Slide 1: Investor Presentation October 2018
Investor Presentation October 2018
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: TherapeuticsMD, A Premier Women's Health Company
TherapeuticsMD, A Premier Women’s Health Company Annovera™ Annovera™ * CONTRACEPTION/ DYSPAREUNIA VASOMOTOR CONTRACEPTION PRENATAL CARE FAMILY PLANNING - (Vulvar & SYMPTOMS PERIMENOPAUSE Vaginal Atrophy) REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT *Investigational product, pending FDA approval 3
Slide 4: Seasoned Management Team with a Proven Track Record of Commercial Execution
Seasoned Management Team with a Proven Track Record of Commercial Execution Jane Barlow Co-Founder Board Member and Director § Former US Secretary of §Former Chief Executive §Former President and §25 years of clinical and §Co-founded vitaMedMD §Co-founded vitaMedMD Health and Human Services §Officer
Slide 5: Responsible and Financially Disciplined Approach to Delivering Results
Responsible and Financially Disciplined Approach to Delivering Results § TXMD has a 10 year history of delivering strong results in a financially efficient manner § We have two recent product approvals (Imvexxy and Annovera) and a PDUFA target action date for TX-001HR of October 28, 2018 § We remain
Slide 6: Track Record of Execution
Track Record of Execution Date Milestone/ Catalyst 3/14/13 First Registered Equity Offering 8/5/13 Commenced Phase 3 Replenish Trial of TX-001HR 9/29/14 Commenced Phase 3 Rejoice Trial of TX-004HR (Imvexxy) 12/7/15 Positive Top-Line Results from Phase 3 Rejoice Trial of TX-004HR (Imvexxy) 7/7/16 Sub
Slide 7: Women's Health Assets With Large Total Addressable Market Opportunities
Women’s Health Assets With Large Total Addressable Market Opportunities Annovera™ TX-001HR Moderate to severe vasomotor Moderate to severe dyspareunia, a Indication Females to prevent pregnancy symptoms (VMS) due to menopause* symptom of VVA, due to menopause Condition Contraception VMS due to Menop
Slide 8: Vulvar and Vaginal Atrophy (VVA) Program
Approved for the treatment of moderate-to- severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Vulvar and Vaginal Atrophy (VVA) Program 8
Slide 9: Imvexxy Key Timeline
Imvexxy Key Timeline § 10 mcg national launch started on August 6, 2018 § 4 mcg commercially available on September 13, 2018 § Bio-Ignite went live August 10, 2018 with 12 pharmacies ordering Imvexxy 9
Slide 10: Imvexxy Launch Update
Imvexxy Launch Update through September 27, 2018 § Over 14,000 units (scripts) of Imvexxy have been dispensed by pharmacies and paid for by over 8,100 patients* ⁃ 11,160 - maintenance packs ⁃ 2,890 - starter packs § 78% of patients are enrolled in commercial insurance with 11% currently being able t
Slide 11: Update on Insurance Coverage
Update on Insurance Coverage § ~36% unrestricted commercial coverage (no step edits and no PA) as of September 27, 2018 - TXMD will start to see the financial benefit of coverage and incremental increase in net revenue approximately 90 days following gaining commercial coverage - Net revenue for Imv
Slide 12: Net Revenue Ramp for Commercially Insured Patients
Net Revenue Ramp for Commercially Insured Patients § TXMD already working to achieve prescriber and patient adoption, prior to full commercial insurance coverage § The 90 day lag in commercial payer reimbursement will have a short-term negative impact on net revenue due to TXMD affordability program
Slide 13: Relationship of Commercial Lives Covered Versus Imvexxy Covered Claims and Realized Net Revenue
Relationship of Commercial Lives Covered Versus Imvexxy Covered Claims and Realized Net Revenue Trendline in chart based on TXMD historical experience and other products 80% % of Commercial Lives Covered Expect Payer Coverage Fully Established 70% % of Rxs Paid by Commercial Insurance Net Revenue as
Slide 14: Variables Impacting Net Revenue Ramp
Variables Impacting Net Revenue Ramp Top Targets Top 10 Commercial Payers Percentage of Total Lives Covered* Express Scripts 15.5% CVS Caremark 14.6% Prime 8.2% Anthem 7.7% United 7.7% OptumRx 5.9% Aetna, Inc. 5.1% CIGNA Health Plans Inc. 4.1% Kaiser Foundation Health Plans 4.0% Blue Cross Blue Shie
Slide 15: Payer Breakdown of FDA-Approved VVA Products
Payer Breakdown of FDA-Approved VVA Products1 Medicaid Cash § As of September 27, 2018, Imvexxy 3% achieved ~36% unrestricted commercial 5% coverage (no step edits or PA) - Expect commercial coverage to peak at 60%+ § Earliest expected Medicare Part D Medicare Part D coverage for Imvexxy would be 25
Slide 16: Vulvar and Vaginal Atrophy (VVA)
Vulvar and Vaginal Atrophy (V VA) § A component of genitourinary syndrome of menopause (GSM) § Chronic and progressive condition that results from decreased estrogen levels characterized by thinning of vaginal tissue § Diagnosed in approximately 50% of postmenopausal women 1 § Primary symptom = dysp
Slide 17: Current US VVA Market Overview
Current US VVA Market Overview 32M with VVA symptoms (1 out of 2 menopausal women) in the United States1,2 50% (16M) seek treatment for VVA4 - 25% (8M) OTC products - 18% (5.7M) past HT users - 7% (2.3M) current HT users Only 7% (2.3M) are § Only 7% of women (2.3M) with current users of VVA symptoms
Slide 18: Professional Societies and FDA Recommend the Lowest Effective Dose
Professional Societies and FDA Recommend the Lowest Effective Dose American College North American Menopause FDA3 of Obstetricians and Society (NAMS)2 “…this guidance encourages Gynecologists (ACOG)1 “The lowest dose of HT should sponsors to develop the lowest “Low-dose and ultra-low be used for the
Slide 19: Imvexxy is "Redefining Relief"
Imvexxy is “Redefining Relief” Owning clinical attributes with the underpinning of a highly effective patient experience Key Clinical Attributes: 1 New lowest approved dose 2 Strong efficacy and safety data Improvement seen at week 12 (primary) and as 3 early as 2 weeks (secondary) PK data where sys
Slide 20: Foundation Built for a Strong Launch
Foundation Built for a Strong Launch TXMD Sales Force in OB/GYN Offices § 81% of total prescribers within current 150 TXMD territories1 § 40% overlap with current prenatal vitamins business § Sales force of 150 § Partnership with inVentiv, leading contract sales organization § Operational and analyt
Slide 21: Current FDA-Approved VVA Products
Current FDA-Approved VVA Products Local estrogen therapy currently represents over 95% market share in the VVA market § Current standard of care per medical society guidelines § Current poor compliance within the class § Imvexxy is the new lowest approved dose with potential for improved compliance
Slide 22: VVA Class Commercial Coverage
VVA Class Commercial Coverage: 1 Top 25 payers represent ~87% of Commercial lives with a majority of access unrestricted Vulvar and Vaginal Atrophy- 184,277,713 Commercial Lives % of Estrace Cream Intrarosa Osphena Premarin Cream Vagifem Yuvafem Estring Controlling Payer/PBM Lives Commerical lives E
Slide 23: Favorable Payer Dynamics: No Substitution Across Branded Products
Favorable Payer Dynamics: No Substitution Across Branded Products Case Study: Vagifem® Generics Launch § Yuvafem launch in October 2016 VVA TRx Market Share (%) VVA TRx Market Share (%) Gains Oct 2015-Sept 2016 Oct 2016-April 2018 (Losses) Vagifem 29.7% 5.4% -24.3% Generic Estradiol Tablets - 24.4%
Slide 24: Prior Authorization Example in the VVA Class
Prior Authorization Example in the VVA Class § The majority of commercial payers do not require PA/ST for branded VVA treatments today1 § However, select payers require written PA and step-through one or two preferred products in select cases ― Unlikely for Imvexxy to step-edit through a higher dose
Slide 25: Recent VVA TRx Launch Trajectories Represent Reasonable Comparators for Imvexxy Launch in Year 1
Recent VVA TRx Launch Trajectories Represent Reasonable Comparators for Imvexxy Launch in Year 1 15,000 14,000 Rate Limited Factors in 13,000 Year 1 that Impact Launch: 12,000 Osphena Total Rx 11,000 Osphena New Rx q Limited number of new 10,000 Intrarosa Total Rx women going onto therapy 9,000 Intr
Slide 26: TXMD's Patient Engagement Programs for Adoption, Affordability & Adherence
TXMD’s Patient Engagement Programs for Adoption, Affordability & Adherence Education & Impact Product Accelerate Access Patient Support Adherence & of Condition Education to HCP Affordability Programs Persistence § Developed over the past 6 years in an effort to improve the long term value of a pati
Slide 27: Results of TXMD Prenatal Vitamin Adoption & Adherence Programs
Results of TXMD Prenatal Vitamin Adoption & Adherence Programs Patient Adherence Prescriber Loyalty Data Insights Industry Avg: 30 prescriptions Industry Avg: 2.5 of 9 months Industry Avg: 60 days per physician per year TXMD Avg: 71 prescriptions TXMD Avg: 7 of 9 months per physician per year TXMD A
Slide 28: 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 29: Patient Engagement Program
Patient Engagement Program Healthcare Provider Writes a Prescription TXMD Affordability and Education Program Affordability Program Maximum Out-of-Pocket $35 Retail Pharmacy Fills Prescription Engagement Program to Increase Compliance and Adherence 29
Slide 30: Incremental Fills Per Year Drive Upside to Net Revenues
Incremental Fills Per Year Drive Upside to Net Revenues Each incremental fill per year can add an estimated $75M to Imvexxy net revenues Year 5 Assumptions1 Total VVA Patients on HT2 2,300,000 Imvexxy Market Share 25 - 30% Imvexxy Patients 665,000 WAC of Loading Dose $405.00 WAC of Maintenance Dose
Slide 31: TX-001HR Combination Estrogen + Progesterone Program
TX-001HR Combination Estrogen + Progesterone (E+P) Program TX-001HR Update - Entered into label discussions with FDA on September 27, 20181 - PDUFA target action date remains October 28, 2018 - We do not anticipate providing updates with respect to label discussions prior to the PDUFA target action
Slide 32: TX-001HR Product Development Rationale
TX-001HR Product Development Rationale § 2002 Women’s Health Initiative (WHI) study showed that the long-term use of certain synthetic hormones (a combination of medroxyprogesterone and conjugated equine estrogens) increased the risk of breast cancer, stroke, heart attack and blood clots (all FDA-ap
Slide 33: 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 P Dosing and Delivery § Once-a-day single oral softgel capsule Single Dose Combination P Addresses Unmet Medical Need VMS Ef
Slide 34: Multi-Billion Dollar Total Substitutable Market Opportunity
Multi-Billion Dollar Total Substitutable Market Opportunity TX-001HR FDA-Approved Compounded Combination Substitutable Separate Bio-Identical Combination Synthetic E+P1 Bio-Identical E+P E & P Pills Market (if approved) TRx US: ~3.8 million1 ~3 million2 12 – 18 million TX-001HR Potential $760M-$950M
Slide 35: TX-001HR Could Fulfill Therapeutic Gap For Stakeholders
TX-001HR Could Fulfill Therapeutic Gap For Stakeholders Patients • If approved, meet demand for bio-identical hormone therapy with a product approved by FDA on safety and efficacy • Reduce of out-of-pocket costs via insurance coverage • Convenience of one combination product • Widely acceptable at p
Slide 36: BIO-IGNITE Compounding Pharmacy Partnership Strategy
BIO-IGNITETM Compounding Pharmacy Partnership Strategy BIO-IGNITETM started as an outreach program to quantify the number of compounded bio-identical estradiol and progesterone prescriptions currently dispensed by the 3,000 high-volume compounding pharmacies, and qualify their interests in distribut
Slide 37: Bio-Identical Customization
Bio-Identical Customization Customization of therapy at compounding pharmacies refers to addressing the overall patient condition including menopausal symptoms, adrenal function, libido, energy levels, thyroid function and nutrition, rather than through micro-dose changes in estrogen/progesterone am
Slide 38: BIO-IGNITE Progress and Results
BIO-IGNITE 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 39: USP <800> Expenses Create Large Barriers for Compounders
USP <800> Expenses Create Large Barriers for Compounders USP <800> Requirements Cost Implementation Time Segregated Clean Room: § USP <800> Design $60,000 - $200,000 § Construction 1 year – 1.5 years Ventilation System $25,000 - $50,000 New Equipment for $15,000 - $50,000 - Hazardous Compounding Tot
Slide 40: Economic Incentives Provide Catalyst to Switch to TX-001HR
Economic Incentives Provide Catalyst to Switch to TX-001HR Economic Support TXMD Partnership for Patient Care Insurance Coverage Present Day Post USP <800> TX-001HR (before 2H14) (2018) (Dec. 2019) Launch 1Q2019 Revenue Patient Co-Pay $50.00 $50.00 $50.00 $50.00 Third-Party Reimbursement $115.00 - -
Slide 41: Annovera (Segesterone Acetate/Ethinyl Estradiol Vaginal System)
AnnoveraÔ (Segesterone Acetate/Ethinyl Estradiol Vaginal System) Approved for use by females of reproductive potential to prevent pregnancy. (Limitation of use: Not adequately evaluated in females with a body mass index of >29 kg/m2). 41
Slide 42: Annovera - 1-Year Vaginal System
Annovera - 1-Year Vaginal System First and only patient-controlled, procedure-free, long-acting, reversible birth control § Annovera approved on August 10, 2018 • Segesterone acetate component of Annovera classified as NCE with 5 year exclusivity § Developed by the Population Council – developer of
Slide 43: Annovera - 1-Year Vaginal System
Annovera - 1-Year Vaginal System Segesterone Acetate [Nestorone®]/Ethinyl Estradiol § The vaginal system is composed of a “squishy” silicone elastomer • 21/7 days cyclical dosing regimen for one year (13 cycles) • 89% overall patient satisfaction in clinical trials1 § Average daily release over one
Slide 44: Clinical Trial Experience
Clinical Trial Experience Efficacy & Safety1 § Based on two pivotal Phase 3 clinical trials with 2,308 women – Efficacy and safety consistent with other birth control pills, patches and hormonal rings § Efficacy – Highly efficacious in preventing pregnancy when used as directed (97.3%) § Primary End
Slide 45: Demonstrated 1-Year Contraceptive Vaginal System High User Satisfaction
Phase 3 Acceptability Study Demonstrated 1-Year Contraceptive Vaginal System High User Satisfaction Acceptability Data1 § Phase 3 acceptability study (n=905 subjects) § Overall satisfaction 89% related to ease of use, side effects, expulsions/feeling the product, and physical effect during sexual ac
Slide 46: Annovera Key Clinical Attributes
Annovera Key Clinical Attributes Clinical Attributes § Only FDA approved long-acting reversible birth control that doesn’t require a procedure or repeat doctor’s visit • Empowers women to be in control of their fertility and menstruation • Annovera is the only user-directed single 12-month birth con
Slide 47: U.S. Prescription Contraceptive Market
U.S. Prescription Contraceptive Market § One of the largest therapeutic categories by script count § ~ > $5B U.S. net sales1 Daily Oral Contraceptives Long Acting Reversible Contraceptives § OC’s continue to lose market share to longer acting § IUDs and Implants are experiencing significant growth s
Slide 48: Top Contraceptive Products Based on Revenue
Top Contraceptive Products Based on Revenue 2017 Net Revenue (mm) NUVARING $564 NEXPLANON IMPLANT $496 LO LOESTRIN FE BIRTH CONTROL PILL $420 MIRENA IUD FAMILY (INCLUDES MIRENA, This includes 3 products $841 KYLEENA & SKYLA) $0 $100 $200 $300 $400 $500 $600 $700 $800 $900 Net Revenue (mm) Company fi
Slide 49: Large Established Ring Market
Large Established Ring Market Annovera compared to existing NuvaRing and potential NuvaRing generic § 1-year duration (vs. monthly) § Soft, pliable, squishy (vs. semi-rigid ring body) § 89% overall patient satisfaction in clinical trials1 § High rates of adherence (94.3%) and continuation (78%)1 § N
Slide 50: Unique Product Characteristics Should Lead to Good Payer Coverage
Unique Product Characteristics Should Lead to Good Payer Coverage § Anticipate parity or discount pricing level ~$1,400 annual WAC cost § 30% decrease to annual WAC of NuvaRing, reflects TXMD’s responsible brand pricing § Allows for improved patient adherence and a potential decrease in unplanned pr
Slide 51: 1-Year Vaginal Contraceptive System Serves an Unmet Need in the U.S. Contraceptive Market
1-Year Vaginal Contraceptive System Serves an Unmet Need in the U.S. Contraceptive Market Annovera™ NuvaRing® IUD’s Oral Contraceptives ü û ü û Duration of Action 1 year (21/7 regimen) 1 month (21/ 7 regimen) 3-10 years Daily pill intake ü ü û ü Patient Control Removable at any time Removable at any
Slide 52: Commercialization Strategy
Commercialization Strategy Launch Timing § Estimated to be commercially available as early as Q3’19 with commercial launch as early as Q4’19 to Q1’20 Attractive Market Segments for Annovera § NuvaRing users – leveraging the physical and clinical strengths of Annovera • No additional sales representa
Slide 53: Complete Women's Healthcare Portfolio
Complete Women’s Healthcare Portfolio Annovera™ * ~60,000 Vasomotor New Prenatal symptoms affect Patients up to 75% of Many will go on perimenopausal contraception after women1 breastfeeding CONTRACEPTION/ FAMILY DYSPAREUNIA PRENATAL CARE VASOMOTOR SYMPTOMS PLANNING -PERIMENOPAUSE (Vulvar & Vaginal
Slide 54: Contraceptive Pipeline
Contraceptive Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 Approval Date 1-Year Contraceptive Vaginal System (NES/EE) Approved 08/10/2018 3-Month Contraceptive Vaginal Ring (NES/E2) Next Generation 1-Year Contraceptive Vaginal System (NES/EE) Exclusive rights to negotiate co-development and marketi
Slide 55: Committed to Become the Leading Women's Health Company
Committed to Become the Leading Women’s Health Company 55
Slide 56: TherapeuticsMD, A Premier Women's Health Company
TherapeuticsMD, A Premier Women’s Health Company Annovera™ Annovera™ * CONTRACEPTION/ DYSPAREUNIA VASOMOTOR CONTRACEPTION PRENATAL CARE FAMILY PLANNING - (Vulvar & SYMPTOMS PERIMENOPAUSE Vaginal Atrophy) REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT *Investigational product, pending FDA approval 56
Slide 57: Significant Insider and Institutional Share Ownership
Significant Insider and Institutional Share Ownership § Board of Directors and Executive Officers have long-term commitment to the company • Beneficially own approximately 20% of the company’s shares • Three founding executives beneficially own approximately 17% of the company’s shares – Includes ve
Slide 58: TXMD: Financial Snapshot
TXMD: Financial Snapshot Listing Insider Shares Exchange Ownership Outstanding ~20% 235.4M (Post-offerings Aug 6, 2018) (October 2018) Net Cash Debt Cash Raised in Aug Offerings $75M $154.4M $90M (as of June 30, 2018) (as of June 30, 2018) 58
Slide 59: Thank You
TherapeuticsMD" For Her. For Life. SS 59