- 4Q19 Total Net Product Revenue of $15.9
Million Exceeded the Company’s Financial Guidance -
- Full-Year 2019 Total Net Product Revenue of
$34.1 Million at the Top End of Financial Guidance -
- Company Launched ANNOVERA, a Novel,
Long-Lasting Contraceptive -
- Company Expects Full-Year 2020 Net Product
Revenue of $90 Million to $110 Million -
- 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, 2019 and
provided 2020 financial guidance.
“I am very pleased with our commercial team’s execution in 2019,
which has put us in a strong position for 2020. We ended the year
exceeding our fourth quarter net revenue guidance and achieved the
top end of our full-year guidance,” said Robert G. Finizio, Chief
Executive Officer of TherapeuticsMD. “Our goal is to build on this
momentum as we make additional investments in our products to
generate a significant revenue inflection point in 2020.”
Fourth Quarter & Recent Highlights
- Net product revenue for the fourth quarter of 2019 increased
94% to $15.9 million compared to the third quarter of 2019.
- ANNOVERA® (segesterone acetate and ethinyl estradiol vaginal
system) achieved net revenue of $5.8 million for the fourth quarter
of 2019 from sales to wholesalers and pharmacies with an average
net revenue per unit of approximately $1,350.
- ANNOVERA has already achieved market access for the majority of
lives under commercial plans with 75% commercial coverage.
- IMVEXXY® (estradiol vaginal inserts) fourth quarter 2019 net
revenue increased by 33% to $6.3 million compared to the third
quarter of 2019. In the fourth quarter of 2019, approximately
123,000 IMVEXXY prescriptions were dispensed and paid for by
patients. Average calculated net revenue per unit was approximately
$51 for the fourth quarter of 2019. Strong IMVEXXY refill rates
continued with patients adhering to therapy at an average rate of
4.4 fills through December 2019. Those patients on IMEXXY for one
year averaged over six fills.
- IMVEXXY has market access for the majority of lives under
commercial plans with 72% unrestricted commercial coverage. IMVEXXY
is now covered by all of the top ten commercial payors of vulvar
and vaginal atrophy (VVA) products. Three of the top six Medicare
Part D payors of VVA products cover IMVEXXY. Additional Medicare
coverage is expected when the 2020 decisions are made for this
class of products.
- BIJUVA® (estradiol and progesterone) capsules fourth quarter
2019 net revenue increased 147% to $1.2 million compared to the
third quarter of 2019. In the fourth quarter of 2019, approximately
22,000 prescriptions were dispensed and paid for by patients.
Average calculated net revenue per unit was $56 for the fourth
quarter of 2019.
- BIJUVA has market access for the majority of lives under
commercial plans with 56% commercial coverage. BIJUVA is covered by
seven of the top ten commercial payors of vasomotor symptoms (VMS)
products.
Fourth Quarter and Full-Year Revenue Performance
For the year ended December 31, 2019, net product revenue
increased 112% to $34.1 million compared to $16.1 million for the
prior year. Net product revenue for the fourth quarter of 2019
increased 94% to $15.9 million compared to $5.1 million for the
prior year’s quarter.
Three Months Ended December
31,
Twelve Months Ended December
31,
2019
2018
2019
2018
(in thousands)
Prenatal vitamins
$2,576,319
$4,243,398
$9,885,493
$15,041,259
IMVEXXY
6,347,301
846,125
16,252,045
1,058,201
BIJUVA
1,211,456
-
1,836,443
-
ANNOVERA
5,766,604
-
6,166,556
-
License revenue
-
-
15,506,400
-
Net revenue
$15,901,680
$5,089,523
$49,646,937
$16,099,460
Net product revenue increased primarily due to an
increase in sales of $15.2 million of IMVEXXY for the year ended
December 31, 2019, partially offset by a decrease in prenatal
vitamin sales of $5.2 million. Product revenue for the year ended
December 31, 2019 also included sales of BIJUVA of $1.8 million and
sales of ANNOVERA of $6.2 million. The decrease in revenue related
to our prenatal vitamins was primarily affected by a lower number
of units sold as compared to the prior year period.
Net revenue for IMVEXXY and BIJUVA has been greatly affected by
the company’s co-pay assistance programs introduced to provide
products at a reasonable cost regardless of insurance coverage. The
company expects net product revenue to improve as commercial and
Medicare payor coverage increases, and plans complete the process
needed to adjudicate IMVEXXY, BIJUVA and ANNOVERA prescriptions at
pharmacies.
Expense, EPS and Related Information
Research and development (R&D) expenses for the full-year
2019 decreased to $19.8 million, compared with $27.3 million for
the prior year. R&D expenses for the fourth quarter of 2019
were $4.4 million compared with $6.8 million for the prior year’s
quarter. R&D costs decreased primarily as a result of
transferring certain costs and activities from R&D expenses to
operations as they begin to support commercial and launch efforts
after the FDA approval of IMVEXXY and BIJUVA. R&D expenses
include costs related to manufacturing validation as well as early
development trials and employment costs of personnel involved in
R&D activities.
Sales, general and administrative (SG&A) expenses for the
full-year 2019 increased to $174.1 million compared with $116.0
million for the prior year. SG&A expenses increased to $52.7
million for the fourth quarter of 2019 compared with $35.4 million
for the prior year’s quarter. The increase in SG&A expenses for
full-year and fourth quarter 2019 was primarily a result of
increased expenses associated with sales and marketing efforts and
personnel costs to support the launch and commercialization of
IMVEXXY, BIJUVA, and ANNOVERA, including outsourced sales personnel
and their related expenses, physician education, advertising, and
travel expenses related to product commercialization. The company
expects sales and marketing expenses to continue to increase as it
continues the launch of BIJUVA and ANNOVERA and continues to
support its growing business and commercialization of its
products.
Net loss for the full-year 2019 was $176.1 million, or $0.72 per
basic and diluted share, compared with $132.6 million, or $0.59 per
basic and diluted share, for full-year 2018. For the fourth quarter
of 2019, net loss increased to $49.4 million, or $0.19 per basic
and diluted share, compared with $39.4 million, or $0.17 per basic
and diluted share, for the fourth quarter of 2018.
Balance Sheet
As of December 31, 2019, the company’s cash on hand totaled
approximately $160.8 million, compared with approximately $161.6
million at December 31, 2018.
Total outstanding debt, net of issuance costs, was approximately
$194.6 million as of December 31, 2019.
On February 18, 2020, the company received the second tranche of
funding under its financing agreement with TPG Specialty Lending,
Inc. in the amount of $50 million following the company’s
achievement of $11 million in net revenues from IMVEXXY, BIJUVA,
and ANNOVERA for the fourth quarter of 2019.
2020 Financial Guidance
The company projects that product net revenue for 2020 will be
between $90 million to $110 million. The company projects that
product net revenue during the second half of the year will be
significantly larger than the first half with the majority of 2020
product net revenue coming from ANNOVERA and IMVEXXY. The company
anticipates high deductible and annual copay resets will impact
first quarter of 2020 revenue for its menopause products and
expects first quarter 2020 product net revenue to come in below
fourth quarter 2019 product net revenue.
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:
Thursday, February 20, 2020
Time:
8:30 a.m. ET
Telephone Access (US):
866-665-9531
Telephone Access
(International):
724-987-6977
Access Code for All Callers:
7359398
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: 7359398.
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 company’s ability to maintain or increase sales
of its products; the company’s ability to develop and commercialize
IMVEXXY®, ANNOVERA®, BIJUVA® and its hormone therapy drug
candidates and obtain additional financing necessary therefor;
whether the company will be able to comply with the covenants and
conditions under its term loan facility, including the conditions
to draw an additional tranche thereunder and whether the lender
will make such tranche available; 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 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.
THERAPEUTICSMD, INC. AND SUBSIDIARIES CONSOLIDATED
BALANCE SHEETS December 31,
2019
2018
ASSETS Current Assets: Cash
$
160,829,713
$
161,613,077
Accounts receivable, net of allowance for doubtful accounts of
$904,040 and $596,602, respectively 24,395,958 11,063,821 Inventory
11,860,716
3,267,670
Other current assets
11,329,793
10,834,693
Total current assets
208,416,180
186,779,261
Fixed assets, net
2,507,775
472,683
Other Assets: License rights, net
39,221,308
20,000,000
Intangible assets, net
5,258,211
4,092,679
Right of use asset
10,109,154
-
Other current assets
473,009
639,301
Total other assets
55,061,682
24,731,980
Total assets
$
265,985,637
$
211,983,924
LIABILITIES AND STOCKHOLDERS' EQUITY Current
Liabilities: Accounts payable
$
19,181,212
$
22,743,841
Other current liabilities
33,823,613
18,334,948
Total current liabilities
53,004,825
41,078,789
Long-Term Liabilities: Long-term debt
194,634,643
73,381,014
Operating lease liability
9,145,049
-
Total liabilities
256,784,517
114,459,803
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:
271,177,076 and 240,462,439 issued and outstanding, respectively
271,177 240,463 Additional paid-in capital
704,351,222
616,559,938
Accumulated deficit
(695,421,279)
(519,276,280)
Total stockholders' equity
9,201,120
97,524,121
Total liabilities and stockholders' equity
$
265,985,637
$
211,983,924
THERAPEUTICSMD, INC. AND
SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended December 31,
Year Ended December 31,
2019
2018
2019
2018
2017
Product revenues, net
$
15,901,680
$
5,089,523
$
34,140,537
$
16,099,460
$
16,777,713
License revenue
-
-
15,506,400
-
-
15,901,680
5,089,523
49,646,937
16,099,460
16,777,713
Cost of goods sold
2,878,590
950,750
6,334,585
2,737,652
2,636,943
Gross profit
13,023,090
4,138,773
43,312,352
13,361,808
14,140,770
Operating expenses:
Sales, general, and administrative
52,734,093
35,410,875
174,112,612
115,988,954
57,703,370
Research and development
4,432,224
6,753,190
19,792,212
27,299,138
33,852,993
Depreciation and amortization
248,830
95,341
612,786
293,886
213,117
Total operating expenses
57,415,147
42,259,406
194,517,610
143,581,978
91,769,480
Operating loss
(44,392,057)
(38,120,633)
(151,205,258)
(130,220,170)
(77,628,710)
Other (expense) income
Loss on extinguishment of debt
-
-
(10,057,632)
-
-
Miscellaneous income
621,126
823,027
2,500,106
2,280,844
695,631
Interest expense
(5,664,583)
(2,093,375)
(17,382,215)
(4,677,834)
-
Accreted interest
-
-
-
-
7,699
Total other (expense) income
(5,043,457)
(1,270,348)
(24,939,741)
(2,396,990)
703,330
Loss before income taxes
(49,435,514)
(39,390,981)
(176,144,999)
(132,617,160)
(76,925,380)
Provision for income taxes
-
-
-
-
-
Net loss
$
(49,435,514)
$
(39,390,981)
$
(176,144,999)
$
(132,617,160)
$
(76,925,380)
Loss per share, basic and
diluted:
Net loss per share, basic and diluted
$
(0.19)
$
(0.17)
$
(0.72)
$
(0.59)
$
(0.37)
Weighted average number of
common shares outstanding, basic and diluted
261,752,076
238,556,492
246,353,318
225,026,300
205,523,288
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year Ended December, 31,
2019
2018
2017
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$
(176,144,999)
$
(132,617,160)
$
(76,925,380)
Adjustments to reconcile net loss to net cash used in operating
activities: Depreciation of fixed assets
415,193
181,412
141,601
Amortization of intangible assets
197,593
112,474
71,516
Write off of patent and trademark cost
78,864
-
-
Non-cash operating lease expense
1,062,318
-
-
Provision for doubtful accounts
307,438
216,022
4,206
Loss of extinguishment of debt
10,057,632
-
-
Share-based compensation
10,693,662
8,661,967
6,889,323
Amortization of intellectual property license fee
778,692
-
-
Amortization of deferred financing costs
856,302
269,859
-
Changes in operating assets and liabilities: Accounts
receivable
(13,639,575)
(6,951,041)
167,691
Inventory
(8,593,046)
(1,782,312)
(409,037)
Other assets
(1,880,048)
(2,657,190)
(4,434,130)
Accounts payable
(3,562,629)
18,646,241
(3,260,914)
Accrued expenses and other liabilities
13,675,008
9,107,947
1,599,510
Net cash used in operating activities
(165,697,595)
(106,811,781)
(76,155,614)
CASH FLOWS FROM INVESTING ACTIVITIES
Payment for intellectual property license
(20,000,000)
(20,000,000)
-
Patent costs
(1,441,989)
(1,105,407)
(765,291)
Purchase of fixed assets
(2,450,285)
(217,040)
(61,817)
Payment of security deposit
(20,420)
(175,410)
-
Net cash used in investing activities
(23,912,694)
(21,497,857)
(827,108)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from exercise of
options and warrants
108,656
1,666,208
4,011,614
Proceeds from sale of common stock, net of costs
77,031,258
89,907,797
68,572,635
Proceeds from Financing Agreement
200,000,000
-
-
Proceeds from Credit Agreement
-
75,000,000
-
Payment of deferred financing fees
(6,652,270)
(3,786,918)
-
Repayment of Credit Agreement
(81,660,719)
-
-
Net cash provided by financing activities
188,826,925
162,787,087
72,584,249
(Decrease) increase in cash
(783,364)
34,477,449
(4,398,473)
Cash, beginning of period
161,613,077
127,135,628
131,534,101
Cash, end of period
$
160,829,713
$
161,613,077
$
127,135,628
Supplemental disclosure of cash flow
information Interest paid
$
17,787,903
$
1,890,166
$
-
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200220005262/en/
Investor Contact Nichol
Ochsner Vice President, Investor Relations 561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
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