© RHINOMED 2014 www.rhinomed.global
R H I N O M E D L I M I T E D
ONEMED FORUM - JANUARY 2015
I N T E R N A L N A S A L T E C H N O L O G Y P L A T F O R M
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Statements contained in this release that are not historical facts are “forward-looking” statements as contemplated by the Private Securities Litigation Reform Act of 1995. This presentation contains forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks that may cause the actual results, performance or achievements of Rhinomed Ltd to be materially different from the statements in this presentation. !!Actual results could differ materially depending on factors such as the availability of resources, the results of clinical studies, the timing and effects of regulatory actions, the strength of competition and the effectiveness of the Company's patent protection. Rhinomed does not undertake to update its forward-looking statements. !!!!
F O R W A R D L O O K I N G S T AT E M E N T S
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RADICALLY IMPROVE THE WAY YOU BREATHE, SLEEP, MAINTAIN YOUR HEALTH, AND TAKE MEDICATION. F
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© RHINOMED 2014 www.rhinomed.global
W H O I S R H I N O M E D ?
• A nasal and respiratory medical technology company based in Melbourne, Australia
• Rhinomed develops, markets and partners it’s internal nasal technology platform into multiple form factors - internal nasal devices !
• Focus is unmet needs in sport & exercise, sleep (snoring, sleep quality and sleep apnea), wellness and drug delivery !
• Launched first product in February 2014, now shipping to 36 countries !• Second product released prior to Christmas!• Raised $7.5m to date !• Market Cap- AUD$13m, CY14 revenue - $527,000 !• Listed: Australian Stock Exchange (ASX:RNO) !• Experienced Board and team including biotech execs and former European CEO of
Nike!
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Nasal dilation
Airflow control
Decongest Filtration
Olfactory Mgmt
Drug Delivery
Air pressure control MeasurementRhinomedBreatheAssist
Technology Platform
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SPORT & EXERCISE Entry market and socialization strategy
OTC SLEEP MARKET Snoring and sleep quality
SLEEP APNEA Clinical applications
WELLNESS Targeting global decongestion, allergy markets
CLINICAL PROGRAM Rhinomed Platform technology
DRUG DELIVERY Acute migraine – sumatriptan –Phase 1 clinical trial
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Preclinical Phase 1 Regulatory In Market
OTC Dyspnoea in Sport and Exercise Further work being
undertaken
• FDA • CE Mark• Early
Revenues
User Trial
OTC Snoring and Sleep Quality
• FDA • CE Mark• Early
Revenues
Preclinical Phase 1 Phase 2 Phase 3 Regulatory In Market
Sleep Apnea Commencing in March
Drug Delivery – Acute Migraine (sumatriptan
Underway
Hayfever - OTC
Congestion - OTC
Anxiety -OTC
E S T A B L I S H E D C L I N I C A L P R O G R A M
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I N I T I A L S T E N T I N G C L I N I C A L T R I A L
• Independent Phase One, proof of principle, clinical trial carried out at the Royal Victorian Eye & Ear Hospital !
• Randomised cross over study (n=20) comparing the RNO001 technology against BreatheRight strips and baseline. !
Stenting the nose with the Rhinomed technology delivered an average of 642.8cc/sec (37.6% increase)in airflow through the nose !
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DRUG DELIVERY
Nasal CongestionOTC WELLNESS
SLEEP
DYSPNOEA
Acute Migraine - Sumatriptan Rhinitus CNS
Snoring Sleep Apnea
Rhinomed Technology Platform
Appetite ManagementAnxiety
Sport & Exercise Yoga & Pilaties
Sleep Quality
Allergy Management
Therapeutic Area
Sleep Screening
M U L T I - P R O D U C T P I P E L I N E - P L AT F O R M T E C H N O L O G Y
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Innovators" Early"Adopters" Early"Majority" Late"Majority"
The"Ch
asm"
10
Early"Market"–"SPORT"(Elite),Athletes,will,more,readily,adopt,technology,that,delivers,value,
Crossing"the"Chasm"–"recreaGonal"trainers"&"snorers"MAMIL’s,A,enthusiasts,who,train,and,snore,and,are,serious,about,their,health,
Mainstream"Market"Broad,market,who,will,accept,the,technology,
based,on,its,clear,uElity,,
S U C C E S S I N E A R LY M A R K E T S D E - R I S K S L AT E R O P P O R T U N I T I E S
• Sleep Quality!• Sleep Apnea!• Snoring!• Clinical treatments!
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SPORT & EXERCISE Entry market and socialization strategy
OTC SLEEP MARKET Snoring and sleep quality
SLEEP APNEA Clinical applications
WELLNESS Targeting global decongestion, allergy markets
CLINICAL PROGRAM Rhinomed Platform technology
DRUG DELIVERY Acute migraine – sumatriptan –Phase 1 clinical trial
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• Registered with US FDA, CE Mark !• Starter pack containing 3 sizes - $12.95 !• Refill 3 pack - $24.95 retail !• Approximately 10 uses per product ($1 a day) !• Optimizing and controlling airflow has advantages in sport and aerobic performance !• Sold on line and through sporting goods stores (15 countries) !• Shipping to over 36 countries since launch in January 2014 !• www.theturbine.com
T H E T U R B I N E
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2 4 . 3 m i l l i o n Americans attended Yoga Studios in 2013
58.5millionAmericans used health clubs in 2012
46 .6mil l ion Americans cycled recreationally in 2013
E A R L Y A D O P T E R T O M A I N S T R E A M G R O W T H
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CHRIS FROOME – 2013 WINNER OF THE TOUR DE FRANCE
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SPORT & EXERCISE Entry market and socialization strategy
OTC SLEEP MARKET Snoring and sleep quality
SLEEP APNEA Clinical applications
WELLNESS Targeting global decongestion, allergy markets
CLINICAL PROGRAM Rhinomed Platform technology
DRUG DELIVERY Acute migraine – sumatriptan –Phase 1 clinical trial
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PHASE 1- OTC SNORING
1"
2"
3"
SLEEP"MARKET"
C L E A R L I N E A R P R O G R E S S I O N I N S L E E P M A R K E T
PHASE 2 - SLEEP QUALITY
PHASE 3 - SLEEP APNEAF
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S N O R I N G I S A R E A L I S S U E F O R M A N Y
64%"OF,AMERICAN,HOUSEHOLDS,HAVE,ONE,OR,MORE,MEMBERS,WHO,SNORE,REGULARLY,,
ONLINE,SURVEY,OF,1005,AMERICAN,HOUSEHOLDS,NOVEMBER,2014,IPSOS,
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I M P A C T S T H E S N O R E R A N D T H E I R P A R T N E R
79%"OF,THE,SUBJECTS,REPORTED,THEIR,PARTNERS,SNORING,EFFECTED,THEIR,ABILITY,TO,GET,AN,UNINTERRUPTED,SLEEP,
ONLINE,SURVEY,OF,1005,AMERICAN,HOUSEHOLDS,NOVEMBER,2014,IPSOS,
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Discrete translucent medical grade polymers!
Dilates from the back of the nose minimising pressure on the Septum!
Designed to mold to the internal surface of the nostril and enable increased airflow!
Enclosed ratchet mechanism that delivers perfect individualised fit!
Unique and anatomically inspired design!
A N A T O M I C A L LY I N S P I R E D , D E S I G N E D F O R C O M F O R T
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• Registered with US FDA, European Authority (CE Mark), Australian TGA !• Available as:!
• Starter pack containing 3 sizes!• Refill pack in Small, Medium, Large!
• Recommended Retail Price!• Starter pack $12.95!• Refill pack $29.95!
• Achieve ten nights per device - $1 a day !• Distribution!
• Sold online at www.mutesnoring.com!• Trialing programs!• Seeking US pharmacy distribution in 2015!
T E S T M A R K E T I N G U N D E R W AY
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M U T E W O R K S - I N H O M E U S E R P R O D U C T T R I A L R E S U LT S
75%"OF,THE,SUBJECTS,REPORTED,A,REDUCTION,IN,SNORING,
2014,USER,TRIAL,N=236,INCLUDING,5,DAYS,OF,CONTINUAL,USE,
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M U T E U S E R S S A W I M P R O V E M E N T A C R O S S T H E B O A R D
78%"IMPROVEMENT,IN,BREATHING,AT,NIGHT,
73%,REDUCTION,IN,SNORING,SEVERITY,
65%,REDUCTION,IN,SNORING,DURATION,
67%,REDUCTION,IN,SNORING,VOLUME,
63%,REDUCTION,IN,SNORING,FREQUENCY,
2014,USER,TRIAL,N=236,INCLUDING,5,DAYS,OF,CONTINUAL,USE,
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S L E E P Q U A L I T Y D R A M A T I C A L LY I M P R O V E D G
OO
D/EX
CELL
ENT
SLEE
P Q
UALI
TY
GO
OD/
EXCE
LLEN
T SL
EEP
QUA
LITY
SNORER! PARTNER!
WITH MUTE WITH MUTE
21%!
57%!
14%!
60%!
2014,USER,TRIAL,N=236,INCLUDING,5,DAYS,OF,CONTINUAL,USE,
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SPORT & EXERCISE Entry market and socialization strategy
OTC SLEEP MARKET Snoring and sleep quality
SLEEP APNEA Clinical applications
WELLNESS Targeting global decongestion, allergy markets
CLINICAL PROGRAM Rhinomed Platform technology
DRUG DELIVERY Acute migraine – sumatriptan –Phase 1 clinical trial
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S L E E P A P N E A – A B I L L I O N D O L L A R M A R K E T
Wisconsin Sleep Cohort Study (WSCS)
Classification % US Pop’n Prevalence
FEMALE MILD 9% 14 million
SEVERE 4% 6.2 million
MALE MILD 24% 36.8 million
SEVERE 9% 13.8 million
• REVENUES – CURRENTY $BILLION !• Vast majority of patients remain undiagnosed !• According to McKinsey & Co analysis (Harvard Medical School, 2010) the Annual total costs of
OSA is $165 billion!
50.8 MILLION PATIENTS!
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W I T H A B I L L I O N D O L L A R P R O B L E M
80% OF THOSE WITH APNEA REMAIN UNDIAGNOSED!
< 38% COMPLIANCE RATES. !
HIGH ENTRY COST FOR TREATMENT. !
FEW ALTERNATIVE TREATMENTS !
ALL HIGHLY INVASIVE AND WITH LOW ACCEPTANCE. !
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• During Inspiration, the Rhinomed technology stents the nostrils allowing an average 38% more air to enter the airways !
• During Expiration the Rhinomed technology can: !– Increase airway pressure and expand the upper airway !– Increased FRC exerts traction on the airway during end expiration. Both
mechanisms can assist in keeping the airway open. !
N A S A L S T E N T I N G A N D VA R I B A L E S T E N T I N G T R I A L
• Variable stenting• Increase air pressure during expiration• Low invasive technology• Targeting mild to moderate Sleep Apnea
Stand alone therapy
• Stenting nose during use of CPAP masks• Stenting nose during use of Manibular
splintsCompanion
therapy
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SPORT & EXERCISE Entry market and socialization strategy
OTC SLEEP MARKET Snoring and sleep quality
SLEEP APNEA Clinical applications
WELLNESS Targeting global decongestion, allergy markets
CLINICAL PROGRAM Rhinomed Platform technology
DRUG DELIVERY Acute migraine – sumatriptan –Phase 1 clinical trial
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OTC"
DecongesGon" Anxiety"
AppeGte"suppressant"
DECONESTION!‣ Proprietary recipe of natural
essential oils!‣ Decongestant !‣ Targeting use in sport and wellness !
ANXIETY!‣ Relaxation and sleep problems !‣ Between 2006-11 OTC Sleep aids
grew by 31%!‣ Proprietary recipe of natural
essential oils!
APPETITE MANAGEMENT!‣ Weight management market !‣ Direct to Consumer program !‣ Proprietary recipe of natural
essential oils!
I N T R O D U C I N G S C E N T I N T O T H E P L AT F O R M
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N O V E L I N - S I T U N A S A L C O N G E S T I O N S O L U T I O N
4,240
1,087.8
677.9
589.3
515.9
283.3
191.7
89.6
1,906.4
456.5
326.2
234.7
253.9
61.7
38
38.6
0 500 1000 1500 2000 2500 3000 3500 4000 4500
Cold/allergy/sinus tablets
Cold/allergy/sinus liquids
Nasal products
Cough drops
Cough syrup
Humidifiers
Hand sanitizer
Chest rubs
Market value in million U.S. dollars
Cou
gh/c
old
prod
uct
Multi-outlet* Drug
Source: Drug Store News; ID 255222
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W E I G H T M A N A G E M E N T M A R K E T O P P O R T U N I T Y
SOURCE:,HIRSCH,AR,,GOMEZ,R:,Weight,reducEon,through,inhalaEon,of,odorants.,J.,Neurological,and,Orthopedic,medicine,and,Surgery,1995,16:26A31,
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SPORT & EXERCISE Entry market and socialization strategy
OTC SLEEP MARKET Snoring and sleep quality
SLEEP APNEA Clinical applications
WELLNESS Targeting global decongestion, allergy markets
CLINICAL PROGRAM Rhinomed Platform technology
DRUG DELIVERY Acute migraine – sumatriptan –Phase 1 clinical trial
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S I G N I F I C A N T O P P O R T U N I T Y - A C U T E M I G R A I N E
37 MILLION AMERICANS SUFFER FROM MIGRAINE!
< 25% ARE SATISFIED WITH THEIR EXISTING THERAPY !
US$1.6 BILLION - WORLDWIDE SALES OF IMITREX
EFFICACY AND SAFETY ESTABLISHED
. ! 7,026,000 SUMATRIPAN PRESCRIPTIONS
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• Investigate potential of drug delivery mechanism: !– API (sumatriptan) delivered direct to nasal mucosa !
D R U G D E L I V E R Y P R O G R A M
Sumatriptan Clinical Program
Phase 1- Bio-equivalence study !Comparator – Imitrex spray (GSK) !
Comparing onset (PK levels)!
N=20!
CMAX (Royal Adelaide Hospital !
Results expected mid year !
Potential competitive advantages
rapid onset!no loss of drug down throat (nausea) !
self titration!
in situ delivery!
established acceptance and awareness !
controlled admin and sustained release vs one-off dosing of nasal sprays!
direct delivery into blood stream avoids first-pass liver drug removal of oral admin!
nose-brain pathway allows direct delivery to circulatory system & cns!
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• Existing pipeline with multiple revenue generating streams both direct and through partnerships!
• Rapid innovation and commercialization model - early revenues starting to flow !
• Growing existing product lines and expanding global distribution footprint!
• Continue clinical development program in Sleep and Drug Delivery !
• Sleep apnea and sleep quality program – July 2015 !
• Drug Delivery – Sumatriptan (Acute Migraine) – May 2015 !
• “Owning sleep” through strong consumer brand focus !
• Near term value inflection points!
• Well financed, business unit breakeven during CY2015 !
I N V E S T M E N T H I G H L I G H T S
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Michael Johnson, CEO [email protected]!
+ 61 (0) 3 8416 0900 !www.rhinomed.global !
!
C O N T A C T
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