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): February 25, 2016
| 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 2.02 | Results of Operations and Financial Condition. |
On February 25, 2016, TherapeuticsMD, Inc. issued a press release announcing its results of operations for the fourth quarter and fiscal year ended December 31, 2015. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
The information in this Current Report on Form 8-K (including the exhibit) is furnished pursuant to Item 2.02 and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in this Current Report shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing.
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 Current 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 | Press Release from TherapeuticsMD, Inc., dated February 25, 2016, entitled “TherapeuticsMD Announces Fourth Quarter and Full Year 2015 Financial Results.” | |
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: February 25, 2016 | THERAPEUTICSMD, INC. | |
| By: | /s/ Daniel A. Cartwright | |
Name: Title: |
Daniel
A. Cartwright Chief Financial Officer | |
EXHIBIT INDEX
| Exhibit Number |
Description |
| 99.1 | Press Release from TherapeuticsMD, Inc., dated February 25, 2016, entitled “TherapeuticsMD Announces Fourth Quarter and Full Year 2015 Financial Results.” |
Exhibit 99.1
FOR IMMEDIATE RELEASE
TherapeuticsMD Announces Fourth Quarter and Full Year 2015 Financial Results
– Company to Present additional positive phase 3 data for TX-004HR at the ISSWSH annual meeting –
– Management to host conference call today at 4:30 p.m. EST –
BOCA RATON, Fla. – February 25, 2016 – TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced its fourth quarter and full year financial results for 2015.
2015 and Recent Developments
| · | Net revenue for the company’s prescription prenatal vitamin business increased to approximately $20.1 million in 2015 compared with approximately $15.0 million for the prior year. | |
| · | Net loss was approximately $85.1 million in 2015, compared with approximately $54.2 million for the prior year, reflecting investment in two phase 3 clinical trials for the company’s novel hormone therapy drug candidates. | |
| · | Reported positive topline data from the Rejoice Trial, a phase 3 clinical trial of TX-004HR, an applicator-free vaginal estradiol softgel drug candidate for the treatment of moderate to severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The results showed patients treated with TX-004HR achieved a statistically significant improvement over placebo across all four co-primary endpoints at all three doses evaluated. The validated co-primary endpoint data and additional secondary endpoint results related to vaginal dryness are scheduled to be presented this week at the International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting 2016. A summary of these data is included below in this press release. | |
| · | Exited over 1,400 of the 1,750 patients enrolled in the Replenish Trial, a phase 3 clinical trial of TX-001HR, a combination estradiol and progesterone drug candidate, for the treatment of moderate to severe vasomotor symptoms due to menopause. Topline results are currently anticipated late in the fourth quarter of 2016. | |
| · | The company’s intellectual property portfolio grew to a current total of 122 patent filings, including 72 international filings, with one allowed and 14 issued U.S. patents. | |
| · | Presented two posters at North American Menopause Society (NAMS) of the company’s transdermal progesterone candidate, TX-005HR, and the company’s transdermal estradiol and progesterone candidate, TX-006HR, demonstrating tissue penetration and target organ activity in a preclinical study. | |
| · | Strengthened relationships with key medical, pharmacy, patient and industry organizations worldwide. | |
| · | Ended the year with approximately $64.7 million in cash and no debt, which was further strengthened by an equity offering in January 2016 that generated approximately $135 million of net proceeds to fund commercialization activities for both of the company’s late stage product candidates and other development activities. |
“2015 was a breakthrough year for our company, as we reported positive topline phase 3 data from the Rejoice Trial for TX-004HR, the first of our two novel pipeline candidates in the women’s health arena,” said TherapeuticsMD CEO Robert G. Finizio. “Based on those compelling results, we are preparing to file an NDA before June 30, while we also expect topline data late in the fourth quarter of 2016 from our Replenish Trial for TX-001HR. We believe we are well positioned from a financial, clinical and commercial standpoint to execute on our goals in 2016 and create significant value for shareholders by advancing our pipeline and preparing to launch our first novel hormone product for women, if approved.”
Summary of 2015 Financial Results
For the year ended December 31, 2015, net revenue increased approximately 34 percent to approximately $20.1 million compared with approximately $15.0 million for the prior year. Net revenue for the fourth quarter of 2015 was approximately $5.6 million compared with net revenue of approximately $4.3 million for the prior year’s quarter. Revenue growth during the fourth quarter was primarily driven by a change in product mix and an increase in the average net sales price of the company’s prenatal vitamin products and revenue growth during the full year was primarily driven by an increase in the number of units sold and an increase in the average sales price of the company’s prenatal vitamin products.
Cost of goods sold increased to approximately $4.5 million for the full year 2015, compared with approximately $3.7 million in the prior year.
Total operating expenses for the fourth quarter and full year 2015 included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D expenses for the full-year 2015 were approximately $72.0 million compared with approximately $43.2 million for the prior year, primarily as a result of an increase in costs related to the company’s phase 3 clinical trials for TX-001HR and TX-004HR and an increase in scale-up and manufacturing activities primarily related to TX-001HR. R&D expenses during the fourth quarter of 2015 were $13.3 million compared to $14.2 million during the prior year’s quarter, reflecting a significant decline in the company’s clinical trial costs, partially offset by an increase in scale-up and manufacturing activities to support commercialization. SG&A expenses for the full-year 2015 were approximately $28.7 million compared with approximately $22.1 million for the prior year, reflecting an increase in human resources related costs, increased consulting and professional costs, increased insurance cost and increased sales and marketing expenses. SG&A expenses for the fourth quarter of 2015 were approximately $8.6 million compared with approximately $5.5 million for the prior year’s quarter, primarily as a result of increased human resource related costs, as well as increased sales and marketing and office expenses.
Non-operating income remained insignificant for the full year 2015 and 2014 and included interest income and other miscellaneous items of income and expense for both periods.
Net loss for the full year 2015 was approximately $85.1 million, or $0.49 per basic and diluted share, compared with approximately $54.2 million, or $0.36 per basic and diluted share, for the full year 2014. Net loss in the fourth quarter of 2015 was approximately $17.5 million, or $0.10 per basic and diluted share, compared with approximately $16.3 million, or $0.10 per basic and diluted share, for the fourth quarter of 2014.
At December 31, 2015, cash on hand was approximately $64.7 million, compared with approximately $51.4 million at December 31, 2014.
Phase 3 Data Results Presented at ISSWSH Annual Meeting 2016
TherapeuticsMD also announced that data from the phase 3 Rejoice Trial would be presented at the ISSWSH Annual Meeting 2016 taking place February 25-28 in Charleston, South Carolina. The poster to be presented includes validated co-primary endpoint results from the Rejoice Trial and secondary endpoint data that demonstrate the effect of TX-004HR on severity of vaginal dryness as compared with placebo at week 12.
Based on the company’s ongoing analyses of the Rejoice Trial data, statistical significance of the results for the co-primary endpoint of severity of participants' self-reported moderate to severe dyspareunia as the most bothersome symptom of VVA has slightly improved for all three doses from the topline results previously reported. The secondary endpoint result for vaginal dryness was also statistically significant for all three doses evaluated in the Rejoice Trial.
Statistical Significance of Results for Co-Primary Endpoints
| ||||||||||||
| 25 mcg | 10mcg | 4 mcg | ||||||||||
| Superficial Cells | P < 0.0001 | P < 0.0001 | P < 0.0001 | |||||||||
| Parabasal cells | P < 0.0001 | P < 0.0001 | P < 0.0001 | |||||||||
| Vaginal pH | P < 0.0001 | P < 0.0001 | P < 0.0001 | |||||||||
| Severity of Dyspareunia | P < 0.0001 | P < 0.0001 | P = 0.0149 | |||||||||
Statistical
Significance of Results for Secondary Endpoint of Severity of Vaginal Dryness
| ||||||||||||
| Severity of Dryness | P < 0.0001 | P < 0.0001 | P = 0.0014 | |||||||||
| LS= Least Squares | ||||||||||||
Conference Call Today
As previously announced, TherapeuticsMD will host a conference call today to discuss these financial results and provide a business update. Details for the call are:
| Date: | Thursday, February 25, 2016 |
| Time: | 4:30 p.m. EST |
| Telephone Access (US): | 866-665-9531 |
| Telephone Access (International): | 724-987-6977 |
| Access Code for All Callers: | 45870409 |
Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com, on the Home Page or under the “Investors & Media” section. A digital recording of the conference call will be available for replay beginning two hours after the call's completion and for at least 30 days with the dial-in 855-859-2056 or international 404-537-3406 and Conference ID: 45870409.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA™ technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The company’s clinical development pipeline includes two phase 3 products. The company also manufactures and distributes branded and generic prescription prenatal vitamins as well as over-the-counter vitamins under the vitaMedMD® and BocaGreenMD® brands. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com and www.bocagreenmd.com.
This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes 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 are outside of the company’s 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 the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize its hormone therapy drug candidates and obtain additional financing necessary therefor; the length, cost and uncertain results of the company’s clinical trials; the potential of adverse side effects or other safety risks that could preclude the approval of the company’s hormone therapy drug candidates; the company’s reliance on third parties to conduct its clinical trials, research and development and manufacturing; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership. PDF copies of the company’s historical press releases and financial tables can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.
# # #
Contacts
Investors:
Dan
Cartwright
Chief Financial Officer
561-961-1900
Dan.Cartwright@TherapeuticsMD.com
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| December 31, | |||||||
| 2015 | 2014 | ||||||
| ASSETS | |||||||
| Current Assets: | |||||||
| Cash | $ | 64,706,355 | $ | 51,361,607 | |||
| Accounts receivable, net of allowance for doubtful accounts of $81,910 and $59,753, respectively | 3,049,715 | 2,154,217 | |||||
| Inventory | 690,153 | 1,182,113 | |||||
| Other current assets | 2,233,897 | 1,537,407 | |||||
| Total current assets | 70,680,120 | 56,235,344 | |||||
| Fixed assets, net | 198,592 | 63,293 | |||||
| Other Assets: | |||||||
| Intangible assets, net | 1,615,251 | 1,228,588 | |||||
| Prepaid expense | 1,109,883 | 1,427,263 | |||||
| Security deposit | 125,000 | 125,000 | |||||
| Total other assets | 2,850,134 | 2,780,851 | |||||
| Total assets | $ | 73,728,846 | $ | 59,079,488 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| Current Liabilities: | |||||||
| Accounts payable | $ | 3,126,174 | $ | 6,327,129 | |||
| Other current liabilities | 7,539,526 | 3,840,639 | |||||
| Deferred revenue | — | 522,613 | |||||
| Total current liabilities | 10,665,700 | 10,690,381 | |||||
| Commitments and Contingencies - See Note 14 | |||||||
| Stockholders’ Equity: | |||||||
| Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding | — | — | |||||
| Common stock - par value $0.001; 350,000,000 and 250,000,000 shares authorized; 177,928,041 and 156,097,019 issued and outstanding, respectively | 177,928 | 156,097 | |||||
| Additional paid-in capital | 282,712,078 | 182,982,846 | |||||
| Accumulated deficit | (219,826,860 | ) | (134,749,836 | ) | |||
| Total stockholders’ equity | 63,063,146 | 48,389,107 | |||||
| Total liabilities and stockholders’ equity | $ | 73,728,846 | $ | 59,079,488 | |||
THERAPEUTICSMD,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENT OF OPERATIONS
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||||||||
| 2015 | 2014 | 2015 | 2014 | 2013 | |||||||||||||||||
| Revenues, net | $ | 5,629,740 | $ | 4,257,647 | $ | 20,142,898 | $ | 15,026,219 | $ | 8,775,598 | |||||||||||
| Cost of goods sold | 1,235,978 | 879,535 | 4,506,673 | 3,671,803 | 1,959,597 | ||||||||||||||||
| Gross profit | 4,393,762 | 3,378,112 | 15,636,225 | 11,354,416 | 6,816,001 | ||||||||||||||||
| Operating expenses: | |||||||||||||||||||||
| Sales, general, and administrative | 8,631,238 | 5,514,057 | 28,721,236 | 22,124,072 | 19,014,837 | ||||||||||||||||
| Research and development | 13,253,472 | 14,166,789 | 72,042,774 | 43,218,938 | 13,551,263 | ||||||||||||||||
| Depreciation and amortization | 18,000 | 12,558 | 62,400 | 52,467 | 58,145 | ||||||||||||||||
| Total operating expenses | 21,902,710 | 19,693,404 | 100,826,410 | 65,395,477 | 32,624,245 | ||||||||||||||||
| Operating loss | (17,508,948 | ) | (16,315,292 | ) | (85,190,185 | ) | (54,041,061 | ) | (25,808,244 | ) | |||||||||||
| Other income and (expenses) | |||||||||||||||||||||
| Miscellaneous income, net | 23,991 | 3,158 | 95,719 | 46,569 | 34,544 | ||||||||||||||||
| Interest income | 2,280 | 9,553 | 17,442 | 37,309 | 27,234 | ||||||||||||||||
| Financing costs | — | — | — | (260,027 | ) | (1,503,922 | ) | ||||||||||||||
| Interest expense | — | — | — | — | (1,165,981 | ) | |||||||||||||||
| Loan guaranty costs | — | — | — | — | (2,944 | ) | |||||||||||||||
| Total other income (expense) | 26,271 | 12,711 | 113,161 | (176,149 | ) | (2,611,069 | ) | ||||||||||||||
| Loss before income taxes | (17,482,677 | ) | (16,302,581 | ) | (85,077,024 | ) | (54,217,210 | ) | (28,419,313 | ) | |||||||||||
| Provision for income taxes | — | — | — | — | — | ||||||||||||||||
| Net loss | $ | (17,482,677 | ) | $ | (16,302,581 | ) | $ | (85,077,024 | ) | $ | (54,217,210 | ) | $ | (28,419,313 | ) | ||||||
| Loss per share, basic and diluted: | |||||||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.10 | ) | $ | (0.10 | ) | $ | (0.49 | ) | $ | (0.36 | ) | $ | (0.22 | ) | ||||||
| Weighted
average number of common shares outstanding, basic and diluted | $ | 177,876,462 | $ | 156,054,938 | $ | 173,174,229 | $ | 149,727,228 | $ | 127,569,731 | |||||||||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Year Ended December, 31, | ||||||||||
| 2015 | 2014 | 2013 | ||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||
| Net loss | $ | (85,077,024 | ) | $ | (54,217,210 | ) | $ | (28,419,313 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||
| Depreciation | 29,959 | 28,987 | 47,883 | |||||||
| Amortization of intangible assets | 32,441 | 23,480 | 10,262 | |||||||
| Provision for (recovery of) doubtful accounts | 22,157 | (5,436 | ) | (15,493 | ) | |||||
| Amortization of debt discount | — | — | 1,102,680 | |||||||
| Share-based compensation | 7,189,699 | 4,970,312 | 3,844,155 | |||||||
| Amortization of deferred financing costs | — | 260,027 | 1,451,934 | |||||||
| Loan guaranty costs | — | — | 2,944 | |||||||
| Changes in operating assets and liabilities: | ||||||||||
| Accounts receivable | (917,656 | ) | (458,028 | ) | (1,068,619 | ) | ||||
| Inventory | 491,960 | (138,495 | ) | 571,592 | ||||||
| Other current assets | (773,532 | ) | 680,281 | (1,386,319 | ) | |||||
| Other assets | (17,442 | ) | (37,309 | ) | (565,706 | ) | ||||
| Accounts payable | (3,200,955 | ) | 4,212,912 | 472,851 | ||||||
| Deferred revenue | (522,613 | ) | (1,079,967 | ) | 457,828 | |||||
| Other current liabilities | 3,698,887 | 239,450 | 2,875,320 | |||||||
| Other liabilities | — | — | (150,068 | ) | ||||||
| Net cash used in operating activities | (79,044,119 | ) | (45,520,996 | ) | (20,768,069 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||
| Patent costs | (419,104 | ) | (586,480 | ) | (439,034 | ) | ||||
| Purchase of fixed assets | (165,257 | ) | (30,962 | ) | (40,790 | ) | ||||
| Refund (payment) of security deposit | — | 10,686 | (103,737 | ) | ||||||
| Net cash used in investing activities | (584,361 | ) | (606,756 | ) | (583,561 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||
| Proceeds from sale of common stock, net of costs | 91,374,649 | 42,771,353 | 78,650,353 | |||||||
| Proceeds from exercise of options | 1,232,579 | 345,746 | 30,910 | |||||||
| Proceeds from exercise of warrants | 366,000 | 181,000 | — | |||||||
| Proceeds bank line of credit | — | — | 500,000 | |||||||
| Repayment of bank line of credit | — | — | (500,000 | ) | ||||||
| Repayment of notes payable | — | — | (4,691,847 | ) | ||||||
| Net cash provided by financing activities | 92,973,228 | 43,298,099 | 73,989,416 | |||||||
| Increase (decrease) in cash | 13,344,748 | (2,829,653 | ) | 52,637,786 | ||||||
| Cash, beginning of period | 51,361,607 | 54,191,260 | 1,553,474 | |||||||
| Cash, end of period | $ | 64,706,355 | $ | 51,361,607 | $ | 54,191,260 | ||||
| SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||||||||||
| Cash paid for interest | $ | — | $ | — | $ | 212,853 | ||||
| Cash paid for income taxes | $ | — | $ | — | $ | — | ||||
| SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES: | ||||||||||
| Warrants issued for financing | $ | — | $ | — | $ | 1,711,956 | ||||
| Warrants issued for services | $ | — | $ | — | $ | 462,196 | ||||