Therapeuticsmd, Inc. · NASDAQ:TXMD

Therapeuticsmd — Investor Presentation (January 2017)

49 slides from Therapeuticsmd's investor presentation, January 2017

1. Slide 1: TXMD Overview

   TXMD Overview January 2017 THER-0086 1/17

2. Slide 2: Forward-Looking Statements

   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

3. Slide 3: TXMD Overview: Innovative women's health company

   (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 3

4. Slide 4: Two Late Stage Women's Health Assets With Large Total Addressable Market Opportunities

   Two Late Stage Women’s Health Assets With Large Total Addressable Market Opportunities TM TX-004HR (Yuvvexy ) TX-001HR Moderate to Severe Dyspareunia, a Moderate to Severe Hot Flashes Proposed Indication Symptom of VVA, due to Menopause due to Menopause Condition Description VVA due to Menopause Men

5. Slide 5: Seasoned Management Team with a Proven Track Record of Commercial Execution

   Seasoned Management Team with a Proven Track Record of Commercial Execution • Former U.S. Secretary of • Former Chief Executive • Former President and Chief • Co-founded vitaMedMD • Co-founded vitaMedMD • Former Clinical Lead of Health and Human Services Officer and Chief Financial Executive Officer

6. Slide 6: TX-001HR | Combination Estrogen + Progesterone (E+P) Program

   TX-001HR | Combination Estrogen + Progesterone (E+P) Program 6

7. Slide 7: Menopause Overview

   Menopause Overview Menopause represents the natural life-stage transition when women stop having periods as the production of Estrogen (E) and Progesterone (P) decreases  Average age of menopause 51 years1  Women may spend, on average, more than one-third of their lives in a hypoestrogenic state M

8. Slide 8: TX-001HR Product Development Rationale

   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 women and healthcare providers have chosen unapproved, bio-identica

9. Slide 9: TX-001HR – Potential Best in Class VMS Therapy

   TX-001HR – Potential Best in Class VMS Therapy TX-001HR Potential first and only: (If Approved) 1) Bio-identical combination 2) FDA-approved Bio-Identical  Dosing and Delivery  Once-a-day Oral Softgel Capsule Single Dose Combination  Addresses Unmet Medical Need VMS Efficacy Data   First and on

10. Slide 10: Medical Societies Discourage Prescribing of Compounded Bio-Identical Hormones

    Medical Societies Discourage Prescribing of Compounded Bio-Identical Hormones  ACOG and ASRM Committee Opinion states compounded hormones may pose additional risks compared to FDA-approved products1  Lack of efficacy and safety data  Lack of Good Manufacturing Practices (GMP)  Variable purity 

11. Slide 11: TX-001HR (if approved) - Healthcare Provider Benefits

    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 insura

12. Slide 12: TX-001HR (if approved) - Pharmacy Benefits

    TX-001HR (if approved) - Pharmacy Benefits  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 compo

13. Slide 13: TX-001HR (if approved) - Patient Benefits

    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

14. Slide 14: TX-001HR | Replenish Trial Overview and Results

    TX-001HR | Replenish Trial Overview and Results 14

15. Slide 15: Replenish Trial Study Design - Flow Chart

    Replenish Trial Study Design - Flow Chart Randomized Study Frequency and Severity of Hot Flash Participants1 diary data was assessed during Screening ≥ 7 moderate or severe hot flashes per day < 7 moderate or severe hot flashes per day or ≥ 50 per week during Screening or < 50 per week during Screen

16. Slide 16: Replenish Trial Co-Primary Endpoints

    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 =

17. Slide 17: Mean Weekly Frequency Reduction from Baseline

    Mean Change from Baseline in Weekly Frequency of Moderate to Severe Hot Flashes for Weeks 1 to 12 0 Mean Weekly Frequency Reduction from Baseline 1 mg E/100 mg P -10 0.5 mg E/100 mg P 0.5 mg E/50 mg P 0.25 mg E/50 mg P Placebo -20 -30 -40 -50 -60 0 1 2 3 4 5 6 7 8 9 10 11 12 Study Week Replenish Tri

18. Slide 18: Mean Weekly Reduction in Severity from Baseline

    Mean Change from Baseline in Weekly Severity of Moderate to Severe Hot Flashes for Weeks 1 to 12 0 Mean Weekly Reduction in Severity from Baseline -0.2 -0.4 -0.6 -0.8 -1 -1.2 -1.4 1 mg E/100 mg P 0.5 mg E/100 mg P -1.6 0.5 mg E/50 mg P 0.25 mg E/50 mg P -1.8 Placebo -2 0 1 2 3 4 5 6 7 8 9 10 11 12 S

19. Slide 19: TX-001HR | Market Opportunity

    TX-001HR | Market Opportunity 19

20. Slide 20: Multi-Billion Dollar Total Substitutable Market Opportunity

    Multi-Billion Dollar Total Substitutable Market Opportunity TX-001HR (if approved) FDA-Approved Compounded Separate Bio-Identical Combination Synthetic Combination E & P Pills E+P1 Bio-Identical E+P TRx US: ~3 million2 ~3 million2 12 – 18 million TX-001HR $600M-$750M3 $600M-$750M3 $2.4B-$4.5B3 Poten

21. Slide 21: Compounded Combination Bio-Identical E+P Substitutable Market Opportunity

    Compounded Combination Bio-Identical E+P Substitutable Market Opportunity Commercialization Strategy: BIO-IGNITE 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: 12M-18M Prescriptions Und

22. Slide 22: BIO-IGNITE Progress and Results

    BIO-IGNITE Progress and Results Partnerships with Large Pharmacy Networks Combination Pharmacy Network Partners Network Size Bio-Identical E+P Scripts 225 Pharmacies ~1,000,000 In Network prescriptions annually 104 Pharmacies ~500,000 In Network prescriptions annually All trademarks are the property

23. Slide 23: Who Writes Compounded Bio-Identical E+P Prescriptions?

    Who Writes Compounded Bio-Identical E+P Prescriptions? 240,000 Total Eligible Physicians1 12M-18M Annual Compounded Bio-Identical (Includes OB/GYNs, PCPs, and Anti-Aging) E+P Prescriptions Breakout by Volume 12,000 High ~8/week 5,000,000 Prescribers (5%) (33%) 30,000 Regular ~4-5/week Prescribers 7,

24. Slide 24: Adverse Reimbursement and Regulatory Environments Continue to Erode Independent Pharmacy Margins

    Adverse Reimbursement and Regulatory Environments Continue to Erode Independent Pharmacy Margins 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 shortage1 June 3,

25. Slide 25: Independent Pharmacy Net Income Per Compounded Script

    Independent Pharmacy Net Income Per Compounded Script Insurance Coverage Present Day Post USP-800 (before 2H14) (2017) (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 $

26. Slide 26: Economic Incentives Provide Catalyst to Switch to TX-001HR

    Economic Incentives Provide Catalyst to Switch to TX-001HR Independent Pharmacy Net Income Per Script with TX-001HR Compounded E+P TX-001HR Post USP-800 Launch 2H18 Revenue Patient Co-Pay 50.00 50.00 Third-Party Reimbursement - 200.00 Total Net Revenue $ 50.00 $ 250.001 Costs of Good Sold 7.50 200.0

27. Slide 27: FDA-Approved Separate Bio-Identical E & P Substitutable Market Opportunity

    FDA-Approved Separate Bio-Identical E & P Substitutable Market Opportunity  Healthcare providers not comfortable with compounding will often prescribe two separate FDA-approved bio-identical products to treat menopausal symptoms Product Use by Age AGES 41-50 AGES 51-60 AGES 61-70 AGES 71+ TRx Total

28. Slide 28: FDA-Approved Combination Synthetic E+P Substitutable Market Opportunity

    FDA-Approved Combination Synthetic E+P Substitutable Market Opportunity TX-001HR (If Approved) FDA-Approved Combination Synthetic E+P Prescriptions by Age AGES AGES AGES AGES AGES Unknown TRx 31-40 41-50 51-60 61-70 71+ Ages Totals 52,575 372,968 1,712,852 759,634 151,821 68,672 3,118,5221 ~3M Poten

29. Slide 29: Expect Robust Insurance Coverage For TX-001HR, If Approved

    Expect Robust Insurance Coverage For TX-001HR, If Approved, In-Line with Product Class % Unrestricted Access of 4,315 Commercial Plans Not Covered Commercial Plans Estrace® (Oral) 96% 1% Prempro® 94% 5% CombiPatch® 93% 4% Climara Pro® 92% 4% FemHRT® 87% 6% Duavee® 86% 5% Vivelle-Dot® 84% 5% Activell

30. Slide 30: TX-004HR (Yuvvexy) Vulvar and Vaginal Atrophy (VVA) Program

    TX-004HR (Yuvvexy )TM Vulvar and Vaginal Atrophy (VVA) Program 30

31. Slide 31: Overview – Vulvar and Vaginal Atrophy (VVA)

    Overview – Vulvar and Vaginal Atrophy (V VA)  Chronic and progressive condition characterized by thinning of vaginal tissue from decreased estrogen levels  Diagnosed in approximately 50% of postmenopausal women1  Primary symptom = dyspareunia  Secondary symptoms include: dryness, itching, irrita

32. Slide 32: Current FDA-Approved VVA Competitive Landscape

    Current FDA-Approved VVA Competitive Landscape 1  U.S. sales more than doubled since 2008 2  Global market expected to be $2.1 billion in 2022  7% current market penetration 2015 TRx 2015 U.S. Sales Product Company Compound (000) 1 ($M)1 WAC Price3 Conjugated equine Premarin® Cream Pfizer 1,615 $

33. Slide 33: Current VVA Market Overview

    Current VVA Market Overview 32M Women with VVA Symptoms1,2 ~50% of women seek treatment for VVA4 OTC Product Users  7%, or 2.3M women, are currently being treated today with Rx hormone therapy (HT)3 Not Seeking 25%  18%, or 5.7M women, have tried HT and were Treatment unsatisfied/unsuccessful4  2

34. Slide 34: Current FDA-Approved VVA Product Use Falls Short

    Current FDA-Approved VVA Product Use Falls Short VVA Market Market Size Perceived Product Shortcomings Opportunity  Long-term safety concerns1 2.3M Women2  Efficacy1 Current HT Users 7% of VVA Population  Messiness1 >$1.5B  Need for applicator1  Unsatisfied / unsuccessful with past 5.7M Women3

35. Slide 35: TX-004HR (Yuvvexy)

    TX-004HR (Yuvvexy ) TM  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 0.69 x 0.3 inch Starter Maintenance Pack Pack Prototype Maintenance

36. Slide 36: TX-004HR – Potential Best In Class VVA Therapy

    TX-004HR – Potential Best In Class VVA Therapy TM Premarin® Vagifem® Estrace® Osphena® Yuvvexy (if approved) Products Method of Admin Vaginal Cream Vaginal Tablet Vaginal Cream Oral Tablet Vaginal Capsule Reusable Reusable Application Vaginal Applicator Oral Daily SERM Digitally Inserted Softgel Vag

37. Slide 37: TX-004HR - Designed for Long Term Compliance

    TX-004HR - Designed for Long Term Compliance Current Market Yuvvexy TM Vaginal Creams: Reasons Women Stop Muco-adhesive, Dissolves Quickly and Completely Messiness1 Mean Duration No Applicator and No Dose Preparation Reusable Applicator1 of Use: 1.5 Months2 Long-term Safety1 Onset-of-Action (Efficac

38. Slide 38: Co-Primary and Key Secondary Efficacy Endpoints TX-004HR 4 mcg

    Co-Primary and Key Secondary Efficacy Endpoints TX-004HR 4 mcg Arithmetic Mean Estradiol Serum Concentrations - LS Mean Change from Baseline to Week 12 Unadjusted TX-004HR 4 mcg (N=18) LS Mean Change from 4 mcg Baseline to Week 12 P-value 4 mcg Placebo Superficial Cells 17% 6% <0.0001 Parabasal Cell

39. Slide 39: Co-Primary and Key Secondary Efficacy Endpoints TX-004HR 10 mcg

    Co-Primary and Key Secondary Efficacy Endpoints TX-004HR 10 mcg Arithmetic Mean Estradiol Serum Concentrations - LS Mean Change from Baseline to Week 12 Unadjusted TX-004HR 10 mcg (N=19) LS Mean Change from 10 mcg Baseline to Week 12 P-value 10 mcg Placebo Superficial Cells 17% 6% <0.0001 Parabasal

40. Slide 40: Co-Primary and Key Secondary Efficacy Endpoints TX-004HR 25 mcg

    Co-Primary and Key Secondary Efficacy Endpoints TX-004HR 25 mcg Arithmetic Mean Estradiol Serum Concentrations - LS Mean Change from Baseline to Week 12 Unadjusted TX-004HR 25 mcg (N=18) LS Mean Change from 25mcg Baseline to Week 12 P-value 25 mcg Placebo Superficial Cells 23% 6% <0.0001 Parabasal C

41. Slide 41: Favorable Regulatory Dynamics Driven by Change in Treatment Paradigm

    Favorable Regulatory Dynamics Driven by Change in Treatment Paradigm  Citizen’s Petition, spearheaded by NAMS, Citizen’s Petition Supporters: for modification of black box warnings Removal of  Nov. 2015 – FDA “boxed warnings” Black Box workshop provided an opportunity for Warning FDA to obtain inp

42. Slide 42: Foundation Built for a Strong Launch

    Foundation Built for a Strong Launch Operational leverage of OB/GYN relationships in key markets Map Legend: Current TXMD Sales Presence Highest Prescribing Physicians for VVA TM 50 Sales Representatives; Planned Increase to 100-120 With Launch of Yuvvexy 42

43. Slide 43: Expect Robust Insurance Coverage For TX-004HR, If Approved

    Expect Robust Insurance Coverage For TX-004HR, If Approved, In-Line with Product Class % Unrestricted Access of 4,312 Commercial Plans Not Covered Commercial Plans Premarin Cream® 94% 2% Estrace Cream® 96% 2% Vagifem® 90% 2% Estring® 93% 1% Data Source MMIT August 17, 2016 – 4,300 commercial plans A

44. Slide 44: TXMD: Financial Snapshot

    TXMD: Financial Snapshot Listing Exchange Debt $0MM Shares Outstanding Cash 196.6MM $147.5MM (as of October 31, 2016) (as of Sept 30, 2016) 44

45. Slide 45: Worldwide Patent Filings

    Worldwide Patent Filings* Strong IP Portfolio with 149 Patent Applications, including 82 international filings, and 17 issued U.S. patents *Not all patent filings filed in all jurisdictions. 45

46. Slide 46: Thank You!

    TherapeuticsMD THANK YOU! TherapeuticsMD”

47. Slide 47: Appendix

    Appendix 47

48. Slide 48: Compounded Combination Bio-Identical E+P: Why Has It Been So Successful?

    Compounded Combination Bio-Identical E+P: Why Has It Been So Successful? Synthetic Progestins Bio-identical Progesterone References No benefits on sleep properties Favorable CNS Profile Freeman, E, et al.1 Increased risk of breast cancer Favorable breast profile E3N-EPIC2 Increased risk of MI, Strok

49. Slide 49: Current FDA Guidance for VMS Drug Products

    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 En

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