Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (September 2017)
45 slides from Therapeuticsmd's investor presentation, September 2017
Slide 1: TXMD Overview
TXMD Overview September 2017 THER-0086 9/17
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 women's health company overview
(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 women1 ▪ Primary symptom = dyspareunia (painful intercourse) ▪ Secondary symptoms include: vaginal dryne
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: TX-004HR Regulatory Update
TX-004HR Regulatory Update ▪ Type A Meeting with the FDA – directors of the Division of Bone, Reproductive, and Urologic Products (DBURP) and the Office of Drug Evaluation III (ODE III) - June 14, 2017 ▪ Submitted additional endometrial safety information to the FDA - July 5, 2017 ▪ Information on t
Slide 16: Potential CRL Resolution Pathways
Potential CRL Resolution Pathways ▪ Submit the additional endometrial safety information to the NDA for TX-004HR - on or before September 18, 2017 ▪ The safety data from the WHI Observational Study was published in the peer-reviewed medical journal, Menopause, on August 16, 2017 ▪ Meeting set with t
Slide 17: Women's Health Initiative Observational Study
Women’s Health Initiative Observational Study ▪ First ever study to evaluate the long-term safety of women using only U.S. FDA-approved vaginal estrogen products ▪ 2,953 users of vaginal estrogen without progestin with an intact uterus ▪ Median duration of use of 2-3 years and median duration of fol
Slide 18: Three Main Fundamental Levers to Drive TX-004HR Launch
Focus on Three Main Fundamental Levers to Drive TX-004HR Launch, If Approved 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 Compliance Build a di
Slide 19: 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 20: 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 21: 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 22: Increasing Compliance Through National Care Model
Increasing Compliance Through National Care Model Represents TXMD Core Competency Prenatal Vitamins Market VVA Market ▪ Market Dynamics: ▪ Market Dynamics: ▪ No Drug Claims ▪ Clinical and physical product differentiation ▪ 9 month condition ▪ Chronic, progressive condition ▪ Industry Average Patient
Slide 23: Compliance and Fills Per Year Drives TX-004HR Net Revenue at Year 5
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 Average R
Slide 24: Payers are Continuing to Provide Choice
Payers are Continuing to Provide Choice 80% of Payers Prefer 2+ Products MMIT Data January 2017 24
Slide 25: TX-001HR Combination Estrogen + Progesterone (E+P) Program
TX-001HR Combination Estrogen + Progesterone (E+P) Program 25
Slide 26: 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 27: 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 28: 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 29: 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 30: 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 31: 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 32: 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 33: 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 34: 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 35: 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 36: Adverse Reimbursement and Regulatory Environments Erode 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 37: 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 38: 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 39: 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 40: TXMD: Financial Snapshot
TXMD: Financial Snapshot Listing Exchange Debt $0M Shares Outstanding Cash 204M $96.5M (as of July 31, 2017) (as of June. 30, 2017) 40
Slide 41: 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. 41
Slide 42: Appendix
Appendix TherapeuticsMD For Her: For Life. 42
Slide 43: 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
Slide 44: 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 45: 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
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