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Bringing Advanced Technology to Male and Female Health
SPECIALTY PHARMACEUTICAL
COMPANY
1
Introduction
• Specialty pharmaceutical company with a focus
on women’s health
• Proprietary and patent protected Topical &
Vaginally delivered technologies
• We have products where others don’t exist
• Where others do, we believe ours are simply
better
• $20B combined marketplace, underserved
• Significant value creation for investors
• Rich Management heritage excited to do it again
2
Presenting today
• William
Bologna –
Chairman &
Chief Scientist
• Oliver Bates Chief
Executive
Officer and
Co-Founder
• Dr. Finn
Larsen M.D Chief Medical
Officer and
Co-Founder
• Betsy Brod –
Investor
Relations,
MBS Value
Partners
3
Heritage & History
• First transdermal patches
developed at Ciba (Novartis)
Key Pharmaceuticals ($900m
exit)
• Columbia Laboratories
founded pioneering women’s
health ($600m exit)
• Ardana Bioscience plc
FTSE:ARA - TestoCream
• Viramal founded 2013
4
Products
• Low Risk Technology
• Known Chemical
Entities
• Focus on physiologic
hormones
5
Viramal's Advantages
• Cosmetically Elegant, No smell and less surface
area required; Most suited for long term use
• Almost no alcohol is required for solubility of API
• Better Bioavailability - Half as much API is required
as Hydro-alcoholics, and in the order of 5-10x less
than oral therapies
• Fantastic tolerability
• Vaginal delivery possible with discharge unlikely
• Lower Cost of Goods compared to “other” hydroalcoholic gels
6
Advanced Technology
Estrocream vs Estrogel pk results 14092015 (to be audited)
Results with all data
• Patented Skin Reservoir
Technology
Estradiol levels in plasma of rats after transdermal
administration of Estrogel and Estrocream
7000
6000
– Increased Bioavailability
– Elegant Cream Base.
Estradiol pg/ml
5000
• Unique Vaginal Delivery
Platform
– Replaces Messy and
Inconvenient Vaginal
Products
4000
3000
ESTROGEL
2000
ESTROCREAM
1000
0
-1000
0
2
4
-2000
6
8
10
12
24
Sampling time (hours)
Results without three aberrant data
• Targeted Vaginal Delivery
– Delivers High Drug
Concentrations To The
Pelvic Cavity
– Minimal Systemic Exposure
CONFIDENTIAL
7
Out-License Ready
• TestoCream – Viramal’s only Men’s Health Rx
–
–
–
–
True hypogonadal men
Diabetes and Obesity as secondary conditions
Highly patient acceptable Cosmetic Grade
Overcome typical 6 month drop-off
• Women’s Health OTC – ready for market entry
– Unique technology minimises clumping and discharge
found in earlier products
– Elegant (TM) Vaginal Moisturiser and pH Balance
– Key expanded markets include Breast Cancer Sufferers
8
2016 Phase I/II Women’s Rx
• Menopausal Hormone Therapy
1) First once weekly Vaginal Estradiol
2) First Estradiol/Progesterone Combination Cream Product
3) Cosmetic-grade Transdermal Estradiol ensuring longterm patient acceptability
• Contraceptive Suite
1) Topical “mini-pill” progestin-only contraceptive
2) First full contraceptive cream (combination hormone)
3) Emergency Contraceptive – Vaginal, significant GI effects
reduction
• Infertility
– Supporting 1st trimester development minimising
discharge associated with other vaginal products
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Endometriosis induced infertility
• Unmet, estimated $5b Endometriosis market
– 10% of Premenopausal Women Suffer from
Endometriosis
– 50% of Endometriosis Patients Present with Infertility
• Locally Targeted Vaginal Danazol for the
Treatment of Endometriosis
– Entering Clinics 2016
– Older Castration Therapies (GnRH Agonists) Cause
Irreversible Bone Loss through enforced early
menopause.
– Expected Pregnancy Rates Following Patented Vaginal
Danazol Therapy 50% - 70%
10
Business Model & Exit Strategies
• Early Stage Commercialisation
– Products developed through Clinical Proof of Concept
– Partner / Co-develop
– 3 products available 2016
• Late Stage Commercialisation
– Products Developed through Pivotal (e.g. Ph. III Studies) or
NDA
– Partner / Co-develop / Sell
– Currently 3 products currently available
• Exit
– Target IPO, NASDAQ
– Divest Commercialised Assets
– Trade Sale Company as alternative to IPO
11
Benchmark Deals
• $216m – Replens and Rephresh sale to Church
& Dwight
• $2.6b – Auxilium Pharmaceuticals sale to Endo
• $190m – Market cap @ IPO Agile Therapeutics
• $335m – Acrux Limited, Androgel license to
Abbvie
• $165m – Trimel Pharmaceuticals, Nateso
license to Endo
• $500m – Neurocrine, Elagolix Licesne to
Abbvie
12
William Bologna
Chairman & Chief Scientist
Oliver Bates
Chief Executive Officer
[email protected]
[email protected]
+1 212 300 3474
+44 (0) 7801 824667
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