Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (June 2013)
30 slides from Therapeuticsmd's investor presentation, Jun 4, 2013
Slide 1: Investor Presentation June 2013
Investor Presentation June 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 | a | 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: approximately 130 million Approximately $40 million in cash; no long - term debt Strong board with blue - chip institutional h olders Gov. Tommy Thompson ,
Slide 5: Innovative Women's Healthcare Company
2013E 2014E 2015E 2016E U.S. Sales (est.)($mm) (1)(2) Combination: 17β Estradiol + Progesterone $2,000 Oral Progesterone $300 Novel estradiol pipeline product in development 17β Estradiol in VagiCap™ $800 Phase 3 Plan Expect to File NDA and PDUFA 4 Innovative Women’s Healthcare Company Two late - st
Slide 6: History of Hormone Therapy
5 History of Hormone Therapy 2002 Women’s Health Initiative (WHI) Study Lower doses = lower side effect profile Estrogen + Progestin ( Prempro ) arm had a 22% increase in breast cancer vs. Estrogen alone arm Resulting Hormone Prescribing Trends Start with the lowest effective dose Progesterone (bioi
Slide 7: HT Combination Market Landscape
Sales of FDA approved oral combination estrogen + progestin products Compounding pharmacy sales of unapproved estradiol + progesterone 6 □ Significant demand HT Combination Market Landscape (1) Phast Prescription Monthly by Source Healthcare Analytics. (2) Based on last twelve months sales through J
Slide 8: 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 9: Novel Drug Design
8 □ 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 10: Building an Extensive Patent Estate
9 Building an Extensive Patent Estate Novel Drug Form Based Approach Solubilized API in combination and stand - alone drug products for HT indications Enabling p latform technology for delivery of bioidenticals to variety of dosage forms and routes of administration (softgel oral, suppository, trans
Slide 11: Senate HELP Bill on Compounding
10 Senate HELP Bill 959 on Compounding New England Compounding Center Response to Meningitis outbreak, killed 50 and made over 700 patients sick Multiple other cases of unsafe drug sales by other compounding pharmacies Senate Bill Highlights (1) Establishes clear FDA oversight funded by compounding
Slide 12: Market Forces Converge
11 Market Forces Converge External market changing events WHI Proposed legislative changes Internal s cientific breakthrough Significant shifts favor TXMD
Slide 13: Why Hormone Therapy?
12 Why Hormone Therapy? HT is projected to be the largest growth segment in the overall women’s health drug market Demographics driving strong growth fundamentals By 2015, nearly half the women in America will be of menopausal age (1) Women will spend more than a third of their life in menopause and
Slide 14: Combination Product
TherapeuticsMD’ i i | Combination Product
Slide 15: Combination Proposed Phase 3 Study
14 Phase 3 Trial Study: 12 month study with 12 week VMS Sites: ~50 Subjects: 1,550 − 4 active arms (350 per arm) − 1 placebo arm (150) Estimated cost: $20 - $25 million Endpoints − Vasomotor: number and severity of hot flashes (4 week and 12 weeks) − Endometrial safety: incidence of endometrial hype
Slide 16: Progesterone Results
n = 62 15 95% Upper Confidence Limit for PK Parameter Prometrium = R1 Prometrium = R2 TXMD = T Parameter Point Estimate T/R Ratio Within Subject Std. Deviation Upper 95% Confidence Bound C max 1.16 1.179 - 0.785 AUC 0 - t 1.05 0.956 - 0.542 Progesterone Results (1) (1) Semilog plots of mean plasma c
Slide 17: 17β Estradiol Results
1 10 100 0 5 10 15 20 25 30 35 40 45 50 Time (hr) Treatment=R1 Treatment=R2 Treatment=T N=62 17 β Estradiol Results (1) n = 62 95% Confidence Interval for PK Parameter 16 Estrace = R1 Estrace = R2 TXMD = T TX 12 - 001HR Estradiol 2mg / Progesterone 200 mg (combination ) vs. Estrace ® 2m g + Prometri
Slide 18: TX 12-001HR Combination Potential Benefits
Drug Improvement General Benefits Patient Benefits Receive FDA approved indication FDA indication / safety and quality assurance Insurance coverage Safety , quality, and stability New lower effective doses Reduced blood levels Better side effect profile Improved safety Improved safety profile vs. no
Slide 19: FDA Approved Products in Use Lack Innovation
Product Progestin U.S. Sales (est.) ($mm) Intl Sales ($mm) (4) Company 17 β E stradiol + NETA / Drospirenone (Activella / FemHRT / Angeliq / others) Non - bioidentical $178 (1)(2) Premarin + MPA (Prempro / Premphase) Non - bioidentical 290 (1)(2) Estradiol + Progesterone (custom compounded ) Unteste
Slide 20: New Lower Dose Progesterone
19 New Lower Dose Progesterone
Slide 21: TX 12-002HR Progesterone Proposed Phase 3 Study
Phase 3 Trial Trial: 2 studies; 12 days, 3 cycles Sites: 10 - 15 each Subject: 180 − 3 arms (60 per arm) Estimated cost: $5 - $8 million RLD = 400 mg Endpoints − Withdrawal bleeding and secretory change 20 TX 12 - 002HR Progesterone — Proposed Phase 3 Study 2012 2013E 2014E 2015E 2016E Q3 '12 Q4 '12
Slide 22: TX 12-002HR Progesterone Candidate
Conducted PK studies in accordance with FDA requirements TXMD 150 mg test dose found to be bioequivalent to 200 mg Prometrium ® Summary evaluations of baseline - corrected Progesterone results for a theoretical 150 mg test capsule vs. 200 mg Prometrium ® capsule 21 Parameter Point Estimate T/R Ratio
Slide 23: TX 12-002HR Progesterone Potential Benefits
Drug Improvement General Benefits Patient Benefits New lower effective doses Lower first - pass metabolites Better side effect profile Less somnolence Improved safety Improved safety profile vs. non - bioidentical progestin Reduced breast cancer risk Improved cardiovascular profile Improved lipid pr
Slide 24: Natural Progesterone Dominates
Product Progestin U.S. Sales (est.) ($mm) (1)(2) INTL Sales (3) Company Generic Available Provera ® ( medroxyprogesterone acetate) Non - bioidentical $26 x Aygestin ® (norethindrone acetate) Non - bioidentical 45 x Prometrium ® (micronized progesterone) Bioidentical 247 x Total Oral Progestin Sales
Slide 25: Other Programs
TherapeuticsMD Yr Other Programs ss
Slide 26: TX 12-004HR Estradiol Product Vulvar/Vaginal Atrophy
Product Compound U.S. Sales (est.) ($mm) (1)(2) Problems Premarin ® Cream Conjugated equine vaginal estrogen $265 Equine source Non - bioidentical Messy Reusable plungers Vagifem ® Tablets Estrace ® Cream Vaginal estradiol $558 Messy Reusable plungers Difficult to use Continuous - use mechanical dev
Slide 27: TX 12-004HR Proposed Phase 3 Study
Phase 3 Trial Trial: 12 weeks Sites: 30 - 40 Subjects: 375 - 400 − 2 active arms (150 per arm) − 100 placebo Endpoints − Cell change − Lowering of pH − Lowering of most bothersome symptoms 26 TX 12 - 004HR Proposed Estradiol Vaginal Suppository — Proposed Phase 3 Study Estradiol 2013E 2014E 2015E 20
Slide 28: Experienced Management and Drug Development Team
27 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 29: Potential Milestones
28 Potential Milestones 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 Vasomotor and Endometrial Protection Study Filed IND
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 $50 million equity financing 5 Robust, growing