Full Press Release Details
Announces Third Quarter 2020 Financial Results
- Significant growth in net revenue, net revenue
per unit and prescriptions across product portfolio-
-Total net revenue increased 80% to $19.3 million
ANNOVERA net revenue increased 250% for 3Q20 compared
- Menopausal products achieved double digit
growth in new and total prescriptions for 3Q20 compared to 2Q20-
-Reduced 3Q20 cash burn by $22 million compared
-Process to divest vitaCare Prescription Services
underway that could generate non-dilutive proceeds-
-Sixth Street reduces minimum cash requirement
from $60 million to $45 million through year end-
- Conference call scheduled for 8:30 a.m. ET
November 9, 2020 - TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women's healthcare company, today
reported financial results for the third quarter ended September 30, 2020.
"We delivered a strong quarter
that resulted in record growth across our product portfolio in the midst of a pandemic and beat net revenue consensus estimates
for the sixth quarter in a row," said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD. "During the quarter,
we significantly reduced our operating expenses and cash burn."
Third Quarter 2020 Summary
ANNOVERA (segesterone
acetate and ethinyl estradiol vaginal system)
IMVEXXY (estradiol vaginal
BIJUVA (estradiol and progesterone)
| Three Months Ended September 30, 2020 | Three Months Ended September 30, 2019 | Three Months Ended June 30, 2020 | ||||||||||
| ANNOVERA | $ | 6,418,990 | $ | 399,952 | $ | 1,835,460 | ||||||
| IMVEXXY | 6,841,592 | 4,772,354 | 5,085,190 | |||||||||
| BIJUVA | 1,646,320 | 490,705 | 1,352,001 | |||||||||
| Prenatal vitamins | 2,435,903 | 2,550,330 | 2,428,382 | |||||||||
| Licensing revenue | 2,000,000 | 15,506,400 | - | |||||||||
| Net revenue | $ | 19,342,805 | $ | 23,719,741 | $ | 10,701,033 |
Potential vitaCare Divesture
TherapeuticsMD today announced the commencement
of a process to divest vitaCare Prescription Services. In recent months, the COVID-19 pandemic has highlighted the value of pharmaceutical
companies being able to connect directly with patients. The Company's vitaCare Prescription Services model is designed to
make a complex process of filling prescriptions simple, cost-effective, and stress free for patients. This in combination with
the rise of interest and investment in other hub service and pharmacy services companies has driven outside interest in vitaCare
both from pharmaceutical companies seeking to utilize vitaCare for their products and from potential partners or sponsors seeking
to acquire a controlling interest in vitaCare. The Company's goal is to unlock substantial value for its shareholders by
divesting vitaCare to a partner who can capitalize the business opportunity. Based on initial indications received, the Company
believes the enterprise value of vitaCare with the right partner can be upwards of $100 million, and, depending on the ultimate
transaction structure, could potentially generate at least $50 million in non-dilutive proceeds to the Company, while also retaining
an interest in the newly-capitalized business. The Company intends that vitaCare's existing dedicated management team will
continue to operate the business to ensure the current level of service to TherapeuticsMD and new customers. The Company has retained
Greenhill & Co. as an advisor for the transaction.
The Company entered into an agreement with its lender, Sixth
Street Partners, to lower the minimum cash balance requirement under the Company's Financing Agreement from $60 million to
$45 million through year end.
Conference Call and Webcast
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: | Monday, November 9, 2020 |
| Time: | 8:30 a.m. ET |
| Telephone Access (US): | 866-665-9531 |
| Telephone Access (International): | 724-987-6977 |
| Access Code for All Callers: | 7747227 |
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: 7747227.
Please see the Full Prescribing Information, including indication
and Boxed WARNING, for each TherapeuticsMD product as follows:
About TherapeuticsMD
TherapeuticsMD, Inc. is an innovative,
leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed
to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus
in family planning, reproductive health, and menopause management. The Company is committed to advancing the health of women and
championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit www.therapeuticsmd.com or
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 the proceeds that may be generated by such divestiture; 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 efficacy supplement for 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.
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.
Vice President, Investor Relations
561-961-1900, ext. 2088
INC. AND SUBSIDIARIES
| September 30, 2020 | December 31, 2019 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 79,633,675 | $ | 160,829,713 | ||||
| Accounts receivable, net of allowance for doubtful accounts | ||||||||
| of $857,176 and $904,040, respectively | 24,059,095 | 24,395,958 | ||||||
| Inventory, net | 9,932,304 | 11,860,716 | ||||||
| Other current assets | 8,819,239 | 11,329,793 | ||||||
| Total current assets | 122,444,313 | 208,416,180 | ||||||
| Fixed assets, net | 1,969,929 | 2,507,775 | ||||||
| Other Assets: | ||||||||
| License rights, net | 36,959,305 | 39,221,308 | ||||||
| Intangible assets, net | 5,537,885 | 5,258,211 | ||||||
| Right of use assets | 9,975,725 | 10,109,154 | ||||||
| Other assets | 403,643 | 473,009 | ||||||
| Total other assets | 52,876,558 | 55,061,682 | ||||||
| Total assets | $ | 177,290,800 | $ | 265,985,637 | ||||
| LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 16,109,638 | $ | 19,181,212 | ||||
| Other current liabilities | 31,220,484 | 33,823,613 | ||||||
| Total current liabilities | 47,330,122 | 53,004,825 | ||||||
| Long-Term Liabilities: | ||||||||
| Long-term debt | 237,051,202 | 194,634,643 | ||||||
| Operating lease liability | 8,907,995 | 9,145,049 | ||||||
| Other long-term liabilities | 35,000 | - | ||||||
| Total long-term liabilities | 245,994,197 | 203,779,692 | ||||||
| Total liabilities | 293,324,319 | 256,784,517 | ||||||
| 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; 600,000,000 and 350,000,000 | ||||||||
| shares authorized: 272,812,271 and 271,177,076 issued and | ||||||||
| outstanding, respectively | 272,812 | 271,177 | ||||||
| Additional paid-in capital | 720,551,488 | 704,351,222 | ||||||
| Accumulated deficit | (836,857,819 | ) | (695,421,279 | ) | ||||
| Total stockholders' (deficit) equity | (116,033,519 | ) | 9,201,120 | |||||
| Total liabilities and stockholders' (deficit) equity | $ | 177,290,800 | $ | 265,985,637 |
INC. AND SUBSIDIARIES
STATEMENTS OF OPERATIONS
| Three Months Ended | Three Months Ended | Nine Months Ended | ||||||||||||||||||
| September 30, | June 30, | September 30, | ||||||||||||||||||
| 2020 | 2019 | 2020 | 2020 | 2019 | ||||||||||||||||
| Product revenue, net | $ | 17,342,805 | $ | 8,213,341 | $ | 10,701,033 | $ | 40,294,495 | $ | 18,238,857 | ||||||||||
| License revenue | 2,000,000 | 15,506,400 | - | 2,000,000 | 15,506,400 | |||||||||||||||
| Total revenue, net | 19,342,805 | 23,719,741 | 10,701,033 | 42,294,495 | 33,745,257 | |||||||||||||||
| Cost of goods sold | 3,278,609 | 1,444,308 | 4,400,485 | 10,394,145 | 3,455,995 | |||||||||||||||
| Gross profit | 16,064,196 | 22,275,433 | 6,300,548 | 31,900,350 | 30,289,262 | |||||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Sales, general, and administrative | 38,751,250 | 45,126,986 | 48,340,628 | 144,018,899 | 121,378,519 | |||||||||||||||
| Research and development | 2,027,195 | 4,077,738 | 2,742,032 | 8,038,056 | 15,359,988 | |||||||||||||||
| Depreciation and amortization | 258,787 | 141,959 | 256,557 | 777,338 | 363,956 | |||||||||||||||
| Total operating expenses | 41,037,232 | 49,346,683 | 51,339,217 | 152,834,293 | 137,102,463 | |||||||||||||||
| Operating loss | (24,973,036 | ) | (27,071,250 | ) | (45,038,669 | ) | (120,933,943 | ) | (106,813,201 | ) | ||||||||||
| Other (expense) income | ||||||||||||||||||||
| Loss on extinguishment of debt | - | - | - | - | (10,057,632 | ) | ||||||||||||||
| Miscellaneous income | 41,405 | 703,662 | 88,858 | 465,745 | 1,878,980 | |||||||||||||||
| Interest expense | (7,679,443 | ) | (5,599,005 | ) | (7,026,853 | ) | (20,968,342 | ) | (11,717,632 | ) | ||||||||||
| Total other expense, net | (7,638,038 | ) | (4,895,343 | ) | (6,937,995 | ) | (20,502,597 | ) | (19,896,284 | ) | ||||||||||
| Loss before income taxes | (32,611,074 | ) | (31,966,593 | ) | (51,976,664 | ) | (141,436,540 | ) | (126,709,485 | ) | ||||||||||
| Provision for income taxes | - | - | - | - | - | |||||||||||||||
| Net loss | $ | (32,611,074 | ) | $ | (31,966,593 | ) | $ | (51,976,664 | ) | $ | (141,436,540 | ) | $ | (126,709,485 | ) | |||||
| Loss per share, basic and diluted: | ||||||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.12 | ) | $ | (0.13 | ) | $ | (0.19 | ) | $ | (0.52 | ) | $ | (0.53 | ) | |||||
| Weighted average number of common | ||||||||||||||||||||
| shares outstanding, basic and diluted | 272,564,635 | 241,261,299 | 271,876,238 | 271,968,981 | 241,163,994 |
INC. AND SUBSIDIARIES
STATEMENTS OF CASH FLOWS