Therapeuticsmd, Inc. · NASDAQ:TXMD

Therapeuticsmd — Investor Presentation (November 2015)

44 slides from Therapeuticsmd's investor presentation, November 2015

1. Slide 1: TXMD Overview

   TXMD Overview November 2015 THER-­‐0063 11/15

2. Slide 2: Forward-Looking Statements

   Forward-­‐Looking Statements This presenta7on by Therapeu7csMD, Inc. (referred to as “we” and “our”) may contain forward-­‐looking statements. Forward-­‐looking statements may include, but are not limited to, statements rela7ng to our objec7ves, plans and strategies, as well as statements, other tha

3. Slide 3: TXMD

   (TXMD) Innova:ve women’s health company exclusively focused on developing and commercializing products for women throughout their life cycles Drug candidate por@olio is built on SYMBODA™ technology to enable solubilizaHon of new bio-­‐idenHcal hormone combinaHons, forms, and administraHon routes 3

4. Slide 4: Unique Confluence of Factors

   Unique Confluence of Factors Scien7fic Regulatory • Progressing pipeline • FDA public mee7ng: Labeling lower-­‐dose — TX-­‐004HR topline data an7cipated estrogen-­‐alone products for VVA6 Q4 2015 • NAMS ci7zen pe77on7 — Replenish Trial fully enrolled • Increasing compounding regula7ons Q3 2015 and enf

5. Slide 5: Pipeline Targets Large Markets

   Pipeline Targets Large Markets Preclinical Phase 1 Phase 2 Phase 3 U.S. Market ($MM) 17ß-­‐estradiol in VagiCap™ TX-­‐004HR $1,546 1 Combina7on: 17ß-­‐estradiol + Progesterone TX-­‐001HR $2,200 1,2 Transdermal Progesterone TX-­‐005HR $407 3 Transdermal 17ß-­‐estradiol + Progesterone TX-­‐006HR $81 1

6. Slide 6: Management with Deep Experience in Women's Health

   Management with Deep Experience in Women’s Health • Former U.S. Secretary of • Co-founded vitaMedMD • Co-founded CareFusion • Co-founded vitaMedMD • Former Clinical Lead of Health and Human Services in 2008 • Held executive, sales, and in 2008 Women’s Health at Pfizer (2001-2005) operation managemen

7. Slide 7: TX-004HR | VVA Program

   TX-OO4HR | VVA Program TherapeuticsMD’

8. Slide 8: Overview – Vulvar and Vaginal Atrophy (VVA)

   Overview – Vulvar and Vaginal Atrophy (V VA) § Diagnosed in approximately 50% of postmenopausal women 1 § Most bothersome symptom commonly reported is dyspareunia 1 § FDA guidance for efficacy requirements: — Sta7s7cally significant increase in superficial cells — Sta7s7cally significant decrease in p

9. Slide 9: VVA Market – Established and Growing

   VVA Market – Established and Growing § U.S. sales more than doubled since 2008 § Global market expected to be $2.1 billion in 20224 § Currently no generic compe77on § 32 million U.S. women currently experiencing VVA symptoms5,6 TRx1 Product 2 Compound U.S. Sales ($MM)1 WAC Price3 12 Month Rollin

10. Slide 10: 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 Vaginal Creams Mean treatment • Messiness 2 dura:on • Long-term safety2 • Dose preparation by user required3 46 days 4 Women primed for conversion to new Vaginal product Mean treatment Tablets dura:on • Long-te

11. Slide 11: 30MM Women with VVA Untreated

    30MM Women with V VA Untreated** 30MM Many untreated 7% 32MM 93% due to estrogen 2.3MM Currently Not Rx treated 3 treated 3 Symptomatic exposure treated** VVA 1,2 concerns $1.5 Billion $20+ Billion $19 Billion Opportunity 1) The North American Menopause Society. Management of symptoma7c vulvovaginal

12. Slide 12: 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* Market Share1 40% 32% (%) § VVA market TRx increased 15% 2009-­‐2014 1 § Vagifem had an 18% decrease of its own market share moving to 10 mcg only 1) Symphony Health Solu7ons PHAST 2.0 Prescrip7on Monthly

13. Slide 13: TX-004HR – Target Product Profile

    TX-­‐004HR – Target Product Profile Target Goals Preliminary Suppor:ve Data Phase 1 data with 10 mcg and 25 mcg Lower systemic exposure suggests lower systemic absorp7on Phase 2 demonstrated efficacy Fast onset of ac:on in 14 days Phase 3 evalua7ng broad range of New lower effec:ve dose doses, including

14. Slide 14: 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 Vagifem is a registered trademark of Novo Nordisk A/S Corp. 14

15. 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 ac7ve, 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 Co-­‐primary Endpo

16. Slide 16: 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 Enrollment Topline Phase 3 Completed Report NDA Prep/Filing/PDUFA § Phase 3 Trial1: 12 weeks, ~100 sites § Subjects: ~700 Fully Enrolled as of June 2015 − 3 ac7ve arms: 4 mcg, 10 mcg, 2

17. Slide 17: TX-004HR Phase 3 Trial Timelines & Milestones

    TX-­‐004HR Phase 3 Trial Timelines & Milestones Q3 1st Subject 2014 1st Subject Screened 4 2015 Last Subject, Last Visit Details Q4 § Endometrial biopsy (EB) – 3 independent pathologists must read 2015 § If insufficient 7ssue, repeat EB Last Subject § If insufficient 7ssue on repeat biopsy – transvag

18. Slide 18: TX-001HR | Combination Program

    TX-­‐001HR | CombinaHon Program 18

19. Slide 19: Menopause Overview

    Menopause Overview Menopause represents the natural life-­‐stage transi:on when women stop having periods May result in physical and emo:onal symptoms § Average age of menopause 51 years1 § Hot flashes due to lower estrogen levels § Estrogen given to reduce hot flashes § Estrogen causes uterus to

20. Slide 20: 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-­‐iden:cal Ac7vella®/ FemHRT®/ Angeliq® containing proges:ns $37 Non bio-­‐iden:cal Generic 17β Q4 + Proges:ns containing proges:ns $230 2015 Premarin + MPA Non bio-­‐iden

21. Slide 21: Total Combination E+P = Two Markets

    Total Combina:on E+P = Two Markets $661MM 1 FDA-­‐Approved Q4 No Bio-­‐iden7cal Combina7ons 2015 $1,500MM 2 = $2.2 billion Compounded Bio-­‐iden:cal Estradiol/Progesterone 1) Symphony Health Solu7ons PHAST 2.0 Prescrip7on Monthly Data, 12 months as of June 30, 2015. 2) Pinkerton, J.V. 2015. Menopaus

22. Slide 22: U.S. Women Using Non-FDA-Approved Compounded HT

    U.S. Women Using Non-­‐FDA-­‐Approved Compounded HT Pinkerton, J.V. Compounded bio-­‐iden7cal U.S. women using hormone therapy: iden7fying use trends custom-compounded and knowledge gaps among U.S. women. 1-2.5MM menopausal hormone Menopause, Vol.22, No.9, 2015. therapy Pinkerton, J.V. Menopause Hor

23. Slide 23: Evidence Supports Bio-identical Progesterone

    Evidence Supports Bio-­‐iden:cal Progesterone Favorable Clinical Profile Compared to Synthe:c Proges:ns E3N-­‐EPIC2 Increased risk of MI, PEPI3, ELITE5 stroke, VTE PEPI3 Adequate endometrial PEPI4 protec:on High incidence of bleeding Lorrain, et al. 6 1) Freeman E, Rickels K, Sondheimer S J. et al. A

24. Slide 24: Evidence Supports Bio-identical Estradiol

    Evidence Supports Bio-­‐iden:cal Estradiol Favorable Clinical Profile Compared to Conjugated Estrogens CEEs (Premarin) were associated The ELITE trial demonstrated that with a higher incidence of estradiol is cardioprotec:ve venous thrombosis and myocardial when given during the early infarc:on than

25. Slide 25: Medical Societies Express Concern Over Compounded Hormones

    Medical Societies Express Concern Over Compounded Hormones § ACOG and ASRM Commikee Opinion states compounded hormones may pose additional risks compared to FDA-­‐approved products 1 — Lack of Good Manufacturing Prac7ces (GMP) — Variable purity — Variable content uniformity — Variable potency (unde

26. Slide 26: Compounding Regulations and Enforcement

    Compounding Regula:ons and Enforcement Drug Quality and Security Act (DQSA) 1 § Prohibits compounding of essen7al copies of FDA-­‐approved drug except in limited circumstances such as drug shortages § An7cipate significant impact on compounding upon FDA approval of first combina7on hormone therapy p

27. Slide 27: TX-001HR – Target Product Profile

    TX-­‐001HR – Target Product Profile Target Goals Preliminary Suppor:ve Data Poten7al for first FDA-­‐approved natural Meet pa7ent demand for estradiol plus natural progesterone bio-­‐iden7cal hormones combina7on soQgel capsule Broad range of doses being New lower effec7ve dose evaluated in phase 3 Bio-

28. Slide 28: 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 § Phase 3 Trial1: ~110 U.S. sites § Subjects: ~1750 fully enrolled as of October 201

29. Slide 29: Key Milestones

    Key Milestones § NDA filing TX-­‐004HR § Transdermal estradiol and progesterone phase 1 results 4Q ‘15 1H ‘16 2H ‘16 § Report phase 3 Rejoice Trial topline results § Report phase 3 Replenish § Completed phase 3 Replenish Trial enrollment Trial topline results § NAMS mee7ng (4Q ‘16 – 1Q ‘17) — 3

30. Slide 30: Early Stage Pipeline | Transdermal Programs

    Early Stage Pipeline | Transdermal Programs 30

31. Slide 31: 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 new pro

32. Slide 32: E+P Topical PK Results

    E+P Topical PK Results New Formula:on PK Data Suggest Sustained 8-­‐hour Dura:on 1 Q4 2015 Q4 2015 § Levels in the saliva and capillary samples are higher than in the serum, where it was not detectable1 § Consistent with published ar7cle from Du and Stanczyk 20132 1) Data on file, Therapeu7csMD. 2)

33. Slide 33: Proof of Concept Efficacy Study

    Proof of Concept Efficacy Study 1 Q4 2015 1) Data on File, Therapeu7csMD. Note: An ovarectomized rat (OVX) is a female rat whose ovaries have been removed. 33

34. Slide 34: Transdermal Market Opportunity

    Transdermal Market Opportunity Product (Combina:on E+P) TRx1 (000) U.S. Sales ($MM)1 Company Estradiol/Levonorgestrel 111 $23 (Climara Pro®) Estradiol/Norethindrone Acet 383 $58 (CombiPatch®) Total Combina:on 494 $81 Transdermal Sales Product (Estradiol Only) TRx1 (000) U.S. Sales ($MM)1 Company Est

35. Slide 35: Intellectual Property | Update

    Intellectual Property | Update 35

36. Slide 36: Growing Patent Portfolio

    Growing Patent Poryolio Non-­‐ Filed Provisional Issued Provisional U.S. 50 15 22 13 Ex-­‐U.S. 61 Q4 §2015Nine new patents issued in 2015, strengthening compe77ve barriers to entry and building on layered coverage strategies § Others issued — Field spanning estradiol and progesterone pharmaceu7cal

37. Slide 37: Worldwide Patent Filings

    Worldwide Patent Filings* Strong IP Por…olio with 61 Patents Pending in 12 Jurisdic7ons Outside the United States *Not all patent filings filed in all jurisdic7ons. 37

38. Slide 38: Investment Rationale

    Investment Ra:onale 38

39. Slide 39: Investment Rationale

    Investment Ra:onale Worldwide commercial rights for mul:ple hormone therapy products in phase 3 and earlier stages § Well-­‐known chemical en77es with established safety and efficacy thresholds § Unique, large, and growing U.S. markets with favorable compe77ve dynamics § Addi7onal early stage pipel

40. Slide 40: TXMD: Financial Snapshot

    TXMD: Financial Snapshot Lis:ng Exchange Debt $0MM Shares Outstanding Cash 177.8MM $81.1MM (as of Nov. 2, 2015) (as of Sept. 30, 2015) 40

41. Slide 41: THANK YOU!

    TherapeuticsMD THANK YOU! TherapeuticsMD”

42. Slide 42: Appendix

    Appendix 42

43. Slide 43: Long-Term Growth Opportunity

    Long-­‐Term Growth Opportunity DIVERSE PRODUCT PORTFOLIO • Two phase 3 products • Topline data for TX-­‐004HR an7cipated Q4 2015 • Completed enrollment of TX-­‐001HR Q3 2015 • Pipeline of novel products • Unpartnered with worldwide rights LARGE UNDERSERVED MARKETS SYMBODATM TECHNOLOGY address • Phas

44. Slide 44: TX-004HR Phase 2 Study Patient Experience Secondary Endpoint

    TX-­‐004HR Phase 2 Study Pa:ent Experience Secondary Endpoint Pa:ent Experience Survey Results Summary 1 § 97% reported “easy to use” § 96% reported the TX-­‐004HR soQgel (VagiCap™) was “easy to insert” § 94% reported “convenient to use” § 0% experienced expulsion of capsule § 60% “very sa7sfied

TherapeuticsMD — Investor Presentation (November 2015) on 6ix