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): August 6, 2015
| 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 August 6, 2015, TherapeuticsMD, Inc. issued a press release announcing its results of operations for its second fiscal quarter ended June 30, 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.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit | ||
| Number | Description | |
| 99.1 | Press Release from TherapeuticsMD, Inc., dated August 6, 2015, entitled “TherapeuticsMD Announces Second Quarter 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: August 6, 2015 | 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 August 6, 2015, entitled “TherapeuticsMD Announces Second Quarter 2015 Financial Results.” |
Exhibit 99.1
FOR IMMEDIATE RELEASE
TherapeuticsMD Announces Second Quarter 2015 Financial Results
| – Completed Enrollment of 700 Patients in Phase 3 Rejoice Trial; Topline Data |
Anticipated in Fourth Quarter of 2015 –
| –
Patient Recruitment
for Phase 3 Replenish Trial Advancing; Enrollment Completion Expected during Second Half of 2015 - | ||
– Management to Host Conference call Today at 4:30 p.m. EDT –
BOCA RATON, Fla. – August 6, 2015 – TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced its second quarter financial results for the period ended June 30, 2015.
Second Quarter and Recent Developments
| · | Net revenue for the company’s prescription prenatal vitamin business increased to approximately $4.8 million for the second quarter of 2015 compared with approximately $3.8 million for the second quarter of 2014. |
| · | Net loss was approximately $27.2 million for the second quarter of 2015, compared with approximately $10.9 million for the second quarter of 2014, reflecting costs associated with the company’s continued enrollment of patients in two phase 3 clinical trials for its novel hormone therapy product candidates. |
| · | Completed patient enrollment in the Rejoice Trial, a phase 3 clinical trial of TX-004HR (estradiol in VagiCap™), an applicator-free vaginal estradiol product candidate for the treatment of moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. |
| · | Continued recruitment of patients for the Replenish Trial, a phase 3 clinical trial of TX-001HR, a combination estradiol and progesterone product candidate, for the treatment of moderate to severe vasomotor symptoms due to menopause. |
| · | Ended the quarter with $67.2 million in cash and no debt. |
| · | Completed an underwritten public offering of common stock in July 2015 that resulted in net proceeds to the company of approximately $32.2 million. |
| · | Grew the company’s intellectual property portfolio to a current total of 111 patent filings, of which 61 were filed in international jurisdictions, including three allowed and 11 issued U.S. patents. |
| · | Supported scientific abstracts and presentations at meetings of the American College of Obstetricians and Gynecologists (ACOG) and the European Society of Menopause and Andropause. |
| · | Continued to develop relationships with key medical and industry organizations. |
“We are very pleased with our progress during the second quarter, most notably completion of enrollment in our 700-patient Rejoice Trial of TX-004HR for the treatment of moderate to severe dyspareunia as a symptom of VVA due to menopause, and ongoing recruitment of patients for the phase 3 Replenish Trial of TX-001HR, our combination estradiol and progesterone product candidate,” said TherapeuticsMD CEO Robert G. Finizio. “We are also focused on building alliances with key medical and industry organizations in order to generate awareness and knowledge of the unmet medical needs among menopausal and post-menopausal women.”
Summary of Second Quarter Financial Results
Net revenue for the second quarter of 2015 totaled approximately $4.8 million compared with net revenue of approximately $3.8 million for the prior year’s quarter, an increase of approximately 29 percent year over year. Revenue growth during the second quarter was primarily driven by increased sales of the company’s prenatal vitamin products and an increase in the average net sales price of the company’s products.
Cost of goods sold increased to approximately $1.0 million for the three months ended June 30, 2015, compared with approximately $0.9 million in the prior year’s quarter.
Total operating expenses for the second quarter of 2015 included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D expenses for the second quarter of 2015 were approximately $24.2 million compared with approximately $8.2 million for the prior year’s quarter, reflecting costs of the company’s two ongoing phase 3 clinical trials for its novel hormone therapy products in development, including completion of enrollment in the Rejoice Trial, as well as scale-up and manufacturing activities. SG&A expenses for the second quarter of 2015 were approximately $6.9 million compared with approximately $5.5 million for the second quarter of 2014, primarily as a result of increased non-cash compensation, legal, director and insurance expenses.
Non-operating income remained insignificant and unchanged for both the second quarter of 2015 and 2014 and included miscellaneous and interest income for both periods.
Net loss for the second quarter of 2015 was approximately $27.2 million, or $0.16 per basic and diluted share, compared with approximately $10.9 million, or $0.07 per basic and diluted share, for the second quarter of 2014.
At June 30, 2015, TherapeuticsMD had cash on hand of approximately $67.2 million, compared with approximately $51.4 million at December 31, 2014. In July 2015, the company completed an underwritten public offering of shares of its common stock in which the net proceeds to the company were approximately $32.2 million.
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 and webcast are:
Date: Thursday, August 6, 2015
Time: 4:30 p.m. EDT
Telephone Access (US): 866-665-9531
Telephone Access (International): 724-987-6977
Access Code for All Callers: 83546010
Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com, under the “Investor” section.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its patented 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 |
| June 30, 2015 | December 31, 2014 | |||||||||
| (Unaudited) | ||||||||||
| ASSETS | ||||||||||
| Current Assets: | ||||||||||
| Cash | $ | 67,245,698 | $ | 51,361,607 | ||||||
| Accounts receivable, net of allowance for doubtful accounts of $90,520 and $59,753, respectively | 3,313,518 | 2,154,217 | ||||||||
| Inventory | 1,248,719 | 1,182,113 | ||||||||
| Other current assets | 1,154,213 | 1,537,407 | ||||||||
| Total current assets | 72,962,148 | 56,235,344 | ||||||||
| Fixed assets, net | 64,604 | 63,293 | ||||||||
| Other Assets: | ||||||||||
| Prepaid expense | 1,233,740 | 1,427,263 | ||||||||
| Intangible assets | 1,293,776 | 1,228,588 | ||||||||
| Security deposit | 125,000 | 125,000 | ||||||||
| Total other assets | 2,652,516 | 2,780,851 | ||||||||
| Total assets | $ | 75,679,268 | $ | 59,079,488 | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
| Current Liabilities: | ||||||||||
| Accounts payable | $ | 5,818,618 | $ | 6,327,129 | ||||||
| Other current liabilities | 5,887,902 | 3,840,639 | ||||||||
| Deferred revenue | — | 522,613 | ||||||||
| Total current liabilities | 11,706,520 | 10,690,381 | ||||||||
| Long-Term Liabilities: | ||||||||||
| Accrued expense | 967,286 | — | ||||||||
| Total liabilities | 12,673,806 | 10,690,381 | ||||||||
| 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; 350,000,000 and 250,000,000 shares authorized, respectively; 173,037,653 and 156,097,019 shares issued and outstanding, respectively | 173,038 | 156,097 | ||||||||
| Additional paid in capital | 245,703,962 | 182,982,846 | ||||||||
| Accumulated deficit | (182,871,538 | ) | (134,749,836 | ) | ||||||
| Total stockholders' equity | 63,005,462 | 48,389,107 | ||||||||
| Total liabilities and stockholders' equity | $ | 75,679,268 | $ | 59,079,488 | ||||||
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS |
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Revenues, net | $ | 4,847,934 | $ | 3,751,778 | $ | 9,322,983 | $ | 6,582,311 | ||||||||
| Cost of goods sold | 1,033,089 | 892,956 | 2,076,730 | 1,723,663 | ||||||||||||
| Gross profit | 3,814,845 | 2,858,822 | 7,246,253 | 4,858,648 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales, general, and administration | 6,865,442 | 5,537,164 | 13,029,054 | 10,566,661 | ||||||||||||
| Research and development | 24,190,714 | 8,234,641 | 42,367,549 | 14,142,719 | ||||||||||||
| Depreciation and amortization | 14,280 | 14,094 | 27,852 | 27,162 | ||||||||||||
| Total operating expense | 31,070,436 | 13,785,899 | 55,424,455 | 24,736,542 | ||||||||||||
| Operating loss | (27,255,591 | ) | (10,927,077 | ) | (48,178,202 | ) | (19,877,894 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Miscellaneous income | 25,585 | 18,579 | 44,098 | 37,151 | ||||||||||||
| Interest income | 2,560 | 9,238 | 12,402 | 18,392 | ||||||||||||
| Financing costs | — | — | — | (260,027 | ) | |||||||||||
| Total other income (expense) | 28,145 | 27,817 | 56,500 | (204,484 | ) | |||||||||||
| Loss before taxes | (27,227,446 | ) | (10,899,260 | ) | (48,121,702 | ) | (20,082,378 | ) | ||||||||
| Provision for income taxes | — | — | — | — | ||||||||||||
| Net loss | $ | (27,227,446 | ) | $ | (10,899,260 | ) | $ | (48,121,702 | ) | $ | (20,082,378 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.16 | ) | $ | (0.07 | ) | $ | (0.29 | ) | $ | (0.14 | ) | ||||
| Weighted average number of common shares outstanding | 172,782,264 | 145,485,505 | 168,734,760 | 145,253,818 | ||||||||||||
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||
| CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||
| (Unaudited) |
| Six Months Ended | ||||||||
| June 30, 2015 | June 30, 2014 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (48,121,702 | ) | $ | (20,082,378 | ) | ||
| Adjustments to reconcile net loss to net cash flows used in operating activities: | ||||||||
| Depreciation | 14,248 | 15,591 | ||||||
| Amortization of intangible assets | 13,604 | 11,570 | ||||||
| Provision for doubtful accounts | 30,767 | 1,393 | ||||||
| Stock based compensation | 2,052,549 | 2,268,599 | ||||||
| Amortization of deferred financing costs | — | 260,027 | ||||||
| Stock based expense for services | 916,262 | 481,024 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (1,190,068 | ) | (475,378 | ) | ||||
| Inventory | (66,606 | ) | (409,376 | ) | ||||
| Other current assets | 383,194 | (460,512 | ) | |||||
| Other assets | (12,410 | ) | (18,392 | ) | ||||
| Accounts payable | (508,511 | ) | 216,040 | |||||
| Deferred revenue | (522,613 | ) | (314,784 | ) | ||||
| Accrued expenses and other current liabilities | 2,047,264 | (271,771 | ) | |||||
| Other long-term liabilities | 967,286 | — | ||||||
| Net cash flows used in operating activities | (43,996,736 | ) | (18,778,347 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Patent costs | (78,792 | ) | (213,089 | ) | ||||
| Purchase of property and equipment | (15,559 | ) | (30,962 | ) | ||||
| Refund of security deposit | — | 10,686 | ||||||
| Net cash flows used in investing activities | (94,351 | ) | (233,365 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from sale of common stock, net of costs | 59,117,827 | — | ||||||
| Proceeds from exercise of options | 491,351 | 287,288 | ||||||
| Proceeds from exercise of warrants | 366,000 | 87,000 | ||||||
| Net cash flows provided by financing activities | 59,975,178 | 374,288 | ||||||
| Increase (decrease) in cash | 15,884,091 | (18,637,424 | ) | |||||
| Cash, beginning of period | 51,361,607 | 54,191,260 | ||||||
| Cash, end of period | $ | 67,245,698 | $ | 35,553,836 | ||||
| SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||||||||
| Cash paid for interest | $ | — | $ | — | ||||
| Cash paid for income taxes | $ | — | $ | — | ||||