Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (September 2019)
54 slides from Therapeuticsmd's investor presentation, September 2019
Slide 1: Investor Presentation: Building a Premier Women's Health Portfolio
Investor Presentation September 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
Y Imvexxy’ estradiol vaginal inserts) 4 meg 10 meg ——— B iJ UV A intin (stradiol and progesterone) capsules nnovera (segesterane acetate and ethinyl estradiol vaginal system) Delivers 0.15 mg/0.013 mg per day General Updates TherapeuticsMD’ For Her: For Life. 3
Slide 4: General Updates and Near-Term Catalysts
General Updates and Near-Term Catalysts § Began IMVEXXY direct to consumer advertising leveraging digital and social media platforms § Held Satellite Media Tour for Menopause Awareness Month (September) No § Expanded payer coverage for BIJUVA and ANNOVERA; awaiting additional decisions on IMVEXXY §
Slide 5: 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 6: 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 7: 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 8: 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 9: 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 10: 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 11: 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 12: Commercial Payer Update
Commercial Payer Update Coverage Decisions Expected to be finalized 1Q20 Selected Regional Plan Coverage Plan Status1 MC-Rx Adjudicating as of April 2019 (ProcareRx) BCBS of Adjudicating at no copay as of August 2019 Massachusetts New Excellus Adjudicating as of September 2019 New EmblemHealth Adjud
Slide 13: 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 14: 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). 14 14
Slide 15: IMVEXXY
The image part with relationship ID rId2 was not found in the file. IMVEXXY 15 15
Slide 16: 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 17: TXMD Product Overview
(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 18: 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 Even though there are o
Slide 19: 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 20: The Scope of VVA in the US
0 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 21: 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 22: 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 23: 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 24: 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 $184,000,000 $257,600,000 $331,200,000 $404,800,000 $100 $230,000,000 $322,000,000 $414,000,000 $506,000,000 Percent of market based on patient
Slide 25: Commercial Payer Status
Commercial Payer Status Top 10 Plans Account for ~71% of all Commercial Pharmacy Lives Plan % of Lives1 Status2 CVS 15.4% Awaiting decision in 3Q ESI 15.3% Adjudicating as of 10/1/18 United 7.5% Adjudicating as of 3/1/19 Anthem 7.3% Adjudicating as of Aug. 2018 Prime 6.5% Adjudicating as of 1/1/19 O
Slide 26: 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 27: 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 28: IMVEXXY Catalysts
The image part with relationship ID rId2 was not found in the file. IMVEXXY Catalysts Direct to Consumer Advertising Medicare Part D Decisions § Expect commercial coverage decisions from CVS and Aetna Begin Copay & Distribution Optimization § Menopause Awareness § NAMS Premier Sponsor Month - Satell
Slide 29: BIJUVA
The image part with relationship ID rId2 was not found in the file. BIJUVA 29 29
Slide 30: 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 + Progestins Estradiol & Progester
Slide 31: 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 32: 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 separate Reps directed to focus on ~10 Q2 bio-identical Estrogen & prescribers in their territory until improved payer Progesterone pills segment covera
Slide 33: 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 § As little as $35 out-of-pocket cost* § Addresses the cost and coverage concerns which are often barriers to early adoption § “Ke
Slide 34: 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 35: 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 36: Market Opportunity
Market Opportunity Total Addressable FDA Market: 3,900,000 Total Addressable Compounding Market: 12,000,000 Percent of Addressable Market Average Net Revenue / Unit 25% 35% 45% 55% $80 $316,000,000 $442,400,000 $568,800,000 $695,200,000 $100 $395,000,000 $553,000,000 $711,000,000 $869,000,000 Market
Slide 37: BIJUVA Catalysts
The image part with relationship ID rId2 was not found in the file. BIJUVA Catalysts Commercial Payer Cycle Completion Expected § Menopause Awareness BIO-IGNITE Expansion Month - Satellite Media Tour Begin Copay and Distribution Optimization § NAMS Premier Sponsor Direct to Consumer § NAMS Publicati
Slide 38: ANNOVERA
The image part with relationship ID rId2 was not found in the file. ANNOVERA 38 38
Slide 39: 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 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 ~ 90M annual scripts to ~20M women2 Long-acting Complete control but Long-acting benefits benefits but requires no long acting benefits without a procedure a procedure and offering compl
Slide 41: 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 42: 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 43: High Patient Satisfaction
High Patient Satisfaction § Phase 3 acceptability study (n=905 subjects)1 § Overall satisfaction (~90%) related to: • Ease of use • Side effects • Expulsions/feeling the product • Physical effect during sexual activity § High rates of adherence (94.3%) and continuation (78%) Ease of Use Ease of reme
Slide 44: 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 45: Launch Approach
The image part with relationship ID rId2 was not found in the file. Launch Approach 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 § Continue dialogue with FDA § Production ramps to Meno
Slide 46: Market Opportunity
Market Opportunity Addressable Birth Control Market Rx Options NRx 28,000,000 Percent of Overall Birth Control Market NRx Average Net Revenue / Unit 1.0% 1.5% 2.0% 2.5% $1,000 $280,000,000 $420,000,000 $560,000,000 $700,000,000 $1,500 $420,000,000 $630,000,000 $840,000,000 $1,050,000,000 $1,750 $490
Slide 47: 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 $184,000,000 $257,600,000 $331,200,000 $404,800,000 $100 $230,000,000 $322,000,000 $414,000,000 $506,000,000 Total Addre
Slide 48: Financial Overview
Y Imvexxy’ estradiol vaginal inserts) 4 meg 10 meg —— Bi UV A inion (stradiol and progesterone) capsules nnovera (segesterane acetate and ethinyl estradiol vaginal system) Delivers 0.15 mg/0.013 mg per day Financial Overview TherapeuticsMD> Lor Her. For Life.
Slide 49: 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 50: 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 51: 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 Prenatal Vitamins PRENATAL CONTRACEPTION/ VASOMOTOR DYSPAREUNIA CONTRACEPTION CARE FAMILY PLANNING - SYMPTOMS (Vulvar & Vaginal PERIMENOPAUSE Atrophy) REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT
Slide 52: Appendix
Appendix ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) 52 52
Slide 53: 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 54: 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 &
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