TherapeuticsMD Announces Fourth Quarter and Full-Year 2016 Financial Results

– Pipeline of two late-stage product candidates advancing towards commercialization, with launch of TX-004HR expected in fourth quarter 2017 pending regulatory approval –

– Management to host conference call today at 8:00 a.m. EST –

BOCA RATON, Fla.--(BUSINESS WIRE)--Feb. 23, 2017-- TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced its fourth quarter and full-year financial results for 2016.

2016 and Recent Developments

Net revenue for the company’s prescription prenatal vitamin business was approximately $19.4 million in 2016 compared with approximately $20.1 million for the prior year.
Net loss was approximately $89.9 million in 2016, compared with approximately $85.1 million for the prior year, reflecting investment in clinical development for the company’s two phase 3 hormone therapy drug candidates.
Ended the year with approximately $131.5 million in cash and no debt.
Reported positive topline data from the Replenish Trial, a phase 3 clinical trial of TX-001HR, the company’s 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. Topline results from the trial in 1,835 post-menopausal women demonstrated that multiple doses of TX-001HR resulted in a statistically significant reduction from baseline in both the frequency and severity of hot flashes compared to placebo. In addition, endometrial safety was established with an incidence rate of endometrial hyperplasia or malignancy of 0% across all doses. The company plans to submit a New Drug Application (NDA) for TX-001HR to the U.S. Food and Drug Administration (FDA) in the third quarter of 2017.
Submitted an NDA for TX-004HR, the company’s applicator-free estradiol vaginal softgel capsule 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 NDA is supported by the complete TX-004HR clinical program, including positive results from all three doses of TX-004HR (4 mcg, 10 mcg and 25 mcg) that were evaluated in the phase 3 Rejoice Trial. The FDA’s Prescription Drug User Fee Act (PDUFA) target action date for the NDA is May 7, 2017.
Published three manuscripts with detailed results of the TX-004HR phase 3 Rejoice Trial in the peer-reviewed journal Menopause. The manuscripts review the positive results of TX-004HR across pre-specified co-primary and secondary endpoints in the Rejoice Trial, data from a pharmacokinetic (PK) substudy demonstrating the low systemic absorption of TX-004HR, as well as data from a patient acceptability and satisfaction survey demonstrating a high level of product acceptability, ease of use, and patient satisfaction with TX-004HR.
The company’s intellectual property portfolio grew to a current total of 144 patent filings, including 74 international filings, with one allowed and 17 issued U.S. patents.
Strengthened relationships with key medical, pharmacy, patient and industry organizations worldwide. This includes the recent launch of the company’s BIO-IGNITE™ program, 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.

“During 2016, we made significant advancements with our two late-stage pipeline candidates while we pursued our goal to bring new healthcare solutions to women to help manage their menopause symptoms,” said TherapeuticsMD CEO Robert G. Finizio. “As we look forward to 2017, we are planning the launch of TX-004HR, pending regulatory approval, as a highly differentiated new treatment for moderate-to-severe dyspareunia, a symptom of VVA due to menopause. We also intend to file an NDA for TX-001HR, which, if approved, would be the first and only FDA-approved bio-identical combination of estradiol and progesterone for the treatment of moderate-to-severe vasomotor symptoms due to menopause.”

Summary of 2016 Financial Results

For the year ended December 31, 2016, net revenue was approximately $19.4 million compared with approximately $20.1 million for the prior year. Net revenue for the fourth quarter of 2016 was approximately $4.5 million compared with net revenue of approximately $5.6 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.

Total operating expenses for the fourth quarter and full-year 2016 included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D expenses for the full-year 2016 were approximately $53.9 million compared with approximately $72.0 million for the prior year. R&D expenses for the fourth quarter of 2016 were approximately $10.3 million compared to approximately $13.3 million during the prior year’s quarter. The decreases in R&D 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 2016 were approximately $51.3 million compared with approximately $28.7 million for the prior year. SG&A expenses for the fourth quarter of 2016 were approximately $16.3 million compared with approximately $8.6 million for the prior year’s quarter. The increases in SG&A were primarily due to higher sales, marketing, regulatory expenditures, and personnel costs to support future commercialization.

Net loss for the full-year 2016 was approximately $89.9 million, or $0.46 per basic and diluted share, compared with approximately $85.1 million, or $0.49 per basic and diluted share, for the full-year 2015. Net loss in the fourth quarter of 2016 was approximately $22.8 million, or $0.12 per basic and diluted share, compared with approximately $17.5 million, or $0.10 per basic and diluted share, for the fourth quarter of 2015.

At December 31, 2016, cash on hand was approximately $131.5 million, compared with approximately $64.7 million at December 31, 2015.

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 23, 2017
Time:			8:00 a.m. EST
Telephone Access (US):			866-665-9531
Telephone Access (International):			724-987-6977
Access Code for All Callers:			68412683

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: 68412683.

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 as well as over-the-counter prenatal vitamins under the vitaMedMD^® and BocaGreenMD^® brands.

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 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 a new drug application for its TX-001HR product candidate and, if prepared, whether the FDA will accept and approve the application; 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 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,
			2016			2015
ASSETS
Current Assets:
	Cash	$	131,534,101		$	64,706,355
	Accounts receivable, net of allowance for doubtful accounts
	of $376,374 and $81,910, respectively		4,500,699			3,049,715
	Inventory		1,076,321			690,153
	Other current assets		2,299,052			2,233,897
	Total current assets		139,410,173			70,680,120

Fixed assets, net			516,839			198,592

Other Assets:
	Intangible assets, net		2,405,972			1,615,251
	Security deposit		139,036			125,000
	Prepaid expense		-			1,109,883
	Total other assets		2,545,008			2,850,134
	Total assets	$	142,472,020		$	73,728,846

LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
	Accounts payable	$	7,358,514		$	3,126,174
	Other current liabilities		7,624,085			7,539,526
	Total current liabilities		14,982,599			10,665,700


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:
	196,688,222 and 177,928,041 issued and outstanding, respectively		196,688			177,928
	Additional paid-in capital		436,995,052			282,712,078
	Accumulated deficit		(309,702,319	)		(219,826,860	)
	Total stockholders' equity		127,489,421			63,063,146
	Total liabilities and stockholders' equity	$	142,472,020		$	73,728,846


THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS

		Three Months Ended December 31,						Year Ended December 31,
			2016			2015			2016			2015			2014


Revenues, net		$	4,487,427		$	5,629,740		$	19,356,450		$	20,142,898		$	15,026,219

Cost of goods sold			709,711			1,235,978			4,185,708			4,506,673			3,671,803

Gross profit			3,777,716			4,393,762			15,170,742			15,636,225			11,354,416

Operating expenses:
	Sales, general, and administrative		16,329,146			8,631,238			51,348,414			28,721,236			22,124,072
	Research and development		10,341,144			13,253,472			53,943,477			72,042,774			43,218,938
	Depreciation and amortization		48,132			18,000			132,451			62,400			52,467

	Total operating expenses		26,718,422			21,902,710			105,424,342			100,826,410			65,395,477

Operating loss			(22,940,706	)		(17,508,948	)		(90,253,600	)		(85,190,185	)		(54,041,061	)

Other income and (expense)
	Miscellaneous income		101,438			23,991			367,317			95,719			46,569
	Accreted interest		2,974			2,280			10,824			17,442			37,309
	Financing costs		-			-			-			-			(260,027	)

	Total other income (expense)		104,412			26,271			378,141			113,161			(176,149	)

Loss before income taxes			(22,836,294	)		(17,482,677	)		(89,875,459	)		(85,077,024	)		(54,217,210	)

Provision for income taxes			-			-			-			-			-

Net loss		$	(22,836,294	)	$	(17,482,677	)	$	(89,875,459	)	$	(85,077,024	)	$	(54,217,210	)

Loss per share, basic and diluted:

Net loss per share, basic and diluted		$	(0.12	)	$	(0.10	)	$	(0.46	)	$	(0.49	)	$	(0.36	)

Weighted average number of common
	shares outstanding, basic and diluted		196,613,297			177,876,462			196,088,196			173,174,229			149,727,228

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS


		Year Ended December, 31,
			2016			2015			2014

CASH FLOWS FROM OPERATING ACTIVITIES
	Net loss	$	(89,875,459	)	$	(85,077,024	)	$	(54,217,210	)
	Adjustments to reconcile net loss to net cash used in
	operating activities:
	Depreciation		77,906			29,959			28,987
	Amortization of intangible assets		54,545			32,441			23,480
	Provision for (recovery of) doubtful accounts		2,524,909			22,157			(5,436	)
	Share-based compensation		17,411,021			7,189,699			4,970,312
	Amortization of deferred financing costs		-			-			260,027
	Changes in operating assets and liabilities:
	Accounts receivable		(3,975,893	)		(917,656	)		(458,028	)
	Inventory		(386,168	)		491,960			(138,495	)
	Other current assets		709,907			(773,532	)		680,281
	Other assets		-			(17,442	)		(37,309	)
	Accounts payable		4,232,340			(3,200,955	)		4,212,912
	Deferred revenue		-			(522,613	)		(1,079,967	)
	Other current liabilities		84,559			3,698,887			239,450


	Net cash used in operating activities		(69,142,333	)		(79,044,119	)		(45,520,996	)

CASH FLOWS FROM INVESTING ACTIVITIES
	Patent costs		(845,266	)		(419,104	)		(586,480	)
	Purchase of fixed assets		(396,154	)		(165,257	)		(30,962	)
	(Payment) refund of security deposit		(14,036	)		-			10,686


	Net cash used in investing activities		(1,255,456	)		(584,361	)		(606,756	)

CASH FLOWS FROM FINANCING ACTIVITIES
	Proceeds from sale of common stock, net of costs		134,863,475			91,374,649			42,771,353
	Proceeds from exercise of options		989,060			1,232,579			345,746
	Proceeds from exercise of warrants		1,373,000			366,000			181,000


	Net cash provided by financing activities		137,225,535			92,973,228			43,298,099

	Increase (decrease) in cash		66,827,746			13,344,748			(2,829,653	)
	Cash, beginning of period		64,706,355			51,361,607			54,191,260
	Cash, end of period	$	131,534,101		$	64,706,355		$	51,361,607

View source version on businesswire.com: http://www.businesswire.com/news/home/20170223005400/en/

Source: TherapeuticsMD, Inc.

TherapeuticsMD, Inc.
Investor Contact
David DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com
or
Media Contact
SparkBioComm
Ami Knoefler, 650-739-9952
Ami@SparkBioComm.com