Txmd investor presentation.4-16-13

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Txmd investor presentation.4-16-13

  1. 1. Investor PresentationApril 2013COPYRIGHT 2013 by TherapeuticsMD
  2. 2. This presentation includes forward-looking statements covered by the safe harbor provision of thePrivate Securities Litigation Reform Act of 1995, including predictions, estimates, and otherinformation that might be considered forward-looking. While these forward-looking statementsrepresent TherapeuticsMD, Inc.’s (“TherapeuticsMD,” “we,” “us,” and “our”) current judgment onwhat the future holds, they are subject to risks and uncertainties, many of which are outside ourcontrol, that could cause actual results to differ materially from the results discussed in theforward-looking statements.You are cautioned not to place undue reliance on these forward-looking statements, which reflectour opinions only as of the date of this presentation. Please keep in mind that we are notobligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information, future events, or otherwise.Throughout this presentation, we will attempt to present some important factors relating to ourbusiness that may affect our predictions. You should also review our most recent Form 10-K, Form10-Q, our Form 8-K dated January 25, 2013, and our other filings with the Securities and ExchangeCommission, for a more complete discussion of these factors and other risks, particularly underthe heading “Risk Factors.” A PDF copy of our press releases and financial tables can be viewedand downloaded on the TherapeuticsMD website:www.therapeuticsmd.com/InvestorRelations.aspx.1Forward-Looking Statements
  3. 3. Company Overview2
  4. 4. 3Investment Highlights1 Novel late-stage hormone therapy candidates2 Clear pivotal trial endpoints / low risk regulatory pathway3Compelling, growing market opportunity, especially with recent concerns regardingcompounders4 Recently completed $50 million equity financing5 Robust, growing patent estate
  5. 5. 2013E 2014E 2015E 2016E U.S. Sales (est.)($mm) (1)(2)Combination:17β Estradiol + Progesterone$2,000Oral Progesterone $300Novel estradiol pipeline product in development17β Estradiol in VagiCap™ $800Phase 3 Plan Expect to File NDA and PDUFA4Innovative Women’s Healthcare CompanyTwo late-stage 505(b)(2) proposed hormone therapy (“HT”)products targeting a multi-billion dollar U.S. market (1)(2)Bioidentical combination of estradiol + progesterone and lower-dosebioidentical progesteroneSet to begin pivotal Phase 3 clinical trials(1) Phast Prescription Monthly by Source Healthcare Analytics.(2) Estimates per: Dr. Loyd Allen Jr., Editor-in-Chief of the International Journal of Pharmaceutical Compounding; Tom Murry, ExecutiveDirector of the Pharmaceutical Compounding Accreditation Board; and Wulf Utian, Consultant on Gynecology and Women¹s Health at TheCleveland Clinic and Executive Director Emeritus and Honorary Founding President of The North American Menopause Society (“NAMS”).
  6. 6. 5Why Hormone Therapy?HT is projected to be the largestgrowth segment in the overall women’shealth drug marketDemographics driving strong growthfundamentalsBy 2015, nearly half the women in America will beof menopausal age (1)Women will spend more than a third of their life inmenopause and post-menopauseVery attractive commercial dynamicsSegment of the market that lacks innovationRelatively little promotional activity in the spaceOpportunity to capture market share(1) U.S. Census Bureau.
  7. 7. Sales of FDA approved oralcombination estrogen +progestin productsCompounding pharmacysales of unapprovedestradiol + progesterone6 Significant demandHT Market Landscape(1) Phast Prescription Monthly by Source Healthcare Analytics.(2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012.(3) Estimate per Wulf Utian, Executive Director Emeritus and Honorary Founding President of NAMS.(4) Dr. Loyd Allen Jr., Editor-in-Chief of the International Journal of Pharmaceutical Compounding, stated the U.S. drug compoundingmarket is $10-$12 billion; and Tom Murry, Executive Director of the Pharmaceutical Compounding Accreditation Board, said HT forpost-menopausal women is by far the largest of four primary segments served by the compounding industry.$1,500 MM (3)(4)$468 MM (1)(2)U.S. Sales (est.)
  8. 8. Side Effect (1) Bioidentical Natural ProgesteroneNon-Bioidentical Progestins(MPA, NETA, drosperinone)Breast cancer More favorable profile (E3N-EPIC study) Increased riskCardiovascular More favorable profile (PEPI trial) Increased risk of MI, stroke, VTELipid profile More favorable profile (PEPI trial)Less favorable effects on lipid profile(cholesterol, HDL, LDL, triglycerides)Glucose / insulinImproved carbohydrate metabolism(PEPI trial)Deterioration of glucose tolerance orhyperinsulemia or bothSleep / mood Improved sleep efficiency (2) No benefit on sleep propertiesQuality of lifeImprovement in symptoms and overall satisfaction with bioidentical progesteroneHT compared to MPA regimen (3)7(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, andMelatonin Secretion in Postmenopausal Women." J Clin Endocrinol Metab 96.4 (2011): 614-23.(3) Fitzpatrick, Pace, and Wiita. "Comparison of Regimens Containing Oral Micronized Progesterone or Medroxyprogesterone Acetate on Quality of Life in Postmenopausal Women: A Cross-Sectional Survey." J Womens Health Gend Based Med 9.4 (2000): 381-87.Bioidentical Progesterone vs. Non-Bioidentical ProgestinThe Market understands the benefits of bioidentical HT
  9. 9. 8 Meet PK 505(b)(2) thresholdsNovel Drug DesignCombination of Estradiol+ ProgesteroneRLD = Reference Listed DrugAPI = Active Pharmaceutical IngredientConverted (API) from solid / crystalline to a New Liquid Drug FormEstrace (RLD) is a tablet—0.5 mg, 1.0 mg, and 2.0 mgPrometrium (RLD) is in suspension—100 mg and 200 mgNew solubilized drug formAchieves FDA requirements of uniformity and stabilityImproved functional effects of API(s)Enabling new combinations, routes, and dosages
  10. 10. 9Building an Extensive Patent EstateNovel Drug Form Based ApproachSolubilized API in combination and stand-alone drug productsfor HT indicationsEnabling platform technology for delivery of bioidenticals to variety ofdosage forms and routes of administration (softgel oral, suppository,transdermal, etc.)Multi-layered Patent StrategyNovel dosage forms, improved PK profiles (lowest effective dose,increased bioavailability) relative to RLD, reduced side effect profile, andformulation advancements (solvent systems, chemical stability, ratios,ranges, and functional effects)Freedom to OperateTwo independent analyses supporting FTO and patent strategy alignment
  11. 11. Combination Product10
  12. 12. 11Phase 3 TrialStudy: 12 month study with 12 week VMSSites: ~50Subjects: 1,550− 4 active arms (350 per arm)− 1 placebo arm (150)Estimated cost: $20-$25 millionEndpoints− Vasomotor: number and severity of hot flushes (4 week and 12 weeks)− Endometrial safety: incidence of endometrial hyperplasia (12 months) Conduct Phase 3 studyTX 12-001HR Combination—Proposed Phase 3 StudyCombination of Estradiol+ Progesterone2012 2013E 2014E 2015E 2016EQ3 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 16FiledINDPilot PKStudiesPivotal PKStudiesNDA and PDUFAPhase 3 Vasomotor and Endometrial Protection StudyTX 12-001HRCombination17β Estradiol+ProgesteroneFile IND Update &Phase 3 Protocol
  13. 13. 1101000 5 10 15 20 25 30 35 40 45 50Time (hr)Treatment=R1Treatment=R2Treatment=TN=6217β Estradiol Results (1)n = 6295% Confidence Interval for PK Parameter12Estrace = R1Estrace = R2TXMD = TTX 12-001HR Estradiol 2mg / Progesterone 200mg (combination)vs. Estrace® 2mg + Prometrium® 200mg (separate tablets)ParameterPoint EstimateT/R RatioWithin SubjectStd. DeviationUpper 95%Confidence BoundCmax 0.88 0.344 -0.040AUC0-t 0.93 0.409 -0.089(1) Semilog plots of mean plasma concentrations over time for Free Estradiol.
  14. 14. n = 621395% Upper Confidence Limit for PK ParameterPrometrium = R1Prometrium = R2TXMD = TParameterPoint EstimateT/R RatioWithin SubjectStd. DeviationUpper 95%Confidence BoundCmax 1.16 1.179 -0.785AUC0-t 1.05 0.956 -0.542Progesterone Results (1)(1) Semilog plots of mean plasma concentrations over time for Progesterone.TX 12-001HR Estradiol 2mg / Progesterone 200mg (combination)vs. Estrace® 2mg + Prometrium® 200mg (separate tablets)
  15. 15. Drug Improvement General Benefits Patient BenefitsReceive FDA approvedindicationFDA indication / safety and qualityassuranceInsurance coverageSafety, quality, and stabilityNew lower effective doses Reduced blood levelsBetter side effect profileImproved safetyImproved safety profile vs.non-bioidentical progestinReduced breast cancer riskImproved cardiovascular and lipidprofileConfidence in treatment regimenNo peanut oil Non-allergenicExcellent for all patient profilesNo worries about potentialallergiesCombined pill vs. 2 pills(E+P sold separately today)Less risk of dosing errors One co-payIncreased compliance14TX 12-001HR Combination Potential BenefitsNote: Potential improvements and benefits, if approved.
  16. 16. Product ProgestinU.S. Sales (est.)($mm)Intl Sales($mm) (4) Company17β Estradiol + NETA /Drospirenone(Activella / FemHRT / Angeliq /others)Non-bioidentical $178 (1)(2)Premarin + MPA(Prempro / Premphase)Non-bioidentical 290 (1)(2)Estradiol + Progesterone(custom compounded)UntestedBioidentical1,500 (3)Not FDA approvedTotal Oral Combination Sales $1,968 $48915FDA Approved Products in Use Lack InnovationAll FDA approved products in use contain non-bioidenticalprogestinsNotes: All FDA approved combination products in use contain a non-bioidentical progestin.(1) Phast Prescription Monthly by Source Healthcare Analytics.(2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012.(3) Estimate per Wulf Utian, Executive Director Emeritus and Honorary Founding President of NAMS.(4) IMS Data
  17. 17. 16New Lower DoseProgesterone
  18. 18. Phase 3 TrialTrial: 2 studies; 12 days, 3 cyclesSites: 10-15 eachSubject: 180− 3 arms (60 per arm)Estimated cost: $5-$8 millionRLD = 400mgEndpoints− Withdrawal bleeding and secretory change17TX 12-002HR Progesterone—Proposed Phase 3 Study2012 2013E 2014E 2015EQ3 12 Q4 12 Q1 13 Q2 13 Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 Q2 15 Q3 15 Q4 15FiledINDPilot PKStudyPivotal PKStudiesFile NDA and PDUFATwo Phase 3 Amenorrhea Studies12 Days & 3 CyclesTX12-002HRProgesteroneFile IND Update &Phase 3 ProtocolProgesterone
  19. 19. Conducted PK studies in accordance with FDA requirementsTXMD 150 mg test dose found to be bioequivalentto 200 mg Prometrium®Summary evaluations of baseline-corrected Progesterone resultsfor a theoretical150 mg test capsule vs. 200 mg Prometrium® capsule18ParameterPoint EstimateT/R RatioWithin SubjectStd. DeviationUpper 95%Confidence BoundCmax 1.03 1.133 -0.747AUC0-t 0.96 0.891 -0.465TX 12-002HR Progesterone Candidate
  20. 20. Drug Improvement General Benefits Patient BenefitsNew lower effective doses Lower first-pass metabolitesBetter side effect profileLess somnolenceImproved safetyImproved safety profile vs.non-bioidentical progestinReduced breast cancer riskImproved cardiovascular profileImproved lipid profileConfidence in treatment regimenNo peanut oil Non-allergenicExcellent for all patient profilesNo worries about potentialallergies19TX 12-002HR Progesterone—Potential BenefitsNote: Potential improvements and benefits, if approved.
  21. 21. Product ProgestinU.S. Sales(est.)($mm) (1)(2) INTL Sales (3) CompanyGenericAvailableProvera®(medroxyprogesteroneacetate)Non-bioidentical$26 Aygestin®(norethindrone acetate)Non-bioidentical45 Prometrium®(micronized progesterone)Bioidentical 247 Total Oral Progestin Sales $318 $60020(1) Phast Prescription Monthly by Source Healthcare Analytics.(2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012.(3) IMS DataNatural Progesterone Dominates
  22. 22. 21Other Programs
  23. 23. Product CompoundU.S. Sales (est.)($mm) (1)(2) ProblemsPremarin®CreamConjugated equinevaginal estrogen$265Equine sourceNon-bioidenticalMessyReusable plungersVagifem®TabletsEstrace®CreamEstring®(vaginal ring)Vaginal estradiol 558MessyReusable plungersDifficult to useContinuous-use mechanical deviceTotal Sales $82322(1) Phast Prescription Monthly by Source Healthcare Analytics.(2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012.TX 12-004HR Estradiol Product—Vulvar / Vaginal Atrophy
  24. 24. Drug Improvement General Benefits Patient BenefitsReduced dose variabilitythrough soft gel technologyMore effective dose delivery thanVagifem®and creamsImproved efficacyEasier to useLess messyReduced burningFlexibility of dosing with0.010 mg and 0.025 mgMore effectiveImprovement vs. Vagifem®No applicator required No risk of vaginal wall puncturesDigitally inserted with easeSimple soft gel VagiCap™ More consistent dosingNo messy creamsUnique bio-adhesive Reduced leaking23TX 12-004HR Vaginal Estradiol—Potential BenefitsNote: Potential improvements and benefits, if approved.
  25. 25. Phase 3 TrialTrial: 12 weeksSites: 30-40Subjects: 375-400− 2 active arms (150 per arm)− 100 placeboEndpoints− Cell change− Lowering of pH− Lowering of most bothersome symptoms24TX 12-004HR Proposed Estradiol VaginalSuppository—Proposed Phase 3 StudyEstradiol2013E 2014E 2015E 2016EQ1 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 16Expect toFileINDFileNDANDAApprovalPilot PKStudyPivotal PKStudiesFile NDA and PDUFAPhase 3 Clinical Vulvar & Vaginal AtrophyTX 12-004HR17β Estradiol in aVagiCapFile IND Update &Phase 3 Protocol™
  26. 26. 25JohnMilliganPresidentJuliaAmadioChiefProductOfficerDanCartwrightChiefFinancialOfficerDr. BrianBernickChiefMedicalOfficer andDirectorRobert FinizioChief Executive OfficervitaMed HT CorporateJasonSpitzVicePresident,MarketingManagement Drug Development TeamProven team with a successful track record of creating shareholder value anddeveloping some of the most successful products in the HT and birth control spaceExperienced Management andDrug Development TeamJulia Amadio and James Pickar, M.D., F.A.C.O.G.‒ Led development and launch of Prempro®, Premphase®,CombiPatch®, Alesse®, and Crinone®, among othersLisa Rarick, M.D. and Daniel Shames, M.D.‒ Former division Director of Reproductive and UrologicProducts for FDA CDERFred Sancilio, Ph.D.‒ Former founder and president of AAI and the innovatorof multiple hormone productsSteve Fontana, J.D.‒ Author of the original estradiol patentsBill Mulholland, J.D.‒ Lead patent attorney; previously, IP counsel at PfizerBoard of Directors / InvestorsTommyThompsonChairmanFormerSec HHS &Gov of WiscCooperCollinsDirectorCEO,PernixMarioFamilyPartnershipErnest MarioFormer CEOof GlaxoWellingtonFidelityHartfordInv. MgmtJohnHancockNickSegalDirectorSeavestCapitalPartners
  27. 27. 26Potential Milestones2012 2013E 2014E 2015E 2016EQ3 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 16FiledINDPilot PKStudiesPivotal PKStudiesNDA and PDUFAPhase 3 Vasomotor and Endometrial Protection StudyFiledINDPilot PKStudyPivotal PKStudiesFile NDA and PDUFATwo Phase 3 Amenorrhea Studies12 Days & 3 CyclesFileINDExpect toFileINDFileNDANDAApprovalPilot PKStudyPivotal PKStudiesFile NDA and PDUFAPhase 3 Clinical Vulvar & Vaginal AtrophyTX 12-001HRCombination17β Estradiol+ProgesteroneTX12-002HRProgesteroneTX 12-004HR17β Estradiol in aVagiCapFile IND Update &Phase 3 ProtocolFile IND Update &Phase 3 ProtocolFile IND Update &Phase 3 Protocol
  28. 28. 27Investment Highlights1 Novel late-stage hormone therapy candidates2 Clear pivotal trial endpoints / low risk regulatory pathway3Compelling, growing market opportunity, especially with recent concerns regardingcompounders4 Recently completed $50 million equity financing5 Robust, growing patent estate

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