Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Investor Presentation (January 2015)
42 slides from Therapeuticsmd's investor presentation, Jan 12, 2015
Slide 1: Investor Overview January 2015
1 Investor Overview JANUARY 2015 w w w . T h e r a p e u t i c s M D . c o m
Slide 2: Forward-looking statements
2 2 This presentation by TherapeuticsMD Inc. (referred to as “we” and “our”) may contain “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of
Slide 3: Our Mission
3 3 Our Mission To develop treatments that promote women’s health and address the unmet needs of this large, underserved market with innovative technology and first - to - market, FDA - regulated products. Our therapeutic portfolio of drug candidates is built on our SYMBODA™ technology platform, whi
Slide 4: TXMD: Long-Term Growth Opportunity
4 • Experienced clinical t eam • Existing commercial infrastructure • Established Customer relationships ( OB/GYNs) TXMD: Long - Term Growth Opportunity WOMEN’S HEALTH PHARMACEUTICAL EXPERTISE SYMBODA TM TECHNOLOGY • 8 7 Patents pending/granted • Pipeline of 7 novel products EFFICIENT FUNDING • No D
Slide 5: Pipeline Targets Large Markets
5 5 Pipeline Targets Large Markets 1) PHAST Prescription Monthly by Source Healthcare Analytics.as of 10/14 2) Estimated U.S. sales, based on half estradiol patch sales 3) In July 2014 we temporarily suspended enrollment in the Spry Trial and, in October we temporarily stopped it in order to update
Slide 6: SYMBODA Enables The Combination
6 6 SYMBODA TM Enables T he C ombination • Hydrophobic • Crystalline • Small amounts • Low doses 0.5 - 1 mg • Low oral bioavailability • Large molecule • High doses 100 - 200 mg • Micronized • Suspended in peanut oil • 100% inter - /intra - subject variability • Hydrophobic • ~7% oral bioavailabilit
Slide 7: TX-004HR VVA Program
TX-004HR VVA Program TherapeuticsMD”
Slide 8: Overview – Vulvar and Vaginal Atrophy (VVA)
8 8 D iagnosed in approximately 50% of postmenopausal women using measure of vaginal pH levels (1) Most bothersome symptoms include: dyspareunia, dryness, itching, irritation , dysuria , bleeding with sexual activity (1 ) FDA guidance for efficacy requirements: Statistical increase in superficial ce
Slide 9: VVA Market – Established and Growing
9 9 VVA Market – Established and Growing Product Compound TRx (MAT 9/14) (1) U.S. Sales ($M) (1) (2) (MAT 9/14) WAC Price (3) Premarin ® Cream Equine Vaginal Estrogen 1,767,810 $448 $220.02 Vagifem ® Tablets Vaginal Estradiol 1,945,711 $378 $222.12 Estrace ® Cream Vaginal Estradiol 1,738,856 $324 $1
Slide 10: TX-004HR – Target Product Profile
10 Phase 2 showed patient satisfaction; 97% said easy to use Improved User Experience Phase 1 data with 10 mcg suggest lower systemic absorption Lower Systemic Exposure Broad range of doses being evaluated in Phase 3, including 4, 10 and 25 mcg New Lower Effective Dose Demonstrated activity at 14 da
Slide 11: VagiCap vs. Vagifem – Single Dose PK Studies
11 11 VagiCap ™ vs. Vagifem ® – Phase 1 Single Dose PK Studies N=36 N=36 Key Findings • Tmax ~2 hours with VagiCap and ~ 8 hours with Vagifem • Systemic absorption AUC (0 - 24 hours ) is 2 - to 3 - fold lower with VagiCap relative to Vagifem 0 6 12 18 24 0 10 20 30 40 Study 499 - 10 mcg time after d
Slide 12: VagiCap Double-Blind, Controlled Phase 2 Study
12 12 VagiCap ™ Double - Blind, Controlled Phase 2 Study • 48 postmenopausal women with VVA (24 active, 24 placebo) • Randomized 1:1 to 10 mcg; 1x daily for 2 - week period • Endpoints measured at 2 weeks; same endpoints to be measured in Phase 3 at 12 weeks • Increase in superficial cells 35% treat
Slide 13: TX-004HR – Potential Competitive Profile
13 13 TX - 004HR – Potential Competitive Profile Product Characteristic* Vagifem Premarin Estrace Design Burning x Discharge x x x Cream x x Quick Dissolution Applicator x x x Placement Issues x TX - 004HR Profile Goals • Not a cream • Improve ease of use/placement • Quick dissolution • Digital inse
Slide 14: Phase 3 – TX-004HR Vaginal Estradiol
14 14 Trial: 12 weeks, Sites: ~100 Subjects: ~700 1 − 3 active arms: 4 mcg, 10 mcg, 25 mcg (~175 per arm) − 175 placebo Co - Primary Endpoints − % change in superficial cells − % change in parabasal cells − Lowering of pH − Reducing dyspareunia as most bothersome symptom Additional Endpoints − PK me
Slide 15: TX-001HR Combination Program
15 15 TX - 001HR Combination Program
Slide 16: Indication Overview
16 16 Indication Overview Menopause is defined as the final menstrual period and is typically confirmed after an otherwise healthy woman has not had a period for 12 consecutive months . • Hot flashes are due to lower e strogen levels • Estrogen is given to reduce hot flashes • Estrogen causes the ut
Slide 17: HT Market = Two Markets
17 17 HT Market = Two Markets FDA - Approved No Bioidentical Combinations $594M (1) Premarin (2) /MPA $336M E2/NETA, DSP $ 42M Generic E2/prog $216M Untested Compounded Bioidentical E2/Progesterone $1,500M (3) Total Combo Markets: $2,094M 1) PHAST by Symphony Health Solutions, last twelve months thr
Slide 18: Compounded Market/Bioidentical HT
18 18 Compounded Market/Bioidentical HT U.S. women using custom - compounded menopausal hormone therapy Annual c ustom - compounded prescriptions 21 - 39M Average monthly cash cost $1 - 2B • No FDA - approved bio - identical E+P combination • Most users unware custom - compounded products are unregu
Slide 19: Drug Quality and Security Act (DQSA)
19 19 Drug Quality and Security Act (DQSA) Spurred by public health scares, DQSA establishes clear FDA oversight of compounding pharmacies Prohibits compounding of essential copies of an FDA - approved and marketed drug except in limited circumstances such as drug shortages Recent FDA enforcement ac
Slide 20: TX-001HR – Differentiated Target Product Profile
20 Bio - identical terminology as both hormones similar to those produced by the ovary Labeling Differentiation Potential for FDA - approved natural estradiol plus natural progesterone combination pill Meet Patient Demand for Bio - identicals Broad range of doses being evaluated in Phase 3, two of w
Slide 21: Rationale for Natural Progesterone vs. Synthetic Progestins
21 21 1) Alone or in combination with estrogen. 2) Caufriez, Anne, Rachel Leproult, Mireille L’Hermite - Bale ´ riau, Myriam Kerkhofs, and Georges Copinschi. "Progesterone Prevents Sleep Disturbances and Modulates GH, TSH , and Melatonin Secretion in Postmenopausal Women." J Clin Endocrinol Metab 96
Slide 22: Phase 3 – TX-001HR (Estrogen + Progesterone)
22 22 22 Phase 3 – TX - 001HR (Estrogen + Progesterone) Designed to enroll 1,750 subjects at ~ U.S. 100 sites Four active arms (N =400 / arm ) ▪ Estradiol 1 mg/Progesterone 100 mg ▪ Estradiol 0.5 mg/Progesterone 100 mg ▪ Estradiol 0.5 mg/Progesterone 50 mg ▪ Estradiol 0.25 mg/Progesterone 50 mg Plac
Slide 23: Growing Opportunity for Hormone Therapy
23 23 Growing Opportunity for Hormone Therapy U.S. Census 2010
Slide 24: Transdermal Programs
Transdermal Programs TherapeuticsMD”
Slide 25: Why Transdermal?
25 25 Why Transdermal? • Transdermal delivery perceived safer due to a lower first - pass effect • No FDA - approved transdermal progesterone • New TXMD PK data suggest leveraging solubilized progesterone, show elevated and sustained transdermal levels • Leveraging this technology creates an opportu
Slide 26: E+P Topical PK Results
26 26 E+P Topical PK Results New Formulation PK Data Suggest Sustained 8 - hour Duration 0.00 1.00 2.00 3.00 4.00 5.00 6.00 0 1 2 3 4 5 6 7 8 pg/ml hrs Log Mean Corrected Progesterone PK (Capillary/Saliva) Log Mean Corrected Capillary Progesterone Log Mean Corrected Saliva Progesterone 0.00 0.50 1.0
Slide 27: Transdermal Market Opportunity
27 Product (Combination E+P) TRx (1)(2) U.S. Sales (est.) (1)(2) Company Estradiol/Levonorgestrel (Climara Pro) 129,755 $ 22.5M Estradiol/Norethindrone Acet (CombiPatch) 408,598 $ 44.0M Total Combination Transdermal Sales 538,353 $ 66.5 M Transdermal Market Opportunity Product (Estradiol Only) TRx (
Slide 28: Intellectual Property Update
28 28 Intellectual Property Update
Slide 29: Growing Patent Portfolio
29 Growing Patent Portfolio Filed Provisional Non - Provisional Issued U.S. 37 13 24 4 Ex - U.S. 53 Two new patents issued; one on method of treating menopausal symptoms which strengthens competitive barriers to entry and builds on layered coverage strategies Others issued: Field spanning estradiol
Slide 30: Worldwide Patent Filings
30 Worldwide Patent Filings* *Not all patent filings filed in all jurisdictions.
Slide 31: Investment Rationale
31 31 Investment Rationale Worldwide commercial rights for multiple hormone therapy products in Phase 3 and earlier stages: Well - known chemical entities with established safety and efficacy thresholds; 505(b)(2) Unique, large and growing markets with favorable competitive dynamics (DQSA) Additiona
Slide 32: Key Milestones
32 Key Milestones 4Q 14 ▪ NAMS data presentation on VVA data ▪ New patent allowances 2Q 15 ▪ ACOG oral & poster compounded surveys ▪ EMAS meeting submissions ▪ Complete Rejoice enrollment 4Q 15 ▪ NAMS meeting 3Q 15 ▪ Report Phase 3 REJOICE results 1Q 15 ▪ Report dermal tissue results ▪ ISSWSH oral p
Slide 33: TXMD: Financial Snapshot
33 TXMD: Financial Snapshot Listing Exchange NYSE MKT Shares outstanding 156 million (as of Nov. 4, 2014) Cash $67 million (as of Sept. 30, 2014) Debt $ 0 million
Slide 34: Thank You
34 Thank You w w w . T h e r a p e u t i c s M D . c o m
Slide 35: Evolution of Hormone Therapy Market
35 Evolution of Hormone Therapy Market 1) PHAST Prescription Monthly by Source Healthcare Analytics. Inflation Adjusted Number* 2) Estimates per: Dr. Loyd Allen Jr ., Editor - in - Chief, the International Journal of Pharmaceutical Compounding ; Tom Murry, Executive Director of the Pharmaceutical Co
Slide 36: Hormone Therapy Use Is Increasing
36 • Post - WHI, expert consensus: HT before 60 has a favorable benefit/risk profile 3 • Women using FDA - approved and compounded HT increasing: • Estimated 30% of use is compounded • Natural or “bioidenticals” preferred • 83% of women believe hormone therapy helps treat their symptoms • More young
Slide 37: Current Demand For Natural Hormones
37 37 Current Demand F or N atural H ormones Women actively requesting “ bioidentical ” hormone therapy ( HT) containing natural estradiol and natural progesterone Compounded drugs are not approved by FDA, including requirements for safety, efficacy or manufacturing quality Emerging evidence of the
Slide 38: Current Evidence Shows Potential Advantages of Natural Estradiol
38 38 Current Evidence Shows Potential Advantages of N atural E stradiol “ CEEs (Premarin) were associated with a higher incidence of venous thrombosis and myocardial infarction than estradio l ” 1 — Journal of the American Medical Association, September 2013 “ Oral estradiol may be associated with
Slide 39: Dose Rationale: TX-001HR (Estradiol/Progesterone)
39 39 Dose Rationale: TX - 001HR (Estradiol/Progesterone) Objective: to provide the first FDA - approved natural estradiol/progesterone (combination) product with lowest effective doses Dose selection: Four estradiol/progesterone combinations being evaluated based upon: • Known effective doses of es
Slide 40: Women's HOPE Study Hot Flashes
40 0 2 4 6 8 10 12 14 0 1 2 3 4 5 6 7 8 9 10 11 12 Range of hot flashes at baseline=11.3 - 13.8. *Adjusted for baseline. † P <0.05 by week 3 compared with placebo. ‡ P <0.05 by week 2 compared with placebo. CEE 0.625 mg/day (n=27) ‡ CEE 0.45 mg/day (n=32) ‡ CEE 0.3 mg/day (n=30) † Placebo (n=28) CEE
Slide 41: History of Compounding Market Shift to Bioidentical Hormone Replacement
41 History of Compounding Market S hift to Bioidentical Hormone Replacement (BHRT) 2002 2002 2005 2012 2013 Women’s Health Initiative - Progestins have elevated FDA vs Western States • First Amendment, specific restrictions on advertising and marketing Wyeth Citizen petition to FDA in reaction BHRT
Slide 42: HT Market Size – Two Markets
42 42 FDA - Approved Product Progestin U.S. Sales (est.) Company 17 β E stradiol + NETA / DSP Activella / FemHRT / Angeliq) Non - bioidentical $ 42M (1)(2) Generic 17 β + Progestins Non - bioidentical $ 216M (1)(2) Premarin + MPA (Prempro / Premphase) Non - bioidentical $ 336M (1)(2) Total FDA Appro
TherapeuticsMD — Investor Presentation (January 2015) on 6ix