TherapeuticsMD 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 –
BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare
company, today announced its fourth quarter and full year financial
results for 2015.
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.
“2015 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.”
Summary of 2015 Financial Results
For 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.
Cost of goods sold increased to approximately $4.5 million for the full
year 2015, compared with approximately $3.7 million in the prior year.
Total 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.
Non-operating 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.
Net 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.
At December 31, 2015, cash on hand was approximately $64.7 million,
compared with approximately $51.4 million at December 31, 2014.
Phase 3 Data Results Presented at ISSWSH Annual Meeting 2016
TherapeuticsMD 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 at week 12.
Based 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 |
10 mcg |
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
(Based on LS Mean Change from Baseline to Week 12 Compared to |
||||||
Severity of Dryness |
P < 0.0001 |
P < 0.0001 |
P = 0.0014 |
|||
LS= Least Squares |
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 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 |
Additionally, 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.
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 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, | |||||||||
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 | |||||||||
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 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||||
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||||||||
2015 | 2014 | 2015 | 2014 | 2013 | |||||||||||||||||
Revenues, net | $ | 5,629,740 | $ | 4,257,647 | $ | 20,142,898 | $ | 15,026,219 | $ | 8,775,598 | |||||||||||
Cost of goods sold | 1,235,978 | 879,535 | 4,506,673 | 3,671,803 | 1,959,597 | ||||||||||||||||
Gross profit | 4,393,762 | 3,378,112 | 15,636,225 | 11,354,416 | 6,816,001 | ||||||||||||||||
Operating expenses: | |||||||||||||||||||||
Sales, general, and administrative | 8,631,238 | 5,514,057 | 28,721,236 | 22,124,072 | 19,014,837 | ||||||||||||||||
Research and development | 13,253,472 | 14,166,789 | 72,042,774 | 43,218,938 | 13,551,263 | ||||||||||||||||
Depreciation and amortization | 18,000 | 12,558 | 62,400 | 52,467 | 58,145 | ||||||||||||||||
Total operating expenses | 21,902,710 | 19,693,404 | 100,826,410 | 65,395,477 | 32,624,245 | ||||||||||||||||
Operating loss | (17,508,948 | ) | (16,315,292 | ) | (85,190,185 | ) | (54,041,061 | ) | (25,808,244 | ) | |||||||||||
Other income and (expenses) | |||||||||||||||||||||
Miscellaneous income, net | 23,991 | 3,158 | 95,719 | 46,569 | 34,544 | ||||||||||||||||
Interest income | 2,280 | 9,553 | 17,442 | 37,309 | 27,234 | ||||||||||||||||
Financing costs |
– |
– |
– |
(260,027 |
) |
(1,503,922 |
) |
||||||||||||||
Interest expense |
– |
– |
– |
– |
(1,165,981 |
) |
|||||||||||||||
Loan guaranty costs |
– |
– |
– |
– |
(2,944 |
) |
|||||||||||||||
Total other income (expense) | 26,271 | 12,711 | 113,161 | (176,149 | ) | (2,611,069 | ) | ||||||||||||||
Loss before income taxes | (17,482,677 | ) | (16,302,581 | ) | (85,077,024 | ) | (54,217,210 | ) | (28,419,313 | ) | |||||||||||
Provision for income taxes | – | – | – | – | – | ||||||||||||||||
Net loss | $ | (17,482,677 | ) | $ | (16,302,581 | ) | $ | (85,077,024 | ) | $ | (54,217,210 | ) | $ | (28,419,313 | ) | ||||||
Loss per share, basic and diluted: | |||||||||||||||||||||
Net loss per share, basic and diluted | $ | (0.10 | ) | $ | (0.10 | ) | $ | (0.49 | ) | $ | (0.36 | ) | $ | (0.22 | ) | ||||||
Weighted average number of common | |||||||||||||||||||||
shares outstanding, basic and diluted | 177,876,462 | 156,054,938 | 173,174,229 | 149,727,228 | 127,569,731 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||||||
Year Ended December, 31, | |||||||||||||
2015 | 2014 | 2013 | |||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||||||
Net loss | $ | (85,077,024 | ) | $ | (54,217,210 | ) | $ | (28,419,313 | ) | ||||
Adjustments to reconcile net loss to net cash used in | |||||||||||||
operating activities: | |||||||||||||
Depreciation | 29,959 | 28,987 | 47,883 | ||||||||||
Amortization of intangible assets | 32,441 | 23,480 | 10,262 | ||||||||||
Provision for (recovery of) doubtful accounts | 22,157 | (5,436 | ) | (15,493 | ) | ||||||||
Amortization of debt discount | – | – | 1,102,680 | ||||||||||
Share-based compensation | 7,189,699 | 4,970,312 | 3,844,155 | ||||||||||
Amortization of deferred financing costs | – | 260,027 | 1,451,934 | ||||||||||
Loan guaranty costs | – | – | 2,944 | ||||||||||
Changes in operating assets and liabilities: | |||||||||||||
Accounts receivable | (917,656 | ) | (458,028 | ) | (1,068,619 | ) | |||||||
Inventory | 491,960 | (138,495 | ) | 571,592 | |||||||||
Other current assets | (773,532 | ) | 680,281 | (1,386,319 | ) | ||||||||
Other assets | (17,442 | ) | (37,309 | ) | (565,706 | ) | |||||||
Accounts payable | (3,200,955 | ) | 4,212,912 | 472,851 | |||||||||
Deferred revenue | (522,613 | ) | (1,079,967 | ) | 457,828 | ||||||||
Other current liabilities | 3,698,887 | 239,450 | 2,875,320 | ||||||||||
Other liabilities | – | – | (150,068 | ) | |||||||||
Net cash used in operating activities | (79,044,119 | ) | (45,520,996 | ) | (20,768,069 | ) | |||||||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||||||||||
Patent costs | (419,104 | ) | (586,480 | ) | (439,034 | ) | |||||||
Purchase of fixed assets | (165,257 | ) | (30,962 | ) | (40,790 | ) | |||||||
Refund (payment) of security deposit | – | 10,686 | (103,737 | ) | |||||||||
Net cash used in investing activities | (584,361 | ) | (606,756 | ) | (583,561 | ) | |||||||
CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||||||
Proceeds from sale of common stock, net of costs | 91,374,649 | 42,771,353 | 78,650,353 | ||||||||||
Proceeds from exercise of options | 1,232,579 | 345,746 | 30,910 | ||||||||||
Proceeds from exercise of warrants | 366,000 | 181,000 | – | ||||||||||
Proceeds bank line of credit | – | – | 500,000 | ||||||||||
Repayment of bank line of credit | – | – | (500,000 | ) | |||||||||
Repayment of notes payable | – | – | (4,691,847 | ) | |||||||||
Net cash provided by financing activities | 92,973,228 | 43,298,099 | 73,989,416 | ||||||||||
Increase (decrease) in cash | 13,344,748 | (2,829,653 | ) | 52,637,786 | |||||||||
Cash, beginning of period | 51,361,607 | 54,191,260 | 1,553,474 | ||||||||||
Cash, end of period | $ | 64,706,355 | $ | 51,361,607 | $ | 54,191,260 | |||||||
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 |
Contacts
TherapeuticsMD, Inc.
Investors:
Dan Cartwright, 561-961-1900
Chief
Financial Officer
Dan.Cartwright@TherapeuticsMD.com