Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Day (June 2018)
94 slides from Therapeuticsmd's investor day presentation, Jun 4, 2018
Slide 1: Investor Day
Investor Day June 4, 2018 THER-0086 1/17
Slide 2: Introduction
Introduction Robert Finizio Co-founder & 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 11:30 am – 12:00 pm Registration – Lunch 12:00 – 12:10 pm Introductions – Robert Finizio Agenda 12:10 – 1:25 pm Overview – Brian Bernick, M.D. IMVEXXY™ (TX-004HR) ▪ VVA & Impact – Sheryl Kingsberg, Ph.D ▪ Market Overview & Product Profile – Sharon Parish, M.D. ▪ Launch Strategy – Dawn Halkuf
Slide 5: TherapeuticsMD (TXMD)
(TXMD) Innovative women’s health company exclusively focused on developing and commercializing products for women throughout their life cycles 1 Worldwide commercial rights for multiple hormone therapy products • Drug candidate portfolio is built on SYMBODA™ technology for the solubilization of bio-
Slide 6: Seasoned Management Team with a Proven Track Record of Commercial Success
Seasoned Management Team with a Proven Track Record of Commercial Success • Former US Secretary of • Former Chief Executive • Former President and • Co-founded vitaMedMD • Co-founded vitaMedMD • Co-founded CareFusion Health and Human Services • Officer and Chief Financial Chief Executive Officer in
Slide 7: Overview
Overview Brian Bernick, M.D. Co-founder & Chief Clinical Officer 7
Slide 8: TherapeuticsMD Approach to Drug Development
TherapeuticsMD Approach to Drug Development ➢ Drug development/discovery ➢ Designed with the patient and healthcare provider in mind ➢ Guiding principles • Better user experience – More comfortable – More convenient – Affordable • Safety and efficacy • Efficiency 8
Slide 9: 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 9
Slide 10: VVA and its Impact
VVA and its Impact Sheryl Kingsberg, Ph.D Division Chief, OB/GYN Behavioral Medicine, UH Cleveland Medical Center ▪ Co-Director, Sexual Medicine and Vulvovaginal Health Program, UH Cleveland Medical Center ▪ Professor, Obstetrics and Gynecology, CWRU School of Medicine ▪ Professor, Psychiatry, CWRU
Slide 11: 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 women1 ▪ Primary symptom = dyspa
Slide 12: 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 13: Market Overview and Product Profile
Market Overview and Product Profile Sharon Parish, M.D. Professor of Medicine in Clinical Psychiatry and Professor of Clinical Medicine at Weill Cornell Medical College ▪ Leading expert and clinician in sexual medicine and menopause ▪ Attending physician at New York Presbyterian Westchester Division
Slide 14: Women's Health Initiative Observational Study
Women’s Health Initiative Observational Study ➢ Long-term safety of women using only U.S. FDA-approved vaginal estrogen products ▪ 45,663 users of vaginal estrogen ▪ Median duration of use of 2-3 years and median duration of follow-up of 7.2 years • Representing over 300,000 patient years of data ▪
Slide 15: Current FDA-Approved VVA Products
Current FDA-Approved VVA Products Estrace® Cream Premarin Cream® Estring® Vagifem® IMVEXXY Intrarosa® Osphena® (estradiol vaginal (conjugated estrogens (estradiol vaginal (estradiol vaginal (estradiol vaginal (prasterone vaginal (ospemifene cream, USP, 0.01%)1 vaginal cream)2 ring)3 inserts)4 insert
Slide 16: 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 17: IMVEXXY product attributes
▪ Small, digitally inserted, softgel capsule that dissolves completely ▪ Easy to use without the need for an applicator ▪ New lowest effective dose of estradiol 4 mcg and 10 mcg ▪ Used any-time of day with high patient satisfaction rates ▪ No label adverse drug reactions of vaginal discharge or abno
Slide 18: Co-Primary and Key Secondary Efficacy Endpoints
Co-Primary and Key Secondary Efficacy Endpoints Co-Primary Endpoints 4 mcg 10 mcg Superficial Cells <0.0001 <0.0001 Parabasal Cells <0.0001 <0.0001 Vaginal pH <0.0001 <0.0001 Severity of Dyspareunia 0.0149 <0.0001 Key Secondary Endpoint Severity of Vaginal Dryness 0.0014 <0.0001 MMRM P-value vs plac
Slide 19: Phase 1 Single Dose PK Studies: TX-004HR vs. Vagifem
Phase 1 - Single Dose PK Studies1 TX-004HR (IMVEXXY) vs. Vagifem® Systemic absorption AUC (0-24 hours) and Cave (0-24 hours) was 2- to 3-fold lower with TX-004HR relative to Vagifem 1) Pickar et al., Climacteric 2016;19(2):181-187 19
Slide 20: TX-004HR Qualitative Attributes
TX-004HR Qualitative Attributes Ease of Use 4 mcg 10 mcg Placebo (N=191) (N=191) (N=192) Easy to Use 171 (89.5%) 172 (90.1%) 164 (85.4%) Patient Satisfaction 4 mcg 10 mcg Placebo (N=191) (N=191) (N=192) Very Satisfied 74 (38.7%) 84 (44.0%) 41 (21.4%) Satisfied 57 (29.8%) 55 (28.8%) 68 (35.4%) Unsure
Slide 21: IMVEXXY Commercialization Launch Plans
IMVEXXY Commercialization Launch Plans Bringing the Vision to Dawn Halkuff Reality Chief Commercial Officer Mitchell Krassan Chief Strategy Officer 21
Slide 22: Commercial Elements are in Place For Launch
Commercial Elements are in Place For Launch Sales Marketing Data Analytics and Sales Operations Market Access 22
Slide 23: Building Imvexxy Momentum
Building Imvexxy Momentum Patient Measurement Territory HCP Activation & and Readiness Adoption Adherence Adaptation Apr May June July August Cactus Campaign Launch Edge • Increase awareness of Meeting State of the Art VVA June 18th! Sales Platform • Profile VVA targets Peach Campaign • Focus first:
Slide 24: 150 Territory Sales Expansion Completed and Activated
150 Territory Sales Expansion Completed and Activated Specialty 33% 66% Womens Health Other Sales Experience 12% 88% =TXMD territories Pharma Sales B2B Sales 24
Slide 25: Salesforce Footprint Considers the Future Portfolio
Salesforce Footprint Considers the Future Portfolio Inside Total Sales Team Sales Team Sales IMVEXXY HCP Targeting Targets 21K HCPs + White Space Targets = Targets 25K HCPs 4K HCPs 84% 85% 79 Further Live coverage Of 150 territories Targeting Alignment of all IMVEXXY will not change Details covers 8
Slide 26: State of the Art Sales Platform
State of the Art Sales Platform Maximizes the effectiveness of Sales Reps: ▪ Deliver the right message to the right HCP at the right time Artificial Intelligence uses real time data to provide actionable insights to sales force 26
Slide 27: Results of Territory Readiness
Results of Territory Readiness Targeted Messaging Our Learning Gives We Took the Time to Training Based on • Us Gd Confidence In Know our Customers Territory Readiness Future Success Results • 16,000 + calls • Our Target Market • Drives momentum by • Understanding of Matches National starting with o
Slide 28: 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 effective dose 2 Strong efficacy and safety data 3 Improvement seen at week 12 (primary) and as early as 2 weeks (secondary) 4 PK data where
Slide 29: Introduction to Imvexxy
Introduction to Imvexxy • HCP communication • Focus on novel experience of Imvexxy • Hints at differences in patient experience that is important to patients and HCP stakeholders * Electronic sales aid in development; pending MRL review and approval 29
Slide 30: Imvexxy Differentiation Comes to Life
Imvexxy Differentiation Comes to Life * Electronic sales aid in development; pending MRL review and approval 30
Slide 31: Fresh Approach to Deliver Imvexxy Messages
Fresh Approach to Deliver Imvexxy Messages * Electronic sales aid in development; pending MRL review and approval 31
Slide 32: Imvexxy Can Drive New Patients into the Category
Imvexxy Can Drive New Patients into the Category 2.4 mm Women Formerly 4.2 mm Using 4.7 mm Never Entered on Therapy Lubricants/OTC Therapy 75% would consider an Rx if 72% never discussed 67% less than satisfied with symptoms with HCP: True recommended: Efficacy and former product: Focus on impact co
Slide 33: Commercial Elements are in Place For Launch
Commercial Elements are in Place For Launch Sales Marketing Data Analytics and Sales Operations Market Access 33
Slide 34: Payer Overview
Payer Overview Bob Lahman Ret. Sr. VP OptumRx Robert Reid VP Market Access Operations Syneos Health Mike Steelman VP Market Access TherapeuticsMD 34
Slide 35: What is Market Access?
What is Market Access? Market access is the process to ensure that all appropriate patients who would benefit, get rapid and maintained access to the brand, at the right price Access Objectives: 1. Reimbursed by health plans and PBMs 2. Easily prescribed by healthcare providers (Unrestricted Access)
Slide 36: IMVEXXY Market Access Dynamics
IMVEXXY Market Access Dynamics ▪ Majority of products in VVA category for majority of plans and PBMs currently have “Unrestricted Access” ▪ Remains a low cost category compared to other therapeutic areas Unrestricted ― Managing this category is not a priority Access ▪ Importance of providing choice
Slide 37: Payer Breakdown of FDA-Approved VVA Products
Payer Breakdown of FDA-Approved VVA Products Medicaid Cash 3% 5% Medicare Part D 25% Commercial 67% MMIT Data April 2018 37
Slide 38: 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 39: 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 stepping-through one or two preferred products in selected cases ― Unlikely for Imvexxy to step-edit through a highe
Slide 40: VVA Class Medicare Coverage
VVA Class Medicare Coverage: 1 Top 10 payers represent ~82% of lives with new favorable clarification from CMS Vulvar and Vaginal Atrophy- 40,964,260 Medicare Lives % of Estrace Intrarosa Osphena Premarin Cream Vagifem Yuvafem Estring Controlling Payer/PBM Lives Medicare Cream Lives UnitedHealth Gro
Slide 41: NAMS Recognizes and Commends CMS Clarification of GSM Drug Coverage
NAMS Recognizes and Commends CMS Clarification of GSM Drug Coverage From JoAnn V Pinkerton, MD, NCMP, Executive Director • The North American Menopause Society (NAMS) joins The International Society for the Study of Women’s Sexual Health, the American College of Obstetricians and Gynecologists, and
Slide 42: Impact of Generics
Impact of Generics • Commercial plans- impact of generics has been to move branded product to 3rd Tier and generic product to 1st Tier.1 • Medicare- impact of generics has been to move brand to not covered and generic to generic/preferred/covered.1 Commercial Medicare Vagifem Yuvafem Vagifem Yuvafem
Slide 43: 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% 2
Slide 44: Favorable Payer Dynamics: Limited Substitution Across Branded Products
Favorable Payer Dynamics: Limited Substitution Across Branded Products Case Study: Estrace Cream Generics Launch ▪ Estrace Cream Generics launched in January 2018 VVA TRx Market Share (%) VVA TRx Market Share (%) Gains Jan-Apr 2017 Jan-Apr 2018 (Losses) Estrace 33.5% 12.2% -21.3% Cream Estrace Cream
Slide 45: 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 effective dose with potential for improved compliance
Slide 46: How Will Coverage Improve Over Time?
How Will Coverage Improve Over Time? ▪ Up to a six month formulary review process is standard for new products ▪ Market Access team is working hard to speed up the review process ▪ Historical trends show recent competitor launch getting to ~65% unrestricted Commercial access 9 months after field lau
Slide 47: Treatment Compliance Program & Gross-to-Net Assumptions
Treatment Compliance Program & Gross-to-Net Assumptions Robert Finizio Co-founder & Chief Executive Officer 47
Slide 48: Developed for Imvexxy and TX-001HR Launch
Developed for Imvexxy and TX-001HR Launch ▪ Prenatal line was developed ONLY as infrastructure to accelerate the launch of Imvexxy and TX-001HR ▪ Compliance and Education program that effectively reduces out of pocket costs for patient 85% of the time ▪ Applied and customized sales rep technology pl
Slide 49: 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 50: 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: 76 prescriptions TXMD Avg: 7 of 9 months TXMD Avg: Real time Data per
Slide 51: Why this Applies to the VVA Market
Why this Applies to the VVA Market Prenatal Vitamins vs. VVA Market Dynamics Prenatal Vitamins Market VVA Market ▪ Industry Average: ▪ Average fills per year: – 3.5 for Vagifem® and Osphena® – 2.5 fills per pregnancy – 1.5 Premarin® and Estrace® creams ▪ Lower priced generics in the market ▪ Lower p
Slide 52: Patient Affordability & Adherence Programs Applied to Imvexxy
Patient Affordability & Adherence Programs Applied to Imvexxy Why programs are applicable to Imvexxy: ▪ Eliminates educational shortcomings leading to improved adoption and compliance ▪ Manage patient out of pocket and coverage issues ▪ Imvexxy was designed with the patient in mind — Elegant design
Slide 53: Recent VVA TRx Launch Trajectories Represent Reasonable Comparators for Imvexxy
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 Limited number of new 10,000 Intrarosa Total Rx women going onto therapy 9,000 Intr
Slide 54: Adherence Creates Increase Ramp Year 2 and Beyond
Adherence Creates Increase Ramp Year 2 and Beyond Assuming the same amount of new prescriptions as Osphena® and Intrarosa® Average of Launch for Osphena® & Intrarosa® TRx average of Osphena® & Intrarosa® 2.3 average fills/year in Year 2 NRx average of Osphena® & Intrarosa® Month 1 Month 3 Month 5 Mo
Slide 55: Adherence Creates Increase Ramp Year 2 and Beyond
Adherence Creates Increase Ramp Year 2 and Beyond Assuming the same amount of new prescriptions as Osphena® and Intrarosa® Imvexxy +31% TRx in year 2 2 TRx if increase average fills/year from 2.3 to 3.0 TRx average of Osphena® & Intrarosa® 2.3 average fills/year in Year 2 NRx average of Osphena® & I
Slide 56: Adherence Creates Increase Ramp Year 2 and Beyond
Adherence Creates Increase Ramp Year 2 and Beyond Assuming the same amount of new prescriptions as Osphena® and Intrarosa® Imvexxy +74% TRx in Year 2 2 TRx if increase average fills/year from 2.3 to 4 TRx if increase average fills/year from 2.3 to 3.0 TRx average of Osphena® & Intrarosa® 2.3 average
Slide 57: Market Potential of Imvexxy at Year 5
Market Potential of Imvexxy at Year 5 Year 5 Assumptions • Total VVA Patients on HT1 2,300,000 • Imvexxy Market Share 25 - 30% • Imvexxy Patients 665,000 • WAC of Loading Dose $405.00 • WAC of Maintenance Dose $180.00 • Sum of Total Discounts per Rx 35% ▪ Assumes zero market growth ▪ Assumes zero pr
Slide 58: Incremental Fills Per Year Drives Significant Upside to Net Revenues
Incremental Fills Per Year Drives Significant Upside to Net Revenues ▪ Each incremental fill per year can add an estimated $75M to Imvexxy net revenues (000s) $800,000 $700,000 $700,000 $625,000 $600,000 $550,000 $500,000 $475,000 $400,000 $400,000 $300,000 $200,000 $100,000 $- 4 Fills Per Patient 5
Slide 59: Trend of Payor Coverage Intrarosa
Trend of Payor Coverage Intrarosa® Historical trends show recent competitor launch getting to ~65% unrestricted Commercial access 9 months after field launch 70 60 50 40 30 20 10 0 Month Month Month Month Month Month Month Month Month Month Month 1 2 3 4 5 6 7 8 9 10 11 References: 1. MMIT 59
Slide 60: Imvexxy Launch Quarterly Gross-to-Net Assumptions
Imvexxy Launch Quarterly Gross-to-Net Assumptions ▪ Long-term gross to net assumptions of 60%+ starting in second year of launch ▪ Increase in GTN directly correlates to increase in commercial insurance coverage 70.0% 60%+ 60.0% 50% 50.0% 40% 40.0% 30% 30.0% 20% 20.0% 10.0% 0.0% 3Q18 4Q18 1Q19 2Q19
Slide 61: How to Measure Progress: KPIs to Track
How to Measure Progress KPI’s to Track Number of new writers & total writers - indicates pace of trial and adoption by HCP New Rx – indicates market penetration against competition Total Rx – overall units sold Refill Rate – affordability and compliance programs taking hold Ramp of commerc
Slide 62: Q&A Panel
Q&A Panel Sheryl Kingsberg Sharon Parish Bob Lahman Robert Reid Robert Finizio Brian Bernick Dawn Halkuff Mitchell Krassan Mike Steelman 62
Slide 63: TX-001HR Combination Estrogen + Progesterone (E+P) Program
TX-001HR Combination Estrogen + Progesterone (E+P) Program 63
Slide 64: Market Opportunity
Market Opportunity Brian Bernick, M.D. Chief Clinical Officer 64
Slide 65: 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 66: 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 67: 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 68: 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 a product approved by FDA on safety and efficacy • safe and effective • Reduce of out-of-pocket costs via insurance coverage • Convenience of one combination product • Widely acc
Slide 69: Compounding Channel
Compounding Channel Dedra Reiger Lyden Strategic Partnerships & Initiatives Lead 69
Slide 70: Compounding Pharmacy Economics
Compounding Pharmacy Economics Richard Moon, PharmD, R.Ph. Principal, Premier Value Pharmacy Compounding Network (PVPCN)/Artiria ▪ Artiria - the largest compounding network representing 350 pharmacies Additional owner of Pharmacy Innovations, a group of 7 specialty and compounding pharmacies through
Slide 71: 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 72: Regulatory Environment Continues to Favor FDA-Approved Products
Regulatory Environment Continues to Favor FDA-Approved Products October 2012 2014 2016 December 2019 Contaminated Creation of “Do Not USP <800> finalized, Final implementation compounded Compound” list and addressing of USP <800> drugs made at established Pharmacy hazardous drugs, NECC kill 64 Compo
Slide 73: Partnering Rationale
Partnering Rationale Increased Regulatory Pressures Facing Compounding Pharmacies ▪ Increased FDA and State enforcement of essential copies ▪ USP <800> now tied to USP <795> significantly increases cost for hormones ▪ OSHA, FDA, DEA, State, Accreditation Bodies (NAPB, JCAHO, PCAB and others) – All r
Slide 74: Benefits of Partnering with TXMD
Benefits of Partnering with TXMD ▪ Reduces or eliminates amount of regulatory pressure ▪ Reduces initial and ongoing costs of compliance ▪ Improved topline revenue ▪ Maintains and improves bottom line profit ▪ Redeploy internal staff to profitable areas ▪ Reduce patient out of pocket costs, keep pat
Slide 75: Independent Pharmacy Net Income Per Compounded Script
Independent Pharmacy Net Income Per Compounded Script 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 - - $200
Slide 76: Small Compounding Pharmacy Economics
Small Compounding Pharmacy Economics John Walcyzk, PharmD, R.Ph. Owner, Johnson’s Compounding and Bird’s Hill Pharmacy ▪ Owner of one of two sterile compounding pharmacies in Massachusetts ▪ Represents one of four USP<800> compliant compounding pharmacies in Massachusetts ▪ Board Member of American
Slide 77: What USP <800> Really Means
What USP <800> Really Means Compounding Bioidentical Compounding BHRT Hormone Therapy (BHRT) Today after December 2019 Adolphe Pierre-Louis - Albuquerque Journal – 2/13/2017 77
Slide 78: 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 79: Increased Compounding Costs Support TX-001HR Partnership
Increased Compounding Costs Support TX-001HR Partnership Independent Pharmacy Net Income Per Script with TX-001HR Compounded E+P TX-001HR Post USP <800> Launch 1Q2019 ▪ Decreased volumes for bio-identical hormones Revenue Patient Co-Pay $89.95 $50.00 ▪ Increased competition on price has resulted in
Slide 80: Financial Effect of USP <800> Costs for Small Pharmacies
Financial Effect of USP <800> Costs for Small Pharmacies ▪ Higher prices needed to recoup capital investment and pay for increased operating expenses ▪ Increased competition on price has resulted in loss of volumes ▪ Current pricing unsustainable ▪ Patients continue to search for lowest cost options
Slide 81: Bio-Ignite
Bio-Ignite Dedra Reiger Lyden Strategic Partnerships & Initiatives Lead 81
Slide 82: 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 83: BIO-IGNITE Implementation Plan
BIO-IGNITETM Implementation Plan Limited Launch Goals IMVEXXY Operationalize – This new Segment Target Program Adoption ✓ Develop Case Studies for Marketing ✓ 50-100 Pharmacy Partners First Year ✓ Build Trust with New Partners ✓ 12 Months ✓ Utilization of Primary & ✓ Actively stocking & filling Seco
Slide 84: BIO-IGNITE Implementation Plan
BIO-IGNITETM Implementation Plan National Rollout TX-001HR Complete Program Launch ✓ Activation of Imvexxy Partners Target Program Adoption ✓ Peer-to-Peer Promotion ✓ 900 pharmacies ✓ Turn-key partner enrollment ✓ 24 Month Ramp ✓ Product acquisition ✓ Account management programs Target List ✓ Qualif
Slide 85: Life Cycle Management & Financial Update
Life Cycle Management & Financial Update Robert Finizio Chief Executive Officer 85
Slide 86: Life Cycle Management
Life Cycle Management ▪ To mitigate risks of competition and increase the overall value of Imvexxy and TX-001HR assuming we are taking significant market share • New formulations / life cycle management for Imvexxy and TX-001HR goals – Improved bioavailability – Reduced variability – Reduced frequen
Slide 87: TX-001HR: Skin Indication
TX-001HR: Skin Indication ▪ Skin improvement often observed with compounded Bio-identical Hormone Therapy ▪ Numerous studies demonstrates that estrogen deprivation leads to: • Skin dryness and atrophy • Decreased skin thickness and decreased collagen in the dermis • Decreased extensibility, consiste
Slide 88: Flexible, Non-Dilutive Term Loan Financing Secured
Flexible, Non-Dilutive Term Loan Financing Secured ▪ Entered into a definitive loan agreement with MidCap Financial, managed by Apollo Capital Management, L.P., for $200 million in non-dilutive term loan financing ▪ The term loan will be available to the company in three tranches following specific
Slide 89: 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 23% of the company’s shares ▪ Three founding executives beneficially own approximately 19% of the company’s shares 1 ▪ Large ins
Slide 90: Q&A Panel
Q&A Panel Rich Moon John Walcyzk Robert Finizio Brian Bernick Dedra Reiger Lyden 90
Slide 91: Thank You!
TherapeuticsMD THANK YOU! _ TherapeuticsMD° For Her: For Life. /| 91
Slide 92: Appendix
Appendix TherapeuticsMD” | 7 For Her: For Life. | 2
Slide 93: 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 94: 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