Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (May 2014)
37 slides from Therapeuticsmd's investor presentation, May 6, 2014
Slide 1: Corporate Overview Q2 2014
NYSE MKT: TXMD Corporate Overview Q2 - 2014 COPYRIGHT 2014 by TherapeuticsMD – May 2014
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 represe
Slide 3: TherapeuticsMD Pipeline
TherapeuticsMD Pipeline (1) PHAST Prescription Monthly by Source Healthcare Analytics. (2) Estimates per: Dr. Loyd Allen Jr., Editor - in - Chief, International Journal of Pharmaceutical Compounding ; Tom Murry , Executive Director of the Pharmaceutical Compounding Accreditation Board; and Wulf Utia
Slide 4: TherapeuticsMD Core Development Metrics
TherapeuticsMD Core Development Metrics 1. Compounds • Well - known chemical entities with defined safety and efficacy therapeutic thresholds 2. Regulatory Pathway • 505(b)(2) offering more defined, shorter pathway with less efficacy risk than NCE pathway • Clear FDA draft guidance requirements for
Slide 5: Combination Product TX-HR E+P
Combination Product TX 001 - HR E+P
Slide 6: Women's Health Initiative (WHI) and History of Hormone Therapy
Women’s Health Initiative (WHI) • Hormone Therapy is linked to Cardiovascular, Cancer and other risks • Estrogen + Progestin ( Prempro ) arm had a 24% increase in breast cancer vs. Estrogen alone History of Hormone Therapy * (1) PHAST Prescription Monthly by Source Healthcare Analytics. Inflation Ad
Slide 7: Market Shift to Bio-identical Hormone Replacement (BHRT)
Market S hift to Bio - identical Hormone Replacement (BHRT) History of Compounding
Slide 8: Understanding the Total Menopause Hormone Market
Understanding the Total Menopause Hormone Market American Academy of Anti - Aging Medicine (A4M) – www.a4m.com World Society of Anti - Aging Medicine (WSOAAM) www.wosaam.ws 24,000 Specialists in United States (1) PHAST Prescription Monthly by Source Healthcare Analytics. (2) Estimates per: Dr. Loyd
Slide 9: Bio-identical Progesterone vs Non-Bioidentical Progestins
Side Effect (1) Bio - identical 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 profil
Slide 10: Rationale for Market Growth: Estradiol vs. Conjugated Estrogens
Journal of the American Medical Association September 30, 2013 CEEs ( Premarin ) were associated with a higher incidence of venous thrombosis and myocardial infarction than oral estradiol Journal of the American Medical Association October 3, 2013 Breast Cancer Risk persists for 13 years after disco
Slide 11: TXMD Novel Drug Design: Estradiol + Progesterone
□ Meet PK 505(b)(2) thresholds x TXMD 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 (RL
Slide 12: E+P HT Market Opportunity
Product Progestin U.S. Sales (est.) Intl Sales (4) Company 17 β E stradiol + NETA / Drospirenone (Activella / FemHRT / Angeliq / others) Non - bioidentical $ 230 mm (1)(2) Premarin + MPA (Prempro / Premphase) Non - bioidentical $ 328 mm (1)(2) Estradiol + Progesterone (custom compounded ) Untested B
Slide 13: Bioequivalence Evaluation of TXMD E2+P Gel-tab
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 Treatm
Slide 14: TX 001HR E+P Phase 3 Study
TX 001HR E+P — Phase 3 Study Combination of Estradiol + P rogesterone 2012 2013E 2014E 2015E 2016E Q3 '12 Q4 '12 Q1 '13 Q2 '13 Q3 '13 Q4 '13 Q1 '14 Q2 '14 Q3 '14 Q4 '14 Q1 '15 Q2 '15 Q3 '15 Q4 '15 Q1 '16 Q2 '16 Q3 '16 Q4 '16 Filed IND Pilot PK Studies Pivotal PK Studies NDA and PDUFA Phase 3 Vasomot
Slide 15: Drug Quality and Security Act
Drug Quality and Security Act Signed by President on 11/27/13 Bill Highlights Establishes requirements for traditional compounding pharmacies and larger - scale outsourcing facilities. Prohibits compounding of essential copies of an FDA approved & marketed drug except in limited circumstances: Tradi
Slide 16: Transdermal Development Phase 1 Study
Transdermal Development Phase 1 Study Q3 2014 Measure circulating Progesterone alone Measure circulating Estradiol and Progesterone
Slide 17: Transdermal Market Opportunity
Product (Combination E+P) TRx (1)(2) U.S. Sales (est.) (1)(2) Company Estradiol/ Levonorgestrel ( Climara Pro) 129,755 $ 22.5 mm Estradiol/ Norethindrone Acet ( CombiPatch ) 408,598 $ 44 mm Total Combination Transdermal Sales 538,353 $ 66.5 mm Transdermal Market Opportunity Notes : (1) PHAST Prescri
Slide 18: Core Development Metrics: Estradiol + Progesterone
TherapeuticsMD Core Development Metrics 1. Estradiol + Progesterone • Well - known chemical entities with defined safety and efficacy therapeutic thresholds 2. Regulatory Pathway • 505(b)(2) offering more defined, shorter pathway with less efficacy risk than NCE pathway • Clear FDA draft guidance re
Slide 19: Vulvar / Vaginal Atrophy (VVA)
Vulvar / Vaginal Atrophy (VVA)
Slide 20: Core Development Metrics
TherapeuticsMD Core Development Metrics 1. Compounds • Well - known chemical entities with defined safety and efficacy therapeutic thresholds 2. Regulatory Pathway • 505(b)(2) offering more defined, shorter pathway with less efficacy risk than NCE pathway • Clear FDA draft guidance requirements for
Slide 21: Mechanism: Low Levels of Estradiol Impact on the Vagina
Mechanism: Low Levels of Estradiol impact on the Vagina R eduction in superficial cells Parabasal cells increase Vagina changes from acidic to basic (increased pH) Most common symptoms: Vaginal Dryness, Dyspareunia, Itching/Irritation, Dysuria, Bleeding with Sexual Activity
Slide 22: How to Measure Efficacy – FDA Guidance for Phase 3
How to Measure Efficacy – FDA Guidance for Phase 3 (12 Weeks) (1) 1. Maturation Index • Statistical increase in superficial cells • Statistical decrease in parabasal cells 2. Statistical changes in vaginal pH from basic to acidic (decrease pH) 3. Reduce most bothersome symptoms: Vaginal Dryness, Dys
Slide 23: VagiCap vs. Vagifem – Phase 1 PK Study
VagiCap vs. Vagifem – Phase 1 PK Study Time ( hr ) Plasma Mean Concentration ( pg /mL) Time ( hr ) Plasma Mean Concentration ( pg /mL) N=36 N=36 Estradiol 25 µg Estradiol 10 µg Key Points: • Tmax ~2hours with VagiCap and ~8 hours with Vagifem • Systemic absorption AUC (0 - 24 hrs ) is 2 - 3 fold low
Slide 24: TX 004HR Positive Phase 2 Study
TX 004HR Positive Phase 2 Study 48 post - menopausal women with symptoms of VVA Randomized 1:1 to 10µg dose of TX 004HR or placebo Self - administered 1x daily for 2 - week period Endpoints (2 weeks) based on Phase 3 (12 weeks) study design criteria As compared to placebo, women treated with TX 004H
Slide 25: TX 004HR Phase 2 Study Results
TX 004HR Phase 2 Study Maturation Index (Mean) Change in pH (Mean) TX 004HR Placebo TX 004HR Placebo Vagicap 10 ug Week 2 44.48 7.08 - 0.92 - 0.40 ____________________________________________________________________ Approved Treatments: Pivotal Clinical Data (Week 12)* Maturation Index (Mean) Change
Slide 26: Leading Estrogen Products
Leading Estrogen Products Product Characteristic * Vagifem Premarin Estrace Design Burning x Discharge x x x Cream x x Quick Dissolution Applicator x x x Placement Issues x TX 004HR Design Goals • Eliminate burning sensation • Not a cream • Improve ease of use/placement • Quick dissolution • Digital
Slide 27: VVA U.S. Sales – Currently No Generics
(1) PHAST Prescription Monthly by Source Healthcare Analytics. (2) Based on last twelve months sales through 12/31/2013. (3) GlobalData 2/12 report https:www/asdreports.com/news.asp?pr_id=420 (4) Estring & Femring data was excluded due to marginal sales (5) GoodRx ; http://www.goodrx.com / last acce
Slide 28: Estradiol Vaginal Suppository Phase 2B/3 Study
Estradiol Vaginal Suppository Phase 2B/3 Study 2014 12 weeks Designed to enroll 150 - 200 subjects in each arm − Multiple Active Arms (4 mcg, 10 mcg, 25 mcg) − Placebo (n=100) Endpoints: − Cell change − Lowering of pH − Evaluation of Adverse Vaginal Effects (Dyspareunia and Dryness)
Slide 29: Hormone Therapy Market Opportunity
Hormone Therapy Market Opportunity
Slide 30: Core Development Metrics: VVA VagiCap
TherapeuticsMD Core Development Metrics 1. VVA VagiCap • Well - known chemical entities with defined safety and efficacy therapeutic thresholds 2. Regulatory Pathway • 505(b)(2) offering more defined, shorter pathway with less efficacy risk than NCE pathway • Clear FDA draft guidance requirements fo
Slide 31: Extensive Patent Filings
Extensive Patent Filings Filed Provisional Non - Provisional Issued U.S. 27 10 17 2 Ex - U.S. 7 Oral combination therapeutics Bioidentical E+P HT combination Natural combination HT and formulations Oral solo therapeutics Progesterone formulations Vulvovaginal atrophy pessary Pipeline applications Op
Slide 32: Milestones
Milestones 2014 E+P Transdermal: File IND for P and E+P Transdermal Q2/Q3 E+P Transdermal: PK Results for P and E+P Transdermal Q2/Q3 E+P Oral : International Menopausal Society Replenish Trial Poster Session Q2 Compounding Market : Symphony Health Report on BHRT Size of Market Q3 Estradiol VagiCap
Slide 33: Key Statistics
Key Statistics NYSE MKT: TXMD Recent market price 1 $4.05 Shares outstanding 2 145 million Market capitalization 1 $590 million Cash & equivalents 2 $45 million Debt 3 $0.00 million 1 Based upon closing price May 1, 2014 2, 3 As of March 31, 2014
Slide 34: Investor Contacts
Investor Contacts COPYRIGHT 2014 by TherapeuticsMD Dan Cartwright Lisa M. Wilson Chief Financial Officer President TherapeuticsMD, Inc. In - Site Communications, Inc. 561 - 961 - 1900 917 - 543 - 9932 Dan.Cartwright@TherapeuticsMD.com lwilson@insitecony.com
Slide 35: TherapeuticsMD Corporate History
TherapeuticsMD Corporate History vitaMedMD, LLC vitaMedMD, LLC Reverse Merger TherapeuticsMD Primary Public Offering $1.70 Primary Public Offering $2.40 Public Secondary Offering $7.10 2008 Q4 2011 Q1 2013 Q3 2013 Q1 2014 • E arly PK data E+P • CMC Success • Limited IPO Qualifiers • Brand Prenatal •
Slide 36: Latest Position Statements on HRT
“HRT prescribed before the age of 60 has a favorable benefit/risk profile .” “Recent evidence suggests that HRT regimens containing progesterone can minimize the metabolic impact and reduce the risk of thromboembolism .” In a large observational cohort study of French teachers, after five years of u
Slide 37: Experienced Management and Drug Development Team
John Milligan President Julia Amadio Chief Product Officer Dan Cartwright Chief Financial Officer Dr. Sebastian Mirkin Chief Medical Officer Robert Finizio Chief Executive Officer vitaMed HT Corporate Dr. Joel Krasnow Chief Scientific Officer Management Drug Development Team Proven team with a succe