Quarterly total net revenue of $28.6 million
ANNOVERA® TRx of 9,329, an increase of 28% over Q2 2021
Conference call scheduled for 8:30 a.m. ET today
BOCA RATON, Fla.--(BUSINESS WIRE)-- TherapeuticsMD, Inc. (“TXMD” or the “Company”) (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the Second Quarter ended June 30, 2022.
“We saw solid revenue growth during the quarter, with an increase of 24% over the prior year period, while also experiencing a 21% decrease in operating expenses. The U.S. Food and Drug Administration’s recent approval of our supplemental new drug application for ANNOVERA has significantly enhanced our ability to meet demand for the product. We were also able to repay $120 million dollars of debt with the proceeds of our successful divestiture of our vitaCare unit,” said Hugh O’Dowd, CEO of TherapeuticsMD.
“With these initiatives and accomplishments behind us, the Company can better focus on our mission of advancing the healthcare of women throughout all stages of life,” concluded O’Dowd.
Second Quarter 2022 Financial Results and Business Highlights
Three Months Ended June 30,
2022
2021
Product revenue:
ANNOVERA
$
18,271
$
9,555
IMVEXXY
6,667
9,838
BIJUVA
2,654
2,156
Prescription vitamin
904
1,402
Product revenue, net
28,496
22,951
License and service
65
50
Total revenue, net
$
28,561
$
23,001
ANNOVERA® (segesterone acetate and ethinyl estradiol vaginal system)
ANNOVERA net product revenue of $18.3 million for the Second Quarter of 2022 increased by approximately $8.7 million compared to $9.6 million for the Second Quarter of 2021.
9,329 ANNOVERA prescriptions were dispensed to patients during the Second Quarter of 2022.
Over 13,000 healthcare providers (HCPs) prescribed ANNOVERA during the Second Quarter, of which 1,487 were new writers.
Growth in total prescribers of approximately 65% over Second Quarter of 2021.
IMVEXXY® (estradiol vaginal inserts)
IMVEXXY net product revenue of $6.7 million for the Second Quarter of 2022 decreased by $3.2 million compared to $9.8 million for the Second Quarter of 2021.
Approximately 97,881 IMVEXXY prescriptions were dispensed to patients during the Second Quarter of 2022.
BIJUVA® (estradiol and progesterone) capsules
BIJUVA net product revenue of $2.7 million for the Second Quarter of 2022 increased by approximately $0.5 million compared to $2.2 million for the Second Quarter of 2021.
BIJUVA net product revenue for the Second Quarter of 2022 includes $0.3 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 $4.7 million with product gross margin of 83% for the Second Quarter of 2022 compared to $4.1 million with product gross margin of 82% for the Second Quarter of 2021. The increase in product gross margins was mainly due to changes in product sales mix, including increased sales volumes for ANNOVERA and BIJUVA, and a decrease in sales volume of IMVEXXY.
Operating Expense, Net Loss and Related Information
Total operating expense of $42.7 million for the Second Quarter of 2022 decreased by $11.4 million compared to $54.1 million for the Second Quarter of 2021.
Net income for the Second Quarter of 2022 was $112.3 million, or $12.83 per basic and $12.39 per diluted share, compared to net loss for the Second Quarter of 2021 of $42.7 million, or $5.41 per basic and diluted share. Included in the net income for the Second Quarter of 2022 was a $143.4 million gain recognized from the sale of vitaCare and other non-operating expenses of $11.7 million, an increase of $4.2 million, or 56.7%, compared to non-operating expenses of $7.5 million for the second quarter of 2021. This increase was a result of higher amortization of deferred financing costs, offset by lower interest expense due to lower average debt balance, and lower interest prepayment fees due to the March 2022 amendment to our financing agreement.
Balance Sheet
As of June 30, 2022, the Company’s cash on hand totaled $26.3 million, compared with $65.1 million as of December 31, 2021. The Company also had $11.3 million in restricted cash related to customary holdbacks as part of the vitaCare divestiture.
As of June 30, 2022, the remaining outstanding principal amount under the Company’s Financing Agreement was $90.8 million, which reflects a repayment of $125.0 million of principal during 2022.
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:
Monday, August 15, 2022
Time:
8:30 a.m. ET
Audio Conference Line
Webcast Link:
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 . 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 in the “Investors & Media” section of the TherapeuticsMD website at .
Please see the Full Prescribing Information, including indication and Boxed WARNING, for each TherapeuticsMD product as follows:
IMVEXXY (estradiol vaginal inserts) at
BIJUVA (estradiol and progesterone) capsules at
ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) at
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)
June 30, 2022
December 31, 2021
Assets:
Current assets:
Cash
$
26,303
$
65,122
Restricted cash
11,250
$
—
Accounts receivable, net of allowance for credit losses of $1,587 and
$1,334 as of June 30, 2022 and December 31, 2021, respectively
45,804
36,176
Inventory
6,150
7,622
Prepaid and other current assets
9,096
10,548
Total current assets
98,603
119,468
Fixed assets, net
710
1,199
License rights and other intangible assets, net
38,721
40,318
Right of use assets
7,914
8,234
Other non-current assets
254
253
Total assets
$
146,202
$
169,472
Liabilities and stockholders' deficit:
Current liabilities:
Current maturities of long-term debt
$
90,780
$
188,269
Accounts payable
13,978
20,318
Accrued expenses and other current liabilities
59,228
44,304
Total current liabilities
163,986
252,891
Operating lease liabilities
7,728
8,063
Other non-current liabilities
554
2,139
Total liabilities
172,268
263,093
Commitments and contingencies
Stockholders' deficit:
Preferred stock, par value $0.001; 10,000 shares authorized, none issued
—
—
Common stock, par value $0.001; 12,000 shares authorized, 8,860 and 8,598
(adjusted for the 50-for-1 reverse stock split) shares issued and outstanding
as of June 30, 2022 and December 31, 2021, respectively
9
9
Additional paid-in capital
962,025
957,730
Accumulated deficit
(988,100
)
(1,051,360
)
Total stockholders' deficit
(26,066
)
(93,621
)
Total liabilities and stockholders' deficit
$
146,202
$
169,472
TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited - in thousands, except per share data)
Three Months Ended June 30,
Six Months Ended June 30,
2022
2021
2022
2021
Revenue, net:
Product
$
28,496
$
22,951
$
47,410
$
42,583
License and service
65
50
484
284
Total revenue, net
28,561
23,001
47,894
42,867
Cost of goods sold
4,740
4,132
9,600
8,819
Total gross profit
23,821
18,869
38,294
34,048
Operating expenses:
Selling and marketing
23,679
32,164
42,574
56,188
General and administrative
17,403
19,873
37,810
38,256
Research and development
1,580
2,011
2,980
4,061
Total operating expenses
42,662
54,048
83,364
98,505
Loss from operations
(18,841
)
(35,179
)
(45,070
)
(64,457
)
Other income (expense):
Gain on sale of business
143,384
—
143,384
—
Loss on extinguishment of debt
—
—
(8,380
)
—
Interest expense and other financing costs
(11,696
)
(7,596
)
(26,108
)
(17,823
)
Other income, net
(16
)
123
(16
)
245
Total other income (expense), net
131,672
(7,473
)
108,880
(17,578
)
Income (loss) before income taxes
112,831
(42,652
)
63,810
(82,035
)
Provision for income taxes
550
—
550
—
Net income (loss)
$
112,281
$
(42,652
)
$
63,260
$
(82,035
)
Earnings (loss) per common share, basic
$
12.83
$
(5.41
)
$
7.29
$
(11.06
)
Weighted average common shares, basic
8,750
7,881
8,682
7,416
Earnings (loss) per common share, diluted
$
12.39
$
(5.41
)
$
7.05
$
(11.06
)
Weighted average common shares, diluted
9,059
7,881
8,971
7,416
TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(Unaudited - in thousands)
Six Months Ended June 30,
2022
2021
Cash flows from operating activities:
Net income (loss)
$
63,260
$
(82,035
)
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Depreciation and amortization
2,146
2,061
Charges (credits) to provision for doubtful accounts
542
445
Inventory charge
73
502
Debt financing fees
16,971
2,681
Share-based compensation
4,281
5,467
Gain on sale of business
(143,384
)
—
Loss on extinguishment of debt
8,380
—
Other
(15
)
434
Changes in operating assets and liabilities:
Accounts receivable
(10,603
)
(1,544
)
Inventory
1,399
(83
)
Prepaid and other current assets
1,373
365
Accounts payable
(5,591
)
(6,503
)
Accrued expenses and other current liabilities
16,913
12,940
Other non-current liabilities
(675
)
358
Total adjustments
(108,190
)
17,123
Net cash used in operating activities
(44,930
)
(64,912
)
Cash flows from investing activities:
Proceeds from sale of business, net of transaction costs
142,634
—
Payment of patent related costs
(267
)
(423
)
Purchase of fixed assets
(20
)
(104
)
Net cash provided by (used in) investing activities
142,347
(527
)
Cash flows from financing activities:
Proceeds from sale of common stock, net of costs
—
151,062
Proceeds from exercise of options and warrants
—
299
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
—
(5,118
)
Net cash (used in) provided by financing activities
(124,986
)
96,377
Net (decrease) increase in cash and restricted cash
(27,569
)
30,938
Cash and restricted cash, beginning of period
65,122
80,486
Cash and restricted cash, end of period
$
37,553
$
111,424
Supplemental disclosure of cash flow information:
Interest paid
$
9,137
$
14,284
Supplemental disclosure of noncash financing activities:
Paid in kind ("PIK") debt financing fees with corresponding increase in debt
$
15,780
$
—
View source version on businesswire.com:
Contacts
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
Source: TherapeuticsMD, Inc.
View this news release online at:
