TXMD TherapeuticsMD Inc

– 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 –

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  

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TherapeuticsMD, Inc.Investor ContactDavid DeLucia, 561-961-1900Director, Investor RelationsDavid.DeLucia@TherapeuticsMD.comorMedia ContactSparkBioCommAmi Knoefler, 650-739-9952Ami@SparkBioComm.com