Slide 1: TXMD Overview May 2016
TXMD Overview May 2016 THER - 0086 5/16
Slide 2: Forward-Looking Statements
2 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, o
Slide 3: TherapeuticsMD: women's health company
3 (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
Slide 4: Why TXMD? Why Now?
4 Why TXMD? Why Now? Worldwide commercial rights for multiple hormone therapy products in phase 3 and earlier stages ▪ Well - known chemical entities with established safety and efficacy thresholds ▪ Large U.S. markets with favorable competitive and regulatory dynamics ▪ Additional early stage pipel
Slide 5: Investigational Pipeline
5 Investigational Pipeline TX - 004HR TX - 001HR TX - 005HR TX - 006HR Combination: 17 ß - estradiol + Progesterone YUVVEXY ™ (17 ß - estradiol Vaginal Softgel Capsule) Transdermal Progesterone Transdermal 17 ß - estradiol + Progesterone Phase 1 Q2 2016 Q4 2016 Q4 2016 Q4 2016 Pre - Clinical NDA Fil
Slide 6: Key Milestones and Anticipated Milestones
6 Key Milestones and Anticipated Milestones ▪ Expected NDA filing for Yuvvexy ▪ Presented results of Rejoice Trial at ENDO and ISSWSH ▪ Expected to report phase 3 Replenish Trial topline results (late 4Q ‘ 16) ▪ Expected transdermal E+P and progesterone alone phase 1 results (4Q ‘16) ▪ Reported phas
Slide 7: YUVVEXY TX-004HR VVA Program
7 YUVVEXY TM TX - 004HR | Vulvar and Vaginal Atrophy (VVA) Program
Slide 8: Overview – Vulvar and Vaginal Atrophy (VVA)
8 Overview – Vulvar and Vaginal Atrophy ( V V A) 1) Kingsberg , Sheryl A., et al. “Vulvar and Vaginal Atrophy in Postmenopausal Women: Findings from the REVIVE ( REal Women’s VIews of Treatment Options for Menopausal Vaginal ChangEs ) Survey.” International Society for Sexual Medicine 2013, no. 10,
Slide 9: 32MM Women with VVA Symptoms
9 32MM Women with V VA Symptoms 1,2 1) The North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause . 2013;20(9):888 – 902. 2) Gass ML, Cochrane BB, Larson JC, et al. Patterns and predictors of sexual
Slide 10: FDA-Approved Competitive Landscape
10 FDA - Approved Competitive Landscape 1) Symphony Health Solutions PHAST Prescription Monthly Powered by IDV, 12 months as of December 31, 2015. 2) Femring data is excluded due to VMS indication. 3) Medi - Span Price Rx Basic as of 4/01/16. * for 18 tablets ($170.16 WAC for 8 tablets) 4) GlobalDat
Slide 11: Products: FDA-Approved Competitive Landscape
11 Products Premarin ® Vagifem ® Estrace ® Cream Osphena ® Estring ® Method of Admin Vaginal Cream Vaginal Tablet Vaginal Cream Oral Tablet Vaginal Ring Application Reusable Vaginal Applicator Vaginal Applicator Reusable Vaginal Applicator Oral Daily SERM Vaginal Ring Active Ingredient 625 mcg/g CEE
Slide 12: Current VVA Market Product Use Falls Short
12 Mean treatment duration 103 days 4 Current V VA Market Product Use Falls Short 1) IMS Health Plan Claims (April 2008 - Mar 2011). 2) Wysocki , S et al, Management of Vaginal Atrophy: Implications from the REVIVE Survey . Clinical Medicine Insights: Reproductive Health 2014:8 23 - 30 doi:10.4137/C
Slide 13: Established Estrogen VVA Market
13 Established Estrogen V VA Market 1) Symphony Health Solutions PHAST Prescription Monthly Powered by IDV, 12 months as of December 31, 2015. 2) Femring data is excluded due to VMS indication. 3) Medi - Span Price Rx Basic as of 2/25/16. * for 18 tablets ($156.24 WAC for 8 tablets) 4) GlobalData Ju
Slide 14: YUVVEXY (TX-004HR)
14 YUVVEXY TM (TX - 004HR) YUVVEXY™ is an investigational drug and is not approved for use by the FDA. ▪ Small, digitally inserted rapidly dissolving softgel capsule ▪ No applicator ▪ Proposed dose packaging to optimize compliance and convenience Prototype Starter Pack Prototype Maintenance Pack 0.6
Slide 15: Co-Primary and Key Secondary Endpoints
15 Co - Primary and Key Secondary Endpoints LS Mean Change from Baseline to Week 12 Compared to Placebo 4 mcg 10 mcg 25 mcg 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 0.0149 <0.0001 <0.0001 Severity of
Slide 16: Efficacy Endpoints TX-004HR 4 mcg
16 Co - Primary and Key Secondary Efficacy Endpoints TX - 004HR 4 mcg 4 mcg LS Mean Change from Baseline to Week 12 P - value 4 mcg Placebo Superficial Cells 17% 6% <0.0001 Parabasal Cells - 41% - 7% <0.0001 Vaginal pH - 1.3 - 0.3 <0.0001 Severity of Dyspareunia - 1.5 - 1.3 0.0149 Severity of Vagina
Slide 17: Efficacy Endpoints TX-004HR 10 mcg
17 Co - Primary and Key Secondary Efficacy Endpoints TX - 004HR 10 mcg MMRM P - value vs placebo LS = Least Squares LS Mean Change from Baseline to Week 12 Arithmetic Mean Estradiol Serum Concentrations - Unadjusted TX - 004HR 10 mcg (N=19) AUC 0 - 24 ( pg.h /mL) C avg (0 - 24) ( pg /mL) 10 mcg 110.
Slide 18: Efficacy Endpoints TX-004HR 25 mcg
18 Co - Primary and Key Secondary Efficacy Endpoints TX - 004HR 25 mcg MMRM P - value vs placebo LS = Least Squares LS Mean Change from Baseline to Week 12 AUC 0 - 24 ( pg.h /mL) C avg (0 - 24) ( pg /mL) 25 mcg 171.56 (80.13) 7.14 (3.33) Placebo 104.16 (66.38) 4.34 (2.76) P - value vs Placebo 0.0108
Slide 19: Unadjusted Change From Baseline Severity Score Dyspareunia
19 Unadjusted Change From Baseline Severity Score Dyspareunia Based on Pivotal Clinical Data - Not Head - to - Head Comparative Studies Vagifem [package label] http://www.novo - pi.com/vagifem.pdf Premarin Vaginal Cream [package label] http://labeling.pfizer.com/showlabeling.aspx?id=132 Estrace Vagi
Slide 20: Dyspareunia and Vaginal Dryness By Study Visit
20 Statistical Significance of Severity of Dyspareunia LS Mean Change from Baseline (by Study Visit) 4 mcg 10 mcg 25 mcg Week 2 0.026 0.0019 0.0105 Week 6 0.0069 0.0009 < 0.0001 Week 8 0.0003 < 0.0001 < 0.0001 Week 12 0.0149 < 0.0001 < 0.0001 Dyspareunia and Vaginal Dryness By Study Visit Statistica
Slide 21: Efficacy and Onset of Action
21 Premarin ® Vagifem ® Estrace ® Osphena ® Estring ® Onset of Action Dyspareunia Week 4+ Week 8 ( composite s core ) Approval without dyspareunia and dryness data Week 12 Approval without dyspareunia and dryness data Onset of Action Dryness Not demonstrated Not demonstrated Efficacy and Onset of Ac
Slide 22: Yuvvexy Qualitative Attributes
22 Yuvvexy Qualitative Attributes 4 mcg (N=181) 10 mc g (N=181) 25 mcg (N=184) Placebo (N=185) Easy to Use 171 (94.5%) 172 (95.0%) 175 (95.1%) 164 (88.9%) Overall p - value = 0.035 Overall p - value <0.0001 4 mcg (N=181) 10 mc g (N=181) 25 mcg (N=184) Placebo (N=185) Very Satisfied 74 (40.1%) 84 (46
Slide 23: Black Box Warning Citizen Petition
23 Black Box Warning Citizen Petition 1. Scientific Workshop on Labeling “Lower” Dose Estrogen - Alone Products for Symptoms of Vulvar and Vaginal Atrophy (VVA) http:// www.fda.gov/Drugs/ NewsEvents /ucm459690.htm 2. Form Letter Comment from North American Menopause Society. http://www.regulations.g
Slide 24: 16MM Women Seeking Treatment Need New Options
24 16MM Women Seeking Treatment Need New Options 1) IMS Health Plan Claims (April 2008 - Mar 2011). 2) TherapeuticsMD “EMPOWER” Survey, 2016 ** Not treated with an FDA approved Rx product. OTC products do not effectively treat the underlying pathological causes of V VA and therefore do not halt or r
Slide 25: Estrogen VVA Market of the Future
25 Estrogen V VA Market of the Future 1) Symphony Health Solutions PHAST Prescription Monthly Powered by IDV, 12 months as of December 31, 2015. 2) GlobalData July 2013 report GDHC54PIDR. All trademarks are the property of their respective owners. TherapeuticsMD VVA Market Goals ▪ Potential launch o
Slide 26: Foundation Built for a Strong Launch
26 Foundation Built for a Strong Launch Map Legend: Current TXMD Sales Presence Highest Prescribing Physicians for VVA Operational leverage of OB/GYN relationships in key markets
Slide 27: TX-001HR Combination Estrogen + Progesterone Program
27 TX - 001HR | Combination Estrogen + Progesterone (E+P) Program
Slide 28: Menopause Overview
28 Menopause Overview 1) National Institutes of Health, National Institute on Aging, https:// www.nia.nih.gov /health/publication/menopause, last accessed November 3, 2015. Menopause represents the natural life - stage transition when women stop having periods May result in physical and emotional sy
Slide 29: Evolution of U.S. HRT Market Post WHI Study
29 Evolution of U.S. HRT Market Post WHI Study 1) Symphony Health Solutions PHAST Data powered by IDV; 12 months as of December 31 2015 2) The reported number of annual custom compounded hormone therapy prescription of oral and transdermal estradiol and progesterones taken combined and in combinatio
Slide 30: 1) Freeman E, Rickels K, Sondheimer S J. et al. A double - blind
30 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 . 1995;274:51 – 57. 2) Fournier A, Berrino F, Clavel - Chapelon F. Unequal risks for breast cancer associated with different hormo
Slide 31: Compounded Bio-identical HRT: Why Has It Been So Successful?
31 Compounded Bio - identical HRT: Why Has It Been So Successful? 1) Smith et al . Lower Risk of Cardiovascular Events in Postmenopausal Women Taking Oral Estradiol Compared with Oral Conjugated Equine Estrog en s (CEE) . 2) Shufelt et al . Hormone Therapy Dose, Formulation, Route of Delivery, and R
Slide 32: Total Addressable Market = 38MM Prescriptions
32 Total Addressable Market = 38MM Prescriptions 1) Symphony Health Solutions PHAST Data powered by IDV; 12 months as of December 31 2015 Includes Single Pill Combination of E+P and Estradiol, Estrogen, Progesterone and Progestins taken in combination (oral and transdermal) 2) The reported number of
Slide 33: Non-FDA-Approved BHRT Market Represents Significant Opportunity
33 Non - FDA - Approved BHRT Market Represents Significant Opportunity for First FDA - Approved Product 30MM 2 $49 1 Annual c ustom - compounded prescriptions Average monthly cash cost • 1. Pinkerton, J.V. Compounded bio - identical hormone therapy: identifying use trends and knowledge gaps among U.
Slide 34: Regulatory Tailwinds for FDA-Approved Products
34 Regulatory Tailwinds for FDA - Approved Products 1) http:// www.fda.gov /Drugs/ DrugSafety / DrugIntegrityandSupplyChainSecurity / DrugSupplyChainSecurityAct /ucm376829.htm 2) http:// www.usp.org /sites/default/files/ usp_pdf /EN/m7808.pdf 3) https:// www.ascp.com /sites/default/files/Joint%20USP
Slide 35: Medical Societies Have Expressed Concerns Over Compounded Hormones
35 Medical Socie t ies Have Expressed Concerns Over Compounded Hormones 1) Committee on Gynecologic Practice and the American Society for Reproductive Medicine Practice Committee, Number 532, Augus t 2 012 (Reaffirmed 2014, Replaces No. 387, November 2007 and No. 322, November 2005). 2) Villiers, T.
Slide 36: FDA-Approved HRT Script Market Share Underwhelming
36 FDA - Approved HRT Script Market Share Underwhelming 1) Symphony Health Solutions PHAST Prescription Monthly Powered by IDV, 12 months as of December 31, 2015. All trademarks are the property of their respective owners. Q4 2015 Q4 2015 Compounded Bio - identical Estradiol/Progesterone FDA - Appro
Slide 37: TX-001HR U.S. Development Timeline
37 TX - 001HR Estradiol + Progesterone U.S. Development Timeline 1) https:// clinicaltrials.gov /ct2/show/NCT01942668?term= replenish+trial&rank =1, last accessed November 3, 2015. ▪ Phase 3 Trial 1 : ~100 U.S. sites ▪ Subjects: ~1750 fully enrolled as of October 2015 ▪ Four active arms (N=400/arm)
Slide 38: TX-001HR Target Product Profile
38 TX - 001HR – Target Product Profile Target Goals Preliminary Supportive Data Meet patient demand for bio - identical hormones New lower effective dose Labeling differentiation Leverage data on natural 17 β - estradiol and progesterone Potential for first FDA - approved natural estradiol plus natu
Slide 39: TXMD: Financial Snapshot
39 TXMD: Financial Snapshot Shares Outstanding 196.2MM (as of April 18, 2016) Debt $0MM Cash $182.1MM (as of March 31, 2016) Listing Exchange
Slide 40: Worldwide Patent Filings
40 Worldwide Patent Filings * *Not all patent filings filed in all jurisdictions. Strong IP Portfolio with 134 Patent Applications, including 72 international filings, and 17 issued U.S. patents
Slide 41: Thank You
TherapeuticsMD THANK YOU! TherapeuticsM>"
Slide 42: Appendix
Appendix TherapeuticsMD’
Slide 43: Management with Deep Experience in Women's Health
43 Management with Deep Experience in Women’s Health Supported by a team of regulatory consultants with decades of FDA experience • Co - founded CareFusion • Held executive sales and operation management positions at McKesson, Cardinal, and Omnicell • 20+ years of operations experience • Former CFO
Slide 44: TX-004HR vs. Vagifem Single Dose PK Studies
44 TX - 004HR vs. Vagife m ® Phase 1 Single Dose PK Studies Vagifem is a registered trademark of Novo Nordisk A/S Corp. Pickar , et al. Climacteric 2016 Key Findings ▪ Tmax ~2 hours with TX - 004HR and ~8 hours with Vagifem ▪ Systemic absorption of estradiol AUC (0 - 24 hours) is 2 - to 3 - fold low