Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (November 2018)
40 slides from Therapeuticsmd's investor presentation, November 2018
Slide 1: Investor Presentation November 2018
Investor Presentation November 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: 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 4: Women's Health Assets With Large Total Addressable Market Opportunities
Women’s Health Assets With Large Total Addressable Market Opportunities ANNOVERA™ Females of reproductive potential to Moderate to severe vasomotor Moderate to severe dyspareunia, a Indication prevent pregnancy symptoms (VMS) due to menopause symptom of VVA, due to menopause Condition Contraception
Slide 5: Vulvar and Vaginal Atrophy (VVA) Program
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. Vulvar and Vaginal Atrophy (VVA) Program 5
Slide 6: IMVEXXY Launch Update
IMVEXXY Launch Update as of November 16, 2018 Total units since launch ~35,600 paid scripts1 dispensed to ~14,000 patients November (1st - 16th) total units of ~7,400 paid scripts1 Refills for November (1st - 16th) of ~5,000 paid scripts1 New Rx for Nov (1st - 16th) of ~2,400 paid scripts1
Slide 7: 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 8: IMVEXXY Payer Update
IMVEXXY Payer Update TRx Payer Breakdown of FDA- Commercial Coverage Approved VVA Products1 ~38% unrestricted commercial lives coverage (no step edits or PA) 2 Medicaid Cash - 90 days lag for each covered plan to operationalize before adjudication begins 5% 3% - Expect to sign major commercial pay
Slide 9: Monthly VVA TRx Launch Comparison
Monthly VVA TRx Launch Comparison 18,000 Imvexxy IMVEXXY Osphena Intrarosa 16,616 16,000 14,000 13,300 13,289 14,669 12,000 13,782 10,000 8,443 8,000 6,276 6,000 3,945 4,000 2,000 154 2,693 0 Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12 Month 13
Slide 10: Monthly VVA TRx Launch Comparison
Monthly VVA TRx Launch Comparison 50,000 TRx Launch Comparison Vagifem as example of succesful launch 45,000 43,208 Imvexxy IMVEXXY Vagifem 25MG Osphena Intrarosa 40,000 35,000 30,000 25,000 13,300 20,000 8,443 15,000 12,601 10,000 8,849 5,000 0 Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month
Slide 11: Monthly VVA TRx Launch Comparison
Monthly VVA TRx Launch Comparison 70,000 Imvexxy TRx Launch Comparison Imvexxy IMVEXXY Vagifem 25MG Osphena Intrarosa 60,000 50,000 56,485 40,000 43,208 30,000 13,300 20,000 8,443 12,601 10,000 8,849 0 Month Month Month Month Month Month Month Month Month Month Month Month Month Month Month Month Mo
Slide 12: IMVEXXY is "Redefining Relief"
IMVEXXY is “Redefining Relief” 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 at week 12 (primary) and as 3 early as 2 weeks (secondary) PK data where sys
Slide 13: 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 inserts
Slide 14: Professional Societies and FDA Recommend the Lowest Effective Dose
Professional Societies and FDA Recommend the Lowest Effective Dose American College North American Menopause FDA3 of Obstetricians and Society (NAMS)2 “…this guidance encourages Gynecologists (ACOG)1 “The lowest dose of HT should sponsors to develop the lowest “Low-dose and ultra-low be used for the
Slide 15: Bio-Identical Combination Estrogen + Progesterone (E+P) Program
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. Bio-Identical Comb
Slide 16: BIJUVA Product Development Rationale
BIJUVA Product Development Rationale Menopause represents the natural life-stage transition when women stop having periods as the production of Estrogen and Progesterone decreases • May result in physical and emotional symptoms1 Symptoms include vasomotor symptoms (hot flashes, night sweats), mo
Slide 17: BIJUVA Indication and Key Attributes
BIJUVA is indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause Key Clinical Attributes First and only bio-identical* combination of estradiol to reduce moderate to severe hot flashes combined with progesterone to help reduce the risk to the
Slide 18: BIJUVA Large Substitutable Market
BIJUVA Large Substitutable Market Column 1 Column 2 Column 3 FDA-Approved Off Label Combination Synthetic Compounded Combination Separate Bio-Identical E+P1 Bio-Identical E+P BIJUVA E & P Pills Substitutable Market TRx US: ~3.8 million (each)1 ~3 million2 12 – 18 million3 BIJUVA Potential $760M-$950
Slide 19: BIJUVA Advantages For Stakeholders
BIJUVA Advantages For Stakeholders Patients • Satisfy demand for bio-identical hormone therapy with a product approved by FDA on safety and efficacy • Reduce of out-of-pocket costs via insurance coverage • Convenience of combined hormones in a single capsule • Widely acceptable at pharmacies and not
Slide 20: BIO-IGNITE Compounding Pharmacy Partnership Strategy
BIO-IGNITETM Compounding Pharmacy Partnership Strategy BIO-IGNITETM started as an outreach program to quantify the number of compounded bio-identical estradiol and progesterone prescriptions currently dispensed by the 3,000 high-volume compounding pharmacies, and qualify their interests in distribut
Slide 21: 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 22: 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). 22
Slide 23: U.S. Prescription Contraceptive Market
U.S. Prescription Contraceptive Market One of the largest therapeutic categories by script count ~ > $5B U.S. net sales1 Daily Oral Contraceptives Long Acting Reversible Contraceptives OC’s continue to lose market share to longer acting IUDs and Implants are experiencing significant growth s
Slide 24: Top Contraceptive Products Based on Revenue
Top Contraceptive Products Based on Revenue 2017 Net Revenue (mm) NUVARING $564 NEXPLANON IMPLANT $496 LO LOESTRIN FE BIRTH CONTROL PILL $420 MIRENA IUD FAMILY (INCLUDES MIRENA, This includes 3 products $841 KYLEENA & SKYLA) $0 $100 $200 $300 $400 $500 $600 $700 $800 $900 Net Revenue (mm) Company fi
Slide 25: ANNOVERA - 1-Year Vaginal System
ANNOVERA - 1-Year Vaginal System First and only patient-controlled, procedure-free, long-acting, reversible birth control ANNOVERA approved on August 10, 2018 • Segesterone acetate component of ANNOVERA classified as NCE with 5 year exclusivity Developed by the Population Council – developer of
Slide 26: 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 control of their fertility and menstruation • Annovera is the only user-directed single 12-month birth control prod
Slide 27: 1-Year Vaginal Contraceptive System Serves an Unmet Need
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
Slide 28: ANNOVERA Commercialization Strategy
ANNOVERA Commercialization Strategy Launch Timing Estimated to be commercially available as early as Q3’19 with commercial launch Q4’19 Attractive Market Segments for Annovera NuvaRing users – leveraging the physical and clinical strengths of ANNOVERA • No additional sales representatives needed
Slide 29: Committed to Become the Leading Women's Health Company
Committed to Become the Leading Women’s Health Company 29
Slide 30: 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 31: Significant Insider and Institutional Share Ownership
Significant Insider and Institutional Share Ownership Board of Directors and Executive Officers have long-term commitment to the company • Beneficially own approximately 20% of the company’s shares* • Three founding executives beneficially own approximately 17%* of the company’s shares – Includes
Slide 32: 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) 32
Slide 33: Appendix
Appendix TherapeuticsMD” For Her: For Life. 33
Slide 34: Current US VVA Market Overview
Current US VVA Market Overview 32M with VVA symptoms (1 out of 2 menopausal women) in the United States1,2 50% (16M) seek treatment for VVA4 - 25% (8M) OTC products - 18% (5.7M) past HT users - 7% (2.3M) current HT users Only 7% (2.3M) are Only 7% of women (2.3M) with current users of VVA symptoms
Slide 35: IMVEXXY Systemic Hormone Levels Within Normal Postmenopausal Range
IMVEXXY 4 and 10 mcg Resulted in Average Systemic Hormone Levels that were within the Normal Postmenopausal Range1,2 In a REJOICE substudy, 54 women received 1 IMVEXXY 4- or 10-mcg vaginal insert or placebo daily for 2 weeks followed by 1 insert twice weekly for 10 weeks with measurement of serum es
Slide 36: Patient Reported Outcomes with BIJUVA
Patient Reported Outcomes with BIJUVA: CGI, MENQOL, and MOS-Sleep (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 and
Slide 37: No Clinically Significant Changes in Cholesterol Levels
No Clinically Significant Changes in Cholesterol Levels were Observed Few women had cholesterol increases (≥50 mg/dL or above normal levels) at 12 months with BIJUVA vs placebo Cholesterol HDL cholesterol LDL cholesterol Mean concentration (mg/dL) 250 80 140 120 200 60 100 150 80 40 100 60 20 40 50
Slide 38: No Clinically Significant Changes in Coagulation Parameters
No Clinically Significant Changes in Coagulation Parameters were Observed with BIJUVA Antithrombin activity Factor XIV Protein S 120 140 100 100 120 80 100 80 Percent 80 60 60 60 40 40 40 20 20 20 0 0 0 1/100 Placebo 1/100 Placebo 1/100 Placebo E2/P4 (mg/mg) E2/P4 (mg/mg) E2/P4 (mg/mg) Baseline Mont
Slide 39: 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 40: Provide Catalyst to Switch to BIJUVA
Example of Economic Incentives Provide Catalyst to Switch to BIJUVA Economic Support TXMD Partnership for Patient Care Insurance Coverage Present Day Post USP <800> BIJUVA (before 2H14) (2018) (Dec. 2019) Est. Launch 2Q2019 Revenue Patient Co-Pay $50.00 $50.00 $50.00 $50.00 Third-Party Reimbursement
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