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TherapeuticsMD is a specialty pharmaceutical company focused on the sales, ...

TherapeuticsMD is a specialty pharmaceutical company focused on the sales,
marketing and development of branded and generic pharmaceutical and overthe-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.

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TherapeuticsMD Presentation TherapeuticsMD Presentation Presentation Transcript

  • TXMD Overview Confidential 0
  • Forward-Looking StatementsThis presentation includes forward-looking statements covered by the safe harbor provision of thePrivate Securities Litigation Reform Act of 1995, including predictions, estimates or other informationthat might be considered forward-looking. While these forward-looking statements represent ourcurrent judgment on what the future holds, they are subject to risks and uncertainties, many of whichare outside our control, that could cause actual results to differ materially from the results discussed inthe forward-looking statements.You are cautioned not to place undue reliance on these forward-looking statements, which reflect ouropinions 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-looking statementsin 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 Form10-Q for a more complete discussion of these factors and other risks, particularly under the heading“Risk Factors.” A PDF copy of our press releases and financial tables can be viewed and downloadedon the TherapeuticsMD website: www.therapeuticsmd.com/InvestorRelations.aspx. Confidential 1
  • Management Team• Robert Finizio, Founder and CEO. 17 years of clinical and vendor healthcare experience at Omnicell Technologies and Endoscopy Specialist Incorporated. Co- Founded CareFusion in 2001, which was acquired by Cardinal Health in 2006.• John Milligan, President. 20 years of healthcare experience at Omnicell, serving software and HBOC, the last two bought by McKesson. Co-Founded CareFusion alongside Robert Finizio.• Dan Cartwright, Chief Financial Officer. 20 years of financial management experience, including M&A and as a CFO of both private and public companies, including American Wireless Systems, Telegeography, and WEB Corp.• Julia Amadio, Chief Product Officer. 25-year background in general management, leading pharmaceutical marketing and product development initiatives focused on women’s health, including J&J’s McNeil Pharmaceutical, Wyeth (Prempro, Premphase, Alesse, and Crinone), Rhone-Poulenc (CombiPatch / Estalis), Aventis (Actonel and Lantus), and Daiichi.• Dr. Brian Bernick, Founder and Chief Medical Director. Obstetrician / gynecologist with 19 years of clinical medical experience. Current board member of VitalMD, LLC, the nation’s largest physician-owned and managed medical group with gross revenue exceeding $165 million annually.• Jason Spitz, Vice President of Marketing. 24 years of sales, marketing, advertising, and general management experience, including a 15-year career at Schering-Plough and subsequent commercial leadership roles at Aesgen, Inc., MGI Pharma, and Beacon Healthcare Communications. Confidential 2
  • Experienced Drug Development Team• Julia Amadio and James Pickar, M.D., F.A.C.O.G. ‒ Developed and launched some of the most successful HRT and birth control products, including Prempro, Premphase, Combi-Patch, Alesse, and Crinone• Lisa Rarick, M.D. and Daniel Shames M.D. ‒ Former Division Directors of Reproductive and Urologic Products for FDA Center for Drug Evaluation and Research (“CDER”)• Fred Sancilio ‒ President of AAI and the innovator of estradiol• Steve Fontana ‒ Author of the original estradiol patents• Bill Mulholland ‒ Lead patent attorney; previously, IP counsel at Pfizer• Carol Houts ‒ President of Clinartis (CRO) with significant experience in women’s health (specifically HRT) Confidential 3
  • Board of Directors and Investors• Honorable Tommy G. Thompson (Chairman) ‒ Former 4-term Governor of Wisconsin and former U.S. Secretary of Health and Human Services• Mario Family Partnership (Investor) ‒ Former CEO of GlaxoSmithKline, Alza, and Reliant Pharmaceuticals• Sam Greco ‒ Current CEO of Careview Communications and former Senior Vice President of Colombia / HCA Hospital Systems• Steve Williamson ‒ Senior Vice President and General Manager of the GYN Surgical Products Division of Hologic Inc.• Seavest Venture Capital ‒ Venture capital arm of Seavest Inc.; 30-year history of investing in healthcare• Pernix Therapeutics Holdings ‒ Specialty pharmaceutical company engaged in the development, marketing, and sale of branded and generic pharmaceutical products primarily for the pediatric market Confidential 4
  • Estradiol and Progesterone Combination Gelatin Capsule Overview Confidential 5
  • Menopause- the Patient Symptoms • Menstrual periods occur less often, eventually stop • Heart pounding or racing • Hot flashes, worse in first 1 - 2 years • Night sweats • Skin flushing • Sleeping problems (insomnia)TreatmentHORMONE THERAPY• Helps severe hot flashes, night sweats, mood issues, or vaginal dryness• Estrogen and, sometimes, progesterone Confidential 6
  • Menopause- Large Patient Population Confidential 7
  • HRT Overview• Menopause and its symptoms are due to the female ovary ceasing production of two hormones 17β Estradiol and Progesterone.• TXMD has the first and only combination product to replace the declining hormone levels with the exact hormones of 17β Estradiol and Progesterone that the body has stopped producing.• First and only solution to use Bio-Identical hormones to treat the symptoms of menopause due to the reduction of those hormones. Estradiol Progesterone Confidential 8
  • TXMD Product Goals1. Introduce the first and only FDA approved natural Bio-Identical combination (Estradiol+Progesterone) Hormone Replacement product suite to compete with Synthetic Combinations2. Provide an FDA approved alternative to Compound Pharmacy sales of Progesterone and Estradiol in combination that were between $100- $350 million in 20113. Introduce a safer (when compared to synthetic combinations¹), more effective product line4. Leverage this platform and profile into other therapeutic solutions in Women’s Health 1 The Writing Group for PEPI, JAMA, Jan 1995;273:3;199-208. Confidential 9
  • 2011 Progestin SalesWhen Sold Alone - Natural Progesterone Dominates the Market 2011 Sales Product / GenericProduct Progestin ($mm) Company Available Provera /Medroxyprogesterone Acetate Synthetic $ 25.5  Aygestin /Norethindrone Acetate Synthetic 44.8  Prometrium /Micronized Progesterone Natural 247.2  Total Oral Progestin Sales $ 317.5 Sources: Company filings, Bloomberg, and IMS. Confidential 10
  • FDA Approved Combination with Natural Progesterone is a Voidin the Market 2011 SalesProduct Progestin ($mm) Product(s) Company Synthetic Activella /Estradiol + Progestin $ 177.7 Progestin Angeliq Synthetic Premphase /Premarin + Progestin 290.2 Progesitn PremproPharmacy Compounding: Natural 96-350Estradiol + Progesterone (1) Total Oral Combination Sales $ 564.0 Sources: Company filings, Bloomberg, and IMS. Notes: All FDA-approved combination products use a synthetic progestin. 1) Compounding sales of HRT products are not FDA approved. Confidential 11
  • Progesterone vs. Synthetic ProgestinSide Effect Progesterone Synthetic Progestins (eg“MPA, NETA”) Micronized progesterone and estrogen results inLipid profile Limited effects on lipid profile significantly higher HDL-C than MPACardiovascular More favorable VTE profile Less favorable VTE profile Augments pancreatic Deterioration of glucose tolerance orGlucose / insulin response to insulin hyperinsulemia or both Micronized progesterone andSleep / mood estrogen significantly No benefit on sleep properties improve sleep efficiencyBreast cancer More favorable profile Less favorable profile Improvement in symptoms and overall satisfaction withQuality of Life micronized progesterone HRT therapy when compared to MPA regimen Confidential 12
  • Bioavailability StudyPrometrium (progesterone) plus Estrace (estradiol) vs. TX-12-001 new combination gelatin tablet of Progesterone & Estradiol• Conducted PK studies in FDA audited and approved site in India• TXMD Combination Gelatin Tablet vs. Estrace and Prometrium• Based on Cmax and AUC, both estradiol and progesterone tended toward bioequivalence.• Progesterone, delivered in our formulation, had a significant reduction of variance between subjects, consistent with expectations. Confidential 13
  • TXMD Progesterone vs. Prometrium (combination)Semilog Plots of Mean Plasma Concentrations over Time for Progesterone(Corrected) Study 352 N=24 100.000 Therapeutic Threshold = 30ng/ml 10.000 Endometrial Protection 1.000 Treatment=R Treatment=T 0.100 0.010 0.001 Sources: Bloomberg and5IMS. 0 10 15 20 25 30 35 40 45 50 Time (hr) Confidential 14
  • TXMD Estradiol vs. Estrace (combination)Semilog plots of Mean Plasma Concentrations over time for Total Estrone Study N=24 100.00 Therapeutic Threshold = 10pg/ml 10.00 Vasomotor Symptom Relief 1.00 Treatment=R Treatment=T 0.10 0.01 0 5 10 15 20 25 30 35 40 45 50 Sources: Bloomberg and IMS. Time (hr) Confidential 15
  • Benefits of Our ProductTXMD’s novel combination of 17β estradiol and progesterone may provide asafer and more effective alternative for hormone therapy.¹²³1. A safer product is seen as a result of a better lipid and CV profile for progesterone versus synthetic progestins ¹2. A more effective product is seen as a result of less variability and higher bioavailability of the progesterone versus RLD when used in this formulation.³ House panel grills FDA about compounding pharmacies 1 The Writing Group for PEPI, JAMA, Jan 1995;273:3;199-208 2 Notelovitz et al,Obstet & Gynecol. 2000;95:726-31. and Hitchcock, CL et al. Menopause 2012;19:8;886-93. 3 Study 352 322 PK results Confidential 16
  • Favorable Risk Profile• Progesterone and Estradiol are VERY clearly understood by the FDA ‒ Phase 3 endpoints are monographed on FDA website ‒ Therapeutic blood levels with new forms have been achieved ‒ Phase 3 studies offer Lower Risk, Capital and Time when compared with typical NCE or new drugs that address large markets ‒ FDA approved combination (E+P) product would help FDA contain compounding pharmacies Confidential 17
  • Combination Phase 3 Costs and Timeline 2012F 2013P 2014P 2015P 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 Filed File NDA IND NDA Approval Pilot PK NDA and PDUFA Studies Estradiol +Progesterone Pivotal PK Phase 3 Vasomotor and Endometrial Protection Study StudiesStudy – Combination Cost LocationPivotal PK $3,545,816 USPhase 3 $16,508,075 30% Russia / 70% US Sources: Bloomberg and IMS.Total $20,053,891 Confidential 18
  • New Drug Cost vs. Opportunity• $600 Million Domestic Combination Market• $1+ Billion International Market• Safer, more effective than current FDA approved solutions• One of the most comonly Pharmacy compounded products with annual sales of $100-350 million in 2011 in the US• Supports Bio-Identical Trend• Supports all Post WHI Trends• Phase 3 risk is marginal compared to New Chemical Entities risk for large market drugs Sources: Bloomberg and IMS. Confidential 19
  • Pipeline Confidential 20
  • When Sold Alone - Natural Progesterone Dominates the Market 2011 Sales Product / GenericProduct Progestin ($mm) Company Available Provera /Medroxyprogesterone Acetate Synthetic $ 25.5  Aygestin /Norethindrone Acetate Synthetic 44.8  Prometrium /Micronized Progesterone Natural 247.2  Total Oral Progestin Sales $ 317.5 Sources: Company filings, Bloomberg, and IMS. Confidential 21
  • PK Study Summaries• Conducted PK studies in FDA audited and approved site in India• Progesterone ‒ 24 males ‒ Fed and fasted ‒ Single dose crossover, 18 blood draws pre and post dose• Estradiol ‒ 24 post-menopausal women ‒ Fed and Fasted ‒ Single dose crossover, 18 blood draws pre and post dose Confidential 22
  • Progesterone PK Fed Study 60 50 40 30 20 Test 10 RLD 0 0 0.25 0.5 0.67 0.83 1 1.33 1.67 Test 2 2.5 3 4 6 8 12 Confidential 24 23
  • Progesterone PK Fed Study Stats Dependent RLD Test Ratio (%) Geo LSM Geo LSM Cmax 12.466 20.834 167.13 AUC0-t 29.937 42.681 142.57 AUC0-I 36.992 59.046 159.62 Tmax 3.25 3.26 100.31 Overall results show a 2:1 ratio of the test versus the RLD for key parameters, indicating potential lowering of the dose by one half.Progesterone Fasted Study showed negligible results for both Reference and Test, due to thehigh food effect with this hormone. Confidential 24