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Share Name | Share Symbol | Market | Type |
---|---|---|---|
TherapeuticsMD Inc | NASDAQ:TXMD | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.01 | -0.53% | 1.86 | 1.86 | 1.88 | 1.90 | 1.86 | 1.87 | 6,236 | 21:41:16 |
- 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 today -
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 Revenue
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)
IMVEXXY® (estradiol vaginal inserts)
BIJUVA® (estradiol and progesterone)
Cost of Goods Sold/Gross Margin
Expense, EPS and Related Information
Balance Sheet
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.
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
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
THERAPEUTICSMD, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS Year Ended December 31, Three Months Ended December 31, Three Months Ended September 30,
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
THERAPEUTICSMD, INC. AND SUBSIDIARIES CONSOLIDATED 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
$
-
$
-
View source version on businesswire.com: https://www.businesswire.com/news/home/20210302005416/en/
Investor Contact Nichol Ochsner Vice President, Investor Relations 561-961-1900, ext. 2088 Nochsner@TherapeuticsMD.com
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