BOCA RATON, Fla.--(BUSINESS WIRE)--TherapeuticsMD, Inc. (NYSE MKT:TXMD), an innovative women’s healthcare company, today announced its third quarter financial results for the quarter ended September 30, 2016.
Third Quarter and Recent Developments
- Announced acceptance of a New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for TX-004HR (conditionally-approved trade name Yuvvexy™), the company’s investigational applicator-free estradiol vaginal softgel capsule 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 phase 3 results with all three doses of TX-004HR (4 mcg, 10 mcg and 25 mcg) that were evaluated in the Rejoice Trial. The FDA’s Prescription Drug User Fee Act (PDUFA) target action date for the NDA is May 7, 2017.
- Anticipate topline results in the fourth quarter of 2016 for the ongoing Replenish Trial, a phase 3 clinical trial of the company’s TX-001HR product candidate, 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.
- Net revenue from the company’s prescription prenatal vitamin business increased 7 percent to approximately $5.5 million for the third quarter of 2016, compared with approximately $5.2 million for the third quarter of 2015.
- Net loss was approximately $25.0 million for the third quarter of 2016, compared with approximately $19.5 million for the third quarter of 2015.
- Ended the quarter with approximately $147.5 million in cash and no debt.
- Supported nine presentations at annual meetings of the International Menopause Society (IMS) and North American Menopause Society (NAMS), including reports on the positive results from the TX-004HR clinical development program and new data that further identify women’s perceptions of VVA and available treatment options.
- Grew the company’s intellectual property portfolio to a current total of 149 patent filings, including 82 international filings, with 17 issued U.S. patents.
- Strengthened relationships with medical, pharmacy, patient and industry organizations internationally.
“We are making excellent progress this year advancing our pipeline and enhancing our commercial capabilities focused on women’s health. During the quarter, we successfully completed the submission of our NDA for TX-004HR as a novel treatment for moderate to severe dyspareunia, a symptom of VVA due to menopause, and we continued ongoing pre-commercialization activities for this important product,” said TherapeuticsMD CEO Robert G. Finizio. “We now eagerly await the topline data from our Replenish Trial for TX-001HR in the fourth quarter of 2016, our second novel hormone therapy program, 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 Third Quarter 2016 Financial Results
Net revenue from the company’s prescription prenatal vitamins increased 7 percent to approximately $5.5 million for the third quarter of 2016 from approximately $5.2 million for the prior year’s quarter.
Cost of goods sold was approximately $1.2 million for the third quarter of both 2016 and 2015.
Total operating expenses for the third quarter of 2016 included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D expenses during the third quarter of 2016 were approximately $14.7 million compared to approximately $16.4 million during the prior year’s quarter, reflecting a decline in the company’s clinical trial costs. SG&A expenses for the third quarter of 2016 were approximately $14.7 million compared with approximately $7.1 million for the prior year’s quarter. Higher SG&A expenses during the third quarter of 2016 were primarily due to an increase in the company’s sales, marketing and regulatory personnel to support future commercialization of the company’s pipeline products.
Net loss for the third quarter of 2016 was approximately $25.0 million, or $0.13 per basic and diluted share, compared with approximately $19.5 million, or $0.11 per basic and diluted share, for the third quarter of 2015.
At September 30, 2016, cash on hand was approximately $147.5 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:
Thursday, November 3, 2016
4:30 p.m. EDT
Telephone Access (US):
Telephone Access (International):
Access Code for All Callers:
Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com, in 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: 99198056.
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; 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|
|September 30, 2016||December 31, 2015|
|Accounts receivable, net of allowance for doubtful accounts|
|of $113,034 and $81,910, respectively||5,033,298||3,049,715|
|Other current assets||2,693,475||2,233,897|
|Total current assets||156,104,236||70,680,120|
|Fixed assets, net||460,546||198,592|
|Intangible assets, net||2,118,378||1,615,251|
|Total other assets||2,257,414||2,850,134|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Other current liabilities||8,243,421||7,539,526|
|Total current liabilities||12,467,840||10,665,700|
|Commitments and Contingencies - See Note 15|
|Preferred stock - par value $0.001; 10,000,000 shares authorized;|
|no shares issued and outstanding||-||-|
|Common stock - par value $0.001; 350,000,000 shares authorized;|
|196,580,212 and 177,928,041 issued and outstanding, respectively||196,580||177,928|
|Additional paid in capital||433,023,801||282,712,078|
|Total stockholders' equity||146,354,356||63,063,146|
|Total liabilities and stockholders' equity||$||158,822,196||$||73,728,846|
|THERAPEUTICSMD, INC. AND SUBSIDIARIES|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Cost of goods sold||1,237,446||1,193,965||3,475,997||3,270,695|
|Sales, general, and administration||14,721,710||7,060,944||35,019,268||20,089,998|
|Research and development||14,664,123||16,421,753||43,602,333||58,789,302|
|Depreciation and amortization||40,460||16,548||84,319||44,400|
|Total operating expense||29,426,293||23,499,245||78,705,920||78,923,700|
|Total other income||112,393||30,390||273,729||86,890|
|Loss before taxes||(25,015,661||)||(19,472,645||)||(67,039,165||)||(67,594,347||)|
|Provision for income taxes||-||-||-||-|
|Net loss per share, basic and diluted||$||(0.13||)||$||(0.11||)||$||(0.34||)||$||(0.39||)|
|Weighted average number of common|
|THERAPEUTICSMD, INC. AND SUBSIDIARIES|
|CONSOLIDATED STATEMENTS OF CASH FLOWS|
|Nine Months Ended|
|September 30, 2016||September 30, 2015|
|CASH FLOWS FROM OPERATING ACTIVITIES|
|Adjustments to reconcile net loss to net cash flows used in|
|Depreciation of fixed assets||45,759||22,104|
|Amortization of intangible assets||38,560||22,296|
|Provision for doubtful accounts||2,261,568||37,163|
|Changes in operating assets and liabilities:|
|Other current assets||379,930||(621,923||)|
|Other current liabilities||703,895||2,546,138|
|Other long-term liabilities||-||1,213,874|
|Net cash used in operating activities||(53,524,389||)||(62,434,546||)|
|CASH FLOWS FROM INVESTING ACTIVITIES|
|Purchase of fixed assets||(307,714||)||(15,559||)|
|Payment of security deposit||(14,036||)||-|
|Net cash used in investing activities||(863,436||)||(133,551||)|
|CASH FLOWS FROM FINANCING ACTIVITIES|
|Proceeds from sale of common stock, net of costs||134,863,475||91,374,649|
|Proceeds from exercise of warrants||1,373,000||366,000|
|Proceeds from exercise of options||979,060||589,829|
|Net cash provided by financing activities||137,215,535||92,330,478|
|Increase in cash||82,827,710||29,762,381|
|Cash, beginning of period||64,706,355||51,361,607|
|Cash, end of period||$||147,534,065||$||81,123,988|