MAYNE PHARMA GROUP LIMITED

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FY11 Annual General Meeting 23[rd ] November 2011

Mr Roger Corbett Chairman Dr Roger Aston Chief Executive Officer

www.maynepharma.com

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Agenda
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Chairman’s address
Chief Executive Officer’s presentation
Formal business
Financial report
Re‐election of Directors
Remuneration report

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Executive Summary

Doryx®

Challenging 12months for Doryx ® with US sales down 46%*
• ® New dual‐scored Doryx 150mg tablet launched in US
Doryx ® has maintained marketing exclusivity in the US post expiry of 30 month stay

SUBACAP®

SUBACAP® on track for approval in the EU during FY12
• Phase III trial to be completed in the US
Sales of other products were up 18%*

Other

products

New business development initiatives expanding product mix and distribution reach
Debt now completely paid down; new facilities in place if
Stable required
financial • Business restructured to improve efficiencies and increase
position capacity utilisation
On the full 12 month FY10 result

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FY11 group results

• Sales and earnings down on annualised FY10 result

FY10 Reported

8 month contribution MPI – Total revenue $50.1m $36.7m – Gross profit $23.2m $18.5m

– Reported EBITDA $7.9m $8.5m – Reported NPAT $1.7m $3.3m – Reported EPS 1.1cps 2.6cps

Reported EPS

– Underlying EBITDA $9.2m*

After adjustments. Includes $1.1m provision for the value of Doryx ® inventory yet to be approved by the FDA, $0.8m non‐cash reduction in the earnout liability and one‐off redundancy costs of $1m for the restructure of the Salisbury production site

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Balance sheet and cash flow stable

Total assets of $53.7m (30 June 2011), including $5.8m cash, $21.5m property, plant & equipment and $12.8m inventory & receivables
US$ debt completely paid down in October
Carrying value of the earn‐out to Hospira is $15.1m with 5 remaining payments
Paid on calendar year revenue in February
FY11 payment of $6.6m representing instalment for the 2010 calendar year
Although no final dividend declared the Board will review at each half after assessing the Company's operating performance and outlook at that time

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Business strategy for growth

Existing products

Maintain a product life-cycle management program to stay ahead of
Improve potential competition formulations • New dose strengths and improved formulations of many existing products under development

Defend & expand markets

Vigorous defense against generic competition
Expansion of proprietary products into new markets / territories
• Expanded sales and marketing effort of the Australian proprietary product portfolio

New products

Develop / in‐license / acquire /

Development and commercialisation of Mayne Pharma’s portfolio of partially completed products
Develop new products (Improved Chemical Entities / “ICEs”) that utilise Mayne Pharma’s proprietary drug delivery systems
Identify new product opportunities for in-licensing / acquisition

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Agenda

• Chairman’s address

Chief Executive Officer’s presentation

• Formal business

Financial report
Re‐election of Directors
Remuneration report

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Key milestones

Achieved

SUBACAP® dossier lodged in the EU
Successful Phase II trial of SUBACAP® in the US
®
Doryx maintaining marketing exclusivity in the US
Maiden dividend and special dividend paid
Debt paid down
Restructured business to deliver ongoing savings
Ongoing
Appointment of marketing and distribution partners
SUBACAP® Phase III trial in the US
Regulatory approval of SUBACAP® in EU and ROW
Clarity around Doryx® patent exclusivity
Develop / in licence / acquire new products

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Proprietary drug development program

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Extended IP
Protection
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New Markets
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Simplified
Regulatory Path
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Controlled Release Taste Masked Proven Drugs Improved Bioavailibility

SuperGeneric Drugs

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Reduced
Development
Time, Cost, Risk
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Safety/ Efficacy
Improvements
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Proprietary Drug Delivery Technologies

proprietary improvements of existing drugs creating next generation pharmaceuticals

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SUBACAP®

Super‐bioavailable itraconazole
Significant improved formulation of itraconazole (Sporanox®) based on SUBA® technology

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Sporanox® hampered by erratic/unpredicatble clinical response (poorly controlled absorption) and safety issues
SUBACAP® formulation provides for significantly less variable drug absorption (fed/fasted state)
Less intra/inter patient variability, more predictable clinical response with increased efficacy and potential for reduced toxicity (blood concentrations similar to Sporanox® at half the dose; 50mg vs 100mg
Reliable, effective broad spectrum anti‐fungal drug
Significant interest from a range of potential licensing partners

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SUBACAP® broad‐spectrum antifungal

	FUNGAL INFECTIONS	FUNGAL INFECTIONS	FUNGAL INFECTIONS	FUNGAL INFECTIONS	FUNGAL INFECTIONS
	Histoplasmosis	Aspergillosis	Onychomycosis	Candidiasis	Cryptococcus
Itraconazole	�	�	�	�	x
Fluconazole	x	x	x	�	�
Posaconazole	x	�	x	�	x
Voriconazole	x	�	x	�	x
Terbinafine	x	x	�	x	x

Itraconazole’s broad‐spectrum makes it a good choice when the fungal species being treated has not been identified

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SUBACAP® – Phase II study

Significantly improved formulation of itraconazole based on SUBA® technology
SUBACAP® significantly superior to placebo at both efficacy endpoints
SPORANOX® not significantly different to placebo
Placebo had no cures

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All cures at Week 24
Significantly superior to placebo
18%
16%
14%
12%
10%
8%
6%
4%
2%
0%
SUBACAP SPORANOX PLACEBO Terbinafine
(Lion study)
% of patients
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Clinical Cure Therapeutic Cure

Mycological cure ‐ negative stain and culture Clinical cure – nail rating score of 0 (<10% of the nail is missing, no thickening and no discoloration)

Therapeutic cure – clinical cure and mycological cure Source: Company data on file

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SUBACAP® – Regulatory update

Europe

Collaborating with MHRA to address its evaluation questions, with approval anticipated in FY12
Launch FY12 subject to approval and appointment of marketing and distribution partner

US

Pre‐phase III meeting requested with the FDA to confirm the scope of the clinical trial
Phase III onychomycosis trial in ~700 people

Rest of World

Meeting scheduled with the TGA for January 2012
Following EU approval, dossier used to support the regulatory process in select Asian and South American countries

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SUBACAP® – Development update

New dose forms in development
Line extensions under review
Manufacturing equipment for commercial supply currently being installed at Salisbury facility

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Doryx®

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®
Dual‐scored Doryx 150mg tablet approved and launched in the US
®
Injunction against Mylan prevented launch of a generic Doryx following the expiry of 30 month stay in September
®
US District court found a reasonable likelihood that the Doryx 161 patent is valid and infringed by Mylan’s generic product
Citizen petition filed with FDA and awaiting response
®
Court date to determine validity of Doryx 161 patent expected 1Q 2012
®
Continuing to lifecycle manage Doryx into new dosages and formulations
®
Other markets being assessed to expand Doryx globally

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Other products

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®
New Astrix formulations under development to expand the product offering to patients
New business development resource appointed to expand the contract manufacturing client base
New product opportunities under review
Specialised generics for the US market
ICEs incorporating Mayne Pharma’s proprietary drug delivery technology
Reviewing new product opportunities for acquisition / in‐licensing

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Trading update

Our year to date performance is up on last year for both sales and EBITDA
Company expects 1H12 EBITDA to be up on last year
Business now debt free
US$5m 3‐year interest only bill facility negotiated, but not drawn
Cash on hand (31/10/11) $5.0m
Net cash up $1.5m from 30 June 2011
Cash rebuild expected in FY12

AI assistant

MAYNE PHARMA GROUP LIMITED AGM Information 2011

65396_rns_2011-11-22_2e7122b5-5d45-4eb7-a2a7-4888305c941e.pdf