UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): January 9, 2017
| TherapeuticsMD, Inc. |
(Exact Name of Registrant as Specified in its Charter)
| Nevada | 001-00100 | 87-0233535 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) | (IRS
Employer Identification No.) |
6800 Broken Sound Parkway NW, Third Floor Boca Raton, FL 33487 |
||
| (Address of Principal Executive Office) (Zip Code) |
Registrant's telephone number, including area code: (561) 961-1900
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 7.01. | Regulation FD Disclosure. |
TherapeuticsMD, Inc. is furnishing as Exhibit 99.1 to this Current Report on Form 8-K an investor presentation which will be used, in whole or in part, and subject to modification, on January 9, 2017 and at subsequent meetings with investors or analysts.
The information in this Current Report on Form 8-K (including the exhibit) is being furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor will any of such information or exhibits be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as expressly set forth by specific reference in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. | |||
| Exhibit Number |
Description | |||
| 99.1 | TherapeuticsMD, Inc. presentation dated January 2017. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: January 9, 2017 | THERAPEUTICSMD, INC. | |
| By: | /s/ Daniel A. Cartwright | |
| Name: | Daniel A. Cartwright | |
| Title: | Chief Financial Officer | |
EXHIBIT INDEX
| Exhibit Number |
Description | |
| 99.1 | TherapeuticsMD, Inc. presentation dated January 2017. |
Exhibit 99.1
TXMD Overview January 2017 THER - 0086 1/17
2 Forward - Looking Statements This presentation by TherapeuticsMD, Inc . (referred to as “we” and “our”) may contain forward - looking statements . Forward - looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future . These statements are often characterized by terminology such as “believe,” “hope,” “may,” “anticipate,” “should,” “intend,” “plan,” “will,” “expect,” “estimate,” “project,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of our managerial experience and perception of historical trends, current conditions, expected future developments and other factors we believe to be appropriate . Forward - looking statements in this presentation are made as of the date of this presentation, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise . Forward - looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which may be outside of our control . Important factors that could cause actual results, developments and business decisions to differ materially from forward - looking statements are described in the sections titled “Risk Factors” in our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10 - K and Quarterly Reports on Form 10 - Q, as well as our current reports on Form 8 - K, and include the following : our ability to maintain or increase sales of our products ; our ability to develop, protect and defend our intellectual property ; our ability to develop and commercialize our hormone therapy drug candidates and obtain additional financing necessary therefore ; whether the company will be able to prepare a new drug application for its TX - 001 HR product candidate and, if prepared, whether the FDA will accept and approve the application ; whether the FDA will approve the company’s new drug application for its TX - 004 HR product candidate and whether any such approval will occur by the PDUFA date ; the length, cost and uncertain results of our clinical trials ; potential adverse side effects or other safety risks that could preclude the approval of our hormone therapy drug candidates ; our reliance on third parties to conduct our clinical trials, research and development and manufacturing ; the availability of reimbursement from government authorities and health insurance companies for our products ; the impact of product liability lawsuits ; the influence of extensive and costly government regulation ; the volatility of the trading price of our common stock ; and the concentration of power in our stock ownership . TX - 004 HR ( Yuvvexy TM ), TX - 001 HR, TX - 005 HR, and TX - 006 HR are investigational drugs and are not approved by the FDA . This non - promotional presentation is intended for investor audiences only . PDF copies of press releases and financial tables can be viewed and downloaded at our website : www.therapeuticsmd.com / pressreleases.aspx .
3 (TXMD) Innovative women’s health company exclusively focused on developing and commercializing products for women throughout their life cycles Drug candidate portfolio is built on SYMBODA ™ technology for the solubilization of bio - identical female hormones
4 1) The North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North Am erican Menopause Society. Menopause . 2013;20(9):888 – 902. 2) Gass ML, Cochrane BB, Larson JC, et al. Patterns and predictors of sexual activity among women in the hormone therapy trials of th e Women’s Health Initiative. Menopause . 2011;18(11):1160 – 1171. 3) Derived from U.S. Census data 4) Based on pre - WHI annual scripts of FDA - approved HT products 5) Based on market pricing of current FDA - approved HT products Two Late Stage Women’s Health Assets With Large Total Addressable Market Opportunities Proposed Indication Condition Description Active Ingredients Form Key Value Proposition Affected US Population US TAM Opportunity Status VVA due to Menopause Menopause Moderate to Severe Dyspareunia, a Symptom of VVA, due to Menopause 32 million women 1,2 36 million women 3 >$20B 5 >$25B 4,5 TX - 001HR Bio - Identical 17 β - Estradiol Bio - Identical 17 β - Estradiol + Bio - Identical Progesterone TX - 004HR ( Yuvvexy TM ) Vaginal softgel capsule Oral softgel capsule Negligible systemic exposure, early onset of action, ease of use Potential first and only bio - identical FDA - approved combination product NDA submitted July 7, 2016 PDUFA target action date: May 7, 2017 Positive Phase 3 topline data NDA submission expected 3Q17 Moderate to Severe Hot Flashes due to Menopause
5 Seasoned Management Team with a Proven Track Record of Commercial Execution • Co - founded CareFusion • Held executive sales and operation management positions at McKesson, Cardinal and Omnicell • 20+ years of operations experience • Former CFO of American Wireless, Telegeography, and WEB Corp • Participated in American Wireless/Arush Entertainment merger • Former KPMG and PricewaterhouseCoopers accountant • 25+ years of women’s health pharmaceutical experience • Product development leader for J&J, Wyeth, Aventis, and others • Worked on development of Prempro ® , Premphase ® , and Estalis ® • Former U.S. Secretary of Health and Human Services (2001 - 2005) • Holds multiple board memberships, including Centene and United Therapeutics • 40 - year public health career • 25+ years of pharmaceutical marketing, sales, and operations experience • Led commercialization of anti - estrogens/estradiol, breast cancer, and ovarian cancer drugs • 20+ years of commercial and marketing experience • SVP of the Pfizer Consumer Healthcare Wellness Organization • Commercial lead for sales and marketing of the Pfizer Women’s Health Division • Head of Global Innovation at Weight Watchers International • Co - founded vitaMedMD in 2008 • 25 years of experience in healthcare/women’s health • Past OBGYN Department Chair - Boca Raton Regional Hospital, and • Past ACOG Committee Member • OBGYN - trained University of Pennsylvania • Former Clinical Lead of Women’s Health at Pfizer • 15+ years of experience developing women’s health products • Reproductive endocrinologist & infertility specialist • Co - founded vitaMedMD in 2008 • Co - founded CareFusion (Sold to Cardinal Health in 2006) • 22 years of experience in early stage healthcare company development • 20+ years of experience in biopharma and consumer businesses • SVP of BD at Paratek Pharmaceuticals • VP and GM at Teva Pharmaceuticals • Senior women’s health positions at Bayer and Pfizer • Former President and Chief Executive Officer of Boehringer Ingelheim (U.S.) • Former EVP of Customer Marketing and Sales of U.S. Human Health at Merck • Holds multiple board memberships, including Catalent • Former Chief Executive Officer and Chief Financial Officer of Shire PLC • Former Vice President of Corporate Finance at AstraZeneca • Holds multiple board memberships, including Chairman of Revance Therapeutics
6 TX - 001HR | Combination Estrogen + Progesterone (E+P) Program
7 Menopause Overview 1) National Institutes of Health, National Institute on Aging, https://www.nia.nih.gov/health/publication/menopause, last acc ess ed November 3, 2015. 2) International Journal on Women’s Health, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3897322/ Menopause represents the natural life - stage transition when women stop having periods as the production of Estrogen (E) and Progesterone (P) decreases ▪ Symptoms include hot flashes, night sweats, mood changes and vaginal dryness ▪ Prolonged lack of estrogen can affect the bones, cardiovascular system, and increases risks for osteoporosis Long history of Estrogen (E) and Progesterone (P) use ▪ Estrogen and Progesterone have been used for over 50 years as treatment ▪ Estrogen to reduce symptoms and other long - term conditions ▪ Progesterone to prevent thickening of the uterine wall 2 ▪ Increased risk for endometrial hyperplasia/endometrial cancer if estrogen unopposed 2 ▪ Average age of menopause 51 years 1 ▪ Women may spend, on average, more than one - third of their lives in a hypoestrogenic state May result in physical and emotional symptoms 1
8 TX - 001HR Product Development Rationale ▪ July 2002 - Women’s Health Initiative (WHI) study showed that synthetic hormones in combination increased the risk of breast cancer, stroke, heart attack and blood clots ▪ Since the WHI, both w omen and healthcare providers have chosen unapproved, b io - identical h ormones that are now cash pay over FDA - approved, synthetic hormones that are covered by insurance ▪ Today, patients have the choice between two second best therapies: • Unapproved, compounded bio - identical hormones that have not been proven safe and effective, or • FDA - approved, synthetic hormones TherapeuticsMD’s goal is to deliver a best in class, bio - identical hormone therapy that is FDA - approved based on safety and efficacy and covered by insurance TX - 001HR Specifically Designed to Deliver This Unmet Medical Need
9 TX - 001HR – Potential Best in Class VMS Therapy Prototype Maintenance Pack Bio - Identical Single Dose Combination VMS Efficacy Data Endometrial Cancer Safety Data FDA - Approved 1 Third - Party Reimbursement 2 ▪ Once - a - day Oral Softgel Capsule ▪ First and only bio - identical combination of E2 and P4 product candidate ▪ Single dose option ▪ Positive Phase 3 Replenish trial safety and efficacy results ▪ Potential FDA - approval with insurance coverage Dosing and Delivery Addresses Unmet Medical Need Potential first and only: 1) Bio - identical combination 2) FDA - approved Benefits to women, healthcare providers, and pharmacies TX - 001HR (If Approved) 1) NDA to be submitted 2) Reimbursement anticipated if FDA - approved
10 Medical Societies Discourage Prescribing of Compounded Bio - Identical Hormones 1) Committee on Gynecologic Practice and the American Society for Reproductive Medicine Practice Committee, Number 532, Augus t 2 012 (Reaffirmed 2014, Replaces No. 387, November 2007 and No. 322, November 2005). ▪ ACOG and ASRM Committee Opinion states compounded hormones may pose additional risks compared to FDA - approved products 1 ▪ Lack of efficacy and safety data ▪ Lack of Good Manufacturing Practices (GMP) ▪ Variable purity ▪ Variable content uniformity ▪ Variable potency (under/over dose) ▪ Lack of stability ▪ Unopposed E / Ineffective P leads to increased risk of endometrial hyperplasia / cancer
11 TX - 001HR (if approved) - Healthcare Provider Benefits ▪ Provide clinically validated dose regimens ▪ Meet medical standards of care and society guidelines while reducing liability ▪ Eliminate risks of compounded hormone therapy ▪ Meet patient demands and reduce patient out - of - pocket costs via insurance coverage
12 » 2014 - Majority of major payors eliminated reimbursement of compounded medications » 2017 - Average pre - tax profit per script of compounded bio - identical hormones is $3 - $5 Pharmacy benefits if TX - 001HR is approved: ▪ Improve net margin per script vs compounded bio - identical hormones ▪ Meet patient and physician demand for bio - identical hormone therapy ▪ Drive top - line growth due to third - party reimbursement ▪ Lower legal and regulatory costs and risk TX - 001HR (if approved) - Pharmacy Benefits
13 TX - 001HR (if approved) - Patient Benefits ▪ Meet demand for bio - identical hormone therapy that is FDA - approved based on safety and efficacy ▪ Eliminate risks of compounded hormone therapy ▪ Reduce out - of - pocket costs via insurance coverage and a single co - pay ▪ Provide convenience of one combination product ▪ Be available at most pharmacies
14 TX - 001HR | Replenish Trial Overview and Results
15 Replenish Trial Study Design - Flow Chart 1. Healthy postmenopausal women aged 40 to 65 years with an intact uterus who were seeking relief from vasomotor symptoms (VMS) and who met all inclusion/exclusion criteria were eligible for 12 months of study treatment. Randomized Study Participants 1 52 - Week Endometrial Safety Study (No Placebo Arm) 12 - Week VMS Efficacy Substudy Frequency and Severity of Hot Flash diary data was assessed during Screening Placebo 0.25 mg/50 mg 0.5 mg/50 mg 0.5 mg/100 mg 1 mg/100 mg 0.25 mg/50 mg 0.5 mg/50 mg 0.5 mg/100 mg 1 mg/100 mg ≥ 7 moderate or severe hot flashes per day or ≥ 50 per week during Screening < 7 moderate or severe hot flashes per day or < 50 per week during Screening All four active arms continue on to 52 - Week Endometrial Safety Study after 12 - Week VMS Efficacy Substudy is completed
16 Replenish Trial Co - Primary Endpoints Primary Efficacy Endpoints: Mean Change in Frequency and Severity of Hot Flashes Per Week Versus Placebo at Weeks 4 and 12, VMS - mITT Population Estradiol/Progesterone 1 mg/100 mg 0.5 mg/100 mg 0.5 mg/50 mg 0.25 mg/50 mg Placebo (n = 141) (n = 149) (n = 147) (n = 154) (n = 135) Frequency Week 4 P - value versus placebo <0.001 0.013 0.141 0.001 - Week 12 P - value versus placebo <0.001 <0.001 0.002 <0.001 - Severity Week 4 P - value versus placebo 0.031 0.005 0.401 0.1 - Week 12 P - value versus placebo <0.001 <0.001 0.018 0.096 - Primary Safety Endpoint: Incidence of Consensus Endometrial Hyperplasia or Malignancy up to 12 months, Endometrial Safety Population Ŧ Endometrial Hyperplasia 0% (0/280) 0% (0/303) 0% (0/306) 0% (0/274) 0% (0/92) MITT = Modified intent to treat Ŧ Per FDA, consensus hyperplasia refers to the concurrence of two of the three pathologists be accepted as the final diagnosis P - value < 0.05 meets FDA guidance and supports evidence of efficacy Primary Efficacy Analysis pre - specified with the FDA in the clinical protocol and Statistical Analysis Plan (SAP) • P - value < 0.05 meets FDA guidance and supports evidence of efficacy Replenish Trial Topline Data
17 Replenish Trial Topline Data Mean Change from Baseline in Weekly Frequency of Moderate to Severe Hot Flashes for Weeks 1 to 12 -60 -50 -40 -30 -20 -10 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Mean Weekly Frequency Reduction from Baseline Study Week 1 mg E/100 mg P 0.5 mg E/100 mg P 0.5 mg E/50 mg P 0.25 mg E/50 mg P Placebo
18 Replenish Trial Topline Data -2 -1.8 -1.6 -1.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Mean Weekly Reduction in Severity from Baseline Study Week 1 mg E/100 mg P 0.5 mg E/100 mg P 0.5 mg E/50 mg P 0.25 mg E/50 mg P Placebo Mean Change from Baseline in Weekly Severity of Moderate to Severe Hot Flashes for Weeks 1 to 12
19 TX - 001HR | Market Opportunity
20 TRx US: FDA - Approved Compounded Combination Bio - Identical E+P Separate Bio - Identical E & P Pills Combination Synthetic E+P 1 ~3 million 2 ~3 million 2 12 – 18 million TX - 001HR Potential Market $600M - $750M 3 $600M - $750M 3 $2.4B - $4.5B 3 TX - 001HR Total Substitutable Market Opportunity $3.6B – $6.0B 1) Includes the following drugs: Activella ®, FemHRT ® , Angeliq ®, Generic 17 b + Progestins , Prempro ®, Premphase ®, Duavee ®, Brisdelle ® 2) Symphony Health Solutions PHAST Data powered by IDV; 12 months as of December 31 2015 3) Assume WAC pricing between $200 - 250 All trademarks are the property of their respective owners. Multi - Billion Dollar Total Substitutable Market Opportunity TX - 001HR (if approved) If approved, TX - 001HR can provide a single pill solution for women and physicians who: 1) Demand an FDA - approved bio - identical combination hormone product 2) Do not trust compounded hormones
21 12M - 18M Prescriptions $2.4B - $4.5B 1 Compounded Combination Bio - Identical E+P Substitutable Market Opportunity BIO - IGNITE is an outreach program to quantify and qualify the interests of 3,000 independent and community based pharmacies that compound bio - identical E+P Goal: Understand and identify the high volume pharmacies and prescribers that have developed a specialty focus around women’s menopausal health Mission: Work with these specialists to transition patients from unapproved compounded therapies to an FDA - approved treatment Commercialization Strategy: BIO - IGNITE
22 BIO - IGNITE Progress and Results Partnerships with Large Pharmacy Networks Pharmacy Network Partners Network Size 104 Pharmacies In Network 225 Pharmacies In Network Combination Bio - Identical E+P Scripts ~500,000 prescriptions annually ~1,000,000 prescriptions annually All trademarks are the property of their respective owners.
23 1) SK&A Nationwide Physician Specialty Report – June 2015 Who Writes Compounded Bio - Identical E+P Prescriptions? Super Prescribers Normal Prescribers 240,000 Total Eligible Physicians 1 (Includes OB/GYNs, PCPs, and Anti - Aging) 30,000 Regular Prescribers (12.5%) 60,000 Low Prescribers (24.5%) 138,000 Never Prescribe (58%) 5,000,000 (33%) 7,000,000 (47%) 3,000,000 (20%) 0 12M - 18M Annual Compounded Bio - Identical E+P Prescriptions Breakout by Volume 12,000 High Prescribers (5%) ~8/week ~4 - 5/week ~1/week
24 1)http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm376829.htm 2) http://www.iacprx.org/general/custom.asp?page=CCIns161314 3) http://www.optum.com.br/content/optum/en/optumrx/pharmacy - insights/restoring - trust - compound - medications.html 4) http://www.usp.org/sites/default/files/usp_pdf/EN/m7808.pdf 5) https://www.ascp.com/sites/default/files/Joint%20USP%20letter%202015%20FINAL.pdf All trademarks are the property of their respective owners July 2018: USP - 800 implementation will set new identification requirements for receipt, storage, mixing, preparing, compounding, dispensing, and administration of hazardous drugs 4,5 • Considered “prohibitively expensive” requiring major pharmacy upgrades and renovations to be compliant • Large fixed capital expenditure requirements, with some totaling >$150,000 per pharmacy to implement June 3, 2014: ESI launches a “Compound Management Solution,” creating a list of excluded ingredients that eliminated almost 95% of all compound claims 2 July 2014: Optum initiates a comprehensive compound management program, including prior authorizations and step therapy for all compounded prescriptions 3 November 2013: Congress enacts Drug Quality and Security Act (DQSA), which prohibits compounding of essential copies of an FDA - approved drug except in limited circumstances such as drug shortage 1 Adverse Reimbursement and Regulatory Environments Continue to Erode Independent Pharmacy Margins
25 1) Includes additional labor, pharmacists, technicians, regulatory, and legal expenses 2) July 2018 Implementation; includes >$150,000 capital expenditure as well as new identification requirements for receipt, s tor age, mixing, preparing, compounding, dispensing, and administration of hazardous drugs Insurance Coverage (b efore 2H14) Present Day (2017) Post USP - 800 (July 2018) Revenue Patient Co - Pay 50.00 50.00 50.00 Third - Party Reimbursement 115.00 - - Total Net Revenue $ 165.00 $ 50.00 $ 50.00 Costs of Good Sold 7.50 7.50 7.50 Gross Profit $ 157.50 $ 42.50 $ 42.50 Gross margin 95.5% 85.0% 85.0% Operating Expenses G&A 15.00 15.00 15.00 S&M 7.50 7.50 7.50 Additional Compounding Costs 1 15.00 15.00 15.00 Cost of USP - 800 Requirements 2 - - 10.00 Total Operating Expenses $ 37.50 $ 37.50 $ 47.50 Pre - Tax Profit $ 120.00 $ 5.00 $ (5.00) Operating margin 72.7% 10.0% - 10.0% Independent Pharmacy Net Income Per Compounded Script
26 Economic Incentives Provide Catalyst to Switch to TX - 001HR 1) Assume AWP - 18% Third - Party Reimbursement 2) Assume $250 WAC less 20% distribution discount 3) Includes additional labor, pharmacists, technicians, regulatory, and legal expenses 4) July 2018 Implementation; includes >$150,000 capital expenditure as well as new identification requirements for receipt, s tor age, mixing, preparing, compounding, dispensing, and administration of hazardous drugs Independent Pharmacy Net Income Per Script with TX - 001HR Compounded E+P Post USP - 800 TX - 001HR Launch 2H18 Revenue Patient Co - Pay 50.00 50.00 Third - Party Reimbursement - 200.00 Total Net Revenue $ 50.00 $ 250.00 1 Costs of Good Sold 7.50 200.00 2 Gross Profit $ 42.50 $ 50.00 Gross margin 85.0% 20.0% Operating Expenses G&A 15.00 15.00 S&M 7.50 5.00 Additional Compounding Costs 3 15.00 - Cost of USP - 800 Requirements 4 10.00 - Total Operating Expenses $ 47.50 $ 20.00 Pre - Tax Profit $ (5.00) $ 30.00 Operating margin - 10.0% 12.0%
27 ▪ Healthcare providers not comfortable with compounding will often prescribe two separate FDA - approved bio - identical products to treat menopausal symptoms 1) Symphony Health Solutions PHAST Data powered by IDV; 12 months as of December 31 2015 2) Assume WAC pricing between $200 - 250 All trademarks are the property of their respective owners. Product Use by Age AGES 41 - 50 AGES 51 - 60 AGES 61 - 70 AGES 71+ TRx Totals Progesterone * 528,325 1,326,618 1,060,666 678,775 3,594,384 1 Estradiol 2,677,210 5,494,846 2,826,636 1,083,726 12,082,418 1 ▪ This regimen carries significant risk of endometrial hyperplasia/cancer if the patient is non - compliant with regular progesterone use ▪ Progesterone’s side effects of nausea and somnolence can lead to a patient not taking the progesterone ▪ Results in two separate co - pays for the patient ~3M Potential Prescriptions for TX - 001HR (if approved) Market Opportunity = $600M - 750M 2 FDA - Approved Separate Bio - Identical E & P Substitutable Market Opportunity *Menopausal use of progesterone directly substitutable to TX - 001HR
28 1) Symphony Health Solutions PHAST Data powered by IDV; 12 months as of December 31 2015 Includes the following drugs: Activella ®, FemHRT ® , Angeliq ®, Generic 17 b + Progestins , Prempro ®, Premphase ®, Duavee ®, Brisdelle ® 2) Assume WAC pricing between $200 - $250 All trademarks are the property of their respective owners. TX - 001HR (If Approved) FDA - Approved Combination Synthetic E+P Prescriptions by Age FDA - Approved Combination Synthetic E+P Substitutable Market Opportunity AGES 31 - 40 AGES 41 - 50 AGES 51 - 60 AGES 61 - 70 AGES 71+ Unknown Ages TRx Totals 52,575 372,968 1,712,852 759,634 151,821 68,672 3,118,522 1 ~3M Potential Prescriptions for TX - 001HR (if approved) Market Opportunity = $600M - 750M 2
29 Expect Robust Insurance Coverage For TX - 001HR, If Approved, In - Line with Product Class 4,315 Commercial Plans % Unrestricted Access of Commercial Plans Not Covered Estrace ® (Oral) 96% 1% Prempro ® 94% 5% CombiPatch ® 93% 4% Climara Pro® 92% 4% FemHRT ® 87% 6% Duavee ® 86% 5% Vivelle - Dot® 84% 5% Activella ® 83% 8% Prometrium ® 83% 6% Data Source MMIT August 17, 2016 – 4,300 commercial plans All trademarks are the property of their respective owners.
30 TX - 004HR ( Yuvvexy TM ) Vulvar and Vaginal Atrophy (VVA) Program
31 Overview – Vulvar and Vaginal Atrophy ( V V A) 1) Kingsberg , Sheryl A., et al. “Vulvar and Vaginal Atrophy in Postmenopausal Women: Findings from the REVIVE ( REal Women’s VIews of Treatment Options for Menopausal Vaginal ChangEs ) Survey.” International Society for Sexual Medicine 2013, no. 10, 1790 - 1799. ▪ Chronic and progressive condition characterized by thinning of vaginal tissue from decreased estrogen levels ▪ Diagnosed in approximately 50% of postmenopausal women 1 ▪ Primary symptom = dyspareunia ▪ Secondary symptoms include: dryness, itching, irritation, dysuria, bleeding with sexual activity ▪ Current treatments include: prescription creams, lubricants and tablets >15% 80% < 5% Superficial cells: Intermediate cells: Parabasal cells: <5% 60% >30% Healthy Vaginal Tissue Atrophic Vaginal Tissue < 5 pH: > 5
32 Current FDA - Approved VVA Competitive Landscape 1) Symphony Health Solutions PHAST Prescription Monthly Powered by IDV, 12 months as of December 31, 2015. 2) GlobalData July 2013 report GDHC54PIDR. 3) Medi - Span Price Rx Basic * for 18 tablets ($170.16 WAC for 8 tablets) **for 18 tablets ($155.18 for 8 tablets) All trademarks are the property of their respective owners. Product Company Compound 2015 TRx (000) 1 2015 U.S. Sales ($M) 1 WAC Price 3 Premarin ® Cream Pfizer Conjugated equine vaginal estrogen 1,615 $502 $288.40 Vagifem ® Tablets Novo Nordisk Vaginal e stradiol 1,620 $456 $382.86* Yuvafem ® Tablets ( Vagifem AG) Amneal Vaginal estradiol Launched October 2016 $349.17** Estrace ® Cream Allergan Vaginal estradiol 1,548 $420 $263.81 Estring ® Ring Pfizer Vaginal estradiol ring 284 $91 $310.44 Osphena ® Tablets Shionogi Oral SERM 263 $66 $530.07 Total 5,330 $1,535 ▪ U.S. sales more than doubled since 2008 1 ▪ Global market expected to be $2.1 billion in 2022 2 ▪ 7% current market penetration
33 1) The North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause . 2013;20(9):888 – 902. 2) Gass ML, Cochrane BB, Larson JC, et al. Patterns and predictors of sexual activity among women in the hormone therapy trials of th e Women’s Health Initiative. Menopause . 2011;18(11):1160 – 1171. 3) IMS Health Plan Claims (April 2008 - Mar 2011). 4) TherapeuticsMD “EMPOWER” Survey, 2016 5) Based on current FDA - approved market pricing ** Not treated with an FDA approved Rx product. OTC products do not effectively treat the underlying pathological causes of V VA and therefore do not halt or reverse the progression of this condition. ~50% of women seek treatment for VVA 4 Not Seeking Treatment 50% OTC Product Users 25% Past HT Users 18% Current HT Users 7% >$20B Branded Total US Market Opportunity 5 Current VVA Market Overview 32M Women with VVA Symptoms 1,2 ▪ 7%, or 2.3M women, are currently being treated today with Rx hormone therapy (HT) 3 ▪ 18%, or 5.7M women, have tried HT and were unsatisfied/unsuccessful 4 ▪ 25%, or 8M women, use OTC products**, such as lubricants 4
34 Current FDA - Approved VVA Product Use Falls Short OTC Product Users Past HT Users Current HT Users ▪ Do not effectively treat the underlying pathological causes of VVA ▪ Do not halt or reverse symptoms ▪ Unsatisfied / unsuccessful with past treatments ▪ Physical and clinical attributes of existing products ▪ Long - term safety concerns 1 ▪ Efficacy 1 ▪ Messiness 1 ▪ Need for applicator 1 Not Seeking Treatment ▪ Not aware that VVA is a treatable condition ▪ Estrogen exposure concerns Perceived Product Shortcomings Market Size VVA Market Opportunity 8M Women 3 25% of VVA Population >$5B 5.7M Women 3 18% of VVA Population >$3B 2.3M Women 2 7% of VVA Population >$1.5B 16M Women 50% of VVA Population >$10B 1) Wysocki , S et al, Management of Vaginal Atrophy: Implications from the REVIVE Survey . Clinical Medicine Insights: Reproductive Health 2014:8 23 - 30 doi:10.4137/CMRH.S14498 2) IMS Health Plan Claims (April 2008 - Mar 2011). 3) TherapeuticsMD “EMPOWER” Survey, 2016
35 TX - 004HR ( Yuvvexy TM ) YUVVEXY™ is an investigational drug and is not approved for use by the FDA. ▪ Small, digitally inserted, rapidly dissolving softgel capsule ▪ No applicator ▪ Proposed dose packaging to optimize compliance and convenience ▪ PDUFA target action date of May 7, 2017 Prototype Starter Pack Prototype Maintenance Pack 0.69 x 0.3 inch Starter Pack Maintenance Pack
36 TX - 004HR – Potential Best In Class VVA Therapy Products Premarin ® Vagifem ® Estrace ® Osphena ® Yuvvexy TM (if approved) Method of Admin Vaginal Cream Vaginal Tablet Vaginal Cream Oral Tablet Vaginal Capsule Application Reusable Vaginal Applicator Vaginal Applicator Reusable Vaginal Applicator Oral Daily SERM Digitally Inserted Softgel Active Ingredient 625 mcg/g CEEs 10 mcg E stradiol 100 mcg/g E stradiol 60,000 mcg ospemifene 4, 10, 25 mcg 17 β - estradiol Avg Maintenance Dose 312.5 mcg 2x/week 10 mcg 2x/week 100 mcg 2x/week 60,000 mcg daily 4, 10, 25 mcg 2x/week Onset of Action* Dyspareunia Week 4+ Week 8 Approval Without Dyspareunia and Dryness Data Week 12 Week 2 Onset of Action* Dryness Not Demonstrated Not Demonstrated Week 2 Easy to Use Easy to Prescribe Negligible Systemic Exposure Vagifem [package label] http://www.novo - pi.com/vagifem.pdf Premarin Vaginal Cream [package label] http://labeling.pfizer.com/showlabeling.aspx?id=132 Estrace Vaginal Cream [package label] http://pi.actavis.com/data_stream.asp?product_group=1880&p=pi&language=E Osphena [package label] http://www.shionogi.com/pdf/pi/osphena.pdf?400706572 All trademarks are the property of their respective owners *Onset of Action = First efficacy observation Based on Product Prescribing Information Not Head - to - Head Comparative Studies
37 1) Wysocki, S et al, Management of Vaginal Atrophy: Implications from the REVIVE Survey . Clinical Medicine Insights: Reproductive Health 2014:8 23 - 30 doi:10.4137/CMRH.S14498 2) Portman, D, et al. One Year Treatment Persistence with Local Estrogen Therapy in Postmenopausal Women Diagnosed as Having Vag inal Atrophy. Menopause. 2015; 22 (11) 1197 - 203 3) The North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North Am erican Menopause Society. Menopause . 2013;20(9):888 – 902. TX - 004HR - Designed for Long Term Compliance Current Market Yuvvexy TM Messiness 1 Reusable Applicator 1 Dose Preparation by User Required 3 Long - term Safety 1 Vaginal Creams: Efficacy 1 Applicator 1 Long - term Safety 1 Systemic Absorption 1 Reasons Women Stop Reasons Women Stop Mean Duration of Use: 1.5 Months 2 Mean Duration of Use: 3.5 Months 2 Muco - adhesive, Dissolves Quickly and Completely No Applicator and No Dose Preparation Negligible Systemic Exposure Onset - of - Action (Efficacy observed at 2 weeks) >75% Patient Satisfaction in a Market with Historically Low Compliance Rate Potential Long Term Usage Vaginal Tablets: 0.69 x 0.3 inch
38 Co - Primary and Key Secondary Efficacy Endpoints TX - 004HR 4 mcg 4 mcg LS Mean Change from Baseline to Week 12 P - value 4 mcg Placebo Superficial Cells 17% 6% <0.0001 Parabasal Cells - 41% - 7% <0.0001 Vaginal pH - 1.3 - 0.3 <0.0001 Severity of Dyspareunia - 1.5 - 1.3 0.0149 Severity of Vaginal Dryness - 1.27 - 0.97 0.0014 MMRM P - value vs placebo AUC 0 - 24 ( pg.h /mL) C avg (0 - 24) ( pg /mL) 4 mcg 87.22 (42.77) 3.634 (1.78) Placebo 104.16 (66.38) 4.34 (2.76) P - value vs Placebo 0.3829 0.3829 Arithmetic Mean Estradiol Serum Concentrations - Unadjusted TX - 004HR 4 mcg (N=18) LS = Least Squares LS Mean Change from Baseline to Week 12 REJOICE Trial Results
39 Co - Primary and Key Secondary Efficacy Endpoints TX - 004HR 10 mcg MMRM P - value vs placebo LS = Least Squares LS Mean Change from Baseline to Week 12 Arithmetic Mean Estradiol Serum Concentrations - Unadjusted TX - 004HR 10 mcg (N=19) AUC 0 - 24 ( pg.h /mL) C avg (0 - 24) ( pg /mL) 10 mcg 110.14 (54.57) 4.58 (2.27) Placebo 104.16 (66.38) 4.34 (2.76) P - value vs Placebo 0.7724 0.7724 10 mcg LS Mean Change from Baseline to Week 12 P - value 10 mcg Placebo Superficial Cells 17% 6% <0.0001 Parabasal Cells - 44% - 7% <0.0001 Vaginal pH - 1.4 - 0.3 <0.0001 Severity of Dyspareunia - 1.7 - 1.3 <0.0001 Severity of Vaginal Dryness - 1.47 - 0.97 <0.0001 REJOICE Trial Results
40 Co - Primary and Key Secondary Efficacy Endpoints TX - 004HR 25 mcg MMRM P - value vs placebo LS = Least Squares LS Mean Change from Baseline to Week 12 AUC 0 - 24 ( pg.h /mL) C avg (0 - 24) ( pg /mL) 25 mcg 171.56 (80.13) 7.14 (3.33) Placebo 104.16 (66.38) 4.34 (2.76) P - value vs Placebo 0.0108 0.0108 Arithmetic Mean Estradiol Serum Concentrations - Unadjusted TX - 004HR 25 mcg (N=18) 25mcg LS Mean Change from Baseline to Week 12 P - value 25 mcg Placebo Superficial Cells 23% 6% <0.0001 Parabasal Cells - 46% - 7% <0.0001 Vaginal pH - 1.3 - 0.3 <0.0001 Severity of Dyspareunia - 1.7 - 1.3 <0.0001 Severity of Vaginal Dryness - 1.47 - 0.97 <0.0001 REJOICE Trial Results
41 Favorable Regulatory Dynamics Driven by Change in Treatment Paradigm Removal of Black Box Warning Changing Perception on Use of Estrogen 1) Scientific Workshop on Labeling “Lower” Dose Estrogen - Alone Products for Symptoms of Vulvar and Vaginal Atrophy (VVA) http://www .fda.gov/Drugs/NewsEvents/ucm459690.htm 2) ACOG Supports the Use of Estrogen for Breast Cancer Survivors http://www.acog.org/About - ACOG/News - Room/News - Releases/2016/ACO G - Supports - the - Use - of - Estrogen - for - BreastCancer - Survivors 3) Manson JE, Chlebowski RT, Stefanick ML, et al. “Menopausal Hormone Therapy and Health Outcomes During the Intervention and Extended Poststopping Phases of the Women’s Health Initiative Randomized Trials.” JAMA. 2013;310(13):1353 - 1368. Estrogen Use in Breast Cancer Survivors ▪ ACOG released opinion stating it is safe for breast cancer survivors to use vaginal estrogen as data showed no increased risk 2 ▪ Healthcare practitioners may now consider topical estrogen therapy for patients with a history of estrogen - dependent breast cancer ▪ Women’s Health Initiative’s Hormone Trials follow up concluded that the risk/benefit profile for estrogen use is positive 3 : ▪ 63% lower risk of dying of breast cancer ▪ 16% reduced risk of illness and death ▪ Preventative for heart disease, diabetes, and other illnesses if started early ▪ Citizen’s Petition, spearheaded by NAMS, for modification of black box warnings ▪ Nov. 2015 – FDA “boxed warnings” workshop provided an opportunity for FDA to obtain input related to prescribing information of lower - dose estrogen alone products 1 Citizen’s Petition Supporters:
42 Foundation Built for a Strong Launch Map Legend: Current TXMD Sales Presence Highest Prescribing Physicians for VVA 50 Sales Representatives; Planned Increase to 100 - 120 With Launch of Yuvvexy TM Operational leverage of OB/GYN relationships in key markets
43 Expect Robust Insurance Coverage For TX - 004HR, If Approved, In - Line with Product Class 4,312 Commercial Plans % Unrestricted Access of Commercial Plans Not Covered Premarin Cream® 94% 2% Estrace Cream® 96% 2% Vagifem ® 90% 2% Estring ® 93% 1% Data Source MMIT August 17, 2016 – 4,300 commercial plans All trademarks are the property of their respective owners.
44 TXMD: Financial Snapshot Shares Outstanding 196.6MM (as of October 31, 2016) Debt $0MM Cash $147.5MM (as of Sept 30, 2016) Listing Exchange
45 Worldwide Patent Filings * *Not all patent filings filed in all jurisdictions. Strong IP Portfolio with 149 Patent Applications, including 82 international filings, and 17 issued U.S. patents
46 THANK YOU!
47 Appendix
48 Low incidence of bleeding 1) Freeman E, Rickels K, Sondheimer S J. et al. A double - blind trial of oral progesterone, alprazolam and placebo in treatment of severe premenstrual syndrome. JAMA . 1995;274:51 – 57. 2) Fournier A, Berrino F, Clavel - Chapelon F. Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study . Breast Cancer Res Treat. 2008;107:103 – 111. 3) Writing Group for the PEPI Trial . Effects of estrogen or estrogen/progestin regimes on heart disease. Risks factors in po stm enopausal women. JAMA . 1995;273:199 – 208. 4) The Writing Group for the PEPI Trial . Effects of hormone replacement therapy on endometrial histology in postmenopausal w oma n. The postmenopausal estrogen/progestin interventions (PEPI) trial. JAMA . 1996;275:370 – 375. 5) Hodis HN, et al. "Testing the menopausal hormone therapy timing hypothesis: The early versus late intervention trial with estradiol " AHA 2014; Abstract 13283. 6) Regidor , P - A, et al. Progesterone in Peri - and Postmenopausal: A Review. Geburtshilfe Frauenheilkd . 2014 Nov; 74 (11): 995 - 1002. Compounded Combination Bio - Identical E+P: Why Has It Been So Successful? Synthetic Progestins No benefits on sleep properties Increased risk of breast cancer Increased risk of MI, Stroke, VTE Less favorable lipid profile effects (cholesterol, LDL, triglycerides) Adequate endometrial protection High incidence of bleeding References Bio - identical Progesterone Favorable CNS Profile Favorable breast profile Favorable cardiovascular profile Favorable lipid profile Adequate endometrial protection Freeman, E, et al. 1 E3N - EPIC 2 PEPI 3 , ELITE 5 PEPI 3 PEPI 4 Regidor, et al. 6
49 Current FDA Guidance for VMS Drug Products * Primary Endpoints • Co - primary efficacy endpoints (12 week VMS Efficacy Population) o Mean Change from Baseline to Weeks 4 and 12 in the frequency and severity of moderate and severe vasomotor symptoms versus placebo • Primary safety endpoint (12 month Endometrial Safety Population) o Incidence rate of endometrial hyperplasia at 12 months (to demonstrate a hyperplasia rate that is ≤ 1% with an upper bound of the one - sided 95% confidence interval for that rate does not exceed 4%) Study Analysis • Clinically meaningful and statistically significant reduction within 4 weeks of initiation of treatment and maintained throughout 12 weeks of treatment Study Considerations • Single, 12 - month study to demonstrate endometrial protection Single Pivotal Phase 3 trial required unless: • The drug to be studied is considered a new molecular entity • The drug to be studied poses unique safety concerns * 2003 FDA Draft Guidance for Industry Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommendations for Clinical Evaluation http://www.fda.gov/ucm/groups/fdagov - public/@fdagov - drugs - gen/documents/document/ucm071643.pdf