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TXMD Overview



     Confidential   0
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 or other information
that might be considered forward-looking. While these forward-looking statements represent our
current judgment on what the future holds, they are subject to risks and uncertainties, many of which
are outside our control, 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 reflect our
opinions only as of the date of this presentation. Please keep in mind that we are not obligating
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 our
business that may affect our predictions. You should also review our most recent Form 10-K and Form
10-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 downloaded
on 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)

Treatment
HORMONE 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 Goals

1. Introduce the first and only FDA approved natural Bio-Identical
    combination (Estradiol+Progesterone) Hormone Replacement product
    suite to compete with Synthetic Combinations
2. Provide an FDA approved alternative to Compound Pharmacy sales of
    Progesterone and Estradiol in combination that were between $100-
    $350 million in 2011
3. Introduce a safer (when compared to synthetic combinations¹), more
    effective product line
4. 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 Sales

When Sold Alone - Natural Progesterone Dominates the Market

                                                                 2011 Sales     Product /     Generic
Product                                           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 Void
in the Market



                                                                                   2011 Sales
Product                                                 Progestin                    ($mm)          Product(s)     Company

                                                         Synthetic                                   Activella /
Estradiol + Progestin                                                             $         177.7
                                                         Progestin                                    Angeliq

                                                         Synthetic                                  Premphase /
Premarin + Progestin                                                                        290.2
                                                         Progesitn                                    Prempro

Pharmacy Compounding:
                                                           Natural                         96-350
Estradiol + 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 Progestin

Side Effect         Progesterone                     Synthetic Progestins (eg“MPA, NETA”)

                    Micronized progesterone and
                    estrogen results in
Lipid profile                                   Limited effects on lipid profile
                    significantly higher HDL-C
                    than MPA

Cardiovascular      More favorable VTE profile       Less favorable VTE profile

                    Augments pancreatic              Deterioration of glucose tolerance or
Glucose / insulin
                    response to insulin              hyperinsulemia or both
                    Micronized progesterone and
Sleep / mood        estrogen significantly      No benefit on sleep properties
                    improve sleep efficiency

Breast cancer       More favorable profile           Less favorable profile

                    Improvement in symptoms and overall satisfaction with
Quality of Life     micronized progesterone HRT therapy when compared to MPA
                    regimen


                                             Confidential                                    12
Bioavailability Study

Prometrium (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 Product

TXMD’s novel combination of 17β estradiol and progesterone may provide a
safer and more effective alternative for hormone therapy.¹²³

1. A safer product is seen as a result of a better lipid and CV profile for
   progesterone versus synthetic progestins ¹

2. 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
                                   Studies




Study – Combination                                  Cost                                                Location

Pivotal PK                                           $3,545,816                                          US

Phase 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 /     Generic
Product                                           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 the
high food effect with this hormone.



                                             Confidential                                     24

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TherapeuticsMD Presentation

  • 1. TXMD Overview Confidential 0
  • 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 or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties, many of which are outside our control, 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 reflect our opinions only as of the date of this presentation. Please keep in mind that we are not obligating 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 our business that may affect our predictions. You should also review our most recent Form 10-K and Form 10-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 downloaded on the TherapeuticsMD website: www.therapeuticsmd.com/InvestorRelations.aspx. Confidential 1
  • 3. 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
  • 4. 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
  • 5. 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
  • 6. Estradiol and Progesterone Combination Gelatin Capsule Overview Confidential 5
  • 7. 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) Treatment HORMONE THERAPY • Helps severe hot flashes, night sweats, mood issues, or vaginal dryness • Estrogen and, sometimes, progesterone Confidential 6
  • 8. Menopause- Large Patient Population Confidential 7
  • 9. 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
  • 10. TXMD Product Goals 1. Introduce the first and only FDA approved natural Bio-Identical combination (Estradiol+Progesterone) Hormone Replacement product suite to compete with Synthetic Combinations 2. Provide an FDA approved alternative to Compound Pharmacy sales of Progesterone and Estradiol in combination that were between $100- $350 million in 2011 3. Introduce a safer (when compared to synthetic combinations¹), more effective product line 4. Leverage this platform and profile into other therapeutic solutions in Women’s Health 1 The Writing Group for PEPI, JAMA, Jan 1995;273:3;199-208. Confidential 9
  • 11. 2011 Progestin Sales When Sold Alone - Natural Progesterone Dominates the Market 2011 Sales Product / Generic Product Progestin ($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
  • 12. FDA Approved Combination with Natural Progesterone is a Void in the Market 2011 Sales Product Progestin ($mm) Product(s) Company Synthetic Activella / Estradiol + Progestin $ 177.7 Progestin Angeliq Synthetic Premphase / Premarin + Progestin 290.2 Progesitn Prempro Pharmacy Compounding: Natural 96-350 Estradiol + 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
  • 13. Progesterone vs. Synthetic Progestin Side Effect Progesterone Synthetic Progestins (eg“MPA, NETA”) Micronized progesterone and estrogen results in Lipid profile Limited effects on lipid profile significantly higher HDL-C than MPA Cardiovascular More favorable VTE profile Less favorable VTE profile Augments pancreatic Deterioration of glucose tolerance or Glucose / insulin response to insulin hyperinsulemia or both Micronized progesterone and Sleep / mood estrogen significantly No benefit on sleep properties improve sleep efficiency Breast cancer More favorable profile Less favorable profile Improvement in symptoms and overall satisfaction with Quality of Life micronized progesterone HRT therapy when compared to MPA regimen Confidential 12
  • 14. Bioavailability Study Prometrium (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
  • 15. 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
  • 16. 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
  • 17. Benefits of Our Product TXMD’s novel combination of 17β estradiol and progesterone may provide a safer and more effective alternative for hormone therapy.¹²³ 1. A safer product is seen as a result of a better lipid and CV profile for progesterone versus synthetic progestins ¹ 2. 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
  • 18. 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
  • 19. 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 Studies Study – Combination Cost Location Pivotal PK $3,545,816 US Phase 3 $16,508,075 30% Russia / 70% US Sources: Bloomberg and IMS. Total $20,053,891 Confidential 18
  • 20. 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 $100-350 million in 2011 in the US • Supports Bio-Identical Trend • Supports all Post WHI Trends • Phase 3 risk is marginal compared to New Chemical Entities risk for large market drugs Sources: Bloomberg and IMS. Confidential 19
  • 21. Pipeline Confidential 20
  • 22. When Sold Alone - Natural Progesterone Dominates the Market 2011 Sales Product / Generic Product Progestin ($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
  • 23. 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
  • 24. 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
  • 25. 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 the high food effect with this hormone. Confidential 24