Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — JP Morgan Conference January 2020
33 slides from Therapeuticsmd's conference presentation, Jan 14, 2020
Slide 1: Building the Premier Women's Health Company
Building the Premier Women’s Health Company JP Morgan Conference January 2020
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,
Slide 3: Portfolio Approach to Women's Health
3 Portfolio Approach to Women’s Health Empowering Women For Life ▪ Innovative customer centric products, chronic conditions, large markets ▪ Products transition from one to the next through the various stages of life • contraception pregnancy contraception vasomotor symptoms vulvar and vagin
Slide 4: The Power of A Women's Health Portfolio
4 The Power of A Women’s Health Portfolio REPRODUCTIVE PORTFOLIO MENOPAUSE PORTFOLIO 5.4M TRx IMVEXXY 15.9M TRx BIJUVA 28M NRx ANNOVERA 1) Symphony Health Integrated Dataverse (2019). The Power of 3 Overlapping Prescribers & Patients Market Opportunity 1 TRx = Total prescriptions NRx = New prescript
Slide 5: Financial Update
FINANCIAL UPDATE TherapeuticsMD
Slide 6: Preliminary Unaudited 4Q19 Financial Results and Loan Facility Update
6 • Preliminary Unaudited 4Q19 Financial Results • Achieved FDA - approved product consolidated net revenue of greater than $11M • Made milestone payment of $20M to Population Council for successful first commercial batch release of ANNOVERA • TPG Sixth Street Partners (Sixth Street) Loan Facility U
Slide 7: Payer Overview
PAYER OVERVIEW TherapeuticsMD
Slide 8: Payer Coverage Today and Target
8 Coverage Today January 15 th Target Coverage Year - end 2020 ANNOVERA Commercial 76%* 75% IMVEXXY Commercial 72% 75% Part D 29% 70% BIJUVA Commercial 57% 75% Significant Payer Coverage and Growing Payers starting reimbursement 1Q20: ANNOVERA: OptumRx/preventative, Envision and ProcareRx IMVEXXY: A
Slide 9: Strategic Priorities for 2020
9 Drive Net Revenues: Control Operating Expenses: ▪ Invest appropriate financial resources to drive sizable net revenue growth for our brands Strategic Priorities for 2020 Execution and Focus 2020 Full portfolio launch to leverage commercial investments ▪ Control internal spend in non - revenue gene
Slide 10: The Power of the Portfolio: Multiple Paths to $1B of Sales
10 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 $1,250 $350M $525M $700M $875M $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
Slide 11: Product Overview & Commercial Updates
PRODUCT OVERVIEW & COMMERCIAL UPDATES
Slide 12: 2020 Brand Strategy
12 2020 Brand Strategy Brand prioritization establishes focused and disciplined capital allocation to drive net revenue growth in 2020 with a view toward profitability in 2021 ▪ Increase sales and marketing investment to drive net revenue growth in 2020 ▪ Favorable payer dynamics and coverage ▪ High
Slide 13: ANNOVERA Important Safety Information
13 Please see Important Safety Information, including BOXED WARNING, available at www.annovera.com / pi.pdf .
Slide 14: ANNOVERA Summary
14 ANNOVERA Summary *Based on pharmacological studies in animals and in vitro studies. The clinical significance of these data is not known. **In clinical trials, 12% of participants discontinued due to an adverse reaction. 1. Narender Kumar, Samuel S. Koide, Yun - Yen Tsong , and Kalyan Sundaram. 2
Slide 15: ANNOVERA Growth Levers
15 ▪ Focus on Empowerment and Control 1,2 ▪ Disruptive Consumer Campaign ▪ Exploring Social Influencer Programs ▪ Exploring College Campus programs ▪ Online Platforms and Partnerships Contraceptive Market Covered with OB/GYN Overlap from Field Force and Marketing Sales Force Launch Consumer Communic
Slide 16: ANNOVERA is a Consumer-Focused Product
16 ANNOVERA is a Consumer - Focused Product 1 ANNOVERA has not been adequately studied in females with a BMI > 29 kg/m2 2 When left in place 21 days and removed 7 days per cycle Nulliparous women and those not in monogamous relationships Ideal for adolescents and anyone who doesn’t want to take a pr
Slide 17: IMVEXXY Important Safety Information
Please see Important Safety Information, including BOXED WARNING, available at www.imvexxy.com / pi.pdf
Slide 18: IMVEXXY Product Attributes
18 ▪ Indicated for moderate to severe dyspareunia ▪ 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 demo
Slide 19: IMVEXXY 2020 Focus Targets
19 IMVEXXY 2020 Focus Targets Not Yet Writing IMVEXXY ▪ ~20,000 HCP marketing targets have not yet prescribed IMVEXXY ▪ Avg ~77 VVA scripts per year/HCP Occasional Writers - Dabblers ▪ ~7,800 HCPs - dabblers ▪ Accounted for 14% of 2019 IMVEXXY TRx ▪ 2019 Avg ~6.5 IMVEXXY TRx /HCP per year Core Write
Slide 20: Increase Awareness of IMVEXXY for VVA Patients
20 Increase Awareness of IMVEXXY That Creates the Standard of Care for VVA Patients KEY OPPORTUNITIES Introduce IMVEXXY as the standard of care to treat her symptoms Show her she doesn’t need to put up with symptoms, she can treat them STRATEGIC IMPERATIVES Support conversations with her HCP around
Slide 21: BIJUVA Important Safety Information
Please see Important Safety Information, including BOXED WARNING, available at www.bijuva.com /pi/pdf
Slide 22: Menopause Portfolio Approach to Grow the Prescriber Base
22 Menopause Portfolio Approach to Grow the Prescriber Base to Ensure Reach & Frequency BIJUVA offers an FDA - approved, reliably manufactured, accessible, convenient & affordable treatment option Targeted approach supporting BIO - IGNITE For prescribers who regularly partner with compounding pharma
Slide 23: BIJUVA's Unique Product Attributes
23 THE CONVENIENCE OF ONE The convenience of a single - capsule combination of 2 hormones, which may improve compliance BIJUVA’s Unique Product Attributes * Efficacy was evaluated in a 12 - week substudy . The pharmacokinetics of BIJUVA show a steady state of estradiol that is sustained over 24 hour
Slide 24: Elevate the BIJUVA Scientific Narrative
24 Elevate the BIJUVA Scientific Narrative & Reset Foundational Knowledge to Drive Meaningful Differentiation Close Partnership with Medical Affairs to Identify Data from REPLENISH & Key Studies Bone Turnover/ Bone Markers QoL/Sleep Cardio - metabolic Data Efficacy & Safety Sub - analyses (by age, s
Slide 25: 2020 Catalysts
25 2020 Catalysts JANUARY • File BIJUVA low dose NDA efficacy supplement with FDA FEBRUARY • Launch Meeting for ANNOVERA late February MARCH • ANNOVERA launch with full sales force and various partners • ANNOVERA consumer campaign launch Q1/Q2 • Begin calling on public health accounts across sectors
Slide 26: Appendix
Appendix TherapeuticsMD
Slide 27: IMVEXXY Medicare Part D Payer Status
27 Top 8 Plans Account for ~ 83 % of all Medicare Part D Pharmacy Lives 1 IMVEXXY Medicare Part D Payer Status Plan % of Lives 2 Status 3 United 21% Adjudicating as of 2/1/19 Humana 18% Bid submitted; awaiting decision CVS Caremark 14% Bid submitted; awaiting decision Wellcare with Aetna lives 14% B
Slide 28: Understanding Contraceptive Reimbursement
28 Understanding Contraceptive Reimbursement • Under the health reform law (Affordable Care Act), all benefit plans must cover certain Preventative Care Medications like contraceptives without a generic equivalent at 100% - without charging a copay, coinsurance or deductible • The following slides a
Slide 29: OptumRx Preventative Care List Adoption
29 OptumRx Preventative Care List Adoption $0 Cost Share Products References: 1. https://one.walmart.com/content/dam/themepage/pdfs/OptumRxPreventiveCareMedications - 2020.pdf 2. https://mynmhc.org/$0 - medications - list.pdf “Under the Health reform law (Affordable Care Act), benefit plans must cov
Slide 30: CVS Preventative Care List Adoption
30 CVS Preventative Care List Adoption $0 Cost Share Products References: 1. https://www.caremark.com/portal/asset/ NoCost_Preventive_List.pdf f
Slide 31: ANNOVERA Deal Terms
31 ANNOVERA Deal Terms ▪ Upon FDA approval: $20M ▪ First commercial batch release: $20M ▪ $200M in cumulative net sales: $40M ▪ $400M in cumulative net sales: $40M ▪ $1B in cumulative net sales: $40M Milestone Payments Royalty % ▪ Step structure: ▪ Annual net sales < $50M: 5% ▪ Annual net sales > $5
Slide 32: 3Q 2019 Key Performance Metrics
32 3Q 2019 Key Performance Metrics ▪ IMVEXXY net revenue totaled $4.8M for 3Q19 (up from $3.1M for 2Q19) ▪ Net revenue continued to grow faster than units due to improving adjudication rates ▪ TRx increased 26% to 134,000 units for 3Q19 (up from106,000 for 2Q19) ▪ Overall adjudication increased to 3
Slide 33: Sixth Street Loan Facility Tranches
33 Amount ($) TXMD Company Milestone 1 Contractual Timing Tranche 1 $200M Closing of the facility Completed in April 2019 Tranche 2 $50M As amended, TPG Sixth Street Partners (“Sixth Street”) has sole and absolute discretion to make tranche available either contemporaneously with the delivery of the