Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Q1 2019 Earnings Presentation
27 slides from Therapeuticsmd's earnings presentation, May 6, 2019
Slide 1: 1Q19 TXMD Update: Building a Premier Women's Health Portfolio
1 1Q19 TXMD UPDATE ANNOVERA ™ Building a Premier Women’s Health Portfolio ( segesterone acetate and ethinyl estradiol vaginal system)
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: IMVEXXY Launch Strategy
3 19,800 23,600 31,200 IMVEXXY LAUNCH STRATEGY Why? ▪ We believe IMVEXXY is a best - in - class product that will change treatment decisions because IMVEXXY’s product attributes deliver a highlight differentiated experience for women $35 or Less Co - pay Remove Barriers to Early Adoption in a market
Slide 4: Launch Results Remain Strong and On-Track: Strategy Is Working
4 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 a one week estimation for the lag in repo
Slide 5: IMVEXXY Patient Adherence
5 Average fills for all patients through April 30, 2019 = 3.14 3 IMVEXXY Patient Adherence 1,2 Month Initial Prescription Filled Average # Fills for those Patients Maximum Allowable Fills Given the Month of Initial Fill April 2019 1 Fill 1 Fill March 2019 1.7 Fills 2 Fills February 2019 2.3 Fills 3
Slide 6: Net Revenue Per Unit Goal
6 ~47.5K units ~75K units 4Q 2018 3Q 2020 1Q 2019 1 $900K $2.0M Goal $108 Net Revenue Per Unit • ~122% increase in net revenue • ~58% increase in units 1) Due to improvement of adjudication rates the overall cost of our affordability program improved revenue per unit by ~$8. T his improvement was li
Slide 7: Patient Mix by Payer Type
7 PATIENT MIX BY PAYER TYPE 1) Patient mix based upon total script volume and payer type sourced from Symphony Health Integrated Dataverse 2) IMVEXXY patient mix is based on IQVIA prescriber level data plus additional volume identified through utilization of our a ffo rdability program. Medicare Par
Slide 8: IMVEXXY Adjudication Rates
8 IMVEXXY ADJUDICATION RATES Medicare Part D Commercial Patients Cash Pay & Other Patients IMVEXXY 1Q19 Actual Patient Mix 34% 60% 6% IMVEXXY Adjudication Rate – 1Q19 5% 41% 0% IMVEXXY Overall Adjudication – 1Q19 27% Actual ▪ Commercial adjudication gap expected to adjust as additional commercial pa
Slide 9: April Improvement: IMVEXXY Adjudication Rates
9 APRIL IMPROVEMENT IMVEXXY ADJUDICATION RATES Medicare Part D Commercial Patients Cash Pay & Other Patients IMVEXXY Adjudication Rate – 1Q19 5% 41% 0% IMVEXXY Adjudication Rate – April 2019 6% 48% 0% IMVEXXY Overall Adjudication - 1Q19 27% Q1 IMVEXXY Overall Adjudication – April 2019 32% April Adju
Slide 10: IMVEXXY Revenue Expected to Normalize at $108 in 3Q20
10 IMVEXXY REVENUE EXPECTED TO NORMALIZE AT $108 IN 3Q20 Expected Payer Coverage Normalization in 2019 • 3Q19 - Complete commercial contracts comprising ~70% • 4Q19 - Complete majority of Part D contracts Expected Distribution and Co - Pay Optimization in 2020 • 1H20 - IMVEXXY copay optimization; ca
Slide 11: Conservative Market Potential of IMVEXXY
11 CONSERVATIVE MARKET POTENTIAL OF IMVEXXY Each incremental fill per year can add an estimated $74 M net revenue $224,000 $298,000 $373,000 $447,000 $522,000 $- $100,000 $200,000 $300,000 $400,000 $500,000 $600,000 3 Fills/ Patient 4 Fills/ Patient 5 Fills/ Patient 6 Fills/ Patient 7 Fills/ Patient
Slide 12: IMVEXXY Growth Levers in 2019
12 IMVEXXY GROWTH LEVERS IN 2019 Lever 1: Patient Affordability • Added 50 sales reps for a total of 200 • Allows reach to add additional ~5,000 targets • Patients pay no more than $35/prescription Lever 2: Payer Access • 3Q19 ~70%+ of Commercial lives expected to contracted • 4Q19 Medicare Part D c
Slide 13: IMVEXXY Launched into BIO-IGNITE
13 IMVEXXY LAUNCHED INTO BIO - IGNITE 15 Vetted Accounts Waiting for First Order 153 Compounding Pharmacies in Vetting and Processing Stage 31 States Reached 33 Live Accounts Dispensing IMVEXXY Since Late Feb ▪ First 27 accounts approximately 8 - 10 new fills per month ▪ Strong early refill rates ma
Slide 14: 1Q19 BIJUVA Update
14 1Q19 BIJUVA UPDATE
Slide 15: A Large Target Market for BIJUVA
15 Once payer coverage achieved, expand BIO - IGNITE partnerships to access the compounding channel Launched April 17, 2019 Target FDA - approved separate bio - identical E&P 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 BIJUVA 1) Symphony
Slide 16: Launch Plan Mirrors IMVEXXY
16 LAUNCH PLAN MIRRORS IMVEXXY Focused on Driving Early Behavior Change that Leads to Long Term Adoption • Focus on IMVEXXY first given payer coverage build • Focused launch of BIJUVA while coverage is building • Portfolio advantage on overlap in menopause with IMVEXXY and BIJUVA • Salesforce expans
Slide 17: Launch Plan Mirrors IMVEXXY: Pay No More Than $35
17 • Pay No More Than $35 from Day 1 of launch* LAUNCH PLAN MIRRORS IMVEXXY Focused on Driving Early Behavior Change that Leads to Long Term Adoption ▪ $35 or less out - of - pocket cost* ▪ Addresses the cost and coverage concerns which are often barriers to early adoption ▪ “Keep Cool” Early Experi
Slide 18: 1Q19 ANNOVERA Update
18 1Q19 ANNOVERA UPDATE ANNOVERA ™ ( segesterone acetate and ethinyl estradiol vaginal system)
Slide 19: ANNOVERA Launch Approach
19 Very likely Somewhat likely Not too likely Not at all likely Universal Acceptance to Prescribe 2 ANNOVERA LAUNCH APPROACH Meet Inbound Demand Align Initial Sales Focus where States Mandate Coverage (19 states) while ACA Decision is Made Full Launch with Initial Focus on OBGYN target overlap with
Slide 20: States Requiring Coverage with No Copay
20 ANNOVERA ™ ( segesterone acetate and ethinyl estradiol vaginal system) 8 - 10 STATES REQUIRE COVERAGE WITH NO COPAY REGARDLESS OF ACA DECISION (~42 Million Women) ANNOVERA coverage required with no co - pay STATE LAWS REGARDLESS OF ACA MANDATES
Slide 21: States Requiring Coverage with Copay
21 ANNOVERA ™ ( segesterone acetate and ethinyl estradiol vaginal system) ANNOVERA coverage required with co - pay 9 STATES REQUIRE COVERAGE WITH COPAY REGARDLESS OF ACA DECISION (~25 Million Women) STATE LAWS REGARDLESS OF ACA MANDATES
Slide 22: Financial Update 1Q 2019
1Q 2019 FINANCIAL UPDATE TherapeuticsMD” For Her: For Life.
Slide 23: IMVEXXY Quarterly Performance
23 IMVEXXY Quarterly Performance $0 $200 $400 $600 $800 $1,000 $1,200 $1,400 $1,600 $1,800 $2,000 3Q18 4Q18 1Q19 Quarterly Net Revenue 3Q18 4Q18 1Q19 0 10 20 30 40 50 60 70 80 3Q18 4Q18 1Q19 Quarterly Scripts to Patients 3Q18 4Q18 1Q19 Thousands Thousands 58% 122% 1Q19 Net Revenue Grew At Twice The
Slide 24: Term Loan Facility
24 Maximum Term Loan Facility Size $ 300 million $200 million Interest Rate 3 - month LIBOR + 7.75%, payable quarterly 1 - month LIBOR + 7.75%, payable monthly Maturity Date March 31, 2024 May 1, 2023 Tranche 1 $200 million drawn at closing on April 24, 2019 - ~$81 million to repay MidCap - Remainin
Slide 25: Path of Stabilization of Net Revenue for Products
25 PATH OF STABILIZATION OF NET REVENUE FOR 3 PRODUCTS By 3Q20 All Products Anticipated to Achieve Average Net Revenue Per Unit Stabilization QTR 3 2018 QTR 4 2018 QTR 1 2019 QTR 2 2019 QTR 3 2019 QTR 4 2019 QTR 1 2020 QTR 2 2020 IMVEXXY BIJUVA ANNOVERA ▪ Company Value – Goal of becoming the best -
Slide 26: Transforming Women's Healthcare with Next Generation Products
26 ANNOVERA ™ ( segesterone acetate and ethinyl estradiol vaginal system) Transforming Women’s Healthcare with Next Generation Products ▪ 3 highly differentiated overlapping products for chronic conditions ▪ Large market opportunities with little to no promotional competition ▪ BIJUVA TAM of $2 to $
Slide 27: TherapeuticsMD
TherapeuticsMD’