Therapeuticsmd, Inc. · NASDAQ:TXMD

Therapeuticsmd — Investor Presentation (January 2016)

51 slides from Therapeuticsmd's investor presentation, January 2016

  1. Slide 1: TXMD Overview

    TXMD Overview January 2016 THER-0072 1/16

  2. 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

  3. Slide 3: (TXMD)

    (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 SYMBODA™ technology for the solubilization of bio-identical female hormones 3

  4. Slide 4: Unique Confluence of Factors

    Unique Confluence of Factors Medical Science Regulatory Environment • Progressing pipeline • FDA public meeting: Labeling lower-dose — TX-004HR Rejoice Trial estrogen-alone products for VVA6  Positive topline data Q4 2015 • NAMS citizen petition7 — TX-001HR Replenish Trial • Increasing compounding

  5. Slide 5: Pipeline Targets Large Markets

    Pipeline Targets Large Markets Preclinical Phase 1 Phase 2 Phase 3 NDA Filing U.S. Market ($MM) 17ß-estradiol in VagiCap™ TX-004HR 1H 2016 $1,546 1 Combination: 17ß-estradiol + Progesterone TX-001HR $2,200 1,2 Transdermal Progesterone TX-005HR $407 3 Transdermal 17ß-estradiol + Progesterone TX-006HR

  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 • Former CFO of American • Co-founded vitaMedMD • Former Clinical Lead of Health and Human Services in 2008 • Held executive sales and Wireless, Telegeography, in 2008 Women’s

  7. Slide 7: TX-004HR | Vulvar and Vaginal Atrophy (VVA) Program

    TX-004HR | Vulvar and Vaginal Atrophy (VVA) Program 7

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

    Overview – Vulvar and Vaginal Atrophy (V VA)  Chronic and progressive condition characterized by thinning of vaginal tissue from decreased estrogen levels  Diagnosed in approximately 50% of postmenopausal women1  Primary symptom = dyspareunia  Secondary symptoms include: dryness, itching, irrita

  9. Slide 9: VVA Market – Established and Growing

    VVA Market – Established and Growing  U.S. sales more than doubled since 20081  Global market expected to be $2.1 billion in 20224  Currently no generic competition  32 million U.S. women currently experiencing VVA symptoms5,6 TRx1 U.S. Sales 2 Product Company Compound 12 Month Rolling ($MM)1 WA

  10. Slide 10: Statistical Significance of Results for Co-Primary Endpoints

    Statistical Significance of Results for Co-Primary Endpoints Mean Change from Baseline to Week 12 Compared to Placebo 25 µg 10 µg 4 µg Superficial Cells <0.0001 <0.0001 <0.0001 Parabasal Cells <0.0001 <0.0001 <0.0001 Vaginal pH <0.0001 <0.0001 <0.0001 Severity of Dyspareunia 0.0001 0.0001 0.0255 10

  11. Slide 11: Statistical Significance of Mean Change from Baseline Severity of Dyspareunia by Study Visit

    Statistical Significance of Mean Change from Baseline Severity of Dyspareunia by Study Visit 25 µg 10 µg 4 µg Week 2 0.0284 0.0026 0.0407 Week 6 0.0001 0.0012 0.0123 Week 8 < 0.0001 < 0.0001 0.0005 Week 12 0.0001 0.0001 0.0255 11

  12. Slide 12: Baseline Adjusted Mean Estradiol Concentration Day 1

    Baseline Adjusted Mean Estradiol Concentration Day 1 12

  13. Slide 13: Baseline Adjusted Mean Estradiol Concentration Day 14

    Baseline Adjusted Mean Estradiol Concentration Day 14 13

  14. Slide 14: 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 2 • Messiness • Re-usable applicator duration 46 days 2 • Long-term safety 4 • Dose preparation Women by user required3 primed for conversion to new Vaginal product Tablets Mean tr

  15. Slide 15: 30MM Women with VVA Untreated

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

  16. Slide 16: Current Products for the Treatment of VVA

    Current Products for the Treatment of VVA Product Characteristic Vagifem® Premarin® Cream Estrace® Cream Osphena® Design Cream   Oral SERM Applicator    Daily Use All trademarks are the property of their respective owners. 16 16

  17. Slide 17: TX-004HR – Target Product Profile

    TX-004HR – Target Product Profile Target Goals Phase 3 Supportive Data Phase 3 data demonstrated statistical significance Efficacy for all 3 doses on the 4 co-primary endpoints Negligible to low systemic absorption with 4 mcg, Low systemic exposure 10 mcg and 25 mcg observed in phase 1 and 3 Fast on

  18. Slide 18: 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. 18

  19. Slide 19: TX-004HR Phase 3 PK Studies

    TX-004HR Phase 3 PK Studies Key Findings  Negligible to low systemic absorption for all three doses  Supportive of the previous phase 1 trial data Rejoice Trial (Phase 3) Baseline Adjusted Mean Estradiol Concentration Day 1 & Day 14 Day 1 Day 14 19

  20. Slide 20: 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 File NDA Data Presentation NDA Prep/Filing/PDUFA  Phase 3 Trial1: 12 Week Double-blinded, Placebo Controlled  Subjects: 764, in 89 Sites across

  21. Slide 21: Black Box Warning

    Black Box Warning Current Black Box Warning1: WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progesti

  22. Slide 22: Black Box Warning Citizen Petition

    Black Box Warning Citizen Petition A Citizen Petition organized by the North American Menopause Society (NAMS) to be submitted to FDA and supported by1:  Endocrine Society  American Congress of Obstetricians and Gynecologists  American Medical Women’s Association  American Society for Reproducti

  23. Slide 23: Sales Expansion

    Sales Expansion Current vitaMedMD Sales Force  32 territories 1 Sales Expansion  21,740 Total OB/GYNs  16,820 OB/GYN Physicians in GYN offices 1. http://www.bls.gov/oes/current/oes291064.htm 23

  24. Slide 24: TX-001HR | Combination Estrogen + Progesterone (E+P) Program

    TX-001HR | Combination Estrogen + Progesterone (E+P) Program 24

  25. Slide 25: Menopause Overview

    Menopause Overview Menopause represents the natural life-stage transition when women stop having periods May result in physical and emotional symptoms  Average age of menopause 51 years1  Hot flashes due to lower estrogen levels  Estrogen given to reduce hot flashes  Estrogen causes uterus to th

  26. Slide 26: Total Addressable Market = 40 MM prescriptions

    Total Addressable Market = 40 MM prescriptions Combined use of FDA-approved Estrace® & Prometrium® 1.5 – 2.5 MM prescriptions1 FDA-approved Single-pill Combination E+P (synthetic) 7-8 MM prescriptions1 Compounded Bioidentical E+P 30MM prescriptions2,3 1) Symphony Health Solutions PHAST 2.0 Prescript

  27. Slide 27: FDA-Approved Hormone Therapy Market Size

    FDA-Approved Hormone Therapy Market Size FDA-Approved Product Non-Bioidentical U.S. Sales ($MM)1 Company 17β-estradiol + NETA / DSP Non bio-identical Activella®/ FemHRT®/ Angeliq® containing progestins $37 Non bio-identical Q4 Generic 17β + Progestins containing progestins $230 2015 Premarin + MPA N

  28. Slide 28: U.S. Women Using Non-FDA-Approved Compounded HT

    U.S. Women Using Non-FDA-Approved Compounded HT Pinkerton, J.V. Compounded bio-identical U.S. women using hormone therapy: identifying use trends custom-compounded and knowledge gaps among U.S. women. 1-2.5MM1 menopausal hormone Menopause, Vol.22, No.9, 2015.1 therapy Pinkerton, J.V. Menopause Hormo

  29. Slide 29: Evidence Supports Bio-identical Progesterone Favorable Clinical Profile Compared to Synthetic Progestins

    Evidence Supports Bio-identical Progesterone Favorable Clinical Profile Compared to Synthetic Progestins High incidence of bleeding 1) Freeman E, Rickels K, Sondheimer S J. et al. A double-blind trial of oral progesterone, alprazolam and placebo in treatment of severe premenstrual syndrome. JAMA. 19

  30. Slide 30: Evidence Supports Bio-identical Progesterone Favorable Clinical Profile Compared to Conjugated Estrogens

    Evidence Supports Bio-identical Progesterone Favorable Clinical Profile Compared to Conjugated Estrogens CEEs (Premarin) were associated The ELITE trial demonstrated that with a higher incidence of estradiol is cardioprotective venous thrombosis and myocardial when given during the early infarction

  31. Slide 31: 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/

  32. Slide 32: Compounding Regulations and Enforcement

    Compounding Regulations and Enforcement Drug Quality and Security Act (DQSA)1  Prohibits compounding of essential copies of FDA-approved drug except in limited circumstances such as drug shortages  Anticipate significant impact on compounding upon FDA approval of first combination hormone therapy

  33. Slide 33: TX-001HR – Target Product Profile

    TX-001HR – Target Product Profile Target Goals Preliminary Supportive Data Potential for first FDA-approved natural Meet patient demand for estradiol plus natural progesterone bio-identical hormones combination softgel capsule Broad range of doses being New lower effective dose evaluated in phase 3

  34. Slide 34: 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: ~100 U.S. sites  Subjects: ~1750 fully enrolled as of October 2015 

  35. Slide 35: Key Milestones and Anticipated Milestones

    Key Milestones and Anticipated Milestones  Expected NDA filing TX-004HR  Expected transdermal estradiol and progesterone phase 1 results 4Q ‘15 1H ‘16 2H ‘16  Reported phase 3 Rejoice Trial topline results  Expected to report  Completed phase 3 Replenish Trial enrollment phase 3 Replenish  NAM

  36. Slide 36: Early Stage Pipeline | Transdermal Programs

    Early Stage Pipeline | Transdermal Programs 36

  37. Slide 37: 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 proge

  38. Slide 38: E+P Topical PK Results

    E+P Topical PK Results New Formulation PK Data Suggest Sustained 8-hour Duration1 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 article from Du and Stanczyk 20132 1) Data on file, TherapeuticsMD. 2)

  39. Slide 39: Proof of Concept Efficacy Study

    Proof of Concept Efficacy Study 1 Q4 2015 1) Data on File, TherapeuticsMD. Note: An ovarectomized rat (OVX) is a female rat whose ovaries have been removed. 39

  40. Slide 40: Transdermal Market Opportunity

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

  41. Slide 41: Intellectual Property | Update

    Intellectual Property | Update 41

  42. Slide 42: Growing Patent Portfolio

    Growing Patent Portfolio Non- Filed Provisional Issued Provisional U.S. 51 16 21 14 Ex-U.S. 61 Q4Ten new patents issued in 2015, strengthening competitive barriers 2015 to entry and building on layered coverage strategies  Others issued — Field spanning estradiol and progesterone pharmaceutical co

  43. Slide 43: Worldwide Patent Filings

    Worldwide Patent Filings* Strong IP Portfolio with 61 Patent Applications Pending in 12 Jurisdictions Outside the United States *Not all patent filings filed in all jurisdictions. 43

  44. Slide 44: vitaMedMD

    vitaMedMD® Manufacture and distribute prescription and over-the-counter (OTC) prenatal vitamins under the vitaMedMD® and BocaGreenMD® brand names.  National sales force  Distribution to drug wholesalers and retail pharmacies  Insurance adjudication 44

  45. Slide 45: Investment Rationale

    Investment Rationale 45

  46. Slide 46: 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  Unique, large, and growing U.S. markets with favorable competitive dynamics  Additional early stage p

  47. Slide 47: TXMD: Financial Snapshot

    TXMD: Financial Snapshot Listing Exchange Debt $0MM Shares Outstanding Cash 177.9MM $81.1MM (as of Dec. 31, 2015) (as of Sept. 30, 2015) 47

  48. Slide 48: THANK YOU!

    TherapeuticsMD THANK YOU! TherapeuticsMD”

  49. Slide 49: Appendix

    Appendix 49

  50. Slide 50: 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 Solutions PHAST 2.0 Prescription Monthly D

  51. Slide 51: 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”; 8

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