Slide 1: Annovera FDA Approval Conference Call
Annovera™ FDA Approval Conference Call August 13, 2018
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: Annovera - 1-Year Vaginal System
Annovera - 1-Year Vaginal System Segesterone Acetate [Nestorone® (NES)]/Ethinyl Estradiol (EE) First and only patient-controlled, procedure-free, long-acting, reversible birth control Product fits into existing TXMD infrastructure • Approved: August 10, 2018 • Segesterone acetate component of Anno
Slide 4: Clinical Trial Experience
Clinical Trial Experience Efficacy & Safety1,2 Based on two pivotal Phase 3 clinical trials with 2,308 women – Efficacy and safety consistent with other birth control pills, patches and hormonal rings Efficacy – 97.3% effective in preventing pregnancy when used as directed Primary Endpoint Pea
Slide 5: Phase 3 Acceptability Study
Phase 3 Acceptability Study Demonstrated 1-Year Contraceptive Vaginal System High User Satisfaction Acceptability Data1 Phase 3 acceptability study (n=905 subjects) Overall satisfaction 89% related to ease of use, side effects, expulsions/feeling the product, and physical effect during sexual ac
Slide 6: Annovera Deal Terms
Annovera Deal Terms Milestone Payments Royalty % Upon FDA approval: $20mm Step structure: First commercial batch release: $20mm Annual net sales < $50mm: 5% $200mm in cumulative net sales: $40mm Annual net sales > $50mm and < $150mm: 10% $400mm in cumulative net sales: $40mm Annual net
Slide 7: NuvaRing – Large Established Ring Market
NuvaRing – Large Established Ring Market NuvaRing Owner: Merck $500mm+ net sales in US ring market with no other branded products in the space* NuvaRing monthly contraceptive ring (vs. Annovera 1-year ring) Annual WAC Price of $2,013 (vs. $1,400) Semi-rigid ring body (vs. pliable/squishy)
Slide 8: U.S. Prescription Contraceptive Market
U.S. Prescription Contraceptive Market One of the largest therapeutic categories by script count U.S. ~ 90mm scripts1 Contraceptive ~ > $5B U.S. net sales2 Market ~ 43 million women are at risk of unintended pregnancy of which ~ 18 million want to avoid pregnancy3 Daily Oral Contraceptives L
Slide 9: Expected Benefits of 1-Year Vaginal Contraceptive System
Expected Benefits of 1-Year Vaginal Contraceptive System Patients • Long-acting reversible birth control that doesn’t require a procedure or repeat doctor’s visit • Softer and more pliable than NuvaRing and doesn’t require refrigeration • “Vaginal System”- a new class of contraception with potential
Slide 10: Unique Product Characteristics Should Lead to Good Payor Coverage
Unique Product Characteristics Should Lead to Good Payor Coverage Anticipate parity or discount pricing level ~$1400 annual WAC cost 40% decrease to annual WAC of NuvaRing, reflects TXMD’s responsible brand pricing Allows for improved patient adherence and a potential decrease in unplanned pre
Slide 11: TXMD Sales Force Has Strong Overlap With NuvaRing Prescribers
TXMD Sales Force Has Strong Overlap With NuvaRing Prescribers NuvaRing Prescribers Overlap with TXMD Sales Force1 81% of total prescribers within current 150 TXMD territories No additional sales representatives needed =TXMD territories 150 Reps 1. IQUVIA Data 11
Slide 12: Commercialization Strategy & Timing
Commercialization Strategy & Timing Focused Launch Strategy - Base Case Market Opportunity NuvaRing customers – monthly ring replaced by annual ring ~60K annual vitaMedMD prenatal customers who may proceed to contraception Patients who prefer long acting reversible contraception but fear proce
Slide 13: Contraceptive Pipeline
Contraceptive Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 PDUFA Date 1-Year Vaginal Contraceptive System (NES/EE) 08/17/2018 3-Month Contraceptive Vaginal Ring (NES/E2) Next Generation 1-Year Vaginal Contraceptive System (NES/EE) Exclusive rights to negotiate co-development and marketing rights1
Slide 14: Complete Women's Healthcare Portfolio
Complete Women’s Healthcare Portfolio Annovera™ * ~60,000 Vasomotor New Prenatal symptoms affect Patients up to 75% of Many will go on perimenopausal contraception after women1 breastfeeding CONTRACEPTION/ FAMILY DYSPAREUNIA PRENATAL CARE VASOMOTOR SYMPTOMS PLANNING -PERIMENOPAUSE (Vulvar & Vaginal
Slide 15: TherapeuticsMD
TherapeuticsMD" For Her: For Life. 15