Powerpoint presentation

Jefferies Global Healthcare
Conference
June 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 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 SEC filings,
press releases and financial tables can be viewed and downloaded on the TherapeuticsMD website:
www.therapeuticsmd.com/InvestorRelations.aspx.

Company Overview
TXMD Company History
Founded in May of 2008
Originally a prenatal vitamin company
Recently listed on NYSE MKT under "TXMD"
Shares outstanding: approximately 130 million
Approximately $40 million in cash; no long-term debt
Strong board with blue-chip institutional holders
Gov. Tommy Thompson, Jules Musing, Ernest Mario (investor) Innovative Women's Healthcare Company
Two late-stage 505(b)(2) proposed hormone therapy ("HT")
products targeting a multi-billion dollar U.S. market (1)(2)
Bioidentical combination of estradiol + progesterone and lower-dose bioidentical progesterone Set to begin pivotal Phase 3 clinical trials U.S. Sales (est.)($mm) (1)(2)
17β Estradiol + Progesterone
Oral Progesterone
Novel estradiol pipeline product in development
17β Estradiol in VagiCap™
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 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"). History of Hormone Therapy
2002 Women's Health Initiative (WHI) Study
Lower doses = lower side effect profile Estrogen + Progestin (Prempro) arm had a 22% increase in breast cancer vs. Estrogen alone arm Resulting Hormone Prescribing Trends
Start with the lowest effective dose Progesterone (bioidentical) popularity over Progestins (non-bioidentical) Bioidentical (exact molecular structure of human Estrogen and Progesterone) sales sky rocket HT Combination Market Landscape
Sales of FDA approved oral
combination estrogen +
progestin products
$468 MM (1)(2)
Average WAC Price $185.09(3) Compounding pharmacy
sales of unapproved
$1,500 MM (3)(4)
estradiol + progesterone
U.S. Sales (est.)
 Significant demand
Phast Prescription Monthly by Source Healthcare Analytics. Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012. Estimate per Wulf Utian, Executive Director Emeritus and Honorary Founding President of NAMS. Dr. Loyd Allen Jr., Editor-in-Chief of the International Journal of Pharmaceutical Compounding, stated the U.S. drug compounding 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. 134 Compounding Pharmacies Survey in 34 States 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) 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
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)
Alone or in combination with estrogen. 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. 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 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) Senate HELP Bill 959 on Compounding
New England Compounding Center
Response to Meningitis outbreak, killed 50 and made over 700 patients sick Multiple other cases of unsafe drug sales by other compounding pharmacies Senate Bill Highlights (1)
Establishes clear FDA oversight funded by compounding pharmacy registration fees "Prohibits compounding of certain drug products, including those identified by regulation as being demonstrably difficult to compound (such as complex dosage forms and biologics), marketed FDA-approved drugs that are not in shortage" Market Forces Converge
External market changing events Proposed legislative changes Internal scientific breakthrough Significant shifts favor TXMD 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. Combination Product
TX 12-001HR Combination—
Proposed Phase 3 Study
File IND Update &
Phase 3 Protocol
TX 12-001HR
Pilot PK Pivotal PK
NDA and PDUFA
Phase 3 Vasomotor and Endometrial Protection Study
Phase 3 Trial
Study: 12 month study with 12 week VMS Sites: 50 Combination of Estradiol
+ Progesterone
− 4 active arms (350 per arm) − 1 placebo arm (150) Estimated cost: $20-$25 million Endpoints − Vasomotor: number and severity of hot flashes (4 week and 12 weeks) − Endometrial safety: incidence of endometrial hyperplasia (12 months)  Conduct Phase 3 study
TX 12-001HR Estradiol 2 mg / Progesterone 200 mg (combination)
vs. Estrace® 2 mg + Prometrium® 200 mg (separate tablets)
Progesterone Results (1)
Prometrium = R1
Prometrium = R2
TXMD = T
95% Upper Confidence Limit for PK Parameter
Point Estimate
Within Subject
Upper 95%
Parameter
T/R Ratio
Std. Deviation
Confidence Bound
(1) Semilog plots of mean plasma concentrations over time for Progesterone. TX 12-001HR Estradiol 2mg / Progesterone 200 mg (combination)
vs. Estrace® 2m g + Prometrium® 200 mg (separate tablets)
17β Estr N=62
adiol Results (1)
Estrace = R2
95% Confidence Interval for PK Parameter
Point Estimate
Within Subject
Upper 95%
Parameter
T/R Ratio
Std. Deviation
Confidence Bound
(1) Semilog plots of mean plasma concentrations over time for Free Estradiol. TX 12-001HR Combination Potential Benefits
Drug Improvement
General Benefits
Patient Benefits
Receive FDA approved
FDA indication / safety and quality Insurance coverage indication
Safety, quality, and stability New lower effective doses
Reduced blood levels Better side effect profile Improved safety profile vs.
Reduced breast cancer risk Confidence in treatment regimen non-bioidentical progestin
Improved cardiovascular and lipid profile No peanut oil
No worries about potential Excellent for all patient profiles Combined pill vs. 2 pills
Less risk of dosing errors (E+P sold separately today)
Increased compliance Note: Potential improvements and benefits, if approved. FDA Approved Products in Use Lack Innovation
All FDA approved products in use contain non-bioidentical
progestins
U.S. Sales (est.)
Intl Sales
Progestin
($mm) (4)
17β Estradiol + NETA /
Drospirenone
$178 (1)(2)
(Activella / FemHRT / Angeliq / others) Premarin + MPA
290 (1)(2)
(Prempro / Premphase) Estradiol + Progesterone
Untested
1,500 (3)
Not FDA approved
(custom compounded) Total Oral Combination Sales
Notes: All FDA approved combination products in use contain a non-bioidentical progestin. (1) Phast Prescription Monthly by Source Healthcare Analytics. Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012. Estimate per Wulf Utian, Executive Director Emeritus and Honorary Founding President of NAMS. New Lower Dose
TX 12-002HR Progesterone—
Proposed Phase 3 Study
File IND Update &
Phase 3 Protocol
Pilot PK Pivotal PK
File NDA and PDUFA
TX12-002HR
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-$8 million RLD = 400 mg Endpoints − Withdrawal bleeding and secretory change TX 12-002HR Progesterone Candidate
Conducted PK studies in accordance with FDA requirements TXMD 150 mg test dose found to be bioequivalent to 200 mg Prometrium® Summary evaluations of baseline-corrected Progesterone results
for a theoretical
150 mg test capsule vs. 200 mg Prometrium® capsule
Point Estimate
Within Subject
Upper 95%
Parameter
T/R Ratio
Std. Deviation
Confidence Bound
TX 12-002HR Progesterone—
Potential Benefits
Drug Improvement
General Benefits
Patient Benefits
New lower effective doses
Lower first-pass metabolites Better side effect profile Improved safety profile vs.
Reduced breast cancer risk Confidence in treatment regimen non-bioidentical progestin
Improved cardiovascular profile Improved lipid profile No peanut oil
No worries about potential allergies Excellent for all patient profiles Note: Potential improvements and benefits, if approved. Natural Progesterone Dominates
U.S. Sales
Progestin
($mm) (1)(2)
INTL Sales (3)
Available
Provera®
(medroxyprogesterone Aygestin®
(norethindrone acetate) (micronized progesterone) Total Oral Progestin Sales
Phast Prescription Monthly by Source Healthcare Analytics. Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012. Other Programs
TX 12-004HR Estradiol Product—
Vulvar / Vaginal Atrophy
U.S. Sales (est.)
Compound
($mm) (1)(2)
Problems
Conjugated equine Non-bioidentical Premarin® Cream vaginal estrogen Reusable plungers Vagifem® Tablets Reusable plungers Vaginal estradiol Difficult to use Continuous-use mechanical device Total Sales
Phast Prescription Monthly by Source Healthcare Analytics. Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012. TX 12-004HR Proposed Estradiol Vaginal
Suppository—Proposed Phase 3 Study
Expect to
File IND Update &
Phase 3 Protocol
Pilot PK Pivotal PK
TX 12-004HR
File NDA and PDUFA
17β Estradiol in a
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) − 100 placebo Estradiol
− Cell change − Lowering of pH − Lowering of most bothersome symptoms Experienced Management and
Drug Development Team
Management
Drug Development Team
Julia Amadio and James Pickar, M.D., F.A.C.O.G.
Robert Finizio
‒ Led development and launch of Prempro®, Premphase®, Chief Executive Officer CombiPatch®, Alesse®, and Crinone®, among others Corporate
Lisa Rarick, M.D. and Daniel Shames, M.D.
‒ Former division Director of Reproductive and Urologic Dr. Brian
Milligan
Cartwright
Products for FDA CDER President Fred Sancilio, Ph.D.
Financial President, ‒ Former founder and president of AAI and the innovator Officer and Marketing of multiple hormone products Board of Directors and Investors
Steve Fontana, J.D.
‒ Author of the original estradiol patents Mario Family
Thompson
Partnership
Bill Mulholland, J.D.
Former Sr. ‒ Lead patent attorney; previously, IP counsel at Pfizer Ernest Mario Executive Sec HHS & Former CEO Johnson & Gov of Wisc 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
Potential Milestones
File IND Update &
Phase 3 Protocol
TX 12-001HR
Pilot PK Pivotal PK
NDA and PDUFA
Phase 3 Vasomotor and Endometrial Protection Study
File IND Update &
Phase 3 Protocol
Pilot PK Pivotal PK
File NDA and PDUFA
TX12-002HR
Two Phase 3 Amenorrhea Studies
12 Days & 3 Cycles
Expect to
File IND Update &
Phase 3 Protocol
Pilot PK Pivotal PK
TX 12-004HR
File NDA and PDUFA
17β Estradiol in a
Phase 3 Clinical Vulvar & Vaginal Atrophy
Product Candidate
Potential Milestones
IND update and Phase 3 study—protocol acceptance 17β Estradiol +
Phase 3 study initiation (first patient in) Phase 3 last patient in (TX 12-001HR) IND update—protocol acceptance (TX 12-002HR) 12 day study, Phase 3 study initiation 3 cycle, Phase 3 study initiation 12 day study, last patient in 3 cycle study, last patient in NDA filed—set PDUFA date 17β Estradiol in
IND acceptance (vaginal estradiol) VagiCapTM
Pivotal PK study and test results (TX 12-004HR) Phase 3 study initiation (first patient in) Investment Highlights
Novel late-stage hormone therapy candidates
Clear pivotal trial endpoints / low risk regulatory pathway
Compelling, growing market opportunity, especially with recent concerns regarding
compounders
Recently completed $50 million equity financing
Robust, growing patent estate

Source: http://www.dracofinancial.com/TXMD-Jefferies_Conf_Investor_Presentation_Final.pdf