-
- PDUFA target action date of
- PDUFA target action date of
First Quarter and Recent Developments
-
Entered into a definitive loan agreement with MidCap Financial,
managed by
Apollo Capital Management, L.P. , for$200 million in non-dilutive term loan financing. The term loan will be available to the company in three tranches following specific milestones throughDecember 31, 2019 :$75 million will be available upon the approval of TX-004HR,$75 million will be available upon the approval and launch of TX-001HR, and$50 million will be available upon certain sales milestones in calendar year 2019, in each case subject to certain terms and conditions.The term loan will accrue interest at 1-month LIBOR plus 7.75%, subject to a LIBOR floor of 1.50%. Interest on amounts borrowed under the term loan will be payable monthly in arrears; principal on each tranche borrowed under the term loan will be payable in 36 equal monthly installments beginningMay 1, 2020 , subject to the company’s ability to extend the interest-only period by an additional 12 months if the company generates certain revenues with respect to TX-004HR and TX-001HR. The maturity date isMay 1, 2023 . -
Entered into negotiations with the U.S. Food and Drug
Administration (
FDA ) regarding the proposed label for TX-004HR, 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, inApril 2018 . The PDUFA target action date for the completion of theFDA's review of the NDA isMay 29, 2018 . -
Submitted the NDA for 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, on
December 28, 2017 . TheFDA in its 74-day letter stated that the application was sufficiently complete to permit a substantive review and that, at such time, theFDA had not identified any potential review issues. The PDUFA target action date for the completion of theFDA's review of the NDA isOctober 28, 2018 . -
Net revenue for the company’s prescription prenatal vitamin business
was approximately
$3.8 million for the first quarter of 2018, compared with approximately$4.0 million for the first quarter of 2017. -
Net loss was approximately
$24.4 million for the first quarter of 2018, compared with approximately$21.2 million for the first quarter of 2017. -
Ended the quarter with approximately
$107.3 million in cash and no debt. - Grew the company’s intellectual property portfolio to a current total of 216 patent filings, including 126 international filings, with one allowed and 19 issued U.S. patents.
“Our company has tremendous opportunity in the coming year,” said
Summary of First Quarter 2018 Financial Results
Net revenue from the company’s prescription prenatal vitamin business
was approximately
Cost of goods sold was approximately
Total 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
Net loss for the first quarter of 2018 was approximately
At
Additional 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
Conference Call Today
As previously announced,
Date: |
Thursday, May 3, 2018 | |
Time: |
4:30 p.m. EST | |
Telephone Access (US): |
866-665-9531 | |
Telephone Access (International): |
724-987-6977 | |
Access Code for All Callers: |
9196916 |
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: 9196916.
About
Forward-Looking Statements
This press release by
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||
CONSOLIDATED BALANCE SHEETS | |||||||
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 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
(Unaudited) | |||||||
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 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||
(Unaudited) | |||||||
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 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20180503006486/en/
Source:
TherapeuticsMD, Inc.
Investor Contact
David
DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com