changing the way the world breathes€¦ · mr ron dewhurst - chairman mr michael johnson – ceo...
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CHANGING THE WAY THE WORLD BREATHES
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R H I N O M E D - N A S A L R E S P I R A T O R Y T E C H N O L O G Y
MASTER INVESTOR APRIL 2016
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This document contains certain forward-looking statements , relating to Rhinomed Limited’s (Rhinomed) business which can be identified by the use of forward lookingterminology such as “promising”, “plans”, “anticipated” “will,” “project,” “believe,” “forecast”, “expected,” “estimated”, “targeting,” “aiming”, “set to”, “potential,” “seekingto”, “goal”, “could provide,” “intends”, “is being developed”, “could be ,” “on track” or similar expressions or by express or implied discussions regarding potential f ilings ormarketing approvals, or potentia l future sales of the company’s technologies and products. Such forward- looking statements involve known and unknown risks, uncertaintiesand other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements.
There can be no assurance that any exis ting or future regulatory filings will satisfy any specific health authority and other health authorities requirements regarding any oneormore product or technology nor can there any assurance that such products or technologies will be approved by any health authorities for sale in any markets or that theywill reach any particular level of sales. In particular,managements expecta tions regarding the approval and commercialization of the technology could be affected by, amongother things, unexpected clinical trial results, including additiona l analysis of exis ting clinical da ta, and new clinical data; unexpected regulatory actions or delays, orgovernment regula tion genera lly; our ability to obtain ormaintain patent or other proprietary inte llectual property protection; competition in general; government, industry,and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, technology, f inancial result, and businessprospects.
Should one of more of these risks or uncertainties materialize , or should underlying assumptions prove incorrect, actual results may vary materially from those describedherein as anticipated, believed, estimated or expected. Rhinomed Is providing this information as of the date of this presentation and does not assume any obligation toupdate any forward –looking statements contained in this document as a result of new information, future events or developments or otherwise.
Disclaimer
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P U R S U I N G A S I G N I F I C A N T G L O B A L O P P O R T U N I T Y
Rhinomedisamplifyingthebeliefthatbetterbreathingcanradicallyimprovehowyouperform,
recover,sleepandmaintainyourhealthbycreatingtheworld’smostelegant,innovativeand
clinicallybackednasalrespiratorytechnology.
Wepartnerwiththeworld’sbestandbrightestpeopletomakethisareality.
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W H O I S R H I N O M E D ?
ASX:RNOEarly stagemedical technology company CashonHand~ 4.0Million
Offices:Melbourne,Australia andCincinnati, USA Revenues FYYTD – AU$750k
SharePrice~AU$0.024 Staff 11
MarketCap~AU$17million 60+patents,13granted plusadditional57designpatents
Globally experiencedboardandmanagementteam
Mr RonDewhurst - Chairman Mr Michael Johnson– CEOandManagingDirector
Mr Brent Scrimshaw- NonExec Director Ms Justineheath - CFO
Dr Eric Knight- NonExec Director Mr ShaneDuncan– HeadAmericas
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Preclinical Phase 1 Regulatory In Market
TURBINE 2.0 OTC Dyspnea in Sport and Exercise
• FDA• TGA
• CANADA HEALTH• CE Mark
Preclinical User Trial
MUTE 1.0OTC Snoring and Sleep Quality
• FDA• TGA
• CANADA HEALTH• CE Mark
Congestion - OTC
Hayfever - OTC
Anxiety - OTC
Preclinical Phase 1 Phase 2 Phase 3 Regulatory In Market
Sleep Apnea
Drug Delivery – Acute Migraine (sumatriptan)
Seeking to partner
A N O V E 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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T U R B I N E – S P O R T B R E A T H I N G T E C H N O L O G Y
• TURBINE2.0- Released Feb2015
• Designed tohelpathletes breatheeasier duringsportandaerobicexercise andhelpsthosesufferingfromnasal
obstruction
• Nowdistributedglobally
• Available inthree sizesandatrialpack
• RRPUS$27.95delivering strongmargins
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TurbinehelpedChrisFroome winhissecondTourdeFrance
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TurbinehelpedShannonRowbury setanewAmericanrecordforthe1500meters
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S L E E P I S A M A J O R E M E R G I N G M A R K E T
Apple includedanew ‘bluelightfunctionintheirnewiphone OS release inMarch‘16
HuffingtonPostfounderAriannaHuffingtonistakingtheUSbystorm
Sleep isbeingpickedupmainstreammedia as a‘healthstory’
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M U T E - C A T E G O R Y D E F I N I N G B R A N D E D T E C H N O L O G Y
• Mutereleased January2015
• Frontline therapy– Snoringandsleep quality
• Available inthree sizesandatrialpack
• RRP£$16.99– delivering strongmargins
• 1pack=1monthssupply(10usesper individualunit)
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M U T E W O R K S – U S E R P R O D U C T T R I A L R E S U L T S
100
100
100
100
100
78%
73%
65%
67%
63%
78%IMPROVEMENT IN BREATHING ATNIGHT
73%REDUCTION IN SNORING SEVERITY
65%REDUCTION IN SNORING DURATION
67%REDUCTION IN SNORING VOLUME
63%REDUCTION IN SNORING FREQUENCY
MuteUser trial.N=236. 5Dayin-homeuser trial.November 2014
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R H I N O M E D H A S A U N I Q U E , C U T T H R O U G H B R A N D
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C U S T O M E R S L O V E M U T E
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SPECIALISTS
GP’S
SLEEPCLINICS
DENTISTS
HOSPITALS
ONLINE
RETAILCHANNEL
ENTSURGEONS
GLOBAL RETAIL PHARMACY
CHANNEL DEPLOYMENT
A M U L T I - C H A N N E L D E P L O Y M E N T M O D E L
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Launched Australia300Pharmacies
UKNov600Pharmacies
NOWTARGETING– 15,000+retailstoresgloballybyendCY17• 2000Pharmacies inAustralia andNew Zealand• 1200Pharmacies inUK• 1200Pharmacies inCanada• 2500Pharmacies inEurope• 15,000Pharmacies inUSA
2015 2016 2017
AppointCanadianDistributor
AppointAmericanSportsDistributor
USLaunchMay1000pharmacies
R A P I D L Y E X P A N D I N G G L O B A L D I S T R U B U T I O N
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I N N O V A T I O N P I P E L I N E
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E N D T O E N D S L E E P C A T E G O R Y S O L U T I O N S
SNORING
ON MARKET
CU
STO
MER
PAT
IEN
T N
UM
BER
MUTE 'CLEAR'Aroma enhanced
(menthol, eucalypt, sleep & relaxation
blends)
NASAL CONGESTION
MILD/MODERATE SLEEP APNEA
SEVERESLEEP APNEA
NAS
AL P
LATF
ORM
RNO INPEAPClinical trials (Reporting
first half 2016)
RNO ASPIRECombination Adjunct
Therapy
RNO + CPAP MaskRNO + Mandibular Splint
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N E X T G E N E R A T I O N N A S A L D E C O N G E S T A N T
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U S $ 8 B I L L I O N D E C O N G E S T I O N M A R K E T
MUTE ‘CLEAR’• Next generationmultiformulation
platform• Overnight nasal decongestant• Class 1product– regulatory process
commencing• Design beingfinalised andproduction
scopingunderway• TARGET RELEASE – DECEMBER 2016
MUTE• Inmarket• Resolves snoring• Improves sleep quality• Adjuncttoexistingsleep therapies
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S L E E P A P N E A – U S $ 3 2 B I L L I O N O P P O R T U N I T Y
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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
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M U T E – A N A D J U N C T T O E X I S T I N G O S A T H E R A P I E S
• Proofofcompliance isincreasingly required byinsurersbefore reimbursement
• RHINOMED nasal stentlowersnasal resistance
• Being increasingly recommended bySleepSpecialists, SleepTechnicians andENT’sasanadjunct
therapy toMandibular AdvancementDevices andLowAHIPatients toresolve compliance issues
• Working closelywithsleep specialists tobeginscopingtrial
Locationof anteriorcoronalsliceLocationof posterior
coronalslice
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I N P E A P – A N E W F R O N T L I N E S L E E P A P N E A T H E R A P Y
• PatentedINPEAPtechnology• Targeting70%ofOSApatientswith
moderateOSA(AHI14-29)• Lowinvasive• Welltolerated• Nasalstentingcoupledwithnasally
deliveredEPAP• TrialunderwayatMonash LungandSleep
Dept.Monash Health
IntranasalPositiveExpiratoryAirwayPressure(INPEAP)
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D R U G D E L I V E R Y – P R O O F O F C O N C E P T
37MILLION AMERICANSSUFFERFROMMIGRAINE
<25%ARESATISFIEDWITHTHEIREXISTINGTHERAPY
US$1.6BILLION - WORLDWIDE SALESOFIMITREX
EFFICACYANDSAFETY ESTABLISHED
. 7,026,000SUMATRIPANPRESCRIPTIONS
WILLSEEKTOPARTNER THISPROGRAM
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S U M M A R Y
• Compellingtechnologyinagrowingglobalmarket
• Businessisrapidlyexpandingrevenuebasethroughglobaldistributionfootprint
• Keyfocusisexpansionin:
• USAandCanada
• UK
• Aust/NZbase
• NearTermnewflow– moredistributionagreements,SleepApneaTrialresultsexpected
• Cashonhand~AU$4.0million
• Compellinginvestmentcomparator– BreatheRightStrips– purchasedbyGSK- US$566min2007
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MICHAEL JOHNSON, CEOe. [email protected]
t. +61 3 8416 0900w. rhinomed.global