- 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)
- ANNOVERA net product revenue increased 42% to $9.1 million for
the fourth quarter of 2020 as compared to $6.4 million for the
third quarter of 2020. Net revenue per unit, calculated from sales
to wholesalers and pharmacies, was $1,336 for the fourth quarter of
2020.
- Approximately 6,000 ANNOVERA prescriptions were dispensed
during the fourth quarter of 2020. ANNOVERA total prescription
volume increased 15% for the fourth quarter of 2020 as compared to
the third quarter of 2020. Strong refill rates continued with
eligible patients.
IMVEXXY® (estradiol vaginal inserts)
- IMVEXXY net product revenue increased 29% to $8.8 million for
the fourth quarter of 2020 as compared to $6.8 million for the
third quarter of 2020. Net revenue per unit, calculated from sales
to wholesalers and pharmacies, was approximately $54 for the fourth
quarter of 2020. Strong IMVEXXY refill rates continued with
patients adhering to therapy.
- Approximately 123,500 IMVEXXY prescriptions were dispensed
during the fourth quarter of 2020. IMVEXXY new prescription volume
increased 3% for the fourth quarter of 2020 as compared to the
third quarter of 2020, which should positively impact total
prescriptions going forward. IMVEXXY total prescriptions declined
6% for the fourth quarter of 2020 as compared to the third quarter
of 2020 due to the pandemic.
BIJUVA® (estradiol and progesterone)
- BIJUVA net product revenue increased 36% to $2.2 million for
the fourth quarter of 2020 as compared to $1.6 million for the
third quarter of 2020. Net revenue per unit, calculated from sales
to wholesalers and pharmacies, was approximately $52 for the fourth
quarter of 2020.
- Approximately 33,000 BIJUVA prescriptions were dispensed in the
fourth quarter of 2020. BIJUVA new prescription volume for the
fourth quarter of 2020 remained consistent with the third quarter
of 2020. Total prescriptions increased 3% during the same
period.
Cost of Goods Sold/Gross Margin
- Cost of goods sold increased $9.6 million to $15.9 million for
the full-year 2020 compared to $6.3 million for the full-year 2019.
Cost of goods sold increased $2.7 million to $5.6 million for the
fourth quarter of 2020 compared to $2.9 million for the fourth
quarter of 2019.
- Cost of goods sold increased $2.3 million to $5.6 million for
the fourth quarter of 2020 compared to $3.3 million for the third
quarter of 2020.
- The increase in cost of goods sold as compared to the third
quarter is attributable to a 30% increase in product revenue, as
well as an increase of $1.7 million in inventory write-downs of
ANNOVERA, IMVEXXY and BIJUVA.
- Gross margin percentage decreased to 75% for the fourth quarter
of 2020 as compared to 83% for the third quarter of 2020, primarily
as a result of the inventory write-downs recorded in the fourth
quarter of 2020.
Expense, EPS and Related Information
- Total operating expenses for the full-year 2020 increased to
$204.4 million compared with $194.5 million for full-year
2019.
- Total operating expenses for the second half of 2020 were $92.6
million, meeting the Company’s target of $80 million excluding
non-cash items and performance-based retention incentives, which
totaled $13 million.
- Total operating expenses for the fourth quarter of 2020
increased by $10.6 million to $51.6 million as compared to $41.0
million for the fourth quarter of 2019.
- The increase in operating expenses was primarily a result of
increased spending focused on delivering the necessary resources to
support the launch of ANNOVERA, continued ramp-up of IMVEXXY, and
ongoing brand management of BIJUVA.
- Net loss for the full-year 2020 was $183.5 million, or $0.67
per basic and diluted share, compared with $176.1 million, or $0.72
per basic and diluted share, for full-year 2019. For the fourth
quarter of 2020 compared to the prior year period, net loss
decreased to $42.1 million, or $0.15 per basic and diluted share,
compared with $49.4 million, or $0.19 per basic and diluted share.
For the fourth quarter of 2020 compared to the quarter ended
September 30, 2020, net loss increased to $42.1 million, or $0.15
per basic and diluted share, compared with $32.6 million, or $0.12
per basic and diluted share.
Balance Sheet
- As of December 31, 2020, the Company’s cash on hand totaled
$80.5 million, compared with $79.6 million as of September 30,
2020.
- Subsequent to year-end, the Company received approximately
$147.9 million in net proceeds from its at-the-market and
underwritten equity offerings and repaid $15.0 million in principal
under its Financing Agreement, plus a 5% prepayment fee.
Sixth Street Partners Additional Information
- In connection with the adjustment to the Sixth Street Partners
total minimum net revenue covenant, the Company paid down $15
million in principal under its Financing Agreement on March 1,
2021, and agreed to pay down an additional $35 million in principal
by the earlier of March 31, 2021 or the closing of the previously
announced potential divestiture of the Company’s vitaCare
Prescription Services business, in each case plus a 5% prepayment
fee. The lenders also consented to a framework for the potential
vitaCare disposition.
- The total minimum net revenue requirement for ANNOVERA,
IMVEXXY, and BIJUVA in 2021 is now $17 million, $20 million, $23
million, and $26.5 million for the first, second, third, and fourth
quarters, respectively, the first quarter of 2022 is $30 million
then increasing by $5 million per quarter thereafter.
- The Company and the lenders also revised the amortization and
prepayment fee schedules under the Financing Agreement to provide
for repayments in an aggregate amount of $35 million of principal
from the first quarter of 2022 through the first quarter of 2023,
with the remaining balance of the loan payable in equal payments
over the following four quarters.
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:
- IMVEXXY (estradiol vaginal inserts) at
https://imvexxy.com/pi.pdf
- BIJUVA (estradiol and progesterone) capsules at
https://www.bijuva.com/pi.pdf
- ANNOVERA (segesterone acetate and ethinyl estradiol vaginal
system) at www.annovera.com/pi.pdf
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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