Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (June 2015)
42 slides from Therapeuticsmd's investor presentation, Jun 23, 2015
Slide 1: TXMD Overview June 2015
1 TXMD Overview June 2015 w w w . T h e r a p e u t i c s M D . c o m A Woman’s Health Company THER - 0060 V1 6/15
Slide 2: Forward-looking statements
2 2 This presentation by TherapeuticsMD, Inc. (referred to as “we” and “our”) may contain forward - looking statements. Forward - looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies as well as statem ent s, other than historical facts,
Slide 3: TherapeuticsMD (TXMD)
3 3 TherapeuticsMD (TXMD) Innovative women’s health company exclusively focused on developing and commercializing products for women throughout their life cycles Drug candidate portfolio is built on patented SYMBODA ™ technology, developed to enable new bio - identical hormone combinations, forms an
Slide 4: TXMD: Long-Term Growth Opportunity
4 • Two phase 3 products • Transdermal portfolio in development • Billion dollar markets • Unpartnered with worldwide rights TXMD: Long - Term Growth Opportunity DIVERSE PRODUCT PORTFOLIO TWO PHASE 3 PRODUCTS • Billion - dollar markets • Unpartnered with worldwide rights EFFICIENT FUNDING • No debt
Slide 5: Pipeline Targets Large Markets
5 5 Pipeline Targets Large Markets 1) PHAST Prescription Monthly by Source Healthcare Analytics.as of 5/15 2) PHAST by Symphony Health Solutions, full year 2014 3) Pinkerton, J.V. 2015. Menopause, Vol.22, No.9, pp 0 - 11 4) Estimated U.S. sales, based on half estradiol patch sales 5) PHAST by Sympho
Slide 6: TXMD SYMBODA Technology Resolves Current Market Challenges
6 6 TXMD SYMBODA TM Technology R esolves C urrent M arket C hemistry and Formulation C hallenges • Hydrophobic • Crystalline • Small amounts • Low doses 0.5 - 1 mg • Low oral bioavailability • Large molecule • High doses 100 - 200 mg • Micronized • Suspended in peanut oil • 100% inter - /intra - sub
Slide 7: TX-004HR VVA Program
TX-004HR VVA Program TherapeuticsMD"
Slide 8: Overview – Vulvar and Vaginal Atrophy (VVA)
8 8 • D iagnosed in approximately 50% of postmenopausal women 1 • Most bothersome symptoms include: dyspareunia, dryness, itching, irritation, dysuria, bleeding with sexual activity 1 • FDA guidance for efficacy requirements: • Statistical increase in superficial cells • Statistical decrease in para
Slide 9: VVA Market – Established and Growing
9 9 VVA Market – Established and Growing Product 2 Compound TRx 1 12 Month Rolling U.S. Sales ($M) 1 12 Month Rolling WAC Price 3 Premarin ® Cream Equine vaginal estrogen 1,780,516 $489 $263.52 Vagifem ® Tablets Vaginal e stradiol 1,894,045 $428 $306.00* Estrace ® Cream Vaginal estradiol 1,756,494 $
Slide 10: VVA Market Dynamics – Untapped Market
10 10 VVA Market Dynamics – Untapped Market 40 % of women with VVA symptoms are currently utilizing treatment ( 12.8 million): • OTC only: (non - estrogenic) 29 % (9.3 Million) • Rx only: 7 % (2.2 Million) • Both Rx and OTC: 4 % (1.3 Million) 32 million U.S. women currently experiencing VVA symptoms
Slide 11: Perceived Challenges in Dyspareunia Treatment
11 11 Perceived Challenges in Dyspareunia Treatment Consumer Perspective Provider Perspective • Exposure to estrogen/estradiol • R eluctance to discuss symptoms with provider • Lack of knowledge regarding treatment options • Messiness of creams , re - washable applicator • Drug placement issues • In
Slide 12: Creams vs. Tablets
12 12 Creams vs. Tablets One - year treatment persistence with local estrogen in women diagnosed as having vaginal atrophy 1 • V aginal tablets ( Vagifem ® ) were associated with greater persistence of use in the treatment of VVA compared to estrogen creams • During 12 - month period, 86.2% to 89.4%
Slide 13: TX-004HR – Target Product Profile
13 Phase 2 showed patient satisfaction; 97% said “easy to use” Improved user e xperience Phase 1 data with 10 mcg and 25 mcg suggest lower systemic absorption Lower systemic e xposure Phase 3 evaluating broad range of doses, including 4, 10 and 25 mcg New lower e ffective d ose Phase 2 d emonstrated
Slide 14: TX-004HR vs. Vagifem Single Dose PK Studies
14 14 TX - 004HR vs. Vagifem ® Phase 1 Single Dose PK Studies N=36 N=36 Key Findings • Tmax ~2 hours with TX - 004HR and ~ 8 hours with Vagifem • Systemic absorption AUC (0 - 24 hours ) is 2 - to 3 - fold lower with TX - 004HR relative to Vagifem 0 6 12 18 24 0 10 20 30 40 Study 499 - 10 mcg time af
Slide 15: TX-004HR Phase 2 Study
15 15 TX - 004HR Phase 2 Study Double - blind and Controlled • 48 postmenopausal women with VVA (24 active, 24 placebo) • Randomized 1:1 to 10 mcg; 1x daily for 2 - week period • Endpoints measured at 2 weeks; same endpoints to be measured in Phase 3 at 12 weeks • Increase in superficial cells 35% t
Slide 16: TX-004HR Phase 2 Study: Patient Experience
16 TX - 004HR Phase 2 Study: Patient Experience Secondary Endpoint • 97% reported “easy to use” • 96% reported the TX - 004HR softgel ( VagiCap ™ ) was “easy to insert” • 94% reported “convenient to use” • 0% experienced expulsion of capsule • 8% were “dissatisfied”; >60% “very satisfied” • 63% repo
Slide 17: TX-004HR Phase 3 Trial Timelines & Milestones
17 17 TX - 004HR Phase 3 Trial Timelines & Milestones 1 st Subject Screened 1 st Subject Randomized Last Subject Enrolled Last Subject Last Visit** Last Patient Out* (Endometrial biopsy rate limiting) Q3 2014 Q4 2014 Q2 2015 Q3 2015 Q4 2015 Q4 2015 Database Lock Last Patient Out Details* • Last subj
Slide 18: Rejoice Trial Co-primary Endpoints
18 18 Rejoice Trial Co - primary Endpoints • FDA required co - primary endpoints for proposed indication (from baseline to week 12 versus placebo) 1 “Treatment of moderate to severe dyspareunia as a symptom of VVA due to menopause” – Statistically significant increase in the percentage of vaginal su
Slide 19: Phase 3 – TX-004HR Vaginal Estradiol
19 19 • Trial: 12 weeks, Sites: ~100 • Subjects: ~700 fully enrolled as of June 2015 − 3 active arms: 4 mcg, 10 mcg, 25 mcg (~175 per arm) − 175 placebo • Co - Primary Endpoints 1 − Statistically significant increase in the % of vaginal superficial cells − Statistically significant decrease in the p
Slide 20: Growing Opportunity for Hormone Therapy
20 20 Growing Opportunity for Hormone Therapy U.S. Census 2010
Slide 21: TX-001HR Combination Program
21 21 TX - 001HR Combination Program
Slide 22: Menopause Overview
22 22 Menopause 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 e strogen levels • Estrogen is given to reduce hot flashes • Estrogen causes the uter
Slide 23: FDA Approved Hormone Therapy Market Size
23 23 FDA - Approved Product U.S. Sales (est.) Company 17 β E stradiol + NETA / DSP Activella ® / FemHRT ® / Angeliq ® Non bio - identical progestins $ 42M 1 Generic 17 β + Progestins Non bio - identical progestins $ 216M 1 Premarin + MPA Prempro ® / Premphase ® Non bio - identical CEE + progestin $
Slide 24: Hormone Therapy Market = Two Markets
24 24 FDA - approved No Bio - identical combinations Untested Compounded Bio - identical E2 / Progesterone Hormone Therapy Market = Two Markets $600M 1 $1,500M 2 Total Combination E+P Market (in $ billions) 1) PHAST by Symphony Health Solutions, full year 2014 2) Pinkerton , J.V. 2015. Menopause, Vo
Slide 25: Number of U.S. Women Using Non-FDA-Approved Compounded HT
25 25 Number of U.S. Women Using Non - FDA - Approved Compounded HT U.S. women using custom - compounded menopausal hormone therapy Annual c ustom - compounded prescriptions 26 - 33M 1 - 2.5M Archer, D.F., et al. Prevalence of Use and Cost of Compounded Menopausal Hormone Therapy (CMHT) 2015 ACOG, p
Slide 26: TX-001HR – Target Product Profile
26 Bio - identical terminology as both hormones similar to those produced by the ovary Labeling differentiation Potential for FDA - approved first natural estradiol plus natural progesterone combination pill Meet patient d emand for bio - identical hormones Broad range of doses being evaluated in Ph
Slide 27: Evidence Supports Bio-identical Progesterone
27 Evidence Supports B io - identical Progesterone Favorable Clinical Profile Compared to Synthetic Progestins Favorable breast profile Favorable lipid profile Favorable cardiovascular profile Adequate endometrial protection Low incidence of bleeding Favorable CNS profile Freeman E, et al E3N - EPIC
Slide 28: Potential Advantages of Natural Estradiol
28 28 Potential Advantages of N atural E stradiol “ CEEs (Premarin) were associated with a higher incidence of venous thrombosis and myocardial infarction than estradiol.” 1 — Journal of the American Medical Association, September 2013 “Oral estradiol may be associated with a lower risk of stroke …
Slide 29: Drug Quality and Security Act (DQSA)
29 29 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 enforcem
Slide 30: Phase 3 – TX-001HR (Estradiol + Progesterone)
30 30 30 Phase 3 – TX - 001HR (Estradiol + Progesterone) • Designed to enroll 1,750 subjects at ~100 U.S. sites • Four active arms ( N=400/arm) • Estradiol 1 mg/Progesterone 100 mg • Estradiol 0.5 mg/Progesterone 100 mg • Estradiol 0.5 mg/Progesterone 50 mg • Estradiol 0.25 mg/Progesterone 50 mg • P
Slide 31: Transdermal Programs
Transdermal Programs Therapeutics!
Slide 32: Why Transdermal?
32 32 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 opportu
Slide 33: E+P Topical PK Results
33 33 E+P Topical PK Results New Formulation PK Data Suggest Sustained 8 - hour 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 1.0
Slide 34: Proof Of Concept Efficacy Study
34 Proof Of Concept Efficacy Study 34 Estradiol Progesterone or Placebo Cream Ovx’d 1 2 3 4 5 6 7 8 Days P l a c e b o C r e a m P r o g S C P r o g C r e a m P l a c e b o C r e a m P r o g S C P r o g C r e a m P l a c e b o C r e a m P r o g S C P r o g C r e a m 0 20 40 60 80 100 Progesterone Le
Slide 35: Transdermal Market Opportunity
35 35 Product (Combination E+P) TRx (1)(2) U.S. Sales (est.) (1)(2) Company Estradiol/Levonorgestrel ( Climara Pro®) 129,755 $ 22.5M Estradiol/Norethindrone Acet ( CombiPatch ®) 408,598 $ 44.0M Total Combination Transdermal Sales 538,353 $ 66.5 M Transdermal Market Opportunity Product (Estradiol Onl
Slide 36: Intellectual Property Update
36 36 Intellectual Property Update
Slide 37: Growing Patent Portfolio
37 Growing Patent Portfolio Filed Provisional Non - Provisional Issued U.S. 46 14 21 11 Ex - U.S. 59 • Seven new patents issued in 2015 strengthening competitive barriers to entry and building on layered coverage strategies • Others issued: • Field spanning estradiol and progesterone pharmaceutical
Slide 38: Worldwide Patent Filings
38 Worldwide Patent Filings* *Not all patent filings filed in all jurisdictions . Strong IP Portfolio with 59 Patents Pending in 12 Jurisdictions Outside the United States
Slide 39: Investment Rationale
39 39 Investment Rationale • Worldwide commercial rights for multiple hormone therapy products in Phase 3 and earlier stages: • Well - known chemical entities with established safety and efficacy thresholds; 505(b)(2) • Unique, large, and growing markets with favorable competitive dynamics (DQSA) •
Slide 40: Key Milestones
40 Key Milestones 2Q 15 ▪ ACOG oral & poster compounded surveys ▪ EMAS meeting symposium ▪ Complete Rejoice Trial enrollment 4Q 15 ▪ Report Phase 3 Rejoice Trial topline results ▪ NAMS meeting ▪ Complete Replenish Trial enrollment ▪ Phase 3 Rejoice Trial last p atient l ast v isit 1H 16 ▪ Dermal p r
Slide 41: TXMD: Financial Snapshot
41 TXMD: Financial Snapshot Listing Exchange NYSE MKT Shares outstanding 173 million (as of May 4, 2015) Cash $91.7 million (as of March 31, 2015) Debt $ 0 million
Slide 42: Thank You
42 Thank You w w w . T h e r a p e u t i c s M D . c o m A Women’s Health Company