RHINOMED LIMITED - ASX · © RHINOMED 2014 RADICALLY IMPROVE THE WAY YOU BREATHE, SLEEP, MAINTAIN...

© 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

For

per

sona

l use

onl

y


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

For

per

sona

l use

onl

y


RADICALLY IMPROVE THE WAY YOU BREATHE, SLEEP, MAINTAIN YOUR HEALTH, AND TAKE MEDICATION. F

or p

erso

nal u

se o

nly


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!

For

per

sona

l use

onl

y


Nasal dilation

Airflow control

Decongest Filtration

Olfactory Mgmt

Drug Delivery

Air pressure control MeasurementRhinomedBreatheAssist

Technology Platform

For

per

sona

l use

onl

y

© RHINOMED 2014 www.rhinomed.global 6

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

1"

2"

3"

4"

5"

6"

For

per

sona

l use

onl

y


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

For

per

sona

l use

onl

y


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 !

For

per

sona

l use

onl

y


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

For

per

sona

l use

onl

y


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!

For

per

sona

l use

onl

y








1"

2"

3"

4"

5"

6"

For

per

sona

l use

onl

y


For

per

sona

l use

onl

y


•  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

For

per

sona

l use

onl

y


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

For

per

sona

l use

onl

y


CHRIS FROOME – 2013 WINNER OF THE TOUR DE FRANCE

For

per

sona

l use

onl

y








1"

2"

3"

4"

5"

6"

For

per

sona

l use

onl

y


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

or p

erso

nal u

se o

nly


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,

For

per

sona

l use

onl

y


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,

For

per

sona

l use

onl

y


For

per

sona

l use

onl

y


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

For

per

sona

l use

onl

y


•  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

For

per

sona

l use

onl

y


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,

For

per

sona

l use

onl

y


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,


For

per

sona

l use

onl

y


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%!


For

per

sona

l use

onl

y








1"

2"

3"

4"

5"

6"

For

per

sona

l use

onl

y


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!

For

per

sona

l use

onl

y


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. !

For

per

sona

l use

onl

y


•  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

For

per

sona

l use

onl

y








1"

2"

3"

4"

5"

6"

For

per

sona

l use

onl

y


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

For

per

sona

l use

onl

y


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

For

per

sona

l use

onl

y


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,

For

per

sona

l use

onl

y








1"

2"

3"

4"

5"

6"

For

per

sona

l use

onl

y


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

For

per

sona

l use

onl

y


•  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!

For

per

sona

l use

onl

y


•  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

For

per

sona

l use

onl

y


Michael Johnson, CEO [email protected]!

+ 61 (0) 3 8416 0900 !www.rhinomed.global !

!

C O N T A C T

For

per

sona

l use

onl

y

RHINOMED LIMITED - ASX · © RHINOMED 2014 RADICALLY IMPROVE THE WAY YOU BREATHE, SLEEP, MAINTAIN...

Documents

Transcript of RHINOMED LIMITED - ASX · © RHINOMED 2014 RADICALLY IMPROVE THE WAY YOU BREATHE, SLEEP, MAINTAIN...