Full Press Release Details
TherapeuticsMD, Inc. 8-K
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 -
- TherapeuticsMD Inc.
company, today announced its financial
results for the quarter ended June 30, 2014.
Quarter 2014 and Recent Developments
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."
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
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,
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.
Chief Financial Officer
| 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 |