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): April 8, 2014
| TherapeuticsMD, Inc. |
(Exact Name of Registrant as Specified in its Charter)
| Nevada | 000-16731 | 87-0233535 | ||
|
(State or Other
Jurisdiction of Incorporation)
|
(Commission File Number) | (IRS Employer Identification No.) |
|
6800 Broken Sound Parkway NW, 3rd 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.
We are furnishing this Current Report on Form 8-K in connection with the disclosure of information, in the form of the textual information from a PowerPoint presentation to be given at meetings with institutional investors or analysts. This information may be amended or updated at any time and from time to time through another Form 8-K, a later company filing, or other means. The PowerPoint presentation attached as Exhibit 99.1 to this Current Report on Form 8-K updates and replaces in its entirety all prior PowerPoint presentations filed by us.
The information in this Current Report on Form 8-K (including the exhibit) is furnished pursuant to Item 7.01 and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section. This Current Report on Form 8-K will not be deemed an admission as to the materiality of any information in the Report that is required to be disclosed solely by Regulation FD.
We do not have, and expressly disclaim, any obligation to release publicly any updates or any changes in our expectations or any change in events, conditions, or circumstances on which any forward-looking statement is based.
The text included with this Report on Form 8-K is available on our website located at www.therapeuticsmd.com, although we reserve the right to discontinue that availability at any time.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit | ||||
| Number | Description | |||
| 99.1 | TherapeuticsMD, Inc. presentation dated Q2 2014. | |||
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: April 8, 2014 | THERAPEUTICSMD, INC. | |
| By: | /s/ Daniel A. Cartwright | |
Name: Title: |
Daniel A. Cartwright Chief Financial Officer | |
EXHIBIT INDEX
| Exhibit | |||
| Number | Description | ||
| 99.1 | TherapeuticsMD, Inc. presentation dated Q2 2014. | ||
Exhibit 99.1
NYSE MKT: TXMD Corporate Overview Q2 - 2014 COPYRIGHT 2014 by TherapeuticsMD
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 filed on March 5 , 2014 , Forms 10 - Q, our Forms 8 - 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 press releases and financial tables can be viewed and downloaded on the TherapeuticsMD website : www . therapeuticsmd . com/InvestorRelations . aspx . 1 Forward - Looking Statements
2 Two late - stage 505(b)(2) hormone therapy (“HT”) product candidates targeting multi - billion dollar U.S. markets ( 1 )(2) Pipeline (1) PHAST Prescription Monthly by Source Healthcare Analytics. (2) Estimates per: Dr. Loyd Allen Jr ., Editor - in - Chief, 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”). (3) Estimated U.S. sales
Combination Product TX 001 - HR E+P 3
4 Women’s Health Initiative (WHI) • Hormone Therapy is linked to Cardiovascular, Cancer and other risks • Estrogen + Progestin ( Prempro ) arm had a 24% increase in breast cancer vs. Estrogen alone History of Hormone Therapy * (1) PHAST Prescription Monthly by Source Healthcare Analytics. Inflation Adjusted Number* (2) Estimates per: Dr. Loyd Allen Jr ., Editor - in - Chief, 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”).
5 Bio - identical Hormone Replacement (BHRT) History of Compounding BB3
Side Effect (1) Bioidentical Natural Progesterone Non - Bioidentical Progestins (MPA, NETA, drosperinone) Breast cancer More favorable profile (E3N - EPIC study) Increased risk Cardiovascular More favorable profile (PEPI trial) Increased risk of MI, stroke, VTE Lipid profile More favorable profile (PEPI trial) Less favorable effects on lipid profile (cholesterol, HDL, LDL, triglycerides) Glucose / insulin Improved carbohydrate metabolism (PEPI trial) Deterioration of glucose tolerance or hyperinsulemia or both Sleep / mood Im proved sleep efficiency (2) No benefit on sleep properties Quality of life Improvement in symptoms and overall satisfaction with bioidentical progesterone HT compared to MPA regimen (3) 6 (1) Alone or in combination with estrogen. (2) 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. (3) 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. Bioidentical Progesterone vs. Non - Bioidentical Progestin
7 Journal of the American Medical Association September 30, 2013 CEEs ( Premarin ) were associated with a higher incidence of venous thrombosis and myocardial infarction than oral estradiol Journal of the American Medical Association October 3, 2013 Breast Cancer Risk persists for 13 years after discontinuation of CEE Menopause September 2013 “ Oral estradiol may be associated with a lower risk of stroke … compared with conventional - dose oral CEE” Estradiol vs. Conjugated Estrogens ( 1) Smith et al. Lower Risk of Cardiovascular Events in Postmenopausal Women Taking Oral Estradiol Compared with Oral Conjugated Equine Estrogens (CEE ) (2 ) Manson et al. Menopausal Hormone Therapy and Health Outcomes During the Intervention and Extended Poststopping Phases of the Women’s Health Initiative Randomized Trials (3 ) Shufelt et al. Hormone Therapy Dose, Formulation, Route of Delivery, and Risk of Cardiovascular Events in Women: Findings from the Women’s Health Initiative Observational Study
8 □ Meet PK 505(b)(2) thresholds x TXMD Novel Drug Design Combination of Estradiol + P rogesterone RLD = Reference Listed Drug API = Active Pharmaceutical Ingredient 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 (improved bioavailability, reduced variability, food effect, lowest effective dose, well tolerated ) Enabling new combinations, routes and dosages (creams, patches, etc.)
9 TX 001 - HR E+P — Phase 3 Study Combination of Estradiol + P rogesterone 2012 2013E 2014E 2015E 2016E 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 Q1 '16 Q2 '16 Q3 '16 Q4 '16 Filed IND Pilot PK Studies Pivotal PK Studies NDA and PDUFA Phase 3 Vasomotor and Endometrial Protection Study TX 12-001HR Combination 17β Estradiol + Progesterone File IND Update & Phase 3 Protocol Pivotal Phase 3 clinical trial initiated Q3 ’13: The REPLENISH Trial Designed to enroll 1,750 subjects at ~70 sites Four active arms (N =400 / arm ) Placebo arm (N=150) 12 - month study with 12 week VMS Endpoints: Vasomotor : number and severity of hot flashes (4 week and 12 weeks) Endometrial safety: incidence of endometrial hyperplasia (12 months )
10 95% Upper Confidence Limit for PK Parameter Prometrium = R1 Prometrium = R2 TXMD = T Parameter Point Estimate T/R Ratio Within Subject Std. Deviation Upper 95% Confidence Bound C max 1.16 1.179 - 0.785 AUC 0 - t 1.05 0.956 - 0.542 1 10 100 0 5 10 15 20 25 30 35 40 45 50 Time (hr) Treatment=R1 Treatment=R2 Treatment=T N=62 95% Confidence Interval for PK Parameter Parameter Point Estimate T/R Ratio Within Subject Std. Deviation Upper 95% Confidence Bound C max 0.88 0.344 - 0.040 AUC 0 - t 0.93 0.409 - 0.089 Estrace = R1 Estrace = R2 TXMD = T Based on C max and AUC, both estradiol and progesterone showed relative bioequivalence (N=62) TXMD 2/200mg E2+P Single Gel - tab versus Separate 2mg Estrace ® tablet + 200mg Prometrium ® Capsule
Transdermal Development 11 Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 File File IND IND E+P Update Transdermal Pilot Preclinical Pilot Phase 1 Studies Studies PK and clinical Study File File IND IND P Update Transdermal Pilot Preclinical Pilot Phase 1 Studies Studies PK and clinical 2012 2013 2014 2015
Product Progestin U.S. Sales (est.) Intl Sales (4) Company 17 β E stradiol + NETA / Drospirenone (Activella / FemHRT / Angeliq / others) Non - bioidentical $ 230 mm (1)(2) Premarin + MPA (Prempro / Premphase) Non - bioidentical $ 328 mm (1)(2) Estradiol + Progesterone (custom compounded ) Untested Bioidentical $ 1,500 mm (3) Not FDA approved Total Oral Combination Sales $2,058 mm $489 mm 12 Enormous E+P HT Market Opportunity All in - market FDA - approved combination products c ontain non - bioidentical progestins Today’s FDA - approved combination products lack innovation Notes : (1) PHAST Prescription Monthly by Source Healthcare Analytics. (2) Based on last twelve months sales through December 31, 2013. (3) Estimate per Wulf Utian, Executive Director Emeritus and Honorary Founding President of NAMS . (4) IMS Data
13 Drug Quality and Security Act Signed by President on 11/27/13 Bill Highlights Establishes requirements for traditional compounding pharmacies and larger - scale outsourcing facilities. Prohibits compounding of essential copies of an FDA approved & marketed drug except in limited circumstances: Traditional compounding pharmacies may not compound essential copies regularly or in inordinate amounts, or unless there is a change in the compounded drug that produces a significant difference for an individual patient. Outsourcing facilities may not compound essential copies unless the approved drug appears on the drug shortage list, or unless there is a change in the compounded drug that produces a clinical difference for an individual patient. http://www.help.senate.gov/imo/media/Compounding_Draft_One_Pager_FINAL.pdf
14 Vulvar / Vaginal Atrophy (VVA)
Mechanism: Low Levels of Estradiol impact on the Vagina R eduction in superficial cells Parabasal cells increase Vagina changes from acidic to basic (increased pH) Most common symptoms: Vaginal Dryness, Dyspareunia, Itching/Irritation, Dysuria, Bleeding with Sexual Activity
VVA US Sales – Currently No Generics 16 (1) PHAST Prescription Monthly by Source Healthcare Analytics. (2) Based on last twelve months sales through December 31, 2013. (3) Source Healthcare Analytics (4) GlobalData 2/12 report https:www/asdreports.com/news.asp?pr_id=420 Product Compound US ($mm) Sales (!) (2)) WAC Price (1) Premarin ® Cream Equine vaginal estrogen $389 $201* Vagifem ® Tablets Vaginal Estradiol $316 $193* Estrace ® Cream Vaginal Estradiol $284 $152* Total $1,100 mm US Sales Grew 22% from June 2012 - 2013 (3) ASD analysis - global market is expected to grow to $3.1 Billion in 2019 (4)
US Sales – Large and Growing 17 * PHAST Prescription Monthly by Source Healthcare Analytics. Based on last twelve months sales through December 31, 2013. Source Healthcare Analytics GlobalData 2/12 report https:www/asdreports.com/news.asp?pr_id=420 Total Number of Prescriptions US Sales 2008 5,030,472 $ 505,917,525 2009 5,370,763 $ 630,210,685 2010 5,381,069 $ 681,598,442 2011 5,425,240 $ 768,532,546 2012 5,550,504 $ 900,519,871 2013 5,832,186 $ 1,100,833,171 “VVA market revenue has more than doubled since 2008”
Leading Estrogen Products vs. TXMD 18 TXMD Solution: VagiCap ™ Deliver an elegant patient experience Eliminate reusable plungers Less messy than creams Burning sensation eliminated Simple - to - use / no placement issues Quick dissolution Does not require a long - term device
How to Measure Efficacy – FDA Guidance for Phase 3 1. Statistical i ncrease in superficial cells 2. Statistical decrease in p arabasal cells 3. Statistical changes in vaginal pH from basic to acidic (decrease pH) Reduce most bothersome symptoms: Vaginal Dryness, Dyspareunia, Itching/Irritation, Dysuria, Bleeding with Sexual Activity
TX 004 - HR Positive Phase 1 20 48 postmenopausal women with symptoms of VVA Randomized 10µg dose of TX 004 - HR or placebo Self - administered 1x daily for two - week period Phase 3 (12 weeks) endpoints measured in phase 1 study (2 weeks) As compared to placebo, women treated with TX 004 - HR showed : Statistically significant decreases in parabasal cells (p<0.0001) Significant increases in superficial cells (p=0.0002) Statistically significant decreases in vaginal pH (p=0.0002 ) Significant reduction in the atrophic effects on epithelial integrity and vaginal secretions Not powered for most bothersome symptom (positive trends)
VagiCap vs. Vagifem 21 Time ( hr ) Plasma Mean Concentration ( pg /mL) Time ( hr ) Plasma Mean Concentration ( pg /mL) N=36 N=36 Estradiol 25 µg Estradiol 10 µg Key Points: • Tmax ~ 2hours with VagiCap and ~8 hours with Vagifem • Systemic absorption AUC (0 - 24 hrs ) is 2 - 3 fold lower with Vagicap relative to Vagifem • Suggests more drug is reaching target tissue and less drug is reaching systemic circulation
What does this mean? Next Generation VVA Product 22 Early data suggests more Solubilized Estradiol is reaching target tissue and less is spilling over into blood (less systemic exposure) compared to Vagifem New technology potentially enabling new lower effective doses (4&10mcg) without the risk of systemic exposure 10 mcg dose achieves Phase 3 endpoints (other than most bothersome symptom) in only 14 days Quick dissolving gelcap enabling an elegant / positive user experience
23 Estradiol Vaginal Suppository Phase 2B/3 Study 2014 12 weeks Designed to enroll 150 - 200 subjects in each arm − Multiple Active Arms (4 mcg, 10 mcg, 25 mcg) − Placebo (n=100) Endpoints: − Cell change − Lowering of pH − Evaluation of Adverse Vaginal Effects (Dyspareunia and Dryness)
Hormone Therapy Market Opportunity 24
Extensive Patent Filings 25 Filed Provisional Non - Provisional Issued U.S. 25 8 17 2 Ex - U.S. 6 Oral combination therapeutics Bioidentical E+P HT combination Natural combination HT and formulations Oral solo therapeutics Progesterone formulations Vulvovaginal atrophy pessary Pipeline applications Opera reporting and analysis software
Milestones 26 2014 VVA: Rabbit Irritation Study Results Q2 E+P Transdermal: File IND for P and E+P Transdermal Q2/Q3 E+P Transdermal: PK Results for P and E+P Transdermal Q2/Q3 E+P Oral : International Menopausal Society Replenish Trial Poster Session Q2 Compounding Market : Symphony Health Report on BHRT Size of Market Q3 Estradiol VagiCap : Commence Phase 2b/III VVA Trial Q3 Oral Progesterone: Complete patient enrollment: Spry Trial Q4 E+P Oral : Complete patient enrollment: Replenish Trial Q4 IP / Patents Annual IP Update to Patent Portfolio Q4 2015 Oral Progesterone Report P III/Spry Trial Results Q1 Estradiol VagiCap : Complete Patient Enrollment Q2 Estradiol VagiCap Report P III/VVA Trial Results Q3 Estradiol VagiCap : File NDA for TX - 12 - 003 HR in VVA Q3 Combination E+P: Report Replenish Trial results Q4 Combination E+P: File NDA for TX - 12 - 001HR E+P Q4
Key Statistics NYSE MTK: TXMD Recent market price 1 $5.04 Shares outstanding 2 145 million Market capitalization 1 $730 Billion Cash & equivalents 2 $54 million Debt 3 $0.00 million 1 Based upon closing price April 7, 2014 2 As at December 31, 2013
Investor Contacts COPYRIGHT 2013 by TherapeuticsMD Dan Cartwright Lisa M. Wilson Chief Financial Officer President TherapeuticsMD, Inc. In - Site Communications, Inc. 561 - 961 - 1900 917 - 543 - 9932 Dan.Cartwright@TherapeuticsMD.com lwilson@insitecony.com
29 “HRT prescribed before the age of 60 has a favorable benefit/risk profile .” “Recent evidence suggests that HRT regimens containing progesterone can minimize the metabolic impact and reduce the risk of thromboembolism .” In a large observational cohort study of French teachers, after five years of use estrogen – progesterone combination, HRT was found to be associated with a significantly lower relative risk (neutral for ‘ever use’ of HRT) than for other types of combined HRT (RR 1.7 – 2.0).” “Data from a large observational study suggest that EPT with micronized progesterone carries a low risk of breast cancer with short - term use .” Latest Position Statements British Menopause Society , 2013 North American Menopause Society , 2012 The 2012 Hormone Therapy Position Statement of The North American Menopause Society, Menopause: The Journal of The North American Menopause Society Vol. 19, No. 3, pp. 257/271 The 2013 British Menopause Society & Women's Health Concern recommendations on hormone replacement therapy , Menopause Int published online May 23, 2013
30 John Milligan President Julia Amadio Chief Product Officer Dan Cartwright Chief Financial Officer Dr. Sebastian Mirkin Chief Medical Officer Robert Finizio Chief Executive Officer vitaMed HT Corporate Dr. Joel Krasnow Chief Scientific Officer Management Drug Development Team 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 Experienced Management and Drug Development Team Julia Amadio and James Pickar, M.D., F.A.C.O.G . ‒ Led development and launch of Prempro®, Premphase®, CombiPatch®, Alesse®, and Crinone®, among others Lisa Rarick, M.D. and Daniel Shames, M.D . ‒ Former division Director of Reproductive and Urologic Products for FDA CDER Fred Sancilio, Ph.D. ‒ Former founder and president of AAI and the innovator of multiple hormone products Marlan Walker, J.D . ‒ Lead Patent Attorney Steve Fontana, J.D. ‒ Author of the original estradiol patents Board Members and Early Investors Tommy Thompson Chairman Former Sec HHS & Gov of Wisc Cooper Collins Director Pernix Mario Family Partnership Ernest Mario Former CEO of Glaxo Jules Musing Former Sr. Executive Johnson & Johnson Nick Segal Director Seavest Capital Partners