TherapeuticsMD Announces Second Quarter 2022 Financial Results

·12 min read

- 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., August 15, 2022--(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

https://register.vevent.com/register/BI7d111b66df2f4e8f849bb6048c1fa4d1

Webcast Link:

https://edge.media-server.com/mmc/p/trnoknyx

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:

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: https://www.businesswire.com/news/home/20220815005058/en/

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