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: |
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Monday, August 15, 2022 |
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Time: |
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8:30 a.m. ET |
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Audio Conference Line |
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https://register.vevent.com/register/BI7d111b66df2f4e8f849bb6048c1fa4d1 |
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Webcast Link: |
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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 in the “Investors & Media” section of the TherapeuticsMD website at www.therapeuticsmd.com.
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) | ||||||||
| 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 |
|
$ |
— |
|
||