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restoring healthy skin

ASX:BOT www.botanixpharma.com

AGM Presentation – 30 November 2016

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2 +Notice

Thispresenta,onpreparedbyBotanixPharmaceu,calsLimited("Company")doesnotcons,tute,orformpartof,anoffertosellorthesolicita,onofanoffertosubscribefororbuyanysecuri,es,northesolicita,onofanyvoteorapprovalinanyjurisdic,on,norshalltherebeanysale,issueortransferofthesecuri,esreferredtointhispresenta,oninanyjurisdic,onincontraven,onofapplicablelaw.Personsneedingadviceshouldconsulttheirstockbroker,bankmanager,solicitor,accountantorotherindependentfinancialadvisor.

Thisdocumentisconfiden,alandhasbeenmadeavailableinconfidence.Itmaynotbereproduced,disclosedtothirdpar,esormadepublicinanywayorusedforanypurposeotherthaninconnec,onwiththeproposedinvestmentopportunitywithouttheexpresswriGenpermissionoftheCompany.

Thispresenta,onshouldnotberelieduponasarepresenta,onofanymaGerthatanadvisororpoten,alinvestorshouldconsiderinevalua,ngtheCompany.TheCompanyanditsrelatedbodiescorporateoranyofitsdirectors,agents,officersoremployeesdonotmakeanyrepresenta,onorwarranty,expressorimplied,astotheaccuracyorcompletenessofanyinforma,on,statementsorrepresenta,onscontainedinthispresenta,on,andtheydonotacceptanyliabilitywhatsoever(includinginnegligence)foranyinforma,on,representa,onorstatementmadeinoromiGedfromthispresenta,on.

Thisdocumentcontainscertainforwardlookingstatementswhichinvolveknownandunknownrisks,delaysanduncertain,esnotundertheCompany’scontrolwhichmaycauseactualresults,performanceorachievementsoftheCompanytobemateriallydifferentfromtheresults,performanceorexpecta,onsimpliedbytheseforwardlookingstatements.TheCompanymakesnorepresenta,onorwarranty,expressorimplied,astoorendorsementoftheaccuracyorcompletenessofanyinforma,on,statementsorrepresenta,onscontainedinthispresenta,onwithrespecttotheCompany.

ItisacknowledgedthattheCompanywillnotundertakeanyobliga,ontoreleasepubliclyanyrevisionsorupdatestotheseforward-lookingstatementstoreflectevents,circumstancesorunan,cipatedeventsoccurringaMerthedateofthispresenta,onexceptasrequiredbylaworbyanyappropriateregulatoryauthority.

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3 + Agenda

1.  Recap on Botanix

2.  Achievements since listing/program update

3.  Acne market opportunities and developments

4.  Permetrex™ and other opportunities

5.  Upcoming news flow and milestones

Confidential Property of Botanix Pharma

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4 + Recap on Botanix

n  Focused on new treatments for serious skin diseases – initial target is acne

n  First product (BTX1503) utilizes a synthetic form of cannabidiol as the drug active - pharmaceutical grade and commercially manufactured

n  Permetrex™ is the drug delivery system that provides the technological advantage

n  First products will be in safety and efficacy studies within 12 months of listing

n  Experienced team with more than 10 FDA approvals between them

n  Raised $3.5M to fund Phase 1 studies for (BTX1503)


Business focus:

– medical dermatology

Initial Product:

– BTX 1503 for acne Drug active: – synthetic cannabidiol Drug delivery system: – Permetrex™ F

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78%

Corporate


Team

Chairman Graham Griffiths •  Nearmap •  Pointerra •  NGIS

Exec Director Matt Callahan •  iCeutica •  Churchill Pharma •  Orthocell

Exec Director Dr Bill Bosch •  iCeutica •  Elan Drug Technologies •  Nanosystems

Director Rob Towner •  bioMD •  Triangle Energy •  Cornerstone Corporate

ASX BOT

Offer Price $0.020

Cash raised under the Offer $3,500,000

Share Price (@ close 30/11/16)

$0.046

Market Capitalisation (@close 30/11/16)

$18.6 million

Corporate

Shareholding Structure*

23% 39% Directors & Management New Shareholders

41% Escrowed

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6 +Cannabidiol drug showing promising results…

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7 + BTX1503 – novel mechanism of action in acne

Reduces inflammation

Blocks cell proliferation

Switches off excessive oil or ‘sebum’ production

Reduces infection

BTX1503 also targeting a benign side effect profile

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8 +Source and purity of drug material is important

Extracted and purified Synthetically manufactured

100+ chemicals 1 chemical

Multiple impurities 100% pure

Scaled up to ≈ 1kg Scaled up to 50kg

Not registered with FDA Registered with FDA

Must comply with FDA’s “Guidance on Botanicals”

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9 + The difference is clear

Naturally extracted Cannabidiol Synthetic Cannabidiol

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10 + BTX1503 - planned positioning versus existing acne products


Reduces Sebum ✓ ✗ ✗ ✗ ✗ ✗ ✓

Anti-inflammatory ✓ ✗ ✓ ✓ ✗ ✗ ✓

Anti-microbial ✓ ✓ ✗ ✗ ✓ ✓ ✓

Topical ✓ ✗ ✓ ✓ ✗ ✗ ✗

Minimal side effects ✓ ✗ ✓ ✓ ✗ ✓ ✗

“…the ‘Holy Grail’ of acne treatments would be a topical that can influence sebum production or the physiochemical properties of sebum.”

Prof Emeritus James Leyden

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11 + Agenda







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12 + Objective – avoid the usual drug development process


Sources: * J. A DiMasi et al J Health Econ. 2016 ** http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm093484.htm

✗ 5 Years 7 Years 2 Years

Partner/Exit

$430m* $0.55m** $25.3m** $34.9m** $54m** $5.25m*

Non-capitalized cost in millions USD (2013) For

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13 + Botanix is pursuing a more investable approach


Sources: * J. A DiMasi et al J Health Econ. 2016 ** http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm093484.htm

$430m* $0.55m** $25.3m** $34.9m** $54m** $5.25m*

✔ 6 months 6 months ~28 months

$1m $1.5m ~$5m ~$15m

5 Years 7 Years 2 Years

Partner/Exit

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14 + Achievements since listing


BTX-1503:

n  Source of commercial scale synthetic cannabidiol secured

n  DEA Schedule-1 manufacturer engaged

n  Phase 1 trial formulation manufactured using FDA quality components

n  Genotox, bioassay, animal tox and other testing advanced

n  Phase 1a and 1b product packaging options refined

n  Clinical trial site identified and contracted

n  Phase 1a and 1b clinical trial protocols written

n  FDA standard Permetrex™ formulation manufactured

n  First Permetrex™ safety/irritation study completed and data pending

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15 + Achievements since listing (cont’d)


General:

n  Experienced staff engaged including:

n  Mark Davis – clinical and regulatory – 35 years experience

n  Steve Newhard – manufacturing and packaging – 30 years experience

n  Doug Bakan - manufacturing and packaging – 28 years experience

n  Phil Johns – toxicology – 35 years experience

n  Initial market positioning and competitive assessment completed

n  Business development engagement with potential licensors and partners advancing

n  Pipeline of new products leveraging Permetrex™ platform identified

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16 + BTX 1503 – updated timeline


2016 2017

Formulation manufacturing and testing

Pre-clinical testing and animal studies

Permetrex™ FDA standard manufacturing

Permetrex™ human safety/irritation trial

BTX-1503 FDA standard manufacturing

BTX-1503 FDA material testing

Ethics application, import and licenses

Phase 1a safety study

Phase 1b acne pilot study For

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17 + Agenda







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18 + Market for prescription acne products is very large

Value of the Global Acne Prescription Market is expected to reach $4.5 billion by 2018 (1)

The top branded topical prescription acne products have achieved peak revenues in the range of $85 - $331 million (2)

1) BCC Research, May 2013. Skin Disease Treatment and Global Markets. 2)  Symphony Health Solutions, Pharmaceutical Audit Suite for 2012 as reported in Dermira S1

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19 + Market for OTC and generic acne products is also very large

Revenue from OTC acne treatments expected to increase to $2.7 billion by 2018 (1)

Market is dominated by “me too” reformulations of old drugs and generics that carry significant side effect and patient usage issues (2)

1)  BCC Research, May 2013. Skin Disease Treatment and Global Markets 2)  IBIS Research Acne Treatment Manufacturing OTC Market Research Report Jul 2014

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20 + Nothing new for the last 10 years and little expected


•  No products have approved by FDA in the last 10 years containing a new active ingredient

•  All “new products” launched in this period contain combinations of old drugs in new formulations or packaging

•  50 million patients in the US alone consumed an acne product in 2015

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21 + Agenda







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22 + Permetrex™ - superior skin delivery

With Permetrex™Unmodified Drug


Epidermis

Dermis

Oral delivery of cannabidiol is only 6% bioavailable

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23 + Pipeline – cannabidiol products


BTX 1308 (psoriasis)

BTX 1204 (dermatitis)

•  7.5 million Americans have psoriasis (most have plaque psoriasis)

•  Cost of injectable biologic treatments in 2014 was $20 billion

•  Biologic drugs have serious side effect issues (including lymphoma)

•  US patient incidence estimated to be 31

million people – 10 -18% of children •  Estimated annual cost of treating Atopic

Dermatitis in the US is $3.8 billion •  Most treatments (such as steroids) only

address the symptoms

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24 + Market for skin care products (particularly facial) is significant


Source: Trefis.com, March 2014. Total sales of skin care products at retail selling price

$100 $105 $110 $115 $121 $127 $133 $140 $147 $154

$0

$20

$40

$60

$80

$100

$120

$140

$160

$180

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 An

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Global Skin Care Market – Projected Revenue through 2021

The global skin care market is estimated to be worth $154 billion by 2021

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25 + Many existing acne products can be improved


EPIDUO (Adapalene 0.1%/ BPO 2.5%) NDA 022320 – Phase 3 Trials (n=564) ACANYA (Clindamycin 1%/ BPO 2.5%) NDA 050819 – Phase 3 Trials (n=809)

42%

31%

48%

29%

35%

26%

37%

32%

20%

8%

26%

16%

0%

10%

20%

30%

40%

50%

60%

BPO 2.5% Vehicle BPO 2.5% Vehicle

% Reduction in Lesions and IGA Success

Inflammatory Lesions NonInflammatory lesions IGA Success

Acanya EPIDUO Vehicle Vehicle

EPIDUO Clinical Trial Acanya Clinical Trial

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26 + Agenda







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27 + Upcoming news flow and milestones in next 9 months

n  Permetrex™ safety and irritation clinical study results

n  Ethics application for Phase 1 studies

n  Import licenses for BTX-1503 clinical trial material

n  Collaborative research arrangements

n  New product addition to pipeline (based on Permetrex™)

n  Ethics approval for Phase 1 studies

n  Commencement of Phase 1a study

n  Completion of Phase 1a study and results

n  Commencement of Phase 1b study

n  Completion of Phase 1b study and results

n  New pipeline products data


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28 +Botanix …a compelling investment case

ü  Significant unmet patient needs in serious skin diseases

ü  Novel treatment for acne with a growing evidence base

ü  Proprietary drug delivery system

ü  Fast and efficient development pathway, relative to usual pharmaceutical development

ü  Very large markets with few competing products in development

ü  Experienced team with track record of FDA approvals


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