Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Day (June 2019)
91 slides from Therapeuticsmd's investor day presentation, Jun 10, 2019
Slide 1: Investor Day June 10, 2019
No INVESTOR DAY June 10, 2019 Image ANNOVERA™ (segesterone acetate 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: Welcome
WELCOME No Image Robert Finizio Chief Executive Officer ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) 3
Slide 4: TXMD Investor Day Agenda
TXMD Investor Day Agenda 11:00-11:10 AM OVERVIEW AND INTRODUCTIONS Welcome – Robert Finizio Introductions – Brian Bernick, M.D. 11:10-11:50 AM KEY OPINION LEADERS – IMVEXXY, BIJUVA AND ANNOVERA IMVEXXY – Risa Kagan, M.D. BIJUVA – James Simon, M.D. ANNOVERA – James Liu, M.D. Portfolio View – Jay Cohe
Slide 5: Clinical Introduction
The image part with relationship ID rId2 was not found in the file. CLINICAL INTRODUCTION Brian Bernick, M.D. Co-founder and Director ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) 5
Slide 6: Portfolio Approach to Women's Health
Portfolio Approach to Women’s Heath Sum of the Parts ANNOVERA™ ANNOVERA™ (segesterone acetate and ethinyl (segesterone acetate and ethinyl estradiol vaginal system) Prenatal Vitamins estradiol vaginal system) Focused on lifespan of the patient and healthcare provider’s needs Innovative products, c
Slide 7: Risa Kagan, MD, FACOG, CCD, NCMP
The image part with relationship ID rId2 was not found in the file. Risa Kagan, MD, FACOG, CCD, NCMP Clinical Professor in the Department of OB/GYN and Reproductive Sciences at UCSF Gynecologist and Clinical Research with Sutter East Bay Medical Foundation Past Trustee of NAMS Leading expert
Slide 8: 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 9: The Scope of VVA in the US
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 Prescription VVA received have symptomatic treatment2 Therapy2,3 Therapy2,3 VVA2 • 18% (~5.7M) are pr
Slide 10: 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 New lowest approve
Slide 11: James A. Simon, MD, CCD, NCMP, IF
The image part with relationship ID rId2 was not found in the file. James A. Simon, MD, CCD, NCMP, IF Clinical Professor Division of Reproductive Endocrinology and Infertility Department of The George Washington University School of Medicine Washington, D.C. President, International Society for
Slide 12: 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 13: 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 14: 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 15: 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 16: ANNOVERA - James Liu, MD
The image part with relationship ID rId2 was not found in the file. ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) James Liu, MD President, North American Menopause Society (NAMS) Chairman, Department of Obstetrics and Gynecology, University Hospitals Health System, MacDona
Slide 17: ANNOVERA 1-Year Vaginal System
A N N O V E R A - 1 - Ye a r Va g i n a l S ys 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 18: U.S. Contraceptive Market
U.S. Contraceptive Market Contraception is most notably used for family planning, but also to control symptoms associated with menstruation, endometriosis, fibroids, acne and perimenopause Nearly all women (99%) have used contraceptives at some point in their lives1 Long-acting methods of cont
Slide 19: 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 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, or inventory Acceptable
Slide 20: 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 21: ANNOVERA Patient Types
A N N O V E R A P a t i e n t Typ e s 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 reversib
Slide 22: Jay Cohen, MD
The image part with relationship ID rId2 was not found in the file. Jay Cohen, MD Medical Director of all Women’s Healthcare of West Broward, Clinical Research, and Discovery Clinical Research, divisions of Envision Women’s Healthcare Board certified OB/GYN at all Women’s Healthcare of West Brow
Slide 23: What Impact of TXMD Portfolio has on Typical Practice
What Impact of TXMD Portfolio has on Typical Practice TXMD portfolio is important when covers critical stages of a woman’s life cycle Leads to trust with Women Very much like Wyeth, Ortho, Warner Chilcott – market is wide open Women are more apt to discuss sexual health with their doctors to
Slide 24: Why Do IMVEXXY and BIJUVA Matter to Typical Clinicians
Why Do IMVEXXY and BIJUVA Matter to Typical Clinicians Addresses the real life discussions between patients and physicians IMVEXXY is a unique product with the lowest approved dose Key issue today systemic vs local estrogen BIJUVA is the only FDA-approved systemic therapy that is bio-identic
Slide 25: How Can ANNOVERA Change Things
How Can ANNOVERA Change Things Only one visit to the doctor and pharmacy Addresses important reasons women discontinue daily and/or monthly contraceptives Access, insurance coverage Adverse events such as bleeding, weight gain, and nausea Long lasting ring (cyclical dosing for 13 cycles)
Slide 26: TherapeuticsMD - For Her. For Life.
TherapeuticsMD Typ For Her: For Life. Nasdaq Listed
Slide 27: Commercial Update
The image part with relationship ID rId2 was not found in the file. COMMERCIAL UPDATE Building a Premier Women’s Health Portfolio Dawn Halkuff Chief Commercial Officer ANNOVERA™ (segesteroneacetate and ethinyl estradiol vaginal system) 27
Slide 28: 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) CONTRACEPTION/ DYSPAREUNIA PRENATAL
Slide 29: 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 30: 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 31: Launch Results Remain Strong and On-Track
Launch Results Remain Strong and On-Track: Strategy is Working Imvexxy TRx Launch Comparison 70,000 60,000 50,000 37,700 40,000 28,100 37,200 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 11 Month 12 Mon
Slide 32: 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 May 2019 1 Fills 1 Fills Apr 2019 1.8 Fills 2 Fills Mar 2019 2.4 Fills 3 Fills Feb 2019 3.
Slide 33: IMVEXXY Momentum Driven by Increased Experience
The image part with relationship ID rId2 was not found in the file. IMVEXXY Momentum Driven by Increased Experience With the Product 2019 Month Over Month Change in Market Share2 Osphena 61% aided awareness among prescribers Growing number of high volume writers every month Intrarosa Highest a
Slide 34: Next Lever to Unlock IMVEXXY Growth is Consumer in Q3
The image part with relationship ID rId2 was not found in the file. The Next Lever to Unlock to Support IMVEXXY Growth is Consumer in Q3 Introducing: “No Interruptions” Research Findings Media Plan Across Demonstrate Strong Multiple Platforms Engagement* Strong Communication Calls out Strong functio
Slide 35: BIJUVA Update
The image part with relationship ID rId2 was not found in the file. BIJUVA UPDATE 35
Slide 36: 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 37: 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 38: Early BIJUVA Uptake Insights
The image part with relationship ID rId2 was not found in the file. E a r l y B I J U VA U p t a k e I n s i g h t s Core HCP Marketing Campaign Opportunity to reinvigorate category given little to no promotion by competitor Initial focus on those prescribers writing 2-Pill regimen ~10 targets
Slide 39: ANNOVERA
The image part with relationship ID rId2 was not found in the file. ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) ANNOVERA 39
Slide 40: 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 and co
Slide 41: Prescribers and Consumers are Open to ANNOVERA
The image part with relationship ID rId2 was not found in the file. Prescribers and Consumers are Open to ANNOVERA • High level of acceptance from prescribers with 89% of prescribers very or somewhat likely to prescribe1 • Providers report that they would expect to use ANNOVERA for 18% of their pati
Slide 42: 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 43: 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) CONTRACEPTION/ DYSPAREUNIA PRENATAL
Slide 44: BIO-IGNITE Introduction
The image part with relationship ID rId2 was not found in the file. BIO-IGNITE Introduction Dedra Reiger Lyden Vice President, Strategic Partnerships & Initiatives 44
Slide 45: 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 46: 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 47: Pharmacy Targeting and Program Stats
Pharmacy Targeting: Over 1,750 are high tier targets These locations produce the highest volume of compounded bio-identical hormone 117 replacement therapy (CBHRT) scripts Contracting 4,459 CBHRT HCP’s Program Stats: 1,750 High Tier 31 States Live Accounts: 45 Reached Targets States Reached:
Slide 48: Donnie Calhoun, BPharm, RPh.
The image part with relationship ID rId2 was not found in the file. Donnie Calhoun, BPharm, RPh. Licensed pharmacist in Alabama and owner of Calhoun Compounding Pharmacy in Anniston, Alabama Past President of the National Community Pharmacists Association, Past President of the Alabama Board of
Slide 49: Scott Mazza PharmD, MS, R.Ph.
The image part with relationship ID rId2 was not found in the file. S c o tt M a z za P h a r m D, M S , R . P h . Over 30 years of clinical pharmacy experience in a variety of practice settings Currently oversees the Therapeutic Interchange Program for Polaris Pharmacy Services Served as Phar
Slide 50: 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 51: Partnership Types
P a r t n e r s h i p Typ e s Pharmacy Profiles 1. Will not be USP <800> Compliant • No longer plans to compound BHRT 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 Bio-Igni
Slide 52: What is the opportunity for IMVEXXY and BIJUVA and why
What is the opportunity for IMVEXXY and BIJUVA and why Headwinds Community Pharmacies that compound are going through a significant market shift Loss of reimbursement for many areas for compounded drugs including hormones Significant increase in cost and regulation associated with compounding
Slide 53: 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 54: 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 55: TherapeuticsMD - For Her. For Life.
TherapeuticsMD Typ For Her: For Life. Nasdaq Listed
Slide 56: Payer Overview
The image part with relationship ID rId2 was not found in the file. PAYER OVERVIEW Bob Lahman Ret. SR VP Optum Rx Mike Steelman TXMD Vice President, Market Access Ambrose Carrejo Ret. Pharmaceutical Contracting Lead Kaiser Permanente ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal syste
Slide 57: 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 58: Commercial Payer Update
C o m m e r c i a l P a ye r U p d a t e • Commercial Average Non Preferred Copay is $59 • IMVEXXY co-pay card offering 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
Slide 59: 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 60: 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 ye 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 61: IMVEXXY Payer Update: ~102M Commercial Lives Unrestricted
I M V E X X Y P a ye r U p d a t e ~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 maj
Slide 62: IMVEXXY Payer Update: ~12M Medicare Lives Unrestricted
I M V E X X Y P a ye r U p d a t e ~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 unrestricte
Slide 63: 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 64: 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 65: Birth Control State Laws Regardless of ACA Mandates
ANNOVERA™ BIRTH CONTROL STATE LAWS REGARDLESS OF ACA MANDATES (segesteroneacetate and ethinyl estradiol vaginal system) 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 66: 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). 66
Slide 67: Payer Insight on Birth Control Coverage
ANNOVERA™ (segesteroneacetate and ethinyl PAYER INSIGHT ON BIRTH estradiol vaginal system) CONTROL COVERAGE Select Quotes from Market Research 1 • Flat open, covered. There is one thing that scares the living hell out of me and it’s a female millennial with a smartphone and a Twitter and Facebook ac
Slide 68: 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 Additional Launch full Med D scale contracts secured Launch in Top 10 commercial 10-19 states payers decisio
Slide 69: How Strategy, Plan, and Model Come Together
No HOW STRATEGY, PLAN, AND MODEL COME TOGETHER Image Mitch Krassan Chief Strategy and Performance Officer 69
Slide 70: IMVEXXY Model Different Than Typical Pharmaceutical Launch
I M V E X X Y M o d e l Different T h a n Typ 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 71: 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 72: How a Prescription is Paid & 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 73: How Adjudication Rate Will Change Over Time: Now
How Adjudication Rate Will Change Over Time: NOW Chart 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 O
Slide 74: Target Adjudication Rate at Fully Established 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 75: Financial Update
No Financial Update Image Robert Finizio Chief Executive Officer ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) 75
Slide 76: $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 77: 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 78: 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 79: TXMD Financial Guidance Overview
TXMD Financial Guidance Overview ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) FDA-Approved Drugs Net Revenue Prenatal Vitamins Net Revenue 79
Slide 80: 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 81: 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 82: TherapeuticsMD - For Her. For Life.
TherapeuticsMD Typ For Her: For Life. Nasdaq Listed
Slide 83: Appendix
The image part with relationship ID rId2 was not found in the file. Appendix 83
Slide 84: Strong IMVEXXY Launch
Strong IMVEXXY Launch IMVEXXY Launch Metrics Total paid scripts dispensed to patients1 ~206,500 (since launch through May 31, 2019) Total paid scripts ~37,700 (May 1-31, 2019) Total patients ~61,800 (since launch through May 31, 2019) Total prescribers2 ~12,000 (since launch through May 31, 2019) Co
Slide 85: 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 May 31, 2019) ~206,500 Total paid scripts (May 1-31, 2019) ~37,700 Total
Slide 86: 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 87: BIJUVA Launch Metrics
BIJUVA Launch Metrics BIJUVA Launch Metrics Total paid scripts dispensed to patients1 (since launch through May 31, 2019) ~2,000 Total paid scripts (May 1-31, 2019) ~1,600 Total patients (since launch through May 31, 2019) ~1,500 Total prescribers2 (since launch through May 31, 2019) ~1,100 1 Total
Slide 88: 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 89: 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 90: 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 91: 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