Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (November 2014)
47 slides from Therapeuticsmd's investor presentation, Nov 18, 2014
Slide 1: Investor Overview November 2014
1 Investor Overview NOVEMBER 2014 w w w . T h e r a p e u t i c s M D . c o m
Slide 2: Forward-looking statements
2 2 This presentation by TherapeuticsMD Inc. (referred to as “we” and “our”) may contain “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of
Slide 3: A Promising Future
3 3 A Promising Future We are an innovative women’s health company exclusively focused on developing and commercializing products for women throughout their life cycles. Our therapeutic portfolio of drug candidates is built on our SYMBODA™ technology platform, which enables new bio - identical hormo
Slide 4: Investment Rationale
4 4 Investment Rationale Worldwide commercial rights for multiple hormone therapy products in Phase 3: Well - known chemical entities with established safety and efficacy thresholds Expected FDA regulatory pathway: 505(b)(2 ) Bio - identical market recently impacted by new Drug Quality and Security
Slide 5: TherapeuticsMD – Value Platform
5 5 TherapeuticsMD – Value Platform Large Growing Market of Post - menopausal Women Early Pipeline Candidates Current Rx Prenatal Business Experienced Women’s Health Business & Clinical Team Unique P3 Candidates: VVA & Combo IP Portfolio & SYMBODA™ Technology
Slide 6: Pipeline Targets Large Markets
6 6 Pipeline Targets Large Markets 1) PHAST Prescription Monthly by Source Healthcare Analytics. 2) Estimated U.S. sales, based on half estradiol patch sales 3) In July 2014, we temporarily suspended enrollment in the SPRY Trial and in October we temporarily stopped it in order to update the Phase 3
Slide 7: SYMBODA Technology Enables Pipeline
7 7 SYMBODA ™ Technology Enables Pipeline Converts estradiol and progesterone from solid / crystalline to a n ew liquid (solubilized) drug form: Achieves FDA requirements of uniformity and stability Improves functional effects (bioavailability , variability , food effect, lowest effective dose, side
Slide 8: TX-004HR VVA Program
TX-004HR VVA Program TherapeuticsMD”
Slide 9: Overview – Vulvar Vaginal Atrophy (VVA)
9 9 Under - diagnosed condition characterized by thinning of vaginal tissue from decreased estrogen levels (1) D iagnosed in approximately 50% of postmenopausal women using measure of vaginal pH levels (1) B othersome symptoms include: d ryness , dyspareunia , itching, irritation , dysuria , bleedin
Slide 10: VVA Market - Established and Growing
10 10 VVA Market - Established and Growing 10 Product Compound TRx (MAT 9/14) (1) US Sales ($M) (1) (2) (MAT 9/14) WAC Price (3) Premarin ® Cream Equine vaginal estrogen 1,767,810 $448 $220.02 Vagifem ® Tablets Vaginal Estradiol 1,945,711 $378 $222.12 Estrace ® Cream Vaginal Estradiol 1,738,856 $324
Slide 11: TX-004HR – Target Product Profile
11 Preliminary patient satisfaction (e.g., no applicator, quick dissolution, no burning) Improved User Experience Phase 1 data suggest lower systemic absorption Lower Systemic Exposure Broad range of doses being evaluated in P3, including 4 mcg New Lower Effective Dose Demonstrated activity at 14 da
Slide 12: VagiCap vs. Vagifem – Phase 1 PK Study
12 12 VagiCap ™ vs. Vagifem ® – Phase 1 PK Study N=36 N=36 Key Findings • Tmax ~2 hours with VagiCap and ~ 8 hours with Vagifem • Systemic absorption AUC (0 - 24 hours ) is 2 - to 3 - fold lower with VagiCap relative to Vagifem 0 6 12 18 24 0 5 10 15 20 Estradiol 10g Study 499 time after dosing (hr
Slide 13: TX-004HR – Promising Phase 2 Data
13 13 TX - 004HR – Promising P2 Data Maturation Index (Mean) Change in pH (Mean) TX - 004HR Placebo TX - 004HR Placebo VagiCap ™ 10 ug n=50 44.48 7.08 - 0.92 - 0.40 Approved Treatments: Pivotal Clinical Data (Week 12)* Maturation Index (Mean) Change in pH (Mean) Active Placebo Active Placebo Premari
Slide 14: TX-004HR Positive Phase 2 Results
14 • 48 post - menopausal women with VVA • Randomized 1:1 to 10µg • Self - administered 1x daily for 2 - week period • Same endpoints measured in Phase 3 (2 vs 12 weeks) Double Blind, Controlled Phase 2 Study TX - 004HR Compared to Placebo • D ecrease in parabasal cells (p<0.0001 ) • I ncrease in su
Slide 15: TX-004HR – Potential Competitive Profile
15 15 TX - 004HR – Potential Competitive Profile 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 Profile Goals • Eliminate burning sensation • Not a cream • Improve ease of use/placement • Qu
Slide 16: Phase 3 – TX-004HR Vaginal Estradiol
16 16 Trial: 12 weeks Sites: ~100 Subjects: ~700 1 − 3 active arms: 4 mcg, 10 mcg, 25 mcg (~175 per arm) − 175 placebo Co - Primary Endpoints − Cell change − Lowering of pH − Reducing Dyspareunia as most bothersome symptom 16 ™ Phase 3 – TX - 004HR Vaginal Estradiol 1) The FDA has to date noted that
Slide 17: TX-001HR Combination Program
17 17 TX - 001HR Combination Program
Slide 18: Indication Overview
18 18 Indication Overview • Menopause is defined as the final menstrual period and is typically confirmed after an otherwise healthy woman has not had a period for 12 consecutive months • Hot flashes are due to lower Estrogen levels • Estrogen is given to reduce hot flashes • Estrogen causes the ute
Slide 19: HT Market Size – Two Markets
19 19 FDA Approved Product Progestin U.S. Sales (est.) Company 17 β E stradiol + NETA / DSP Activella / FemHRT / Angeliq ) Non - bioidentical $ 42 mm (1)(2) Generic 17 β + Progestins Non - bioidentical $ 216 mm (1)(2) Premarin + MPA (Prempro / Premphase) Non - bioidentical $ 336 mm (1)(2) Total FDA
Slide 20: Compounding Market Dynamics
20 • Compounding prescriber (1) base: • 66% Wellness practitioners • 33% OB/GYNs • Growing cash pay market • $46 average cost per unit • An estimated 1M - 2.5M women in the US use BHRT Compounding Market Dynamics (1) - Pharmacy Survey conducted by Rose Research on behalf of inThought Research and th
Slide 21: Drug Quality and Security Act (DQSA)
21 21 Drug Quality and Security Act (DQSA) Spurred by public health scares, DQSA establishes clear FDA oversight of compounding pharmacies Prohibits compounding of essential copies of an FDA - approved and marketed drug except in limited circumstances such as drug shortages Recent FDA enforcement ac
Slide 22: TX-001HR – Differentiated Target Product Profile
22 Bio - identical terminology as both hormones similar to those produced by the ovary Labeling Differentiation Potential for FDA approved natural estradiol plus natural progesterone combination pill Meet Patient Demand for Bio - identicals Broad range of doses being evaluated in P3, one of which wo
Slide 23: Rationale for Natural Progesterone vs. Synthetic Progestins
23 23 (1) Alone or in combination with estrogen. (2) Caufriez , Anne, Rachel Leproult , Mireille L’Hermite - Bale ´ riau , Myriam Kerkhofs , and Georges Copinschi . "Progesterone Prevents Sleep Disturbances and Modulates GH , TSH , and Melatonin Secretion in Postmenopausal Women." J Clin Endocrinol
Slide 24: Phase 3 Vasomotor and Endometrial Protection Study
24 24 24 TX 001 - HR (Estrogen/Progesterone) Phase 3 Study - REPLENISH Designed to enroll 1,750 subjects at ~ US 100 sites Four active arms (N =400 / arm ) ▪ Estradiol 1mg/Progesterone 100mg ▪ Estradiol 0.5 mg/Progesterone 100mg ▪ Estradiol 0.5 mg/Progesterone 50 mg ▪ Estradiol 0.25 mg/Progesterone
Slide 25: Transdermal Programs
Transdermal Programs TherapeuticsMD”
Slide 26: Why Transdermal?
26 26 Why Transdermal? • Transdermal delivery perceived safer due to a lower first pass effect • No FDA - approved transdermal progesterone • New TXMD PK data suggest leveraging solubilized progesterone, show elevated and sustained transdermal levels • Leveraging this technology creates an opportuni
Slide 27: E+P Topical PK Results
27 27 E+P Topical PK Results New Formulation PK Data Suggest Sustained 8 hr Duration 0.00 1.00 2.00 3.00 4.00 5.00 6.00 0 1 2 3 4 5 6 7 8 pg /ml hrs Log Mean Corrected Progesterone pK (Capillary/Saliva) Log Mean Corrected Capillary Progesterone Log Mean Corrected Saliva Progesterone 0.00 0.50 1.00 1
Slide 28: Transdermal Market Opportunity
28 Product (Combination E+P) TRx (1)(2) U.S. Sales (est.) (1)(2) Company Estradiol/ Levonorgestrel ( Climara Pro) 129,755 $ 22.5 M Estradiol/ Norethindrone Acet ( CombiPatch ) 408,598 $ 44.0 M Total Combination Transdermal Sales 538,353 $ 66.5 M Transdermal Market Opportunity Notes : (1) PHAST Presc
Slide 29: Growing Opportunity for Hormone Therapy
29 29 Growing Opportunity for Hormone Therapy US Census 2010
Slide 30: Intellectual Property Update
30 30 Intellectual Property Update
Slide 31: Growing Patent Portfolio
31 Growing Patent Portfolio Filed Provisional Non - Provisional Issued U.S. 37 13 24 4 Ex - U.S. 21 Two new patents issued; one on method of treating menopausal symptoms which strengthens competitive barriers to entry and builds on layered coverage strategies Others issued: Field spanning estradiol
Slide 32: Key Milestones
32 Key Milestones 3Q 14 ▪ Start Phase 3 REJOICE Trial ▪ Report transdermal PK data ▪ New patent a llowances 4Q 14 ▪ NAMS data presentation on VVA data 2Q 15 ▪ Complete REJOICE enrollment 4Q 15 3Q 15 ▪ Report Phase 3 REJOICE results 1Q 15 ▪ Report dermal tissue results ▪ Complete REPLENISH enrollment
Slide 33: TXMD: Financial Snapshot
33 TXMD: Financial Snapshot Listing Exchange NYSE MKT Shares outstanding 156 million (as of Nov 4, 2014) Cash $67 million (as of Sept 30, 2014) Debt $ 0 million
Slide 34: Thank You
34 Thank You w w w . T h e r a p e u t i c s M D . c o m
Slide 35: TX-004HR – VVA Program - Appendix
35 35 TX - 004HR – VVA Program - Appendix -
Slide 36: TX-004HR Positive Phase 2 Study
36 TX - 004HR Positive Phase 2 Study 48 postmenopausal 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
Slide 37: TX-001HR Combination Program - Appendix
37 37 TX - 001HR Combination Program - Appendix -
Slide 38: Evolution of Hormone Therapy Market
38 Evolution of Hormone Therapy Market (1) PHAST Prescription Monthly by Source Healthcare Analytics. Inflation Adjusted Number* (2) Estimates per: Dr. Loyd Allen Jr ., Editor - in - Chief, the International Journal of Pharmaceutical Compounding ; Tom Murry , Executive Director of the Pharmaceutical
Slide 39: Hormone Therapy Use Is Increasing
39 • Post - WHI, expert consensus: HT before 60 has a favorable benefit/risk profile 3 • Women using FDA - approved and compounded HT increasing: • Estimated 30% of use is compounded • Natural or “Bio - identicals ” preferred • 83% of women believe hormone therapy helps treat their symptoms • More y
Slide 40: Current Demand For Natural Hormones
40 40 Current Demand F or N atural H ormones Women actively requesting “ bio - identical ” hormone therapy ( HT) containing natural estradiol and natural progesterone Compounded drugs are not approved by FDA, including requirements for safety, efficacy, or manufacturing quality Emerging evidence of
Slide 41: Current Evidence Shows Potential Advantages of Natural Estradiol
41 41 Current Evidence Shows Potential Advantages of N atural E stradiol “ CEEs ( Premarin ) were associated with a higher incidence of venous thrombosis and myocardial infarction than estradio l ” 1 — Journal of the American Medical Association, September 2013 “ Oral estradiol may be associated wit
Slide 42: Dose Rationale: TX-001HR (Estradiol/Progesterone)
42 42 Dose Rationale: TX - 001HR (Estradiol/Progesterone) Objective: to provide the first FDA approved natural estradiol/progesterone (combination) product with lowest effective doses Dose selection: Four estradiol/progesterone combinations being evaluated based upon: • Known effective doses of estr
Slide 43: Women's HOPE Study Hot Flashes
43 0 2 4 6 8 10 12 14 0 1 2 3 4 5 6 7 8 9 10 11 12 Range of hot flashes at baseline=11.3 - 13.8. *Adjusted for baseline. † P <0.05 by week 3 compared with placebo. ‡ P <0.05 by week 2 compared with placebo. CEE 0.625 mg/day (n=27) ‡ CEE 0.45 mg/day (n=32) ‡ CEE 0.3 mg/day (n=30) † Placebo (n=28) CEE
Slide 44: Low Dose Approvals
44 44 Low Dose Approvals Activella – mean # HFlashes Placebo E2/NETA .25/.1 E2/NETA .5/.1 E2/NETA 1/.5 E2/NETA 2/1 Baseline 72 74.4 73.4 69.6 70.1 Week 4 (vs Pbo ) 39.7 37.1 (p=0.397) 32.5 (p=0.122) 22.9 (p=0.005) 16.4 (p=0.000) Week 8 32.1 26.9 (p=0.163) 18.5 (p=0.004) 14.6 (p=0.002) 7.5 (p=0.000)
Slide 45: History of Compounding Market Shift to Bio-identical Hormone Replacement
45 History of Compounding Market S hift to Bio - identical Hormone Replacement (BHRT) 2002 2002 2005 2012 2013 Women’s Health Initiative - Progestins have elevated FDA vs Western States • First Amendment, specific restrictions on advertising and marketing Wyeth Citizen petition to FDA in reaction BH
Slide 46: The Total Menopause Hormone Market
46 46 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 Allen Jr
Slide 47: ~2 Million Women are Using Compounded HT
47 ~2 Million Women are Using Compounded HT Estimate from Pharmacies 2.3 million women use compounded HT Estimate from Physicians 2.5 million women use compounded HT Estimate from Patients 2.1 million women use compounded HT ▪ Women using FDA - approved HT has increased slowly from 4.5 million in 20
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