Full Press Release Details
TherapeuticsMD, Inc. 8-K
Announces Second Quarter 2018 Financial Results
early experience program underway; national launch to commence August 6, 2018-
target action date of October 28, 2018 for TX-001HR-
RATON, Fla. - July 30, 2018 - TherapeuticsMD, Inc. (NASDAQ:
TXMD), an innovative women's healthcare
company, today announced its financial results for the quarter ended June 30, 2018.
Quarter and Recent Developments
| Ended the quarter with approximately $154.4 million in cash and approximately $73.1 million in outstanding debt. | ||
| Grew the company's intellectual property portfolio to a current total of 237 global patent applications with 20 issued foreign patents and 19 issued U.S. patents. |
made important progress during the first half of 2018 that has given us an exciting start to the year," said Robert G. Finizio,
Chief Executive Officer of TherapeuticsMD. "We are focused on commercial and operational execution with the launch of Imvexxy
and an approaching PDUFA date for TX-001HR."
of Second Quarter 2018 Financial Results
revenue from the company's prescription prenatal vitamin business was approximately $3.8 million for the second quarter
of 2018 compared with net revenue of approximately $4.3 million for the prior year's quarter. This decrease was primarily
attributable to a decrease in the average net revenue per unit of the company's products, which was primarily related to
higher estimates related to offered discounts in 2018, partially offset by an increase in the number of units sold.
of goods sold was approximately $0.5 million for the second quarter of 2018, compared with approximately $0.7 million for the
prior year's quarter.
operating expenses for the second quarter of 2018 included research and development (R&D) expenses and sales, general, and
administrative expenses (SG&A). R&D expenses for the second quarter of 2018 were approximately $6.8 million compared with
approximately $8.7 million for the prior year's quarter. The decrease in R&D was a direct result of the completion of
the Replenish Trial for TX-001HR. SG&A expenses for the second quarter of 2018 were approximately $29.5 million compared with
approximately $14.6 million for the prior year's quarter, primarily due to higher sales, marketing, and personnel costs
to support commercialization of Imvexxy and pre-commercialization expenses for TX-001HR.
loss for the second quarter of 2018 was approximately $33.2 million, or $0.15 per basic and diluted share, compared with approximately
$19.7 million, or $0.10 per basic and diluted share, for the second quarter of 2017.
of June 30, 2018, the company's cash on hand totaled approximately $154.4 million, compared with approximately $127.1 million
at December 31, 2018. Total outstanding debt, net of issuance of costs, was approximately $73.1 million as of June 30, 2018.
Call and Webcast Details
will host a conference call and audio webcast this morning, July 30, 2018, at 8:30 a.m. ET to present second quarter 2018 results
and provide a business update.
Access (US): 866-665-9531
Access (International): 724-987-6977
Code for All Callers: 8884867
live webcast and audio archive for the event may be accessed on the home page or from the "Investors & Media"
section of the TherapeuticsMD website at www.therapeuticsmd.com.
Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may
be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least 30 days. In addition,
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: 8884867
(estradiol vaginal inserts) is approved in the U.S. for the treatment of moderate-to-severe dyspareunia (vaginal pain associated
with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Imvexxy is the only product in its therapeutic
class to offer a 4 mcg and 10 mcg dose, the 4 mcg representing the lowest approved dose of vaginal estradiol available. The full
prescribing information may be viewed by visiting www.Imvexxy.com.
SAFETY INFORMATION FOR IMVEXXY
note that this information is not comprehensive. Please visit www.Imvexxy.com
for the Full Prescribing Information, including the Boxed Warning.
TherapeuticsMD, Inc.
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 recently received FDA approval
for TX-004HR, branded as Imvexxy (estradiol vaginal inserts), for the treatment of moderate to severe dyspareunia, a symptom
of vulvar and vaginal atrophy, due to menopause. The company's late stage clinical pipeline includes TX-001HR being evaluated
for treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause. The company also manufactures and distributes branded
and generic prescription prenatal vitamins under the vitaMedMD and BocaGreenMD brands.
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: whether the FDA will approve the NDA for the company's TX-001HR product candidate and whether
such approval will occur by the PDUFA target action date; 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 be able to comply with the covenants and conditions under its term loan agreement; 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 or adversely affect the commercialization of
the company's current or future approved products; 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
President Investor Relations
INC. AND SUBSIDIARIES
| June 30, 2018 | December 31, 2017 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 154,386,930 | $ | 127,135,628 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $418,604 and $380,580, respectively | 5,625,987 | 4,328,802 | ||||||
| Inventory | 1,880,577 | 1,485,358 | ||||||
| Other current assets | 5,203,734 | 6,604,284 | ||||||
| Total current assets | 167,097,228 | 139,554,072 | ||||||
| Fixed assets, net | 403,574 | 437,055 | ||||||
| Other Assets: | ||||||||
| Intangible assets, net | 3,488,401 | 3,099,747 | ||||||
| Prepaid expenses-long term | 759,229 | - | ||||||
| Security deposit | 150,522 | 139,036 | ||||||
| Total other assets | 4,398,152 | 3,238,783 | ||||||
| Total assets | $ | 171,898,954 | $ | 143,229,910 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 11,427,160 | $ | 4,097,600 | ||||
| Accrued expenses and other current liabilities | 9,785,210 | 9,223,595 | ||||||
| Total current liabilities | 21,212,370 | 13,321,195 | ||||||
| Long-term Liabilities: | ||||||||
| Long-term debt | 73,141,311 | - | ||||||
| Total long-term liabilities | 73,141,311 | - | ||||||
| Total liabilities | 94,353,681 | 13,321,195 | ||||||
| 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: | ||||||||
| 216,834,059 and 216,429,642 issued and outstanding, respectively | 216,834 | 216,430 | ||||||
| Additional paid-in capital | 521,608,436 | 516,351,405 | ||||||
| Accumulated deficit | (444,279,997 | ) | (386,659,120 | ) | ||||
| Total stockholders' equity | 77,545,273 | 129,908,715 | ||||||
| Total liabilities and stockholders' equity | $ | 171,898,954 | $ | 143,229,910 |
INC. AND SUBSIDIARIES
STATEMENTS OF OPERATIONS
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenues, net | $ | 3,763,010 | $ | 4,250,433 | $ | 7,536,402 | $ | 8,235,897 | ||||||||
| Cost of goods sold | 454,161 | 681,725 | 1,087,784 | 1,341,360 | ||||||||||||
| Gross profit | 3,308,849 | 3,568,708 | 6,448,618 | 6,894,537 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales, general, and administration | 29,466,770 | 14,628,927 | 50,224,007 | 31,466,544 | ||||||||||||
| Research and development | 6,798,380 | 8,716,395 | 13,837,677 | 16,441,235 | ||||||||||||
| Depreciation and amortization | 65,603 | 53,189 | 125,224 | 102,888 | ||||||||||||
| Total operating expense | 36,330,753 | 23,398,511 | 64,186,908 | 48,010,667 | ||||||||||||
| Operating loss | (33,021,904 | ) | (19,829,803 | ) | (57,738,290 | ) | (41,116,130 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Miscellaneous income | 334,238 | 149,054 | 648,795 | 275,022 | ||||||||||||
| Accreted interest | - | 3,832 | - | 7,699 | ||||||||||||
| Interest expense | (531,382 | ) | - | (531,382 | ) | - | ||||||||||
| Total other (expense) income | (197,144 | ) | 152,886 | 117,413 | 282,721 | |||||||||||
| Loss before taxes | (33,219,048 | ) | (19,676,917 | ) | (57,620,877 | ) | (40,833,409 | ) | ||||||||
| Provision for income taxes | - | - | - | - | ||||||||||||
| Net loss | $ | (33,219,048 | ) | $ | (19,676,917 | ) | $ | (57,620,877 | ) | $ | (40,833,409 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.15 | ) | $ | (0.10 | ) | $ | (0.27 | ) | $ | (0.20 | ) | ||||
| Weighted average number of common shares outstanding | 216,640,186 | 203,384,610 | 216,583,067 | 200,602,778 |
INC. AND SUBSIDIARIES
STATEMENTS OF CASH FLOWS
| Six Months Ended | ||||||||
| June 30, 2018 | June 30, 2017 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (57,620,877 | ) | $ | (40,833,409 | ) | ||
| Adjustments to reconcile net loss to net cash flows used in operating activities: | ||||||||
| Depreciation of fixed assets | 79,201 | 69,000 | ||||||
| Amortization of intangible assets | 46,023 | 33,888 | ||||||
| Provision for (recovery of) doubtful accounts | 38,024 | (18,106 | ) | |||||
| Share-based compensation | 4,128,440 | 3,051,357 | ||||||
| Amortization of deferred financing costs | 30,155 | - | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (1,335,209 | ) | 1,122,386 | |||||
| Inventory | (395,219 | ) | (337,694 | ) | ||||
| Other current assets | 2,539,394 | (58,601 | ) | |||||
| Accounts payable | 7,329,560 | 749,520 | ||||||
| Accrued interest | 501,227 | - | ||||||
| Accrued expenses and other current liabilities | 60,388 | (2,443,867 | ) | |||||
| Net cash used in operating activities | (44,598,893 | ) | (38,665,526 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Patent costs | (434,677 | ) | (367,602 | ) | ||||
| Purchase of fixed assets | (45,720 | ) | (35,849 | ) | ||||
| Payment of security deposit | (11,486 | ) | - | |||||
| Net cash used in investing activities | (491,883 | ) | (403,451 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from term loan | 75,000,000 | - | ||||||
| Payment of deferred financing fees | (3,786,918 | ) | - | |||||
| Proceeds from exercise of options | 1,128,996 | 212,360 | ||||||
| Proceeds from exercise of warrants | - | 3,798,999 | ||||||
| Net cash provided by financing activities | 72,342,078 | 4,011,359 | ||||||
| Increase (decrease) in cash | 27,251,302 | (35,057,618 | ) | |||||
| Cash, beginning of period | 127,135,628 | 131,534,101 | ||||||
| Cash, end of period | $ | 154,386,930 | $ | 96,476,483 |