TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced its fourth quarter and full-year financial results for the period ending Dec. 31, 2014.
2014 and recent corporate developments
- Net revenue increased to approximately $15.0 million in 2014 compared with approximately $8.8 million in the prior year, reflecting a 71 percent increase in product sales.
- Net loss was approximately $54.2 million in 2014 compared with approximately $28.4 million in the prior year, reflecting the company’s increased investment in clinical trials for two phase 3 pipeline products.
- The company initiated enrollment of patients in the phase 3 Rejoice Trial for TX-004HR, the VagiCap™ investigational softgel vaginal suppository for treatment of painful intercourse, a symptom of vulvar vaginal atrophy (VVA) due to menopause.
- The company continued enrollment of patients in the phase 3 Replenish Trial for TX-001HR, a novel investigational bio-identical estradiol-progesterone combination product candidate.
- The company’s intellectual property portfolio grew to include a current total of 93 patent filings, 55 of which were filed in international jurisdictions, and includes 11 U.S. patent allowances or issuances.
- The company completed the year with no outstanding debt and a cash balance of approximately $51.4 million, which was further strengthened by an equity offering in February 2015 that generated approximately $59.1 million in net proceeds.
“During 2014, we made significant advancements on both the commercial and R&D fronts, working toward our goal to build a leading women’s health company,” said TherapeuticsMD CEO Robert G. Finizio. “Our two lead pipeline programs continued to advance in phase 3 clinical trials, and sales from our current women’s health business grew at an impressive rate, which highlights the capabilities of our existing commercial infrastructure. We look forward to further advancing our pipeline this coming year, including completing enrollment in our phase 3 investigational combination therapy and VVA programs and delivering phase 3 results from the VVA program as planned.”
Summary of 2014 financial results
For the year ended Dec. 31, 2014, net revenue was approximately $15.0 million compared with approximately $8.8 million for the prior year. Revenue for the fourth quarter of 2014 was approximately $4.3 million compared with approximately $2.9 million in the prior year’s quarter, an increase of approximately 49 percent. Revenue growth during the fourth quarter and full-year of 2014 was primarily driven by increased sales of the company’s prenatal vitamin products, including the launch of new products and volume growth of existing products.
Cost of goods sold increased to approximately $3.7 million for the full-year 2014 compared with approximately $2.0 million for the prior year.
Total operating expenses for the fourth quarter of 2014 and full-year ended Dec. 31, 2014, included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D expenses for the full-year 2014 were approximately $43.2 million compared with approximately $13.6 million for 2013, reflecting the company’s investment in two ongoing phase 3 clinical trials for its novel hormone therapy products in development. R&D expenses in the fourth quarter of 2014 were approximately $14.2 million compared with approximately $5.8 million in the prior year’s quarter, primarily due to the addition of a second phase 3 trial to support the company’s pipeline. SG&A expenses for the full-year 2014 were approximately $22.1 million compared with approximately $19.0 million for 2013. SG&A expenses in the fourth quarter of 2014 were approximately $5.5 million compared with approximately $4.6 million for the fourth quarter of 2013.
Non-operating income for the full-year 2014 included miscellaneous and interest income of approximately $84,000, offset by financing costs of approximately $260,000.
Net operating loss for the full-year 2014 was approximately $54.2 million or $0.36 per basic and diluted share, compared with approximately $28.4 million or $0.22 per basic and diluted share for 2013. Net operating loss in the fourth quarter of 2014 was approximately $16.3 million or $0.10 per basic and diluted share, compared with approximately $8.4 million or $0.06 per basic and diluted share for 2013.
At Dec. 31, 2014, TherapeuticsMD had cash on hand of approximately $51.4 million, compared with approximately $54.2 million at Dec. 31, 2013. In February 2015, the company completed a public offering of shares of its common stock for net proceeds of approximately $59.1 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 include:
Date: | March 10, 2015 | ||||||||||
Time: | 4:30 p.m. EDT | ||||||||||
Telephone Access (US): | 866-665-9531 | ||||||||||
Telephone Access (International): | 724-987-6977 | ||||||||||
Access Code for All Callers: | 91862074 |
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 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 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.
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||
| CONSOLIDATED BALANCE SHEETS | |||||||||
| December 31, | |||||||||
| 2014 | 2013 | ||||||||
| ASSETS | |||||||||
| Current Assets: | |||||||||
| Cash | $ | 51,361,607 | $ | 54,191,260 | |||||
| Accounts receivable, net of allowance for doubtful accounts | |||||||||
| of $21,119 and $26,555, respectively | 2,154,217 | 1,690,753 | |||||||
| Inventory | 1,182,113 | 1,043,618 | |||||||
| Other current assets | 1,537,407 | 2,477,715 | |||||||
| Total current assets | 56,235,344 | 59,403,346 | |||||||
| Fixed assets, net | 63,293 | 61,318 | |||||||
| Other Assets: | |||||||||
| Prepaid expense | 1,427,263 | 1,750,455 | |||||||
| Intangible assets | 1,228,588 | 665,588 | |||||||
| Security deposit | 125,000 | 135,686 | |||||||
| Total other assets | 2,780,851 | 2,551,729 | |||||||
| Total assets | $ | 59,079,488 | $ | 62,016,393 | |||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
| Current Liabilities: | |||||||||
| Accounts payable | $ | 6,327,129 | $ | 2,114,217 | |||||
| Deferred revenue | 522,613 | 1,602,580 | |||||||
| Other current liabilities | 3,840,639 | 3,601,189 | |||||||
| Total current liabilities | 10,690,381 | 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; | |||||||||
| 156,097,019 and 144,976,757 issued and outstanding, respectively | 156,097 | 144,977 | |||||||
| Additional paid in capital | 182,982,846 | 135,086,056 | |||||||
| Accumulated deficit | (134,749,836 | ) | (80,532,626 | ) | |||||
| Total stockholders' equity | 48,389,107 | 54,698,407 | |||||||
| Total liabilities and stockholders' equity | $ | 59,079,488 | $ | 62,016,393 | |||||
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||||
| Three Months Ended | |||||||||||||||||||||
| December 31, | Year Ended December 31, | ||||||||||||||||||||
| 2014 | 2013 | 2014 | 2013 | 2012 | |||||||||||||||||
| Revenues, net | $ | 4,257,647 | $ | 2,862,798 | $ | 15,026,219 | $ | 8,775,598 | $ | 3,818,013 | |||||||||||
| Cost of goods sold | 879,535 | 467,242 | 3,671,803 | 1,959,597 | 1,348,113 | ||||||||||||||||
| - | |||||||||||||||||||||
| Gross profit | 3,378,112 | 2,395,556 | 11,354,416 | 6,816,001 | 2,469,900 | ||||||||||||||||
| Operating expenses: | |||||||||||||||||||||
| Sales, general, and administrative | 5,514,057 | 4,558,998 | 22,124,072 | 19,014,837 | 14,069,701 | ||||||||||||||||
| Research and development | 14,166,789 | 5,840,717 | 43,218,938 | 13,551,263 | 4,492,362 | ||||||||||||||||
| Depreciation and amortization | 12,558 | 7,196 | 52,467 | 58,145 | 56,260 | ||||||||||||||||
| - | - | ||||||||||||||||||||
| Total operating expense | 19,693,404 | 10,406,911 | 65,395,477 | 32,624,245 | 18,618,323 | ||||||||||||||||
| Operating loss | (16,315,292 | ) | (8,011,355 | ) | (54,041,061 | ) | (25,808,244 | ) | (16,148,423 | ) | |||||||||||
| Other income and (expense) | - | ||||||||||||||||||||
| Miscellaneous income | 3,158 | 19,100 | 46,569 | 34,544 | 3,001 | ||||||||||||||||
| Interest income | 9,553 | 9,101 | 37,309 | 27,234 | - | ||||||||||||||||
| Financing costs | - | (337,941 | ) | (260,027 | ) | (1,503,922 | ) | - | |||||||||||||
| Interest expense | - | (58,044 | ) | - | (1,165,981 | ) | (1,905,409 | ) | |||||||||||||
| Loan guaranty costs | - | - | - | (2,944 | ) | (45,036 | ) | ||||||||||||||
| Loss on extinguishment of debt | - | - | - | - | (10,307,864 | ) | |||||||||||||||
| Beneficial conversion feature | - | - | - | - | (6,716,504 | ) | |||||||||||||||
| Total other income (expense) | 12,711 | 367,784 | (176,149 | ) | (2,611,069 | ) | (18,971,812 | ) | |||||||||||||
| - | |||||||||||||||||||||
| Loss before taxes | (16,302,581 | ) | (8,379,139 | ) | (54,217,210 | ) | (28,419,313 | ) | (35,120,235 | ) | |||||||||||
| Provision for income taxes | - | - | - | - | - | ||||||||||||||||
| Net loss | $ | (16,302,581 | ) | $ | (8,379,139 | ) | $ | (54,217,210 | ) | $ | (28,419,313 | ) | $ | (35,120,235 | ) | ||||||
| Net loss per share, basic and diluted | $ | (0.10 | ) | $ | (0.06 | ) | $ | (0.36 | ) | $ | (0.22 | ) | $ | (0.38 | ) | ||||||
| Weighted average number of common | |||||||||||||||||||||
| shares outstanding | 156,054,938 | 144,983,681 | 149,727,228 | 127,569,731 | 91,630,693 | ||||||||||||||||
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||||||
| CONSOLIDATED STATEMENTS OF STOCKHOLDERS' (DEFICIT) EQUITY | |||||||||||||||||
| FOR THE YEARS ENDED DECEMBER 31, 2014, 2013 AND 2012 | |||||||||||||||||
| Additional | |||||||||||||||||
| Common Stock | Paid in | Accumulated | |||||||||||||||
| Shares | Amount | Capital | Deficit | Total | |||||||||||||
| Balance, December 31, 2011 | 82,978,804 | 82,979 | 15,198,241 | (16,993,078 | ) | (1,711,858 | ) | ||||||||||
| Shares issued in private placement, net of cost | 3,953,489 | 3,954 | 7,891,531 | - | 7,895,485 | ||||||||||||
| Shares issued in exchange for debt | 2,775,415 | 2,775 | 1,051,882 | - | 1,054,657 | ||||||||||||
| Shares issued for exercise of options | 1,931,788 | 1,932 | 189,068 | - | 191,000 | ||||||||||||
| Shares issued for exercise of warrants | 8,145,486 | 8,145 | 3,093,855 | - | 3,102,000 | ||||||||||||
| Employee share based compensation | - | - | 1,832,061 | - | 1,832,061 | ||||||||||||
| Warrants issued for financing costs | - | - | 13,014,784 | - | 13,014,784 | ||||||||||||
| Warrants issued for services | - | - | 1,563,620 | - | 1,563,620 | ||||||||||||
| Warrants issued as compensation-related party | - | - | 36,284 | - | 36,284 | ||||||||||||
| Warrants issued for cash | - | - | 400 | - | 400 | ||||||||||||
| Cancellation of warrants issued for loan guaranty costs-related parties | - | - | (7,830 | ) | - | (7,830 | ) | ||||||||||
| Beneficial ownership feature | - | - | 6,716,504 | - | 6,716,504 | ||||||||||||
| Net loss | - | - | - | (35,120,235 | ) | (35,120,235 | ) | ||||||||||
| Balance, December 31, 2012 | 99,784,982 | 99,785 | 50,580,400 | (52,113,313 | ) | (1,433,128 | ) | ||||||||||
| Shares issued in private placements, net of cost | 45,116,352 | 45,117 | 78,605,236 | - | 78,650,353 | ||||||||||||
| Shares issued for exercise of options | 75,423 | 75 | 30,835 | - | 30,910 | ||||||||||||
| Employee share based compensation | - | - | 3,170,954 | - | 3,170,954 | ||||||||||||
| Non-employee share based compensation | - | - | 83,129 | - | 83,129 | ||||||||||||
| Warrants issued for financing costs | - | - | 1,711,956 | - | 1,711,956 | ||||||||||||
| Warrants issued for services | - | - | 867,262 | - | 867,262 | ||||||||||||
| Warrants issued as compensation-related party | - | - | 36,284 | - | 36,284 | ||||||||||||
| Net loss | - | - | - | (28,419,313 | ) | (28,419,313 | ) | ||||||||||
| Balance, December 31, 2013 | 144,976,757 | 144,977 | 135,086,056 | (80,532,626 | ) | 54,698,407 | |||||||||||
| Shares issued in private placements, net of cost | 9,850,106 | 9,850 | 42,761,503 | - | 42,771,353 | ||||||||||||
| Shares issued for exercise of options | 854,573 | 855 | 344,891 | - | 345,746 | ||||||||||||
| Shares issued for exercise of warrants | 365,583 | 365 | 180,635 | - | 181,000 | ||||||||||||
| Shares issued for exercise of restricted stock units | 50,000 | 50 | (50 | ) | - | - | |||||||||||
| Employee share based compensation | - | - | 4,239,358 | - | 4,239,358 | ||||||||||||
| Non-employee share based compensation | - | - | 370,453 | - | 370,453 | ||||||||||||
| Net loss | - | - | - | (54,217,210 | ) | (54,217,210 | ) | ||||||||||
| Balance, December 31, 2014 | 156,097,019 | $ | 156,097 | $ | 182,982,846 | $ | (134,749,836 | ) | $ | 48,389,107 | |||||||
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||
| CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||||||
| Year Ended December, 31, | |||||||||||||
| 2014 | 2013 | 2012 | |||||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||||||
| Net loss | $ | (54,217,210 | ) | $ | (28,419,313 | ) | $ | (35,120,235 | ) | ||||
| Adjustments to reconcile net loss to | |||||||||||||
| net cash flows used in | |||||||||||||
| operating activities: | |||||||||||||
| Depreciation | 28,987 | 47,883 | 27,484 | ||||||||||
| Amortization of intangible assets | 23,480 | 10,262 | 28,776 | ||||||||||
| Provision for doubtful accounts | (5,436 | ) | (15,493 | ) | 40,548 | ||||||||
| Loss on extinguishment of debt | - | - | 10,307,864 | ||||||||||
| Beneficial conversion feature | - | - | 6,716,504 | ||||||||||
| Amortization of debt discount | - | 1,102,680 | 1,604,240 | ||||||||||
| Stock based compensation | 4,239,358 | 3,207,238 | 1,868,345 | ||||||||||
| Amortization of deferred financing costs | 260,027 | 1,451,934 | - | ||||||||||
| Stock based expense for services | 730,954 | 636,917 | 338,457 | ||||||||||
| Loan guaranty costs | - | 2,944 | 45,036 | ||||||||||
| Changes in operating assets and liabilities: | |||||||||||||
| Accounts receivable | (458,028 | ) | (1,068,619 | ) | (728,253 | ) | |||||||
| Inventory | (138,495 | ) | 571,592 | (1,027,137 | ) | ||||||||
| Other current assets | 680,281 | (1,386,319 | ) | 42,281 | |||||||||
| Other assets | (37,309 | ) | (565,706 | ) | - | ||||||||
| Accounts payable | 4,212,912 | 472,851 | 1,334,855 | ||||||||||
| Deferred revenue | (1,079,967 | ) | 457,828 | 1,144,752 | |||||||||
| Accrued expenses and other current liabilities | 239,450 | 2,875,320 | 639,157 | ||||||||||
| Other liabilities | - | (150,068 | ) | - | |||||||||
| Net cash flows used in operating activities | (45,520,996 | ) | (20,768,069 | ) | (12,737,326 | ) | |||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | |||||||||||||
| Patent costs, net of abandoned costs | (586,480 | ) | (439,034 | ) | (206,101 | ) | |||||||
| Purchase of property and equipment | (30,962 | ) | (40,790 | ) | (66,405 | ) | |||||||
| Refund (payment) of security deposit | 10,686 | (103,737 | ) | - | |||||||||
| Net cash flows used in investing activities | (606,756 | ) | (583,561 | ) | (272,506 | ) | |||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||||||
| Proceeds from sale of common stock, net of costs | 42,771,353 | 78,650,353 | 7,895,485 | ||||||||||
| Proceeds from exercise of options | 345,746 | 30,910 | 191,000 | ||||||||||
| Proceeds from exercise of warrants | 181,000 | - | - | ||||||||||
| Proceeds from notes and loans payable | - | - | 8,700,000 | ||||||||||
| Proceeds bank line of credit | - | 500,000 | - | ||||||||||
| Proceeds from sale of warrants | - | - | 400 | ||||||||||
| Repayment of bank line of credit | - | (500,000 | ) | (300,000 | ) | ||||||||
| Repayment of notes payable-related party | - | - | (200,000 | ) | |||||||||
| Repayment of notes payable | - | (4,691,847 | ) | (1,850,000 | ) | ||||||||
| Net cash flows provided by financing activities | 43,298,099 | 73,989,416 | 14,436,885 | ||||||||||
| Increase in cash | (2,829,653 | ) | 52,637,786 | 1,427,053 | |||||||||
| Cash, beginning of period | 54,191,260 | 1,553,474 | 126,421 | ||||||||||
| Cash, end of period | $ | 51,361,607 | $ | 54,191,260 | $ | 1,553,474 | |||||||
| SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | |||||||||||||
| Cash paid for interest | $ | - | $ | 212,853 | $ | 17,253 | |||||||
| Cash paid for income taxes | $ | - | $ | - | $ | - | |||||||
| SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES: | |||||||||||||
| Warrants issued for financing | $ | - | $ | 1,711,956 | $ | 2,509,537 | |||||||
| Warrants issued for services | $ | - | $ | 462,196 | $ | 1,532,228 | |||||||
| Warrants exercised in exchange for debt and accrued interest | $ | - | $ | - | $ | 3,102,000 | |||||||
| Shares issued in exchange for debt and accrued interest | $ | - | $ | - | $ | 1,054,658 | |||||||
| Notes payable issued for accrued interest | $ | - | $ | - | $ | 15,123 | |||||||
Contacts:
Investors:
Dan Cartwright, 561-961-1900
Chief
Financial Officer
Dan.Cartwright@TherapeuticsMD.com
or
Media:
Julia
Amadio, 561-961-1900
Chief Product Officer
Julia.Amadio@TherapeuticsMD.com
