Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (September 2018)
59 slides from Therapeuticsmd's investor presentation, Sep 24, 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: Responsible and Financially Disciplined Approach to Delivering Results
5 Responsible and Financially Disciplined Approach to Delivering Results ▪ TXMD has a 10 year history of delivering strong results in a financially efficient manner ▪ We have two recent product approvals (Imvexxy and Annovera) and a PDUFA target action date for TX - 001HR of October 28, 2018 ▪ We re
Slide 6: Track Record of Execution
6 Track Record of Execution Date Milestone/ Catalyst 3/14/13 First Registered Equity Offering 8/5/13 Commenced Phase 3 Replenish Trial of TX - 001HR 9/29/14 Commenced Phase 3 Rejoice Trial of TX - 004HR (Imvexxy) 12/7/15 Positive Top - Line Results from Phase 3 Rejoice Trial of TX - 004HR (Imvexxy)
Slide 7: Women's Health Assets With Large Total Addressable Market Opportunities
7 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 8: Vulvar and Vaginal Atrophy (VVA) Program
8 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 9: Imvexxy Key Timeline
9 Imvexxy Key Timeline ▪ 10 mcg national launch started on August 6, 2018 ▪ 4 mcg commercially available on September 13, 2018 ▪ Bio - Ignite went live August 10, 2018 with 12 pharmacies ordering Imvexxy
Slide 10: Imvexxy Launch Update as of September 19, 2018
10 Imvexxy Launch Update as of September 19, 2018 ▪ Over 10,700 units (scripts) of Imvexxy have been dispensed by pharmacies and paid for by over 6,900 patients* ⁃ 8,650 - maintenance packs ⁃ 2,050 - starter packs ▪ 78% of patients are enrolled in commercial insurance with 11% currently being able t
Slide 11: Update on Insurance Coverage
11 References: 1. MMIT Update on Insurance Coverage ▪ ~36% unrestricted commercial coverage (no step edits and no PA) as of September 19, 2018 - TXMD will start to see the financial benefit of coverage and incremental increase in net revenue approximately 90 days following gaining commercial coverag
Slide 12: Net Revenue Ramp for Commercially Insured Patients
12 Net Revenue Ramp for Commercially Insured Patients ▪ TXMD already working to achieve prescriber and patient adoption, prior to full commercial insurance coverage ▪ The 90 day lag in commercial payer reimbursement will have a short - term negative impact on net revenue due to TXMD affordability pr
Slide 13: Commercial Coverage Versus Covered Claims and Net Revenue
13 References: 1. MMIT 0% 10% 20% 30% 40% 50% 60% 70% 80% Jun-18 Sep-18 Dec-18 Mar-19 Jun-19 Sep-19 Dec-19 % of Commercial Lives Covered % of Rxs Paid by Commercial Insurance Net Revenue as a % of WAC * * No net revenue generation today. TXMD will start to see the financial benefit of coverage and i
Slide 14: Variables Impacting Net Revenue Ramp
14 Variables Impacting Net Revenue Ramp * MMIT, 9/19/2018 ▪ Achieving 60% net revenue assumes access to top 10 commercial payers by 4Q 2019 ▪ Recently achieved ~67% u nrestricted commercial access with Express Scripts and ~93% with Anthem ▪ We are in various stages of the negotiation process with th
Slide 15: Vulvar and Vaginal Atrophy (VVA)
15 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 16: Current US VVA Market Overview
16 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 17: Professional Societies and FDA Recommend the Lowest Effective Dose
17 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 18: Imvexxy is Redefining Relief
18 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 19: Foundation Built for a Strong Launch
19 ▪ 40% overlap with current prenatal vitamins business ▪ Sales force of 150 ▪ Partnership with inVentiv, leading contract sales organization ▪ Operational and analytic systems TXMD Sales Force in OB/GYN Offices Foundation Built for a Strong Launch =TXMD territories
Slide 20: References
20 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 21: Payer Breakdown of FDA-Approved VVA Products
21 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 September 19, 2018, Imvexxy achieved ~36% unrestricted commercial coverage (no step edits or PA) - Expect commercial coverage to peak at 60%+ ▪ Earliest ex
Slide 22: VVA Class Commercial Coverage
22 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 23: Case Study: Vagifem Generics Launch
23 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 24: Prior Authorization Example in the VVA Class
24 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 25: Recent VVA TRx Launch Trajectories
25 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 26: TXMD's Patient Engagement Programs for Adoption, Affordability & Adherence
26 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 27: Results of TXMD Prenatal Vitamin Adoption & Adherence Programs
27 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 28: Current VVA Market Messiness
28 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 29: Patient Engagement Program
29 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 30: Incremental Fills Per Year Drive Upside to Net Revenues
30 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 31: TX-001HR Combination Estrogen + Progesterone (E+P) Program
31 TX - 001HR Combination Estrogen + Progesterone (E+P) Program
Slide 32: TX-001HR Product Development Rationale
32 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 33: TX-001HR – Potential Best in Class Therapy
33 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 34: Multi-Billion Dollar Total Substitutable Market Opportunity
34 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 35: TX-001HR Could Fulfill Therapeutic Gap For Stakeholders
35 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 36: BIO-IGNITE
36 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 37: Bio-Identical Customization
37 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 38: BIO-IGNITE Progress and Results
38 BIO - IGNITE 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 proper
Slide 39: USP <800> Expenses Create Large Barriers for Compounders
39 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 40: Economic Support: Partnership for Patient Care
40 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 41: Annovera (Segesterone Acetate/Ethinyl Estradiol Vaginal System)
41 Annovera (Segesterone Acetate/Ethinyl Estradiol Vaginal System) Approved for use by females of reproductive potential to prevent pregnancy. (Limitation of use: Not adequately evaluated in females with a body mass index of >29 kg/m2).
Slide 42: Annovera - 1-Year Vaginal System
42 ▪ Annovera approved on August 10, 2018 • Segesterone acetate component of Annovera 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 Jadelle ® implan
Slide 43: Annovera - 1-Year Vaginal System
43 ▪ 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 44: Clinical Trial Experience Efficacy & Safety
44 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 45: Acceptability Data
45 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 46: Annovera Product Advantages
46 ▪ Only FDA approved long - acting reversible birth control that doesn’t require a procedure or repeat doctor’s visit • Empowers women to be in control of their fertility and menstruation • Annovera is the only user - directed single 12 - month birth control product ▪ Highly effective in preventin
Slide 47: U.S. Prescription Contraceptive Market
47 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 48: Top Contraceptive Products Based on Revenue
48 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 49: Large Established Ring Market
49 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 50: Unique Product Characteristics Should Lead to Good Payer Coverage
50 Unique Product Characteristics Should Lead to Good Payer 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 51: 1-Year Vaginal Contraceptive System Serves an Unmet Need
51 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 52: Commercialization Strategy
52 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 53: Complete Women's Healthcare Portfolio
53 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 54: Contraceptive Pipeline
54 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 55: Committed to Become the Leading Women's Health Company
55 Committed to Become the Leading Women’s Health Company
Slide 56: TherapeuticsMD, A Premier Women's Health Company
56 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 57: Significant Insider and Institutional Share Ownership
57 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 58: TXMD: Financial Snapshot
58 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 59: Thank You
Thank You A\S\\ TherapeuticsMD” For Her: For Life 4 —
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