Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (March 2014)
33 slides from Therapeuticsmd's investor presentation, Mar 4, 2014
Slide 1: Corporate Overview Q1 2014
NYSE MKT: TXMD Corporate Overview Q1 - 2014 COPYRIGHT 2014 by TherapeuticsMD
Slide 2: Forward-Looking Statements
This presentation includes forward - looking statements covered by the safe harbor provision of the Private Securities Litigation Reform Act of 1995, including predictions, estimates, and other information that might be considered forward - looking. While these forward - looking statements represent
Slide 3: Hormone Therapy Market Opportunity
Hormone Therapy Market Opportunity 2
Slide 4: Two late-stage 505(b)(2) hormone therapy product candidates
3 Two late - stage 505(b)(2) hormone therapy (“HT”) product candidates targeting multi - billion dollar U.S. markets ( 1 )(2) Pipeline (1) PHAST Prescription Monthly by Source Healthcare Analytics. (2) Estimates per: Dr. Loyd Allen Jr ., Editor - in - Chief, International Journal of Pharmaceutical C
Slide 5: Combination Product TX-001HR E+P
Combination Product TX 12 - 001HR E+P 4
Slide 6: History of Hormone Therapy
5 Women’s Health Initiative (WHI) • Hormone Therapy is linked to Cardiovascular, Cancer and other risks • Estrogen + Progestin ( Prempro ) arm had a 24% increase in breast cancer vs. Estrogen alone History of Hormone Therapy * (1) PHAST Prescription Monthly by Source Healthcare Analytics. Inflation
Slide 7: Bio-identical Hormone Replacement History of Compounding
6 Bio - identical Hormone Replacement (BHRT) History of Compounding
Slide 8: Bioidentical Progesterone vs Non-Bioidentical Progestins
Side Effect (1) Bioidentical Natural Progesterone Non - Bioidentical Progestins (MPA, NETA, drosperinone) Breast cancer More favorable profile (E3N - EPIC study) Increased risk Cardiovascular More favorable profile (PEPI trial) Increased risk of MI, stroke, VTE Lipid profile More favorable profile (
Slide 9: Estradiol vs. Conjugated Estrogens
8 Journal of the American Medical Association September 30, 2013 CEEs ( Premarin ) were associated with a higher incidence of venous thrombosis and myocardial infarction than oral estradiol Journal of the American Medical Association October 3, 2013 Breast Cancer Risk persists for 13 years after dis
Slide 10: TXMD Novel Drug Design
9 □ Meet PK 505(b)(2) thresholds x TXMD Novel Drug Design Combination of Estradiol + P rogesterone RLD = Reference Listed Drug API = Active Pharmaceutical Ingredient Converted (API) from solid / crystalline to a New Liquid Drug Form Estrace (RLD) is a tablet — 0.5 mg, 1.0 mg, and 2.0 mg Prometrium (
Slide 11: TX-001HR E+P Phase 3 Study
10 TX 12 - 001HR E+P — Phase 3 Study Combination of Estradiol + P rogesterone 2012 2013E 2014E 2015E 2016E Q3 '12 Q4 '12 Q1 '13 Q2 '13 Q3 '13 Q4 '13 Q1 '14 Q2 '14 Q3 '14 Q4 '14 Q1 '15 Q2 '15 Q3 '15 Q4 '15 Q1 '16 Q2 '16 Q3 '16 Q4 '16 Filed IND Pilot PK Studies Pivotal PK Studies NDA and PDUFA Phase 3
Slide 12: Relative Bioequivalence PK Results
11 95% Upper Confidence Limit for PK Parameter Prometrium = R1 Prometrium = R2 TXMD = T Parameter Point Estimate T/R Ratio Within Subject Std. Deviation Upper 95% Confidence Bound C max 1.16 1.179 - 0.785 AUC 0 - t 1.05 0.956 - 0.542 1 10 100 0 5 10 15 20 25 30 35 40 45 50 Time (hr) Treatment=R1 Tre
Slide 13: Transdermal Development
Transdermal Development 12 Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 File File IND IND E+P Update Transdermal Pilot Preclinical Pilot Phase 1 Studies Studies PK and clinical Study File File IND IND P Update Transdermal Pilot Preclinical Pilot Phase 1 Stu
Slide 14: Enormous E+P HT Market Opportunity
Product Progestin U.S. Sales (est.) Intl Sales (4) Company 17 β E stradiol + NETA / Drospirenone (Activella / FemHRT / Angeliq / others) Non - bioidentical $ 230 mm (1)(2) Premarin + MPA (Prempro / Premphase) Non - bioidentical $ 328 mm (1)(2) Estradiol + Progesterone (custom compounded ) Untested B
Slide 15: Drug Quality and Security Act
14 Drug Quality and Security Act Signed by President on 11/27/13 Bill Highlights Prohibits compounding of essentially a copy of an FDA approved & marketed drug Prohibits compounding of certain drug products, including those identified by regulation as being demonstrably difficult to compound such as
Slide 16: Vulvar / Vaginal Atrophy (VVA)
15 Vulvar / Vaginal Atrophy (VVA)
Slide 17: VVA Mechanism and Symptoms
Mechanism: Decreased estradiol levels cause a reduction in superficial cells Parabasal cells increase Vagina changes from acidic to basic (increased pH) Most common symptoms: Burning, dyspareunia, UTI & itching Chronic condition; requires ongoing therapy for the rest of a woman's life
Slide 18: VVA Market
17 The North American Menopause Society (NAMS ) Position Statement: “ Management of Symptomatic Vulvovaginal Atrophy (VVA),” … affecting nearly 50% of women ; … low - dose vaginal estrogen is the preferred treatment and may be continued as long as the symptoms are present . (1) ASD analysis indicate
Slide 19: US Sales - Vulvar / Vaginal Atrophy
Product Compound U.S. Sales (est.) ($mm) (1)(2) Problems Premarin ® Cream Conjugated equine vaginal estrogen $389 Equine source Non - bioidentical Messy Reusable plungers Vagifem ® Tablets Estring ® Insert Femring ® Insert Estrace ® Cream Vaginal estradiol $316 $81 $23 $284 Messy Reusable plungers D
Slide 20: Leading Estrogen Products vs. TXMD VagiCap
Leading Estrogen Products vs. TXMD 19 TXMD Solution: VagiCap ™ Less messy than creams Well tolerated Easier to use Does not require a long - term device Flexibility of dosing 0.01 mg 0.025 mg
Slide 21: Positive Phase I Study Outcomes
TX 12 - 004 - HR Positive Phase I Study Outcomes 20 48 postmenopausal women with symptoms of VVA Randomized to receive 10µg dose of TX 12 - 004 - HR or placebo VagiCap Self - administered 1x daily for two - week period As compared to placebo, women treated with TX 12 - 004 - HR showed: Statistically
Slide 22: VagiCap vs. Vagifem
VagiCap vs. Vagifem 21 Time ( hr ) Plasma Mean Concentration ( pg /mL) Time ( hr ) Plasma Mean Concentration ( pg /mL) N=36 N=36 Estradiol 25 µg Estradiol 10 µg Key Points: • Tmax ~ 2hours with VagiCap and ~8 hours with Vagifem • Systemic absorption AUC (0 - 24 hrs ) is 2 - 3 fold lower with Vagicap
Slide 23: VagiCap Product Goals
VagiCap Product Goals 22 • Next G eneration product to treat VVA - well tolerated, achieve expected clinical endpoints • Achieve significantly lower or negligible systemic estrogen exposure • Obtain a new indication under the FDA’s new VVA guidance • Deliver an elegant patient experience • Simple -
Slide 24: Estradiol Vaginal Suppository Phase 2B/3 Study
23 Estradiol Vaginal Suppository Phase 2B/3 Study 2014 12 weeks Designed to enroll 250 - 300 subjects in each arm − Multiple Active Arms − Placebo (n=100) Endpoints: − Cell change − Lowering of pH − Evaluation of Adverse Effects
Slide 25: Lower Dose Progesterone TX-002HR
24 Lower Dose Progesterone TX 12 - 002HR
Slide 26: TX-002HR Progesterone Highlights
Conducted PK studies in accordance with FDA requirements TXMD 150 mg test dose found to be bioequivalent to 200 mg Prometrium ® Product Goals Lower first - pass effect, less metabolites = 25% Increase in bioavailability Lower blood level = TXMD target dose 225mg vs. 400mg Prometrium ® Removed peanut
Slide 27: TX-002HR Progesterone Phase 3 Study
26 TX 12 - 002HR Progesterone — Phase 3 Study Progesterone 2016 Q1 2012 Q2 2012 Q3 2012 Q4 2012 Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Filed File IND update & IND P3 protocol Pilot PK Pivotal Studies PK P3 Amenorrhea Study - Progestero
Slide 28: Natural Progesterone Dominates
Product Progestin U.S. Sales (est.) ($mm) (1)(2) INTL Sales (3) Company Generic Available Provera ® ( medroxyprogesterone acetate) Non - bioidentical $26 mm x Aygestin ® (norethindrone acetate) Non - bioidentical $48 mm x Prometrium ® (micronized progesterone) Bioidentical $290 mm x Total Oral Proge
Slide 29: Extensive Patent Filings
Extensive Patent Filings 28 Filed Provisional Non - Provisional Issued U.S. 25 8 17 2 Ex - U.S. 6 Oral combination therapeutics Bioidentical E+P HT combination Natural combination HT and formulations Oral solo therapeutics Progesterone formulations Vulvovaginal atrophy pessary Pipeline applications
Slide 30: Key Statistics
Key Statistics NYSE MTK: TXMD Recent market price 1 $6.12 Shares outstanding 2 145 million Market capitalization 1 $887.4 million Cash & equivalents 2 $54 million Debt 3 $0.00 million 1 Based upon closing price February 14, 2014 2 As at December 31, 2013
Slide 31: Investor Contacts
Investor Contacts COPYRIGHT 2013 by TherapeuticsMD Dan Cartwright Lisa M. Wilson Chief Financial Officer President TherapeuticsMD, Inc. In - Site Communications, Inc. 561 - 961 - 1930 917 - 543 - 9932 Dan.Cartwright@TherapeuticsMD.com lwilson@insitecony.com
Slide 32: Experienced Management and Drug Development Team
31 John Milligan President Julia Amadio Chief Product Officer Dan Cartwright Chief Financial Officer Dr. Sebastian Mirkin Chief Medical Officer Robert Finizio Chief Executive Officer vitaMed HT Corporate Dr. Joel Krasnow Chief Scientific Officer Management Drug Development Team Proven team with a su
Slide 33: Latest Position Statements
32 “HRT prescribed before the age of 60 has a favorable benefit/risk profile .” “Recent evidence suggests that HRT regimens containing progesterone can minimize the metabolic impact and reduce the risk of thromboembolism .” In a large observational cohort study of French teachers, after five years o