Confidential

TXMD Overview

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Confidential

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.

Forward-Looking Statements

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Management Team

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• 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.

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Experienced Drug Development Team

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• 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)

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Board of Directors and Investors

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• 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

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Estradiol and Progesterone Combination Gelatin Capsule

Overview

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Menopause- the Patient

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HORMONE THERAPY

• Helps severe hot flashes, night sweats,

mood issues, or vaginal dryness

• Estrogen and, sometimes, progesterone

• 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)

Symptoms

Treatment

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Menopause- Large Patient Population

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HRT Overview

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• 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.

ProgesteroneEstradiol

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TXMD Product Goals

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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.

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Product Progestin

2011 Sales

($mm)

Product /

Company

Generic

Available

Medroxyprogesterone Acetate Synthetic $ 25.5Provera /

Norethindrone Acetate Synthetic 44.8Aygestin /

Micronized Progesterone Natural 247.2Prometrium /

Total Oral Progestin Sales $ 317.5

When Sold Alone - Natural Progesterone Dominates the Market

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Sources: Company filings, Bloomberg, and IMS.

2011 Progestin Sales

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Product Progestin

2011 Sales

($mm) Product(s) Company

Estradiol + ProgestinSynthetic

Progestin$ 177.7

Activella /

Angeliq

Premarin + ProgestinSynthetic

Progesitn290.2

Premphase /

Prempro

Pharmacy Compounding:

Estradiol + Progesterone (1) Natural 96-350

Total Oral Combination Sales $ 564.0

FDA Approved Combination with Natural Progesterone is a Void

in the Market

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.

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

Lipid profile

Micronized progesterone and

estrogen results in

significantly higher HDL-C

than MPA

Limited effects on lipid profile

Cardiovascular More favorable VTE profile Less favorable VTE profile

Glucose / insulin Augments pancreatic

response to insulin

Deterioration of glucose tolerance or

hyperinsulemia or both

Sleep / mood

Micronized progesterone and

estrogen significantly

improve sleep efficiency

No benefit on sleep properties

Breast cancer More favorable profile Less favorable profile

Quality of Life

Improvement in symptoms and overall satisfaction with

micronized progesterone HRT therapy when compared to MPA

regimen

Progesterone vs. Synthetic Progestin

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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.

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Sources: Bloomberg and IMS.

0.001

0.010

0.100

1.000

10.000

100.000

0 5 10 15 20 25 30 35 40 45 50

Time (hr)

Treatment=R

Treatment=T

N=24

Semilog Plots of Mean Plasma Concentrations over Time for Progesterone

(Corrected) Study 352

TXMD Progesterone vs. Prometrium(combination)

Endometrial Protection

Therapeutic Threshold = 30ng/ml

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Sources: Bloomberg and IMS.

0.01

0.10

1.00

10.00

100.00

0 5 10 15 20 25 30 35 40 45 50

Time (hr)

Treatment=R

Treatment=T

N=24

Semilog plots of Mean Plasma Concentrations over time for Total Estrone Study

Vasomotor Symptom Relief

Therapeutic Threshold = 10pg/ml

TXMD Estradiol vs. Estrace(combination)

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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

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• 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

Favorable Risk Profile

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Sources: Bloomberg and IMS.

Combination Phase 3 Costs and Timeline

Study – Combination Cost Location

Pivotal PK $3,545,816 US

Phase 3 $16,508,075 30% Russia / 70% US

Total $20,053,891

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

Estradiol

+

Progesterone

Filed

IND

File

NDA

NDA

Approval

Pilot PK

StudiesNDA and PDUFA

Pivotal PK

StudiesPhase 3 Vasomotor and Endometrial Protection Study

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Sources: Bloomberg and IMS.

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

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Pipeline

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Product Progestin

2011 Sales

($mm)

Product /

Company

Generic

Available

Medroxyprogesterone Acetate Synthetic $ 25.5Provera /

Norethindrone Acetate Synthetic 44.8Aygestin /

Micronized Progesterone Natural 247.2Prometrium /

Total Oral Progestin Sales $ 317.5

When Sold Alone - Natural Progesterone Dominates

the Market

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Sources: Company filings, Bloomberg, and IMS.

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PK Study Summaries

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• 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

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Progesterone PK Fed Study

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Test

0

10

20

30

40

50

60

0

0.2

5

0.5

0.6

7

0.8

3 1

1.3

3

1.6

7 2

2.5 3 4 6 8

12

24

Test

RLD

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Progesterone PK Fed Study Stats

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Dependent RLD

Geo LSM

Test

Geo LSM

Ratio (%)

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

Progesterone Fasted Study showed negligible results for both Reference and Test, due to the

high food effect with this hormone.

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.