Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (March 2019)
49 slides from Therapeuticsmd's investor presentation, March 2019
Slide 1: Investor Presentation March 2019
Investor Presentation March 2019
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 women's health company overview
(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 4: Key Planned Levers for Growth
Key Planned Levers for Growth ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) § 1Q 2019 - 50 additional sales reps § 2Q 2019 (April) - U.S. commercial § 2H (targeting 3Q) 2019 - U.S. added launch of BIJUVA and draw second commercial launch of ANNOVERA § 1Q 2019 – Maximize IMVEXX
Slide 5: Opportunities to Strengthen our Position Once All Products are Launched and Covered
Opportunities to Strengthen our Position Once All 3 Products are Launched and Covered § 1Q 2020 - All 3 products are expected to be covered by payers § Based on volume generated by 3 products concentrated in women’s health care, TXMD can optimize distribution costs, relationships and partnerships §
Slide 6: IMVEXXY approved for moderate-to-severe dyspareunia
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. 6
Slide 7: Strong IMVEXXY Launch
Strong IMVEXXY Launch IMVEXXY (estradiol vaginal inserts) Launch Metrics Total paid scripts dispensed to patients1 ~109,600 (since launch through Feb. 28, 2019) Total paid scripts ~23,600 (February 1-28, 2019) Total patients ~37,600 (since launch through Feb. 28, 2019) Total prescribers2 ~9,000 (sin
Slide 8: Strong Patient Adherence & Compliance
Strong Patient Adherence & Compliance through February 28, 2019 IMVEXXY Patient Compliance1,2 Maximum Allowable Month Initial Average # Fills for Fills Given the Month Prescription Filled those Patients of Initial Fill January 2019 1.9 Fills 2 Fills December 2018 2.5 Fills 3 Fills November 2018 3.2
Slide 9: Successful Launch Execution
Successful Launch Execution IMVEXXY TRx Launch Comparison 70,000 § IMVEXXY continues to grow both weekly average volume and daily 60,000 average volume for February (28 day month) vs January (31 day month) 56,500 § Average daily volume for 28 days in February 2019 increase to 842 from 758 for the 31
Slide 10: IMVEXXY Commercial Payer Update
IMVEXXY Commercial Payer Update TRx Payer Breakdown of FDA- Approved VVA Products1 Top 10 Plans Account for ~73% of all Commercial Pharmacy Lives Medicaid Cash Plan % of Lives2 Status3 CVS 15.5% 5% 3% ESI 15.4% Adjudicating as of 10/1/18 United 7.6% Adjudicating as of 3/1/19 Anthem 7.4% Adjudicating
Slide 11: IMVEXXY Medicare Part D Payer Update
IMVEXXY Medicare Part D Payer Update United and Kaiser Medicare Part D are Now Adjudicating (Paying) Medicare Part D Update § United Healthcare and Kaiser Medicare Part D are now adjudicating § United Healthcare is the largest Medicare Part D payer § Bids submitted for other Medicare Part D plans To
Slide 12: TXMD Strategy Built to Maximize Value of IMVEXXY
TXMD Strategy Built to Maximize Value of IMVEXXY Growth of Imvexxy Market Share 500,000 25.0% 450,000 428,700 429,800 412,700 405,100 400,000 20.0% 350,000 IMVEXXY Monthly Market Share VVA Category Monthly TRx 300,000 15.0% 250,000 200,000 10.0% 150,000 5.7% 100,000 4.6% 5.0% 3.0% 3.4% 50,000 0 0.0%
Slide 13: What is Leading to Rapid Uptake?
What is Leading to Rapid Uptake? 13
Slide 14: IMVEXXY is Clearly Differentiated from Other Treatment Options
IMVEXXY is Clearly Differentiated from Other Treatment Options 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 as early as 2 weeks 3 (secondary endpoint) P
Slide 15: IMVEXXY Growth Levers in 2019
IMVEXXY Growth Levers in 2019 Lever 1: Lever 2: Lever 3: Lever 4: HCP Education and Payer Access Medical Education Consumer Patient Affordability • Commercial • Goal of 70 Speaker • DTC rollout in 2H19 • ~9,000 targets contracts with programs in 1Q19 • Launching when have written as majority of top
Slide 16: Synergies Provide Potential to Expand the Market
Synergies Provide Potential to Expand the Market BIJUVA is a Significant Sales Force Pull-Through Opportunity for IMVEXXY in 2019 § VMS and VVA are different symptoms of menopause1 that are addressed with BIJUVA and IMVEXXY in one complementary product portfolio § Menopausal women often experience b
Slide 17: BIJUVA first FDA-approved bio-identical combination hormone therapy
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. 17
Slide 18: 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 strong feelings of heat or sweating § Occur predominan
Slide 19: WHI Impact on FDA Approved Hormone Therapy
WHI Impact on FDA Approved Hormone Therapy 100% Market Share of Synthetic vs Bio-Identical 90% 2018 16.9 Million TRx 80% 2000 70% 88.7 Million TRx 60% % of Market - FDA Approved Synthetic HRT 50% % of Market - FDA Approved Bio-Identical HRT 40% 30% 2018 20% 7.7 Million TRx 2000 10% 18.8 Million TRx
Slide 20: BIJUVA Addressable Markets
BIJUVA Addressable Markets BIJUVA Substitutable Market FDA-Approved Off-Label Combination Synthetic Compounded Combination Separate Bio-Identical E+P1 Bio-Identical E+P E & P Pills ~3.9 million TRx (each)1 ~2.5 million TRx2 12 million – 18 million TRx3 ~$836M4 TAM ~$5364 TAM ~$2.5B-$3.8B4 TAM 2 copa
Slide 21: BIJUVA Addressable Market: FDA Approved Products
BIJUVA Addressable Market: FDA Approved Products BIJUVA – KEY CONVERSION ATTRIBUTES PATIENT DEMAND Satisfies demand for bio-identical hormone therapy PROPRIETARY TECHNOLOGICAL INNOVATION Off-Label Separate Solubilization of estradiol and progesterone led to significant improvements in numerous secon
Slide 22: BIJUVA Addressable Market: Compounded Products
BIJUVA Addressable Market: Compounded Products BIJUVA – KEY ADOPTION ATTRIBUTES STRONG EFFICACY AND SAFETY DATA Bio-Identical formulation supported by strong, independent efficacy and safety data TECHNOLOGICAL INNOVATION Compounded Technology unique to BIJUVA not documented or reproducible by compou
Slide 23: BIJUVA's Phase 3 Clinical Attributes
BIJUVA’s Phase 3 Clinical Attributes 23
Slide 24: No Clinically Significant Changes in Lipid Parameters were Observed
No Clinically Significant Changes in Lipid Parameters were Observed In REPLENISH, lipid parameters were measured at baseline and Month 12 Total Cholesterol LDL cholesterol Triglycerides Mean concentration (mg/dL) 250 120 140 120 100 200 100 80 150 80 60 100 60 40 40 50 20 20 0 0 0 BIJUVA Placebo BIJ
Slide 25: No Clinically Significant Changes in Coagulation Parameters with BIJUVA
No Clinically Significant Changes in Coagulation Parameters were Observed with BIJUVA 14 Activated Partial Fibrinogen 50 Mean Concentration (Umol/L) Thromboplastin Prothrombin 14 12 40 12 10 Mean Time (s) Mean Time (s) 10 8 30 8 6 20 6 4 4 10 2 2 0 0 0 BIJUVA Placebo BIJUVA Placebo BIJUVA Placebo An
Slide 26: Patient-reported Outcomes Secondary Endpoints: CGI, MENQOL, and MOS-Sleep
Patient-reported Outcomes Secondary Endpoints: CGI, MENQOL, and MOS-Sleep Clinical Global Impression (CGI) § Significantly more women rated their condition CGI response: as very much or much improved with BIJUVA Clinically meaningful improvement compared with placebo at Weeks 4 and 12 100 Menopause-
Slide 27: BIJUVA's Launch Strategy
BIJUVA’s Launch Strategy TherapeuticsMD For Her: For Life. 27
Slide 28: A Large Target Market for BIJUVA
A Large Target Market for 1 Launch Expected: April 2019 Initial focus on FDA-approved 2 off-label separate bio-identical E&P pills segment of market during 6 month payer block ~3.9M TRx (each)1 I $836M2 TAM Maximize the launch of the 3 Selectively leverage compounding channel this channel until comm
Slide 29: Payer Breakdown of FDA-Approved VMS Products
Payer Breakdown of FDA-Approved VMS Products1 Cash and Pt Assistance § Compared to IMVEXXY Medicaid 9% Medicare Part D is a smaller segment of the population 8% § Expect 6 month commercial Commercial payer block and similar payer Medicare Part D 70% onboarding timeline to 13% IMVEXXY 1 IMS Data 2018
Slide 30: Salesforce Footprint Considers Distinct Market And Overlap
Salesforce Footprint Considers Distinct Market And Overlap Portfolio Optimization Summary § Ensure momentum with IMVEXXY writers IMVEXXY BIJUVA • 2019 Salesforce reaches 24,431 total targets Decile Decile • 94% Coverage of decile 6-10 target decile 6-10 6-10 • 62% Coverage of total market TRx § Laun
Slide 31: 2019 TXMD Salesforce Expansion
2019 TXMD Salesforce Expansion ü 191 Field Sales Territories ü 4 Inside Sales Assignments (whitespace coverage) ü 8.5 to 1 Rep to Manager ratio ü 24 Sales Teams 31
Slide 32: Strategic Partnerships and Initiatives
Strategic Partnerships and Initiatives 32
Slide 33: IMVEXXY and BIJUVA Addressable Markets
Independent Community Pharmacy IMVEXXY and BIJUVA Addressable Markets IMVEXXY Substitutable Market BIJUVA Substitutable Market Product TRx Count FDA-Approved Osphena® 217,000 Off-Label Combination Compounded Separate Bio-Identical Synthetic E+P1 Combination E & P Pills Bio-Identical E+P Estrace® & G
Slide 34: Genesis of Bio-Ignite = Innovative Commercial Approach
Genesis of Bio-Ignite = Innovative Commercial Approach Confluence of Events Support Robust Growth of TXMD Compounding Platform Large, Untapped Market § Over 3,000 physicians are Regulatory Environment currently writing high Innovation in Women’s Health volumes of bio-identical § FDA-approval of IMVE
Slide 35: What is an Independent Community Compounding Pharmacy?
What is an Independent Community Compounding Pharmacy? There are more than 23,000 independent community pharmacies across the United States These pharmacies dispense approximately 40% of the nation’s retail prescription drugs § 72% of independent community pharmacies that compound prescriptions prov
Slide 36: Pathway of Prescription – Holistic Approach
Pathway of Prescription – Holistic Approach Customization is adding therapy…not tweaking dosages Estradiol & Progesterone Claims Estrone, Estriol & DHEA Claims Base for all Patients Controls VMS symptoms Testosterone Claims Promotes sleep & Breast cancer calming reduction/prevention Progesterone to
Slide 37: Pharmacy Targeting: Program Stats
SM Pharmacy Targeting: 700+ are high tier targets (T1-T4 based on byte data) § These locations produce the highest potential volume of compounded bio-identical hormone replacement therapy (CBHRT) scripts Program Stats (6 Months since Pilot): Live Accounts Dispensing IMVEXXY now or shortly in anticip
Slide 38: 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 * ~1,500,000 >300 Pharmacies prescriptions annually New National Compounding ~100 Pharmacies (vet
Slide 39: National High-Decile Compounding Pharmacies and TXMD Sales Team Overlap
National High-Decile Compounding Pharmacies and TXMD Sales Team Overlap § Yellow indicates field sales territory reach § Red, Blue and Green indicate Compounding Pharmacy Targets § Black Stars indicate TXMD pharmacy rep location *This does not include the sales expansion territories 39
Slide 40: 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). 40
Slide 41: 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 • 21/7 days cyclical dosing regimen for one year (13 cycles) • Segesterone acetate component of ANNOVERA was classified as a new chemical e
Slide 42: ANNOVERA Clinical & Physical Attributes
ANNOVERA Clinical & Physical Attributes Clinical Attributes § Highly effective in preventing pregnancy when used as directed (97.3%) § Low daily release of ethinyl estradiol (13 mcg) § Only product with new novel progestin - segesterone acetate1 • No androgenic, estrogenic or glucocorticoid effects
Slide 43: Phase 3 Acceptability Study
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 44: Reversible Birth Control Market in the U.S.
Reversible Birth Control Market in the U.S. 2017 Women's Use of Contraception (Total 29 Million Women) §OC’s continue to lose market Other share to longer acting 14% solutions such as IUDs, Oral contraceptives Implants and Rings 31% Condoms §IUDs and Implants are 22% experiencing significant growth
Slide 45: ANNOVERA – Addressing an Unmet Need
ANNOVERA – Addressing an Unmet Need Target Market Segments Long-acting Complete control but Long-acting benefits benefits but requires no long acting benefits without a procedure a procedure and and complete control does not offer over fertility and complete control menstruation 45
Slide 46: ANNOVERA Key Attributes
ANNOVERA Key Attributes Oral Contraceptives Vaginal Ring Contraceptive Injection Vaginal System IUDs NuvaRing® ANNOVERA™ Duration of Action Daily pill intake 1 month (21/ 7 regimen) 3 months 1 year (21/7 regimen) 3-10 years Stop at any time Removable at any time Stop at any time, but residual Remova
Slide 47: TherapeuticsMD, A Premier Women's Health Company
TherapeuticsMD, A Premier Women’s Health Company ANNOVERA™ ANNOVERA™ (segesterone acetate and ethinyl (segesterone acetate and ethinyl Prenatal Vitamins estradiol vaginal system) estradiol vaginal system) CONTRACEPTION/ DYSPAREUNIA VASOMOTOR CONTRACEPTION PRENATAL CARE FAMILY PLANNING - (Vulvar & SY
Slide 48: TXMD: Financial Snapshot
TXMD: Financial Snapshot Listing Insider Shares Exchange Ownership Outstanding ~15% 241.2M (Feb. 18, 2019) (Dec. 31, 2018) Debt Cash $75M $161.6M (as of Dec 31, 2018) (as of Dec. 31, 2018) 48
Slide 49: Thank You
TherapeuticsMD" For Her. For Life. SS 49