Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (October 2013)
30 slides from Therapeuticsmd's investor presentation, Oct 8, 2013
Slide 1: TXMD Corporate Overview October 2013
TXMD Corporate Overview October 2013 COPYRIGHT 2013 by TherapeuticsMD ®
Slide 2: Forward-Looking Statements
This presentation includes forward - looking statements covered by the safe harbor provision of the Private Securities Litigation Reform Act of 1995, including predictions, estimates, and other information that might be considered forward - looking. While these forward - looking statements represent
Slide 3: Company Overview
TherapeuticsMD | iF ll | i Company Overview
Slide 4: TXMD Company History
3 TXMD Company History Founded in May of 2008 Originally a prenatal vitamin company Recently listed on NYSE MKT under “TXMD” Shares outstanding: 145 million Well - capitalized – approximately $64.4 million in cash; no debt Strong board with blue - chip institutional h olders Gov. Tommy Thompson , Ju
Slide 5: Innovative Women's Healthcare Company
4 Innovative Women’s Healthcare Company Two late - stage 505(b)(2) proposed hormone therapy (“HT”) products targeting a multi - billion dollar U.S. market ( 1 )(2) (1) Phast Prescription Monthly by Source Healthcare Analytics. (2) Estimates per: Dr. Loyd Allen Jr ., Editor - in - Chief of the Intern
Slide 6: Vulvar / Vaginal Atrophy (VVA)
5 Vulvar / Vaginal Atrophy (VVA)
Slide 7: Vulvar/vaginal atrophy mechanism and symptoms
Decrease in Estradiol Increase in Parabasal Cells Increase vaginal pH Decreased Estradiol levels cause a reduction in superficial cells Parabasal cells increase Vagina changes from acidic to basic (increased pH) Burning, dyspareunia, UTI, itching are the most common symptoms Chronic condition that r
Slide 8: VVA Market
7 VVA Market The North American Menopause Society (NAMS ) Position Statement “ Management of Symptomatic Vulvovaginal Atrophy (VVA),” … affecting nearly 50% of women ; … low - dose vaginal estrogen is the preferred treatment and may be continued as long as the symptoms are present . (1) ASD analysis
Slide 9: US Sales - Vulvar / Vaginal Atrophy
Product Compound U.S. Sales (est.) ($mm) (1)(2) Problems Premarin ® Cream Conjugated equine vaginal estrogen $350 Equine source Non - bioidentical Messy Reusable plungers Vagifem ® Tablets Estring ® Insert Femring ® Insert Estrace ® Cream Vaginal estradiol $286 $77 $23 $264 Messy Reusable plungers D
Slide 10: Leading Estrogen Products vs. TXMD vagiCap
9 Leading Estrogen Products vs. TXMD “ vagiCap ™” TXMD Solution Less messy than creams and burning sensation eliminated Easier to use, not requiring a long - term device Flexibility of dosing with 0.01 mg & 0.025 mg
Slide 11: Estradiol Vaginal Suppository – Phase 3 Update
10 Estradiol Vaginal Suppository – P1 Update 8 - 22 - 2013 Study – Estradiol Cost ($mm) Phase 3 Trial Phase 3 $14.4 Trial: 12 weeks Sites: 30 - 40 Subjects: 375 - 400 − 2 active arms (150 per arm) - 10mcg & 25mcg − 100 placebo Total $15.6 Endpoints − Cell change − Lowering of pH − Lowering of most b
Slide 12: Combination Product
TherapeuticsMD ” 7 "Combination Product Ss
Slide 13: History of Hormone Therapy
12 History of Hormone Therapy (1) Phast Prescription Monthly by Source Healthcare Analytics. (2) Estimates per: Dr. Loyd Allen Jr ., Editor - in - Chief of the International Journal of Pharmaceutical Compounding; Tom Murry , Executive Director of the Pharmaceutical Compounding Accreditation Board; a
Slide 14: Bioidentical progesterone vs. non-bioidentical progestins side effects
Side Effect (1) Bioidentical Natural Progesterone Non - Bioidentical Progestins (MPA, NETA, drosperinone) Breast cancer More favorable profile (E3N - EPIC study) Increased risk Cardiovascular More favorable profile (PEPI trial) Increased risk of MI, stroke, VTE Lipid profile More favorable profile (
Slide 15: Estradiol vs. Conjugated Estrogens
14 JAMA September 30, 2013 • CEEs ( Premarin ) were associated with a higher incident of venous thrombosis and myocardial infarction than oral estradiol (1) JAMA October 3, 2013 • Breast Cancer Risk persists for 13 years after discontinuation of CEE (2) Menopause September 2013 • “ Oral estradio l m
Slide 16: Latest Position Statements
15 “HRT prescribed before the age of 60 has a favorable benefit/risk profile .” (1) “ Recent evidence suggests that HRT regimens containing progesterone can minimize the metabolic impact and reduce the risk of thromboembolism .” (1) In a large observational cohort study of French teachers, after fiv
Slide 17: Novel Drug Design: Estradiol + Progesterone
16 □ Meet PK 505(b)(2) thresholds x Novel Drug Design Combination of Estradiol + P rogesterone RLD = Reference Listed Drug API = Active Pharmaceutical Ingredient Converted (API) from solid / crystalline to a New Liquid Drug Form Estrace (RLD) is a tablet — 0.5 mg, 1.0 mg, and 2.0 mg Prometrium (RLD)
Slide 18: TX 12-001HR Combination Potential Benefits
Drug Improvement General Benefits Patient Benefits Receive FDA approved indication FDA indication / safety and quality assurance Insurance coverage Safety , quality, and stability New lower effective doses Reduced blood levels Better side effect profile Improved safety Improved safety profile vs. no
Slide 19: TX 12-001HR Combination — Phase 3 Study
18 Phase 3 Trial Study: 12 month study with 12 week VMS Sites: ~50 (14 sites active) Subjects: 1,550 − 4 active arms (350 per arm): [1.0mg/100mg, 0.5mg/100mg, 0.5mg/50mg, 0.25mg/50mg] − 1 placebo arm (150) Estimated cost: $20 - $25 million Endpoints − Vasomotor: number and severity of hot flashes (4
Slide 20: Pharmacokinetic bioequivalence results vs. Prometrium and Estrace
19 95% Upper Confidence Limit for PK Parameter Prometrium = R1 Prometrium = R2 TXMD = T Parameter Point Estimate T/R Ratio Within Subject Std. Deviation Upper 95% Confidence Bound C max 1.16 1.179 - 0.785 AUC 0 - t 1.05 0.956 - 0.542 1 10 100 0 5 10 15 20 25 30 35 40 45 50 Time (hr) Treatment=R1 Tre
Slide 21: Combination Transdermal Development
20 Combination Transdermal Development Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 File File IND IND Update Combination Pilot Preclinical Pilot PK Pivotal 17β estradiol + Studies Studies PK and clinical progesterone
Slide 22: FDA Approved Products in Use Lack Innovation
Product Progestin U.S. Sales (est.) ($mm) Intl Sales ($mm) (4) Company 17 β E stradiol + NETA / Drospirenone (Activella / FemHRT / Angeliq / others) Non - bioidentical $222 (1)(2) Premarin + MPA (Prempro / Premphase) Non - bioidentical $313 (1)(2) Estradiol + Progesterone (custom compounded ) Untest
Slide 23: New Lower Dose Progesterone
22 New Lower Dose Progesterone
Slide 24: TX 12-002HR Progesterone Highlights
Conducted PK studies in accordance with FDA requirements TXMD 150 mg test dose found to be bioequivalent to 200 mg Prometrium ® Product Goals Lower first - pass effect, less metabolites = 25% Increase in bioavailability Lower blood level = TXMD target dose 225mg vs. 400mg Prometrium ® Non - allergen
Slide 25: TX 12-002HR Progesterone — Phase 3 Study
Phase 3 Trial Trial: 1 study, 3 cycles – estrogen priming and 2 progesterone treatment cycles Sites: 10 - 15 each Subject: 180 − 3 arms (60 per arm): 225mg, 300mg, Placebo Estimated cost: $5 - $8 million RLD = 400 mg Endpoints = Withdrawal bleeding and secretory change 24 TX 12 - 002HR Progesterone
Slide 26: Natural Progesterone Dominates
Product Progestin U.S. Sales (est.) ($mm) (1)(2) INTL Sales (3) Company Generic Available Provera ® ( medroxyprogesterone acetate) Non - bioidentical $26 x Aygestin ® (norethindrone acetate) Non - bioidentical $46 x Prometrium ® (micronized progesterone) Bioidentical $269 x Total Oral Progestin Sale
Slide 27: Extensive Patent Filings
Title Application(s) Earliest Filing Date Projected Expiry (1) Status Oral Combination Therapeutics Natural E+P HT Combination » US Provisional » US Non - Provisional » PCT 23 - Nov - 2011 Nov - 2032 US – Case under Accelerated Exam ; Final Office Action received; Interviewed at USPTO PCT – Int’l Se
Slide 28: Extensive Patent Filings - Other
Extensive Patent Filings - Other Title Application(s) Earliest Filing Date Projected Expiry (1) Status Opera Software System and Method of Ongoing Evaluation Reporting and Analysis » US Non - Provisional 17 - Sept - 2009 Sept - 2029 US – Allow ed System and Method for Distributor Reporting and Analy
Slide 29: Experienced Management and Drug Development Team
28 John Milligan President Julia Amadio Chief Product Officer Dan Cartwright Chief Financial Officer Dr. Brian Bernick Chief Medical Officer and Director Robert Finizio Chief Executive Officer vitaMed HT Corporate Jason Spitz Vice President, Marketing Management Drug Development Team Proven team wit
Slide 30: Investment Highlights
29 Investment Highlights 1 Novel late - stage hormone therapy candidates 2 Clear pivotal trial endpoints / low risk regulatory pathway 3 Compelling, growing market opportunity, especially with recent concerns regarding compounders 4 Recently c ompleted $33 million equity financing 5 Robust, growing
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