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company overview MARCH 2016

company overview - Home – Sienna Biopharmaceuticalssiennabio.com/wp-content/uploads/Sienna-Biopharma... · company overview MARCH 2016 . 2 ... on developing aesthetic and dermatology

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company overview

M A R C H 2 0 1 6

2 / CONFIDENTIAL and PROPRIETARY

our focus

DISCOVERY CLINICAL DEVELOPMENT COMMERCIALIZATION

INNOVATION in Aesthetics and Dermatology

3 / CONFIDENTIAL and PROPRIETARY

the sienna opportunity

EXCEPTIONAL TEAM with a track record of success across leading global brands

UNIQUELY FOCUSED on developing aesthetic and dermatology products that will change

the practice of medicine

CLEAR STRATEGY for building pipeline of early to late stage novel assets

BUILD MULTI-ASSET PIPELINE first asset secured

4 / CONFIDENTIAL and PROPRIETARY

sienna’s vision to build a leading aesthetic company

Founding vision

!  Apply high scientific rigor to aesthetics and dermatology

!  Develop and commercialize innovative products that add value to patients and physician’s practice

Near-term execution

!  Develop and commercialize Silver Plasmonic Therapy (SPT) for light hair removal and acne

!  Maximize the value of SPT platform through expansion in new indications

!  Aggressively expand product portfolio / pipeline

Long-term strategy

!  Leverage world-class team’s experience in aesthetics and dermatology

!  Build a leading portfolio

!  Establish commercial leadership with Dermatologists, Plastic Surgeons, and Core Aesthetic Physicians

5 / CONFIDENTIAL and PROPRIETARY

clear strategy for building our pipeline

Innovative breakthroughs

SCIENCE

Aesthetics and Dermatology MARKET

Minimum $250 - $500M peak sales per product COMMERCIAL OPPORTUNITIES

Self pay and reimbursed REIMBURSEMENT

Develop a Comprehensive Pipeline of Early

to Late Stage Novel Assets

6 / CONFIDENTIAL and PROPRIETARY

our vision: bring innovative products to market which change the practice of medicine

AESTHETIC AND DERMATOLOGY TARGETS

HAIR REMOVAL

and GROWTH CONTOURING ACNE/

ROSACEA ATOPIC

DERMATITIS PSORIASIS SKIN

REJUVENATION

AESTHETIC DERMATOLOGY

7 / CONFIDENTIAL and PROPRIETARY

leading team in aesthetic and medical dermatology Frederick C. Beddingfield III MD, PhD President and CEO

•  Former Chief Medical Officer

•  Former VP and Head of Dermatology and Aesthetics R&D

•  Associate Clinical Professor of Dermatology

Paul F. Lizzul MD, PhD Chief Medical Officer

Jere Fellmann PhD Head of Development Operations

•  Former Vice President of Research

•  Former Director, Lead Discovery and Molecular Biology

•  Former Sr. Medical Director

•  Former Assoc. Director Clinical Research, Dermatology

•  Former Chief Financial Officer

•  Former VP of Finance and Administration

•  Former VP Clinical Operations

•  Former Director of Clinical Affairs and PRIALT® WW Program Development Lead

Serge Lichtsteiner PhD Head of Research

Diane Stroehmann MS, RAC Chief of Staff and Head of Regulatory Affairs & Quality

Todd Harris PhD President of Sienna Labs and Head of Corporate Development

Ted Schwarz Head of Global Strategic Marketing

•  Former VP of Regulatory Affairs, PV, and Research Compliance

•  Former Head of Regulatory Affairs

•  Founder & CEO

•  Former Manager

•  Former NIH Fellow and Doctoral Student

•  Former President

•  Former President

•  Former Director of Global Marketing & Business Development

John W. Smither Chief Financial Officer

Susan Lundeen Vice President, Human Resources

•  Former VP Human Resources

•  Former VP Human Resource and Administration

Majed Kheir MBA Vice President, Operations

•  Former Executive Dir. Supply Chain and Planning

•  Former Director Operations Strategic Planning

8 / CONFIDENTIAL and PROPRIETARY

strong board

Frederick C. Beddingfield III MD, PhD Co-Founder, President and CEO Sienna Biopharmaceuticals

Todd Harris PhD Founder and President Sienna Labs, Head of Corporate Development, Sienna Biopharmaceuticals

Keith Leonard Executive Chairman

Former CEO, Kythera

Robert Nelsen Co-Founder, Managing Director, ARCH Venture Partners

Kristina Burow Managing Director, ARCH Venture Partners

Bob More MBA Chairman, One Revolution

9 / CONFIDENTIAL and PROPRIETARY

this team has developed top brands

DERMATOLOGY PRODUCTS AESTHETIC PRODUCTS

FROM DISCOVERY TO COMMERCIALIZATION AT GLOBAL COMPANIES

10 / CONFIDENTIAL and PROPRIETARY

team’s demonstrated success commercializing new scientific breakthroughs

65+ PRODUCTS

WORKED ON

100 INTERNATIONAL

REGULATORY FILINGS AND APPROVALS FOR VARIOUS INDICATIONS

6 FDA ADVISORY COMMITTEES

17 FDA

APPROVALS

11 / CONFIDENTIAL and PROPRIETARY

track record of driving meaningful value

Unanimous FDA Advisory Committee

(17-0)

KYBELLA® (U.S.) and BELKYRA®

(Canada) Regulatory Approvals

KYTH-105 (setipiprant) In-licensing

and IND Acceptance

12 / CONFIDENTIAL and PROPRIETARY

silver plasmonic therapy

•  Breakthrough technology: silver plasmonic therapy •  Based on the science of plasmonic resonance •  Secured through Sienna Labs

OVERVIEW

•  Light hair removal •  Acne •  Potential for skin rejuvenation

UNMET NEEDS

•  Works with current existing base of energy devices •  Expands populations who are candidates for treatment

MARKET

•  Clinical proof-of-concept: – Prolonged efficacy – Favorable safety profile

•  Aggressive and expanding IP portfolio: – 9 issued patents – 20+ patents pending

•  Aesthetic product which benefits doctor and patients and a clear regulatory pathway for approval

– Class II device – 510(k) clearance

STATUS

13 / CONFIDENTIAL and PROPRIETARY

ULTRA EFFICIENT, NEAR INFRARED LIGHT ABSORBING SILVER BASED PARTICLES

•  Contained in a topical pre-treatment solution

•  Activation by a pulse of laser light causes a burst of energy

•  Energy thermally changes the sebaceous glands and pores

•  Particles do not penetrate through the epithelial barriers

Heat

Oscillations of Electrons

Near-IR Light

E-field

what are plasmonic particles?

14 / CONFIDENTIAL and PROPRIETARY

an innovative mechanism of action

OVERVIEW

CLINICAL RESULT Selective Restructuring of Pilosebaceous Unit

Hair: Permanent reduction in terminal hair counts including light-pigmented hair Acne: Prolonged reduction in acne lesions

Near-IR Light

DARK HAIR REMOVAL by Selective Photothermolysis

LIGHT HAIR REMOVAL with Silver Plasmonic Therapy

Near-IR Light

Thermal Injury Zone

Plasmonic Particles

Delivered to the Pilosebaceous

Unit and Activated with

Light

15 / CONFIDENTIAL and PROPRIETARY

SILVER PLASMONIC THERAPY

large, unmet needs

$250M - $500M PEAK YEAR OPPORTUNITY PER INDICATION

No Effective Solution

• $2B+ procedure market1

• 6M procedure opportunity4

Lack of Effective Procedural Solutions

ACNE

• $3B+ prescription market2

• 7M procedure opportunity4

LIGHT HAIR REMOVAL

1. Medical Insight Inc., 2. IMS Data, 3. ASAPS 2014, 4. company market research and analysis

16 / CONFIDENTIAL and PROPRIETARY

opportunities for expansion with SPT

Time

$

Existing laser hair removal consumers with light / mixed hair

Light hair consumers

being turned away AND

acne sufferers seeking

treatment from Derms

Potential for expansion

in hair removal:

•  Darker skin •  Increased

efficacy in all hair types

Potential for other future

indications:

•  Rosacea •  Sebaceous

gland hyperplasia

•  Keratosis Pyloris

17 / CONFIDENTIAL and PROPRIETARY

EXCEPTIONAL TEAM

UNIQUE FOCUS

DEVELOPING PIPELINE

CLEAR STRATEGY

INNOVATION in Aesthetics and Dermatology