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, 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) 961-1911
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 2.02. Results of Operations and Financial Condition.
On August 6, 2014, TherapeuticsMD, Inc. issued a press release announcing its results of operations for its second fiscal quarter ended June 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.
| (a) | Exhibits | ||
| Exhibit | |||
| Number | Description | ||
| 99.1 | Press Release from TherapeuticsMD, Inc., dated August 6, 2014, entitled “TherapeuticsMD Announces Second Quarter 2014 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, 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 August 6, 2014, entitled “TherapeuticsMD Announces Second Quarter 2014 Financial Results.” |
Exhibit 99.1
FOR IMMEDIATE RELEASE
THERAPEUTICSMD ANNOUNCES SECOND QUARTER 2014 FINANCIAL RESULTS
– Company Significantly Strengthens Cash Balance with Recent Equity Offering –
– Combination and VVA Hormone Therapy Programs Advancing on Schedule –
– Management to Host Conference Call Today at 4:30 p.m. EDT –
Boca Raton, FL – August 6, 2014 – TherapeuticsMD Inc. (NYSE MKT: TXMD), a women’s healthcare company, today announced its financial results for the quarter ended June 30, 2014.
Second Quarter 2014 and Recent Developments
| · | Net revenue increased to $3.8 million from $2.1 million for the prior year’s quarter |
| · | Net loss was $10.9 million compared with $6.0 million for the prior year’s quarter |
| · | Received notification of issuance for two additional patents regarding combination hormone therapies generated by the company’s SYMBODA™ technology |
| · | Received positive input from FDA regarding advancement of the phase 3 study for TX-004HR (VagiCap™), the first softgel vaginal suppository for treatment of vulvar vaginal atrophy (“VVA”) |
| · | Ended the quarter with $35.6 million in cash and recently completed $46 million equity offering |
“During the second quarter, we continued recruitment in the ongoing REPLENISH™ phase 3 study for our combination hormone therapy pill, engaged a contract research organization to start up our phase 3 study of VagiCap in the VVA indication, and strengthened our intellectual property position with notification of two new patent allowances,” said TherapeuticsMD CEO Robert G. Finizio. “More recently, we’ve solidified our cash position through a recent equity offering, providing us with additional resources to advance our ongoing programs and support our earlier stage pipeline, including novel transdermal product opportunities that leverage our proprietary SYMBODA technology.”
Summary of Financial Results
For the second quarter of 2014, net revenue was $3.8 million compared with $2.1 million during the prior year period. This increase was largely driven by continued growth of the company’s current women’s health products, including the launch of additional prenatal vitamin products.
Cost of goods sold increased to $0.9 million for the second quarter of 2014 compared with $0.5 million for the prior year quarter.
Total operating expenses for the second quarter of 2014 were $13.8 million, compared with $7.2 million for the prior year quarter. The increase was primarily due to higher research and development (R&D) expenses related to late-stage clinical trials for hormone therapy product candidates. R&D expenses for the second quarter of 2014 were $8.2 million, including clinical costs associated with multiple phase 3 clinical development programs, compared to $1.7 million for the prior year quarter. Sales, general and administration expenses for the quarter were $5.5 million, relatively flat compared with the prior year quarter.
Net loss was $10.9 million for the second quarter of 2014, or $0.07 per basic and diluted share, compared with $6.0 million, or $0.05 per basic and diluted share, in the prior year quarter.
At June 30, 2014, TherapeuticsMD had cash of approximately $35.6 million, compared to approximately $54.2 million at December 31, 2013. The company recently completed a public offering of shares of its common stock
for gross proceeds of approximately $46 million. The proceeds will be used toward development of the company’s late-stage pipeline of novel hormone therapies and to support advancement of its earlier stage and preclinical programs.
As of August 4, 2014, there were 155,807,765 shares of the company's common stock outstanding.
Conference Call Today
As previously announced, TherapeuticsMD will host a conference today to discuss these financial results and provide a business update which may include forward-looking statements. Details for the conference call include:
| Date | August 6, 2014 |
| Time | 4:30pm EDT |
| Telephone access: U.S. and Canada | 866-665-9531 |
| Telephone access: International | 724-987-6977 |
| Access code for all callers | 81301505 |
| Live audio webcast |
www.therapeuticsmd.com See Events and Presentations on Investors tab
|
About TherapeuticsMD
TherapeuticsMD Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. TherapeuticsMD is developing advanced hormone therapy pharmaceutical products based on novel technologies that enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. 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.
Except for the historical information contained herein, the matters set forth in this press release, including statements relating to future events or performance, including statements regarding the company’s performance; the significantly strengthened cash balance; the combination and VVA therapy programs advancing on schedule; the receipt of additional patents generated by the company’s SYMBODA technology; positive input from FDA regarding advancement of phase 3 study for VagiCap; the continued recruitment in the ongoing REPLENISH phase 3 study; the engagement of a contract research organization for phase 3 study of VagiCap; the strengthening of the company’s intellectual property position; the solidification of the company’s cash position; the advancement of the company’s ongoing programs or support the company’s early stage pipeline, including novel transdermal product opportunities that leverage SYMBODA technology; the increase in sales driven by continued growth of the company’s current women’s health products; the launch of additional prenatal vitamins; the impact of development of the company’s late-stage pipeline of novel hormone therapies or advancement of the company’s early stage and preclinical programs are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including but not limited to: timely and successful completion of clinical studies and the results thereof; challenges and costs inherent in product marketing; the risks and uncertainties associated with economic and market conditions; risks and uncertainties associated with the company’s business and finances in general; and other risks detailed in the company’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K filed on March 5, 2014, reports on Form 10-Q and Form 8-K, and other such filings. These forward-looking statements are based on current information that may change. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
# # #
Contacts:
For Investors:
Dan Cartwright
Chief Financial Officer
561-961-1900
Dan.Cartwright@TherapeuticsMD.com
For Media:
Julia Amadio
Chief Product Officer
561-961-1900
Julia.Amadio@TherapeuticsMD.com
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||
| June 30, 2014 | December 31, 2013 | |||||||||
| (Unaudited) | ||||||||||
| ASSETS | ||||||||||
| Current Assets: | ||||||||||
| Cash | $ | 35,553,836 | $ | 54,191,260 | ||||||
| Accounts receivable, net of allowance for doubtful accounts of $27,948 and $26,555, respectively | 2,164,738 | 1,690,753 | ||||||||
| Inventory | 1,452,994 | 1,043,618 | ||||||||
| Other current assets | 2,678,200 | 2,477,715 | ||||||||
| Total current assets | 41,849,768 | 59,403,346 | ||||||||
| Fixed assets, net | 76,689 | 61,318 | ||||||||
| Other Assets: | ||||||||||
| Prepaid expense | 1,511,549 | 1,750,455 | ||||||||
| Intangible assets | 867,107 | 665,588 | ||||||||
| Security deposit | 125,000 | 135,686 | ||||||||
| Total other assets | 2,503,656 | 2,551,729 | ||||||||
| Total assets | $ | 44,430,113 | $ | 62,016,393 | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||
| Current Liabilities: | ||||||||||
| Accounts payable | $ | 2,330,257 | $ | 2,114,217 | ||||||
| Deferred revenue | 1,287,796 | 1,602,580 | ||||||||
| Other current liabilities | 3,329,418 | 3,601,189 | ||||||||
| Total current liabilities | 6,947,471 | 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; 145,926,973 and 144,976,757 issued and outstanding, respectively | 145,927 | 144,977 | ||||||||
| Additional paid-in capital | 137,951,719 | 135,086,056 | ||||||||
| Accumulated deficit | (100,615,004 | ) | (80,532,626 | ) | ||||||
| Total stockholder’ equity | 37,482,642 | 54,698,407 | ||||||||
| Total liabilities and stockholders’ equity | $ | 44,430,113 | $ | 62,016,393 | ||||||
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||||
| June 30, | June 30, | |||||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||||
| Revenues, net | $ | 3,751,778 | $ | 2,080,885 | $ | 6,582,311 | $ | 3,618,080 | ||||||||||
| Cost of goods sold | 892,956 | 463,606 | 1,723,663 | 843,952 | ||||||||||||||
| Gross profit | 2,858,822 | 1,617,279 | 4,858,648 | 2,774,128 | ||||||||||||||
| Operating expenses: | ||||||||||||||||||
| Sales, general, and administration | 5,537,164 | 5,476,553 | 10,566,661 | 10,003,135 | ||||||||||||||
| Research and development | 8,234,641 | 1,747,084 | 14,142,719 | 3,312,285 | ||||||||||||||
| Depreciation and amortization | 14,094 | 10,636 | 27,162 | 18,593 | ||||||||||||||
| Total operating expense | 13,785,899 | 7,234,273 | 24,736,542 | 13,334,013 | ||||||||||||||
| Operating loss | (10,927,077 | ) | (5,616,994 | ) | (19,877,894 | ) | (10,559,885 | ) | ||||||||||
| Other income (expense): | ||||||||||||||||||
| Miscellaneous income | 18,579 | 3,479 | 37,151 | 3,479 | ||||||||||||||
| Interest income | 9,238 | — | 18,392 | — | ||||||||||||||
| Interest expense | — | (150 | ) | — | (1,165,981 | ) | ||||||||||||
| Financing costs | — | (395,981 | ) | (260,027 | ) | (659,968 | ) | |||||||||||
| Loan guaranty costs | — | — | — | (2,944 | ) | |||||||||||||
| Total other income (expense) | 27,817 | (392,652 | ) | (204,484 | ) | (1,825,414 | ) | |||||||||||
| Loss before taxes | (10,899,260 | ) | (6,009,646 | ) | (20,082,378 | ) | (12,385,299 | ) | ||||||||||
| Provision for income taxes | — | — | — | — | ||||||||||||||
| Net loss | $ | (10,899,260 | ) | $ | (6,009,646 | ) | $ | (20,082,378 | ) | $ | (12,385,299 | ) | ||||||
| Loss per share, basic and diluted: | ||||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.07 | ) | $ | (0.05 | ) | $ | (0.14 | ) | $ | (0.11 | ) | ||||||
| Weighted average number of common shares outstanding | 145,485,505 | 130,851,978 | 145,253,818 | 116,866,764 | ||||||||||||||
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||||
| Six Months Ended | ||||||||||
| June 30, | ||||||||||
| 2014 | 2013 | |||||||||
| (Unaudited) | (Unaudited) | |||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||
| Net loss | $ | (20,082,378 | ) | $ | (12,385,299 | ) | ||||
| Adjustments to reconcile net loss to net cash flows used in operating activities: | ||||||||||
| Depreciation | 15,591 | 12,084 | ||||||||
| Amortization of intangible assets | 11,570 | 6,509 | ||||||||
| Provision for doubtful accounts | 1,393 | 58,337 | ||||||||
| Stock based compensation | 2,268,599 | 1,179,912 | ||||||||
| Stock based expense for services | 481,024 | 637,155 | ||||||||
| Amortization of deferred financing costs | 260,027 | 659,938 | ||||||||
| Amortization of debt discount | — | 1,102,680 | ||||||||
| Loan guaranty costs | — | 2,944 | ||||||||
| Changes in operating assets and liabilities: | ||||||||||
| Accounts receivable | (475,378 | ) | (409,475 | ) | ||||||
| Inventory | (409,376 | ) | 109,151 | |||||||
| Other current assets | (460,512 | ) | (1,696,551 | ) | ||||||
| Other assets | (18,392 | ) | (899,000 | ) | ||||||
| Accounts payable | 216,040 | 403,750 | ||||||||
| Deferred revenue | (314,784 | ) | 74,320 | |||||||
| Accrued expenses and other current liabilities | (271,771 | ) | 458,792 | |||||||
| Net cash flows used in operating activities | (18,778,347 | ) | (10,684,753 | ) | ||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||
| Patent and trademark costs, net of abandoned costs | (213,089 | ) | (112,192 | ) | ||||||
| Purchase of property and equipment | (30,962 | ) | (22,905 | ) | ||||||
| Refund (payment) of security deposit | 10,686 | (125,000 | ) | |||||||
| Net cash flows used in investing activities | (233,365 | ) | (260,097 | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||
| Proceeds from exercise of options | 287,288 | 6,231 | ||||||||
| Proceeds from exercise of warrants | 87,000 | — | ||||||||
| Proceeds from sale of common stock, net | — | 48,512,460 | ||||||||
| 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 | 374,288 | 43,826,844 | ||||||||
| (Decrease) increase in cash | (18,637,424 | ) | 32,881,994 | |||||||
| Cash, beginning of period | 54,191,260 | 1,553,474 | ||||||||
| Cash, end of period | 35,553,836 | 34,435,468 | ||||||||
| 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 | ||||||