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): June 3, 2013
| 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.) |
|
951 Broken Sound Parkway NW, Suite 320 Boca Raton, FL 33487 |
| (Address of Principal Executive Office) (Zip Code) |
Registrant's telephone number, including area code: (561) 961-1911
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 June 2013. |
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: June 3, 2013 | 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 June 2013. |
Investor Presentation June 2013 COPYRIGHT 2013 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 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 . 1 Forward - Looking Statements
Company Overview 2
3 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 $40 million in cash; no long - term debt Strong board with blue - chip institutional h olders Gov. Tommy Thompson , Jules Musing, Ernest Mario (investor)
2013E 2014E 2015E 2016E U.S. Sales (est.)($mm) (1)(2) Combination: 17β Estradiol + Progesterone $2,000 Oral Progesterone $300 Novel estradiol pipeline product in development 17β Estradiol in VagiCap™ $800 Phase 3 Plan Expect to File NDA and PDUFA 4 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 (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”).
5 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
Sales of FDA approved oral combination estrogen + progestin products Compounding pharmacy sales of unapproved estradiol + progesterone 6 □ Significant demand HT Combination Market Landscape (1) Phast Prescription Monthly by Source Healthcare Analytics. (2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012 . (3) Estimate per Wulf Utian, Executive Director Emeritus and Honorary Founding President of NAMS. (4) 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. (5) 134 Compounding Pharmacies Survey in 34 States x $1,500 MM (3)(4) $468 MM (1)(2) U.S. Sales (est.) Average Selling Price $46.89 (5) Average WAC Price $185.09 (3)
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) 7 (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 The Market understands the benefits of bioidentical HT
8 □ Meet PK 505(b)(2) thresholds x 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 of API(s) Enabling new combinations, routes, and dosages
9 Building an Extensive Patent Estate Novel Drug Form Based Approach Solubilized API in combination and stand - alone drug products for HT indications Enabling p latform 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)
10 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” (1) http ://www.help.senate.gov/imo/media/Compounding_Draft_One_Pager_FINAL.pdf
11 Market Forces Converge External market changing events WHI Proposed legislative changes Internal s cientific breakthrough Significant shifts favor TXMD
12 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 13
14 Phase 3 Trial Study: 12 month study with 12 week VMS Sites: ~50 Subjects: 1,550 − 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 Combination — Proposed Phase 3 Study x 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
n = 62 15 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 Progesterone Results (1) (1) Semilog plots of mean plasma concentrations over time for Progesterone. TX 12 - 001HR Estradiol 2 mg / Progesterone 200 mg (combination) vs. Estrace ® 2 mg + Prometrium ® 200 mg (separate tablets)
1 10 100 0 5 10 15 20 25 30 35 40 45 50 Time (hr) Treatment=R1 Treatment=R2 Treatment=T N=62 17 β Estradiol Results (1) n = 62 95% Confidence Interval for PK Parameter 16 Estrace = R1 Estrace = R2 TXMD = T TX 12 - 001HR Estradiol 2mg / Progesterone 200 mg (combination ) vs. Estrace ® 2m g + Prometrium ® 200 mg (separate tablets) 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 (1) Semilog plots of mean plasma concentrations over time for Free Estradiol.
Drug Improvement General Benefits Patient Benefits Receive FDA approved indication FDA indication / safety and quality assurance Insurance coverage Safety , quality, and stability New lower effective doses Reduced blood levels Better side effect profile Improved safety Improved safety profile vs. non - bioidentical progestin Reduced breast cancer risk Improved cardiovascular and lipid profile Confidence in treatment regimen No peanut oil Non - allergenic Excellent for all patient profiles No worries about potential allergies Combined pill vs. 2 pill s (E+P sold separately today) Less risk of dosing errors One co - pay Increased compliance 17 TX 12 - 001HR Combination Potential Benefits Note: Potential improvements and benefits, if approved.
Product Progestin U.S. Sales (est.) ($mm) Intl Sales ($mm) (4) Company 17 β E stradiol + NETA / Drospirenone (Activella / FemHRT / Angeliq / others) Non - bioidentical $178 (1)(2) Premarin + MPA (Prempro / Premphase) Non - bioidentical 290 (1)(2) Estradiol + Progesterone (custom compounded ) Untested Bioidentical 1,500 (3) Not FDA approved Total Oral Combination Sales $1,968 $489 18 FDA Approved Products in Use Lack Innovation All FDA approved products in use contain non - bioidentical progestins Notes: All FDA approved combination products in use contain a non - bioidentical progestin. (1) Phast Prescription Monthly by Source Healthcare Analytics. (2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012 . (3) Estimate per Wulf Utian, Executive Director Emeritus and Honorary Founding President of NAMS . (4) IMS Data
19 New Lower Dose Progesterone
Phase 3 Trial Trial: 2 studies; 12 days, 3 cycles Sites: 10 - 15 each Subject: 180 − 3 arms (60 per arm) Estimated cost: $5 - $8 million RLD = 400 mg Endpoints − Withdrawal bleeding and secretory change 20 TX 12 - 002HR Progesterone — Proposed Phase 3 Study 2012 2013E 2014E 2015E 2016E Q3 '12 Q4 '12 Q1 '13 Q2 '13 Q3 '13 Q4 '13 Q1 '14 Q2 '14 Q3 '14 Q4 '14 Q1 '15 Q2 '15 Q3 '15 Q4 '15 Filed IND Pilot PK Study Pivotal PK Studies File NDA and PDUFA Two Phase 3 Amenorrhea Studies 12 Days & 3 Cycles TX12-002HR Progesterone File IND Update & Phase 3 Protocol Progesterone
Conducted PK studies in accordance with FDA requirements TXMD 150 mg test dose found to be bioequivalent to 200 mg Prometrium ® Summary evaluations of baseline - corrected Progesterone results for a theoretical 150 mg test capsule vs. 200 mg Prometrium ® capsule 21 Parameter Point Estimate T/R Ratio Within Subject Std. Deviation Upper 95% Confidence Bound C max 1.03 1.133 - 0.747 AUC 0 - t 0.96 0.891 - 0.465 TX 12 - 002HR Progesterone Candidate
Drug Improvement General Benefits Patient Benefits New lower effective doses Lower first - pass metabolites Better side effect profile Less somnolence Improved safety Improved safety profile vs. non - bioidentical progestin Reduced breast cancer risk Improved cardiovascular profile Improved lipid profile Confidence in treatment regimen No peanut oil Non - allergenic Excellent for all patient profiles No worries about potential allergies 22 TX 12 - 002HR Progesterone — Potential Benefits Note: Potential improvements and benefits, if approved.
Product Progestin U.S. Sales (est.) ($mm) (1)(2) INTL Sales (3) Company Generic Available Provera ® ( medroxyprogesterone acetate) Non - bioidentical $26 x Aygestin ® (norethindrone acetate) Non - bioidentical 45 x Prometrium ® (micronized progesterone) Bioidentical 247 x Total Oral Progestin Sales $318 $600 23 (1) Phast Prescription Monthly by Source Healthcare Analytics . (2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012 . (3) IMS Data Natural Progesterone Dominates
24 Other Programs
Product Compound U.S. Sales (est.) ($mm) (1)(2) Problems Premarin ® Cream Conjugated equine vaginal estrogen $265 Equine source Non - bioidentical Messy Reusable plungers Vagifem ® Tablets Estrace ® Cream Vaginal estradiol $558 Messy Reusable plungers Difficult to use Continuous - use mechanical device Total Sales $823 25 (1) Phast Prescription Monthly by Source Healthcare Analytics. (2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012 . TX 12 - 004HR Estradiol Product — Vulvar / Vaginal Atrophy
Phase 3 Trial Trial: 12 weeks Sites: 30 - 40 Subjects: 375 - 400 − 2 active arms (150 per arm) − 100 placebo Endpoints − Cell change − Lowering of pH − Lowering of most bothersome symptoms 26 TX 12 - 004HR Proposed Estradiol Vaginal Suppository — Proposed Phase 3 Study Estradiol 2013E 2014E 2015E 2016E 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 Expect to File IND File NDA NDA Approval Pilot PK Study Pivotal PK Studies File NDA and PDUFA Phase 3 Clinical Vulvar & Vaginal Atrophy TX 12-004HR 17β Estradiol in a VagiCap File IND Update & Phase 3 Protocol ™
27 John Milligan President Julia Amadio Chief Product Officer Dan Cartwright Chief Financial Officer Dr. Brian Bernick Chief Medical Officer and Director Robert Finizio Chief Executive Officer vitaMed HT Corporate Jason Spitz Vice President, Marketing 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 Steve Fontana, J.D. ‒ Author of the original estradiol patents Bill Mulholland, J.D. ‒ Lead patent attorney; previously , IP counsel at Pfizer Board of Directors and Investors Tommy Thompson Chairman Former Sec HHS & Gov of Wisc Cooper Collins Director CEO, Pernix Mario Family Partnership Investor Ernest Mario Former CEO of Glaxo Jules Musing Former Sr. Executive Johnson & Johnson Nick Segal Director Seavest Capital Partners
28 Potential Milestones 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 Filed IND Pilot PK Study Pivotal PK Studies File NDA and PDUFA Two Phase 3 Amenorrhea Studies 12 Days & 3 Cycles File IND Expect to File IND File NDA NDA Approval Pilot PK Study Pivotal PK Studies File NDA and PDUFA Phase 3 Clinical Vulvar & Vaginal Atrophy TX 12-001HR Combination 17β Estradiol + Progesterone TX12-002HR Progesterone TX 12-004HR 17β Estradiol in a VagiCap File IND Update & Phase 3 Protocol File IND Update & Phase 3 Protocol File IND Update & Phase 3 Protocol
29 Investment Highlights 1 Novel late - stage hormone therapy candidates 2 Clear pivotal trial endpoints / low risk regulatory pathway 3 Compelling, growing market opportunity, especially with recent concerns regarding compounders 4 Recently c ompleted $50 million equity financing 5 Robust, growing patent estate