Full Press Release Details
TherapeuticsMD, Inc. 8-K
TherapeuticsMD Announces Fourth Quarter
and Full-Year 2020 Financial Results
- Full-year 2020 total net product revenue increased
84% to $62.9 million compared to 2019 -
- 4Q20 total net product revenue increased 30%
to $22.6 million compared to 3Q20 -
- ANNOVERA net product revenue increased
42% for 4Q20 compared to 3Q20 -
- Financing Agreement amended to update minimum
net revenue covenants for remainder of loan; Company to pay down $50 million in debt -
- vitaCare divesture progressing with multiple
interested parties -
- Conference call scheduled for 8:30 a.m. ET
March 2, 2021 - TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women's healthcare company, today
reported financial results for the full-year and fourth quarter ended December 31, 2020 and provided a business update.
"We delivered a strong year and quarter
with record total net product revenue for our Company," said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD.
"The Company successfully executed on multiple priorities, demonstrating operational agility while maintaining a strict focus
on commercial execution and financial discipline. We have lowered our operating expenses, updated our net revenue covenants for
the remainder of the term of our loan, and strengthened our balance sheet through a series of equity capital raises and a reduction
in our debt." Mr. Finizio continued, "We believe these actions position us well to continue to invest in our products
and deliver on our growth objectives."
Fourth Quarter and Full-Year
| Three Months Ended December 31, | Three Months Ended September 30, | Twelve Months Ended December 31, | ||||||||||||||||||
| 2020 | 2019 | 2020 | 2020 | 2019 | ||||||||||||||||
| IMVEXXY | $ | 8,820,005 | $ | 6,347,301 | $ | 6,841,592 | $ | 27,139,387 | $ | 16,252,045 | ||||||||||
| BIJUVA | 2,244,039 | 1,211,456 | 1,646,320 | 6,353,963 | 1,836,443 | |||||||||||||||
| ANNOVERA | 9,084,074 | 5,766,604 | 6,418,990 | 19,611,286 | 6,166,556 | |||||||||||||||
| Prenatal vitamins | 2,429,667 | 2,576,319 | 2,435,903 | 9,767,644 | 9,885,493 | |||||||||||||||
| License revenue | - | - | 2,000,000 | 2,000,000 | 15,506,400 | |||||||||||||||
| Net revenue | $ | 22,577,785 | $ | 15,901,680 | $ | 19,342,805 | $ | 64,872,280 | $ | 49,646,937 |
ANNOVERA (segesterone acetate
and ethinyl estradiol vaginal system)
(estradiol vaginal inserts)
(estradiol and progesterone)
Cost of Goods Sold/Gross
Sixth Street Partners Additional Information
Conference Call and Webcast Details
TherapeuticsMD will host a conference
call and live audio webcast today at 8:30 a.m. ET to discuss these financial results and provide a business update.
| Date: | Tuesday, March 2, 2021 |
| Time: | 8:30 a.m. ET |
| Telephone Access (US): | 866-665-9531 |
| Telephone Access (International): | 724-987-6977 |
| Access Code for All Callers: | 6184646 |
A 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: 6184646.
Please see the Full Prescribing Information,
including indication and Boxed WARNING, for each TherapeuticsMD product as follows:
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 effects of the COVID-19 pandemic;
the company's ability to maintain or increase sales of its products; the company's ability to develop and commercialize
IMVEXXY , ANNOVERA , and BIJUVA and obtain additional financing necessary therefor; whether the company will be able
to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest
its vitaCare business and how the proceeds that may be generated by any such divestiture will be utilized; the potential of adverse
side effects or other safety risks that could adversely affect the commercialization of the company's current or future approved
products or preclude the approval of the company's future drug candidates; whether the FDA will approve the lower dose of
BIJUVA; the company's ability to protect its intellectual property, including with respect to the Paragraph IV notice letters
the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company's
reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company's
licensees to commercialize and distribute the company's products; the ability of the company's marketing contractors
to market ANNOVERA; 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.
Vice President, Investor Relations
561-961-1900, ext. 2088
INC. AND SUBSIDIARIES
| December 31, | ||||||||
| 2020 | 2019 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 80,485,784 | $ | 160,829,713 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $1,117,854 and $904,040, respectively | 32,381,701 | 24,395,958 | ||||||
| Inventory, net | 7,993,087 | 11,860,716 | ||||||
| Other current assets | 7,543,397 | 11,329,793 | ||||||
| Total current assets | 128,403,969 | 208,416,180 | ||||||
| Fixed assets, net | 1,942,224 | 2,507,775 | ||||||
| Other Assets: | ||||||||
| License rights, net | 36,196,916 | 39,221,308 | ||||||
| Intangible assets, net | 5,247,723 | 5,258,211 | ||||||
| Right of use assets | 9,565,700 | 10,109,154 | ||||||
| Other current assets | 253,121 | 473,009 | ||||||
| Total other assets | 51,263,460 | 55,061,682 | ||||||
| Total assets | $ | 181,609,653 | $ | 265,985,637 | ||||
| LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 21,068,327 | $ | 19,181,212 | ||||
| Other current liabilities | 38,169,869 | 33,823,613 | ||||||
| Total current liabilities | 59,238,196 | 53,004,825 | ||||||
| Long-Term Liabilities: | ||||||||
| Long-term debt | 237,697,531 | 194,634,643 | ||||||
| Operating lease liability | 8,675,477 | 9,145,049 | ||||||
| Total long-term liabilities | 246,373,008 | 203,779,692 | ||||||
| Total liabilities | 305,611,204 | 256,784,517 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders' (Deficit) Equity: | ||||||||
| Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding | - | - | ||||||
| Common stock - par value $0.001; 600,000,000 and 350,000,000 shares authorized: 299,765,396 and 271,177,076 issued and outstanding, respectively | 299,765 | 271,177 | ||||||
| Additional paid-in capital | 754,644,100 | 704,351,222 | ||||||
| Accumulated deficit | (878,945,416 | ) | (695,421,279 | ) | ||||
| Total stockholders' (deficit) equity | (124,001,551 | ) | 9,201,120 | |||||
| Total liabilities and stockholders' (deficit) equity | $ | 181,609,653 | $ | 265,985,637 |
INC. AND SUBSIDIARIES
STATEMENTS OF OPERATIONS
| Three Months Ended December 31, | Three Months Ended September 30, | Year Ended December 31, | ||||||||||||||||||||||
| 2020 | 2019 | 2020 | 2020 | 2019 | 2018 | |||||||||||||||||||
| Product revenues, net | $ | 22,577,785 | $ | 15,901,680 | $ | 17,342,805 | $ | 62,872,280 | $ | 34,140,537 | $ | 16,099,460 | ||||||||||||
| License revenue | - | - | 2,000,000 | 2,000,000 | 15,506,400 | - | ||||||||||||||||||
| Total revenue, net | 22,577,785 | 15,901,680 | 19,342,805 | 64,872,280 | 49,646,937 | 16,099,460 | ||||||||||||||||||
| Cost of goods sold | 5,580,832 | 2,878,590 | 3,278,609 | 15,974,977 | 6,334,585 | 2,737,652 | ||||||||||||||||||
| Gross profit | 16,996,953 | 13,023,090 | 16,064,196 | 48,897,303 | 43,312,352 | 13,361,808 | ||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||
| Sales, general, and administrative | 48,945,068 | 52,734,093 | 38,751,250 | 192,963,967 | 174,112,612 | 115,988,954 | ||||||||||||||||||
| Research and development | 2,393,851 | 4,432,224 | 2,027,195 | 10,431,907 | 19,792,212 | 27,299,138 | ||||||||||||||||||
| Depreciation and amortization | 264,832 | 248,830 | 258,787 | 1,042,170 | 612,786 | 293,886 | ||||||||||||||||||
| Total operating expenses | 51,603,751 | 57,415,147 | 41,037,232 | 204,438,044 | 194,517,610 | 143,581,978 | ||||||||||||||||||
| Operating loss | (34,606,798 | ) | (44,392,057 | ) | (24,973,036 | ) | (155,540,741 | ) | (151,205,258 | ) | (130,220,170 | ) | ||||||||||||
| Other (expense) income | ||||||||||||||||||||||||
| Loss on extinguishment of debt | - | - | - | - | (10,057,632 | ) | - | |||||||||||||||||
| Miscellaneous income | 131,902 | 621,126 | 41,405 | 597,647 | 2,500,106 | 2,280,844 | ||||||||||||||||||
| Interest expense | (7,612,701 | ) | (5,664,583 | ) | (7,679,443 | ) | (28,581,043 | ) | (17,382,215 | ) | (4,677,834 | ) | ||||||||||||
| Total other expense | (7,480,799 | ) | (5,043,457 | ) | (7,638,038 | ) | (27,983,396 | ) | (24,939,741 | ) | (2,396,990 | ) | ||||||||||||
| Loss before income taxes | (42,087,597 | ) | (49,435,514 | ) | (32,611,074 | ) | (183,524,137 | ) | (176,144,999 | ) | (132,617,160 | ) | ||||||||||||
| Provision for income taxes | - | - | - | |||||||||||||||||||||
| Net loss | $ | (42,087,597 | ) | $ | (49,435,514 | ) | $ | (32,611,074 | ) | $ | (183,524,137 | ) | $ | (176,144,999 | ) | $ | (132,617,160 | ) | ||||||
| Loss per share, basic and diluted: | ||||||||||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.15 | ) | $ | (0.19 | ) | $ | (0.12 | ) | $ | (0.67 | ) | $ | (0.72 | ) | $ | (0.59 | ) | ||||||
| Weighted average number of common shares outstanding, basic and diluted | 286,607,277 | 261,752,076 | 272,564,635 | 275,648,552 | 246,353,318 | 225,026,300 |
INC. AND SUBSIDIARIES
STATEMENTS OF CASH FLOWS
| Year Ended December, 31, | ||||||||||||
| 2020 | 2019 | 2018 | ||||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||||
| Net loss | $ | (183,524,137 | ) | $ | (176,144,999 | ) | $ | (132,617,160 | ) | |||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
| Depreciation of fixed assets | 772,624 | 415,193 | 181,412 | |||||||||
| Amortization of intangible assets | 269,546 | 197,593 | 112,474 | |||||||||
| Write off of patent and trademark cost | 1,131,776 | 78,864 | - | |||||||||
| Write off of deferred financing fees | 275,379 | - | - | |||||||||
| Non-cash operating lease expense | 1,405,443 | 1,062,318 | - | |||||||||
| Provision for doubtful accounts | 213,814 | 307,438 | 216,022 | |||||||||
| Lease impairment | 136,832 | . | - | |||||||||
| Inventory charge | 7,204,818 | - | - | |||||||||
| Loss on extinguishment of debt | - | 10,057,632 | - | |||||||||
| Share-based compensation | 10,678,992 | 10,693,662 | 8,661,967 | |||||||||
| Amortization of intellectual property license fee | 3,024,391 | 778,692 | - | |||||||||
| Amortization of deferred financing costs | 2,256,429 | 856,302 | 269,859 | |||||||||
| Changes in operating assets and liabilities: | ||||||||||||
| Accounts receivable | (8,199,558 | ) | (13,639,575 | ) | (6,951,041 | ) | ||||||
| Inventory | (3,337,189 | ) | (8,593,046 | ) | (1,782,312 | ) | ||||||
| Other assets | 3,429,443 | (1,880,048 | ) | (2,657,190 | ) | |||||||
| Accounts payable | 1,887,115 | (3,562,629 | ) | 18,646,241 | ||||||||
| Accrued expenses and other liabilities | 2,903,947 | 13,675,008 | 9,107,947 | |||||||||
| Net cash used in operating activities | (159,470,335 | ) | (165,697,595 | ) | (106,811,781 | ) | ||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||||
| Payment for intellectual property license | - | (20,000,000 | ) | (20,000,000 | ) | |||||||
| Patent costs | (1,390,834 | ) | (1,441,989 | ) | (1,105,407 | ) | ||||||
| Purchase of fixed assets | (207,073 | ) | (2,450,285 | ) | (217,040 | ) | ||||||
| Payment of security deposit | - | (20,420 | ) | (175,410 | ) | |||||||
| Net cash used in investing activities | (1,597,907 | ) | (23,912,694 | ) | (21,497,857 | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||||
| Proceeds from exercise of options and warrants | 271,678 | 108,656 | 1,666,208 | |||||||||
| Proceeds from sale of common stock, net of costs | 31,702,635 | 77,031,258 | 89,907,797 | |||||||||
| Proceeds from Financing Agreement | 50,000,000 | 200,000,000 | - | |||||||||
| Proceeds from Credit Agreement | - | - | 75,000,000 | |||||||||
| Payment of deferred financing fees | (1,250,000 | ) | (6,652,270 | ) | (3,786,918 | ) | ||||||
| Repayment of Credit Agreement | - | (81,660,719 | ) | - | ||||||||
| Net cash provided by financing activities | 80,724,313 | 188,826,925 | 162,787,087 | |||||||||
| (Decrease) increase in cash | (80,343,929 | ) | (783,364 | ) | 34,477,449 | |||||||
| Cash, beginning of period | 160,829,713 | 161,613,077 | 127,135,628 | |||||||||
| Cash, end of period | $ | 80,485,784 | $ | 160,829,713 | $ | 161,613,077 | ||||||
| Supplemental disclosure of cash flow information | ||||||||||||
| Interest paid | $ | 25,849,236 | $ | 17,787,903 | $ | 1,890,166 | ||||||
| Non-cash investing activity | ||||||||||||
| Warrant granted in relation to Financing Agreement | $ | 7,668,161 | $ | - | $ | - |