Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (November 2017)
48 slides from Therapeuticsmd's investor presentation, Nov 13, 2017
Slide 1: TXMD Overview November 2017
TXMD Overview November 2017 THER - 0086 11/17
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 - looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, as well as statements, o
Slide 3: Innovative women's health company focused on products across life cycles
3 (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
Slide 4: Two Late Stage Women's Health Assets With Large Total Addressable Markets
4 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 horm
Slide 5: Significant Catalysts Within Next Months
5 Significant Catalysts Within Next 12 Months December 2017 Planned NDA submission for TX - 001HR November 3, 2017 Face to face meeting with the FDA; agreed to the resubmission of the NDA for TX - 004HR December 2017 Potential acceptance of the NDA for TX - 004HR January 2018 Potential approval of t
Slide 6: Complete Financing Strategy In Place
6 Complete Financing Strategy In Place Phase 1 Equity Financing Phase 2 Term Loan Debt Financing Phase 3 Partnership Opportunities ▪ Potential for upfront payments and royalty revenue streams to further support additional product opportunities ▪ $68.6M equity offering, closed on September 28 th ▪ Se
Slide 7: Seasoned Management Team with a Proven Track Record of Commercial Execution
7 Seasoned Management Team with a Proven Track Record of Commercial Execution • 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 • P
Slide 8: TX-004HR Vulvar and Vaginal Atrophy (VVA) Program
8 TX - 004HR Vulvar and Vaginal Atrophy (VVA) Program
Slide 9: Vulvar and Vaginal Atrophy (VVA)
9 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 - 1799
Slide 10: VVA market and treatment landscape
10 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 11: Current VVA Products
11 Products Estrace Cream ® Premarin Cream ® Vagifem ® Estring ® Osphena ® Intrarosa ® FDA Approval 1984 1978 1999 1996 2013 2016 TRx Dollars 2016 1 $511,035,880 $505,351,340 $502,715,665 a $105,040,703 $72,755,311 Approved 11/2016 Method of Admin Vaginal Cream Vaginal Cream Vaginal Tablet Ring Oral
Slide 12: Compliance and Fills Per Year Drives Top-Line Revenue
12 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 13: TX-004HR: Product Candidate Profile
13 TX - 004HR: Product Candidate Profile ▪ 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 softgel capsule without the need for a
Slide 14: Co-Primary and Key Secondary Efficacy Endpoints
14 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 - val
Slide 15: TX-004HR Complete Response Letter (CRL) Review
15 TX - 004HR Complete Response Letter (CRL) Review ▪ May 5, 2017 - received a CRL with one approvability issue identified by the FDA ▪ Lack of long - term safety data beyond the 12 weeks studied in the Rejoice Trial ▪ June 14, 2017 – Type A Meeting with the directors of the Division of Bone, Reprod
Slide 16: TX-004HR CRL Resolution Pathway
16 TX - 004HR CRL Resolution Pathway TX - 004HR Resubmission Pathway for Approval ▪ Resubmit amended NDA in the coming weeks ▪ Establish new target action date ▪ If Class 1 Resubmission, approval decision within 60 days of resubmission ▪ If Class 2 Resubmission, approval decision within 180 days of
Slide 17: Three Main Levers to Drive TX-004HR Launch
17 Build a differentiated national care model for successful diagnosis, treatment, and management of symptoms of VVA caused by menopause Commercial Execution Elevate importance of VVA by demonstrating true impact of disease Differentiate TX - 004HR as new treatment option that redefines relief Drive
Slide 18: Foundation Already Built for a Strong Launch
18 Map Legend: Current TXMD Sales Presence Highest Prescribing Physicians for VVA ▪ 40% overlap with current prenatal vitamins business ▪ Currently calling on VVA targets with disease awareness campaign ▪ Planned sales force of 100 in place prior to launch ▪ Partnership with inVentiv , leading contr
Slide 19: HCP Stated Preference Share
19 HCP Stated Preference Share (Adjusted Percent of Prescriptions, n = 400 HCPs) 30.0% 34.0% 22.0% 27.0% 19.0% 15.0% 9.0% 10.0% 9.0% 6.0% 5.0% 8.0% 6.0% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% Current Landscape Post-TX-004HR Launch Market Share (Stated) TX-004HR Premarin Cream Estrace Cream Vagifem Osph
Slide 20: REJOICE Trial Results: Patients Choose TX-004HR
20 Convenience Safety/ Side Effects Efficacy ▪ Products difficult to use 1 ▪ Inadequate instructions on use 1 ▪ Hormone exposure concerns 1 ▪ Messiness 1 ▪ 1 in 4 women achieve limited relief 1 ▪ Delayed onset of efficacy 1 Perceived Shortcomings TX - 004HR Solution ▪ No applicator; any time of day
Slide 21: Increasing Compliance Through National Care Model
21 Prenatal Vitamins Market VVA Market ▪ Market Dynamics: ▪ No Drug Claims ▪ 9 month condition ▪ Market Dynamics: ▪ Clinical and physical product differentiation ▪ Chronic, progressive condition ▪ Industry Average Patient Compliance: ▪ 2.5 fills per pregnancy ▪ Industry Average Patient Compliance: ▪
Slide 22: TX-004HR Net Revenue at Year 5 of Launch
22 Compliance and Fills Per Year Drives TX - 004HR Net Revenue at Year 5 of Launch $257,431 $336,640 $415,850 $495,059 $574,269 $653,478 $732,688 $- $100,000 $200,000 $300,000 $400,000 $500,000 $600,000 $700,000 $800,000 2 Fills Per Yr 3 Fills Per Yr 4 Fills Per Yr 5 Fills Per Yr 6 Fills Per Yr 7 Fi
Slide 23: Payers are Continuing to Provide Choice
23 Payers are Continuing to Provide Choice 80% of Payers Prefer 2+ Products MMIT Data January 2017
Slide 24: Favorable Payer Dynamics: Generic Risk Is Brand Specific
24 Favorable Payer Dynamics: Generic Risk Is Brand Specific ▪ Overall low cost category compared to other therapeutic areas ▪ Prior authorizations and step edits are not economically favorable for payers and do not currently exist ▪ Cost of a prior authorization runs between $80 - $140 per patient p
Slide 25: Yuvafem Authorized Generic Launch Case Study
25 1,470,493 453,336 965,027 1,470,493 1,418,363 400,000 600,000 800,000 1,000,000 1,200,000 1,400,000 1,600,000 Oct 2015-Sept 2016 Oct 2016-Sept 2017 Vagifem Yuvafem Total Case Study: Yuvafem Authorized Generic Launch (Year 1) Vagifem and Yuvafem Total TRx - 3.5% y/y Symphony Health Solutions PHAST
Slide 26: TX-001HR Combination Estrogen + Progesterone (E+P) Program
26 TX - 001HR Combination Estrogen + Progesterone (E+P) Program
Slide 27: Menopause Overview
27 Menopause Overview 1) National Institutes of Health, National Institute on Aging, https://www.nia.nih.gov/health/publication/menopause, last acc ess ed November 3, 2015. 2) International Journal on Women’s Health, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3897322/ Menopause represents the natur
Slide 28: TX-001HR Product Development Rationale
28 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
Slide 29: Medical Societies Discourage Compounded Bio-Identical Hormones
29 Medical Societies Discourage Prescribing of Compounded Bio - Identical Hormones 1) Committee on Gynecologic Practice and the American Society for Reproductive Medicine Practice Committee, Number 532, Augus t 2 012 (Reaffirmed 2014, Replaces No. 387, November 2007 and No. 322, November 2005). ▪ AC
Slide 30: TX-001HR: Potential Best in Class Therapy
30 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 ▪ Once - a - day single oral softgel capsule ▪ First and only combination of
Slide 31: Replenish Trial Co-Primary Endpoints
31 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
Slide 32: Multi-Billion Dollar Total Substitutable Market Opportunity
32 TRx US: FDA - Approved Compounded Combination Bio - Identical E+P Separate Bio - Identical E & P Pills Combination Synthetic E+P 1 ~3.5 million 2 ~3 million 2 12 – 18 million TX - 001HR Potential Market $700M - $875M 3 $600M - $750M 3 $2.4B - $4.5B 3 TX - 001HR Total Substitutable Market Opportun
Slide 33: Understanding the Compounding Pharmacy
33 Understanding the Compounding Pharmacy Compounding Pharmacies % of Business (by Prescription Units) N = 3,000 - 3,500 Compounding Focused Pharmacies 1,2,3 (1) 2013 National Community Pharmacists Association Digest: Financial Benchmarks (Sponsored by Cardinal Health) (2) NCPA Community Pharmacy Co
Slide 34: Compounding Pharmacy Menopausal Treatment Paradigm
34 Compounding Pharmacy Menopausal Treatment Paradigm 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
Slide 35: Small Number of Physicians Account for Large Share of Compounded BHRT
35 1) SK&A Nationwide Physician Specialty Report – June 2015 Small Number of Physicians Account for Large Percentage of the Compounded BHRT Market Super Prescribers Normal Prescribers ~ 150,000 Total Eligible Physicians 1 (Includes OB/GYNs, PCPs, and Anti - Aging) 4,700 Regular Prescribers (3%) 55,0
Slide 36: BIO-IGNITE Compounding Pharmacy Partnership Strategy
36 BIO - IGNITE TM BIO - IGNITE TM 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 distributing our hormone product candi
Slide 37: BIO-IGNITE Progress and Results
37 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 38: USP-800 and Compounding Regulatory Changes
38 1)http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm376829.htm 2) http://www.iacprx.org/general/custom.asp?page=CCIns161314 3) http://www.optum.com.br/content/optum/en/optumrx/pharmacy - insights/restoring - trust - compound - medications.html 4
Slide 39: Economic Incentives Provide Catalyst to Switch to TX-001HR
39 Economic Incentives Provide Catalyst to Switch to TX - 001HR 1) Assume AWP - 18% Third - Party Reimbursement 2) Assume $250 WAC less 20% distribution discount 3) Includes additional labor, pharmacists, technicians, regulatory, and legal expenses 4) July 2018 Implementation; includes >$150,000 cap
Slide 40: Innovation, Regulatory Environment, Commercial Opportunity; PVPCN Distribution Agreement
40 Innovation Regulatory Environment Commercial Opportunity ▪ Potential low - dose local estrogen therapy for VVA ▪ Potential first and only FDA - approved bio - identical combination of E+P ▪ Clinical validation of current treatment paradigm for menopausal symptoms ▪ Drug Quality and Security Act ▪
Slide 41: Expect Robust Insurance Coverage For TX-001HR, If Approved
41 Expect Robust Insurance Coverage For TX - 001HR, If Approved, In - Line with Product Class 4,315 Commercial Plans % Unrestricted Access of Commercial Plans Not Covered Estrace ® (Oral) 96% 1% Prempro ® 94% 5% CombiPatch ® 93% 4% Climara Pro® 92% 4% FemHRT ® 87% 6% Duavee ® 86% 5% Vivelle - Dot® 8
Slide 42: TXMD: Financial Snapshot
42 TXMD: Financial Snapshot Shares Outstanding 216.4M (as of Oct 30, 2017) Debt $0M Cash $148.3M (as of Sept 30, 2017) Listing Exchange
Slide 43: Worldwide Patent Filings
43 Worldwide Patent Filings * *Not all patent filings filed in all jurisdictions. Strong IP Portfolio with 158 Patent Applications, including 82 international filings, and 18 issued U.S. patents
Slide 44: Appendix
Appendix TherapeuticsMD” For Her: For Life
Slide 45: Women's Health Initiative Observational Study
45 Women’s Health Initiative Observational Study ▪ First ever study to evaluate the long - term safety of women using only U.S. FDA - approved vaginal estrogen products ▪ 2,953 users of vaginal estrogen without progestin with an intact uterus ▪ Median duration of use of 2 - 3 years and median durati
Slide 46: TX-004HR vs. Vagifem Single Dose PK Studies
46 TX - 004HR vs. Vagife m ® Phase 1 Single Dose PK Studies Vagifem is a registered trademark of Novo Nordisk A/S Corp. Pickar , et al. Climacteric 2016 Key Findings ▪ Tmax ~2 hours with TX - 004HR and ~8 hours with Vagifem ▪ Systemic absorption of estradiol AUC (0 - 24 hours) is 2 - to 3 - fold low
Slide 47: Separate FDA-approved bio-identical products: potential TX-001HR prescriptions
47 ▪ Healthcare providers not comfortable with compounding will often prescribe two separate FDA - approved bio - identical products to treat menopausal symptoms 1) Symphony Health Solutions PHAST Data powered by IDV; 12 months as of December 31 2015 2) Assume WAC pricing between $200 - 250 All trad
Slide 48: Synthetic E+P Substitutable Market Opportunity
48 1) Symphony Health Solutions PHAST Data powered by IDV; 12 months as of December 31 2015 Includes the following drugs: Activella ®, FemHRT ® , Angeliq ®, Generic 17 b + Progestins , Prempro ®, Premphase ®, Duavee ®, Brisdelle ® 2) Assume WAC pricing between $200 - $250 All trademarks are the prop
TherapeuticsMD — Investor Presentation (November 2017) on 6ix