Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Oppenheimer 29th Annual Healthcare Conference (March 2019)
39 slides from Therapeuticsmd's conference presentation, Mar 19, 2019
Slide 1: Investor Presentation
Investor Presentation March 19, 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: New Product Launches Address Large Market Opportunities in Women's Health
New Product Launches Address Large Market Opportunities in Women’s Health ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) Easy to use, lowest effective First and only bio-identical FDA- First and only patient-controlled, Key Value dose, designed to support approved combination p
Slide 4: 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. 4
Slide 5: 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 6: Strong Launch
Strong 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 (since launc
Slide 7: 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 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: Commercial Payer Update
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 as of A
Slide 10: Medicare Part D Payer Update
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 Top 6 Plan
Slide 11: Growth Levers in 2019
Growth Levers in 2019 Lever 1: Lever 2: Lever 3: Lever 4: HCP Education and Payer Access Market Expansion Consumer Patient Affordability • Commercial • Maximize launch • DTC rollout in 2H19 • ~9,000 targets contracts with through BIO- • Launching when have written as majority of top IGNITE HCP aware
Slide 12: 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 13: BIJUVA: first FDA-approved bio-identical estradiol and progesterone combination
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. 13
Slide 14: 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 15: 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 16: Addressable Markets
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 copays 1 co
Slide 17: BIJUVA is indicated for moderate to severe vasomotor symptoms due to menopause
BIJUVA is indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause Key Clinical Attributes § First and only bio-identical combination of estradiol to reduce moderate to severe hot flashes combined with progesterone to help reduce the risk to the
Slide 18: No Clinically Significant Changes in Coagulation Parameters
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 Baseline Month 12 Baseline Month 12 Baseline Mo
Slide 19: No Clinically Significant Changes in Lipid Parameters
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 Baseline Month 12
Slide 20: Improvement in Quality of Life Measures
Improvement in Quality of Life Measures 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-Specific Quality of Life 82* Quest
Slide 21: 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 22: 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 23: 2019 TXMD Salesforce Expansion
2019 TXMD Salesforce Expansion ü 200 sales representative 23
Slide 24: Regulatory Environment Continues to Favor FDA-Approved Products
Regulatory Environment Continues to Favor FDA-Approved Products October 2012 2014 2016 December 2019 Contaminated Creation of “Do Not USP <800> finalized, Final implementation compounded Compound” list and addressing of USP <800> drugs made at established Pharmacy hazardous drugs, NECC kill 64 Compo
Slide 25: 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 26: Progress and Results
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 >400 Pharmacies TXMD Outreach to with Prescription >500,
Slide 27: Program Stats (6 Months since Pilot)
Program Stats (6 Months since Pilot): Live Accounts Dispensing IMVEXXY now or shortly in anticipation for BIJUVA: 29 (up 7 from Feb. 22, 2019) States Reached: 31 § AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, KS, LA, MA, MD, MI, MO, MS, NC, NJ, NV, NY, OH, OK, PA, RI, SC, TN, TX, VA, WA Compounding P
Slide 28: 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 28
Slide 29: ANNOVERA
ANNOVERA™ (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). 29
Slide 30: 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 31: 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 32: Acceptability Data
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 33: 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 34: 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 34
Slide 35: 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 36: 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 37: Opportunities to Strengthen our Position Once All 3 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 38: 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 39: Thank You
TherapeuticsMD" For Her. For Life. SS 39
TherapeuticsMD — Oppenheimer 29th Annual Healthcare Conference (March 2019) on 6ix