Slide 1: TXMD Overview
A Woman’s Health Company TXMD Overview August 2015 www.TherapeuticsMD.com 1 THER-0061 V3 8/15
Slide 2: Forward-Looking Statements
Forward-Looking Statements 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 statements, other than h
Slide 3: TherapeuticsMD (TXMD)
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 and admin
Slide 4: Pipeline Targets Large Markets
Pipeline Targets Large Markets Pre-Clinical Phase 1 Phase 2 Phase 3 U.S. Market Opp. ($MM) 17ß Estradiol in VagiCap™ TX-004HR $1,5461 Combination: 17ß Estradiol + Progesterone TX-001HR $2,2001,2 TXMD Oral Progesterone TX-002HR temporarily stopped trial* $4161 Transdermal Progesterone TX-005HR $4073
Slide 5: Key Milestones
Key Milestones § Phase 3 Rejoice Trial § NDA filing TX-004HR last subject last visit § Transdermal estradiol and progesterone Phase 1 results 3Q 15 4Q 15 1H 16 2H 16 § Report Phase 3 § Phase 3 Replenish Trial Rejoice Trial topline results last subject out § Complete Phase 3 § Report Phase 3 R
Slide 6: TX-004HR VVA Program
TX-004HR VVA Program ff pat TherapeuticsMD
Slide 7: Overview – Vulvar and Vaginal Atrophy (VVA)
Overview – Vulvar and Vaginal Atrophy (VVA) 1 • Diagnosed in approximately 50% of postmenopausal women 1 • Most bothersome symptom commonly reported is dyspareunia • FDA guidance for efficacy requirements: • Statistically significant increase in superficial cells • Statistically significant decrease
Slide 8: VVA Market – Established and Growing
VVA Market – Established and Growing • U.S. sales more than doubled since 2008 • Global market expected to be $2.1 billion in 2022 4 • Currently no generic competition • 32 million U.S. women currently experiencing VVA symptoms 2 TRx1 U.S. Sales ($MM)1 Product Compound 12 Month Rolling WAC Price3 12
Slide 9: VVA Market Dynamics – Ready for New Product
VVA Market Dynamics – Ready for New Product Only 2.3MM U.S. women 1 treated with Rx product Creams • Messiness2 Mean treatment • Long-term safety2 duration Women • Dose preparation by user required3 46 days 4 primed for Tablets Mean treatment conversion to • Long-term safety2 • Systemic absorption2
Slide 10: 30MM Women with VVA Untreated in U.S.
30MM Women with VVA Untreated in U.S.** 30MM 2.3MM 7% 32MM 93% Many untreated Rx treated 3 Currently 3 Symptomatic Not due to estrogen treated 1,2 VVA treated** exposure concerns $1.5 Billion $20 + Billion $19 Billion Opportunity 1) The North American Menopause Society. Management of symptomatic vul
Slide 11: Vagifem 25 mcg to 10 mcg Market Share
Vagifem 25 mcg to 10 mcg Market Share ® Vagifem Year 2009 2014 Dosage Strength 25 mcg* 10 mcg* Loss due to Market Share1 (%) 40% 32% market share decline * 1 • VVA market TRx increased 15% 2009-2014 • Vagifem had an 18% decrease of its own market share moving to 10 mcg only 1) Symphony Health Soluti
Slide 12: TX-004HR – Target Product Profile
TX-004HR – Target Product Profile Target Goals Preliminary Supportive Data Phase 1 data with 10 mcg and 25 mcg Lower systemic exposure suggest lower systemic absorption Faster onset of action Phase 2 demonstrated efficacy in 14 days Phase 3 evaluating broad range of doses, New lower effective dose i
Slide 13: TX-004HR Vaginal Estradiol U.S. Launch Timeline
TX-004HR Vaginal Estradiol U.S. Launch Timeline Q1 '15 Q2 '15 Q3 '15 Q4 '15 Q1 '16 Q2 '16 Q3 '16 Q4 '16 Q1 '17 E n ro llme n t T o p lin e C o mp le te d R e p o rt NDA Prep/Filing/PDUFA ™ Phase 3 • Phase 3 Trial1: 12 weeks, ~100 sites • Subjects: ~700 fully enrolled as of June 2015 − 3 active arms:
Slide 14: TX-004HR Phase 3 Trial Timelines & Milestones
TX-004HR Phase 3 Trial Timelines & Milestones Last Subject Last Complete* 1st Subject Subject (Endometrial biopsy Screened Enrolled rate limiting) Q3 Q4 Q2 Q3 Q4 Database Q4 2014 2014 2015 2015 2015 Lock 2015 1st Subject Last Randomized Subject Last Visit** Last Subject Last Visit Details* • Last su
Slide 15: TX-004HR Phase 2 Study Double-blind and Placebo-controlled
TX-004HR Phase 2 Study Double-blind and Placebo-controlled Study Design • 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 1 Co-primary Endpoint Result
Slide 16: TX-004HR vs. Vagifem Phase 1 Single Dose PK Studies
TX-004HR vs. Vagifem ® Phase 1 Single Dose PK Studies 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 S tu d y 4 9 9 - 1 0 m c g m e a n p la s m a c o n c e n tr a tio n (p g /m L ) S
Slide 17: TX-001HR Combination Program
TX-001HR Combination Program 17
Slide 18: Menopause Overview
Menopause Overview Menopause represents the natural life-stage transition when women stop having periods and may result in physical and emotional symptoms. • Average age of menopause is 51 years1 • Hot flashes are due to lower estrogen levels • Estrogen is given to reduce hot flashes • Estrogen caus
Slide 19: FDA Approved Hormone Therapy Market Size
FDA Approved Hormone Therapy Market Size FDA-Approved Product U.S. Sales ($MM)1 Company 17β Estradiol + NETA / DSP Non bio-identical Activella / FemHRT / Angeliq ® ® ® containing progestins $37 Non bio-identical Generic 17β + Progestins containing progestins $230 Premarin + MPA Non bio-identical Pre
Slide 20: Hormone Therapy Market = Two Markets
Hormone Therapy Market = Two Markets Total Combination E+P Market $661MM 1 FDA-Approved No Bio-identical Combinations $2.2 billion = $1,500MM 2 Compounded Bio-identical Estradiol / Progesterone 1) Symphony Health Solutions PHAST 2.0 Prescription Monthly Data, 12 months as of June 30, 2015. 20 2) Pin
Slide 21: Number of U.S. Women Using Non-FDA-Approved Compounded HT
Number of U.S. Women Using Non-FDA-Approved Compounded HT U.S. women using Pinkerton, J.V. Compounded bio-identical hormone 1-2.5MM custom-compounded therapy: identifying use trends and knowledge gaps menopausal hormone therapy among U.S. women. Menopause Vol.22, No.9, 2015. Pinkerton, J.V. Menopaus
Slide 22: Evidence Supports Bio-identical Progesterone
Evidence Supports Bio-identical Progesterone Favorable Clinical Profile Compared to Synthetic Progestins Bio-identical Progesterone Synthetic Progestins References 1 Favorable CNS profile No benefit on sleep properties Freeman E, et al 2 Favorable breast profile Increased risk of breast cancer E3N-E
Slide 23: Evidence Supports Bio-identical Estradiol
Evidence Supports Bio-identical Estradiol Favorable Clinical Profile Compared to Conjugated Estrogens “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 estradio
Slide 24: Medical Societies Express Concern Over Compounded Hormones
Medical Societies Express Concern Over Compounded Hormones • ACOG and ASRM Committee Opinion states compounded hormones may pose additional risks compared to FDA approved products1 • Lack of Good Manufacturing Practices (GMP) • Variable purity • Variable content uniformity • Variable potency (under/
Slide 25: Compounding Regulations and Enforcement
Compounding Regulations and Enforcement 1 Drug Quality and Security Act (DQSA) • Prohibits compounding of essential copies of an FDA-approved drug except in limited circumstances such as drug shortages • Anticipate significant impact on compounding upon FDA-approval of first combination hormone ther
Slide 26: TX-001HR – Target Product Profile
TX-001HR – Target Product Profile Target Goals Preliminary Supportive Data Potential for FDA-approved first natural Meet patient demand for estradiol plus natural progesterone bio-identical hormones combination softgel Broad range of doses being evaluated in New lower effective dose Phase 3 Bio-iden
Slide 27: TX-001HR Estradiol + Progesterone U.S. Launch Timeline
TX-001HR Estradiol + Progesterone U.S. Launch Timeline Q1 '15 Q2 '15 Q3 '15 Q4 '15 Q1 '16 Q2 '16 Q3 '16 Q4 '16 Q1 '17 Q2 '17 Q3 '17 Q4 '17 Q1 '18 Phase 3 Vasomotor & Endometrial Safety NDA Prep/Filing/ PDUFA • Phase 3 Replenish Trial to enroll 1,750 subjects at ~100 U.S. sites • Four active arms (N=
Slide 28: Early Stage Pipeline: Transdermal Programs
Early Stage Pipeline: Transdermal Programs 28
Slide 29: Why Transdermal?
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 opportunity for n
Slide 30: E+P Topical PK Results
E+P Topical PK Results New Formulation PK Data Suggest Sustained 8-hour Duration1 Log Mean Corrected Progesterone PK Log Mean Corrected Estradiol PK 3.00 (Capillary and Saliva) (Capillary and Saliva) 6.00 2.50 5.00 2.00 pg/ml 4.00 1.50 Log Mean Corrected Capillary Estradiol pg/ml Log Mean Corrected
Slide 31: Proof Of Concept Efficacy Study
Proof Of Concept Efficacy Study 1 Progesterone or Placebo Cream Estradiol Days 1 2 3 4 5 6 7 8 Ovarectomized rat (OVX) P r o g e s te r o n e L e v e ls U t e r in e W e ig h t s L u m in a l E p it h e lia l C e ll H e ig h t 100 0 .5 60 n g p r o g /m L ( g ) s a m p le U t e r in e W e ig h t ( g
Slide 32: Transdermal Market Opportunity
Transdermal Market Opportunity Product (Combina1on E+P) TRx1 (000) U.S. Sales ($MM)1 Company Estradiol/Levonorgestrel 111 $23 (Climara Pro®) Estradiol/Norethindrone Acet 383 $58 (CombiPatch®) Total Combina1on 494 $81 Transdermal Sales Product (Estradiol Only) TRx1 (000) U.S. Sales ($MM)1 Company Est
Slide 33: Intellectual Property Update
Intellectual Property Update 33
Slide 34: Growing Patent Portfolio
Growing Patent Portfolio Non- Filed Provisional Issued Provisional U.S. 48 15 22 11 Ex-U.S. 61 • 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 compos
Slide 35: Worldwide Patent Filings
Worldwide Patent Filings* Strong IP Portfolio with 61 Patents Pending in 12 Jurisdictions Outside the United States 35 *Not all patent filings filed in all jurisdictions.
Slide 36: Investment Rationale
Investment Rationale 36
Slide 37: Investment Rationale
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) • Addition
Slide 38: TXMD: Financial Snapshot
TXMD: Financial Snapshot Listing Exchange NYSE MKT Shares outstanding 177.5 million (as of August 3, 2015) Cash $67.2 million (as of June 30, 2015) Financing net proceeds $32.2 million (offering July 10, 2015) Debt $ 0 million 38
Slide 39: Thank You!
Thank You! www.TherapeuticsMD.com 39
Slide 40: Appendix
Appendix » A Therapeutics! | eS TherapeuticsMD’
Slide 41: Long-Term Growth Opportunity
Long-Term Growth Opportunity DIVERSE PRODUCT PORTFOLIO • Two Phase 3 products • Trial completion for lead product expected Q4 2015 • Complete enrollment for second product expected Q4 2015 • Pipeline of 8 novel products • Expedited and cost effective development – 505(b)(2) pathway • Unpartnered wit
Slide 42: TX-004HR Phase 2 Study Patient Experience Secondary Endpoint
TX-004HR Phase 2 Study Patient Experience Secondary Endpoint Patient Experience Survey Results Summary 1 • 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 • >60% “very satisfied”