Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (August 2018)
44 slides from Therapeuticsmd's investor presentation, August 2018
Slide 1: Investor Presentation August 2018
Investor Presentation August 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: 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 6: Annovera
Annovera (Segesterone Acetate/Ethinyl Estradiol Vaginal System) The first FDA-approved long-acting prescription birth control that is patient- controlled, procedure-free and reversible 6
Slide 7: 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 expected to be classified as NCE with 5 year exclusivity Developed by the Population Council
Slide 8: 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 9: 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 10: 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 11: 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 complete control of their fertility and menstruation • Annovera is the only user-directed single 12-month
Slide 12: 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 13: 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 14: 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 15: Unique Product Characteristics Should Lead to Good Payor Coverage
Unique Product Characteristics Should Lead to Good Payor 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 16: 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 Duration of Action 1 year (21/7 regimen) 1 month (21/ 7 regimen) 3-10 years Daily pill intake Patient Control Removable at any time Removable at any
Slide 17: 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 18: 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 19: 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 20: 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 20
Slide 21: 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 22: 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 23: 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 Improvement seen at week 12 (primary) and as 3 early as 2 weeks (secondary) PK data where sy
Slide 24: 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 25: 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 26: 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 27: 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 Limited number of new 10,000 Intrarosa Total Rx women going onto therapy 9,000 Intr
Slide 28: 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 29: 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 TXMD Avg: Real time Data per
Slide 30: 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 30
Slide 31: Imvexxy Launch Quarterly Gross-to-Net Assumptions
Imvexxy Launch Quarterly Gross-to-Net Assumptions Already Achieved ~23% Unrestricted Commercial Coverage as of August 15, 2018 Increase in GTN directly correlated to increase in commercial insurance coverage Gross to Net Projections 3Q18 4Q18 1Q19 2Q19 3Q19 and beyond 20% 30% 40% 50% 60%+ 70.0%
Slide 32: Imvexxy Launch
Imvexxy Launch July 9, 2018 an early experience program with the 10 mcg dose of the Imvexxy monthly starter pack was sampled to a select group of healthcare providers (HCPs) • As of August 16, 2018 – Over 1,700 HCPs started at least 1 patient on the sample starter pack and sent in a prescription f
Slide 33: TX-001HR Combination Estrogen + Progesterone (E+P) Program
TX-001HR Combination Estrogen + Progesterone (E+P) Program 33
Slide 34: 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 35: 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 36: Multi-Billion Dollar Total Substitutable Market Opportunity $3.7B - $6.1B
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 37: 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 38: 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 39: 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 40: Committed to Become the Leading Women's Health Company
Committed to Become the Leading Women’s Health Company 40
Slide 41: 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 41
Slide 42: 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 21% of the company’s shares • Three founding executives beneficially own approximately 17% of the company’s shares – Includes ve
Slide 43: TXMD: Financial Snapshot
TXMD: Financial Snapshot Listing Shares Insider Exchange Ownership Outstanding ~21% 235.4M (Post-offerings Aug 6, 2018) (Post-offerings Aug 6, 2018) Net Cash Debt Cash Raised in Aug Offerings $75M $154.4M $90M (as of June 30, 2018) (as of June 30, 2018) 43
Slide 44: Thank You
Thank You TherapeuticsMD" For Her: For Life.