Jefferies Global HealthcareConferenceJune 2013COPYRIGHT 2013 by TherapeuticsMD
This presentation includes forward-looking statements covered by the safe harbor provision of thePrivate Securities Litiga...
Company Overview2
3TXMD Company HistoryFounded in May of 2008Originally a prenatal vitamin companyRecently listed on NYSE MKT under “TXMD”Sh...
2013E 2014E 2015E 2016E U.S. Sales (est.)($mm) (1)(2)Combination:17β Estradiol + Progesterone$2,000Oral Progesterone $300N...
5History of Hormone Therapy2002 Women’s Health Initiative (WHI) StudyLower doses = lower side effect profileEstrogen + Pro...
Sales of FDA approved oralcombination estrogen +progestin productsCompounding pharmacysales of unapprovedestradiol + proge...
Side Effect (1) Bioidentical Natural ProgesteroneNon-Bioidentical Progestins(MPA, NETA, drosperinone)Breast cancer More fa...
8 Meet PK 505(b)(2) thresholdsNovel Drug DesignCombination of Estradiol+ ProgesteroneRLD = Reference Listed DrugAPI = Ac...
9Building an Extensive Patent EstateNovel Drug Form Based ApproachSolubilized API in combination and stand-alone drug prod...
10Senate HELP Bill 959 on CompoundingNew England Compounding CenterResponse to Meningitis outbreak, killed 50 and made ove...
11Market Forces ConvergeExternal market changingeventsWHIProposed legislativechangesInternal scientificbreakthroughSignifi...
12Why Hormone Therapy?HT is projected to be the largestgrowth segment in the overall women’shealth drug marketDemographics...
Combination Product13
14Phase 3 TrialStudy: 12 month study with 12 week VMSSites: ~50Subjects: 1,550− 4 active arms (350 per arm)− 1 placebo arm...
n = 621595% Upper Confidence Limit for PK ParameterPrometrium = R1Prometrium = R2TXMD = TParameterPoint EstimateT/R RatioW...
1101000 5 10 15 20 25 30 35 40 45 50Time (hr)Treatment=R1Treatment=R2Treatment=TN=6217β Estradiol Results (1)n = 6295% Con...
Drug Improvement General Benefits Patient BenefitsReceive FDA approvedindicationFDA indication / safety and qualityassuran...
Product ProgestinU.S. Sales (est.)($mm)Intl Sales($mm) (4) Company17β Estradiol + NETA /Drospirenone(Activella / FemHRT / ...
19New Lower DoseProgesterone
Phase 3 TrialTrial: 2 studies; 12 days, 3 cyclesSites: 10-15 eachSubject: 180− 3 arms (60 per arm)Estimated cost: $5-$8 mi...
Conducted PK studies in accordance with FDA requirementsTXMD 150 mg test dose found to be bioequivalentto 200 mg Prometriu...
Drug Improvement General Benefits Patient BenefitsNew lower effective doses Lower first-pass metabolitesBetter side effect...
Product ProgestinU.S. Sales(est.)($mm) (1)(2) INTL Sales (3) CompanyGenericAvailableProvera®(medroxyprogesteroneacetate)No...
24Other Programs
Product CompoundU.S. Sales (est.)($mm) (1)(2) ProblemsPremarin®CreamConjugated equinevaginal estrogen$265Equine sourceNon-...
Phase 3 TrialTrial: 12 weeksSites: 30-40Subjects: 375-400− 2 active arms (150 per arm)− 100 placeboEndpoints− Cell change−...
27JohnMilliganPresidentJuliaAmadioChiefProductOfficerDanCartwrightChiefFinancialOfficerDr. BrianBernickChiefMedicalOfficer...
28Potential 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 ...
29Investment Highlights1 Novel late-stage hormone therapy candidates2 Clear pivotal trial endpoints / low risk regulatory ...
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TherapeuticsMD TXMD Slide Show June 2013

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TherapeuticsMD (TXMD) - PowerPoint presentation to be given at meetings with institutional investors or analysts.
Company Info: http://www.dracofinancial.com/txmd/

TherapeuticsMD to Present at Jefferies 2013 Global Healthcare Conference to be held June 3-6, 2013 at the Grand Hyatt New York

Robert Finizio, Chief Executive Officer, will present on Wednesday, June 5, 2013 at 1:30 p.m. Eastern Daylight Time.

The presentation will also be available via a live audio webcast at the following link:
http://wsw.com/webcast/jeff77/txmd/

Following the presentation, a replay will be available through TherapeuticsMD’s website at
www.therapeuticsmd.com under the "Investor Relations" section and will remain available for 30 days
after the actual presentation date.

TherapeuticsMD is a specialty pharmaceutical company focused on creating safe and effective branded and generic prescription, and over-the-counter products targeted exclusively for women. We are driven to pursue the development and commercialization of three advanced hormone replacement products designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies. These development candidates have received Investigational New Drug acceptance by the U.S. Food and Drug Administration.

TherapeuticsMD is a specialty pharmaceutical company focused on the sales, marketing and development of branded and generic pharmaceutical and over-the-counter (OTC) products for the women's health market. In 2012 the Company launched six prescription prenatal vitamins and announced the funding of pharmacokinetic (PK) trials required before it can begin Phase III trials on its three investigational new drugs (INDs) for hormone replacement therapy (HRT) that were accepted by the FDA.

Draco Financial is a corporate consulting and investor relations firm committed to creating long-term awareness for our client companies. Whether working with a small emerging company or a Fortune 500 large cap, we make a difference and we are passionate about it.

Draco builds profitable long lasting relationships with our network. It takes years of communication trust and successful investment strategies to build a responsive investor network. Our network of financial advisors, funds, and institutions are active growth oriented investors that genuinely pursue attractive opportunities.

Draco Financial Website:
http://www.dracofinancial.com

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TherapeuticsMD TXMD Slide Show June 2013

  1. 1. Jefferies Global HealthcareConferenceJune 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 the forward-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 not obligatingourselves to revise or publicly release the results of any revision to these forward-lookingstatements 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 and ourother filings with the Securities and Exchange Commission, for a more complete discussion of thesefactors and other risks, particularly under the heading “Risk Factors.” A PDF copy of our SEC filings,press releases and financial tables can be viewed and downloaded on the TherapeuticsMD website:www.therapeuticsmd.com/InvestorRelations.aspx.1Forward-Looking Statements
  3. 3. Company Overview2
  4. 4. 3TXMD Company HistoryFounded in May of 2008Originally a prenatal vitamin companyRecently listed on NYSE MKT under “TXMD”Shares outstanding: approximately 130 millionApproximately $40 million in cash; no long-term debtStrong board with blue-chip institutional holdersGov. Tommy Thompson, Jules Musing, Ernest Mario (investor)
  5. 5. 2013E 2014E 2015E 2016E U.S. Sales (est.)($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. 5History of Hormone Therapy2002 Women’s Health Initiative (WHI) StudyLower doses = lower side effect profileEstrogen + Progestin (Prempro) arm had a 22% increase in breast cancer vs.Estrogen alone armResulting Hormone Prescribing TrendsStart with the lowest effective doseProgesterone (bioidentical) popularity over Progestins (non-bioidentical)Bioidentical (exact molecular structure of human Estrogen and Progesterone)sales sky rocket
  7. 7. Sales of FDA approved oralcombination estrogen +progestin productsCompounding pharmacysales of unapprovedestradiol + progesterone6 Significant demandHT Combination 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.(5) 134 Compounding Pharmacies Survey in 34 States$1,500 MM (3)(4)$468 MM (1)(2)U.S. Sales (est.)Average SellingPrice $46.89(5)Average WACPrice $185.09(3)
  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)
  11. 11. 10Senate HELP Bill 959 on CompoundingNew England Compounding CenterResponse to Meningitis outbreak, killed 50 and made over 700 patients sickMultiple other cases of unsafe drug sales by other compounding pharmaciesSenate Bill Highlights (1)Establishes clear FDA oversight funded by compounding pharmacyregistration fees“Prohibits compounding of certain drug products, including those identifiedby regulation as being demonstrably difficult to compound (such as complexdosage forms and biologics), marketed FDA-approved drugs that are not inshortage”(1) http://www.help.senate.gov/imo/media/Compounding_Draft_One_Pager_FINAL.pdf
  12. 12. 11Market Forces ConvergeExternal market changingeventsWHIProposed legislativechangesInternal scientificbreakthroughSignificant shifts favor TXMD
  13. 13. 12Why 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.
  14. 14. Combination Product13
  15. 15. 14Phase 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 flashes (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
  16. 16. n = 621595% 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 2 mg / Progesterone 200 mg (combination)vs. Estrace® 2 mg + Prometrium® 200 mg (separate tablets)
  17. 17. 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 Parameter16Estrace = R1Estrace = R2TXMD = TTX 12-001HR Estradiol 2mg / Progesterone 200 mg (combination)vs. Estrace® 2m g + Prometrium® 200 mg (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.
  18. 18. 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 compliance17TX 12-001HR Combination Potential BenefitsNote: Potential improvements and benefits, if approved.
  19. 19. 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 $48918FDA 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
  20. 20. 19New Lower DoseProgesterone
  21. 21. Phase 3 TrialTrial: 2 studies; 12 days, 3 cyclesSites: 10-15 eachSubject: 180− 3 arms (60 per arm)Estimated cost: $5-$8 millionRLD = 400 mgEndpoints− Withdrawal bleeding and secretory change20TX 12-002HR Progesterone—Proposed Phase 3 Study2012 2013E 2014E 2015EQ3 12 Q4 12 Q1 13 Q2 13 Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 Q2 15 Q3 15 Q4 15FiledINDPilot PKStudyPivotal PKStudiesFile NDA and PDUFATwo Phase 3 Amenorrhea Studies12 Days & 3 CyclesTX12-002HRProgesteroneFile IND Update &Phase 3 ProtocolProgesterone
  22. 22. Conducted PK studies in accordance with FDA requirementsTXMD 150 mg test dose found to be bioequivalentto 200 mg Prometrium®Summary evaluations of baseline-corrected Progesterone resultsfor a theoretical150 mg test capsule vs. 200 mg Prometrium® capsule21ParameterPoint EstimateT/R RatioWithin SubjectStd. DeviationUpper 95%Confidence BoundCmax 1.03 1.133 -0.747AUC0-t 0.96 0.891 -0.465TX 12-002HR Progesterone Candidate
  23. 23. Drug Improvement General Benefits Patient BenefitsNew lower effective doses Lower first-pass metabolitesBetter side effect profileLess somnolenceImproved safetyImproved safety profile vs.non-bioidentical progestinReduced breast cancer riskImproved cardiovascular profileImproved lipid profileConfidence in treatment regimenNo peanut oil Non-allergenicExcellent for all patient profilesNo worries about potentialallergies22TX 12-002HR Progesterone—Potential BenefitsNote: Potential improvements and benefits, if approved.
  24. 24. Product ProgestinU.S. Sales(est.)($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 $60023(1) Phast Prescription Monthly by Source Healthcare Analytics.(2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012.(3) IMS DataNatural Progesterone Dominates
  25. 25. 24Other Programs
  26. 26. Product CompoundU.S. Sales (est.)($mm) (1)(2) ProblemsPremarin®CreamConjugated equinevaginal estrogen$265Equine sourceNon-bioidenticalMessyReusable plungersVagifem®TabletsEstrace®CreamVaginal estradiol $558MessyReusable plungersDifficult to useContinuous-use mechanical deviceTotal Sales $82325(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
  27. 27. 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 symptoms26TX 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™
  28. 28. 27JohnMilliganPresidentJuliaAmadioChiefProductOfficerDanCartwrightChiefFinancialOfficerDr. 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 and InvestorsTommyThompsonChairmanFormerSec HHS &Gov of WiscCooperCollinsDirectorCEO,PernixMario FamilyPartnershipInvestorErnest MarioFormer CEOof GlaxoJulesMusingFormer Sr.ExecutiveJohnson &JohnsonNickSegalDirectorSeavestCapitalPartners
  29. 29. 28Potential 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
  30. 30. 29Investment 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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