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SYNTARA LIMITED AGM Information 2013

Nov 26, 2013

65830_rns_2013-11-26_b0c61b41-4cf7-426f-86aa-648873e6584d.pdf

AGM Information

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Annual General Meeting 27 November 2013

An Australian based speciality pharmaceutical company developing therapeutic products for chronic respiratory diseases

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Production GMP manufacture of respirable dry powders

Short term value drivers

Bronchitol for US

•US revenue opportunity - US$160m (adults) •Clarity over approval path achieved – FDA requirements, time and cost •Partnering process underway

Sales of Bronchitol for CF in rest of world

•Revenue opportunity (adults) of US$75m in EU & Australia (direct) and US$70m RoW (indirect) •Sales growth in approved/priced markets •Accessing new markets

Early stage pipeline

•External funds for early stage program •Retain strategic interest in programs

Secure financial footing

•Reduction in cost base•Non equity financing provides US$40m additional funding

Cystic fibrosis

Median FEV1% Predicted versus Age

Source: Cystic Fibrosis Foundation Patient registry report, 2010

Source: Australian CF Registry

Background

  • • Disease characterised by poorly hydrated, tenacious, thick mucus
  • • Main therapeutics
    • •Mostly delivered by nebulizer
    • • rhDNase (Pulmozyme®): global sales ~US$ 500m (2011)
    • • Various inhaled antibiotics: global sales ~US$ 300m

Bronchitol for CF

Adapted from Davis 1996 Am J Respir Crit Care Med

Bronchitol

  • • active ingredient mannitol delivered as an inhalable dry powder
  • •restores airway surface liquid
  • • mucus flow properties improved
  • •increases cilia beat frequency
  • •mucus clearance enhanced

Predictable results in adult CF patients

Bronchitol US value drivers

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Bronchitol unit sales by country

(1 unit = 14 day pack of Bronchitol)

GAliUKTtermanysraau ltoa
Sliaesncreaseover
S-12158%48%epnm 179%
J1314%17%87%un- 25%

Sales of Bronchitol for CF in rest of world

Riegon Ahidceve Ntex
E1ropeu GermanyLhdJ2012ancene•uu/C100%fl8%fllFlii5oargeoacncs•ibiBhiltprescrngroncoPiliddhttaencompanceanaerence•bitsuopmumUKSfhditt•ronggrowseenonceunng()ildAil2013ssuesresoveprfliiibi65%•ocncsprescrngBhiltroncoGdlidittoocompanceanpaen•ittreenonRfEtesoropeuLhdiAi&Dktancensraenmar•uuPdiiitttaearcpaens(C)EUdiiilF204ttpaearcra•dittcommencerecrmenu Iitttncreasecenrepeneraon•Piliiiidittttttonaesorecepaen•vulidffBhiltccngonanoroncoydiidhttanmprovepaenaerencedliancompanceIittt•ncreasecenrepeneraonSdht•upporaerenceQIldil4tttanamepaensaes•y–Piiliitrogressprcngappcaons•fiiEUktorremanngmares

Sales of Bronchitol for CF in rest of world

Riegon Ahidceve Ntex
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Strategic interest in an innovative pipeline of early stage compounds

bjiOtecev Ahidceev Ntex
1 PlilittttursuemupesraegesofdldlttunearysageeveopmenhiitttareanmaxmumiiifPhittparcpaonorarmaxshhldsareoersPhhaarmaresearcllbitcoaoraons Dildiifidiitteaescencscssons•uihhitparmacompanesw Al(Q4ssessae•vuCY)2013
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•Sales increased 15% over June 2012

Australia

•Minimal sales investment in FTE's: US 2.6; RoW 1.0

Jun 09 Jun 10 Jun 11 Jun 12 Jun 13

Europe Korea Clinical Trials US

Aridol Sales

(A$'000)

Aridol

Identifies airway hyperresponsiveness which helps physicians in the overall assessment of asthma

Secure financial footing

Ob jitecev Ahidceev Ntex
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2 Nifiitoneqnancnguy Nidiitttegoaennoae•vv$SU40fiifmnancngromQNtovaues $SRiiU20illiemanngmon•ilblfaaaeromvfSUtcommencemenoliililtcncara

Financial Overview

Annual General Meeting

November 2013

Financial statements

Yddearene 30June
('000hd)ttexceppersareaa J30-13n-u J30-12n-u
$A
Rflfdevenueromsaeogoos 3,237 1,331
Cfltososaes ()1,141 ()522
Gfitrosspro 2,096 809
Iittneresncome 2,695 3,049
Gdhittrananoerncome 5,675 3,874
Expenses
Sl&kitaesmareng ()13,893 ()11,073
Sfdildlttaemecaanregaory,uy ()815,5 ()4,904
Adiiittmnsraon (6,030) (248)5,
Rh&dlBhilt -tesearceeopmenroncov ()18,531 ()19,850
Rh&dlddlt -tesearceveopmennewrugeveopmen ()3315, ()4,195
Fi&litnanceroyaes ()2,945 ()856
Rihttesrcrngcargesuu ()1,690 -
Tltoaexpenses (4,001)5 (46,40)5
Nlbftteosseoreax ()43,535 ()38,718
Itncomeaepensexx ()2 47
Nlfttteossaerax (43,3)57 (38,644)
$Biddildi(l)htascanueearnngsosspersare- (0.030) (0.042)

Revenue

  • •Sales increase
  • • R&D tax credit significant

Sales revenue – FY 2013

  • Bronchitol sales 53% of total
  • Aridol sales increased 15%

Bronchitol sales by country – FY 2013 Total: $1.7m

Mix represents market size and timing of pricing approval /launch sequence

  • •Germany June 12
  • •UK April 13
  • •Australia Aug 12

Financial statements

Ydearene dJ30une
('000hd)ttexceppersareaa 30-J13n-u 30-J12n-u
$A
ffRldeeneromsaeogoosvu 3,237 1,331
Cfltososaes (1,141) (22)5
Gfitrosspro 2,096 809
Iittneresncome 2,695 3,049
Gdhittrananoerncome 5,675 3,874
Epensesx
Sl&kitaesmareng ()13,893 ()11,073
Sfdildlttaemecaanregaory,uy ()815,5 ()4,904
Adiiittmnsraon ()6,030 ()5,248
Rh&dlBhilt -tesearceeopmenroncov ()18,531 ()19,850
Rh&dlddlt -tesearceveopmennewrugeveopmen ()5,331 ()4,519
Fi&litnanceroaesy ()2,945 ()856
Rihttesrucurngcarges (1,690) -
Tltoaepensesx ()54,001 ()46,450
Nlbftteosseoreax (43,3)55 (38,18)7
Itncomeaxexpense ()2 74
Nlfttteossaerax ()43,357 ()38,644
$()Biddildilhtascaneearnngsosspersareu- ()0.030 ()0.042

Expenses

  • • Sales & marketing – mainly EU
  • • Safety – includes FDA costs
  • • Admin – consolidation of functions, corp costs
  • • Finance includes non cash NQ finance expense
  • Restructuring charge re CY 2013 actions, paid out FY 2014
  • •R&D – next slide

Research & development expense (A$'000)

Total R&D tax credit: $5.3m Net cash cost of new drug development: $2.3m

Balance sheet – 30 June 2013 (A$ mil)

Liabilities (A$44m)

  • • Additional US$20m available under NovaQuest agreement on commencement of US CF trial

  • • 2013 R&D tax credit of $4.8m received Oct 13

  • • Finance lease is 15 year lease over 20 Rodborough Rd (11 years remaining)

  • • NovaQuest financing – amount received plus accrued charge. Not repayable other than as % of sales

Shareholder Questions

Annual General Meeting

November 2013

Formal Business

Annual General Meeting

November 2013

Resolution 1 – Financial Report, Directors' Report and the Auditor's Report

No shareholder vote is required

Resolution 2: Adoption of the Remuneration Report

Resolution:

"That the remuneration report of the Company for the year ended 30 June 2013 is adopted."

Resolution 2: Adoption of the Remuneration Report

The Company has received:

  • •43,085,823 proxy votes in favour of the resolution;
  • •8,415,789 proxy votes against the resolution;
  • •47,769,637 proxy votes abstaining from the resolution;
  • •512,127 proxy votes excluded from voting;
  • • 1,116,928 proxies able to be voted by the chair which the chair intends to vote in favour of the resolution.

* Voting exclusions apply

Resolution 3: Re-election of Mr Malcolm McComas as a Non Executive Director

Resolution:

"That Mr Malcolm McComas is re-elected as a non executive director of the Company."

Resolution 3: Re-election of Mr Malcolm McComas as a Non Executive Director

The Company has received:

  • •93,093,208 proxy votes in favour of the resolution;
  • •6,312,013 proxy votes against the resolution;
  • •286,297 proxy votes abstaining from the resolution;
  • • 1,208,786 proxies able to be voted by the chair which the chair intends to vote in favour of the resolution.

Resolution 4: Grant of Performance Rights to Mr Gary Phillips

Resolution:

"That, for the purposes of Listing Rule 10.14 of the Listing Rules of the Australian Securities Exchange (ASX Listing Rules), the Corporations Act 2001 (Cth) (Corporations Act) and for all other purposes, approval is given for the grant of 2,000,000 zero grant and zero exercise price employee options (Performance Rights) to Mr Gary Phillips under the Company's performance rights plan, resolved to be granted by the Board in June 2013 and, upon exercise of those Performance Rights, the acquisition of 2,000,000 ordinary shares underlying those Performance Rights, in accordance with the terms of the performance rights plan and the explanatory statement accompanying this notice of meeting."

Resolution 4: Grant of Performance Rights to Mr Gary Phillips

The Company has received:

  • •90,428,428 proxy votes in favour of the resolution;
  • •8,621,428 proxy votes against the resolution;
  • •303,106 proxy votes abstaining from the resolution;
  • •412,127 proxy votes excluded from voting;
  • • 1,135,215 proxies able to be voted by the chair which the chair intends to vote in favour of the resolution.

* Voting exclusions apply

Thank you for your participation