SYNTARA LIMITED — AGM Information 2011

Nov 20, 2011

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Innovative products for respiratory diseases

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Annual General Meeting November 2011

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Company Overview
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		The development of products for respiratory diseases Aridol: •assessment of asthma •approved & launched in major markets Bronchitol for cystic fibrosis: •approved in Australia •recommended for approval in EU US NDA i ti • n prepara on Bronchitol for bronchiectasis: •Phase III trial in progress ASM8 for asthma: •Phase II trial in progress PXS25 M6P receptor blocker PXS4686 SSAO / VAP-1 inhibitor ASX (Nov 2003): PXS Sydney, Australia●Philadelphia, USA●London, UK Manufacture of Aridol & Bronchitol 132 (31/10/11) A$34 million (30/9/11) Shares outstanding: 229m; Options outstanding: 12m (30/9/11)
	Objective	The development of products for respiratory diseases
	Lead products	Aridol: •assessment of asthma •approved & launched in major markets
		Bronchitol for cystic fibrosis: •approved in Australia •recommended for approval in EU US NDA i ti • n prepara on
		Bronchitol for bronchiectasis: •Phase III trial in progress
		ASM8 for asthma: •Phase II trial in progress
	Discovery	PXS25 M6P receptor blocker
		PXS4686 SSAO / VAP-1 inhibitor
	Listing	ASX (Nov 2003): PXS
	Locations	Sydney, Australia●Philadelphia, USA●London, UK
	Facility	Manufacture of Aridol & Bronchitol
	Employees	132 (31/10/11)
	Cash	A$34 million (30/9/11)
	Shares & Options	Shares outstanding: 229m; Options outstanding: 12m (30/9/11)

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Bronchitol - Cystic Fibrosis
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• Background

• ~

• Genetic disorder affecting 40 , 000 in Western Europe , ~30,000 in US and ~3,000 in Australia

• Poorly hydrated, tenacious, thick mucus

• Median predicted age of survival approximately 35 years (2009 – US and UK)

• Main Therapeutics

• Mostly delivered by nebulizer (preparation, sterilization)

• rhDNase (Pulmozyme[®] ): global sales ~CHF 513m (2010)

• ~

• Tobramycin (Tobi[®] ): global sales US$ 279m (2010)

• Aztreonam (Cayston[®] ): approved EU: 09/09; US: 02/10

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Bronchitol - Clearance of Thick Mucus
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Mechanism of Action

Before treatment

After Bronchitol administration

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representation
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representation
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Lung surface dehydrated

Lung hydrated

Airway surface fluid layer impaired

Airway surface liquid restored

Lung defense and hygiene compromised

Improved lung clearance

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Bronchitol - Progression of CF Lung Disease
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Defective CF Gene
Defective/Deficient CFTR VX770
New
Therapies Reduced airway surface liquid Bronchitol
Impaired mucociliary
clearance
Pulmozyme
Infection Antibiotics
Current
Therapies
Inflammation
Inadequate Lung Function Transplantation
Poor Prognosis
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Bronchitol - Cystic Fibrosis Clinical Program
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Two Pivotal Phase III trials – same design

• Multicentre, double blind, controlled

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• Approx 300 subjects greater than 6 years old per trial

• 6 month treatment, 400mg twice per day followed by 6 month open label

• Primary endpoint:

• lung function (FEV1)

• Secondary endpoints:

• Other lung function measures

• Mucus clearance

• Exacerbations

• Antibiotic use

• Quality of life

• CF301: 40 centres in UK, Ireland, Australia & New Zealand

• CF302: 53 centres in US, Canada, Argentina, Germany, France, Belgium, & Netherlands

• Subjects remain on existing best standard of care

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Bronchitol - Improvements in Lung Function
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Change in lung function after 6 months Bronchitol treatment

Results of Clinical Trials CF301 and CF302 - Combined

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Paediatric Adolescents Adults Overall
( 6-11 y rs ) ( 12-17 y rs ) ( ≥18 y rs ) ( n = 569)
FEV1 FEV1 FEV1 FEV1 p value
% difference
versus control 4.16 1.25 4.88 3.80 <0.001
(mL)
% change
from baseline 13.19 8.41 4.68 7.32 <0.001
(mL)
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Overall treatment response (FEV1) over 26-weeks – all age groups (Pooled Data) * not statistically significant

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Bronchitol - Sustained Treatment Effect
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Change in lung function after 12 months Bronchitol treatment

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10 **
Percent 8
change in
6
FEV1
4 8.1 8.2
from
baseline 2
0
(n = 82) (n = 144)
denotes <0.001
p
CF301 CF302
Clinical Trial
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CF301 an d CF302 – D ou bl e Bli n d f or mon 6 th s o f ll owe d b y pen a O L b e l f or mon 6 th s

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Bronchitol - Exacerbation Incidence Reduced
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	Percentage reduction in exacerbation incidence after 6 months Bronchitol treatment CF301 35% p=0.045 CF302 20% p>0.05 CF301 +CF302 combined 29% p=0.039

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Bronchitol - Cystic Fibrosis (Europe)
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First two launch markets: UK and Germany

30,000 CF Patients in Top 5 EU Countries

• Revenues from Qtr 2 2012

• Free pricing on approval

• NICE to review pricing / effectiveness post launch (UK)

• 110 CF clinics in Germany and 50 in UK

Next three: France / Italy / Spain

• To be launched after reimbursement (6-12 months)

• 110 additional clinics

Remaining EU countries

• Subsequent rollout on country-by-country basis

Label expansion to include adolescents and children

• Short clinical trial required

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9,000
7,500
6,000
3,800
4,500
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• Represents one third of total market

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Bronchitol - Cystic Fibrosis (USA)
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Regulatory

• NDA scheduled submission H1 2012

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• Earliest FDA review completed H1 2013

• Orphan drug provides 7 years market exclusivity from date of FDA approval

Marketing

• ~150 to 180 CF centres

• Anticipated requirement for 20 - 25 person field force

• ~30,000 people in the US with CF

• Pulmozyme price ~ US$22,000 per patient per annum

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Bronchitol - Bronchiectasis
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Indication

Target Product Profile

Market Size

Competitors

Status

Bronchiectasis (non Cystic Fibrosis)

‐ Effective clearance of mucus ‐ Reduction in exacerbation incidence

Approximately 110,000 people in the US and 210,000 in the EU are seeking treatment

Antibiotics & CF drugs; lack of targeted clinical develo ment in this disease state p

Phase III trial (B305) recruitment ongoing

Ph ase r a c ose III t i l l d o recru t it men t – Q4 2011 Next Milestones Data – 1H 2013

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B305: Phase III Trial in Bronchiectasis – Status Mid Nov 2011
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Target
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Aridol [®]
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• Identifies airway hyperresponsiveness which helps physicians in the overall assessment of asthma

• An easy-to-use test kit provides rapid results and doesn’t re uire s ecialized e ui ment q p q p

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Aridol – commercialisation status
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				2008 2009 2010 2011 216 232 268 253 137 267 398 398 - 32 162 205 174 64 - - - - - 54 527 595 828 910	2008 2009 2010 2011 216 232 268 253 137 267 398 398 - 32 162 205 174 64 - - - - - 54 527 595 828 910	2008 2009 2010 2011 216 232 268 253 137 267 398 398 - 32 162 205 174 64 - - - - - 54 527 595 828 910	2008 2009 2010 2011 216 232 268 253 137 267 398 398 - 32 162 205 174 64 - - - - - 54 527 595 828 910
	Financial years ending 30 June			2008	2009	2010	2011
	Sales(A$’000)
	Australia	Launched 2006	Direct	216	232	268	253
	Europe	Staggered launch from 2006	Individual country distributors;	137	267	398	398
			UK – direct
	South Korea	Launched 2009	Distributor	-	32	162	205
			Dit
	Cli i l n ca trials		rec	174	64	-	-
	US	Launched Feb 2011	Direct	-	-	-	54
				527	595	828	910

Potential growth

• US and South Korea – full reimbursement for procedure and product

• Asthma management – recent investigator initiated trial published

• COPD – recent investigator initiated trial published

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ASM8 – Asthma
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local delivery to multi target
gene silencing
the lungs knockdown
all combined in one product
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Phase IIa dose profiling trial

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% Eosinophils
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60
50
40
↓ 52%
30
20
10
M ean  SEM p=0.0005
0
Screen 1 mg BID 2 mg BID 4 mg BID 8 mg OD
phils (%) h
Sputum Eosino 7 + 24
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Moderate to severe asthma for patients who do not respond to inhaled steroids or cannot tolerate high doses

Indication

‐Greater efficacy through multi‐ targeting ‐Better tolerability & convenience compared with current treatments ‐Once daily nebulisation

Target Product Profile

Market Size Affects ~12 million people worldwide

Competitors Xolair (US$369M, 2010)

Status Phase II trial fully recruited

Next Phase II trial results – Q2 2012 Milestone

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PXS25 / PXS64 – Idiopathic Pulmonary Fibrosis
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alveoli thickening and O2 exchange reduction

The effect of PXS64 vs pirfenidone in primary derived human lung fibroblasts

Indication Idiopathic Pulmonary Fibrosis (IPF) Target M6P receptor blocker ‐Inhi b i t i o n o f fi b r os i s a n d infl a mm at i o n to Target Product lung tissue Profile ‐Local administration to the lung ‐Safe & well tolerated in humans Market Size Affects ~200,000 people in the USA Pirfenidone (just launched in EU), Competitors immunosuppressives & steroids Status Initial Phase I trial (intravenous) completed Confirmatory in‐vivo data Next Milestone Clinical plan in development

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PXS4686 – Lung Inflammation
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small molecule inhibitor of SSAO

Treatment of inflammatory disease, such as Indication asthma Target SSAO / VAP‐1 inhibitor -Neutrophilic asthma Target Product Profile ‐ O nce a d il y ora os ng l d i Market Size Affects ~23 million people worldwide Significant clinical activity amongst Competitors pharmaceutical companies Status Pre‐clinical development Next Milestone Lead development candidate – Q4 2011

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Summary
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• Respiratory company with approved products and strong pipeline

• Aridol

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 Approved in Australia, South East Asia, Europe and USA

• Fully reimbursed in USA and South Korea

• Bronchitol

• Approved in Australia for cystic fibrosis

• Recommended for approval in Europe

  • Fi rs t l aunc h expec e t d 1H 2012

• USA marketing application to be filed 1H 2012

• Clinical trials in progress to extend reach into Bronchiectasis

• ASM8 for asthma

• Phase IIb trial results due 1H 2012

• PXS 25 for Idiopathic Pulmonary Fibrosis

• Phase I trial completed with IV formulation

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Chief Financial Officer

David McGarvey

Annual General Meeting ~~November 2011~~

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Financial Statements
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													2006 A$ 8 6 4,282 1,299 (16,978) (1 946) , (4,391) - (23,315) (17,728) (5) (17,733) 947 1,124
	Year ended 30 June		2011		2010		2009		2008		2007		2006
			A$		A$		A$		A$		A$		A$
	Income Statements
	Revenue from sale of goods		910		828		595		527		205		8
	Gross profit		568		521		442		398		156		6
	Interest		3,083		3,935		5,347		7,402		5,278		4,282
	Other income		465		616		523		1,576		2,152		1,299
	Expenses
	Research & development		(34,632)		(35,140)		(29,308)		(19,996)		(23,840)		(16,978)
	Commercial		(9 163) ,		(5 657) ,		(6 202) ,		(4 557) ,		(3 240) ,		(1 946) ,
	Administration		(5,171)		(9,715)		(5,800)		(5,231)		(4,666)		(4,391)
	Finance expenses		(859)		(854)		(122)		-		-		-
	Total expenses		(49,825)		(51,366)		(41,432)		(29,784)		(31,746)		(23,315)
	Loss before income tax		(45,709)		(46,294)		(35,120)		(20,408)		(24,160)		(17,728)
	Income tax expense		(49)		(51)		(51)		(32)		(19)		(5)
	Loss for the year		(45,758)		(46,345)		(35,171)		(20,440)		(24,179)		(17,733)
	Depreciation & amortisation		4 767 ,		2 783 ,		1 242 ,		1 024 ,		939		947
	Fair value of securities issued to employees		1,567		2,495		2,432		3,434		1,488		1,124

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Research & Development 2011- $35m
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Manufacturing,
29%
Device
Development,
3%
Amortisation, 5%
Clinical
Development,
50% Drug Discovery,
13%
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Europe - Direct Sales Resources Required
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		Country Targeted Launch Sequence Sales Force Personnel Centres/Sales Person United Kingdom Q2 2012 6 8 Germany Q2 2012 5 22 France Q4 2012 5 13 Italy Q1 2013 4 9 Spain Q1 2013 3 12 Rest of Western Q3 2012–Q3 7 N/A Europe 2013 Central & Eastern Europe From Q3 2012 onwards Distributor strategy Distributor strategy	Country Targeted Launch Sequence Sales Force Personnel Centres/Sales Person United Kingdom Q2 2012 6 8 Germany Q2 2012 5 22 France Q4 2012 5 13 Italy Q1 2013 4 9 Spain Q1 2013 3 12 Rest of Western Q3 2012–Q3 7 N/A Europe 2013 Central & Eastern Europe From Q3 2012 onwards Distributor strategy Distributor strategy	Country Targeted Launch Sequence Sales Force Personnel Centres/Sales Person United Kingdom Q2 2012 6 8 Germany Q2 2012 5 22 France Q4 2012 5 13 Italy Q1 2013 4 9 Spain Q1 2013 3 12 Rest of Western Q3 2012–Q3 7 N/A Europe 2013 Central & Eastern Europe From Q3 2012 onwards Distributor strategy Distributor strategy	Country Targeted Launch Sequence Sales Force Personnel Centres/Sales Person United Kingdom Q2 2012 6 8 Germany Q2 2012 5 22 France Q4 2012 5 13 Italy Q1 2013 4 9 Spain Q1 2013 3 12 Rest of Western Q3 2012–Q3 7 N/A Europe 2013 Central & Eastern Europe From Q3 2012 onwards Distributor strategy Distributor strategy
		Country	Targeted Launch Sequence	Sales Force Personnel	Centres/Sales Person
	OP 5	United Kingdom	Q2 2012	6	8
		Germany	Q2 2012	5	22
		France	Q4 2012	5	13
	T	Italy	Q1 2013	4	9
		Spain	Q1 2013	3	12
		Rest ofWestern	Q3 2012–Q3	7	N/A
		Europe	2013
		Central & Eastern Europe	From Q3 2012 onwards	Distributor strategy	Distributor strategy

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European Commercial Infrastructure
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• UK – Pharmaxis UK subsidiary and sales force in place (currently promoting Aridol)

• Remainder Western Europe (13 countries) – Quintiles:

• Recruit and manage dedicated Pharmaxis sales force

• Local market knowledge to speed access

• Full back office support

• Satellite model leveraging PXS Top 5 country management infrastructure

• European CF market support – Pharmaxis UK subsidiary

• Marketing

• Pricing

• Medical information and pharmacovigilance

• Build to total ~40 people in EU for CF

• • d Logistics infrastructure by 3[r] party

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Financial Statements
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	As at 30 June		2011		2010		2009		2008		2007		2006
	Balance Sheet Data
	Cash and cash equivalents	44,343		85,787		124,993		111,842		76,182		97,840
	Pl t & i t an equ pmen	30 570 ,		32 537 ,		32 698 ,		3 668 ,		3 521 ,		3 205 ,
	Intangible assets	15,954		17,702		1,193		1,227		1,239		1,195
	Total assets	94,572		140,767		163,997		125,049		82,648		104,267
	Total liabilities	(23,742)		(25,751)		(26,306)		(5,928)		(6,089)		(5,379)
	Total shareholders’ equity	70,830		115,016		137,691		119,121		76,559		98,888
	Share Data
	Ordinary shares on issue	228,290		225,410		217,659		194,515		177,949		176,904
	Options over ordinary shares on issue	12,727		13,155		15,075		11,536		9,836		9,692

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Frenchs Forest Facility ~ $33million
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Lab
Other
Equipment
Initial capacity - 1 spray drier: Building
• 40,000 patients p.a. Water Spray Drier
Expanded capacity - 2nd spray drier:
System
• 80,000 patients p.a.
Fitout
Encapsulator
Blister
Packing
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Share Capital
(including options)
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Management – 5%

Other/retail – 36%

Institutions – 59% (62 institutions)

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30 September 2011: 229m shares; 12m options

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Key Terms of the Offer
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• 1 for 3 accelerated pro-rata non-renounceable entitlement offer to raise approximately $80 million, comprised of:

• Entitlement Offer Structure – Institutional Entitlement Offer and Retail Entitlement Offer –

• and Size Initially underwritten to $40m by Merrill Lynch International (Australia) Ltd and Wilson HTM Corporate Finance Ltd, now fully underwritten to $80m

• • Record date is 7pm (Sydney time) on 21 November 2011 • A$1.05 per new share

• Offer Price • 19 . 2% discount to Pharmaxis ’ closing price of A$1 . 30 on 15 November 2011 • 15.2% discount to the theoretical ex-rights price (TERP)[(1)]

• Institutional Entitlement Offer[(2)] • Institutional Entitlement Offer from 16 November 2011 to 17 November 2011 • Retail Entitlement Offer from 24 November 2011 to 8 December 2011

• Retail Entitlement Offer[(2)] Ranking • Shares issued under the Entitlement Offer will rank equally with existing shares

Notes:

1. The theoretical ex-rights price is the price at which Pharmaxis shares should trade immediately after the ex-date for the Entitlement Offer assuming 100% take-up of the Entitlement Offer. The theoretical ex-rights price is a theoretical calculation only and the actual price at which Pharmaxis shares trade immediately after the ex date for the Entitlement Offer will depend on many factors and may not be equal to the theoretical ex-rights price. The theoretical ex-rights price is calculated by reference to Pharmaxis’ closing price of $1.30 on 15 November 2011

2. Dates are indicative only and subject to change. All times refer to Sydney time

6

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Living with Cystic Fibrosis

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Annual General Meeting November 2011

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Shareholder Questions

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Annual General Meeting November 2011

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Formal Business

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Annual General Meeting November 2011

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Resolution 1 – Financial Report, Directors’
Report and the Auditor’s Report
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• No shareholder vote is required

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Resolution 2: Remuneration Report
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Resolution: “That the remuneration report of the Company for the year ended 30 June 2011 is adopted.”

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Remuneration Framework
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		Senior executive officers	Non-executive directors
	Contract	Three year fixed term contracts with 3 months notice	Retire by rotation at AGM as per constitution and Listing
			Rules
	Salary	Base salary,plus	Fixed fee
		•Superannuation of 9% of base	No variable component
		•Variable cash incentive component, average of 20% of base salary in 2011. Achieved less	Fees reviewed by external advisors when last increased
		than 50%, paid nil
		•Equityremuneration
	Sl i	Al d ti	Lt dtt 2006
	aary revew	nnua an on promoon	as ajusmen
	Equity Remuneration	Annual grant of performance rights byBoard. Nil re FY 2011	Once only sign-on grant of 30,000 restricted shares
	V ti / es ng Restrictions	V t ft 3 t i t d f es a er years, res r c e or additional year, Board approval to sell	V t ft 3 B d es a er years, oar approval to sell

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Resolution 2: Remuneration Report
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The Com an has received: p y

• 115,897,193 proxy votes in favour of the resolution;

• 868,211 proxy votes against the resolution;

• 599,340 proxy votes abstaining from the resolution;

• 1,790,421 proxy votes prohibited from from voting;

• • Nil proxies able to be voted by the chair which the chair intends to vote in favour of the resolution.

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Resolution 3: Re-election of Mr Denis Hanley
as a Non Executive Director
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Resolution: “That Mr Denis Hanley is re-elected as a non executive director of the Company.”

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Resolution 3: Re-election of Mr Denis Hanley
as a Non Executive Director
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The Com an has received: p y

• 118,300,431 proxy votes in favour of the resolution;

• 604,583 proxy votes against the resolution;

• 141,173 proxy votes abstaining from the resolution;

• 409,222 proxies able to be voted by the chair which the chair intends to vote in favour of the resolution .

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Resolution 4: Re-election of Mr William
Delaat as a Non Executive Director
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Resolution: “That Mr William Delaat is re-elected as a non executive director of the Company.”

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Resolution 4: Re-election of Mr William
Delaat as a Non Executive Director
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The Com an has received: p y

• 118,599,064 proxy votes in favour of the resolution;

• 303,168 proxy votes against the resolution;

• 143,955 proxy votes abstaining from the resolution;

• • 409,222 proxies able to be voted by the chair which the chair intends to vote in favour of the resolution .

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Thank You for Your Participation

Annual General Meeting November 2011