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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2021

or

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from _______________ to _______________

Commission File Number: 001-00100

 

 

THERAPEUTICSMD, INC.

(Exact name of Registrant as specified in its Charter)

 

Nevada

87-0233535

(State or other jurisdiction

(I.R.S. Employer Identification No.)

of incorporation or organization)

 

 

 

951 Yamato Road, Suite 220

 

Boca Raton, Florida

33431

(Address of principal executive offices)

(Zip Code)

 

561-961-1900

(Registrant’s telephone number, including area code)

 

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

 

 

Trading

 

Title of Each Class

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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

 

Large Accelerated Filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

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.

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

As of November 11, 2021, there were 424,928,670 shares of the registrant’s common stock, par value $0.001 per share, outstanding.

 

 


 

Table of Contents

 

Part I – Financial Information

Page

Item. 1.

Financial Statements (Unaudited)

 

 

Consolidated Balance Sheets

1

 

Consolidated Statements of Operations

2

 

Consolidated Statements of Stockholders’ Equity (Deficit)

3

 

Consolidated Statements of Cash Flows

4

 

Notes to Unaudited Consolidated Financial Statements

5

Item 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

19

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

31

Item 4.

Controls and Procedures

31

Part II – Other Information

 

Item 1.

Legal Proceedings

32

Item 1A.

Risk Factors

32

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

35

Item 3.

Defaults Upon Senior Securities

35

Item 4.

Mine Safety Disclosures

35

Item 5.

Other Information

35

Item 6.

Exhibits

36

Signatures

37

 

 

 


 

 

Part I – Financial Information

Item 1.Financial Statements

TherapeuticsMD, Inc. and Subsidiaries

Consolidated Balance Sheets

(In thousands, except per share data)

 

 

 

September 30, 2021

 

 

December 31, 2020

 

 

 

(Unaudited)

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash

 

$

104,841

 

 

$

80,486

 

Accounts receivable, net of allowance for credit losses of $1,351 and $1,118

   as of September 30, 2021 and December 31, 2020, respectively

 

 

37,402

 

 

 

32,382

 

Inventory

 

 

7,362

 

 

 

7,993

 

Prepaid and other current assets

 

 

10,374

 

 

 

7,543

 

Total current assets

 

 

159,979

 

 

 

128,404

 

Fixed assets, net

 

 

1,388

 

 

 

1,942

 

License rights and other intangible assets, net

 

 

39,617

 

 

 

41,445

 

Right of use assets

 

 

8,391

 

 

 

9,566

 

Other non-current assets

 

 

253

 

 

 

253

 

Total assets

 

$

209,628

 

 

$

181,610

 

Liabilities and stockholders' equity (deficit):

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Current maturities of long-term debt

 

$

15,000

 

 

$

 

Accounts payable

 

 

19,592

 

 

 

21,068

 

Accrued expenses and other current liabilities

 

 

51,674

 

 

 

38,170

 

Total current liabilities

 

 

86,266

 

 

 

59,238

 

Long-term debt, net

 

 

171,738

 

 

 

237,698

 

Operating lease liabilities

 

 

8,226

 

 

 

8,675

 

Other non-current liabilities

 

 

758

 

 

 

 

Total liabilities

 

 

266,988

 

 

 

305,611

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

 

 

Stockholders' equity (deficit):

 

 

 

 

 

 

 

 

Preferred stock, par value $0.001; 10,000 shares authorized, none issued

 

 

 

 

 

 

Common stock, par value $0.001; 600,000 shares authorized, 424,879 and 299,765

   issued and outstanding as of September 30, 2021 and December 31, 2020, respectively

 

 

425

 

 

 

300

 

Additional paid-in capital

 

 

950,615

 

 

 

754,644

 

Accumulated deficit

 

 

(1,008,400

)

 

 

(878,945

)

Total stockholders' deficit

 

 

(57,360

)

 

 

(124,001

)

Total liabilities and stockholders' equity

 

$

209,628

 

 

$

181,610

 

 

The accompanying notes are an integral part of these consolidated financial statements.

1


 

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,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue, net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product

 

$

24,469

 

 

$

17,342

 

 

$

67,102

 

 

$

40,294

 

License

 

 

937

 

 

 

2,000

 

 

 

1,171

 

 

 

2,000

 

Total revenue, net

 

 

25,406

 

 

 

19,342

 

 

 

68,273

 

 

 

42,294

 

Cost of goods sold

 

 

5,282

 

 

 

3,279

 

 

 

14,101

 

 

 

10,394

 

Total gross profit

 

 

20,124

 

 

 

16,063

 

 

 

54,172

 

 

 

31,900

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling and marketing

 

 

30,005

 

 

 

22,373

 

 

 

86,193

 

 

 

91,056

 

General and administrative

 

 

28,435

 

 

 

16,637

 

 

 

66,691

 

 

 

53,740

 

Research and development

 

 

1,605

 

 

 

2,027

 

 

 

5,666

 

 

 

8,038

 

Total operating expenses

 

 

60,045

 

 

 

41,037

 

 

 

158,550

 

 

 

152,834

 

Loss from operations

 

 

(39,921

)

 

 

(24,974

)

 

 

(104,378

)

 

 

(120,934

)

Other (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense and other financing costs

 

 

(7,518

)

 

 

(7,680

)

 

 

(25,341

)

 

 

(20,969

)

Other income, net

 

 

19

 

 

 

42

 

 

 

264

 

 

 

466

 

Total other (expense), net

 

 

(7,499

)

 

 

(7,638

)

 

 

(25,077

)

 

 

(20,503

)

Loss before income taxes

 

 

(47,420

)

 

 

(32,612

)

 

 

(129,455

)

 

 

(141,437

)

Provision for income taxes

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(47,420

)

 

$

(32,612

)

 

$

(129,455

)

 

$

(141,437

)

Loss per common share, basic and diluted

 

$

(0.11

)

 

$

(0.12

)

 

$

(0.33

)

 

$

(0.52

)

Weighted average common shares, basic and diluted

 

 

422,216

 

 

 

272,565

 

 

 

388,111

 

 

 

271,969

 

 

The accompanying notes are an integral part of these consolidated financial statements.

2


 

TherapeuticsMD, Inc. and Subsidiaries

Consolidated Statements of Stockholders' Equity (Deficit)

(Unaudited - in thousands)

 

 

 

Common Stock

 

 

Additional

Paid in

 

 

Accumulated

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Total

 

Balance, January 1, 2021

 

 

299,765

 

 

$

300

 

 

$

754,644

 

 

$

(878,945

)

 

$

(124,001

)

Shares issued for sale of common stock, net of cost

 

 

92,870

 

 

 

93

 

 

 

150,806

 

 

 

 

 

 

150,899

 

Shares issued for exercise of warrants, net of cashless exercises

 

 

503

 

 

 

 

 

 

50

 

 

 

 

 

 

50

 

Shares issued for vested restricted stock units

 

 

52

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation

 

 

 

 

 

 

 

 

2,957

 

 

 

 

 

 

2,957

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(39,383

)

 

 

(39,383

)

Balance, March 31, 2021

 

 

393,190

 

 

 

393

 

 

 

908,457

 

 

 

(918,328

)

 

 

(9,478

)

Shares issued for sale of common stock, net of cost

 

 

125

 

 

 

 

 

 

163

 

 

 

 

 

 

163

 

Shares issued for exercise of warrants

 

 

600

 

 

 

1

 

 

 

227

 

 

 

 

 

 

228

 

Shares issued for exercise of options

 

 

54

 

 

 

 

 

 

21

 

 

 

 

 

 

21

 

Shares issued for vested restricted stock units

 

 

929

 

 

 

1

 

 

 

(1

)

 

 

 

 

 

 

Shares issued for sale of common stock related to employee

   stock purchase plan

 

 

150

 

 

 

 

 

 

134

 

 

 

 

 

 

134

 

Share-based compensation

 

 

 

 

 

 

 

 

2,510

 

 

 

 

 

 

2,510

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(42,652

)

 

 

(42,652

)

Balance, June 30, 2021

 

 

395,048

 

 

 

395

 

 

 

911,511

 

 

 

(960,980

)

 

 

(49,074

)

Shares issued for sale of common stock, net of cost

 

 

28,770

 

 

 

29

 

 

 

31,790

 

 

 

 

 

 

31,819

 

Shares issued for exercise of options

 

 

7

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Shares issued for vested restricted stock units

 

 

1,054

 

 

 

1

 

 

 

(1

)

 

 

 

 

 

 

Share-based compensation

 

 

 

 

 

 

 

 

7,312

 

 

 

 

 

 

7,312

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(47,420

)

 

 

(47,420

)

Balance, September 30, 2021

 

 

424,879

 

 

$

425

 

 

$

950,615

 

 

$

(1,008,400

)

 

$

(57,360

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, January 1, 2020

 

 

271,177

 

 

$

271

 

 

$

704,351

 

 

$

(695,421

)

 

$

9,201

 

Shares issued for exercise of options

 

 

351

 

 

 

 

 

 

72

 

 

 

 

 

 

72

 

Shares issued for vested restricted stock units

 

 

150

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation

 

 

 

 

 

 

 

 

2,366

 

 

 

-

 

 

 

2,366

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(56,849

)

 

 

(56,849

)

Balance, March 31, 2020

 

 

271,678

 

 

 

271

 

 

 

706,789

 

 

 

(752,270

)

 

 

(45,210

)

Shares issued for exercise of options

 

 

313

 

 

 

1

 

 

 

94

 

 

 

 

 

 

95

 

Shares issued for vested restricted stock units

 

 

303

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation

 

 

 

 

 

 

 

 

3,003

 

 

 

 

 

 

3,003

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(51,976

)

 

 

(51,976

)

Balance, June 30, 2020

 

 

272,294

 

 

 

272

 

 

 

709,886

 

 

 

(804,246

)

 

 

(94,088

)

Shares issued for exercise of options and warrants, net

 

 

518

 

 

 

1

 

 

 

105

 

 

 

 

 

 

106

 

Warrants issued in relation to debt financing agreement

 

 

 

 

 

 

 

 

7,428

 

 

 

 

 

 

7,428

 

Share-based compensation

 

 

 

 

 

 

 

 

3,133

 

 

 

 

 

 

3,133

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(32,612

)

 

 

(32,612

)

Balance, September 30, 2020

 

 

272,812

 

 

$

273

 

 

$

720,552

 

 

$

(836,858

)

 

$

(116,033

)

 

The accompanying notes are an integral part of these consolidated financial statements.

3


 

TherapeuticsMD, Inc. and Subsidiaries

Consolidated Statements of Cash Flows

(Unaudited - in thousands)

 

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(129,455

)

 

$

(141,437

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

3,091

 

 

 

3,039

 

Charges (credits) to provision for doubtful accounts

 

 

540

 

 

 

(47

)

Inventory charge

 

 

1,082

 

 

 

5,744

 

Debt financing fees

 

 

4,158

 

 

 

1,645

 

Share-based compensation

 

 

12,779

 

 

 

8,502

 

Other

 

 

726

 

 

 

1,719

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(5,560

)

 

 

384

 

Inventory

 

 

(451

)

 

 

(3,816

)

Prepaid and other current assets

 

 

(2,831

)

 

 

2,038

 

Accounts payable

 

 

(1,476

)

 

 

(3,072

)

Accrued expenses and other current liabilities

 

 

13,504

 

 

 

(3,813

)

Other non-current liabilities

 

 

758

 

 

 

 

Total adjustments

 

 

26,320

 

 

 

12,323

 

Net cash used in operating activities

 

 

(103,135

)

 

 

(129,114

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Payment of patent related costs

 

 

(675

)

 

 

(1,065

)

Purchase of fixed assets

 

 

(34

)

 

 

(39

)

Net cash used in investing activities

 

 

(709

)

 

 

(1,104

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from sale of common stock, net of costs

 

 

182,881

 

 

 

 

Proceeds from exercise of options and warrants

 

 

302

 

 

 

272

 

Proceeds from sale of common stock related to employee stock purchase plan

 

 

134

 

 

 

 

Repayments of debt

 

 

(50,000

)

 

 

 

Borrowings of debt

 

 

 

 

 

50,000

 

Payment of debt financing fees

 

 

(5,118

)

 

 

(1,250

)

Net cash provided by financing activities

 

 

128,199

 

 

 

49,022

 

Net increase (decrease) in cash

 

 

24,355

 

 

 

(81,196

)

Cash, beginning of period

 

 

80,486

 

 

 

160,830

 

Cash, end of period

 

$

104,841

 

 

$

79,634

 

 

 

 

 

 

 

 

 

 

Supplemental disclosure of noncash financing activities:

 

 

 

 

 

 

 

 

Warrants issued in relation to debt financing agreement

 

$

 

 

$

7,428

 

 

 

 

 

 

 

 

 

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

Interest paid

 

$

19,675

 

 

$

12,032

 

 

The accompanying notes are an integral part of these consolidated financial statements.


4


 

TherapeuticsMD, Inc. and Subsidiaries

Notes to the Consolidated Financial Statements

(Unaudited)

1.

Basis of presentation and summary of significant accounting policies

General

TherapeuticsMD, Inc., a Nevada corporation (the “Company”), and its consolidated subsidiaries are referred to collectively in this Quarterly Report on Form 10-Q (“10-Q Report”) as “TherapeuticsMD,” “we,” “our” and “us.”  This 10-Q Report includes our trademarks, trade names and service marks, such as TherapeuticsMD®, vitaMedMD®, BocaGreenMD®, vitaCareTM, IMVEXXY®, BIJUVA® and ANNOVERA®, which are protected under applicable intellectual property laws and are the property of, or licensed to, the Company. Solely for convenience, trademarks, trade names and service marks referred to in this 10-Q Report may appear without the ®, TM or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties.

We are a women’s healthcare company with a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause. At TherapeuticsMD, we combine entrepreneurial spirit, clinical expertise, and business leadership to develop and commercialize health solutions that enable new standards of care for women. Our solutions range from a patient-controlled, long-lasting contraceptive to advanced hormone therapy pharmaceutical products. We also have a portfolio of branded and generic prescription prenatal vitamins under the vitaMedMD and BocaGreenMD brands. Our portfolio of products focused on women’s health allows us to efficiently leverage our sales and marketing plan to grow our recently approved products.