Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (November 2018)
79 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 estradiol vaginal system) estradiol vaginal system) CONTRACEPTION/ DYSPAREUNIA VASOMOTOR CONTRACEPTION PRENATAL CARE FAMILY PLANNING - (Vulvar & SYMPTOMS PERIMENOPAU
Slide 4: Seasoned Management Team with a Proven Track Record of Commercial Execution
Seasoned Management Team with a Proven Track Record of Commercial Execution Jane Barlow Co-Founder Board Member and Director § Former US Secretary of §Former Chief Executive §Former President and §25 years of clinical and §Co-founded vitaMedMD §Co-founded vitaMedMD Health and Human Services §Officer
Slide 5: Responsible and Financially Disciplined Approach to Delivering Results
Responsible and Financially Disciplined Approach to Delivering Results § TXMD has a 10 year history of delivering strong results in a financially efficient manner § Three recent product approvals (IMVEXXY, BIJUVA and ANNOVERA) § Remain well-financed, including our flexibility of having an additional
Slide 6: Track Record of Execution
Track Record of Execution Date Milestone/ Catalyst 3/14/13 First Registered Equity Offering 8/5/13 Commenced Phase 3 Replenish Trial of TX-001HR (BIJUVA) 9/29/14 Commenced Phase 3 Rejoice Trial of TX-004HR (IMVEXXY) 12/7/15 Positive Top-Line Results from Phase 3 Rejoice Trial of TX-004HR (IMVEXXY) 7
Slide 7: 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 8: 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 8
Slide 9: IMVEXXY Key Timeline
IMVEXXY Key Timeline § 10 mcg national launch started on August 6, 2018 § 4 mcg commercially available on September 13, 2018 § Bio-Ignite went live August 10, 2018 with 12 pharmacies ordering IMVEXXY 9
Slide 10: IMVEXXY Launch Update
IMVEXXY Launch Update § Total units since launch ~28,200 paid scripts* dispensed to ~12,800 patients § October total units of ~13,300 paid scripts* § Refills for October of ~8,100 paid scripts § New RXs for October of ~5,200 paid scripts § 58% month over month growth (Sept/Oct) § Blended starter and
Slide 11: Market Growth Through Treatment Compliance
Market Growth Through Treatment Compliance § As of October 31, 2018 • 2.2 IMVEXXY fills per patient in the first 4 months* • Previous two dyspareunia product launches during the first year of launch averaged 1.7 fills per patient** • IMVEXXY average refill rate ~74% • Last week of October, over ~2,0
Slide 12: Next Phase of Growth
Next Phase of Growth § Launched speaker programs across the US § Adding additional sales reps to increase IMVEXXY market share and launch BIJUVA § Launching IMVEXXY consumer marketing effort Q1 of 2019 § Increasing Bio-Ignite pharmacies with IMVEXXY § Launch BIJUVA in the 2Q of 2019 § Launch ANNOVER
Slide 13: VVA TRx Launch Comparison
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 Month Mont
Slide 14: VVA TRx Launch Comparison
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 Imv exxy
Slide 15: VVA TRx Launch Comparison
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 7 Month
Slide 16: IMVEXXY Payer Update
IMVEXXY Payer Update TRx Payer Breakdown of FDA- § As of November 8th, IMVEXXY achieved ~37% unrestricted Approved VVA Products1 commercial lives coverage (no step edits or PA) 1 - Expect unrestricted commercial lives coverage to peak at Medicaid Cash 60%+ - TXMD will start to see the financial bene
Slide 17: 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 18: Foundation Built for a Strong Launch
Foundation Built for a Strong Launch TXMD Sales Force in OB/GYN Offices § 81% of total NuvaRing prescribers within current 150 TXMD territories1 § 40% overlap with current prenatal vitamins business § Sales force of 150 § Partnership with inVentiv, leading contract sales organization § Operational a
Slide 19: Vulvar and Vaginal Atrophy
Vulvar and Vaginal Atrophy Involves changes to the histology and physiology of the vaginal tissue due to decreased estrogen levels1 Premenopause Postmenopause Superficial Superficial Intermediate Intermediate Parabasal Parabasal Associated with these changes are decreased vaginal moisture and increa
Slide 20: 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 21: 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 22: IMVEXXY Product Characteristics
IMVEXXY Product Characteristics Safety Efficacy Patient Experience § Lowest approved § Provides relief at 12 • Small, applicator-free vaginal estradiol dose weeks and beginning softgel estradiol (4 mcg)1 as early as week 2 vaginal insert that • Average systemic (secondary dissolves completely1 hormo
Slide 23: 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 24: IMVEXXY Demonstrated Statistically Significant Improvement Across All Objective Co-Primary Endpoints
IMVEXXY Demonstrated Statistically Significant Improvement Across All Objective Co-Primary Endpoints1,2 LS Mean Change From Baseline to Week 121-3 4 mcg 10 mcg P valuea P valuea IMVEXXY 4 mcg IMVEXXY 10 mcg Placebo 18% 17% 6% Superficial cells <0.0001 <0.0001 (n = 170) (n = 171) (n = 172) -41% -44%
Slide 25: IMVEXXY Improvement in Moderate to Severe Dyspareunia Demonstrated at Week 12
IMVEXXY Improvement in Moderate to Severe Dyspareunia Demonstrated at Week 12 (primary endpoint) and Beginning As early as week 2 (secondary endpoint) LS mean change from baseline to week 12 in MBS of moderate to severe dyspareunia1a 4 mcg (n=151) 10 mcg (n=154) Placebo (n=163) *P<0.05, **P<0.01, **
Slide 26: IMVEXXY Resulted in Average 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 27: Patients Treated with IMVEXXY Reported Significant Improvement in Dyspareunia as Early as 2 Weeks
Patients Treated with IMVEXXY Reported Significant Improvement in Dyspareunia Beginning as Early as 2 Weeks of treatment Onset of action for moderate to severe Product dyspareunia (weeks)* IMVEXXY (estradiol vaginal insert)1 2 (secondary endpoint) Osphena® (ospemifene)2,3 4 (secondary endpoint) Intr
Slide 28: Favorable Payer Dynamics: No Substitution Across Branded Products
Favorable Payer Dynamics: No Substitution Across Branded Products Case Study: Vagifem® Generics Launch § Yuvafem® launch in October 2016 VVA TRx Market Share (%) VVA TRx Market Share (%) Gains Oct 2015-Sept 2016 Oct 2016-April 2018 (Losses) Vagifem 29.7% 5.4% -24.3% Generic Estradiol Tablets - 24.4%
Slide 29: Committed to Responsible Medicine Pricing
The leadership of TherapeuticsMD is committed to pricing our medicines in a responsible manner, reflecting the value of the innovation while staying at parity with or below our competitors § Former US Secretary of Health § Co-founded vitaMedMD § Co-founded vitaMedMD and Human Services (2001- in 2008
Slide 30: 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 31: Clinical Overview
= Biyuva (stradiol and progesterone) capsules 1.0maq/100mg Clinical Overview |i
Slide 32: Vasomotor Symptoms are the Most Common Symptoms Associated with Menopause
Vasomotor Symptoms are the Most Common Symptoms Associated with Menopause1 Vasomotor symptoms are extreme thermoregulatory responses characterized by episodes of profuse heat accompanied by sweating and flushing2,3 § Also known as hot flashes or flushes § Occur predominantly around the head, neck, c
Slide 33: Hormone Therapy is the Recommended Treatment for Vasomotor Symptoms
Hormone Therapy is the Recommended Treatment for Vasomotor Symptoms Recommendations from the American College of Obstetricians and Gynecologists (ACOG) and the North American Menopause Society (NAMS)1,2 Hormone therapy is the The lowest dose of Formulation, dose, and most effective treatment hormone
Slide 34: Progesterone is Needed to Reduce the Risk of Endometrial Cancer Associated with Estrogen
Progesterone is Needed to Reduce the Risk of Endometrial Cancer Associated with Estrogen1 Chronic, unopposed endometrial exposure to estrogen increases the risk for endometrial hyperplasia or cancer1 Adding a progestogen* to estrogen therapy in postmenopausal women has been shown to reduce the risk
Slide 35: Both Bio-identical and Synthetic Hormones are used to Treat Vasomotor Symptoms
Both Bio-identical and Synthetic Hormones are used to Treat Vasomotor Symptoms Bio-identical hormones1 Synthetic hormones2 Not identical to hormones Have the same chemical and produced in the body molecular structure as hormones May be derived from natural naturally produced in the body sources (eg,
Slide 36: Synthetic Progestins May be Associated with Higher Risks of Breast Cancer and Stroke
Synthetic Progestins May be Associated with Higher Risks of Breast Cancer and Stroke1 In a observational study OR for breast cancer risk with E + synthetic P: 1.722 of 1555 postmenopausal women OR for breast cancer risk with E + natural P: 0.802 In a study of 54,548 RR for breast cancer with E + syn
Slide 37: BIJUVA is a Novel Combination of Bio-identical Estradiol and Progesterone
BIJUVA is a Novel Combination of Bio-identical* Estradiol and Progesterone1,2 BIJUVA is a combination product composed of both estradiol and progesterone active ingredients1 § The first combined prescription product of bio- identical estradiol and bio-identical progesterone evaluated for efficacy an
Slide 38: BIJUVA Improvements in Frequency of Vasomotor Symptoms
BIJUVA Demonstrated Statistically Significant Improvements in Frequency of Vasomotor Symptoms1,2 Co-primary endpoint Mean change from baseline in weekly frequency § Statistically significant reduction in 0 number of moderate and severe Mean reduction from baseline -10 vasomotor symptoms at Weeks 4 a
Slide 39: BIJUVA Improvements in Severity of Vasomotor Symptoms
BIJUVA Demonstrated Statistically Significant Improvements in Severity of Vasomotor Symptoms1,2 Co-primary endpoint Mean change from baseline in weekly severity § Statistically significant reductions 0.0 in severity of vasomotor Mean reduction from baseline -0.2 symptoms at -0.4 Weeks 4 and 12 -0.6
Slide 40: Secondary Efficacy Endpoints Support the Consistency of Effect with BIJUVA
Secondary Efficacy Endpoints Support the Consistency of Effect with BIJUVA P values: Frequency reduction P values: Severity reduction Weeks 1 through 12 Weeks 1 through 12 Week 4 vs placebo <0.001 0.027 Week 12 vs placebo <0.001 <0.001 § Statistically significant reductions from placebo in the numbe
Slide 41: BIJUVA Met the Primary Safety Endpoint of Endometrial Hyperplasia
BIJUVA Met the Primary Safety Endpoint of a ≤1% Incidence Rate of Endometrial Hyperplasia Following 12 Months of Therapy1,2 The safety of estradiol and progesterone capsules was assessed in a 1-year Phase 3 trial of 1835 postmenopausal women 1 mg E2/ 100 mg P4 Placebo (N=281) (N=92) Hyperplasia inci
Slide 42: Patient Reported Outcomes with BIJUVA: CGI, MENQOL, and MOS-Sleep
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 43: Adverse reactions reported with BIJUVA
Adverse reactions reported with BIJUVA1,2 Treatment-emergent adverse reactions reported at a frequency of ≥3% and numerically more common in women receiving BIJUVA Adverse reactions, n (%) 1-mg E2/100-mg P4 (N=415) Placebo (N=151) Breast tenderness 43 (10.4) 1 (0.7) Headache 14 (3.4) 1 (0.7) Vaginal
Slide 44: No Clinically Significant Changes in Cholesterol Levels were Observed
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 45: 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 46: Product Overview
Biyuva (stradiol and progesterone) capsules 1.0mg/100mg Product Overview TherapeuticsMD For Her: For Life.
Slide 47: BIJUVA is indicated for moderate to severe vasomotor symptoms due to menopause
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 48: 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 million1 ~3 million2 12 – 18 million3 BIJUVA Potential $760M-$950M4 $600
Slide 49: BIJUVA Fulfills the Unmet Need of a Combination Bio-Identical Hormone Therapy
BIJUVA Fulfills the Unmet Need of a Combination Bio-Identical Estrogen and Progesterone Hormone Therapy Option1 Compounded Generic separate BIJUVA1-3 Prempro1,6 E + P4,5 E + P pills1,7-9 FDA approval for ü x ü x combination usage Adverse event ü x ü ü reporting Bio-identical ü ü x ü No ability to ta
Slide 50: BIJUVA Approval
BIJUVA Approval § Post-Marketing Commitment • To further develop and validate in-vitro dissolution to show manufacturing consistency between drug batches of how the drug is released from the capsule in an in-vitro setting for quality control assessments • Expect to submit the final report in Decembe
Slide 51: 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 52: 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 53: 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 54: 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 55: USP <800> Expenses Create Large Barriers for Compounders
USP <800> Expenses Create Large Barriers for Compounders USP <800> Requirements Cost Implementation Time Segregated Clean Room: § USP <800> Design $60,000 - $200,000 § Construction 1 year – 1.5 years Ventilation System $25,000 - $50,000 New Equipment for $15,000 - $50,000 - Hazardous Compounding Tot
Slide 56: Economic Incentives Provide Catalyst to Switch to BIJUVA
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 $115.00 -
Slide 57: Annovera (Segesterone Acetate/Ethinyl Estradiol Vaginal System)
AnnoveraÔ (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). 57
Slide 58: 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 59: 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 repeated cyclical dosing regimen for one year (13 cycles) • 89% overall patient satisfaction in clinical trials1 § Average daily release
Slide 60: Clinical Trial Experience
Clinical Trial Experience Efficacy & Safety1 § 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 – Highly efficacious in preventing pregnancy when used as directed (97.3%) § Primary End
Slide 61: Demonstrated 1-Year Contraceptive Vaginal System High User Satisfaction
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 62: Annovera Key Clinical Attributes
Annovera Key Clinical 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 con
Slide 63: 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 64: 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 65: Large Established Ring Market
Large Established Ring Market Annovera compared to existing NuvaRing and potential NuvaRing generic § 1-year duration (vs. 1 month) § Soft, pliable, squishy (vs. semi-rigid ring body) § 89% overall patient satisfaction in clinical trials1 § High rates of adherence (94.3%) and continuation (78%)1 § N
Slide 66: Foundation Built for a Strong Launch
Foundation Built for a Strong Launch TXMD Sales Force in OB/GYN Offices § 81% of total NuvaRing prescribers within current 150 TXMD territories1 § 40% overlap with current prenatal vitamins business § Sales force of 150 § Partnership with inVentiv, leading contract sales organization § Operational a
Slide 67: Unique Product Characteristics Should Lead to Good Payer Coverage
Unique Product Characteristics Should Lead to Good Payer Coverage § Anticipate parity or discount pricing level ~$1,400 annual WAC cost § 30% decrease to annual WAC of NuvaRing, reflects TXMD’s responsible brand pricing § Allows for improved patient adherence and a potential decrease in unplanned pr
Slide 68: 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 ü û ü û Duration of Action 1 year (21/7 regimen) 1 month (21/ 7 regimen) 3-10 years Daily pill intake ü ü û ü Patient Control Removable at any time Removable at any
Slide 69: Commercialization Strategy
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 • 81% of
Slide 70: TherapeuticsMD, A Premier Women's Health Company
TherapeuticsMD, A Premier Women’s Health Company Annovera™ Annovera™ (segesterone acetate and ethinyl (segesterone acetate and ethinyl estradiol vaginal system) estradiol vaginal system) CONTRACEPTION/ DYSPAREUNIA VASOMOTOR CONTRACEPTION PRENATAL CARE FAMILY PLANNING - (Vulvar & SYMPTOMS PERIMENOPAU
Slide 71: Contraceptive Pipeline
Contraceptive Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 Approval Date 1-Year Contraceptive Vaginal System (NES/EE) Approved 08/10/2018 3-Month Contraceptive Vaginal Ring (NES/E2) Next Generation 1-Year Contraceptive Vaginal System (NES/EE) Exclusive rights to negotiate co-development and marketi
Slide 72: Committed to Become the Leading Women's Health Company
Committed to Become the Leading Women’s Health Company 72
Slide 73: 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 v
Slide 74: TXMD: Financial Snapshot
TXMD: Financial Snapshot Listing Insider Shares Exchange Ownership Outstanding ~20% 237.9M (Nov. 2018) (Sept. 2018) Debt Cash $75M $190M (as of Sept. 30, 2018) (as of Sept. 30, 2018) 74
Slide 75: Appendix
TherapeuticsMD" For Her. For Life. 75
Slide 76: BIJUVA Phase 3 trial design
BIJUVA Phase 3 trial design TXC12-05: a randomized, double-blind, placebo-controlled, multicenter study1,2 Postmenopausal women 1-mg estradiol/100-mg progesterone (N=141) aged 40 to 65 years (N=726) Criteria for inclusion3 § ≥7 moderate-to-severe hot RANDOMIZED flushes per day or ≥50 per week § Inta
Slide 77: Primary and Secondary Endpoints Assessed for BIJUVA
Primary and Secondary Endpoints Assessed for BIJUVA Primary endpoints1,2 § Co-primary efficacy endpoints: Mean weekly reduction in frequency and severity of moderate to severe vasomotor symptoms with BIJUVA compared to placebo at Weeks 4 and 12 Safety endpoint: ≤1% incidence rate of endometrial hype
Slide 78: Women Diagnosed with Menopausal Symptoms incur Higher Costs
Women Diagnosed with Menopausal Symptoms incur Higher Costs than those without Diagnosed Symptoms Adjusted annual health benefit costs Direct costs Indirect costs $5,000 $700 (P<0.0001) (P<0.0001) $4,000 $600 $500 (P=0.1510) $3,000 $400 $2,000 $300 (P<0.0001) $1,000 $200 $100 $0 $0 Medical costs Dru
Slide 79: Untreated Vasomotor Symptoms Associated with Higher Healthcare Resource Utilization
In Addition, Untreated Vasomotor Symptoms are Associated with even Higher Healthcare Resource Utilization Healthcare resource utilization for women with untreated vasomotor symptoms vs women without vasomotor symptoms (n=252,273) 100% Utilization was 121% higher for vasomotor symptom-related outpati
TherapeuticsMD — Investor Presentation (November 2018) on 6ix