Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — IPO Roadshow (October 2019)
32 slides from Therapeuticsmd's IPO roadshow presentation, Oct 24, 2019
Slide 1: Building a Premier Women's Health Portfolio
Issuer Free Writing Prospectus dated October 24, 2019 Relating to Preliminary Prospectus Supplement dated Oct. 23, 2019 Filed Pursuant to Rule 433 Registration No. 333-226452 TherapeuticsMD, Inc. October 24, 2019 Building a Premier Women’s Health Portfolio
Slide 2: Forward-Looking Statements
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, other than
Slide 3: Transaction Overview
TRANSACTION OVERVIEW Issuer TherapeuticsMD, Inc. Ticker / Exchange TXMD / Nasdaq Global Select Market Offering Size 22,000,000 shares of Common Stock Option to Purchase Additional Shares 15% Securities Offered Common stock (100% primary) Use of Proceeds Commercialization of IMVEXXY, BIJUVA and ANNOV
Slide 4: Portfolio Approach to Women's Health
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 various stages of life contraception à prenatal vitamins à contraception à
Slide 5: million women1,2 million women4 >$20B3 >$25B3,5 Approved May 29, 2018 Launched August 2018 Approved
32 million women1,2 36 million women4 >$20B3 >$25B3,5 Approved May 29, 2018 Launched August 2018 Approved October 28, 2018 Launched April 2019 43 million women6 $5B7 Approved August 10, 2018 Test & Learn Introduction: 4Q19 Full scale launch expected: 1Q20 Affected US Population US TAM Opportunity St
Slide 6: The Power of A Women's Health Portfolio
The Power of A Women’s Health Portfolio Market Opportunity1 Overlapping Prescribers & Patients The Power of 3 Even though there are over 400,000 total writers for these products2 ~26,000 targets we call on represent over 60% of market opportunity for each product2 REPRODUCTIVE Portfolio MENOPAUSE PO
Slide 7: Financial Overview
¥ Imvexxy stracil vaginal inserts a Financial Overview TherapeuticsMD’ For Her: For Life.
Slide 8: 3Q19 Preliminary Financial Information
3Q19 Preliminary Financial Information FDA-Approved Products Net Revenue Prenatal Vitamins Net Revenue Total TXMD Net Revenue 3Q2019 Guidance1 3Q2019 Preliminary Financial Information $4.50 - 6.50M $2.25 - 2.50M $6.75 - 9.00M As our sales force focus shifts to our FDA-approved products and payer hea
Slide 9: ANNOVERA
¥ Imvexxy stracil vaginal inserts qm ANNOVERA TherapeuticsMD’ Por Her: For Life.
Slide 10: ANNOVERA Market Update
ANNOVERA Market Update Net revenue for ANNOVERA estimated at $375,000 to $400,000 for 3Q19 Strong initial commercial net revenue of ~$1,250 per unit with the potential for improvement1 ~7,500 units expected to be available for sale in 4Q19 Building inventory for planned full launch in Feb. 2020; est
Slide 11: ANNOVERA Market Opportunity
ANNOVERA Market Opportunity Total Addressable Birth Control Market NRx: 28M Average Net Revenue / Unit 1.0% Total Addressable Birth Control Market NRx 1.5% Total Addressable Birth Control Market NRx 2.0% Total Addressable Birth Control Market NRx 2.5% Total Addressable Birth Control Market NRx $1,00
Slide 12: ANNOVERA DTC Distribution Options
ANNOVERA DTC Distribution Options Why the Payer Landscape for Contraception is Unique Coverage laws are favorable to both doctors and patients in the contraceptive category when there is no generic equivalent Affordable Care Act Implementation (Part XXVI) specifies if an individual’s attending provi
Slide 13: ANNOVERA Commercial Payer Update
ANNOVERA Commercial Payer Update Already Achieved ~62% Unrestricted Access1 Plan % of Lives2 Status3 CVS 16% Adjudicating with no copay as of October 2019 ESI 16% Adjudicating at T3 as of September 2019 United 8% In discussions Anthem 7% Adjudicating at T3, no copay as of August 2019 Prime 6% In dis
Slide 14: ANNOVERA Commercial Payer Update: Fast Uptake in Regional Plans
ANNOVERA Commercial Payer Update Fast Uptake in Regional Plans Selected Regional Plan Coverage Adjudication of claim by payer: ANNOVERA is on payer formulary as covered product and is being submitted to insurance company for payment by payer to pharmacy. 1Plan numbers as of October 2019 2MMIT Octobe
Slide 15: Birth Control State Laws Regardless of ACA Mandates
11 STATES, plus Washington D.C., REQUIRE COVERAGE WITH NO COPAY REGARDLESS OF ACA DECISION (~52 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 Commiss
Slide 16: Birth Control State Laws Regardless of ACA Mandates (co-pay)
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). + Population numbers identified for each state are total population numbers, i
Slide 17: ANNOVERA Key Attributes
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 time, but
Slide 18: IMVEXXY
IMVEXXY TherapeuticsMD’ Por Her: For Life.
Slide 19: IMVEXXY Results
IMVEXXY Results Net revenue for IMVEXXY estimated at $4.5M to $4.8M for 3Q19 (up from approximately $3.1M for 2Q19) Net revenue continues to grow faster than units due to improving adjudication rates TRx increased approximately 26% to approximately 134,000 for 3Q19 (up from approximately 106,000 for
Slide 20: IMVEXXY Progress Update
IMVEXXY Progress Update Achieved ~68% commercial unrestricted access1 8 of the top 10 commercial payers adjudicating Additional Medicare Part D decisions expected this quarter Copay for patients without insurance increased from $35 to $50 as of October 1, 2019 – not expected to impact volume Initiat
Slide 21: Value of Additional Fills
Value of Additional Fills IMVEXXY: 4.0 fills/yr1 (through Sept) 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 bas
Slide 22: Target Adjudication Rate Over Time for IMVEXXY
Target Adjudication Rate* Over Time for IMVEXXY Column A Column B Column C IMVEXXY No Insurance Commercial Insurance Medicare Eligible Patients % of Business 4% 62% 33% % Adjudicated 0% 55% 12% Contribution to Overall Adjudication Rate 0% 34% 4% Overall Adjudication Rate 38% (up from 34% 2Q19) 3Q 20
Slide 23: Commercial Payer Status
Commercial Payer Status Achieved ~68% Unrestricted Commercial Access1 8 of the Top 10 Commercial Payers Secured Plan % of Lives2 Status3 CVS 16% Adjudicating as of September 2019 ESI 16% Adjudicating as of 10/1/18 United 8% Adjudicating as of 3/1/19 Anthem 7% Adjudicating as of August 2018 Prime 6%
Slide 24: Medicare Part D Payer Status
Medicare Part D Payer Status Additional Decisions Expected This Quarter Plan % of Lives2 Status3 United 21% Adjudicating as of 2/1/19 Humana 18% Decision expected 4Q19 CVS Caremark 14% Decision expected 4Q19 Wellcare with Aetna lives 14% Decision expected 4Q19 Express Scripts/ Cigna 8% Decision expe
Slide 25: BIJUVA
¥ Imvexxy stracil vaginal inserts i ae BIJUVA TherapeuticsMD’ Por Her: For Life.
Slide 26: BIJUVA Results
Net revenue for BIJUVA estimated at $450,000 to $500,000 for 3Q19 (up from approximately $134,000 for 2Q19) TRx increased to approximately 15,800 for 3Q19 (up from approximately 4,600 for 2Q19) Achieved ~54% of unrestricted commercial access1 6 of the top 10 commercial payers currently adjudicating;
Slide 27: BIJUVA Update
BIJUVA Update TXMD plans to submit a New Drug Application (NDA) supplement for the 0.5/100 mg dose of BIJUVA to FDA for approval After meeting with FDA, TXMD plans to submit an NDA efficacy supplement using existing REPLENISH Phase 3 data with new analyses Anticipate no new clinical trials required
Slide 28: BIO-IGNITE Update: Process & Status
Process & Status Expect BIJUVA launch into BIO-IGNITE end of 4Q19 119 Contracting In Vetting Process 70 Live Accounts 136 In Contracting Process 119 BIO-IGNITE Update1 New 1 Information as of October 19, 2019 2 Compounded Bio-Identical Hormone Replacement Therapy 2,641 High-Value CBHRT2 HCP’s 136 Li
Slide 29: BIJUVA Commercial Payer Update
BIJUVA Commercial Payer Update Additional Coverage Decisions Expected This Quarter Plan % of Lives2 Status3 CVS 16% In discussions ESI 16% Adjudicating as of 4/19/19 United 8% Adjudicating as of 8/1/19 Anthem 7% In discussions Prime 6% In discussions OptumRx 6% Adjudicating as of 8/1/19 Kaiser 5% In
Slide 30: BIJUVA Target Adjudication Rate
Column A Column B Column C BIJUVA No Insurance Commercial Insurance Medicare Eligible Patients % of Business 5% 89% 6% % Adjudicated 0% 50% 15% Contribution to Overall Adjudication Rate 0% 44% 1% Overall Adjudication Rate 45% (up from 34% 2Q19) 3Q 2019 Actuals Column A Column B Column C BIJUVA No In
Slide 31: The Power of the Portfolio: Multiple Paths to $1B of Peak Sales
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 Ne
Slide 32: The Power of a Women's Health Portfolio
REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT Prenatal Vitamins The Power of a Women’s Health Portfolio CONTRACEPTION PRENATAL CARE CONTRACEPTION/ Family Planning - Perimenopause VASOMOTOR SYMPTOMS DYSPAREUNIA (Vulvar & Vaginal Atrophy)