Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (July 2019)
67 slides from Therapeuticsmd's investor presentation, Jul 9, 2019
Slide 1: Investor Update July 9, 2019
INVESTOR U P D AT E July 9, 2019 Building a Premier ANNOVERA™ Women’s Health Portfolio (segesteroneacetate and ethinyl estradiol vaginal system) 1
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: 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 4: TXMD: Innovative women's health company
(TXMD) Innovative women’s health company exclusively focused on developing and commercializing products for women throughout their life cycles ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) DYSPAREUNIA VASOMOTOR SYMPTOMS PREGNANCY PREVENTION (a symptom of VVA due to (Hot Flashe
Slide 5: Portfolio Approach to Women's Health
Portfolio Approach to Women’s Health Sum of the Parts ANNOVERA™ ANNOVERA™ (segesterone acetate and ethinyl (segesterone acetate and ethinyl Prenatal Vitamins estradiol vaginal system) estradiol vaginal system) Focused on lifespan of the patient and healthcare provider’s needs § Innovative products,
Slide 6: The Power of A Women's Health Portfolio
The image part with relationship ID rId2 was not found in the file. The Power of A Women’s Health Portfolio Overlapping Market Opportunity1 Prescribers & Patients The Power of 3 REPRODUCTIVE PORTFOLIO 5.5M units 15.8 units IMVEXXY BIJVUA 28M units MENOPAUSE ANNOVERA PORTFOLIO ANNOVERA™ (segesteronea
Slide 7: Women are Menopausal More Than One-third of Their Lives
Women are Menopausal More Than One-third of Their Lives 1 Median age of menopause 82 years is the median life onset is 51 years1,2 expectancy of women today3 AGE 40 50 60 70 80 90 (YEARS) Genitourinary Symptoms Vasomotor Symptoms (Vulvar and Vaginal Atrophy) Vulvar and Vaginal Atrophy (VVA) is a chr
Slide 8: The Scope of VVA in the US
8 The Scope of VVA in the US 1 64 Million Menopausal Women in the US ~1in2 ...but ONLY That means or 50% 7% 93% ~32M menopausal women (~16M) have are Treated with Prescription VVA are NOT Treated with received Prescription VVA have symptomatic treatment2 Therapy2,3 Therapy2,3 VVA2 • 18% (~5.7M) are
Slide 9: IMVEXXY is "Redefining Relief"
IMVEXXY is “Redefining Relief” A highly effective patient experience supported by strong clinical attributes §Small, digitally inserted, vaginal softgel insert that dissolves completely §Easy to use without the need for an applicator §Mess-free administration §Use any-time of day §Lowest approved do
Slide 10: Launch Approach Developed to Shift Entrenched Behavior
The image part with relationship ID rId2 was not found in the file. Launch Approach Developed to Shift Entrenched Behavior Remove Barriers Drive Early Experience for a Drive Share Momentum Differentiated Product Through New Writers and Share of Existing Writers § No new Estrogen product § Open acces
Slide 11: Strong IMVEXXY Launch
Strong IMVEXXY Launch IMVEXXY Launch Metrics Total paid scripts dispensed to patients1 ~244,000 (since launch through June 30, 2019) Total paid scripts ~37,500 (June 1-30, 2019) Total patients ~69,700 (since launch through June 30, 2019) Total prescribers2 ~12,900 (since launch through June 30, 2019
Slide 12: Launch Results Remain Strong and On-Track: Strategy is Working
Launch Results Remain Strong and On-Track: Strategy is Working Imvexxy TRx Launch Comparison 70,000 60,000 50,000 43,200 37,700 40,000 28,100 37,200 37,500 30,000 19,800 28,700 20,000 21,000 8,400 10,000 8,800 0 Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 1
Slide 13: Strong Patient Adherence = Women are Staying on IMVEXXY
Strong Patient Adherence = Women are Staying on IMVEXXY IMVEXXY Patient Adherence1,2 Maximum Allowable Fills Month Initial Prescription Average # Fills for those Given the Month of Initial Filled Patients Fill Jun 2019 1 Fill 1 Fill May 2019 1.7 Fills 2 Fills Apr 2019 2.4 Fills 3 Fills Mar 2019 2.9
Slide 14: IMVEXXY VVA Market Share
IMVEXXY VVA Market Share TXMD VVA Market Share 8.5% 7.3% 6.7% 6.9% 5.5% 4.1% 3.1% 2.7% 2.0% 1.3% JUL-18 AUG-18 SEP-18 OCT-18 NOV-18 DEC-18 JAN-19 FEB-19 MAR-19 APR-19 MAY-19 TXMD - TRx References: 1. Total prescription data is based on IQVIA prescriber level data plus additional unique patient data
Slide 15: Commercial Payer Update
Commercial Payer Update • Commercial Average Non Preferred Copay is $59 • IMVEXXY co-pay card offer can bring this down to $35 Source: 2018 Employer Health Benefits Survey, Section 9: Prescription Drug Benefits (KFF, Oct. 3, 2018), https://www.kff.org/report-section/2018-employer-health-benefits-sur
Slide 16: Medicare Part D Payer Update
Medicare Part D Payer Update Medicare Part D Median Preferred Copay is $40 Source: Juliette Cubanski, Anthony Damico, and Tricia Neuman, Medicare Part D: A First Look at Precription Drug Plans in 2019 (Kff, Oct. 16, 2018), https://www.kff.org/report-section/medicare-part-d-a-first-look-at-prescripti
Slide 17: IMVEXXY Payer Update
IMVEXXY Payer Update ~102M Commercial Lives are Unrestricted2 TRx Payer Breakdown of Commercial Payer Update2, 3 FDA-Approved VVA Products1 • Strategy: Continue to seek unrestricted access in a fiscally responsible manner Medicaid Cash • ~102 million lives are unrestricted with the majority being ad
Slide 18: IMVEXXY Payer Update
IMVEXXY Payer Update ~12M Medicare Lives are Unrestricted2 Medicare Part D Update1, 2 § Strategy: Continue to seek Preferred unrestricted access in a fiscally responsible manner § IMVEXXY launched in July 2018, after the 2019 bid cycle was completed. § ~12 million lives are unrestricted with a major
Slide 19: BIJUVA
The image part with relationship ID rId2 was not found in the file. BIJUVA 19 19
Slide 20: Menopause Overview
Menopause Overview 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 and night sweats), mood changes and va
Slide 21: BIJUVA Product Development Rationale
BIJUVA Product Development Rationale § 2002 Women’s Health Initiative (WHI) study showed that the long-term use of certain synthetic hormones (a combination of medroxyprogesterone acetate and conjugated equine estrogens) increased the risk of breast cancer, stroke, heart attack and blood clots – Pri
Slide 22: Current Hormone Therapy Options for Vasomotor Symptoms
Current Hormone Therapy Options for Vasomotor Symptoms After WHI (2002), a majority of women and clinicians shifted to bio-identical hormone therapy1,2 FDA-APPROVED NOT FDA-APPROVED Combination Synthetic Separate Bio-identical Compounded Bio-identical Estrogens + Progestins Estradiol & Progesterone
Slide 23: BIJUVA indication and key clinical attributes
BIJUVA is indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause K E Y C L I N I C A L AT T R I B U T E S § First and only bio-identical combination of estradiol to reduce moderate to severe hot flashes combined with progesterone to help reduce
Slide 24: A Large Target Market For BIJUVA
The image part with relationship ID rId2 was not found in the file. A Large Target Market For BIJUVA Q2 Launched April 17, 2019 Target FDA-approved Q2 separate bio-identical E&P pills segment ~3.9M TRx (each)1 I $836M2 TAM Once payer coverage achieved, Q4 expand BIO-IGNITE partnerships to access the
Slide 25: Launch Plan Mirrors IMVEXXY
The image part with relationship ID rId2 was not found in the file. Launch Plan Mirrors IMVEXXY Focused on Driving Early Behavior Change that Leads to Long Term Adoption § $35 or less out-of-pocket cost* § Addresses the cost and coverage concerns which are often barriers to early adoption § “Keep Co
Slide 26: BIJUVA Launch Metrics
BIJUVA Launch Metrics BIJUVA Launch Metrics Total paid scripts dispensed to patients1 (since launch through June 30, 2019) ~4,600 Total paid scripts (June 1-30, 2019) ~2,600 Total patients (since launch through June 30, 2019) ~2,900 Total prescribers2 (since launch through June 30, 2019) ~1,700 1 To
Slide 27: BIJUVA Payer Update
BIJUVA Payer Update ~77M Commercial Lives are Unrestricted2 TRx Payer Breakdown of Commercial Payer Update2,3 FDA-Approved VMS Products1 § Strategy: Seek unrestricted access in a fiscally Cash responsible manner Medicaid 9% § BIJUVA clinical and financial reviews are underway 8% with payers Medicare
Slide 28: Bio-Ignite = Innovative Collaborative Approach
Bio-Ignite = Innovative Collaborative Approach Large, Untapped Market § Over 3,000 physicians are currently writing high volumes of bio-identical hormones § Over 700 pharmacies are currently dispensing high volumes of bio-identical hormones § With marketing reps § HYBRID pharmacy model (filling FDA
Slide 29: A Four-Phase Strategic Initiative
A Four-Phase Strategic Initiative Goal to activate all current stakeholders involved in the Bio-identical Hormone Replacement Therapy (BHRT) community, ensuring that TherapeuticsMD’s portfolio has the best national access and uptake possible 50-100 Locations 700+ Locations Phase 1 Phase 2 Phase 3 Ph
Slide 30: Pharmacy Targeting
Pharmacy Targeting: § Over 1,750 are high tier targets § These locations produce the highest volume of compounded bio-identical hormone replacement 117 therapy (CBHRT) scripts Contracting 4,459 CBHRT HCP’s Program Stats as of June 7, 2019: 1,750 High Tier 31 States § Live Accounts: 45 Reached Target
Slide 31: USP <800> Compliance Deadline December 2019
USP <800> Compliance Deadline December 2019 The practice of pharmacy as we know it today will be changing The U.S. Pharmacopeial Convention (USP) has issued USP General Chapter <800> Hazardous Drug Handling in Healthcare Settings describing practice and quality standards for handling hazardous drugs
Slide 32: Partnership Types
P a r t n e r s h i p Ty p e s Pharmacy Profiles 1. Will not be USP <800> Compliant • No longer plans to compound BHRT ü Bio-Ignite provides access to the greatest subset of BHRT patients and prescribing HCPs 2. Will be USP 800 Compliant • Will still be capable of compounding forms of BHRT ü Bio-Ign
Slide 33: Why are Community Pharmacies Right for this Opportunity
Why are Community Pharmacies Right for this Opportunity § Compounding pharmacies offer a concierge experience with patients § Available 24/7 and offer cell phone contact § Pharmacy business model has changed significantly over the past few years and will continue to change § Lower reimbursement, inc
Slide 34: Hybrid Pharmacy Based Rx Model
Hybrid Pharmacy Based Rx Model § The “Hybrid” pharmacy- compounding, specialty care and traditional Rxs § Compounders are local community pharmacy providers and have key relationships with physicians and other community based health care providers § Engage regularly with the prescriber community § P
Slide 35: ANNOVERA
The image part with relationship ID rId2 was not found in the file. ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) ANNOVERA 35 35
Slide 36: ANNOVERA 1-Year Vaginal System
A N N O V E R A - 1 - Ye a r Va g i n a l S y s t e m Segesterone Acetate [Nestorone®]/Ethinyl Estradiol First and only patient-controlled, procedure-free, long-lasting, reversible birth control § ANNOVERA approved on August 10, 2018 • Segesterone acetate component of ANNOVERA classified as NCE with
Slide 37: ANNOVERA Key Attributes
ANNOVERA Key Attributes A C C E S S AT T R I B U T E S § Market shift to long-acting reversible contraceptives § Offer women a long-term birth control option without requiring a procedure for insertion and removal like IUDs or Implants § Available to all prescribers – no special training, equipment,
Slide 38: ANNOVERA Key Attributes
ANNOVERA Key Attributes C L I N I C A L AT T R I B U T E S § Only FDA-approved long-lasting reversible birth control that doesn’t require a procedure or repeat visit – Empowers women to be in control of their fertility and menstruation – ANNOVERA is the only user-directed single 12-month birth contr
Slide 39: U.S. Contraceptive Market
The image part with relationship ID rId2 was not found in the file. U.S. Contraceptive Market $5B U.S. net sales1 ~ 90mm annual scripts to ~20 million women2 Long-acting Complete control but Long-acting benefits benefits but requires no long acting benefits without a procedure a procedure and offeri
Slide 40: ANNOVERA Patient Types
ANNOVERA Patient Types § Broad-based product – a single contraceptive product for most patient and prescriber types § Supports patient preference § Amenable to women of all reproductive ages and demographics § Highly effective § Self-administered, long-lasting product that is reversible § Nulliparou
Slide 41: ANNOVERA Launch Approach
The image part with relationship ID rId2 was not found in the file. ANNOVERA Launch Approach Full launch with initial focus on OBGYN target overlap with Menopause Products Align initial sales Early consumer focus focus where given how influential states mandate women are in the coverage while choice
Slide 42: Access to Contraception
ANNOVERA™ (segesteroneacetate and ethinyl estradiol vaginal system) Access to Contraception § In 2012, the Affordable Care Act (ACA) required all health insurances to cover, without cost-sharing, the full range of contraceptive methods and services approved by the FDA as prescribed for women – 18 me
Slide 43: Birth Control State Laws Regardless of ACA Mandates
ANNOVERA™ (segesteroneacetate and ethinyl BIRTH CONTROL STATE LAWS estradiol vaginal system) REGARDLESS OF ACA MANDATES 10 STATES REQUIRE COVERAGE WITH NO COPAY REGARDLESS OF ACA DECISION (~42 Million women in these states) 2 1 ANNOVERA coverage required with no co-pay 1 Data on file (May 2019). 2 W
Slide 44: Birth Control State Laws Regardless of ACA Mandates
ANNOVERA™ (segesteroneacetate and ethinyl BIRTH CONTROL STATE LAWS estradiol vaginal system) REGARDLESS OF ACA MANDATES 9 STATES REQUIRE COVERAGE WITH COPAY REGARDLESS OF ACA DECISION (~25 Million women in these states) 1 ANNOVERA coverage required with co-pay 1 Data on file (May 2019). 44 44
Slide 45: 2019 US Payer Environment is Rapidly Evolving
2019 US Payer Environment is Rapidly Evolving Acquisitions New Pricing Pressures § Authorized generics and lower WAC strategies are impacting rebate guarantees § Rebate and Admin Fee pass through (transparency) tightening profitability § HHS Proposed Rule may reshape prescription drug prices § FDA a
Slide 46: The Power of 3 in the Payer World
T h e P o w e r o f 3 i n t h e P a y e r Wo r l d Expected widespread insurance coverage across the portfolio in 1st Half, 2020 Target Timeline for Insurance Coverage from Launch § Establishes TXMD as a Women’s Health company with products across the life • 1-3 Quarters ANNOVERA™ stages from launch
Slide 47: How Strategy, Plan, and Model Come Together
HOW STRATEGY, PLAN, AND MODEL COME TOGETHER 47 47
Slide 48: IMVEXXY Model Different Than Typical Pharmaceutical Launch
I M V E X X Y M o d e l Different T h a n Ty p i c a l Pharmaceutical Launch Gross Revenue Patient Copay Assistance Where We Focused Wholesale Costs Pharmacy Discounts Payer Rebates Returns, Allowances & Other Accruals Net Revenue Cost of Sales Gross Margin Sales Cost Realized; Marketing Cost Sales
Slide 49: Example: How a Prescription is Paid & the Impact on Manufacturer
Example: How a Prescription is Paid & the Impact on Manufacturer Column A Column B Column C Column D Patient’s Commercial Commercial Medicare Part D Insurance Insurance Used Insurance Used Insurance Used Doesn’t Cover w/ Patient w/ Average w/ Average Product Yet Deductible Not Copay Copay Yet Met &
Slide 50: How Adjudication Rate Will Change Over Time: NOW
How Adjudication Rate Will Change Over Time: NOW Charts are based on May Actuals Column A Column B Column C IMVEXXY No Commercial Medicare Insurance Insurance Eligible Patients % of % of Business 5% 61% 35% Business % Adjudicated 0% 47% 7% Contribution to Overall 0% 29% 2% Adjudication Rate Overall
Slide 51: Target Adjudication Rate at Fully Established Insurance Coverage
Target Adjudication Rate at Fully Established Insurance Coverage Column A Column B Column C IMVEXXY No Commercial Medicare Insurance Insurance Eligible Patients % of Business 8% 68% 24% % of % Adjudicated 0% 75% 65% Business Contribution to Overall 0% 51% 17% Adjudication Rate Overall Adjudication R
Slide 52: TXMD Power of the Portfolio
TXMD Power of the Portfolio Gain IMVEXXY commercial coverage, Expected target HCPs with covered Annual widespread insurance lives and high coverage for all deductibles met products Q3/Q4 2019 Q 3 20 /Q4 20 1H 19 20 Additional Launch full 2020 Med D 2019 Q4 1H contracts scale secured 20 /Q4 Q4 9 20 1
Slide 53: Financial Update
Financial Update ANNOVERA™ (segesteroneacetate and ethinyl estradiol vaginal system) 53
Slide 54: $300M Non-Dilutive Term Loan Financing Secured
$300M Non-Dilutive Term Loan Financing Secured $200M accessed to date with up to additional $100M through Specific Company Milestones Amount TXMD Company Anticipated Timing ($) Milestone1 Tranche 1 $200 million Closing of the facility Completed in April 2019 Tranche 2 $50 million Designation of ANNO
Slide 55: The Power of the Portfolio at Peak Sales $1B
The Power of the Portfolio at Peak Sales $1B Percent of Market Based on Patient Count of 2.3M and 4 fills per year Average Net Revenue / Unit 20% 30% 40% 50% $ 60 $ 110,400,000 $ 165,600,000 $ 220,800,000 $ 276,000,000 $ 80 $ 147,200,000 $ 220,800,000 $ 294,400,000 $ 368,000,000 $ 100 $ 184,000,000
Slide 56: 2019 TXMD Quarterly Financial Guidance
2019 TXMD Quarterly Financial Guidance 1Q2019 2Q2019 3Q2019 4Q2019 FY2019 Actual Expectation Expectation Expectation Expectation FDA-Approved Drugs $2.0M $2.5-3.0M $4.5-6.5M $11-13M $20-24.5M Net Revenue Prenatal Vitamins $1.9M $2.0-2.5M $1.75-2.25M $1.5-2.0M $7.15-8.65M Net Revenue Total TXMD Net R
Slide 57: 2019 TXMD Annual Financial Guidance
2019 TXMD Annual Financial Guidance FY2018 Actual FY2019 y/y growth1 Expectation FDA-Approved Drugs Net Revenue $1.0M $20-24.5M 2,125% Prenatal Vitamins Net Revenue $15M $7.15-8.65M (47%) Total TXMD Net Revenue $16M $27.1-33.1M ~88% § Important Guidance Notes: § As our sales force focus shifts to ou
Slide 58: TXMD: Financial Snapshot
TXMD: Financial Snapshot Listing Insider Shares Exchange Ownership Outstanding ~15% 241.2M (as of May 1, 2019) (as of March 31, 2019) TSSP Cash Facility $122M $300M* (as of March 31, 2019) * $300 million non-dilutive term loan facility with TPG Sixth Street Partners (TSSP) entered into on April 24,
Slide 59: The Power of a Women's Health Portfolio
The image part with relationship ID rId2 was not found in the file. The Power of a Women’s Health Portfolio ANNOVERA™ ANNOVERA™ (segesterone acetate and ethinyl (segesterone acetate and ethinyl Prenatal Vitamins estradiol vaginal system) estradiol vaginal system) PRENATAL CONTRACEPTION/ VASOMOTOR DY
Slide 60: Appendix
Appendix ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) 60 60
Slide 61: Model To Change Behavior Is Working
Model To Change Behavior Is Working Scripts are accelerating while adjudication is increasing and adherence (staying on therapy) is growing IMVEXXY Launch Metrics Total paid scripts dispensed to patients1 (since launch through June 30, 2019) ~244,000 Total paid scripts (June 1 - 30, 2019) ~37,500 To
Slide 62: Relationship of Cost of Copay Card vs Net Revenue Driven by Insurance Adjudication
Example: Relationship of Cost of Copay Card vs Net Revenue Driven by Insurance Adjudication Relative Cost of Patient Affordability Programs Impact on Net Revenue from Payer Coverage Adjudication Rate At Launch Qtr 3 2018 Normalization Qtr 4 2018 Qtr 1 2019 Qtr 2 2019 Qtr 3 2019 Qtr 4 2019 Qtr 1 2020
Slide 63: IMVEXXY Product Characteristics Compare Favorably
IMVEXXY Product Characteristics Compare Favorably1-9 Estrogens Non-estrogens Estrace® Cream Premarin® Vagifem® Intrarosa® Osphena® (conjugated estrogens) IMVEXXY® (estradiol vaginal (estradiol vaginal (prasterone) (ospemifene) (estradiol vaginal inserts)5 cream, USP, 0.01%)1 Vaginal Cream2 inserts)4
Slide 64: ANNOVERA Key Attributes
ANNOVERA Key Attributes Oral Vaginal Ring Contraceptive Vaginal System IUDs Contraceptives NuvaRing® Injection ANNOVERA™ Duration of Daily pill intake 1 month (21/7 3 months 1 year (21/7 regimen) 3-10 years Action regimen) Stop at any time, but Patient Stop at any time Removable at any time residual
Slide 65: Top Contraceptive Products Based on Revenue
Top Contraceptive Products Based on Revenue 2018 Net Revenue (mm) NUVARING $722 NEXPLANON IMPLANT $495 LO LOESTRIN FE BIRTH CONTROL $528 PILL MIRENA IUD FAMILY (INCLUDES This includes 3 MIRENA, KYLEENA & SKYLA) $750 $0 $300 $600 $900 Net Revenue (mm) Company filings; Net sales as reported in 2018 co
Slide 66: Overview of TXMD's Patents
O v e r v i e w o f T X M D ’s P a t e n t s • As of June 7, 2019, TherapeuticsMD’s patent portfolio includes: • 293 patent applications: • 24 issued U.S. patents • 12 U.S. patents have been listed in the Orange Book for BIJUVA • 3 U.S. patents have been listed in the Orange Book for IMVEXXY • 27 is
Slide 67: Overview of TXMD's Patents for BIJUVA and IMVEXXY
O v e r v i e w o f T X M D ’s P a t e n t s f o r B I J U VA a n d I M V E X X Y BIJUVA Patent Summary IMVEXXY Patent Summary Formulation and Method Claims Formulation and Method Claims; Design Patent US Issued / Allowed 12* / 0 US Issued / Allowed 4/3 Expiration 2032 Expiration No earlier than 203