Full Press Release Details
Announces Fourth Quarter and Full Year 2015 Financial Results
Company to Present additional positive phase 3 data for TX-004HR at the ISSWSH annual meeting -
Management to host conference call today at 4:30 p.m. EST -
RATON, Fla. - February
25, 2016 - TherapeuticsMD,
Inc. (NYSE MKT: TXMD), an
innovative women's healthcare company, today
announced its fourth quarter and full year financial results for 2015.
and Recent Developments
| Net revenue for the company's prescription prenatal vitamin business increased to approximately $20.1 million in 2015 compared with approximately $15.0 million for the prior year. | ||
| Net loss was approximately $85.1 million in 2015, compared with approximately $54.2 million for the prior year, reflecting investment in two phase 3 clinical trials for the company's novel hormone therapy drug candidates. | ||
| Reported positive topline data from the Rejoice Trial, a phase 3 clinical trial of TX-004HR, an applicator-free vaginal estradiol softgel drug candidate for the treatment of moderate to severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The results showed patients treated with TX-004HR achieved a statistically significant improvement over placebo across all four co-primary endpoints at all three doses evaluated. The validated co-primary endpoint data and additional secondary endpoint results related to vaginal dryness are scheduled to be presented this week at the International Society for the Study of Women's Sexual Health (ISSWSH) Annual Meeting 2016. A summary of these data is included below in this press release. | ||
| Exited over 1,400 of the 1,750 patients enrolled in the Replenish Trial, a phase 3 clinical trial of TX-001HR, a combination estradiol and progesterone drug candidate, for the treatment of moderate to severe vasomotor symptoms due to menopause. Topline results are currently anticipated late in the fourth quarter of 2016. | ||
| The company's intellectual property portfolio grew to a current total of 122 patent filings, including 72 international filings, with one allowed and 14 issued U.S. patents. | ||
| Presented two posters at North American Menopause Society (NAMS) of the company's transdermal progesterone candidate, TX-005HR, and the company's transdermal estradiol and progesterone candidate, TX-006HR, demonstrating tissue penetration and target organ activity in a preclinical study. | ||
| Strengthened relationships with key medical, pharmacy, patient and industry organizations worldwide. | ||
| Ended the year with approximately $64.7 million in cash and no debt, which was further strengthened by an equity offering in January 2016 that generated approximately $135 million of net proceeds to fund commercialization activities for both of the company's late stage product candidates and other development activities. |
was a breakthrough year for our company, as we
reported positive topline phase 3 data from the Rejoice Trial for TX-004HR, the first of our two novel pipeline candidates in
the women's health arena," said TherapeuticsMD
CEO Robert G. Finizio.
"Based on those compelling results, we are preparing to file an NDA before June 30, while we also expect topline
data late in the fourth quarter of 2016 from our Replenish Trial for TX-001HR. We believe we are well positioned from a financial,
clinical and commercial standpoint to execute on our goals in 2016 and create significant value for shareholders by advancing
our pipeline and preparing to launch our first novel hormone product for women, if approved."
of 2015 Financial Results
the year ended December 31, 2015, net revenue increased approximately 34 percent to approximately $20.1 million compared with
approximately $15.0 million for the prior year. Net revenue for the fourth quarter of 2015 was approximately $5.6 million compared
with net revenue of approximately $4.3 million for the prior year's quarter. Revenue growth during the fourth quarter was
primarily driven by a change in product mix and an increase in the average net sales price of the company's prenatal vitamin
products and revenue growth during the full year was primarily driven by an increase in the number of units sold and an increase
in the average sales price of the company's prenatal vitamin products.
of goods sold increased to approximately $4.5 million for the full year 2015, compared with approximately $3.7 million in the
operating expenses for the fourth quarter and full year 2015 included research and development (R&D) expenses and sales, general
and administrative expenses (SG&A). R&D expenses for the full-year 2015 were approximately $72.0 million compared with
approximately $43.2 million for the prior year, primarily as a result of an increase in
costs related to the company's phase 3 clinical trials for TX-001HR and TX-004HR and an increase in scale-up and manufacturing
activities primarily related to TX-001HR. R&D expenses during the fourth quarter of 2015 were $13.3 million compared to $14.2
million during the prior year's quarter, reflecting a significant decline in the company's clinical trial costs, partially
offset by an increase in scale-up and manufacturing activities to support commercialization. SG&A expenses for the full-year
2015 were approximately $28.7 million compared with approximately $22.1 million for the prior year, reflecting an increase in
human resources related costs, increased consulting and professional costs, increased insurance cost and increased sales and marketing
expenses. SG&A expenses for the fourth quarter of 2015 were approximately $8.6 million compared with approximately $5.5 million
for the prior year's quarter, primarily as a result of increased human resource related costs, as well as increased sales
and marketing and office expenses.
income remained insignificant for the full year
2015 and 2014 and included interest income and other miscellaneous items of income and expense for both periods.
loss for the full year 2015 was approximately $85.1 million, or $0.49 per basic and diluted share, compared with approximately
$54.2 million, or $0.36 per basic and diluted share, for the full year 2014. Net loss in the fourth quarter of 2015 was approximately
$17.5 million, or $0.10 per basic and diluted share, compared with approximately $16.3 million, or $0.10 per basic and diluted
share, for the fourth quarter of 2014.
December 31, 2015, cash on hand was approximately $64.7 million, compared with approximately $51.4 million at December
3 Data Results Presented at ISSWSH Annual Meeting 2016
also announced that data from the phase 3 Rejoice Trial would be presented at the ISSWSH Annual Meeting 2016 taking place February
25-28 in Charleston, South Carolina. The poster to be presented includes validated co-primary endpoint results from the Rejoice
Trial and secondary endpoint data that demonstrate the effect of TX-004HR on severity of vaginal dryness as compared with placebo
on the company's ongoing analyses of the Rejoice Trial data, statistical significance of the results for the
co-primary endpoint of severity of participants' self-reported moderate to severe dyspareunia as the most bothersome symptom
of VVA has slightly improved for all three doses from the topline results previously reported. The secondary endpoint result
for vaginal dryness was also statistically significant for all three doses evaluated in the Rejoice Trial.
| Statistical Significance of Results for Co-Primary Endpoints (Based on LS Mean Change from Baseline to Week 12 Compared to Placebo) | ||||||||||||
| 25 mcg | 10mcg | 4 mcg | ||||||||||
| Superficial Cells | P < 0.0001 | P < 0.0001 | P < 0.0001 | |||||||||
| Parabasal cells | P < 0.0001 | P < 0.0001 | P < 0.0001 | |||||||||
| Vaginal pH | P < 0.0001 | P < 0.0001 | P < 0.0001 | |||||||||
| Severity of Dyspareunia | P < 0.0001 | P < 0.0001 | P = 0.0149 |
| Statistical Significance of Results for Secondary Endpoint of Severity of Vaginal Dryness (Based on LS Mean Change from Baseline to Week 12 Compared to Placebo) | ||||||||||||
| Severity of Dryness | P < 0.0001 | P < 0.0001 | P = 0.0014 | |||||||||
| LS= Least Squares |
previously announced, TherapeuticsMD will host a conference call today to discuss these financial results and provide a business
update. Details for the call are:
| Date: | Thursday, February 25, 2016 |
| Time: | 4:30 p.m. EST |
| Telephone Access (US): | 866-665-9531 |
| Telephone Access (International): | 724-987-6977 |
| Access Code for All Callers: | 45870409 |
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: 45870409.
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 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.
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.
Chief Financial Officer
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| December 31, | |||||||
| 2015 | 2014 | ||||||
| ASSETS | |||||||
| Current Assets: | |||||||
| Cash | $ | 64,706,355 | $ | 51,361,607 | |||
| Accounts receivable, net of allowance for doubtful accounts of $81,910 and $59,753, respectively | 3,049,715 | 2,154,217 | |||||
| Inventory | 690,153 | 1,182,113 | |||||
| Other current assets | 2,233,897 | 1,537,407 | |||||
| Total current assets | 70,680,120 | 56,235,344 | |||||
| Fixed assets, net | 198,592 | 63,293 | |||||
| Other Assets: | |||||||
| Intangible assets, net | 1,615,251 | 1,228,588 | |||||
| Prepaid expense | 1,109,883 | 1,427,263 | |||||
| Security deposit | 125,000 | 125,000 | |||||
| Total other assets | 2,850,134 | 2,780,851 | |||||
| Total assets | $ | 73,728,846 | $ | 59,079,488 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| Current Liabilities: | |||||||
| Accounts payable | $ | 3,126,174 | $ | 6,327,129 | |||
| Other current liabilities | 7,539,526 | 3,840,639 | |||||
| Deferred revenue | 522,613 | ||||||
| Total current liabilities | 10,665,700 | 10,690,381 | |||||
| Commitments and Contingencies - See Note 14 | |||||||
| 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 and 250,000,000 shares authorized; 177,928,041 and 156,097,019 issued and outstanding, respectively | 177,928 | 156,097 | |||||
| Additional paid-in capital | 282,712,078 | 182,982,846 | |||||
| Accumulated deficit | (219,826,860 | ) | (134,749,836 | ) | |||
| Total stockholders' equity | 63,063,146 | 48,389,107 | |||||
| Total liabilities and stockholders' equity | $ | 73,728,846 | $ | 59,079,488 |
INC. AND SUBSIDIARIES