Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (January 2019)
42 slides from Therapeuticsmd's investor presentation, January 2019
Slide 1: Investor Presentation January 2019
Investor Presentation January 2019
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: TherapeuticsMD, A Premier Women's Health Company: 3 Recently Approved Products
TherapeuticsMD, A Premier Women’s Health Company 3 Recently Approved Products ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) PROCEDURE-FREE, DYSPAREUNIA VASOMOTOR SYMPTOMS LONG-ACTING (a symptom of VVA due to (Hot Flashes due to Menopause) Menopause) REVERSIBLE CONTRACEPTION La
Slide 4: New Product Launches Address Large Market Opportunities in Women's Health
New Product Launches Address Large Market Opportunities in Women’s Health ANNOVERA™ Easy to use, lowest effective First and only bio-identical FDA- First and only patient-controlled, Key Value dose, designed to support approved combination product procedure-free, long-acting, Proposition patient adh
Slide 5: IMVEXXY approved for moderate-to-severe dyspareunia due to menopause
Approved for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. 5
Slide 6: Strong Positive Launch
Strong Positive Launch through December 31st, 2018 Total units since launch ~62,400 paid scripts1 dispensed to ~25,500 patients Dec. 1st – Dec. 31st total units of ~19,800 paid scripts1 (increase of ~38% Nov/Dec) Week ending December 21st ~6,100 total paid scripts1,2 ~7,300 prescribers had a
Slide 7: Monthly VVA TRx Launch Comparison Demonstrates Successful Launch Execution
Monthly VVA TRx Launch Comparison Demonstrates Successful Launch Execution Imvexxy TRx Launch Comparison 70,000 60,000 56,485 50,000 IMVEXXY TRxs 43,208 40,000 up ~38% Nov to Dec 30,000 21,036 20,000 13,273 19,842 10,000 12,601 0 Month Month Month Month Month Month Month Month Month Month Month Mont
Slide 8: What is Leading to Rapid Uptake?
What is Leading to Rapid Uptake? 8
Slide 9: IMVEXXY is Clearly Differentiated from Other Treatment Options
IMVEXXY is Clearly Differentiated from Other Treatment Options Owning clinical attributes with the underpinning of a highly effective patient experience Key Clinical Attributes: 1 New lowest approved dose 2 Strong efficacy and safety data Improvement seen as early as 2 weeks 3 (secondary endpoint) P
Slide 10: Effective IMVEXXY Detailing
Effective IMVEXXY Detailing The messaging by TXMD sales reps is proving effective, both at increasing the importance of treating VVA and educating Prescribers about IMVEXXY Prescribers detailed1: Direct Mail • Are more comfortable with estrogen • Regard VVA and dyspareunia as more serious • Are more
Slide 11: New Levers and Messaging Planned to Support Driving NRx Trends in 2019
New Levers and Messaging Planned to Support Driving NRx Trends in 2019 1Q-2Q19 2Q19 IMVEXXY.COM | 0.0 IMVEXXY.COM - HOMEPAGE 2H19 New Tools Evolved E-Detail & Tools DTC Launch Continued rollout of speaker programs Streamlined based on research results and salesforce input Introducing an Additi
Slide 12: Synergies Provide Potential to Expand the Market Sales Force
Synergies Provide Potential to Expand the MarketSales Force BIJUVA is a Significant Pull-Through Opportunity for IMVEXXY in 2019 VMS and VVA are different symptoms of menopause1 that are addressed with BIJUVA and IMVEXXY in one complementary product portfolio Menopausal women often experience bo
Slide 13: IMVEXXY Payer Update
IMVEXXY Payer Update Payer Adjudication Begins Throughout 1Q 2019 TRx Payer Breakdown of Strong IMVEXXY commercial payer progress FDA-Approved VVA Products1 No major road blocks seen Medicaid Cash Most major covered plans listed below begin adjudication at various points in 1Q19 5% 3% Plan Liv
Slide 14: Key Drivers for IMVEXXY in 2019
Key Drivers for IMVEXXY in 2019 Products First new differentiated estrogen treatment for VVA in over 12 years Launch of BIJUVA and ANNOVERA increase exposure in prescriber offices Promotion Elevate the importance of the company with the prescriber with dual detail Leverage full year of provi
Slide 15: BIJUVA: First and Only FDA-Approved Bio-identical Hormone Therapy Combination
The first and only FDA-approved bio- identical hormone therapy combination of estradiol and progesterone in a single, oral softgel capsule for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus. 15
Slide 16: BIJUVA Market Opportunity
BIJUVA Market Opportunity Expanded women's health/menopause footprint that allows us to connect with prescribers and women throughout the menopausal journey First and only FDA approved Bio-identical combination product* Little to no promotion in FDA approved hot flash category creates an opportu
Slide 17: BIJUVA's Phase 3 Clinical Attributes
BIJUVA’s Phase 3 Clinical Attributes 17
Slide 18: No Clinically Significant Changes in Coagulation Parameters with BIJUVA
No Clinically Significant Changes in Coagulation Parameters were Observed with BIJUVA BIJUVA Phase 3 results supports unique lipid, metabolic and clotting profiles for an oral estrogen Benefits are likely due in part to BIJUVA’s fully solubilized estrogens BIJUVA is the only hot flash product
Slide 19: No Clinically Significant Changes in Lipid Parameters with BIJUVA
No Clinically Significant Changes in Lipid Parameters were Observed with BIJUVA BIJUVA Phase 3 results supports unique lipid, metabolic and clotting profiles for an oral estrogen Benefits are likely due in part to BIJUVA’s use of fully solubilized estrogens in a lipid based technology system N
Slide 20: Confirmed BIJUVA Efficacy on Primary and Secondary Endpoints
Confirmed BIJUVA Efficacy: With a Consistency of Effect on Primary and Secondary Endpoints Clinical Global Impression (CGI) CGI Response: Significantly more women rated their condition Clinically meaningful improvement as very much or much improved with BIJUVA 100 compared with placebo at Weeks 4
Slide 21: BIJUVA Launch Strategy
BIJUVA Launch Strategy TherapeuticsMD’ For Her: For Life. 21
Slide 22: Focus on Three Main Fundamental Levers to Drive BIJUVA Launch
Focus on Three Main Fundamental Levers to Drive BIJUVA Launch Drive Market Share Market Expansion Clearly Position BIJUVA as the Activate Women to Take Care of New Standard of Care for Themselves during Menopause Vasomotor Symptoms Market Acceleration Through Adherence and New Access Points Partners
Slide 23: Salesforce Footprint Considers Distinct BIJUVA Market And IMVEXXY Overlap
Salesforce Footprint Considers Distinct BIJUVA Market And IMVEXXY Overlap Portfolio Optimization Summary Targeting Summary Writing behavior across all 3 market segments IMVEXXY Ensured that any higher IMVEXXY writing stayed Decile intact • 2019 Salesforce reaches 24,431 total Targets 6-10 • 94%
Slide 24: 2019 TXMD Salesforce Expansion
2019 TXMD Salesforce Expansion 195 Field Sales Territories 5 Inside Sales Assignments (whitespace coverage) 8.5 to 1 Rep to Manager ratio 23 Sales Teams 24
Slide 25: A Large Target Market for BIJUVA
A Large Target Market for BIJUVA Phase 2 Bio-Ignite: Maximize the Launch Expected: Phase 1: Initial focus launch of the compounding channel Early 2Q19 during 6 month payer block commensurate with securing commercial reimbursement Selectively leverage this channel until payer coverage begins due to c
Slide 26: BIO-IGNITE Provides Economic and Regulatory Benefits
BIO-IGNITE TM Provides Economic and Regulatory Benefits Compounding Pharmacy Partnership Strategy BIO-IGNITETM Program: Strategic partnership to work jointly with compounding pharmacies -- the largest and most influential channel for physicians and patients in bio- identical hormone therapy Secu
Slide 27: Payer Breakdown of FDA-Approved VMS Products
Payer Breakdown of FDA-Approved VMS Products1 Cash and Pt Assistance Expect 6 month commercial Medicaid 9% payer block and similar payer onboarding timeline to IMVEXXY 8% Commercial Medicare Part D 70% 13% 1 IMS Data 2018 27
Slide 28: ANNOVERA
ANNOVERA (Segesterone Acetate/Ethinyl Estradiol Vaginal System) Approved for use by females of reproductive potential to prevent pregnancy. (Limitation of use: Not adequately evaluated in females with a body mass index of >29 kg/m2). 28
Slide 29: ANNOVERA - 1-Year Vaginal System
ANNOVERA - 1-Year Vaginal System Segesterone Acetate [Nestorone®]/Ethinyl Estradiol The vaginal system is composed of a “squishy” silicone elastomer • 21/7 days cyclical dosing regimen for one year (13 cycles) • 89% overall patient satisfaction in clinical trials1 Average daily release over one
Slide 30: 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 31: Annovera Key Attributes
Annovera Key Attributes Clinical Attributes Only FDA approved long-acting reversible birth control that doesn’t require a procedure or repeat doctor’s visit • Empowers women to be in complete control of their fertility and menstruation • Annovera is the only user-directed single 12-month birth con
Slide 32: ANNOVERA Commercialization Strategy
ANNOVERA Commercialization Strategy Attractive Market Segments Long acting reversible contraceptives, such as IUDs and implants are experiencing significant growth as the market shifts to long-acting solutions growing at a CAGR of 15.3%1 Requires a procedure for insertion and removal Daily ora
Slide 33: Looking Ahead: Key Expected Events in 2019
Looking Ahead: Key Expected Events in 2019 1Q- IMVEXXY 6 month payer block ends and payer adjudication starts at various points throughout 1Q 1Q- Sales Force increase for IMVEXXY and BIJUVA 2H- Begin direct-to-consumer marketing for IMVEXXY 2Q- Expansion of Bio-Ignite program with BIJUVA lau
Slide 34: TherapeuticsMD, A Premier Women's Health Company
TherapeuticsMD, A Premier Women’s Health Company ANNOVERA™ ANNOVERA™ (segesterone acetate and ethinyl (segesterone acetate and ethinyl Prenatal Vitamins estradiol vaginal system) estradiol vaginal system) CONTRACEPTION/ DYSPAREUNIA VASOMOTOR CONTRACEPTION PRENATAL CARE FAMILY PLANNING - (Vulvar & SY
Slide 35: Appendix
Appendix TherapeuticsMD For Her: For Life. 35
Slide 36: TXMD: Financial Snapshot
TXMD: Financial Snapshot Listing Shares Insider Exchange Ownership Outstanding ~20% 237.9M (Nov. 1, 2018) (Nov. 1, 2018) Debt Cash $75M $190M (as of Sept. 30, 2018) (as of Sept. 30, 2018) 36
Slide 37: Expected Net Revenue Ramp for IMVEXXY
Expected Net Revenue Ramp for IMVEXXY Net Revenue Ramp for Commercially Insured Patient Starter Pack WAC $405 60% net = $243 average net revenue per unit (script) - Company expects to net on average 60% of WAC when commercial insurance coverage is fully established Remaining 40% includes other
Slide 38: IMVEXXY Product Characteristics Compare Favorably
IMVEXXY Product Characteristics Compare Favorably 1-9 Estrogens Non-estrogens Estrace® Cream Premarin® Vagifem® Intrarosa® Osphena® (conjugated estrogens) IMVEXXY® (estradiol vaginal (estradiol vaginal (prasterone) (ospemifene) (estradiol vaginal inserts)5,6 cream, USP, 0.01%)1 Vaginal Cream2 insert
Slide 39: The First and Only FDA-Approved Bio-Identical Combination Hormone Replacement Therapy
The First and Only FDA-Approved Bio-Identical Combination Hormone Replacement Therapy (HRT) Combination of bio-identical* estradiol and progesterone Strong efficacy and safety data Statistically significant reduction in both the frequency and severity of moderate to severe hot flashes Clinic
Slide 40: BIO-IGNITE Progress and Results
BIO-IGNITE Progress and Results Partnerships with Large Pharmacy Network and Individual Pharmacies Pharmacy Network and Combination # of Pharmacies Individual Pharmacy Partners Bio-Identical E+P Scripts * >300 Pharmacies ~1,500,000 In Network prescriptions annually >400 Pharmacies TXMD Outreach to w
Slide 41: Bio-Identical Customization
Bio-Identical Customization Customization of therapy at compounding pharmacies refers to addressing the overall patient condition including menopausal symptoms, adrenal function, libido, energy levels, thyroid function and nutrition, rather than through micro-dose changes in estrogen/progesterone am
Slide 42: 1-Year Vaginal Contraceptive System Serves an Unmet Need in the U.S. Contraceptive Market
1-Year Vaginal Contraceptive System Serves an Unmet Need in the U.S. Contraceptive Market ANNOVERA™ NuvaRing® IUD’s Oral Contraceptives Duration of Action 1 year (21/7 regimen) 1 month (21/ 7 regimen) 3-10 years Daily pill intake Patient Control Removable at any time Removable at any
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