- 1Q21 total net revenue increased to $19.9
million -
- 1Q21 total net product revenue increased 60%
to $19.6 million compared to 1Q20 -
- ANNOVERA prescriptions continue to grow with
increasing consumer support and acceptance -
- Further strengthened ANNOVERA® patent family
through June 2039 –
- Significantly improved average net revenue
per unit for IMVEXXY® to $61 and BIJUVA® to $69 -
-vitaCare’s divesture process continues in an
effort to unlock shareholder value-
- 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 first quarter ended March 31, 2021.
“I am pleased with our ongoing execution across the
organization, which is in-line with our 2021 operating plan led by
ANNOVERA, which performed well in a challenging environment. Our
financial performance continues to improve year-over-year. Both
menopausal products, IMVEXXY and BIJUVA, had record net revenue per
unit. We are also pleased to report that three new ANNOVERA patents
were obtained, strengthening durability and extending exclusivity
through June 2039. The Company won its appeal for the new low-dose
BIJUVA 0.5/100 with the FDA. We are confident that these
milestones, together with our existing and new commercial
strategies, will continue to deliver strong growth throughout
2021,” said Robert G. Finizio, Chief Executive Officer of
TherapeuticsMD.
First Quarter Review
Total net product revenue for the first quarter of 2021
increased 60% to $19.6 million compared to the first quarter of
2020. When compared to the fourth quarter of 2020, total net
product revenue decreased by 13% for the first quarter of 2021.
ANNOVERA (segesterone acetate and ethinyl estradiol vaginal
system)
- ANNOVERA net product revenue increased by $6.5 million to $8.8
million for the first quarter of 2021 as compared to $2.3 million
for the first quarter of 2020.
- Net revenue per unit, calculated from sales to wholesalers and
pharmacies, was $1,071 for the first quarter of 2021. The Company
expects net revenue per unit for ANNOVERA to average approximately
$1,100 for the year.
- Approximately 6,240 ANNOVERA prescriptions were dispensed to
patients during the first quarter of 2021. ANNOVERA total
prescription volume increased 164% for the first quarter of 2021 as
compared to the first quarter of 2020. ANNOVERA total prescription
volume increased 5% for the first quarter of 2021 as compared to
the fourth quarter of 2020. Strong refill rates continued with
eligible patients.
- During the first quarter the United States Patent and Trademark
Office (USPTO) issued three new ANNOVERA patents, which are now
listed in the U.S. Food and Drug Administration’s (FDA) Approved
Drug Products with Therapeutic Equivalence Evaluations (commonly
known as the Orange Book). With these additional patents, the
Orange Book lists a total of six patents for ANNOVERA. These newly
issued patents protect key properties of ANNOVERA and extend patent
protection for ANNOVERA from February 2039 to June 2039.
IMVEXXY® (estradiol vaginal inserts)
- IMVEXXY net product revenue increased by 10% to $7.0 million
for the first quarter of 2021 as compared to $6.4 million for the
first quarter of 2020.
- Net revenue per unit, calculated from sales to wholesalers and
pharmacies, was approximately $61 for the first quarter of 2021
reflecting a 39% improvement in net price compared to the first
quarter of 2020.
- The impact of the Company’s increase in cash pay price for
IMVEXXY on January 1, 2021, had a positive impact on net revenue
per unit and a short-term impact on volume. Approximately 108,200
prescriptions were dispensed to patients during the first quarter
of 2021. As expected, IMVEXXY total prescription volume declined
14% for the first quarter of 2021 as compared to the first quarter
of 2020. IMVEXXY fill rates remained at an average of approximately
6 fills per patient annually.
- The Company recently launched Long May She Reign, a new
consumer campaign for IMVEXXY, designed to educate menopausal women
about vaginal health during menopause.
BIJUVA® (estradiol and progesterone)
- BIJUVA net product revenue increased 120% to $2.5 million for
the first quarter of 2021 as compared to $1.1 million for the first
quarter of 2020.
- Net revenue per unit, calculated from sales to wholesalers and
pharmacies, was approximately $69 for the first quarter of 2020
reflecting an 85% improvement in net price as compared to the first
quarter of 2020.
- The Company increased the cash pay price for BIJUVA on January
1, 2021, which was expected to have a short-term impact on volume.
Approximately 30,800 BIJUVA prescriptions were dispensed to
patients in the first quarter of 2021.
- The Company won its appeal for the new low-dose BIJUVA 0.5
mg/100 mg with the FDA. The Company has been granted a meeting with
the FDA in May to discuss next steps.
- Theramex, the Company’s licensee, was granted additional
European approvals of BIJUVA (1 mg/100 mg).
Cost of Goods Sold/Gross Margin
- Cost of goods was $4.7 million with gross margin of 76% for the
first quarter of 2021 as compared to $5.6 million with gross margin
of 75% for the fourth quarter of 2020 and $2.7 million with gross
margin of 78% for the first quarter of 2020. The Company’s gross
margin of 76% for the first quarter of 2021 was adversely affected
by production related write-offs for ANNOVERA of $0.9 million.
Expense, Net Loss and Related Information
- Total operating expenses for the first quarter of 2021
decreased by $16 million from $60.5 million to $44.5 million for
the first quarter of 2020. Total operating expenses for the first
quarter of 2021 decreased by $7.1 million from $51.6 million for
the fourth quarter of 2020.
- The decrease in operating expenses was primarily a result of
measures initiated by the Company to reduce overall operating
expenses.
- Net loss continues to improve. The first quarter of 2021 was
$39.4 million, or $0.11 per basic and diluted share, compared with
net loss for the first quarter of 2020 of $56.8 million, or $0.21
per basic and diluted share and net loss for the fourth quarter of
2020 of $42.1 million, or $0.15 per basic and diluted share.
Balance Sheet
- As of March 31, 2021, the Company’s cash on hand totaled $137.6
million, compared with $80.5 million as of December 31, 2020.
- The Company received $150.9 million in net proceeds from its
at-the-market and underwritten equity offerings and repaid $50
million of principal under its Financing Agreement. The remaining
outstanding principal amount under the Financing Agreement is $200
million.
vitaCare Update
The Company continues the vitaCare divestiture process to unlock
shareholder value. The Company believes vitaCare is creating a
significant revenue opportunity with two new live customers, a
third scheduled to launch in the fourth quarter, and a pipeline
with approximately twenty potential new deals. vitaCare continues
to build its foundation to become a free-standing entity in a
rapidly growing sector with no established leader.
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, May 6, 2021
Time:
8:30 a.m. ET
Telephone Access (US):
866-665-9531
Telephone Access
(International):
724-987-6977
Access Code for All Callers:
5683435
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: 5683435.
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 (In thousands, except per share data)
March 31, December 31,
2021
2020
(Unaudited) Assets: Current assets: Cash
$
137,617
$
80,486
Accounts receivable, net of allowance for credit losses of $1,231
and $1,118 as of March 31, 2021 and December 31, 2020, respectively
33,719
32,382
Inventory
7,346
7,993
Prepaid and other current assets
8,360
7,543
Total current assets
187,042
128,404
Fixed assets, net
1,812
1,942
License rights and other intangible assets, net
40,994
41,445
Right of use assets
9,205
9,566
Other non-current assets
253
253
Total assets
$
239,306
$
181,610
Liabilities and stockholders' equity (deficit): Current
liabilities: Current maturities of long-term debt
$
5,000
$
-
Accounts payable
10,310
21,068
Accrued expenses and other current liabilities
45,974
38,170
Total current liabilities
61,284
59,238
Long-term debt, net
178,970
237,698
Operating lease liabilities
8,530
8,675
Total liabilities
248,784
305,611
Commitments and contingencies Stockholders' equity
(deficit): Preferred stock, par value $0.001; 10,000 shares
authorized, none issued
-
-
Common stock, par value $0.001; 600,000 shares authorized, 393,190
and 299,765 issued and outstanding as of March 31, 2021 and
December 31, 2020, respectively
393
300
Additional paid-in capital
908,457
754,644
Accumulated deficit
(918,328
)
(878,945
)
Total stockholders' deficit
(9,478
)
(124,001
)
Total liabilities and stockholders' equity (deficit)
$
239,306
$
181,610
TherapeuticsMD, Inc. Consolidated
Statements of Operations (Unaudited - in thousands, except per
share data) Three Months Ended March 31, December 31,
2021
2020
2020
Product revenue, net
$
19,632
$
12,251
$
22,577
License revenue
234
-
-
Total revenue, net
19,866
12,251
22,577
Cost of goods sold
4,687
2,715
5,581
Gross profit
15,179
9,536
16,996
Operating expenses: Selling, general and administrative
42,407
57,189
49,210
Research and development
2,050
3,269
2,394
Total operating expenses
44,457
60,458
51,604
Loss from operations
(29,278
)
(50,922
)
(34,608
)
Other (expense) income: Interest expense and other financing costs
(10,227
)
(6,262
)
(7,613
)
Other income, net
122
335
133
Other (expense), net
(10,105
)
(5,927
)
(7,480
)
Loss before income taxes
(39,383
)
(56,849
)
(42,088
)
Provision for income taxes
-
-
-
Net loss
$
(39,383
)
$
(56,849
)
$
(42,088
)
Loss per common share, basic and diluted
$
(0.11
)
$
(0.21
)
$
(0.15
)
Weighted average common shares, basic and diluted
347,219
271,460
286,607
TherapeuticsMD, Inc. Consolidated Statements of
Cash Flows (Unaudited - in thousands, except per share data)
Three Months Ended March 31,
2021
2020
Cash flows from operating activities: Net loss
$
(39,383
)
$
(56,849
)
Adjustments to reconcile net loss to net cash used in operating
activities: Depreciation and amortization
1,019
1,008
Charges (credits) to provision for doubtful accounts
230
(123
)
Inventory charge
502
136
Debt financing fees
1,272
320
Non-cash operating lease expense
216
352
Share-based compensation
2,957
2,366
Impairment of other intangible assets and operating lease
-
Changes in operating assets and liabilities Accounts receivable
(1,567
)
3,855
Inventory
145
(2,883
)
Prepaid and other current assets
(817
)
4,436
Other assets
-
-
Accounts payable
(10,758
)
9,533
Accrued expenses and other current liabilities
7,804
(1,262
)
Total adjustments
1,003
17,738
Net cash used in operating activities
(38,380
)
(39,111
)
Cash flows from investing activities: Payment of patent related
costs
(375
)
(422
)
Purchase of fixed assets
(63
)
(21
)
Net cash used in investing activities
(438
)
(443
)
Cash flows from financing activities: Proceeds from sale of common
stock, net of costs
150,899
-
Proceeds from exercise of options and warrants
50
72
Repayments of debt
(50,000
)
-
Borrowings of debt
-
50,000
Payment of debt financing fees
(5,000
)
(1,250
)
Net cash provided by financing activities
95,949
48,822
Net increase in cash
57,131
9,268
Cash, beginning of period
80,486
160,830
Cash, end of period
$
137,617
$
170,098
Supplemental disclosure of cash flow information Interest
paid
$
8,955
$
5,893
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210506005372/en/
Nichol Ochsner Vice President, Investor Relations 561-961-1900,
ext. 2088 Nochsner@TherapeuticsMD.com
In-Site Communications, Inc. Lisa M. Wilson 212-452-2793
lwilson@insitecony.com
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