Slide 1: 4Q and Full-Year 2018 Financial Results
4Q and Full-Year 2018 Financial Results February 21, 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, 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 4: Strong IMVEXXY Launch
Strong IMVEXXY Launch IMVEXXY (estradiol vaginal inserts) Launch Metrics Total paid scripts dispensed to patients1 ~86,000 (since launch through Jan. 31, 2019) Total paid scripts ~23,500 (January 1-31, 2019) Total patients ~30,100 (since launch through Jan. 31, 2019) Total prescribers2 ~8,100 (since
Slide 5: Strong Patient Adherence & Compliance
Strong Patient Adherence & Compliance through January 31, 2019 IMVEXXY Patient Compliance1,2 Maximum Allowable Month Initial Average # Fills for Fills Given the Month Prescription Filled those Patients of Initial Fill December 2018 1.9 Fills 2 Fills November 2018 2.6 Fills 3 Fills October 2018 3.1 F
Slide 6: 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 7: 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 on 3/1/194 Anthem 7.4% Adjudicating a
Slide 8: 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 9: IMVEXXY Growth Levers in 2019
IMVEXXY Growth Levers in 2019 1 2 3 4 Lever 1: HCP Lever 2: Payer Lever 3: Medical Lever 4: Consumer Education and Access Education • DTC rollout in 2H19 Patient Affordability • Commercial • Goal of 70 Speaker • Launching when • ~8,100 targets contracts with programs in 1Q19 HCP awareness have writt
Slide 10: 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 11: 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 12: BIJUVA Addressable Markets
BIJUVA Addressable Markets BIJUVA Substitutable Market FDA-Approved Off-Label Combination Synthetic E+P1 Compounded Combination Separate Bio-Identical Bio-Identical E+P E & P Pills ~3.9 million TRx (each)1 ~2.5 million TRx2 12 – 18 million TRx3 $780M-$975M4 TAM $500M-$625M4 TAM $2.4B-$4.5B4 TAM 2 co
Slide 13: 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 14: 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 15: 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 16: BIJUVA Fulfills the Unmet Need of an FDA-approved Combination Bio-identical Option
BIJUVA Fulfills the Unmet Need of an FDA-approved Combination Bio-identical Estrogen and Progesterone Hormone Therapy Option1 Synthetic Separate Compounded FDA-Approved FDA-Approved Combination Estradiol BIJUVA1-3 Combination Products Estradiol pills and and Progesterone (example Prempro®)1,4 Proges
Slide 17: A Large Target Market for BIJUVA
A Large Target Market for BIJUVA Phase 2 Bio-Ignite: Maximize the Launch Expected: Phase 1: Initial focus on FDA- launch of the compounding channel Early 2Q19 approved segment of market commensurate with securing during 6 month payer block commercial reimbursement Selectively leverage this channel u
Slide 18: IMVEXXY and BIJUVA Addressable Markets
Independent Community Pharmacy IMVEXXY and BIJUVA Addressable Markets IMVEXXY Substitutable Market BIJUVA Substitutable Market FDA-Approved Product TRx Count Off-Label Combination Synthetic Compounded Osphena® 217,000 Separate Bio-Identical E+P1 Combination E & P Pills Bio-Identical E+P Estrace® & G
Slide 19: Pharmacy Targeting: Program Stats
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 (5 Months of Launch): Live Accounts: 22 States Reached: MA, OH, TX, VA, TN, AL, NH,
Slide 20: 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) All Other 4,044 14% Oral Contraceptive Pill 9,099 31% Condoms 6,283 Contraceptive Ring & Patch 867 Long-acting Reversible Contraception 7,438 3 Month Injection 1,517 Source: Centers for Disease Con
Slide 21: ANNOVERA
ANNOVERA (Segesterone Acetate and Ethinyl Estradiol Vaginal System) Clinical Attributes § Only FDA approved long-acting reversible birth control that doesn’t require a procedure or repeat doctor’s visit • Empowers women to be in control of their fertility and menstruation • Annovera is the only user
Slide 22: ANNOVERA Physical Attributes
ANNOVERA Physical Attributes Physical Attributes § Softer and more pliable than NuvaRing § Acceptable for women who haven’t had a child (nulliparous) or are not in a monogamous relationship1 § “Vaginal System” – the only product in a new class of contraception with potential for $0 co-pay § Cost and
Slide 23: ANNOVERA – Long-Acting and Patient Controlled
ANNOVERA – Long-Acting and Patient Controlled Target Market Segments 1 2 3 Long-acting, prescription NuvaRing®: Short-acting Oral Contraceptives: reversible contraceptives Potential Compliance Issues (IUDs, implants): Requires a Procedure for insertion and removal ANNOVERA: The Only Long-Acting, Pro
Slide 24: TXMD Presence at Upcoming Medical Meetings
TXMD Presence at Upcoming Medical Meetings § International Society for the Study of Women’s Sexual Health (ISSWSH), March • BIJUVA secondary endpoints - vaginal health • ANNOVERA sexual outcomes and acceptability § Endocrine Society meeting, March • ANNOVERA – strong efficacy – bleeding profile – la
Slide 25: IMVEXXY Prescription Performance
IMVEXXY Prescription Performance IMVEXXY Launch Metrics 3Q18 4Q18 FY18 Total paid scripts1 ~14,900 ~47,500 ~64,400 1 Total prescription data is based on IQVIA prescriber level data plus additional unique patients identified through utilization of our affordability program. This includes a one week e
Slide 26: Looking Ahead: Key Expected Events in 2019
Looking Ahead: Key Expected Events in 2019 § 1Q 2019 - Speaker programs throughout the U.S. highlighting the clinical and physical attributes of IMVEXXY § 1Q 2019 - through 3Q 2019 – Expand IMVEXXY Part D coverage § 2H 2019 - Begin direct-to-consumer marketing for IMVEXXY § 2Q 2019 – U.S. commercial
Slide 27: Questions
QUESTIONS ANSWERS _ TherapeuticsMD For Her: For Life.