txmd-8k_20221114.htm
false 0000025743 0000025743 2022-11-14 2022-11-14

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): November 14, 2022

 

THERAPEUTICSMD, INC.

(Exact Name of Registrant as Specified in its Charter)

 

Nevada

 

001-00100

 

87-0233535

(State or Other

Jurisdiction of Incorporation)

 

(Commission File Number)

 

(IRS Employer
Identification No.)

 

951 Yamato Road, Suite 220

Boca Raton, FL 33431

(Address of Principal Executive Office) (Zip Code)

 

Registrant’s telephone number, including area code:  (561) 961-1900

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class

Trading Symbol

Name of Each Exchange on Which Registered

Common Stock, par value $0.001 per share

TXMD

The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230-405) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.


 


 

 

Item 2.02

Results of Operations and Financial Condition.

 

The information provided in Item 7.01 of this Current Report on Form 8-K is incorporated in this Item 2.02 by reference.

 

Item 7.01

Regulation FD Disclosure.

 

On November 14, 2022, the Company issued a press release announcing its financial results for the third quarter ended September 30, 2022. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.  

 

The information in this Item 7.01 and the information contained in Exhibit 99.1 is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as may be expressly set forth by specific reference in any such filing, regardless of any general incorporation language in the filing.

 

The Company does not have, and expressly disclaims, any obligation to release publicly any updates or any changes in its expectations or any change in events, conditions, or circumstances on which any forward-looking statement is based.

 

Item 9.01

Financial Statements and Exhibits.

 

(d)   

Exhibits

 

Exhibit Index

Exhibit No.

Description

 

 

 

 

99.1

Press Release from TherapeuticsMD, Inc., dated November 14, 2022, entitled "TherapeuticsMD Announces Third Quarter 2022 Financial Results."

 

 

104

Cover Page Interactive Data File (the cover page tags are embedded within the Inline XBRL document).


 


 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date:  November 14, 2022

 

THERAPEUTICSMD, INC.

 

 

 

 

 

 

 

/s/ Michael C. Donegan

 

 

Michael C. Donegan

 

 

Interim Chief Financial Officer, Chief Accounting Officer and Vice President Finance

 

 

txmd-ex991_6.htm

Exhibit 99.1

 

 

TherapeuticsMD Announces Third Quarter 2022 Financial Results

 

- Q3 total revenue of $20.9 million -

- ANNOVERA TRx growth of 10% year-over-year -

- Reduced operating expenses by $22 million year-over-year -

 

BOCA RATON, Fla. November 14, 2022 – 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 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

 

 

$

 

 

 

 

 

 

 

 

 

 

 


 

 

CONTACT:

Michael C. Donegan

Lisa M. Wilson

Interim Chief Financial Officer,

Chief Accounting Officer and

Vice President Finance

In-Site Communications, Inc.

212-452-2793

lwilson@insitecony.com

561-961-1900