opportunities For personal use only Specific criteria Attractive fundamentals ● Barriers to entry Segment attractiveness and / or platforms for ● Competitive landscape growth Acquisition has compelling ● Leverages existing competencies Strategic rationale str
Slide 100: Balanced approach to drive long-term shareholder value
Creating a balanced approach to drive long-term shareholder value For personal use only Near term growth M&A Longer term growth M&A Increases scale Exceeds IRR Cash flow helps Creates Exceeds IRR Supports and provides benchmark; to fund sustainable benchmark; ongoing runway synergies near-term EPS a
Slide 101: In-licensing and partnering frameworks
In-licensing and partnering frameworks For personal use only Dofetilide Fentanyl TDS Myring® ● Entered into a partnership to ● Acquired ANDA for fentanyl ● Long-term exclusive license and share the costs of development reservoir patch from Par Pharma supply agreement with Mithra and profits equally
Slide 102: Track record of on-strategy value accretive transactions
Track record for delivering ‘on strategy’ and value accretive transactions for shareholders For personal use only Metrics acquisition Libertas acquisition Doryx® acquisition ● Provided US operating platform ● Expanded commercial capability ● Created new specialty brands ● Acquired contract services
Slide 103: Successful strategic alliances from recent M&A
Track record for establishing series of successful strategic alliances from recent M&A activities For personal use only portfolio acquisition foam products acquisition November 2012 July 2013 August 2016 August 2016 Relationship with Relationship with Relationship with Relationship with Mikart Johns
Slide 104: Leveraging M&A to establish new business pathways
Leveraging M&A to establish new business pathways For personal use only GSK foam product acquisition illustrates Mayne Pharma ability to create a completely integrated business targeting high value product opportunities Idea generation & Research & Distribution, sales product selection development M
Slide 105: Key takeaways – Corporate & Business Development
Key takeaways – Corporate & Business Development For personal use only Partnerships and alliances play a M&A is a core key role in adding platform for technologies and growth capabilities Targeting double digit return on Opportunities capital employed available for well- across future M&A funded pla
Slide 106: Closing Remarks
For personal use only 8 Closing Remarks Scott Richards
Slide 107: Operational Update and Earnings Outlook
Operational Update and Earnings Outlook For personal use only ● Tougher generics pricing environment in 2H17 which is expected to result in FY17 Teva portfolio generic sales below original guidance ● Teva portfolio gross profit margins tracking ahead of 50% guidance and EBITDA is broadly in line ● U
Slide 108: Final takeaways – our strategic pillars
Final takeaways – our strategic pillars…. For personal use only US Generic Leverage and Specialty Brands Products diversify drug expansion expansion delivery platforms Commercial Operational execution excellence 108
Slide 109: …to drive our 2021 strategic ambitions
…to drive our 2021 strategic ambitions For personal use only ● Triple size of the business in revenue terms to >A$1.5bn ● Double digit CAGR EPS growth ● R&D investment to return to ~8-10% of group revenue ● New products to drive revenue and earnings growth (US$7bn pipeline1) ● Business development t
Slide 110: A specialty pharmaceutical company with a diversified portfolio
A specialty pharmaceutical company with an increasingly diversified For personal use only portfolio of products, technologies and footprint 110