Full Press Release Details
TherapeuticsMD, Inc. 8-K
TherapeuticsMD Announces First Quarter
2017 Financial Results
BOCA RATON, Fla. - May 2, 2017 -
TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women's healthcare company, today announced its financial results for
the quarter ended March 31, 2017.
First Quarter and Recent Developments
| - | Net revenue for the company's prescription prenatal vitamin business was approximately $4.0 million for the first quarter of 2017 compared with approximately $4.9 million for the first quarter of 2016. | |
| - | Net loss was approximately $21.2 million for the first quarter of 2017, compared with approximately $20.9 million for the first quarter of 2016. | |
| - | Ended the quarter with approximately $113.5 million in cash and no debt. | |
| - | Anticipate FDA action on the New Drug Application (NDA) for TX-004HR on or before the originally scheduled Prescription Drug User Fee Act (PDUFA) target action date of May 7, 2017. TX-004HR is the company's investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. | |
| - | Presented two posters at ENDO 2017 reviewing data from the Replenish Trial, a phase 3 clinical trial of TX-001HR, the company's investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause. The results from the trial in 1,835 postmenopausal women demonstrated that multiple doses of TX-001HR resulted in a statistically significant and clinically meaningful reduction from baseline in both the frequency and severity of hot flashes compared to placebo. The company plans to submit the NDA for TX-001HR as early as the third quarter of 2017. | |
| - | Launched BIO-IGNITE TM , an outreach program to quantify the number of compounded bio-identical estradiol and progesterone prescriptions currently dispensed by the 3,000-3,500 high-volume compounding pharmacies and qualify their interests in distributing the company's bio-identical hormone product candidates, if approved. Through the BIO-IGNITE TM program, the company currently has a distribution agreement with Premier Value Pharmacy Compounding Network (PVPCN), representing over 300 pharmacies and 1.5 million annual prescriptions of compounded bio-identical estradiol and progesterone (E+P), to dispense the company's products in lieu of compounding, if approved. The company has also received prescription data from over 400 additional pharmacies, representing over 500,000 annual prescriptions of compounded bio-identical E+P. | |
| - | Grew the company's intellectual property portfolio to a current total of 158 patent filings, including 82 international filings, with one allowed and 17 issued U.S. patents. |
"We are focused on advancing our pipeline of novel hormone
therapies and, if approved, bringing new, differentiated treatment options to women suffering from symptoms of menopause,"
said TherapeuticsMD CEO Robert G. Finizio.
Summary of First Quarter 2017
Net revenue from the company's prescription prenatal vitamin
business was approximately $4.0 million for the first quarter of 2017 compared with net revenue of approximately $4.9 million for
the prior year's quarter. These changes were primarily due to a decrease in the average
net sales price of our products, partially offset by an increase in the number of units sold.
Cost of goods sold was approximately
$0.7 million for the first quarter of 2017, compared with approximately $1.1 million in the prior year's quarter.
Total operating expenses for the first quarter of 2017 included
research and development (R&D) expenses and sales, general, and administrative expenses (SG&A). R&D expenses during
the first quarter of 2017 were approximately $7.7 million compared with approximately $15.1 million for the prior year's
quarter. The decrease in R&D was a direct result of the completion of the Replenish Trial for TX-001HR. SG&A expenses for
the first quarter of 2017 were approximately $16.8 million compared with approximately $9.7 million for the prior year's
quarter, primarily due to higher sales, marketing, regulatory expenditures, and personnel
costs to support future commercialization.
Net loss for the first quarter of 2017 was approximately $21.2 million,
or $0.11 per basic and diluted share, compared with approximately $20.9 million, or $0.11 per basic and diluted share, for the
first quarter of 2016.
At March 31, 2017, cash on hand was approximately $113.5 million,
compared with approximately $131.5 million at December 31, 2016.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative healthcare company focused
on developing and commercializing products exclusively for women. With its 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 late stage clinical pipeline includes two phase 3 product candidates: TX-001HR
for treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause and TX-004HR for treatment of moderate-to-severe
vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The company
also manufactures and distributes branded and generic prescription prenatal vitamins under the vitaMedMD and BocaGreenMD
Forward-Looking Statements
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
resolve the deficiencies identified by the FDA in the company's NDA for its TX-004HR product candidate; whether the FDA
will approve the company's new drug application for its TX-004HR product candidate and whether any such approval will occur
by the PDUFA date; 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; whether the company
will be able to prepare an NDA for its TX-001HR product candidate and, if prepared, whether the FDA will accept and approve the
NDA; 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.
Director, Investor Relations
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| March 31, 2017 | December 31, 2016 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 113,525,419 | $ | 131,534,101 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $374,771 and $376,374, respectively | 3,921,359 | 4,500,699 | ||||||
| Inventory | 1,338,618 | 1,076,321 | ||||||
| Other current assets | 2,488,121 | 2,299,052 | ||||||
| Total current assets | 121,273,517 | 139,410,173 | ||||||
| Fixed assets, net | 511,073 | 516,839 | ||||||
| Other Assets: | ||||||||
| Intangible assets, net | 2,497,360 | 2,405,972 | ||||||
| Security deposit | 139,036 | 139,036 | ||||||
| Total other assets | 2,636,396 | 2,545,008 | ||||||
| Total assets | $ | 124,420,986 | $ | 142,472,020 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 6,146,278 | $ | 7,358,514 | ||||
| Other current liabilities | 7,940,723 | 7,624,085 | ||||||
| Total current liabilities | 14,087,001 | 14,982,599 | ||||||
| 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 shares authorized: | ||||||||
| 198,593,268 and 196,688,222 issued and outstanding, respectively | 198,593 | 196,688 | ||||||
| Additional paid-in capital | 441,025,624 | 436,995,052 | ||||||
| Accumulated deficit | (330,890,232 | ) | (309,702,319 | ) | ||||
| Total stockholders' equity | 110,333,985 | 127,489,421 | ||||||
| Total liabilities and stockholders' equity | $ | 124,420,986 | $ | 142,472,020 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended | ||||||||
| March 31, 2017 | March 31, 2016 | |||||||
| Revenues, net | $ | 3,985,464 | $ | 4,930,091 | ||||
| Cost of goods sold | 659,635 | 1,108,443 | ||||||
| Gross profit | 3,325,829 | 3,821,648 | ||||||
| Operating expenses: | ||||||||
| Sales, general, and administrative | 16,837,617 | 9,678,552 | ||||||
| Research and development | 7,724,840 | 15,097,017 | ||||||
| Depreciation and amortization | 49,699 | 19,597 | ||||||
| Total operating expenses | 24,612,156 | 24,795,166 | ||||||
| Operating loss | (21,286,327 | ) | (20,973,518 | ) | ||||
| Other income | ||||||||
| Miscellaneous income | 125,968 | 41,617 | ||||||
| Accreted interest | 3,867 | 2,536 | ||||||
| Total other income | 129,835 | 44,153 | ||||||
| Loss before income taxes | (21,156,492 | ) | (20,929,365 | ) | ||||
| Provision for income taxes | - | - | ||||||
| Net loss | $ | (21,156,492 | ) | $ | (20,929,365 | ) | ||
| Loss per share, basic and diluted: | ||||||||
| Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.11 | ) | ||
| Weighted average number of common | ||||||||
| shares outstanding, basic and diluted | 197,790,040 | 194,901,560 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH
| Three Months Ended | ||||||||
| March 31, 2017 | March 31, 2016 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (21,156,492 | ) | $ | (20,929,365 | ) | ||
| Adjustments to reconcile net loss to net cash used in | ||||||||
| operating activities: | ||||||||
| Depreciation | 33,600 | 8,363 | ||||||
| Amortization of intangible assets | 16,099 | 11,234 | ||||||
| (Recovery of) provision for doubtful accounts | (1,603 | ) | 236,151 | |||||
| Share-based compensation | 1,413,195 | 4,381,690 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | 580,943 | (2,250,209 | ) | |||||
| Inventory | (262,297 | ) | (267,281 | ) | ||||
| Other current assets | (253,518 | ) | 477,312 | |||||
| Other assets | - | (2,536 | ) | |||||
| Accounts payable | (1,212,236 | ) | 304,475 | |||||
| Other current liabilities | 316,638 | (1,373,762 | ) | |||||
| Net cash used in operating activities | (20,525,671 | ) | (19,403,928 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Patent costs | (107,487 | ) | (90,529 | ) | ||||
| Purchase of fixed assets | (27,834 | ) | (74,478 | ) | ||||
| Net cash used in investing activities | (135,321 | ) | (165,007 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from sale of common stock, net of costs | - | 134,863,475 | ||||||
| Proceeds from exercise of options | 192,310 | 786,450 | ||||||
| Proceeds from exercise of warrants | 2,460,000 | 1,310,000 | ||||||
| Net cash provided by financing activities | 2,652,310 | 136,959,925 | ||||||
| (Decrease) increase in cash | (18,008,682 | ) | 117,390,990 | |||||
| Cash, beginning of period | 131,534,101 | 64,706,355 | ||||||
| Cash, end of period | $ | 113,525,419 | $ | 182,097,345 |