Idt Australia Limited · ASX:IDT
Idt Australia — Investor Presentation (June 2016)
22 slides from Idt Australia's investor presentation, Jun 27, 2016
Slide 1: Portfolio Update
For personal use only PORTFOLIO UPDATE 22Jun16
Slide 2: Investment Proposition
IDT AUSTRALIA LTD (ASX.IDT) INVESTMENT PROPOSITION For personal use only The Business: US FDA approved generic drug portfolio Aggregate Addressable Two in-house products, one FDA approved Market over US$750m Growing contract drug development revenues Growing contract drug manufacturing revenues Grow
Slide 3: 35 Year History: A Platform for Rapid Growth
35 YEAR HISTORY A PLATFORM FOR RAPID GROWTH For personal use only IDT Service Business: IDT Specialty Generics: Provides revenues and capabilities Leverages facilities and multiplies margins Drug development services revenues Revenue Step Change via Proprietary IDT Generic Contract drug Drug Portfol
Slide 4: IDT Generic Portfolio Snapshot
IDT GENERIC PORTFOLIO SNAPSHOT For personal use only • 25 products with multiple SKUs • Aggregate US addressable markets C. USD750m • Variety of clinical indications • Most are solid oral dose (tablets or capsules) • Good facility fit to IDT Boronia manufacturing • Established distribution arrangeme
Slide 5: IDT Portfolio Overview
IDT PORTFOLIO OVERVIEW For personal use only Aminophylline Leucovorin Carbi/Levodopa Methoxsalen Ciprofloxacin Mexiletine Clarithromycin Nefazodone Dexamethasone Nortriptyline Dextroamphetamine Pindolol Diflunisal Prazosin Dipyridamole Procainamide Doxazosin Procainamide ER Etodolac Temozolomide Eto
Slide 6: Portfolio Progress and Potential
IDT PORTFOLIO PROGRESS and POTENTIAL For personal use only Product Priority Manufacturer US Distributor Addressable Market (USD millions, 2015) Carbi/Levodopa 1 Wellspring ANI $65 Diflunisal 1 Wellspring ANI $9 Doxazosin 1 IDT ANI $84 Flecainide 1 IDT/Wellspring TBA $39 Leucovorin 1 IDT ANI $2 Mexil
Slide 7: Lower Priority Molecules
IDT LOWER PRIORITY MOLECULES For personal use only Product Priority Manufacturer US Distributor Aminophylline 3 ANI Dexamethasone 3 ANI Dextroamphetamine 3 ANI Dipyridamole 3 ANI Etodolac 3 Etodolac ER 3 Methoxsalen 3 ANI Procainamide 3 Procainamide ER 3 Tetracycline 3 ANI These dossiers will be ass
Slide 8: Completed Portfolio Milestones as at 02Jun16
COMPLETED PORTFOLIO MILESTONES as at 02Jun16 For personal use only Marketing Temozolomide Development Manufactured Stability FDA Review Approval Doxazosin Development Manufactured Stability Leucovorin Development Manufactured Pindolol Development Prazosin Development Mexilitine Thiotepa Development
Slide 9: Temozolomide
PRODUCT TEMOZOLOMIDE For personal use only • Addressable US market USD200m (Dec15) • Treatment for a variety of malignant brain cancers • ANDA filed Dec2013 • ANDA approved by FDA March 2016 • Mayne Pharma appointed as distributor • IDT manufacture • Likely launch window Q2 FY2016/17 www.idtaus.com.
Slide 10: Doxazosin
PRODUCT DOXAZOSIN For personal use only • Addressable US market USD84m (Dec15) • Treatment for benign prostatic hyperplasia • Development and stability studies complete • Likely Prior Approval Supplement pathway • ANI Pharma appointed as distributor • IDT manufacture www.idtaus.com.au 10
Slide 11: Leucovorin
PRODUCT LEUCOVORIN For personal use only • Addressable US market USD2m (Mar16) • Treatment to improve chemotherapy effectiveness • Development complete • Likely CBE30 pathway • IDT manufacture • ANI Pharma appointed as distributor www.idtaus.com.au 11
Slide 12: Pindolol
PRODUCT PINDOLOL For personal use only • Addressable US market USD10m (Dec15) • Treatment for hypertension • Development complete • Likely CBE30 pathway • ANI Pharma appointed as distributor • Wellspring manufacture www.idtaus.com.au 12
Slide 13: Prazosin
PRODUCT PRAZOSIN For personal use only • Addressable US market USD42m (Dec15) • Treatment for high blood pressure, PTSD and panic disorder • Development commenced • Likely CBE30 pathway • ANI Pharma appointed as distributor • Wellspring manufacture www.idtaus.com.au 13
Slide 14: Mexiletine
PRODUCT MEXILETINE For personal use only • Addressable US market USD12m (Dec15) • Treatment for cardiac arrhythmias • Development commenced • Prior Approval Supplement pathway • ANI Pharma appointed as distributor • Wellspring manufacture www.idtaus.com.au 14
Slide 15: Thiotepa
PRODUCT THIOTEPA For personal use only • C. USD12m API product for IDT over the next 4 years • Addressable global finished good (injectable) market USD80m (estimate) • Treatment for stem cell transplant preparedness and relapsing hormone dependant cancers • Development prototyping complete • ANDA pa
Slide 16: IDT US Distributor Snapshot
IDT US DISTRIBUTOR SNAPSHOT (15Jun16) For personal use only ANI Pharma (NASDAQ:ANIP) Mayne Pharma (ASX. • Market cap. USD $630m • Market cap. USD $1.3b • Located Minnesota, USA • Located Salisbury, Australia • US wide distribution and North Carolina, USA capability • US wide distribution • Focus on
Slide 17: Contract Manufacturing
PRODUCT CONTRACT MANUFACTURING For personal use only • Revenue growth continues, with reactivation of most of the Melbourne site • Some headcount expansion has been needed to service this reactivation • Higher than anticipated CAPEX: repairs, facility remodelling and capacity expansion • Reliable ba
Slide 18: Plant and Site Upgrades and Expansions
PLANT AND SITE UPGRADES AND EXPANSIONS For personal use only • Building of new cytotoxic capsuling and packing lines – Expanded capacity for temozolomide – Better segregation of potent and non‐potent molecules • New, larger tableter and blender: – Tripling of tableting capacity – Reduction in doxazo
Slide 19: Clinical Services
PRODUCT CLINICAL SERVICES For personal use only • Oldest, largest and most experienced clinical unit in Australia • New, state‐of‐the‐art facility recently opened in Adelaide • Consistent double digit year on year growth • Reliable, predictable profits and free cash generation • Strong forward work
Slide 20: Target 2016 Milestones
TARGET 2016 MILESTONES For personal use only INCREASED ORGANIC SALES TOWARDS PROFITABILITY CONTINUE TO PROGRESS TEMOZOLOMIDE THROUGH FDA MOVEMENT OF AN ADDITIONAL INTERNAL PRODUCT TOWARDS MARKET PROGRESS WITH RE-COMMERCIALISATION OF US GENERIC PORTFOLIO MOVE FROM SERVICE PROVIDER, TOWARDS SPECIALTY
Slide 21: Financially Positioned to Deliver
FINANCIALLY POSITIONED TO DELIVER For personal use only FINANCIALS (ASX: IDT) MARKET CAP $58.9m (20Jun16) FY2014 FY2015 1H FY2016 REVENUE $13.4m $15.7m $6.5m EARNINGS AFTER ($6.6m) ($3.0m) ($3.5m) TAX NET ASSETS $25.5m $39.2m $43.7m CAPITAL STRUCTURE CASH $2.40 $0.13 $4.90 DEBT* $0.1m $0.0m $0.0m SH
Slide 22: Summary: 2016/17 Year Outlook
SUMMARY 2016/17 YEAR OUTLOOK For personal use only • Modest growth of base business revenues expected to continue • Cost containment while supporting growth and new business remains a key focus • First proprietary generic product launches expected • More generics to move into recommercialization in