Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (April 2014)
31 slides from Therapeuticsmd's investor presentation, Apr 8, 2014
Slide 1: Corporate Overview Q2 2014
NYSE MKT: TXMD Corporate Overview Q2 - 2014 COPYRIGHT 2014 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 represe
Slide 3: Two late-stage 505(b)(2) hormone therapy product candidates
2 Two late - stage 505(b)(2) hormone therapy (“HT”) product candidates targeting multi - billion dollar U.S. markets ( 1 )(2) Pipeline (1) PHAST Prescription Monthly by Source Healthcare Analytics. (2) Estimates per: Dr. Loyd Allen Jr ., Editor - in - Chief, International Journal of Pharmaceutical C
Slide 4: Combination Product TX-HR E+P
Combination Product TX 001 - HR E+P 3
Slide 5: History of Hormone Therapy
4 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
Slide 6: Bio-identical Hormone Replacement (BHRT) History of Compounding
5 Bio - identical Hormone Replacement (BHRT) History of Compounding BB3
Slide 7: Bioidentical Progesterone vs Non-Bioidentical Progestins
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 8: Estradiol vs. Conjugated Estrogens
7 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 dis
Slide 9: TXMD Novel Drug Design: Combination of Estradiol + Progesterone
8 □ 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 (
Slide 10: TX-HR E+P Phase 3 Study and Timeline
9 TX 001 - HR 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 Va
Slide 11: Bioequivalence PK Results vs Estrace and Prometrium
10 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 12: Transdermal Development
Transdermal Development 11 Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 File File IND IND E+P Update Transdermal Pilot Preclinical Pilot Phase 1 Studies Studies PK and clinical Study File File IND IND P Update Transdermal Pilot Preclinical Pilot Phase 1 Stu
Slide 13: Enormous 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 14: Drug Quality and Security Act
13 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: Tr
Slide 15: Vulvar / Vaginal Atrophy (VVA)
14 Vulvar / Vaginal Atrophy (VVA)
Slide 16: 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 17: VVA US Sales – Currently No Generics
VVA US Sales – Currently No Generics 16 (1) PHAST Prescription Monthly by Source Healthcare Analytics. (2) Based on last twelve months sales through December 31, 2013. (3) Source Healthcare Analytics (4) GlobalData 2/12 report https:www/asdreports.com/news.asp?pr_id=420 Product Compound US ($mm) Sal
Slide 18: US Sales – Large and Growing
US Sales – Large and Growing 17 * PHAST Prescription Monthly by Source Healthcare Analytics. Based on last twelve months sales through December 31, 2013. Source Healthcare Analytics GlobalData 2/12 report https:www/asdreports.com/news.asp?pr_id=420 Total Number of Prescriptions US Sales 2008 5,030,4
Slide 19: Leading Estrogen Products vs. TXMD VagiCap
Leading Estrogen Products vs. TXMD 18 TXMD Solution: VagiCap ™ Deliver an elegant patient experience Eliminate reusable plungers Less messy than creams Burning sensation eliminated Simple - to - use / no placement issues Quick dissolution Does not require a long - term device
Slide 20: How to Measure Efficacy – FDA Guidance
How to Measure Efficacy – FDA Guidance for Phase 3 1. Statistical i ncrease in superficial cells 2. Statistical decrease in p arabasal cells 3. Statistical changes in vaginal pH from basic to acidic (decrease pH) Reduce most bothersome symptoms: Vaginal Dryness, Dyspareunia, Itching/Irritation, Dysu
Slide 21: TX-004HR Positive Phase 1 Results
TX 004 - HR Positive Phase 1 20 48 postmenopausal women with symptoms of VVA Randomized 10µg dose of TX 004 - HR or placebo Self - administered 1x daily for two - week period Phase 3 (12 weeks) endpoints measured in phase 1 study (2 weeks) As compared to placebo, women treated with TX 004 - HR showe
Slide 22: VagiCap vs. Vagifem
VagiCap vs. Vagifem 21 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 lower with Vagicap
Slide 23: What does this mean? Next Generation VVA Product
What does this mean? Next Generation VVA Product 22 Early data suggests more Solubilized Estradiol is reaching target tissue and less is spilling over into blood (less systemic exposure) compared to Vagifem New technology potentially enabling new lower effective doses (4&10mcg) without the risk of s
Slide 24: Estradiol Vaginal Suppository Phase 2B/3 Study
23 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 25: Hormone Therapy Market Opportunity
Hormone Therapy Market Opportunity 24
Slide 26: Extensive Patent Filings
Extensive Patent Filings 25 Filed Provisional Non - Provisional Issued U.S. 25 8 17 2 Ex - U.S. 6 Oral combination therapeutics Bioidentical E+P HT combination Natural combination HT and formulations Oral solo therapeutics Progesterone formulations Vulvovaginal atrophy pessary Pipeline applications
Slide 27: Milestones 2014-2015
Milestones 26 2014 VVA: Rabbit Irritation Study Results Q2 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 o
Slide 28: Key Statistics
Key Statistics NYSE MTK: TXMD Recent market price 1 $5.04 Shares outstanding 2 145 million Market capitalization 1 $730 Billion Cash & equivalents 2 $54 million Debt 3 $0.00 million 1 Based upon closing price April 7, 2014 2 As at December 31, 2013
Slide 29: Investor Contacts
Investor Contacts COPYRIGHT 2013 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 30: Latest Position Statements on HRT
29 “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 o
Slide 31: Experienced Management and Drug Development Team
30 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 su