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 6, 2014
| 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 6, 2014, TherapeuticsMD, Inc. issued a press release announcing its results of operations for its third fiscal quarter ended September 30, 2014. 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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit | |||
| Number | Description | ||
| 99.1 | Press Release from TherapeuticsMD, Inc., dated November 6, 2014, entitled “TherapeuticsMD announces third quarter 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 6, 2014 | 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 November 6, 2014, entitled “TherapeuticsMD announces third quarter financial results.” | ||
Exhibit 99.1
FOR IMMEDIATE RELEASE
TherapeuticsMD announces third quarter financial results
– Company advances two phase 3 programs for novel hormone therapy product candidates –
– Sales increased by 82 percent over prior year period –
– Management to host conference call today at 4:30 p.m. EST –
Boca Raton, Fla., Nov. 6, 2014 – TherapeuticsMD Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced its third quarter financial results for the period ending Sept. 30, 2014.
Third quarter and recent developments
| · | Net revenue increased to approximately $4.2 million compared with approximately $2.3 million in the prior year, reflecting an 82 percent increase in product sales |
| · | Net loss was approximately $17.8 million compared with approximately $7.7 million in the prior year, reflecting continued investment in two phase 3 pipeline products |
| · | The company initiated its phase 3 REJOICE Trial for TX-004HR (VagiCap™), the investigational softgel vaginal suppository for treatment of painful intercourse, a symptom of vulvar and vaginal atrophy (VVA) due to menopause |
| · | The company continues to enroll patients in its phase 3 REPLENISH Trial for TX-001HR, a novel investigational bio-identical estradiol-progesterone combination product candidate |
| · | Cash totaled approximately $67.0 million as of the end of the quarter with no outstanding debt |
“The third quarter was an important time of progress at TherapeuticsMD, with our late-stage clinical programs advancing and our current women’s health business continuing to perform well,” said TherapeuticsMD CEO Robert G. Finizio. “Additionally, market dynamics continue to evolve in favor of our novel hormone therapy development programs, and we are progressing toward study results for our phase 3 VVA program next year.”
Summary of financial results
For the third quarter ended Sept. 30, 2014, net revenue totaled approximately $4.2 million compared with approximately $2.3 million for the prior year’s quarter, reflecting an 82 percent increase in sales of the company’s current women’s health products. Revenue growth during the quarter was primarily driven by recently launched prenatal vitamin products and continued growth of product sales in this highly competitive market.
Cost of goods sold increased to approximately $1.1 million for the third quarter of 2014, compared with approximately $0.6 million for the prior year’s third quarter.
Total operating expenses for the third quarter of 2014 included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D expenses for the quarter were approximately $14.9 million, reflecting a one-time investment of approximately $4.1 million in clinical recruitment costs for the company’s ongoing phase 3 REPLENISH Trial. Third quarter 2013 R&D totaled approximately $4.1 million. SG&A expenses for the third quarter of 2014 were approximately $6.0 million and included marketing and sales expenses to support the launch of new prenatal products. SG&A totaled approximately $4.8 million for the third quarter of 2013.
Non-operating income for the third quarter of 2014 included miscellaneous and interest income of approximately $16,000, compared with expenses of approximately $436,000 primarily from financing costs in the prior year’s third quarter.
Net loss was approximately $17.8 million for the third quarter of 2014 or $0.12 per basic and diluted share, compared with approximately $7.7 million or $0.06 per basic and diluted share for the third quarter of 2013.
At Sept. 30, 2014, TherapeuticsMD had cash of approximately $67.0 million, compared with approximately $54.2 million at Dec. 31, 2013. At Nov. 4, 2014, TherapeuticsMD common stock outstanding totaled 156,030,476 shares.
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 conference call include:
| Date: | Nov. 6, 2014 | |
| Time: | 4:30 p.m. EST | |
| Telephone access (U.S. & Canada): | 866-665-9531 | |
| Telephone access (International): | 724-987-6977 | |
| Access code for all callers: | 20658896 |
Additionally, a live webcast may be accessed on the company’s website, www.therapeuticsmd.com, under the “Investor” section.
About TherapeuticsMD
TherapeuticsMD Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its patented SYMBODA™ technology platform, 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 three phase 3 products. The company also manufactures and distributes branded and generic prescription prenatal vitamins as well as over-the-counter vitamins and cosmetics 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 within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. 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
Media:
Julia Amadio
Chief Product Officer
561-961-1900
Julia.Amadio@TherapeuticsMD.com
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||
| September 30, 2014 | December 31, 2013 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 66,999,114 | $ | 54,191,260 | ||||
| Accounts receivable, net of allowance for doubtful accounts | ||||||||
| of $29,149 and $26,555, respectively | 2,148,724 | 1,690,753 | ||||||
| Inventory | 1,011,945 | 1,043,618 | ||||||
| Other current assets | 2,020,118 | 2,477,715 | ||||||
| Total current assets | 72,179,901 | 59,403,346 | ||||||
| Fixed assets, net | 69,567 | 61,318 | ||||||
| Other Assets: | ||||||||
| Prepaid expense | 1,392,264 | 1,750,455 | ||||||
| Intangible assets | 841,741 | 665,588 | ||||||
| Security deposit | 125,000 | 135,686 | ||||||
| Total other assets | 2,359,005 | 2,551,729 | ||||||
| Total assets | $ | 74,608,473 | $ | 62,016,393 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 5,648,679 | $ | 2,114,217 | ||||
| Deferred revenue | 848,149 | 1,602,580 | ||||||
| Other current liabilities | 4,511,079 | 3,601,189 | ||||||
| Total current liabilities | 11,007,907 | 7,317,986 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders' Equity: | ||||||||
| Preferred stock - par value $0.001; 10,000,000 shares authorized; | ||||||||
| no shares issued and outstanding | — | — | ||||||
| Common stock - par value $0.001; 250,000,000 shares authorized; | ||||||||
| 156,030,476 and 144,976,757 issued and outstanding, respectively | 156,030 | 144,977 | ||||||
| Additional paid-in capital | 181,891,791 | 135,086,056 | ||||||
| Accumulated deficit | (118,447,255 | ) | (80,532,626 | ) | ||||
| Total stockholder' equity | 63,600,566 | 54,698,407 | ||||||
| Total liabilities and stockholders' equity | $ | 74,608,473 | $ | 62,016,393 | ||||
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Revenues, net | $ | 4,186,261 | $ | 2,294,720 | $ | 10,768,572 | $ | 5,912,800 | ||||||||
| Cost of goods sold | 1,068,605 | 648,403 | 2,792,268 | 1,492,355 | ||||||||||||
| Gross profit | 3,117,656 | 1,646,317 | 7,976,304 | 4,420,445 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales, general, and administration | 6,043,354 | 4,752,062 | 16,610,015 | 14,455,839 | ||||||||||||
| Research and development | 14,909,430 | 4,098,903 | 29,052,149 | 7,710,546 | ||||||||||||
| Depreciation and amortization | 12,747 | 32,356 | 39,909 | 50,949 | ||||||||||||
| Total operating expense | 20,965,531 | 8,883,321 | 45,702,073 | 22,217,334 | ||||||||||||
| Operating loss | (17,847,875 | ) | (7,237,004 | ) | (37,725,769 | ) | (17,796,889 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Miscellaneous income | 6,260 | 11,965 | 43,411 | 15,444 | ||||||||||||
| Interest income | 9,364 | — | 27,756 | 18,133 | ||||||||||||
| Interest expense | — | — | — | (1,165,981 | ) | |||||||||||
| Financing costs | — | (447,969 | ) | (260,027 | ) | (1,107,937 | ) | |||||||||
| Loan guaranty costs | — | — | — | (2,944 | ) | |||||||||||
| Total other income (expense) | 15,624 | (436,004 | ) | (188,860 | ) | (2,243,285 | ) | |||||||||
| Loss before taxes | (17,832,251 | ) | (7,673,008 | ) | (37,914,629 | ) | (20,040,174 | ) | ||||||||
| Provision for income taxes | — | — | — | — | ||||||||||||
| Net loss | $ | (17,832,251 | ) | $ | (7,673,008 | ) | $ | (37,914,629 | ) | $ | (20,040,174 | ) | ||||
| Loss per share, basic and diluted: | ||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.12 | ) | $ | (0.06 | ) | $ | (0.26 | ) | $ | (0.16 | ) | ||||
| Weighted average number of common | ||||||||||||||||
| shares outstanding | 152,200,455 | 131,212,706 | 147,594,810 | 121,701,292 | ||||||||||||
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
| Nine Months Ended | ||||||||||
| September 30, | ||||||||||
| 2014 | 2013 | |||||||||
| (Unaudited) | (Unaudited) | |||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||
| Net loss | $ | (37,914,629 | ) | $ | (20,040,174 | ) | ||||
| Adjustments to reconcile net loss to net cash flows used in | ||||||||||
| operating activities: | ||||||||||
| Depreciation | 22,713 | 41,186 | ||||||||
| Amortization of intangible assets | 17,196 | 9,764 | ||||||||
| Provision for doubtful accounts | 2,594 | 48,355 | ||||||||
| Stock based compensation | 3,226,241 | 1,926,992 | ||||||||
| Stock based expense for services | 708,595 | 804,878 | ||||||||
| Amortization of deferred financing costs | 260,027 | 1,055,948 | ||||||||
| Amortization of debt discount | — | 1,102,680 | ||||||||
| Loan guaranty costs | — | 2,944 | ||||||||
| Changes in operating assets and liabilities: | ||||||||||
| Accounts receivable | (460,565 | ) | (1,235,433 | ) | ||||||
| Inventory | 31,673 | 467,624 | ||||||||
| Other current assets | 197,569 | (1,927,156 | ) | |||||||
| Other assets | (17,069 | ) | (984,974 | ) | ||||||
| Accounts payable | 3,534,462 | 830,585 | ||||||||
| Deferred revenue | (754,431 | ) | 707,520 | |||||||
| Accrued expenses and other current liabilities | 909,890 | 1,190,178 | ||||||||
| Net cash flows used in operating activities | (30,235,734 | ) | (15,999,083 | ) | ||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||
| Patent and trademark costs, net of abandoned costs | (193,349 | ) | (257,633 | ) | ||||||
| Purchase of property and equipment | (30,962 | ) | (23,755 | ) | ||||||
| Net cash flows used in investing activities | (224,311 | ) | (281,388 | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||
| Proceeds from sale of common stock, net | 42,771,353 | 78,984,960 | ||||||||
| Proceeds from exercise of options | 315,546 | 6,231 | ||||||||
| Proceeds from exercise of warrants | 181,000 | — | ||||||||
| Proceeds from line of credit | — | 500,000 | ||||||||
| Repayment of line of credit | — | (500,000 | ) | |||||||
| Repayment of notes payable | — | (4,691,847 | ) | |||||||
| Net cash flows provided by financing activities | 43,267,899 | 74,299,344 | ||||||||
| Increase in cash | 12,807,854 | 58,018,873 | ||||||||
| Cash, beginning of period | 54,191,260 | 1,553,474 | ||||||||
| Cash, end of period | 66,999,114 | 59,572,347 | ||||||||
| 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 | ||||||