Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (October 2019)
59 slides from Therapeuticsmd's investor presentation, Oct 1, 2019
Slide 1: Building a Premier Women's Health Portfolio
1 Investor Presentation October 2019 Building a Premier Women’s Health Portfolio
Slide 2: Forward-Looking Statements
2 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,
Slide 3: General Updates
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Slide 4: ANNOVERA Test and Learn Market Introduction Update
No Image 4 4 ▪ ANNOVERA Test and Learn Market Introduction has begun ▪ Full launch expected in 1Q 2020 ▪ Current Test and Learn Market Introduction sales staffing ▪ 36 Sales Representatives from existing 190 territories will now promote ANNOVERA in addition to our other products ▪ 23 current Regiona
Slide 5: Commercial payer environment for contraceptives
5 5 ▪ Commercial payer environment for contraceptives provides patient affordability without the need for a TXMD open access program ▪ In 2012, the Affordable Care Act (ACA) required all health insurances to cover, without cost - sharing, the full range of contraceptive methods and services approved
Slide 6: IMVEXXY
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Slide 7: Portfolio Approach to Women's Health
7 7 Focused on lifespan of the patient and healthcare provider’s needs ▪ Innovative products, chronic conditions, large markets ▪ 200 sales representatives focused on single call point ▪ Products transition from one to the next through the various stages of life • contraception prenatal vitamins
Slide 8: Portfolio products, affected population and TAM
8 8 32 million women 1,2 36 million women 4 >$20B 3 >$25B 3,5 Approved May 29, 2018 Launched August 2018 Approved October 28, 2018 Launched April 2019 43 million women 6 $5B 7 Approved August 10, 2018 Test & Learn Introduction: 4Q19 Full scale launch expected: 1Q20 Affected US Population US TAM Oppo
Slide 9: The Scope of VVA in the US
9 9 The Scope of VVA in the US 64 Million Menopausal Women in the US 1 9 1. Wysocki S et al. Clin Med Insights Reprod Health . 2014;8:23 - 30. 2 . Kingsberg SA et al. J Sex Med . 2017;14:413 - 424. 3. IMS Health Plan Claims (April 2008 - Mar 2011). menopausal women have symptomatic VVA 2 ~1 i n 2 or
Slide 10: Launch Approach Developed to Shift Entrenched Behavior
No Image 10 10 Launch Approach Developed to Shift Entrenched Behavior Drive Share Momentum Through New Writers and Share of Existing Writers Drive Early Experience for a Differentiated Product Remove Barriers ▪ Open access approach only works for a product that delivers a good patient experience ▪ $
Slide 11: IMVEXXY is Redefining Relief
11 11 ▪ Small, digitally inserted, softgel vaginal insert that dissolves completely ▪ Easy to use without the need for an applicator ▪ Mess - free administration ▪ Use any - time of day ▪ L owest approved doses of estradiol 4 mcg and 10 mcg ▪ Efficacy demonstrated as early as 2 weeks (secondary endp
Slide 12: IMVEXXY August Launch Metrics
12 12 August Launch Metrics 1 Total prescription data is based on IQVIA prescriber level data plus additional unique patients identified through utilizatio n o f our affordability program. This includes a two week estimation for the lag in reporting retail data, which can cause minor fluctuations in
Slide 13: Launch Results Remain Strong and On-Track
13 13 Launch Results Remain Strong and On - Track: Strategy is Working References: 1. Total prescription data is based on IQVIA prescriber level data plus additional unique patient data identified through utiliz ati on of our affordability program. This includes two weeks of estimation for the lag i
Slide 14: Continued Strong Patient Adherence
14 14 Continued Strong Patient Adherence IMVEXXY: 3.8 fills/yr 3 (through Aug) • Vaginal creams: average 1.5 fills/yr 4 • Vaginal tablets: average 3.5 fills/yr 4 IMVEXXY Patient Adherence 1,2 Month Initial Prescription Filled Average # Fills for Those Patients Maximum Allowable Fills Given the Month
Slide 15: Value of Additional Fills
15 15 Value of Additional Fills Percent of market based on patient count of 2.3M and 4 fills per year Average Net Revenue / Unit 25% 35% 45% 55% $80 $184M $257.6M $331.2M $404.8M $100 $230M $322M $414M $506M 6 Fills/year 5 Fills/year 4 Fills/year Percent of market based on patient Count of 2.3M and
Slide 16: The VVA Market Exceeds $1.7B Gross Revenue Annually
16 16 The VVA Market Exceeds $1.7B Gross Revenue Annually Product 12 Months through June 2019 Total Units 1 Gross Dollars for 2018 1 Estrace ® Cream Brand & Generics 2,000,000 $554,450,000 Premarin® 1,190,000 $460,760,000 Vagifem ® Brand & Generics 1,500,000 $454,550,000 Estring® 259,000 $114,360,00
Slide 17: Commercial Payer Status
17 17 Commercial Payer Status Plan % of Lives 1 Status 2 CVS 15.4% Adjudicating as of September 2019 ESI 15.3% Adjudicating as of 10/1/18 United 7.5% Adjudicating as of 3/1/19 Anthem 7.3% Adjudicating as of August 2018 Prime 6.5% Adjudicating as of 1/1/19 OptumRx 6.1% Adjudicating as of 1/1/19 Kaise
Slide 18: Medicare Part D Payer Status
18 18 Medicare Part D Payer Status Decisions Expected 3Q/4Q19 Plan % of Lives 1 Status 2 United 20.7% Adjudicating as of 2/1/19 Humana 17.9% Decision expected 3Q/4Q19 CVS Caremark 14.1% Decision expected 3Q/4Q19 Wellcare with Aetna lives 13.6% Decision expected 3Q/4Q19 Express Scripts/ Cigna 8.5% De
Slide 19: How Adjudication Rate Will Change Over Time
19 19 How Adjudication Rate * Will Change Over Time Column A Column B Column C IMVEXXY No Insurance Commercial Insurance Medicare Eligible Patients % of Business 3% 62% 35% % Adjudicated 0% 50% 8% Contribution to Overall Adjudication Rate 0% 31% 3% Overall Adjudication Rate 34% (up from 27% in 1Q19)
Slide 20: IMVEXXY Model Different Than Typical Pharmaceutical Launch
20 20 • Improve mix of starter and maintenance packs • Increase Average Selling Price (ASP) • Increase copay for those without insurance • Set limits on patients with high deductibles • Negotiate lower rates as volume increases by leveraging portfolio of products (ANNOVERA) • Direct sales opportunit
Slide 21: How a Prescription is Paid & Impact on Manufacturer
21 21 Example : How a Prescription is Paid & the Impact on Manufacturer Column A Column B Column C Column D Patient’s Insurance Doesn’t Cover Product Yet Commercial Insurance Used w/ Patient Deductible Not Yet Met & High Deductible Plans Commercial Insurance Used w/ Average Copay Medicare Part D Ins
Slide 22: BIJUVA
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Slide 23: Product Development Rationale
23 23 Product Development Rationale ▪ 2002 Women’s Health Initiative (WHI) study showed that the long - term use of certain synthetic hormones (a combination of medroxyprogesterone acetate and conjugated equine estrogens) increased the risk of breast cancer, stroke, heart attack and blood clots – Pr
Slide 24: Hormone Therapy Options for Vasomotor Symptoms Before BIJUVA
24 24 Hormone Therapy Options for Vasomotor Symptoms Before BIJUVA After WHI (2002), a majority of women and clinicians shifted to bio - identical hormone therapy 1 FDA - APPROVED NOT FDA - APPROVED Combination Synthetic Estrogens + Progestins 2 Separate Bio - identical Estradiol & Progesterone Comp
Slide 25: BIJUVA key attributes
25 25 ▪ First and only bio - identical combination of estradiol to reduce moderate to severe hot flashes combined with progesterone to help reduce the risk to the endometrium ▪ Strong efficacy and safety data ▪ Sustained steady state of estradiol ▪ No clinically meaningful changes in weight or blood
Slide 26: A Large Target Market For BIJUVA
No Image 26 26 BIJUVA introduced into Bio - Ignite Channel, once payer coverage established Launched April 17, 2019 Target FDA - approved separate bio - identical Estrogen & Progesterone pills segment Q2 ~3.9M TRx (each) 1 I $836M 2 TAM 12M – 18M TRx 3 I $2.5B - 3.8B 2 TAM A Large Target Market For
Slide 27: BIJUVA August Launch Metrics
27 27 August Launch Metrics BIJUVA Launch Metrics Total paid scripts dispensed to patients 1 (since launch through August 31, 2019) ~14,200 Total paid scripts (August 1 - 31, 2019) ~5,300 Total patients (since launch through August 31, 2019) ~6,800 Total prescribers 2 (since launch through August 31
Slide 28: Commercial Payer Update
28 28 Commercial Payer Update Coverage Decisions Expected by 4Q19 Plan % of Lives 1 Status 2 CVS 15.4% In discussions ESI 15.3% Adjudicating as of 4/19/19 United 7.5% Adjudicating as of 8/1/19 Anthem 7.3% In discussions Prime 6.5% In discussions OptumRx 6.1% Adjudicating as of 8/1/19 Kaiser 4.7% In
Slide 29: How Adjudication Rate Will Change Over Time
29 29 How Adjudication Rate * Will Change Over Time Column A Column B Column C BIJUVA No Insurance Commercial Insurance Medicare Eligible Patients % of Business 3% 89% 8% % Adjudicated 0% 38% 7% Contribution to Overall Adjudication Rate 0% 33.8% 0.6% Overall Adjudication Rate 34% (up from 25% in May
Slide 30: Compounding Pharmacy Onboarding Process and Status
30 30 ▪ Unique compounded bio - identical hormone replacement therapy (CBRT) prescribers Identified: 10,759 ▪ 2,328 are identified as high - value CBHRT HCP’s targeted by Key Account Managers National Reach 105 Live Accounts 2,183 High Tier Targets 124 Contracting 10,759 CBHRT HCP’s In Vetting Proce
Slide 31: Market Opportunity
31 31 Market Opportunity Market opportunity is calculated by multiplying the annual addressable market units (3.9M units of FDA - approved E+P plus the low - end of the estimated compounded market of 12M prescriptions) times the market share times the average potential net revenue per u nit . Total
Slide 32: ANNOVERA
Amovers, ANNOVERA TherapeuticsMD’
Slide 33: U.S. Contraceptive Market
No Image 33 33 U.S. Contraceptive Market $5B U.S. net sales 1 ~ 90M annual scripts to ~20M women 2 Complete control but no long acting benefits Long - acting benefits without a procedure offering complete control over fertility and menstruation Long - acting benefits but requires a procedure and doe
Slide 34: Market shift to long-acting contraception
34 34 1 Lohr , et al. Use of intrauterine devices in nulliparous women. Contraception 95 (2017); 529 - 537 Access Attributes ▪ Market shift to long - acting contraception ▪ Offer women a long - term birth control option without requiring a procedure for insertion and removal like IUDs or Implants ▪
Slide 35: ANNOVERA key attributes
35 35 ▪ Only FDA - approved long - lasting reversible birth control that doesn’t require a procedure or repeat visit – Empowers women to be in control of their fertility and menstruation – ANNOVERA is the only user - directed single 12 - month birth control product (used in repeated 4 - week cycles
Slide 36: High Patient Satisfaction
36 36 1 Merkatz, Ruth B., Marlena Plagianos , Elena Hoskin, Michael Cooney, Paul C. Hewett, and Barbara S. Mensch. 2014. “Acceptability of the Nestorone ®/ethinyl estradiol contraceptive vaginal ring: Development of a model; implications for introduction,” Contraception 90(5): 514 – 521. 2 Adherence
Slide 37: Launch Approach: Test and Learn Market Introduction Underway
No Image 37 37 Launch Approach Test and Learn Market Introduction Underway ▪ Initial focus on OBGYN target overlap with Menopause Products ▪ Early consumer focus given how influential women are in the choice of birth control ▪ Full - scale production anticipated 1Q20 ▪ WAC Price set at $2,000/ unit
Slide 38: Patient Types
38 38 ▪ Broad - based product – a single contraceptive product for most patient and prescriber types ▪ Supports patient preference ▪ Amenable to women of all reproductive ages and demographics ▪ Highly effective ▪ Self - administered, long - lasting product that is reversible ▪ Nulliparous women (ne
Slide 39: Recent Payer Updates
39 39 ▪ ESI adjudicating ANNOVERA at Tier 3 as of September 2019 ▪ Anthem adjudicating ANNOVERA at Tier 3 with no copay as of August 2019 1 ▪ Kaiser Washington ACA drug list covers ANNOVERA at no copay 1 ▪ Cigna adjudicating ANNOVERA at Tier 3 as of August 2019 1 ▪ Starting on January 1, 2020, New Y
Slide 40: Commercial Payer Update
40 40 Commercial Payer Update Coverage Decisions Expected to be finalized 1Q20 Plan % of Lives 1 Status 2 CVS 15.4% In discussions ESI 15.3% Adjudicating at T3 as of September 2019 United 7.5% In discussions Anthem 7.3% Adjudicating at T3, no copay as of August 2019 Prime 6.5% In discussions OptumRx
Slide 41: Selected Regional Plan Coverage
41 41 Commercial Payer Update Coverage Decisions Expected to be finalized 1Q20 Plan % of Lives 1 Status 2 MC - Rx (ProcareRx) 0.64% Adjudicating as of April 2019 Magellan Rx 0.47% Adjudicating at no copay as of August 2019 BCBS of Massachusetts 0.47% Adjudicating at no copay as of August 2019 Excell
Slide 42: Birth Control State Laws: No Copay
42 42 11 STATES, plus Washington D.C., REQUIRE COVERAGE WITH NO COPAY REGARDLESS OF ACA DECISION (~51 Million women in these states) ANNOVERA coverage required with no co - pay BIRTH CONTROL STATE LAWS REGARDLESS OF ACA MANDATES 1 Data on file (July 2019). 2 Washington State Office of the Insurance
Slide 43: Birth Control State Laws: Copay
43 43 ANNOVERA coverage required with co - pay 8 STATES REQUIRE COVERAGE WITH COPAY REGARDLESS OF ACA DECISION (~27 Million women in these states) BIRTH CONTROL STATE LAWS REGARDLESS OF ACA MANDATES 1 1 Data on file (July 2019). ANNOVERA coverage required with no co - pay 1
Slide 44: Market Opportunity
44 44 Market Opportunity Addressable Birth Control Market Rx Options NRx: 28M Percent of Overall Birth Control Market NRx Average Net Revenue / Unit 1.0% 1.5% 2.0% 2.5% $1,000 $280M $420M $560M $700M $1,500 $420M $630M $840M $1.05B $1,750 $490M $735M $980M $1.2B Addressable NuvaRing Market NRx: 1.2M
Slide 45: The Power of the Portfolio: Multiple Paths to $1B of Peak Sales
45 45 Total Addressable Birth Control Market NRx: 28M Average Net Revenue / Unit 1.0% 1.5% 2.0% 2.5% $1,000 $280M $420M $560M $700M $1,500 $420M $630M $840M $1.05B $1,750 $490M $735M $980M $1.2B Percent of Market Based on Patient Count of 2.3M and 4 fills per year Average Net Revenue / Unit 25% 35%
Slide 46: Financial Overview
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Slide 47: 2019 Financial Guidance
47 47 2019 Financial Guidance FDA - Approved Products Net Revenue Prenatal Vitamins Net Revenue Total TXMD Net Revenue 3Q2019 Estimate 4Q2019 Estimate FY2019 Estimate $4.50 - 6.50M $2.25 - 2.50M $6.75 - 9.00M $11.00 - 13.00M $1.75 - 2.25M $12.75 - 15.25M $20.75 - 24.75M $8.70 - 9.45M $29.45 - 34.20M
Slide 48: $300M Non-Dilutive Term Loan Financing
48 48 $300M Non - Dilutive Term Loan Financing Secured Amount ($) TXMD Company Milestone 1 Anticipated Timing Tranche 1 $200 million Closing of the facility Completed in April 2019 Tranche 2 $50 million Designation of ANNOVERA as a new category of birth control by the U.S. Food and Drug Administrati
Slide 49: TXMD: Financial Snapshot
49 49 TXMD: Financial Snapshot Shares Outstanding 241.2M (as of August 2, 2019 ) Cash $182.8M (as of June 30, 2019 ) Listing Exchange Insider Ownership ~15% (as of June 30, 2019 ) * $300 million non - dilutive term loan facility with TPG Sixth Street Partners (TSSP) entered into on April 24, 2019. T
Slide 50: The Power of a Women's Health Portfolio
No Image 50 50 CONTRACEPTION PRENATAL CARE CONTRACEPTION/ FAMILY PLANNING - PERIMENOPAUSE VASOMOTOR SYMPTOMS DYSPAREUNIA (Vulvar & Vaginal Atrophy) REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT Prenatal Vitamins The Power of a Women’s Health Portfolio
Slide 51: Appendix
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Slide 52: The Power of A Women's Health Portfolio Market Opportunity
No Image 52 52 The Power of A Women’s Health Portfolio Market Opportunity 1 Overlapping Prescribers & Patients The Power of 3 Even though there are over 400,000 total writers for these products 2 ~25,000 targets we call on represent over 60% of market opportunity for each product 2 REPRODUCTIVE PORT
Slide 53: Women are Menopausal More Than One-third of Their Lives
53 53 Women are Menopausal More Than One - third of Their Lives 1 1. Parish SJ, et al. Menopause. 2018;25(8):937 - 941. 2. North American Menopause Society. Menopause 101. www.menopause.org/for - women/menopauseflashes/menopause - symptoms - and - treatments/menopause - 101 - a - primer - for - the
Slide 54: IMVEXXY Product Characteristics Compare Favorably
54 54 IMVEXXY Product Characteristics Compare Favorably 1 - 9 There have been no head - to - head trials between IMVEXXY and any of the products listed above. All trademarks are the property of their respective owners. Abbreviations: WAC, wholesale acquisition cost. Product Estrace ® Cream (estradio
Slide 55: Commercial Average Non Preferred Copay
55 55 • Commercial Average Non Preferred Copay is $59 • IMVEXXY co - pay card offer can bring this down to $35 Source: 2018 Employer Health Benefits Survey, Section 9: Prescription Drug Benefits (KFF, Oct. 3, 2018), https://www.kff.org/report - section/2018 - employer - health - benefits - survey -
Slide 56: Medicare Part D Median Preferred Copay
56 56 Medicare Part D Median Preferred Copay is $40 S ource: Juliette Cubanski, Anthony Damico, and Tricia Neuman, Medicare Part D: A First Look at Precription Drug Plans in 2019 (Kff, Oct. 16, 2018), https://www.kff.org/report - section/medicare - part - d - a - first - look - at - prescription - d
Slide 57: IMVEXXY Quarterly Performance
57 57 IMVEXXY Quarterly Performance $0 $500 $1,000 $1,500 $2,000 $2,500 $3,000 $3,500 3Q18 4Q18 1Q19 2Q19 Quarterly Net Revenue 3Q18 4Q18 1Q19 2Q19 0 20 40 60 80 100 120 3Q18 4Q18 1Q19 2Q19 Quarterly Scripts to Patients 3Q18 4Q18 1Q19 2Q19 Thousands Thousands 55% 41%
Slide 58: ANNOVERA Key Attributes
58 58 ANNOVERA Key Attributes Oral Contraceptives Vaginal Ring NuvaRing ® Contraceptive Injection Vaginal System ANNOVERA™ IUDs Duration of Action Daily pill intake 1 month (21/7 regimen) 3 months 1 year (21/7 regimen) 3 - 10 years Patient Control Stop at any time Removable at any time Stop at any t
Slide 59: Top Contraceptive Products Based on Revenue
59 59 Top Contraceptive Products Based on Revenue $750 $528 $495 $722 $0 $300 $600 $900 MIRENA® IUD FAMILY (INCLUDES MIRENA, KYLEENA® & SKYLA®) LO LOESTRIN® FE BIRTH CONTROL PILL NEXPLANON® IMPLANT NUVARING® 2018 Net Revenue (Millions) Net Revenue (M) This includes 3 Company filings; Net sales as re
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