TherapeuticsMD Announces Third Quarter 2017 Financial Results

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- Resubmission of New Drug Application for TX-004HR expected in the coming weeks -

- Submission of New Drug Application for TX-001HR expected in December 2017 -

TherapeuticsMD, Inc. TXMD, an innovative women's healthcare company, today announced its financial results for the quarter ended September 30, 2017.

Third Quarter and Recent Developments

  • On November 3, 2017, the Company participated in an in-person meeting with the Division of Bone, Reproductive, and Urologic Products of the Food and Drug Administration (FDA). At the meeting, the Division agreed to the resubmission of the New Drug Application (NDA) for TX-004HR without the need for an additional pre-approval study. The Company will commit to conduct a post-approval observational study. The Company plans to resubmit the NDA for TX-004HR in the coming weeks.
  • Presented 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 plans to submit the NDA for TX-001HR in December 2017.
  • Net revenue for the company's prescription prenatal vitamin business was approximately $4.4 million for the third quarter of 2017 compared with approximately $5.5 million for the third quarter of 2016.
  • Net loss was approximately $14.7 million for the third quarter of 2017, compared with approximately $25.0 million for the third quarter of 2016.
  • Ended the quarter with approximately $148.3 million in cash and no debt, which includes approximately $68.6 million in net proceeds from an equity offering in September 2017.
  • Grew the company's intellectual property portfolio to a current total of 158 patent filings, including 82 international filings, with one allowed and 18 issued U.S. patents.

"We continue to focus on advancing our pipeline of novel hormone therapies and, if approved, bringing new, differentiated treatment options to women suffering from symptoms of menopause," said TherapeuticsMD CEO Robert G. Finizio.

Summary of Third Quarter 2017 Financial Results

Net revenue from the company's prescription prenatal vitamin business was approximately $4.4 million for the third quarter of 2017 compared with net revenue of approximately $5.5 million for the prior year's quarter. These changes were primarily due to a decrease in the average net sales price of our products and a slight decrease in the number of units sold.

Cost of goods sold was approximately $0.7 million for the third quarter of 2017, compared with approximately $1.2 million for the prior year's quarter.

Total operating expenses for the third quarter of 2017 included research and development (R&D) expenses and sales, general, and administrative expenses (SG&A). R&D expenses for the third quarter of 2017 were approximately $6.4 million compared with approximately $14.7 million for the prior year's quarter. The decrease in R&D expenses was a direct result of the completion of the REPLENISH Trial for TX-001HR. SG&A expenses for the third quarter of 2017 were approximately $12.1 million compared with approximately $14.7 million for the prior year's quarter, primarily due to lower sales and marketing expenditures.

Net loss for the third quarter of 2017 was approximately $14.7 million, or $0.07 per basic and diluted share, compared with approximately $25.0 million, or $0.13 per basic and diluted share, for the third quarter of 2016.

At September 30, 2017, cash on hand was approximately $148.3 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.

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 under the vitaMedMD® and BocaGreenMD® brands.

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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 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 company will be able to prepare an amended NDA for its TX-004HR product candidate and, if prepared, whether the FDA will accept and approve the NDA; 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 an NDA for its TX-001HR product candidate and, if prepared, whether the FDA will accept and approve the NDA; 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.

 
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
         
September 30, 2017 December 31, 2016
(Unaudited)
 
ASSETS
Current Assets:
Cash $ 148,292,654 $ 131,534,101

Accounts receivable, net of allowance for doubtful accounts of $377,929 and $376,374, respectively

4,392,635 4,500,699
Inventory 1,293,517 1,076,321
Other current assets   3,001,777     2,299,052  
Total current assets   156,980,583     139,410,173  
 
Fixed assets, net   448,066     516,839  
 
Other Assets:
Intangible assets, net 2,793,421 2,405,972
Security deposit   139,036     139,036  
Total other assets   2,932,457     2,545,008  
Total assets $ 160,361,106   $ 142,472,020  
 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable $ 4,199,369 $ 7,358,514
Other current liabilities   6,677,232     7,624,085  
Total current liabilities   10,876,601     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 514,499,865 436,995,052
Accumulated deficit   (365,231,790 )   (309,702,319 )
Total stockholders' equity   149,484,505     127,489,421  
Total liabilities and stockholders' equity $ 160,361,106   $ 142,472,020  
 
               
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
 
Three Months Ended Nine Months Ended
September 30, September 30,
2017 2016 2017 2016
 
Revenues, net $ 4,417,598 $ 5,535,685 $ 12,653,495 $ 14,869,023
 
Cost of goods sold   700,814     1,237,446     2,042,174     3,475,997  
Gross profit   3,716,784     4,298,239     10,611,321     11,393,026  
 
Operating expenses:
Sales, general, and administration 12,057,868 14,721,710 43,524,412 35,019,268
Research and development 6,436,802 14,664,123 22,878,037 43,602,333
Depreciation and amortization   54,055     40,460     156,943     84,319  
Total operating expense   18,548,725     29,426,293     66,559,392     78,705,920  
 
Operating loss   (14,831,941 )   (25,128,054 )   (55,948,071 )   (67,312,894 )
 
Other income:
Miscellaneous income 167,300 109,942 442,322 265,879
Accreted interest   -     2,451     7,699     7,850  
Total other income   167,300     112,393     450,021     273,729  
 
Loss before taxes (14,664,641 ) (25,015,661 ) (55,498,050 ) (67,039,165 )
 
Provision for income taxes   -     -     -     -  
 
Net loss $ (14,664,641 ) $ (25,015,661 ) $ (55,498,050 ) $ (67,039,165 )
 
Net loss per share, basic and diluted $ (0.07 ) $ (0.13 ) $ (0.27 ) $ (0.34 )
 

Weighted average number of common shares outstanding

  207,938,338     196,502,327     203,282,335     195,912,173  
 
       
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
 
Nine Months Ended
September 30, 2017 September 30, 2016
 
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (55,498,050 ) $ (67,039,165 )

Adjustments to reconcile net loss to net cash flows used in operating activities:

Depreciation of fixed assets 104,622 45,759
Amortization of intangible assets 52,321 38,560
Provision for doubtful accounts 1,555 2,261,568
Share-based compensation 5,037,783 13,385,215
Changes in operating assets and liabilities:
Accounts receivable 106,509 (4,245,151 )
Inventory (217,196 ) (153,245 )
Other current assets (831,623 ) 379,930
Accounts payable (3,159,145 ) 1,098,245
Other current liabilities   (946,853 )   703,895  
Net cash used in operating activities   (55,350,077 )   (53,524,389 )
 
CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs (439,770 ) (541,686 )
Purchase of fixed assets (35,849 ) (307,714 )
Payment of security deposit   -     (14,036 )
Net cash used in investing activities   (475,619 )   (863,436 )
 
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs 68,572,635 134,863,475
Proceeds from exercise of warrants 3,798,999 1,373,000
Proceeds from exercise of options   212,615     979,060  
Net cash provided by financing activities   72,584,249     137,215,535  
 
Increase in cash 16,758,553 82,827,710
Cash, beginning of period   131,534,101     64,706,355  
Cash, end of period $ 148,292,654   $ 147,534,065  
 

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