ASX  Release  No.  803   17  November  2015   Page  1  of  1  

                               ACN  090  987  250  

ASX  Release  

SUDA  LTD:  2015  ANNUAL  GENERAL  MEETING  

PRESENTATION  

PERTH,   AUSTRALIA   -­‐   17   November   2015:   SUDA   LTD   (ASX:   SUD)   announces   that   the  Company’s   2015   Annual   General   Meeting   will   be   held   today   at   10.30am   (GMT+8)   in  Perth,  Western  Australia.  

The  following  presentation  will  be  given  at  the  Meeting.  

 

Further  information:  STEPHEN  CARTER  MANAGING  DIRECTOR  /  CEO  SUDA  LTD  Tel:  +61  8  6142  5555  sjcarter@sudaltd.com.au    NOTES  TO  EDITORS:  

About  SUDA  LTD  SUDA  LTD  (ASX:  SUD)  is  a  drug  delivery  company  focused  on  oro-­‐mucosal  administration,  headquartered  in  Perth,  Western  Australia.  The  Company   is  developing  novel  oral  spray  formulations  of  existing  off-­‐patent  pharmaceuticals   using   its   proprietary   OroMist®   drug   delivery   technology   platform.   The   many   potential  benefits  of  administering  drugs  through  the  oral  mucosa  (ie:  cheeks,  tongue,  gums  and  palate)  include  ease  of   use,   lower   dosage,   reduced   side   effects   and   faster   response   time.   SUDA’s   product   pipeline   includes  ZolpiMist®,  a   first-­‐in-­‐class  oral   spray  of  zolpidem  for   insomnia.  ZolpiMist®  has  been  approved   in   the  USA  and   SUDA   has   rights   to   the   product   outside   of   the   Americas   and   South   Africa.   SUDA’s   most   advanced  development-­‐stage  product,  ArTiMist™,  is  a  novel  sublingual  malaria  treatment  for  children.  In  a  Phase  III  trial,  ArTiMist™  was  shown  to  be  superior  to  intravenous  quinine.  Other  products  in  development  include  oral  sprays  for  the  treatment  of  migraine  headache,  chemotherapy-­‐induced  nausea  and  vomiting,  erectile  dysfunction  and  pre-­‐procedural  anxiety.  For  more  information,  visit  www.sudaltd.com.au  

 

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Drug  delivery  through  the  oral  mucosa  

Stephen  Carter  -­‐  Chief  Execu;ve  Officer  

ANNUAL  GENERAL  MEETING  17  November  2015  

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The purpose of the presentation is to provide an update of the business of SUDA LTD (ASX:SUD) [‘SUDA’]. These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by SUDA and should not be relied upon as an independent source of information. Please contact SUDA and/or refer to the Company's website for further information.

The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified. No representation or warranty is made as to the accuracy, completeness or reliability of the information.

Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside SUDA’s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks. Because actual results could differ materially to assumptions made and SUDA’s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution.

This presentation should not be relied on as a recommendation or forecast by SUDA. Nothing in this presentation should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.

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Disclaimer  

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Introduc;on  

§ Oral  mucosa  is  ideal  for  drug  delivery,  avoiding  first-­‐pass  metabolism  effects  

§ Oro-­‐mucosal  sprays  have  unique  advantages  vs.  other  routes  of  administra=on  

§  SUDA’s  OroMist  sprays  facilitate  new  indica=ons  and  can  breathe  new  life  into  exis=ng  therapies  with  poor  bioavailability  or  requiring  a  rapid  therapeu=c  effect  

§  SUDA  has  mul=ple  patent  families  granted  and  pending  in  both  North  America  and  Europe,  covering  300  high-­‐usage  exis=ng  drugs    

§  SUDA  has  extensive  proprietary  technology,  exper=se  and  knowhow  in  formula=ng  and  manufacturing  oral  sprays  

§  SUDA’s  first-­‐in-­‐class  oral  sprays  have  demonstrated  meaningful  advantages  vs.  standard-­‐of-­‐care  tablets  in  mul=ple  clinical  studies  

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Oro-­‐mucosal  spray  delivery  |  Highly  effec;ve  drug  delivery  method  

Source:  Physician’s  Desk  Reference,  NPPDR,  No.  18:676,  1997    

Bioavailability  in  excess  of  90%  via  the  oral  mucosa  

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Oro-­‐mucosal  spray  delivery  |  Efficient  &  effec;ve  

§ Oral  mucosa  is  the  lining  of  the  mouth,  richly  supplied  by  blood  vessels  

§ Oral  mucosa  comprises  various  surfaces  with  differing  levels  of  kera=niza=on  

§ Key  areas  within  the  oral  mucosa,  in  decreasing  order  of  absorp=on  are:  

– Sublingual  

– Lingual  

– Buccal  

– Gingival  

– Palatal  

Drugs  absorbed  via  the  oral  mucosa  are  delivered  directly  into  the  blood,  avoiding  first-­‐pass  metabolism  effects  of  the  liver  and  gut  wall  

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Oro-­‐mucosal  spray  delivery  |  Unique  advantages  

§  Avoids  hepa=c  first-­‐pass  effect  

§  Faster  onset  of  ac=on  

§  Increased  bioavailability,  hence  reduc=on  in  dose  

§  Reduces  plasma  level  variability  for  drugs  with  food  effect  

§  Avoids  gastro-­‐intes=nal  side  effects  

§  Greater  tolerability  in  pa=ents  with  nausea  and  vomi=ng    

§  Can  be  administered  to  unconscious  and  uncoopera=ve  pa=ents  

§  High  pa=ent   compliance  due   to   elimina=on  of   injec=on  pain   or   the  need   to  swallow1,2  or  inhale  

1.  >40%  of  adults  experience  difficul=es  swallowing  2.  >50%  of  children  (6  to  11  years)  have  problems  swallowing  tablets   6  

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OroMist®  technology  |  Drug  &  device  capabili;es  

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§ Technology  for  producing  OroMist®  formula=ons  u=lising   polar   and   non-­‐polar   solvents,   GRAS  excipients  and  propellants  

§ Experience   with   different   pump   systems   -­‐   air-­‐ac=vated   pumps   and     propellant-­‐driven   aerosol  sprays  

§ Experience  with    different  containers  -­‐  mul=-­‐dose  and  single-­‐unit  

§ Exper=se   with   a   range   of   flavoring   and   taste  modifying   agents,   -­‐   synthe=c   or   natural  peppermint,  spearmint,  citrus  oils,   fruit  flavours,  honey  and  sweeteners    

§ Exper=se  with  penetra=on  enhancers  to  increase  permeability  via  mucosa  

 

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Pipeline|  Targe;ng  large  markets  

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USA  

*    SUDA  has  an  exclusive  license  to  ZolpiMist®  in  all  countries  excluding  the  Americas  and  South  Africa  

Product   Ac=ve  Ingredient  

Mkt  Size  

Marke=ng  Approval  Clinical  Pre-­‐

clinical  

Insomnia  *ZolpiMist®   $2.1bn  Zolpidem  

Chemotherapy  induced  nausea  &  vomi=ng  SUD-­‐002   $2.5bn  Ondansetron  

Pre-­‐procedural  anxiety  SUD-­‐005   $170m  Midazolam  

Migraine  headache  SUD-­‐001   $3.2bn  Sumatriptan  

Erec=le  dysfunc=on  SUD-­‐003  DuroMist™   $4.1bn  Sildenafil  

Pulmonary  arterial  hypertension  SUD-­‐004   $2.7bn  Sildenafil  

Malaria  Ar=Mist™   >$500m  Artemether  

Partnerships  (Incl.  territories)  

• Amherst  (Americas  &  ZA)  •  Kwang  Dong  (Korea)      

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2015  Highlights|  Progressing  towards  our  BD  goals  

§  Mee=ngs  with  approx  200  Pharma  since  start  of  outreach  in  March  2014  

§  Ac=ve  discussions  span  in-­‐house  pipeline  &  applica=ons  of  OroMist®  technology  

§  Over  30  companies  at  various  stages  of  due  diligence  or  term  sheet  nego=a=on  

§  Poten=al  for  mul=ple  licensing  deals  in  FY2015/6  and  beyond  

Number  of  Pharma  companies  met  since  start  of  outreach  

     196  

Number  of  companies  in  ac=ve  

discussions    56  

Number  of  cos.  in  confiden=al  

dialogue/full  DD    31  

Number  of  Material  Transfer  Agreements    

   7  signed  

2  under  review  

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2015  Highlights|  Adding  value  to  ArTiMist™  

§  Expanding  the  use  of  ArTiMist™  as  an  early  interven=onal  ‘pre-­‐referral’  therapy  -  Clinical  Advisory  Board  has  finalised  the  clinical  protocol    

-  Ongoing  support  from  the  Medicines  for  Malaria  Venture  

-  Global  philanthropic  funds  have  indicated  interest  in  funding  the  trial  

§  Pursuing  adop=on  by  WHO  in  Treatment  Guidelines  for  severe  paediatric  malaria  

-  Ongoing  dialogue  with  WHO’s  Global  Malarial  Programme  

-  Preparing  to  submit  for  stringent  regulatory  review  by  the  TGA  in  Australia  

-  Three  peer-­‐reviewed  papers  published  in  pres=gious  US  medical  journal  

ArTiMist™  has  huge  potenDal  as  an  early  intervenDonal  treatment  for  

children  with  malaria  

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2015  Highlights|  Gained  ZolpiMist®  oral  insomnia  spray  

ZolpiMist®  has  a  superior  profile  to  market-­‐leading  

Ambien®  tablet  

§  Rapidly   absorbed   with   detectable   plasma  levels  immediately  following  administra=on  

§  ZolpiMist®   requires   no   further   development  work  for  approval  in  most  countries  

§  Progressing   licensing   discussions   in   several  territories  with  compe==ve  interest  

§  ZolpiMist®   is   a   first-­‐in-­‐class   oral   spray   of   zolpidem   (Sanofi’s   S=lnox®   tablet)  for  treatment  of  insomnia  

§  ZolpiMist®  has  been  approved  by  the  FDA  and  licensed  to  SUDA  for  the  world  excluding  Americas  &  South  Africa  in  January  2015  

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ZolpiMist®  |  Sleep  response  

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S;lnox®    ZolpiMist®  

Head-­‐to-­‐head  drowsiness  study  of  ZolpiMist®  against  market  leading  S;lnox®  tablets  

Redu

c;on

 in  DSST  Score  from

 baseline  at  13  min.  

-­‐12  

-­‐10    

-­‐8    

-­‐6    

-­‐4    

-­‐2  

0  

1      

-­‐3.7  

-­‐8.2  

-­‐3.3  

-­‐13.6  

P  <  0.001   P  <  0.005  

10mg   5mg  

Digit  Symbol  SubsDtuDon  Test  (DSST)  is  a  measure  of  aQenDon,  perceptual  speed,  motor  speed,  visual  scanning  and  memory  (ie:  alertness)  

ZolpiMist®  demonstrated  significant  faster  onset  of  seda;on    compared  to  S;lnox®  tablets  

The Most Widely Prescribed Agent for Treating Insomnia is now

available as a convenient 0ral Spray

CIV

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2015  Highlights  |  Successful  SUD-­‐001  mee;ng  with  FDA  §  SUD-­‐001  is  first  oral  spray  of  sumatriptan  (GSK’s  Imitrex®  tablet)  for  rapid  relief  of  

migraine  headache  

§  Phase  II  study  showed  quicker  onset  of  ac=on  and  less  drug  needed  to  achieve  pain  relief  vs.  Imitrex®  tablet  

§  Primary  Market  Research  suggests  prescribers  &  payers  see  important  role  for  SUD-­‐001  in  pa=ents  with  nausea,  GI  problems  or  sudden  onset  headaches  

§  Op=mised  second-­‐genera=on  SUD-­‐001  with  pleasant  mint  flavour  

§  Successful  mee=ng  with  FDA  in  July  2015  regarding  pivotal  development  plan  

-  FDA  accepted  novel  pharmacokine=c  trial  design,  thus  avoiding  the  need  for  costly  efficacy  studies  prior  to  approval    

SUD-­‐001  has  superior  profile  to  market  leading  Imitrex®  tablet  

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2015  Highlights  |  Enhanced  2nd-­‐gen  SUD-­‐003  formula;on  

§  SUD-­‐003  (DuroMist™)  is  first  oral  spray  of  sildenafil  (Pfizer’s  Viagra®  tablet)  for  erec=le  dysfunc=on  

§  First-­‐genera=on  SUD-­‐003  showed  superior  bioavailability  vs.  Viagra®  

§  Op=mising   second-­‐genera=on   formula=on   with   mint   flavour   and   enhanced  absorp=on  characteris=cs    

§  Objec=ve   to   achieve   quicker   onset   of   ac=on   with   second-­‐genera=on  formula=on  

DuroMist™  offers  ease  of  administraDon  and  potenDally  faster  onset  of  acDon  than  

Viagra®  tablet  

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2nd-­‐genera;on  SUD-­‐003  shows  16x  increase  in  permea;on  vs.  1st-­‐genera;on  SUD-­‐003  at  1-­‐hr  ;me  point  in  in-­‐vitro  Franz  Cell  passive  membrane  studies    

SUD-­‐003  |  In-­‐vitro  data  confirm  permea;on  enhancement  

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2015  Highlights  |  Westcoast  growth  &  investment  

§  Wholly-­‐owned  subsidiary,  surgical  and  medical  supplies,  based  in  Western  Australia  

§  Four  core  business  units  servicing:    

-  Aged  care    

-  Hospitals  

-  Allied  health  

-  Mining  

§  FY2015  revenue  (excluding  deten=on  centres)  increased  23%  to  $5.7  million  vs.  previous  year  

§  Inves=ng  in  new  higher-­‐margin  revenue  streams    

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Financials    (Year-­‐end:  June)

Revenue  FY2015 $5.7  million

Net  opera<ng  cash  loss  FY2015 ($3.2  million)

Net  cash  30  September  2015 $4.2  million

Shares  in  issue 1,141  million

Conver<ble  notes $1.6  million  conver<ble  to  54  million  shares

Key  data  &  financial  snapshot  Corporate  key  data

ASX  Code SUD:AU

Current  share  price  (Australian  $) $0.030

52  week  range $0.024-­‐$0.075

Average  volume  (30-­‐day) 1.8  million

Market  cap $34  million

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Summary  §  World-­‐leading  proprietary  technology  for  reformula=ng  drugs  into  high-­‐value  

oral  sprays  

§  Pipeline   of   oral   sprays   offering   superior   profiles   (eg:   faster   onset)   than  standard  of  care  

§  Targe=ng  large  markets  with  short  =melines  for  development    

§  Strategy  for  rapid  value  crea=on  through  collabora=ons  or  trade  sales  

-  An=cipate  first  cash  inflow  from  licensing  deals  in  FY2015/16  

-  An=cipate  first  royalty  streams  from  product  sales  in  FY2016/17  

 

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 Level  1,  Unit  12,  55  Howe  Street  Osborne  Park,  Western  Australia  6017  PO  Box  1719  Osborne  Park  BC,  WA  6916  

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 (T)  +61  8  6142  5555  (F)  +61  8  9443  8858  (W)  www.sudaltd.com.au  (E)  suda@sudaltd.com.au    

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