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Investor Presentation

        April 2013




                     COPYRIGHT 2013 by TherapeuticsMD
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, and other
information that might be considered forward-looking. While these forward-looking statements
represent TherapeuticsMD, Inc.’s (“TherapeuticsMD,” “we,” “us,” and “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, Form
10-Q, our Form 8-K dated January 25, 2013, and our other filings with the Securities and Exchange
Commission, 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.

                                                                                                     1
Company Overview



                   2
Investment Highlights


1    Novel late-stage hormone therapy candidates


2    Clear pivotal trial endpoints / low risk regulatory pathway

     Compelling, growing market opportunity, especially with recent concerns regarding
3
     compounders

4    Recently completed $50 million equity financing


5    Robust, growing patent estate



                                                                                     3
Innovative Women’s Healthcare Company
     Two 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-dose
         bioidentical progesterone
         Set to begin pivotal Phase 3 clinical trials
                               2013E                   2014E                           2015E                           2016E               U.S. Sales (est.)($mm) (1)(2)
Combination:
                                                                                                                                                         $2,000
17β Estradiol + Progesterone

Oral Progesterone                                                                                                                                          $300



     Novel estradiol pipeline product in development
17β Estradiol in VagiCap™                                                                                                                                  $800

                                     Phase 3 Plan                    Expect to File NDA and PDUFA
                               (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, Executive   4
                                     Director of the Pharmaceutical Compounding Accreditation Board; and Wulf Utian, Consultant on Gynecology and Women¹s Health at The
                                     Cleveland Clinic and Executive Director Emeritus and Honorary Founding President of The North American Menopause Society (“NAMS”).
Why Hormone Therapy?
HT is projected to be the largest
growth segment in the overall women’s
health drug market
Demographics driving strong growth
fundamentals
  By 2015, nearly half the women in America will be
  of menopausal age (1)
  Women will spend more than a third of their life in
  menopause and post-menopause

Very attractive commercial dynamics
  Segment of the market that lacks innovation
  Relatively little promotional activity in the space
  Opportunity to capture market share


                              (1)   U.S. Census Bureau.   5
HT Market Landscape


Sales of FDA approved oral
combination estrogen +
progestin products                     $468 MM (1)(2)


                                                                                                                       Compounding pharmacy
                                                            $1,500 MM (3)(4)                                           sales of unapproved
                                                                                                                       estradiol + progesterone


                                                            U.S. Sales (est.)



                                                                                                       
                                                                                                        Significant demand
                             (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 compounding   6
                                   market is $10-$12 billion; and Tom Murry, Executive Director of the Pharmaceutical Compounding Accreditation Board, said HT for
                                   post-menopausal women is by far the largest of four primary segments served by the compounding industry.
Bioidentical Progesterone vs. Non-Bioidentical Progestin
      The Market understands the benefits of bioidentical HT
                                                                                                                Non-Bioidentical Progestins
Side Effect (1)     Bioidentical Natural Progesterone                                                           (MPA, NETA, drosperinone)

Breast cancer       More favorable profile (E3N-EPIC study)                                                     Increased risk


Cardiovascular      More favorable profile (PEPI trial)                                                         Increased risk of MI, stroke, VTE

                                                                                                                Less favorable effects on lipid profile
Lipid profile       More favorable profile (PEPI trial)
                                                                                                                (cholesterol, HDL, LDL, triglycerides)

                    Improved carbohydrate metabolism                                                            Deterioration of glucose tolerance or
Glucose / insulin
                    (PEPI trial)                                                                                hyperinsulemia or both

Sleep / mood        Improved sleep efficiency (2)                                                               No benefit on sleep properties

                    Improvement in symptoms and overall satisfaction with bioidentical progesterone
Quality of life
                    HT compared to MPA regimen (3)
                                (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 96.4 (2011): 614-23.                                                                                        7
                                (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.
Novel Drug Design

Converted (API) from solid / crystalline to a New Liquid Drug Form
   Estrace (RLD) is a tablet—0.5 mg, 1.0 mg, and 2.0 mg
   Prometrium (RLD) is in suspension—100 mg and 200 mg

New solubilized drug form
   Achieves FDA requirements of uniformity and stability
   Improved functional effects of API(s)
                                                                                Combination of Estradiol
                                                                                   + Progesterone
   Enabling new combinations, routes, and dosages




                                                            
                                                             Meet PK 505(b)(2) thresholds
                   RLD = Reference Listed Drug
                                                                                                           8
                   API = Active Pharmaceutical Ingredient
Building an Extensive Patent Estate
Novel Drug Form Based Approach
    Solubilized API in combination and stand-alone drug products
    for HT indications
    Enabling platform technology for delivery of bioidenticals to variety of
    dosage forms and routes of administration (softgel oral, suppository,
    transdermal, etc.)

Multi-layered Patent Strategy
    Novel dosage forms, improved PK profiles (lowest effective dose,
    increased bioavailability) relative to RLD, reduced side effect profile, and
    formulation advancements (solvent systems, chemical stability, ratios,
    ranges, and functional effects)

Freedom to Operate
    Two independent analyses supporting FTO and patent strategy alignment
                                                                                   9
Combination Product



                      10
TX 12-001HR Combination—
 Proposed Phase 3 Study
                         2012                         2013E                                 2014E                                 2015E                               2016E
                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   Q1 '16   Q2 '16   Q3 '16   Q4 '16

                 Filed                File IND Update &
                  IND                 Phase 3 Protocol
TX 12-001HR
                Pilot PK Pivotal PK
Combination                                                                                                                                                      NDA and PDUFA
                Studies Studies
17β Estradiol
     +                                                                       Phase 3 Vasomotor and Endometrial Protection Study
Progesterone


                                                                                     Phase 3 Trial
                                               Study: 12 month study with 12 week VMS
                                               Sites: ~50
Combination of Estradiol                       Subjects: 1,550
   + Progesterone
                                                − 4 active arms (350 per arm)
                                                − 1 placebo arm (150)
                                               Estimated cost: $20-$25 million
                                               Endpoints
                                                − Vasomotor: number and severity of hot flushes (4 week and 12 weeks)
                                                − Endometrial safety: incidence of endometrial hyperplasia (12 months)




                                                                                                         
                                                                                                          Conduct Phase 3 study                                                            11
TX 12-001HR Estradiol 2mg / Progesterone 200mg (combination)
vs. Estrace® 2mg + Prometrium® 200mg (separate tablets)
                                        17β Estradiol Results (1)
                                                 N=62

       100




        10                                                                                                              Estrace = R1
                                                                                                                        Treatment=R1
                                                                                                                        Estrace = R2
                                                                                                                        Treatment=R2

                                                                                                                        TXMD = T
                                                                                                                        Treatment=T




                               n = 62
         1
             0        5   10     15          20          25         30          35         40          45          50
                                                     Time (hr)


                           95% Confidence Interval for PK Parameter
                                       Point Estimate                  Within Subject                    Upper 95%
             Parameter
                                         T/R Ratio                     Std. Deviation                 Confidence Bound
             Cmax                            0.88                             0.344                            -0.040
             AUC0-t                          0.93                             0.409                            -0.089

                                 (1)   Semilog plots of mean plasma concentrations over time for Free Estradiol.
                                                                                                                                       12
TX 12-001HR Estradiol 2mg / Progesterone 200mg (combination)
vs. Estrace® 2mg + Prometrium® 200mg (separate tablets)
                                  Progesterone Results (1)




                                                                                                           Prometrium = R1
                                                                                                           Prometrium = R2
                                                                                                           TXMD = T




                       n = 62




                     95% Upper Confidence Limit for PK Parameter
                                 Point Estimate                 Within Subject                   Upper 95%
         Parameter
                                   T/R Ratio                    Std. Deviation                Confidence Bound
         Cmax                          1.16                            1.179                           -0.785
         AUC0-t                        1.05                            0.956                           -0.542

                           (1)   Semilog plots of mean plasma concentrations over time for Progesterone.
                                                                                                                             13
TX 12-001HR Combination Potential Benefits
Drug Improvement              General Benefits                                               Patient Benefits

Receive FDA approved            FDA indication / safety and quality                            Insurance coverage
indication                      assurance                                                      Safety, quality, and stability


New lower effective doses       Reduced blood levels                                           Improved safety
                                Better side effect profile

Improved safety profile vs.     Reduced breast cancer risk                                     Confidence in treatment regimen
non-bioidentical progestin      Improved cardiovascular and lipid
                                profile
No peanut oil                   Non-allergenic                                                 No worries about potential
                                Excellent for all patient profiles                             allergies


Combined pill vs. 2 pills       Less risk of dosing errors                                     One co-pay
(E+P sold separately today)                                                                    Increased compliance


                                   Note: Potential improvements and benefits, if approved.
                                                                                                                                 14
FDA Approved Products in Use Lack Innovation
      All FDA approved products in use contain non-bioidentical
      progestins
                                                                         U.S. Sales (est.)                   Intl Sales
Product                                       Progestin                       ($mm)                          ($mm) (4)                            Company
17β Estradiol + NETA /
Drospirenone
                                        Non-bioidentical                            $178 (1)(2)
(Activella / FemHRT / Angeliq /
others)

Premarin + MPA
                                        Non-bioidentical                             290 (1)(2)
(Prempro / Premphase)


Estradiol + Progesterone                     Untested
                                                                                  1,500 (3)                                                Not FDA approved
(custom compounded)                         Bioidentical


   Total Oral Combination Sales                                                 $1,968                           $489


                                  Notes: 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.
                                                                                                                                                              15
                                  (3) Estimate per Wulf Utian, Executive Director Emeritus and Honorary Founding President of NAMS.
                                  (4) IMS Data
New Lower Dose
 Progesterone



                 16
TX 12-002HR Progesterone—
 Proposed Phase 3 Study
                             2012                      2013E                                  2014E                                2015E
                    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 IND Update &
                     IND                          Phase 3 Protocol
                Pilot PK Pivotal PK
                                                                                                                    File NDA and PDUFA
TX12-002HR       Study    Studies
Progesterone

                                                                        Two Phase 3 Amenorrhea Studies
                                                                              12 Days & 3 Cycles




                                                                      Phase 3 Trial
                                         Trial: 2 studies; 12 days, 3 cycles
                                         Sites: 10-15 each
                                         Subject: 180
                                          − 3 arms (60 per arm)
                                         Estimated cost: $5-$8 million
     Progesterone                        RLD = 400mg
                                         Endpoints
                                          − Withdrawal bleeding and secretory change




                                                                                                                                                      17
TX 12-002HR Progesterone Candidate
 Conducted PK studies in accordance with FDA requirements

 TXMD 150 mg test dose found to be bioequivalent
 to 200 mg Prometrium®


Summary evaluations of baseline-corrected Progesterone results
                      for a theoretical
    150 mg test capsule vs. 200 mg Prometrium® capsule
                    Point Estimate   Within Subject      Upper 95%
        Parameter
                      T/R Ratio      Std. Deviation   Confidence Bound
        Cmax            1.03             1.133             -0.747
        AUC0-t          0.96             0.891             -0.465



                                                                         18
TX 12-002HR Progesterone—
   Potential Benefits
Drug Improvement              General Benefits                                               Patient Benefits

New lower effective doses       Lower first-pass metabolites                                   Less somnolence
                                Better side effect profile                                     Improved safety




Improved safety profile vs.     Reduced breast cancer risk                                     Confidence in treatment regimen
non-bioidentical progestin
                                Improved cardiovascular profile
                                Improved lipid profile


No peanut oil                   Non-allergenic                                                 No worries about potential
                                                                                               allergies
                                Excellent for all patient profiles




                                   Note: Potential improvements and benefits, if approved.
                                                                                                                                 19
Natural Progesterone Dominates

                                                            U.S. Sales
                                                              (est.)                                                                           Generic
Product                          Progestin                 ($mm) (1)(2)             INTL Sales (3)                 Company                    Available
Provera®
                                   Non-
(medroxyprogesterone                                              $26                                                                               
                                bioidentical
acetate)

Aygestin®                          Non-
                                                                    45                                                                              
(norethindrone acetate)         bioidentical

Prometrium®
                                Bioidentical                      247                                                                               
(micronized progesterone)


   Total Oral Progestin Sales                                   $318                       $600




                                   (1)   Phast Prescription Monthly by Source Healthcare Analytics.
                                                                                                                                                               20
                                   (2)   Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012.
                                   (3)   IMS Data
Other Programs



                 21
TX 12-004HR Estradiol Product—
   Vulvar / Vaginal Atrophy

                                                                 U.S. Sales (est.)
Product                  Compound                                  ($mm) (1)(2)                    Problems

                                                                                                           Equine source
           ®             Conjugated equine                                                                 Non-bioidentical
Premarin Cream                                                            $265
                         vaginal estrogen                                                                  Messy
                                                                                                           Reusable plungers

                                                                                                           Messy
Vagifem® Tablets
       ®                                                                                                   Reusable plungers
Estrace Cream            Vaginal estradiol                                   558
       ®                                                                                                   Difficult to use
Estring (vaginal ring)
                                                                                                           Continuous-use mechanical device

  Total Sales                                                             $823




                                   (1)   Phast Prescription Monthly by Source Healthcare Analytics.
                                                                                                                                                               22
                                   (2)   Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012.
TX 12-004HR Vaginal Estradiol—
   Potential Benefits
Drug Improvement              General Benefits                                               Patient Benefits

Reduced dose variability        More effective dose delivery than                              Improved efficacy
through soft gel technology     Vagifem® and creams
                                                                                               Easier to use

Flexibility of dosing with      More effective                                                 Less messy
0.010 mg and 0.025 mg                                                                          Reduced burning
                                Improvement vs. Vagifem®

No applicator required          No risk of vaginal wall punctures

                                Digitally inserted with ease

Simple soft gel VagiCap™        More consistent dosing

                                No messy creams

Unique bio-adhesive             Reduced leaking




                                   Note: Potential improvements and benefits, if approved.
                                                                                                                   23
TX 12-004HR Proposed Estradiol Vaginal
       Suppository—Proposed Phase 3 Study
                                      2013E                                  2014E                                    2015E                                  2016E
                      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 '16

                               Expect to
                                                    File IND Update &   File                          NDA
                                  File
                                                    Phase 3 Protocol    NDA                         Approval
                                  IND
  TX 12-004HR                   Pilot PK Pivotal PK
                                                                                                                                   File NDA and PDUFA
17β Estradiol in a               Study    Studies
    VagiCap™


                                                                          Phase 3 Clinical Vulvar & Vaginal Atrophy




                                                                                 Phase 3 Trial
                                                              Trial: 12 weeks
                                                              Sites: 30-40
                                                              Subjects: 375-400
                                                               − 2 active arms (150 per arm)
          Estradiol                                            − 100 placebo
                                                              Endpoints
                                                               − Cell change
                                                               − Lowering of pH
                                                               − Lowering of most bothersome symptoms




                                                                                                                                                                             24
Experienced Management and
      Drug Development Team
                           Management                                                         Drug Development Team

                             Robert Finizio                                   Julia Amadio and James Pickar, M.D., F.A.C.O.G.
                         Chief Executive Officer
                                                                               ‒ Led development and launch of Prempro®, Premphase®,
                                                                                    CombiPatch®, Alesse®, and Crinone®, among others
vitaMed          HT                                Corporate                  Lisa Rarick, M.D. and Daniel Shames, M.D.
  John          Julia              Dan              Dr. Brian      Jason
                                                                                ‒ Former division Director of Reproductive and Urologic
 Milligan      Amadio           Cartwright          Bernick        Spitz            Products for FDA CDER

 President      Chief              Chief              Chief         Vice      Fred Sancilio, Ph.D.
               Product
               Officer
                                 Financial
                                  Officer
                                                    Medical
                                                   Officer and
                                                                 President,    ‒ Former founder and president of AAI and the innovator
                                                                 Marketing
                                                    Director
                                                                                   of multiple hormone products

                Board of Directors / Investors                                Steve Fontana, J.D.
                                                                               ‒ Author of the original estradiol patents
 Tommy        Cooper             Nick            Mario           Wellington
Thompson      Collins           Segal            Family            Fidelity   Bill Mulholland, J.D.
Chairman      Director         Director        Partnership        Hartford     ‒ Lead patent attorney; previously, IP counsel at Pfizer
  Former        CEO,           Seavest         Ernest Mario      Inv. Mgmt
Sec HHS &      Pernix           Capital        Former CEO           John
Gov of Wisc                    Partners          of Glaxo         Hancock




                Proven team with a successful track record of creating shareholder value and
              developing some of the most successful products in the HT and birth control space
                                                                                                                                          25
Potential Milestones

                              2012                         2013E                                  2014E                                    2015E                                  2016E
                     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   Q1 '16     Q2 '16   Q3 '16   Q4 '16

                      Filed                File IND Update &
                       IND                 Phase 3 Protocol
 TX 12-001HR
                     Pilot PK Pivotal PK
 Combination                                                                                                                                                                 NDA and PDUFA
                     Studies   Studies
 17β Estradiol
      +                                                                              Phase 3 Vasomotor and Endometrial Protection Study
 Progesterone




                      Filed                          File IND Update &
                       IND                           Phase 3 Protocol
                     Pilot PK Pivotal PK
                                                                                                                         File NDA and PDUFA
 TX12-002HR           Study    Studies
 Progesterone

                                                                           Two Phase 3 Amenorrhea Studies
                                                                                 12 Days & 3 Cycles


                                                    Expect to
                       File                                              File IND Update &   File                          NDA
                                                       File
                       IND                                               Phase 3 Protocol    NDA                         Approval
                                                       IND
  TX 12-004HR                                        Pilot PK Pivotal PK
                                                                                                                                                        File NDA and PDUFA
17β Estradiol in a                                    Study    Studies
    VagiCap


                                                                                               Phase 3 Clinical Vulvar & Vaginal Atrophy




                                                                                                                                                                                                   26

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Txmd investor presentation.4-17-2013

  • 1. Investor Presentation April 2013 COPYRIGHT 2013 by TherapeuticsMD
  • 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, and other information that might be considered forward-looking. While these forward-looking statements represent TherapeuticsMD, Inc.’s (“TherapeuticsMD,” “we,” “us,” and “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, Form 10-Q, our Form 8-K dated January 25, 2013, and our other filings with the Securities and Exchange Commission, 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. 1
  • 4. Investment Highlights 1 Novel late-stage hormone therapy candidates 2 Clear pivotal trial endpoints / low risk regulatory pathway Compelling, growing market opportunity, especially with recent concerns regarding 3 compounders 4 Recently completed $50 million equity financing 5 Robust, growing patent estate 3
  • 5. Innovative Women’s Healthcare Company Two late-stage 505(b)(2) proposed hormone therapy (“HT”) products targeting a multi-billion dollar U.S. market (1)(2) Bioidentical combination of estradiol + progesterone and lower-dose bioidentical progesterone Set to begin pivotal Phase 3 clinical trials 2013E 2014E 2015E 2016E U.S. Sales (est.)($mm) (1)(2) Combination: $2,000 17β Estradiol + Progesterone Oral Progesterone $300 Novel estradiol pipeline product in development 17β Estradiol in VagiCap™ $800 Phase 3 Plan Expect to File NDA and PDUFA (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, Executive 4 Director of the Pharmaceutical Compounding Accreditation Board; and Wulf Utian, Consultant on Gynecology and Women¹s Health at The Cleveland Clinic and Executive Director Emeritus and Honorary Founding President of The North American Menopause Society (“NAMS”).
  • 6. Why Hormone Therapy? HT is projected to be the largest growth segment in the overall women’s health drug market Demographics driving strong growth fundamentals By 2015, nearly half the women in America will be of menopausal age (1) Women will spend more than a third of their life in menopause and post-menopause Very attractive commercial dynamics Segment of the market that lacks innovation Relatively little promotional activity in the space Opportunity to capture market share (1) U.S. Census Bureau. 5
  • 7. HT Market Landscape Sales of FDA approved oral combination estrogen + progestin products $468 MM (1)(2) Compounding pharmacy $1,500 MM (3)(4) sales of unapproved estradiol + progesterone U.S. Sales (est.)   Significant demand (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 compounding 6 market is $10-$12 billion; and Tom Murry, Executive Director of the Pharmaceutical Compounding Accreditation Board, said HT for post-menopausal women is by far the largest of four primary segments served by the compounding industry.
  • 8. Bioidentical Progesterone vs. Non-Bioidentical Progestin The Market understands the benefits of bioidentical HT Non-Bioidentical Progestins Side Effect (1) Bioidentical Natural Progesterone (MPA, NETA, drosperinone) Breast cancer More favorable profile (E3N-EPIC study) Increased risk Cardiovascular More favorable profile (PEPI trial) Increased risk of MI, stroke, VTE Less favorable effects on lipid profile Lipid profile More favorable profile (PEPI trial) (cholesterol, HDL, LDL, triglycerides) Improved carbohydrate metabolism Deterioration of glucose tolerance or Glucose / insulin (PEPI trial) hyperinsulemia or both Sleep / mood Improved sleep efficiency (2) No benefit on sleep properties Improvement in symptoms and overall satisfaction with bioidentical progesterone Quality of life HT compared to MPA regimen (3) (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 96.4 (2011): 614-23. 7 (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.
  • 9. Novel Drug Design Converted (API) from solid / crystalline to a New Liquid Drug Form Estrace (RLD) is a tablet—0.5 mg, 1.0 mg, and 2.0 mg Prometrium (RLD) is in suspension—100 mg and 200 mg New solubilized drug form Achieves FDA requirements of uniformity and stability Improved functional effects of API(s) Combination of Estradiol + Progesterone Enabling new combinations, routes, and dosages   Meet PK 505(b)(2) thresholds RLD = Reference Listed Drug 8 API = Active Pharmaceutical Ingredient
  • 10. Building an Extensive Patent Estate Novel Drug Form Based Approach Solubilized API in combination and stand-alone drug products for HT indications Enabling platform technology for delivery of bioidenticals to variety of dosage forms and routes of administration (softgel oral, suppository, transdermal, etc.) Multi-layered Patent Strategy Novel dosage forms, improved PK profiles (lowest effective dose, increased bioavailability) relative to RLD, reduced side effect profile, and formulation advancements (solvent systems, chemical stability, ratios, ranges, and functional effects) Freedom to Operate Two independent analyses supporting FTO and patent strategy alignment 9
  • 12. TX 12-001HR Combination— Proposed Phase 3 Study 2012 2013E 2014E 2015E 2016E 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 Q1 '16 Q2 '16 Q3 '16 Q4 '16 Filed File IND Update & IND Phase 3 Protocol TX 12-001HR Pilot PK Pivotal PK Combination NDA and PDUFA Studies Studies 17β Estradiol + Phase 3 Vasomotor and Endometrial Protection Study Progesterone Phase 3 Trial Study: 12 month study with 12 week VMS Sites: ~50 Combination of Estradiol Subjects: 1,550 + Progesterone − 4 active arms (350 per arm) − 1 placebo arm (150) Estimated cost: $20-$25 million Endpoints − Vasomotor: number and severity of hot flushes (4 week and 12 weeks) − Endometrial safety: incidence of endometrial hyperplasia (12 months)   Conduct Phase 3 study 11
  • 13. TX 12-001HR Estradiol 2mg / Progesterone 200mg (combination) vs. Estrace® 2mg + Prometrium® 200mg (separate tablets) 17β Estradiol Results (1) N=62 100 10 Estrace = R1 Treatment=R1 Estrace = R2 Treatment=R2 TXMD = T Treatment=T n = 62 1 0 5 10 15 20 25 30 35 40 45 50 Time (hr) 95% Confidence Interval for PK Parameter Point Estimate Within Subject Upper 95% Parameter T/R Ratio Std. Deviation Confidence Bound Cmax 0.88 0.344 -0.040 AUC0-t 0.93 0.409 -0.089 (1) Semilog plots of mean plasma concentrations over time for Free Estradiol. 12
  • 14. TX 12-001HR Estradiol 2mg / Progesterone 200mg (combination) vs. Estrace® 2mg + Prometrium® 200mg (separate tablets) Progesterone Results (1) Prometrium = R1 Prometrium = R2 TXMD = T n = 62 95% Upper Confidence Limit for PK Parameter Point Estimate Within Subject Upper 95% Parameter T/R Ratio Std. Deviation Confidence Bound Cmax 1.16 1.179 -0.785 AUC0-t 1.05 0.956 -0.542 (1) Semilog plots of mean plasma concentrations over time for Progesterone. 13
  • 15. TX 12-001HR Combination Potential Benefits Drug Improvement General Benefits Patient Benefits Receive FDA approved FDA indication / safety and quality Insurance coverage indication assurance Safety, quality, and stability New lower effective doses Reduced blood levels Improved safety Better side effect profile Improved safety profile vs. Reduced breast cancer risk Confidence in treatment regimen non-bioidentical progestin Improved cardiovascular and lipid profile No peanut oil Non-allergenic No worries about potential Excellent for all patient profiles allergies Combined pill vs. 2 pills Less risk of dosing errors One co-pay (E+P sold separately today) Increased compliance Note: Potential improvements and benefits, if approved. 14
  • 16. FDA Approved Products in Use Lack Innovation All FDA approved products in use contain non-bioidentical progestins U.S. Sales (est.) Intl Sales Product Progestin ($mm) ($mm) (4) Company 17β Estradiol + NETA / Drospirenone Non-bioidentical $178 (1)(2) (Activella / FemHRT / Angeliq / others) Premarin + MPA Non-bioidentical 290 (1)(2) (Prempro / Premphase) Estradiol + Progesterone Untested 1,500 (3) Not FDA approved (custom compounded) Bioidentical Total Oral Combination Sales $1,968 $489 Notes: 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. 15 (3) Estimate per Wulf Utian, Executive Director Emeritus and Honorary Founding President of NAMS. (4) IMS Data
  • 17. New Lower Dose Progesterone 16
  • 18. TX 12-002HR Progesterone— Proposed Phase 3 Study 2012 2013E 2014E 2015E 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 IND Update & IND Phase 3 Protocol Pilot PK Pivotal PK File NDA and PDUFA TX12-002HR Study Studies Progesterone Two Phase 3 Amenorrhea Studies 12 Days & 3 Cycles Phase 3 Trial Trial: 2 studies; 12 days, 3 cycles Sites: 10-15 each Subject: 180 − 3 arms (60 per arm) Estimated cost: $5-$8 million Progesterone RLD = 400mg Endpoints − Withdrawal bleeding and secretory change 17
  • 19. TX 12-002HR Progesterone Candidate Conducted PK studies in accordance with FDA requirements TXMD 150 mg test dose found to be bioequivalent to 200 mg Prometrium® Summary evaluations of baseline-corrected Progesterone results for a theoretical 150 mg test capsule vs. 200 mg Prometrium® capsule Point Estimate Within Subject Upper 95% Parameter T/R Ratio Std. Deviation Confidence Bound Cmax 1.03 1.133 -0.747 AUC0-t 0.96 0.891 -0.465 18
  • 20. TX 12-002HR Progesterone— Potential Benefits Drug Improvement General Benefits Patient Benefits New lower effective doses Lower first-pass metabolites Less somnolence Better side effect profile Improved safety Improved safety profile vs. Reduced breast cancer risk Confidence in treatment regimen non-bioidentical progestin Improved cardiovascular profile Improved lipid profile No peanut oil Non-allergenic No worries about potential allergies Excellent for all patient profiles Note: Potential improvements and benefits, if approved. 19
  • 21. Natural Progesterone Dominates U.S. Sales (est.) Generic Product Progestin ($mm) (1)(2) INTL Sales (3) Company Available Provera® Non- (medroxyprogesterone $26  bioidentical acetate) Aygestin® Non- 45  (norethindrone acetate) bioidentical Prometrium® Bioidentical 247  (micronized progesterone) Total Oral Progestin Sales $318 $600 (1) Phast Prescription Monthly by Source Healthcare Analytics. 20 (2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012. (3) IMS Data
  • 23. TX 12-004HR Estradiol Product— Vulvar / Vaginal Atrophy U.S. Sales (est.) Product Compound ($mm) (1)(2) Problems Equine source ® Conjugated equine Non-bioidentical Premarin Cream $265 vaginal estrogen Messy Reusable plungers Messy Vagifem® Tablets ® Reusable plungers Estrace Cream Vaginal estradiol 558 ® Difficult to use Estring (vaginal ring) Continuous-use mechanical device Total Sales $823 (1) Phast Prescription Monthly by Source Healthcare Analytics. 22 (2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012.
  • 24. TX 12-004HR Vaginal Estradiol— Potential Benefits Drug Improvement General Benefits Patient Benefits Reduced dose variability More effective dose delivery than Improved efficacy through soft gel technology Vagifem® and creams Easier to use Flexibility of dosing with More effective Less messy 0.010 mg and 0.025 mg Reduced burning Improvement vs. Vagifem® No applicator required No risk of vaginal wall punctures Digitally inserted with ease Simple soft gel VagiCap™ More consistent dosing No messy creams Unique bio-adhesive Reduced leaking Note: Potential improvements and benefits, if approved. 23
  • 25. TX 12-004HR Proposed Estradiol Vaginal Suppository—Proposed Phase 3 Study 2013E 2014E 2015E 2016E 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 '16 Expect to File IND Update & File NDA File Phase 3 Protocol NDA Approval IND TX 12-004HR Pilot PK Pivotal PK File NDA and PDUFA 17β Estradiol in a Study Studies VagiCap™ Phase 3 Clinical Vulvar & Vaginal Atrophy Phase 3 Trial Trial: 12 weeks Sites: 30-40 Subjects: 375-400 − 2 active arms (150 per arm) Estradiol − 100 placebo Endpoints − Cell change − Lowering of pH − Lowering of most bothersome symptoms 24
  • 26. Experienced Management and Drug Development Team Management Drug Development Team Robert Finizio Julia Amadio and James Pickar, M.D., F.A.C.O.G. Chief Executive Officer ‒ Led development and launch of Prempro®, Premphase®, CombiPatch®, Alesse®, and Crinone®, among others vitaMed HT Corporate Lisa Rarick, M.D. and Daniel Shames, M.D. John Julia Dan Dr. Brian Jason ‒ Former division Director of Reproductive and Urologic Milligan Amadio Cartwright Bernick Spitz Products for FDA CDER President Chief Chief Chief Vice Fred Sancilio, Ph.D. Product Officer Financial Officer Medical Officer and President, ‒ Former founder and president of AAI and the innovator Marketing Director of multiple hormone products Board of Directors / Investors Steve Fontana, J.D. ‒ Author of the original estradiol patents Tommy Cooper Nick Mario Wellington Thompson Collins Segal Family Fidelity Bill Mulholland, J.D. Chairman Director Director Partnership Hartford ‒ Lead patent attorney; previously, IP counsel at Pfizer Former CEO, Seavest Ernest Mario Inv. Mgmt Sec HHS & Pernix Capital Former CEO John Gov of Wisc Partners of Glaxo Hancock Proven team with a successful track record of creating shareholder value and developing some of the most successful products in the HT and birth control space 25
  • 27. Potential Milestones 2012 2013E 2014E 2015E 2016E 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 Q1 '16 Q2 '16 Q3 '16 Q4 '16 Filed File IND Update & IND Phase 3 Protocol TX 12-001HR Pilot PK Pivotal PK Combination NDA and PDUFA Studies Studies 17β Estradiol + Phase 3 Vasomotor and Endometrial Protection Study Progesterone Filed File IND Update & IND Phase 3 Protocol Pilot PK Pivotal PK File NDA and PDUFA TX12-002HR Study Studies Progesterone Two Phase 3 Amenorrhea Studies 12 Days & 3 Cycles Expect to File File IND Update & File NDA File IND Phase 3 Protocol NDA Approval IND TX 12-004HR Pilot PK Pivotal PK File NDA and PDUFA 17β Estradiol in a Study Studies VagiCap Phase 3 Clinical Vulvar & Vaginal Atrophy 26