- Q3 total revenue of $20.9 million - -
ANNOVERA TRx growth of 10% year-over-year - - Reduced operating
expenses by $22 million year-over-year -
TherapeuticsMD, Inc. (“TXMD” or the “Company”) (NASDAQ: TXMD),
an innovative, leading women’s healthcare company, today reported
financial results for the third quarter ended September 30,
2022.
“Our products continue to be adopted by healthcare providers and
patients, and we continue to believe that they represent a
significant opportunity. Our prescriber bases grew, and we added
around 1,500 new prescribers for ANNOVERA and around 1,600 for
IMVEXXY. Total quarterly prescriptions for both products remained
relatively stable compared to the second quarter of 2022, and
ANNOVERA’s total prescriptions grew 10% compared to the third
quarter of 2021. While our third quarter 2022 net revenues declined
$4.5 million compared with the prior year, through disciplined cost
control measures, we were able to reduce our operating expenses by
$22 million year-over-year,” said Mark Glickman, co-Interim-CEO of
TherapeuticsMD.
“During the quarter, we were able to move past the inventory
issues we experienced in the first half of the year, and our
wholesale network is now fully stocked. With these developments and
the recent cash infusion from Rubric Capital, we believe our
operations have stabilized, and we continue on our path forward
toward our goal of meeting the demand for our products and helping
to advance women’s health,” added Glickman. “Our Board of Directors
and management team continue to actively assess strategic
alternatives to strengthen the Company’s long-term financial
position.” concluded Glickman.
Third Quarter 2022 Financial Results and Business
Highlights
Three Months Ended September
30,
Nine Months Ended September
30,
2022
2021
2022
2021
Product revenue: ANNOVERA
$
10,415
$
11,807
$
37,196
$
30,112
IMVEXXY
6,947
8,016
20,583
24,866
BIJUVA
2,663
3,298
7,877
7,899
Prescription vitamin
892
1,335
2,671
4,162
Product revenue, net
20,917
24,456
68,327
67,039
License and service revenue
—
950
484
1,234
Total revenue, net
$
20,917
$
25,406
$
68,811
$
68,273
ANNOVERA® (segesterone acetate and ethinyl estradiol
vaginal system)
- ANNOVERA net product revenue of $10.4 million for the third
quarter of 2022 decreased by $1.4 million compared to $11.8 million
for the third quarter of 2021.
- Approximately 9,200 ANNOVERA prescriptions were dispensed to
patients during the third quarter of 2022.
- Over 15,000 healthcare providers (HCPs) prescribed ANNOVERA
since launch through the third quarter of 2022, of which more than
1,500 were new writers.
IMVEXXY® (estradiol vaginal inserts)
- IMVEXXY net product revenue of $6.9 million for the third
quarter of 2022 decreased by $1.1 million compared to $8.0 million
for the third quarter of 2021.
- Approximately 91,300 IMVEXXY prescriptions were dispensed to
patients during the third quarter of 2022.
BIJUVA® (estradiol and progesterone) capsules
- BIJUVA net product revenue of $2.7 million for the third
quarter of 2022 decreased by approximately $0.6 million compared to
$3.3 million for the third quarter of 2021.
- BIJUVA net product revenue for the third quarter of 2022
includes $0.4 million of export sales through our international
licensing and supply agreement with Theramex HQ UK Limited.
Cost of Goods Sold and Gross Margin
- Cost of goods was $3.8 million with product gross margin of 82%
for the third quarter of 2022 compared to $5.3 million with product
gross margin of 78% for the third quarter of 2021. The increase in
product gross margins was mainly due to changes in product sales
mix.
Operating Expense, Net Loss and Related Information
- Total operating expense of $37.9 million for the third quarter
of 2022 decreased by approximately $22.2 million compared to $60.0
million for the third quarter of 2021.
- Net loss for the third quarter of 2022 was $29.0 million, or
$3.13 per basic and diluted share, compared to net loss for the
third quarter of 2021 of $47.4 million, or $5.62 per basic and
diluted share.
Balance Sheet
- As of September 30, 2022, the Company’s cash on hand totaled
$27.1 million, compared with $65.1 million as of December 31, 2021.
Subsequent to quarter end, the Company closed a $7 million private
investment in the Company’s Series A Preferred Stock from Rubric
Capital Management LP. The Company also had $11.3 million in
restricted cash related to customary holdbacks as part of the
vitaCare Prescription Services divestiture.
- As of September 30, 2022, the Company’s aggregate balance of
net debt, lender warrants derivative liability, make-whole payment
derivative liability and mandatory redeemable preferred stock was
$117.1 million.
In light of the Company’s ongoing strategic alternatives
process, the Company will not be hosting a conference call.
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: whether the company will be able to refinance the
indebtedness under its term loan facility, and, if not, whether the
company will be able to continue as a going concern; whether the
company will be able to raise capital to fund its operations;
whether and how the executive order on contraception is
implemented; 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; the
effects of supply chain issues on the supply of the company’s
products; 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; the company’s
ability to protect its intellectual property; 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 impact of
leadership transitions; and the volatility of the trading price of
the company’s common stock.
- Financial Statements to Follow -
TherapeuticsMD, Inc. and Subsidiaries Consolidated
Balance Sheets (Unaudited - in thousands, except per share
data) September 30, 2022 December 31, 2021 Assets:
Current assets: Cash
$
27,080
$
65,122
Restricted cash
11,250
—
Accounts receivable, net of allowance for credit losses of $1,621
and $1,334 as of September 30, 2022 and December 31, 2021,
respectively
32,157
36,176
Inventory
6,701
7,622
Prepaid and other current assets
10,290
10,548
Total current assets
87,478
119,468
Fixed assets, net
551
1,199
License rights and other intangible assets, net
37,876
40,318
Right of use assets
7,749
8,234
Other non-current assets
253
253
Total assets
$
133,907
$
169,472
Liabilities and stockholders' deficit: Current liabilities: Debt,
net
$
93,602
$
188,269
Lender Warrants derivative liability
2,058
—
Make-whole payment derivative liability
1,751
—
Mandatory Redeemable Preferred Stock
19,709
—
Accounts payable
13,383
20,318
Accrued expenses and other current liabilities
43,568
44,304
Total current liabilities
174,071
252,891
Operating lease liabilities
7,553
8,063
Other non-current liabilities
554
2,139
Total liabilities
182,178
263,093
Commitments and contingencies Stockholders' deficit: Preferred
stock, par value $0.001; 10,000 shares authorized, 22 issued and
included in liabilities due to their redemption provisions
—
—
Common stock, par value $0.001; 12,000 shares authorized, 9,467 and
8,598 (adjusted for the 50-for-1 reverse stock split) shares issued
and outstanding as of September 30, 2022 and December 31, 2021,
respectively
9
9
Additional paid-in capital
968,785
957,730
Accumulated deficit
(1,017,065
)
(1,051,360
)
Total stockholders' deficit
(48,271
)
(93,621
)
Total liabilities and stockholders' deficit
$
133,907
$
169,472
TherapeuticsMD, Inc. and Subsidiaries Consolidated
Statements of Operations (Unaudited - in thousands, except per
share data)
Three Months Ended September
30,
Nine Months Ended September
30,
2022
2021
2022
2021
Revenue, net: Product
$
20,917
$
24,456
$
68,327
$
67,039
License and service
—
950
484
1,234
Total revenue, net
20,917
25,406
68,811
68,273
Cost of goods sold
3,788
5,282
13,388
14,101
Total gross profit
17,129
20,124
55,423
54,172
Operating expenses: Selling and marketing
19,129
30,005
61,703
86,193
General and administrative
17,635
28,435
55,445
66,691
Research and development
1,112
1,605
4,092
5,666
Total operating expenses
37,876
60,045
121,240
158,550
Loss from operations
(20,747
)
(39,921
)
(65,817
)
(104,378
)
Other (expense) income: Gain on sale of business
—
—
143,384
—
Expense for accretion of Mandatory Redeemable Preferred Stock
(3,457
)
—
(3,457
)
—
Fair value loss on Lender Warrants derivative liability
(76
)
—
(76
)
—
Loss on extinguishment of debt
—
—
(8,380
)
—
Interest expense and other financing costs
(4,833
)
(7,518
)
(30,941
)
(25,341
)
Other (expense) income, net
(112
)
19
(128
)
264
Total other (expense) income, net
(8,478
)
(7,499
)
100,402
(25,077
)
(Loss) income before income taxes
(29,225
)
(47,420
)
34,585
(129,455
)
(Benefit) provision for income taxes
(260
)
—
290
—
Net (loss) income
$
(28,965
)
$
(47,420
)
$
34,295
$
(129,455
)
(Loss) earnings per common share, basic
$
(3.13
)
$
(5.62
)
$
3.86
$
(16.68
)
Weighted average common shares, basic
9,261
8,444
8,877
7,762
(Loss) earnings per common share, diluted
$
(3.13
)
$
(5.62
)
$
3.73
$
(16.68
)
Weighted average common shares, diluted
9,261
8,444
9,205
7,762
TherapeuticsMD, Inc. and Subsidiaries Consolidated
Statements of Cash Flows (Unaudited - in thousands)
Nine Months Ended September
30,
2022
2021
Cash flows from operating activities: Net income (loss)
$
34,295
$
(129,455
)
Adjustments to reconcile net income (loss) to net cash used in
operating activities: Depreciation and amortization
3,181
3,091
Charges to provision for doubtful accounts
542
540
Inventory charge
73
1,082
Debt financing fees
20,053
4,158
Share-based compensation
8,587
12,779
Gain on sale of business
(143,384
)
—
Expense for accretion of Mandatory Redeemable Preferred Stock
3,457
—
Loss on extinguishment of debt
8,380
—
Other
50
726
Changes in operating assets and liabilities:
Accounts receivable
3,044
(5,560
)
Inventory
848
(451
)
Prepaid and other current assets
180
(2,831
)
Accounts payable
(6,186
)
(1,476
)
Accrued expenses and other current liabilities
3,705
13,504
Other non-current liabilities
(675
)
758
Total adjustments
(98,145
)
26,320
Net cash used in operating activities
(63,850
)
(103,135
)
Cash flows from investing activities: Proceeds from sale of
business, net of transaction costs
142,634
—
Payment of patent related costs
(297
)
(675
)
Purchase of fixed assets
(21
)
(34
)
Net cash provided by (used in) investing activities
142,316
(709
)
Cash flows from financing activities: Proceeds from sale of
Mandatory Redeemable Preferred Stock, net of costs
16,252
—
Proceeds from make-whole derivative
1,751
—
Proceeds from sale of common stock, net of costs
2,454
182,881
Proceeds from exercise of options and warrants
—
302
Proceeds from sale of common stock related to employee stock
purchase plan
14
134
Repayments of debt
(125,000
)
(50,000
)
Payment of debt financing fees
(729
)
(5,118
)
Net cash (used in) provided by financing activities
(105,258
)
128,199
Net (decrease) increase in cash and restricted cash
(26,792
)
24,355
Cash and restricted cash, beginning of period
65,122
80,486
Cash and restricted cash, end of period
$
38,330
$
104,841
Supplemental disclosure of cash flow information: Interest paid
$
8,371
$
19,675
Supplemental disclosure of noncash financing activities: Paid in
kind ("PIK") interest with corresponding increase in debt
$
2,452
$
—
PIK debt financing fees with corresponding increase in debt
$
16,980
$
—
Issue of warrants to lenders related to debt financing fees
$
1,983
$
—
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221114005733/en/
Michael C. Donegan Interim Chief Financial Officer, Chief
Accounting Officer and Vice President Finance 561-961-1900 Lisa M.
Wilson In-Site Communications, Inc. 212-452-2793
lwilson@insitecony.com
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