Slide 1: TXMD Overview
TXMD Overview June 2017 THER-0086 6/17
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
Slide 3: TXMD: Innovative women's health company
(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
Slide 4: Two Late Stage Women's Health Assets With Large Total Addressable Market Opportunities
Two Late Stage Women’s Health Assets With Large Total Addressable Market Opportunities TX-004HR TX-001HR Moderate to severe dyspareunia, a Moderate to severe hot flashes Proposed Indication symptom of VVA, due to menopause due to menopause Condition Description VVA due to Menopause Menopause Bio-Ide
Slide 5: Seasoned Management Team with a Proven Track Record of Commercial Execution
Seasoned Management Team with a Proven Track Record of Commercial Execution • Former U.S. Secretary of • Former Chief Executive • Former President and Chief • Co-founded vitaMedMD • Co-founded vitaMedMD • Former Clinical Lead of Health and Human Services Officer and Chief Financial Executive Officer
Slide 6: TX-004HR Vulvar and Vaginal Atrophy (VVA) Program
TX-004HR Vulvar and Vaginal Atrophy (VVA) Program 6
Slide 7: Vulvar and Vaginal Atrophy (VVA)
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 women 1 ▪ Primary symptom = dyspareunia (painful intercourse) ▪ Secondary symptoms include: vaginal dryn
Slide 8: Current US VVA Market Overview
Current US VVA Market Overview 32M Women with VVA Symptoms1,2 ~50%, or ~16M seek treatment for VVA4 OTC Product Users ▪ Only 7%, or ~2.3M women, are currently being treated Not today with Rx hormone therapy (HT)3 Seeking 25% – Long-term safety concerns6 Treatment – Efficacy6 Past HT Users – Messines
Slide 9: Current FDA-Approved VVA Products
Current FDA-Approved VVA Products Estrace Cream® Premarin Cream® Vagifem® Estring® Osphena® Intrarosa® Products FDA Approval 1984 1978 1999 1996 2013 2016 TRx Dollars 20161 $511,035,880 $505,351,340 $502,715,665a $105,040,703 $72,755,311 Approved 11/2016 Method of Admin Vaginal Cream Vaginal Cream V
Slide 10: Compliance and Fills Per Year Drives Top-Line Revenue
Compliance and Fills Per Year Drives Top-Line Revenue Current VVA Market Vaginal Creams: Reasons Women Stop Vaginal Tablets: Reasons Women Stop Average: Messiness1 Average: Efficacy1 1.5 Fills Per Year2 Reusable Applicator1 3.5 Fills Per Year2 Applicator1 Long-term Safety1 Long-term Safety1 Dose Pre
Slide 11: TX-004HR: Product Candidate Profile
TX-004HR: Product Candidate Profile 0.69 x 0.3 inch Starter Maintenance Pack Pack ▪ First vaginal estrogen (4 mcg and 10 mcg) with negligible systemic exposure ▪ Strong efficacy data on both dyspareunia and vaginal dryness with a 2-week onset of action ▪ Small, digitally inserted, rapidly dissolving
Slide 12: Co-Primary and Key Secondary Efficacy Endpoints
Co-Primary and Key Secondary Efficacy Endpoints 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 Vaginal Dryness 0.0014 <0.0001 <0.0001 MMRM P-value vs p
Slide 13: TX-004HR New Drug Application (NDA) Background
TX-004HR New Drug Application (NDA) Background ▪ Type of Filing ▪ 505(b)(2) ▪ Ability to reference non-clinical and clinical safety data for estrogen available in medical literature ▪ FDA Guidance ▪ 12-week study required for estrogen alone products ▪ “We recommend that studies be randomized, double
Slide 14: TX-004HR Complete Response Letter (CRL)
TX-004HR Complete Response Letter (CRL) ▪ NDA for TX-004HR received a CRL on May 5, 2017 ▪ There was one approvability issue identified by the FDA: ▪ Lack of long-term endometrial safety data beyond the 12 weeks studied in the Rejoice Trial ▪ No cases of endometrial hyperplasia were observed in the
Slide 15: Potential CRL Resolution Pathways
Potential CRL Resolution Pathways ▪ Type A Meeting set with the FDA - June 14, 2017 ▪ TXMD Proposal: ▪ Resubmit NDA for immediate approval of TX-004HR 4 mcg and 10 mcg doses ▪ Adopt labeling consistent with 2005 Labeling Guidance, including current boxed warning, and notation that the product has no
Slide 16: Focus on Three Main Fundamental Levers to Drive TX-004HR Launch, If Approved
Focus on Three Main Fundamental Levers to Drive TX-004HR Launch, If Approved Drive Market Share TX-004HR Targeted Market Growth Market Expansion Through Compliance 16
Slide 17: Aligned HCP and Patient Strategies Drive Fundamental Levers of Growth
Aligned Healthcare Providers (HCPs) and Patient Strategies Drive Fundamental Levers of Growth Drive Market Share Targeted Market Expansion Differentiate TX-004HR as new Elevate importance of VVA by treatment option that redefines relief demonstrating true impact of disease Market Growth Through Comp
Slide 18: Efficacy, Safety, and Positive User Experience Redefines Relief
Efficacy, Safety, and Positive User Experience Redefines Relief Perceived Shortcomings TX-004HR Solution ▪1 in 4 women achieve limited relief1 ▪Early efficacy observed at week 2 Efficacy ▪Delayed onset of efficacy1 ▪Efficacy for vaginal dryness Safety/ ▪ Hormone exposure concerns1 ▪Negligible system
Slide 19: HCPs Estimate Giving TX-004HR 30% Market Share
HCPs Estimate Giving TX-004HR 30% Market Share HCP Stated Preference Share (Adjusted Percent of Prescriptions, n = 400 HCPs) 100.0% 8.0% 6.0% 6.0% 5.0% 9.0% 80.0% 10.0% ▪ Large share gains from Market Share (Stated) 9.0% 15.0% 3 largest competitors 60.0% 19.0% 27.0% 22.0% ▪ Set attainable 3-5 year 4
Slide 20: Foundation Already Built for a Strong Launch
Foundation Already Built for a Strong Launch TXMD Sales Force Currently in OB/GYN Offices ▪ 40% overlap with current prenatal vitamins business ▪ Currently calling on VVA targets with disease awareness campaign ▪ Planned sales force of 100 in place prior to launch ▪ Partnership with inVentiv, leadin
Slide 21: Opportunity to Further Increase Compliance with Focus on Patient Journey Drop Off Points
Opportunity to Further Increase Compliance with Focus on Patient Journey Drop Off Points Prescribed Pick up at Start Continue Pharmacy Therapy Therapy Rx Cost Concerns Product Risk Concerns Correct Utilization (32%) (31%) (56%) National Care Model Patient Care • Financial • Condition and product edu
Slide 22: Increased Compliance and Fills Per Year Drives TX-004HR Net Revenue at Year 5
Increased Compliance and Fills Per Year Drives TX-004HR Net Revenue at Year 5 of Launch Year 5 Assumptions Total VVA Patients on HT1 2,218,252 Zero market growth TX-004HR Market Share 30% TX-004HR Patients 665,000 WAC of Loading Dose $ 382.86 Parity pricing - Vagifem WAC of Maintenance Dose $ 170.16
Slide 23: Payers are Continuing to Provide Choice
Payers are Continuing to Provide Choice 80% of Payers Prefer 2+ Products MMIT Data January 2017 23
Slide 24: TX-001HR Combination Estrogen + Progesterone (E+P) Program
TX-001HR Combination Estrogen + Progesterone (E+P) Program 24
Slide 25: Menopause Overview
Menopause Overview Menopause represents the natural life-stage transition when women stop having periods as the production of Estrogen (E) and Progesterone (P) decreases ▪ Average age of menopause 51 years1 ▪ Women may spend, on average, more than one-third of their lives in a hypoestrogenic state M
Slide 26: TX-001HR Product Development Rationale
TX-001HR Product Development Rationale ▪ 2002 Women’s Health Initiative (WHI) study showed that synthetic hormones increased the risk of breast cancer, stroke, heart attack and blood clots (all FDA-approved combination hormonal products contain a synthetic Progestin and not a bio-identical Progester
Slide 27: Medical Societies Discourage Prescribing of Compounded Bio-Identical Hormones
Medical Societies Discourage Prescribing of Compounded Bio-Identical Hormones ▪ ACOG and ASRM Committee Opinion states compounded hormones may pose additional risks compared to FDA-approved products1 ▪ Lack of efficacy and safety data ▪ Lack of Good Manufacturing Practices (GMP) ▪ Variable purity ▪
Slide 28: TX-001HR – Potential Best in Class Therapy
TX-001HR – Potential Best in Class Therapy TX-001HR Potential first and only: (If Approved) 1) Bio-identical combination estradiol & progesterone 2) FDA-approved Bio-Identical Dosing and Delivery ▪ Once-a-day single oral softgel capsule Single Dose Combination Addresses Unmet Medical Need VMS Ef
Slide 29: Replenish Trial Co-Primary Endpoints
Replenish Trial Co-Primary Endpoints Primary Efficacy Endpoints: Mean Change in Frequency and Severity of Hot Flashes Per Week Versus Placebo at Weeks 4 and 12, VMS-mITT Population Estradiol/Progesterone 1 mg/100 mg 0.5 mg/100 mg 0.5 mg/50 mg 0.25 mg/50 mg Placebo (n = 141) (n = 149) (n = 147) (n =
Slide 30: Multi-Billion Dollar Total Substitutable Market Opportunity
Multi-Billion Dollar Total Substitutable Market Opportunity TX-001HR (if approved) FDA-Approved Compounded Separate Bio-Identical Combination Synthetic Combination E & P Pills E+P1 Bio-Identical E+P TRx US: ~3.5 million2 ~3 million2 12 – 18 million TX-001HR $700M-$875M3 $600M-$750M3 $2.4B-$4.5B3 Pot
Slide 31: Understanding the Compounding Pharmacy
Understanding the Compounding Pharmacy Collaborative Relationship Compounding Pharmacies % of Business (by Prescription Units) Sterile Compounding 17% Patient Physician FDA Approved Products 47% Non-Sterile Compounding 36% Pharmacist N = 3,000-3,500 Compounding Focused Pharmacies1,2,3 (1) 2013 Natio
Slide 32: Compounding Pharmacy Menopausal Treatment Paradigm
Compounding Pharmacy Menopausal Treatment Paradigm Customization is adding therapy…not tweaking dosages Estradiol & Progesterone Claims Estrone, Estriol & DHEA Claims Base for all Patients Controls VMS symptoms Testosterone Claims Promotes sleep & Breast cancer calming reduction/prevention Progester
Slide 33: BIO-IGNITE Compounding Pharmacy Partnership Strategy
BIO-IGNITETM Compounding Pharmacy Partnership Strategy BIO-IGNITETM is an outreach program to quantify the number of compounded bio-identical estradiol and progesterone prescriptions currently dispensed by the 3,000-3,500 high-volume compounding pharmacies, and qualify their interests in distributin
Slide 34: BIO-IGNITE Progress and Results
BIO-IGNITETM Progress and Results Partnerships with Large Pharmacy Network and Individual Pharmacies Pharmacy Network and Combination # of Pharmacies Individual Pharmacy Partners Bio-Identical E+P Scripts >300 Pharmacies ~1,500,000 In Network prescriptions annually >400 Pharmacies TXMD Outreach to w
Slide 35: Adverse Reimbursement and Regulatory Environments Continue to Erode Independent Pharmacy Margins
Adverse Reimbursement and Regulatory Environments Continue to Erode Independent Pharmacy Margins November 2013: Congress enacts Drug Quality and Security Act (DQSA), which prohibits compounding of essential copies of an FDA-approved drug except in limited circumstances such as drug shortage1 June 3,
Slide 36: Economic Incentives Provide Catalyst to Switch to TX-001HR
Economic Incentives Provide Catalyst to Switch to TX-001HR Independent Pharmacy Net Income Per Script with TX-001HR Compounded E+P TX-001HR Post USP-800 Launch 2H18 Revenue Patient Co-Pay 50.00 50.00 Third-Party Reimbursement - 200.00 Total Net Revenue $ 50.00 $ 250.001 Costs of Good Sold 7.50 200.0
Slide 37: PVPCN Distribution Agreement Rationale
PVPCN Distribution Agreement Rationale Innovation ▪ Potential low-dose local Regulatory Environment estrogen therapy for VVA ▪ Drug Quality and Security Act ▪ Potential first and only FDA- ▪ Loss of Third-Party Reimbursement approved bio-identical ▪ USP-800 – Hazardous Drugs combination of E+P ▪ Cli
Slide 38: FDA-Approved Separate Bio-Identical E & P Substitutable Market Opportunity
FDA-Approved Separate Bio-Identical E & P Substitutable Market Opportunity ▪ Healthcare providers not comfortable with compounding will often prescribe two separate FDA-approved bio-identical products to treat menopausal symptoms Product Use by Age AGES 41-50 AGES 51-60 AGES 61-70 AGES 71+ TRx Total
Slide 39: FDA-Approved Combination Synthetic E+P Substitutable Market Opportunity
FDA-Approved Combination Synthetic E+P Substitutable Market Opportunity TX-001HR (If Approved) FDA-Approved Combination Synthetic E+P Prescriptions by Age AGES AGES AGES AGES AGES Unknown TRx 31-40 41-50 51-60 61-70 71+ Ages Totals 52,575 372,968 1,712,852 759,634 151,821 68,672 3,118,5221 ~3M Poten
Slide 40: Expect Robust Insurance Coverage For TX-001HR, If Approved
Expect Robust Insurance Coverage For TX-001HR, If Approved, In-Line with Product Class % Unrestricted Access of 4,315 Commercial Plans Not Covered Commercial Plans Estrace® (Oral) 96% 1% Prempro® 94% 5% CombiPatch® 93% 4% Climara Pro® 92% 4% FemHRT® 87% 6% Duavee® 86% 5% Vivelle-Dot® 84% 5% Activell
Slide 41: TXMD: Financial Snapshot
TXMD: Financial Snapshot Listing Exchange Debt $0M Shares Outstanding Cash 203.9M $113.5M (as of April 27, 2017) (as of March. 31, 2017) 41
Slide 42: Worldwide Patent Filings
Worldwide Patent Filings* Strong IP Portfolio with 158 Patent Applications, including 82 international filings, and 17 issued U.S. patents *Not all patent filings filed in all jurisdictions. 42
Slide 43: Appendix
Appendix TherapeuticsMD For Her: For Life. 43
Slide 44: 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 of estradiol 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. Pickar, et