Full Press Release Details
THERAPEUTICSMD, INC. 8-K
Announces First Quarter 2018 Financial Results
$200 Million Non-Dilutive Term Loan Financing Completed to Support Commercialization -
PDUFA target action date of May 29, 2018 for TX-004HR -
PDUFA target action date of October 28, 2018 for TX-001HR -
RATON, Fla. - May 3, 2018 - TherapeuticsMD,
Inc. (NASDAQ: TXMD), an innovative women's
healthcare company, today announced its financial results for the quarter ended March
Quarter and Recent Developments
company has tremendous opportunity in the coming year," said TherapeuticsMD CEO Robert G. Finizio. "We have the potential
for approvals of both of our late-stage product candidates in 2018, representing major inflection points for our company."
of First Quarter 2018 Financial Results
revenue from the company's prescription prenatal vitamin business was approximately $3.8 million for the first quarter of
2018 compared with net revenue of approximately $4.0 million for the prior year's quarter. These changes were primarily
due to a decrease in the average net sales price of the company's products, partially offset by an increase in the number
of goods sold was approximately $0.6 million for the first quarter of 2018, compared with approximately $0.7 million for the prior
operating expenses for the first quarter of 2018 included research and development (R&D) expenses and sales, general, and
administrative expenses (SG&A). R&D expenses for the first quarter of 2018 were approximately $7.0 million compared with
approximately $7.7 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 first quarter of 2018 were approximately $20.8 million compared with
approximately $16.8 million for the prior year's quarter, primarily due to higher sales, marketing, and personnel costs
to support future commercialization.
loss for the first quarter of 2018 was approximately $24.4 million, or $0.11 per basic and diluted share, compared with approximately
$21.2 million, or $0.11 per basic and diluted share, for the first quarter of 2017.
March 31, 2018, cash on hand was approximately $107.3 million, compared with approximately $127.1 million at December 31, 2017.
information regarding the company's loan agreement with MidCap Financial is available in the Current Report on Form 8-K
filed by the Company with the Securities and Exchange Commission today. Cowen acted as lead arranger and financial advisor
to TherapeuticsMD with respect to the MidCap Financial transaction and Oppenheimer & Co. acted as co-financial advisor in
previously announced, TherapeuticsMD will host a conference call today to discuss these financial results and provide a business
update. Details for the call are:
Access (US): 866-665-9531
Access (International): 724-987-6977
Code for All Callers: 9196916
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: 9196916.
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's late stage clinical pipeline includes
two product candidates that have completed phase 3 trials and are awaiting approval by the FDA: 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.
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 FDA will
approve the amended NDA for the company's TX-004HR product candidate and whether such approval will occur by the PDUFA target
action date; 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, 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.
INC. AND SUBSIDIARIES
| March 31, 2018 | December 31, 2017 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 107,349,460 | $ | 127,135,628 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $403,535 and $380,580, respectively | 5,096,731 | 4,328,802 | ||||||
| Inventory | 1,620,872 | 1,485,358 | ||||||
| Other current assets | 5,098,132 | 6,604,284 | ||||||
| Total current assets | 119,165,195 | 139,554,072 | ||||||
| Fixed assets, net | 425,539 | 437,055 | ||||||
| Other Assets: | ||||||||
| Intangible assets, net | 3,220,686 | 3,099,747 | ||||||
| Security deposit | 150,522 | 139,036 | ||||||
| Total other assets | 3,371,208 | 3,238,783 | ||||||
| Total assets | $ | 122,961,942 | $ | 143,229,910 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 6,283,824 | $ | 4,097,600 | ||||
| Other current liabilities | 9,375,818 | 9,223,595 | ||||||
| Total current liabilities | 15,659,642 | 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: 216,584,274 and 216,429,642 issued and outstanding, respectively | 216,584 | 216,430 | ||||||
| Additional paid-in capital | 518,146,665 | 516,351,405 | ||||||
| Accumulated deficit | (411,060,949) | (386,659,120) | ||||||
| Total stockholders' equity | 107,302,300 | 129,908,715 | ||||||
| Total liabilities and stockholders' equity | $ | 122,961,942 | $ | 143,229,910 |
INC. AND SUBSIDIARIES
STATEMENTS OF OPERATIONS
| Three Months Ended | ||||||||
| March 31, 2018 | March 31, 2017 | |||||||
| Revenues, net | $ | 3,773,392 | $ | 3,985,464 | ||||
| Cost of goods sold | 633,623 | 659,635 | ||||||
| Gross profit | 3,139,769 | 3,325,829 | ||||||
| Operating expenses: | ||||||||
| Sales, general, and administrative | 20,757,237 | 16,837,617 | ||||||
| Research and development | 7,039,297 | 7,724,840 | ||||||
| Depreciation and amortization | 59,621 | 49,699 | ||||||
| Total operating expenses | 27,856,155 | 24,612,156 | ||||||
| Operating loss | (24,716,386 | ) | (21,286,327 | ) | ||||
| Other income | ||||||||
| Miscellaneous income | 314,557 | 125,968 | ||||||
| Accreted interest | - | 3,867 | ||||||
| Total other income | 314,557 | 129,835 | ||||||
| Loss before income taxes | (24,401,829 | ) | (21,156,492) | |||||
| Provision for income taxes | - | - | ||||||
| Net loss | $ | (24,401,829 | ) | $ | (21,156,492 | ) | ||
| Loss per share, basic and diluted: | ||||||||
| Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.11 | ) | ||
| Weighted average number of common shares outstanding, basic and diluted | 216,525,316 | 197,790,040 |
INC. AND SUBSIDIARIES
STATEMENTS OF CASH FLOWS
| Three Months Ended | ||||||||
| March 31, 2018 | March 31, 2017 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (24,401,829 | ) | $ | (21,156,492 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 38,424 | 33,600 | ||||||
| Amortization of intangible assets | 21,197 | 16,099 | ||||||
| Provision for (recovery of) doubtful accounts | 22,955 | (1,603 | ) | |||||
| Share-based compensation | 1,751,358 | 1,413,195 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (790,885 | ) | 580,943 | |||||
| Inventory | (135,514 | ) | (262,297 | ) | ||||
| Other current assets | 1,506,152 | (253,518 | ) | |||||
| Accounts payable | 2,186,224 | (1,212,236 | ) | |||||
| Other current liabilities | 152,223 | 316,638 | ||||||
| Net cash used in operating activities | (19,649,695 | ) | (20,525,671 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Patent costs | (142,136 | ) | (107,487 | ) | ||||
| Purchase of fixed assets | (26,908 | ) | (27,834 | ) | ||||
| Payment of security deposit | (11,486 | ) | - | |||||
| Net cash used in investing activities | (180,530 | ) | (135,321 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from exercise of options | 44,057 | 192,310 | ||||||
| Proceeds from exercise of warrants | - | 2,460,000 | ||||||
| Net cash provided by financing activities | 44,057 | 2,652,310 | ||||||
| Decrease in cash | (19,786,168 | ) | (18,008,682 | ) | ||||
| Cash, beginning of period | 127,135,628 | 131,534,101 | ||||||
| Cash, end of period | $ | 107,349,460 | $ | 113,525,419 |