Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (September 2019)
63 slides from Therapeuticsmd's investor presentation, Sep 25, 2019
Slide 1: Investor Presentation: Building a Premier Women's Health Portfolio
Investor Presentation September 25, 2019 Building a Premier Women’s Health Portfolio 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: General Updates
¥ Imvexxy estradiol vaginal inserts) 4 meg-10 meg ——— B iJ UV intin (stradiol and progesterone) capsules General Updates TherapeuticsMD’ For Her: For Life. 3
Slide 4: General Updates and Catalysts
General Updates and Catalysts § Began IMVEXXY direct to consumer advertising leveraging digital and social media platforms No § Expanded payer coverage for IMVEXXY and BIJUVA; awaiting additional coverage decisions § Expanded commercial coverage for IMVEXXY with the addition of CVS1 § Awaiting comme
Slide 5: Near-Term Events
Near-Term Events § Held Satellite Media Tour for Menopause Awareness Month (September) No § IMVEXXY and BIJUVA data will be presented at 2019 Annual Meeting of the North American Menopause Society being held Sept. 25-28, 2019 (2 oral presentations and 5 posters): § Results from the REPLENISH Phase 3
Slide 6: August Launch Metrics
August Launch Metrics IMVEXXY Launch Metrics Total paid scripts1 ~44,600 (August 1-31, 2019) Total patients ~87,400 (since launch through August 31, 2019) Total prescribers2 ~14,800 (since launch through August 31, 2019) 1 Total prescription data is based on IQVIA prescriber level data plus addition
Slide 7: 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 9% 8% 47,900 50,000 43,200 6% 44,600 40,000 4% 37,500 28,700 30,000 2% 21,000 28,100 20,000 19,800 8,800 10,000 8,400 0 Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 M
Slide 8: Continued Strong Patient Adherence
Continued Strong Patient Adherence IMVEXXY Patient Adherence1,2 Maximum Average # Fills Month Initial Allowable Fills for Those Prescription Filled Given the Month Patients of Initial Fill Aug 2019 1 Fill 1 Fill IMVEXXY: 3.8 fills/yr3 (through Aug) Jul 2019 1.9 Fills 2 Fills • Vaginal creams: averag
Slide 9: Commercial Payer Status
Commercial Payer Status Top 10 Plans Account for ~71% of all Commercial Pharmacy Lives Plan % of Lives1 Status2 New CVS 15.4% Adjudicating as of September 2019 ESI 15.3% Adjudicating as of 10/1/18 United 7.5% Adjudicating as of 3/1/19 Anthem 7.3% Adjudicating as of August 2018 Prime 6.5% Adjudicatin
Slide 10: August Launch Metrics
August Launch Metrics BIJUVA Launch Metrics Total paid scripts dispensed to patients1 (since launch through August 31, 2019) ~14,200 Total paid scripts (August 1-31, 2019) ~5,300 Total patients (since launch through August 31, 2019) ~6,800 Total prescribers2 (since launch through August 31, 2019) ~3
Slide 11: Commercial Payer Update
Commercial Payer Update Coverage Decisions Expected by 4Q19 Quicker Process to Top 10 Plans Account for ~71% Payer Coverage than IMVEXXY of all Commercial Pharmacy Lives § Commercial segment represents vast Plan % of Lives1 Status2 majority of BIJUVA patients § Expect 3-4 quarters coverage cycle (fr
Slide 12: Key Payer Updates
Key Payer Updates ANNOVERA has 40% Unrestricted Coverage in Commercial Health Plans1 § Anthem adjudicating ANNOVERA at Tier 3 with no copay as of August 20191 § Kaiser Washington ACA drug list covers ANNOVERA at no copay1 § Cigna adjudicating ANNOVERA at Tier 3 as of August 20191 § Starting on Janua
Slide 13: Commercial Payer Update
Commercial Payer Update Coverage Decisions Expected to be finalized 1Q20 Top 10 Plans Account for ~71% of all Commercial Pharmacy Lives Plan % of Lives1 Status2 CVS 15.4% In discussions ESI 15.3% In discussions United 7.5% In discussions New Anthem 7.3% Adjudicating at T3, no copay as of August 2019
Slide 14: Commercial Payer Update
Commercial Payer Update Coverage Decisions Expected to be finalized 1Q20 Selected Regional Plan Coverage Plan % of Lives1 Status2 MC-Rx (ProcareRx) 0.64% Adjudicating as of April 2019 New Magellan Rx 0.47% Adjudicating at no copay as of August 2019 BCBS of 0.47% Adjudicating at no copay as of August
Slide 15: Birth Control State Laws Regardless of ACA Mandates
BIRTH CONTROL STATE LAWS REGARDLESS OF ACA MANDATES 11 STATES, plus Washington D.C., REQUIRE COVERAGE WITH NO COPAY REGARDLESS OF ACA DECISION (~51 Million women in these states) 2 New * ANNOVERA1 coverage required with no co-pay 1 ANNOVERA coverage required with co-pay 1 Data on file (July 2019). 2
Slide 16: Birth Control State Laws Regardless of ACA Mandates
BIRTH CONTROL STATE LAWS REGARDLESS OF ACA MANDATES 8 STATES REQUIRE COVERAGE WITH COPAY REGARDLESS OF ACA DECISION (~27 Million women in these states) 1 ANNOVERA coverage required with co-pay ANNOVERA1 coverage required with no co-pay 1 Data on file (July 2019). 16 16
Slide 17: IMVEXXY
¥ Imvexxy IMVEXXY estradiol vaginal inserts) 4 mcg: 10 mcg TherapeuticsMD For Her: For Life. 17
Slide 18: Portfolio Approach to Women's Health
Portfolio Approach to Women’s Health Sum of the Parts Prenatal Vitamins Focused on lifespan of the patient and healthcare provider’s needs § Innovative products, chronic conditions, large markets § 200 sales representatives focused on single call point § Products transition from one to the next thro
Slide 19: TXMD: Focused on Women Throughout Their Life Cycles
(TXMD) Focused on developing and commercializing products for women throughout their life cycles Easy to use, lowest approved First and only long-lasting (one Key Value First and only FDA-approved bio- year/13 cycles), procedure-free, Proposition dose, designed to support identical combination produ
Slide 20: The Power of A Women's Health Portfolio
The Power of A Women’s Health Portfolio Overlapping Market Opportunity1 Prescribers & Patients The Power of 3 5.5M units IMVEXXY No 15.8 units BIJVUA REPRODUCTIVE PORTFOLIO Image 28M units MENOPAUSE ANNOVERA PORTFOLIO Even though there are over 400,000 total writers for these products2 ~25,000 targe
Slide 21: 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 22: The Scope of VVA in the US
2 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 23: 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 24: Launch Approach Developed to Shift Entrenched Behavior
Launch Approach Developed to Shift Entrenched Behavior Remove Barriers No § No new Estrogen product Drive Early Experience for a Differentiated Product § Open access approach only Drive Share Momentum Through New Writers and Share of Existing Writers § Continuous unlocking of Image launched since 20
Slide 25: IMVEXXY is "Redefining Relief"
IMVEXXY is “Redefining Relief” A highly effective patient experience supported by strong clinical attributes §Small, digitally inserted, softgel vaginal 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 26: The VVA Market Exceeds $1.7B Gross Revenue Annually
The VVA Market Exceeds $1.7B Gross Revenue Annually 12 Months through June Product Gross Dollars for 20181 2019 Total Units1 Estrace® Cream Brand & Generics 2,000,000 $554,450,000 Premarin® 1,190,000 $460,760,000 Vagifem® Brand & Generics 1,500,000 $454,550,000 Estring® 259,000 $114,360,000 Osphena®
Slide 27: Value of Additional Fills
Value of Additional Fills Percent of market based on patient count of 2.3M and 4 fills per year Average Net 4 Revenue / Unit 25% 35% 45% 55% Fills/year $80 $184M $257.6M $331.2M $404.8M $100 $230M $322M $414M $506M Percent of market based on patient Count of 2.3M and 5 fills per year Average Net Rev
Slide 28: Commercial Average Non Preferred Copay
C o m m e r c i a l Av e r a g e N o n P r e f e r r e d C o p a y • 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/repor
Slide 29: Medicare Part D Median Preferred Copay
Medicare Part D Median Preferred Copay 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-
Slide 30: Medicare Part D Payer Status
Medicare Part D Payer Status Decisions Expected 3Q/4Q19 Top 6 Plans Account for ~78% of all Medicare Part D Pharmacy Lives Plan % of Lives1 Status2 United 20.7% Adjudicating as of 2/1/19 Humana 17.9% Decision expected 3Q/4Q19 CVS Caremark 14.1% Decision expected 3Q/4Q19 Wellcare with 13.6% Decision
Slide 31: How Adjudication Rate Will Change When Payer Cycle Completes
How Adjudication Rate * Will Change When Payer Cycle Completes 2Q 2019 Actuals Column A Column B Column C Chart IMVEXXY No Insurance Commercial Medicare Eligible Insurance Patients 1 % of Business 3% 62% 35% % Adjudicated 0% 50% 8% Contribution to Overall Adjudication Rate 0% 31% 3% Overall Adjudica
Slide 32: 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 33: 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 34: IMVEXXY Catalysts
IMVEXXY Catalysts No Direct to Consumer Advertising Additional Commercial Decisions Medicare Part D Decisions § Menopause Awareness Begin Copay & Distribution Optimization Image Month - Satellite Media Tour § NAMS Premier Sponsor § NAMS Publications 3Q 2019 4Q 2019 34 34
Slide 35: BIJUVA
BiyUV ann BIJUVA (:stradiol and progesterone) capsules TherapeuticsMD’ For Her: For Life. 35
Slide 36: Product Development Rationale
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 – Prior to B
Slide 37: Hormone Therapy Options for Vasomotor Symptoms Before BIJUVA
Hormone Therapy Options for Vasomotor Symptoms Before BIJUVA After WHI (2002), a majority of women and clinicians shifted to bio-identical hormone therapy1 FDA-APPROVED NOT FDA-APPROVED Combination Synthetic Separate Bio-identical Compounded Bio-identical Estrogens + Progestins2 Estradiol & Progeste
Slide 38: 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 39: A Large Target Market For BIJUVA
A Large Target Market For BIJUVA No Q2 Launched April 17, 2019 Target FDA-approved separate Reps directed to focus on ~10 Q2 bio-identical Estrogen & prescribers in their territory until improved payer Progesterone pills segment coverage Image ~3.9M TRx (each)1 I $836M2 TAM BIJUVA introduced into Bi
Slide 40: Launch Plan Mirrors IMVEXXY
Launch Plan Mirrors IMVEXXY Focused on Driving Early Behavior Change that Leads to Long Term Adoption No § As little as $35 out-of-pocket cost* § Addresses the cost and coverage concerns which are often barriers to early adoption Image § “Keep Cool” Early Experience Program drives appropriate patien
Slide 41: Impact of Faster Payer Cycle on Adjudication Rate
Impact of Faster Payer Cycle on Adjudication Rate * 2Q 2019 Actuals Column A Column B Column C Chart No Insurance Commercial Medicare Eligible BIJUVA 1 Insurance Patients % of Business 3.1% 89.1% 7.8% % Adjudicated 0% 37.6% 7.6% Contribution to Overall Adjudication Rate 0% 33.4% 0.6% Overall Adjudic
Slide 42: Compounding Pharmacy Onboarding Process and Status
Compounding Pharmacy Onboarding Process and Status 124 In Vetting Process 80 Contracting 10,759 CBHRT HCP’s In Contracting 2,183 Process 124 National High Tier Targets Reach 105 Live Accounts Live Accounts 105 § Unique compounded bio-identical hormone replacement therapy (CBRT) prescribers Identifie
Slide 43: Market Opportunity
Market Opportunity Total Addressable FDA Market: 3.9M Total Addressable Compounding Market: 12M Percent of Addressable Market Average Net Revenue / Unit 25% 35% 45% 55% $80 $316M $442.4M $568.8M $695.2M $100 $395M $553M $711M $869M Market opportunity is calculated by multiplying the annual addressab
Slide 44: BIJUVA Catalysts
BIJUVA Catalysts No Commercial Payer Cycle Completion Expected § Menopause Awareness BIO-IGNITE Expansion Month - Satellite Media Tour Begin Copay and Distribution Optimization Image § NAMS Premier Sponsor Direct to Consumer § NAMS Publications Advertising 3Q 19 3Q 2019 4Q 2019 1H 2020 44 44
Slide 45: ANNOVERA
Annovera ANNOVERA ethiny Delive TherapeuticsMD’ For Ler: For Life. 45
Slide 46: ANNOVERA: 2019 Prix Galien USA Award Nominee
ANNOVERA: 2019 Prix Galien USA Award Nominee The Prix Galien Award, counted among the global health innovation industry’s most prized honors, recognizes outstanding biomedical and medical technology product achievement that improves the human condition Best Pharmaceutical Product Past Award Winners
Slide 47: U.S. Contraceptive Market
U.S. Contraceptive Market $5B U.S. net sales1 ~ 90M annual scripts to ~20M women2 Complete control but no long acting benefits No Long-acting benefits without a procedure offering complete control over fertility and menstruation Long-acting benefits but requires a procedure and does not offer comple
Slide 48: Top Contraceptive Products Based on Revenue
Top Contraceptive Products Based on Revenue 2018 Net Revenue (Millions) NUVARING® $722 NEXPLANON® IMPLANT $495 LO LOESTRIN® FE BIRTH $528 CONTROL PILL MIRENA® IUD FAMILY (INCLUDES This includes 3 MIRENA, KYLEENA® & SKYLA®) $750 $0 $300 $600 $900 Net Revenue (M) Company filings; Net sales as reported
Slide 49: Access Attributes
Access Attributes § Market shift to long-acting contraception § 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 for women who haven’t
Slide 50: Clinical Attributes
Clinical Attributes § 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 control product (used in repeated 4-week cyc
Slide 51: High Patient Satisfaction
High Patient Satisfaction § Phase 3 acceptability study (n=905 subjects)1 § Overall, nearly 90% of women in a global clinical trial were satisfied with ANNOVERA as a form of contraception § Most women ranked ANNOVERA highly in characteristics related to: - Ease of use - Comfort - Expulsion - Physica
Slide 52: 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 Removable at any Removable at Patient Control Stop at a
Slide 53: Patient Types
P a t i e n t Ty p 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 reversible § Nulliparou
Slide 54: Launch Approach
Launch Approach Test and Learn Market Introduction Begins Week of September 30, 2019 No Pre-Launch Activities National Launch § WAC Price set at $2,000/ § Test and learn market § Initial focus on OBGYN unit (1 year) introduction target overlap with Menopause Products § Continue dialogue with FDA § P
Slide 55: Market Opportunity
Market Opportunity Addressable Birth Control Market Rx Options NRx: 28M Percent of Overall Birth Control Market NRx Average Net Revenue / Unit 1.0% 1.5% 2.0% 2.5% $1,000 $280M $420M $560M $700M $1,500 $420M $630M $840M $1.05B $1,750 $490M $735M $980M $1.2B Addressable NuvaRing Market NRx: 1.2M Perce
Slide 56: The Power of the Portfolio: Multiple Paths to $1B of Peak Sales
The Power of the Portfolio Multiple Paths to $1B of Peak Sales Percent of Market Based on Patient Count of 2.3M and 4 fills per year Average Net Revenue / Unit 25% 35% 45% 55% $80 $184M $257.6M $331.2M $404.8M $100 $230M $322M $414M $506M Total Addressable FDA Market : 3.8M Total Addressable Compoun
Slide 57: Financial Overview
¥ Imvexxy’ estradiol vaginal inserts) 4 meg-10 meg Financial Overview eS B iJ UV intin (stradioland progesterone) capsules TherapeuticsMD> For Her: For Life.
Slide 58: 2019 Financial Guidance
2019 Financial Guidance 3Q2019 4Q2019 FY2019 Estimate Estimate Estimate FDA-Approved Products Net Revenue $4.50 - 6.50M $11.00 - 13.00M $20.75 - 24.75M Prenatal Vitamins $2.25 - 2.50M $1.75 - 2.25M $8.70 - 9.45M Net Revenue Total TXMD Net Revenue $6.75 - 9.00M $12.75 - 15.25M $29.45 - 34.20M Importa
Slide 59: $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 60: TXMD: Financial Snapshot
TXMD: Financial Snapshot Listing Insider Shares Exchange Ownership Outstanding ~15% 241.2M (as of August 2, 2019) (as of June 30, 2019) TSSP Cash Facility $182.8M $300M* (as of June 30, 2019) * $300 million non-dilutive term loan facility with TPG Sixth Street Partners (TSSP) entered into on April 2
Slide 61: The Power of a Women's Health Portfolio
The Power of a Women’s Health Portfolio No Prenatal Vitamins Image PRENATAL CONTRACEPTION/ VASOMOTOR DYSPAREUNIA CONTRACEPTION CARE FAMILY PLANNING - SYMPTOMS (Vulvar & Vaginal PERIMENOPAUSE Atrophy) REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT 61 61
Slide 62: Appendix
¥ Imvexxy’ estradiol vaginal inserts) 4 meg-10 meg eS B iJ UV intin (stradioland progesterone) capsules Appendix TherapeuticsMD> For Her: For Life.
Slide 63: IMVEXXY Quarterly Performance
IMVEXXY Quarterly Performance Quarterly Scripts to Patients Quarterly Net Revenue 120 $3,500 100 $3,000 55% 41% Thousands $2,500 80 Thousands $2,000 60 $1,500 40 $1,000 20 $500 0 $0 3Q18 4Q18 1Q19 2Q19 3Q18 4Q18 1Q19 2Q19 3Q18 4Q18 1Q19 2Q19 3Q18 4Q18 1Q19 2Q19 63 63
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