Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Day (March 2017)
115 slides from Therapeuticsmd's investor day presentation, Mar 1, 2017
Slide 1: Investor Day
Investor Day March 1, 2017 THER-0086 1/17
Slide 2: Introduction
Introduction Robert Finizio Chief Executive Officer 2
Slide 3: 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 4: Today's Agenda
Today’s Agenda 8:30-8:40 a.m. Introduction 8:40-10:00 a.m. TX-004HR Disease & VVA Market Overview - Brian Bernick, M.D. Labeling & Regulatory Background - Lisa Rarick, M.D.; Sheryl Kingsberg, Ph.D. Payer Overview – Joseph Auci; Tony Lanzone, inVentiv Launch Strategy – Dawn Halkuff 9:30-10:00
Slide 5: TherapeuticsMD (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 5
Slide 6: Business Transformation
Business Transformation May 2008 April 2013 December 2015 December 2016 vitaMedMD founded TherapeuticsMD (TXMD) Released positive top-line Released positive top-line in Boca Raton, Florida listed and traded on the results from the Phase 3 results from the Phase 3 NYSE MKT Rejoice Trial for TX-004HR
Slide 7: 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 8: 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 9: TX-004HR Vulvar and Vaginal Atrophy (VVA) Program
TX-004HR Vulvar and Vaginal Atrophy (VVA) Program 9
Slide 10: VVA Overview
VVA Overview Brian Bernick, M.D. Chief Clinical Officer 10
Slide 11: 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 12: 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 13: Current FDA-Approved VVA Products
Current FDA-Approved VVA Products Estrace Cream® Premarin Cream® Vagifem® Estring® Osphena® Intrarosa® Products 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 Vaginal Tablet Ring Oral Tablet Vaginal Inse
Slide 14: 2016 VVA Market Overview and Metrics
2016 VVA Market Overview and Metrics TRx TRx Count TRx TRx Dollars Patient Patient Count Product Count1 % Share1 Dollars1 % Share1 Count2 % Share2 Estrace® 1,603,209 32% $511,035,880 30% 868,052 39% Premarin® 1,363,725 28% $505,351,340 30% 750,185 34% Vagifem® 1,280,708 26% $452,289,452 27% 330,045
Slide 15: 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 16: 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 17: 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 18: TX-004HR Qualitative Attributes
TX-004HR Qualitative Attributes Ease of Use 4 mcg 10 mcg 25 mcg Placebo (N=191) (N=191) (N=190) (N=192) Easy to Use 171 (89.5%) 172 (90.1%) 175 (92.1%) 164 (85.4%) Patient Satisfaction 4 mcg 10 mcg 25 mcg Placebo (N=191) (N=191) (N=190) (N=192) Very Satisfied 74 (38.7%) 84 (44.0%) 83 (43.7%) 41 (21.
Slide 19: Labeling & Regulatory Background
Labeling & Regulatory Background Lisa Rarick, M.D. Board Certified OB/GYN FDA Medical Officer 1988-2003 CDER, Division Director, Division of Reproductive and Urologic Products from its creation (1995-1999) Office of the Commissioner, Office of Women’s Health (2002-2003) 2003-Present Independen
Slide 20: TX-004HR Potential Label Discussions
TX-004HR Potential Label Discussions Current Product Labels (based generally on Base Case Upside case Premarin Vaginal Cream label) BOXED WARNINGS BOXED WARNINGS BOXED WARNINGS Estrogen-Alone Therapy Boxed Warning Class labeling Removal of Boxed Warning related to Estrogen Plus Progestin Therapy Box
Slide 21: TX-004HR Potential Label Discussions
TX-004HR Potential Label Discussions Current Product Labels (based generally on Base Case Upside case Premarin Vaginal Cream label) Section 3 DOSAGE FORMS AND STRENGTHS Section 3 DOSAGE FORMS AND STRENGTHS Section 3 DOSAGE FORMS AND STRENGTHS TX-004HR is a small, light pink, tear-shaped, TX-004HR is
Slide 22: TX-004HR Potential Label Discussions
TX-004HR Potential Label Discussions Current Product Labels (based generally on Base Case Upside Case Premarin Vaginal Cream label) Section 6 ADVERSE REACTIONS Section 6 ADVERSE REACTIONS Section 6 ADVERSE REACTIONS - Dysuria Information from the clinical trials included here Specifically state that
Slide 23: TX-004HR Potential Label Discussions
TX-004HR Potential Label Discussions Current Product Labels (based generally on Base Case Upside Case Premarin Vaginal Cream label) Section 12 CLINICAL PHARMACOLOGY Section 12 CLINICAL PHARMACOLOGY Section 12 CLINICAL PHARMACOLOGY 12.3 Pharmacokinetics Absorption 12.3 Pharmacokinetics Absorption 12.
Slide 24: TX-004HR Potential Label Discussions
TX-004HR Potential Label Discussions Current Product Labels (based generally on Base Case Upside Case Premarin Vaginal Cream label) Section 17 PATIENT COUNSELING Section 17 PATIENT COUNSELING Section 17 PATIENT COUNSELING 24
Slide 25: Labeling & Regulatory Background
Labeling & Regulatory Background Sheryl Kingsberg, Ph.D Chief, Behavioral Medicine at University Hospitals Case Medical Center Specializes in sexual medicine, female sexual disorders, menopause, pregnancy, postpartum, psychological aspects of infertility Principal investigator for clinical trial
Slide 26: Continued Activism Against VVA Black Box Warnings
Continued Activism Against VVA Black Box Warnings History of Activism FDA “boxed warnings” ACOG Committee Opinion Citizen Petition, Women’s Congressional workshop provided an supporting use of vaginal spearheaded by NAMS, Caucus writes letter to the opportunity for FDA to obtain estrogen in women wi
Slide 27: Payer Overview
Payer Overview Joseph Auci VP, Managed Care, Distribution, and Policy 27
Slide 28: Payer Breakdown of FDA-Approved VVA Products
Payer Breakdown of FDA-Approved VVA Products Medicaid Cash 3% 5% Medicare Part D 24% Commercial 68% MMIT Data January 2017 28
Slide 29: Payers are Continuing to Provide Choice
Payers are Continuing to Provide Choice 80% of Payers Prefer 2+ Products MMIT Data January 2017 29
Slide 30: Why are Payers Providing Open Access?
Why are Payers Providing Open Access? Several reasons: Overall low cost category compared to other therapeutic areas Importance of providing choice for women Lack of innovation in the VVA category Prior authorization to drug cost ratio is not favorable Cost of a prior authorization runs be
Slide 31: Pathway to Obtaining Broad Coverage
Pathway to Obtaining Broad Coverage TherapeuticsMD has seasoned managed care professionals on team with significant payer relationships Building out managed care team with inVentiv to help staff appropriately for launch Performed ad boards and significant payer research pre-launch Establishe
Slide 32: Payer Overview
Payer Overview Tony Lanzone Managing Director, inVentiv Health Consulting 25 years of consulting in pharmaceutical/life sciences industry; member of Pricing and Market Access Practice Former director of Healthcare Informatics at Premier, a hospital GPO; provided consulting and market research
Slide 33: Primary Research: VVA Management
Primary Research VVA Management VVA products are considered to be a very low budget impact category, and as such, the utilization management techniques are minimal, with no PA/SE for most commercial payers. Hormone Replacement Therapy (HRT) in general and Vulvar and Vaginal Atrophy (VVA) specifica
Slide 34: Primary Research: Product X (TX-004HR) Initial Reaction
Primary Research Product X (TX-004HR) Initial Reaction Reaction to Product X was positive, and respondents are quick to pick up the features of Product X that stand out: elegance, low dose, absence of applicator and local administration. Unaided mentions of high differentiation features include: “Ad
Slide 35: TX-004HR Launch Strategy
TX-004HR Launch Strategy* Dawn Halkuff Chief Commercial Officer Former SVP of the Pfizer Consumer Healthcare Wellness Organization Former Marketing and Sales Lead of the Pfizer Women’s Health Division Former Head of Global Innovation at Weight Watchers International 20+ years of commercial e
Slide 36: Experience Aligns to VVA Market Needs
Experience Aligns to VVA Market Needs Important Touch Point of VVA Market Kimberly Clark – Marketing Feminine Protection Private subject; Innovation through user experience Weight Watchers - Global Innovation Drive urgency to take care of an ongoing and worsening issue Pfizer Women’s Health
Slide 37: Local Estrogen Therapy Current Standard of Care
Local Estrogen Therapy Current Standard of Care Local estrogen therapy currently represents over 95% market share in the VVA market Current standard of care per medical society guidelines OB/GYNs comfortable with safety and efficacy profile – low education hurdle However, there has been zero inn
Slide 38: Focus on Three Main Fundamental Levers to Drive TX-004HR Launch
Focus on Three Main Fundamental Levers to Drive TX-004HR Launch Drive Market Share TX-004HR Targeted Market Growth Market Expansion Through Compliance 38
Slide 39: 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 40: Drive Market Share
Drive Market Share Differentiate TX-004HR as new treatment option for VVA that Redefines Relief Drive Market Share TX-004HR Targeted Market Growth Market Expansion Through Compliance 40
Slide 41: 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 42: 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 43: Market Share Comes From High Writing HCPs
Market Share Comes From High Writing HCPs Target HCPs Representing 80% of Active Prescribing Volume in Market Sales force targets – 8,000 practices = 22,000 HCPs Group practice focus vs. individual HCP to maximize impact - Efficient launch plan to maximize sales force ROI Experienced women’s h
Slide 44: Our Approach: Detailed HCP Strategy
Our Approach: Detailed HCP Strategy What needs are we addressing? What are our core tactics? Simplify the Prescribing Experience What We Are Doing Today Simplify the conversation Preparing the sales force: learning from HCPs the main barriers of diagnosing Simplify the product experience – how
Slide 45: 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 market condition campaign Planned sales force of 100 in place prior to launch Partnership with inVentiv, leading
Slide 46: Targeted Market Expansion
Targeted Market Expansion Drive Market Share TX-004HR Targeted Market Growth Market Expansion Through Compliance Elevate the importance of VVA by demonstrating true impact of disease 46
Slide 47: Significant Untapped Opportunity in the VVA Market
Significant Untapped Opportunity in the VVA Market ~29.7M (93%) Untreated Women ~2.3M (7%) Rx Treated1 Past HT users = ~5.7M2 OTC users = ~8M2 Not seeking treatment = ~16M2 1) IMS Health Plan Claims (April 2008-Mar 2011) 2) TherapeuticsMD “EMPOWER” Survey, 2016 47
Slide 48: Main Barriers to Expansion: Education and Motivation
Main Barriers to Expansion: Education and Motivation Women’s Reality Plan to Address 42% believe VVA is natural Help women self-identify part of aging 67% never spoke to doctor Prepare women to have a about the condition conversation Educate and Motivate By • Educate and motivate through Tru
Slide 49: Educate and Motivate Women Through True Impact
Educate and Motivate Women Through True Impact “I dread going to bed. I’m so guilt-ridden. He doesn’t deserve this...” “He doesn’t want to hurt me. He knows it’s not the same…” “We’re still young. We want to be young. You just feel so old, dried-up…” For example purposes only 49
Slide 50: Our Approach: Detailed Patient Strategy
Our Approach: Detailed Patient Strategy What needs are we addressing? What are our core tactics? Women’s Understanding and Comfort What We Are Doing Pre-Launch Educate her on the condition and Unbranded communications to provide tools to help self-identify educate on true impact – live, print, a
Slide 51: Other Opportunities To Expand the Market
Other Opportunities To Expand the Market Relevant Suffering Populations: Expanding the Mainstream Market: Oncology* Primary Care Physicians (PCPs) Currently 3M breast cancer survivors on PCPs currently write about 10-15% of the Aromatase Inhibitors prescriptions for local estrogen therapy Most
Slide 52: Market Growth Through Compliance
Market Growth Through Compliance Drive Market Share TX-004HR Targeted Market Growth Market Expansion Through Compliance Build a differentiated national care model for successful diagnosis, treatment, and management of symptoms of VVA caused by menopause 52
Slide 53: Current VVA Market Average Compliance and Fills Per Year
Current VVA Market Average Compliance and Fills Per Year Vaginal Creams Reasons Women Stop Average: Messiness1 1.5 Fills Per Year2 Reusable applicator1 Long-term safety1 Dose preparation Vaginal Tablets required by user3 Reasons Women Stop Average: Efficacy1 3.5 Fills Per Year2 Applicator1 Long-term
Slide 54: Opportunity to Further Increase Compliance with Patient Journey Focus
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 55: 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 56: TX-004HR Launch Timeline
TX-004HR Launch Timeline January - April May - September 4Q 2017 (Pre-Approval) (FDA-Approval) (Launch) Sales force preparedness PDUFA date - May 7th Branded launch Patient Payer pipeline discussions Continued build out of the HCP campaign sales force Speaker programs Launch planni
Slide 57: Conclusion
Conclusion Drive Market Share TX-004HR Targeted Focus on Market Expansion Compliance TX-004HR designed for Focus on 3 fundamental levers Commitment to women’s clinical success and for continued growth and health drives goodwill improved user experience strong execution and brand loyalty 57
Slide 58: Q&A Panel
Q&A Panel Steven Goldstein, M.D. Robert Gregory, R.Ph. Dawn Halkuff Sheryl Kingsberg, Ph.D. Lisa Rarick, M.D. Rob Reid James Simon, M.D. 58
Slide 59: TX-001HR Combination Estrogen + Progesterone (E+P) Program
TX-001HR Combination Estrogen + Progesterone (E+P) Program 59
Slide 60: Menopause & VMS Overview
Menopause & VMS Overview Brian Bernick, M.D. Chief Clinical Officer 60
Slide 61: 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 62: 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 63: 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 64: 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 65: TX-001HR Could Fulfill Therapeutic Gap For All Participants
TX-001HR Could Fulfill Therapeutic Gap For All Participants Patients • Meet demand for bio-identical hormone therapy with an FDA approved product that is proven safe and effective • Reduce of out-of-pocket costs via insurance coverage • Convenience of one combination product • Widely acceptable at a
Slide 66: Replenish Trial Results
Replenish Trial Results Sebastian Mirkin, M.D. Chief Medical Officer 66
Slide 67: Replenish Trial Overview
Replenish Trial Overview A Phase 3, Double-Blind, Placebo- Controlled, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Estradiol in Combination with Progesterone in Postmenopausal Women with an Intact Uterus 67
Slide 68: Current FDA Guidance for VMS Drug Products
Current FDA Guidance for VMS Drug Products* • Co-primary efficacy endpoints (12 week VMS Efficacy Population) o Mean change from baseline to Weeks 4 and 12 in the frequency and severity of moderate and severe vasomotor symptoms versus placebo • Primary safety endpoint (12 month Endometrial Safety Po
Slide 69: Replenish Trial Study Design - Flow Chart
Replenish Trial Study Design - Flow Chart Randomized Study Frequency and Severity of hot flash diary Participants1 data was assessed during screening ≥ 7 moderate or severe hot flashes per day < 7 moderate or severe hot flashes per day or ≥ 50 per week during Screening or < 50 per week during Screen
Slide 70: 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 71: Mean Weekly Frequency Reduction from Baseline
Mean Change from Baseline in Weekly Frequency of Moderate to Severe Hot Flashes for Weeks 1 to 12 0 Mean Weekly Frequency Reduction from Baseline 1 mg E/100 mg P -10 0.5 mg E/100 mg P 0.5 mg E/50 mg P 0.25 mg E/50 mg P Placebo -20 -30 -40 -50 -60 0 1 2 3 4 5 6 7 8 9 10 11 12 Study Week Replenish Tri
Slide 72: Mean Weekly Reduction in Severity from Baseline
Mean Change from Baseline in Weekly Severity of Moderate to Severe Hot Flashes for Weeks 1 to 12 0 Mean Weekly Reduction in Severity from Baseline -0.2 -0.4 -0.6 -0.8 -1 -1.2 -1.4 1 mg E/100 mg P 0.5 mg E/100 mg P -1.6 0.5 mg E/50 mg P 0.25 mg E/50 mg P -1.8 Placebo -2 0 1 2 3 4 5 6 7 8 9 10 11 12 S
Slide 73: Quantifying the Market Opportunity
Quantifying the Market Opportunity Robert Finizio Chief Executive Officer 73
Slide 74: 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 75: TXMD Has the Most Comprehensive Body of Research Quantifying the Compounded BHRT Space
TXMD has the Most Comprehensive Body of Research Available Quantifying the Compounded BHRT Space Date Purpose Size 15 question Internet Survey to identify % of women going or Consumer Survey July 2013 having been through menopause and quantify symptoms and 1,100 women age 45 to 60 with 801 Harris In
Slide 76: Methodologies to Quantify Compounded E+P Segments
Methodologies to Quantify Compounded E+P Segments Top-Tier Consultant Simple Extrapolation Addressable % BIO-IGNITETM Validation • Simple extrapolation • Quantify overall • Segment pharmacies by • Outreach to individual from survey data compounded hormone size using prescription compounding applying
Slide 77: Learnings from Our Research
Learnings from Our Research: Problems Using Physician and Consumer Data to Quantify BHRT Market Size • Physician Survey Data: 67% of prescribers of compounded BHRT believe it is FDA-approved Difficult to capture the population of compounded BHRT prescribers: - Prescribers are dispersed across sp
Slide 78: 3 Primary Reasons
Compounded BHRT Market is Difficult to Extrapolate Using Physician Data 3 Primary Reasons 1 2 67% of physicians who prescribe compounded Prescribers are dispersed among 4 specialties with BHRT falsely believe that these are FDA approved many high volume writers outside of OB/GYNs Are prescription co
Slide 79: Small Number of Physicians Account for Large Percentage of Compounded BHRT Market
3 Small Number of Physicians Account for Large Percentage of the Compounded BHRT Market 150,000 Total Eligible Physicians1 ~12M Annual Compounded Bio-Identical E+P (Includes OB/GYNs, PCPs, and Anti-Aging) Prescriptions Breakout by Volume 4,700 High ~21/week 5,000,000 Prescribers (3%) (42%) 4,700 Reg
Slide 80: 2 Primary Reasons
Compounded BHRT Market is Difficult to Extrapolate Using Consumer Data 2 Primary Reasons 1 2 78% of compounded BHRT patients falsely believe that More than half of menopausal women purchased their their prescription is FDA-approved hormone therapy at a “local pharmacy” Do you believe that the produc
Slide 81: Methodologies to Quantify Compounded E+P Segments
Methodologies to Quantify Compounded E+P Segments Simple Extrapolation Addressable % McKinsey Approach BIO-IGNITETM • Simple extrapolation • Quantify overall • Segment pharmacies by • Outreach to individual from survey data compounded hormone size using prescription compounding applying average ther
Slide 82: 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 83: 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 84: Conclusions
Conclusions Total E+P market size of $3.7B - $6.1B 12 – 18 million compounded E+P scripts 6.5 million FDA-approved E+P scripts Large, readily convertible compounded E+P market Meaningful economic incentives for compounding pharmacies to convert patients to TX-001HR Regulatory incentives
Slide 85: Launch Strategies & Case Studies
Launch Strategies & Case Studies Joseph Auci VP, Managed Care, Distribution, and Policy 85
Slide 86: Understanding the Traditional Retail Pharmacy
Understanding the Traditional Retail Pharmacy Transactional Relationship Patient feels sick Traditional Retail Pharmacies % of Business (by Prescription Units) Patient visits Physician FDA-Approved Products ~100% Physician writes Rx CVS, Walgreens, Duane Reade, … Patient picks up Rx from Pharmacy 86
Slide 87: 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 88: 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 89: 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 90: Compounded E+P Conversion Strategy
Compounded E+P Conversion Strategy Objective Collaborate to expand utilization of BHRT for menopausal women Convert the majority of compounded preparations for E+P to TX-001HR Tactics Create a cooperative network Establish relationships with top BHRT compounding pharmacies to execute Rx tran
Slide 91: 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 362 Pharmacies TXMD Outreach to with
Slide 92: TXMD Is Not Re-Inventing The Wheel
TXMD Is Not Re-Inventing The Wheel Makena® Case Study Androgel® Case Study Case studies are for example only and not indicate of how other products, including TX-004HR, may perform. 92
Slide 93: Makena Case Study: History
Makena® Case Study: History Makena® approved and launched in February 2011 by KV Pharmaceutical Planned to limit distribution and rely on FDA enforcement FDA and CMS guidance on 3-31-2011 stated that there will be no government enforcement of making “essential” copies of a commercially availab
Slide 94: Makena Case Study: History
Makena® Case Study: History KV Pharmaceutical entered bankruptcy in August 2012 with less than 3% market share “Overall, the FDA’s public stance on compounding 17P and failure to take enforcement action against compounding pharmacies combined with CMS reimbursement policies invited numerous comp
Slide 95: Makena Case Study: Collaboration Works
Makena® Case Study: Collaboration Works Collaboration discussions begin with the compounding pharmacy community in 4Q13 Initial distribution agreements finalized in 1Q14 Broad distribution implemented in 2Q14 and growth significantly expanded 2Q14 volume growth of 38% q/q and 32% y/y 2Q14
Slide 96: Makena Market Launch Dynamics vs Potential TX-001HR Market Launch Dynamics
Makena® Market Launch Dynamics vs Potential TX-001HR Market Launch Dynamics Makena® TX-001HR (if approved) Large Affected No Yes Product Populations Specific Exorbitant Pricing Model Yes No Corporate Collaborative Strategy Approach to No Yes Compounders DQSA Implementation No Yes Reimbursement for R
Slide 97: AndroGel Case Study: FDA-Approved Drug Replacing Unapproved Compounded Product
AndroGel® Case Study: Example of an FDA-Approved Drug Replacing an Unapproved Compounded Product • Pre-2000, unapproved compounded bio-identical testosterone was heavily compounded whereas synthetic FDA-approved methyltestosterone sales were small • In 2000, AndroGel® launched as the first FDA-appro
Slide 98: Androgel Market Launch Dynamics vs Potential TX-001HR Market Launch Dynamics
Androgel® Market Launch Dynamics vs Potential TX-001HR Market Launch Dynamics Androgel® TX-001HR (if approved) Large Affected Yes Yes Product Populations Specific Exorbitant Pricing Model No No Launch Collaborative Strategy Approach to No Yes Compounders DQSA Implementation No Yes Reimbursement for
Slide 99: Numerous Other Examples of Prior Success
Numerous Other Examples of Prior Success Multiple examples exist where replacing less effective or unapproved compounded options with FDA-approved treatments captured significant market share and became standards of care Previously Compounded Preparations Evolved to FDA-Approved Products Rectiv
Slide 100: 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 101: TXMD Salesforce Has High Overlap with Targeted Compounding Pharmacies
TXMD Salesforce Has High Overlap with Targeted Compounding Pharmacies to Drive Successful Conversion Map Legend: High Volume Compounding Pharmacies Sales Territories 101
Slide 102: Compounding Regulatory Dynamics
Compounding Regulatory Dynamics David Miller, R.Ph. Former Executive VP and CEO for the International Academy of Compounding Pharmacists (2010-2015) Director of Pharmacy Affairs at Merck (1996-2010); involved in launch planning, distribution and stocking programs for more than a dozen products
Slide 103: Regulatory Changes Have Constrained the Compounding Pharmacy Marketplace
Regulatory Changes Have Constrained the Compounding Pharmacy Marketplace Drug Quality & Security Act of 2013 gave the FDA unprecedented authority and enforcement, which represents an on-going risk burden for compounders The FDA is actively enforcing DQSA and Guidance documents and regulations introd
Slide 104: Elimination of Coverage and Reimbursement Slashed Compounding Revenue Stream
Elimination of Coverage and Reimbursement Slashed Compounding Revenue Stream Questionable billing practices by compounders caused insurers and PBMs to terminate coverage in 2014, reducing revenue by ~90% Uncontrolled billing by compounders drove the category to Management Programs the third most PMP
Slide 105: Mandatory USP-800 Compliance Creates New and Unplanned Expenses
Mandatory USP-800 Compliance Creates New and Unplanned Expenses by July 2018 The cost burden of USP-800 will cause many compounders to exit the compounded hormone replacement market space Initial investment of $100,000 to $750,000 per pharmacy Ongoing costs of ~$10,000 to $25,000/month per pharmacy
Slide 106: What USP-800 Really Means
What USP-800 Really Means Compounding BHRT Today Compounding BHRT after July 2018 Adolphe Pierre-Louis - Albuquerque Journal – 2/13/2017 106
Slide 107: Compounding Pharmacy Economics
Compounding Pharmacy Economics Richard Moon, PharmD, R.Ph. Principal, Premier Value Pharmacy Compounding Network Represents one of the largest compounding pharmacy networks Owner of Pharmacy Innovations, a group of 7 specialty and compounding pharmacies throughout the United States Former IACP
Slide 108: Independent Pharmacy Net Income Per Compounded Script
Independent Pharmacy Net Income Per Compounded Script Insurance Coverage Present Day Post USP-800 (before 2H14) (2017) (July 2018) Revenue Patient Co-Pay 50.00 50.00 50.00 Third-Party Reimbursement 115.00 - - Total Net Revenue $ 165.00 $ 50.00 $ 50.00 Costs of Good Sold 7.50 7.50 7.50 Gross Profit $
Slide 109: 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 110: 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 111: Q&A Panel
Q&A Panel Joseph Auci David Miller Sebastian Mirkin, M.D. Rich Moon James Pickar, M.D. John Walcyzk 111
Slide 112: Closing Remarks
Closing Remarks Robert Finizio Chief Executive Officer 112
Slide 113: TXMD: Financial Snapshot
TXMD: Financial Snapshot Listing Exchange Debt $0M Shares Outstanding Cash 197.5M $131.5M (as of Feb. 21, 2017) (as of Dec. 31, 2016) 113
Slide 114: Worldwide Patent Filings
Worldwide Patent Filings* Strong IP Portfolio with 144 Patent Applications, including 74 international filings, and 17 issued U.S. patents *Not all patent filings filed in all jurisdictions. 114
Slide 115: Thank You
TherapeuticsMD THANK YOU! _ TherapeuticsMD° For Her: For Life. 7