TXMD is developing a combination estradiol and progesterone gelatin capsule to treat menopause symptoms. Their product aims to provide a safer and more effective alternative to existing FDA-approved synthetic hormone combinations by using bioidentical estradiol and progesterone. PK studies found their combination tended toward bioequivalence with an estradiol/progesterone combination, and progesterone in their formulation had significantly less variability than Prometrium alone. If approved, their product could capture part of the large domestic and international markets for menopause treatment and help regulate the compounding pharmacy industry.
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.
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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)
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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
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
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-
$350 million in 2011
3. Introduce a safer (when compared to synthetic combinations¹), more
effective product line
4. Leverage this platform and profile into other therapeutic solutions in
Women’s Health
1 The Writing Group for PEPI, JAMA, Jan 1995;273:3;199-208.
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11. 2011 Progestin Sales
When Sold Alone - Natural Progesterone Dominates the Market
2011 Sales Product / Generic
Product Progestin ($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.
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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
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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.
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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)
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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
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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
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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 $100-350 million in 2011 in the US
• Supports Bio-Identical Trend
• Supports all Post WHI Trends
• Phase 3 risk is marginal compared to New Chemical Entities risk for large
market drugs
Sources: Bloomberg and IMS.
Confidential 19
22. When Sold Alone - Natural Progesterone Dominates
the Market
2011 Sales Product / Generic
Product Progestin ($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
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