Full Press Release Details
TherapeuticsMD, Inc. 8-K
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
to host conference call today at 8:00 a.m. EST -
February 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
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.
Director, Investor Relations
THERAPEUTICSMD, INC.
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.
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.
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 |