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BOTANIX PHARMACEUTICALS LTD AGM Information 2022

Nov 22, 2022

64551_rns_2022-11-22_d9caeebf-5a36-43b0-859b-30237c1ed50c.pdf

AGM Information

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Investor Update AGM November 2022

Preparing for FDA approval of first product in 3Q 2022

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Botanix: a leader in topical drug development

First product filed for FDA approval in a $1.6 billion market

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Dermatology focus

New treatments for common skin diseases - such as excessive sweating (hyperhidrosis), rosacea and acne – as well as lifethreatening bacterial infections

World class team

US based team that have been responsible for more than 30 dermatology drug developments and launches

Successful rosacea Phase 1/2 study Both 10% and 20% BTX 1702 active arms showed clinically meaningful improvements across all efficacy endpoints

Sofpironium Bromide

First and only new drug for “primary axillary hyperhidrosis” (medical condition which results in excessive underarm sweating) already approved in Japan and sales ramping up with partner[1]

Near-term catalysts

Upcoming Day 74 date for Sofpironium Bromide in December CY2022 and mid-cycle review in March CY2023

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Source 1 : ASX release May 4 2022

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Corporate Modest market cap for a
Overview company with a Phase 3 asset
pending FDA approval
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ASX: BOT TRADING INFORMATION

Share price A$0.063 6-month low / high A$0.056/0.077 Shares outstanding 1,156,011,477 Market Capitalisation A$72.8m Cash (30 Sep 2022) A$ 10.1m* Debt (30 Sep 2022) Nil Enterprise value A$62m

SUBSTANTIAL SHAREHOLDERS

Shareholder % Board and Management 8.0% Antares Capital Partners 6.1%

SHARE PRICE PERFORMANCE

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BOT
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6.3 cents
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  • Excludes $5M placement to Antares Capital Partners in October 2022

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Sofpironium Bromide leads
late-stage pipeline Filed for FDA approval in 3Q 2022
with 12-month review period
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INDICATION PRODUCT PHASE 1 PHASE 1B PHASE 2 PHASE 3 APPROVED STATUS (CY)
Axillary Hyperhidrosis
(excessive underarm
sweating)
Sofprionium
Bromide
FDA approval filing
planned for 3Q 2022
Moderate to
severe acne
BTX 1503 Phase 3 study
commencement pending
Rosacea BTX 1702 Successful Phase 2 study
announced in 3Q 2022
Atopic Dermatitis BTX 1204A Canine study
completed 3Q 2022
Antimicrobial BTX 1801 Phase 2 study pending

Bromide is a in its own Sofpironium significant opportunity right, but also fits well rosacea and dermatitis alongside acne,

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Sofpironium Bromide

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Recap – NDA filed for Sofpironium Bromide in 3Q 2022

Positive Phase 3 data, Japanese approval and rapidly growing Japanese sales help de-risk FDA approval and launch

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Addressing unmet needs

First and only new chemical entity for “primary axillary hyperhidrosis”

Positive Phase 3 Data

All co-primary and secondary endpoints were statistically significant with no treatment-related serious adverse events

Significant Market

More than 16 million people suffer from hyperhidrosis in the US - market is ~$US1.6B per annum and projected to grow to $US2.8B by 2030[1,2]

NDA submitted and milestones upcoming NDA submitted in 3Q 2022, with Day 74 letter expected in December 2022, mid-cycle review in March 2023 and approval in 3Q 2023

De-risked Asset

Molecule already approved by Japanese equivalent of the FDA with partner Kaken Pharmaceuticals and recently launched in Japan

Sources: 1. Doolittle, J. et al. Arch Dermatol Res, 2016. 2. Reports and Data, “Hyperhidrosis Treatment Market By Treatment Type, By Disease Type, By End-User, By Regional Outlook, and Segment Forecasts, 2022.

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Significant unmet need
Few options that are effective and
for new hyperhidrosis
affordable for patients
treatments
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Stakeholders indicated the top two unmet needs are as follows: 1) New treatment options (i.e., limited options) and 2) and More efficacious treatments without access/cost concerns.

A rating of 4 out of 7 is high based on our experience with payers across therapeutic areas

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Unmet Need: ~6 out of 7
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Unmet Need: ~4 out of 7
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Unmet Need: ~6 out of 7
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“I can count on one hand my total armory for treating hyperhidrosis. I need more tools in my toolbox and a ” . convenient product for my patients

– Dermatologist

“The treatments that we have are not very convenient “We are always looking for more efficacious therapies and are pretty costly . I just feel like there are not that are easier to take …”enough options. Payer – Patient

With ~13M hyperhidrosis patients in the US , a significant opportunity exists for a new topical product to address an unmet need if it is effective, convenient, and not priced prohibitively.

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Source: Triangle Insights conducted interviews with US dermatologists (n=20), US payers (n=10), US patients (n=20)

Confirmation of first and second line treatment usage

Hyperhidrosis Current Treatment

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First-Line Second Line
Third-Line &
Initial Presentation Failure of 1L
(1L) (2L)
Beyond
to Dermatologist Therapy
Physician- OTC Topical Rx Topical
Patients Failing Qbrexza Miradry
Reported [2] Antiperspirants Antiperspirant (Drysol)
1L Therapy:
Average Systemic Orals Surgery
~47%
Botox Injections ETS
Severity
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(ETS) Endoscopic thoracic sympathectomy

Source: Triangle Insights conducted interviews with US dermatologists (n=20), US payers (n=10), US patients (n=20)

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SB is positioned to largely displace other to ical roducts p p

Both first line and second line prescription preferences favor SB

Dermatologist Treatment Preferences and Anticipated Future SBG Prescribing

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*Share of patients by treatment type shows a weighted average across severities Source: Triangle Insights conducted interviews with US dermatologists (n=20), US payers (n=10), US patients (n=20)

Market opportunity for hyperhidrosis[1]

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336,107m
USA population
16.1m
Hyperhidrosis patients
11.2m
All severe patients
7.3m
Severe axillary only
3.7m
Seek Medical
Treatment
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Even a modest market share provides a significant financial opportunity

Share of patients already
seeking treatment
Patients Potential gross
sales*
0.5% 18,500 $144,300,000
1.0% 36,700 $288,600,000
1.5% 55,500 $432,900,000
2.0% 74,000 $577,200,000
2.5% 92,500 $721,500,000
3.0% 111,000 $865,800,000
  • Current yearly cost of topical treatment is ~US$7,800

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Source. 1.Reports and Data, “Hyperhidrosis Treatment Market By Treatment Type, By Disease Type, By End-User, By Regional Outlook, and Segment Forecasts, 2022.

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Pipeline dermatology programs

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BTX 1702 Rosacea Clinical Study

Statistically significant data and clear superiority of BTX 1702 to vehicle

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Positive Phase 1b/2 study

Randomised, double blind, controlled Phase 1b/2 clinical study in 133 subjects, with moderate to severe papulopustular rosacea

Safe and well tolerated

No serious adverse events in any arm of the study, with the 10% BTX 1702 active arm showing superior safety and tolerability

Clinically relevant improvements Both 10% and 20% BTX 1702 active arms showed clinically meaningful improvements across all efficacy endpoints

Statistical significance Improvements in reduction in inflammatory lesions was statistically significant for 10% target dose

Highlights Permetrex™performance Permetrex™technology enabled formulation of very high doses and successful delivery into the skin for efficacy and safety results

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Limitations of current
therapeutic options
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Oracea
(oral Antibiotic)
Rhofade
(α-1A adrenergic agonist)
Finacea
(azelaic acid)
MetroCream
(Metronidazole)
Soolantra
(Ivermectin)
Limitations Resistance
No erythema reduction
Potential Birth control
interaction

Rebound erythema
No lesion count
reduction


Application site
reactions
Lower lesion count
reduction
No erythema reduction

Application site
reactions
Lower lesion count
reduction

Application site
reactions
No Erythema reduction
WAC* $796 $548 $383 $363 $636
Coverage 65% 70% 87% 80% 90%

Clear value proposition for a product with multiple mechanisms of action

  • Only product in market or development with a dual mechanism of action – Anti-inflammatory antimicrobial (without antimicrobial resistance) and favorable side effect profile

  • Cosmetically elegant Permetrex[TM] based formulation designed for use with make up

  • A product meeting the target product profile is anticipated to receive favorable market access

Source: MMIT Formulary Lookup and NDC List, *Wholesale Acquisition Cost

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Example patient images from
Clear visual improvements and key
BTX 1702 10% arm
tool for future studies
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Baseline
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Day 57
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BTX 1702 - 10%
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Baseline

Day 57

Reduction in inflammatory lesions and improvements in redness, shown for moderate and severe patient examples

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Example patient images from
vehicle arm
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Baseline
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Day 57
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Vehicle
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Baseline

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Day 57
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No noticeable reduction in lesions or improvements in redness

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Calendar year

NDA submission complete

Day 74 letter December 2022

Mid-cycle review March 2023

FDA approval

3Q 2023

3Q 2022

Important Notice & Disclaimer

1. Summary information

This presentation has been prepared by Botanix Pharmaceuticals Ltd (“Botanix”) and contains summary information about Botanix and the business conducted by it which is current as at the date of this presentation (“Presentation”) (unless otherwise indicated).

The information in this Presentation is general in nature and does not purport to be accurate nor complete, nor does it contain all of the information that an investor may require in evaluating a possible investment in Botanix, nor does it contain all the information which would be required in a disclosure document or prospectus prepared in accordance with the requirements of the Corporations Act 2001 (Cth). It has been prepared by Botanix with due care but no representation or warranty, express or implied, is provided in relation to the accuracy, reliability, fairness or completeness of the information, opinions or conclusions in this Presentation by Botanix or any other party.

The information in this Presentation remains subject to change without notice. Reliance should not be placed on information or opinions contained in this Presentation, and Botanix does not have any obligation to finalise, correct or update the content of this Presentation. Certain data used in this Presentation has been obtained from research, surveys or studies conducted by third parties, including industry or general publications. To the maximum extent permitted by law, Botanix is not responsible for updating, nor undertakes to update, this Presentation. It should be read in conjunction with Botanix’s other periodic and continuous disclosure announcements lodged with the ASX, which are available at www2.asx.com.au or at https://botanixpharma.com/category/asx-releases/.

2. Not an offer

Neither this Presentation nor any of its contents will form the basis of any understanding, proposal, offer, invitation, contract or commitment. 3. Industry data

Certain market and industry data used in connection with or referenced in this Presentation has been obtained from public filings, research, surveys or studies made or conducted by third parties, including as published in industry-specific or general publications. Neither Botanix nor its advisers, or their respective representatives, have independently verified any such market or industry data.

4. Financial data

All dollar values are in United States dollars ($ or US$) unless otherwise stated. Amounts, totals and change percentages are calculated on whole numbers and not the rounded amounts presented. 5. Forward-looking statements and forecasts

This Presentation contains certain “forward-looking statements” and comments about future matters. Forward-looking statements can generally be identified by the use of forward-looking words such as, “expect”, “anticipate”, “likely”, “intend”, “should”, “could”, “may”, “predict”, “plan”, “propose”, “will”, “believe”, “forecast”, “estimate”, “target” “outlook”, “guidance” and other similar expressions and include, but are not limited to, plans and prospects for the Company, the Company’s strategy, future operations, the expected timing and/or results of regulatory approvals and prospects of commercialising product candidates or research collaborations with its partners, including in Japan, the outcome and effects of Sofpironium Bromide and the market for Sofpironium Bromide. Indications of, and guidance or outlook on, future earnings or financial position or performance are also forward-looking statements. You are cautioned not to place undue reliance on forward-looking statements. Any such statements, opinions and estimates in this Presentation speak only as of the date hereof, are preliminary views and are based on assumptions and contingencies subject to change without notice, as are statements about market and industry trends, projections, guidance and estimates. Forward-looking statements are provided as a general guide only. The forward-looking statements contained in this Presentation are not indications, guarantees or predictions of future performance and involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Botanix, and may involve significant elements of subjective judgement and assumptions as to future events which may or may not be correct.

Any such forward looking statements are also based on assumptions and contingencies which are subject to change and which may ultimately prove to be materially incorrect, as are statements about market and industry trends, which are based on interpretations of current market conditions. Investors should consider the forward looking statements contained in this Presentation in light of those disclosures and not place undue reliance on such statements (particularly in light of the current economic climate and significant volatility, uncertainty and disruption caused by the COVID-19 pandemic). The forward looking statements in this Presentation are not guarantees or predictions of future performance and may involve significant elements of subjective judgment, assumptions as to future events that may not be correct, known and unknown risks, uncertainties and other factors, many of which are outside the control of Botanix.

Except as required by law or regulation, Botanix undertakes no obligation to finalise, check, supplement, revise or update forward-looking statements or to publish prospective financial information in the future, regardless of whether new information, future events or results or other factors affect the information contained in this Presentation.

6. No liability

The information contained in this document has been prepared in good faith by Botanix. Neither Botanix, nor any of its advisers or any of their respective affiliates, related bodies corporate, directors, officers, partners, advisers, employees and agents have authorised, permitted or caused the issue, lodgement, submission, dispatch or provision of this Presentation in a final form and none of them makes or purports to make any binding statement in this Presentation and there is no statement in this Presentation which is based on any statement by them. To the maximum extent permitted by law, Botanix and its advisers, affiliates, related bodies corporate, directors, officers, partners, employees and agents:

expressly disclaims any and all liability, including, without limitation, any liability arising out of fault or negligence, for any loss arising from the use of or reliance on information contained in this document including representations or warranties or in relation to the accuracy or completeness of the information, statements, opinions, forecasts, reports or other matters, express or implied, contained in, arising out of or derived from, or for omissions from, this document including, without limitation, any estimates or projections and any other financial information derived therefrom, whether by way of negligence or otherwise; and

expressly exclude and disclaim all liabilities in respect of, make no representations regarding, any part of this Presentation and make no representation or warranty as to the currency, accuracy, adequacy, reliability or completeness or fairness of any statements, estimates, options, conclusions or other information contained in this Presentation.

Operations: 3602 Horizon Drive, Suite 160 King of Prussia PA 19406

Corporate Office: Level 1, 50 Angove Street North Perth W. Australia 6006

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Authorised for release by Vince Ippolito, Executive Chairman

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