Full Press Release Details
THERAPEUTICSMD, INC. 8-K
Announces Fourth Quarter and Full Year 2017 Financial Results
PDUFA target action date of May 29, 2018 for TX-004HR -
Acceptance of New Drug Application for TX-001HR expected in March 2018 -
RATON, Fla. - February 20, 2018 - TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women's healthcare
company, today announced its fourth quarter and full-year financial results for 2017.
and Recent Developments
the New Drug Application (NDA) for TX-004HR, 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, on November 29, 2017. The Food and Drug Administration (FDA) has acknowledged that the resubmission
is a complete, class 2 response to the Complete Response Letter (CRL) received on May 5, 2017 for TX-004HR. The PDUFA target action
date for the completion of the FDA's review of the NDA is May 29, 2018.
five oral abstracts at NAMS 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 submitted the NDA for TX-001HR on December 28, 2017.
revenue for the company's prescription prenatal vitamin business was approximately $16.8 million for 2017 compared with
approximately $19.4 million for 2016.
loss was approximately $76.9 million for 2017, compared with approximately $89.9 million for 2016.
the year with approximately $127.1 million in cash and no debt, which includes approximately $68.6 million in net proceeds from
an equity offering in September 2017.
the company's intellectual property portfolio to a current total of 211 patent filings, including 123 international filings,
with one allowed and 18 issued U.S. patents.
company has tremendous opportunity in 2018," said TherapeuticsMD CEO Robert G. Finizio. "We have the potential for
approvals of both of our late-stage product candidates in 2018, representing a major inflection point for our company."
of 2017 Financial Results
the year ended December 31, 2017, net revenue was approximately $16.8 million compared with approximately $19.4 million for the
prior year. Net revenue for the fourth quarter of 2017 was approximately $4.1 million compared with net revenue of approximately
$4.5 million for the prior year's quarter. These changes were primarily due to a decrease in the average net revenue per
unit of the company's products, primarily related to higher coupons in 2017, partially offset by a slight increase in the
number of units sold.
operating expenses for the fourth quarter and full-year 2017 included research and development (R&D) expenses and sales, general
and administrative expenses (SG&A). R&D expenses for the full-year 2017 were approximately $33.9 million compared with
approximately $53.9 million for the prior year. R&D expenses for the fourth quarter of 2017 were approximately $11.0 million
compared to approximately $10.3 million during the prior year's quarter. The decreases in R&D for full-year 2017 were
primarily due to lower clinical trial costs as the company completed its phase 3 clinical trials for TX-001HR and TX-004HR. SG&A
expenses for the full-year 2017 were approximately $57.7 million compared with approximately $51.3 million for the prior year.
SG&A expenses for the fourth quarter of 2017 were approximately $14.2 million compared with approximately $16.3 million for
the prior year's quarter. The increases in SG&A for full-year 2017 were primarily due to higher sales, marketing, regulatory
expenditures, and personnel costs to support future commercialization.
loss for the full-year 2017 was approximately $76.9 million, or $0.37 per basic and diluted share, compared with approximately
$89.9 million, or $0.46 per basic and diluted share, for the full-year 2016. Net loss in the fourth quarter of 2017 was approximately
$21.4 million, or $0.10 per basic and diluted share, compared with approximately $22.8 million, or $0.12 per basic and diluted
share, for the fourth quarter of 2016.
December 31, 2017, cash on hand was approximately $127.1 million, which includes approximately $68.6 million in net proceeds from
an equity offering in September 2017, compared with approximately $131.5 million at December 31, 2016.
previously announced, TherapeuticsMD will host a conference call today to discuss these financial results and provide a business
update. Details for the call are:
Access (International):
Code for All Callers:
a live webcast can be accessed on the company's website, www.therapeuticsmd.com, on the Home Page or under the "Investors
& Media" section. A digital recording of the conference call will be available for replay beginning two hours after
the call's completion and for at least 30 days with the dial-in 855-859-2056 or international 404-537-3406 and Conference ID:
TherapeuticsMD, Inc.
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 brands.
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
new drug application for its TX-004HR product candidate and the time frame associated with such resolution; whether the FDA will
approve the amended NDA for the company's TX-004HR product candidate and whether such approval will occur by the PDUFA target
action 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 FDA will
accept and approve the NDA for the company's TX-001HR product candidate; the length, cost and uncertain results of the company's
clinical trials, including any additional clinical trials that the FDA may require in connection with TX-004HR; 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.
INC. AND SUBSIDIARIES
| December 31, | ||||||||
| 2017 | 2016 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 127,135,628 | $ | 131,534,101 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $380,580 and $376,374, respectively | 4,328,802 | 4,500,699 | ||||||
| Inventory | 1,485,358 | 1,076,321 | ||||||
| Other current assets | 6,604,284 | 2,299,052 | ||||||
| Total current assets | 139,554,072 | 139,410,173 | ||||||
| Fixed assets, net | 437,055 | 516,839 | ||||||
| Other Assets: | ||||||||
| Intangible assets, net | 3,099,747 | 2,405,972 | ||||||
| Security deposit | 139,036 | 139,036 | ||||||
| Total other assets | 3,238,783 | 2,545,008 | ||||||
| Total assets | $ | 143,229,910 | $ | 142,472,020 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 4,097,600 | $ | 7,358,514 | ||||
| Other current liabilities | 9,223,595 | 7,624,085 | ||||||
| Total current liabilities | 13,321,195 | 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: 216,429,642 and 196,688,222 issued and outstanding, respectively | 216,430 | 196,688 | ||||||
| Additional paid-in capital | 516,351,405 | 436,995,052 | ||||||
| Accumulated deficit | (386,659,120 | ) | (309,702,319 | ) | ||||
| Total stockholders' equity | 129,908,715 | 127,489,421 | ||||||
| Total liabilities and stockholders' equity | $ | 143,229,910 | $ | 142,472,020 |
INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||||||
| 2017 | 2016 | 2017 | 2016 | 2015 | ||||||||||||||||
| Revenues, net | $ | 4,124,218 | $ | 4,487,427 | $ | 16,777,713 | $ | 19,356,450 | $ | 20,142,898 | ||||||||||
| Cost of goods sold | 594,769 | 709,711 | 2,636,943 | 4,185,708 | 4,506,673 | |||||||||||||||
| Gross profit | 3,529,449 | 3,777,716 | 14,140,770 | 15,170,742 | 15,636,225 | |||||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Sales, general, and administrative | 14,178,958 | 16,329,146 | 57,703,370 | 51,348,414 | 28,721,236 | |||||||||||||||
| Research and development | 10,974,956 | 10,341,144 | 33,852,993 | 53,943,477 | 72,042,774 | |||||||||||||||
| Depreciation and amortization | 56,174 | 48,132 | 213,117 | 132,451 | 62,400 | |||||||||||||||
| Total operating expenses | 25,210,088 | 26,718,422 | 91,769,480 | 105,424,342 | 100,826,410 | |||||||||||||||
| Operating loss | (21,680,639 | ) | (22,940,706 | ) | (77,628,710 | ) | (90,253,600 | ) | (85,190,185 | ) | ||||||||||
| Other income | ||||||||||||||||||||
| Miscellaneous income | 253,309 | 101,438 | 695,631 | 367,317 | 95,719 | |||||||||||||||
| Accreted interest | - | 2,974 | 7,699 | 10,824 | 17,442 | |||||||||||||||
| Total other income | 253,309 | 104,412 | 703,330 | 378,141 | 113,161 | |||||||||||||||
| Loss before income taxes | (21,427,330 | ) | (22,836,294 | ) | (76,925,380 | ) | (89,875,459 | ) | (85,077,024 | ) | ||||||||||
| Provision for income taxes | - | - | - | - | - | |||||||||||||||
| Net loss | $ | (21,427,330 | ) | $ | (22,836,294 | ) | $ | (76,925,380 | ) | $ | (89,875,459 | ) | $ | (85,077,024 | ) | |||||
| Loss per share, basic and diluted: | ||||||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.10 | ) | $ | (0.12 | ) | $ | (0.37 | ) | $ | (0.46 | ) | $ | (0.49 | ) | |||||
| Weighted average number of common | ||||||||||||||||||||
| shares outstanding, basic and diluted | 216,429,642 | 196,613,297 | 205,523,288 | 196,088,196 | 173,174,229 |
INC. AND SUBSIDIARIES
STATEMENTS OF CASH FLOWS
| Year Ended December, 31, | ||||||||||||
| 2017 | 2016 | 2015 | ||||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||||
| Net loss | $ | (76,925,380 | ) | $ | (89,875,459 | ) | $ | (85,077,024 | ) | |||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
| Depreciation | 141,601 | 77,906 | 29,959 | |||||||||
| Amortization of intangible assets | 71,516 | 54,545 | 32,441 | |||||||||
| Provision for doubtful accounts | 4,206 | 2,524,909 | 22,157 | |||||||||
| Share-based compensation | 6,889,323 | 17,411,021 | 7,189,699 | |||||||||
| Changes in operating assets and liabilities: | ||||||||||||
| Accounts receivable | 167,691 | (3,975,893 | ) | (917,656 | ) | |||||||
| Inventory | (409,037 | ) | (386,168 | ) | 491,960 | |||||||
| Other current assets | (4,434,130 | ) | 709,907 | (773,532 | ) | |||||||
| Other assets | (17,442 | ) | ||||||||||
| Accounts payable | (3,260,914 | ) | 4,232,340 | (3,200,955 | ) | |||||||
| Deferred revenue | (522,613 | ) | ||||||||||
| Other current liabilities | 1,599,510 | 84,559 | 3,698,887 | |||||||||
| Net cash used in operating activities | (76,155,614 | ) | (69,142,333 | ) | (79,044,119 | ) | ||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||||
| Patent costs | (765,291 | ) | (845,266 | ) | (419,104 | ) | ||||||
| Purchase of fixed assets | (61,817 | ) | (396,154 | ) | (165,257 | ) | ||||||
| Payment of security deposit | (14,036 | ) | ||||||||||
| Net cash used in investing activities | (827,108 | ) | (1,255,456 | ) | (584,361 | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||||
| Proceeds from sale of common stock, net of costs | 68,572,635 | 134,863,475 | 91,374,649 | |||||||||
| Proceeds from exercise of options | 212,615 | 989,060 | 1,232,579 | |||||||||
| Proceeds from exercise of warrants | 3,798,999 | 1,373,000 | 366,000 | |||||||||
| Net cash provided by financing activities | 72,584,249 | 137,225,535 | 92,973,228 | |||||||||
| (Decrease) increase in cash | (4,398,473 | ) | 66,827,746 | 13,344,748 | ||||||||
| Cash, beginning of period | 131,534,101 | 64,706,355 | 51,361,607 | |||||||||
| Cash, end of period | $ | 127,135,628 | $ | 131,534,101 | $ | 64,706,355 |