Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (September 2018)
53 slides from Therapeuticsmd's investor presentation, Sep 5, 2018
Slide 1: Investor Presentation September 2018
Investor Presentation September 2018
Slide 2: Forward-Looking Statements
2 Forward - Looking Statements This presentation by TherapeuticsMD, Inc. (referred to as “we” and “our”) may contain forward - looking statements. Forward - lookin g statements may include, but are not limited to, statements relating to our objectives, plans and strategies, as well as state men ts,
Slide 3: TherapeuticsMD, A Premier Women's Health Company
3 TherapeuticsMD, A Premier Women’s Health Company CONTRACEPTION PRENATAL CARE CONTRACEPTION/ FAMILY PLANNING - PERIMENOPAUSE VASOMOTOR SYMPTOMS DYSPAREUNIA (Vulvar & Vaginal Atrophy) REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT *Investigational product, pending FDA approval * Annovera ™ Annovera ™
Slide 4: ▪ Co - founded CareFusion ▪ Held executive sales and operation management positions at
4 ▪ Co - founded CareFusion ▪ Held executive sales and operation management positions at McKesson, Cardinal, and Omnicell ▪ 20+ years of operations experience ▪ Former CFO of American Wireless, Telegeography, and WEB Corp ▪ Participated in American Wireless/Arush Entertainment merger ▪ Former KPMG a
Slide 5: Women's Health Assets With Large Total Addressable Market Opportunities
5 Women’s Health Assets With Large Total Addressable Market Opportunities VVA due to Menopause VMS due to Menopause Moderate to severe dyspareunia, a symptom of VVA, due to menopause 32 million women 5,6 36 million women 3 >$20B 7 >$25B 4,7 TX - 001HR Bio - Identical 17 β - Estradiol Bio - Identical
Slide 6: Vulvar and Vaginal Atrophy (VVA) Program
6 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
Slide 7: Imvexxy Key Timeline
7 Imvexxy Key Timeline ▪ 10 mcg national launch started on August 6, 2018 ▪ 4 mcg expected to be available the week of September 10, 2018 ▪ Bio - Ignite went live August 10, 2018 with 12 pharmacies ordering Imvexxy
Slide 8: Imvexxy Launch Update as of September 4, 2018
8 Imvexxy Launch Update as of September 4, 2018 ▪ Over 6,300 units of Imvexxy have been dispensed by pharmacies * and can be recognized as revenue by TXMD ⁃ 5,300 - maintenance packs ⁃ 1,000 - starter packs ▪ Over 4,800 patients paid out of pocket to fill their prescription * ⁃ 96% of patients paid
Slide 9: MMIT Update on Insurance Coverage
9 References: 1. MMIT Update on Insurance Coverage ▪ ~35% unrestricted commercial coverage (no step edits and no PA) as of August 31, 2018 - As TXMD gains commercial coverage with a payor – Imvexxy is covered by the payor shortly thereafter - TXMD will start to see the financial benefit of coverage
Slide 10: Vulvar and Vaginal Atrophy (VVA)
10 Vulvar and Vaginal Atrophy ( V V A) 1) Kingsberg , Sheryl A., et al. “Vulvar and Vaginal Atrophy in Postmenopausal Women: Findings from the REVIVE ( REal Women’s VIews of Treatment Options for Menopausal Vaginal ChangEs ) Survey.” International Society for Sexual Medicine 2013, no. 10, 1790 - 179
Slide 11: Current US VVA Market Overview
11 1) The North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North Am erican Menopause Society. Menopause . 2013;20(9):888 – 902. 2) Gass ML, Cochrane BB, Larson JC, et al. Patterns and predictors of sexual activity among women in the hor
Slide 12: Professional Societies and FDA Recommend the Lowest Effective Dose
12 Professional Societies and FDA Recommend the Lowest Effective Dose References: 1. ACOG Practice Bulletin No. 141: management of menopausal symptoms. Obstet Gynecol. 2014;123(1):202 - 216. 2. The North American Menopause Society. Clinical care recommendations chapter 8: prescription therapies. htt
Slide 13: Imvexxy is "Redefining Relief"
13 Improvement seen at week 12 (primary) and as early as 2 weeks (secondary) Imvexxy is “Redefining Relief” Key Clinical Attributes: New lowest approved dose 1 Strong efficacy and safety data 2 3 Owning clinical attributes with the underpinning of a highly effective patient experience Ease of use an
Slide 14: References
14 References: 1. Estrace Vaginal Cream [package insert]. Irvine, CA: Allergan USA, Inc.; 2017. 2. Premarin Vaginal Cream [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.; 2017. 3. Estring [package insert]. New York, NY: Pharmacia & Upjohn Company LLC, a su
Slide 15: Payer Breakdown of FDA-Approved VVA Products
15 Payer Breakdown of FDA - Approved VVA Products 1 1 MMIT Data April 2018 2 MMIT Medicaid Cash Commercial 67% Medicare Part D 25% 5% 3% ▪ As of August 31, 2018, Imvexxy achieved ~35% unrestricted commercial coverage (no step edits or PA) - Expect commercial coverage to peak at 60%+ ▪ Earliest expec
Slide 16: VVA Class Commercial Coverage
16 VVA Class Commercial Coverage : 1 Top 25 payers represent ~87% of Commercial lives with a majority of access unrestricted Controlling Payer/PBM Lives Express Scripts PBM 28,507,971 15%Covered Covered Covered Preferred Covered Preferred Preferred CVS Caremark RX 27,256,869 15%Preferred Covered Pre
Slide 17: Case Study: Vagifem Generics Launch
17 Symphony Health Solutions PHAST Data powered by IDV Vagifem and Yuvafem (authorized generic of Vagifem) VVA TRx Market Share (%) Oct 2015 - Sept 2016 VVA TRx Market Share (%) Oct 2016 - April 2018 Gains (Losses) Vagifem 29.7% 5.4% - 24.3% Generic Estradiol Tablets (including Yuvafem and others) -
Slide 18: Prior Authorization Example in the VVA Class
18 Prior Authorization Example in the VVA Class ▪ The majority of commercial payers do not require PA/ST for branded VVA treatments today 1 ▪ 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 hig
Slide 19: Recent VVA TRx Launch Trajectories as Comparators for Imvexxy
19 Recent VVA TRx Launch Trajectories Represent Reasonable Comparators for Imvexxy Launch in Year 1 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 10,000 11,000 12,000 13,000 14,000 15,000 Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12 Osp
Slide 20: Patient Engagement Programs for Adoption, Affordability & Adherence
20 TXMD’s Patient Engagement Programs for Adoption, Affordability & Adherence Education & Impact of Condition Product Education Accelerate Access to HCP Patient Support Affordability Programs Adherence & Persistence ▪ Developed over the past 6 years in an effort to improve the long term value of a p
Slide 21: Results of TXMD Prenatal Vitamin Adoption & Adherence Programs
21 Results of TXMD Prenatal Vitamin Adoption & Adherence Programs Patient Adherence Prescriber Loyalty Data Insights Industry Avg: 2.5 of 9 months TXMD Avg : 7 of 9 months Industry Avg: 30 prescriptions per physician per year TXMD Avg : 71 prescriptions per physician per year Industry Avg: 60 days T
Slide 22: Compliance and Fills Per Year Drives Top-Line Revenue
22 1) Wysocki, S et al, Management of Vaginal Atrophy: Implications from the REVIVE Survey . Clinical Medicine Insights: Reproductive Health 2014:8 23 - 30 doi:10.4137/CMRH.S14498 2) Total Rx/Patient Count 3) The North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013
Slide 23: Patient Engagement Program
23 Patient Engagement Program Healthcare Provider Writes a Prescription Affordability Program Maximum Out - of - Pocket $35 Retail Pharmacy Fills Prescription TXMD Affordability and Education Program Engagement Program to Increase Compliance and Adherence
Slide 24: Incremental Fills Per Year Drive Upside to Net Revenues
24 Incremental Fills Per Year Drive Upside to Net Revenues $400,000 $475,000 $550,000 $625,000 $700,000 $- $100,000 $200,000 $300,000 $400,000 $500,000 $600,000 $700,000 $800,000 4 Fills Per Patient 5 Fills Per Patient 6 Fills Per Patient 7 Fills Per Patient 8 Fills Per Patient (000s) Each increment
Slide 25: TX-001HR Combination Estrogen + Progesterone (E+P) Program
25 TX - 001HR Combination Estrogen + Progesterone (E+P) Program
Slide 26: TX-001HR Product Development Rationale
26 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
Slide 27: TX-001HR – Potential Best in Class Therapy
27 TX - 001HR – Potential Best in Class Therapy Prototype Maintenance Pack Bio - Identical Single Dose Combination VMS Efficacy Data Endometrial Cancer Safety Data FDA - Approved 1 Third - Party Reimbursement 2 Dosing and Delivery ▪ Once - a - day single oral softgel capsule Addresses Un
Slide 28: Multi-Billion Dollar Total Substitutable Market Opportunity
28 FDA - Approved Compounded Combination Bio - Identical E+P Separate Bio - Identical E & P Pills Combination Synthetic E+P 1 TRx US: ~3.8 million 1 ~3 million 2 12 – 18 million TX - 001HR Potential Substitutable Market $760M - $950M 3 $600M - $750M 3 $2.4B - $4.5B 3 TX - 001HR Total Substitutable M
Slide 29: TX-001HR Could Fulfill Therapeutic Gap For Stakeholders
29 TX - 001HR Could Fulfill Therapeutic Gap For Stakeholders • 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
Slide 30: BIO-IGNITE
30 BIO - IGNITE TM BIO - IGNITE TM 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 distributing our hormone product candi
Slide 31: Bio-Identical Customization
31 Bio - Identical Customization Estradiol & Progesterone Claims Base for all Patients Controls VMS symptoms Promotes sleep & calming Progesterone to oppose Estradiol - safety Estrone, Estriol & DHEA Claims Breast cancer reduction/prevention Decrease clotting Glucose maintenance Improves lipids prof
Slide 32: BIO-IGNITE Progress and Results
32 BIO - IGNITE TM Progress and Results Partnerships with Large Pharmacy Network and Individual Pharmacies Pharmacy Network and Individual Pharmacy Partners # of Pharmacies >300 Pharmacies In Network Combination Bio - Identical E+P Scripts ~1,500,000 prescriptions annually All trademarks are the pro
Slide 33: USP <800> Expenses Create Large Barriers for Compounders
33 USP <800> Expenses Create Large Barriers for Compounders USP <800> Requirements Cost Implementation Time Segregated Clean Room: ▪ USP <800> Design ▪ Construction $60,000 - $200,000 1 year – 1.5 years Ventilation System $25,000 - $50,000 New Equipment for Hazardous Compounding $15,000 - $50,000 -
Slide 34: Economic Support: TXMD Partnership for Patient Care
34 1) Includes additional labor, pharmacists, technicians, regulatory, and legal expenses 2) December 2019 Implementation; includes >$150,000 capital expenditure as well as new identification requirements for receip t, storage, mixing, preparing, compounding, dispensing, and administration of hazard
Slide 35: Annovera Contraceptive Vaginal System
35 Annovera (Segesterone Acetate/Ethinyl Estradiol Vaginal System) The first FDA - approved long - acting prescription birth control that is patient - controlled, procedure - free and reversible
Slide 36: Annovera - 1-Year Vaginal System
36 ▪ 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 – developer of multi - billion dollar long acting contraceptive products • ParaGard® and Mirena® IUDs ; Norplant® and J
Slide 37: Annovera - 1-Year Vaginal System
37 ▪ 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 trials 1 ▪ Average daily release over one year of use: • 0.15 mg/day segesterone acetate • 0.013 mg/day ethinyl estradiol
Slide 38: Clinical Trial Experience Efficacy & Safety
38 Clinical Trial Experience Efficacy & Safety 1 ▪ 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
Slide 39: Acceptability Data
39 Acceptability Data 1 ▪ 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 activity ▪ High rates of adherence (94.3%) and continuation (78%) 1 Merkatz, Ruth B., Marlena Plag
Slide 40: ▪ Only FDA approved long - acting reversible birth control that doesn’t require a
40 ▪ 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 birth control product ▪ Highly effective in
Slide 41: U.S. Prescription Contraceptive Market
41 U.S. Prescription Contraceptive Market $3.5 $3.4 $3.2 $3.1 $3.0 $2.8 $0.0 $0.5 $1.0 $1.5 $2.0 $2.5 $3.0 $3.5 $4.0 2012 2013 2014 2015 2016 2017 Daily Oral Contraceptives Long Acting Reversible Contraceptives ▪ OC’s continue to lose market share to longer acting solutions such as IUDs, Implants an
Slide 42: Top Contraceptive Products Based on Revenue
42 Top Contraceptive Products Based on Revenue Company filings; Symphony Health Solutions PHAST Data powered by IDV. Net sales as reported in company filings. $841 $420 $496 $564 $0 $100 $200 $300 $400 $500 $600 $700 $800 $900 MIRENA IUD FAMILY (INCLUDES MIRENA, KYLEENA & SKYLA) LO LOESTRIN FE BIRTH
Slide 43: Large Established Ring Market
43 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 trials 1 ▪ High rates of adherence (94.3%) and continuation (7
Slide 44: Unique Product Characteristics Should Lead to Good Payor Coverage
44 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
Slide 45: 1-Year Vaginal Contraceptive System Serves an Unmet Need
45 1 - Year Vaginal Contraceptive System Serves an Unmet Need in the U.S. Contraceptive Market Annovera™ NuvaRing ® IUD’s Oral Contraceptives Duration of Action x 1 year (21/7 regimen) 1 month (21/ 7 regimen) x 3 - 10 years Daily pill intake Patient Control x Removable at any time x Removable at
Slide 46: Commercialization Strategy
46 1 IQUVIA Data 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
Slide 47: Complete Women's Healthcare Portfolio
47 Annovera ™ VASOMOTOR SYMPTOMS Complete Women’s Healthcare Portfolio Vasomotor symptoms affect up to 75% of perimenopausal women 1 1. https:// www.ncbi.nlm.nih.gov / pmc /articles/PMC4539866/ *Investigational product, pending FDA approval * DYSPAREUNIA (Vulvar & Vaginal Atrophy) PRENATAL CARE CONT
Slide 48: Next Generation Contraceptive Pipeline
48 Next Generation 1 - Year Contraceptive Vaginal System (NES/EE) Contraceptive Pipeline 3 - Month Contraceptive Vaginal Ring (NES/E2) 1 - Year Contraceptive Vaginal System ( NES/EE) Phase 1 Approved 08/10/2018 Pre - Clinical Phase 3 Phase 2 Approval Date ▪ 3 month ring using NES plus bio - identica
Slide 49: Committed to Become the Leading Women's Health Company
49 Committed to Become the Leading Women’s Health Company
Slide 50: TherapeuticsMD, A Premier Women's Health Company
50 TherapeuticsMD , A Premier Women’s Health Company CONTRACEPTION PRENATAL CARE CONTRACEPTION/ FAMILY PLANNING - PERIMENOPAUSE VASOMOTOR SYMPTOMS DYSPAREUNIA (Vulvar & Vaginal Atrophy) REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT *Investigational product, pending FDA approval * Annovera™ Annovera™
Slide 51: Significant Insider and Institutional Share Ownership
51 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 – Includ
Slide 52: TXMD: Financial Snapshot
52 TXMD: Financial Snapshot Shares Outstanding 235.4M (Post - offerings Aug 6, 2018) Debt $75M (as of June 30, 2018 ) Cash $154.4M (as of June 30, 2018) Listing Exchange Insider Ownership ~21% (Post - offerings Aug 6, 2018) Net Cash Raised in Aug Offerings $90M
Slide 53: Thank You
Thank You A\S\\ TherapeuticsMD” For Her: For Life 4 —
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