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): November 3, 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 November 3, 2016, TherapeuticsMD, Inc. issued a press release announcing its results of operations for its third fiscal quarter ended September 30, 2016. 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 November 3, 2016, entitled “TherapeuticsMD Announces Third Quarter 2016 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: November 3, 2016 | THERAPEUTICSMD, INC. | |
| By: | /s/ Daniel A. Cartwright | |
| Name: Daniel A. Cartwright | ||
| Title: Chief Financial Officer | ||
EXHIBIT INDEX
| Exhibit | |
| Number | Description |
| 99.1 | Press Release from TherapeuticsMD, Inc., dated November 3, 2016, entitled “TherapeuticsMD Announces Third Quarter 2016 Financial Results.” |
Exhibit 99.1
FOR IMMEDIATE RELEASE
TherapeuticsMD Announces Third Quarter 2016 Financial Results
- Topline phase 3 data for TX-001HR Replenish Trial on track for fourth quarter of 2016 -
- TX-004HR PDUFA target action date of May 7, 2017 -
BOCA RATON, Fla. – Nov. 3, 2016 – TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced its third quarter financial results for the quarter ended September 30, 2016.
Third Quarter and Recent Developments
| • | Announced acceptance of a New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for TX-004HR (conditionally-approved trade name Yuvvexy™), the company’s investigational applicator-free estradiol vaginal softgel capsule 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 NDA is supported by the complete TX-004HR clinical program, including positive phase 3 results with all three doses of TX-004HR (4 mcg, 10 mcg and 25 mcg) that were evaluated in the Rejoice Trial. The FDA’s Prescription Drug User Fee Act (PDUFA) target action date for the NDA is May 7, 2017. |
| • | Anticipate topline results in the fourth quarter of 2016 for the ongoing Replenish Trial, a phase 3 clinical trial of the company’s TX-001HR product candidate, which, if approved, would be the first and only FDA-approved bio-identical combination of estradiol and progesterone for the treatment of moderate-to-severe vasomotor symptoms due to menopause. |
| • | Net revenue from the company’s prescription prenatal vitamin business increased 7 percent to approximately $5.5 million for the third quarter of 2016, compared with approximately $5.2 million for the third quarter of 2015. |
| • | Net loss was approximately $25.0 million for the third quarter of 2016, compared with approximately $19.5 million for the third quarter of 2015. |
| • | Ended the quarter with approximately $147.5 million in cash and no debt. |
| • | Supported nine presentations at annual meetings of the International Menopause Society (IMS) and North American Menopause Society (NAMS), including reports on the positive results from the TX-004HR clinical development program and new data that further identify women’s perceptions of VVA and available treatment options. |
| • | Grew the company’s intellectual property portfolio to a current total of 149 patent filings, including 82 international filings, with 17 issued U.S. patents. |
| • | Strengthened relationships with medical, pharmacy, patient and industry organizations internationally. |
“We are making excellent progress this year advancing our pipeline and enhancing our commercial capabilities focused on women’s health. During the quarter, we successfully completed the submission of our NDA for TX-004HR as a novel treatment for moderate to severe dyspareunia, a symptom of VVA due to menopause, and we continued ongoing pre-commercialization activities for this important product,” said TherapeuticsMD CEO Robert G. Finizio. “We now eagerly await the topline data from our Replenish Trial for TX-001HR in the fourth quarter of 2016, our second novel hormone therapy program, which, if approved, would be the first and only FDA-approved bio-identical combination of estradiol and progesterone for the treatment of moderate-to-severe vasomotor symptoms due to menopause.”
Summary of Third Quarter 2016 Financial Results
Net revenue from the company’s prescription prenatal vitamins increased 7 percent to approximately $5.5 million for the third quarter of 2016 from approximately $5.2 million for the prior year’s quarter.
Cost of goods sold was approximately $1.2 million for the third quarter of both 2016 and 2015.
Total operating expenses for the third quarter of 2016 included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D expenses during the third quarter of 2016 were approximately $14.7 million compared to approximately $16.4 million during the prior year’s quarter, reflecting a decline in the company’s clinical trial costs. SG&A expenses for the third quarter of 2016 were approximately $14.7 million compared with approximately $7.1 million for the prior year’s quarter. Higher SG&A expenses during the third quarter of 2016 were primarily due to an increase in the company’s sales, marketing and regulatory personnel to support future commercialization of the company’s pipeline products.
Net loss for the third quarter of 2016 was approximately $25.0 million, or $0.13 per basic and diluted share, compared with approximately $19.5 million, or $0.11 per basic and diluted share, for the third quarter of 2015.
At September 30, 2016, cash on hand was approximately $147.5 million, compared with approximately $64.7 million at December 31, 2015.
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, November 3, 2016 |
| Time: | 4:30 p.m. EDT |
| Telephone Access (US): | 866-665-9531 |
| Telephone Access (International): | 724-987-6977 |
| Access Code for All Callers: | 99198056 |
Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com, in 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: 99198056.
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.
Forward-Looking Statements
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; whether the FDA will approve the company’s new drug application for its TX-004HR product candidate and whether any such approval will occur by the PDUFA date; 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.
# # #
Investor Contact
David DeLucia
Director, Investor Relations
561-961-1900
David.DeLucia@TherapeuticsMD.com
Media Contact
Ami Knoefler
SparkBioComm
650-739-9952
Ami@SparkBiocomm.com
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| September 30, 2016 | December 31, 2015 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 147,534,065 | $ | 64,706,355 | ||||
| Accounts receivable, net of allowance for doubtful accounts | ||||||||
| of $113,034 and $81,910, respectively | 5,033,298 | 3,049,715 | ||||||
| Inventory | 843,398 | 690,153 | ||||||
| Other current assets | 2,693,475 | 2,233,897 | ||||||
| Total current assets | 156,104,236 | 70,680,120 | ||||||
| Fixed assets, net | 460,546 | 198,592 | ||||||
| Other Assets: | ||||||||
| Intangible assets, net | 2,118,378 | 1,615,251 | ||||||
| Prepaid expense | — | 1,109,883 | ||||||
| Security deposit | 139,036 | 125,000 | ||||||
| Total other assets | 2,257,414 | 2,850,134 | ||||||
| Total assets | $ | 158,822,196 | $ | 73,728,846 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 4,224,419 | $ | 3,126,174 | ||||
| Other current liabilities | 8,243,421 | 7,539,526 | ||||||
| Total current liabilities | 12,467,840 | 10,665,700 | ||||||
| Total liabilities | 12,467,840 | 10,665,700 | ||||||
| Commitments and Contingencies - See Note 15 | ||||||||
| 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 shares authorized; | ||||||||
| 196,580,212 and 177,928,041 issued and outstanding, respectively | 196,580 | 177,928 | ||||||
| Additional paid in capital | 433,023,801 | 282,712,078 | ||||||
| Accumulated deficit | (286,866,025 | ) | (219,826,860 | ) | ||||
| Total stockholders' equity | 146,354,356 | 63,063,146 | ||||||
| Total liabilities and stockholders' equity | $ | 158,822,196 | $ | 73,728,846 | ||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues, net | $ | 5,535,685 | $ | 5,190,175 | $ | 14,869,023 | $ | 14,513,158 | ||||||||
| Cost of goods sold | 1,237,446 | 1,193,965 | 3,475,997 | 3,270,695 | ||||||||||||
| Gross profit | 4,298,239 | 3,996,210 | 11,393,026 | 11,242,463 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales, general, and administration | 14,721,710 | 7,060,944 | 35,019,268 | 20,089,998 | ||||||||||||
| Research and development | 14,664,123 | 16,421,753 | 43,602,333 | 58,789,302 | ||||||||||||
| Depreciation and amortization | 40,460 | 16,548 | 84,319 | 44,400 | ||||||||||||
| Total operating expense | 29,426,293 | 23,499,245 | 78,705,920 | 78,923,700 | ||||||||||||
| Operating loss | (25,128,054 | ) | (19,503,035 | ) | (67,312,894 | ) | (67,681,237 | ) | ||||||||
| Other income: | ||||||||||||||||
| Miscellaneous income | 109,942 | 27,630 | 265,879 | 71,728 | ||||||||||||
| Accreted interest | 2,451 | 2,760 | 7,850 | 15,162 | ||||||||||||
| Total other income | 112,393 | 30,390 | 273,729 | 86,890 | ||||||||||||
| Loss before taxes | (25,015,661 | ) | (19,472,645 | ) | (67,039,165 | ) | (67,594,347 | ) | ||||||||
| Provision for income taxes | — | — | — | — | ||||||||||||
| Net loss | $ | (25,015,661 | ) | $ | (19,472,645 | ) | $ | (67,039,165 | ) | $ | (67,594,347 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.13 | ) | $ | (0.11 | ) | $ | (0.34 | ) | $ | (0.39 | ) | ||||
| Weighted average number of common | ||||||||||||||||
| shares outstanding | 196,502,327 | 177,206,168 | 195,912,173 | 171,589,595 | ||||||||||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| Nine Months Ended | ||||||||
| September 30, 2016 | September 30, 2015 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (67,039,165 | ) | $ | (67,594,347 | ) | ||
| Adjustments to reconcile net loss to net cash flows used in | ||||||||
| operating activities: | ||||||||
| Depreciation of fixed assets | 45,759 | 22,104 | ||||||
| Amortization of intangible assets | 38,560 | 22,296 | ||||||
| Provision for doubtful accounts | 2,261,568 | 37,163 | ||||||
| Share-based compensation | 13,385,215 | 4,740,906 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (4,245,151 | ) | (1,549,532 | ) | ||||
| Inventory | (153,245 | ) | 312,054 | |||||
| Other current assets | 379,930 | (621,923 | ) | |||||
| Other assets | — | (15,162 | ) | |||||
| Accounts payable | 1,098,245 | (1,025,504 | ) | |||||
| Deferred revenue | — | (522,613 | ) | |||||
| Other current liabilities | 703,895 | 2,546,138 | ||||||
| Other long-term liabilities | — | 1,213,874 | ||||||
| Net cash used in operating activities | (53,524,389 | ) | (62,434,546 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Patent costs | (541,686 | ) | (117,992 | ) | ||||
| Purchase of fixed assets | (307,714 | ) | (15,559 | ) | ||||
| Payment of security deposit | (14,036 | ) | — | |||||
| Net cash used in investing activities | (863,436 | ) | (133,551 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from sale of common stock, net of costs | 134,863,475 | 91,374,649 | ||||||
| Proceeds from exercise of warrants | 1,373,000 | 366,000 | ||||||
| Proceeds from exercise of options | 979,060 | 589,829 | ||||||
| Net cash provided by financing activities | 137,215,535 | 92,330,478 | ||||||
| Increase in cash | 82,827,710 | 29,762,381 | ||||||
| Cash, beginning of period | 64,706,355 | 51,361,607 | ||||||
| Cash, end of period | $ | 147,534,065 | $ | 81,123,988 | ||||